BioStem Receives Institutional Review Board (IRB) Approval to Advance Clinical Study Evaluating the Value of Vendaje® Compared to the Standard of Care for Non-Healing Diabetic Foot Ulcers
BioStem Technologies Inc. (OTC: BSEM) has received Institutional Review Board (IRB) approval for a clinical study evaluating Vendaje® against standard care for non-healing diabetic foot ulcers (DFUs). The study aims to accelerate product adoption by providing data to healthcare professionals and payers on Vendaje's benefits. Vendaje is a placental-derived allograft using BioStem's proprietary BioREtain technology.
The multi-center, randomized, controlled study will assess the percentage of subjects achieving complete wound closure within 12 weeks as its primary endpoint. Secondary endpoints include time to closure, percent change in wound area, and total applications used. This research supports BioStem's growth strategy and aims to secure broader payer coverage, including Medicare.
BioStem Technologies Inc. (OTC: BSEM) ha ricevuto l'approvazione della Commissione Etica (IRB) per uno studio clinico che valuta Vendaje® rispetto alla terapia standard per le ulcere del piede diabetico non cicatrizzanti (DFUs). Lo studio mira ad accelerare l'adozione del prodotto fornendo dati ai professionisti sanitari e ai pagatori sui benefici di Vendaje. Vendaje è un allograft derivato dalla placenta che utilizza la tecnologia BioREtain di BioStem.
Lo studio multicentrico, randomizzato e controllato valuterà la percentuale di soggetti che raggiungono una chiusura completa della ferita entro 12 settimane come obiettivo primario. Gli obiettivi secondari includono il tempo di chiusura, la percentuale di cambiamento nell'area della ferita e il numero totale di applicazioni utilizzate. Questa ricerca supporta la strategia di crescita di BioStem e mira a garantire una copertura più ampia da parte dei pagatori, compresi i programmi Medicare.
BioStem Technologies Inc. (OTC: BSEM) ha recibido la aprobación de la Junta de Revisión Institucional (IRB) para un estudio clínico que evalúa Vendaje® en comparación con la atención estándar para úlceras diabéticas del pie (DFUs) que no cicatrizan. El estudio tiene como objetivo acelerar la adopción del producto ofreciendo datos a los profesionales de la salud y a los pagadores sobre los beneficios de Vendaje. Vendaje es un aloinjerto derivado de la placenta que utiliza la tecnología BioREtain de BioStem.
El estudio, multicéntrico, aleatorizado y controlado, evaluará el porcentaje de sujetos que logran el cierre completo de la herida en un plazo de 12 semanas como su objetivo principal. Los objetivos secundarios incluyen el tiempo de cierre, el cambio porcentual en el área de la herida y el total de aplicaciones utilizadas. Esta investigación respalda la estrategia de crecimiento de BioStem y tiene como objetivo asegurar una mayor cobertura de los pagadores, incluidos Medicare.
BioStem Technologies Inc. (OTC: BSEM)는 비치유성 당뇨병 발족 궤양(DFUs)을 위한 표준 치료와 비교하여 Vendaje®를 평가하는 임상 연구의 기관 윤리 위원회(IRB) 승인 을 받았습니다. 이 연구는 헬스케어 전문가와 지불자에게 Vendaje의 이점에 대한 데이터를 제공함으로써 제품 채택을 가속화하는 것을 목표로 합니다. Vendaje는 BioStem의 독점 기술인 BioREtain technology를 사용하는 태반 유래 동종 이식편입니다.
다기관, 무작위, 대조군 연구는 12주 이내에 완전 상처 폐쇄에 도달한 피험자의 비율을 주요 목표로 평가할 것입니다. 이차 목표에는 폐쇄까지 걸리는 시간, 상처 면적의 백분율 변화, 사용된 총 응용 횟수가 포함됩니다. 이 연구는 BioStem의 성장 전략을 지원하며 Medicare를 포함한 더 넓은 지불자 보장을 확보하는 것을 목표로 합니다.
BioStem Technologies Inc. (OTC: BSEM) a reçu l'approbation du Comité d'éthique (IRB) pour une étude clinique évaluant Vendaje® par rapport aux soins standards pour les ulcères du pied diabétique non cicatrisants (DFUs). L'étude vise à accélérer l'adoption du produit en fournissant des données aux professionnels de la santé et aux assureurs sur les bénéfices de Vendaje. Vendaje est un allogreffe dérivée de la placenta utilisant la technologie BioREtain de BioStem.
L'étude multicentrique, randomisée et contrôlée évaluera le pourcentage de sujets atteignant une fermeture complète de la plaie dans un délai de 12 semaines comme objectif principal. Les objectifs secondaires incluent le temps nécessaire à la fermeture, le pourcentage de changement de la surface de la plaie et le nombre total d'applications utilisées. Cette recherche soutient la stratégie de croissance de BioStem et vise à obtenir une plus large couverture des assureurs, y compris Medicare.
BioStem Technologies Inc. (OTC: BSEM) hat die Genehmigung der Ethikkommission (IRB) für eine klinische Studie erhalten, die Vendaje® im Vergleich zur Standardbehandlung bei nicht heilenden diabetischen Fußgeschwüren (DFUs) bewertet. Die Studie zielt darauf ab, die Einführung des Produkts zu beschleunigen, indem Daten über die Vorteile von Vendaje für Gesundheitsfachkräfte und Kostenträger bereitgestellt werden. Vendaje ist ein plazentabasiertes Allograft, das die proprietäre BioREtain technology von BioStem nutzt.
Die multizentrische, randomisierte, kontrollierte Studie wird den Prozentsatz der Teilnehmer bewerten, die innerhalb von 12 Wochen eine vollständige Wundheilung erreichen, als primären Endpunkt. Sekundäre Endpunkte sind die Zeit bis zur Heilung, die prozentuale Veränderung der Wundfläche und die insgesamt verwendeten Anwendungen. Diese Forschung unterstützt die Wachstumsstrategie von BioStem und zielt darauf ab, umfassendere Kostenträgerabdeckungen, einschließlich Medicare, zu sichern.
- IRB approval received for clinical study of Vendaje® for diabetic foot ulcers
- Study aims to accelerate product adoption and secure broader payer coverage
- Vendaje® is already reimbursed through Medicare
- Trial designed to provide real-world data on Vendaje's efficacy compared to standard care
- None.
Study supports BioStem’s strategic growth initiatives and accelerates product adoption by providing data to healthcare professionals and payers on the benefits of Vendaje
POMPANO BEACH, Fla., Aug. 21, 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 that the Institutional Review Board (IRB) has approved a clinical study to evaluate Vendaje® for diabetic foot ulcers (DFU), a key product in the company’s placental-derived allograft portfolio. This study aims to assess the efficacy of Vendaje compared to standard of care in diabetic patients with non-healing DFU’s, providing critical data to support both patient outcomes and payer decisions.
Jason Matuszewski, CEO of BioStem, stated, "This study supports BioStem’s strategic growth initiatives and aims to accelerate product adoption by providing real-world data to healthcare professionals and payers like Medicare on the benefits and value of Vendaje. Our primary goal with these studies is to secure broader payer coverage and increase patient access to Vendaje. With our proprietary BioREtain technology, we deliver a superior product for treating diabetic foot ulcers. We look forward to advancing these trials and will provide regular updates as patient enrollment and treatment progress.”
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, the product 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. The product is used in private office and hospital/surgical settings, and which is currently reimbursed through Medicare.
Vendaje Trial Overview:
This trial is a multi-center, randomized, controlled study of non-healing DFUs treated with standard of care with or without Vendaje. The primary endpoint of the study is the percentage of subjects whose target ulcer achieve complete wound closure within 12 weeks. Secondary endpoints comparing differences between treatment groups include the time to closure, percent change in wound area and volume at 12-weeks, total number of applications used to achieve complete wound closure, and time to closure for subjects that crossover. The safety endpoint will evaluate spontaneously reported and elicited adverse events, and the exploratory endpoint will assess the differences between treatment groups in clinical signs and symptoms of infection.
Diabetic Foot Ulcers Market Facts:
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. These ulcers pose a significant economic strain on healthcare systems, with annual treatment costs estimated to range from
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
Facebook: BioStemTechnologies
PCG Advisory
Jeff Ramson
jramson@pcgadvisory.com
646-863-6893
FAQ
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