The COMS® One Therapy System Receives CE Mark
Piomic Medical, has received CE certification for its Class IIa medical device. The COMS One Therapy System is intended to promote wound healing in chronic leg and foot ulcers.
Piomic Medical, has received CE certification for its Class IIa medical device. The COMS® One Therapy System is a portable, hand-held device which incorporates the technologies for optical and magnetic stimulation, intended to promote wound healing in chronic leg and foot ulcers. The initial clinical study provides evidence, that the treatment is safe and leads to accelerated wound closure, overall reduced pain and increased quality of life. With successful CE certification Piomic Medical AG has reached its most important milestone in the company’s history.
It is estimated that up to 1 % of the population suffer from leg and foot ulcers. These wounds cause pain, immobility, dramatically reduced quality of life and remain the leading cause for minor and major amputations. Driven by diabetes and the effects of an ageing population, hard-to-heal wounds remain a major challenge for modern healthcare systems, generating about €100 billion in annual direct costs around the globe.
The COMS® One therapy system integrates an innovative technological approach into a wearable and compact medical device. The therapy supports physiological wound healing processes and restores the metabolic potential of impaired tissue. This synergistic concept acts like a kick-start for the wound. The therapy is locally applied via a soft disposable barrier and an ergonomic fixation strap. The easy-to-use, single button operated device integrates smoothly into the patient’s healing journey with usage in stationary and ambulant facilities but also in patient’s homes.
The timely transfer of patients from stationary settings to less expensive post-acute care settings, such as the outpatient or homecare setting, has become a top priority to reduce health care costs in developed countries. The human-centered design allows to minimize training efforts and fits seamlessly into the workflow of healthcare professionals. Along with the possibility for self-administration, the COMS® One device offers optimal conditions to enable patient self-management in a cost-effective manner.
Validated with key opinion leaders in a multicentric clinical trial
Early traction allowed Piomic to conduct a multicentric clinical trial with key opinion leaders in Switzerland. “Research has difficulties to create innovations for treatment of wounds that do not heal or heal poorly. The COMS® technology is finally bringing a new and very promising therapeutic approach to the field and seems to initiate a significant improvement in wound healing, even in patients with poor healing prospects. After many years of experience in conducting clinical trials in wound care, I am proud to have been involved in the development of such a promising technology” says Dr. Jürg Traber, Director at Venenklinik Bellevue, Switzerland.
Expanding clinical research towards the United States
Piomic will now introduce its product to their network of key opinion leaders in Europe. Simultaneously a large randomized controlled trial (RCT) is being initiated to further strengthen the body of evidence for clinical efficacy and subsequent US market clearance of the COMS® technology. In the US alone, it is estimated that the cost of chronic wound care ranges from 28 to 50 billion USD per year.