Fibrothelium Partners with Vivolta to Manufacture SimplySilk® Membrane for Bone Regeneration

Fibrothelium and Vivolta Entered into a Manufacturing Contract

Announcement

Vivolta, a medical mechanism solution provider, entered a long-term contract with Fibrothelium, a pioneer in silk protein biomaterial. The partnership’s motive is to manufacture electro-driven components for use in fibrothelium’s simplysilk® membrane. It’s an advanced electro-driven silk membrane introduced to contribute to guiding bone regeneration (GBR) in oral surgery.

Agreement

According to the agreement, Vivolta will be available as a center contract manufacturer of simplysilk membrane electro-driven components, accelerating its automated medispin technology to generate the electro-driven membranes at market margin. Also promising regulatory compliance and high-quality.

About the SimplySilk Membrane

The SimplySilk membrane is a resorbable barrier membrane deliberately designed to develop bone regrowth in periodontal procedures, cranio-maxillo-facial and dental implant surgery. It is generated with Fibrothelium’s proprietary silk fibroin technology. The membrane holds a robust multi-layer design, with a secured prolonged barrier function on clinical needs. The two porous, fleece-like outer layers promote substantial integration of soft tissue. Whereas the alternative compact silk fibroin film core slows down biodegradation and improves mechanical stability.

In comparison to conventional GBR membranes driven from animal collagen, the simplysilk membrane is animal tissue-free, discarding the risk factor of pathogen transmission and contributing to the expansion of degradation profiles. The fibrothelium’s biocompatible puresilk material highlights its safety and healing to the defective bones. The membrane instantly eliminates the need for a second surgery for patients that was once mandatory after the healing process.

Demand for Regenerative Dental Solutions

The global demand for regenerative dental solutions is rapidly skyrocketing with the elevation of dental implant procedures and the rapid growth of the prevalence of periodontal disease. The GBR membrane market was approximately near to $520 million in 2024 and is predicted to increase to $950 million by 2033 at 7.5% annually. The growth is fueling due to the need for advanced biomaterial membranes that enhance clinical outcomes in oral surgery and implantology.

The studies show that around 50% of dental implant patients need a form of GBR or bone grafting to regrow lost bone. The simplysilk membrane is an emerging innovation in this flourishing market. The SimplySilk membrane is a CE-stamped class 3 medical device and is available in the European market commercially. The ongoing clinical studies have shown a remarkable performance in the routine clinical applications. Along with its MDR recertification, Fibrothelium is planning for FDA submission, along with us market approval expected by 2027.