Eximo Medical has successfully completed a multicentre 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 355nm. 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 355nm 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.
Waclaw Kuczmik, Senior surgeon at the Medical University of Silesia in Katowice, Poland, stated, “We are proud to be the first medical centre 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.”