MediWound announces NexoBrid marketing approval from Israeli Ministry of Health

Previously, NexoBrid received marketing authorization from the European Medicines Agency for this same indication in the European Union (EU), and the product was commercially launched.

"We are especially pleased to have NexoBrid available to severe burn patients in Israel as this innovative product and its underlying proteolytic enzyme technology were developed here and leading burn centers in Israel have accumulated substantial clinical experience. To date, burn specialists in Israel have used the product in clinical studies and on a specific patient/institution basis. With this marketing authorization, they will now be able to prescribe NexoBrid for their burn patients. NexoBrid represents a new paradigm in the treatment of burns and offers significant advantages over current standard-of-care," stated Gal Cohen, President and Chief Executive Officer of MediWound.

"Importantly, clinical studies have shown with statistical significance that NexoBrid successfully debrides burn wounds much earlier than the current standard-of-care, and significantly reduces the number and extent of surgical excision and autografting. The ability to promptly and effectively remove the eschar allows clinicians to directly visually assess burn severity while significantly reducing surgical burden on patients as well as on health systems. NexoBrid may play a major role in mass casualty events where surgical capacity might be limited and rapid severity assessment is imperative," added Mr. Cohen.

"We are delighted to have NexoBrid approved for use in Israel as many burn centers have first-hand experience with the clinical benefits it offers our severe burn patients," stated Josef Haik, M.D., Head of the Israeli Burn Association. "We believe NexoBrid can significantly contribute to burn management by providing an effective diagnostic tool and a nonsurgical means to remove nonviable tissues without harming the surrounding or underlying viable tissues."

"Following our launch of NexoBrid in Europe last December, we are looking forward to commercializing NexoBrid in our home country during this quarter. We are confident that a focused and knowledgeable sales force can effectively provide product support and collaboratively work with the burn teams in Israel to further improve patient outcomes," concluded Mr. Cohen.