Q: Tell us a bit about your background and how you got involved with EDAP.
I've been with EDAP for more than 18 years and have held Sales Management positions in most region of the world. I became EDAP COO in 2004 until I was promoted to CEO in 2007.
Q: What is your current vision for EDAP?
The clearance of HIFU for prostate ablation by the FDA has given our technology world class recognition and acceptance. The vision for EDAP is to further expand and penetrate the prostate market worldwide and to continue our investment in innovation in non-invasive therapies based on therapeutic ultrasound.
Q: What is the current scope of the company for treating prostate – number/name of marketed systems, installation base, number of countries with regulatory approval, number of patients treated, etc.?
Today, EDAP has a complete range of HIFU devices for prostate ablation with our Ablatherm Robotic HIFU and our Focal One. We have an installed base of more than 100 devices in more than 30 countries. Our HIFU technology has performed approximately 45,000 treatments worldwide, all of them on patients with prostate cancer – this is by far the highest experience in the world.
Q: What is unique about your EDAP system?
Our system is the only fully robotized and motorized HIFU device for prostate ablation, and it is the only device with an endorectal probe with two specific transducers, one for imaging and one for treating, which allows for the best quality of planning and efficacy of treatment, without the need to compromise between the two functions (as opposed to other systems). This unique two-transducers-in-one probe also allows a unique capability for real-time treatment monitoring . Finally, our system has a number of unique safety features.
Q: What do you see as the ideal role for HIFU in the treatment of prostate disease?
As a non-invasive, precise, accurate, repeatable, radiation-free, and ablative technology, it allows the urologist to use this great tool in a number of treatment strategies from radical to partial ablation and from primary care to salvage treatment. The low level of side effects reported in the literature and the safety features of our Ablatherm Robotic HIFU device shows its high capacity and potential in preserving patients’ quality of life – this is key today in both patients’ and urologists’ minds.
Q: What is your go-to-market strategy for success in the US?
As we uniquely did in Europe, the main goal and strategy is to start working with big institutions and academic centers to build scientific and clinical recognition of the HIFU technology for the ablation of prostate tissue. We also want to partner and help robotic surgeons and urologists expand their armamentarium offering in managing prostate issues.
Q: Where does the US market for prostate fit into your overall company plans?
We've invested 10 years in the FDA process to access the US market, simply because the US market is at the center of the company's plans. The penetration of the US market fits well the company's global expansion plans on both the geographical and business opportunity fronts.
Q: What is your strategy for gaining US reimbursement?
Our strategy is clearly to work on getting the technology reimbursed so that a majority of patients can benefit from this great and non-invasive technology. To make that happen, we will properly position our offering and work with the deciding authorities, and this is something we've already started.
Q: What are the next indications you are pursuing?
EDAP is a global leader in focused ultrasound, with a large portfolio of patents treated. We continue to invest in research programs, with our historical partner INSERM (the French equivalent of the National Institutes of Health). We are currently working on several projects and have clinical trials for liver metastases, pancreatic cancer, gynecologic applications, and others.
Q: Any interesting challenges/opportunities you are pursuing?
Bringing new horizons to therapy has been, is, and will remain our main goal and challenge.
Q: Where do you see the field of focused ultrasound going?
It is extremely promising. I see a huge and great future for focused ultrasound technologies in the medical and surgical field.
Q: What has been the value of the Focused Ultrasound Foundation to your company and/or the field?
The Foundation adds value by bringing companies, laboratories, and practitioners together to share their work and experience; this is key in creating synergies and giving pathways and dynamism to research and development. The Foundation has also been very supportive to us in the FDA process (the FUS presentation during the FDA Advisory Panel reviewing Ablatherm Robotic HIFU in July 2014 in Washington, DC is one example).
Q: What role do you think that the Focused Ultrasound Foundation should play?
It should continue to play the role of supporting the field and creating synergies, as well as its support to the technology in doing events, taking action, and creating lobbying campaigns.