BioStem Technologies Reports Breakthrough Results with AmnioWrap2® in Retrospective Wound Care Study

Rhea-AI Summary

BioStem Technologies (OTC: BSEM) announced the publication of a study in Health Science Reports, showcasing the effectiveness of its AmnioWrap2® for diabetic foot ulcers (DFUs). The study analyzed 41 subjects and compared BioStem's RE-AC, processed with the BioREtain® method, with a competitor's L-AC. Results showed that RE-AC reduced DFU areas by 67.3% over 12 weeks, compared to 52.6% for L-AC, and required fewer applications. Both methods had similar probabilities for complete wound closure. CEO Jason Matuszewski highlighted the clinical advantages and cost-efficiency of BioStem's products. Clinical studies are planned for 2024.

Positive

• RE-AC achieved a 67.3% reduction in DFU areas over 12 weeks, compared to 52.6% for L-AC.
• RE-AC required fewer applications, indicating greater efficiency in wound management.
• The study validates BioStem's BioREtain® method and its clinical utility.
• BioStem's products could lead to cost savings, enhanced patient comfort, and better compliance.

Negative

• None.

Study published in peer-reviewed journal finds BioStem’s products offer overall better treatment efficiency, and greater efficiency in general wound closure

POMPANO BEACH, Fla., June 26, 2024 (GLOBE NEWSWIRE) -- BioStem Technologies Inc. (OTC: BSEM), a leading regenerative medicine company focused on the development, manufacture, and commercialization of placental derived allografts for advanced wound care, today announced that an article validating its proprietary processing method and its placental allograft products has been published in the international, peer-reviewed journal, Health Science Reports.

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.

The study’s primary objective was to evaluate and compare the effectiveness of two wound care products for managing diabetic foot ulcers, including BioStem’s AmnioWrap2^® (RE-AC), processed using the BioREtain^® method, and (L-AC) processed through a more ablative method used by a leading competitor in the industry. The study found that RE-AC products required fewer applications, suggesting greater efficiency in managing wounds, and that they offered overall better efficiency.

The research found that RE-AC achieved a significantly higher expected Percent Area Reduction (xPAR) in DFUs compared to L-AC at 12 weeks (67.3% vs. 52.6%). Additionally, RE-AC required fewer applications, suggesting greater efficiency in general wound management. The probability of full wound closure was similar in both groups (0.738 vs. 0.740 in RE-AC and L-AC, respectively), further emphasizing the effectiveness of the treatment.

Jason Matuszewski, BioStem’s Chief Executive Officer, said, “This complete analysis of wound care products not only provides validation of BioStem’s proprietary BioREtain method, it is a testament to the clinical utility of our allografts. Current standard of care (SOC) methods are ineffective for many patients, with up to 70% of diabetic foot ulcers (DFU) not achieving healing even after 20 weeks of treatment. Our products lead to cost savings, enhanced patient comfort, and improved compliance with treatment protocols.

“BioStem’s advanced tissue allografts are specifically designed to support the natural wound healing process. We are very pleased that this study showcases our products’ advantages over other wound care management products on the market today.”

BioStem expects to initiate clinical studies during 2024 to showcase the effectiveness of its allograft products in a real-world setting.

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
Website: http://www.biostemtechnologies.com
E-Mail: info@biostemtech.com
Twitter: @BSEM_Tech
Facebook: BioStemTechnologies

PCG Advisory
Jeff Ramson
jramson@pcgadvisory.com
646-863-6893

FAQ

What were the results of BioStem Technologies' study on AmnioWrap2®?

The study showed that AmnioWrap2® reduced diabetic foot ulcer areas by 67.3% over 12 weeks, required fewer applications, and exhibited similar probabilities for full wound closure compared to a competitor's product.

What is the significance of the BioREtain® method for BioStem Technologies (BSEM)?

The BioREtain® method demonstrated superior efficiency in reducing diabetic foot ulcer areas and required fewer applications, validating its clinical utility.

How does BioStem's AmnioWrap2® compare to competitor products?

BioStem's AmnioWrap2® reduced DFU areas more significantly (67.3% over 12 weeks) and required fewer applications compared to a leading competitor's product.

When does BioStem Technologies plan to initiate further clinical studies?

BioStem Technologies plans to initiate additional clinical studies in 2024 to further investigate the effectiveness of its allograft products.