As Theraclion enters its 15th year of business, it is in the process of pursuing a new indication that proposes to give the company the financial stability it needs to take it into the next decade and beyond. Theraclion executives believe that using focused ultrasound to repair damaged veins is the key to the future of the company. We interviewed CEO David Caumartin, to review Theraclion’s history, learn more about what the company is doing now, and hear about his exciting vision for the future.
How was the company started?
About 14 years ago, the Vice President of Research and Development (R&D) at EDAP-TMS had the idea to use their prostate transducer for noninvasive head and neck surgery. After completing some initial experiments, EDAP spun off the new company and named it Theraclion. The new company was in development for 6 years before earning its first CE Mark in 2009 for thyroid nodules. They added the CE mark for breast fibroadenomas in 2012 and commercialized both indications in 2013. Their goal was to have two indications before launching into full commercial activity, and the company went public in 2014. Theraclion is based in Malakoff, France near Paris. More than half of its 30 employees are dedicated to R&D and clinical trials.
How did you get involved in starting or joining the company?
In 2014, I was working as a consultant, and I knew Jean-Yves Burel, Theraclion’s Chairman, from my time at GE. He was looking for someone with expertise in direct distribution and asked me to join the company to use the money from the IPO to move Theraclion from indirect to direct distribution. So I was recruited to drive the direct sales operation, oversee refinancing, and develop new business partnerships.
Tell us about your company structure: ownership, lead executives, and their roles.
Theraclion is a publicly traded company that is listed on Alternext Paris. Besides Jean-Yves Burel as Chairman and President and myself as CEO, we have David Auregan as CFO and Michel Nuta, MD, as Chief Medical Officer. Dr. Nuta has extensive experience with vein indications. He came to Theraclion from the vein industry, where he worked at VNUS, a radiofrequency ablation company that developed the application for varicose vein closure. Anja Kleber is Vice President of Marketing and Market Access, and she came to Theraclion from Accuray, where she was instrumental in the successful promotion of their image-guided cancer therapies. As Vice President of Operations, Laurence Aucoin oversees service, manufacturing, and applications. Jose Abellan-Martinez is Vice President for sales and business development worldwide.
In general, what is the current status of your company?
Theraclion is about to go to market for varicose vein treatment. We have completed the initial clinical trials and are waiting for some technical files to be completed. The current plan is to file for both European and US approval at the same time with the same data. The next step will be a phase III study with a total of 300 patients (150 in Europe and 150 in the US) who will be followed for 12 months after treatment. We are seeking investors to secure financing for the phase III clinical trials, and they will begin as soon as that is in place. In preparation, we have already secured 90% of the treatment sites with key opinion leaders in the field.
How do you describe your treatment platform?
Theraclion’s cutting-edge engineering team developed the Echopulse treatment platform to provide accurate, tailored, and noninvasive outpatient treatment of multiple diseases. The Echopulse “echotherapy” technology combines focused ultrasound therapy with ultrasound guidance and monitoring in one standalone unit.
What are some of the technical challenges your group has to overcome to develop a fully noninvasive system?
It is difficult to master efficient ultrasound transmission through the body without causing harm outside the focal spot zones. Despite that challenge, we developed a very nice way of understanding how the acoustic energy is transmitted and how to control it under ultrasound guidance with a single element of focused ultrasound control and a single linear element transducer. That has taken some time, but has produced excellent results in the thyroid application. It took 6 years for the first phase of development, but we invested that amount of time and effort to make it safer and faster year after year. Going from the thyroid to veins has been much easier because of the meticulous work that was done when the company was beginning and because of Dr. Nuta’s expertise in endovenous RF ablation at VNUS for 12 years.
What are the benefits of your technology over companies?
The Echopulse system has always been unique and differently designed as compared to other focused ultrasound systems. Echopulse was designed to be used by any single physician with ultrasound imaging experience (e.g., surgeon, endocrinologist, nuclear medicine, dermatologist, and more). It was designed for simplicity without the need for assistance from a radiologist or interventional radiologist. The system design, especially going forward, should allow any physician using ultrasound diagnostics to treat any indication for which he or she is trained to treat right after the diagnostic confirmation. The patient may not need to return for a separate treatment appointment.
Echopulse allows simpler, faster treatment because using our system is similar to performing an ultrasound examination.
What challenges do you have to tackle moving forward?
Similar to other focused ultrasound companies, Theraclion was initially focused on oncology-related applications (thyroid nodules and breast fibroadenomas). However, these applications take a lot of time and effort and small companies have limited financial resources for conducting large-scale safety and efficacy oncology studies. Moving forward, we decided to focus primarily on developing the indication for varicose veins because there are many more cases (i.e., it is an extremely common condition) and a significant part of the market falls into an out-of-pocket payment model. It is the type of indication that can help Theraclion gain financial autonomy. After we achieve that, we can develop the oncology applications. Last October I presented this development model at the 4th European Symposium on Focused Ultrasound Therapy in Leipzig. Becoming a financially stable and thriving company will give us the basis to continue work on combination treatments such as the breast cancer immunotherapy study that we are conducting with Dr. Patrick Dillon at the University of Virginia.
Tell us more about the breast cancer immunotherapy study at the University of Virginia.
The patient recruitment for this clinical trial has been relatively slow, which is understandable because it is only for patients who are very sick and who have failed at least one (but it is usually more than one) other treatment option. So their life condition is difficult and fragile, and they may not be capable of staying in a clinical trial for three months to receive all of the treatments. Dr. Dillon did present the data from the first patient at a recent scientific meeting, and the data showed proof of concept based on the biopsy results. The study will need to enroll 6 to 12 patients with similarly positive results to gain the funding needed to continue this work.
Have you learned any lessons for watching the experience of the other companies?
As I mentioned earlier, most young focused ultrasound companies have started by addressing cancer tumor treatment, and very few are cash flow positive today. That lesson told us not to go for cancer immediately. Instead, we plan to gain autonomy and then prepare the right path to oncology. Right now we see the right oncology path as a combination treatment with immunotherapy or chemotherapy, but we are not ready to fund such a trial at this point in time.
Do you partner with other companies?
Not at the moment, but we are very open to it. It makes sense to collaborate with companies that are not competitors to prove that a technology with lifesaving benefits can generate substantial revenues and earnings. It is difficult to compete against existing standards of care, such as surgery, radiotherapy, and drug therapies, so I think it would be better to initially combine focused ultrasound with an existing therapeutic solution and join forces with an original equipment manufacturer (OEM) if it made sense. Although it can be challenging to form these types of partnerships, it can truly accelerate the ability to treat deadly diseases, and it is something that needs to be done.
Is your system approved for commercial use in any markets? If so, how is it being used in these markets?
Echopulse is approved to treat thyroid nodules and breast fibroadenomas in Europe, and the benign breast tumor study in the US is 74% complete for patient recruitment. We hope to complete recruitment by the end of the year, and after the 12-month follow-up period, we will file for US approval. The interim results are giving us confidence that the treatment is safe and effective.
If our filing for varicose veins is cleared, this will be the application that is the first to go to the US. I don’t believe that thyroid will develop in the US in the short term, because it is a small market that requires a large infusion of money (e.g., 2 to 3 million dollars) to complete a cumbersome US clinical study. The incidence in the US is much lower than in Europe, and it is insignificant when compared with China.
Our current plans are to pursue the thyroid market in Asia/China and to pursue the varicose veins and benign breast tumor market in the US.
Which health conditions or diseases is your technology used for?
Besides thyroid nodules and benign breast tumors, we are primarily focused on developing the market for using Echopulse to treat varicose veins. In varicose veins, the faulty valves allow blood to flow in the wrong direction, which causes them to become enlarged, swollen, and twisted. The Echopulse device directs the focused ultrasound energy to the walls of the damaged veins to create collagen thickening in the vein’s wall, which blocks the blood flow or returns the blood flow to normal by narrowing the vein’s diameter.
How does your veterinary research program fit into the company’s goals?
We consider the US-based veterinary program to be a part of R&D. Thanks to the help of the Focused Ultrasound Foundation, this research is currently underway at several sites, and the veterinary teams have been able to successfully treat many pets with sarcoma. We see a future market for animal health, but right now our main business focus is our vein program.
Is there anything else we should know about your company?
We are eager to show that with varicose veins we have a compelling indication wherein focused ultrasound can be a serious alternative to surgery, endovenous ablation, or sclerotherapy. This disease affects 22 million women and 11 million men between the ages of 40 to 80 years (JAMA 2012). Its high prevalence affects quality of life and carries a considerable cost burden, especially when accounting for its associated complications (e.g., chronic venous ulcers). Echotherapy has the potential to be an excellent first-line therapy for this indication, and our preliminary clinical trial results are very encouraging.
We are excited about our product and we think that we have a huge potential in front of us.
First Patient Enrolled in French Innovation Study for Breast Fibroadenomas July 2018
Theraclion Announces Varicose Vein Study October 2017
Pivotal Trial Begins for Breast Fibroadenoma February 2017
Technology Upgrade Reduces Fibroadenoma Treatment Time December 2015
Company Profile: Theraclion May 2014