• Long-term manufacturing partnership – VIVOLTA to scale production of electrospun silk fibroin, a critical component in Fibrothelium’s SimplySilk® membrane for dental and maxillo-facial applications
• VIVOLTA will be exclusive electrospinning manufacturer of Fibrothelium’s electrospun components for global clinical and commercial use
• Advancing regenerative dentistry – SimplySilk® membrane addresses growing demand for animal-free, resorbable dental membranes in guided bone regeneration (GBR)

WAALRE, Netherlands–(BUSINESS WIRE)–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.

Unlike conventional GBR membranes derived from animal collagen, SimplySilk® membrane is entirely free of animal tissue, eliminating the risk of pathogen transmission and supporting extended degradation profiles. Fibrothelium’s biocompatible PureSilk® material promotes safe, predictable healing of bone defects. The membrane naturally resorbs over time, removing the need for patients to undergo a second surgery to remove it once the healing process is complete.

Global demand for regenerative dental solutions is rising, fueled by growth in dental implant procedures and the increasing prevalence of periodontal disease. The GBR membrane market was estimated at roughly $520 million in 2024 and is forecast to nearly double to $950 million by 2033, growing at about 7.5% annually. This growth is driven by the need for advanced biomaterial membranes that improve clinical outcomes in implantology and oral surgery.¹

Studies indicate that over 50% of dental implant patients require some form of bone grafting or GBR to rebuild lost bone.² With implant procedures on the rise worldwide, clinicians are seeking high-performance barrier membranes that provide reliable regeneration of bone tissue while minimizing complications. SimplySilk® membrane’s long-term barrier function and animal-tissue-free composition positions it as a timely innovation in this expanding market.³

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.

Denis Leissing, CEO of VIVOLTA, said:

“This partnership with Fibrothelium underscores VIVOLTA’s ability to support innovators from concept through commercialization. We are excited to apply our electrospinning expertise and MediSpin™ manufacturing platform to scale up SimplySilk® membrane production.

“By combining Fibrothelium’s groundbreaking silk biomaterial with our unique high-volume electrospinning capabilities, we will help bring this advanced GBR membrane to dental patients worldwide. Our team is proud to enable a new animal-tissue-free solution that can improve healing and outcomes in regenerative procedures.”

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 our SimplySilk® membrane to clinicians worldwide as a safe, effective new animal-tissue-free option for regenerative procedures that supports optimal tissue regeneration and patient care.”

About VIVOLTA

VIVOLTA is a fully integrated medical electrospinning solutions provider devoted to the development and high-volume manufacturing of electrospun medical products for its clients. Vivolta offers end-to-end services from material R&D and product development through clinical-scale and commercial manufacturing, using its proprietary MediSpin™ platform to produce nanofiber-based medical devices and components with high precision and unwavering quality.

About Fibrothelium

Fibrothelium GmbH (Aachen, Germany) is a biomedical company specializing in silk fibroin-based biomaterials for clinical use. A spin-off from RWTH Aachen University in 2017, Fibrothelium has core expertise in isolating and purifying highly biocompatible, bioresorbable fibroin proteins from natural silk without the use of toxic solvents. This fibroin solution is the backbone of a proprietary process to create advanced regenerative products, enabling the transformation of silk fibroin into various forms and functions. Fibrothelium’s technology is used to develop and manufacture next-generation resorbable implants – including the SimplySilk® membrane – that support tissue repair and regeneration in a safe and sustainable way.

Sources:

1. Verified Market Reports – GBR Membrane Market Insights 2025.
2. Cha HS, Kim JW, Hwang JH, Ahn KM. Frequency of bone graft in implant surgery. Maxillofac Plast Reconstr Surg. 2016 Mar 31;38(1):19.
3. https://www.fibrothelium.com/simplysilk-membrane/

Contacts

Enquiries

VIVOLTA
Denis Leissing, CEO

+31 40 2827 956

Vigo Consulting (Media enquiries)
Rozi Morris

+44 20 7390 0231
vivolta@vigoconsulting.com