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Rigicon Initiates AUSOME Study for Artificial Urinary Sphincter FDA Approval

FDA Approval
  • Rigicon has begun patient enrollment in the AUSOME Study, a pivotal clinical investigation designed to support FDA Premarket Approval for its artificial urinary sphincter technology.
  • The first two patients were enrolled in the UK under the leadership of Dr. Rowland Rees, with the study evaluating safety, effectiveness, and patient-reported outcomes.
  • The company plans to expand enrollment across global urology centers and is developing additional product lines including electronic artificial urinary sphincter and penile prostheses.
  • Rigicon's device offers advancements in patient comfort, usability, and durability compared to existing artificial urinary sphincter solutions on the market.

Viatris Wins Patent Battle Against Novo Nordisk Over Generic Wegovy

FDA Approval
  • A federal district court in Delaware ruled that Viatris' generic version of Wegovy does not infringe on Novo Nordisk's patent for the GLP-1 receptor agonist semaglutide.
  • The court determined that Viatris' product label does not encourage use without other therapeutic agents, which was a key limitation in Novo Nordisk's patent claim.
  • This victory removes one patent obstacle for Viatris' generic Wegovy, which is currently awaiting FDA approval, while the global Wegovy market reached $8.4 billion in 2024.
  • The ruling comes amid ongoing patent disputes in the lucrative obesity drug market, with GlobalData forecasting the obesity market to exceed $173.5 billion by 2031.

FDA Rejects Replimune's Melanoma Drug Amid Evolving Regulatory Standards

FDA ApprovalOncology
  • The FDA rejected Replimune's melanoma drug in a complete response letter, citing inadequate single-arm study design and patient enrollment differences as key concerns.
  • The agency questioned whether the single-arm study provided substantial evidence of effectiveness and raised issues with the company's confirmatory trial design.
  • Analysts interpret the rejection as evidence of changing FDA approval standards, with Replimune CEO expressing surprise at the decision given prior agency meetings.
  • The rejection highlights the evolving regulatory landscape for oncology drug approvals, particularly for single-arm studies in melanoma treatment.

Nestmedic Partners with Curavit for U.S. Clinical Trial of AI-Enabled Prenatal Monitoring Device

AIFDA Approval
  • Nestmedic S.A. has selected Curavit Clinical Research to lead the U.S. clinical trial of PregnaOne, an AI-enabled remote prenatal monitoring solution designed to provide continuous insight into fetal and maternal well-being.
  • The FDA-required Non-Significant Risk study will enroll 50 expectant mothers across multiple U.S. sites over 11 months to evaluate the safety and effectiveness of home-based prenatal monitoring.
  • The trial aims to generate foundational evidence to support future regulatory approval in the U.S., with Curavit managing all aspects including IRB submissions, site selection, data management, and clinical study reporting.

MVP Health Care Partners with Renalytix to Expand Access to AI-Powered Kidney Disease Testing

AIPrecision MedicineFDA Approval
  • MVP Health Care and Renalytix announced a partnership to expand access to the FDA-approved kidneyintelX.dkd test for patients with type 2 diabetes and chronic kidney disease.
  • The collaboration aims to identify patients at higher risk for progressive kidney function decline earlier, enabling more targeted therapeutic interventions and personalized care plans.
  • The test will be available to all MVP customers in New York, including Medicare and Medicaid beneficiaries, and is recommended by KDIGO clinical guidelines.
  • Renalytix reports measurable improvements in patient outcomes and quality metrics, including HEDIS measures for blood pressure and HbA1c control in high-risk populations where the test is implemented.

RedHill Biopharma Receives FDA Approval for Groundbreaking MAP-Targeted Crohn's Disease Study

FDA ApprovalOrphan Drug
  • RedHill Biopharma received positive FDA feedback for the first-ever clinical study targeting Mycobacterium avium subspecies paratuberculosis (MAP) infected Crohn's disease patients with RHB-204.
  • The novel Phase 2 study will test MAP as a root cause of Crohn's disease, potentially making RHB-204 a paradigm-shifting therapy treating both the suspected cause and symptoms.
  • RHB-204 is supported by positive Phase 3 data from RHB-104 showing 64% improvement in efficacy and offers a 40% pill burden reduction with patent protection through 2041.
  • The Crohn's disease market is expected to grow from $13.6 billion in 2024 to over $19 billion by 2033, presenting significant commercial potential for new therapies.

XVIVO Initiates US Continued Access Protocol Study for Heart Assist Transport Device Following Successful PRESERVE Trial

FDA Approval
  • XVIVO Perfusion has enrolled the first patient in its US PRESERVE Continued Access Protocol (CAP) study for the XVIVO Heart Assist Transport device, allowing up to 60 patients across 26 transplant centers to access the technology.
  • The FDA-approved CAP study enables continued clinical use of the heart transport device while XVIVO analyzes one-year follow-up data from the PRESERVE trial in preparation for Pre-Market Approval submission.
  • The Centers for Medicare & Medicaid Services has granted continued cost recovery approval, providing essential financial support for participating transplant centers and patients during the interim regulatory period.

UroMems Receives FDA and ANSM Clearance for Pivotal Trial of Smart Artificial Urinary Sphincter

FDA Approval
  • UroMems received investigational device exemption approval from the FDA and French ANSM to begin the SOPHIA2 pivotal trial of its UroActive smart implant for treating male stress urinary incontinence.
  • The UroActive system represents the first automated artificial urinary sphincter with smart technology, utilizing a MyoElectroMechanical System that adapts treatment based on patient activity without complex manipulation.
  • The multicenter trial follows strong feasibility study results in France showing over one year with no need for revision or explant, with the study serving as the basis for regulatory submissions to commercialize in US and European markets.

A Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter (AUS)

NCT06968741RecruitingNot Applicable
UroMems SAS
Posted 5/1/2025

Clinical Investigation to Assess a New Artificial Urinary Sphincter to Treat Urinary Incontinence in Men

NCT05547672Active, Not RecruitingNot Applicable
UroMems SAS
Posted 8/31/2022

Clinical Investigation to Assess a New Artificial Urinary Sphincter to Treat Urinary Incontinence in Women

NCT05828979Active, Not RecruitingNot Applicable
UroMems SAS
Posted 5/2/2023

Saluda Medical Launches EVA Sensing Technology for Personalized Spinal Cord Stimulation in U.S.

FDA Approval
  • Saluda Medical has launched EVA sensing technology in the U.S. following FDA approval in December 2024, marking a significant advancement in spinal cord stimulation therapy.
  • The technology objectively scans and analyzes patients' spinal cords to deliver personalized therapy with precision beyond human capability, utilizing neural response biomarkers.
  • EVA has been used in over 3,000 commercial patient visits during limited market release and automates manual programming steps to improve patient experience.
  • New clinical data will be presented at ASPN 2025 Annual Conference, adding to over 37 publications including the landmark EVOKE Study showing 36-month efficacy.

Stargardt Disease Pipeline Shows Promising Progress with Multiple Gene Therapies Advancing to Late-Stage Trials

Rare DiseaseFDA Approval
  • Ocugen's OCU410ST gene therapy has received FDA approval to launch a Phase 2/3 pivotal confirmatory trial for treating all forms of Stargardt disease, with the potential to serve as the foundation for a biologics license application.
  • SpliceBio has administered the first dose in its Phase 1/2 ASTRA clinical trial evaluating SB-007, a dual AAV vector-based gene therapy for Stargardt disease, marking another significant milestone in gene therapy development.
  • Alkeus Pharmaceuticals reported positive interim results from its TEASE-3 study, showing that early-stage Stargardt disease patients receiving oral gildeuretinol acetate exhibited no disease progression and maintained stable visual acuity over multiple years.
  • The Stargardt disease pipeline now includes over 20 companies developing more than 20 treatment therapies, with emerging therapies like MCO-010, Tinlarebant, and others expected to significantly impact the market.

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