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FDA Approves First Integrated Sacral Neuromodulation System for Urinary Urge Incontinence

FDA Approval
  • The FDA has approved Neuspera Medical's integrated sacral neuromodulation (iSNM) system, the first battery-free device for treating urinary urge incontinence (UUI).
  • The pivotal SANS-UUI trial demonstrated that 84.2% of 128 patients achieved at least 50% reduction in urgent leaks, with 42% of responders becoming completely dry.
  • The innovative system uses a miniaturized implanted neurostimulator activated by an external disc worn for 2 hours daily, eliminating complications from implanted batteries.
  • The approval addresses a significant unmet need for approximately 1 in 5 women in the U.S. affected by overactive bladder conditions.

Neuspera's Implantable Sacral Nerve Stimulation System in Patients With Symptoms of Urinary Urgency Incontinence (UUI)

NCT04232696Active, Not RecruitingNot Applicable
Neuspera Medical, Inc.
Posted 12/13/2019

ReGelTec Initiates U.S. Pivotal Trial for HYDRAFIL System in Chronic Low Back Pain Treatment

FDA Approval
  • ReGelTec has enrolled the first patient in its HYDRAFIL-D FDA investigational device exemption clinical trial, marking a significant milestone for the percutaneous hydrogel implant system designed to treat chronic low back pain caused by degenerative disc disease.
  • The 225-patient, multicenter, randomized controlled trial follows promising European clinical data showing more than 80% improvement in disability scores and greater than 70% reduction in pain scores sustained for two years in 75 patients.
  • The HYDRAFIL System addresses a critical treatment gap for the more than 10 million Americans with degenerative disc disease, offering a minimally invasive outpatient alternative to major spine surgery performed under local anesthesia.

FDA Approves First Simultaneous Whole Exome and Transcriptome Cancer Test for Precision Oncology

FDA Approval
  • Caris Life Sciences received FDA approval for MI Cancer Seek, the first simultaneous whole exome and whole transcriptome sequencing-based companion diagnostic test for solid tumors.
  • The test demonstrates over 97% agreement with other FDA-approved diagnostic tools and can analyze both DNA and RNA from minimal tissue samples as small as 50 ng.
  • MI Cancer Seek includes companion diagnostic indications for multiple targeted therapies across breast, lung, colon, melanoma, and endometrial cancers for both adult and pediatric patients.
  • The comprehensive assay detects key biomarkers including PIK3CA, EGFR, BRAF, and KRAS/NRAS mutations while measuring tumor mutational burden and microsatellite instability.

Clinical Trial Launches in Florida to Test Investigational Oral Medication for Severe Thunderstorm Aversion in Dogs

FDA Approval
  • A clinical study is evaluating an investigational oral medication given twice-daily during storm season for dogs with severe thunderstorm aversion, with the goal of achieving FDA approval.
  • The study is recruiting dogs in Florida who display intense fear behaviors during thunderstorms, including hiding, trembling, destructiveness, and self-harm.
  • Nearly 50% of dog owners report their dogs show fear when exposed to noises, highlighting the significant prevalence of this veterinary behavioral condition.
  • Qualifying dogs receive all study-related care including evaluations, diagnostic testing, and medication at no cost during Florida's storm season.

Elite Pharmaceuticals Achieves Bioequivalence for Generic Anticoagulant in $27 Billion Market

FDA Approval
  • Elite Pharmaceuticals reported positive bioequivalence results for an undisclosed generic anticoagulant targeting a branded product with $27 billion in annual sales.
  • The crossover bioequivalence study in healthy subjects demonstrated that Elite's generic formulation is bioequivalent to the branded reference product.
  • The company is preparing to file an Abbreviated New Drug Application with the FDA, though commercialization depends on patent resolution and regulatory approval.
  • No generic competitor currently exists in this anticoagulant market, presenting a significant commercial opportunity for Elite upon successful market entry.

InspireMD Receives FDA Approval for CGuard Prime Carotid Stent System with Record-Low Stroke Rates

FDA Approval
  • InspireMD's CGuard Prime Carotid Stent System received FDA premarket approval based on the C-GUARDIANS pivotal trial showing the lowest 30-day (0.95%) and 1-year (1.93%) major adverse event rates of any carotid intervention study.
  • The device features proprietary MicroNet mesh technology that combines the largest open-cell frame with the smallest mesh pore size to prevent plaque protrusion and provide sustained embolic protection beyond five years.
  • The approval triggers a $17.9 million warrant tranche from InspireMD's $113.6 million financing agreement and enables immediate commercial launch in the United States following prior CE Mark approval in Europe.
  • The C-GUARDIANS trial enrolled 316 patients across 24 sites in the US and Europe, with 25% being symptomatic patients at high risk for carotid endarterectomy surgery.

UCB Announces $5 Billion U.S. Biologics Manufacturing Investment to Strengthen Supply Chain

FDA Approval
  • UCB plans to invest $5 billion in a new state-of-the-art biologics manufacturing facility in the United States, creating 300 permanent high-skilled jobs and over 500 construction positions.
  • The investment reflects UCB's commitment to serving its growing U.S. patient base and building a more resilient supply chain for immunology and central nervous system disease treatments.
  • Since 2017, UCB has expanded its U.S. workforce by 73% to around 2,000 employees and achieved 15 FDA approvals, with eight coming in the past two years alone.

Medera Showcases Human Mini-Heart Technology Breakthroughs at ISSCR 2025, Advancing Gene Therapy Clinical Trials

FDA Approval
  • Medera and Novoheart presented seven scientific abstracts at ISSCR 2025, featuring their proprietary human mini-Heart technology that has informed FDA approvals for first-in-human gene therapy trials.
  • The company's human-based cardiac tissue platform received FDA recognition as an animal-free alternative under the FDA Modernization Act 2.0, supporting IND and Fast Track designations for heart failure treatments.
  • Breakthrough technologies demonstrated include high-throughput screening automation that reduces cell use by over 90% and AI-driven drug classification algorithms that outperform conventional approaches.
  • The platform has directly supported three ongoing clinical trials targeting different forms of heart failure, including HFpEF and HFrEF, with gene therapies SRD-001 and SRD-002.

Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Reduced Ejection Fraction

NCT04703842RecruitingPhase 1
Sardocor Corp.
Posted 9/23/2021

Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Preserved Ejection Fraction

NCT06061549RecruitingPhase 1
Sardocor Corp.
Posted 8/24/2023

FDA Accepts Tamarack Biotics' UV Light Milk Treatment Technology as Safe Alternative to Traditional Pasteurization

FDA Approval
  • Tamarack Biotics secured FDA acceptance for its TruActive® UV light-based milk treatment process, marking the first scientifically verified safe raw milk equivalent in the dairy industry.
  • The innovative technology eliminates harmful pathogens while preserving bioactive compounds like enzymes and immunity-supporting proteins that are typically destroyed by heat-based pasteurization.
  • A UC Davis clinical trial demonstrated that milk protein concentrate treated with TruActive® restored immune function in aging populations, while European studies showed raw milk consumption protected children from allergies.
  • The FDA approval initially covers powdered dairy ingredients, with liquid raw milk treatment expected as early as 2027.

US Small Molecule API CDMO Market Projected to Reach $12.49 Billion by 2030 Driven by FDA Approvals and HPAPI Demand

FDA Approval
  • The US Small Molecule Innovator API CDMO Market is valued at $8.78 billion in 2024 and expected to reach $12.49 billion by 2030, growing at a 6.03% CAGR.
  • Rising demand for highly potent active pharmaceutical ingredients (HPAPIs) across oncology, cardiovascular, and neurological disorders is driving market expansion.
  • In 2024, 50 novel drug approvals by the FDA, including new molecular entities and biologics, are boosting demand for specialized CDMO services.
  • CDMOs are evolving into strategic partners offering integrated end-to-end solutions, from early research to commercial-scale production, to support faster drug development timelines.

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