Setting investors’ expectations is key. Giving investors transparency and detailed status of the company’s performance helps build their trust. Even if the updates are not always what they want to hear — and they have not always been delighted with the news I have shared with them — they know they can count on us to deliver reliable information. In dealing with investors, you do not have anything if you do not have honesty, integrity, and credibility. And we have been fortunate to have long-time investors supporting EDAP who have trusted us and remained confident, even during tough times.
As a part of our series about cutting edge technological breakthroughs, I had the pleasure of interviewing Marc Oczachowski.
Marc Oczachowski is Chairman of the Board and Chief Executive Officer of EDAP TMS, a high-tech medical company which develops, manufactures markets minimally invasive therapeutic ultrasound solutions for urology, tumor removal, localized prostate cancer, and infectious diseases. Marc joined EDAP TMS in May 1997 as Area Sales Manager. From 2001 to 2004, he was General Manager of EDAP Technomed Malaysia. In November 2004, he was appointed Chief Operating Officer of EDAP TMS based in Lyon, France, and became Chief Executive Officer of the Company in March 31, 2007. On July 1, 2012, he managed US operations and lead the FDA approval process of the Company’s HIFU devices for four years. On March 25, 2020, he was appointed Chairman of the Board of Directors. He is graduated from Lyon University (Molecular Biology), and from Institute Commercial de Lyon, France.
Thank you so much for joining us Marc! Can you tell us a story about what brought you to this specific career path?
I started my career as Area Sales Manager for Sodem Systems which develops power tools for orthopedics. In 1997 I joined EDAP TMS, which designs minimally-invasive medical therapies using ultrasound technology for diseases of the prostate, kidneys, female reproductive organs, and other diseases we continue to research to apply our technology. I started working at EDAP headquarters in Lyon, France as a sales representative and became so fascinated by these technology advancements and excited to introduce such life-changing innovations to doctors and patients around the world.
After holding various sales management positions in most regions around the world, I became EDAP COO in 2004 until I was promoted to CEO in 2007. Since that time, I have led the company in developing and perfecting focal robotic HIFU (High-Intensity Focused Ultrasound), which is an incisionless and radiation free device that employs ultrasound technology where soundwaves heat up and burn (ablate) diseased prostate tissue. It is an alternative to traditional prostate cancer treatments such as radiation and radical surgery, which both can cause urinary incontinence and erectile dysfunction. I am proud to say our HIFU technology has been used to successfully treat more than 60,000 men worldwide.
Can you share the most interesting story that happened to you since you began your career?
Our journey to bring HIFU to the U.S. to get it through the regulatory approval process and reach the point where it would be covered by insurance was challenging and at times painful. Many medical device companies never achieve market success because they fail to anticipate the long, arduous process involved. We had regulatory approval in other countries and about 40,000 men had gone through the procedure. But this had no bearing on the FDA approval process. Luckily, we started this process with our eyes open and knew we were in it for the long haul. It took more than 10 years to finally achieve FDA clearance for our first and second generation of HIFU devices.
Even with FDA clearance, the HIFU procedure, which men preferred to surgery and radiation because of their life altering side effects, was not covered by private insurers and Medicare covered a very small portion, which did not include the doctor’s fee. Our next hurdle was to obtain a Category 1 CPT code from the American Medical Association (AMA). This would help facilitate reimbursement from payers. But it’s a process that can take several years.
We partnered with our top competitor as well as the American Urological Association and jumped through several hurdles, including getting HIFU clinical studies with different patient populations published in five different clinical journals. With our due diligence, we were able to win approval from the AMA in the first round of our application. The AMA established the new Category 1 CPT code for HIFU which went into effect on January 1, 2021.
Can you tell us about the “bleeding edge” technological breakthroughs that you are working on? How do you think that will help people?
What makes focal robotic HIFU technology a breakthrough in robotic therapy is its intelligence in carrying out the precisely targeted ablation of diseased tissue. This is true robotic surgery. The urologist first plans the navigation to the diseased area then inputs the plan into our Focal One® system which automatically directs the probe toward the location of the tumor, destroys only this designated area and adjusts as needed, in real time. The urologist can stop and readjust manually if necessary so he is always in full control. Our robotic technology is similar to a pilot flying a commercial aircraft. He first enters the flight plan and coordinates into the navigational system and the jet uses sensors and makes adjustments to fly safely to the chosen destination, with the pilot maintaining full control in case intervention is required.
Because our device is so precise in destroying only the diseased portion of the prostate, with no damage to surrounding tissues, men get to maintain their quality of life. Unlike radical surgery and radiation — current standards of care for prostate cancer — which tend to damage nerves, effecting urinary and sexual function. Both side effects can be a great burden in work and social situations, and often devastate relationships. The HIFU procedure gives men a future they can enjoy.
How do you think this might change the world?
About 1 in 8 men will be diagnosed with prostate cancer during his lifetime, but it is one of the most curable diseases, because it is one of the slowest growing cancers and can be caught in the early stages due to annual testing. And we now have safer, effective therapies and treatments backed by years of research. Andthanks to new innovations in precision technology, such as Focal HIFU, prostate cancer is no longer an unfortunate quality of life “sentence” for men. They can avoid the disruptive side effects associated with radiation and surgery, and take advantage of a safer, noninvasive medical procedure through hospitals that are leading the way. Others can avoid the unbearable process of watching and waiting, knowing there is cancer living inside their bodies. This gives more men the chance to live a long, healthy, and quality life.
Keeping “Black Mirror” in mind can you see any potential drawbacks about this technology that people should think more deeply about?
Undergoing robotic HIFU therapy may still sound like a sci-fi novel for some, even though this method is an advancement in traditional robotic technology. But our robotic technology actually avoids incisions and organ removal, and associated complications.
The HIFU device is equipped with many automatic safety features and the treatment parameters can be monitored in real time for maximum safety and effectiveness. Devices like Focal One are designed for the doctor to easily and precisely operate and control. With Focal One, urologists execute instructions, then the device produces movements within a millimeter of accuracy.
The main drawback has been the out-of-pocket cost which averages 25,000 dollars. Most patients have had to borrow the money and accrue debt to have the procedure. This expense should be mitigated by the new CPT code that the AMA assigned HIFU and which went into effect on January 1, 2021.
Was there a “tipping point” that led you to this breakthrough? Can you tell us that story?
We knew that we had to tap into the US market to really create a “tipping point” for HIFU technology. Penetrating the US market was always part of our global expansion plan, but we knew it would take work. Now that men are eligible for reimbursement, I believe that brings us to that tipping point right now. The clearance of HIFU for prostate ablation has given our technology world class recognition and acceptance, and we continue to innovate using our ultrasound technology.
What do you need to lead this technology to widespread adoption?
We have already been successful in commercializing and delivering our technologies throughout the world, including the U.S., Europe, Asia, and North and South America. However, in the U.S. HIFU is not yet the standard of care, unlike surgery and radiation. To achieve widespread adoption is a matter of education and outreach, making sure as many patients and urologists as possible are aware of HIFU and understand that in many cases it is a better option with better outcomes, most importantly preserving the patient’s quality of life. I believe the more published research that demonstrates HIFU’S positive outcomes, the more urologists will become aware and will push hospitals to acquire the device and recommend the procedure to patients with localized prostate cancer.
What have you been doing to publicize this idea? Have you been using any innovative marketing strategies?
We have always used the same strategy to spread awareness of HIFU. First, we break into the market by partnering with medical and academic institutions to gain scientific and clinical support for HIFU. We also leverage these institutions’ studies by sharing with top urology journals, medical device publications, and consumer health media outlets to spread awareness. Hospitals that acquire our device receive a 6-month marketing and PR plan from EDAP and they work with our PR firm to spread local, regional and online awareness of the hospital’s new offering for prostate cancer patients.
During the pandemic we put together a communications plan to help our urologists communicate with prostate cancer patients and allay fears of treatment delays. We created videos, email patient letters, blog posts, etc. for hospital patients. EDAP customers have recognized the company as a true partner and market leader during this challenging period.
We have also been partnering with U.S. robotic surgeons, urologists, prostate cancer advocacy groups, and patients who have gone through the procedure to share their stories about HIFU, why they chose this procedure and how it has benefitted them in their lives.
None of us are able to achieve success without some help along the way. Is there a particular person who you are grateful towards who helped get you to where you are? Can you share a story about that?
I have three groups of people to thank:
- The EDAP employees: A lot of EDAP’s employees have been at EDAP for many years (like me, 24 years) and have participated from scratch in the development of the HIFU technology. I would like to thank all of them for their consistencey, commitment and engagement to the company and the technology, without which we could not have brought HIFU to where it is today.
- The clinicians and investigators: They have believed from the beginning in the added value of our HIFU technology and the strong interest for their prostate cancer patients. I would like to particularly thank the first investigators Professor Dubernard, Professor Gelet from Lyon and Professor Chaussy and Dr. Thuroff from Munich with whom we initiated the first treatment, the first studies and their publication, and who have continuously, for more than 20 years, supported the development of the technology, both clinically and scientifically.
- I have huge gratitude for our EDAP shareholders for their continuous support and confidence in our ability to bring the technology to a point where its commercial development and marketing success begins. Their patience and consistent faith have been key in a long process. We are happy to see now that all stars are aligned the story can really start!
How have you used your success to bring goodness to the world?
More men across the world (now nearly 60,000) are able to choose HIFU over surgery and radiation and preserve their quality of life — avoiding the life-altering side effects of incontinence and impotence that can result from other treatments. This definitely brings goodness to the world.
We have also been ambitious in developing different HIFU applications with different types of probes for use in other specialty therapeutic areas. In fact, the FDA registered our Focal One HIFU device as an ablation tool for destroying diseased tissue rather than registering it as a prostate cancer treatment. It shows HIFU and our Focal One device are truly the tools of the future to replace invasive surgery for numerous clinical applications: rectal endometriosis, pancreatic cancer and liver tumor, just to name a few that we are currently investigating.
What are your “5 Things I Wish Someone Told Me Before I Started”?
- Do not let naysayers throw you off course. Often when you are bringing something innovative to market there will be a small army of people lined up to say why you will not, cannot or should not do it. I cannot tell you how many naysayers we have proven wrong. Coming from a sales background, I am comfortable with intense scrutiny. I know we did our due diligence, and our technology is bulletproof, and its ROI is undeniable. Surely all innovators have faced the naysayers — only, for us, they are energizing. If we would have listened to them, we would not be delivering life-changing technology that has improved the quality of life for so many men with localized prostate cancer around the world.
- Making progress every single day adds up. We are very clear on our goals at EDAP and they have remained clear and consistent. We have committed to driving a huge paradigm shift in the way prostate disease is treated — the end result is like night and day for patients. I believe that making progress every single day — taking key steps and making difficult decisions — propels us forward and leads us to huge accomplishments. Bringing EDAP’s HIFU technology into the U.S. market was a decade-long project. But making consistent progress and hitting key milestones has brought HIFU to a whole population of American men who will, and who already have, been able to receive treatment and go on with their lives without the life-changing side effects that are common with standard treatments like surgery and radiation.
- Tenaciously staying the course pays off. Some business endeavors can take years and require a tremendous amount of due diligence. Some roadmaps are not always smooth, and success is not always a straight line. That being said, the pressure and impatience from investors is always present — and we are grateful to our long-term and supportive shareholders who strongly believe in EDAP. To be successful takes grit and tenacity. With EDAP, we simply did not give ourselves any other way out than to keep moving ahead and staying committed. We commercialized HIFU in Europe, and since have tenaciously brought it to other countries around the world — including to the U.S. Now, at another significant step with the establishment of the CPT code and insurance reimbursement, we will tenaciously pursue insurance companies to make this procedure something that is more accessible to the greater male population versus only those who can afford to pay out of pocket.
- Do not be afraid to fail, go for the big idea! Understanding that failure is inevitable when going for the big idea is important. Too often people see failure as a personal slight or as an indicator they should not push forward. That is when it is critical to regroup and move ahead. Setbacks teach us important things. The lessons we have learned as a result of small failures at EDAP have carried us to where we are today.Our path with FDA to get this technology approved took us through years of ups and downs. The day we received a negative vote from an advisory panel was an all-time low which could have led a lot of companies and projects to an end. And I must admit the temptation was strong. In retrospect, this has given us the strength to fight back and find ways to achieve our ultimate goals: to make this life-changing technology available to all patients in America.
- Setting investors’ expectations is key. Giving investors transparency and detailed status of the company’s performance helps build their trust. Even if the updates are not always what they want to hear — and they have not always been delighted with the news I have shared with them — they know they can count on us to deliver reliable information. In dealing with investors, you do not have anything if you do not have honesty, integrity, and credibility. And we have been fortunate to have long-time investors supporting EDAP who have trusted us and remained confident, even during tough times.
You are a person of great influence. If you could inspire a movement that would bring the most amount of good to the most amount of people, what would that be? You never know what your idea can trigger. 🙂
I am so honored to be a part of the Focused Ultrasound Foundation that was established to improve the lives of millions of people with serious medical conditions by accelerating the development and adoption of focused ultrasound, which is the gentlest way of treating previously untreatable diseases like Parkinson’s Disease, pancreatic cancer, brain tumors, and prostate cancer.
EDAP is one of the forerunners in this movement, bringing focused ultrasound from concept to reality, overcoming the technological, economic, regulatory, and reimbursement hurdles that are driving this entire class of therapeutics forward. Every day that we succeed in bringing this technology forward, prove its efficacy, clear the obstacles and drive adoption, we feel proud and excited that we are part of a greater mission to make this medical breakthrough more accessible to patients and their families who need it. And all of the lives we have improved along the way — and all the steppingstones we have set for other focused ultrasound companies to follow in our footsteps gives us great pride.
Can you please give us your favorite “Life Lesson Quote”? Can you share how that was relevant to you in your life?
In the past few years in my career, EDAP has overcome many obstacles. Most small medical device companies fail to realize the long term commitment involved in bringing their products to market, often lose momentum along the way and in the end fail to realize their vision. Bringing our HIFU devices to market all over the world has been a battle I have never thought I would experience but it has been so worth the effort. We are seeing incredible progress, transforming the way patients are treated in a non-invasive way — and the quality of life they can preserve as a result. “Teamwork makes the dream work” has never been so true!
Some very well-known VCs read this column. If you had 60 seconds to make a pitch to a VC, what would you say? He or she might just see this if we tag them 🙂
Every day well-meaning urologists treat localized prostate cancer with radical prostatectomy and radiation that can leave men incontinent and impotent for a long time — primarily because they are either not aware of less invasive options like HIFU or because it is the standard of care and guaranteed reimbursement by Medicare and private insurers. But it is not always in the patient’s best interest.
Focal One HIFU is an FDA-cleared, minimally invasive, radiation-free robotic device programmed to “search and destroy” only that portion of the prostate using high intensity sound waves. These sound waves heat up and burn the diseased area of the prostate, while sparing other parts of the gland and potentially reducing the risk of side effects like impotence or incontinence. Also, a new Category 1 CPT code for HIFU reimbursement in the U.S. went into effect on January 1, 2021. EDAP HIFU technology has been used to treat more than 60,000 patients in the world with remarkable results in terms of both survival rates and quality of life.
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