Osiris Therapeutics

What Osiris Therapeutics does

Osiris Therapeutics is a regenerative medicine company founded in 1992 by Kevin Kimberlin and Dr. Arnold Caplan, with operations historically based in Columbia, USA. The company develops therapies based on mesenchymal stem cell (MSC) technology, an adult stem cell platform derived from bone marrow and other tissue sources. Its clinical and commercial work has centered on remestemcel-L, branded RYONCIL, which in 2020 became the first mesenchymal stromal cell therapy to receive FDA approval, indicated for steroid-refractory acute graft-versus-host disease (aGvHD) in pediatric patients.

The company's business model is built around proprietary cell-therapy IP and a partnered commercialization pathway. Rather than commercializing RYONCIL independently, Osiris licensed the asset to Mesoblast Limited for Phase 3 clinical development and global commercialization, receiving milestone and royalty economics in return. This structure allowed Osiris to monetize its MSC platform without standing up proprietary sales, manufacturing scale-up, or distribution infrastructure. The company was publicly traded on NASDAQ under the ticker OSIR and raised capital across multiple funding rounds between 2005 and 2018, including a strategic $15M investment from Mesoblast in 2014.

The entity no longer appears to operate as an independent commercial enterprise. The osiris.com domain is listed for sale, and the company's primary asset sits within Mesoblast's commercial pipeline. Effectively, Osiris has transitioned from an independent MSC development company to an absorbed entity whose principal strategic significance is the provenance of an FDA-approved cell therapy and the associated intellectual property that underpins Mesoblast's commercial positioning. The company reports between 501 and 1,000 employees on its corporate profile, though headcount figures may reflect historic or aggregated disclosures rather than current operational reality.

Name

Osiris Therapeutics

Legal name

Osiris Therapeutics

Website

https://osiris.com

Company type

Private

Founded year

1992

Operating status

Acquired

Headcount range

501–1,000 employees

Short description

Osiris Therapeutics is a regenerative medicine company that developed RYONCIL, the first FDA-approved mesenchymal stromal cell therapy, for pediatric steroid-refractacute graft-versus-host disease, with commercial rights licensed to Mesoblast Limited.

Ownership category

akta.pro rank

Product category

Regenerative Medicine Cell Therapy

NAICS

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

SIC

Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Stem Cell Therapies (MSC/iPSC/HSC-derived) (HLAAABAE)

akta.pro secondary industries

Stem Cell–Based Regenerative Therapies (HLAAAGAA), Cell Therapy Developers (Allogeneic/Off-the-shelf) (HLAAABAB), Rare Pediatric & Congenital Disorder Therapies (HLAIAIAN)

Keywords

• Regenerative medicine
• Cell therapy
• Stem cell treatment
• Mesenchymal stromal cells
• Transplant medicine

Headquarters

HQ city

Columbia

HQ country

United States

HQ region

North America

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Distribution channels1 record

Core offering

Osiris Therapeutics develops and patents stem cell-based regenerative medicine products, most notably RYONCIL (remestemcel-L), the first FDA-approved mesenchymal stromal cell (MSC) therapy for treating steroid-refractory acute graft-versus-host disease in pediatric patients two months and older. The company developed this therapy and licensed it to Mesoblast Limited for Phase 3 trials and commercialization, with the product distributed to transplant centers and hospitals across the United States.

Product overview

Osiris Therapeutics is a regenerative medicine company focused on developing cell-based therapies. The company is noted for co-developing RYONCIL, the first FDA-approved mesenchymal stromal cell therapy, which was developed and patented by Osiris Therapeutics and licensed to Mesoblast Limited for Phase 3 trials and commercialization.

Differentiator

Problem solved

Functional benefit

Products and services

• RYONCIL (remestemcel-L) First FDA-approved mesenchymal stromal cell therapy for treating steroid-refractory acute graft-versus-host disease in pediatric patients two months and older; developed and patented by Osiris Therapeutics and licensed to Mesoblast Limited for commercialization, with immediate availability at transplant centers and hospitals across the United States.

Quantifiable outcome

• RYONCIL immediately available at transplant centers and hospitals across the United States

Segments1 record

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature1 record

Partnerships

One partnership is on record.

• Mesoblast LimitedcoreOEM/ Whitelabel/ Licensing Partner · 16 January 2025RYONCIL, the first FDA-approved mesenchymal stromal cell therapy developed and patented by Osiris Therapeutics, was licensed to Mesoblast Limited for Phase 3 trials and commercialization. Mesoblast is responsible for bringing the therapy to market across transplant centers and hospitals in the United States.

Recent moves5 records

Expansion highlights2 records

Direct peers

• Mesoblast Limited: Listed parent and commercialization partner for RYONCIL/remestemcel-L. Mesoblast develops MSC-based therapies for inflammatory and immunologic conditions, directly overlapping Osiris's core technology and indication.
• Pluristem Therapeutics: Develops placenta-derived allogeneic cell therapies for hematologic, inflammatory, and ischemic conditions. Competes with Osiris in the allogeneic cell therapy category and has overlapping regenerative medicine positioning.
• Athersys: Clinical-stage cell therapy company developing MultiStem, an off-the-shelf allogeneic stem cell therapy, for ischemic stroke, ARDS, and GVHD—directly overlapping Osiris's MSC-based approach and target indications.
• Vericel Corporation: Commercial-stage cell therapy company with FDA-approved autologous cartilage repair (MACI) and burn wound products. Comparable as a commercial-stage cell therapy developer in regenerative medicine.
• StemCells, Inc. Pioneer in neural and liver stem cell therapies; wound down standalone operations, providing a comparable cautionary precedent for cell therapy developers facing commercialization and capital challenges.

Broad incumbents

• BlueRock Therapeutics: Bayer subsidiary developing iPSC-derived cell therapies for cardiology and neurology. A well-capitalized incumbent in regenerative cell therapy, representing the broader competitive landscape Osiris operates in.

Regional players

• Holostem Terapie Avanzate: European-based developer of advanced stem cell therapies including Holoclar (limbal stem cell therapy). Comparable as a cell therapy company in regenerative medicine, primarily serving European markets.

Emerging players

• BrainStorm Cell Therapeutics: Developer of NurOwn, an autologous MSC-based cell therapy for neurodegenerative diseases (ALS, MS). Uses MSC technology analogous to Osiris's platform but targets neurological indications.
• Capricor Therapeutics: Develops cell therapy products including CAP-1002 (cardiac-derived cell therapy) for Duchenne muscular dystrophy and COVID-19. Comparable as a clinical-stage cell therapy developer in regenerative medicine.
• Cytori Therapeutics: Developed cell therapy technologies using adipose-derived regenerative cells. Comparable as a regenerative medicine company built around adult stem/stromal cell platforms.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat3 records

Key risks5 records

Key highlights5 records

Customer concentration

• LinkedInlinkedin.com/company/osiris-therapeutics

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds4 records

Investors3 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 Osiris Therapeutics