BioRestorative Therapies Receives Patent Allowance for ThermoStem® Metabolic Disease Program
BioRestorative Therapies has received a Notice of Allowance from the Israel Patent Office for its ThermoStem® technology platform. This marks the 14th international patent outside the U.S. for this technology. The patent covers brown adipose derived stem cell (BADSC) aggregates, encapsulation systems, and treatment methods. The company believes ThermoStem®-based BADSCs could offer better efficacy and tolerability compared to GLP-1 drugs. In May 2024, BioRestorative announced development of an exosome-based biologic program targeting obesity and plans to file a Drug Master File with the FDA. The company is also in discussions with an undisclosed regenerative medicine company regarding potential licensing of ThermoStem® intellectual property.
BioRestorative Therapies ha ricevuto un Avviso di Concessione dall'Ufficio Brevetti di Israele per la sua piattaforma tecnologica ThermoStem®. Questo segna il 14° brevetto internazionale al di fuori degli Stati Uniti per questa tecnologia. Il brevetto copre aggregati di cellule staminali derivate dal tessuto adiposo bruno (BADSC), sistemi di incapsulazione e metodi di trattamento. L'azienda crede che i BADSC basati su ThermoStem® possano offrire una migliore efficacia e tollerabilità rispetto ai farmaci GLP-1. A maggio 2024, BioRestorative ha annunciato lo sviluppo di un programma biologico a base di esosomi per affrontare l'obesità e prevede di presentare un Drug Master File alla FDA. L'azienda è anche in trattative con una società di medicina rigenerativa non divulgata riguardo al potenziale licensing della proprietà intellettuale di ThermoStem®.
BioRestorative Therapies ha recibido un Aviso de Concesión de la Oficina de Patentes de Israel para su plataforma tecnológica ThermoStem®. Esto marca la 14ª patente internacional fuera de los EE. UU. para esta tecnología. La patente cubre agregados de células madre derivadas del tejido adiposo marrón (BADSC), sistemas de encapsulación y métodos de tratamiento. La empresa cree que los BADSC basados en ThermoStem® podrían ofrecer mejor eficacia y tolerabilidad en comparación con los medicamentos GLP-1. En mayo de 2024, BioRestorative anunció el desarrollo de un programa biológico basado en exosomas dirigido a la obesidad y planea presentar un Archivo Maestro de Medicamentos a la FDA. La empresa también está en discusiones con una compañía de medicina regenerativa no divulgada sobre la posible licencia de propiedad intelectual de ThermoStem®.
BioRestorative Therapies는 이스라엘 특허청으로부터 ThermoStem® 기술 플랫폼에 대한 허가 통지서를 받았습니다. 이는 미국 이외의 국가에서 이 기술에 대한 14번째 국제 특허를 의미합니다. 특허는 갈색 지방 유래 줄기 세포(BADSC) 집합체, 캡슐화 시스템 및 치료 방법을 포함합니다. 회사는 ThermoStem® 기반 BADSC가 GLP-1 약물에 비해 더 나은 효능과 내약성을 제공할 수 있을 것이라고 믿습니다. 2024년 5월, BioRestorative는 비만을 목표로 하는 엑소좀 기반 생물학 프로그램을 개발한다고 발표했으며, FDA에 의약품 마스터 파일을 제출할 계획입니다. 이 회사는 또한 ThermoStem® 지적 재산권의 잠재적 라이센싱에 대해 공개되지 않은 재생 의학 회사와 논의 중입니다.
BioRestorative Therapies a reçu un Avis de Concession de l'Office des Brevets d'Israël pour sa plateforme technologique ThermoStem®. Cela marque le 14ème brevet international en dehors des États-Unis pour cette technologie. Le brevet couvre des agrégats de cellules souches dérivées du tissu adipeux brun (BADSC), des systèmes d'encapsulation et des méthodes de traitement. L'entreprise croit que les BADSC basés sur ThermoStem® pourraient offrir une meilleure efficacité et tolérance par rapport aux médicaments GLP-1. En mai 2024, BioRestorative a annoncé le développement d'un programme biologique à base d'exosomes ciblant l'obésité et prévoit de soumettre un Dossier Maître de Médicaments à la FDA. L'entreprise est également en discussions avec une entreprise de médecine régénérative non divulguée concernant une éventuelle licence de propriété intellectuelle de ThermoStem®.
BioRestorative Therapies hat eine Zulassungsbenachrichtigung vom israelischen Patentamt für seine ThermoStem®-Technologieplattform erhalten. Dies ist das 14. internationale Patent außerhalb der USA für diese Technologie. Das Patent deckt aggretierte aus braunem Fettgewebe stammende Stammzellen (BADSC), Kapselsysteme und Behandlungsmethoden ab. Das Unternehmen ist der Ansicht, dass auf ThermoStem® basierende BADSC eine bessere Wirksamkeit und Verträglichkeit im Vergleich zu GLP-1-Arzneimitteln bieten könnten. Im Mai 2024 kündigte BioRestorative die Entwicklung eines exosomenbasierten biologischen Programms zur Bekämpfung von Fettleibigkeit an und plant, eine Drug Master File bei der FDA einzureichen. Das Unternehmen führt auch Gespräche mit einem nicht offengelegten Unternehmen der regenerativen Medizin über eine mögliche Lizenzierung des geistigen Eigentums von ThermoStem®.
- Secured 14th international patent for ThermoStem® technology
- Potential licensing deal under discussion with commercial stage regenerative medicine company
- Advancing development of novel exosome-based biologic program for obesity treatment
- No assurance of successful completion of licensing agreement
Insights
The patent allowance in Israel for BioRestorative's ThermoStem® technology represents a significant milestone in protecting their brown adipose derived stem cell (BADSC) platform. The patent's scope is comprehensive, covering both the product and manufacturing methods, which strengthens their competitive position in the metabolic disease space.
The company's strategic positioning against GLP-1 drugs in the obesity market is particularly noteworthy. With the obesity therapeutics market experiencing unprecedented growth, driven by drugs like Wegovy and Ozempic, BRTX's alternative approach using stem cell therapy could potentially capture market share if proven effective. The ongoing discussions with a commercial stage regenerative medicine company for licensing further validates the technology's potential value.
However, investors should note that the company is still in early stages, with the FDA process just beginning for their exosome-based program. The path to commercialization remains long and uncertain, typical of cell therapy development.
This patent allowance significantly enhances BRTX's intellectual property portfolio, marking their 14th international patent for the ThermoStem® platform. The Israeli market is strategically important given its prominence in stem cell research and innovation. The broad patent claims covering both product and method aspects create multiple layers of protection and potential monetization opportunities.
The timing of this patent allowance, coupled with ongoing licensing discussions, strengthens BRTX's negotiating position. The comprehensive IP protection could attract more potential partners and increase licensing value. However, the current market cap of
– Further expands already formidable intellectual property estate the Company has been building for its novel ThermoStem® technology platform –
MELVILLE, N.Y., Oct. 31, 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 Israel Patent Office has issued a Notice of Allowance for a new patent application (Israeli Patent Appl. No. 287557) covering several fundamental aspects of the Company’s allogeneic, off-the-shelf ThermoStem® platform.
This, the 14th international patent to issue outside of the U.S. for BioRestorative’s ThermoStem® technology platform, covers non-naturally occurring three-dimensional brown adipose derived stem cell (“BADSC”) aggregates; an encapsulation system comprising the non-naturally occurring three-dimensional brown adipose derived stem cell aggregates; a method of making a non-naturally occurring three-dimensional brown adipose derived stem cell aggregate; and a method of treating a patient with a disorder.
“We believe that our ThermoStem®-based BADSCs hold tremendous promise to deliver a superior efficacy and tolerability profile over GLP-1 drugs,” said Lance Alstodt, BioRestorative’s Chief Executive Officer. “This latest patent issuance demonstrates our strong commitment to protecting the innovation of our ThermoStem® program and the significant potential commercial opportunity that it represents for ourselves and any current and/or future potential licensing partners. And, given Israel’s global prominence in stem cell research, we are particularly excited by this latest patent issuance.”
In May 2024, BioRestorative revealed 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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