Q. & A. with Dr. Sylvain Yon, Theraclion’s Chief Technology Officer
Q. In general, what is the current status of your company?
Theraclion is a French company that was created in 2004 and currently employs about 20 people who specialize in high-tech therapeutic ultrasound. Theraclion conceived, developed, and commercialized an innovative device, the Echopulse, which combines high intensity focused ultrasound for therapy and real-time ultrasound imaging for monitoring for the noninvasive treatment of benign thyroid nodules and breast fibroadenomas (BFAs). The CE mark is granted for both indications.
Q. How many years has the ECHOPULSE System been in development, and what are its origins?
In 2004, Theraclion spun-off from EDAP-TMS, the pioneering therapeutic ultrasound company that commercialized both HIFU (Ablatherm®) and extracorporeal lithotripsy systems to address urology pathologies. After 10 years of research and development, Theraclion developed the Echopulse to treat patients suffering from benign tumors like thyroid nodules and BFAs. Echopulse is protected by more than 90 patents.
Q. What is the unmet medical need in breast fibroadenoma?
BFA is the most common benign tumor of the breast, occurring in 10% of women over the course of their life. Until now, only two options were available for the patients and the doctors: the removal of the BFA with invasive or mini-invasive procedures or medical surveillance with strict control of the fibroadenoma. Echotherapy is the only 100% non-invasive treatment that offers patients a new alternative that is scar-less and performed under local anesthesia with no hospitalization or recovery time needed.
Q. Tell us about your U.S. clinical study that just started. What does this milestone mean for the company? Will other sites be added to the study before the next phase pilot study or only at that time?
In collaboration with the University of Virginia, the study will be conducted on 20 patients with BFA. It is designed to collect data on the safety and efficacy of the Echopulse system in this indication and will be the first step to commercialize it in the United States. After this clinical trial is completed, the next step will be to start a randomized multi-center study whose results will be the main element for the U.S. FDA application.
Q. What were some of the technical challenges your group has had to overcome to develop the system? What challenges will you have to tackle moving forward?
The most challenging aspects associated with device development are related to our goal to make it user friendly; Echopulse integrates functions as various as ultrasound imaging for guidance, cooling, robotics, and therapy beam generation in a single device. Making this work together in a user friendly fashion and with total patient safety required an incredible amount of work with designers, ergonomic specialists, and developers. Moving forward, Theraclion will keep improving the Echopulse to enable faster and easier procedures for widespread adoption of the technique.
Q. The treatment is currently available and approved in France, Italy, and Germany. How has your system been accepted and utilized in these markets?
The Echopulse is raising a lot of interest from the medical community. There are currently about 10 units in use, and Theraclion expects to significantly increase sales of Echopulse as soon as echotherapy obtains reimbursement from local healthcare authorities.
Q. Theraclion recently underwent an IPO. What will you do with these new resources?
The company’s shares trading on the Alternext Paris market were intended to provide the company with the means to finance further development, in particular:
- the rollout of the distribution network and the organization of teams for the company’s marketing strategy
- the clinical studies and regulatory formalities required to penetrate the North American and Chinese markets
- the enhancement of R&D efforts and of the organization of production and service teams
Q. What other indications will you pursue or are you already pursuing with the Echopulse system?
Theraclion’s ive is to become the undisputed leader in the noninvasive treatment of breast and thyroid pathologies, today in benign tumors and tomorrow in cancer.
Past coverage of Theraclion:
April 2014 - News story about Theraclion gaining FDA approval for breast fibroadenoma study in the U.S. and link to their press release. http://www.fusfoundation.org/news/1338-focused-ultrasound-clinical-trial-for-breast-fibroadenoma-gains-fda-approval?highlight=WyJ0aGVyYWNsaW9uIl0=
December 2013 - Theraclion is mentioned in our newsletter "read more" story about FUS breast research http://www.fusfoundation.org/news/1107-focused-ultrasound-breast-research-december-2013-update?highlight=WyJ0aGVyYWNsaW9uIl0=
October 2013 - Newsletter mention in "Media" section about Theraclion's Thyroid Nodules study. http://www.fusfoundation.org/the-foundation/news-media/317-fusf-newsletter-october-2013?highlight=WyJ0aGVyYWNsaW9uIl0=
January 2013 - News blurb (link 1), Newsletter story (link 2), and video announcement (link 3) of bone mets clinical trial beginning in France
December 2012 - Echo Pulse gets CE Mark for Breast Fibroadenoma in Europe http://www.fusfoundation.org/news/784-theraclions-echopulse-receives-ce-marking-for-treatment-of-breast-fibroadenoma?highlight=WyJ0aGVyYWNsaW9uIl0=