BioRestorative Therapies

What BioRestorative Therapies does

BioRestorative Therapies, Inc. (NASDAQ: BRTX) is a clinical-stage regenerative medicine company founded in 1997 and headquartered in Melville, NY, developing adult stem cell-based therapeutics and biologics. Its lead program, BRTX-100, is an autologous cell therapy that uses the patient's own bone marrow-derived mesenchymal stem cells (MSCs) grown under hypoxic conditions and supplemented with platelet lysate, delivered as a single intradiscal injection to treat chronic lumbar disc disease. BRTX-100 has FDA Fast Track designation and completed enrollment of 99 patients across 15 U.S. clinical sites in its Phase 2 trial (NCT04042844), with topline safety and efficacy data expected in Q2 2027 and a Phase 3 IND targeted for the second half of 2026. A second program, ThermoStem, is an allogeneic, off-the-shelf platform using human brown adipose-derived stem cells (BADSC) for obesity and metabolic disorders, currently in preclinical development with granted Australian patent and Japanese Notice of Allowance.

The third line, BioCosmeceuticals (sub-branded BioX), is the company's commercial product platform leveraging secretome technology including exosomes, growth factors, cytokines, and peptides for regenerative aesthetics and dermatology. Products are manufactured in a vertically integrated cGMP ISO-7 certified cleanroom in Melville. Commercial distribution is anchored by an exclusive 5-year agreement with Cartessa Aesthetics for the aesthetic channel, while a 2026 strategic collaboration with 203 Creates provides brand architecture, digital infrastructure, and omnichannel go-to-market execution across professional, retail, and direct-to-consumer channels. BioRestorative is publicly traded on NASDAQ with a market capitalization of approximately $2.69 million as of March 2026, reported a $14.3 million LTM EBITDA loss, and has financed operations through a series of registered direct and public offerings totaling roughly $16.2 million between July 2023 and February 2026. Activist hedge fund Kaos Capital disclosed a 4.9% stake in May 2026 and is publicly urging strategic alternatives including a potential pivot toward AI.

Name

BioRestorative Therapies

Legal name

BioRestorative Therapies, Inc.

Website

https://biorestorative.com

Company type

Public

Founded year

1997

Operating status

Operating

Headcount range

1–10 employees

Short description

BioRestorative Therapies is a clinical-stage regenerative medicine company developing adult stem cell-based therapies, including BRTX-100 for chronic lumbar disc disease (Phase 2) and the ThermoStem metabolic program, while commercially launching secretome-based BioCosmeceuticals under the BioX brand via channel partners Cartessa Aesthetics and 203 Creates.

Ownership category

akta.pro rank

Product category

Regenerative Medicine

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical and Medicine Manufacturing (3254), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834)

akta.pro primary industry

Stem Cell–Based Regenerative Therapies (HLAAAGAA)

akta.pro secondary industries

Cell Therapy Developers (Allogeneic/Off-the-shelf) (HLAAABAB), Cartilage, Bone & Musculoskeletal Regeneration (HLAAAGAH), Skin Substitutes & Biologic/Regenerative Wound Therapies (Matrices, Grafts) (HLAHALAE), Dermatology Specialty Pharmaceuticals (HLAIACAL)

Keywords

• Stem cell therapy
• Regenerative medicine
• Cell-based therapeutics
• Mesenchymal stem cells
• Biocosmeceuticals

Headquarters

HQ city

Melville

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Therapeutic Product Revenue (BRTX-100): Revenue from FDA-approved stem cell therapy BRTX-100 for chronic lumbar disc disease. Currently in Phase 2/3 development with Fast Track designation. Revenue model will be one-time treatment-based with potential for premium pricing in regenerative medicine.
2. ThermoStem Metabolic Therapy Revenue: Revenue from ThermoStem cell-based therapy for obesity and metabolic disorders. Allogeneic off-the-shelf product positioning for broader market access. Potential licensing and partnership revenue streams.
3. BioCosmeceuticals Commercial Products: Commercial biologics-based cosmetic and dermatological products using secretome technology. Products targeted for skin rejuvenation, wound repair, and hair health applications. Revenue through professional, retail, and direct-to-consumer channels.

Go-to-market motion3 records

Distribution channels4 records

Marketing channels4 records

Core offering

BioRestorative Therapies develops stem cell-based therapeutic candidates targeting chronic lumbar disc disease (BRTX-100, Phase 2) and obesity/metabolic disorders (ThermoStem, preclinical), and commercializes a BioCosmeceuticals platform leveraging proprietary secretome-derived biologics for aesthetic and skincare applications marketed under the BioX brand. The company manufactures its products in an in-house cGMP ISO-7 certified cleanroom facility and distributes through U.S. clinical sites, physician partnerships, and a professional aesthetics channel partnership with Cartessa Aesthetics.

Product overview

BioRestorative Therapies is a clinical-stage regenerative medicine company developing a portfolio of stem cell-based therapeutic products. The company operates two core therapeutic programs: BRTX-100 (autologous bone marrow-derived MSC therapy for chronic lumbar disc disease in Phase 2) and ThermoStem (allogeneic brown adipose-derived stem cell therapy for obesity and metabolic disorders in preclinical development). The company also commercializes a BioCosmeceuticals platform (branded as BioX) offering secretome-based biologics including exosomes, growth factors, and cytokines for aesthetic medicine applications. BRTX-100 has received FDA Fast Track designation and completed Phase 2 enrollment with 99 patients.

Differentiator

Problem solved

Functional benefit

Brands

• BioX: Product portfolio brand for biocosmeceutical products developed by BioRestorative Therapies, managed through strategic collaboration with 203 Creates for brand architecture and commercial execution.

Products and services

• BRTX-100 Autologous stem cell therapy candidate in Phase 2 clinical development for the treatment of chronic lumbar disc disease (cLDD); designed for adult patients with chronic lumbar disc-related back pain and intended for administration by trained spine specialists at clinical sites or specialty centers.
• ThermoStem Allogeneic stem cell therapy candidate in preclinical development leveraging proprietary Brown Adipose-Derived Stem Cell (BADSC) technology for the treatment of obesity and metabolic disorders; intended to be developed for biopharmaceutical partners or via licensing for eventual use by metabolic disease specialists.
• BioCosmeceuticals (BioX brand) Commercial line of secretome-derived biologic skincare and aesthetic products marketed under the BioX brand, sold to aesthetic medicine professionals, dermatologists, plastic surgeons, and medical spas for in-office use and resale; manufactured in-house at the company's cGMP ISO-7 certified facility.

Quantifiable outcome

• 52% of evaluable patients achieved at least 50% improvement in both pain (VAS) and function (ODI) measures at 52 weeks
• +4 more outcomes

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Three partnerships are on record, tiered major and core.

• Dr. David J. GoldbergmajorStrategic or Co-development Partner · 21 April 2026Strategic partnership with leading dermatology innovator to lead prospective controlled human clinical study evaluating BioCosmeceutical platform containing secretome-derived biologics, exosomes, growth factors, cytokines, and peptides. Study designed to generate comparative outcome data on skin appearance and quality improvements. Forms part of BioRestorative's three-pillar strategy combining manufacturing capability, commercial execution, and independent clinical validation.
• 203 Creates, LLCcoreStrategic or Co-development Partner · 7 April 2026Strategic collaboration to build and commercialize BioCosmeceutical platform bridging biotechnology and premium skincare. 203 Creates leads development of brand architecture, digital infrastructure, and omnichannel go-to-market execution for BioX product portfolio. Expected to accelerate time to market and establish scalable systems for customer acquisition, retention, and global distribution.
• Cartessa AestheticscoreChannel Partner/ Reseller/ DistributorExclusive 5-year commercial agreement for distribution of BioCosmeceutical aesthetic products. Cartessa Aesthetics operates in the medical aesthetics space.

Scale indicators15 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Mesoblast: Allogeneic cell therapy developer with a late-stage mesenchymal stem cell asset (remestemcel-L) in inflammatory and musculoskeletal indications. Most directly comparable to BRTX-100 as a stem cell-based therapeutic targeting large chronic disease populations with similar regulatory and commercial dynamics.
• DiscGenics: Clinical-stage company developing an allogeneic cell therapy (IDCT) for degenerative disc disease. Closest direct competitor to BRTX-100 in the chronic lumbar disc disease indication with overlapping mechanism and patient population.
• Vericel: Commercial-stage cell therapy company marketing MACI (autologous cultured chondrocytes) for cartilage defects and Epicel for burns. Comparable as a commercialized autologous cell therapy with vertically integrated manufacturing and a similar orthopedic/regenerative focus.
• Lineage Cell Therapeutics: Clinical-stage cell therapy company with allogeneic platforms targeting ophthalmologic, neurologic, and orthopedic indications. Comparable to BioRestorative as a multi-program cell therapy developer using allogeneic/off-the-shelf approaches similar in concept to ThermoStem.
• Capricor Therapeutics: Clinical-stage biotech developing cell-derived exosome and cell therapy products (CAP-1002, CAP-2003) for Duchenne muscular dystrophy and other indications. Comparable as a small-cap cell and exosome-based therapeutics developer with overlapping secretome/vesicle technology.
• Athersys: Clinical-stage regenerative medicine company developing MultiStem, an adult stem cell therapy for inflammatory, neurologic, and cardiovascular indications. Comparable as a small-cap, multi-program, stem cell therapy developer with similar capital structure and trial-stage profile.
• Pluristem Therapeutics: Clinical-stage cell therapy company using placenta-derived mesenchymal-like adherent stromal cells (PLX cells) for inflammatory and musculoskeletal indications. Comparable as a publicly listed allogeneic cell therapy developer with analogous regulatory and commercialization pathway.

Broad incumbents

• Organogenesis: Commercial-stage regenerative medicine company marketing wound care and surgical biologics (Apligraf, Dermagraft). Comparable as a vertically integrated regenerative medicine company with both advanced wound care and surgical product lines, providing a model for BioRestorative's commercial scale-up.

Emerging players

• ViaCyte: Clinical-stage company developing stem cell-derived cell therapies for type 1 diabetes. Comparable in using allogeneic stem cell platforms for metabolic disease, conceptually parallel to ThermoStem's metabolic disorder program.
• ExoCoBio: Commercial-stage exosome-based aesthetics and regenerative skincare company. Comparable to BioCosmeceuticals/BioX as a competitor in the secretome/exosome regenerative aesthetics category that BioRestorative is targeting with its BioX brand.

Market position

Strengths4 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/biorestorative
• LinkedInlinkedin.com/company/biorestorative-therapies-inc-

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Funding overview

Funding rounds7 records

Investors2 records

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 BioRestorative Therapies