POMPANO BEACH, FL / ACCESSWIRE / September 29, 2023 / BioStem Technologies Inc. (OTC PINK:BSEM), a leading regenerative medicine company focused on the development, manufacture, and commercialization of placental derived biologics for advanced wound care, today hails a decision by the Centers for Medicare & Medicaid Services (CMS) as being in the best interests of patients.
Three Medicare Administrative Contractors today announced a decision to withdraw the final local coverage determinations (LCDs) for cellular and/or tissue-based products for the treatment of Diabetic Foot Ulcers (DFU) and Venous Leg Ulcers (VLU) that were scheduled to take effect on October 1, 2023.
Jason Matuszewski, Chief Executive Officer of BioStem, said: "This is a win for patients whose lives and treatment options will be positively impacted by this far-reaching resolution. Following months of uncertainty, which saw patient treatment plans interrupted, we are delighted to have hospitals and physicians back on online."
"Today's decision is an important milestone as BioStem works to achieve its mission of delivering cutting-edge wound care management products, and as we strategically address a significant market opportunity, adding long-term value for shareholders."
This month, BioStem received Investigational Review Board (IRB) approval for a clinical study that aims to investigate the utilization and effects of the company's VendajeⓇ wound care products in DFU. Diabetic Foot Ulcers are a significant risk for people with diabetes. Between 14 and 24 percent of people that develop DFU will require an amputation.
Vendaje is a placental-derived, minimally manipulated dehydrated tissue allograft that serves as a protective covering for soft tissue wounds. The product is comprised of extracellular matrix scaffolding which provides mechanical protection and functional support for cell attachment, growth factors that help modulate proliferation and angiogenesis, and anti-inflammatory cytokines that inhibit inflammatory effects, all critical in aiding the body's natural healing cascade.
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.
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.
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