Welcome to our dedicated page for Biorestorative Therapies news (Ticker: BRTX), a resource for investors and traders seeking the latest updates and insights on Biorestorative Therapies stock.
BioRestorative Therapies Inc (BRTX) is a pioneering biotechnology company advancing autologous stem cell therapies for chronic disc/spine conditions and metabolic disorders. This dedicated news hub provides investors and industry professionals with essential updates on clinical developments, regulatory milestones, and corporate announcements.
Access timely information about BRTX-100 clinical trials, metabolic program research, financial disclosures, and strategic partnerships. Our curated collection ensures transparent tracking of progress in regenerative medicine, featuring official press releases and verified news coverage.
Key focus areas include FDA communications, peer-reviewed study results, intellectual property developments, and executive leadership updates. Users benefit from centralized access to critical information for informed decision-making without promotional bias.
Bookmark this page for ongoing updates on BioRestorative Therapies' innovative work in cell-based medical solutions. Check regularly for new developments in non-surgical treatment alternatives and metabolic health innovations.
BioRestorative Therapies (NASDAQ:BRTX), a clinical stage regenerative medicine company specializing in stem cell-based therapies, has announced its CEO Lance Alstodt will participate in the Benzinga All-Access Show on April 15, 2025, at 10:50 a.m. Eastern time.
During the interview, the company plans to discuss their recent achievements in clinical and regulatory milestones, along with highlighting commercial opportunities. The session will be accessible via live webcast and will subsequently be archived in the Investors section of the company's website.
BioRestorative Therapies (NASDAQ:BRTX) confirms no material impact from new U.S. tariffs due to its domestic production strategy for BRTX-100, its lead cell-based therapeutic targeting areas with blood flow. The company reports significant clinical progress with:
- FDA Fast Track designation for BRTX-100 in treating chronic lumbar disc disease (cLDD), following positive Phase 2 preliminary data
- FDA clearance of IND application for BRTX-100 in treating chronic cervical discogenic pain (cCDP)
- Strong financial position with over $10 million in cash, cash equivalents, and marketable securities at the end of 2024
BioRestorative Therapies (NASDAQ:BRTX) reported significant financial improvements for 2024, with total revenue increasing 175% to $401,000 from $146,000 in 2023. The company reduced its operating loss by 24% to $11.6 million and improved net loss by 14% to $9.0 million ($1.16 per share).
Key developments include:
- FDA Fast Track designation for BRTX-100 program for chronic lumbar disc disease (cLDD) treatment
- FDA clearance for BRTX-100 IND application for chronic cervical discogenic pain
- Provisional license from NY State Department of Health for allogeneic tissue processing
- Positive preliminary Phase 2 trial data for BRTX-100 showing no serious adverse events
The company ended 2024 with $10.7 million in cash and investments, with no outstanding debt. BioCosmeceuticals generated $300,000 in revenue for 2024.
BioRestorative Therapies (NASDAQ:BRTX), a clinical stage regenerative medicine company specializing in stem cell-based therapies, has scheduled the release of its 2024 financial results for Thursday, March 27, 2025, after market close. The company's management team will conduct a conference call following the announcement to discuss the financial performance and provide updates on business operations.
Investors and interested parties can access the live broadcast and archived recording of the conference call through the company's website at biorestorative.com/investor-relations under the Events section.
BioRestorative Therapies (NASDAQ:BRTX) has received FDA clearance for its Investigational New Drug (IND) application for BRTX-100, marking a significant advancement in stem cell-based therapies. The treatment, designed to target areas with blood flow, will be evaluated for chronic cervical discogenic pain (cCDP) in a Phase 2 trial.
BRTX-100 represents the first and only stem cell product candidate cleared for evaluation in cervical degenerative disc disease. This expansion builds upon the company's existing FDA Fast Track-designated program for chronic lumbar disc disease (cLDD). The upcoming Phase 2 study will be conducted as a double-blind, sham-controlled, randomized trial to assess safety and preliminary efficacy of intradiscal BRTX-100 injections.
BioRestorative Therapies (NASDAQ:BRTX), a clinical stage regenerative medicine company specializing in stem cell-based therapies, has rescheduled its webcasted conference call to discuss pipeline updates. The call will now take place on Thursday, February 27, 2025, at 10:30am EST.
Participants can join via telephone by dialing 888-506-0062 (US) or 973-528-0011 (International) using access code 440089. The conference call will be broadcast live and archived in the Investor Relations section of the company's website at biorestorative.com.
BioRestorative Therapies (NASDAQ:BRTX) has announced it will provide a positive clinical pipeline update before market open on Thursday, February 27, 2025. The regenerative medicine company, which focuses on stem cell-based therapies, will share what CEO Lance Alstodt describes as "meaningful key developments" regarding their clinical pipeline.
Alstodt expressed enthusiasm about the upcoming announcement, noting that it reflects "the very solid work of our scientific team over the last several years come to fruition" and mentioned additional positive events related to BRTX-100, one of the company's products.
The company will host a webcasted conference call at 8:00am EST on February 27, 2025, accessible by dialing 888-506-0062 (US) or 973-528-0011 (International) with participant access code 440089. The call will also be broadcast live and archived on the Investor section of BioRestorative's website.
BioRestorative Therapies (NASDAQ:BRTX) has received FDA Fast Track designation for its BRTX-100 program targeting chronic lumbar disc disease (cLDD). This designation highlights the significant unmet medical need for alternatives to opioids and surgical interventions in cLDD treatment.
The Fast Track status was granted based on positive preliminary Phase 2 safety and efficacy data reported to date. This designation may accelerate the development process, potentially leading to Priority Review and expedited Biologics License Application (BLA) approval for BRTX-100.
The company's stem cell therapy aims to provide effective pain relief and functional improvement for millions of cLDD patients who have experienced ineffective conservative non-surgical approaches or failed surgical interventions.
BioRestorative Therapies (NASDAQ:BRTX) presented new blinded preliminary data from its Phase 2 clinical trial of BRTX-100 at the Orthopaedic Research Society annual meeting. The data, now covering 15 patients with chronic lumbar disc disease (cLDD), showed significant improvements:
- Pain reduction (VAS): 71.20% at 26 weeks and 73.58% at 52 weeks
- Function improvement (ODI): 69.04% at 26 weeks and 65.16% at 52 weeks
- No serious adverse events reported
- First-time MRI analysis showed potential disc microenvironment remodeling
These results significantly exceed the FDA's minimum threshold requirement of 30% improvement. The ongoing Phase 2 trial will enroll up to 99 subjects across 16 U.S. clinical sites, randomized 2:1 to receive either BRTX-100 or placebo.
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.
