MAR 21, 201911 Minutes with Shri (VIDEO)
For the first installment of SANUWAVE's new video blog series "11 Minutes With Shri", SANUWAVE President Shri Parikh interviews American surgeon and researcher Dr. David Armstrong, renowned for his work in amputation prevention, wound healing, and the diabetic foot. Dr. Armstrong is Professor of Surgery and Director of the Southwestern Academic Limb Salvage Alliance (SALSA) at the Keck School of Medicine of the University of Southern California and has produced more than 475 peer reviewed manuscripts and more than 80 book chapters.
Over the course of the interview, Dr. Armstrong:
· Applies his 'cancer analogy' to reveal sobering stats on the diabetic foot, the economic and quality-of-life impact on sufferers and the challenges that DFUs and other diabetes-related complications pose to providers in the industry.
· Stresses the importance of raising awareness, including improved messaging, public affairs, and an increase in affiliate organizations such as 'Save A Limb, Save A Life' that play a crucial role in getting the word out.
· Discusses the difference between being healed and being in remission, the likelihood of recurrence, and why it is important to focus on long-term follow-up vs individual events.
· Discloses his choice of The Lakers or The Clippers, The Rams or the Chargers, and reveals his all-time favorite team
DEC 26, 2018Seasoned Executive Shares his Views on Shockwave Technology, its Past, Present, and Future
A. Michael Stolarski, the Owner, President, and Chief Executive Officer of Premier Shockwave, Inc. and Premier Shockwave Wound Care, Inc.
By Iulian Cioanta, PH.D.
A. Michael (Mike) Stolarski holds a Bachelor of Science degree in Accounting and Finance from University of Maryland at College Park, a Masters in Finance from Loyola College - Baltimore, and is a Certified Public Accountant (CPA) [Inactive].
Mike started his career at Integrated Health Services, Inc., first as a paralegal, then as an Internal Auditor, eventually accepting a promotion to Controller and again later as the Chief Financial Officer (CFO) of the kidney lithotripsy division. After the lithotripsy division was sold to Healthtronics, Inc., he became its Vice President of Finance and later promoted to the President of the orthopedic division. After overseeing the sale of the orthopedic division to SANUWAVE, Inc., Mike became Acting Chief Financial Officer and Vice President of Business Development for SANUWAVE, Inc. Later, Mike purchased SANUWAVE’s orthopedic division, and became the President and Chief Executive Officer (CEO) of the new company called Premier Shockwave, Inc. He also sits on the Board of Directors for SANUWAVE Health, Inc. and the Augusta Symphony, Inc.
In December 2017, SANUWAVE was granted the de novo clearance for treating diabetic foot ulcers (DFUs) using its flagship dermaPACE® System. Soon thereafter, SANUWAVE reached a partnership agreement with Premier Shockwave Wound Care, Inc. and Premier Shockwave, Inc. for distribution of the dermaPACE® Systems in selected markets in the United States. Specifically, the agreement covers the Veteran’s Administration (VA), Indian Health Service (IHS) and Tribally Operated Healthcare Services, and US Military Treatment Facilities (MTFs).
Premier Shockwave, Inc. is the leading shockwave company for podiatric and orthopedic applications in the United States and currently serves over 30 VA Hospitals and Military Treatment Facilities (MTFs) in the continental United States and Alaska. Premier Shockwave, Inc. will manage the dermaPACE® business for Premier Shockwave Wound Care, Inc.
Mike has 25-years of experience in the healthcare industry, with the last 20-years in the shockwave industry in various C-Level positions. Mike used his broad knowledge and experience in dealing with various aspects of corporate accounting and finance, including business development, mergers & acquisitions, strategic planning, SEC filings, investor relations, negotiating bank credit facilities, and assisting in quarterly and year-end audit work.
A. Michael Stolarski the Founder, President, and Chief Executive Officer (CEO) of Premier Shockwave, Inc., and Premier Shockwave Wound Care, Inc. recently chatted with Iulian Cioanta, Ph.D., the Chief Science and Technology Officer for SANUWAVE. Their dynamic dialogue brings up Mike’s personality and business vision, opens the discussion on shockwave technology used for the medical industry, identifies mutual business opportunities, and describes personal experiences that influenced Mike’s life and career, as presented in the following interview:
Iulian: Hi Mike, thank you for taking the time to be here; we're just going to make this casual. Trying to understand your career, how you got in contact with the shockwaves and things like that, and how we ended up working together with a lot of things.
Iulian: So, the first question is just a general one about the beginning of your life. Who besides your parents had the biggest impact on your life?
Mike: Oh, professionally, probably it would be Marshall Elkins, who was the General Counsel at Integrated Health Services. He was the first senior executive to ever give me a big break. That started my career in healthcare, and through a cascade of events, led me to where I am today.
Iulian: What are some of the turning points in your career that lead to where you are now?
Mike: Well, actually that would be going back again with Integrated Health Services. I was an accounting and finance double major in college and graduated during a recession in '92. I floundered for a couple of years and then I worked as a temp paralegal for Integrated Health Services reporting directly to Marshall. After a couple of years, as I sat in his office I said, “Marshall, I think I'm going to go and become a lawyer.” He quickly replied, “Michael, you do not want to do that. What you want to do is to go get your MBA (Master of Business Administration), your CPA (Certified Public Accountant), and you want to go down the finance route.” Not that I wasn't interested in finance and accounting, it was my double major in undergrad, but that was a moment where my career would have gone off on a tangent, and if it had, we wouldn’t be sitting here chatting today.
Iulian: Yeah. Being a lawyer and working in finance are very different. I have experience with one of my sons who thought about becoming a lawyer but then felt that he would be able to excel more in the finance route. He is very successful there. The important thing is to find your niche.
Mike: Exactly, exactly.
Iulian: How did you get on a collision course with the shockwave technology? How did you get into this field? A fantastic field.
Mike: Well following Marshall’s advice, I pursued my Master's in Finance taking evening classes at Loyola College in Baltimore. One evening, after a course on International Investment, Steve Bellone, who was one of my classmates and the Senior Vice President of Finance of Integrated Health Services mentioned to me that he was looking for a CPA to become Controller of the lithotripsy division. [Lithotripsy is the use of shockwaves to break up kidney stones.] Very fortuitously, I had just passed the CPA a couple of weeks before. I told him that I was a CPA, and a couple of weeks later I was the controller of the Lithotripsy Division. Then, nine months later, I caught the President of the division embezzling three quarters of a million dollars. So, he got fired, the CFO (Chief Financial Officer) left, and then I was promoted to CFO. I was kind of like Horatio at the end of Hamlet [Shakespearean play] where I was the only one standing. It's being in the right place at the right time.
Iulian: Now you are the President and Chief Executive Officer (CEO) of Premier Shockwave. Could you tell us more about your company?
Mike: We have 70 of the 72 OssaTrons that were brought into the United States through SANUWAVE – Healthtronics deal, Healthtronics’ Orthopedic Division being the entity from which SANUWAVE was formed. We have placed that medical equipment all throughout the United States. We service about 35 states in any given year. Our main customer is the military treatment facilities (MTFs). We have been working with them since our inception in 2008.
Iulian: You know, just to make some clarifications. OssaTrons are bigger/larger devices specifically designed for certain applications, right? And a dermaPACE® System is the subject of collaboration between SANUWAVE and Premier Shockwave, in the field of diabetic foot ulcers (DFUs)?
Mike: The OssaTron® is FDA approved for plantar fasciitis and lateral epicondylitis. It's the only high energy extracorporeal electro-hydraulic shockwave device that's actually approved for orthopedic and podiatric indications, and it is the “gold standard device”. When I left SANUWAVE and created Premier Shockwave, I could have very easily, and for much less money, have gone out and bought a fleet of Siemens Sonocur or Dornier Epos electromagnetic devices, but the fact of the matter is, they're not as good – in fact, there are a number of White Papers concluding that electromagnetic shockwave does no better than placebo. So, that's why I wanted to continue working with the OssaTrons, because electro-hydraulic shockwave works, and the clinical evidence backs that up.
Iulian: And you are continuing your legacy by bringing the first and only shockwave device approved for wound care by FDA and practically initiating the marketing of it throughout the United States.
Mike: We performed our first dermaPACE® in-service at Fort Lewis in Seattle in early March, and over the last several months we have exhibited at several Veteran Affairs Hospitals (VAs), Indian Health Service (IHS) and tribal nation trade shows, and at about 20 facilities. There is a lot of excitement about this game changing technology, and I am confident that we will have device placements by the end of the year.
Iulian: What is your prediction about the future of the use of shockwave technology in the medical field? Do you see other things there where we could branch out?
Mike: Well, besides treating wounds and burns, to me the most exciting thing is what SANUWAVE is doing at the University of Georgia. You are applying shockwaves to staph aureus in vitro, and other nasty types of bacteria and biofilms, and seeing a multiple log reduction in bacteria counts. Now, in vitro is not inside the body, but I believe further testing will demonstrate similar results in vivo - treating inside the body.
Iulian: Indeed, these tests offer a lot of applications [for shockwaves] because the bacteria and the biofilms are at the base, the origin, of a lot of problems including chronic wounds and infections.
Iulian: How ambitious are you?
Mike: I think I'm ambitious. You don't take rather large financial risks, albeit well-calculated risks without being, you know, ambitious. But, I think the most important thing with bringing this vital technology to market is that if we are successful, then patients will have their wounds heal faster and fewer people will have lower limbs amputated. Because, in the end, when you get to be 80-years old and you look back on your life, being a part of a company that cured diabetic wounds and diabetic foot ulcers is a tremendous thing. It is a great way to spend your life. You know, it was great mark to leave, and that's what really motivates me.
Iulian: If you could, would call up anybody in the world and have a one-hour conversation, who would you call?
Mike: Wow. Dead or alive?
Iulian: Whoever it is easier for you.
Mike: So a one-hour conversation with anyone? John Lennon would be cool or Paul McCartney. Paul's alive. That'd be cool. Yeah! You can tell that I listened to the Beatles channel on the way over here.
Iulian: So, you are on the board of the Augusta Symphony, what composer would you want to speak with?
Mike: Mozart, if I was able to speak German, would be great.
Iulian: Okay. Fantastic. Which values are the most important to you in general?
Mike: Honestly, just doing what you say you're going to do is important. When people say they're going to do something, then they should. I appreciate people who are reliable and follow through.
Iulian: What is the most outrageous thing you want to achieve?
Mike: I think that the most outrageous thing to do would to be a disruptor in the wound care industry. That would be shocking, no pun intended, to be a disruptor in this enormous industry would be mind-blowing.
Iulian: Yeah, there is a lot of education and awareness needed about the shockwave technology, but once people understand it, they get enthusiastic. It is a lot of work to do if you want to accomplish this, but it is a great cause.
Mike: I still remember being on a ski slope in November of 2004 when I was made the President of the Orthopedic Division. Some peers of mine and I were going up the ski lift, and they were telling me about these doctors over in Europe, who were using shockwaves to treat diabetic foot ulcers, actually it was leg ulcers at the time, and that's what got me jazzed about this.
Iulian: Fantastic. Okay. Please share with us what are the two things you are most passionate about?
Mike: Passionate about? Spending time with my wife. I absolutely adore my wife.
Iulian: Okay. Great choice.
Mike: I also love tennis and travel. We went to Wimbledon this year and it was great to combine my love of tennis with my love of travel. My wife and I enjoy watching tennis at a professional level.
Iulian: What features make you to think someone will go on to be successful? You said before, that's somebody who has to be serious and follow up for whatever they say. What else?
Mike: I think a good, well-rounded education is the most important thing. Looking back at my education, it was very business-oriented, and I had no interest in anything outside of business courses. I wish I had had more of an experience in liberal arts because there are a lot of gaps that would have been easier for me to fill throughout my career, if I had a more well-rounded education. But as far as someone being successful, let's just consider what would have happened if Marshall Elkins [General Counsel at Integrated Health Services] didn't want to keep me on as a temp in the Legal Department, then I am almost certain that I would not be here today. My point is that all you can do is to attempt to prepare yourself for whatever comes at you in life. But as you know, it is not as easy as telling someone just do “a, b, c, d, and e” and then, okay, great, you're going to be a multimillionaire, successful and you're going to have a happy life. It's a bit of crapshoot. All you can really do is to help yourself by preparing, but as we all know, there are no guarantees in life.
Iulian: Which is your favorite piece of technology that you use?
Mike: Probably my iPhone, just because I use it all the time. It's totally changed the world. But also, the ability now for me to be anywhere. I could be in Paris or London, and I can do what I do at home on the computer. I don't have to be in the office anymore. I can just take it with me, and I can go anywhere. That's huge. It's really this technology working for us and giving us freedom.
Iulian: It really was a game changer. I mean, when you think about it. If we forget our cell phone at home, it's like we left one arm or something. Before you didn't have that. You had to wait until you reached somewhere to call using a landline and stuff like that. But it's a blessing and also a lot of other things, right? Everybody can reach you everywhere.
Mike: Yeah, that's right. I can bug you 24/7 now.
Iulian: What sports do you like to watch?
Mike: Tennis. Yeah that's the main one. I mean golf's alright, but I really like tennis.
Iulian: Okay. Now I know that you're living in Augusta, Georgia. I would like to ask you, what impresses you the most about the Masters tournament?
Mike: The golf course is immaculate. It is beautiful. It’s almost like walking into a fairy tale. The thing people at home don't realize, from watching on TV, is just how hilly the course is for every shot. Also, the community has a fantastic relationship with the Masters and it is great seeing all of our neighbors come together around this golfing major event every year.
Iulian: Well that's it.
Mike: That's it.
Iulian: Thank you very much, Mike.
Iulian: It was interesting to find out some of the insights of your life.
Iulian: Thank you.
DEC 18, 2018After Six Months with SANUWAVE Health, Inc.
Shri Parikh, the President of Healthcare Division, Offers His Personal Perspective on the Business and His New Role with SANUWAVE
By Iulian Cioanta, PH.D.
Shri joined SANUWAVE Health, Inc. on May 31, 2018, as the President of the Healthcare division. Shri Parikh was born and raised in Charlotte, North Carolina. He holds a Bachelor of Arts degree in Medical Ethics and Economics from Davison College, a Master of Business Administration, Health Economics, Finance, and Business Law from Jacksonville University, and an Advanced Management Program degree from the University of Chicago, Booth School of Business.
Before SANUWAVE, Shri was the Vice President of Sales and Marketing for Molnlycke Health Care. Prior to Molnlycke, he was the Director of National Accounts at Stryker, a leading medical technology company with products and services in Medical and Surgical Equipment, Orthopedics, Neurotechnology, and Spine. Shri also had 10 years with St. Jude Medical in a variety of roles, serving most recently as the Vice President for Strategic Sales and National Accounts. Prior to St. Jude, he was the Senior Director for Corporate Accounts/National Accounts and earlier was the Regional Sales Director for Cardiac Rhythm Management and Electrophysiology. At the beginning of his career, Shri was Senior Regional Sales Consultant with Guidant Corporation for cardiac rhythm products and also served as the Hospital Institutional Sales Group Director for Cardiovascular and Metabolics Division of Bristol-Myers Squibb.
As a healthcare industry leader and professional, Shri brings a fresh view deeply rooted in healthcare practice efficiencies which combined with his business ethics, communication and high-level of customer-engaging relationships is positioned to lead the company in developing strategic partnerships, increasing revenue and generating support through innovative and collaborative programs. Shri’s involvement in the wound care space combined with his 20+ years’ experience in the medical devices industry, pharmaceuticals, interventional cardiology, electrophysiology, metabolics, clinical studies, and business implementation, provides creative and resourceful solutions, in order to enhance the culture, mission, vision, and operational objectives.
Shri Parikh, the President of Healthcare Division for SANUWAVE, was interviewed by Iulian Cioanta, Ph.D., the Chief Science and Technology Officer for SANUWAVE. During their amicable conversation, Shri expressed his fresh perspective about SANUWAVE Health, Inc., shockwave technology, business opportunities, and personal experiences that influenced his life and career, as presented in the following interview:
Shri Parikh: Hi Iulian.
Iulian Cioanta: Hi Shri.
Shri Parikh: How are you?
Iulian Cioanta: Perfect.
Shri Parikh: You look extra sharp today.
Iulian Cioanta: You too. I have to match that. Thank you very much for taking this interview. It is a pleasure for me and it will give our customers the opportunity to understand your personality, and I hope that it will be fantastic.
Shri Parikh: Well, we hope it's an asset.
Iulian Cioanta: Yes, exactly. So I'll just go read my questions. The first one, what guided you towards a career in the medical field?
Shri Parikh: I have a history of physicians in my family, generations, parents, siblings, etc. And I was told ever since I was two years old that I was going to be a physician. I grew up in healthcare following patient journeys with mentors, friends and family members, and lo and behold, even pursued that route. So, I got into medical school, and after undergrad, I went to India to work with an uncle of mine. It was at that time that I chose, I wanted to remain in the healthcare field but perhaps not as a physician.
Iulian Cioanta: Yeah. It happened kind of the same thing with me. I wanted to be a physician, but I was afraid about the dual life where you just go and treat patients, see a lot of problems and then go back home smiling. I didn't know if I could do that, but I learned very quickly in the army that I could do it, but it was too late. So who's the most influential person from your life?
Shri Parikh: That's a really good question. In my active life, I would have to say my father because he sacrificed a lot. He gave up his medicine dream to have a better life for, at the time, my three older sisters. So he and my mother both emigrated from India really for no other reason, but to pursue an opportunity to have greater education for their children. My twin brother and I were born later, unplanned, here in the US, so we didn't know any different, but it really came to me later in life as maturity in age and experience and reflection settle in many trips back to India, as a teenager and even a young adolescent up to my elder years. I realized that degree of sacrifice is something significant and likely something I probably would be reluctant in being able to do today.
Iulian Cioanta: On a similar note, is your cultural heritage a big influence on your professional approach?
Shri Parikh: Yes. Similar to many cultures, such as yours, education is strict, so there is a big influence by parents onto their children to ensure that they achieve their potential. They sort of place their children on a path of what's best starting at a very early age and you follow that path in somewhat of an adherent and draconian manner. So, that was introduced to me very early on as I was lead to be a doctor. And I think that the cultural heritage speaks to that. And so, once you understand that everyone with a similar type of cultural background is following that path, it makes it easier for you to follow that path as well. That being said, being American born and going through the adjustments of trying to retain that cultural background, while finding your own personality and the new environment in America, you learn to branch out in different ways. And some of those things created heartburn for my parents. But it also made me who I am today.
Iulian Cioanta: Well, it's a nice mixture of things that kind of makes your life more structured and organized, but also with the open mind of a child born in the United States. How did your family values impact your career? I know you have very strict family values based on your Indian culture and being a second generation immigrant. It's interesting how you've combined those two identities and the role they have played in your life.
Shri Parikh: I've learned the value of people, understanding, having good instincts, judging people and character, and building almost an alliance or an affinity with many you want to work together, all coming from my cultural heritage. I didn't really understand that as well until I worked with a company that was based in Europe. It wasn’t until I was going back and forth and engaging at a professional level with that group that I realized it was a true asset for me. I began at some point in my career to depend on it and almost utilize it and leverage it as a true asset. And that's not to say that the European culture has anything wrong with it, but it is certainly much more distant. Visiting parts of Asia frequently as a child and growing up in America, I’ve observed a greater dependence on the instincts of the people dynamic, reading, understanding, and working with people while understanding the merits of collaboration. I think that American society is a good blend of both, but I believe that having great self-awareness and being able to understand the value of people has certainly been an attribute I’ve found to be successful.
Iulian Cioanta: Because the people are the greatest asset.
Shri Parikh: Absolutely.
Iulian Cioanta: What were some of the setbacks you had that ultimately got you to where you are today – something that kind of changed your course?
Shri Parikh: Yeah, I think there were probably a few seminal moments, but one specifically was, as I mentioned earlier, when I went to India before I was to start med school in the fall semester or late summer. I came back and shared with my family, and specifically my mom, that I wasn't thinking of pursuing medicine. So, I deferred a year and that bothered her to such a great level that she was angry and refused to speak to me for a good part of a year. The disappointment that I witnessed and observed in her for a career decision that I chose knowing to be right, drove me and continues to drive me, to ensure me that I'm successful in this alternate path – even though not fully blessed by my mother before her passing. This change of course is what drove me and continues to drive me moving forward.
Iulian Cioanta: Interesting. What would you say is the project that you have worked on that you are most proud of?
Shri Parikh: I would say that as we put the premium on people, it's a strategy with people and understanding what's going on to achieve their greatest potential. I read a lot and understanding what's going on in the marketplace and working well with people to be able to support what will happen. So, for example, there was a bet that I had with a former boss of mine in the cardiovascular space when I was working at St. Jude’s Medical. I said to him that a realignment and redeployment of people would result in at least a minimum increase of $5 million in revenue. He disagreed but supported my move, and the bet started with a handshake. Lo and behold, we were able to grow that business almost $50 million, more precisely $48.9 million, at the end of one calendar year. This is tenfold more than what the bet was. I'm very competitive. I believe that if I put the right type of process in place, together with the right people, support the strategy and speak to it in a structural fashion that we can accomplish anything. And that was an example of one that I still reflect on, I'm very proud, and then brings a smile to my face.
Iulian Cioanta: You should be proud. I mean increasing revenue 10 times fold is very good in one year.
Shri Parikh: And the bragging rights with this one particular person made it even better.
Iulian Cioanta: So, talking about your job and career, what is your primary source of motivation in your work?
Shri Parikh: Yeah, I love working with people and helping them understand the business potential in their personal and professional capabilities. I think that's the greatest joy that I have. Sometimes you fail. You may not hit the stretch goal, or you may not even hit the goal that you want, but I think it's the process of going and working towards it where that developmental opportunity is learned and where the people come together as a result of that. Because then you'd take that competency, you can replicate it for future investments or a future opportunity. I think that's been my greatest joy, and I should say that I think much of that was probably learned through my years of playing soccer. I played soccer competitively and all the way up through college. I think even though I wasn't the best player on the team in the later years, as I began to play with others from all over the country, I think that the leadership and the teamwork dynamic is what helped me to be more of a contributing supporter on the team. By helping others overcome some of the challenges that they faced during games and that specific dynamic is a replication of what I see, as I work with people in the professional world.
Iulian Cioanta: What position did you play?
Shri Parikh: I played striker and right wing.
Iulian Cioanta: Okay. Important ones.
Shri Parikh: So the World Cup has been very visible in our household. I was pulling for Croatia. I was disappointed that England was out. Croatia was hungry and I think that actually helped them.
Iulian Cioanta: Yeah. They overcome a lot of adversity.
Shri Parikh: You know, the other interesting thing is that they did not give up. They played with no fatigue, and it's almost as if they got better without giving up, which is actually an attribute. When you think about some teams with experience, they sometimes show signs of retreat when they are down at 70, 75, 80 minute mark. Croatia continued to be on the attack for a full 90 plus minutes, and that is clearly what helped them beat England and other teams earlier in the World Cup stages.
Iulian Cioanta: It is a great psychology from their point of view, because in former communist countries, the mentality is not positive. You can see in the sports, they think as though the sky will fall, if things aren't going their way. That's why I think Croatia was as motivated as they were.
Shri Parikh: There is so much you can build off of this because you can take that and apply it to the business and life in general. The work ethic, the discipline, all of the vigor that's necessary to condition yourself to be at that level, but then never giving up. Never showing retreat. Croatia has clearly gotten the attention of many people across the globe.
Iulian Cioanta: I'm sorry for the little diversion. Maybe it's linked somehow.
Shri Parikh: If not, we'll find a way to weave it back.
Iulian Cioanta: If you are asked to do a task you thought was impossible at first, how do you approach this kind of task?
Shri Parikh: Wow. Impossible? I try not to use that in my vocabulary.
Iulian Cioanta: Let’s not say impossible but difficult.
Shri Parikh: Very challenging. I think the best way is to break it down and build it up. So, I think if you're able to break something down into many pieces, then you can rely on your processes in a systematic fashion to build up, and you have an empirical and didactic knowledge that will help you build it in the right way. In this way you can start bringing some meaning to it. I think that's probably how I've approached a number of things that I found challenging both in my career, personal, or professional decisions. So, I think going back to the basics, stripping something, breaking it down, looking at it and all of its individual parts, and then bringing it together again provides perspective. It provides a lot of different domain knowledge from the experience that you will find in a relationship to something that you've probably been able to overcome in the past.
Iulian Cioanta: Yeah. No rushing to conclusions.
Shri Parikh: Yeah, that's a great point.
Iulian Cioanta: Just take a deep breath, look at it. We put the man on the moon, and we're going to put the man on Mars too. Nothing is impossible.
Shri Parikh: That's right.
Iulian Cioanta: So now I kind of want to steer the discussion towards SANUWAVE shockwave technology. Why did you choose the job that you have right now, as President of SANUWAVE?
Shri Parikh: Yeah, that's a great question. I think the biggest reason is that there is just remarkable potential both in the technology, and the many verticals that we can enter. That is the first one of the number of reasons. Number two is the people, the dynamics and the tenure of the employees, who I met along the way. Here at SANUWAVE there is a sort of vigor that you all have demonstrated before I arrived here. This vigor is used in combination with the chemistry of people in the office and their authenticity. It was really reading and understanding the pulse of the company along with those other variables that I found so much potential and satisfaction, which agitated me to become increasingly more curious. And as that curiosity grew and continues to grow, you can't help but love what we stand for. What we can potentially help to cure, and the remarkable impact that we're making on the quality of patient suffering right now with diabetic foot ulcers (DFUs), but as well, a whole list of other verticals that we can enter into and help that patient population improve their quality of their life.
Iulian Cioanta: This is one of the best parts of working in a medical device company. You can see the impact that your products have in the daily lives of patients and the improvement of their quality of life. In reference to your mentioning of the many verticals, where do you see the shockwave technology's role in the medicine and science?
Shri Parikh: There are so many applications. Right now our focus is diabetic foot ulcers with dermaPACE in the international markets. You see the benefit that it's having. So, working appropriately, diligently putting it to work, and showing some restraint with physicians that are so excited to take this technology to move it into other verticals is necessary. I think we have a responsibility to kind of pull them back and direct them to where FDA has given us/granted us clearance to move forward. So, shockwave technology, albeit having been in the market for quite some time with lithotripsy, has made it into this new space. I think there are many verticals that we can be taken with this very proven technology, using the wide assortment of variables, like the energy source for shockwaves and the type of therapies that can be changed to have a profound effect on patients. What we've got to do is to continue to support that, never lose that excitement, and being able to support a remodeling effect, by improving and making a significant attribute towards advances in each of those verticals. But we're also a “for profit organization”, as well. So we've got to capitalize on what we have successfully proven to date, build enough of a profitability, and windfall of cash flow, so that we can further innovate and invest in research and development, in a manner that will help us to make those advances and those other verticals.
Iulian Cioanta: So, from all of these verticals, what do you think it would be a new revolutionary application of the shockwave technology?
Shri Parikh: So again, this is where I may have some bias because of my background. My time at Stryker orthopedics in the US, particularly sports medicine. My experience there has created a great potential, which allows me to see a fantastic opportunity here at SANUWAVE. Not to mention what people are spending out of pocket on plastic surgery and cosmetology. So I think there's a profound potential there as well. But I do think that there is a calculus that we've got to work to develop, so that our talk track is consistent with the remediations and improvements that people are looking for in that space. And that takes money, takes investments, and takes other investors becoming increasingly enthusiastic to support us. So again, I think there's a step wise approach. To use a baseball analogy, we've got to capitalize and get a run or a home run and do it every time we're at plate, with the indication that we have right now for DFU. We must establish credibility quickly and being able to introduce this technology in a disciplined and measured fashion, so that our dermaPACE systems are being used in every wound care center to treat DFUs is the goal. As we are treating patients, we start to begin to see DFU patients benefiting and subsequently the number of amputations coming down. We would like to take that, replicate it, demonstrate a compelling cost savings scenario, and move into other verticals.
Iulian Cioanta: Now I will just try to go back to your personality and life. So, what do you value the most in a person?
Shri Parikh: I think a few things. One is their integrity, their background. So, if they are humble, and true. Something that I often look for is their curiosity. Do they want to learn, do they want to develop, and are they wishing to step out of their comfort zone to challenge themselves with the predisposition of curiosity? And those are qualities I look for in both my social circles and professional circles. The similarity between the two gets me excited.
Iulian Cioanta: Do you have any special talents that not many people know about?
Shri Parikh: I can juggle. We were able to save money when my kids were younger. They're teenagers now, but when they were younger, we didn't have to hire the clowns because I could play that role. Outside of that, I spend a lot of time coaching and refereeing again when my kids were young. I love being involved with kids’ sports and anything related to helping people grow and develop has been a passion of mine.
Iulian Cioanta: What would you say have been the most significant milestone that you hit in your life?
Shri Parikh: I don't think I've hit one yet. I think that's still unwritten. Hopefully it'll be here at SANUWAVE, and we can all celebrate when that's achieved.
Iulian Cioanta: That will be great. What is the best piece of advice you have ever gotten?
Shri Parikh: I think, as I shared with you before, that the individual who had the most significant impact on my life is my father. And my father was Indian and was actually a part of the Mahatma Gandhi Movement for India, to gain its independence. A lot of his quotes and his philosophies were shared with me as a young child growing up, and one specific had a profound effect on me: "Be the change you wish to see in the world." That quote was shared with me many times. I believe my dad was at one of Mahatma Gandhi's rallies when he shared either that line or something very similar to it. That had a profound impact and effect on my father, who would then pass that down to his children. And that was one that resonated and still influences me today - BE THE CHANGE YOU WISH TO SEE IN THE WORLD.
Iulian Cioanta: Fantastic. Now, talking about advices, what piece of advice would you like to give to those that look up to you?
Shri Parikh: Well, as I indicated earlier, I think the attributes that I look for are the same as advices that I would give, which is to be humble, be hungry, and always remain curious.
Iulian Cioanta: If you had the ability to learn a new skill overnight what would that be?
Shri Parikh: I'm a horrible cook, so I would love to be able to become a master chef, specifically with the grill and barbecuing. I would make my household very happy.
Iulian Cioanta: How do you find time to balance your personal life with work and challenges that are coming with that?
Shri Parikh: Yeah, it used to be more of a struggle when I felt pressured to do something. Now it's a hobby. I believe work is a hobby. I'm here because it's a hobby and I feel it has a noble purpose. You must have satisfaction and enjoy what you're doing. I think travel becomes too heavy at times, but then I balance that out by making time for my family, whether it's a vacation or more time at home, so I balance it out that way. I think as you go through different stages across these two journeys, professional and personal life, as long as there is full understanding by all the parts in both families, the professional family and the personal family, I think you're able to have an easier way of balancing it. So, I would say in the last eight, nine years, it hasn't been as much of a challenge as it was earlier in my life. And I should also say that the positions I've had in the past eight to nine years are more significant as well, leading larger parts of businesses, leading more people, etc. So, I think remaining grounded has helped me provide that level of balance. And I'm living an active healthy lifestyle too. Age certainly isn't on my side. So, you know, running three and a half miles today takes two times longer than it did 10 years ago. But I'm committed to it, because I understand the benefits of that. Now you guys just hear me complaining about it, because I'm sore, and I'm trying to get chiropractor's names and things like that, but it’s become a rewarding balance.
Iulian Cioanta: If you run for longer times, it gives you more time to think. So some advantages, in a positive way.
Shri Parikh: There's many, many advantages. You're absolutely right.
Iulian Cioanta: What activities are you involved outside the work in the community and for fun?
Shri Parikh: Yeah. So, my wife and I have been very supportive to a couple of different charities. American Diabetes Association is one that actually took a backseat to one that we became passionate towards during my time at Molnlycke, and that was Operation Smile. So, kids in third world countries have a propensity to have what's called “cleft lip and cleft palate”. I've had the pleasure and the good fortune of being able to go to third world countries and be a part of a couple of these surgeries and donate, a little bit of time and products from my previous companies. And last year was particularly special because I was able to take my daughter with me to the Philippines to a small city outside Manila called Iloilo. As a parent and one that has been highly critical of my daughter and her level of giving and maturity, I was very happy to see her engage with surgeons, to not be fearful in the operating room, and to be a part of these young kids life before surgery, during the surgery, and then follow up afterwards. And it's actually led to her interest in pursuing medicine at the tender age of 16, so we'll see where that story is written. But similar to that commitment to Operation Smile, I'd like to take a much deeper type of involvement with American Diabetes Association, particularly since we're tied to it anyway.
Iulian Cioanta: The last question is this - as President of the company, what do you intend to do with the company to keep it environmentally and energy friendly? Do you have any plans regarding these kind of activities?
Shri Parikh: I think it starts with just our practices in the office first, so finding one that's supportive to the environmental conditions that we look for in an office building. The way we choose to conduct our behaviors in an office also translates to how we wish to make an impact with the innovative stages of what SANUWAVE can impact. So again, it's one of these things where I feel our abilities to be curious – to start crawling first and then understand with the help of our leadership team, what we can do to make these advances, so that we have more of a footprint towards improving the world we live in.
Iulian Cioanta: Perfect. Well, welcome aboard, and thank you very much for the interview.
Shri Parikh: It was a pleasure. Thank you Iulian.
APR 12, 2018Microcirculation Connection with Shock Wave Stimulation
A Personal Perspective from Dr. Maria Siemionow - One of the Great Innovators in Microsurgery and Active Researcher in Shock Wave Clinical Science
Dr. Maria Siemionow (born 1950 in Krotoszyn) is a Polish transplant surgeon and scientist who as Director of Plastic Surgery Research and Head of Microsurgical Training for Cleveland Clinic’s Department of Plastic Surgery, led a team of eight surgeons through the world's first near-total face transplant in 2008. The patient, Connie Culp, a 45-year-old woman from a small town in Ohio, was exceedingly disfigured by a close-range shotgun blast in 2004. The procedure took 22 hours.
Dr. Siemionow practiced in Cleveland until 2014, when she was appointed Professor of Orthopedics and Director of Microsurgery Research at The University of Illinois from Chicago, where she practices today.
She is regarded as a world leader in nerve regeneration enhancement and in developing minimal immunosuppression regimens following transplantation. Dr. Siemionow specializes in microsurgery, hand surgery, peripheral nerve surgery, transplantation and microsurgery research. She is President of the American society for Reconstructive Transplantation and is past president of both the International Hand and Composite Tissue Allotransplantation Society and the American Society for Peripheral Nerve. Dr. Siemionow is a member of the Warrior Restoration Consortium, an academic-industry team focused on developing new treatments for wounded soldiers.
Dr. Siemionow was twice honored with the James Barrett Brown Award for best publication in a plastic surgery journal in 2004 and 2007, and received the Folkert Belzeer Award in 2001. She is the recipient of the Commander's Cross Polonia Restituta award given by the President of Poland (2009), and in 2014, she received the Great Immigrants Award from the Carnegie Foundation of New York.
In December 2017, during the SANUWAVE’s Clinical and Science Symposium from Chateau Elan, Braselton, GA, USA, Dr. Maria Siemionow presented her research on the effects of the PACE® (Pulsed Acoustic Cellular Expression) technology on microcirculation. Her presentation also gave us the opportunity to talk with Dr. Siemionow on various subjects. The interview is presented below.
Dr. I. Cioanta: First of all, let me thank you very much for accepting to do this (interview) and for being here (at our Symposium), and you know there are a lot of things that we know about you and for example the first thing is you grew up in Poland, I grew up in Romania, and I know that were very demanding things to get into the medical school.
Dr. M. Siemionow: Sure.
Dr. I. Cioanta: And it may sound personal, but I need to think, you know, what or who practically inspired you to go to the medical school?
Dr. M. Siemionow: I think, generally it was my education in high school, which was very oriented to the humanitarian help, as well as the languages, and a little bit of the history from the ancient time, which they were putting a lot of emphases on, and ethics were taught in high school. That was a special high school, which was oriented towards just very humanitarian ideas. So, I think this is something, which I always thought that will be great to be able to be between people and help people.
Dr. I. Cioanta: I truly understand that. I had the same dilemma when I was young. Ha, ha! So, in your opinion right now, which are the most significant changes that practically are happening in this modern medicine, as it is practiced right now?
Dr. M. Siemionow: Well, there are certain changes. In a way the practice is not similar, but there are new opportunities, there are new, specifically in my field, new therapies, new devices, which are actually coming very fast into the practice. In the past, the surgeons were more conservative, in the way of using a method of a very well-known professor. And as you know, all surgical procedures have names – “Millard II” (rotation-advancement procedure for cleft lip repair, also known as the Millard Repair, is designed to create a softer, more natural-looking lip) and you know from the physician and so. So, in our days nobody really cares in terms of whose name is that? People more are thinking about well bringing to the table the innovation.
Dr. I. Cioanta: Yeah, right. So, if you are to describe yourself with one word what it gone be?
Dr. M. Siemionow: Consistent.
Dr. I. Cioanta: Ha, ha! That’s very important. For such a prestigious career, yeah, consistency it’s very important.
Dr. I. Cioanta: So, what or who inspires you every day or what motivates you to get out of bed in the morning, just to do whatever you have to do?
Dr. M. Siemionow: Well, I will say mostly young people I educate. So, as you know, I have a large laboratory, in University of Illinois in Chicago, where I have usually about ten (10) researchers. All of them are either early in their careers or in their PhDs. Some of them are just young after training, and all summer I have international students, many of them coming, of course from Poland, from Medical School, rotating for three (3) months. So, this is a constantly a powerful opportunity, first to teach them but also they challenge you. So, they ask questions, which sometimes you are not ready, because they think differently. And this is on the research part, but also I see the same, as an orthopedic hand surgeon. We have the largest program in Chicago. Fifty (50) residents of orthopedics. That’s huge, it’s the biggest in Chicago. So, also I give them lectures and they help me in the clinic and assist me. They ask questions or they don’t ask questions and then I ask them questions. And it’s a good vibrant opportunity to keep you, you know, I will say, young, because you try to be with them on the same line.
Dr. I. Cioanta: I agree. Ha, ha! Sometimes it is difficult to keep up with the young.
Dr. M. Siemionow: It is, it is.
Dr. I. Cioanta: So, your successful face transplant for Connie Culp is considered a big milestone in medicine. How that influenced your career and your life in general, after that significant event?
Dr. M. Siemionow: Sure. Well, my life was busy before. Become very busy. Now it will be, next year will be ten (10) years. So, there was at the beginning, for quite a while, we were the first and the only, so there was not only interest, of course with the media as usual, but also colleagues were interested. They were asking for the lectures, for presentations with details, procedure. We had most interest, it was always the fact that many of my colleagues in reconstructive plastic surgery, they were interested also in ethical protocol. Because bioethics and ethics approval of the IRB, Institutional Review Board, was a corner step to go forward. So, it become really very busy, and I think I enjoy it. I only traveled more than I even wish, at that time, and even today, even if there are more face transplants. We have done in fact two (2) more face transplants. So there are three (3) cases, three (3) patients under my protocol and under support of Department of Defense, where I have the contact list.
Dr. I. Cioanta: Yeah. So, I know that a lot of awards came after that and a lot of things for your prestigious career, and I have few of them together. The Polish Order of Merit that I think it is very dear for you.
Dr. M. Siemionow: Aha.
Dr. I. Cioanta: The 41 “great Immigrants” from the Carnegie Corp., the James Barrett Brown awards, the Folkert Belzeer award, Commander's Cross Polonia Restituta. So, a lot of awards and congratulations for such a prestigious, you know, career and accolades.
Dr. M. Siemionow: Thank you.
Dr. I. Cioanta: How do you get used to being such a celebrity?
Dr. M. Siemionow: Ah! Well it comes with timing, you know. So, I think you are getting used to that. One thing which I will say, as much as I appreciated the awards, I know they will end. So, I am not, you know, waiting for more. I am just, heck, there is another one from a different society, or an appreciation. And this is probably something, which (is) maybe just my personality. I think based on my education, I always was trying to do the best, and the best turned out to be also appreciated by others. And this is probably the most important part, because it looks like you are trying your best and people are recognizing it. So, that’s very fulfilling.
Dr. I. Cioanta: Yeah, and is also probably the fact, we are the first generation of immigrants, and we knew that, we knew to work harder than everybody else to be sure that we gone succeed. That’s kind of the mentality that can put you in front.
Dr. M. Siemionow: Exactly, absolutely. Yeah.
Dr. I. Cioanta: So, in relationship to your success and life approach, how do you push through your worst times?
Dr. M. Siemionow: Well, this maybe where you asked me about how I would define myself. It is consistency and patience. Because, you know it took four (4) years to get approval of the first face transplant protocol. And people didn’t’ believe, it will ever happen, because when I submitted the protocol to IRB, they were coming back with questions and there were other questions. And then finally after IRB approval, the major obstacle was the Organ Procurement Organizations. They didn’t want to approve the face transplant, because they were afraid that the donors of solid organ transplant will be scared. They didn’t understood that this is a special protocol, special consent. But now, ten (10) years later, face is considered an organ and was approved by UNOS (United Network for Organ Shearing) and was approved by all Organ Procurement Organizations, as an organ. So that’s a major milestone, which took ten (10) years. But in the beginning, it almost looked like will never happen.
Dr. I. Cioanta: It’s a reality that face transplant involves much more than anything else, because you have to attach everywhere the nerves, the vessels, the muscles and everything else.
Dr. M. Siemionow: Sure. Yeah.
Dr. I. Cioanta: It is very difficult and I see people not understanding from the beginning and putting a lot of questions and ethical stuff. So, what projects are you currently working on right now?
Dr. M. Siemionow: Clinically, we have just completed, this year there was a third face transplantation, still in Cleveland Clinic. And I am PI, Primary Investigator, even if I am at the University of Illinois of Chicago (UIC). This is the Department of Defense supported protocol. So it was logical that at least because the patients were already on the schedule and they were selected, so I am just still overviewing this. There is at UIC, I opened a hand surgery, a hand transplant program. So I got IRB approval, as well the UNOS approval, to hopefully perform first in Chicago area, a hand transplantation, which is really very rewarding. And as a hand transplant (surgeon) from the beginning of, as a hand surgeon from the beginning of my career, that’s also of my interest. On the research account though, I have really devoted a lot of time to new therapies, where we are performing the fusion between the donor and recipient cells, for tolerance induction in transplantation, creating these “chimeric” cells. But recently, and this is the big project, there was actually the IP (intellectual propriety/patents) at the university, and with my son Chris, we had spin-off the company out of the university. I have licensed this. We did it in Poland, and we have found very receptive and funding organization by grant and also by some of the supporters or sponsors. So, this is big because for Duchenne Muscular Dystrophy there is no cure apparently and we are creating a new generation of cells. We call them “DEC”, Dystrophy Expressing Chimeric cells, which are based on the fusion in between the father and the son. So the father’s cells are having dystrophy and the son’s cells are not having dystrophy. And after fusion, we are planning to treat them, because we have confirmed on the mouse model of Duchenne that actually we can bring dystrophy to the Duchenne mouse and this is correlating with increased function. So, that’s very exciting.
Dr. I. Cioanta: Wow! Very exciting and the fact that you reduced rejection, it is very important, because that is one of the problems with implants.
Dr. M. Siemionow: Exactly.
Dr. I. Cioanta: So, now because we are talking about research, maybe we can help with shock waves there, maybe we can see that we can stimulate those cells. But just going back to shock waves, do you find your work in the shock wave field enticing or intriguing?
Dr. M. Siemionow: I will say both probably, because in the beginning it was, you know, well totally new field. It was really more based on understanding of engineering than the medicine, because the way the shock wave works was first developed and checked more on, even for medical applications, in kidney stones and so on. Still was, the surgeons were the users or the physicians were the users. But I think there is a depth of education, which is to find ways to understand the process and to maybe even develop more. But there was interesting having in my lab experimental models, where we could see directly what is happening after application of shock waves or PACE therapy, as we call it now. It’s, it was really interesting to see the differences, which were directly applicable to my clinical practice of microsurgery. So, it was exciting as well.
Dr. I. Cioanta: Fantastic. So, where do you think that SANUWAVE should concentrate efforts?
Dr. M. Siemionow: Well, you have your, I will say, branding around the diabetic ulcers treatment, the clinical trial, you have the branding around the wound healing and you are very well known for that. I think, I will be presenting today at my lecture some other applications, which you know you may be interested in collaboration. But I think there is a void, which was never rechecked. It’s in the nerve regeneration. And application of the shock wave therapy, as we have spoken some time ago, to the stem cell therapy. So, that will be great.
Dr. I. Cioanta: That is a very interesting subject. So, where do you find most important things, when teach the new generation of physicians that they look up to you? What is the most important thing when you do that?
Dr. M. Siemionow: Well, you know just talking about being patient and persistent, I think this is important for new generation now. Because, they want it fast everything and if it’s not fast they just leave it, and they think, well let’s just try something else, and something else also is not fast. So, this becomes confusing. So, I think the first thing is to let them know that something which you want to achieve takes time, always was taking time, maybe faster now than before, but that’ s not all now. But also in a way when you are fast you are losing distance and you are not paying attention to detail and, you know, it is so easy now to learn so much over internet, but you are getting a very superficial knowledge, I mean if you go fast. If you go deep takes time, but nobody wants to take time. Ha, ha! So this is a “double sword”, you know. You can learn faster than we did, because there was no access to international journals many, many years ago. It was difficult to get books, which were, you know, in English, in the countries which were not English-speaking countries. So, we appreciate maybe more that investment of time to the knowledge.
Dr. I. Cioanta: That is not easy to go into details and to have patience and study deep, deep down. That is the key to it.
Dr. M. Siemionow: Sure, absolutely.
Dr. I. Cioanta: Do you think there is any current medical trend that makes less sense to you?
Dr. M. Siemionow: Well, bureaucracy.
Dr. I. Cioanta: Ha, ha, ha!
Dr. M. Siemionow: And this is menacing and this is taking too much time and too much effort and really less and less sense.
Dr. I. Cioanta: And it’s everywhere. What topic could you can talk for hours, without any problems?
Dr. M. Siemionow: Well, I think that, yeah it is part of my expertise, of course. Few fields. One is the transplantation, not only human transplantation but also transplantation research, tolerance inclusive studies. The other topic I like is nerve regeneration. And I am a past President of American Society for Peripheral Nerves and I was very much involved in that. And daily I see many patients with carpal-tunnels, because my practice of course has to be not only face transplants, which are expected once in a while or in few years. And the third topic, which was a part of my work for SANUWAVE, it’s on microcirculation and looking directly into the muscle, vessels, and modalities, and everything, to be sure you have actually the possibility of checking what’s going on, after the clinically relevant surgical insult.
Dr. I. Cioanta: So now a personal question - how do you balance work and your private live?
Dr. M. Siemionow: Well, I have a lot of support from my husband and colleagues, of course. And still even now when it comes more to, he will traveling with me and supporting me. He always did, when I was “on call” and you know helping also, taking care of our son. And I did as well, but that’s very important to know that someone is there, who will not, you know, make you feel uncomfortable that you are missing something.
Dr. I. Cioanta: Well, Dr. Siemionow thank you very much for your time.
Dr. M. Siemionow: Thank you so much.
Dr. I. Cioanta: It’s always a pleasure to talk to you, and we are looking forward for all these great things to happen, you know, like we talked into this interview.
Dr. M. Siemionow: Well, I hope also, Iulian, that part of that it will may be the upcoming future with SANUWAVE
Dr. I. Cioanta: Yes, truly we believe that and we want to do that.
Dr. M. Siemionow: Thank you so much.
MAR 20, 2018Shock Wave Applications in Medical Field
A Personal Prospective from One of the Lead and Renowned Researchers in the Field - Dr. Ching-Jen Wang
By Iulian Cioanta, PH.D.
Dr. Ching-Jen Wang is the world-wide distinguished researcher in medical applications for extracorporeal shock waves. From 1997 to present, Dr. Wang is Professor of Orthopedic Surgery at the Chang Gung University College of Medicine and Chang Gung Memorial Hospital, Taiwan. He was the former President of the International Society for Musculoskeletal Shockwave Therapy (ISMST). During the course of his career, he has conducted more than 50 clinical and basic scientific researches in orthopedics surgery and applications of shock wave technology in musculoskeletal afflictions, and published over 160 articles related to orthopedics and shock waves. His main interests are in total joint and ligament surgeries around the knee and musculoskeletal shock wave therapies. In the shock wave field his research focuses on treating bones, cartilage ligaments, and soft tissue. Also, he perform studies on the use of stem cells in conjunction with shock waves.
In December 2017, during the SANUWAVE’s Clinical and Science Symposium from Chateau Elan, Braselton, GA, USA, Dr. Ching-Jen Wang presented some of his distinguish research. I took the opportunity to talk with him on various subjects, as part of a short interview presented below.
Dr. I. Cioanta: First of all, it is a pleasure, as always, to have a discussion with you and I am glad that you accepted to do an interview. You have a prestigious career, you are the best in the shock waves field and this is why we would like to do this interview.
Dr. C-J Wang: Thank you for the comment.
Dr. I. Cioanta: The first thing, let’s talk about you career. What do you think that made it so successful, as it is right now? What triggered the big success that you have?
Dr. C-J Wang: Well, I kept get involved with the clinical work for almost twenty years and at the beginning the introduction of a device to me triggered curiosity and uncertainty. So, I tried a clinical trial. After about three or four series of the most serious cases in the clinical trial, I found out patients to respond very favorable. That is why I tried, I think I was looking to start doing and organize clinical trials and animal experiments. That began in 1999, and the more we did it, the more people responded. People basically asked their friends to come to join and to receive the treatment, because they were feeling so good.
Dr. I. Cioanta: Yeah, it is. In a way, shock waves look like Star Trek, you know. When they go with the shock wave applicators on top of things, the patients don’t heal in two minutes, like they show in the movie, but we know very well the shock waves have a huge effect and they can do a lot of things, good things, for the patients and also for the physicians and the whole society. Of what thing you feel the most proud from your distinguish career?
Dr. C-J Wang: I am proud when in a project I happen to discover something, which has never been discovered before. For example, as it happen with the biological mechanism for shock waves, even though so far still we do not know 100%, but the data will show to a download the ingrowth of neovascularization and the tissue regeneration. These are all accumulation from previous studies and a cumulate fact now that most studies support this theory. So, it is a proven fact we seen definitely the shock waves work biologically.
Dr. I. Cioanta: And this is why you proved that. Everybody was thinking, yeah I see something is happening, but you gave the key factors for proving that. That is indeed a proud thing to do, you know. Was there any event in your life that you thought was going to be amazing but then turned completely different?
Dr. C-J Wang: For myself?
Dr. I. Cioanta: For yourself, for the practice, for whatever you’ve done in your career.
Dr. C-J Wang: I am an orthopedic surgeon. I am actually consider retiring as orthopedic surgeon. I still doing part-time practice and part-time research. Research does not have too many restrictions to do in whatever you are interested in and there are so many grants. You can do anything, as long as you are approved by the hospital. So, I am still very active in doing research, especially shock wave related and partially in clinical practice. I still perform surgeries, but usually with the help by younger surgeons.
Dr. I. Cioanta: Your physicians that you taught them how to do something like that?
Dr. C-J Wang: Yeah, my previous students. They are all grown-up right now. They are helping me out, but also they get paid by doing that.
Dr. I. Cioanta: You know, it is good to have mentors and being able to mentoring such good physicians, and you know, by doing that the more you do the more you put on the map the shock wave technology. What scientific discovery do you think it would change the course of humanity overnight, if it were to be discovered?
Dr. C-J Wang: I am a surgeon and I make a living by doing surgeries. However, I honestly I feel many surgeries are unnecessary and some are subjective and some are objective. Shock waves, for example, are objectively ready to replace many surgeries already. And that feels good, saves the money, saves the patient from the risks of such surgery, become perfused, etc., and also save them from recovery from unnecessary surgery.
Dr. I. Cioanta: That’s very interesting. How and why did you start your prestigious work in shock wave field? I mean, what triggered that? You said initially that, you know yeah you saw that is working but what convinced you to follow-up that path even more and more and more?
Dr. C-J Wang: To me is the story that I strongly believe shock waves not only work in soft tissue, but they should work in bone. And I’ve done a bone disease, AVN is one example, and saw other conditions that can be treated. And if I can avoid surgery and cure a disease, one disease only, I feel very proud of myself.
Dr. I. Cioanta: Yeah, correct. And you have done many of those not only one.
Dr. C-J Wang: Correct.
Dr. I. Cioanta: Yeah. So, in your opinion, which is the next significant step in shock wave field, the next hot topic?
Dr. C-J Wang: I think the biggest problem is the inconsistency in the bureaucratic approval. I think FDA approval is very critical. Even though it does not change the clinical patient, but because their support. That makes people to trust more the technology. One thing that I don’t like it that much is that in European Community (CE Mark), they approve so many so quickly. In contrast, United States FDA is slow and very, very impatient. In the past fifteen years (15), fifteen (15), I don’t believe any new indication has been approved.
Dr. I. Cioanta: No. The dermaPACE indication is the only one that probably will gone be approved.
Dr. C-J Wang: Yeah. That does not catch-up with the reality.
Dr. I. Cioanta: I agree. I mean, there are so many applications for shock waves.
Dr. C-J Wang: The question is - they should step into it and then talking to what is the problem. But just to not respond for fifteen (15) years. That I personally think it is wrong. Meaning, they have to consider all the causality, but it cannot just ignore the shock wave technology, that is not good.
Dr. I. Cioanta: Yeah. There are also the insurance companies and stuff like that. So, what is the most significant projects at this time for you? Is the stem cells, is still work on the bone or the soft tissue?
Dr. C-J Wang: From the previous results, my opinion is that by combining stem cells and shock waves, definitely potentiate each other nicely. And if you think is ... the new vessel formation, tissue regeneration, or overgrowth, we do not know. We should look at cartilage. It’s is first time I discovered cartilage can regrow after shock waves therapy alone. It does not need any stem cells to equally improve.
Dr. I. Cioanta: That is fantastic. Because few years ago everybody was saying that the cartilage will not regrow.
Dr. C-J Wang: I had the same opinion too, about five years ago. Now, since last year, with the results shown to me, I changed my mind. Cartilage can grow.
Dr. I. Cioanta: That’s fantastic. That’s a very good thing for a population, which is more active and active and prone to sport’s injuries.
Dr. C-J Wang: That is where our research is currently expanding.
Dr. I. Cioanta: Perfect. So, what is your opinion about the annual ISMST conference, and I do not mean their wonderful locations, where they take place?
Dr. C-J Wang: ISMST (International Society for Musculoskeletal Shockwave Therapy)! I can tell you too, my association to ISMST has been steadily decreasing. Because they are looking not for an academic per se. They are looking for the good locations, expensive hotels. I think that they are going into that direction and actually this does not accomplish anything academically or for basic research. For example, I told them to talk to each membership and act like a godfather. Overall every country’s society should have a chance to give a guideline ... and they can use that as a reference. Because so far still not a definitely guideline. That is very bad, for such a rapidly developing treatment. It should have a strictly guideline. You can only change it from time to time. Without that you can’t really accomplish anything.
Dr. I. Cioanta: So, practically what are you saying they do less important research, basic research, like you promoted for many years at this conference.
Dr. C-J Wang: There are too many talks.
Dr. I. Cioanta: Yeah. You know like you said, probably we have to develop the universal guidelines to do the treatment for this and that and that (shock wave treatment). And that is practically the purpose of such society. What is the best compliment, the most wonderful compliment that you received as a researcher?
Dr. C-J Wang: I think the one that struck me the most is recently I was told that in Taiwan when patients come to see the visiting office or the hospital, the one question that they always ask – “Do you have a shock wave treatment? If you do shock wave treatments, I will make the appointment, if you don’t, I go somewhere else”.
Dr. I. Cioanta: Where they have something.
Dr. C-J Wang: That is right. Yeah. The shock waves have become very popular. The public accept that as a fact. The shock waves are very effective and have very good results. Even though they (patients) pay out-of-pocket, the patients’ acceptance is very, very high. I have very rarely a patient review (change) the appointment, just because of money.
Dr. I. Cioanta: That’s fantastic. When people don’t look at the money, just to be sure that they receive the right treatment and especially the shock waves. In your relationship with persons, how do you evaluate a person’s personality? What are your criteria to look for that?
Dr. C-J Wang: My criteria is very simple. I think for anybody I know, I observed them for a short period of time, and then I can make a comment. The most important is the consistency. If a guy is consistent, no matter how smart or stupid, doesn’t matter. People coming and see these things developing, they want everything, and do nothing.
Dr. I. Cioanta: That’s the easiest way in life.
Dr. C-J Wang: Yeah. People who make their mind, even they have multiple choices, but still can choose in between 1, 2, 3, through 9. In this way they can basically focus in that area. Nobody could do everything, it’s impossible.
Dr. I. Cioanta: I agree.
Dr. C-J Wang: So when you are focused in one area, he/she is more concentrated, he/she is more dedicated to it, and have more achievements per se.
Dr. I. Cioanta: Yeah. So you follow your idea and just choose the right topic. What near future predictions do you have for the medical field?
Dr. C-J Wang: I think the breakthrough is the shock wave technology. If you can eliminate or prevent arthritis, isn’t that be a very big contribution to the society, to the whole society.
Dr. I. Cioanta: Do you think that the shock waves can also have a role in a preventive way?
Dr. C-J Wang: Yes, absolutely. If you have the arthritis, the concept in the mind is a booster. You can still do a little bit of stimulant in a while, otherwise the tissue regeneration does not last forever. So, every six-months or every four-months you should give a little bit of a treatment, stimulation.
Dr. I. Cioanta: That means that the technology should get into the family physician hands?
Dr. C-J Wang: That’s correct.
Dr. I. Cioanta: What is something that most people do not know about you, as a person?
Dr. C-J Wang: I am very conservative and I am more internal, rather than external. I participate in sport activity, but not as aggressive I should.
Dr. I. Cioanta: OK. Well, being conservative is very good, you know.
Dr. C-J Wang: I also focus pretty much. If I want to do something, for example, whether this month I want to complete this particular project, I think I try to strive to finish it up before I go to the next project. That is my personal habit.
Dr. I. Cioanta: Ah, OK. What are you most grateful for in your life?
Dr. C-J Wang: To be a doctor, to be a clinician, whereas an academic physician and that is what I like to do, and I think I achieved some level of satisfaction. I don’t want to be a strictly academia, I want to be an academic clinician and to create a practice with some percentage into research. How much research might be in it, can change from time to time.
Dr. I. Cioanta: Yeah. And also is the family, which is coming into the equation too. So, if you can master one skill you do not have right now, what would it be?
Dr. C-J Wang: Be a GOD. Ha, ha! Hmmm, what kind of skill I do not have right now? I don’t know.
Dr. I. Cioanta: You don’t know? Maybe, you mastered all of them. The most important thing is that you mastered the important things.
Dr. C-J Wang: Maybe, if I may start my medical career right now, I may or may not choose the orthopedic. I may choose something more academic.
Dr. I. Cioanta: Well, thank you very much. It is a pleasure all the time, and I hope we can continue the dialogue in the future.
Dr. C-J Wang: You’re welcomed. It’s my pleasure too.
AUG 1, 2017Don’t Judge a Medical Shock Wave by its Cover
What makes the difference among different medical shock waves devices? The following are just a few characteristics.
The way by which shocks are generated (electrohydraulic, electromagnetic, piezoelectric, ballistic, etc.) The construction material of the reflector, which is the element that focuses the shock waves The geometry of the reflector (ellipsoidal, paraboloid, spherical, etc.) The treatment zone location relatively to the focal point, such as before, in or after the focal point, and also to the depth of penetration in skin or tissue, such as near the skin, inside the tissue, deep inside the tissue, etc. The type of treated tissue dictates the optimal location of the focal point in respect to the treatment zone Settings such as energy input value, frequency of shock waves, total number of pulses, etc., which is known as “dosage”
Based on the above parameters when using different shock wave devices, there are significant differences in the energy deposited in the tissue from the treatment zone, which differentiates them in performance. In other words, in order to obtain the maximum performance for the targeted application, the above parameters are to be tuned.
Shock waves travel unidirectional without loss via heat, which makes the medical focused shock wave technology a “cold” high energy therapy. Depending on energy setting, the focused shock waves are capable of producing tissue regeneration or tissue ablation in the “focal zone” or “targeted treatment zone” without producing any heat. Also, the focusing of shock waves without significant energy loss makes the focused shock waves efficient and capable to be concentrated superficially or deep inside the human or animal bodies. Any tissue depth penetration can be accomplished with focused shock waves based on reflector’s geometry, either shallower or deeper, and by varying the membrane’s height, as seen in the following figure.
Focused Shock Waves Different Penetration Based on Applicator’s Construction
In the focal zone or the targeted treatment zone, focused shock waves generate a pressure signal that has two major components – the “compressive phase”, where compressive pressures are generated inside the tissue, and the “tensile phase”, where negative pressures produce cavitation in any fluids present in the targeted treatment zone.
Typical Shock Wave Pressure Pulse
Focused shock waves are characterized by intensive compressive waves followed by significant cavitation generation and with very limited and localized and transient heat produced inside the tissue. Thus, one can talk about a “macro-level effect” generated by high compressive forces that can produce tissue micro-tears or tissue strains. During tensile phase, the collapse of large shock wave cavitation bubbles produces powerful high-speed jets with action within a few micrometers, which means at cellular level or “micro-level effect”.
Focused Shock Waves Effects
At macro and micro tissue levels, the synergetic action of the compressive pressures and cavitational high-speed jets seems to give faster and better results in healing wounds, chronic fractures, etc., for focused shock waves. In contrast, the “unfocused” shock waves produce much lower pressures inside the treated tissue and also significantly reduced cavitational action, since cavitation bubbles cannot grow to their full potential, thus producing lower therapeutic effects when compared to focused shock waves.
Unfocused Reflector and Its Targeted Treatment Zone
As seen from the above pictogram, for unfocused shock waves, the treatment zone should be completely before the “Focal Volume”. This is done in order to be able to treat an area larger than the cross section of the focal volume with one position of the applicator, and to avoid high energies found inside the focal volume, as it happens for focused shock waves. Due to lower energy delivered inside the unfocused treatment zone, the unfocused shock waves are also known as “soft shock waves”.
Practically, in the treatment with unfocused shock waves the focal volume should be completely out of the patient, which means that the focal point and its associated focal volume for such device should be far away from the unfocused treatment zone. To better visualize this, imagine a patient being treated in one room with unfocused shock waves with an applicator that has its focal volume positioned in the next room, for avoiding the focal volume to overlap with the patient in any treatment situation. For example, if the abdominal area is treated at the skin level from the left side, then the focal volume should be at all times outside the patient’s right side of the abdomen, which accounts for more than 20 inches or 500 mm for an average-size person. It means that the length of the unfocused treatment zone should be very large in order to accomplish such requirements.
For focused shock waves, the reflectors are approximately a half an ellipsoid, with a surface area depicted as A0 in the following picture. It is also known that the amount of “Energy” that is focused from the point of origin of the shock waves to the treatment zone is directly proportional with the reflective area of the reflector. Thus, the larger the area, the more energy is found in the focal volume.
Dependence of Unfocused Treatment Zone on Reflector’s Geometry
If the reflector area is reduced to 70% or 40% from the initial reflector’s surface area A0, consequently the “Energy” reflected towards focal volume becomes 70% or 40% of the energy for the reflector with A0 reflective surface. The reduced energy translates in reduced pressures and also focal volumes, as depicted in the above pictogram.
In case of unfocused shock waves the half-ellipsoidal reflectors cannot be used even for superficial treatments, due to the fact that the focused zone will be then placed inside the patient body, with unknown consequences. In this case, this is why it is most likely to utilize a reflector with reduced reflective area, where only a small fraction of the ellipsoidal area can be used. Therefore from the start, in the unfocused region, the unfocused applicators will produce significantly lower pressures gradients, when compared with those from half ellipsoid focal volume that represents the optimum for focused shock waves, assuming the same energy setting.
Pressures Comparison in Between Focused and Unfocused Zones
It means that the treatment can be gentler to the tissue when using unfocused shock waves. In the same time, treatments using unfocussed devices lose their therapeutic significance very fast, due to lower energy delivered inside the treatment zone, and thus requiring increased number of treatment sessions to deliver an equivalent amount of energy to the tissue and achieve results relatively close to those produced by fewer focused shock wave treatment sessions.
According to international standard on shock waves, for focused shock waves, the “Focal Volume” is defined as the -6dB Focal Volume that encompasses pressures from maximum pressure (Pmax) generated in geometrical focal point F2 of the treatment zone to half of that maximum pressures (Pmax/2). Another region of importance is the 5MPa Region that incorporates all pressures higher of 5MPa, which is defined as the minimum pressure generating some therapeutic effect inside living tissues.
To better understand the spatial relationship between -6dB Focal Volume and 5MPa Region when a low energy setting is used, the pressure distribution along the reflector’s longitudinal axis is presented in the following pictogram.
Pressure Distribution around Focal Point F2 for Low Energy Setting
In the “Focusing Region”, the shock waves focus towards the second focal point of the ellipsoid, F2, which transforms the sinusoidal waves generated in F1, the first focal point of the ellipsoid, into classic “saw-tooth” distorted pressures signals that are characteristic for shock waves. In this case, the Focusing Region runs from the reflector edge until a pressure of 13 MPa is reached, which represents the half-pressure of 26 MPa from the focal point F2. This is the region where the treatment zone should be place when unfocused shock waves are used.
The “Focused Region” is the region where the shock waves are focused and where the largest pressures and energies are created. The pressure signals from this region have high compressive pressures, very fast rise times, and significant tensile pressures that produce cavitation. The length of the Focused Region is equal with the length of the -6dB Focal Volume. Interesting to note is that for this example, the maximum pressure from F2 (26 MPa) is also the maximum pressure generated in the whole Focused Region.
The “Diffusing Region” is the region where the pressure shock waves are rapidly defocusing and transform themselves in distorted sinusoidal waves that have the positive and negative peak pressures relatively equal in size. The high pressures and energies decrease fast in this region, and generally are at values equivalent to those from the Focusing Region. This can be seen by analyzing the shape of the pressures signals, before and after the geometrical focal point F2.
As presented in the next pictogram, when the energy setting is increased, a higher pressure of 29 MPa is generated in the geometrical focal point F2, which stretches the length of the “Focused Region” or -6dB Focal Volume, when compared to the low energy setting presented before.
The length increase of the -6dB Focal Volume pushes the “Focusing Region” towards the reflector, and limits the available space for unfocused waves region. This shows that the energy setting can severely influence the available unfocused treatment zone length, which limits the treatment options for unfocused devices. This observation brings another important difference between focused and unfocused shock waves.
Pressure Distribution around the Focal Point F2 for High Energy Setting
For high energy setting, it is also interesting to note that the maximum pressure of 31MPa from the Focused Region is found at 6 mm away from F2, which indicates a shift in the focal point of the shock waves from the geometric focal point F2. This finding is common for focused shock wave devices, and it can be produced by the combination of reflector’s geometry and the energy setting for voltage discharge inside the reflector, at the point of origin for the focused shock waves.
For this case of high energy setting, the length of the 5MPa Region also increased significantly. Similarly, it shows that higher energy setting decreases the available length for the unfocused treatment zone, and most importantly it points out the possibility of a larger treatment zone with focused shock waves, which gives a considerable advantage for treatment options with focused shock waves.
Using unfocused shock waves means that living tissue may be treated with all that is not focused on the way to the focus. It looks such as “treatment energy arrows” are all over the place outside a target, due to a target aiming with an unfocused eye, as pictured below.
Focused and Unfocused Effects
The “blurry” aspect of the unfocused notion can easily be transferred to unfocused shock waves’ science and effects, which is in great contrast with the “clear” and “standardized” science behind the focused shock waves.
The “cover story” for unfocused devices benefits is the delivering of lower energies in a possible larger treatment zone, when compared to focused shock wave devices. This can be advantageous in treatment situations where the treatment zone is significantly large and actual low-pressure therapy reduces the patient’s possible pain sensation generated by shock waves. However, the increased number of treatment sessions, necessary to achieve the desired therapeutic results, may be an inconvenience to the patient from logistics, compliance, and financial point of view. In the same time, the construction of the unfocused applicator has its challenges that may reduce treatment possibilities, which can ultimately increase the total number of applicators needed to cover the range of treatments for a specific medical condition.
Therefore, each “cover story” involving shock waves needs to be seen from multiple angles, to understand all consequences, benefits, and disadvantages. Shock waves are never boring!!!
JUN 26, 2017The “Shock”-ing Truth about Pressure Waves
When extracorporeal shock wave technology was adopted in the medical field, the race for developing more performant and least costly devices started immediately. Due to this initiative, the shock wave devices were changed from expensive “water-bath” to “dry” devices. “Water bath” devices required the patient to be immersed in a bathtub filled with degassed water, while the newer “dry” devices were much more cost effective by allowing a therapy head filled with water to become the delivery system for shock waves while the patient was laying on a regular medical table. The change generated a significant price drop (80% to 90%) for the “dry” devices when compared to the “water-bath” systems.
The initial medical devices used a spark-gap discharge to produce pressure shock waves. These systems are known as “electrohydraulic” devices. The newer designs produced medical pressure waves by using one of three methods, “electromagnetic”, “piezoelectric”, or “concussive”. The electromagnetic devices use an electrical coil in close proximity to a metal plate. Piezo-crystal vibration was the next advancement in the field and led to the creation of piezoelectric devices. Concussive designs created an expanding wave front away from the concussion plate as a “radial wave”, sometimes also known as “soft”, ”unfocused/non-focused”, or “dispersive” waves. The new designs did not improved the performance and in some cases, it even dropped. However, their price was more attractive to physicians and patients, which constantly drove acceptance. At the forefront of the price drop are the radial devices, due to their relatively simple construction and durability, as they last large number of pulses without refurbishment.
Radial Devices’ principle of operation
As seen from above pictures, radial waves are created by accelerating a metal projectile inside a cylinder, known as an applicator body. The accelerated metal projectile then suddenly hits an impact body, concussion plate, or radial head that vibrates. These vibrations generate radial and unfocused pressure waves. Based on Physics principles, the energy decreases with the increase in radius from the source, which makes these radial waves have maximum pressure immediately at the exit from the applicator head at the impact body or point of origin. Therefore, upon entering the human body, they rapidly attenuate, thus the maximum effects of radial pressure waves are at skin surface. The radial waves can generate slight or strong side effects ranging from skin reddening to hematoma, depending on the energy/pressure generated by the radial shock waves.
Similar to ultrasound, the radial pressure waves can be described as ripples created when someone drops a rock in water. The intensity of the ripples, height of the ridges and their total number, depends on the size of the rock. The heavier the rock the higher the intensity.
Similarity of radial waves with water ripples
Just as the intensity of ripples-effect in water, for radial pressure waves the higher the pressure in their epicenter or origin, the larger their penetration and action in the tissue will be. The same principle of action applies for High Strikers, as another analogy to better understand the action and functioning of radial pressure waves.
Similarity of radial waves with High Striker
The punch’s intensity delivered by the hammer on High Striker moves the needle to various heights, which is similar to penetrations of radial pressure waves. Just to have a little fun with this analogy, strikingly enough, if the force or pressure is sufficient to get to the “1” mark for the High Striker, it can be equated to a penetration depth of 1 cm for radial waves. The “1” mark for the High Striker indicates a very weak guy or a “wimp”. By continuing the analogy with the High Striker, for a 2 cm penetration of radial waves, the Striker puts a person in the “daisy” category. A penetration of 3 cm gives a “big boy”, 4 cm translates in “big dog” and a 5 cm penetration makes you “he man”. Based on this analogy, the higher the initial pressure of radial waves, the more impressive the results should be, if not for the restrictive side effects, which might limit the radial waves to the “wimp” or “daisy” status of the High Striker.
Correspondingly, the radial waves in their epicenter can be compared to a boxing punch delivered during training to the punching bag.
Similarity of radial waves with the boxing punch
In order to avoid debilitating side effects, the intensity of the radial pressure waves should be careful tuned down to dodge a “knockout punch” that can end the good effects of the radial pressure waves, or continuing with analogies, ending a boxing match.
High intensity radial waves can produce a “Knockout”
Based on what we learned so far, the question that comes to mind is regarding the nature of radial pressure waves. Hence, are the radial waves truly shock waves or not?
To answer the question, manufacturers of such radial devices say “yes”, but the scientists say “no”. The debate reached the German Scientific Committee for Physics and Technology and the International Society for Extracorporeal Shock Wave Therapy. Based on these two scientific forums, a fundamental characteristic of medical shock wave devices is their ability to be focused, for achieving the maximum therapeutic effects at deep penetrations inside the human body and within their focus. Since the requirements for each treatment indication are different, it should be possible to adjust the depth of penetration for the focus to where the maximum shock wave energy should be found.
Differences in between focused shock waves and radial unfocused pressure waves
As seen from the above pictures, the radial pressure waves are not focused and have limited pressure or energy in order to not produce severe side effects such as a hematoma, which makes them NOT A SHOCK WAVE.
The German Scientific Committee for Physics and Technology and the International Society for Extracorporeal Shock Wave Therapy debated also about the specific parameters that characterize or ”makes” a shock wave and distinguish a shock wave from a pressure wave. Such parameters are the wave’s “rise time”, its “travel speed”, and the temporal duration of a pressure signal generated in the treatment zone, also known as “pulse duration”.
Comparison of key parameters in between focused shock waves and radial unfocused waves
The shock wave standards and theory states that pressure waves reach the shock wave status when the shock waves’ “rise time” gets very short (tens of nanoseconds). As seen from the above picture, the radial waves have a rise time of few microseconds (or few thousands of nanoseconds), which is enormous when compared to tens of nanoseconds for shock waves. This large “rise time” shows that radial waves are slow-developing events when compared to shock waves.
The “travel speed” for shock waves is constantly the speed of sound, which is 300 m/s (0.186 mile/s) in air, 1500 m/s (0.932 mile/s) in liquids and up to 9000 m/s (5.592 mile/s) in solids. In general, the amplitude of a pressure wave dictates its non-linear distortion during propagation, which can speed up the wave enough to reach the speed of sound. As seen in the above picture, the radial waves can produce pressure of few MPa to reduce side effects, which based on theory will require tens of meters for traveling distance in order to reach the speed of sound. Clearly that will not happen in reality and thus the radial pressure waves used in medical field do not reach speeds equal to the speed of the sound.
The third parameter, “pulse duration”, shows a fast or a slow event. Shock waves have a “pulse duration” less than 10 microseconds, whereas the “pulse duration” for radial waves is more than 1000 microseconds, which points out a very slow event for radial waves when compared to shock waves.
Based on these main parameters characteristics that distinguish a shock wave from a pressure wave, the radial pressure waves are NOT SHOCK WAVES.
Furthermore, the following figure illustrates the difference between an extracorporeal shock wave therapy (ESWT) device and a radial device in terms of energy distribution and depth of penetration.
Energy as a function of the depth of penetration for a radial pressure wave and a focused shock wave
Due to the radial propagation, there is no focus for radial pressure waves. Radial pressure waves are the strongest at the tissue entrance and dissipate very fast afterwards. Based on the above graph, the radial pressure waves are efficiently used only for less than 1 cm penetration. This result is also confirmed by the graphic display or mapping of the pressure distribution produced by a radial device with a flat impact body, or concussion plate, or radial head. The largest pressures of 1 MPa generated by the lowest energy setting for the radial device are found in a region that has a 10 mm radius (corresponding to the radial head radius) and below 1 cm (10 mm) in axial direction from applicator head (positioned at the left side of the map).
Pressure distribution produced by a radial device with flat concussion plate
(Adapted from Cleveland, Chitnis and McClure (2007))
In an effort to produce better penetrations, the radial devices’ manufacturers created a design for the impact body, or concussion plate, or radial head so that it has a concave surface to produce some focusing.
Pressure distribution produced by a radial device with concave concussion plate
(Adapted from Cleveland, Chitnis and McClure (2007))
In this case, the largest pressures of 7 MPa generated by the highest energy setting for the radial device are found in a region that has a radius of 5 mm (corresponding to the concave portion radius of the radial head) and below 2 cm (20 mm) in axial direction from the applicator head (positioned at the left side of the map). It means that the radial pressure waves’ penetration can be increased by using a higher energy setting and by designing the impact body, or concussion plate, or radial head with a concave surface to produce some focusing. However, the radial pressure waves are still have the highest impact at the entrance into the patient skin and decrease quickly after 1-2 cm of penetration.
The significant differences between acoustic pressure shock waves and radial pressure waves can also be seen from the output-effects produced by these technologies, as cavitation generated by the negative portion of their respective pressure profile in the treatment zone. As seen before in one of the previous pictures, the pressure signal created by a radial device has a much smaller region of negative pressures when compared to the large region produced by the pressure shock waves, which should translate in less cavitational activity for the radial devices.
Cavitation produced by shock waves (left) and by radial waves (right)
(Adapted from Cleveland, Chitnis and McClure (2007))
The above high-speed pictures of the cavitation bubbles confirm that for radial devices the cavitation phenomenon is greatly reduced and it is localized to the applicator head. In contrast for shock wave devices, the cavitation happens in a much larger volume known as focal region and at deeper penetration.
The German Scientific Committee for Physics and Technology and the International Society for Extracorporeal Shock Wave Therapy summarized in the following table their findings regarding the comparison of radial pressure waves (unfocused pressure wave therapy –UDWT) with the shock waves (extracorporeal shock wave therapy – ESWT).
Comparison of ESWT (Extracorporeal Shock Wave Therapy) with UDWT (Unfocused Pressure Wave Therapy or Radial Waves Therapy)
Extracorporeal shock wave therapy (ESWT) is designed as a therapeutic modality in which focused shock waves are used. The maximum energy is in the therapeutic zone and the depth of penetration can be adjusted. Radial pressure wave therapy does not meet these criteria and therefore it is not an ESWT. In conclusion, the “shock”-ing truth is that the radial devices cannot produce any proper shock waves and by designating the radial pressure waves as “shock wave therapy” is misleading.
JUN 7, 2017Shock Waves and Ultrasound – Apples and Oranges
Sound waves with frequencies above 18,000 Hz are called ultrasonic or ultrasound. Ironically, ultrasound waves although they are “sound” waves cannot be detected by the human ear that is capable of hearing only frequencies in between 20 Hz and 18,000 Hz (18 kHz).
However, in nature, ultrasound waves are generated in air and “heard back” by bats who are using the ultrasound waves for spatial orientation based on ultrasound reflection on possible obstacles or targeted “food”. This approach for orientation used by bats is called echolocation.
The first submarines were used during World War One, and submarine detection devices were developed to pinpoint their location using the same echolocation principle employed by bats, this time applied in water. As it happened with many other technologies from our lives, after its first military use the ultrasound was adapted for more peaceful purposes in medical and industrial fields, where the sound waves frequencies are in between 250 thousands and 15 million Hz (25 kHz to 15 MHz).
When ultrasound propagates, it has two perpendicular components – the transversal wave and the longitudinal wave, as seen from next figure.
The transversal wave moves particles perpendicular to direction of ultrasound propagation, in a sinusoidal pattern, while the longitudinal wave compresses the matter particles in the direction of propagation. The lateral sinusoidal move of matter particles, produced by ultrasound transversal component, creates friction in between different layers of particles, which generates heat and thus continuously reducing the ultrasound energy during its propagation. This is called absorption, which is energy lost by ultrasound as it overcomes the matter internal friction while traveling through it.
An increase in wave amplitude and frequency (frequency = 1/(wave period) will increase the amount of energy lost by ultrasound on its way to the target through heat absorption. Ultimately it translates in less penetration for the ultrasound. This is illustrated in next figure that shows the large period/lower frequency radial ultrasound waves travel further when compared to the small period/high frequency waves (see the size of the black arrows).
Lower Frequency Waves travel further and High Frequency Waves have less penetration
In medicine, to reduce the ultrasound heat loss/absorption rate, the non-continuous pulsed waves were developed besides the continuous ultrasound, as can be seen from the following figure.
The ultrasound used in medicine has a frequency range of 0.7 to 5.0 MHz. The low frequency ultrasound is used for diagnostic, the high frequency ultrasound is used for therapeutic and/or ablation of soft tissue. Diagnostic ultrasound is used in determining viability of pregnancy, diagnosis of gallbladder disease, detection of heart problems, and discovery of cysts and tumors. However, ultrasound is primarily associated with letting us know about pregnancy by visualizing the fetus starting from its early stages up to delivery, as seen from the following figure.
Therapeutic ultrasound or high frequency ultrasound is usually used for treating inflammation and soft tissue growth stimulation, whereas High Intensity Focused Ultrasound or HIFU is used when heat is extensively generated for ablation of unwanted tumors or cysts.
Similar to shock waves, a sound wave cannot travel by itself. It needs a medium for transmission (solid, liquid, gas). For medical applications ultrasound must enter from the air medium into the skin/fat, of a significantly higher density, and can produce a 100% reflection of the sound wave at the air-skin interface. If a coupling medium such as gel is used at skin interface (ultrasound gel has similar acoustic properties to skin or soft tissue), the reflection is reduced to 0.1%. This means that the sound energy will be transmitted through the skin barrier without any absorption, until it reaches tissues with high collagen content such as bone, periosteum, ligaments, capsules, fascia, tendons, and tissue interface (bursa). At the change from one medium to another, ultrasound energy is lost due to reflection or scattering of the sound beam on a reflecting surface, from different acoustic properties of the mediums.
Both ultrasound and shock wave devices are using ultrasound gel to couple their energy to human body. It is the main reason a lot of people consider that ultrasound and shock waves are the same type of technology. Differences between these technologies are many, from the functioning principle to the treatment targeted tissue, and their outcome efficiency.
From a higher perspective, a sound wave might look similar to a shock wave, yet the two are not the same. While a sound wave/ultrasound can be described as the ripples (sinusoidal waves) created when a small rock is dropped in water, a shock wave is faster and not as smooth. Due to their high intensity and faster nature, the shock waves look more similar to the V-shaped bow wave of a boat. The analogy of the V-shaped bow wave with shock waves is illustrated below by the shock waves produced with a bullet fired inside a water tank. Furthermore, the V-shaped bow wave is analogous to a shock wave formed by an airplane traveling faster than sound.
In contrast to ultrasound, shock waves travel nearly unchanged through fluids without any heat loss, and hence body’s soft tissues, exerting their effects only where there is a change in acoustic impedance along their path. As shock waves energy is not lost through heat on the path to their target, shock wave technology can be defined as “cold” technology, able to penetrate to any depth, a sharp contrast with the therapeutic ultrasound that produces heat and loses energy along the way to the target. Ultimately, because of unavoidable heat loss, ultrasound limits its depth penetration and thus treatment possibilities deep inside the human body. The following graph for High Intensity Focused Ultrasound (HIFU) shows that the maximum penetration may be 8 cm with 1 MHz ultrasound, and then drops exponentially to less than 2 cm for 3.5 MHz.
The increase in the ultrasound frequency produces a higher attenuation due to heat loss and ultimately reduced tissue penetration
Shock wave pressure signal (see below) lasts for 5 to 8 micro-seconds (5 to 8 x 10-6 seconds). For the sake of curiosity, if shock waves could be continuously generated one after another (as in continuous ultrasound), then that translates into a frequency of 125 to 200 kHz, which puts shock waves in the bracket of diagnostic ultrasound. In reality, shock waves are used only for therapeutic purposes and their max frequency is 10 Hz (10 shocks per second), another marked difference from ultrasound.
Shock wave characteristic pressure signal in the targeted treatment zone
Furthermore, ultrasound produces sinusoidal waves in the treatment area (alternating positive and negative pressures of equal values - up to 15 MPa/150 bars for high frequency ultrasound). This is different from focused shock waves that generate asymmetric distribution of pressure in the treatment zone, with high compressive pressures (up to 100 MPa/1000bars) for up to 3 micro-seconds, followed by negative pressures up to 15 MPa for the remaining 5 microseconds (tensile phase). Thus, all types of ultrasound produce much lower pressures inside the body and generate heat on the way to the treatment zone. This translates into small/limited penetrations.
Practically, shock waves are characterized by intensive compressive pressures and significant cavitation generation, with limited and localized heat produced inside the tissue by the collapse of the cavitational bubbles. There is a “macro effect” generated by high compressive forces producing tissue micro-tears and a “micro effect” given by the collapse of cavitation bubbles causing micro-jets in excess of 100 m/s. The synergetic effect of these two actions give faster and better therapeutic results for shock waves when compared to ultrasound.
Moreover, cavitation phenomenon generated by ultrasound is much lower in intensity or inexistent. This is given by the low ultrasound negative/tensile pressures, which makes the ultrasound cavitation bubbles smaller and thus generating less powerful micro-jets during their collapse, when compared to shock waves. Also, the ultrasound cavitation bubbles in many cases cannot grow to their full dimensions, since they are crushed by the immediate incoming positive cycle of the ultrasound, which reduces their therapeutic significance. This is valid for low intensity ultrasound (diagnostic ultrasound), high intensity ultrasound (therapeutic ultrasound), and High Intensity Focused Ultrasound – HIFU (ablation ultrasound).
Comparison of low intensity ultrasound with shock waves
Comparison of high intensity ultrasound with shock waves
Comparison of High Intensity Focused Ultrasound (HIFU) with shock waves
Finally, therapeutic ultrasound (frequencies in the range of 18 kHz to 1 MHz) cannot be focused, which is in contrast with shock waves that can be focused where the treatment is needed, regardless of depth inside the human body. High Intensity Focused Ultrasound (higher than 1 MHz) can be focused. However, HIFU generates significant amounts of heat and is applied only for tissue ablation. This is why cannot be used in the same applications as shock waves.
For medical applications, shock waves succeed in healing faster compared to ultrasound. This is done by supplying the treatment area with a high intensity energy in a short period of time and with synergistic effects at both macro and micro tissue levels. To obtain the same amount of energy from ultrasound (without the guarantee of healing success), it would be necessary to supply the relatively low power energy generated by ultrasound for much longer periods of time and in increased number of treatment sessions. The result of the longer treatment time would be storage of energy in tissue, with concomitant heating and tissue degradation, which practically eliminates this option. The alternative is to give small dosages of energy in increased number of treatments, which is harder to achieve due to poor patient compliance. Patients in general do not like to come by the doctor’s office for many treatments and the increased financial burden created by additional treatments represents another deterrent for majority of the patients, which results in poor compliance.
To summarize, below is presented a synopsis of major differences in between shock waves and different forms of ultrasound, which clearly demonstrates the title’s “apples and oranges” reference that is used “for two things that look the same but are fundamentally different”:
Unidirectional action generates no loss through heat – “cold” high energy therapy Long duration of Tensile Phase, when compared to ultrasound (7x to 10x longer), generates large cavitation bubbles of only one category: Gaseous (tensile phase expands gaseous mini-voids from body fluids) Collapse of larger shock wave cavitation bubbles generates powerful high speed jets with action within a few micrometers (cellular level) Any tissue depth penetration is based on reflector’s geometry Treat any type of tissue (hard, semi-soft or soft tissue) There are no limitations on treatment type (regeneration or ablation)
THERAPEUTIC /HIGH INTENSITY OR FOCUSED ULTRASOUND
Bi-directional action generates heat inside tissue reducing energy due to heat losses Cavitation by negative pressure generates small cavitation bubbles that are collapsed rapidly by next incoming ultrasound wave (they cannot reach their full potential): Gaseous (tensile phase expands gaseous mini-voids from body fluids) Vaporous (low negative pressures transforms fluid in vapor) Boiling (high temperatures generated during HIFU produce bubbles) Penetration depth is reduced by tissue’s ultrasound absorption, that generates heat Regenerative treatment or ablation treatment is effective only for soft tissue
MAR 28, 2017Shock Wave’s Modus Operandi
Kinematics, mechanics and the world of Physics…simple, yet so complex to observe phenomenon and express it in mathematical form. Arguably one of the best in the matter of mechanics, Sir Isaac Newton summarized as the third law of motion that for every action, there is an equal and opposite reaction. Forces always come in pairs - known as "action-reaction force pairs." Does this principle apply to shock waves? The answer is without exception, yes.
It is a fact that shock waves are capable to generate the “action” force via compressive pressure of its positive pressure signal, and high velocity jets (another “action” force) during the implosion of cavitational bubbles produced by tensile/negative pressure of the shock wave pressure signal (only when shock waves are traveling through liquids).
Typical Shockwave Pressure Pulse
However, it is even more complex when living organism are involved, and toned-down medical shock waves are acting at the cellular level or tissue level. The action-reaction principle is still applicable at the moment shock waves pass through tissue, which gives the instantaneous “action” of the shock waves and “reaction” of the tissue (macro level) and at cellular level (micro level). The less typical and interesting part is the “secondary reaction” or “delayed reaction”, with far more implications on the tissue and cells, as the medical professionals nicknamed “MOA” or mechanism of action.
When produced by explosion, the shock waves’ action-reaction effect is noticed immediately in close proximity to the point of origin, as seen in the one presented below, from archive photos of first nuclear explosion tests. The compressive force generated by acoustic pressure shock waves is the “action” that rolled/pushed the school bus for about 50 feet, and the “reaction” is the rolling motion of the bus that consumed completely the “action” force until the bus got to a complete rest. At the time when the bus stopped from its rolling motion, the shock wave front that started the “action” on the bus was further away, due to the fact that shock waves travel in air with 300 m/s (0.186 mile/s), thus shock wave “action” was then felt in other places.
What happens at large distances away from the explosion’s epicenter? It’s fast and furious.
When military tried to monitor one atomic bomb explosion, from the air and at a considered safe distance from explosion’s epicenter, the high energy-generated shock waves showed action farther than expected. To general surprise, the zeppelin used for observation turned into a “victim” of the shock wave action by crushing it and easily sending it down, as seen from picture below.
When they specifically travel through liquids and not atmosphere, the other possible “action” forces of shock waves are the cavitational jets produced by the collapse/implosion of the cavitation bubbles generated by the negative pressure of the shock waves in its tensile phase, as seen below.
Shock Wave Bubbles Implosion with Micro-jets
In many cases, cavitation action forces can generate undesirable consequences. In devices such as propellers and pumps, cavitation causes a great deal of noise, damage to components, vibrations, and a loss of efficiency. In domestic plumbing, when a pipe is suddenly closed at the outlet (downstream), the mass of water before the closure is still moving, thereby building up high pressure and a resulting shock wave that manifest as a loud banging resembling a hammering noise, known as “water hammer”, which can cause pipelines to break, if the pressure is high enough. The action forces produced by cavitation can produce “reaction forces” in materials surrounding the fluid, that can exceed the strength of the material, which can be devastating, as it shows in the below picture depicting the total destruction by cavitation of a headrace cement tunnel from a hydroelectric dam.
In medicine, the shock waves are used either to destroy kidney stones or to stimulate living tissue to repair and regenerate. The immediate “action” of the shock waves is practically to stretch the tissue and produce tissue strain, thus generating the immediate tissue “reaction” (macro level, immediate reaction). When cavitation bubbles produced in any of the body’s fluids (blood, interstitial fluid, urine, etc.) collapse, they produce micro-jets (the “action force”) that interact at micro-level with individual cells from the fabric of the tissue or the adjacent structures.
Regarding kidney stones destruction, the shock wave “action” forces exceed the kidney stone’s strength, thus producing stone fragmentation. For tissue regeneration medical application, the shock wave “action forces” are reduced in intensity in order to produce “reaction forces” at the macro and micro level and generate a cascade of “secondary body reactions”, as the reactive oxygen species (ROS) inside body fluids, expression of growth factors, angiogenic factors, inflammation modulation, improved microcirculation and oxygen supply that ultimately produce cell proliferation and differentiation.
The summary of all these reactions, demonstrated with numerous scientific publications results, are part of the shock waves mechanism of action or “MOA” inside the living tissue, as presented in the following movie.
In conclusion, shock waves definitely follow the nature principle of action and reaction, although shock waves have their own nuances when it comes to living tissue reaction: a “double reaction” (instantaneous and delayed) can be seen, can regenerate cells/tissues and constitute a non-invasive mean to add to our armamentarium of ways to keep one healthy, repair damaged tissue, which ultimately translates in a more productive life for both society and personal benefit.
FEB 23, 2017What Is A Shock Wave?
It is the theory that the Universe started with the “Big Bang”, which is the first cosmic scale shock wave that created the vast expanse of the stellar space. It was just the beginning, as planets, stars and galaxies still continue to form through collisions, explosions, implosions and other events which created other shock waves at cosmic scale.
When life appeared on Earth at cellular, multicellular level and complex organisms, there was a constant bombardment of meteors, intense volcanic activity, and sustained earthquakes, all sources of strong shock waves. As a reaction to the environmental generated shock waves, in time, living organisms adjusted to mechanical/pressure stimulus produced by shock waves similar to their reaction to other stimuli such as heat/cold, chemical, electrical, etc. This explains human body’s sustained reaction when subject to modulated shock waves, that translates in healing and regeneration due to cellular/tissue interaction.
Generally, an acoustic pressure shock waves is an audible and very strong pressure impulse in any elastic medium (air, water or solid), created by supersonic craft, lightning, explosions, earthquakes or other extreme phenomena that generate sudden and significant changes in pressure.
Explosions of any kind produce shock waves in air/water/solids, as can be seen from next videos:
Shock waves are very fast, invisible, powerful and propagate in any direction through all types of organic and inorganic matter. They travel with 300 m/s (0.186 mile/s) in air, 1500 m/s (0.932 mile/s) in liquids and up to 9000 m/s (5.592 mile/s) in solids, which makes them to reach almost instantaneous proximity targets and can travel large distances. Humans have used shock waves for their destructive power mainly in military purposes, but in the second half of the last century also for medical purposes (breaking of kidney stones and for tissue stimulation and regeneration).
The “beauty” of medical acoustic pressure shock waves is the harnessing and modulation of their power to be focused and pass through the human body without destroying soft tissue, when kidney stones are targeted, or for stimulating tissue regeneration (both hard tissues, as bone, and soft tissues, as skin and muscles). The focusing and propagation of shock waves is presented in the following picture captured using high speed photography.
The pressure profile of a shock wave is characterized by a sudden increase in compressive pressure (compressive phase) followed by an exponential decrease until the pressures get negative in the tensile phase of the shock waves. Medical shock waves are usually producing compressive pressures up to 100 MPa (1000 bar) that act on tissue macro level and negative/tensile pressures of up to -15 MPa (150 bar) that produce cavitation in fluids and act at cellular micro level.
In our divided world for any possible reasons, where the same event can be seen as “bad” or “good” depending on one’s opinion, it seems that acoustic pressure shock waves fit the same mold too. On one hand, shock waves can be used for their significant destructive power, whereas on the other hand they can heal the human body. The choice is always in front of us.