Medisse, a medical device company focused on the development of a new generation of resorbable flexible implants, announced today that it has successfully completed the biocompatibility evaluation of its novel resorbable FlexiSurge™ biomaterial in accordance with the international ISO 10993 standards. Regulatory agencies such as the European Council or the U.S. Food and Drug Administration (FDA) rely on the ISO standards to ensure the safety of biocompatible materials before clinical trials are initiated. Completion of the ISO 10993 is an essential step in bringing FlexiSurge's commercial development forward.
Medisse's lead product based on its proprietary FlexiSurge biomaterial is an adhesion barrier for use in surgery. Adhesion occurs in the body when two neighbouring organs "stick" to each other by a band of scar-like tissue that prevents or disturbs the organs from functioning normally. Adhesion constitutes a major complication after surgery: approximately 95% of patients develop internal adhesions after surgery, often causing chronic pelvic pain, infertility, intestinal obstruction and many other complications.
Sandra de Vos, founder and CEO of Medisse said: "FlexiSurge has all the right properties to significantly reduce the risk of adhesion, which is a major cause of serious complications after surgery. The effective and safe physical barrier that FlexiSurge provides and its ideal handling properties overcome the shortcomings of current solutions used in surgery."
The FlexiSurge biomaterial is flexible and elastic and together with its resorption profile is a unique material for soft tissue resorbable implants. The material resorbs via surface erosion, leaving the implant functional until almost fully resorbed. Resorption time and functionality can be tailored to the clinical need.