PRESS RELEASES




Actamax Receives Approval to Begin Pivotal Clinical Trial for Actamax™ Adhesion Barrier

EXTON, Penn. USA, September 20, 2017 – Actamax Surgical Materials LLC, a wholly owned subsidiary of DSM, focused on design of bioresorbable medical devices to reduce the burden of post-operative complications for patients undergoing surgery, announced it has received conditional approval of an Investigational Device Exemption (IDE) from the US Food and Drug Administration (FDA). This approval allows Actamax to begin a pivotal clinical trial to evaluate the safety and efficacy of Actamax™ Adhesion Barrier.

Adhesion formation occurs as part of the body’s healing response to surgery, trauma, infection and chronic inflammation (such as endometriosis). Adhesions are excessive scar tissue that forms between adjacent internal tissues and may cause complications such as discomfort, chronic pain, female infertility, small bowel obstruction, and some cases may require reoperation.

“There has long been a need in the market for advances in medical technology to address adhesive disease. Adhesions continue to be a major cause of complications and morbidity in postoperative patients undergoing routine abdominal-pelvic surgery. This novel technology, an easy to use sprayable barrier device, has a promising future in preventing the formation of adhesions”, noted surgeon Geoffrey Trew (Hammersmith Hospital, London, UK), principal investigator for the pivotal clinical trial.

"We are pleased to have reached this initial milestone, further advancing our Actamax™ Adhesion Barrier on the path to market approval and commercialization", stated Marc Hendriks, PhD, President of Actamax. “Subject to study registrations and Institutional Review Board approvals, we expect to commence the evaluation of the Actamax™ Adhesion Barrier in a prospective, randomized controlled trial in gynecological laparoscopic surgery in clinical centers in the US and Europe in the second quarter of 2018.”

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. In the ensuing 12 months clinical follow-up of 47 study patients, there was evidence suggestive of improved long-term outcomes, including a lower recurrence rate of pre-study symptoms, and a higher probability of pregnancy in patients treated with the Actamax™ Adhesion Barrier.

About Actamax
Actamax Surgical Materials LLC is a DSM company. Actamax was founded in 2011 and is developing a new generation of resorbable, biocompatible surgical devices designed to improve patient outcomes. 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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09/20/17