ECM Therapeutics

What ECM Therapeutics does

ECM Therapeutics, Inc. is a privately held regenerative medicine company founded in 2018 and headquartered in Warrendale, Pennsylvania. The company develops and manufactures therapeutic products derived from extracellular matrix (ECM), a naturally occurring biological material that contains structural and signaling components capable of guiding tissue repair. Its commercial-stage science traces to more than 30 years of research led by co-founder and Chief Medical Officer Dr. Stephen Badylak at the University of Pittsburgh's McGowan Institute for Regenerative Medicine, which generated the first FDA-approved ECM-based bioscaffold in 1999 and the 2016 discovery of Matrix-Bound Nanovesicles (MBV).

The company's product portfolio rests on two proprietary technology platforms. The first is decellularized ECM hydrogels — flowable, ready-to-use injectable biomaterials designed for wound management and, as ECMT-100, for anorectal fistula repair. The second is Matrix-Bound Nanovesicles, naturally occurring vesicles embedded in ECM that modulate immune response and cellular differentiation, being developed as an eye-drop formulation for corneal disease. As of late 2025, the wound-care ECM hydrogel is under FDA 510(k) review (submitted November 2025) and ECMT-100 is in a first-in-human IDE clinical study (initiated December 2025) at Dartmouth Hitchcock Medical Center and University of Pittsburgh Medical Center, with an MBV ocular program in preclinical development.

ECM Therapeutics is pre-revenue with no commercial products approved. Its intended revenue model is product sales of ECM hydrogel therapies once regulatory clearances are obtained, complemented by potential licensing royalties on the ECM and MBV platforms. Go-to-market targets hospitals, specialty clinics, and academic medical centers through direct enterprise sales and clinical-channel partnerships. Two named clinical study sites (Dartmouth Hitchcock and UPMC) and a Compassionate Use / Expanded Access Program form the current patient-access infrastructure. Funding to date totals approximately $51 million across disclosed rounds in 2018 and 2019.

Name

ECM Therapeutics

Legal name

ECM Therapeutics, Inc.

Website

https://ecmtherapeutics.com

Company type

Private

Founded year

2018

Operating status

Operating

Headcount range

11–50 employees

Short description

ECM Therapeutics is a regenerative medicine company developing injectable extracellular matrix (ECM) hydrogels and Matrix-Bound Nanovesicle (MBV) therapies to treat complex wounds, anorectal fistulas, and corneal disease, serving hospitals, specialty clinics, and academic medical centers.

Ownership category

akta.pro rank

Product category

Regenerative Medicine Therapeutics

NAICS

Surgical and Medical Instrument Manufacturing (339112), Surgical Appliance and Supplies Manufacturing (339113), Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Surgical & Medical Instruments & Apparatus (3841), Biological Products, (No Disgnostic Substances) (2836)

akta.pro industry

PRIMARYHLAAAGAF

Acellular/Decellularized Matrices & ECM Products

Healthcare & Life Sciences/Biotechnology & Biologics/Regenerative Medicine & Tissue Engineering

Keywords

• Regenerative medicine
• Extracellular matrix
• Wound care biomaterials
• Tissue engineering
• Hydrogel therapeutics

Headquarters

HQ city

Warrendale

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Product Sales (Future): Once regulatory approvals are obtained, ECM Therapeutics will generate revenue through the sale of ECM hydrogel products for wound care and anorectal fistula treatment, as well as potential future MBV-based ocular therapies.
2. Licensing Royalties (Future): The company may pursue licensing arrangements for its proprietary ECM technology and MBV platform to other medical device and pharmaceutical companies.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels3 records

Core offering

ECM Therapeutics develops and manufactures therapeutic products derived from naturally occurring extracellular matrix (ECM). Its portfolio includes injectable ECM hydrogels for advanced wound care and anorectal fistula repair, and Matrix-Bound Nanovesicles (MBV) biologics being developed for ocular indications. The company pursues FDA regulatory pathways (510(k) and IDE) to commercialize these regenerative medicine products for use by healthcare providers.

Product overview

ECM Therapeutics is a regenerative medicine company with a platform based on naturally derived extracellular matrix (ECM) technology. The company commercializes injectable ECM Hydrogel products and Matrix-Bound Nanovesicles (MBV) biologics. The core product portfolio includes ECM Hydrogel for advanced wound care (510(k) pending with FDA), ECMT-100 for anorectal fistula repair (IDE clinical study ongoing), and an MBV-based ocular program for corneal disease in pre-clinical development. The ECM platform enables tissue regeneration and functional restoration across wound management, surgical repair, and epithelial healing applications.

Differentiator

Problem solved

Functional benefit

Products and services

• ECM Hydrogel (Advanced Wound Care) Flowable, ready-to-use ECM hydrogel for management of partial and full-thickness wounds including pressure ulcers, venous ulcers, diabetic ulcers, surgical wounds, trauma wounds, and tunneling or undermined wounds. Designed for hospital and specialty clinic use; provides mechanical support, maintains wound hydration, and acts as a biological scaffold to guide tissue repair.
• ECMT-100 (Anorectal Fistula Hydrogel) Injectable ECM hydrogel (ECMT-100) for treatment of anorectal fistulas, a condition affecting approximately 70,000 to 100,000 patients annually in the United States. Currently under clinical investigation via IDE study. Targeted at colorectal surgeons and hospital departments.
• Matrix-Bound Nanovesicles (MBV) Ocular Therapy Naturally occurring vesicles embedded within extracellular matrix that carry bioactive cargo to modulate immune response, influence cellular differentiation, and support tissue repair pathways. In pre-clinical development as an eye drop formulation targeting corneal disease including post-procedural healing, dry eye disease, and environmental damage.

Quantifiable outcome

• More than 8 million patients have been treated with bioscaffolds developed in Dr. Badylak's laboratory
• +2 more outcomes

Named customers2 records

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Scale indicators5 records

Recent moves5 records

Expansion highlights5 records

Emerging players

• Aroa Biosurgery: Aroa Biosurgery (ASX: ARX) develops soft-tissue regeneration products from ovine forestomach ECM, with applications in wound care and surgical soft tissue repair. It is a closely analogous emerging peer using a similar ECM-derived biomaterials approach across overlapping indications.
• TELA Bio: TELA Bio develops and commercializes biologic reinforcement materials for soft tissue reconstruction, combining biologic and synthetic inputs. It is a relevant emerging regenerative medicine peer operating in adjacent surgical indications (hernia, abdominal wall) using biologic matrices.

Broad incumbents

• Integra LifeSciences: Integra LifeSciences is a diversified medical device company with a substantial regenerative tissue technologies franchise (including the former ACell MatriStem ECM-based products) serving wound care, surgical, and ENT markets. It competes with ECM Therapeutics in wound care via ECM-based offerings but across a far broader portfolio.
• Smith+Nephew: Smith+Nephew operates one of the world's largest advanced wound management businesses, including collagen- and skin-substitute products. It is the broadest incumbent peer against which ECM Therapeutics will compete for hospital formulary inclusion and reimbursement.
• Vericel: Vericel develops advanced cell therapies and specialty biologics for the sports medicine and severe burn care markets. While its core focus is autologous cell therapy rather than ECM, it operates in adjacent regenerative medicine commercialization channels and targets similar hospital-based specialties.
• ConvaTec: ConvaTec is a global medical products company with a major advanced wound care franchise (e.g., AQUACEL, InnovaMatrix). It represents the dominant incumbent in the wound care channel that ECM Therapeutics will need to displace or partner with to scale the ECM hydrogel product.

Direct peers

• MiMedx Group: MiMedx develops and commercializes regenerative medicine products derived from placental tissue, including wound care and surgical applications. It is one of the most directly comparable ECM/regenerative medicine peers to ECM Therapeutics in terms of product philosophy, target indications (wound management), and hospital channel.
• Organogenesis: Organogenesis is a leading regenerative medicine company commercializing living cell-based and cellularized matrix products for wound care and surgical applications. It is a direct competitor to ECM Therapeutics' ECM hydrogel wound care product, sharing the same advanced wound care end-market and hospital/clinic channel.
• ACell (a Coloplast Company): ACell developed MatriStem, a urinary bladder matrix-based ECM product for wound management and surgical applications, and was acquired by Coloplast. It is a direct technology peer to ECM Therapeutics in decellularized ECM scaffolds for wound care and soft tissue repair.
• Cook Biotech: Cook Biotech (a Cook Medical entity) is a pioneer and leading commercializer of ECM-based small intestinal submucosa (SIS) products for wound care, hernia repair, and other surgical applications. It is a foundational ECM technology peer and likely long-term competitive benchmark.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds2 records

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about ECM Therapeutics