Harvard Apparatus Regenerative Technology
Harvard Apparatus Regenerative Technology is a clinical-stage biotechnology company developing the Cellspan Esophageal Implant, a regenerative-medicine device for repairing damaged esophagi in adults with potential pediatric expansion. It currently has no commercial revenue and is conducting Phase 1 trials at Mayo Clinic.
- Company typePrivate
- Founded2012
- HeadquartersHolliston, United States
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
What Harvard Apparatus Regenerative Technology does
Harvard Apparatus Regenerative Technology, Inc. is a clinical-stage biotechnology company headquartered in Holliston, Massachusetts, developing regenerative-medicine implants to repair damaged organs. Its lead product candidate is the Cellspan Esophageal Implant, a cell-based regenerative device designed to create a continuous biological neoconduit for esophageal repair in adults suffering damage from cancer, trauma, or birth defects, with planned pediatric expansion for esophageal birth defect repairs. The company holds key patents and orphan-drug designations, and has secured FDA-approved Phase 1 and Phase 2 clinical trials, with the first patient dosed at Mayo Clinic in April 2026 in a Phase 1 feasibility and safety study enrolling up to ten patients.
The company operates a pre-commercial business model with no product revenue; it is funded through a sequence of small private placements, PIPE financings, and convertible debt (notably from its CEO). Partnerships are anchored on a single clinical site at Mayo Clinic, with IQVIA Biotech providing project management support across trial execution. Marketing and stakeholder communications are conducted primarily through press releases, SEC filings, and investor disclosures rather than direct commercial channels.
The leadership team is founder-led, with David Green serving as Chairman and CEO, William Fodor as Chief Scientific Officer, and Joseph Damasio as Chief Financial Officer. Headcount is reported at 1-10 employees, consistent with a tightly resourced clinical-stage operation. Operating geographies are concentrated in North America, and the legal entity is incorporated in Delaware. The company trades on the OTCQB under the symbol HRGN and files periodic disclosures with the SEC.
Harvard Apparatus Regenerative Technology firmographics
Firmographics- Name
- Harvard Apparatus Regenerative Technology
- Legal name
- Harvard Apparatus Regenerative Technology, Inc.
- Website
- https://hregen.com
- Company type
- Private
- Founded year
- 2012
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Harvard Apparatus Regenerative Technology is a clinical-stage biotechnology company developing the Cellspan Esophageal Implant, a regenerative-medicine device for repairing damaged esophagi in adults with potential pediatric expansion. It currently has no commercial revenue and is conducting Phase 1 trials at Mayo Clinic.
- Ownership category
- akta.pro rank
Harvard Apparatus Regenerative Technology industry classification
Industry- Product category
- Regenerative Medicine Medical Devices
- NAICS
- Surgical Appliance and Supplies Manufacturing (339113)
- SIC
- Orthopedic, Prosthetic & Surgical Appliances & Supplies (3842)
- akta.pro primary industry
- Stem Cell–Based Regenerative Therapies (HLAAAGAA)
Keywords
Where Harvard Apparatus Regenerative Technology is headquartered
LocationHeadquarters
- HQ city
- Holliston
- HQ country
- United States
- HQ region
- North America
Markets served
Harvard Apparatus Regenerative Technology business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Operations
Revenue model
- Pre-commercial / Clinical Stage: Harvard Apparatus Regenerative Technology is a pre-revenue clinical-stage company developing regenerative-medicine treatments. The company is not yet generating revenue from product sales and is funded through private placements, investments, and debt financing.
Go-to-market motion1 record
Distribution channels1 record
Marketing channels2 records
Harvard Apparatus Regenerative Technology product offering
Product offeringCore offering
Harvard Apparatus Regenerative Technology develops the Cellspan™ Esophageal Implant, a regenerative-medicine scaffold intended to create a continuous biological neoconduit that repairs damaged esophagi caused by cancer, trauma, or birth defects. The product is currently in FDA-approved Phase 1 and Phase 2 clinical trials in adults, with potential future expansion to pediatric patients for esophageal birth defect repairs. The company is pre-revenue and funded through private placements, PIPE financings, and debt financing to advance clinical development.
Product overview
Harvard Apparatus Regenerative Technology develops regenerative medicine treatments for organ repair, with a focus on its Cellspan™ Esophageal Implant product. The company's technology platform enables regeneration of damaged organs caused by cancer, trauma, or birth defects. The portfolio centers on the Cellspan™ Esophageal Implant, which is currently in Phase 1 clinical trials at Mayo Clinic, and represents the company's lead product candidate for regenerative esophageal repair.
Differentiator
Problem solved
Functional benefit
Brands
- Cellspan™ Esophageal Implant: Regenerative medicine product - an esophageal implant designed for biological neoconduit formation in patients requiring esophageal repair
Products and services
- Cellspan™ Esophageal Implant A regenerative-medicine esophageal implant designed to create a continuous biological neoconduit to repair damaged esophagi caused by cancer, trauma, or birth defects. Intended for adult patients undergoing esophageal repair and, subject to adult safety data, for future pediatric use in congenital esophageal birth defect repairs. Currently in FDA-approved Phase 1 and Phase 2 clinical trials.
Quantifiable outcome
- Establish continuous biological neoconduit by three months post-surgery
Companies that use Harvard Apparatus Regenerative Technology
Customer profileNamed customers1 record
Segments2 records
Ideal customer profiles2 records
Harvard Apparatus Regenerative Technology technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature2 records
Harvard Apparatus Regenerative Technology partnerships and signals
Strategic signalPartnerships
Two partnerships are on record, tiered core and minor.
- Mayo CliniccoreMayo Clinic in Rochester, Minnesota serves as the primary clinical trial site for Harvard Apparatus Regenerative Technology's Phase 1 feasibility and safety clinical trial of the Cellspan Esophageal Implant. The trial will enroll up to ten patients and aims to establish a continuous biological neoconduit by three months post-surgery.
- IQVIA BiotechminorIQVIA Biotech provides project management support for Harvard Apparatus Regenerative Technology in executing the clinical trial across multiple sites.
Scale indicators9 records
Recent moves6 records
Expansion highlights4 records
Harvard Apparatus Regenerative Technology competitors and assessment
Company assessmentDirect peers
- Humacyte: Clinical-stage regenerative medicine company developing bioengineered human tissues (vascular conduits and other tubular structures) for surgical repair. Highly comparable to HART's approach of creating biological neoconduits for organ repair, with similar pre-commercial scale and FDA regulatory pathway.
- Athersys: Clinical-stage regenerative medicine company developing cell therapy for inflammatory and tissue damage indications. Comparable as a small-cap, clinical-stage regenerative medicine company with limited commercialization, similar funding profile and execution risk profile.
- Mesoblast: Clinical-stage cell therapy company developing mesenchymal stem cell-based regenerative treatments for inflammatory and cardiovascular conditions. Comparable as a clinical-stage regenerative medicine company with similar long path to commercialization and reliance on dilutive financings.
- Capricor Therapeutics: Clinical-stage biotechnology company developing cell-derived regenerative therapies for Duchenne muscular dystrophy and other indications. Comparable as a small-cap, clinical-stage regenerative medicine company with similar funding and execution dynamics.
- Pluristem Therapeutics: Clinical-stage regenerative medicine company developing placenta-derived cell therapy products for multiple indications. Comparable as a small-cap clinical-stage cell therapy company with similar pre-commercial profile.
Broad incumbents
- Vericel: Commercial-stage cell therapy and regenerative medicine company with FDA-approved autologous cell-based products for cartilage repair and severe burns. Comparable regenerative medicine platform but already revenue-generating and at commercial scale, providing a benchmark for what HART could become with successful clinical development.
- Organogenesis: Commercial-stage regenerative medicine company focused on wound care and surgical biologics, including skin substitutes for wound healing. Comparable regenerative medicine platform serving surgical/repair use cases, though operating at much larger scale and already generating significant revenue.
- MiMedx: Commercial-stage regenerative medicine company developing placental tissue-based products for wound healing and surgical recovery. Comparable regenerative medicine platform but at commercial scale with established revenue base.
- Integra LifeSciences: Larger medical device company with significant regenerative tissue technology portfolio (dural repair, dermal regeneration, wound care). Comparable in addressing tissue regeneration and surgical repair, but operating as a much broader, well-capitalized incumbent.
- Cook Medical: Large privately-held medical device manufacturer with regenerative medicine and tissue-engineered products for surgical repair applications. Comparable in serving surgical tissue regeneration use cases but as a much larger, well-capitalized established player.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat3 records
Key risks7 records
Key highlights6 records
Customer concentration
Harvard Apparatus Regenerative Technology social profiles
Digital presenceHarvard Apparatus Regenerative Technology financial estimates
Financial estimateRevenue estimate
Valuation estimate
Harvard Apparatus Regenerative Technology leadership team
Management profileNumber of profiles
Profiles3 records
Harvard Apparatus Regenerative Technology funding detail
Funding detailFunding overview
Funding rounds15 records
Investors1 record
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Harvard Apparatus Regenerative Technology 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 Harvard Apparatus Regenerative Technology
What does Harvard Apparatus Regenerative Technology do?
Harvard Apparatus Regenerative Technology develops the Cellspan™ Esophageal Implant, a regenerative-medicine scaffold intended to create a continuous biological neoconduit that repairs damaged esophagi caused by cancer, trauma, or birth defects. The product is currently in FDA-approved Phase 1 and Phase 2 clinical trials in adults, with potential future expansion to pediatric patients for esophageal birth defect repairs. The company is pre-revenue and funded through private placements, PIPE financings, and debt financing to advance clinical development.
Is Harvard Apparatus Regenerative Technology a public or private company?
Harvard Apparatus Regenerative Technology is a private company. It is classified as public and is currently operating.
When was Harvard Apparatus Regenerative Technology founded?
Harvard Apparatus Regenerative Technology was founded in 2012. It employs 11 to 50 people.
Where is Harvard Apparatus Regenerative Technology based?
Harvard Apparatus Regenerative Technology is headquartered in Holliston, United States, in the North America region.
How does Harvard Apparatus Regenerative Technology make money?
One revenue line is on record: pre-commercial / Clinical Stage.
Who are Harvard Apparatus Regenerative Technology's main competitors?
Direct peers on record are Humacyte, Athersys, Mesoblast, Capricor Therapeutics and Pluristem Therapeutics. Broad incumbents are Vericel, Organogenesis, MiMedx, Integra LifeSciences and Cook Medical.
Does Harvard Apparatus Regenerative Technology have an API?
No public API is recorded for Harvard Apparatus Regenerative Technology.
What industry is Harvard Apparatus Regenerative Technology in?
Harvard Apparatus Regenerative Technology's product category is Regenerative Medicine Medical Devices. Its primary akta.pro industry code is HLAAAGAA, Stem Cell–Based Regenerative Therapies. Its NAICS code is 339113 and its SIC code is 3842.