Innovacell GmbH

What Innovacell GmbH does

Innovacell GmbH is an Austrian biotech company headquartered in Innsbruck that develops and manufactures autologous cell therapy products (自家細胞治療) for regenerative medicine using human cells cultivated at its GMP manufacturing facility in Austria. Its portfolio consists of three pipeline products targeting incontinence disorders — both fecal incontinence and urinary incontinence — with the lead asset ICEF15 in an international joint Phase III clinical trial that has completed US FDA IND review and obtained US enrollment approval.

The company's operating model is to globally source autologous cell therapy candidates, develop them through clinical stages, and commercialize them in worldwide markets. Its core technical asset is the proprietary GMP manufacturing technology developed at the Austrian facility. The Austrian facility became the first facility located outside Asia to receive Japan's "特定細胞加工物製造認定" (Specific Cell Processing Product Manufacturing Certification) under Article 39, Paragraph 1 of the Act on Securing Safety of Regenerative Medicine, creating a cross-border regulatory pathway for autologous cell product supply into Japan.

Innovacell GmbH commercializes through a jointly controlled Japanese subsidiary, イノバセル株式会社 (InnovaCell Inc.), headquartered in Tokyo, which develops and markets Innovacell's cell therapy pipeline in Japan using licensed Austrian manufacturing technology. The company is pre-commercial with no revenue, no disclosed pricing, and no established distribution channels as of the source data. Headcount stands at 22 employees. Information on external investors, IPO status of the Austrian parent, or management team is not disclosed in the available data.

Name

Innovacell GmbH

Legal name

Innovacell GmbH

Website

https://innovacell.at

Company type

Private

Operating status

Operating

Headcount range

11–50 employees

Short description

Austrian biotech Innovacell GmbH develops autologous cell therapies for fecal and urinary incontinence, operating a GMP manufacturing facility in Innsbruck. It is commercializing three pipeline assets — led by Phase III ICEF15 — via its Japanese subsidiary イノバセル株式会社 (InnovaCell Inc.).

Ownership category

akta.pro rank

Product category

Regenerative Medicine / Cell Therapy

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical and Medicine Manufacturing (32541)

SIC

Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Cell Therapy Developers (Autologous) (HLAAABAA)

akta.pro secondary industries

Cell Therapy Manufacturing Platforms & Automation (closed systems, bioreactors, fill-finish) (HLAAABAG), Cell Therapy Manufacturing Services (GMP, autologous/allogeneic) (HLAAAKAC), Cell Processing & Ancillary Materials (media, cytokines, beads, vectors, disposables) (HLAAABAH)

Keywords

• Autologous cell therapy
• Regenerative medicine
• GMP manufacturing
• Incontinence treatment
• Biopharmaceutical development

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Marketing channels1 record

Core offering

Innovacell GmbH develops autologous cell therapy pipelines (using the patient's own human cells) targeting fecal incontinence and urinary incontinence. The company's core offering is its proprietary GMP manufacturing technology, cultivated at its Austrian GMP facility, which is the first facility outside Asia certified under Japan's Specific Cell Processing Product Manufacturing framework. It currently manages three autologous cell therapy pipeline products, including the ICEF15 program in Phase III clinical trials.

Product overview

Innovacell GmbH and its Japanese subsidiary InnovaCell Inc. operate as a cell therapy development and commercialization company with a unified portfolio consisting of three autologous cell therapy pipeline products targeting incontinence disorders (fecal incontinence and urinary incontinence). The core offering centers on their GMP manufacturing technology developed at their Austrian facility, which enables the production of regenerative medicine products using human cells. The company follows a business model of globally sourcing cell therapy candidates, developing them through clinical stages, and commercializing in global markets. The ICEF15 Phase III clinical trial represents their most advanced pipeline program.

Differentiator

Problem solved

Functional benefit

Products and services

• Autologous Cell Therapy Pipeline (自家細胞治療パイプライン) Three autologous cell therapy pipeline products targeting fecal incontinence and urinary incontinence, developed from human cells (regenerative medicine products). The company sources these cell therapy candidates globally, develops them, and commercializes them in global markets, including Japan via its subsidiary イノバセル株式会社.
• GMP Manufacturing Technology (製造技術) Proprietary GMP manufacturing technology for autologous cell therapy products developed at Innovacell GmbH's GMP facility in Austria. Enables production of regenerative medicine products and formulations using human cells, and serves as the basis for technology licensing to the Japanese subsidiary.
• ICEF15 Phase III Clinical Trial Program An international joint Phase III clinical trial program for an autologous cell therapy targeting incontinence disorders, including fecal incontinence and urinary incontinence. The program has completed FDA IND review and obtained US enrollment approval, making it the most advanced pipeline program in the portfolio.

Segments1 record

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature2 records

Recent moves5 records

Expansion highlights5 records

Others

• Lonza Group: Lonza is a leading global CDMO with extensive cell and gene therapy manufacturing capabilities, serving as a potential manufacturing partner or competitive benchmark for Innovacell's autologous GMP manufacturing platform.

Broad incumbents

• Novartis (Cell & Gene Therapy unit): Novartis operates a major cell and gene therapy franchise (including Kymriah), representing a broad incumbent with deep cell-therapy manufacturing, regulatory, and commercial capabilities relevant to Innovacell's late-stage cell therapy ambitions.
• Astellas Pharma: Astellas is a major Japanese pharmaceutical company with established regenerative medicine and cell therapy programs (including partnerships with Universal Cells), serving as a broad incumbent in the same Japanese regulatory and commercial landscape Innovacell is entering.

Direct peers

• Mesoblast Limited: Mesoblast develops mesenchymal stem cell-based therapies for inflammatory and degenerative diseases, operating in the same regenerative medicine category as Innovacell and navigating similar late-stage clinical and regulatory milestones in cell therapy.
• Healios K.K. Healios is a Japanese-listed regenerative medicine company developing autologous and allogeneic cell therapies, with deep expertise in navigating Japan's Act on the Safety of Regenerative Medicine framework — directly relevant to Innovacell's Japanese commercialization strategy.
• Pluristem Therapeutics: Pluristem develops placenta-derived cell therapies with manufacturing and clinical operations spanning multiple jurisdictions, comparable to Innovacell's model of developing a cell-therapy platform for global commercialization.
• Caladrius Biosciences: Caladrius develops cell-based therapies targeting ischemic and inflammatory conditions, with a comparable profile of late-stage clinical development, autologous cell platforms, and partnership-driven commercialization strategy.
• Cook MyoSite (Cook Medical): Cook MyoSite develops autologous cell therapies for incontinence and other muscle-related disorders, making it the most direct therapeutic-area peer to Innovacell's incontinence-focused autologous pipeline. Both companies target fecal and urinary incontinence using cell-based regenerative approaches.
• JCR Pharmaceuticals: JCR Pharmaceuticals is a Japanese specialty biopharma with cell-based and regenerative medicine products commercialized under Japan's regenerative-medicine regulatory framework, providing a comparable Japanese commercial pathway to Innovacell's planned launches.

Emerging players

• Vericel Corporation: Vericel commercializes autologous cell therapies (MACI, Epicel) in the US market, providing a useful comparable for Innovacell's anticipated autologous cell therapy commercialization pathway and reimbursement dynamics.

Market position

Strengths4 records

Weaknesses3 records

Competitive moat3 records

Key risks4 records

Key highlights5 records

Customer concentration

• LinkedInlinkedin.com/company/innovacell-gmbh

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Subsidiaries1 record

Funding overview

Funding rounds

Investors

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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 Innovacell GmbH