First Trial Patient for FlexiSurge® Adhesion Barrier

Post-surgical adhesions, particuarly after open colorectal surgery, remain problematic, despite industry’s best efforts over the past few decades. Now a Dutch implant company, Medisse BV, has announced the successful treatment of a first patient in a clinical trial for its FlexiSurge® Adhesion Barrier.

Background

Adhesions are formed on average in 70-90% of open abdominal surgical procedures and can have severe clinical consequences. These can include serious conditions such as small bowel obstruction, secondary infertility in females, complications in re-operations and chronic abdominal pain.

The FlexiSurge Adhesion Barrier is a physical barrier overlaid on at-risk structures to prevent fibrous tissue from growing across to other organs/tissue. Flexisurge is absorbable, remaining in the body for about 12 weeks, long enough to ensure that the barrier is present whilst the surgical site is healing and the risk of scarring is present. The implant is made from Medisse’s novel Poly(1,3-Trimethylene Carbonate) polymer platform. The sheet is easy to handle during the application due to its transparency and high conformability to the underlying tissue.

Medisse claims it s implant resorbs by a phenomenon it calls surface degradation, the thickness of the material gradually reducing, rather than breaking up into multiple uncontrollable bits during the resorption period. This has the added potential benefit of not delivering a burst of degradation products into the body.In any event, because PTMC is a carbonate, no acidic degradation products are released into the body, unlike lactide-based equivalents.

Medisse says FlexiSurge has the potential to make an enormous impact on colorectal procedures and suggests the market could be worth $2-3 Billion globally.

The study, being conducted in three hospitals in the Netherlands, will investigate the safety of FlexiSurge, and its ability to reduce formation of adhesions after open colorectal surgery.

Investigator comments

“We are happy to have successfully treated the first patient in the FlexiSurge study,” said Prof Dr. ND Bouvy of the Academic Medical Center, Maastricht, in The Netherlands. “We look forward to diminish the problem of adhesion formation in the future by this promising anti-adhesive film.”

Company comments

“The treatment of this first patient is a major milestone for our company and will be our first class 3 product in humans,” said Tjeerd Homsma, Chief Executive Officer of Medisse. “Our FlexiSurge product has the potential to revolutionize anti-adhesion treatment in abdominal surgeries and address a huge cost to society for treatment of the clinical consequences, >3B$ annually in the US alone. We are privileged to work with such a renowned group of doctors who recognize the need for this product on a daily basis.”

Source: Medisse BV., Business Wire

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