What Circe Biomedical does

Circe Biomedical is a privately held, development-stage biotechnology company founded in 1999 and headquartered at 99 Hayden Avenue in Lexington, Massachusetts. The company is engaged in the development, production, and intended commercialization of bioartificial organs and therapeutic cell systems designed to replace the function of failing liver and pancreatic organs by integrating living cells with extracorporeal and implantable devices. Its intended end users are patients with acute liver failure (bridged to organ recovery or transplantation) and insulin-dependent diabetics.

The company's product portfolio rests on two proprietary technology pillars: isolation, purification, and cryopreservation of primary mammalian cells, and fabrication of semipermeable biocompatible membranes that regulate molecular passage and provide immunologic isolation. Its lead program, the HepatAssist Liver Support System, is an extracorporeal bioartificial liver device incorporating primary pig hepatocytes in a hollow fiber bioreactor with charcoal columns, a membrane oxygenator, and a pump; each treatment session runs six hours, with cryopreserved cells shipped to clinical sites. Circe states the HepatAssist system has advanced further in controlled clinical trials for acute liver failure than any competing system. Its second program, the PancreAssist System, is an implantable, disk-shaped bioartificial pancreas enclosing pancreatic islets within a tubular membrane; it is in preclinical development and is designed to deliver physiologic insulin response without immunosuppressant drugs. Both HepatAssist and PancreAssist are registered trademarks.

Circe has not yet commercialized a product and is pre-revenue. Its anticipated revenue model, once approved, is hardware and consumable sales of medical devices and disposable cell-based cartridges to hospital transplant centers and acute care facilities, distributed through direct clinical partnerships. The company raised $28 million in a December 2000 financing led by Polaris Partners, with Advanced Technology Ventures, Burrill & Company, and HLM Management Company participating. The leadership team is led by President and CEO Elizabeth Chen, CFO Ted Owens, and VP Operations Shawn Cain, with a small group of directors covering clinical operations, quality systems, and regulatory affairs. The company website carries a 2002 copyright and the contact page states the firm is not contracting new services or supplementing staffing, indicating a very small, maintenance-mode operation as of the most recent publicly available signals.

Name

Circe Biomedical

Legal name

Circe Biomedical, Inc.

Website

https://circebio.com

Company type

Private

Founded year

1999

Operating status

Operating

Headcount range

11–50 employees

Short description

Circe Biomedical is a privately held, development-stage biotechnology company developing bioartificial organ systems — the HepatAssist extracorporeal liver support device (in clinical trials) and the PancreAssist implantable bioartificial pancreas (in preclinical development) — for patients with acute liver failure and insulin-dependent diabetes.

Ownership category

akta.pro rank

Product category

Bioartificial Medical Devices

NAICS

Surgical Appliance and Supplies Manufacturing (339113)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Hepatology & Liver Disease (HLAKAEAB)

akta.pro secondary industry

Transplant Hepatology (HLAKAEAK)

Keywords

• Bioartificial organ systems
• Liver support devices
• Cell therapy technology
• Biocompatible membrane devices
• Implantable pancreas systems

Headquarters

HQ city

Lexington

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Bioartificial Organ Systems Commercialization: Development-stage company focused on commercializing bioartificial organs and therapeutic cell systems. Revenue model anticipated to be through sale of medical devices and related consumables for liver and pancreatic support systems.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels1 record

Core offering

Circe Biomedical develops and intends to commercialize bioartificial organ systems for liver and pancreatic diseases. Its lead product, the HepatAssist Liver Support System, is an extracorporeal bioartificial liver incorporating primary pig hepatocytes in a hollow fiber bioreactor to bridge acute liver failure patients to recovery or transplantation. The preclinical PancreAssist System is an implantable bioartificial pancreas that uses a proprietary semipermeable membrane to provide immunologic isolation of pancreatic islets for insulin-dependent diabetes therapy.

Product overview

Circe Biomedical is developing bioartificial organ systems based on proprietary mammalian cell and semi-permeable membrane technologies. The company's portfolio consists of two distinct products: the HepatAssist® Liver Support System, an extracorporeal device currently in clinical development for acute liver failure that integrates primary hepatocytes with biocompatible membranes; and the PancreAssist® System, an implantable bioartificial pancreas in preclinical development for insulin-dependent diabetes that incorporates pancreatic islets within a membrane-based housing. Both systems leverage the company's core technology platform combining isolated mammalian cells with semipermeable membranes to replace organ function.

Differentiator

Problem solved

Functional benefit

Brands

• HepatAssist: HepatAssist® Liver Support System - an extracorporeal, bioartificial liver support system incorporating primary hepatocytes (pig liver cells) designed to treat patients with acute liver failure.
• PancreAssist

Products and services

• HepatAssist Liver Support System An extracorporeal bioartificial liver support system incorporating primary hepatocytes (pig liver cells) in a hollow fiber bioreactor, with charcoal columns, a membrane oxygenator, and a pump. Each treatment lasts 6 hours, with cryopreserved hepatocytes shipped to clinical sites and thawed prior to treatment. It is intended for patients with acute liver failure who need temporary liver function support to bridge them to organ recovery or transplantation, used in hospital transplant centers and acute care facilities.
• PancreAssist System An implantable bioartificial pancreas incorporating living pancreatic islets within a single tubular semipermeable membrane enclosed in a disk-shaped housing, designed for implantation near the kidney and connection to the circulatory system via standard vascular grafts. The membrane pores prevent white blood cells and antibodies from attacking the islets, eliminating the need for immunosuppressant drugs, and the device is intended to provide insulin in response to blood glucose changes for patients with insulin-dependent diabetes.

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Scale indicators1 record

Recent moves5 records

Expansion highlights5 records

Direct peers

• ViaCyte: Develops encapsulated stem-cell-derived pancreatic progenitor therapies for insulin-dependent diabetes using immunoprotective membranes — the closest functional analog to Circe's PancreAssist, with a similar mission of immunosuppression-free cell replacement.
• Teraklin (now part of CytoPherx / HepaWash): Developer of extracorporeal liver support therapies (MARS-like cell-free systems and successor approaches). A direct competitor in the acute liver failure supportive care market where HepatAssist would compete.
• Defymed: French developer of MailPan, an implantable bioartificial pancreas using semipermeable membranes to encapsulate pancreatic islets. Shares Circe's core thesis of immunoisolated cell therapy for diabetes without immunosuppression.
• Vital Therapies: Developer of the ELAD (Extracorporeal Liver Assist Device) bioartificial liver system, the most direct head-to-head competitor to Circe's HepatAssist in the acute liver failure space. Both companies pursued extracorporeal cell-based liver support as a bridge to transplant or recovery.
• Semma Therapeutics (Vertex Cell Therapy): Developed stem-cell-derived islet cell therapies for type 1 diabetes (acquired by Vertex Pharmaceuticals). Directly comparable to PancreAssist in its goal of restoring insulin production in insulin-dependent diabetics, though using a different encapsulation/cell approach.
• Arbios Systems: Developed the SEPET bioartificial liver system, another extracorporeal cell-based liver support device. Directly comparable to Circe in technology approach and target indication (acute liver failure).
• Excorp Medical: Developer of the BLSS (Bioartificial Liver Support System), another extracorporeal bioartificial liver device. Directly comparable to HepatAssist in modality, indication, and target clinical sites (transplant centers).

Broad incumbents

• Organogenesis: Publicly traded commercial-stage regenerative medicine company using living cell-based products. Relevant as a broader incumbent in cell-based therapeutics, though its product focus (wound care) is adjacent to Circe's organ-replacement focus.
• Vertex Pharmaceuticals: Large-cap biopharmaceutical company that acquired Semma Therapeutics and is advancing the leading stem-cell-derived therapy for type 1 diabetes (zimislecel). Represents the most capitalized competitive threat to PancreAssist in insulin-dependent diabetes.

Emerging players

• Aspect Biosystems: Developer of 3D bioprinted tissue therapeutics, including pancreatic tissue for diabetes. Relevant as an emerging player pursuing cell-based organ replacement with an alternative (bioprinting) manufacturing approach.

Market position

Strengths4 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Funding overview

Funding rounds1 record

Investors4 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 Circe Biomedical