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.

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

14Publications

4FDA-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.

01

Scientific Development

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

PRODUCT STRATEGY · TRANSLATIONAL RESEARCH
02

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
03

Commercial Translation

Align technical positioning, manufacturing, licensing, and commercialization so strong science leads to market success.

MARKET POSITIONING · LICENSING
04

Contract R&D

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

ASEPTIC PROCESSING · ANALYTICAL TESTING
Product development from discovery and feasibility through 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.

Discuss Your Program →Illustration of the cellular organization of a cartilage growth plate
  1. 01Evaluate — Find the differentiated product thesis

    Technology assessment, technical due diligence, risk mapping, and market positioning.

  2. 02Develop — Build the evidence and development plan

    Assays, preclinical strategy, biomaterial characterization, and regulatory alignment.

  3. 03Translate — Move with confidence toward market

    Manufacturing transfer, licensing support, commercialization, and launch readiness.

Deep Domain Focus

Specialized where biology, materials, and devices converge

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

01Bone Regeneration02Orthobiologics03Synthetic Bone Grafts04Bioactive Biomaterials05Tissue-Based Technologies06BMP Delivery Systems07Implant Surface Engineering08Combination Products09Manufacturing Scale-Up10Technology Licensing

Founder Track Record

Representative Accomplishments

FDA 510(k)TechnologyRepresentative Contributions
K082615Grafton II Enhanced DBM (MagniFuse®)

Conceived the product concept and led scientific development of this procedure-specific DBM platform through FDA clearance.

K121316Alpine Adjustable Implant System

Identified titanium plasma spray (TPS) as the preferred surface roughening technology following characterization of osteoblast responses in tissue culture.

K171495Zyston 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.

K203218CaP 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 →

Wet Lab Research Capability

Strategy informed by experimental reality

Our research facility in Pasadena, California, 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 performing cell culture work in 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.

He is also Founder and Managing Director of Applied Regenerative Therapeutics, a division and trade name of Applied Regeneration LLC.

20+U.S. Patents14Publications & ChaptersUCLAPh.D. Training

A New Chapter in Product Development

Applied Regenerative Therapeutics

A Product Development Division of Applied Regeneration LLC

Applied Regeneration LLC has launched Applied Regenerative Therapeutics to advance internally developed regenerative-medicine technologies toward clinical and commercial application. ART complements ARLLC's consulting and contract-research activities with an internally focused product-development platform.

Visit Applied Regenerative Therapeutics →

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Reduce uncertainty and make informed decisions throughout your product development journey