BioStem Technologies Initiates BR-AC-DFU-101 Clinical Trial to Study BioREtain® in Diabetic Foot Ulcers
BioStem Technologies has initiated the BR-AC-DFU-101 clinical trial to evaluate its BioREtain technology against standard care for non-healing diabetic foot ulcers (DFUs). The study involves 60 patients at 10 U.S. sites, with a completion target by the end of 2025. The trial aims to demonstrate that weekly applications of BioREtain will result in a higher rate of complete wound healing within 12 weeks compared to standard care alone.
Primary outcomes focus on the probability of complete wound closure, while secondary outcomes measure time to closure, wound area reduction, and the number of applications needed. BioStem aims to leverage successful results to enhance insurance coverage and market growth, building on its record revenue of over $100 million in the first half of 2024. DFUs are a significant health issue, affecting 15% of diabetics, with substantial risks for amputation and high treatment costs.
BioStem Technologies ha avviato lo studio clinico BR-AC-DFU-101 per valutare la sua tecnologia BioREtain rispetto ai trattamenti standard per le ulcere del piede diabetico non cicatrizzanti (DFU). Lo studio coinvolge 60 pazienti in 10 centri negli Stati Uniti, con un obiettivo di completamento entro la fine del 2025. L'obiettivo dello studio è dimostrare che applicazioni settimanali di BioREtain porteranno a un tasso di guarigione completa delle ferite superiore entro 12 settimane rispetto al solo trattamento standard.
Gli esiti primari si concentrano sulla probabilità di chiusura completa della ferita, mentre gli esiti secondari misurano il tempo necessario per la chiusura, la riduzione dell'area della ferita e il numero di applicazioni necessarie. BioStem mira a sfruttare risultati di successo per migliorare la copertura assicurativa e la crescita del mercato, dopo aver registrato un fatturato record di oltre 100 milioni di dollari nella prima metà del 2024. Le DFU rappresentano un importante problema di salute, colpendo il 15% dei diabetici, con rischi significativi di amputazione e costi elevati per il trattamento.
BioStem Technologies ha iniciado el ensayo clínico BR-AC-DFU-101 para evaluar su tecnología BioREtain en comparación con el tratamiento estándar para las úlceras del pie diabético no cicatrizantes (DFU). El estudio involucra a 60 pacientes en 10 centros en los Estados Unidos, con un objetivo de finalización para finales de 2025. El ensayo tiene como objetivo demostrar que las aplicaciones semanales de BioREtain resultarán en una tasa más alta de curación completa de heridas en un plazo de 12 semanas en comparación con el tratamiento estándar por sí solo.
Los resultados primarios se centran en la probabilidad de cierre completo de la herida, mientras que los resultados secundarios miden el tiempo hasta el cierre, la reducción del área de la herida y el número de aplicaciones necesarias. BioStem pretende aprovechar los resultados exitosos para mejorar la cobertura de seguros y el crecimiento del mercado, basándose en sus ingresos récord de más de 100 millones de dólares en la primera mitad de 2024. Las DFU son un problema de salud significativo, afectando al 15% de los diabéticos, con riesgos sustanciales de amputación y altos costos de tratamiento.
BioStem Technologies는 비치유성 당뇨발 궤양(DFU)에 대한 표준 치료와 비교하여 BioREtain 기술을 평가하기 위해 BR-AC-DFU-101 임상 시험을 시작했습니다. 본 연구는 미국 내 10개 사이트에서 60명의 환자를 포함하며, 2025년 말까지 완료하는 것을 목표로 하고 있습니다. 이 시험의 목표는 BioREtain을 주간으로 적용했을 때, 표준 치료 단독에 비해 12주 이내에 완전한 상처 치유율이 더 높아질 것임을 입증하는 것입니다.
주된 결과는 완전한 상처 폐쇄 확률에 중점을 두고 있으며, 이차 결과는 폐쇄 시간, 상처 면적 감소 및 필요한 적용 수를 측정합니다. BioStem은 성공적인 결과를 활용하여 보험 적용 강화 및 시장 성장을 촉진하고, 2024년 상반기에 1억 달러 이상의 기록적인 수익을 기록했습니다. DFU는 15%의 당뇨병 환자에게 영향을 미치는 중요한 건강 문제로, 절단 위험과 높은 치료 비용을 동반합니다.
BioStem Technologies a lancé l'essai clinique BR-AC-DFU-101 pour évaluer sa technologie BioREtain par rapport aux traitements standards pour les ulcères du pied diabétique non cicatrisants (DFU). L'étude implique 60 patients sur 10 sites aux États-Unis, avec un objectif de fin d'étude d'ici la fin de 2025. L'essai vise à démontrer que les applications hebdomadaires de BioREtain entraîneront un taux de cicatrisation complète des plaies plus élevé dans un délai de 12 semaines par rapport au traitement standard seul.
Les résultats primaires se concentrent sur la probabilité de fermeture complète de la plaie, tandis que les résultats secondaires mesurent le temps jusqu'à la fermeture, la réduction de la surface de la plaie et le nombre d'applications nécessaires. BioStem vise à tirer parti des résultats positifs pour renforcer la couverture d'assurance et la croissance du marché, s'appuyant sur ses revenus records de plus de 100 millions de dollars au premier semestre 2024. Les DFU représentent un problème de santé majeur, affectant 15 % des personnes diabétiques, avec des risques importants d'amputation et des coûts de traitement élevés.
BioStem Technologies hat die klinische Studie BR-AC-DFU-101 gestartet, um die Technologie BioREtain im Vergleich zur Standardbehandlung für nicht heilende diabetische Fußgeschwüre (DFU) zu bewerten. Die Studie umfasst 60 Patienten an 10 Standorten in den USA, mit einem Ziel für den Abschluss bis Ende 2025. Der Versuch zielt darauf ab zu zeigen, dass wöchentliche Anwendungen von BioREtain zu einer höheren Rate vollständiger Wundheilung innerhalb von 12 Wochen im Vergleich zur Standardbehandlung allein führen werden.
Die primären Ergebnisse konzentrieren sich auf die Wahrscheinlichkeit der vollständigen Wundverschließung, während sekundäre Ergebnisse die Zeit bis zur Verschließung, die Reduktion der Wundfläche und die Zahl der benötigten Anwendungen messen. BioStem beabsichtigt, erfolgreiche Ergebnisse zu nutzen, um die Versicherungdeckung und das Marktwachstum zu verbessern, nachdem das Unternehmen in der ersten Hälfte des Jahres 2024 einen Rekordumsatz von über 100 Millionen US-Dollar erzielt hat. DFU sind ein erhebliches Gesundheitsproblem, das 15 % der Diabetiker betrifft und erhebliche Risiken für Amputationen sowie hohe Behandlungskosten mit sich bringt.
- Initiation of BR-AC-DFU-101 trial to evaluate BioREtain.
- Study targets 60 patients at 10 U.S. sites, completion by end of 2025.
- Potential for higher rate of complete wound healing within 12 weeks.
- Success could enhance insurance coverage and market growth.
- BioStem reported over $100 million in revenue in H1 2024.
- None reported.
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, Fla., Oct. 02, 2024 (GLOBE NEWSWIRE) -- 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
Jason Matuszewski, CEO of BioStem Technologies, commented: “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
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
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
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
- Link: https://www.clinicaltrials.gov/study/NCT06511596?term=biostem&rank=2
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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.
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
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