RANCHO CORDOVA, Calif., April 3, 2020 — ThermoGenesis Holdings, Inc. (Nasdaq: THMO), a market leader in automated cell processing tools and services in the cell and gene therapy field, announced today that it was featured on a CBS 13 news segment titled, “Different Kind of Coronavirus Test”, regarding the Company’s SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit (the “Kit”). As announced earlier, the Company and ImmuneCyte Life Sciences, Inc. are working together to develop, register, import and seek U.S. Food and Drug Administration (FDA) approval for an advanced point-of-care test, for professional use, that will allow rapid diagnosis of the COVID-19 virus, including asymptomatic cases. The Kit requires just a single drop of blood without the need for special lab equipment and delivers results in less than 10 minutes.
As previously noted, ThermoGenesis is in the process of conducting validations of the Kit in accordance with the U.S. Food and Drug Administration (FDA) regulation, “Policy for Diagnostic Test for Coronavirus Disease – 2019 during the Public Health Emergency: Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff issued on March 16, 2020 for Serological Diagnostics.” The Company will notify the FDA upon completion of validation, prior to product launch.
The CBS News story is accessible via the link below:
An informational presentation on the COVID-19 Kit is available on the Company’s website. The presentation is for educational purposes and will allow users to better understand how the antibody test works and how to evaluate the results. Please visit the link below:
Inquiries from health professionals and the media about the Kit should be directed via email to email@example.com.
About ThermoGenesis Holdings, Inc
ThermoGenesis Holdings, Inc. develops, commercializes and markets a range of automated technologies for CAR-T and other cell-based therapies. The Company currently markets a full suite of solutions for automated clinical biobanking, point-of-care applications, and automation for immuno-oncology, including its semi-automated, functionally-closed CAR-TXpress™ platform, which streamlines the manufacturing process for the emerging CAR-T immunotherapy market. For more information about ThermoGenesis, please visit: www.thermogenesis.com.
About ImmuneCyte Life Sciences, Inc.
ImmuneCyte develops and commercializes immunological products and services. The Company provides clients the opportunity to bank their own immune cells when the cells are “healthy and unaffected” as a future resource for cellular immunotherapies, such as CAR-T. ImmuneCyte utilizes a proprietary CAR-TXpress™ platform, a GMP compliant close-system capable of automated separating and cryopreserving different components from blood. For more information about ImmuneCyte Life Sciences Inc., please visit: www.immunecyte.com.
This press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical facts, but rather reflect the current expectations of ThermoGenesis concerning future events and results. Forward-looking statements based on ThermoGenesis’ current assumptions, expectations and beliefs are generally identifiable by use of words “may,” “might,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential” or “continue,” or similar expressions and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. Such forward-looking statements, including statements regarding the intended use of net proceeds from the registered direct offering as well as those factors concerning our expectations, involve risks, uncertainties and other factors, some of which are beyond our control, which may cause our actual results, performance or achievements, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. These risks, uncertainties and factors include, but are not limited to, market and other conditions, as well as those risk factors discussed in Item 1A of our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) as well as other documents that may be filed by ThermoGenesis from time to time with the SEC, which are available at www.sec.gov. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. You are cautioned not to unduly rely on such forward-looking statements when evaluating the information presented in this press release.
Paula Schwartz, Rx Communications