IonMed Surgical Closure Gets CE

IonMed has received CE mark clearance for its Bioweld1™ cold plasma system for surgical incision closure. Bioweld1 is the first system in the rapidly emerging field of plasma medicine designed for use in operating room settings as an alternative to surgical staples, sutures, and sealants.

The patented Bioweld1 system combines a plasma-generating device, including a disposable plasma-emitting head and a medical plaster, Chitoplast™, which covers the wound and assists in approximating the incision edges. To seal the incision and promote coagulation and healing, the Chitoplast “solder” is affixed to the incision edges, and the plasma jet is applied along the incision edge. Chitoplast consists of adhesive plaster strips and a film, based on chitin, a natural biomaterial with established hemostatic and antimicrobial properties.

The CE Mark clearance is based on positive preclinical as well as clinical studies, including a trial of 20 women undergoing elective Cesarean section and a pilot human evaluation of skin grafting. Other studies in preclinical models have documented safety, rapid disinfection, and efficacy in skin graft closure.