Regenerative Medicine · Orthobiologics · Biomaterials

Helping Clients Translate Scientific Innovation into Clinically Meaningful Solutions

Applied Regeneration LLC helps innovators in regenerative medicine, biomaterials, and tissue-based products optimize scientific, product-development, and regulatory decisions by reducing uncertainty and managing risk on the path toward clinical and commercial application.

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Applied Regeneration emblem, a stag and fawn line drawing

Experience Brought to Engagements

Technical depth.
Regulatory judgment.
Commercial perspective.

20+ years in
regenerative medicine

20+ U.S. patents

14 publications

4 FDA-cleared platforms

Integrated Capabilities

From scientific promise to product reality

An integrated approach to product development, regulatory strategy, and commercialization planning—realizing opportunity through informed decisions that reduce uncertainty and support thoughtful risk management.

Scientific Development

Translate promising concepts into differentiated products with practical technical plans, assays, and preclinical strategies.

PRODUCT STRATEGY · TRANSLATIONAL RESEARCH

Regulatory Strategy

Navigate device, HCT/P, and combination-product pathways with decisions grounded in product science and market reality.

FDA 510(k) · SECTION 361 HCT/P

Commercial Translation

Align technical positioning, manufacturing, licensing, and commercialization so strong science becomes a viable business.

MARKET POSITIONING · LICENSING

Contract R&D

Advance programs with hands-on execution in BSL-1 and BSL-2 capable wet-lab facilities in Pasadena, California.

ASEPTIC PROCESSING · ANALYTICAL TESTING

Infographic showing product development from discovery and feasibility through product development, preclinical and clinical evaluation, regulatory strategy, manufacturing and scale-up, to commercialization — Our engagement follows the full arc from discovery to commercialization

Expanded Capabilities

Data Science & Computational Modeling

Applied Regeneration LLC has expanded its consulting capabilities to include analytical data science, integrating advanced statistical and computational methods to strengthen evidence, reduce uncertainty, and support informed decision-making.

We help transform complex biomedical data into informed decisions that strengthen product development, regulatory strategy, and commercialization planning.

Statistical analysis and experimental design

Analysis of large and complex biological datasets

Computational modeling and simulation, including machine learning

Predictive analytics and quantitative decision support

AI-assisted literature analysis and scientific knowledge synthesis

Research workflow optimization and technology evaluation

Discuss Your Data Science Needs →

The Product Journey

Decisions get harder where disciplines meet

Orthobiologic technologies rarely fit neatly within scientific, regulatory, or commercial boundaries. Applied Regeneration integrates these perspectives early to reduce uncertainty and realize opportunity.

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01 Evaluate — Find the differentiated product thesis
Technology assessment, technical due diligence, risk mapping, and market positioning.
02 Develop — Build the evidence and development plan
Assays, preclinical strategy, biomaterial characterization, and regulatory alignment.
03 Translate — Move with confidence toward market
Manufacturing transfer, licensing support, commercialization, and launch readiness.

Deep Domain Focus

Specialized where biology, material, and device converge

Grounded in decades of hands-on experience with growth factors, biomaterials, tissue technologies, implants, and advanced delivery systems.

01Bone Regeneration 02Orthobiologics 03Synthetic Bone Grafts 04Bioactive Biomaterials 05Tissue-Based Technologies 06BMP Delivery Systems 07Implant Surface Engineering 08Combination Products 09Manufacturing Scale-Up 10Technology Licensing

Founder Track Record

Representative Accomplishments

FDA 510(k)	Technology	Representative Contributions
K082615	Grafton II Enhanced DBM (MagniFuse®)	Conceived the product concept and led scientific development of this procedure-specific DBM platform through FDA clearance.
K121316	Alpine Adjustable Implant System	Identified titanium plasma spray (TPS) as the preferred surface roughening technology following characterization of osteoblast responses in tissue culture.
K171495	Zyston Strut 3D-Printed Titanium Cage	Diagnosed prototype fracture failures via SEM/EDS, traced the cause to print-media contamination, and resolved it — keeping the program on track.
K203218	CaP Sphere Pellet Pack Synthetic Bone Void Filler	Developed the formulation, final product configuration, and delivery system, and supported manufacturing scale-up and technical market positioning.

See full publications, patent and FDA clearance record →

Wetlab Research Capability

Strategy informed by experimental reality

Our research facility in Pasadena, CA supports BSL-1 and BSL-2 tissue culture studies, aseptic sample processing, biochemical and analytical testing, and cell-based assays — ensuring program decisions are grounded in experimental evidence.

Scientist in a lab coat and gloves using a pipette to transfer liquid into a petri dish inside a biosafety cabinet

Founder & Principal

Keyvan Behnam, Ph.D., MBA

More than two decades advancing regenerative medicine and orthobiologics from discovery through FDA clearance and commercialization.

Keyvan has held scientific leadership roles at Zimmer Biomet, Biomet, Lanx, Osteotech, and Intuitive Biotechnologies. He holds a Ph.D. in Physiological Science from UCLA, where he trained under Dr. Marshall R. Urist in the characterization, regulation, and delivery of bone morphogenetic proteins, along with an MBA in Finance and a B.S. in Bioengineering from UC Berkeley.

20+U.S. Patents 14Publications & Chapters UCLAPh.D. Training

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Reduce uncertainty and make informed decisions throughout your product development journey

Benefit from Our Experience

Schedule a Consultation → info@appliedregeneration.com