BioStem Receives Institutional Review Board (IRB) Approval to Advance Clinical Trial Demonstrating the Therapeutic Benefits of BioREtain® Technology in Treating Venous Leg Ulcers
BioStem Technologies (OTC: BSEM) has received Institutional Review Board (IRB) approval for a clinical study evaluating its proprietary BioREtain® Amnion Chorion (BR-AC) for treating venous leg ulcers (VLU). The multicenter, randomized, controlled study will enroll at least 60 subjects across 15 U.S. sites, comparing BR-AC to standard care over 12 weeks.
The trial will focus on patients with non-healing, non-infected VLUs with confirmed venous reflux. Subjects will undergo a two-week run-in period with standard wound care before randomization. The primary objective is to assess whether BR-AC increases complete wound closure likelihood compared to standard care alone.
This marks BioStem's third prospective clinical trial across various wound indications. The company's BioREtain® technology is designed to retain tissue's native properties while maintaining the structure and matrix found in fresh perinatal tissue. The VLU market is growing at over 4% CAGR, affecting up to two million people annually in the United States.
BioStem Technologies (OTC: BSEM) ha ricevuto l'approvazione del Comitato Etico (IRB) per uno studio clinico volto a valutare il suo esclusivo BioREtain® Amnion Chorion (BR-AC) per il trattamento delle ulcere venose agli arti inferiori (VLU). Lo studio multicentrico, randomizzato e controllato arruolerà almeno 60 soggetti in 15 siti negli Stati Uniti, confrontando BR-AC con le cure standard per un periodo di 12 settimane.
La sperimentazione si concentrerà su pazienti con VLU non guarite e non infette, con reflusso venoso confermato. I soggetti seguiranno un periodo di preparazione di due settimane con cure standard per le ferite prima della randomizzazione. L'obiettivo principale è valutare se BR-AC aumenti la probabilità di chiusura completa della ferita rispetto alle sole cure standard.
Questo segna il terzo trial clinico prospettico di BioStem in diverse indicazioni per le ferite. La tecnologia BioREtain® dell'azienda è progettata per mantenere le proprietà native dei tessuti, preservando al contempo la struttura e la matrice presenti nei tessuti perinatali freschi. Il mercato delle VLU sta crescendo a oltre il 4% CAGR, colpendo fino a due milioni di persone ogni anno negli Stati Uniti.
BioStem Technologies (OTC: BSEM) ha recibido la aprobación de la Junta de Revisión Institucional (IRB) para un estudio clínico que evalúa su exclusivo BioREtain® Amnion Chorion (BR-AC) para el tratamiento de úlceras venosas en las piernas (VLU). El estudio multicéntrico, aleatorizado y controlado inscribirá al menos a 60 sujetos en 15 sitios en EE. UU., comparando BR-AC con el cuidado estándar durante 12 semanas.
El ensayo se centrará en pacientes con VLU no cicatrizadas y no infectadas con reflujo venoso confirmado. Los sujetos pasarán por un período de preparación de dos semanas con cuidado estándar de heridas antes de la aleatorización. El objetivo principal es evaluar si BR-AC aumenta la probabilidad de cierre completo de la herida en comparación con el cuidado estándar solo.
Este es el tercer ensayo clínico prospectivo de BioStem en diversas indicaciones de heridas. La tecnología BioREtain® de la compañía está diseñada para conservar las propiedades nativas del tejido mientras mantiene la estructura y la matriz que se encuentran en el tejido perinatal fresco. El mercado de VLU está creciendo a más del 4% CAGR, afectando a hasta dos millones de personas anualmente en los Estados Unidos.
BioStem Technologies (OTC: BSEM)는 정맥성 하지 궤양(VLU) 치료를 위한 독점 BioREtain® Amnion Chorion (BR-AC)의 임상 연구에 대한 기관 윤리 위원회(IRB) 승인을 받았습니다. 이 다기관, 무작위, 대조 연구는 미국 내 15개 사이트에서 최소 60명의 피험자를 모집하여 12주 동안 BR-AC와 표준 치료를 비교할 예정입니다.
이 시험은 확인된 정맥 역류가 있는 치료되지 않은 비감염성 VLU 환자에 초점을 맞출 것입니다. 피험자들은 무작위 배정 전에 표준 상처 치료와 함께 2주간의 준비 기간을 거치게 됩니다. 주요 목표는 BR-AC가 표준 치료만으로는 완전한 상처 폐쇄 가능성을 증가시키는지를 평가하는 것입니다.
이것은 BioStem의 다양한 상처 지표에 대한 세 번째 전향적 임상 시험입니다. 회사의 BioREtain® 기술은 신선한 주산 조직에서 발견되는 구조와 기질을 유지하면서 조직의 고유한 특성을 보존하도록 설계되었습니다. VLU 시장은 연평균 4% 이상 성장하고 있으며, 매년 미국에서 최대 200만 명에게 영향을 미치고 있습니다.
BioStem Technologies (OTC: BSEM) a reçu l'approbation du Comité d'éthique institutionnel (IRB) pour une étude clinique évaluant son BioREtain® Amnion Chorion (BR-AC) exclusif pour le traitement des ulcères veineux des membres inférieurs (VLU). L'étude multicentrique, randomisée et contrôlée recrutera au moins 60 sujets dans 15 sites aux États-Unis, en comparant BR-AC aux soins standards sur une période de 12 semaines.
L'essai se concentrera sur des patients présentant des VLU non guéries et non infectées avec reflux veineux confirmé. Les sujets subiront une période de préparation de deux semaines avec des soins standard des plaies avant la randomisation. L'objectif principal est d'évaluer si BR-AC augmente la probabilité de fermeture complète de la plaie par rapport aux soins standards seuls.
Ceci marque le troisième essai clinique prospectif de BioStem concernant diverses indications de plaies. La technologie BioREtain® de l'entreprise est conçue pour conserver les propriétés natives des tissus tout en maintenant la structure et la matrice présentes dans les tissus périnatals frais. Le marché des VLU connaît une croissance de plus de 4 % CAGR, touchant jusqu'à deux millions de personnes chaque année aux États-Unis.
BioStem Technologies (OTC: BSEM) hat die Genehmigung der Institutional Review Board (IRB) für eine klinische Studie erhalten, die das proprietäre BioREtain® Amnion Chorion (BR-AC) zur Behandlung von venösen Beingeschwüren (VLU) bewertet. Die multizentrische, randomisierte, kontrollierte Studie wird mindestens 60 Probanden an 15 Standorten in den USA einschreiben und BR-AC über einen Zeitraum von 12 Wochen mit der Standardversorgung vergleichen.
Die Studie konzentriert sich auf Patienten mit nicht heilenden, nicht infizierten VLUs mit bestätigtem venösem Reflux. Die Probanden durchlaufen vor der Randomisierung eine zweiwöchige Vorbereitungsphase mit Standardwundversorgung. Das Hauptziel besteht darin zu bewerten, ob BR-AC die Wahrscheinlichkeit einer vollständigen Wundheilung im Vergleich zur alleinigen Standardversorgung erhöht.
Dies ist die dritte prospektive klinische Studie von BioStem zu verschiedenen Wundindikationen. Die BioREtain®-Technologie des Unternehmens ist darauf ausgelegt, die natürlichen Eigenschaften des Gewebes zu erhalten, während die Struktur und Matrix des frischen perinatalen Gewebes beibehalten werden. Der VLU-Markt wächst mit über 4 % CAGR und betrifft jährlich bis zu zwei Millionen Menschen in den Vereinigten Staaten.
- Received IRB approval for new clinical trial
- Expanding into VLU market affecting 2 million U.S. patients annually
- Market growing at >4% CAGR
- Previously published peer-reviewed study showed breakthrough results for diabetic foot ulcers
- Company has incurred significant losses since inception
- Faces significant market competition
- Success depends on convincing physicians to adopt products
- Requires continued funding to expand business
Study comparing BioStem’s proprietary amnion chorion allograft versus the standard of care aims to demonstrate superior outcomes, further validating its clinical efficacy to support market expansion
POMPANO BEACH, Fla., Feb. 24, 2025 (GLOBE NEWSWIRE) -- BioStem Technologies, Inc. (OTC: BSEM), a leading MedTech company focused on the development, manufacturing, and commercialization of placental-derived products for advanced wound care, announces Institutional Review Board (IRB) approval for a clinical study to evaluate its proprietary BioREtain® Amnion Chorion (BR-AC) for the treatment of venous leg ulcers (VLU). This study aims to assess the efficacy of BR-AC compared to standard of care in patients with non-healing VLUs, providing critical data to support continued market adoption of its proprietary technology.
Jason Matuszewski, CEO of BioStem, stated: "This is our third prospective clinical trial across various wound indications, and we continue to advance these trials for our allograft products with the goal of demonstrating clinical superiority for healthcare professionals and payers. We previously announced the publication of a peer-reviewed study demonstrating breakthrough results with the application of this product for diabetic foot ulcers. BioStem is confident that the benefits of our technology will become evident in additional indications such as VLUs and looks forward to providing updates as the trial progresses.”
About BioREtain®:
BioStem’s allografts are processed utilizing the Company’s proprietary BioREtain® method, which retains the tissue’s native 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 wound treatment. For a full overview of BioREtain, please visit: HERE.
BR-AC consists of unseparated amnion and chorion membranes, including the intact intermediate layer. It contains collagen, extracellular matrix, and a wide array of protein components including growth factors, cytokines, and chemokines. BR-AC is a minimally manipulated dehydrated tissue allograft that serves as a protective covering for soft tissue wounds.
BR-AC-VLU Clinical Trial Overview and Design:
- Title: Non-healing Venous Leg Ulcers Treated with Standard Care, With or Without BR-AC
- Primary Outcome Measures: The primary objective of this study is to assess whether the addition of BR-AC increases the likelihood of achieving complete wound closure in venous leg ulcers (VLUs) compared to standard of care alone. The study will evaluate the proportion of subjects who achieve full wound closure, defined as
100% re-epithelialization, over a 12-week treatment period. - Clinicaltrials.gov Link: HERE
The BR-AC-VLU trial is a multicenter, randomized, controlled study that will enroll at least 60 subjects with a non-healing VLU at approximately 15 sites across the United States. The study will focus on a patient population with non-healing, non-infected VLUs having confirmed venous reflux by duplex Doppler ultrasound. All consented subjects will enter a two-week run-in period receiving only standard wound care. Those who comply with compression therapy, have not healed greater than30% and continue to meet criteria after two-weeks will be randomized in a 1:1 fashion. Weekly study visits will be conducted to monitor compliance with wound care protocols and compression therapy, as well as to document when wound closure is achieved. A follow-up phase will commence for all subjects that achieve complete wound closure, which is designed to measure longevity and durability of the closed wound. This follow-up will consist of a four-week period with two visits at each two-week interval.
Venous Leg Ulcers Facts:
Venous leg ulcers are chronic sores that develop on the legs due to poor blood flow in the veins and affect up to two million people in the United States annually. The venous leg ulcer market, focused on the treatment and management of these ulcers, is growing at a CAGR of more than
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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. 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 advanced wound care, 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
What is the primary objective of BSEM's new VLU clinical trial?
How many patients will be enrolled in BSEM's VLU clinical trial?
What is the market size for venous leg ulcers that BSEM is targeting?
How long is the follow-up period in BSEM's VLU clinical trial?
What previous clinical success has BSEM demonstrated with BioREtain technology?
