IonMed announced today that the Yokneam-based company has received CE mark clearance for a cold plasma biowelding device that connects tissues post-surgically, signifying that the product meets EU safety, health and environmental protection requirements.
The BioWeld1 system couples a cold plasma jet with a proprietary solder derived from chitosan, a natural biomaterial found in the hard outer exoskeleton of shellfish. The combination of the plaster and plasma create a breathable graft that reduces healing time and tissue scarring.
CEO Shai Levanon made the following statement:
The use of cold plasma holds enormous promise as a new therapeutic paradigm in wound care, and more broadly in medicine. With the CE Mark clearance of Bioweld1, our first system, we have achieved important validation for our technology, a key milestone for the company, and a significant step towards commercialization.
The CE Mark clearance was based on positive results in preclinical as well as clinical studies, including a study of the incision closure of 20 women who underwent Caesarean section. The results showed safe and effective closure of wounds, reduced scarring, and ease of use by surgeons.
IonMed is a portfolio company of The Trendlines Group and of Generali Financial Holdings Fund.