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– The Annual Meeting of the International stem cell research society (“ISSCR”) is the annual meeting of the world of stem and regenerative medicine leaders –
– The updated data presented in ISSCR 2025 demonstrate> 50% of improvement in pain and function in a significant portion of the CLDD subjects –
-The number of subjects evaluated increases more than twice from the last update-
Melville, NY, June 13, 2025 (Globe Newswire) -BioresTorta Therapies, Inc. (“Bioresorrative”, “BRTX” or “Company”) (NASDAQ: BRTX), a clinical stage regenerative medicine company that develops the blind data of the stem cells of the 36 of the 36 of the 36 years. Phase 2 clinical trial of BRTX-100, a stem cell autologous therapy for chronic lumbar disk disease (CLDD). These data were shared at the prestigious Annual Meeting of ISSCR 2025 in Hong Kong by Francisco Silva, Vice President of Research and Development.
The Food and Medicines Administration of the USA (the “FDA”) requires at least one improvement of more than 30% in the function in the Oswestry disability index (“Odi”) and a reduction of more than 30% in the pain in the visual analog scale (“you go”) to determine if the clinical test will be allowed to proceed and finally the approval of the biological license (Bla).
Outstanding key:
Number of growth patients: The number of subjects evaluated has increased from 15 to 36 since the company’s last press release, an important milestone towards the complete registration of phase 2 (up to 99 subjects). Convincing clinical signals: More than 74% of the subjects showed> 50% of improvement in the (ODI) function at 52 weeks; More than 72% of the subjects reported> 50% reduction in pain (vas) for 52 weeks; The combined improvement> 50% in Odi and Vas measures was achieved through a significant part of the subjects in all points of time. Excellent security profile: There are no serious adverse events (SAE) or limiting toxicities of the dose reported between 26 and 104 weeks in the target dose (40 million cells). Strengthening data: Each new data analysis has surpassed the previous versions, highlighting an ascending trend in efficacy markers.
The following is a detailed breakdown of the subjects who had an improvement of more than 50% in the function, as measured by ODI, greater than 50% pain in pain, measured by vas, and more than 50% improvement in hate and go:
“With each new analysis, our confidence grows that BRTX-100 is positioned to fulfill and potentially exceed functional thresholds and FDA pain reduction,” said Lance Alstodt, executive director of BioresTorrative. “We are excited about the trajectory of this material milestone and its potential to address a massive need dissatisfied in chronic lower back pain, one of the greatest loads of global medical care. We believe that these data bring us closer to a step closer to bringing a very necessary and non -surgical therapeutic option closer to us and we should increase the additional value of the inflection in the inflection value to the point of inflection.”
The data were presented as part of the clinical innovations track in ISSCR 2025, an event that attracts the main researchers, doctors and investors of regenerative medicine in the world.
About phase 2 BRTX-100 test
BRTX-100 is a new cell-based autologous therapy designed to treat patients suffering from a painful degeneration of the lumbosacro disk. Phase 2 test is a randomized, double-blind study, placebo controlled that will register up to 99 subjects in 16 main US sites.
About BioresTorrative Therapies, Inc.
BioresTorrative (www.burosTorta.com) Develops therapeutic products using cellular and tissue protocols, mainly that involve adult stem cells. As described below, our two basic clinical development programs are related to the treatment of disc disease/spine and metabolic disorders, and we also operate a commercial biocosmecéutic platform:
• Disco/Spine Program (BRTXDISC ™): Our main cell therapy candidate, BRTX-100, is a product formulated from mesenquimal stem cells autological (own) collected from the patient’s bone marrow. We intend that the product is used for non -surgical treatment of painful lumbosacral disk or as a complementary therapeutic procedure to a surgical procedure. The BRTX-100 production process uses patented technology and involves collecting the bone marrow of a patient, isolating and cultivating bone marrow stem cells and cryoprear cells. In an outpatient procedure, BRTX-100 must be injected by a doctor in the patient’s damaged disk. The treatment is intended for patients whose pain has not been relieved by non -invasive procedures and that potentially face the perspective of surgery. We have started a phase 2 clinical trial with BRTX-100 to treat chronic low back pain that arises from the degenerative disease of the disc. We have also obtained the authorization of new research medications (“IND”) of the US Drug and Drug Administration to evaluate BRTX-100 in the treatment of chronic cervical discogenic pain.
• Metabolic program (Thermostem®): We are developing cell -based therapy candidates to direct obesity and metabolic disorders using stem cells derived from brown adipose (fat) (“BADSC”) to generate brown adipose tissue (“bat”), as well as exosomes secreted by BADSC. BAT is intended to imitate natural brown adipose deposits that regulate metabolic homeostasis in humans. Initial preclinical research indicates that the highest amounts of brown fat in animals can be responsible for additional caloric burning, as well as reduced levels of glucose and lipids. Researchers have found that people with higher levels of brown fat can have a reduced risk of obesity and diabetes. BADSC secreted exosomes can also affect weight loss.
• Biocosmeceuticals: We operate a biocosmeceutical commercial platform. Our current commercial product, formulated and manufactured using our CGMP Certified Clean Room room, is a cell -based secrete that contains exosomes, proteins and growth factors. This patented biological serum has been specifically designed by us to reduce the appearance of fine lines and wrinkles and produce other areas of cosmetic effectiveness. In the future, we also intend to explore the potential to expand our commercial offer to include a broader family of biological aesthetic and therapeutic products based on cells through IND studies, with the aim of being pioneers in FDA approvals in the emerging space of biocosmeceuticals.
Declarations with advance
This press release contains “prospective statements” in the sense of section 27a of the 1933 Securities Law, according to amended section 21 of the 1934 Securities Exchange Law, according to amended, and such vision statements of the future are made of the presentation of the risks of the safe port of the Private Securities Reform Law of 1995. You are agreed that the statements are subject to a multi -grade risks and events of the inferences of litigation of values of 1995. The results will differ materially from those projected in the prospective statements as a result of several factors and other risks, including, among others, those established in the last form 10-K of the company, presented before the Bag and Securities Commission. You should consider these factors to evaluate the statements with a vision of the future included in this document, and not establish an undue dependence on such statements. The prospective statements in this launch are made as of the date of the present and the company does not have the obligation to update these statements.
CONTACT:
Stephen Kilmer
Investor relationships
DIRECT: (646) 274-3580
Email: skilmer@bioresTorto.com
