Polyganics Innovations BV
Developer and manufacturer of bioresorbable and biocompatible medical materials and implants, offering contract development and manufacturing (CDM) services across collagen, synthetic polymer, bioceramic and mineral platforms. Provides product development, regulatory support and global manufacturing for regenerative surgical and dental applications.
Industries
N/A
Nr. of Employees
small (1-50)
Products
Bioresorbable meniscal scaffold implant (FDA-cleared)
A bioabsorbable scaffold implant intended to reinforce and support repair of the medial meniscus and to facilitate regeneration of native meniscal tissue; cleared through a regulatory 510(k) process.
Fibrillar collagen wound dressing (510(k)-cleared)
Absorbent microfibrillar collagen matrix intended for management of moderately to heavily exudating wounds and control of minor bleeding.
Electrospun synthetic dental membrane (CE-marked)
Non-woven synthetic electrospun membrane developed for dental surgical applications and launched into select markets with CE marking.
Polymer-based nerve and dural repair devices
Bioresorbable polymer devices designed for peripheral nerve repair and dural sealing/repair used in neurosurgery and peripheral nerve applications.
Bioresorbable meniscal scaffold implant (FDA-cleared)
A bioabsorbable scaffold implant intended to reinforce and support repair of the medial meniscus and to facilitate regeneration of native meniscal tissue; cleared through a regulatory 510(k) process.
Fibrillar collagen wound dressing (510(k)-cleared)
Absorbent microfibrillar collagen matrix intended for management of moderately to heavily exudating wounds and control of minor bleeding.
Electrospun synthetic dental membrane (CE-marked)
Non-woven synthetic electrospun membrane developed for dental surgical applications and launched into select markets with CE marking.
Polymer-based nerve and dural repair devices
Bioresorbable polymer devices designed for peripheral nerve repair and dural sealing/repair used in neurosurgery and peripheral nerve applications.
Services
Development, scale-up and commercial manufacturing of regenerative implants and components using collagen, polymers and bioceramics.
Preparation of regulatory submissions and supporting documentation for market clearances and approvals (e.g., 510(k), CE, NMPA).
Supply and custom formulation of collagen matrices, synthetic polymers and mineral/bioceramic materials for device manufacturing and R&D.
Custom device design, private-label production and distribution support across dental, orthopedic, spine, neurosurgery and wound care markets.
Development, scale-up and commercial manufacturing of regenerative implants and components using collagen, polymers and bioceramics.
Preparation of regulatory submissions and supporting documentation for market clearances and approvals (e.g., 510(k), CE, NMPA).
Supply and custom formulation of collagen matrices, synthetic polymers and mineral/bioceramic materials for device manufacturing and R&D.
Custom device design, private-label production and distribution support across dental, orthopedic, spine, neurosurgery and wound care markets.
Expertise Areas
- Contract development and manufacturing (CDM)
- Bioresorbable biomaterials
- Regulatory submissions and global market access
- Clinical and preclinical study support
Key Technologies
- Electrospinning
- Collagen scaffold fabrication
- Synthetic bioresorbable polymer processing
- Bioceramic and mineral-based biomaterials
News & Updates
Company announced FDA 510(k) clearance for a regenerative meniscus implant (meniscal scaffold).
Company announced 510(k) clearance for an absorbent fibrillar collagen wound dressing, marking its 40th 510(k).
Recipient of a 2025 R&D 100 Award for a regenerative meniscal implant product and recognition of manufacturing and development capabilities.
Acquisition of Polyganics to expand polymer platform capabilities, international manufacturing and R&D reach.
Acquisition of a synthetic bone graft and membrane product line and associated electrospinning capabilities, expanding dental product portfolio.
Company announced regulatory approval in China for a collagen dental membrane following a multicenter clinical study.
Company announced FDA 510(k) clearance for a regenerative meniscus implant (meniscal scaffold).
Company announced 510(k) clearance for an absorbent fibrillar collagen wound dressing, marking its 40th 510(k).
Recipient of a 2025 R&D 100 Award for a regenerative meniscal implant product and recognition of manufacturing and development capabilities.
Acquisition of Polyganics to expand polymer platform capabilities, international manufacturing and R&D reach.
Acquisition of a synthetic bone graft and membrane product line and associated electrospinning capabilities, expanding dental product portfolio.
Company announced regulatory approval in China for a collagen dental membrane following a multicenter clinical study.