Bringing innovation to life—together
From concept to commercialization, Regenity’s integrated contract development and manufacturing (CDMO) model delivers proven expertise, efficiency, and trust—partnering with you to develop transformative regenerative solutions.
Bringing innovation to life—together
Capabilities
Are you looking for a partner to help bring your next innovation to market? Regenity can bridge the gap between your vision and your commercially ready product—as we have for the world’s most trusted medical device companies.
Our CDMO experience, materials expertise, and regulatory track record combine to support the successful design, development, and scalability of regenerative and bioresorbable medical devices across a wide range of clinical segments.
From early-stage design and materials engineering to full-scale manufacturing, we’re ready to co-create life-changing solutions with you. We’ll work with you to create an end-to-end custom product development solution or provide tailored development support to augment your in-house team.
“They are incredible partners. I can only say positive things about the relationship. They are amazing resources that have developed great technologies.”
– Vice President of R&D, Oncology Partner
Our CDMO experience, materials expertise, and regulatory track record combine to support the successful design, development, and scalability of regenerative and bioresorbable medical devices across a wide range of clinical segments.
From early-stage design and materials engineering to full-scale manufacturing, we’re ready to co-create life-changing solutions with you. We’ll work with you to create an end-to-end custom product development solution or provide tailored development support to augment your in-house team.
“They are incredible partners. I can only say positive things about the relationship. They are amazing resources that have developed great technologies.”
– Vice President of R&D, Oncology Partner
Your needs drive our innovation
Regenity’s comprehensive product development capabilities give you an edge on the competition and a clearer, more efficient path to market.
Click to toggle to view our product development approach.
CUSTOMER NEEDS
We Begin With Your Functional Requirements
Every groundbreaking regenerative solution starts with an idea—one that meets a critical unmet clinical need. As your innovation partner, we begin with the material properties required to meet that need, then bring together the right combination of our capabilities to make your idea a commercial reality.
We Begin With Your Functional Requirements
Absorb • Adhere • Anti-adhere • Anti-infection • Carry • Coat • Connect • Deliver • Expand • Repair • Regenerate • Resorb • Support • Wrap
TECHNOLOGY PLATFORMS
Our Technology Platforms are the foundation for your success
Our biomaterials technologies have been used to develop the world’s most tranformative regenerative innovations–and we’ll do the same for yours.
Collagen
- Extracellular Matrix
- Gelatin
- Soluble
- Reconstituted
- Coatings + Films
Bioceramics
- Apatites
- Bioglass
- B-TCP
- Calcium Phosphates
Polymers
- Co-Polymers
- Dopamines
- Fumarates
- Polyurethanes
- Thermoplastics
- Tissue Adhesives
Specialty Metals
- Copper
- Magnesium
- Silver
- Zinc
Other
- APIs
- Chitosan
- Growth Factors
- Hyaluronic Acid
PROCESSES
We adapt our processes to deliver exceptional performance
We apply our proprietary processing to the right biomaterial to reach your end specifications and optimize material handling and performance
Tissue decellularization
Collagen fiber reconstitution
Collagen porous foam formation
Collagen film casting
Bone deproteinization
Polymer synthesis
Solvent casting
Compression molding
Component blending
Lyophilization / freeze drying
-
Sintering
-
Crosslinking
-
Die cutting
-
Grinding
-
Sieving
-
Sieving
-
Labeling
PRODUCTS
The Result: Your next great innovation
Your finished product can take many forms, depending on your needs, our guidance, and the possibilities we explore and bring to life—together.
Antimicrobial Sponges
Bioactive Pucks & Blocks
Dental Bone Grafts
Dental Dressings
Dental Membranes
Dental Plugs
Dural Repair Membranes
ENT Nasal Packing
Hernia Mesh
Meniscal Repair Implants
Nerve Tubes & Wraps
Powdered Fibrillar Wounds
Spine Bone Graft Putty / Strip
Tendon Repair
Tendon Repair Membranes
Tendon Repair Wraps
Wound Dressings / Sponges
DESIGN ASSETS AT EVERY STAGE
Our Proprietary Design Assets Facilitate Speed, Assuredness, and Innovation
Over our nearly 30-year history in regenerative science, we’ve developed a deep and broad library of design assets and validation data to draw on, so your innovation will be built on our proven success.
Testing Data • Packaging validations • Shelf-life studies • Design History Files
CUSTOMER NEEDS
We Begin With Your Functional Requirements
Every groundbreaking regenerative solution starts with an idea—one that meets a critical unmet clinical need. As your innovation partner, we begin with the material properties required to meet that need, then bring together the right combination of our capabilities to make your idea a commercial reality.
We Begin With Your Functional Requirements
Absorb • Adhere • Anti-adhere • Anti-infection • Carry • Coat • Connect • Deliver • Expand • Repair • Regenerate • Resorb • Support • Wrap
TECHNOLOGY PLATFORMS
Our Technology Platforms are the foundation for your success
Our biomaterials technologies have been used to develop the world’s most tranformative regenerative innovations–and we’ll do the same for yours.
Collagen
- Extracellular Matrix
- Gelatin
- Soluble
- Reconstituted
- Coatings + Films
Polymers
- Co-Polymers
- Dopamines
- Fumarates
- Polyurethanes
- Thermoplastics
- Tissue Adhesives
Bioceramics
- Apatites
- Bioglass
- B-TCP
- Calcium Phosphates
Specialty Metals
- Copper
- Magnesium
- Silver
- Zinc
Other
- APIs
- Chitosan
- Growth Factors
- Hyaluronic Acid
PROCESSES
We adapt our processes to deliver exceptional performance
We apply our proprietary processing to the right biomaterial to reach your end specifications and optimize material handling and performance
-
Tissue decellularization
-
Collagen fiber reconstitution
-
Collagen porous foam formation
-
Collagen film casting
-
Bone deproteinization
-
Polymer synthesis
-
Solvent casting
-
Compression molding
-
Component blending
-
Coating – Surface treatment
-
Lyophilization / freeze drying
-
Sintering
Crosslinking
Die cutting
Grinding
Sieving
Sterile packaging, thermoform packaging
Labeling
PRODUCTS
The Result: Your next great innovation
Your finished product can take many forms, depending on your needs, our guidance, and the possibilities we explore and bring to life—together.
-
Antimicrobial Sponges
-
Bioactive Pucks & Blocks
-
Dental Bone Grafts
-
Dental Dressings
-
Dental Membranes
-
Dental Plugs
Dural Repair Membranes
ENT Nasal Packing
Hernia Mesh
Meniscal Repair Implants
Nerve Tubes & Wraps
Powdered Fibrillar Wounds
Spine Bone Graft Putty / Strip
Tendon Repair
Tendon Repair Membranes
Tendon Repair Wraps
Wound Dressings / Sponges
DESIGN ASSETS AT EVERY STAGE
Our Proprietary Design Assets Facilitate Speed, Assuredness, and Innovation
Over our nearly 30-year history in regenerative science, we’ve developed a deep and broad library of design assets and validation data to draw on, so your innovation will be built on our proven success.
Testing Data • Packaging validations • Shelf-life studies • Design History Files
What makes Regenity your CDMO partner of choice?
Deep materials science expertise in collagen-based and synthetic polymers.
We bring nearly 30 years of product development and manufacturing experience to every CDMO partnership, turning raw bioabsorbable materials into advanced regenerative implants used in tissue and bone repair. You can count on us to set and reach the highest benchmarks for quality, precision, reliability, and performance.
Comprehensive global regulatory knowledge.
Securing approvals can be challenging in a shifting regulatory landscape. With a solid track record of gaining regulatory approvals for regenerative devices in more than 80 countries, we can help you save time and resources by supporting you through the entire process—from designing preclinical and clinical studies, to generating data for regulatory approvals, to developing claims, to preparing submission packages and responding to agency inquiries.
Accelerated speed to market.
We leverage our proprietary technology platforms, library of design assets and biocompatibility data, and scientific and regulatory expertise to streamline your path to commercialization, including rapid product iterations and approvals.
And with state-of-the-art Class 10,000 (ISO Class 7) controlled environments, more than 170,000 square feet of manufacturing space across the US and EU, and established compliance and regulatory certifications, we can scale up immediately to meet your goals for full commercial production in the markets you need to reach.
Scalable manufacturing.
We have five manufacturing facilities across the US and Europe totaling over 170,000 square feet, and a proven track record of producing over 30 million devices since the company’s founding. Today, we ship more than 5 million devices annually to customers around the world.
Proven scale, proven science
3
decades of biomaterials innovation
5M+
regenerative devices produced annually
<2 years
from concept to commercialization*
*Based on historical development timelines for Regenity 510(k)-cleared products; actual timelines may vary by program.
“On-time delivery. Ongoing, consistent quality without recalls or supply disruption. Friendly, dually beneficial partnership.”
– General Manager, Dental Partner
“In working with Regenity, I believe we are building a very strong, collaborative team to help us on our journey.”
– Chief Operating Officer, Neurology Partner
Our innovation partnership pathway
Choose from end-to-end custom product development solutions or discrete development support to augment your in-house team.
CDMO FAQ
Regenity provides end-to-end CDMO services for bioresorbable medical devices, including:
- Material sourcing and processing (collagen, polymers, bioceramics)
- Prototype development and design engineering
- Process development and validation
- Analytical, biological, and material testing
- Packaging and sterilization validation
- Regulatory submission support
- Clinical and commercial-scale manufacturing
- Distribution and lifecycle support
We support medtech partners from early feasibility through full commercialization, designing our processes with commercialization in mind from the start.
Regenity differentiates itself through a materials-first approach and an integrated development-to-commercialization model. We align material science, regulatory strategy, process validation, and scalable manufacturing to reduce risk and accelerate time to market.
At Regenity, quality is built into every stage of development and manufacturing, supported by our:
- ISO 13485-certified quality management system (QMS)
- MDSAP certification for multiple global markets
- ISO 22442-compliant US manufacturing site
- Validated packaging, sterilization, and shelf-life studies
- Full traceability and controlled sourcing for biological materials
Together, our regulatory and quality systems ensure consistent product performance, compliance with global standards, and readiness for regulatory submission.
With five manufacturing facilities across the United States and Europe, totaling more than 170,000 square feet (and growing), Regenity is well positioned to support new high-volume regenerative product development opportunities.
We also have a proven track record of success to back up our scale, with more than 30 million regenerative medical devices produced since the company was founded. Currently, we ship over 5 million devices to our medtech partners each year.
“You’re going to have iterations, you’re going to have failures. It’s their culture and willingness to collaborate to get to the right solution that sets Regenity apart.”
– Senior Director – Business Development, Sports Medicine Partner
Let’s explore how we can move your next development forward—faster, together.
Innovation thrives on connection. Reach out today to discuss how our regenerative solutions can help you achieve better clinical outcomes.