NOTE 18. Subsequent Events
The Company has made a review of material subsequent events from September 30, 2020 through the date of issuance of this report and has determined to
include the following subsequent events:
On December 3, 2020, the Company entered into a Cooperative Research and Development Agreement ( CRADA) with Walter Reed National Military Medical
Center (WRNMMC), the nation’s largest and most renowned joint military medical center serving the Army, Navy, Air Force and Marines located in Bethesda,
Maryland.
A Cooperative Research and Development Agreement ( CRADA) is a written agreement between a government agency and a non-federal entity that allows the
federal government and its non-federal partners to optimize and maximize use of their resources, exchange technical expertise in a protected fashion, share
intellectual property resulting from collaborative effort, and speed commercialization of federally developed technology. The Company has committed to provide
materials including ATCell samples and Umbilical Cord stem cells, ACSelerate Max Growth and differentiation mediums testing and other processing supplies,
processing and testing methods. The Company’s total in-kind and financial commitments are limited to $120,000 in supplies and expense reimbursement during
the life of the Agreement.
The Company maintains the rights to commercialize all technology developed under this CRADA Agreement. The technology is centered on creating in vitro
(test tube) assays to standardize and commercialize new treatment protocols; optimizing quality control measures; and developing standardized protocol potency
assays for precise therapy dosing.
Management believes that these new assays can be commercialized to generate substantial sales and licensing revenues and create value for the Company’s
stakeholders.
Through the Collaboration entitled “Stem Cells for Regeneration and Medical Innovation, a multi-faceted and multi-staged research project with WRNMMC
Biomedical Laboratories, the Company plans to develop, validate and standardize baseline and assay metrics to identify mesenchymal stem cell (MSC)
characteristics and quantities across various cell biomarkers and exosome expressions data sets for its ATCell™ product for biologics developers’ use
worldwide. The focus of the Collaboration is to enable the creation of predictive and prescriptive cellular models which will further enhance American CryoStem’s
mission as a premier biologics’ manufacturer and developer and be highly valuable to the medical community, biotech developers, and the public at large.
WRNMMC is part of The Military Health System (MHS) which is the enterprise within the United States Department of Defense that provides health care to
active duty, Reserve component and retired U.S. Military personnel and their dependents
The missions of the MHS are complex and interrelated: To ensure America’s 1.4 million active duty and 331,000 reserve-component personnel are healthy so
they can complete their national security missions.
· To ensure that all active and reserve medical personnel in uniform are trained and ready to provide medical care in support of operational forces around
the world.
· To provide a medical benefit commensurate with the service and sacrifice of more than 9.5 million active duty personnel, military retirees and their
families.
The MHS also provides health care, through the TRICARE health plan, to:
· active duty service members and their families,
· retired service members and their families,
· Reserve component members and their families,
· surviving family members,
· Medal of Honor recipients and their families
· some former spouses, and
· Others identified as eligible in the Defense Enrollment Eligibility Reporting System.
The MHS has a $50+ billion budget and serves approximately 9.5 million beneficiaries. The MHS employs more than 144,217 in 51 hospitals, 424 clinics, 248
dental clinics and 251 veterinary facilities across the nation and around the world, as well as in contingency and combat-theater operations worldwide.
The Company’s long term research is focused on further developing standardized cellular processing models to support FDA, IND treatment protocol approvals
by further identifying, and validating certain mechanisms and characteristics of mesenchymal stem cells related to regulating modulation of immune response(s)
and promoting tissue regeneration and stability (homeostasis) for the treatment of traumatic injuries, inflammation, auto-immune diseases, and brain and organ
damage associated with viruses such as SARS-CoV-2 (COVID-19), including, the expanding group of people dealing with the chronic and debilitating symptoms
of what is commonly termed “Long Haul COVID” or “Long COVID.”
