Restem Group

What Restem Group does

Restem Group is a clinical-stage biopharmaceutical company developing off-the-shelf, allogeneic cell-based therapeutics for autoimmune, inflammatory, and age-related diseases. The company's core platforms are Restem-L, derived from proprietary Umbilical Cord Lining Modified Progenitor Cells (UMPCs) that exhibit a more youthful phenotype and superior immunomodulatory profile compared to bone marrow or fat-derived mesenchymal stem cells, and Activated Natural Killer (aNK) cells targeting cellular senescence. RESTEM holds FDA Fast Track Designation for Restem-L in idiopathic inflammatory myopathy (IIM) and FDA Orphan Drug Designation for its ULSC Program in polymyositis and dermatomyositis, and is currently advancing a Phase 2/3 trial (IIMPACT) in IIM, a Phase 2 trial in rheumatoid arthritis, and a Phase 1/2a trial in facioscapulohumeral muscular dystrophy (FSHD) conducted at Stanford University with SOLVE FSHD funding.

The company operates GMP-compliant manufacturing in Corona, California, claiming commercial-scale production capacity of millions of doses, with its corporate office in Miami, Florida. Its revenue model is presently pre-commercial for the therapeutic pipeline; near-term revenue is generated via the JuveXO consumer skincare and haircare line, developed from the Restem-X exosome/secretome platform through a collaboration with TheBioBox and Eternus Biosciences, distributed through retail and physician channels globally. Long-term revenue is intended to come from commercialization of cell therapies upon regulatory approval and from licensing and partnership agreements. RESTEM engages investors and partners through major biotech conferences (BIO International Convention, BIO Investment & Growth Summit, H.C. Wainwright, Biotech Showcase, EULAR, ACR) and supports clinical trial recruitment via its corporate website with pre-screening questionnaires.

Name

Restem Group

Legal name

Restem Group

Website

https://restem.com

Company type

Private

Founded year

2008

Operating status

Operating

Headcount range

11–50 employees

Short description

Restem Group is a clinical-stage biopharmaceutical company developing off-the-shelf cell therapies based on umbilical cord lining progenitor cells and activated NK cells for autoimmune, inflammatory, and age-related diseases. It also sells consumer skincare products via its JuveXO brand.

Ownership category

akta.pro rank

Product category

Cell Therapy / Regenerative Medicine Biopharmaceuticals

NAICS

Pharmaceutical Preparation Manufacturing (325412), Medical and Diagnostic Laboratories (62151)

SIC

Pharmaceutical Preparations (2834), Services-Medical Laboratories (8071), Services-Misc Health & Allied Services, Nec (8090)

akta.pro primary industry

Cell Therapy Clinical Services & Treatment Centers (apheresis, administration, monitoring) (HLAAABAJ)

akta.pro secondary industries

Dermocosmetics & Medical-Grade Skincare (CRABAAAF), Medical Wellness & Longevity (Health Screening, Biohacking, Anti-aging Programs) (THAJAHAI)

Keywords

• Allogeneic cell therapy
• Autoimmune disease therapeutics
• Umbilical cord stem cells
• Exosome biocosmetics
• Clinical-stage biopharmaceutical

Headquarters

HQ city

Miami

HQ country

United States

HQ region

North America

Offices2 records

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. Off-the-shelf Cell Therapy Products (Future): Once approved, RESTEM plans to commercialize its off-the-shelf allogeneic cell therapies (Restem-L) for autoimmune, inflammatory, and age-related diseases. As a clinical-stage company currently in Phase 1/2 and Phase 2/3 trials, no commercial revenue is currently generated.
2. aNK Cell Therapeutics (Future): RESTEM's activated NK cell program targeting cellular senescence and age-related disorders represents a future revenue stream through therapeutic product commercialization upon regulatory approval.
3. Consumer Skincare / Biocosmetics (JuveXO): Through the Restem-X exosome platform and collaboration with TheBioBox, RESTEM generates revenue from consumer skincare and haircare products (JuveXO) sold through retail and physician channels. This represents an existing near-term revenue stream alongside the longer-term pharmaceutical pipeline.
4. Licensing and Partnerships: RESTEM may generate revenue through licensing agreements for its proprietary cell platforms, intellectual property, and technology partnerships with other biotechnology or pharmaceutical companies.

Go-to-market motion3 records

Distribution channels4 records

Marketing channels5 records

Core offering

Restem Group is a clinical-stage biopharmaceutical company that develops off-the-shelf allogeneic cell therapeutics — Restem-L (UMPCs) and activated Natural Killer (aNK) cells — for autoimmune, inflammatory, and age-related diseases. In parallel, the company manufactures and sells exosome-based topical biocosmetic products (JuveXO, Restem-X, UCM-X) for skin and hair rejuvenation through physician and consumer channels.

Product overview

Restem Group offers a portfolio of cell-based therapeutic products centered on two proprietary platforms: Restem-L (Umbilical Lining Modified Progenitor Cells) for autoimmune and inflammatory diseases, and Activated Natural Killer (aNK) Cells for age-related diseases targeting cellular senescence. The company also commercializes Restem-X/UCM-X exosome-based topical products for skin and haircare through its JuveXO brand. Restem-L is an allogeneic, off-the-shelf cell therapy that can be administered without prior cell harvesting, positioning it as a differentiated offering compared to patient-specific cell therapies.

Differentiator

Problem solved

Functional benefit

Brands

• Restem-L: Proprietary Umbilical Lining Modified Progenitor Cells (UMPCs) therapy for autoimmune diseases
• RESTEM-X
• UCM-X
• JUVEXO
• aNK Cells

Products and services

• Restem-L (UMPC cell therapy) An off-the-shelf allogeneic cell therapy product composed of a Unique Mixed Population of Cells (UMPCs) derived from umbilical cord tissue, in clinical and compassionate use for patients with inflammatory myopathies, rheumatoid arthritis, and FSHD. Targeted at specialty physicians and clinical trial investigators managing refractory autoimmune and rare disease patients.
• aNK Cells (Activated Natural Killer cell therapy) An activated Natural Killer (aNK) cell therapy product derived from umbilical cord blood CD56+ cells, developed for inflammatory, autoimmune, and oncology-adjacent indications within the company's cell therapy pipeline.
• JuveXO Commercial exosome-based topical product line (skincare and haircare) developed from the company's UCM-X platform, sold to aesthetic and dermatology practices and to consumers online for skin and hair rejuvenation.
• Restem-X / UCM-X (exosome and secretome platform products) Restem-X / UCM-X is the company's exosome and secretome product platform, providing the biological basis for the JuveXO topical line and serving as a foundation for additional exosome-derived products.

Quantifiable outcome

• Phase 1 trial in IIM patients showed clinically meaningful and durable improvements in Total Improvement Score (TIS)
• +4 more outcomes

Segments4 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Six partnerships are on record, tiered core and minor.

• JAR of Hope FoundationcoreStrategic or Co-development Partner · 6 September 2022JAR of Hope Foundation and RESTEM announced a strategic partnership and clinical trial launch for next-generation cell therapy targeting patients with Duchenne Muscular Dystrophy. This partnership combines RESTEM's cell therapy expertise with JAR of Hope Foundation's patient advocacy and support capabilities to advance a novel treatment for DMD.
• UF Center for Regenerative MedicineminorStrategic or Co-development Partner · 2 August 2022The UF Center for Regenerative Medicine, part of UF Health, was recruiting for a trial on potential therapy for autoimmune disorders in collaboration with RESTEM. Dr. Keith L. March serves as Director of the University of Florida's Center for Regenerative Medicine and Professor in the Division of Cardiovascular Medicine.
• TheBioBoxcoreStrategic or Co-development PartnerRESTEM collaborated with TheBioBox to launch Eternus Biosciences and develop JuveXO, an exosome product gaining global recognition among physicians and expanding into the retail cosmetic market. Brian Pla, RESTEM's Chief Business Development Officer, co-founded Eternus Biosciences with TheBioBox and serves as President of Congela Biocosmetics, driving innovation in regenerative hair and skin care solutions.
• Stanford UniversitycoreStrategic or Co-development PartnerStanford University is the clinical site for RESTEM's Phase 1/2a clinical trial of Restem-L for facioscapulohumeral muscular dystrophy (FSHD). Dr. Robert S. Negrin, Professor of Medicine and former Chief of the Division of Blood and Marrow Transplantation at Stanford University, serves as a trusted advisor to RESTEM.
• Miami Cancer Institute / Baptist Health South FloridaminorStrategic or Co-development PartnerDr. Guenther Koehne, Director of Cell Therapies & Cancer Institute at Baptist Hospital (Miami Cancer Institute, part of Baptist Health South Florida), serves as a trusted advisor to RESTEM. He is an internationally renowned expert in stem cell transplantation and is involved in numerous clinical trials.
• Florida International UniversityminorStrategic or Co-development PartnerDr. Robert Sackstein serves as Senior Vice-President for Global Health Affairs at Florida International University and as a trusted advisor to RESTEM. He is a Professor Emeritus at Harvard Medical School with expertise in cell-based therapeutics.

Scale indicators4 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Capricor Therapeutics: Cell therapy company developing CAP-1002 (cardiosphere-derived cells) for Duchenne muscular dystrophy and other rare diseases. Comparable in targeting rare neuromuscular indications (overlaps with RESTEM's FSHD and DMD programs) and in cell-therapy regulatory approach.
• Mesoblast: Clinical-stage cell therapy company developing mesenchymal stem cell (MSC) products (remestemcel-L) for inflammatory and autoimmune diseases — directly comparable in cell type, indication overlap (graft-vs-host, inflammatory conditions), and allogeneic manufacturing approach.
• Celularity: Cell therapy company developing placenta and umbilical cord-derived cellular therapeutics for cancer, autoimmune, and degenerative diseases. Closely comparable in umbilical cord-derived cell source, immunomodulatory mechanism, and overlapping target indications.
• Mesoblast Limited: Listed again for emphasis — the most directly comparable pure-play MSC competitor with remestemcel-L in late-stage development for SR-aGvHD, and broader pipeline in heart failure, IBD, and chronic inflammatory conditions.
• Athersys: MultiStem (MAPC) cell therapy platform targeting inflammatory and autoimmune conditions including ARDS and ischemic stroke. Directly comparable as a small-cap clinical-stage allogeneic cell therapy developer with multiple Phase 2/3 programs.
• BrainStorm Cell Therapeutics: Cell therapy company developing autologous MSC-NTF cells for neurodegenerative diseases (ALS, MS). Comparable as a small clinical-stage cell therapy company in autoimmune/neurodegenerative indications, though autologous rather than allogeneic.
• Lineage Cell Therapeutics: Clinical-stage cell therapy company developing allogeneic treatments for neurodegenerative, ophthalmologic, and oncology indications. Comparable in being a small clinical-stage allogeneic cell therapy developer with multiple pipeline programs.
• Pluristem Therapeutics: Placenta-derived MSC-like cell therapy (PLX cells) for inflammatory and hematological conditions. Closely comparable as a small clinical-stage allogeneic cell therapy company targeting overlapping autoimmune/inflammatory indications with a similar off-the-shelf manufacturing model.

Broad incumbents

• Gilead Sciences (Kite Pharma): Major biopharma with approved cell therapy franchise (Yescarta, Tecartus) through Kite Pharma. Broader incumbent with approved cell therapy products and infrastructure; relevant as a strategic acquirer / benchmark for cell therapy commercialization.
• Bristol-Myers Squibb (Celgene/Juno): Major biopharma with multiple approved cell therapies (Breyanzi, Abecma) and a leading cell therapy manufacturing footprint. Relevant as an incumbent cell therapy player and a potential strategic acquirer for RESTEM's allogeneic platform.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/RESTEM_bio
• Facebookfacebook.com/RESTEMbio

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 records

Subsidiaries1 record

Funding overview

Funding rounds1 record

Investors1 record

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

M&A

Investments1 record

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

Frequently asked questions about Restem Group