MALAKOFF, France--(BUSINESS WIRE)--Regulatory News:
THERACLION (Alternext, FR0010120402 – ALTHE), a company specialized in leading-edge medical equipment for echotherapy, announces a major milestone in its efforts to enter into the varicose veins market: the last patient of the CE marking study has been treated.
The study is being conducted by Dr. Obermayer in Melk, Austria. “We are happy with the clinical outcomes. We have treated patients who received various sorts of existing treatment options before receiving echotherapy and finally we have found a suitable alternative” says Dr. Alfred Obermayer, M.D.. Dr. Obermayer is a vascular surgeon at the St. Joseph Hospital in Vienna and is director of the Karl Landsteiner Institute for Functional Phlebology – Melk, Austria. He presented preliminary Echotherapy results at the International Vein Congress in Miami earlier this year. “There was definitely a high level of international interest in these data: this non-invasive method will be a game changer in the varicose vein market.”
“Existing methods, even if minimally invasive, have a long list of shortcomings: an incision and therefore the need for a sterile intervention room, the mandatory tumescence anesthesia, which is cumbersome or even general anesthesia, side effects like pigmentation, inflammation, nerve damage or induration. Patients need someone to accompany them after the treatment.” Says Michel Nuta, VP Veins & CMO. He concludes: “Echotherapy has the potential to bring an answer to the shortcomings of existing methods.”
Healthcare costs related to the varicose vein market have grown to USD 9 billion annually. This figure excludes the treatment of telangiectasia, or so-called spider veins. The market for medical devices has grown at 12% CAGR in the past 10 years from around USD 160 million to over USD 500 million thanks to the rapid adoption of minimally invasive methods such as radiofrequency and laser. “We expect the veins device market to grow beyond $2 billion dollars annually within 10 years with echotherapy driving this acceleration” says Anja Kleber, VP Marketing and Market Access Theraclion. “We are facing a market where key opinion leaders recognize that patient procedure preference drives procedure adoption. This is a market in which minimally invasive methods have paved the way and demonstrated that patients are ready to pay out of pocket in many countries, including the biggest markets.”
“As we have built on the breast & thyroid indications, we are now extending our disruptive, practice-changing technology to a new space; this new indication changes the ultrasound therapeutic market dimensions for Theraclion”, concludes David Caumartin. “Our plan for CE marking and FDA submission will soon be disclosed. We have concentrated most of our research, & development and clinical effort to transform this huge market opportunity. We will address this market with answers to clear unmet medical needs and deliver multiple benefits coming from our echotherapy technology. We bring a revolutionary, non-invasive, accurate & safe approach which addresses current options’ shortcomings. The whole project looks extremely promising.”
Theraclion will disclose details about the clinical experience, customer feedback, as well as regulatory and market access milestones in a web conference held on June 18th at 3pm CET. To participate please contact firstname.lastname@example.org .
Theraclion is a French company specializing in high-tech medical equipment using therapeutic ultrasound. Drawing on leading-edge technologies, Theraclion has designed and manufactured an innovative solution for echotherapy, the Echopulse®, allowing non-invasive tumor treatment through ultrasound-guided high-intensity focused ultrasound. Theraclion is ISO 13485 certified and has received the CE mark for non-invasive ablation of breast fibroadenomas and thyroid nodules. Based in Malakoff, near Paris, France Theraclion has brought together a team of 35 people, 50% of whom are dedicated to R&D and clinical trials. For more information, please visit Theraclion’s website: www.theraclion.com
Theraclion is listed on Euronext Growth Paris
Mnemonic: ALTHE - ISIN Code: FR0010120402