REHOVOT, Israel, April 6, 2016 /PRNewswire/ --
Eximo Medical, a medical device company that is developing a laser system and unique catheters for the treatment of peripheral artery disease (PAD), has successfully completed a multicenter clinical trial for the purpose of obtaining CE approval for marketing in Europe. The results of the trial indicate that use of the Eximo system provides a safe, precise and highly efficacious solution in cases of partial blockage, complete blockage and severe calcification. The trial, which was led by two physicians from Poland, included 20 patients, some of whom required bypass surgery or leg amputation and are no longer at risk of amputation following the treatment.
Eximo was founded by Accelmed, a medical device investment fund, in 2012. In July 2015, Eximo completed its round A investment, led by Accelmed. Following the success of the trial, the company is now pursuing CE Mark and will be looking to receive FDA approval in 2017.
The Eximo system is based on a solid-state ultraviolet laser with a wavelength of 355 nm. The system is connected to a hybrid catheter, which combines tissue ablation by means of the laser and resection with a blunt mechanical blade. Eximo is the first company in the world to have succeeded in actively combining a 355 nm laser with a mechanical blade in a way that enables a high level of accuracy in cutting through vascular blockages. Eximo's proprietary hybrid laser-mechanical blade design removes blockages irrespective of the type of blockage or the size of the blood vessel, and increases the efficacy and safety of performance while reducing the risk of puncturing the blood vessel, compared to competing technologies.
Vascular blockage of the lower extremities is the main cause of 66% of limb amputations in the United States (approximately 120,000 amputations per year), with an estimated total cost of $8.3 billion to the US health system. Treatment with the system developed by Eximo will enable the blockage to be efficiently and safely eliminated, saving many patients from limb amputations. Today, there are over 12 million PAD patients in the United States and the market size is estimated to be in excess of $1 billion.
Dr. Waclaw Kuczmik, Senior surgeon at the Medical University of Silesia in Katowice, Poland, stated: "We are proud to be the first medical center in the world to have treated patients with the Eximo system. The treatment of all 14 patients by us was highly successful, without any complications. All of the patients have experienced significant pain relief in the treated limb and significant improvement in quality of life."
Yoel Zabar, CEO of Eximo, stated: "We are pleased to announce the successful completion of a first-in-human study with a PAD application, which constitutes a significant milestone that will enable the receipt of CE marketing approval in Europe. We are proud that thanks to the unique technology developed by our company, we were able to alleviate patients' suffering and prevent complicated, unnecessary surgeries, which could, in extreme cases, even have led to amputation of the leg. The completion of the trial represents an additional significant step toward a multi-participant FDA trial in the United States - a potential market of billions of dollars."
Eximo Medical Ltd., which is located in Rehovot, is an Israeli company that was founded in 2012 by Accelmed. The company is devoted to developing efficacious and safe solutions for the treatment of vascular blockages. The company's catheters are based on an innovative hybrid technology, which includes a combination of a compact laser system and mechanical elements.
Eximo's future products include solutions for the removal of pacemaker electrodes (LE - Lead Extraction) in cases of damage to the electrode or infection, and, at a later stage, catheters for procedures in the digestive tract.
In March 2016, Eximo won the Innovative Company Award at the IDSS Electrophysiology Conference.
The founders of the company and a scientific consulting committee, which includes renowned specialists from American and Israeli medical institutes, support the Eximo Medical management team.
Additional information is available on the company's website: http://www.eximomedical.com
Accelmed is the largest pure play medical device fund in Israel. Accelmed focuses on global investments in mature companies that might serve as a platform to Israeli companies and also builds companies that develop innovative medical devices solutions for major markets - such as diabetes, obesity and heart diseases - in which there is currently no medical solution. Since it was founded in 2009 by Mori Arkin, the chairman of the investment committee, and Dr. Uri Geiger, the managing partner, Accelmed has made 18 investments in medical device companies, including M&A and IPO of five of them.
Accelmed manages over $250 million invested in medical device, and has recently announced initial closing for its third fund: Accelmed Growth Partners - AGP. Existing companies in the portfolio include Corvia, Valcare, EndoSpan, SoniVie, CartiHeal, Nitiloop, Digma, Memic and NitiNotes.
Accelmed has a large and experienced investment management team which, other than Dr Uri Geiger and Mori Arkin, includes four additional partners (Dr. Irit Yaniv, Ilan Ben Oren, Lior Shav, and Amir Blatt) together with a team of analysts and well-known advisors.
More information can be found on Accelmed's website: http://www.accelmed.com
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