Abstract on FrostBite™ EUS-Compatible Cryocatheter Accepted for Presentation at the American College of Gastroenterology 2022 Annual Meeting

    OWEGO, NY, August 26, 2022 /24-7PressRelease/ -- GI Cryo, Inc., a preclinical medical device development spin-off company from CPSI Biotech, will be presenting on the development and evaluation of the novel FrostBite™ endoscopic ultrasound (EUS) cryocatheter at the annual meeting for the American College of Gastroentrology (ACG2022) this October. The abstract titled "Evaluation of a Novel EUS-Compatible Cryoablation Device for the In Situ Destruction of Pancreatic Cancer" was accepted for poster presentation and will discuss results of studies focused on FrostBite™ development including results from lab bench engineering, tissue model and pre-clinical testing.

FrostBite™, when used in conjunction with the patented PSN cryodevice, is designed to freeze (cryoablate) and destroy a targeted tissue in situ (in place within the body). FrostBite™ is designed to support the growing field of natural orifice transluminal endoscopic surgery (NOTES) in which "scarless" abdominal operations can be performed with an endoscope wherein surgical tools, such as FrostBite™, can be introduced to target various tissues via the stomach wall, avoiding the need for invasive external surgical procedures.

Discussing the study, Dr. John M Baust (Study Lead; Founder, GI Cryo and President, CPSI Biotech) stated "Our team has been involvement in the field of cryoablation for years on both the cancer biology and device development fronts. This has allowed us to integrate cancer biology and cryogenic engineering to develop a better suite of surgical tools to destroy cancer. In the area of GI cancers, cryoablation has been shown to be very effective; however, technological limitations have limited its use. The FrostBite™ cryocatheter aims to overcome this, providing physicians an advanced tool to combat these pervasive and highly lethal diseases. The results to be presented at ASC2022 demonstrate the ability of FrostBite™ to effectively target and ablate unwanted tissues deep within the body using a minimally invasive endoscopic approach."

The preclinical studies were conducted in conjunction with Dr. Isaac Raijman, AGAF, FASGE, FACP, a luminary internationally recognized endoscopist. Commenting on the study, Dr. Raijman stated "We are very encouraged by the results we obtained with our pre-clinical study. The ability to target and freeze tissues in situ under endoscopic ultrasound guidance will provide a more precise and minimally invasive strategy to treat cancer. The consistency of the ablative zone created by FrostBite™ and the ability to target tissues close to major blood vessels was also impressive." When asked about the potential impact Dr. Raijman stated "I believe FrostBite™ has the potential to change how gastroenterologists approach treating pancreatic cancer. FrostBite™ could be used to treat all stages of pancreatic cancer, serving as either a primary or adjunctive treatment in combination with chemotherapy. Additionally, FrostBite™ may also be able to be used to reduce tumor size (down stage), converting non-surgical candidates to surgical candidates, thereby offering late-stage patients a new treatment path."

Christen Springs (CEO, EndoRX Medical) commented, "FrostBite™ is truly a first of a kind cryoablation catheter. The ability to visualize cryoneedle placement and cryolesion formation on the ultrasound image is truly unique within the GI space. Looking forward, the overall objective of FrostBite™ is to provide a powerful ablative tool to attack pancreatic cancer, which ultimately may reduce our reliance on other traditional approaches such as chemotherapy, radiation or major surgery to treat this deadly disease. We are excited to be working with GI Cryo and CPSI to advance the platform from the pre-clinical stage through FDA approvals and into clinical studies."

This study is part of GI Cryo's ongoing research and technology development program focused on the development of a next generation cryoablation device and approach for the treatment of pancreatic cancer. The initial development efforts behind FrostBite™ were supported, in part, by NIH SBIR grants awarded to CPSI by the National Cancer Institute. Ongoing efforts at GI Cryo are focusing on design for manufacturing freeze, manufacturing and verification and validation testing of FrostBite™ and GastroCS in support of regulatory approval submission to the FDA for the treatment of pancreatic and other GI based cancers. To this end, Mr. Springs further commented, "We are actively engaged with GI Cryo, seeking investors and partners to join our team to bring this potentially lifesaving technology platform to the market. Once commercialized, FrostBite™ will enable gastroenterologists to combine the power of cryoablation with that of endoscopic ultrasound based approaches to treat pancreatic cancer."

More information on the FrostBite™ cryoablation platform can be found at www.GICryo.com, www.endorxmedical.com or www.CPSIBiotech.com.

About GI Cryo - GI Cryo is a private, start-up medical device company focused on the commercialization of the novel Pressurized Subcooled Nitrogen (PSN) GastroCS system, FrostBite™ EUS-compatible cryocatheter and other devices for the treatment of gastroenterological based cancers and other GI diseases. GI Cryo has partnered with CPSI Biotech to gain access to this advanced, patent protected cryoablation platform in the GI space. This platform includes technologies which may ultimately be used to target cancerous and non-cancerous tissues within the pancreas, liver, stomach and esophagus.

About CPSI Biotech - CPSI Biotech, a private, integrative bio/medtech greenhouse company, develops and designs life science research products and cryo-medical devices for applications in cancer, cardiovascular disease treatments and cell therapy bioprocessing. Ongoing R&D and business development activities continue to produce innovative technologies, devices and intellectual property for commercialization, licensing or sales in support of diverse clinical and research applications. By leveraging the innovation, flexibility and R&D strengths of CPSI Biotech in combination with the development, commercialization, manufacturing and clinical expertise of partnering organizations, rapid and efficient product development is attainable.

About EndoRx – EndoRx is an early-stage medical device development and management consulting company with a focus in advanced endoscopy. EndoRx's first device project, a novel biliary stone retrieval device, was successfully commercialized and acquired by ConMed. EndoRx maintains an organic pipeline of disruptive endoscopic technologies and assists other startups in transitioning their device projects from the research and development phase to successful commercialization.

Disclaimer: The views and opinions expressed by Dr. Raijman are his alone and are not nor in no way reflect that of the University of Texas Health Science Center of Houston or Baylor College of Medicine.

Disclosure Notice: The information contained in this release is as of August 24, 2022. The parties assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. GI Cryo and CPSI's technologies do not have regulatory clearance for commercial sale and are currently intended for "Research Use Only".

With the exception of the historical information contained in this release, this release contains materials and statements related to future business, financial performance, future events and/or developments which constitute forward-looking statements. The matters described herein contain forward-looking statements that involve risk and uncertainties that may individually or mutually impact the matters herein described, including but not limited to, any parties ability to develop and market new products, to retain and attract key employees, to obtain regulatory clearances and approvals for its products, to effectively react to other risks and uncertainties, such as fluctuation of quarterly financial results, contract and grants acquisition, reliance on third party manufacturers and suppliers, litigation or other proceedings, economic, competitive, governmental impacts, whether pending patents will be granted or defendable, validity of intellectual property and patents, the ability to license patents, the ability to commercialize developmental products, competition from existing and new products and procedures and any parties ability to raise the capital that is required to accomplish the foregoing.

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