Intervertebral Disc Displacement

MELVILLE, N.Y., March 11, 2024 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative” or the “Company”) (NASDAQ:BRTX), a clinical stage company focused on stem cell-based therapies, today announced its participation in the 36th Annual ROTH Conference being held March 17-19, 2024 at the Ritz Carlton, Laguna Niguel in Dana Point, California BioRestorative’s Chief Executive Officer, Lance Alstodt, is scheduled to participate in a fireside chat hosted by Jonathan Aschoff, Ph.D., Managing Director, Senior Research Analyst at ROTH MKM, on Monday, March 18, 2024 at 12:00pm PDT. The fireside chat will be broadcast live and archived on the investor section of the Company’s website at . Mr. Aschoff and other members of the Company’s management team will also participate in a series of one-on-one meetings with investors during the conference. To arrange a meeting with BioRestorative, attending investors are encouraged to contact thier ROTH MKM sales representative or email oneononerequests@roth.com. About BioRestorative Therapies, Inc. BioRestorative Therapies, Inc. ( ) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. Our two core programs, as described below, relate to the treatment of disc/spine disease and metabolic disorders: • 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 a cell-based therapy candidate to target obesity and metabolic disorders using brown adipose (fat) derived stem cells to generate brown adipose tissue (“BAT”). 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. 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 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: Email: ir@biorestorative.com

GENEVA, March 8, 2024 /PRNewswire/ -- Spineart SA, manufacturer of the BAGUERA®C Cervical Disc Prosthesis, today announced it has completed enrollment in its U.S. IDE trial studying the BAGUERA®C Cervical Disc Prosthesis in patients with cervical disc disease at two contiguous levels between C3 to C7 compared to a commercially marketed cervical disc implant. The multi-center, prospective, randomized controlled trial enrolled over 300 patients at 25 sites across the United States. The primary endpoint of the study is the clinical success rate of BAGUERA®C in two contiguous levels from C3 to C7 compared with two-level cervical disc replacement with a commercially available disc replacement implant. The Company announced the completion of enrollment for its one-level IDE trial at the end of February 2024. Jerome Trividic, CEO of Spineart, said, "The enrollment completion of our two-level BAGUERA®C IDE study marks a significant milestone in Spineart's ambition to emerge as a global leader in spine arthroplasty. Coupled with the ongoing one-level BAGUERA®C IDE study, Spineart is spearheading the gathering of crucial long-term clinical evidence from nearly 600 artificial disc recipients across the United States. This unprecedented achievement underscores our commitment to advancing the adoption of cutting-edge technologies in spinal surgery. We extend our sincere gratitude to our esteemed investigators and their teams whose dedicated participation has been instrumental in this endeavor. We eagerly anticipate bringing these two studies to fruition." Domagoj Coric, neurosurgeon at Carolina Neurosurgery & Spine Associates in Charlotte, NC, and co-lead investigator of the IDE trials, stated, "The outcomes from this study will further build the level I evidence supporting the safety and effectiveness of cervical disc arthroplasty with its head-to-head comparison against another cervical implant with similar design features." The BAGUERA®C Cervical Disc prosthesis is evaluated in two separate IDE trials in the U.S. for one- and two-level cervical disc disease. The BAGUERA®C implant has been commercially available in selected European and worldwide markets since 2008. Internationally, early long-term feedback has shown substantial improvement in patient pain scores and functional improvement after treatment. BAGUERA®C CERVICAL DISC PROSTHESIS The BAGUERA®C Cervical Disc Prosthesis, developed by Spineart SA (Geneva, Switzerland), is an investigational device designed to maintain or restore segmental motion and disc height in the cervical region of the spine following single- or two-level discectomy for symptomatic cervical disc disease. The BAGUERA®C is designed to maintain the natural behavior of a functional spinal unit. This design enables the BAGUERA®C nucleus to move in all six degrees of freedom, with independent angular rotations (flexion-extension, lateral bending, and axial rotation) along with independent translational motions (anterior-posterior and lateral translations). SPINEART Spineart's mission is to transform spine surgery for patients, surgeons, and hospitals by developing procedures and medical devices that are safe and efficient, used by surgeons to enhance their patient's life. True to its values: Quality, Innovation, Simplicity, Spineart is renowned as a pioneer in the fields of disc prosthesis, simplification of surgical acts, 3D printed porous titanium and traceability of surgical implants. Today, Spineart remains at the forefront of its sector with the development of a complete portfolio of procedural solutions and digital technologies for surgical assistance. Spineart was awarded the "Prix de l'Economie Genevoise 2022" for its contribution to technological and scientific innovations, commercial activities, job creations and ESG principles. Please visit and follow us on Linkedin (Spineart) SOURCE Spineart

GENEVA, Feb. 29, 2024 /PRNewswire/ -- Spineart SA, manufacturer of the BAGUERA®C Cervical Disc Prosthesis, is delighted to announce completion of enrollment in its U.S. IDE trial studying the BAGUERA®C Cervical Disc Prosthesis in patients with single-level cervical disc disease between C3 to C7 compared to a commercially marketed cervical disc implant. "We would like to thank all the investigators, their staff and the patients participating in the BAGUERA®C trial for their dedication and support," said Jerome Trividic, chief executive officer of Spineart. "We are committed to advancing spine arthroplasty worldwide and establishing BAGUERA®C as a leading motion preserving technology for US surgeons and their patients." Hyun W. Bae, MD, with the Spine Institute, Santa Monica, CA and one of the lead investigators for the study, said, "Cervical Disc Arthroplasty is becoming the preferred option in the treatment of degenerative disc disease as it allows to achieve decompression of the nerves, while preserving physiologic segmental motion. I am excited to continue following up my patients in the BAGUERA®C IDE study and confirming the initial positive outcomes we have collected so far." The BAGUERA®C Cervical Disc Prosthesis has been commercially available in selected European and worldwide markets since 2008 with over 60,000 implants sold. BAGUERA®C CERVICAL DISC PROSTHESIS The BAGUERA®C Cervical Disc Prosthesis, developed by Spineart SA (Geneva, Switzerland), is an investigational device designed to maintain or restore segmental motion and disc height in the cervical region of the spine following single- or two-level discectomy for symptomatic cervical disc disease. The BAGUERA®C is designed to maintain the natural behavior of a functional spinal unit. This design enables the BAGUERA®C nucleus to move in all six degrees of freedom, with independent angular rotations (flexion-extension, lateral bending, and axial rotation) along with independent translational motions (anterior-posterior and lateral translations). CAUTION: Investigational Device. Limited by Federal (United States) law to investigational use. ABOUT THE BAGUERA®C IDE CLINICAL TRIALS The BAGUERA®C IDE trials, prospective, multi-center, randomized clinical studies, will evaluate the safety and efficacy of BAGUERA®C compared to the Mobi-C® cervical disc in the treatment of symptomatic cervical disc disease at a single- or two contiguous levels in the cervical spine. Each study will enroll approximately 300 subjects at up to 30 study sites in the U.S. Results of this pivotal clinical trial will be the basis of a premarket approval (PMA) submission to the U. S. Food and Drug Administration. SPINEART Spineart's mission is to transform spine surgery for patients, surgeons, and hospitals by developing procedures and medical devices that are safe and efficient, used by surgeons to enhance their patient's life. True to its values: Quality, Innovation, Simplicity, Spineart is renowned as a pioneer in the fields of disc prosthesis, simplification of surgical acts, 3D printed porous titanium and traceability of surgical implants. Today, Spineart remains at the forefront of its sector with the development of a complete portfolio of procedural solutions and digital technologies for surgical assistance. Spineart was awarded the "Prix de l'Economie Genevoise 2022" for its contribution to technological and scientific innovations, commercial activities, job creations and ESG principles. Please visit and follow us on Linkedin (Spineart) SOURCE Spineart