BRTX-100 / BioRestorative Therapies - LARVOL DELTA

BioRestorative....announced that it has been granted a Type B meeting with the U.S. Food and Drug Administration (“FDA”) to discuss a potential accelerated Biologics License Application (“BLA”) approval pathway for the Fast-Track-Designated BRTX-100 program for the treatment of chronic lumbar disc disease (“cLDD”). The Type B meeting is scheduled for mid-December. (GlobeNewswire) - "'During the Type B meeting with the FDA, we plan on discussing the consistently positive safety and efficacy signals from our ongoing Phase 2 clinical trial of BRTX-100 in cLDD, as demonstrated by every new data analysis completed to-date.'"

FDA event • P2 data • Back Pain

A Single Dose of BRTX 100 for Patients With Chronic Lumbar Disc Disease (cLDD) (clinicaltrials.gov) - P2 | N=99 | Recruiting | Sponsor: BioRestorative Therapies | Trial completion date: Aug 2025 ➔ Dec 2027 | Trial primary completion date: Aug 2024 ➔ Dec 2026

Trial completion date • Trial primary completion date

BioRestorative Announces FDA Clearance of IND for Phase 2 Trial of BRTX-100 in Chronic Cervical Discogenic Pain (GlobeNewswire) - "BioRestorative Therapies...announced the U.S. Food and Drug Administration ('FDA') has cleared its Investigational New Drug ('IND') application for BRTX-100, a novel cell-based therapeutic engineered to target areas of the body that have little blood flow, for the treatment of chronic cervical discogenic pain ('cCDP')....'We are laying plans to evaluate the safety and preliminary efficacy of intradiscally injected BRTX-100 for patients with cCDP in a double-blind, sham-controlled, randomized Phase 2 study as soon as is practicable'."

IND • New P2 trial • Musculoskeletal Pain • Pain

BioRestorative Receives FDA Fast Track Designation for BRTX-100 Chronic Lumbar Disc Disease Program (GlobeNewswire) - "BioRestorative Therapies, Inc...today announced that the U.S. Food and Drug Administration ('FDA') has granted Fast Track designation to the BRTX-100 program for the treatment chronic lumbar disc disease ('cLDD')...'We are thrilled that the FDA has granted Fast Track designation, underscoring the potential of BRTX-100 to fill significant unmet medical needs in the treatment of cLDD resulting from ineffective conservative non-surgical approaches or failed surgical interventions, and reflecting the comparatively very positive preliminary Phase 2 clinical data that we have reported to date'..."

Fast track • Lumbar Back Pain

BRTX-100 Front and Center at ORS 2025 (GlobeNewswire) - P2 | N=99 | NCT04042844 | Sponsor: BioRestorative Therapies | "No serious adverse events (SAEs) were reported, and there was no dose (40X106 cells) limiting toxicity at 26-52 weeks...As reported at ORS 2025, preliminary blinded VAS and ODI data collected at weeks 26 and 52 post-injection demonstrated an exceptionally positive trend compared to baseline. With respect to decrease in pain at 26 weeks, the average improvement in VAS versus baseline was 71.20%, and at 52 weeks, the average improvement was 73.58%. Improvement in ODI versus baseline at 26 weeks averaged 69.04%, and at 52 weeks, the average improvement was 65.16%. These results are significantly better than the requisite FDA minimum threshold of 30% improvement in VAS and ODI, respectively."

P2 data • Lumbar Back Pain

BioRestorative Therapies Reports Second Quarter 2024 Financial Results and Provides Business Update (GlobeNewswire) - "BioRestorative continues to work toward achieving completion of patient enrollment in the Phase 2 BRTX-100 study, as well as providing additional preliminary data updates, before the end of 2024."

Enrollment status • P2 data • Back Pain • CNS Disorders • Pain

BioRestorative Therapies Announces FDA Clearance of Phase 2 BRTX-100 Clinical Study Protocol Amendment (BioSpace) - "BioRestorative Therapies, Inc...today announced that the U.S. Food and Drug Administration ('FDA') has cleared an important amendment to the protocol of the ongoing Phase 2 study investigating the use of BRTX-100, the Company’s lead cell therapy candidate, in treating chronic lumbar disc disease ('cLDD'). The protocol amendment removes saline injection in the control arm of the study and replaces it with a sham injection....A total of up to 99 eligible subjects will be enrolled at up to 16 clinical sites in the United States. Subjects included in the trial will be randomized 2:1 to receive either BRTX-100 or placebo."

Clinical protocol • Back Pain • CNS Disorders • Lumbar Back Pain • Musculoskeletal Pain • Pain

BioRestorative Therapies Partners with Galen Patient Recruitment to Accelerate Completion of Enrollment in Phase 2 Trial of BRTX-100 in Chronic Lumbar Disc Disease (GlobeNewswire) - "BioRestorative Therapies, Inc...today announced a collaboration with Galen Patient Recruitment, Inc. ('Galen') which, combined with the recent expansion of clinical trial capacity from approximately 10 to 30 participants per month, is expected to help accelerate the completion of patient enrollment in the ongoing Phase 2 study of BioRestorative’s lead clinical candidate, BRTX-100, in chronic lumbar disc disease ('cLDD')."

Licensing / partnership • Back Pain • CNS Disorders • Lumbar Back Pain • Pain

BioRestorative Therapies Presents Preliminary Clinical Data from Phase 2 Study of BRTX-100 in Chronic Lumbar Disc Disease (Yahoo Finance) - P2 | N=99 | NCT04042844 | Sponsor: BioRestorative Therapies | "BioRestorative Therapies, Inc...today announced the public availability of a poster, presented yesterday at the Orthopaedic Research Society (ORS) 2024 Annual Meeting, which describes preliminary 26 and 52 week blinded data from the ongoing Phase 2 clinical trial of the Company’s lead clinical candidate, BRTX-100, in subjects with chronic lumbar disc disease....Although this is blinded and early clinical data, it is important to note that the Visual Analog Scale, Oswestry Disability Index, Roland Morris Disability Questionnaire, and Functional Rating Index collected at weeks 26 and 52 post-injection demonstrated a positive trend compared to baseline."

P2 data • Back Pain • CNS Disorders • Lumbar Back Pain • Pain

BioRestorative Therapies to Present Preliminary BRTX-100 Clinical Data at the Orthopaedic Research Society (ORS) 2024 Annual Meeting (GlobeNewswire) - "BioRestorative Therapies, Inc...today announced that preliminary 26–52 week blinded data from the ongoing Phase 2 clinical trial of BRTX-100 in subjects with chronic lumbar disc disease ('cLDD') will be presented by Francisco Silva, Vice President of Research and Development, at the Orthopaedic Research Society (ORS) 2024 Annual Meeting, taking place February 2-6, 2024 in Long Beach, California...The safety and efficacy of BRTX-100 in treating cLDD is being evaluated in a Phase 2, prospective, randomized, double-blinded and controlled study...The presentation....is scheduled for Sunday, February 4, 2024 between 10:15am-11:15am PST."

P2 data • Back Pain • CNS Disorders • Lumbar Back Pain • Musculoskeletal Pain • Pain

BioRestorative Therapies Announces Activation of Northwell Health in the Company's Phase 2 Clinical Trial Targeting Chronic Lumbar Disc Disease (GlobeNewswire) - "Site activation allows for patients in the State of New York to participate in the BRTX-100 trial; 15 Clinical Sites Identified, 12 of the 15 Activated and Recruiting Subjects...BioRestorative Therapies, Inc...today announced that Northwell Health, New York State's largest health care provider, has been activated and can now start recruitment in the State of New York for BioRestorative’s ongoing Phase 2 clinical trial targeting chronic lumbar disc disease ('cLDD'). BioRestorative and Northwell Health entered into a clinical trial agreement in May with regard to the Phase 2 trial. Much effort and collaboration have taken place and, now that site specific training is complete, the site can initiate patient recruitment and enrollment."

Enrollment status • Trial status • Back Pain • CNS Disorders • Lumbar Back Pain • Musculoskeletal Pain • Pain

BioRestorative Therapies Announces $2.1 Million Registered Direct Offering (Market Screener) - "BioRestorative Therapies, Inc...today announced it has entered into a definitive agreement with several accredited and institutional investors for the sale of 685,033 shares of the Company’s common stock at an offering price of $3.03 per share in a registered direct offering. The gross proceeds of the offering will be approximately $2.1 million, before deducting placement agent fees and other estimated offering expenses. The closing of the offering is expected to take place on or about July 13, 2023, subject to the satisfaction of customary closing conditions. The Company intends to use the net proceeds of the offering in connection with its clinical trials with respect to its lead cell therapy candidate, BRTX-100, pre-clinical research and development with respect to its metabolic ThermoStem Program and for general corporate purposes and working capital."

Financing • Back Pain • CNS Disorders • Lumbar Back Pain • Musculoskeletal Pain • Pain

BioRestorative Therapies Receives Unanimous Recommendation from Data Safety Monitoring Board (DSMB) to Continue its Phase 2 Clinical Trial without any Changes (GlobeNewswire) - P2 | N=99 | NCT04042844 | Sponsor: BioRestorative Therapies | "BioRestorative Therapies, Inc...today announced that the independent Data Safety Monitoring Board ('DSMB')...unanimously recommended the continuation of BioRestorative’s study in accordance with the current version of the protocol with no changes....This safety run-in was used to evaluate the safety and dose limiting toxicity of BRTX-100. There were no DLTs observed in the patients within the safety run segment of the study. Based on the clinical results of the safety run-in segment of the Phase 2 trial, the DSMB recommended that the Company be permitted to commence open enrollment of the 99 patient study. Each of these additional patients (other than those receiving a placebo) will be treated with BRTX-100, which includes 40,000,000 hypoxic cultured mesenchymal stem cells."

DSMB • P2 data • Back Pain • CNS Disorders • Lumbar Back Pain • Musculoskeletal Pain • Pain

BioRestorative Therapies Announces Key Milestone of Dosing Completion in Safety Cohort of Phase 2 Trial Targeting Chronic Lumbar Disc Disease (GlobeNewswire) - "BioRestorative Therapies, Inc...today announced that the final subject in its BRTX-100 Phase 2 clinical trial safety cohort has been dosed. Four study participants were dosed at a 3:1 ratio with either BRTX-100 or control."

Trial status • Back Pain • CNS Disorders • Lumbar Back Pain • Musculoskeletal Pain • Pain

BioRestorative Therapies and Northwell Health Enter into Agreement to Participate in the Company’s Phase 2 Clinical Trial (GlobeNewswire) - "BioRestorative Therapies, Inc...today announced that it has signed a clinical trial agreement with Northwell Health, New York State's largest health care provider and private employer, and Northwell’s Feinstein Institutes for Medical Research. The signing of the agreement will allow Northwell Health to participate in BioRestorative Therapies ongoing Phase 2 clinical trial targeting chronic lumber disc disease (cLDD)."

Licensing / partnership • Back Pain • CNS Disorders • Lumbar Back Pain • Musculoskeletal Pain • Pain

BioRestorative Therapies Announces Completion of Patient Enrollment for Safety Run-In Component of its Phase 2 Clinical Study of BRTX-100 (GlobeNewswire) - "BioRestorative Therapies, Inc...today announced that it has completed enrollment for the safety run-in component of its Phase 2 clinical study of BRTX-100 targeting patients suffering from chronic lumbar disc disease (cLDD)."

Enrollment closed • Back Pain • CNS Disorders • Lumbar Back Pain • Musculoskeletal Pain • Pain

BioRestorative Therapies to Seek FDA Approval to Expand the Clinical Application of BRTX-100 (GlobeNewswire) - "BioRestorative Therapies, Inc...today announced that it has entered into an agreement with the Bruder Consulting & Venture Group ('BCVG'), a full service strategic advisory firm with focus areas in biologics, tissue repair, biomaterials and regenerative medicine. BCVG has been engaged to assist the Company in seeking FDA approval of the expansion of the clinical application of BRTX-100."

Licensing / partnership • Back Pain • CNS Disorders • Lumbar Back Pain • Musculoskeletal Pain • Pain

"$BRTX BioRestorative Therapies to Seek FDA Approval to Expand the Clinical Application of BRTX-100 https://t.co/yB6kzp0CnP #fdaapproval" (@stock_titan)

Clinical • FDA event

BioRestorative (NASDAQ: BRTX) Ramps Up Production In Anticipation Of Positive Phase 2 Results (Yahoo News) - "Although the primary endpoints will be unblinded after all 99 patients have been treated, a critical milestone for BRTX is scheduled in March or April 2023 related to the safety profile of the product....In anticipation of positive findings from this study, BRTX is increasing its manufacturing and quality control capacity and hiring new scientists to meet the demands for the BRTX-100 Phase 2 enrollment. The additional demand is expected not only for the phase 2 study in cLLD but for studies in other conditions affecting the neck, knee and hip. Clearing the safety hurdle of the trial enables the Company to expand its BRTX-100 platform into other indications more easily and at a greater pace."

Commercial • P2 data • Back Pain • CNS Disorders • Lumbar Back Pain • Musculoskeletal Pain • Pain

BioRestorative Therapies Enters Agreement with Regenexx, Granting BRTX Exclusive License Rights for Intellectual Property Related to the Development and Commercialization of its BRTX-100 Disc Program to Treat Chronic Lumbar Disc Disease (GlobeNewswire) - "BioRestorative Therapies, Inc...announced an agreement with Regenexx, LLC pursuant to which the license rights granted by Regenexx to the Company for intellectual property developed to address chronic lumbar disc disease have been made exclusive. The intellectual property now exclusively licensed to the Company represents important technological framework for BRTX’s disc/spine technology related to the Company’s BRTX-100® lead clinical program, currently in a Phase 2 trial with approximately 15 sites selected across the United States. The intellectual property was developed in the lab of Dr. Christopher Centeno. Dr. Centeno has been a leader in the field of cellular therapy for musculoskeletal indications for over 17 years."

Licensing / partnership • Back Pain • CNS Disorders • Lumbar Back Pain • Musculoskeletal Pain • Pain

BioRestorative Therapies CEO Lance Alstodt to be Interviewed on Famela and Friends Talk Radio Show (GlobeNewswire) - "BioRestorative Therapies, Inc...announced that its CEO, Lance Alstodt, will be interviewed on Famela and Friends Talk Radio Show to discuss the Company’s progress and updates on its clinical development pipeline."

Clinical • Back Pain • CNS Disorders • Lumbar Back Pain • Musculoskeletal Pain • Pain

BioRestorative Therapies to Participate in the Roth Inaugural Healthcare Opportunities Conference (GlobeNewswire) - "BioRestorative Therapies, Inc...announced that CEO Lance Alstodt will be participating in the Roth Inaugural Healthcare Opportunities Conference being held at The Yale Club in New York City on October 6, 2022. Company management will also be participating in one-on-one meetings throughout the conference. Mr. Alstodt will provide an update on its Phase 2 clinical trial using autologous hypoxic bone marrow-derived stem cells targeted to treat chronic lumbar disc disease."

Clinical • Back Pain • CNS Disorders • Lumbar Back Pain • Musculoskeletal Pain • Pain

BioRestorative Therapies to Present at the H.C. Wainwright 24th Annual Global Investment Conference on September 14 (GlobeNewswire) - "BioRestorative Therapies...announced that it will present on September 14, 2022 at the H.C. Wainwright 24th Annual Global Investment Conference being held virtually September 12-14, 2022. Lance Alstodt, President and CEO of the Company, will be speaking and providing an update on the Company's expanded pipeline and near-term catalysts of its ongoing Phase 2 clinical trial targeting chronic lumbar disc disease."

Clinical • Back Pain • CNS Disorders • Lumbar Back Pain • Musculoskeletal Pain • Pain

A Single Dose of BRTX 100 for Patients With Chronic Lumbar Disc Disease (cLDD) (clinicaltrials.gov) - P2 | N=99 | Recruiting | Sponsor: BioRestorative Therapies | Not yet recruiting ➔ Recruiting | Trial completion date: Aug 2023 ➔ Aug 2025 | Trial primary completion date: Jun 2023 ➔ Aug 2024

Enrollment open • Trial completion date • Trial primary completion date

BioRestorative Therapies Announces First Patient Enrolled for the Company’s Phase 2 Clinical Trial to Treat Chronic Lumbar Disc Disease (cLDD) (GlobeNewswire) - "BioRestorative Therapies, Inc...announced that the first patient has been enrolled in the Company’s Phase 2 clinical trial evaluating the safety and preliminary efficacy of BRTX-100, an autologous bone marrow-derived mesenchymal stem cell targeting chronic lumbar disc disease (cLDD). The clinical study is being conducted at up to 15 sites in the United States."

Enrollment open • Back Pain • CNS Disorders • Lumbar Back Pain • Pain