Retrospective Study demonstrates clinical efficacy and statistical support for tissue processed via BioREtain to care for treatment-resistant chronic wounds
Study published in the peer-reviewed journal, ‘International Wound Journal’
POMPANO BEACH, Fla., Oct. 17, 2024 (GLOBE NEWSWIRE) — BioStem Technologies, Inc. (OTC: BSEM), a leading MedTech company focused on the development, manufacturing, and commercialization of placental-derived biologics for advanced wound care, announces breakthrough results published in the peer-reviewed journal, International Wound Journal. The study validates the clinical efficacy of BioREtain®-processed placental membranes (RE-AC) compared to the standard of care (SOC). Utilizing a real-world population with large, hard-to-heal, complex chronic diabetic foot ulcers (DFUs), the study demonstrates a clear advantage in 12-week wound healing rates for the RE-AC-treated group compared to the SOC group.
Jason Matuszewski, CEO of BioStem Technologies Inc., commented: “We are consistently proving the clinical effectiveness of our BioREtain technology through retrospective studies published in peer-reviewed journals. This study evaluated very challenging DFUs, characterized by long, complicated histories and significantly larger sizes compared to those seen in most controlled studies, and we are thrilled that this study highlighted the unique benefits of BioREtain-processed membranes compared to the standard of care. As we advance our clinical strategy, we will continue conducting head-to-head studies to demonstrate wound healing superiority for our products, resulting in an increase in market awareness and adoption of our products.”
Study Overview:
In this study, researchers conducted a retrospective analysis to evaluate the effectiveness of a sterile, dehydrated amnion/chorion membrane processed using a proprietary method (RE-AC) compared to a cohort of patients treated with standard of care (SOC) measures in healing hard-to-heal diabetic foot ulcers (DFUs) in a real-world environment. A total of 21 subjects met the study’s inclusion criteria, which included factors such as wound type (DFU), medical history, and previous treatment involving the RE-AC placental membrane product. The DFU wounds in the study were considerably larger than those typically included in randomized controlled trials (RCTs), averaging nearly 14 cm², compared to an average wound size of about 5 cm² in most RCTs.
Study Results Synopsis:
The study demonstrated that patients treated with RE-AC experienced an 8.53% higher probability of achieving full wound closure compared to the standard of care (SOC) group after 12 weeks. Notably, the study included large, complex DFUs with significant co-morbidities and other exacerbating factors, often excluded from typical studies due to their unfavorable outcomes, regardless of intervention. For those wounds that did not achieve complete closure, the RE-AC group still showed a 93.6% improvement in expected area reduction, were as the SOC group stalled or grew larger, confirming RE-AC’s superior performance over SOC in managing difficult DFUs. The relative risk for wound closure in the RE-AC group was 52% higher than in the SOC group, underscoring the product’s effectiveness even under challenging conditions. Despite the complexity of the wounds, which averaged nearly 14 cm² and often persisted for extended durations, the RE-AC group achieved a statistically significant advantage in healing rates over SOC.
Read the International Wound Journal Article:
The article, titled Retention processed placental membrane versus standard of care in treating diabetic foot ulcers provides a retrospective analysis of wound care using BioREtain-processed membranes against the standard of care.
Diabetic Foot Ulcers Market Statistics:
Diabetic foot ulcers (DFUs) are a serious and chronic condition affecting millions of individuals within the diabetic population. According to the American Podiatric Medical Association (APMA), a leading authority on foot and ankle health, approximately 15% of people with diabetes will develop foot ulcers. Alarmingly, 6% of these individuals may require hospitalization due to infections or other complications related to their ulcers. The risks for diabetic patients are substantial, as DFUs are the leading cause of lower extremity amputations in the U.S. Studies indicate that between 14% and 24% of individuals with diabetes who develop foot ulcers will ultimately need an amputation.
Recent data analysis from GlobalData Plc., a prominent global data provider, revealed that 2.2 million patients received treatment for DFUs in 2023, with numbers projected to rise in the coming years. The economic burden of these ulcers on healthcare systems is significant, with annual treatment costs estimated between $9 billion and $13 billion in the United States alone.
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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 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 AmnioWrap 2 ™, 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
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PCG Advisory
Jeff Ramson
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646-863-6893
