News
VIVOLTA and Fibrothelium partner to manufacture SimplySilk® membranes for Guided Bone Regeneration
WAALRE, Netherlands – 7 August, 2025 – VIVOLTA, the medical electrospinning solutions provider, has signed a long-term partnership with Fibrothelium, a specialist in silk protein biomaterials, to manufacture electrospun components for use in Fibrothelium’s SimplySilk® membrane – an advanced electrospun silk membrane designed to support guided bone regeneration (GBR) in oral surgery.
Under the agreement, VIVOLTA will serve as the exclusive contract manufacturer of SimplySilk® membrane electrospun components, leveraging its fully automated MediSpin™ technology to produce the electrospun membranes at commercial scale while ensuring consistent quality and regulatory compliance.
SimplySilk® membrane is a resorbable barrier membrane intended to facilitate bone regrowth in dental implants, periodontal procedures and cranio-maxillo-facial surgery. Developed with Fibrothelium’s proprietary silk fibroin technology, the membrane features a unique multi-layer design, ensuring prolonged barrier function when clinically needed. Two porous, fleece-like outer layers promote rapid soft tissue integration, while an optional compact silk fibroin film core slows biodegradation and enhances mechanical stability.
SimplySilk® membrane is a CE-marked Class III medical device and is commercially available in Europe. Ongoing clinical studies demonstrate excellent performance in routine clinical applications. In parallel with its MDR recertification, Fibrothelium is preparing for FDA submission, with U.S. market approval targeted for 2027.
Hans Leemhuis, CEO of Fibrothelium, commented:
“Partnering with VIVOLTA marks a key milestone in scaling the production and the global availability of our SimplySilk® membrane. Vivolta’s proven know-how in electrospun medical products and its state-of-the-art MediSpin™ system give us great confidence in the quality, reproducibility and scalability of our product as we ramp up production.
“We look forward to delivering SimplySilk® to clinicians worldwide as a safe, effective new animal-tissue-free option for regenerative procedures that supports optimal tissue regeneration and patient care.”
