Silk for medical devices
AMSilk provides unique functional biopolymers based on silk polymers to improve design, functionality and performance of medical devices used in procedures and therapies worldwide. One of the main application for AMSilk’s recombinant silk polymers is implant coating for better biocompatibility and reduced biofilm formation as well as reduced inflammation / fibrosis.
Other applications use various morphologies of the silk polymers to improve handling and clinical profile in devices such as surgical meshes, wound dressings, electrical implants, as well as orthopedic and dental implants. Our wide range of knowledge and expertise in silk polymers and its processing results in scalable application processes, equipment and device specific tooling for effective large-scale production.
As an example, silicone implants are commonly used in breast augmentation or reconstructive surgery. While silicone is the material of choice, the implants are still recognized by the immune system as foreign to the body. Often, the healing process is impaired, inflammation of the surrounding tissue occurs around the implant, leading to fibrosis. AMSilk’s implant coating can be applied to any silicone implant, thereby reducing inflammation as well as capsular fibrosis formation.
Similarly, most other implant surfaces can be coated, from metal to synthetic polymers and in most shapes and forms. The homogeneous coating layer is non-covalently bound and thus slowly biodegradable, resistant to most common sterilization methods, and can be applied with tunable thickness.
Devices such as surgical meshes, wound dressings, and biosensors can also be enhanced with the silk polymer technology, either replacing or in combination with existing synthetic materials. The achieved benefits range from better device performance, biocompatibility, reduced biofilm formation to better handling for the surgeon.
AMSilk is always looking for joint development opportunities in specific medical technology applications such as implant coating and innovative product design with a reasonable time to market. Contact us today to inquire about how we can support you.
Silk is Safe
AMSilk’s silk technology is safe. The material is non-immunogenic, non-inflammatory, non-toxic and “invisible” to the human immune system. No harmful reactions have been reported. Its functionality is purely physical – no pharmacological effect is caused by our products. AMSilk’s silk technology has been tested by several independent laboratories in preclinical studies. Clinical studies are ongoing, further demonstrating the good biocompatibility.
Silk Technology for YOUR Product
AMSilk’s unique and proprietary coating technology is very versatile and we provide strong expertise for integration in large-scale manufacturing processes. Almost any material and any product can be treated or coated with the silk technology. With our sophisticated in-house process facilities and research laboratories, we are experts in developing the appropriate coating technique and application for a specific device and objective. Commonly used coating techniques include dip coating or spraying. The resulting silk coating withstands common sterilization methods as well as common finishing and handling processes. In close cooperation with our customers, our team of medical experts provides support for clinical studies and marketing authorization.
All our polymers used in medical device applications conform to applicable regulatory requirements for such devices and are produced in our certified facilities in a sustainable, cleantech manner that follows principles of the Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP). Our manufacturing processes have been validated by large, multinational biologics CMOs for conformity with medical device quality standards.
Prof. Dr. Hisham Fansa
Co-owner of the Heitmann-Fansa Aesthetic Medicine Practice in Munich. Served as President of the German Society of Woundhealing and -management.
„AMSilk’s coating technology has the potential to be a game changer in the field of implant coating. Being a natural material it is almost invisible to the immune system, resulting in reduced adverse reactions such as inflammation and capsular fibrosis as shown in preclinical trials.”
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