Gaudi Clinical

What Gaudi Clinical does

Gaudi Clinical is a Tokyo-based regenerative medicine outsourcing company founded in June 2021 that operates a contract cell-processing and medical-institution support platform under Japan's Act on the Safety of Regenerative Medicine (安確法). The company licenses proprietary Specific Cell Processing Product Manufacturing facilities (currently two in central Tokyo) and provides outsourced manufacturing of PRP (platelet-rich plasma) and ASC (adipose-derived stem cell) therapies to contracted hospitals and clinics, alongside a portfolio of regulatory compliance, data collection, and clinical coordination services. Its flagship physical product, KiOSK, is a portable variable-pressure compact clean booth that enables in-clinic or near-clinic cell processing on standard 100V power without construction, intended to address the 'last mile' problem of regenerative medicine delivery.

Name

Gaudi Clinical

Legal name

株式会社Gaudi Clinical

Website

https://gaudi-clinical.co.jp

Company type

Private

Founded year

2021

Operating status

Operating

Headcount range

1–10 employees

Short description

Gaudi Clinical is a Tokyo-based regenerative medicine outsourcing company that provides licensed cell-processing (PRP and ASC) manufacturing services and proprietary KiOSK clean-booth equipment to contracted hospitals and clinics across Japan.

Ownership category

akta.pro rank

Product category

Regenerative Medicine Services

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714), Scientific Research and Development Services (5417)

SIC

Services-Commercial Physical & Biological Research (8731), Services-Specialty Outpatient Facilities, Nec (8093)

akta.pro primary industry

Cell Therapy Manufacturing Services (GMP, autologous/allogeneic) (HLAAAKAC)

Keywords

• Regenerative medicine services
• Cell processing outsourcing
• Clean room equipment
• Stem cell therapy
• Medical institution support

Headquarters

HQ city

Hongo

HQ country

Japan

HQ region

Asia

Offices3 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Cell Manufacturing Outsourcing Services: CPC-based cell processing and manufacturing services for PRP (Platelet-Rich Plasma) and ASCs (Adipose-derived Stem Cells) under the Act on Safety of Regenerative Medicine. Medical institutions outsource cell manufacturing to Gaudi Clinical's licensed facilities.
2. Medical Institution Support Services: Comprehensive support for medical institutions implementing regenerative medicine, including administrative procedures, regulatory compliance, medical staff education, and treatment data collection under the regenerative medicine law.
3. KiOSK Product Sales: Sale of proprietary KiOSK compact clean booth equipment to medical institutions for in-house cell processing operations.
4. Treatment Data Analysis Services: Analysis and management of treatment data collected from regenerative medicine procedures, supporting evidence-based medicine and regulatory compliance.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Gaudi Clinical provides outsourced cell manufacturing and end-to-end support services that allow medical institutions to deliver PRP and adipose-derived stem cell (ASC) regenerative medicine treatments without building in-house cell processing infrastructure. Its offering combines licensed Cell Processing Center (CPC) manufacturing, the proprietary KiOSK portable clean booth, and an accompaniment (伴走型) support program covering regulatory filing, quality management, and treatment-data collection under Japan's Act on the Safety of Regenerative Medicine.

Product overview

Gaudi Clinical operates a regenerative medicine platform providing cell processing services and clean room technology. The core product is the KiOSK (据置型室圧可変式小型クリーンブース), a compact clean booth that enables cell processing near medical institutions. Services include PRP (platelet-rich plasma) and ASCs (adipose-derived stem cells) therapy manufacturing support, cell culture processing contracting (細胞培養加工受託事業), and comprehensive medical institution support services (医療機関支援サービス). The company also provides regenerative medicine data analysis support (再生医療データ解析支援事業) to help collect and analyze treatment data required under Japanese regenerative medicine regulations.

Differentiator

Problem solved

Functional benefit

Brands

• KiOSK: 据置型室圧可変式小型クリーンブース (Stationary variable room pressure small clean booth) - A compact cell manufacturing unit designed for medical institutions, featuring proprietary negative pressure control technology for safe cell processing.

Products and services

• KiOSK Compact Clean Booth (据置型室圧可変式小型クリーンブース) A stand-mounted, variable-pressure compact clean booth designed for regenerative-medicine cell processing at medical institutions. Features proprietary negative-pressure maintenance while achieving a clean environment, requires no construction or dedicated air conditioning, and operates on standard 100V power. Meets basic requirements for cell processing facilities under Japan's Act on the Safety of Regenerative Medicine. Sold to hospitals and clinics as a hardware product enabling in-house cell processing.
• PRP (Platelet-Rich Plasma) Therapy Support Service (多血小板血漿療法支援サービス) Outsourced manufacturing and support service for PRP (Platelet-Rich Plasma) therapy. PRP is produced from the patient's own blood through centrifugation and provides tissue repair and anti-inflammatory effects via growth factors released from activated platelets. All manufactured PRP undergoes sterility testing before release. Service is for hospitals, orthopedic clinics, dental clinics, and sports medicine practices offering regenerative treatments.
• ASCs (Adipose-derived Stem Cells) Therapy Support Service (自己脂肪由来幹細胞療法支援サービス) Outsourced manufacturing and support service for ASC (Adipose-derived Stem Cell) therapy. Requires only minimal subcutaneous fat tissue (less than 1 gram) collected via small incision. All ASC products undergo sterility, endotoxin, mycoplasma, and virus testing per Japanese Pharmacopoeia standards before release. Service is for medical institutions offering regenerative treatments for orthopedic, dental, and sports-medicine indications.
• Cell Processing Outsourcing Service (細胞培養加工受託事業) Contract cell manufacturing service using academia-validated regenerative medicine technologies. CPCs (Cell Processing Centers) serve as regional hub facilities, with KiOSK-type preparation rooms positioned near medical institutions for local cell processing and quality confirmation. Target customers are medical institutions implementing regenerative medicine under Japan's Act on the Safety of Regenerative Medicine.
• Medical Institution Support Services (医療機関支援サービス) Comprehensive accompaniment (伴走型) support services for medical institutions implementing regenerative medicine, including administrative procedures, regulatory filing support, data collection, scheduling management, and coordinated support from dedicated regenerative medicine coordinators.
• Regenerative Medicine Data Analysis Support Service (再生医療データ解析支援事業) Support service for collecting and analyzing treatment data required under Japan's Act on the Safety of Regenerative Medicine, including treatment data, patient subjective evaluations, and cell manufacturing data, helping medical institutions meet regulatory data requirements and contribute to evidence-based practice.

Quantifiable outcome

• 5000+ PRP treatments annually at partner institution (Juntendo University)
• +2 more outcomes

Named customers13 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Six partnerships are on record, tiered core and flagship.

• Sysmex CorporationcoreStrategic or Co-development Partner · 13 May 2025Business and capital partnership for regenerative and cell medicine quality control. Combines Gaudi Clinical's cell manufacturing and medical institution support services with Sysmex's inspection equipment and reagents for quality management in regenerative medicine.
• Veritas Co., Ltd.coreStrategic or Co-development Partner · 1 March 2024Co-development partner in joint research with Juntendo University for developing novel regenerative medicine technologies. Contributes to basic and clinical research on mechanism of action.
• Juntendo UniversityflagshipStrategic or Co-development Partner · 1 February 2024Joint research course 'Musculoskeletal Regenerative Medicine' established for developing regenerative medicine technologies for orthopedic conditions and social implementation as advanced medical care.
• NORM CorporationcoreStrategic or Co-development Partner · 1 February 2024Co-development partner analyzing nutritional factors and growth factors in blood alongside blood counts and biochemical tests for musculoskeletal disease patients to explore factors affecting treatment efficacy.
• Sysmex CorporationcoreStrategic or Co-development Partner · 1 November 2023Joint research with Juntendo University on PRP treatment efficacy. Sysmex conducts cytokine and growth factor measurements to explore responder/non-responder factors in regenerative medicine treatments.
• Hitachi Global Life Solutions, Inc.coreStrategic or Co-development Partner · 1 October 2023Joint operation of Regenerative Medicine Innovation Center at Nihonbashi. Co-investment in facility development and shared usage of cell processing infrastructure.

Scale indicators5 records

Recent moves9 records

Expansion highlights6 records

Broad incumbents

• Sysmex Corporation: Major in-vitro diagnostics and clinical lab equipment company and Gaudi Clinical's strategic capital and business partner. Comparable because Sysmex's QC instruments and reagents are now bundled with Gaudi's cell manufacturing offering for regenerative medicine.
• Catalent, Inc. Global CDMO with cell therapy development and manufacturing services. Comparable as a large-scale incumbent offering contract cell processing infrastructure analogous to Gaudi Clinical's CPC outsourcing.
• Lonza Cell & Gene: Global cell and gene therapy CDMO offering autologous and allogeneic manufacturing services. Comparable to Gaudi Clinical's contract cell manufacturing business at a global, scaled incumbent level — useful for benchmarking platform economics.
• FUJIFILM Cellular Dynamics: Fujifilm subsidiary developing iPSC-derived cell therapies and manufacturing capabilities. Comparable as a Japan-headquartered regenerative medicine platform with broader indications than Gaudi Clinical's current PRP/ASC focus.
• Terumo BCT: Global leader in blood component collection, cell processing, and cell therapy manufacturing equipment. Comparable as an incumbent in cell processing infrastructure; serves as a broad equipment and consumables supplier where Gaudi Clinical operates a clinical-services CDMO model.

Direct peers

• Japan Tissue Engineering Co., Ltd. (J-TEC): Subsidiary of Fujifilm focused on regenerative medicine products (autologous cultured epidermis, cartilage) with proprietary cell processing capabilities. Comparable as a Japan-based cell therapy manufacturer serving clinical use cases.
• MEDINET Co., Ltd. Japanese cell therapy CDMO specializing in contract cell processing and manufacturing for regenerative medicine and immuno-cell therapy. Most directly comparable to Gaudi Clinical's CPC outsourcing business under Japan's regenerative medicine framework.

Emerging players

• Veritas Co., Ltd. Japan-based co-development partner in regenerative medicine research with Juntendo University. Comparable as a niche cell therapy enabler in the same Juntendo research ecosystem Gaudi Clinical is anchored to.
• CellGenix GmbH: Supplier of high-quality GMP-grade raw materials and reagents for cell therapy manufacturing. Comparable as a cell therapy enabling technology provider feeding into autologous and allogeneic manufacturing workflows.

Regional players

• Hitachi Global Life Solutions: Operates the joint Regenerative Medicine Innovation Center with Gaudi Clinical at Nihonbashi. Comparable as a Japan-based infrastructure partner for cell processing facilities, with overlap in facility operations.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Facebookfacebook.com/gaudi.juntendo
• LinkedInlinkedin.com/company/gaudi-clinical

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds1 record

Investors8 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 Gaudi Clinical