SINAI HEALTH SYSTEM
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- -
- Established
- 2015-01-01
- Employees
- -
- Market Cap
- -
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.
Abbott's Groundbreaking AVEIR Leadless Pacemaker Shows Promise in First-in-Human Conduction System Pacing Study
• Abbott's AVEIR Conduction System Pacing leadless pacemaker demonstrated successful implantation in the left bundle branch area of the heart in a first-of-its-kind feasibility study presented at HRS 2025.
• The company has initiated the ASCEND CSP pivotal trial to evaluate its investigational Conduction System Pacing Implantable Cardioverter-Defibrillator lead, which will enroll up to 414 patients across 70 global sites.
• Both the AVEIR CSP leadless pacemaker and CSP ICD lead have received FDA Breakthrough Device Designation, potentially accelerating development of physiologic pacing options for patients with cardiac rhythm disorders.
Engineered "Invisible" Brain Cells Reverse Parkinson's Symptoms in Preclinical Study
• Australian researchers have developed human brain cells with an "invisibility cloak" that evades immune detection, successfully restoring muscle function in rat models of Parkinson's disease without requiring immunosuppressant drugs.
• The engineered cells contain eight modified genes that mimic natural immune evasion mechanisms found in placenta and cancer cells, creating a potential "universal" cell line for transplantation across multiple neurological conditions.
• This breakthrough could eliminate the need for anti-rejection medications that increase infection risk and cause tissue damage, representing a significant advancement toward off-the-shelf cell therapies for conditions including Parkinson's, stroke, and Huntington's disease.
Epilepsy Drug Ezogabine Shows Promise as Novel Depression Treatment by Targeting Brain Potassium Channels
• Two recent studies reveal that ezogabine, an FDA-approved epilepsy medication, may effectively treat depression by normalizing hyperactivity in the brain's reward circuitry through KCNQ potassium channel modulation.
• Researchers at Mount Sinai found ezogabine reduced abnormal connectivity between reward centers and regions associated with negative thoughts, potentially addressing anhedonia—the inability to experience pleasure—which is often resistant to conventional treatments.
• The findings represent a significant advancement in depression treatment, offering a fundamentally different biological approach for patients who don't respond to first-line therapies.
Walden Biosciences Strengthens Board with Appointment of Rare Disease Expert Howard Mayer
• Walden Biosciences has appointed Howard Mayer, M.D., former Executive VP of R&D at Ipsen, to its Board of Directors as the company approaches key clinical milestones.
• Dr. Mayer brings extensive experience in clinical development and regulatory affairs, particularly in rare diseases, as Walden prepares for Phase 2 data readout of WAL0921 for glomerular kidney diseases.
• The appointment comes at a strategic time as Walden advances its pipeline, including the progression of WAL0623, a dynamin stabilizer, into clinical trials.
Biotronik's Solia CSP S Lead Under Evaluation for Enhanced Left Bundle Branch Area Pacing
• Biotronik has enrolled the first patient in the second arm of the BIO-CONDUCT study to evaluate the Solia CSP S pacing lead for left bundle branch area pacing (LBBAP).
• The Solia CSP S lead features design enhancements like a fixed helix and optimized distal end, aiming to simplify LBBAP procedures and improve patient outcomes.
• LBBAP is gaining traction as a more physiological pacing method compared to conventional techniques, potentially offering better outcomes for heart failure patients.
• Several vendors, including Medtronic, Boston Scientific, and Abbott, are developing and receiving FDA clearances for LBBAP-related devices and systems.
Neuralink Implants Third Human with Brain-Computer Interface, Plans Expansion
• Neuralink has successfully implanted its brain-computer interface device in a third human patient, with all three implants reported to be functioning well.
• The company plans to expand its human trials significantly, aiming to implant the device in 20 to 30 more individuals in 2025.
• Upgrades to the Neuralink device include more electrodes, higher bandwidth, and longer battery life, enhancing its potential for restoring digital independence.
• A new clinical trial site will open at the University of Miami, focusing on patients with paralysis or ALS, to further research and development of the technology.
HeartBeam Submits FDA Application for 12-Lead ECG Synthesis Software
• HeartBeam has submitted a 510(k) application to the FDA for its 12-lead ECG synthesis software, designed to assess various cardiac rhythms and arrhythmias.
• The submission is supported by data from the VALID-ECG pivotal study, involving 198 patients across five clinical sites, demonstrating clinical equivalence to standard ECGs.
• The software synthesizes signals from three directions into a 12-lead ECG, using a personalized transformation matrix, for convenient cardiac monitoring.
• Future advancements include AI-based classification algorithms and heart attack detection, aiming to reduce 'symptom to door' times for patients.
Abbott Completes First-in-Human Leadless Left Bundle Branch Area Pacing Procedures
• Abbott has successfully completed first-in-human procedures using its AVEIR CSP leadless pacemaker system for left bundle branch area pacing (LBBAP).
• The AVEIR CSP system aims to provide a new treatment option for individuals with slower-than-normal heart rhythms by pacing the left bundle branch area.
• The FDA has granted Breakthrough Device Designation to Abbott's AVEIR CSP leadless pacemaker system, expediting its review process.
• The AVEIR CSP system leverages leadless pacing technology, potentially reducing long-term risks associated with traditional pacemakers.
CardioFocus Initiates Clinical Trial of OptiShot Pulsed Field Ablation System for Atrial Fibrillation
• CardioFocus has commenced a clinical trial (VISION AF) evaluating the OptiShot Pulsed Field Ablation (PFA) System for paroxysmal atrial fibrillation treatment.
• The OptiShot system features an ultra-compliant balloon for precise pulsed energy delivery and tissue contact during pulmonary vein isolation.
• The first-in-human trial aims to enroll up to 50 patients, with a 12-month follow-up to assess the technology's efficacy through remapping procedures.
• Early user feedback highlights confidence in the system's design for improved long-term outcomes in atrial fibrillation ablation.
BALANCE Trial Shows Shorter Antibiotic Treatment Effective for Bloodstream Infections
• The BALANCE trial demonstrated that a seven-day antibiotic course is as effective as a 14-day regimen for bloodstream infections.
• The study involved 3,608 patients and was conducted across various hospital wards, including general medicine units.
• Shorter antibiotic use reduces hospital stays, lowers the risk of antibiotic resistance, and enhances healthcare efficiency.
• Sinai Health's innovative clinical trial framework facilitated the large-scale randomized clinical trial in general hospital wards.
BTL's Novel Catheter Shows Promise in Early Atrial Fibrillation Ablation
• BTL announced successful treatment of initial patients in a first-in-human study using a next-generation catheter for atrial fibrillation (AF) ablation.
• The catheter system employs pulsed-field ablation (PFA) to enhance the safety, speed, and effectiveness of AF treatments.
• Early results from six patients indicate the new catheter is safe, effective, and straightforward, aligning with preclinical study outcomes.
• The novel catheter features single-shot pulmonary vein isolation (PVI) and is designed for intuitive placement, improving procedural reliability.
Transferrin Receptor-Targeted ASOs Show Promise in Crossing the Blood-Brain Barrier
• Researchers have developed antisense oligonucleotides (ASOs) conjugated with a transferrin receptor (TfR)-targeting antibody fragment for enhanced brain delivery.
• Intravenous administration of these TfR-ASO conjugates in mice demonstrated effective ASO distribution throughout the brain.
• The TfR-ASO conjugates led to significant target mRNA reduction in the brain, showcasing their potential for treating neurological disorders.
• This targeted delivery approach may improve the efficacy and reduce systemic exposure of ASO therapeutics for CNS diseases.
Talquetamab and Teclistamab Combination Shows Promising Results in Relapsed/Refractory Multiple Myeloma
• Updated results from the Phase 1b RedirecTT-1 study show the combination of talquetamab and teclistamab yields high response rates in relapsed/refractory multiple myeloma patients.
• The bispecific antibody combination demonstrates durable responses and a manageable safety profile, consistent with each agent's monotherapy profile.
• Patients with extramedullary disease, often resistant to standard therapies, also showed meaningful overall response rates and duration of response with the combination.
• The findings support further investigation of talquetamab-based combinations in multiple myeloma treatment, especially for those with limited options.
September 2024: FDA Actions Span Diabetes, Neurology, and Rare Diseases
• The FDA approved Embecta's tubeless patch pump for insulin delivery in adults with type 1 and type 2 diabetes, offering a 300-unit reservoir based on patient feedback.
• Sparsentan (Filspari) received full FDA approval to slow kidney function decline in adults with primary IgA nephropathy (IgAN), based on positive Phase 3 PROTECT study data.
• Approvals for arimoclomol (Miplyffa) and levacetylleucine (Aqneursa) mark the first specific treatments for neurological symptoms of Niemann-Pick disease type C (NPC).
• Dupilumab (Dupixent) gained approval for COPD, chronic rhinosinusitis with nasal polyps, and was submitted for label expansion for adult growth hormone deficiency.
Summit Therapeutics Completes Enrollment in Phase III HARMONi Trial and Receives FDA Fast Track Designation for Ivonescimab
• Summit Therapeutics has completed enrollment in the Phase III HARMONi trial evaluating ivonescimab plus chemotherapy for EGFR-mutated NSCLC after TKI failure.
• The FDA granted Fast Track designation to ivonescimab in combination with platinum-based chemotherapy for EGFR-mutated NSCLC post EGFR-TKI therapy.
• HARMONi is a multi-regional trial conducted in North America, Europe, and China, with topline data expected in mid-2025.
• Ivonescimab, a bispecific antibody targeting PD-1 and VEGF, has shown promise in clinical trials, including HARMONi-2 where it outperformed pembrolizumab.
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