BioRestorative Receives FDA Fast Track Designation for BRTX-100 Chronic Lumbar Disc Disease Program
BioRestorative Therapies (NASDAQ:BRTX) has received FDA Fast Track designation for its BRTX-100 program targeting chronic lumbar disc disease (cLDD). This designation highlights the significant unmet medical need for alternatives to opioids and surgical interventions in cLDD treatment.
The Fast Track status was granted based on positive preliminary Phase 2 safety and efficacy data reported to date. This designation may accelerate the development process, potentially leading to Priority Review and expedited Biologics License Application (BLA) approval for BRTX-100.
The company's stem cell therapy aims to provide effective pain relief and functional improvement for millions of cLDD patients who have experienced ineffective conservative non-surgical approaches or failed surgical interventions.
BioRestorative Therapies (NASDAQ:BRTX) ha ricevuto la designazione Fast Track della FDA per il suo programma BRTX-100 che mira a trattare la malattia del disco lombare cronica (cLDD). Questa designazione evidenzia l'importante bisogno medico non soddisfatto di alternative agli oppioidi e agli interventi chirurgici nel trattamento della cLDD.
Lo stato di Fast Track è stato concesso sulla base di dati preliminari positivi sulla sicurezza e l'efficacia della Fase 2 riportati fino ad oggi. Questa designazione potrebbe accelerare il processo di sviluppo, portando potenzialmente a una Revisione Prioritaria e all'approvazione accelerata della Domanda di Licenza Biologica (BLA) per BRTX-100.
La terapia con cellule staminali dell'azienda mira a fornire un efficace sollievo dal dolore e un miglioramento funzionale per milioni di pazienti affetti da cLDD che hanno sperimentato approcci conservativi non chirurgici inefficaci o interventi chirurgici falliti.
BioRestorative Therapies (NASDAQ:BRTX) ha recibido la designación Fast Track de la FDA para su programa BRTX-100 dirigido a la enfermedad crónica del disco lumbar (cLDD). Esta designación destaca la importante necesidad médica insatisfecha de alternativas a los opioides y a las intervenciones quirúrgicas en el tratamiento de la cLDD.
El estatus de Fast Track se otorgó basado en datos preliminares positivos de seguridad y eficacia de la Fase 2 reportados hasta la fecha. Esta designación puede acelerar el proceso de desarrollo, lo que potencialmente conduce a una Revisión Prioritaria y a la aprobación acelerada de la Solicitud de Licencia Biológica (BLA) para BRTX-100.
La terapia con células madre de la empresa tiene como objetivo proporcionar un alivio efectivo del dolor y una mejora funcional para millones de pacientes con cLDD que han experimentado enfoques conservadores no quirúrgicos ineficaces o intervenciones quirúrgicas fallidas.
BioRestorative Therapies (NASDAQ:BRTX)는 만성 요추 디스크 질환(cLDD)을 목표로 하는 BRTX-100 프로그램에 대해 FDA의 패스트트랙 지정을 받았습니다. 이 지정은 cLDD 치료에서 오피오이드 및 수술적 개입에 대한 대체 치료의 중요한 의료적 필요성을 강조합니다.
패스트트랙 상태는 지금까지 보고된 2상 안전성과 효능에 대한 긍정적인 초기 데이터를 바탕으로 부여되었습니다. 이 지정은 개발 과정을 가속화할 수 있으며, 잠재적으로 BRTX-100에 대한 우선 검토 및 신속한 생물학적 제품 허가(BLA) 승인을 이끌어낼 수 있습니다.
회사의 줄기세포 치료법은 비효과적인 보존적 비수술적 접근이나 실패한 수술적 개입을 경험한 수백만 명의 cLDD 환자들에게 효과적인 통증 완화와 기능 개선을 제공하는 것을 목표로 합니다.
BioRestorative Therapies (NASDAQ:BRTX) a reçu la désignation Fast Track de la FDA pour son programme BRTX-100 visant à traiter la maladie chronique du disque lombaire (cLDD). Cette désignation met en lumière le besoin médical non satisfait d'alternatives aux opioïdes et aux interventions chirurgicales dans le traitement de la cLDD.
Le statut Fast Track a été accordé sur la base de données préliminaires positives sur la sécurité et l'efficacité de la Phase 2 rapportées jusqu'à présent. Cette désignation pourrait accélérer le processus de développement, menant potentiellement à un examen prioritaire et à une approbation accélérée de la demande de licence biologique (BLA) pour BRTX-100.
La thérapie par cellules souches de l'entreprise vise à fournir un soulagement efficace de la douleur et une amélioration fonctionnelle pour des millions de patients atteints de cLDD qui ont connu des approches conservatrices non chirurgicales inefficaces ou des interventions chirurgicales échouées.
BioRestorative Therapies (NASDAQ:BRTX) hat die Fast-Track-Designation der FDA für sein BRTX-100-Programm zur Behandlung der chronischen lumbalen Bandscheibenerkrankung (cLDD) erhalten. Diese Auszeichnung hebt den bedeutenden ungedeckten medizinischen Bedarf an Alternativen zu Opioiden und chirurgischen Eingriffen bei der Behandlung von cLDD hervor.
Der Fast-Track-Status wurde auf der Grundlage von positiven vorläufigen Daten zur Sicherheit und Wirksamkeit der Phase 2 gewährt, die bis heute berichtet wurden. Diese Auszeichnung könnte den Entwicklungsprozess beschleunigen und potenziell zu einer Prioritätsprüfung sowie einer beschleunigten Genehmigung des Biologischen Lizenzantrags (BLA) für BRTX-100 führen.
Die Stammzelltherapie des Unternehmens zielt darauf ab, Millionen von cLDD-Patienten, die ineffektive konservative nicht-chirurgische Ansätze oder gescheiterte chirurgische Eingriffe erlebt haben, eine effektive Schmerzlinderung und funktionale Verbesserung zu bieten.
- Received FDA Fast Track designation for BRTX-100
- Positive preliminary Phase 2 safety and efficacy data
- Potential for Priority Review and accelerated BLA approval
- Enhanced collaboration opportunities with FDA
- None.
Insights
The FDA's Fast Track designation for BRTX-100 marks a pivotal regulatory achievement that substantially enhances BioRestorative's market position in the $7.7 billion chronic lower back pain treatment market. This designation offers several critical advantages:
The accelerated development pathway typically reduces the time to market by 2-3 years and can result in significant cost savings, often 20-30% lower than traditional development costs. More importantly, it enables more frequent FDA interactions and rolling review of the Biologics License Application (BLA), which can dramatically streamline the approval process.
The therapeutic positioning of BRTX-100 as an alternative to opioids and surgery is particularly strategic given the current healthcare landscape. With approximately 4.8 million lumbar surgeries performed annually in the US, and opioid prescriptions facing increasing scrutiny, a cell-based therapy offering a middle-ground intervention could capture significant market share.
The preliminary Phase 2 safety and efficacy data, while not detailed in the announcement, gains additional credibility through this FDA designation, as Fast Track requires demonstration of potential advantage over available therapy. This suggests the data likely shows meaningful clinical benefits in terms of pain reduction and functional improvement.
From a competitive standpoint, this designation positions BRTX-100 ahead of many regenerative medicine competitors in the space, potentially attracting partnership opportunities with larger pharmaceutical companies seeking to expand their spine treatment portfolios. The designation's provision for potential Priority Review could reduce the standard 10-month review period to 6 months, significantly accelerating time to market.
– Underscores high unmet need for a therapeutic alternative to opioids and surgical interventions –
– Reflects positive preliminary Phase 2 Safety and Efficacy data reported to date –
– May also lead to Priority Review and Accelerated Biologics License Application (“BLA”) Approval for BRTX-100 –
MELVILLE, N.Y., Feb. 20, 2025 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a clinical stage regenerative medicine innovator focused on stem cell-based therapies and products, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track designation to the BRTX-100 program for the treatment chronic lumbar disc disease (“cLDD”).
“We are thrilled that the FDA has granted Fast Track designation, underscoring the potential of BRTX-100 to fill significant unmet medical needs in the treatment of cLDD resulting from ineffective conservative non-surgical approaches or failed surgical interventions, and reflecting the comparatively very positive preliminary Phase 2 clinical data that we have reported to date,” said Lance Alstodt, Chief Executive Officer of BioRestorative. “Achieving Fast Track designation is an important milestone for BioRestorative, enabling us to work more collaboratively with the FDA as we continue to advance our lead BRTX-100 clinical program toward BLA approval to bring this important and novel stem cell therapy to the millions of cLDD patients waiting for effective pain relief and functional improvement.”
About Fast Track Designation
The FDA's Fast Track program is aimed to facilitate the development, and expedite the review, of investigational treatments that are designed to treat serious conditions and have the potential to address significant unmet medical needs. Benefits of the program include early and frequent interactions with the FDA during the clinical development process, and stem cell product candidates with Fast Track designation may also be eligible for Priority Review and Accelerated BLA Approval.
About Chronic Lumbar Disc Disease
cLDD is a common, often confounding problem for patients and physicians. In the United States, at least
About BRTX-100
BRTX-100, a novel cell-based therapeutic engineered to target areas of the body that have little blood flow, is BioRestorative’s lead clinical candidate. The safety and efficacy of BRTX-100 in treating cLDD is being evaluated in a Phase 2, prospective, randomized, double-blinded and controlled study. A total of up to 99 eligible subjects will be enrolled at up to 16 clinical sites in the United States. Subjects included in the trial will be randomized 2:1 to receive either BRTX-100 or placebo. Further details of the trial can be found at www.clinicaltrials.gov under NCT identifier: NCT04042844.
About BioRestorative Therapies, Inc.
BioRestorative (www.biorestorative.com) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. As described below, our two core clinical development programs relate to the treatment of disc/spine disease and metabolic disorders, and we have also recently begun offering BioCosmeceutical products:
• Disc/Spine Program (brtxDISC™): Our lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a person’s own) cultured mesenchymal stem cells collected from the patient’s bone marrow. We intend that the product will be used for the non-surgical treatment of painful lumbosacral disc disorders or as a complementary therapeutic to a surgical procedure. The BRTX-100 production process utilizes proprietary technology and involves collecting a patient’s bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells. In an outpatient procedure, BRTX-100 is to be injected by a physician into the patient’s damaged disc. The treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery. We have commenced a Phase 2 clinical trial using BRTX-100 to treat chronic lower back pain arising from degenerative disc disease.
• Metabolic Program (ThermoStem®): We are developing cell-based therapy candidates to target obesity and metabolic disorders using brown adipose (fat) derived stem cells (“BADSC”) to generate brown adipose tissue (“BAT”), as well as exosomes secreted by BADSC. BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical research indicates that increased amounts of brown fat in animals may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes. BADSC secreted exosomes may also impact weight loss.
• BioCosmeceuticals: We operate a commercial BioCosmeceutical platform. Our current commercial product, formulated and manufactured using our cGMP ISO-7 certified clean room, is a cell-based secretome containing exosomes, proteins and growth factors. This proprietary biologic serum has been specifically engineered by us to reduce the appearance of fine lines and wrinkles and bring forth other areas of cosmetic effectiveness. Moving forward, we also intend to explore the potential of expanding our commercial offering to include a broader family of cell-based biologic aesthetic products and therapeutics via Investigational New Drug (IND)-enabling studies, with the aim of pioneering U.S. Food and Drug Administration (FDA) approvals in the emerging BioCosmeceuticals space.
Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements as a result of various factors and other risks, including, without limitation, those set forth in the Company's latest Form 10-K, as amended, and Form 10-Q filed with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and the Company undertakes no obligation to update such statements.
CONTACT:
Stephen Kilmer
Investor Relations
Direct: (646) 274-3580
Email: skilmer@biorestorative.com
FAQ
What is the significance of FDA Fast Track designation for BRTX-100?
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