BioStem Announces Notice of Allowance for U.S. Patent Application for Sterile Human Placental Allografts

POMPANO BEACH, Fla., Nov. 25, 2024 (GLOBE NEWSWIRE) -- (OTC: BSEM), a leading MedTech company focused on the development, manufacturing, and commercialization of placental-derived products for advanced wound care, today announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for BioStem’s patent application No. 18/591,883 for STERILE HUMAN PLACENTAL ALLOGRAFTS HAVING A PLURALITY OF SLITS, OPENINGS, AND/OR FENESTRATIONS FORMED THEREON. The patent application will grant as U.S. Patent No. 12,144,831 on November 19, 2024.

This patent will be used in the development of novel placental allografts designed for advanced wound care using BioStem’s BioREtain^® process, which preserves essential natural factors. The allografts using this technology will feature flaps that open to allow exudate to escape without sacrificing surface area, making them suitable for both acute and chronic wound settings. This technology is unique, as there are no other fenestrated allografts on the market that offer the same benefits.

Jason Matuszewski, Chief Executive Officer of BioStem, stated: “BioStem continues to drive innovation in the wound care space, and we are pleased to enhance our intellectual property portfolio with the issuance of this significant patent. This is the first and only patent granted for use in tabular fenestrated allografts, which will support our commercial efforts and expands our IP portfolio. With 27 patents pending and 42 issued, BioStem has a strong portfolio across the wound care landscape that will protect the company as we advance in the market.”

A product using this technology is under development and is currently not commercially available and will be introduced using the HCT/P regulatory pathway. Once developed, the new allografts could be used as a protective covering for exudating wounds across the acute or chronic setting.

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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. 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 advanced wound care, 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.

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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.

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Jeff Ramson



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