Clinical study marks first use for silk inside the human body

^{Polytech and AMSilk announce start of joint international clinical study for silk-coated medical implants – the first time that bioengineered silk will be inside the human body.}

AMSilk, a global industrial supplier of synthetic silk biopolymers for medical devices, is partnering with Polytech Health & Aesthetics, the manufacturer of soft-tissue silicone implants, to begin the clinical study POSIS, the first-in-human clinical safety testing of silk-coated silicone SILKline breast implants in Europe. The study, which started with several patients in the first week at a number of medical universities in Austria, may be extended to further European countries for comprehensive testing.

Polytech’s silicone breast implants have been available to international customers for many decades, and demand has recently reached an all-time high, with the company selling over 200,000 silicone implants in 2016. As part of Polytech’s quality control system, all implants are produced under stringent quality guidelines and fulfill maximum safety requirements. To ensure consistent quality, the implants are produced manually, and are checked after each production step according to the highest standards.

The partnership with AMSilk marks the first time that bioengineered silk will be inside the human body. AMSilk’s unique silk coating forms a thin and flexible physical protein interface between the silicone surface of Polytech’s implant and the surrounding tissue. The body recognises the physical protein interface as a natural surface, leading to a much better biocompatibility. In preclinical studies, SILKline silk-coated silicone breast implants resulted in superior tolerability. Therefore, it is expected that minor post-operative complications and minimization of sometimes painful side effects that accompany traditional implants (eg. capsular fibrosis) will occur.

“With the new SILKline implants, Polytech plans to further increase the safety and tolerability standards of our products,” said Wolfgang Steimel, CEO of Polytech. “Working with AMSilk enables us to provide our customers the newest and best technology available to support patients’ wellbeing and satisfaction, combined with the objective to reduce complications with real innovative technology.”

Jens Klein, CEO of AMSilk added: “Through our multi-year partnership with the experts at Polytech, we’ve created a new and groundbreaking product for the medical devices market. The SILKline implants are the first product providing our silk coating in the medical device sector – but other products utilising the extraordinary biocompatibility of our silk coatings will soon follow.”