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Creative Medical Technology Holdings Receives Notice of Allowance for ImmCelz™ for Treatment of Heart Failure and/or Post Infarct Pathological Remodeling
Globenewswire· 2025-07-11 12:01
Core Insights - Creative Medical Technology Holdings, Inc. has received a Notice of Allowance for a U.S. patent related to treating heart failure and post-infarct pathological remodeling using its ImmCelz product, with the patent expected to be effective until at least 2040 [1][2]. Group 1: Patent and Product Details - The patent covers treatment for patients at risk of or already experiencing heart failure, utilizing the proprietary ImmCelz product [2]. - The total addressable market for heart failure treatment in the U.S. exceeds five million patients, with an additional six million patients suffering from chronic chest pain who may benefit from the ImmCelz product [2]. - ImmCelz is administered through an ultra-minimally invasive outpatient procedure [2]. Group 2: Company Strategy and Technology - The CEO of Creative Medical emphasized that the Notice of Allowance enhances the company's intellectual property portfolio and reflects the potential of its cell-based technology for developing therapies across various indications [3]. - The ImmCelz platform involves reprogramming a patient's immune cells outside the body with optimized cell-free factors before re-injecting them, which is believed to enhance their regenerative properties [4]. - Creative Medical is focused on pioneering regenerative medicine solutions across multiple indications, including pain management, neurology, and urology [5].
ProKidney Reports Statistically and Clinically Significant Topline Results for the Phase 2 REGEN-007 Trial Evaluating Rilparencel in Patients with Chronic Kidney Disease and Diabetes
GlobeNewswire News Room· 2025-07-08 11:00
Full results from REGEN-007 are being held and will be submitted to the American Society of Nephrology 2025 Kidney Week as a late-breaking clinical trialIn Group 1 (n=24), kidney function stabilized in patients randomized to receive two rilparencel injections (one in each kidney). The annual decline in eGFR slope improved by 78% from -5.8 mL/min/1.73m2 in the pre-injection period to -1.3 mL/min/1.73m2 in the period following the last rilparencel injection. This 4.6 mL/min/1.73m2 per year difference was stat ...
Longeveron® Appoints Than Powell as Chief Business Officer
Globenewswire· 2025-06-26 13:05
Core Insights - Longeveron Inc. has appointed Than Powell as Chief Business Officer to lead its business strategy and international efforts, particularly in Alzheimer's disease and hypoplastic left heart syndrome (HLHS) programs [1][2][4] - The company has recently completed enrollment for its pivotal Phase 2 trial of laromestorcel for HLHS, with top-line data expected in approximately 13 months, which could support the first Biological License Application (BLA) submission [2][6] Company Overview - Longeveron is a clinical stage biotechnology company focused on developing regenerative medicines for life-threatening and chronic aging-related conditions [6] - The lead investigational product, laromestrocel (Lomecel-B™), is an allogeneic mesenchymal stem cell therapy derived from young, healthy adult donors, with potential applications across various disease areas [6] - The company is pursuing three pipeline indications: HLHS, Alzheimer's disease, and aging-related frailty, and has received multiple FDA designations for its programs [6] Leadership Background - Than Powell brings over 25 years of experience in the pharmaceutical and biotech industries, having held leadership roles at organizations such as GSK and Eli Lilly [4][5] - Prior to joining Longeveron, Powell led Corporate Development & Strategy for Surescripts, culminating in the company's acquisition by TPG [4]
Longeveron® Announces Completion of Enrollment of Pivotal Phase 2b Clinical Trial Evaluating Laromestrocel as a Treatment for Hypoplastic Left Heart Syndrome (HLHS)
Globenewswire· 2025-06-24 10:30
Nataliya Agafonova Nataliya Agafonova, M.D., Chief Medical Officer, Longeveron Top-line trial results are anticipated in the third quarter of 2026, after the final follow-up at 12-monthsLaromestrocel Biological License Application (BLA) submission for full traditional approval for HLHS anticipated in 2026, if ELPIS II results are positiveU.S. FDA has awarded laromestrocel HLHS program Rare Pediatric Disease designation, Orphan drug designation, and Fast track designationLaromestrocel HLHS program addres ...
Capricor Therapeutics Announces Orphan Drug Designation for Becker Muscular Dystrophy and Regulatory Progress for Duchenne Muscular Dystrophy Program
GlobeNewswire News Room· 2025-06-17 13:00
U.S. FDA grants Orphan Drug Designation to Deramiocel for the treatment of Becker Muscular Dystrophy, broadening Capricor’s focus in neuromuscular diseasesCapricor remains on track for the August 31, 2025, PDUFA date for Deramiocel in Duchenne Muscular Dystrophy following successful FDA Pre-License Inspection SAN DIEGO, June 17, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseas ...
Ernst & Young LLP (EY US) Announces Jason Matuszewski, CEO of BioStem Technologies, as an Entrepreneur Of The Year® 2025 Florida Award Winner
Globenewswire· 2025-06-17 12:59
Award celebrates bold leaders shaping the future through the world’s most ground-breaking companiesPOMPANO BEACH, Fla., June 17, 2025 (GLOBE NEWSWIRE) -- Ernst & Young LLP (EY US) announced that Jason Matuszewski, CEO and Chairman of the Board of BioStem Technologies (OTC: BSEM), was named an Entrepreneur Of The Year 2025 Florida Award winner. Entrepreneur Of The Year is the preeminent competitive awards program for entrepreneurs and leaders of high-growth companies. For 40 years, EY US has celebrated ambit ...
Home Run! Adia Med of Winter Park's AHCA Triumph Brings Insurance-Covered Healing to Patients
Newsfile· 2025-06-16 13:00
Home Run! Adia Med of Winter Park's AHCA Triumph Brings Insurance-Covered Healing to PatientsJune 16, 2025 9:00 AM EDT | Source: Adia Nutrition Inc.Winter Park, Florida--(Newsfile Corp. - June 16, 2025) - Adia Nutrition, Inc. (OTCQB: ADIA), a leading innovator in regenerative medicine and nutritional supplements, is thrilled to announce that its state-of-the-art clinic, Adia Med of Winter Park, has received full approval from the Agency for Health Care Administration (AHCA). This milestone all ...
Global Longevity Summit 2025: Spotlight on Dr. Steve Horvath, New Advisory Board Members, and Early Registration Opportunity
Globenewswire· 2025-06-12 15:00
Informa Connect’s Global Longevity Summit continues to break new ground in the science of aging and human performance with the announcement of its 2025 keynote speaker, new advisory board appointments, and a call to act before the upcoming ticket price increase.GENEVA, SWITZERLAND, June 12, 2025 (GLOBE NEWSWIRE) -- Biogerontologist and epigenetic researcher Dr. Steve Horvath will headline the event as its keynote speaker and will be formally recognized as the recipient of the 2025 Global Longevity Award for ...
Cryoport Completes CRYOPDP Divestiture and Commences Strategic Partnership with DHL Group
Prnewswire· 2025-06-12 12:00
NASHVILLE, Tenn., June 12, 2025 /PRNewswire/ -- Cryoport, Inc. (Nasdaq: CYRX) ("Cryoport" or the "Company"), a leader in temperature-controlled supply chain solutions for the Life Sciences, with a focus on regenerative medicine, today announced the completion of the previously disclosed divestiture of its specialty courier business, CRYOPDP, to DHL Group ("DHL"), one of the world's leading logistics providers, in a transaction that includes cash payments of approximately $200 million to Cryoport.Concurrentl ...
Capricor Therapeutics Announces Key Regulatory Updates for its Duchenne Muscular Dystrophy Program
Globenewswire· 2025-06-11 13:25
U.S. FDA successfully completed Pre-License Inspection; Company expects facility will meet all requirements to support licensureAdvisory Committee meeting scheduled for July 30, 2025Mid-cycle meeting recently completed with no significant issues or major deficiencies; late-cycle meeting planned for mid-JulyBiologics License Application remains under priority review with PDUFA target action date of August 31, 2025 SAN DIEGO, June 11, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnol ...