American CryoStem 2015 Update:
As 2015 gets underway, we would like to use this opportunity to focus our corporate message and inform you of several material developments that we believe will reflect positively for our Company over the next few quarters. I have included a short review of our activities to date that management believes will position American CryoStem as a significant contributor in the Biotech industry and allow us to fully utilize our adipose derived stem cell platform and create long term growth opportunities for the Company in coming years.
Advancements in Regenerative Medicine have been notably pronounced and continue to fuel the growing international excitement surrounding the many possible uses of adipose tissue and Adipose Derived Stem Cells (ADSCs). We continue to believe these advancements serve to validate that American CryoStem’s focus on its cellular processing platform technology business of collecting, transporting, processing, commercial bio-banking and manufacturing of cellular and cosmetic applications using adipose tissue and ADSCs is indeed right on the mark. Currently, cell-based therapies represent one of the most mature sub-sectors of Regenerative Medicine with a growing number of patients around the world seeking alternative therapies and, other adipose derived stem cell therapy developers seeking collection, processing and storage services. The increase in international demand for cell based medicine is evolving the standard of care, leading to new and exciting frontiers for our platform technology.
American CryoStem Corporation (OTCQB: CRYO); was founded in 2008, and has evolved to become a biotechnology pioneer, standardizing adipose tissue derived technologies for the fields of Regenerative and Personalized Medicine. The Company has developed Standard Operating Procedures (SOPs) to operate a state-of-art, FDA-registered, clinical laboratory dedicated to the collection, processing, bio-banking, culturing and differentiation of autologous adipose tissue (fat) and ADSCs. We are leveraging our IRB approved platform and developed products to create a global footprint of licensed laboratory affiliates and physicians networks to deliver current and future cellular applications using a standardized platform. The Company maintains a strategic portfolio of intellectual property that surrounds our technology which supports a growing pipeline of stem cell applications and biologic products. The Company’s R&D efforts are focused on university and private collaborations to discover, develop and commercialize ADSC therapies by combining our products with synergistic technologies to create jointly developed applications and intellectual property.
International Licensing Platform: Hong Kong and Shenzhen, China
In 2014, we executed our first international laboratory licensing agreement with Health Innovative Technology Company, LTD, a cord blood collection and storage company with operations in Hong Kong and Shenzhen, China. The laboratory conversion and staff training was completed in December 2014. This first license is a significant milestone in establishing a global footprint of laboratories that utilize our Standard Operating Procedures (SOP’s), purchase our processing consumables and market our branded products outside of the United States. We are currently in discussion with additional international territories who have expressed interest in licensing American CryoStem’s laboratory platform.
Regenerative Medicine: Cayman Islands
The Company obtained Institutional Review Board (IRB) approval from the Institute of Regenerative Cellular Medicine (IRCM) on July 24, 2014 and is the sponsor of a 100 patient study focused on the safety of our cellular products. The study is titled “Proposal for a non-randomized, patient sponsored, multi-center study studying the impact and safety of the utilization of culture expanded autologous, adipose-derived mesenchymal stem cells deployed via intravenous injection for the treatment of Multiple Sclerosis (MS)”. The Primary Investigator(s) is Louis A. Cona, MD., and the study will take place at the Da Vinci Center, Georgetown, Grand Cayman Island. On November 1, 2014 the first MS patient was treated under this approved study. The study is listed on ClinicalTrials.gov (identifier: NCT02326935)
IRB Approval of our Core Laboratory Processes
In 2014 the Company submitted its tissue processing platform to the Institutional Review Board of the Institute of Regenerative Cellular Medicine (the “IRCM”) and on July 23, 2014 the IRCM, IRB approved the following studies:
Intellectual Property (IP) filed in 2014
During 2014, we made 3 additional patent filings to add to our growing intellectual property portfolio of 7 patents, 1 jointly owned university patent and 8 in-licensed patents;
University Research and Private Collaborations
To further expand the Company’s research affiliations and pursue additional products and IP opportunities we have been selectively offering our clinically prepared stem cell lines, patented cell culture and differentiation mediums to leading stem cell research institutions. These collaborative efforts, utilizing our products and technologies, are focused on a diverse set of cellular therapy applications, including wound healing, cancer drug delivery, lung disease, muscular dystrophy, and multiple sclerosis, collaborations that management believes may provide long term financial growth for the Company.
During 2014-2015, the Company and Rutgers University investigated various combinations of NanoScript and ATCELL™ focused on the regeneration of neural, cartilage and muscle cells. This research led to filing new Intellectual Property jointly owned by Rutgers and the Company, and the publication of scientific papers and posters by Rutgers. The Rutgers team also received an initial seed grant from Rutgers University’s neural engineering group. In 2014 the team filed for a new grant with the National Institute of Health (NIH) to continue its research, publication efforts and development of new Intellectual Property.
Additionally, the Company has executed NDA’s and Material Transfer Agreements (MTS’s) with The University of Washington and the University of Miami. We have provided both Universities our clinical grade stem cells and mediums. We are moving forward with defined projects at the Universities.
During 2013- 2015, the collaborative efforts between Autogenesis Corp. (CRYO 50% ownership) resulted in successful initial “proof of concept” studies combining Protein Genomics unique biomaterial and the Company’s ATCELL™ product. Management believes the publication of the preliminary results showed successful healing of full depth wounds on the backs of immune deficient mice. Following this publication, the partnership filed grant applications to fund additional research.
In 2015, we will continue advancing with several private companies who we have NDA’s and MTA agreements with to distribute our ATCELL- stem cells and ACSeletate – patented mediums. We continue to pursue additional research affiliations with which we hope to advance to collaborative arrangements in the future.
ACS Laboratory: Products Division
The company continues to enhance, optimize and develop its laboratory services, stem cell products and cell culture products for the Cosmetic and Regenerative Medicine market. Additionally, managements believes the Company is in the final stages of completing sales agreements with large biotechnology companies in the U.S and abroad to distribute the company’s products;
CELLECT – Collection, Transportation, and Storage System: An unbreakable “chain of custody” clinical tissue solution for physicians and researchers to collect and deliver tissue samples utilizing proprietary and patent pending methods and materials. The Cellect system incorporates our ACSelerate–TR transport medium into all collection bags which supports the health of the tissue during transport. The CELLECT® kit is an integral part of our validated ATGRAFT™ and ATCELL™ technology platform used by all customers and licensees.
ATGRAFT™ – Adipose Tissue Storage Service: This past year, we made headway branding our ATGRAFT service into the plastic and cosmetic surgery market, expanding our physician network and securing an additional sales distribution arrangement with a medical device manufacturer. ATGRAFT is revolutionizing fat grafting procedures by eliminating the need for multiple liposuctions. Patients can safely and securely store their excess body fat to be used as a natural biocompatible filler overtime for cosmetic enhancement procedures including volume corrections in the hands, face, breast and other areas of the body that experience tissue loss as we age.
ACSelerate™ – Cell growth and differentiation medium: for internal use and sale to the cellular research marketplace; (12) patented cell culture media products for growing human stromal cells (including all cells found in human skin, fat and other connective tissue). Certain ACSelerate™ cell culture media lines are available in animal serum-free versions, which are suitable for human clinical and therapeutic uses; and a low serum version for application development and research purposes.
ATCELL™ – Adipose Derived Stem Cells (ADSCs): Clinically processed and characterized adipose-derived stem cells (ADSCs) created using the Company’s proprietary Standard Operating Procedures and patented cell culture media. The Company is creating multiple master and differentiated cell lines labeled according to their characterization (i.e. ATCELL™ (adipose-derived stem cells) ATCELL-SVF™ (stromal vascular fraction), ATCELL–CH™ (differentiated chondrocytes) , etc. Cell lines for sale into research may be custom created to fit the researchers’ needs. Individual cell lines are created and stored for clients use in future Regenerative Medicine procedures.
Product Commercialization Strategies
As we progress through 2015, capital permitting, we believe, an important factor, in implementing our proposed business will be our ability to execute marketing strategies that will increase the number of physicians, universities, private researchers, customers, and international territories utilizing our wide range of technologies, cellular products, and laboratory services. To date these strategies include:
Financing / Investor Relations Activities
Since our Company’s founding in 2008, American CryoStem has largely relied on “friends and family” to finance our growth, develop our products and services, and to meet working capital requirements. However, we believe to move our Company through its next critical phase of growth, development, and commercialization, and to attempt to ensure we are positioned to support our international efforts, research collaborations, and product market penetration strategies another financial channel is needed. Late in 2014, we opened discussions with financial firms and individuals engaged in the financial services industry to serve as our financial advisor(s) to assist us in attempting to raise $7 million of new capital. Concurrently, the company has been speaking with firms to assist us with bringing our corporate message to the investment community and liquidity to the company’s securities.
By way of this letter, I have endeavored to share several of the many positive developments of the Company to date. I urge you to read our 10-K for additional clarification. The Company is optimistic about its future in the Regenerative and Personalized Medicine industries and we believe that we are now in position to transition to a revenue producing biotech Company, and license our platform technology internationally. In 2015, capital permitting, we plan to strengthen our executive management team, and focus on marketing/branding our developed products, international laboratory licensing platform, IRB’s, and Private/University research collaborations. We are indeed standing at the forefront of a new era, Regenerative Medicine, during which unprecedented medical breakthroughs will continue on a near routine basis thanks to the increasing understanding of the power and capabilities of human stem cells.
In closing, I’d like to express my sincere appreciation for your commitment to American CryoStem’s mission and for your continued trust and confidence in the Regenerative Medicine industry.
John S Arnone, Chairman