BioRestorative Therapies Announces Notice of Allowance of Key New Patent Protecting ThermoStem® Metabolic Disease Program
BioRestorative Therapies (NASDAQ:BRTX) has received a Notice of Allowance from the European Patent Office for a new patent application covering their ThermoStem® metabolic disease platform. The patent (No. 20798130.9) protects the method of creating non-naturally occurring three-dimensional brown adipose derived stem cell aggregates and is expected to provide protection until April 29, 2040.
The company is developing an exosome-based biologic program targeting obesity and plans to initiate the FDA process by filing a Drug Master File. BioRestorative is currently in discussions with an unnamed commercial stage regenerative medicine company regarding potential licensing of their ThermoStem® metabolic intellectual property, though no agreement has been finalized.
BioRestorative Therapies (NASDAQ:BRTX) ha ricevuto una Notifica di Accettazione dall'Ufficio Europeo dei Brevetti per una nuova domanda di brevetto che copre la loro piattaforma per malattie metaboliche ThermoStem®. Il brevetto (n. 20798130.9) protegge il metodo per la creazione di aggregati di cellule staminali derivate da tessuto adiposo bruno non naturali e si prevede che fornisca protezione fino al 29 aprile 2040.
L'azienda sta sviluppando un programma biologico basato su esosomi mirato all'obesità e prevede di avviare il processo FDA presentando un Drug Master File. BioRestorative è attualmente in discussione con un'azienda di medicina rigenerativa in fase commerciale non nominata riguardo a una potenziale licenza della loro proprietà intellettuale metabolica ThermoStem®, anche se non è stato finalizzato alcun accordo.
BioRestorative Therapies (NASDAQ:BRTX) ha recibido un Aviso de Concesión de la Oficina Europea de Patentes para una nueva solicitud de patente que cubre su plataforma de enfermedades metabólicas ThermoStem®. La patente (n° 20798130.9) protege el método de creación de agregados de células madre derivadas de tejido adiposo marrón no naturales y se espera que brinde protección hasta el 29 de abril de 2040.
La compañía está desarrollando un programa biológico basado en exosomas dirigido a la obesidad y planea iniciar el proceso de la FDA presentando un Drug Master File. BioRestorative está actualmente en conversaciones con una empresa de medicina regenerativa en etapa comercial no nombrada sobre una posible licencia de su propiedad intelectual metabólica ThermoStem®, aunque no se ha finalizado ningún acuerdo.
BioRestorative Therapies (NASDAQ:BRTX)는 유럽 특허청으로부터 그들의 ThermoStem® 대사 질환 플랫폼을 다루는 새로운 특허 신청에 대한 허가 통지를 받았습니다. 이 특허(번호 20798130.9)는 비자연적으로 발생하는 3차원 갈색 지방 유래 줄기세포 집합체를 생성하는 방법을 보호하며, 2040년 4월 29일까지 보호할 것으로 예상됩니다.
회사는 비만을 목표로 하는 엑소좀 기반 생물학 프로그램을 개발하고 있으며, 약물 마스터 파일을 제출하여 FDA 프로세스를 시작할 계획입니다. BioRestorative는 현재 이름이 밝혀지지 않은 상업 단계의 재생 의학 회사와 ThermoStem® 대사 지적 재산의 잠재적 라이센스에 대해 논의 중이며, 아직 최종 계약이 체결되지 않았습니다.
BioRestorative Therapies (NASDAQ:BRTX) a reçu un Avis d'Acceptation de l'Office Européen des Brevets pour une nouvelle demande de brevet portant sur leur plateforme de maladies métaboliques ThermoStem®. Le brevet (n° 20798130.9) protège la méthode de création d'agrégats de cellules souches dérivées de tissu adipeux brun non naturels et devrait offrir une protection jusqu'au 29 avril 2040.
L'entreprise développe un programme biologique basé sur des exosomes visant à lutter contre l'obésité et prévoit de démarrer le processus FDA en déposant un Drug Master File. BioRestorative est actuellement en discussion avec une entreprise de médecine régénérative en phase commerciale non nommée concernant la possibilité d'une licence de leur propriété intellectuelle métabolique ThermoStem®, bien qu'aucun accord n'ait été finalisé.
BioRestorative Therapies (NASDAQ:BRTX) hat eine Zustimmungsmitteilung vom Europäischen Patentamt für einen neuen Patentantrag für ihre ThermoStem® Plattform zur Behandlung von Stoffwechselerkrankungen erhalten. Das Patent (Nr. 20798130.9) schützt das Verfahren zur Schaffung von nicht-naturlich vorkommenden dreidimensionalen, aus braunem Fettgewebe abgeleiteten Stammzellaggregaten und wird voraussichtlich bis zum 29. April 2040 Schutz bieten.
Das Unternehmen entwickelt ein exosomenbasiertes biologisches Programm zur Bekämpfung von Fettleibigkeit und plant, den FDA-Prozess mit der Einreichung eines Drug Master Files zu initiieren. BioRestorative führt derzeit Gespräche mit einem nicht benannten kommerziellen Unternehmen für regenerative Medizin über eine potenzielle Lizenzvergabe ihrer ThermoStem®-metabolischen geistigen Eigentumsrechte, auch wenn noch kein Vertrag abgeschlossen wurde.
- Secured new European patent protection until 2040 for ThermoStem® technology
- Advancing towards FDA filing for obesity treatment program
- Potential licensing deal under discussion with commercial stage company
- None.
Insights
The European patent allowance for BioRestorative's ThermoStem® technology represents a significant intellectual property milestone, specifically protecting their brown adipose derived stem cell (BADSC) manufacturing process until 2040. This strengthens their competitive position in the rapidly growing metabolic disease market, particularly against GLP-1 competitors.
The patent's timing is strategic, coinciding with their recent announcements about an exosome-based program for obesity and ongoing licensing discussions. The manufacturing process protection is important for potential commercialization, especially considering the current market dominance of GLP-1 drugs in obesity treatment.
However, while this patent strengthens their IP portfolio, BRTX remains a clinical-stage company with a small market cap of
The Notice of Allowance from the European Patent Office significantly enhances BRTX's intellectual property protection in key European markets. The patent's scope, covering manufacturing processes for three-dimensional brown adipose derived stem cell aggregates, provides robust protection until 2040, creating substantial barriers to entry for competitors.
The timing aligns with their strategic initiatives, including the planned FDA Drug Master File submission and ongoing licensing discussions. This patent could strengthen their negotiating position in these discussions and potentially increase the value of any licensing agreements.
However, investors should note that despite the patent protection, the company's disclosure about licensing discussions includes standard cautionary language about uncertainty of completion. This reflects the early stage nature of these negotiations and the need for careful due diligence in evaluating their commercial potential.
– Covers cGMP manufacturing processes –
– Expected to provide protection until April 29, 2040 –
MELVILLE, N.Y., Dec. 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, is pleased to announce that the European Patent Office has issued a Notice of Allowance for a new patent application (European Patent Appl. No. 20798130.9) covering key aspects of the Company’s allogeneic, off-the-shelf ThermoStem® metabolic disease platform.
Claims granted under the new patent cover a method of making a non-naturally occurring three-dimensional brown adipose derived stem cell aggregate.
“This patent allowance further validates the novel advancements we have made in our metabolic disease program,” said Lance Alstodt, BioRestorative’s Chief Executive Officer. “Given the tremendous market opportunity for ThermoStem®-based BADSCs to potentially transform the GLP-1 dominated treatment landscape for obesity and related metabolic diseases in important geographies around the world, we are particularly pleased that this patent provides broad coverage of our proprietary technology platform.”
In May 2024, BioRestorative announced the development of a novel exosome-based biologic program targeting obesity, advising that the Company plans to initiate the formal U.S. Food and Drug Administration (FDA) process for this ThermoStem ® -based therapeutic candidate by filing a Drug Master File (DMF). On the heels of that announcement, BioRestorative reported that it had begun to engage in substantive discussions with an undisclosed commercial stage regenerative medicine company with regard to a potential license of BioRestorative’s allogeneic, off-the-shelf ThermoStem® metabolic intellectual property. Those discussions are continuing; however, no assurances can be given that a license agreement will be entered into whether on commercially reasonable terms or otherwise.
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
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