Rehovot-based 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 company says that 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 atherosclerosis. 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 US regulatory 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. Eximo says that treatment with the system it has developed 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 13 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.”
Eximo CEO Yoel Zabar said, “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’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.
Published by Globes [online], Israel business news - www.globes-online.com - on April 6, 2016
© Copyright of Globes Publisher Itonut (1983) Ltd. 2016