RegenMed Systems
RegenMed Systems Inc. is a Stanford Biodesign–originated medical device company that develops the FDA 510(k)-cleared MarrowMiner — a rotating FlexShaft system enabling single-entry-point bone marrow harvest under local anesthesia — and is extending the platform via MarrowRx into intraosseous gene-therapy delivery for transplant centers, regenerative-medicine researchers, and gene-therapy developers.
- Company typePrivate
- Founded2007
- HeadquartersMenlo Park, United States
- Headcount1–10
- GTM typeB2B
- OfferingHardware or Manufacturing
What RegenMed Systems does
RegenMed Systems Inc. is a privately held, Stanford Biodesign–originated medical device company developing minimally invasive tools for bone marrow harvest and intraosseous therapeutic delivery. Its lead commercial product, the MarrowMiner, is an FDA 510(k)-cleared (and CE-Marked) sterile, single-use device consisting of an ergonomic powered handle attached to a rotating FlexShaft with a marrow-entry trocar that navigates the cancellous marrow cavity via a single bone puncture under local anesthesia. The platform removes the multi-puncture, general-anesthesia operating-room workflow that has dominated bone marrow collection for 50 years, claiming 4–10x faster harvests (10–20 minutes), a single entry point, and significantly higher mesenchymal, hematopoietic and endothelial progenitor cell yields (MARVELOUS-I trial, published in BBMT, 2019).
The business model is a medical-device hardware sale to institutional customers — major bone-marrow transplant centers, regenerative-medicine researchers, and gene-therapy developers (the latter accessed via the MarrowRx program). Go-to-market appears to be enterprise field sales supplemented by clinical evidence (peer-reviewed publications, conference presentations, TED showcase, company website) rather than broad marketing. The company's headquarters is listed at Stanford, CA; founder-led team includes CEO/Chairman Michael McCullough, MD; CMO Daniel Kraft, MD (the Stanford Biodesign inventor of the FlexShaft architecture); VP Engineering Michael Crocker (15+ medical device patents); co-founder John Stevens, MD (HeartFlow founding CEO, Heartport co-founder); and COO Diana Saville.
Beyond the core harvest device, RegenMed is extending the FlexShaft platform into intraosseous gene-therapy delivery through the MarrowRx program — a $1.1M Bill & Melinda Gates Foundation–funded collaboration with Fred Hutchinson Cancer Center and the University of Washington. Preclinical non-human-primate proof-of-concept was demonstrated in March 2024, and the company presented at the ARPA-H BioHybrid Device Summit in May 2024. The company is small (1–10 employees), uses research grants rather than institutional VC, and remains at an early-commercial or pre-commercial revenue stage based on the available data.
RegenMed Systems firmographics
Firmographics- Name
- RegenMed Systems
- Legal name
- RegenMed Systems Inc.
- Website
- https://regenmedsystems.com
- Company type
- Private
- Founded year
- 2007
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- RegenMed Systems Inc. is a Stanford Biodesign–originated medical device company that develops the FDA 510(k)-cleared MarrowMiner — a rotating FlexShaft system enabling single-entry-point bone marrow harvest under local anesthesia — and is extending the platform via MarrowRx into intraosseous gene-therapy delivery for transplant centers, regenerative-medicine researchers, and gene-therapy developers.
- Ownership category
- akta.pro rank
RegenMed Systems industry classification
Industry- Product category
- Bone Marrow Harvesting Medical Devices
- SIC
- Orthopedic, Prosthetic & Surgical Appliances & Supplies (3842)
- akta.pro primary industry
- Bone Marrow & Stem Cell Transplant (BMT/HSCT) (HLAKAFAI)
- akta.pro secondary industries
- Cell Therapy Manufacturing Services (GMP, autologous/allogeneic) (HLAAAKAC), Stem Cell–Based Regenerative Therapies (HLAAAGAA), Stem Cell Therapies (MSC/iPSC/HSC-derived) (HLAAABAE)
Keywords
Where RegenMed Systems is headquartered
LocationHeadquarters
- HQ city
- Menlo Park
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
RegenMed Systems business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Personnel, Technology or R&D, Supply Chain, Operations, Marketing or Sales, Others
Revenue model
- MarrowMiner Device Sales: Sale of the MarrowMiner medical device system - a sterile, disposable device consisting of an ergonomic powered handle attached to a rotating FlexShaft with marrow entry trocar. The system is FDA 510(k) cleared and commercially available.
Go-to-market motion1 record
Distribution channels1 record
Marketing channels5 records
RegenMed Systems product offering
Product offeringCore offering
RegenMed Systems develops and sells the MarrowMiner, an FDA 510(k)-cleared, sterile, minimally invasive bone marrow harvesting system featuring a rotating FlexShaft that follows the contours of the marrow cavity through a single bone entry point under local anesthesia. The system harvests higher concentrations of stem cells in 10-20 minutes (vs. 50-100+ punctures and 1+ hours with traditional methods) and is sold to bone marrow transplant centers, regenerative medicine programs, and gene therapy developers for clinical and research use.
Product overview
RegenMed Systems offers two related product offerings centered on its core MarrowMiner platform. The primary product is the FDA-cleared MarrowMiner, a medical device for minimally invasive bone marrow stem cell harvest using a proprietary rotating FlexShaft technology. The secondary offering is MarrowRx, an application of the MarrowMiner platform for intraosseous gene therapy delivery, developed in collaboration with academic partners and funded by the Bill & Melinda Gates Foundation. The technology enables both harvesting of bone marrow for transplantation and direct delivery of therapeutic agents into the bone marrow cavity.
Differentiator
Problem solved
Functional benefit
Brands
- MarrowMiner: FDA-approved, rapid, minimally invasive system for harvesting bone marrow from a single puncture under local anesthesia. The first significant improvement in bone marrow harvesting in the last 50 years.
- MarrowRx
Products and services
- MarrowMiner FDA 510(k)-cleared and CE Mark certified sterile, minimally invasive bone marrow harvesting system comprising an ergonomic powered handle attached to a rotating FlexShaft with a marrow entry trocar. The FlexShaft follows the contours of the marrow cavity through a single bone entry point under local anesthesia, harvesting 1.5x-6x higher stem cell yields in 10-20 minutes compared to traditional needle aspiration requiring 50-100+ punctures and 1+ hour OR-based collection. Sold to bone marrow transplant centers and regenerative medicine research institutions.
- MarrowRx Application program adapting the MarrowMiner FlexShaft platform for intraosseous delivery of gene vectors and cells directly into the bone marrow cavity, enabling in-vivo gene therapy for genetic diseases (e.g., sickle cell, thalassemia) and infectious diseases (e.g., HIV). Developed in collaboration with Fred Hutchinson Cancer Center / University of Washington and funded by a $1.1M Bill & Melinda Gates Foundation research award in October 2022.
Quantifiable outcome
- 1.5x higher Hematopoietic Stem Cells (HSC) yield compared to needle aspiration
- +6 more outcomes
Companies that use RegenMed Systems
Customer profileSegments3 records
Ideal customer profiles3 records
RegenMed Systems technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature4 records
RegenMed Systems partnerships and signals
Strategic signalPartnerships
Two partnerships are on record, tiered core.
- Stanford BiodesigncoreMarrowMiner was developed as part of the Stanford Biodesign Program. RegenMed holds an exclusive technology license of IP from Stanford University. Dr. Kraft invented the Bone Marrow Harvest System as a Bone Marrow Transplant Fellow at Stanford while participating in the Stanford BioDesign Program.
- Fred Hutchinson Cancer Center / University of WashingtoncoreCollaboration with Dr. Hans-Peter Kiem and colleagues at Fred Hutchinson Cancer Center and University of Washington for the MarrowRx gene therapy study. The study aims to develop and build an optimized 'MarrowRx' device specifically for intraosseous (IO) gene delivery.
Scale indicators4 records
Recent moves5 records
Expansion highlights5 records
RegenMed Systems competitors and assessment
Company assessmentEmerging players
- Mesoblast: Mesoblast develops allogeneic cellular medicines using bone-marrow-derived mesenchymal lineage cells for inflammatory and cardiovascular indications. Comparable as a downstream consumer of MarrowMiner-style marrow-cell harvests for cell-therapy development.
- Pluristem Therapeutics: Pluristem develops placenta-derived cell therapies for regenerative indications and hematologic disorders. Adjacent regenerative-medicine peer that similarly depends on cell sourcing and could be either a customer or a strategic partner for marrow-derived cell harvesting platforms.
Direct peers
- Teleflex: Teleflex manufactures the Jamshidi bone marrow biopsy/aspiration needle, the long-standing incumbent tool against which MarrowMiner is benchmarked. Directly comparable product category (bone marrow access devices), same institutional buyer (BMT centers) and overlapping surgical-medical-device sales channels.
- Argon Medical Devices: Argon markets bone marrow biopsy and aspiration devices (e.g., MarrowCellution-style products) used by oncologists and transplant physicians. Closest direct competitor in the bone-marrow harvest device niche, selling into the same hematology/oncology end-users.
- Becton Dickinson (BD): BD supplies bone marrow biopsy needles and broader biopsy/aspiration devices to hospitals and pathology labs. Directly comparable in the bone-marrow access device category and via MedSurg distribution into the same academic transplant centers targeted by RegenMed.
- Terumo BCT: Terumo BCT supplies cell-collection and processing systems (apheresis, bone marrow processing) used by BMT centers and cell-therapy manufacturers. Directly comparable in the broader bone-marrow/cell-harvest workflow that MarrowMiner's single-puncture harvest feeds into.
- Ranfac Corporation: Ranfac manufactures bone-marrow harvest needles (e.g., Marrowcril) used in OR and bedside bone-marrow collection. Another direct incumbent competing for the same procedural niche, with comparable surgical-appliance positioning.
Broad incumbents
- Stryker: Stryker operates a broad medical/surgical device portfolio including instruments used in orthopedic and surgical harvest workflows. Comparable as a large incumbent in the surgical-medical-device space that could acquire or partner for adjacent harvest/cell-collection capability.
- Smith+Nephew: Smith+Nephew operates a broad orthopedic and sports-medicine surgical-device portfolio. Comparable broad-incumbent in surgical/orthopedic devices; relevant because RegenMed's regenerative-medicine use cases intersect with the orthopedic biologics category.
- Medtronic: Medtronic is a global diversified medical-device manufacturer with relevant adjacent experience in catheter-based and minimally invasive surgical tools. Comparable as a broad-incumbent strategic acquirer of novel minimally invasive harvest/delivery devices.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks7 records
Key highlights7 records
Customer concentration
RegenMed Systems social profiles
Digital presenceRegenMed Systems compliance and trust
Trust signalCompliance1 record
RegenMed Systems financial estimates
Financial estimateRevenue estimate
Valuation estimate
RegenMed Systems leadership team
Management profileNumber of profiles
Profiles6 records
RegenMed Systems funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
RegenMed Systems M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about RegenMed Systems
What does RegenMed Systems do?
RegenMed Systems develops and sells the MarrowMiner, an FDA 510(k)-cleared, sterile, minimally invasive bone marrow harvesting system featuring a rotating FlexShaft that follows the contours of the marrow cavity through a single bone entry point under local anesthesia. The system harvests higher concentrations of stem cells in 10-20 minutes (vs. 50-100+ punctures and 1+ hours with traditional methods) and is sold to bone marrow transplant centers, regenerative medicine programs, and gene therapy developers for clinical and research use.
Is RegenMed Systems a public or private company?
RegenMed Systems is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was RegenMed Systems founded?
RegenMed Systems was founded in 2007. It employs 1 to 10 people.
Where is RegenMed Systems based?
RegenMed Systems is headquartered in Menlo Park, United States, in the North America region.
How does RegenMed Systems make money?
One revenue line is on record: marrowMiner Device Sales.
Who are RegenMed Systems's main competitors?
Emerging players on record are Mesoblast and Pluristem Therapeutics. Direct peers are Teleflex, Argon Medical Devices, Becton Dickinson (BD), Terumo BCT and Ranfac Corporation. Broad incumbents are Stryker, Smith+Nephew and Medtronic.
Does RegenMed Systems have an API?
No public API is recorded for RegenMed Systems.
What industry is RegenMed Systems in?
RegenMed Systems's product category is Bone Marrow Harvesting Medical Devices. Its primary akta.pro industry code is HLAKAFAI, Bone Marrow & Stem Cell Transplant (BMT/HSCT), with a secondary code of HLAAAKAC, Cell Therapy Manufacturing Services (GMP, autologous/allogeneic). Its SIC code is 3842.