ThermoGenesis Holdings, Inc. develops and commercializes a range of automated technologies for cell-banking, cell-processing, and cell-based therapeutics.
The company is a leading provider of automated systems that isolate, purify and cryogenically store units of hematopoietic stem and progenitor cells for the cord blood banking industry.
Medical Device Products for Automated Cell Processing
The company provides the AutoXpress and BioArchive platforms for automated clinical bio-banking, PXP p...
ThermoGenesis Holdings, Inc. develops and commercializes a range of automated technologies for cell-banking, cell-processing, and cell-based therapeutics.
The company is a leading provider of automated systems that isolate, purify and cryogenically store units of hematopoietic stem and progenitor cells for the cord blood banking industry.
Medical Device Products for Automated Cell Processing
The company provides the AutoXpress and BioArchive platforms for automated clinical bio-banking, PXP platform for point-of-care cell-based therapies, and X-Series products for cell processing services.
Clinical Bio-Banking Applications
AXP II Automated Cell Separation System – an automated, fully closed cell separation system for isolating stem and progenitor cells from umbilical cord blood, registered as a U.S. FDA 510(k) medical device.
BioArchive Automated Cryopreservation System – an automated, robotic, liquid nitrogen controlled-rate-freezing and cryogenic storage system for cord blood samples and cell therapeutic products used in clinical applications, registered as a U.S. FDA 510(k) medical device.
Point-of-Care Applications
PXP Point-of-Care System – an automated, fully closed, sterile system allows for the rapid, automated processing of autologous peripheral blood or bone marrow aspirate derived stem cells at the point-of-care, such as surgical centers or clinics, registered as a U.S. FDA 510(k) medical device.
PXP-1000 System – an automated, fully closed system that provides fast, reproducible separation of multiple cellular components from blood with minimal red blood cell contamination, registered as a U.S. FDA 510(k) medical device.
Cell Processing
X-Series Products for general laboratory use: X-Lab for cell isolation, X-Wash System for cell washing and reformulation, and X-Mini for high efficiency small scale cell purification.
Contract Development and Manufacturing Services for Cell and Cell-Based Gene Therapies
The company expanded its business to include contract development and manufacturing services for cell and cell-based gene therapies. In October 2023, the company announced the completion of its new state-of-the-art facility, housing ISO 7 cGMP cleanroom suites, along with research and development labs giving it the capabilities to become a Contract Development and Manufacturing Organization (‘CDMO’) for cell and cell-based gene therapies. The ReadyStart cGMP Cleanrooms and IncuStart Wet Labs are an incubator facility which provide the cleanroom environment, equipment, and services needed for R&D and cGMP manufacturing of cell and gene therapies and other life science products. The ReadyStart Cleanrooms consist of twelve leasable cGMP compliant ISO 7 cleanroom suites. Each private cGMP suite comes fully equipped and can be configured to meet the client’s specific needs. Within the cGMP facility are the IncuStart Wet Labs.
Sales and Distribution Channels
The company markets and sells its medical device products through independent distributors, except in North America and India, where it sells direct to end-user customers.
Research and Development
The company’s research and development expenses related to the company’s medical device products were $1,284,000 for the year ended December 31, 2023.
Manufacturing and Raw Materials
The company source components for its medical device products from multiple suppliers that manufacture to its engineering specifications. The company’s high-volume AXP disposable products are manufactured using contract manufacturers. The company utilizes its manufacturing facility and in-house clean room in Rancho Cordova, California for production of its higher complexity devices and X-Series disposable cartridges. Various raw materials are used to manufacture its products. The raw materials are generally available from multiple sources. The company has not had significant difficulty obtaining necessary raw materials.
Quality System
The company’s quality system for its medical device products business is compliant with domestic and international standards and is appropriate for the specific devices the company manufactures. The company’s corporate quality policies govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. Such policies are intended to ensure that the products the company markets are safe, effective, and otherwise in compliance with the FDA Quality System Regulation (‘QSR’) (21 C.F.R. Part 820), EN ISO 13485: 2016 standard, the European Union Medical Device Regulations (EU MDR 2017/745), the Canadian Medical Device Regulations (SOR 98-282), the Brazil ANVISA RDC 16/2013, UK MDR and/or other applicable local, state, national and international regulations.
The company and its contract manufacturers are subject to inspections by the FDA and other regulatory agencies to ensure compliance with the FDA’s QSRs. Compliance requirements relate to manufacturing processes, product testing, documentation control and other quality assurance procedures. The company’s facilities have undergone International Organization of Standards (‘ISO’) 13485:2016 and EU Medical Device Directive (‘MDD’) (93/42/EEC) inspections and the company has obtained approval to CE-Mark the company’s products. The company has received its updated certificate demonstrating compliance to this standard under the Medical Device Single Audit Program (‘MDSAP’).
Regulatory Scheme and Strategy
The development, manufacture, and marketing of the company’s medical device products are subject to regulation by the FDA, as well as the equivalent agencies of other countries, including the countries of the European Union and India.
The company has a quality and regulatory compliance management system that meets the requirements of the ISO 13485: 2003 standard, the FDA’s QSRs, the EU MDD, Canadian Medical Device Regulations (SOR 98-282), and all other applicable local, state, national, and international regulations.
Several of the company’s products, including the BioArchive and the AXP II are categorized as U.S. Class II medical devices and require premarket notification, also known as a section 510(k) clearance, prior to commercialization.
Patents and Proprietary Rights
The company currently have over 30 issued patents globally relating to its medical devices that will expire at various times between March 2031 and May 2040.
Material Agreements
Corning Incorporated
On August 30, 2019, the company entered into a Supply Agreement with Corning (the ‘Supply Agreement’). The Supply Agreement has an initial term of five years with automatic two-year renewal terms, unless terminated by either party in accordance with the terms of the Supply Agreement (collectively, the ‘Term’). Pursuant to the Supply Agreement, the company has granted to Corning exclusive worldwide distribution rights for substantially all X-Series products (the ‘Products’) manufactured by its subsidiary, ThermoGenesis Corp., for the duration of the Term, subject to certain geographical and other exceptions. In addition, the company has granted Corning rights of first refusal for the exclusive worldwide distribution of certain future products developed or introduced by the company relating to cell isolation or cell selection, including any such products substantially related or similar to the Products (the ‘ROFR Products’).
CBR Systems, Inc. (‘CBR’)
Manufacturing and Supply Agreement
Effective July 13, 2020, the company entered a Manufacturing and Supply Amending Agreement #2 (the ‘Amendment’) with CBR Systems, Inc. (‘CBR’), an amendment to the Manufacturing Supply Amending Agreement #1 effective March 16, 2020 and the Manufacturing and Supply Agreement effective May 15, 2017 (the ‘CBR Agreement’), in which the company agreed to supply CBR with AXP cord blood processing system and disposables.
Technology License and Escrow Agreement
As part of the Amendment, the company updated the compliance conditions in the Technology License and Escrow Agreement (the ‘Escrow Agreement’), which was originally signed by the company and CBR in June 2010. Under the Escrow Agreement, the company granted CBR a perpetual, royalty-free license to certain intellectual property necessary for the manufacture of AXP devices and disposables. The license is for the sole and limited purpose of ensuring continued supply of AXP devices and disposables for use by CBR. The licensed intellectual property is held in escrow and available to CBR only in the event of a default under the Escrow Agreement. The company was in compliance with the License and Escrow Agreement at December 31, 2023.
History
The company was founded in 1986. It was incorporated in the state of Delaware in 1986. The company was formerly known as Cesca Therapeutics Inc. and changed its name to ThermoGenesis Holdings, Inc. in November 2019.
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