PRESS RELEASES




Actamax announces presentation on 12 months clinical follow-up outcomes of novel sprayable adhesion barrier device

BERKELEY, Cal. USA, 14 November 2016 – Actamax Surgical Materials LLC, a DSM-DuPont Joint Venture focusing on the development and commercialization of resorbable, biocompatible surgical medical devices, today announced that 12 months, long-term clinical follow-up results on its novel adhesion barrier device will be presented at the 45th Global Congress on Minimally Invasive Gynecology in Orlando, Florida this week. The presentation will be by Dr. Geoff Trew, a noted surgeon at London’s Hammersmith Hospital and principal investigator for this study.

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. Previously, 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. Now, in the 12 months clinical follow-up study, results indicate that use of the Actamax adhesion barrier results in a reduction in symptomatology and an increased pregnancy rate. This outcome 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.

Surgeon Geoffrey Trew (Hammersmith Hospital, London, UK), principal investigator for this study noted “The clinical community is in strong need of products that prevent new adhesions as well as their reformation. Adhesions are a clinical problem in both open and keyhole surgeries. The results from this 12 months, long-term follow-up clinical study of this adhesion barrier product are very promising and encouraging. Further investigation with a larger population will help clarify the product’s place in this challenging area which has been a significant concern of surgeons for decades.”

Marc Hendriks, President of Actamax stated, “We are excited about these positive long-term follow up results on our product. These results confirm that we are on the right track to deliver a long awaited innovative solution that minimizes patient discomfort and complications following surgery. This surgical specialty product perfectly positions Actamax in today’s medical technology market that requires companies to come up with solutions that can reduce overall cost of care.”

Actamax is in advanced stages to seek IDE approval and CE Mark registration for this device.

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.

Surgeon Geoffrey Trew is presenting details of the study on 15 November at the 45th Global Congress on Minimally Invasive Gynecology to be held at the Rosen Hotel at Shingle Creek, Orlando, Florida.

About Actamax
Actamax Surgical Materials LLC is a joint venture between DSM 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.

Actamax contact:
Marc Hendriks, President
Tel: +1 510 809 4388
marc.hendriks@dsm.com

Media Contact:
Hugh Welsh
DSM
Tel: +1 973 257 8208
hugh.welsh@dsm.com

Actamax Forward-looking statements
This press release may contain forward-looking statements with respect to Actamax’s future (financial) performance and position. Such statements are based on current expectations, estimates and projections of Actamax and information currently available to the company. Actamax cautions readers that such statements involve certain risks and uncertainties that are difficult to predict and therefore it should be understood that many factors can cause actual performance and position to differ materially from these statements. Actamax has no obligation to update the statements contained in this press release, unless required by law.

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11/14/16