Orgenesis

What Orgenesis does

Orgenesis Inc. is a publicly traded biotechnology company that operates a decentralized cell and gene therapy (CGT) manufacturing platform under the POCare brand. Founded in 2008 and headquartered in Germantown, Maryland, Orgenesis went public in August 2011 and currently trades on the OTC Expert Market under ticker ORGS after being delisted from Nasdaq, with a market valuation of approximately $1.87 million as of January 2026. The company's core function is to enable hospitals, healthcare providers, and biotechnology companies to produce advanced personalized therapies at the point of care rather than relying on centralized manufacturing infrastructure, through a network spanning the United States, Israel, Belgium, and South Korea.

The POCare Platform is built on three integrated components: POCare Therapies (a pipeline of owned, licensed, and partnered candidates including ORGCAR19, Kyslecel — which holds FDA orphan drug designation for total pancreatectomy — Bioxome exosomes, DUVAC, MOTC, and RanTop); POCare Technologies, anchored by the OMPUL (Orgenesis Mobile Processing Units and Labs), a proprietary closed-loop bioprocessing unit with Grade A/B or A/D clean room environments, automated single-use sensors, and cloud-based data connectivity; and POCare Network, a global collaborative framework spanning partner institutions in the US, Israel, Belgium, South Korea, Spain, Greece, Austria, Germany, and China. OMPUL implementation compresses typical CGT deployment timelines from 18-24 months to 3-6 months, and the Korean GMP plant supports commercial-scale manufacturing.

Orgenesis generates revenue across three primary streams: therapeutic licensing and royalties from its owned and partnered therapy pipeline, hardware sales of OMPUL processing systems, and point-of-care processing services delivered through decentralized POCare centers within a six-hour radius of patients. Its customer base spans three vertical segments — hospitals and healthcare providers (primary), biotechnology companies requiring CGT scale-up support, and academic and research institutions. The company has raised over $35 million in cumulative funding, with Metalmark Capital as the principal institutional backer. As of 2024, Orgenesis continues to report operating losses and dependence on external financing, has divested its ranpirnase portfolio to Okogen Inc. (March 2026), and has undergone leadership transitions including a new CFO (Doug Karriker) and new directors appointed in March 2026.

Name

Orgenesis

Legal name

Orgenesis Inc.

Website

https://orgenesis.com

Company type

Public

Founded year

2008

Operating status

Operating

Headcount range

101–250 employees

Short description

Orgenesis is a public biotech operating a decentralized cell and gene therapy manufacturing platform, serving hospitals, biotech companies, and research institutions via its global POCare Network and proprietary mobile processing units (OMPUL).

Ownership category

akta.pro rank

Product category

Cell and Gene Therapy Manufacturing

NAICS

Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Cell Therapy CDMO (Autologous/Allogeneic Manufacturing) (HLAGAGAA)

akta.pro secondary industry

Clinical Trial Material (CTM) Manufacturing & Supply CDMO (HLAGABAK)

Keywords

• Cell therapy manufacturing
• Gene therapy services
• Biotechnology platforms
• Mobile processing labs
• Point-of-care therapies

Headquarters

HQ city

White Plains

HQ country

United States

HQ region

North America

Offices7 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Technology or R&D, Operations, Infrastructure

Revenue model

1. Therapeutic Licensing and Royalties: By identifying and partnering with early-stage biotechnology developers, Orgenesis brings development and validation in-house to create a pipeline of owned, licensed, and partnered therapies. The company applies know-how in CGT development and production to build long-term opportunities via processing licenses and royalties at the POCare Network level.
2. Technology Processing Systems: Revenue generated from customized, automated processing systems (OMPUL) that enable point-of-care production of cell and gene therapies. Systems are validated for each therapy to intensify production as high-margin scalable solutions.
3. Point-of-Care Processing Services: Revenue from providing processing services through the decentralized network of POCare centers and OMPUL hubs located at hospitals and healthcare facilities globally.

Go-to-market motion2 records

Distribution channels2 records

Marketing channels5 records

Core offering

Orgenesis is a biotechnology company that operates a decentralized point-of-care (POCare) platform for cell and gene therapy manufacturing and processing. The company develops therapeutic products, supplies mobile processing units and labs (OMPUL), and provides a distributed network enabling hospitals, biotech firms, and academic institutions to perform cell and gene therapy processing close to patients.

Product overview

Orgenesis offers a unified platform ecosystem centered on the POCare Platform, which integrates three core components: POCare Therapies (a pipeline of advanced cell and gene therapies), POCare Technologies (customized automated processing systems), and POCare Network (a global collaborative network). The key product is the Orgenesis Mobile Processing Units and Labs™ (OMPUL™), a fully integrated closed-loop bioprocessing unit that enables decentralized CGT manufacturing at point-of-care locations. The therapy pipeline includes named candidates such as ORGCAR19 (CD19 CAR-T), MOTC, DUVAC, RanTop, Kyslecel™, and Bioxome™ spanning immuno-oncology, viral diseases, metabolic diseases, and vascular/musculoskeletal applications. The company serves academic medical centers, hospitals, and biotechnology companies through POCare Centers that can be deployed rapidly using OMPUL™ technology.

Differentiator

Problem solved

Functional benefit

Brands

• POCare Platform: Point-of-care platform providing a pathway for unlocking the full potential of cell and gene therapies (CGTs) in an affordable and accessible format.
• OMPUL (Orgenesis Mobile Processing Units and Labs)
• POCare Therapies
• POCare Technologies
• POCare Network
• Morgenesis

Products and services

• POCare Therapies Cell and gene therapeutic products developed and supplied by Orgenesis, delivered to hospitals and clinical partners through the POCare decentralized manufacturing model.
• POCare Technologies Proprietary processing technology systems and platforms licensed or sold to partners for cell and gene therapy manufacturing at the point of care.
• POCare Network A distributed service network that connects hospitals, biotech companies, and academic institutions to enable point-of-care processing, development, and delivery of cell and gene therapies.
• OMPUL (Mobile Processing Units and Labs) Modular mobile processing units and laboratory infrastructure that Orgenesis deploys at hospital or partner sites to enable decentralized manufacturing of cell and gene therapies at the point of care.

Quantifiable outcome

• Implementation time reduced from 18-24 months to 3-6 months
• +2 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

Two partnerships are on record, tiered major and core.

• Harley Street Healthcare GroupmajorStrategic or Co-development Partner · 14 August 2024Strategic partnership to launch a global longevity and wellness initiative with an investment commitment of up to $10 million over three years. Joint venture to develop health and wellness services including regenerative therapies and preventative care, targeting multiple regions worldwide.
• BioWincoreStrategic or Co-development PartnerBioWin is a consortium member of the EXOFASTTRACK project. BioWin is the health and biotech cluster of Wallonia, Belgium, supporting collaborative initiatives in therapeutic exosome development.

Scale indicators6 records

Recent moves6 records

Expansion highlights6 records

Emerging players

• IsoPlexis: Provides single-cell analytics platforms used in cell therapy development and manufacturing quality control. Operates in the broader cell therapy ecosystem with technology that could integrate with Orgenesis's POCare quality harmonization framework.
• CellPoint (acquired by Lonza): Developed point-of-care CAR-T manufacturing technology that was acquired by Lonza in 2022, validating the decentralized manufacturing thesis but now competing under Lonza's broader CDMO portfolio against Orgenesis.

Direct peers

• Cellares: Direct competitor in decentralized cell therapy manufacturing with its Cell Shuttle platform—an automated, closed-system manufacturing solution aimed at scaling cell therapy production. Competes head-to-head with Orgenesis's OMPUL for biotech and hospital customers.
• Vineti: Provides cell and gene therapy orchestration software and supply chain management for therapy developers and treatment centers. Complementary/competing with Orgenesis's POCare Network by enabling CGT delivery to patients at point-of-care.

Broad incumbents

• Lonza: Global CDMO leader offering cell and gene therapy manufacturing services including viral vectors, autologous/allogeneic cell therapies, and biologics. Operates large-scale centralized facilities that compete with Orgenesis's decentralized POCare model for the same biotech customers.
• Gilead Sciences (Kite Pharma): Operates Kite Pharma, a leading CAR-T manufacturer (Yescarta, Tecartus). Competes in the same autologous cell therapy commercial space where Orgenesis is building its decentralized production capabilities.
• AGC Biologics: Global CDMO with cell and gene therapy manufacturing services including autologous and allogeneic cell therapy production. Competes with Orgenesis for biotech customers requiring GMP-compliant CGT manufacturing capacity.
• Catalent: Major CDMO with cell therapy manufacturing capabilities serving gene therapy and CAR-T developers. Its Paragon Gene Therapy and cell therapy services overlap with Orgenesis's POCare platform for biotech clients needing manufacturing scale-up.
• Novartis: Pharma company that pioneered commercial CAR-T therapy (Kymriah) and operates large-scale cell therapy manufacturing. Represents both a potential OMPUL/POCare customer and a competitive threat in autologous cell therapy commercialization.
• Thermo Fisher Scientific (Patheon): Operates a global CDMO business with dedicated cell and gene therapy manufacturing services. Competes with Orgenesis for biotech customers needing commercial-scale production of advanced therapies and offers integrated clinical trial material supply.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/orgenesis-inc-orgs-

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Subsidiaries5 records

Funding overview

Funding rounds9 records

Investors4 records

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

M&A2 records

Investments

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

Frequently asked questions about Orgenesis