Regenity Biosciences

Regenity Biosciences, formerly Collagen Matrix, Inc., is the leading regenerative medicine contract development and manufacturing partner for the medical device community, leveraging a platform of bioresorbable technologies to drive medtech breakthroughs.

Regenity designs and delivers the most differentiated products, most efficiently, via its 27+ years of in-depth know-how and experience in product development and trade secret manufacturing of regenerative devices. The company brings deep R&D expertise, a diverse portfolio of collagen, bioceramic, and synthetic polymer technology platforms, extensive regulatory experience, and robust manufacturing capabilities to drive scalable growth for medical device partners of all sizes.

Vertically Integrated Regenerative Device Manufacturing

Regenity offers clients highly customizable manufacturing solutions with a comprehensive suite of services to support the growth of your business at every step, including:
1) Vertically integrated production and supply chain for worldwide distribution;
2) 70,000+ square feet of manufacturing space, including 20,000 square feet of state-of-the-art, ISO Class 7 controlled environments;
3) Operational capacity to “lift and shift” manufacturing processes and equipment to its facilities. Whether you need to fast-track market entry or optimize costs, Regenity delivers contract manufacturing and contract development solutions with the agility, expertise, and vertically integrated infrastructure to meet your evolving needs.

Raw Biomaterials with Unmatched Purity, Quality and Consistency

Regenity ensures the highest purity, quality, and consistency in its biomaterials through rigorous sourcing and in-house processing. Our materials include:

• Proprietary synthetic polymer production, managed entirely in-house for precision and reliability.
• Animal-derived (xenograft) collagen sourced from Australia, New Zealand, and the U.S., meeting international regulatory standards.
• Documented chain of custody to ensure full traceability and minimize risk.

With Regenity’s stringent quality controls, our partners can rely on biomaterials engineered for peak performance and regulatory compliance.

Contract Development Expertise to Fuel Continuous Innovation and Optimization

Regenity’s R&D team is dedicated to advancing biomaterial science and optimizing regenerative medical technologies. Our expertise spans:

• Customized technology selection to match the best biomaterial platform with your product goals.
• Proprietary processing techniques to enhance handling, absorbability, and clinical performance.
• Rapid prototyping and in-house testing to accelerate development, optimize performance, and streamline the path to commercialization.

At Regenity, our tenured team is driven by a shared passion for innovation and a deep commitment to transforming patient care.

Deep Regulatory Experience + Established Certifications Enabling Speed to Market and Immediate Scale-up

With over 27 years of regulatory expertise in biomaterials and synthetic polymers, Regenity ensures compliance across global markets. Our certifications include:

• ISO certifications for bovine and porcine xenografts.
• US FDA approvals, EUMDR approvals, and adherence to other international medical device regulations.
• Medical Device Single Audit Program (MDSAP) certification for seamless global market entry.

We support partners throughout the regulatory submission process, including claims development, clinical study design, and dossier preparation—accelerating approval timelines and mitigating risk.

Comprehensive Manufacturing Services + Advanced Analytical Solutions for Biodegradable Device Development

Regenity provides comprehensive manufacturing services, including process development and validation, packaging, and sterilization validation, shipping and storage studies, shelf-life testing, labeling, and distribution. Its advanced analytical solutions enhance efficiency, covering cell biology testing, biocompatibility, material characterization, to name a few. For polymers, in-house testing and equipment includes residual solvent detection, molecular weight and thermal analysis, and more—delivering cost savings, scalability, and custom solutions.

Collagen and Polymer Coating Capabilities

Regenity applies cutting-edge processing techniques to engineer specialized coatings that push the boundaries of material science. We can apply collagen, ceramics, chitosan, and advanced polymeric derivatives—with or without the pre-loading of active pharmaceutical ingredients (APIs)—to a diverse range of substrates, including biomaterials, plastics, and metals.

• Enhancing material compatibility for seamless integration into medical applications
• Optimizing performance to improve durability, bioactivity, and therapeutic potential
• Reducing biofilm formation to support better patient outcomes and device longevity

Unlike conventional coating providers, Regenity’s proprietary expertise in regenerative biomaterials allows us to tailor solutions, delivering next-generation coatings that redefine what’s possible in medtech innovation.

Press Releases

Regenity Demonstrates Next-Generation Regenerative Technologies at MEDICA 2025

Regenity Biosciences, a global leader in regenerative biomaterials and contract development and manufacturing (CDM) partner for the medtech community, announced its participation in MEDICA 2025, the world’s largest exhibition for medical technology and healthcare advancement, taking place November 17–20 in Düsseldorf, Germany. Regenity will exhibit in Hall 10, Booth 10F57.

Regenity Redefines Medical Device Innovation Via Advanced Contract Development and Manufacturing Expertise, Honored with Prestigious 2025 R&D 100 Award

Paramus, N.J., September 5, 2025 — Regenity Biosciences, a global leader in regenerative medicine and Linden Capital Partners portfolio company, today announced that it has been recognized as a winner of the 2025 R&D 100 Awards for its RejuvaKnee™ meniscal repair innovation.