POMPANO BEACH, FL, July 10, 2024 - BioStem Technologies Inc. (OTC: BSEM), a leading regenerative medicine company focused on the development, manufacture, and commercialization of placental-derived biologics for advanced wound care, announces that the IRB has approved a clinical study to evaluate AmnioWrap2™ (AW2) in diabetic foot ulcers (DFU), one of the company’s placental-derived allograft commercial products.
“Diabetic foot ulcers are a critical health issue and can lead to lower limb amputations, illness and death in diabetic patients. The medical community is constantly seeking new treatments to prevent or lessen these complications and their considerable impact on patients, families, and the healthcare system as a whole. Our clinical team has developed a novel, standardized clinical trial protocol utilizing advanced technologies to ensure the collection of high-quality data. The diabetic foot ulcer patient population stands to benefit significantly from our advanced wound care technologies. Through this innovative trial, we aim to demonstrate the efficacy of our unique AW2 allograft, manufactured with our patented BioREtain(TM) technology."
Jason Matuszewski, CEO of BioStem
Following the completion of this study, BioStem will aim to commercially advance AW2 with expanded Payer Insurance Coverage within the diabetic foot ulcer market. Diabetic foot ulcers are among the most prevalent and severe complications affecting the lower extremities in individuals with diabetes mellitus. These ulcers pose a significant economic strain on healthcare systems, with annual treatment costs estimated to range from $9 to $13 billion in the United States alone.
AW2 Trial Overview:
BioStem has received IRB approval to proceed with the clinical study evaluating AW2 in patients with diabetic foot ulcers. The primary endpoint of the study is the percentage of subjects whose target ulcer achieve complete wound closure within 12 weeks. Secondary endpoints comparing differences between treatment groups include the time to closure, percent change in wound area and volume at 12-weeks, total number of applications used to achieve complete wound closure, and time to closure for subjects that crossover. The safety endpoint will evaluate spontaneously reported and elicited adverse events, and the exploratory endpoint will assess the differences between treatment groups in clinical signs and symptoms of infection.
AW2 consists of unseparated amnion and chorion membranes, including the intact intermediate layer. The allografts contain collagen, extracellular matrix, and a wide array of regulatory proteins such as growth factors, cytokines, and chemokines. AW2 is a minimally manipulated dehydrated tissue allograft that serves as a protective covering for soft tissue wounds.
BioStem recently announced breakthrough results using AmnioWrap2 in a retrospective wound care study. The article was published in the international, peer-reviewed journal, Health Science Reports, and validated its proprietary processing method and its placental allograft products. The article, titled Assessing placental membrane treatment efficiency in diabetic foot ulcers: Processing for retention versus lamination, provides a retrospective analysis of wound care in 41 subjects, and can be read HERE.
About BioStem Technologies, Inc. (OTC: BSEM): BioStem Technologies is a leading innovator focused on harnessing the natural properties of perinatal tissue in the development, manufacture, and commercialization of allografts for regenerative therapies. The Company is focused on manufacturing products that change lives, leveraging its proprietary BioREtain® processing method. BioREtain® has been developed by applying the latest research in regenerative medicine, focused on maintaining growth factors and preserving tissue structure. BioStem Technologies' quality management system and standard operating procedures have been reviewed and accredited by the American Association of Tissue Banks ("AATB"). These systems and procedures are established per current Good Tissue Practices ("cGTP") and current Good Manufacturing Processes ("cGMP"). Our portfolio of quality brands includes AmnioWrap2™, VENDAJE®, VENDAJE AC®, and VENDAJE OPTIC®. Each BioStem Technologies placental allograft is processed at the Company's FDA registered and AATB accredited site in Pompano Beach, Florida. For more information visit biostemtechnologies.com and follow us on Twitter and Linkedin.
Forward-Looking Statements: Except for statements of historical fact, this release also contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to expectations or forecasts of future events. Forward-looking statements may be identified using words such as "forecast," "intend," "seek," "target," "anticipate," "believe," "expect," "estimate", "plan," "outlook," and "project" and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Forward-looking statements with respect to the operations of the Company, strategies, prospects and other aspects of the business of the Company are based on current expectations that are subject to known and unknown risks and uncertainties, which could cause actual results or outcomes to differ materially from expectations expressed or implied by such forward-looking statements. These factors include, but are not limited to: (1) the impact of any changes to the reimbursement levels for the Company's products; (2) the Company faces significant and continuing competition, which could adversely affect its business, results of operations and financial condition; (3) rapid technological change could cause the Company's products to become obsolete and if the Company does not enhance its product offerings through its research and development efforts, it may be unable to effectively compete;(4) to be commercially successful, the Company must convince physicians that its products are safe and effective alternatives to existing treatments and that its products should be used in their procedures; (5) the Company's ability to raise funds to expand its business; (6) the Company has incurred significant losses since inception and may incur losses in the future; (7) changes in applicable laws or regulations; (8) the possibility that the Company may be adversely affected by other economic, business, and/or competitive factors; (9) the Company's ability to maintain production of its products in sufficient quantities to meet demand; and (10) the COVID-19 pandemic and its impact, if any, on the Company's fiscal condition and results of operations; You are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made. Although it may voluntarily do so from time to time, the Company undertakes no commitment to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable securities laws.
BioStem Technologies, Inc.
Phone: 954-380-8342
Phone: 954-380-8342
Website: http://www.biostemtechnologies.com
E-Mail: info@biostemtech.com
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