Regeneron to Acquire 23andMe for $256 Million, Expanding Genetics-Driven Drug Discovery Capabilities
• Regeneron Pharmaceuticals has won the bankruptcy auction for 23andMe's assets with a $256 million bid, aiming to maintain the consumer genetics service while enhancing its drug discovery platform.
• The acquisition includes 23andMe's Personal Genome Service, Total Health, Research Services, and Biobank assets, but excludes the Lemonaid Health business.
• Regeneron has committed to prioritizing privacy and ethical use of customer data, working with a court-appointed Customer Privacy Ombudsman to ensure compliance with existing policies.
Novel Contact Force-Sensing Pulsed Field Ablation Catheter Shows Promise in Paroxysmal AF Treatment
• First-in-human data demonstrates 100% acute procedural success with Omnypulse, a novel contact force-sensing pulsed field ablation catheter for paroxysmal atrial fibrillation treatment.
• The catheter showed promising durability with 84.5% of pulmonary veins remaining isolated at 3-month follow-up, with only four non-device-related adverse events reported.
• Comparable technology from Kardium (Globe) demonstrated 78% freedom from treatment failure at 12 months with 95% pulmonary vein isolation durability, suggesting significant advancements in AF ablation technology.
Pharma Leadership Shuffle: Key Executive Moves in Early 2025 Reshape Industry Landscape
• The pharmaceutical industry has experienced significant leadership changes in early 2025, with major transitions at companies including Pfizer, Boehringer Ingelheim, and Takeda.
• Former FDA CDER Director Patricia Cavazzoni's move to Pfizer as Chief Medical Officer has sparked "revolving door" criticisms, highlighting ongoing concerns about regulatory-industry transitions.
• Several biotechnology firms have strengthened their executive teams with specialized expertise in clinical development, particularly in areas like stroke treatment, antibody-drug conjugates, and neuropsychiatric therapies.
Boston Scientific's FARAPULSE PFA System Shows Promising Results for Persistent Atrial Fibrillation Treatment
• The second phase of Boston Scientific's ADVANTAGE AF trial demonstrated 73.4% freedom from atrial fibrillation, atrial flutter, and atrial tachycardia in patients with persistent AF, exceeding the performance goal of 40%.
• The FARAPULSE Pulsed Field Ablation System showed a strong safety profile with only a 2.4% event rate and no reports of serious complications such as pulmonary vein stenosis or atrio-esophageal fistula.
• Boston Scientific anticipates FDA approval to expand labeling for persistent AF and regulatory approvals for the FARAPOINT PFA Catheter in the second half of 2025, potentially offering new treatment options for the approximately 25% of AF patients with persistent forms.
Perfuze Completes Enrollment in Pivotal Stroke Treatment Trial, Strengthens Leadership Team
• Perfuze has completed patient enrollment in its MARRS pivotal IDE clinical trial ahead of schedule, evaluating the Millipede 088 Superbore aspiration catheter for large vessel occlusion stroke treatment.
• The study successfully enrolled over 180 patients across multiple centers in the United States and Europe, with data expected to provide important insights for future stroke treatment approaches.
• Perfuze has appointed Joe Rotger, a seasoned executive with 25+ years of experience in neurovascular technologies, as Executive Vice President of Sales to strengthen its commercial leadership.
FDA Grants Breakthrough Device Designation to Orchestra BioMed's AVIM Therapy for Hypertension
• Orchestra BioMed received FDA Breakthrough Device Designation for its atrioventricular interval modulation therapy, designed to reduce blood pressure in high-risk patients with uncontrolled hypertension.
• The designation provides accelerated FDA review and potential pathways for higher reimbursement for AVIM-enabled pacemakers, benefiting an estimated 7.7 million eligible patients in the U.S.
• The therapy is currently being evaluated in the BACKBEAT pivotal study in partnership with Medtronic, with Orchestra BioMed's stock surging over 25% following the announcement.
FDA Grants Orphan Drug Designation to NeuroNOS for Phelan-McDermid Syndrome Treatment
• NeuroNOS's lead therapy BA-102 receives FDA Orphan Drug Designation for Phelan-McDermid Syndrome, a rare genetic disorder linked to Autism Spectrum Disorder with no current FDA-approved treatments.
• The designation provides significant development incentives including seven years of market exclusivity, tax credits for clinical trials, and FDA application fee waivers.
• NeuroNOS, a Beyond Air subsidiary, plans to initiate first-in-human clinical trials in the United States for Autism Spectrum Disorder in 2026, targeting the regulation of Nitric Oxide levels in the brain.
Field Medical Secures $40 Million Series A Financing to Advance Pulsed Field Ablation for Ventricular Tachycardia
• Field Medical Inc. has raised $40 million in Series A financing to advance its FieldForce™ Ablation System, which delivers instantaneous cardiac ablation therapy in a fraction of a second.
• The funding will support completion of two pilot studies (VCAS for ventricular tachycardia and Field PULSE for atrial fibrillation) and preparation for the pivotal VERITAS trial focused on VT.
• The company's technology received FDA Breakthrough Device Designation in 2024, addressing a significant market with VT affecting over 6 million people in the US and Europe.
LUMA Vision's Verafeye 4D Cardiac Imaging System Receives FDA Clearance
• LUMA Vision has received FDA clearance for its Verafeye platform, a novel 4D ultrasound-based cardiac visualization system that provides real-time, 360-degree imaging during cardiac procedures.
• The catheter-based technology can capture images from up to 120mm away, potentially reducing procedure time and minimizing risks in electrophysiology and structural heart interventions.
• Verafeye advances beyond traditional 2D imaging catheters by combining proprietary sensors with deep learning, eliminating the need for external imaging systems like X-ray or CT scanners.
FDA Clears First Stapler for Single-Port Robotic Surgery with da Vinci SP System
• Intuitive Surgical received FDA 510(k) clearance for the SureForm 45 stapler, marking the first stapler designed specifically for single-port robotic surgery in the United States.
• The fully-wristed stapler features SmartFire technology that continuously monitors tissue compression before and during firing, helping surgeons enhance staple line integrity and reduce tissue damage risk.
• The device is cleared for use with the da Vinci SP surgical system in urologic, thoracic, and colorectal procedures, allowing surgeons greater control without relying on assistants.
Novo Nordisk Launches NovoCare® Pharmacy, Offering Authentic Wegovy® at $499 Monthly
• Novo Nordisk has introduced NovoCare® Pharmacy, providing FDA-approved Wegovy® (semaglutide) at $499 per month for cash-paying patients, with convenient home delivery service.
• The new service aims to combat the rising problem of counterfeit semaglutide products by offering reliable access to authentic medication in a once-weekly, single-dose pen format.
• This initiative addresses affordability concerns for weight management medication while ensuring patients receive legitimate FDA-approved treatment amid growing demand for GLP-1 receptor agonists.
BHF PROTECT-TAVI Trial Fails to Show Benefit of Cerebral Embolic Protection During TAVI
• The large-scale BHF PROTECT-TAVI trial found no reduction in stroke risk with routine cerebral embolic protection during transcatheter aortic valve implantation, confirming similar results from the earlier PROTECTED TAVR trial.
• Despite the device's ability to capture dislodged emboli during procedures, researchers found no clinical benefit across any patient subgroups, challenging the intuitive assumption that debris capture would translate to improved outcomes.
• Following these negative findings, experts predict further decline in embolic protection device usage, which had already decreased from 13.5% to 10.2% in US hospitals after the PROTECTED TAVR results were published.
Medtronic's Evolut TAVR System Demonstrates Superior Durability and Performance at Five-Year Mark
• Medtronic's Evolut TAVR system showed comparable rates of all-cause mortality or disabling stroke to surgical valve replacement at five years (15.5% vs 16.4%), with numerically lower cardiovascular mortality rates.
• The self-expanding Evolut valve demonstrated significantly larger effective orifice areas and lower mean gradients compared to surgical valves, reinforcing its superior hemodynamic performance in low-risk aortic stenosis patients.
• These five-year outcomes, presented at the American College of Cardiology's Annual Scientific Session, support Evolut TAVR as a durable alternative to surgery regardless of surgical risk, potentially shifting treatment paradigms for younger patients.
FDA Approves Abbott's Coronary IVL System Trial for Treating Calcified Coronary Artery Disease
• Abbott Laboratories has received FDA approval for an Investigational Device Exemption to evaluate its Coronary Intravascular Lithotripsy System in patients with severely calcified coronary artery disease.
• The TECTONIC CAD IVL Trial will enroll up to 335 U.S. patients, using high-energy sound pressure waves to modify calcification before stent placement, potentially improving outcomes for complex CAD cases.
• This strategic move positions Abbott in the highly competitive IVL market, following Johnson & Johnson's $13 billion acquisition of Shockwave Medical in 2024 and Boston Scientific's recent entry through its Bolt Medical acquisition.
BD Initiates Pivotal STANCE Trial Testing GalaFLEX LITE Scaffold for Reducing Capsular Contracture in Breast Implant Revision Surgery
• BD (Becton, Dickinson and Company) has treated the first patient in its STANCE clinical trial, evaluating GalaFLEX LITE Scaffold for reducing capsular contracture recurrence during breast implant revision surgery.
• Capsular contracture affects 10-20% of breast implant patients, with conventional revision techniques showing recurrence rates as high as 54%, highlighting the significant unmet medical need this trial addresses.
• The multi-center study will enroll 250 patients across 40 sites, randomizing subjects 2:1 to receive either the bioabsorbable P4HB scaffold or standard care without supportive matrix.
Insulet Expands Omnipod 5 Automated Insulin Delivery System to Australia and Three Additional Markets
• Insulet's tubeless Omnipod 5 Automated Insulin Delivery System is now commercially available in Australia and will soon launch in Belgium, Canada, and Switzerland, expanding access to thousands more diabetes patients globally.
• The system integrates with continuous glucose monitors from Dexcom (G6 and G7) and Abbott's FreeStyle Libre 2 Plus, automatically adjusting insulin delivery every five minutes using SmartAdjust technology.
• Insulet plans further expansion to five additional Middle Eastern markets including Israel, Saudi Arabia, UAE, Qatar, and Kuwait, strengthening its global leadership position in automated insulin delivery technology.
CS Diagnostics Partners with Lachman Consultants to Fast-Track FDA Approval for Novel Cancer Radiation Therapy Hydrogel
• CS Diagnostics (OTCQB: CSDX) has engaged regulatory experts Lachman Consultants to expedite FDA approval for CS-Protect Hydrogel, an innovative organ spacer device for radiation therapy, with approval expected within 3-4 months.
• The CS-Protect Hydrogel technology represents a significant advancement in cancer radiotherapy by eliminating contamination risks and enabling more precise treatment delivery, addressing critical needs in oncology care.
• Market potential for the technology appears substantial, with company executives noting that Boston Scientific previously acquired a similar product for $500 million, highlighting the commercial value of organ-sparing innovations in cancer treatment.
FDA Grants 510(k) Clearance for ReWalk 7 Exoskeleton for Spinal Cord Injury Patients
• Lifeward Ltd. has received FDA clearance for its ReWalk 7 exoskeleton, the seventh generation of its wearable device that enables individuals with spinal cord injury to stand and walk.
• The new generation includes enhanced features and follows significant regulatory milestones, including the 2024 CMS national reimbursement policy for qualified beneficiaries.
• Lifeward, which made history in 2014 with the nation's first FDA-cleared exoskeleton for SCI patients, will begin U.S. sales of ReWalk 7 as soon as the product becomes available.
CS Diagnostics Enlists Lachman Consultants to Secure FDA Approval for Novel Cancer Treatment Hydrogel
• CS Diagnostics Corp. (OTCQB:CSDX) has appointed Lachman Consultants to navigate the FDA approval process for its innovative CS-Protect Hydrogel, an organ spacer technology for cancer radiotherapy treatments.
• The CS-Protect Hydrogel offers significant advantages over previous products, including enhanced versatility for multiple pathologies, ready-to-use application, and reduced contamination risks during cancer treatment procedures.
• The company anticipates FDA approval within 3-4 months and projects production to begin in Q1 2026, with executives noting that a predecessor technology was acquired by Boston Scientific for $500 million.
Tempus AI Acquires Deep 6 AI to Enhance Clinical Trial Matching and Patient Care
• Tempus AI has acquired Deep 6 AI, a platform that accelerates clinical trial recruitment by mining structured and unstructured EMR data across healthcare organizations.
• Deep 6 AI's integration with over 750 provider site locations covering more than 30 million patients will significantly expand Tempus' existing network and connectivity infrastructure.
• The acquisition aims to enhance Tempus' AI-enabled precision medicine solutions, including its Next and TIME applications that help physicians close care gaps and match patients to potentially life-saving clinical trials.
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