American CryoStem to Study New Standardized Treatment Protocols for Wound Healing

Rhea-AI Summary

American CryoStem Corporation (OTC PINK:CRYO) has developed a new standardized wound healing protocol in collaboration with Advanced Regenerative Associates. This protocol utilizes human tissue and cell products while complying with FDA exemptions. The initial study, involving 10 patients in New Jersey, aims to validate the treatment's effectiveness for chronic wounds, which affect over 6.5 million people in the U.S. The company plans to collect data for future FDA-approved advanced wound care therapies.

Positive

• Completion of a new standardized wound healing protocol.
• Collaboration with Advanced Regenerative Associates to validate the treatment.
• Focus on chronic wounds, addressing a significant unmet medical need.

Negative

• None.

EATONTOWN, NJ / ACCESSWIRE / November 16, 2021 / American CryoStem Corporation (OTC PINK:CRYO), a clinical stage biotechnology company, global licensor and a pioneer in autologous cellular processing and therapies announced today that it has completed the development of a new standardized wound healing protocol utilizing its tissue based technologies with Advanced Regenerative Associates (Tinton Falls, NJ). The Company's wound healing technologies rely on exemptions from FDA clinical study and approval for the use of human tissue and cell products (PHS 361 and 21CFR1271.10) and is incorporated into the current standards of care protocols currently in use. The new protocol is focusing on realigning the microenvironment of the treatment area to achieve greater healing support during the treatment period utilizing current standard of care protocols. The initial rollout is fashioned as a study to collect additional information about the wound environment and healing progress. The Company intends to obtain informed consent from each participant for the collection, analysis and potential publication of the assessment data as required under current regulations.

The collaboration with Advanced Regenerative Associates (ARA) is a multi-faceted and multi-staged project centered on an initial 10 patient study to be conducted in New Jersey. The Company will be validating the treatment protocol as the basis for future development of advanced therapies for non-healing diabetic, non-diabetic and decubitus wounds and ulcers.

The treatment protocol study will be initially conducted through a joint effort between ARA and CRYO and, ultimately made available to wound care physicians nationally and through our international partners globally. Long term, the Company will be collecting data from all administrations of the new protocol to support development of advanced wound healing products requiring FDA clinical study and approval.

Advanced Regenerative Associates is multi-specialty physician group with decades of wound healing experience. ARA's primary focus is proactive healing of complicated wounds resulting mainly from diabetes or profound peripheral vascular disease. The collaboration between ARA and CRYO allows the physicians the ability to offer advanced wound healing options to patients not responding to current treatment protocols and products.

Anthony Dudzinski, COO of American CryoStem commented; "This Agreement is a first step in the Company's focused efforts to expand the use of its current FDA exempt products to pursue more advanced therapies based upon the knowledge gained by our work with ARA. We look forward to a successful rollout of the new protocols and to making these new protocols available to all patients with this significant unmet medical need."

Chronic wounds affect over 6.5 million people in the United States. It is estimated that the US spends over $25 Billion annually on the treatment of these chronic wounds. Multiple therapies are currently utilized in the treatment of these wounds, many of these treatments fall short of their desired intent. This leads to prolonged immobility and in some cases limb loss, which further increases long term health care costs and large unmet medical needs.

American CryoStem believes that its standardized technologies provide the industry with much-needed protocols required to advance manufacturing capabilities and accelerate the development of cellular therapy applications. American CryoStem is utilizing its existing patented methods, protocols, technologies, cell lines, intellectual property portfolio and centralized laboratory model to support collaborative efforts for medical developments and innovation.

For further information please visit: www.americancryostem.com, send email to: info@americancryostem.com or contact the Company directly at 732-747-1007.

About American CryoStem Corporation: (CRYO), founded in 2008, is a clinical-stage biotechnology Company, developing and delivering autologous mesenchymal stem cell (MSC) therapies leveraging its CMC (Chemistry, Manufacturing, and Control) platform to collect-process-store-return to point of care genetically matched personalized MSC-ATCELL therapy. The Platformsupports a growing pipeline of biologic therapies, products and processes, collaborative development opportunities, clinical and cellular developers' services, and international licensing opportunities. The Company's patented platform provides patients the opportunity for a single adipose-tissue (fat) harvest to be processed, stored and ultimately used for cosmetic fat transfer purposes or for immediate or future processing to MSC's. The platform is configured to produce large quantities of genetically matched mesenchymal stem cells (ATCELL) for future individual or successive multiple treatments as needed, "on demand". The Company has strategically positioned its cellular therapy product pipeline to; attract additional collaborative partners, accelerate creation of new treatment applications, and improve manufacturing processes and testing methods. Each new collaborative effort is designed to result in additional intellectual property and targeted commercial products to ultimately produce significant future revenue. CRYO is targeting topical applications and untreatable and incurable neurologic diseases, disorders, and conditions that have a large unmet medical need and US FDA Orphan drug designation. The Company operates a cGMP compliant, FDA registered laboratory, located in Monmouth Junction, New Jersey, USA, and licensed laboratory operations in Hong Kong, China and Thailand.

SOURCE: American CryoStem Corporation

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FAQ

What new treatment protocol is American CryoStem developing for chronic wounds?

American CryoStem is developing a new standardized wound healing protocol in collaboration with Advanced Regenerative Associates.

How many patients will be involved in the initial wound healing study by CRYO?

The initial study will involve 10 patients conducted in New Jersey.

What is the purpose of the new wound healing protocol by American CryoStem?

The protocol aims to validate treatment effectiveness for chronic non-healing diabetic and decubitus wounds.

How does American CryoStem's protocol comply with FDA regulations?

The protocol relies on FDA exemptions for human tissue and cell products, allowing for its use without pre-market approval.

What is the estimated market for chronic wound treatment in the U.S.?

The U.S. spends over $25 billion annually on chronic wound treatments.