Strategic head-to-head study of BR-AC vs. standard of care aims to demonstrate healing superiority potential to support increased payor coverage and market growth
The study will be conducted in 60 patients at 10 sites across the U.S. and the first patients have begun treatment
POMPANO BEACH, Florida, October 2, 2024 - PRISM MediaWire - BioStem Technologies, Inc. (OTC: BSEM), a leading MedTech company focused on the development, manufacture, and commercialization of placental-derived biologics for advanced wound care, announces the initiation of the BR-AC-DFU-101 (BioREtain - Amnion Chorion - Diabetic Foot Ulcers) clinical trial to evaluate BR-AC (BioREtain - Amnion Chorion) against the standard of care for patients suffering from non-healing diabetic foot ulcers (DFUs).
Study Overview and Design:
The BR-AC-DFU-101 study will examine a patient population with a DFU (diabetic foot ulcer) that has adequate perfusion without clinical signs and symptoms of infection. The trial will enroll 60 patients with non-healing diabetic foot ulcers at ten sites across the United States, with an expected completion date by the end of 2025. Weekly subject visits will be conducted to monitor compliance in wound care and off-loading, as well as to document when wound closure is achieved. Historical data has demonstrated that around 30% of DFUs heal within 12 weeks using standard care alone. However, roughly half of patients suffering from DFUs require additional measures, including advanced therapy. It is hypothesized that weekly applications of the human placental allograft BR-AC applied to a non-healing DFU will result in a higher rate of complete wound healing within 12 weeks of initiating therapy compared to standard care alone.
The BR-AC-DFU-101 study will examine a patient population with a DFU (diabetic foot ulcer) that has adequate perfusion without clinical signs and symptoms of infection. The trial will enroll 60 patients with non-healing diabetic foot ulcers at ten sites across the United States, with an expected completion date by the end of 2025. Weekly subject visits will be conducted to monitor compliance in wound care and off-loading, as well as to document when wound closure is achieved. Historical data has demonstrated that around 30% of DFUs heal within 12 weeks using standard care alone. However, roughly half of patients suffering from DFUs require additional measures, including advanced therapy. It is hypothesized that weekly applications of the human placental allograft BR-AC applied to a non-healing DFU will result in a higher rate of complete wound healing within 12 weeks of initiating therapy compared to standard care alone.
“We are excited to initiate the BR-AC-DFU-101 clinical trial, which aims to potentially demonstrate the clinical significance of our proprietary BioREtain technology against the standard of care. We believe the findings from this trial will enhance the understanding of the healing benefits of our products and pave the way for broader insurance coverage and market acceptance. BioStem is focused on driving revenue growth through improving the payor network for our products to build from the record revenue of more than $100 million we reported in the first half of 2024. Our patented BioREtain process is the technology utilized in our products and will be a key differentiator for BioStem’s commercial products going forward. Ultimately, we aim to better address the needs of patients suffering from non-healing diabetic foot ulcers and improve their quality of life. We are confident that the results will highlight the strength of our technology and provide substantial benefits to support BioStem and its shareholders as the company advances.”
Jason Matuszewski, CEO of BioStem Technologies
Trial Primary & Secondary Outcome Goals:
The primary outcome of the study is to determine whether DFUs treated with standard care plus BR-AC results in a higher probability of achieving complete wound closure compared to standard care alone over a 12-week period. Secondary outcome measures include comparing the differences between treatment groups in proportions of wounds with complete wound closure, based on time in days to closure over a 12-week period. Secondary outcomes also include the differences between treatment groups in percent change in wound area (cm2) and (cm3), as well as the total number of applications of BR-AC needed to achieve complete wound closure.
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
About BioREtain®:
BioStem’s allografts are processed utilizing the Company’s proprietary BioREtain® method, which focuses on preserving the tissue’s endogenous biological properties while maintaining the structure and matrix found in fresh perinatal tissue. The patented six-step BioREtain® process is gentle, minimally invasive, and preserves the natural integrity of the amniotic tissue/ components critical to the inherent wound healing process. For a full overview of BioREtain, please visit: https://biostemtechnologies.com/our-science/#six-steps.
Clinical Trial Information:
For more information about the BR-AC-DFU-101 study, please visit Clinical Trials.gov for a full overview:
· Title: A Prospective Trial of Non-healing Diabetic Foot Ulcers Treated with Standard Care with or Without BR-AC
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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 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.
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.
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.
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
Phone: 954-380-8342
Website: http://www.biostemtechnologies.com
E-Mail: info@biostemtech.com
Twitter: @BSEM_Tech
Facebook: BioStemTechnologies
Source: BioStem Technologies, Inc.