Bio One

What Bio One does

Bio One is a Tokyo-headquartered, venture-capital-backed private medical device company founded on September 30, 2003 by President & CEO Akihiro Shimosaka, Ph.D., to commercialize the INTERCEPT Blood System — a photochemical pathogen inactivation platform for blood products — across East Asian markets. The company's sole product is licensed from Cerus Corporation (with clinical development heritage from Baxter Healthcare Corporation) and applies a proprietary combination of the S-59 psoralen derivative and UV irradiation to inactivate a broad spectrum of pathogens (including those in the diagnostic window period) and to inactivate lymphocytes in platelet and plasma blood products in a single process. BioOne monetizes this through hardware sales of the disposable INTERCEPT system and via exclusive territorial licensing rights, targeting hospitals and blood transfusion centers as its primary customer segment in Japan, China, and Southeast Asia.

The company's go-to-market is structured around three regional entities: direct sales to Japanese healthcare institutions, the Beijing BioOne Medical Technology joint venture with China's SFDA-affiliated CCPIE for the Chinese market (and subsequent 2008 import approval for irradiated blood products), and the wholly owned BBS PTE. LTD. subsidiary in Singapore for Southeast Asia. Marketing relies on medical-conference participation (Japan Society of Transfusion Medicine and Cell Therapy symposia, ISBT Asia) and trade-press coverage. BioOne raised approximately 4,225 million yen (~$32–35M USD) across two funding rounds — 3,575M yen in August 2004 from a JAFCO-led consortium including Apax Globis and Mizuho Capital, and 650M yen via third-party allocation in July 2006 — ahead of its December 2006 acquisition of exclusive East Asian INTERCEPT plasma rights.

BioOne has not disclosed revenue, headcount, or operating metrics in any source, and the most recent documented commercial activity (a May 2009 co-sponsored luncheon seminar) is more than fifteen years old. Paid-in capital stood at only 30 million yen as of October 2007, indicating either capital deployment against commercialization costs or a thin equity cushion relative to medical device distribution scale. The company's economic position therefore rests almost entirely on its exclusive territorial license to a clinically validated, regulatorily cleared pathogen inactivation platform — a high-barrier but narrow single-product business with limited disclosed evidence of sustained commercial traction.

Name

Bio One

Legal name

バイオワン株式会社 (BioOne Corporation)

Website

https://zero-bio.com

Company type

Private

Founded year

2003

Operating status

Operating

Short description

Bio One is a Tokyo-based medical device company that commercializes the INTERCEPT Blood System, a photochemical pathogen inactivation technology for platelet and plasma blood products, exclusively in East Asian hospitals and blood transfusion centers.

Ownership category

akta.pro rank

Product category

Blood Safety Medical Devices

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Blood Bank, Transfusion Medicine & Immunohematology (HLAHAAAH)

akta.pro secondary industry

Plasma-Derived Therapy Quality, Safety & Pharmacovigilance (Pathogen Reduction/Testing) (HLAIAHAK)

Keywords

• Pathogen inactivation systems
• Blood safety medical devices
• Transfusion medicine solutions
• Blood component processing
• Photodynamic pathogen reduction

Headquarters

HQ city

Chuo

HQ country

Japan

HQ region

Asia

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Medical Device Sales: Development, manufacturing, import, export and sales of medical devices, specifically the INTERCEPT Blood System for pathogen inactivation in blood products.
2. Licensing and Distribution Rights: BioOne holds exclusive manufacturing and commercialization rights for INTERCEPT Blood System in East Asian markets, generating revenue through licensed distribution of the technology.

Go-to-market motion2 records

Distribution channels3 records

Marketing channels2 records

Core offering

BioOne develops, manufactures, and commercializes the INTERCEPT Blood System, a medical device that uses S-59 (psoralen derivative) combined with UV irradiation to inactivate pathogens and lymphocytes in blood products (platelets and plasma) before transfusion. The company holds exclusive manufacturing and commercialization rights for this technology in East Asian markets under license from Cerus Corporation, and also provides related medical-device consulting services.

Product overview

BioOne Corporation offers a single unified product - the INTERCEPT Blood System - a pathogen inactivation technology for blood products. The system uses a photochemical treatment process combining S-59 (psoralen derivative) with UV irradiation to inactivate pathogens (RNA/DNA replication suppression) and lymphocytes in platelet and plasma blood products. This technology addresses transfusion-transmitted infections by providing an additional safety layer beyond traditional screening methods, targeting both known and unknown pathogens including those in the window period.

Differentiator

Problem solved

Functional benefit

Products and services

• INTERCEPT Blood System Medical device system that inactivates pathogens and lymphocytes in blood products (platelets and plasma) using S-59 (psoralen derivative) combined with UV irradiation; commercialized by BioOne for East Asian hospitals and blood transfusion centers to reduce transfusion-transmitted infections and prevent graft-versus-host disease.

Quantifiable outcome

• Inactivates pathogens in blood products in a single process using photochemical treatment

Segments1 record

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature1 record

Partnerships

Three partnerships are on record, tiered core.

• China Center for Pharmaceutical International Exchange (CCPIE)coreStrategic or Co-development Partner · 27 July 2005Joint venture partner for establishing Beijing BioOne Medical Technology Co. Ltd. CCPIE is a direct agency of China's State Food and Drug Administration (SFDA). Capital contribution of $500,000 USD (BioOne: $450,000; CCPIE: $50,000) for the purpose of obtaining import approval for INTERCEPT Blood System in China.
• Cerus CorporationcoreTechnology or IntegrationLicensor of INTERCEPT Blood System technology. BioOne obtained rights to manufacture and commercialize the technology in East Asian markets.
• Baxter Healthcare CorporationcoreTechnology or IntegrationPartner for clinical development of INTERCEPT Blood System technology. BioOne licensed the technology which Baxter had been advancing through clinical development.

Scale indicators5 records

Recent moves8 records

Expansion highlights4 records

Direct peers

• Cerus Corporation: Developer and worldwide licensor of the INTERCEPT Blood System pathogen-inactivation technology. Cerus is the originating source of the platform BioOne exclusively distributes in East Asia, making it the most direct peer in product and IP terms, though it operates as the upstream licensor rather than a competitor in BioOne's territory.
• Terumo BCT: Global leader in blood component collection, processing, and storage systems (apheresis devices, automated blood processing). Terumo BCT sells directly to the same blood-center customers BioOne targets in Japan and Asia and competes for the same hospital/blood-bank budget line items for blood safety equipment.
• Haemonetics Corporation: US-listed medical device company specializing in blood and plasma component collection, processing, and pathogen reduction systems. Competes with INTERCEPT in the broader blood-safety/collection device category for blood-bank capex and consumables.
• Macopharma SA: French medical device manufacturer of in-line leukocyte-reduction and pathogen-inactivation systems (MacoPharma's family of blood filters and the THERAFLEX UV technology). Direct competitor to INTERCEPT in the pathogen-reduction device category with overlap in transfusion medicine customers across Asia and Europe.
• Fenwal (Fresenius Kabi): Blood component collection, processing, and storage business acquired by Fresenius Kabi. Sells the Amicus separator and related blood-processing consumables to the same transfusion-medicine customers BioOne serves, with overlapping sales channels in Asia.

Broad incumbents

• Octapharma AG: Global plasma-derived therapeutics manufacturer with solvent-detergent pathogen inactivation applied at the plasma-pool level. Operates as a broad incumbent in the safer-blood supply value chain relevant to BioOne's positioning.
• CSL Behring: Plasma-derived therapies subsidiary of CSL Limited. While not a pathogen-inactivation competitor, it is a broad incumbent in the plasma supply chain BioOne serves, with Asia-Pacific presence and a complementary view on blood-bank procurement decisions.
• Grifols S.A. Global plasma fractionator and blood-diagnostic incumbent. While Grifols primarily fractionates plasma-derived therapeutics (a different model), it operates a blood-screening and donor-management business that competes for the same hospital/blood-bank budgets and has an established Asia-Pacific commercial footprint BioOne competes against.

Regional players

• Asahi Kasei Medical: Japanese-based manufacturer of leukocyte-reduction filters (Sepacell) and related blood-processing devices directly serving Japanese blood centers. Closest Japanese incumbent competitor for blood-safety device budgets in BioOne's home market.
• Shanghai RAAS Blood Products: China's largest domestic blood-products company (plasma fractionation). Represents the regional incumbent in the Chinese blood-safety value chain and the natural counterparty BioOne's Beijing JV must navigate in competitive hospital tenders.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Subsidiaries2 records

Funding overview

Funding rounds

Investors

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 Bio One