Latest news with #regenerative medicine
Yahoo
9 hours ago
- Business
- Yahoo
BioRestorative Therapies Reports Second Quarter 2025 Financial Results and Provides Business Update
MELVILLE, N.Y., Aug. 12, 2025 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. ('BioRestorative', 'BRTX' or the 'Company') (NASDAQ:BRTX), a regenerative medicine innovator focused on stem cell-based therapies and products, today reported financial results for the second quarter ended June 30, 2025 and provided an update on its business. 'We have continued to execute well across our business, including the achievement of key clinical program milestones, since the start of 2025,' said Lance Alstodt, Chief Executive Officer of BioRestorative. 'Moving forward, we remain focused on aggressively executing our growth strategy while carefully managing our resources, and see many potential value enhancing inflection points ahead.' Recent Highlights CORPORATE In April, the Company confirmed that it currently faces no material exposure to newly imposed U.S. tariffs. BioRestorative believes that its 'made-in-America' production and manufacturing strategy, combined with its use of domestic inputs, enables it to effectively manage costs amid global supply chain shifts. In June, BioRestorative announced that its Board of Directors authorized a stock repurchase program under which the Company may repurchase up to $2 million of its outstanding common stock through June 16, 2026. Also in June, BioRestorative welcomed serial regenerative medicine entrepreneur, company builder and leader, Sandy Lipkins, to its team. In this newly created role, Mr. Lipkins is responsible for sourcing, structuring, negotiating and executing strategic alliances and licensing/co-development agreements for BioRestorative domestically and internationally, as well as providing new product and sales expertise to the Company. In July, BioRestorative's Chief Executive Officer, Lance Alstodt, was interviewed during the Benzinga All-Access Show. An archive of the interview can be accessed here. DEVELOPMENT Disc/Spine Program In May, preliminary 26-, 52- and 104-week blinded preliminary data from the first 15 patients with chronic lumbar disc disease ('cLDD') enrolled in the ongoing Phase 2 clinical trial of BRTX-100 was presented by BioRestorative's Vice President of Research and Development, Francisco Silva, at the International Society for Cell & Gene Therapy ('ISCT') 2025 Annual Meeting. The preliminary blinded data continued to be in-line to meet the primary safety endpoint of the study, and positive preliminary efficacy trends continued as well. On the heels of the ISCT 2025 presentation on 15 patients, in June, promising preliminary blinded data from the first 36 subjects in the ongoing BRTX-100 Phase 2 clinical trial was shared by Mr. Silva at the prestigious International Society for Stem Cell Research ('ISSCR') 2025 Annual Meeting in Hong Kong. The U.S. Food and Drug Administration (FDA) is requiring at least a greater than 30% improvement in function in the Oswestry Disability Index ('ODI') and a greater than 30% reduction in pain on the Visual Analog Scale ('VAS') in determining whether the clinical trial will be allowed to proceed and ultimately gain Biologics License Application (BLA) approval. The data presented at ISSCR 2025 demonstrated >50% improvement in both ODI and VAS in a significant portion of cLDD subjects. Metabolic Program Previously reported substantive discussions with an undisclosed commercial stage regenerative medicine company with regard to a potential license of BioRestorative's ThermoStem® metabolic intellectual property are continuing; however, no assurances can be given that a license agreement will be entered into whether on commercially reasonable terms or otherwise. Summary Second Quarter 2025 Financial Results For the quarter ended June 30, 2025, the Company reported revenues of approximately $303,000, which consisted primarily of BioCosmeceutical sales in connection with its exclusive supply agreement with Cartessa Aesthetics, LLC. Second quarter 2025 revenues increased 240% over Q2-2024. The Company's second quarter 2025 loss from operations of $3.3 million compared to $2.5 million for the comparable period of 2024. The Company's second quarter 2025 net loss was $2.7 million, or $0.30 per share, compared to a net loss of $4.0 million, or $0.50 per share, for the second quarter of 2024. The Company ended the 2025 second quarter in a strong financial position, with cash, cash equivalents, and investments held in marketable securities of $7.4 million, with no outstanding debt. For complete financial results, please see BioRestorative's filings at and on the Company's website at under "SEC Filings" in the Investors section. Conference Call Details BioRestorative management will host a webcasted conference call with an associated slide presentation today at 4:30pm EDT to review its second quarter 2025 financial results and provide a business update. To join the conference call via telephone and participate in the live Q&A session, please dial 888-506-0062 (United States) or 973-528-0011 (International), participant access code 436077. The call will also be webcast live and archived on the Company's website at under 'News & Events/IR Calendar'' in the Investors section. About BioRestorative Therapies, Inc. BioRestorative ( 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 also operate a commercial BioCosmeceutical platform: • 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. We have also obtained U.S. Food and Drug Administration ('FDA') Investigational New Drug ('IND') clearance to evaluate BRTX-100 in the treatment of chronic cervical discogenic pain. • 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 IND-enabling studies, with the aim of pioneering 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 KilmerInvestor RelationsDirect: (646) 274-3580 Email: skilmer@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Forbes
15 hours ago
- Health
- Forbes
A New Chapter For Diabetes—and Regenerative Medicine
For decades, the ambitious goal of regenerative medicine has been to replace damaged or lost tissues with healthy, functioning ones. Nowhere is this objective more compelling—or challenging—than in type 1 diabetes. Countless research efforts over the years have sought to restore these cells. Breakthroughs in cell engineering and transplantation are beginning to overcome long-standing roadblocks, and these recent advances are a significant achievement for regenerative medicine as a whole. For millions living with the constant demands and worries of type 1 diabetes, this is more than promising data. It's a moment that hints at a world where glucose monitors and needles might finally become relics of the past. With this, a life free from the daily burdens of diabetes suddenly feels not just possible, but Is Type 1 Diabetes? Type 1 diabetes is a chronic autoimmune disorder defined by the immune system's destruction of insulin-producing beta cells in the pancreas. Insulin is the hormone responsible for moving glucose from the bloodstream into the body's cells for energy. Without it, blood sugar rises to dangerous levels. Over time, it can damage virtually every organ. Most people diagnosed are children or young adults, and living with type 1 diabetes requires ongoing vigilance: regular blood glucose testing, carefully calibrated insulin administration, and persistent risk of life-threatening hypoglycemia. To survive, people with type 1 diabetes must monitor their blood sugar levels constantly. They frequently perform fingerstick tests throughout the day to check their blood glucose levels. Also, they must adjust their diet, exercise routine, and daily schedule to accommodate frequent insulin injections or an insulin pump. Despite advances in technology, keeping blood glucose within a safe range remains challenging, and the risk of life-threatening 'hypoglycemic' episodes—when blood sugar drops too low—is Stem Cell Therapy: Replacing What's Lost This is where the new therapies come into play. They go straight to the heart of the problem: the loss of the body's own insulin-producing cells. Instead of requiring patients to rely on lifelong injections, the focus is now on developing stem cells grown in controlled laboratory environments. These stem cells are engineered to become fully functional islet cells. These are the very clusters that regulate blood sugar in a healthy pancreas. The "off-the-shelf" nature of these cells is crucial. Earlier islet transplant procedures relied on donated organs, which are rare, variable in quality, and subject to lengthy waitlists. The engineered cells, on the other hand, are produced in large quantities. Also, they can be made available as needed. When infused, typically into the liver, these new cells integrate and begin responding to blood sugar levels in real time, releasing insulin as needed. In essence, the therapy is designed to restore the natural balance lost due to the disease. The promise of this approach is already becoming a the Latest Study The most recent results in the development of stem cell–derived therapies for type 1 diabetes stem from a clinical trial conducted by Vertex Pharmaceuticals. This study enrolled patients with established, severe type 1 diabetes. This is a group for whom current treatments often fail to prevent sudden and dangerous drops in blood sugar. Each patient in the trial received a single infusion of lab-grown islet cells, now referred to as zimislecel. To translate the science: the stem cells are first turned into insulin-producing islet cells in the lab. These are then infused into the patient's liver, not the pancreas. If successful, they begin sensing blood sugar levels and releasing insulin as needed, just like a healthy pancreas would. Think of this as swapping out a faulty part with a working one, rather than relying on external fixes. The results over twelve months were consistent and dramatic. All participants in the study were found to be producing their own insulin again. This was confirmed by checking bloodwork to verify that the islet cells were now active. Therefore, the transplanted cells integrated well, and the patients' bodies were able to produce insulin naturally for the first time in years. Even more remarkably, ten of these individuals were able to discontinue daily insulin injections entirely. Every participant met or surpassed the American Diabetes Association's stringent targets for glycemic control. Notably, none suffered severe hypoglycemic This Matters: The Science and Its Impact These results represent a shift in the care landscape for type 1 diabetes. Previous attempts at islet cell replacement used donor cells, which were in very limited supply. By creating islets from universal stem cells, this therapy can be scaled up. It brings the possibility of universal therapies with consistent quality and availability. This offers real hope to millions worldwide. It also signals a foundational advance in regenerative medicine itself. Demonstrating that we can produce, transplant, and integrate functional cell populations to cure a chronic, complex condition illustrates the practical power of stem cell technology. The methodology used here is already being adapted for other therapeutic targets: engineered heart muscle for cardiac repair, retinal cells for vision restoration, and dopaminergic neurons for Parkinson's disease. It establishes a blueprint for tackling similar disorders and builds a bridge from bench research to real-world clinical impact. These advances, however, are not without their complexities. Because the transplanted islet cells are not the patient's own, recipients currently require immunosuppressive medications to prevent rejection—a challenge shared by all current forms of tissue and organ transplantation. Although initial safety profiles are encouraging and side effects manageable, ongoing studies are exploring methods to reduce or eliminate immune suppression, such as gene editing and immune cloaking Road Ahead: What's Next? The achievements described here are far more than incremental progress in diabetes care. They represent proof-of-concept for the broad ambitions of regenerative medicine: restoring lost tissue function, curing chronic diseases, and making transformative treatments widely accessible. As these strategies mature and diversify, their impact will almost certainly extend well beyond any single disease. They offer a pathway to fundamentally change how we approach a broad spectrum of degenerative and autoimmune conditions. The future of regenerative medicine, once hypothetical and distant, now approaches with real hope for curing—not simply managing—a host of devastating chronic conditions.
Globe and Mail
05-08-2025
- Business
- Globe and Mail
Longeveron® to Report Second Quarter 2025 Financial Results and Host Conference Call on August 13, 2025
MIAMI, Aug. 05, 2025 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening, rare pediatric and chronic aging-related conditions, today announced that it will report second quarter 2025 financial results and provide a business update on Wednesday, August 13, 2025 after the U.S. financial markets close. The Company will host a conference call and webcast the same day at 4:30 p.m. ET. An archived replay of the webcast will be available on the ' Events & Presentations ' section of the Company's website following the conference. About Longeveron Inc. Longeveron is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The Company's lead investigational product is laromestrocel (Lomecel-B™), an allogeneic mesenchymal stem cell (MSC) therapy product isolated from the bone marrow of young, healthy adult donors. Laromestrocel has multiple potential mechanisms of action encompassing pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair and healing effects with broad potential applications across a spectrum of disease areas. Longeveron is currently pursuing four pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer's disease, Pediatric Dilated Cardiomyopathy (DCM), and Aging-related Frailty. Laromestrocel development programs have received five distinct and important FDA designations: for the HLHS program - Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation; and, for the AD program - Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation. For more information, visit or follow Longeveron on LinkedIn, X, and Instagram.
Yahoo
28-07-2025
- Business
- Yahoo
Xtant Medical Partners With B2i Digital to Educate Investors on Its Orthobiologics Innovation and Market Opportunity
NEW YORK, NY - July 28, 2025 (NEWMEDIAWIRE) - B2i Digital is pleased to announce that Xtant Medical Holdings (NYSE American: XTNT) has been named a B2i Digital Featured Company. Xtant is a global medical technology company that develops, manufactures, and markets a full-service portfolio of regenerative medicine products and related medical devices for orthopedic and neurosurgical specialists. The company's vertically integrated model allows it to offer a full-service product line that includes bone-healing grafts, growth-factor biologics, cellular allografts, synthetics, and amnion products. This integration, combined with a robust R&D pipeline that includes multiple next-generation biologics scheduled for launch through 2025, underpins its strategy for driving margin improvement and long-term, sustainable growth. "We are pleased to showcase Xtant Medical to our investor community at this pivotal time in the company's expansion and evolution," said David Shapiro, CEO of B2i Digital. "With its vertically integrated platform covering all five major orthobiologic categories and a clear trajectory of revenue growth, the company presents a compelling story for investors interested in the medical technology sector. Xtant's established distribution network and robust product pipeline position it well within a multi-billion-dollar market." Sean Browne, CEO of Xtant Medical, commented, "Our partnership with B2i Digital will help us share our growth story and the value of our comprehensive biologics platform to the investment community. We are focused on execution and believe this collaboration will enhance our connection with current and prospective shareholders." Xtant Medical has demonstrated strong business fundamentals, reporting fiscal year 2024 revenue of $117.5 million, a 29% year-over-year increase. The company has established significant market access through 450 integrated delivery network (IDN) contracts and a network of over 670 independent distributors, serving a $2.5 billion U.S. orthobiologics market within a $10.1 billion global spine market. About B2i Digital, Inc. B2i Digital, Inc. partners with investor conferences, public companies, and capital markets advisors through its Featured Conference, Featured Company, and Featured Expert programs. The firm leverages digital marketing technologies, a network of 1.3 million investors, and targeted introductions to connect key players in the markets. B2i Digital was founded in 2021 by David Shapiro, previously the Chief Marketing Officer and an investment banker at Maxim Group, LLC. David was also one of the founders of Maxim's investor awareness platform, B2i Digital Contact Information: David ShapiroChief Executive OfficerB2i Digital, Officedavid@ About Xtant Medical Holdings, Inc. Xtant Medical's mission of honoring the gift of donation so that our patients can live as full and complete a life as possible, is the driving force behind our company. Xtant Medical Holdings, Inc. ( is a global medical technology company focused on the design, development, and commercialization of a comprehensive portfolio of orthobiologics and spinal implant systems to facilitate spinal fusion in complex spine, deformity and degenerative procedures. Xtant people are dedicated and talented, operating with the highest integrity to serve our customers. Investor Contact Information: Kevin GardnerManaging DirectorLifeSci Advisors646.889.1200KGardner@ View the original release on Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
The Australian
28-07-2025
- Business
- The Australian
Orthocell adds new director, eyes US growth
Experienced corporate leader Michael McNulty will join the board as a non-executive director and chair of audit committee US-based independent non-executive director Dr Ravi Thadhani elevated to lead independent director Former opposition leader and US ambassador Kim Beazley to step down from board for health reasons but will still advise on US and defence matters Special Report:Perth-based regenerative medicine company Orthocell has made a strong addition to its board as it accelerates plans for US commercialisation, appointing highly experienced director Michael McNulty. As Orthocell (ASX:OCC) accelerates plans for US commercialisation of its flagship nerve repair product Remplir following Food & Drug Administration (FDA) approval in April, McNulty joins as a non-executive director and chair of the audit committee from September. The highly experienced exec brings deep governance and financial expertise to support Orthocell's global growth strategy. He is a chartered accountant with extensive experience as a director across listed companies and not-for-profit organisations. And he has served as managing partner of Deloitte's Perth office for more than a decade, and as a board member of both Deloitte Australia and the Deloitte Foundation. McNulty has also held various executive roles, including on Deloitte's national consulting executive, as relationship partner for the WA health team, and as Asia Pacific energy and resources leader. Orthocell said McNulty's expertise as a director and strategic consultant aligns strongly with its mission to expand the commercial roll-out of its innovative regenerative solutions and will play a key role in supporting the company's continued growth. With the new appointment confirmed, the Orthocell board now comprises five directors including four Independent non-executive directors and one executive director. In addition to McNulty's appointment, current US-based independent non-executive director Dr Ravi Thadhani has been elevated to lead independent director. Thadhani will also lead a new committee focused on the US commercialisation of Remplir. The board changes follow the recent appointment of senior executives including Jim Piper as chief financial officer, and Adam Wood to the newly created role of chief commercial officer. The appointments are part of Orthocell's strategy to scale up international commercialisation of its product portfolio, particularly in the US. Beazley's contributions invaluable Chairman John Van Der Wielen said the board and executive team are deeply grateful for Beazley's contributions, which have helped guide Orthocell's global strategy during a key phase in the company's development. He said his significant US experience and deep understanding of advocacy were instrumental in positioning Orthocell as a leader in regenerative medicine and supporting its US expansion. 'I would like to extend our sincere gratitude to Kim Beazley for his contributions to the board,' he said. 'Kim's extensive US experience, garnered from his extraordinary political and diplomatic career and decades of public service, has been pivotal in strengthening Orthocell's international expansion – particularly in the United States, the world's largest healthcare market.' Beazley said it had been a privilege to serve on the board of a company with 'such brilliant products for human relief'. 'I thank the chairman, the CEO, my fellow board members and our wonderful workforce for the superb work they are doing,' he said. 'Orthocell board members need to be able to fully participate in all locations where advocacy is useful or meetings need to take place. 'My circumstances mean I must stand down. As I recover, I look forward to assisting – particularly in the US and with defence applications.' Appointments to help drive expansion strategy Van Der Wielen said he was delighted to welcome McNulty to the board and as chair of the audit committee and see Thadhani become lead independent director. ' significant leadership experience as a director and senior executive across a broad range of industries – particularly healthcare and resources – will greatly complement our board. 'Meanwhile, Dr Ravi Thadhani's elevation to lead independent director will bring enhanced collaboration with a dedicated focus on the US market. 'We look forward to working with Michael and Ravi as we accelerate our global expansion strategy.' As part of his appointment, Orthocell will issue McNulty two million options, in addition to director's fees, with an exercise price of $1.53 and a three-year expiry. The options will vest after two years, subject to McNulty remaining on the board. Orthocell said they do not require shareholder approval as he was not a director at the time of negotiation and had no influence over the decision. This article was developed in collaboration with Orthocell, a Stockhead advertiser at the time of publishing. This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
