EATONTOWN, NJ / ACCESSWIRE / December 5, 2019 / American CryoStem Corporation (OTC PINK:CRYO) a leading strategic developer, marketer and global licensor of patented adipose tissue-based cellular products and technologies for the Regenerative and Personalized Medicine industries, issues the following letter on behalf of the CEO:
Dear Fellow Shareholders: Business Partners and Friends:
Nearing the end of 2019, I want to take this opportunity to inform you about several industry and corporate developments that were initiated and/or came to fruition in 2019. These developments should reflect positively for American CryoStem in 2020. During fiscal 2019, CRYO began transitioning its FDA registered laboratory facility from tissue bank status to full biologics manufacturer by upgrading our main laboratory facility in New Jersey. Additionally, the Company filed its first Investignational New Drug (IND) Application with the FDA, for its ATCELL™ adipose derived mesenchymal cellular therapy product, a major milestone for the Company and patients. We believe that with our core patents, significant growth for the Companys future lies in utilizing customers newly processed or stored adipose tissue/stem cells to create personalized regenerative medicine applications.
As we enter 2020, our standardized stem cell processing platform provides all individuals with a cost effective “wellness” platform for their current or future regenerative medicine and/or cosmetic needs. Access to the Company’s end-to-end, centralized laboratory processing model and standardized cell manufacturing platform provides physicians, researchers, and collaborators the opportunity to develop new cellular applications and products without the expense of operating a GMP laboratory. This methodology can reduce R&D development delays and requirements to re-discover and re-create the necessary processing technology (Collect-Process-Store) required for the development of new therapies and their respective medical indication. As per a report by Transparency Market Research, the global market for stem cells is expected to register a healthy CAGR of 13.8% during the period from 2017 to 2025 to become worth US$270.5 bn by 2025.
We continue to believe that advancements in Regenerative Medicine in 2019 serve to validate that American CryoStem’s focus on its cellular processing platform technology business of collecting – transporting – processing – commercial bio-banking – return to point of care, and manufacturing of cellular and cosmetic applications utilizing adipose tissue and ADSCs is indeed right on the mark. Additionally, the Facial Fat Transfer market is riding a wave of popularity and new advent technologies and procedures are being lifted along with it. The cosmetic market is growing at a rapid pace; mainly due to the increasing demand for natural facial fat transfer treatments and introduction of advanced facial rejuvenation technology. The global Facial Fat Transfer market is projected to reach ~4.20 Billion by 2022 from USD 1.50 billion in 2015. (Market Research Future)
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 in new markets. According to www.Clinicaltrials.gov, there are currently 6,401 studies registered utilizing Adult Stem Cells. The number of Clinical Trials involving adipose tissue, adipose derived stem cells, and other adipose derived products such as stromal vascular fraction has increased every year for the past several years and that increase appears to be accelerating.
ACS Laboratory: During 2019 we consolidated our primary FDA registered laboratory in Monmouth Junction, New Jersey and constructed a new laboratory facility with a ISO Class 7 clean room working toward our cGMP certification. We completed the installation, certification and qualification of our new facility, equipment and validation of our processing methods for manufacturing in the new facility in preparation for the launch of our clinical study. The study is currently under review by the FDA Center for Biologics Evaluation and Research (CBER) and we have provided additional information to them as they have requested. This study is a first with human subjects for the treatment of Post Concussion Syndrome utilizing adipose derived autologous cultured mesenchymal stem cells.
Investigational New Drug Application (IND): FDA Study Highlights
In 2019 the Company filed an Investignational New Drug (IND) Application with the FDA;
Title of Study: ATCELL™ Expanded Autologous, Adipose-Derived Mesenchymal Stem Cells Deployed via Intravenous Infusion for the Treatment of Post Concussion Syndrome (PCS) in Retired Military and Athletes:
- IND FDA filing date: September 4, 2019
- Name of Investigational Product: ATCELL™
- Name of Active Ingredient: ATCELL™ Autologous Mesenchymal Stem Cells
- Phase: Phase I, Single Sight Safety Study
- Number of Subjects: 20
- Study Period: Estimated date of subjects enrolled: Q4,2019 – Q1,2020
- Estimated date for completion: Q1-2021
- Duration of study: 1 year
- Sponsor: American CryoStem Corporation: email@example.com
- Institutional Review Board: The Institute of Regenerative and Cellular Medicine:
- Summary: Phase I Clinical Safety Study intended to provide preliminary assessments of the safety, tolerability, and clinical alleviation of symptoms associated with Post Concussion Syndrome (PCS), also known as Chronic Concussive Syndrome (CCS). (2019 ICD-10-CM Diagnosis Code F07.81)
- Proposed Study Design: Single-site, double-blind, placebo-controlled involving a single administration of either individual, autologous ATCELL™ lines or placebo delivered for immediate use.
The Company recognizes the significant market opportunity for its new autologous cellular therapy treatment modality for the treatment of Post Concussion Syndrome and mild Traumatic Brain Injury via infusion therapy of Autologous Expanded Adipose Derived Mesenchymal Cells and intends to leverage its early clinical study using this delivery protocol for the treatment of other diseases and muscle-skeletal injuries with significant multibillion-dollar treatment and therapy markets. We believe that once we establish safety we will be able to partner with additional clinicians and clinical research centers to study alternative applications of our product and method of administration to target additional unmet medical needs that we believe can be addressed with autologous cellular infusion therapies.”
Since our Company’s founding in 2008, American CryoStem has largely relied on independent investors to finance our growth, develop our products and services and to meet working capital requirements. During 2019 we have entered into discussions with large synergistic companies and investment groups who we believe will be able to assist 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, marketing programs and investor relations strategies. Additionally, the Company has been meeting with Investor Relations firms to assist with bringing our corporate message and liquidity to the Company’s securities trading market place.
In 2020 the Company intends to leverage its early clinical study and focus on the development of additional, novel, first-in-class or best-in-class therapies for muscle-skeletal disease and injuries, a multibillion-dollar therapy market. The Company will also be exploring ways to bridge its clinical studies into other countries under the International Council for Harmonization guidelines upon the approval of the Study by the US FDA through existing and future licensees. Additional plans include an aggressive marketing program for our ATGRAFT services and products and the roll-out of our ATCELL product into the Orthopedic market under the FDA safe harbor contained in its 2017 Guidance. The Company’s R&D activities will leverage its expertise in collection, processing and cryobanking to develop and deliver innovative autologous therapeutics designed to improve patients’ lives.
By way of this letter, I have endeavored to share several of the many transitional developments of the Company in 2019. The Company is optimistic about its future in the rapidly growing Regenerative and Personalized Medicine. Capital permitting, we plan to strengthen our executive management team, continue focus on expanding our international licensing platform, and augment our physician network and customer base. We are indeed standing at the forefront of a new era, during which unprecedented medical breakthroughs will continue on a near routine basis thanks to the increasing understanding of the power and capabilities of human adult stem cells.
In closing, I would like to use this opportunity to express my sincere appreciation to all of our shareholders for your commitment to American CryoStem’s mission and for your continued trust and confidence in our industry and leadership.
John S Arnone, CEO
American CryoStem Corporation
ABOUT CRYO: American CryoStem Corporation (OTCQB: CRYO); was founded in 2008, and has evolved to become a biotechnology pioneer, standardizing adipose tissue derived technologies (Adult Stem Cells) for the fields of Regenerative and Personalized Medicine. The Company operates a state-of-art, FDA-registered, clinical laboratory in New Jersey and licensed laboratories in Hong Kong, China, Tokyo, Japan, and Thailand operating on our proprietary platform, dedicated to the collection, processing, bio-banking, culturing and differentiation of adipose tissue (fat) and adipose derived stem cells (ADSCs) for current or future use in regenerative medicine. We are leveraging our proprietary, compliant platform and developed product portfolio to create a domestic and global footprint of licensed laboratory affiliates, physicians networks and research organizations who purchase tissue collection, processing and storage services and consumables from our Company. CRYO maintains a strategic portfolio of intellectual property that surrounds our proprietary technology which supports a growing pipeline of stem cell applications and biologic products. Our laboratory stem cell bank/line products are characterized adult human Mesenchymal Stem Cell (MSC’s) derived from adipose tissue that work in conjunction with our 13 patented medium lines. The Company’s R&D efforts are focused on collaborations to discover, develop and commercialize ADSC therapies by utilizing our standardized collection-processing-storage methodology and laboratory products combined with synergistic technologies to create jointly developed regenerative medicine applications and new intellectual property.
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This press release may contain forward-looking statements, including information about management’s view of American CryoStem Corporation’s (“the Company”) future expectations, plans and prospects. In particular, when used in the preceding discussion, the words “believes,” “expects,” “intends,” “plans,” “anticipates,” or “may,” and similar conditional expressions are intended to identify forward-looking statements. Any statements made in this press release other than those of historical fact, about an action, event or development, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other factors, which may cause the results of the Company, its subsidiaries and concepts to be materially different than those expressed or implied in such statements. Unknown or unpredictable factors also could have material adverse effects on the Company’s future results. The forward-looking statements included in this press release are made only as of the date hereof. The Company cannot guarantee future results, levels of activity, performance or achievements. Accordingly, you should not place undue reliance on these forward-looking statements. Finally, the Company undertakes no obligation to update these statements after the date of this release, except as required by law, and also takes no obligation to update or correct information prepared by third parties that are not paid for by American CryoStem Corporation.
SOURCE: American CryoStem Corporation
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