BioRestorative Therapies Receives Expanded Tissue License from New York State Department of Health
BioRestorative Therapies (BRTX) has received a provisional license from the New York State Department of Health for processing allogeneic donor tissue material. This expanded license allows for the isolation, expansion, and cryopreservation of various cell types, including stem cells, for medical research. Previously, BRTX was only licensed for processing mesenchymal stem cells from autologous donors. The new license enables the company to process, bank, and distribute clinical grade allogeneic biologics using its cGMP manufacturing capabilities. NYSDOH licensure requires compliance with regulations ensuring safe and ethical tissue handling through comprehensive facility inspections.
BioRestorative Therapies (BRTX) ha ricevuto una licenza provvisoria dal Dipartimento della Salute dello Stato di New York per la lavorazione di materiale tissutale da donatori allogenici. Questa licenza amplificata consente l'isolamento, l'espansione e la crioconservazione di vari tipi di cellule, comprese le cellule staminali, per la ricerca medica. In precedenza, BRTX era autorizzata solo alla lavorazione di cellule staminali mesenchimali da donatori autologhi. La nuova licenza permette all'azienda di processare, conservare e distribuire biologici allogenici di grado clinico utilizzando le sue capacità di produzione cGMP. La licenza del NYSDOH richiede la conformità alle normative che garantiscono una gestione sicura ed etica dei tessuti attraverso ispezioni complete delle strutture.
BioRestorative Therapies (BRTX) ha recibido una licencia provisional del Departamento de Salud del Estado de Nueva York para el procesamiento de material tisular de donantes alogénicos. Esta licencia ampliada permite la aislamiento, expansión y criopreservación de varios tipos de células, incluidas las células madre, para la investigación médica. Anteriormente, BRTX solo tenía licencia para el procesamiento de células madre mesenquimatosas de donantes autólogos. La nueva licencia habilita a la empresa para procesar, almacenar y distribuir biológicos alogénicos de grado clínico utilizando sus capacidades de manufactura cGMP. La licencia del NYSDOH exige el cumplimiento de las regulaciones que garantizan un manejo seguro y ético de los tejidos a través de inspecciones exhaustivas de las instalaciones.
BioRestorative Therapies (BRTX)는 뉴욕주 보건부로부터 동종 기증자 조직 물질을 처리하기 위한 임시 라이센스를 받았습니다. 이 확장된 라이센스는 다양한 세포 유형, including 줄기 세포의 분리, 확장 및 냉동 보존을 허용하여 의학 연구를 지원합니다. 이전에, BRTX는 자가 기증자에서 유래한 중간엽 줄기 세포 처리에 대해서만 라이센스를 보유하고 있었습니다. 새 라이센스는 회사를 통해 임상 등급의 동종 생물 제품을 처리, 은행에 저장 및 배포할 수 있게 해줍니다. NYSDOH 라이센스는 포괄적인 시설 검사를 통해 안전하고 윤리적인 조직 처리를 보장하는 규정을 준수해야 합니다.
BioRestorative Therapies (BRTX) a reçu une licence provisoire du Département de la santé de l'État de New York pour le traitement de matériau tissulaire de donneurs allogènes. Cette licence étendue permet l'isolement, l'expansion et la cryoconservation de divers types de cellules, y compris les cellules souches, à des fins de recherche médicale. Auparavant, BRTX était uniquement autorisée à traiter des cellules souches mésenchymateuses provenant de donneurs autologues. La nouvelle licence permet à l'entreprise de traiter, conserver et distribuer des produits biologiques allogènes de qualité clinique en utilisant ses capacités de fabrication cGMP. La licence du NYSDOH exige le respect des réglementations garantissant une manipulation sûre et éthique des tissus grâce à des inspections complètes des installations.
BioRestorative Therapies (BRTX) hat eine vorläufige Lizenz vom Gesundheitsministerium des Bundesstaates New York für die Verarbeitung von gewebematerial von allogenen Spendern erhalten. Diese erweiterte Lizenz ermöglicht die Isolierung, Expansion und Kryokonservierung verschiedener Zelltypen, einschließlich Stammzellen, für die medizinische Forschung. Zuvor war BRTX nur für die Verarbeitung von mesenchymalen Stammzellen aus autologen Spendern lizenziert. Die neue Lizenz ermöglicht es dem Unternehmen, klinisch geeignete allogene Biologika zu verarbeiten, zu lagern und zu verteilen, indem es seine cGMP-Herstellungskapazitäten nutzt. Die Lizenzierung durch das NYSDOH erfordert die Einhaltung von Vorschriften, die eine sichere und ethische Gewebehandhabung durch umfassende Anlageninspektionen sicherstellen.
- Received expanded provisional license for processing allogeneic donor tissue
- Enhanced capability to develop off-the-shelf cell-based biologic products
- Validation of company's cGMP manufacturing facility quality standards
- None.
Insights
The expanded NYSDOH tissue license represents a significant operational advancement for BioRestorative Therapies. The shift from solely autologous to include allogeneic tissue processing capabilities opens substantial new market opportunities. Allogeneic ("off-the-shelf") therapies offer several advantages over autologous treatments:
- Lower production costs through economies of scale
- Immediate availability without patient cell harvesting
- Standardized product quality
- Broader market reach
The cGMP manufacturing facility validation through NYSDOH's rigorous inspection process also strengthens BRTX's position for potential partnerships and contract manufacturing opportunities. This regulatory milestone enables the company to expand its pipeline beyond current autologous programs, potentially accelerating the path to commercialization for new cell therapy products.
– Allows for the processing of allogeneic (non-autologous) donor tissue material, including stem cells, for medical research –
MELVILLE, N.Y., Nov. 05, 2024 (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 it has received a provisional license from the New York State Department of Health (“NYSDOH”) for the processing of allogeneic (non-autologous) donor tissue material for the isolation, expansion and cryopreservation of various cell types, including stem cells, for medical research. Previously, BioRestorative was licensed by the NYSDOH to act as a tissue bank for the processing of mesenchymal stem cells derived from autologous donors only.
The expanded license allows BioRestorative to leverage its state-of-the-art cGMP manufacturing capabilities to enable the processing, banking and distribution of clinical grade allogeneic (off-the-shelf) biologics.
NYSDOH licensure is an intensive and diligent process, and is required for all tissue and cell-related activities in New York, including collection, processing, storage, and distribution, as well as for any facility distributing tissues to other states. Holders of a New York State license are required to comply with regulations to ensure safe and ethical handling of tissues. Through a comprehensive on-site survey process, facilities are inspected and assessed for acceptable standards of practice and regulatory compliance in order to receive a full license.
“We believe being awarded this expanded provisional license from the NYSDOH serves as a testament to both the ground-breaking nature of our clinical work with stem cell therapies and products, and the outstanding quality of our clinical grade cell therapy cGMP manufacturing facility,” said Lance Alstodt, BioRestorative’s Chief Executive Officer. “Importantly, it will significantly enhance our ability to develop an unrivaled clinical pipeline of off-the-shelf cell-based biologic products.”
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, 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 new license did BioRestorative Therapies (BRTX) receive from NYSDOH in November 2024?
How does the new NYSDOH license expand BRTX's capabilities?
What requirements must BRTX meet to maintain its NYSDOH tissue license?
