POMPANO BEACH, FL / ACCESSWIRE / September 26, 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, announced today the approval of an Investigational Review Board (IRB) sanctioned clinical study. This study aims to investigate the utilization and effects of Vendaje in diabetic patients suffering from foot ulcers.
"This is a landmark study for us," said Jason Matuszewski, Chief Executive Officer of BioStem. "Our proprietary BioREtain® process is truly special in that it is minimally invasive and gentle on tissue, which results in the natural components inherent in placental tissue to be maintained and available to help heal difficult wounds.
"We have already demonstrated scientifically that our process and product is exceptional. This study will enhance our scientific understanding with meaningful real-world results, providing critical data necessary for acceptance by the medical community and significantly improving the care and quality of life for people with diabetes at risk of amputation due to foot ulcers," said Matuszewski.
Diabetic Foot Ulcers are a significant risk for people with diabetes. According to the American Podiatric Medical Association (APMA), a leading resource for foot and ankle health, approximately 15 percent of people with diabetes develop foot ulcers. Of those 15 percent, six percent go on to be hospitalized due to infection or other ulcer-related complications. The risk to patients with diabetes is significant, as it is the leading cause of lower extremity amputations in the U.S. Approximately 14 to 24 percent of people with diabetes that develop foot ulcers will require an amputation.
Vendaje is a placental-derived, minimally manipulated dehydrated tissue allograft that serves as a protective covering for soft tissue wounds. Composed of the amnion layer of the placenta, Vendaje naturally possesses extracellular matrix scaffolding that 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. (OTCQB: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
SOURCE: BioStem Technologies, Inc.
via PRISM Mediawire, LLC
https://www.accesswire.com/787279/biostem-receives-irb-approval-for-clinical-study-to-evaluate-vendajer-in-diabetic-foot-ulcers
