Tissue Genesis
Tissue Genesis designs and manufactures the Icellator2, an automated point-of-care device that extracts adult stem cells from adipose tissue using a proprietary enzyme, serving regenerative medicine clinics and research institutions across the US, South Korea, Ukraine, Bahamas, Japan, and China.
- Company typePrivate
- Founded2001
- HeadquartersHonolulu, United States
- Headcount1–10
- GTM typeB2B
- OfferingHardware or Manufacturing
What Tissue Genesis does
Tissue Genesis, LLC is a privately held medical device company founded in 2001 and headquartered in Leander, Texas, operating as part of the Okyanos Global Health, Inc. portfolio with intellectual property held by Orgenesis Inc. The company designs and manufactures the Icellator2, an automated, enclosed point-of-care system that isolates stromal vascular fraction (SVF) and adult stem cells from a patient's own adipose tissue in approximately one hour using a proprietary Adipase enzyme and a single-use, gamma-irradiated Cell Icellation Kit. The platform is manufactured under FDA cGMP and ISO 13485 quality systems and is IEC 61010/60601 compliant. In the United States the device remains limited to investigational use under FDA-approved IDE studies; clinical-use approvals have been obtained in South Korea, Ukraine, and The Bahamas.
The company's revenue model combines capital-equipment sales (Icellator2 instruments) with a recurring consumables stream (single-use Cell Icellation Kits required per patient procedure), supplemented by clinical study revenues. Go-to-market is hybrid: direct enterprise sales to clinics and research institutions domestically, complemented by an exclusive 10-year distribution agreement with Human Life CORD Japan (a Nihon Trim group company) covering Japan and China. Customer segments include regenerative medicine clinics, academic medical centers, and research institutions running clinical studies across multiple indications such as Critical Limb Ischemia, Erectile Dysfunction, Xerostomia, and Rotator Cuff Tears. The company maintains a lean operating footprint of 1-10 employees and has received approximately $19.6M in disclosed funding since 2004, with the most recent round in September 2014.
Operations are supported by five granted US patents covering the Icellator system and consumables, ISO 13485 / FDA cGMP / IEC certifications, and ongoing clinical evidence generation through partnerships with sites such as Okyanos Center for Regenerative Medicine (Bahamas) and V.P. Komisarenko Institute of Endocrinology and Metabolism (Ukraine). Leadership includes Dr. Marc Penn as CEO and Chief Medical Officer, Ben Chlebina as General Manager, and Dr. Rolf Wolters as Director of Product Management, alongside co-founders Thomas F. Cannon (EVP) and Anton C. Krucky (President and CEO).
Tissue Genesis firmographics
Firmographics- Name
- Tissue Genesis
- Legal name
- Tissue Genesis, LLC
- Website
- https://tissuegenesis.com
- Company type
- Private
- Founded year
- 2001
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- Tissue Genesis designs and manufactures the Icellator2, an automated point-of-care device that extracts adult stem cells from adipose tissue using a proprietary enzyme, serving regenerative medicine clinics and research institutions across the US, South Korea, Ukraine, Bahamas, Japan, and China.
- Ownership category
- akta.pro rank
Tissue Genesis industry classification
Industry- Product category
- Regenerative Medicine Medical Devices
- NAICS
- Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Biological Product (except Diagnostic) Manufacturing (325414)
- SIC
- Surgical & Medical Instruments & Apparatus (3841), Biological Products, (No Disgnostic Substances) (2836)
- akta.pro primary industry
- Cell Therapy CDMO (Autologous/Allogeneic Manufacturing) (HLAGAGAA)
- akta.pro secondary industries
- Skin Substitutes & Biologic/Regenerative Wound Therapies (Matrices, Grafts) (HLAHALAE), Cardiovascular & Vascular Regeneration (vascular grafts, angiogenesis) (HLAAAGAJ), Cartilage, Bone & Musculoskeletal Regeneration (HLAAAGAH)
Keywords
Where Tissue Genesis is headquartered
LocationHeadquarters
- HQ city
- Honolulu
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Tissue Genesis business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Personnel, Technology or R&D, Supply Chain, Operations, Marketing or Sales, Infrastructure
Revenue model
- Icellator Hardware Systems: Sale of Icellator2 and Icellator X automated cell processing instruments to medical facilities, clinics, and research institutions.
- ICELLATION Kit Consumables: Recurring revenue from sterile, single-use disposable cartridge kits used per patient treatment. Each procedure requires a replacement kit.
Go-to-market motion2 records
Distribution channels3 records
Marketing channels5 records
Tissue Genesis product offering
Product offeringCore offering
Tissue Genesis manufactures and sells the Icellator2, an automated point-of-care medical device that extracts adult stem cells (stromal vascular fraction) from a patient's own adipose tissue using a proprietary enzyme-based isolation process. The company also sells the single-use Cell Icellation Kit consumable and proprietary Adipase enzyme used with each patient treatment, generating revenue from capital equipment sales and recurring per-procedure consumables.
Product overview
Tissue Genesis offers a unified product ecosystem centered on the Icellator® 2 automated point-of-care cell isolation system, which extracts adult stem cells from a patient's own adipose tissue. The system uses proprietary Adipase® enzyme and a single-use Cell Icellation™ Kit to produce stromal vascular fraction (SVF) for therapeutic applications in approximately one hour. The company also supports the legacy Icellator (first generation) which remains approved in certain markets. All products are manufactured under FDA cGMP and ISO 13485 quality standards.
Differentiator
Problem solved
Functional benefit
Brands
- Icellator: Automated point-of-care device that extracts adult stem cells from adipose tissue using enzyme-derived cell isolation technology. The product line includes the original Icellator, Icellator X, and Icellator2.
- Icellation
- Adipase
Products and services
- Icellator 2 Automated Cell Isolation System Automated point-of-care medical device that extracts adult stem cells (stromal vascular fraction) from a patient's adipose tissue in approximately one hour. Processes 60–100 mL of lipoaspirate to produce approximately 50 million SVF cells per 100 mL, with a multilingual touchscreen interface and compliance with FDA cGMP, ISO 13485, and IEC 61010 & 60601 standards. Sold to regenerative-medicine clinics, hospitals, and research labs.
- Cell Icellation Kit (Single-Use Disposable)
Quantifiable outcome
- Approximately 50 million SVF cell recovery per 100 mL of adipose tissue in approximately 1 hour
- +2 more outcomes
Companies that use Tissue Genesis
Customer profileNamed customers2 records
Segments3 records
Ideal customer profiles2 records
Tissue Genesis technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature4 records
Tissue Genesis partnerships and signals
Strategic signalPartnerships
Four partnerships are on record, tiered core and minor.
- Okyanos Center for Regenerative MedicinecoreOkyanos clinic in Freeport, Bahamas was the site of the first clinical application of the Icellator X technology. Patients were treated for conditions including Parkinson's disease, osteoarthritis, fibromyalgia, and rheumatoid arthritis. The clinic uses Tissue Genesis technology on-site for patient treatments.
- V.P. Komisarenko Institute of Endocrinology and MetabolismcoreKiev, Ukraine research institution conducting clinical study using Icellator for Critical Limb Ischemia treatment. The study investigates whether adipose-derived SVF therapy can reduce amputation, accelerate wound healing, and increase ambulatory function.
- Faon LLCminorUkrainian company that helped organize the Critical Limb Ischemia clinical study in collaboration with Tissue Genesis and the V.P. Komisarenko Institute.
- Human Life CORD Japan, Inc.coreExclusive 10-year partnership agreement with Human Life CORD Japan, a group company of Nihon Trim (Tokyo Stock Exchange 1st Section, Cord No. 6788), to distribute Tissue Genesis proprietary stem cell processing products in commercial clinics, research institutions, and hospitals in Japan and China. This represents a major strategic expansion into the Asian market for regenerative medicine.
Scale indicators4 records
Recent moves6 records
Expansion highlights5 records
Tissue Genesis competitors and assessment
Company assessmentDirect peers
- Ingeneron: Developer of the Transpose RT system, an automated point-of-care device that processes adipose tissue into SVF for autologous cell therapy. Closely comparable in target customer (regenerative medicine clinics), indication mix (orthopedic, wound), and automated enzyme-based processing approach.
- Healeon Medical: Provider of point-of-care adipose-derived cell processing systems and consumables for regenerative medicine practitioners. Targets the same clinic-based, autologous cell therapy use cases as Tissue Genesis.
- Cytori Therapeutics: Developed the Celution system, an automated point-of-care device for isolating adipose-derived regenerative cells (SVF/stem cells) for clinical use. Direct competitor to Tissue Genesis' Icellator, serving the same regenerative medicine clinics with a similar point-of-care cell processing proposition.
- Cesca Therapeutics (now part of ThermoGenesis Holdings): Historically developed the SurgWerks and ThermoGenesis cell processing platforms for autologous point-of-care cell therapy, including bone marrow concentrate systems. Direct peer offering alternative automated cell processing devices to regenerative medicine clinics.
Emerging players
- RoosterBio: Supplier of MSC and cell therapy raw materials and scalable manufacturing solutions for regenerative medicine developers. Partially overlapping customer base (cell therapy developers) but focused on allogeneic scalable production rather than point-of-care adipose processing.
- STEMCELL Technologies: Supplies cell isolation, culture, and processing tools, reagents, and instruments used by regenerative medicine researchers and clinicians. Comparable as an enabling tools provider into the same cell therapy workflows that Tissue Genesis serves.
Broad incumbents
- Lonza Group: Global cell and gene therapy CDMO offering autologous and allogeneic cell therapy manufacturing services, including process development for SVF-based therapies. Comparable because it serves the same end customers (cell therapy developers/clinics) via cell manufacturing services rather than point-of-care devices.
- Miltenyi Biotec: Provider of cell separation and processing instruments, reagents, and consumables widely used in cell therapy and regenerative medicine workflows. Comparable because clinics and research institutions use its systems as an alternative or complement to automated SVF isolation platforms.
- Terumo BCT: Large medical device incumbent offering automated cell processing platforms (e.g., cell expansion, wash, and separation systems) used across cell therapy, blood banking, and regenerative medicine. Broad incumbent with overlapping cell-processing capabilities for hospitals and cell therapy developers.
- Catalent: Major cell therapy CDMO providing development and manufacturing services for autologous and allogeneic cell therapies. Competes indirectly with Tissue Genesis' point-of-care model by offering centralized manufacturing infrastructure for the same regenerative medicine end markets.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks6 records
Key highlights7 records
Customer concentration
Tissue Genesis social profiles
Digital presenceTissue Genesis compliance and trust
Trust signalCompliance3 records
Tissue Genesis financial estimates
Financial estimateRevenue estimate
Valuation estimate
Tissue Genesis leadership team
Management profileNumber of profiles
Profiles5 records
Tissue Genesis funding detail
Funding detailFunding overview
Funding rounds6 records
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Tissue Genesis M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Tissue Genesis
What does Tissue Genesis do?
Tissue Genesis manufactures and sells the Icellator2, an automated point-of-care medical device that extracts adult stem cells (stromal vascular fraction) from a patient's own adipose tissue using a proprietary enzyme-based isolation process. The company also sells the single-use Cell Icellation Kit consumable and proprietary Adipase enzyme used with each patient treatment, generating revenue from capital equipment sales and recurring per-procedure consumables.
Is Tissue Genesis a public or private company?
Tissue Genesis is a private company. It is classified as corporate owned and is currently operating.
When was Tissue Genesis founded?
Tissue Genesis was founded in 2001. It employs 1 to 10 people.
Where is Tissue Genesis based?
Tissue Genesis is headquartered in Honolulu, United States, in the North America region.
How does Tissue Genesis make money?
Two revenue lines are on record. Icellator Hardware Systems are the primary driver. The others are ICELLATION Kit Consumables.
Who are Tissue Genesis's main competitors?
Direct peers on record are Ingeneron, Healeon Medical, Cytori Therapeutics and Cesca Therapeutics (now part of ThermoGenesis Holdings). Emerging players are RoosterBio and STEMCELL Technologies. Broad incumbents are Lonza Group, Miltenyi Biotec, Terumo BCT and Catalent.
Does Tissue Genesis have an API?
No public API is recorded for Tissue Genesis.
What industry is Tissue Genesis in?
Tissue Genesis's product category is Regenerative Medicine Medical Devices. Its primary akta.pro industry code is HLAGAGAA, Cell Therapy CDMO (Autologous/Allogeneic Manufacturing), with a secondary code of HLAHALAE, Skin Substitutes & Biologic/Regenerative Wound Therapies (Matrices, Grafts). Its NAICS code is 334510 and its SIC code is 3841.