Sernova

Name

Sernova

Legal name

Sernova Corp.

Website

https://sernova.com

Company type

Public

Founded year

2006

Operating status

Operating

Headcount range

11–50 employees

Short description

Sernova Biotherapeutics is a clinical-stage regenerative medicine company developing the Cell Pouch bio-hybrid organ, an implantable vascularized device for therapeutic cells, primarily targeting a functional cure for type 1 diabetes.

Ownership category

akta.pro rank

Product category

Regenerative Medicine Cell Therapy

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Medical Equipment and Supplies Manufacturing (3391)

SIC

Biological Products, (No Disgnostic Substances) (2836), Orthopedic, Prosthetic & Surgical Appliances & Supplies (3842)

akta.pro industry

PRIMARYHLAAAGAD

Organoids & Organ-on-Chip (regenerative models)

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

SECONDARYHLAAACAE

Gene Therapy for Rare/Monogenic Diseases

Healthcare & Life Sciences/Biotechnology & Biologics/Gene Therapy (AAV/lentiviral/other vectors)

Keywords

• Regenerative medicine
• Cell therapy
• Implantable medical device
• Type 1 diabetes treatment
• Bio-hybrid organ

Headquarters

HQ city

London

HQ country

Canada

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Future therapeutic product sales: As a clinical-stage company, Sernova does not currently generate revenue. The company is developing regenerative medicine cell therapies targeting a functional cure for chronic diseases including type 1 diabetes, thyroid disease, and hemophilia A. Upon regulatory approval, revenue would be generated from sales of its Cell Pouch bio-hybrid organ and associated therapeutic cell products.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels6 records

Core offering

Sernova develops the Cell Pouch bio-hybrid organ, an implantable, scalable medical device that creates a natural vascularized tissue environment for therapeutic cells to survive long-term and release essential hormones/proteins. The platform is being advanced through Phase I/II clinical trials for type 1 diabetes (lead indication), with pipeline programs in hypothyroid disease and hemophilia A, supported by partnerships with Evotec SE for iPSC-derived cells and University of Miami for conformal coating immune protection technology.

Product overview

Sernova is a regenerative medicine company developing therapeutic technologies with a platform-based approach centered on the Cell Pouch System. The core product is the Cell Pouch bio-hybrid organ, an implantable medical device that creates a vascularized environment for therapeutic cells. The platform supports multiple therapeutic programs including: the lead Cell Pouch System for type 1 diabetes (partnered with Evotec for iPSC-based islet replacement), Conformal Coating Technology for immune protection, a Hemophilia A gene therapy program, and a Hypothyroid treatment program. The company is conducting Phase 1/2 clinical trials at the University of Chicago.

Differentiator

Problem solved

Functional benefit

Products and services

• Cell Pouch System (Cell Pouch Bio-Hybrid Organ)

Quantifiable outcome

• 14 months insulin independence achieved in Phase I/II clinical trial patient
• +6 more outcomes

Named customers1 record

Segments3 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Eleven partnerships are on record, tiered major, core and minor.

• Eledon PharmaceuticalsmajorStrategic or Co-development Partner · 9 July 2025Collaboration to advance a potential functional cure for type 1 diabetes. Eledon provides investigational immunomodulatory antibodies (including tegoprubart) for use in Sernova's clinical trials as an alternative to standard immunosuppression.
• Evotec SEcoreStrategic or Co-development Partner · 1 May 2022Global strategic partnership to develop an implantable off-the-shelf iPSC (induced pluripotent stem cells) based islet replacement therapy. Evotec provides scalable GMP manufacturing of islet-like clusters (ILCs) from human GMP-grade iPSC lines, while Sernova provides the Cell Pouch System for implantation. This partnership provides Sernova a potentially unlimited supply of insulin-producing cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2).
• University of MiamicoreTechnology or Integration · 4 August 2020Exclusive worldwide license agreement for novel conformal coating immune protection technologies developed by Dr. Alice Tomei, Dr. Jeffrey Hubbell, and Aaron Stock at the Diabetes Research Institute. The technology shields therapeutic cells from immune system attack, potentially eliminating the need for chronic systemic immunosuppression.
• University of ChicagocoreStrategic or Co-development PartnerClinical trial partnership for Phase I/II study of Cell Pouch System for type 1 diabetes. Dr. Piotr Witkowski serves as Principal Investigator and Director of the Pancreatic Islet Transplant Program at University of Chicago.
• AstraZenecaminorStrategic or Co-development PartnerStrategic partnership and collaboration mentioned on Sernova's partnerships page as one of the industry leaders Sernova collaborates with to bring better therapies to patients.
• BIOTEC CanadaminorOthersMember of BIOTEC Canada, the national trade association for Canada's biotech sector.
• Alliance for Regenerative MedicineminorOthersMember of the Alliance for Regenerative Medicine, the leading international organization representing the cell and gene therapy sector.
• Ontario Institute for Regenerative Medicine (OIRM)minorOthersMember of OIRM, Ontario's regenerative medicine research and commercialization organization.
• National Research Council Canada (NRC-CNRC)minorOthersPartner organization supporting Canadian regenerative medicine research.
• Breakthrough T1DminorOthersPartnership with Breakthrough T1D (formerly JDRF) as part of Sernova's collaborative approach to advancing type 1 diabetes research.
• Biotechnology Innovation Organization (BIO)minorOthersMember of BIO, the world's largest trade association representing the biotechnology industry.

Scale indicators8 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Vertex Pharmaceuticals: Vertex is developing zimislecel (VX-880) and VX-264, allogeneic stem-cell-derived islet cell therapies for type 1 diabetes acquired from ViaCyte/Semma. It is the most directly comparable peer to Sernova, targeting the same functional-cure T1D population with cell-based implants.
• ViaCyte: ViaCyte pioneered stem-cell-derived islet cell therapies encapsulated in medical devices for T1D; it was acquired by Vertex in 2022. Its PEC-Direct and PEC-QT programs are the closest historical analogues to Sernova's Cell Pouch approach combining encapsulation devices with stem-cell-derived beta cells.
• Semma Therapeutics: Semma developed stem-cell-derived islet cell therapies for T1D before being acquired by Vertex in 2021 for ~$950M. It represents a comparable platform in regenerative beta-cell replacement and serves as a benchmark for what a successful T1D cell therapy platform can be valued at.
• Sigilon Therapeutics: Sigilon developed encapsulated cell therapies (including for T1D) using its Afibromer sphere technology. Comparable to Sernova as a clinical-stage cell encapsulation company pursuing functional cures through implanted cell-device combinations.

Broad incumbents

• Humacyte: Humacyte is a publicly traded regenerative medicine company developing bioengineered human tissues. It is comparable to Sernova as a clinical-stage public regenerative-medicine platform with a similar capital-markets profile and indication-expansion approach.
• Organogenesis: Organogenesis is a commercial-stage regenerative medicine company focused on wound care and surgical biologics. Comparable as a public peer in the broader regenerative medicine space, though more mature commercially and focused on different indications.
• BioMarin Pharmaceutical: BioMarin markets ROCTAVIAN, a gene therapy for hemophilia A, and is a broad incumbent in rare-disease biologic therapeutics. Comparable to Sernova's hemophilia A program as a competing therapeutic modality for the same patient population.

Emerging players

• Pluristem Therapeutics: Pluristem develops placenta-derived cell therapy products (PLX cells) for multiple indications including inflammatory and ischemic conditions. Comparable as a small-cap public cell-therapy company pursuing platform expansion across chronic diseases.
• Athersys: Athersys developed MultiStem, an off-the-shelf cell therapy platform for regenerative medicine applications. Comparable to Sernova as a clinical-stage public regenerative-medicine company with platform ambitions across multiple chronic indications.
• CRISPR Therapeutics: CRISPR Therapeutics is developing ex vivo gene-edited cell therapies including CASGEVY and is advancing gene therapy programs in hemophilia A and B — directly comparable to Sernova's hemophilia A gene therapy program using Cell Pouch.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks7 records

Key highlights7 records

Customer concentration

• Xx.com/SernovaCorp
• Facebookfacebook.com/sernovacorp
• LinkedInlinkedin.com/company/sernova-corp.

Revenue estimate

Valuation estimate

Number of profiles

Profiles11 records

Funding overview

Funding rounds9 records

Investors2 records

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M&A

Investments

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

Frequently asked questions about Sernova