Cellular Preservation Technologies
Cellular Storage Solutions That Save Lives
Platelets are used to treat cancer patients in chemotherapy, people with blood disorders, to save the lives of mothers during high-risk pregnancies, and various other intensive care needs. But every year, more than 220,000 units of platelets are wasted in the United States due to the short shelf life of the life-saving blood component. That’s at least 10% of the nation’s supply and it could provide much needed therapy to critically ill patients.
Cellular Preservation Technologies (CPT) is a development stage medical technology company with a platform technology that preserves human tissues and cells. The first application is a platelet storage system that extends the shelf life of platelets from 5 days to 14. When implemented in blood centers across America, this breakthrough technology could cut waste to just 2% meaning hundreds of thousands more patients can receive treatment, It will also provide substantial savings to the centers.
The CPT storage system is a medical device that uses a combination of cold temperatures, motion, pressure, and xenon gas to vastly improve the shelf life of platelets, resulting in an increased supply, reduced waste, and reduced risk of bacterial infection. This ensures the integrity and reliability of the platelets for use after storage. It also improves logistics and transportation of platelets over greater geographical distances.
CPT’s use of xenon gas is a key component of the system. By taking advantage of xenon’s unique qualities as a non-toxic inert gas but biologically active at controlled levels, CPT technology creates an environment conducive to refrigeration and long-term storage, while simultaneously preserving the functional characteristics of the platelets. Storage in a hyperbaric xenon atmosphere has been proven to prevent immediate clearance of cold stored platelets from the blood stream upon transfusion. By remaining in circulation, stored platelets have long-term hemostatic functionality.
Refrigeration of platelets prevents bacterial growth, addressing the contamination concerns that currently limit the allowable length of platelet storage. Refrigeration has also been shown to effectively slow down cell metabolism and inhibit cell death pathways within the cell. This allows extended storage of platelets while maintaining their functional integrity.
The process for platelet storage is simple. The platelets are collected as today in a standard storage bag. The unit is then placed and sealed in proprietary barrier film bag unique to the CPT system. The bag is then infused with xenon gas and placed into the storage unit which keeps the platelets at the proper temperature and pressure, while inducing just enough movement to prevent clotting.
When the platelets are needed, staff removes the unit from the device and ships it in the barrier bag to the location of need. Once at the location, the bag is opened and two hours later the platelets are ready for treatment.
Cellular Preservation Technologies has already been issued seven patents and has one pending for the system. Their pre-clinical research was completed with the help of institutions that include Dartmouth, the Mayo Clinic, Cleveland Clinic, U.S. Army Institute of Surgical Research, Boston Children’s Hospital and Vitalant.
Cellular Preservation Technologies have received an IDE (Investigational Device Exemption) from the FDA, which is an approval to begin clinical trials. The FDA had designated the system a device-only pathway to approval. They have an agreement with the American Red Cross to conduct the first human clinical trial in one of their labs and this phase is expected to be completed in 6-12 months. Final engineering design will take up to 18 months with full regulatory U.S. approval expected in 3 years. CPT also has defined regulatory pathways in the UK and EU.
Once approved, key customers in the U.S.– which make up 95% of the market – will be national blood centers: American Red Cross, Vitalant, and American Blood Centers; 16 regional blood centers, and larger hospital systems with cancer centers. This is an easily identifiable universe and won’t require a massive marketing investment. CPT’s revenue will come from three sources: device sales, maintenance contracts, and proprietary barrier film bags for the 7.69 million units collected globally each year.
While platelet storage is a significant market, company leaders believe the technology can serve as a platform for storage of other cells, tissue, and organs including bone marrow, stem cells, red blood cells, and transplant organs.
Cellular Preservation Technologies is led by CEO, John Librie, a seasoned executive with more than 30 years experience in the biopharmaceutical/medical technology industry. He has held senior executive positions including CEO of ONY Biotech and Shore Therapeutics. In addition, he drove the early commercialization of Genentech and Acorda Therapeutics.
CPT’s Chief Technical Officer is Ilya Ilyin, PhD, MBA, an original inventor of the technology. He is a research and development leader with 25 years of experience in new product and technology development. Prior to CPT he held management positions at GEN3 Partners where he helped Fortune 500 companies build processes and cultures for innovation. Dr. Ilyin has a background in bioengineering and is the author of 20 patents with many articles and a textbook chapter to his credit.
CPT has a corporate partnership with Rich Products Corporation which is a licensing partner and provides back office administrative support, legal services, and a financial backstop. They are also collaborating with Linde/Praxair on engineering and as a xenon supplier.
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