RegenMed Development Organization

What RegenMed Development Organization does

RegenMed Development Organization (ReMDO) is a 501(c)3 non-profit ecosystem organization founded in 2014 and headquartered at 391 Technology Way in Winston-Salem, North Carolina's Innovation Quarter, co-located with the Wake Forest Institute for Regenerative Medicine (WFIRM). Its stated function is to de-risk and accelerate the clinical and commercial translation of regenerative medicine technologies by pooling industry, academic, and government stakeholders around shared infrastructure, regulatory expertise, and standards-setting. ReMDO operates a portfolio of branded programs under the RegeneratOR umbrella — a five-pillar platform comprising the Test Bed (shared biomanufacturing laboratory with advanced equipment), Innovation Accelerator (physical incubator space for tenant companies), Workforce Development (training pipeline), Regulatory NavigatOR (FDA pathway advisory led by former FDA officials), and Product Trials Catalyst (a clinical trial network reportedly reaching 6 million patients across 67 hospitals via the Atrium Health/Wake Forest School of Medicine and Javara partnerships). Adjacent programs include the Regenerative Manufacturing Innovation Consortium (RegMIC), an industry-led body of 145+ member entities that publishes road-mapping white papers and convenes annual meetings; the Regenerative Medicine Manufacturing Society (RMMS), a free professional membership society; and four funded research programs (Universal Bioink, Standardized Cell Culture Media, Scalable RegMed Bioreactor, Cell Isolation) that address core biomanufacturing gaps.

The underlying technology stack is anchored by WFIRM's bioprinting capabilities, including the iTOPS platform used in programs such as the B.R.E.A.S.T. bioregenerative breast matrix project. ReMDO integrates third-party technologies — SAS IoT analytics for smart manufacturing, Oracle cloud/ML infrastructure, BioSpherix sterile modular units, PHC Group precision instruments, Aiforia AI pathology software, and QIAGEN/Phase Holographic Imaging analytical tools — into the Test Bed environment. It does not develop these technologies itself; rather, it curates and deploys partner capabilities as shared infrastructure. The core differentiator versus commercial incubators is co-location with WFIRM's 400+ researchers and access to a 6 million-patient clinical trial network.

ReMDO's business model is that of a non-profit convening and ecosystem-building organization rather than a product vendor. Revenue (undisclosed) is derived from a mix of federal and foundation grants (notably the 2024 NSF Innovation Engine award and the 2023 internal grant program distributing $50K-$200K awards), consortium membership and participation, Test Bed and Innovation Accelerator access/space fees, and in-kind or contracted support from industry partners including SAS, Oracle, and PHC Group. Customer segments span regenerative medicine startups (e.g., BioMedInnovations, Immunaeon, Conexeu Sciences), established industry leaders (PHC Group/Epredia/Aiforia, MIMEDX, QIAGEN, SAS), and government/academic collaborators (FDA, BARDA, NASA, ARPA-H, NSF, SCB). The organization is small — between 1 and 10 disclosed employees — with leadership including Dr. Joshua Hunsberger (CTO), Dr. Steve Bauer (Regulatory Expert; 31 years FDA tenure), Karen Barnes (Ecosystem Builder), and Gary Green (COO).

Name

RegenMed Development Organization

Legal name

RegenMed Development Organization

Website

https://remdo.org

Company type

Private

Founded year

2014

Operating status

Operating

Headcount range

1–10 employees

Short description

ReMDO is a 501(c)3 non-profit ecosystem organization that convenes regenerative medicine startups, industry, academia, and government around shared biomanufacturing infrastructure, FDA regulatory guidance, and a 145+ member consortium headquartered in Winston-Salem, NC.

Ownership category

akta.pro rank

Product category

Regenerative Medicine Ecosystem Services

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Veterinary Regenerative Medicine Manufacturing (GMP/CDMO, Cell Processing) (HLAMANAI)

akta.pro secondary industry

Cartilage, Bone & Musculoskeletal Regeneration (HLAAAGAH)

Keywords

• Regenerative medicine ecosystem
• Biomanufacturing services
• Bioprinting research
• FDA regulatory consulting
• Clinical trials network

Headquarters

HQ city

Winston Salem

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Marketing or Sales, Infrastructure

Revenue model

1. Ecosystem/Accelerator Services: Revenue generated through membership fees, Test Bed access fees, Innovation Accelerator space rental, and service fees for biomanufacturing equipment access and prototyping support provided to startups and companies in the regenerative medicine ecosystem.
2. Grant Funding: ReMDO receives grant funding from government agencies and public-private partnerships. Award amounts to companies (e.g., $50,000 to $200,000 grants to Phase Holographic Imaging, BioSpherix, SAS Institute, QIAGEN) are distributed through competitive grant programs funded by NSF and other public sources.
3. Consortium Membership (RegMIC & RMMS): The Regenerative Medicine Manufacturing Society (RMMS) offers free membership providing access to monthly meetings, webinars, publications, and networking. Revenue model for ReMDO likely includes membership-derived value through consortium participation, though direct fees are not specified.

Go-to-market motion3 records

Distribution channels6 records

Marketing channels7 records

Core offering

ReMDO operates as a 501(c)3 non-profit ecosystem organization that accelerates the commercialization of regenerative medicine technologies. It provides access to biomanufacturing infrastructure (Test Bed), commercial real estate and business support (Innovation Accelerator), FDA regulatory guidance (Regulatory NavigatOR), and a clinical trials network covering 6 million patients (Product Trials Catalyst). ReMDO also coordinates the RegMIC industry consortium of 145+ members and runs internal research programs addressing biomanufacturing gaps in bioink, cell culture media, bioreactors, and cell isolation.

Product overview

ReMDO operates as a regenerative medicine ecosystem platform with multiple interconnected programs. The RegeneratOR initiative serves as the core offering, comprising five pillars: Test Bed (shared biomanufacturing facility), Innovation Accelerator (commercialization support), Workforce Development (training programs), Regulatory NavigatOR (FDA guidance), and Product Trials Catalyst (clinical trial network with 6 million patients). ReMDO also manages the Regenerative Manufacturing Innovation Consortium (RegMIC) with 145+ members and the Regenerative Medicine Manufacturing Society (RMMS). Research programs include Universal Bioink, Standardized Cell Culture Media, Scalable Bioreactor, and Cell Isolation initiatives.

Differentiator

Problem solved

Functional benefit

Brands

• RegeneratOR: Dynamic initiative powered by ReMDO designed to propel regenerative medicine forward by connecting innovators with resources, expertise, and talent. Built on five interconnected pillars: Test Bed, Innovation Accelerator, Workforce Development, Product Trials Catalyst, and Regulatory NavigatOR.
• RegMIC
• RMMS

Products and services

• RegeneratOR Test Bed Shared laboratory providing startups and emerging companies with access to advanced biomanufacturing equipment, expert guidance, and prototyping support for early regenerative medicine product development. Integrates SAS IoT analytics and smart manufacturing capabilities.
• Innovation Accelerator Physical space located at WFIRM within Innovation Quarter providing companies with real estate, resources, and strategic business planning support to validate market potential, create business strategies, and bring new regenerative medicine therapies to patients.
• Workforce Development Training program connecting educational institutions with industry to create a skilled talent pipeline, including degree tracks and short-term courses for the regenerative medicine biomanufacturing workforce.

Quantifiable outcome

• First manufacturing road map for tissue engineering and regenerative medicine published in Stem Cells Translational Medicine journal
• +4 more outcomes

Named customers4 records

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

17 partnerships are on record, tiered supporting, core and flagship.

• Standards Coordinating Body (SCB)supportingStrategic or Co-development Partner · 15 May 2024Dawn Henke, Executive Director of the Standards Coordinating Body, participated as a speaker at the 10th annual RegMIC meeting, contributing to discussions on organoid-specific standards development.
• Phase Holographic Imaging (PHI)supportingTechnology or Integration · 12 September 2023Award recipient under ReMDO's Regenerative Medicine Manufacturing grant program ($50,000-$200,000 range). PHI provides non-invasive single-cell imaging data quantifying cellular behavior and morphology without using compromising reagents as part of the strategic technology development alliance.
• QIAGENsupportingTechnology or Integration · 12 September 2023Award recipient under ReMDO's Regenerative Medicine Manufacturing grant program. QIAGEN (6,000 employees) provides DNA, RNA, and protein molecular data to over 500,000 customers globally and contributes instrumentation for the AI-based process control tools being developed in the alliance.
• Javara Inc.coreStrategic or Co-development Partner · 18 January 2023Javara, a Winston-Salem-based Integrated Research Organization (IRO), partners with the Clinical Trials Catalyst program to integrate clinical research and clinical care, ensuring clinical trials are readily accessible as care options for patients at Atrium Health/Wake Forest School of Medicine facilities.
• SAS InstitutecoreTechnology or Integration · 16 November 2022SAS provides IoT analytics and smart manufacturing capabilities to the RegeneratOR Test Bed. Their technology helps companies optimize environmental conditions and parameters to maximize product yield while minimizing variability, contamination, and cost. SAS brings decades of life sciences experience to the regenerative medicine ecosystem.
• OraclesupportingTechnology or Integration · 23 June 2021Oracle contributes cloud computing power and machine learning/data analytics capabilities to solve regenerative medicine manufacturing challenges. Their infrastructure supports the RegeneratOR's research and development environments.
• BioSpherixsupportingTechnology or Integration · 23 June 2021BioSpherix provides modular units for manufacturing clinical products. Their sealed, sterile, cell-friendly environment enables cells to be cultured at controlled temperature, oxygen, and CO2 levels without human contact, supporting the biomanufacturing workflow in the Test Bed.
• PHC Group (Panasonic Healthcare Corporation)coreTechnology or Integration · 23 June 2021PHC Group (formerly Panasonic Healthcare Corporation) provides best-in-class precision and digital solutions ranging from tissue processing technologies to AI capabilities for improving workflow efficiencies. Expanded presence through PHC Group, Epredia, and Aiforia joining the Innovation Accelerator.
• Wake Forest Institute for Regenerative Medicine (WFIRM)coreStrategic or Co-development PartnerWFIRM is ReMDO's primary collaborative research partner. The two organizations jointly operate the RegeneratOR ecosystem, Innovation Accelerator, and Clinical Trials Catalyst. WFIRM provides the scientific infrastructure, researchers (400+), and world-leading expertise in regenerative medicine. ReMDO provides the organizational and commercialization framework. WFIRM is led by Dr. Anthony Atala and is located in the Innovation Quarter in Winston-Salem, NC.
• ARPA-H (Advanced Research Projects Agency for Health)flagshipStrategic or Co-development PartnerARPA-H announced its BioStabilization Systems (BoSS) program at the RegMIC annual meeting. The BoSS program aims to develop technologies to produce, store, and ship cell therapies at room temperature, removing expensive and fragile cold chain dependency. ReMDO serves as a convener of the diverse innovator community needed to achieve BoSS goals.
• U.S. Food and Drug Administration (FDA)coreStrategic or Co-development PartnerFDA participates in RegMIC conferences and is involved in standards development initiatives. The Regulatory NavigatOR (led by former FDA officials Dr. Steven Bauer and Dr. Stephen Sawyer) spearheads FDA research collaborations with WFIRM on potency assays and regenerative medicine product characterization.
• BARDA (Biomedical Advanced Research and Development Authority)coreStrategic or Co-development PartnerBARDA participates in RegMIC annual meetings as a federal agency partner. Ben Perman, Health Scientist at BARDA, was listed as a speaker at the 10th annual RegMIC meeting covering organoid-specific standards.
• NASA Human Research ProgramcoreStrategic or Co-development PartnerNASA participates in RegMIC conferences. Dr. Kristin Fabre, Associate Chief Scientist, and Michael Roberts (ISS National Laboratory/CASIS) presented at the 10th annual RegMIC meeting. NASA's involvement connects to in-space biomanufacturing as a future frontier identified by ReMDO.
• Innovation Quarter (Wexford Science + Technology)coreStrategic or Co-development PartnerInnovation Quarter is a mixed-use innovation district in downtown Winston-Salem, NC, developed by Wexford Science + Technology. It is the physical home of the RegenMed Hub, WFIRM, and ReMDO. Innovation Quarter has attracted ~$900 million in investment across 2 million square feet of space and is driving the growth of Winston-Salem's biotech ecosystem.
• Greater Winston-Salem, Inc. / Innovation QuartercoreStrategic or Co-development PartnerReMDO and WFIRM have made Innovation Quarter the home of the RegenMed Hub. Isaac Perry serves as head of biotech and life sciences ecosystem development to promote Winston-Salem as a top city for regenerative medicine and clinical trials innovation. Interest from life sciences companies increased more than 600% since 2018.
• Axiom SpacesupportingStrategic or Co-development PartnerAxiom Space is a notable company within the RegenMed Hub ecosystem, contributing to discussions on in-space biomanufacturing as identified by ReMDO as a future frontier.
• MIMEDXsupportingStrategic or Co-development PartnerMIMEDX is a regenerative medicine company that has joined the RegenMed Hub Innovation Accelerator, participating in the ecosystem of companies advancing the regenerative medicine field nationally.

Scale indicators7 records

Recent moves6 records

Expansion highlights6 records

Others

• ATCC (American Type Culture Collection): ATCC is a non-profit biological resource center providing cell lines, microbial strains, and standards for regenerative medicine research. It is an adjacent enabling organization that supports the regenerative medicine ecosystem in a similar non-profit capacity, with overlap to ReMDO's Standardized Cell Culture Media and Cell Isolation programs.

Broad incumbents

• CIRM / Mayo Clinic Center for Regenerative Medicine: The Mayo Clinic Center for Regenerative Medicine is an established clinical-regenerative medicine program with biomanufacturing infrastructure and clinical trial capabilities. It is comparable to ReMDO/WFIRM as a clinical-academic hub for regenerative medicine translation, though at substantially larger institutional scale.
• California Institute for Regenerative Medicine (CIRM): CIRM is a large, established state-funded agency advancing stem cell and regenerative medicine research through grants and infrastructure. It is comparable to ReMDO in mission (accelerating regenerative medicine commercialization) but operates at much greater scale as a California state agency with billions in funding.
• Lonza Cell & Gene Technologies: Lonza is a leading global CDMO with extensive cell and gene therapy manufacturing services. It overlaps with ReMDO's RegeneratOR Test Bed and Innovation Accelerator roles as a biomanufacturing service provider, though Lonza operates as a much larger commercial player with global infrastructure.
• Catalent Cell & Gene Therapy: Catalent is a major global CDMO providing cell therapy development and manufacturing services. Comparable to ReMDO as a biomanufacturing service provider for regenerative medicine companies, though operating commercially at much larger scale across multiple modalities.

Direct peers

• Standards Coordinating Body (SCB): SCB coordinates the development of standards for regenerative medicine and advanced therapies, with direct overlap to ReMDO's RegMIC roadmapping and standards-setting activities. ReMDO's Executive Director Dawn Henke actually participated in RegMIC, indicating the close collaboration between the two organizations.
• Alliance for Regenerative Medicine (ARM): ARM is the leading international advocacy and member organization for the regenerative medicine and cell therapy sector. It is directly comparable to ReMDO's RegMIC consortium as an industry convening body focused on advancing commercialization, policy, and standards for the field.
• Center for Breakthrough Medicines: Center for Breakthrough Medicines is a cell, gene, and regenerative medicine CDMO offering process development, manufacturing, and analytical services. It competes directly with ReMDO's RegeneratOR Test Bed for emerging regenerative medicine tenants needing biomanufacturing capacity.
• International Society for Cell & Gene Therapy (ISCT): ISCT is the global professional society driving the translation of cell and gene therapies into clinical practice through standards, education, and advocacy. It parallels ReMDO's RMMS professional society role and is a peer in regenerative medicine manufacturing community-building.

Emerging players

• New York Stem Cell Foundation (NYSCF): NYSCF is a non-profit research institute advancing stem cell biology and cell therapy development with its own research programs and infrastructure. It parallels ReMDO as a non-profit advancing regenerative medicine through research coordination, training, and ecosystem support.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xtwitter.com/RemdoOrg
• LinkedInlinkedin.com/company/regenmed-development-organization-remdo

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Subsidiaries4 records

Funding overview

Funding rounds

Investors

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M&A

Investments

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Frequently asked questions about RegenMed Development Organization