Actamax announces positive results from first clinical trial demonstrating safety, ease of use and efficacy of novel sprayable adhesion barrier device
Actamax, Joint Venture between DSM and DuPont, releases positive findings
Actamax Surgical Materials LLC, a DSM-DuPont Joint Venture focusing on the development and commercialization of resorbable, biocompatible surgical medical devices, today announced positive safety and efficacy results from the first clinical evaluation of its novel adhesion barrier device.
Adhesions are excessive scar tissue that forms between adjacent internal tissues. They are a consequence of normal wound healing and occur after 50-90% of surgeries. Today’s announcement brings the medical community one step closer to meeting what is widely accepted amongst surgeons as a long-term unmet need - significant reduction in the prevalence and severity of adhesions in order to minimize patient suffering, promote healing and reduce complications.
“Adhesions are a huge clinical problem in both open and keyhole surgeries,” noted Surgeon Geoffrey Trew (Hammersmith Hospital, London, UK), principal investigator for this study. “This study clearly shows that this product is not only safe and easy to use, but also has very promising clinical results. Further research will clarify its place in preventing new adhesions as well as the reformation of adhesions, both of which cause long-term suffering in sizeable proportions of patients undergoing routine surgery. This product is a potential game changer in this very difficult area which has worried surgeons for decades."
The safety, efficacy, and ease of use of the Actamax adhesion barrier was demonstrated in a 78-patient, multi-center clinical study in women undergoing a variety of gynecological surgeries. Study results show no serious adverse events and no product-related adverse events, which demonstrate the safety of the product. In this relatively small patient population the efficacy endpoint (adhesion score) also showed a significant reduction in the incidence, severity and extent of adhesions formed. Furthermore, the operating surgeons confirmed that the product is easy to use and apply.
“This is a very positive result for the treatment of adhesions,” stated Hans van den Hombergh, President of Actamax. “Actamax has developed a novel, sprayable barrier device to address adhesions in a wide range of surgical applications. These results confirm that our new adhesion prevention technology is sound and provides surgeons with an effective solution to minimize patient discomfort and complications.”
Surgery, trauma, infection and chronic inflammation (such as endometriosis) can elicit the formation of adhesions as part of the body’s normal healing response. A significant number of patients with adhesions develop complications ranging from discomfort, chronic pain and infertility (in women), to life-threatening complications such as small bowel obstruction. Post-surgical adhesions continue to be a significant concern, especially following intra-abdominal and pelvic surgery, and are now considered the most frequent complication in abdominopelvic surgery.
Actamax is in the process of obtaining regulatory approval and Surgeon Geoffrey Trew is presenting details of the study on Thursday, 20 November at the 43rd Global Congress of the American Association of Gynecologic Laparoscopists in Vancouver, Canada (Vancouver Convention Centre West, Rooms 109-110, Session “Open Comm. 16, New Instruments”, 2:15 pm).
Actamax Surgical Materials LLC is a joint venture between DSM Biomedical Inc. and DuPont. Actamax was founded in 2011 and is developing a new generation of resorbable, biocompatible surgical device solutions dedicated to improve patient outcomes and lives. For more information please visit www.actamax.com.