AMSilk has completed preclinical testing of its proprietary silicone implant coating made from spider silk. AMSilk’s coating consists of a thin layer of spider silk proteins manufactured by AMSilk. It modifies the implant, presenting a more acceptable surface to the human tissue. The coating can be applied to any silicone implant in the final production step, just prior to packaging and sterilization; it does not alter the mechanical performance of the implant.
The preclinical results have been published in Advanced Functional Materials. In this study surgeons and AMSilk scientists could show that the AMSilk spider silk coating significantly reduces the rate of major post-operative complications, such as capsular fibrosis, capsular thickness, hardening, and inflammation. These positive effects are based on a reduction of the typical foreign body-induced infiltration and differentiation of immune cells. The coating also results in a change in collagen processing and fiber formation in the scar tissue – consistent with a reduced risk of capsule formation over time. The coating modulated the foreign body response to the implant and is expected to reduce the risk of corrective surgery after cosmetic surgery and breast reconstruction.
Assistant medical director Dr. med. Zeplin from the University Hospital of Leipzig, who is the principal investigator of the preclinical studies, stated: “AMSilk’s technology is perfectly suited to reduce post operative and long-term complications. AMSilk’s spider silk protein coating can significantly improve the medical outcomes related to the use of silicone implants in reconstructive and aesthetic breast surgery.”
“Breakthroughs such as this implant coating study allow us to expand the number of new and unique medical products in our development pipeline.” said Dr. Lin Römer, Chief Science Officer of AMSilk. “We are confident, that our technology will significantly improve the health of many patients, not only after breast surgery but also after other surgical and wound treatment procedures.”
The study published in Advanced Functional Materials was conducted by Priv.-Doz. Dr. med. habil. Zeplin now at the University Hospital of Leipzig in cooperation with Prof. Dr. Scheibel from the University of Bayreuth and scientists from AMSilk.
Spider Silk Coatings as a Bioshield to Reduce Periprosthetic Fibrous Capsule Formation, Authors: Philip H. Zeplin; Nathalie C. Maksimovikj; Martin C. Jordan; Joachim Nickel; Gregor Lang; Axel H. Leimer; Lin Römer; Thomas Scheibel, Advanced Functional Materials (January 2014) DOI: 10.1002/adfm.201302813