Scribe Therapeutics Inc. has obtained clearance from Australia’s Therapeutic Goods Administration (TGA) to initiate a first-in-human study of STX-1150 for the treatment of hypercholesterolemia, a major driver of atherosclerotic cardiovascular disease (ASCVD). The phase I study will enroll adults with elevated LDL-C at increased cardiovascular risk at sites in Australia and New Zealand.
As interests and competition in the intravascular lithotripsy (IVL) market heats up, Shockwave Medical Inc. said it believes that its latest coronary IVL catheter, the C2 Aero, and other projects in the pipeline, will help it to maintain its leadership in calcium modification.
Nanjing Reju Therapeutics Inc. has reported new nicotinamide phosphoribosyltransferase (NAmPRTase; Nampt) activators potentially useful for the treatment of atherosclerosis, Duchenne muscular dystrophy, heart failure, multiple sclerosis, obesity, cardiomyopathy, Alzheimer’s and Parkinson’s disease, among others.
A subgroup analysis of data from Boston Scientific Corp.’s Champion-AF trial, which looked at the outcomes for patients with atrial fibrillation treated with a left atrial appendage closure (LAAC) device compared to direct oral anticoagulants (DOACs), found that the efficacy and safety of LAAC compared to DOAC are not affected by age. The data were presented at the EuroPCR conference in Paris.
Data from the All Women clinical trial, which looked at the Allegra transcatheter aortic valve replacement (TAVR) system compared to balloon-expandable valves (BEV) in women with aortic stenosis, showed that Allegra delivered lower mean gradients and less prosthesis-patient mismatch than BEVs. The data presented at the EuroPCR conference in Paris was the first randomized head-to-head comparison of different TAVR platforms conducted exclusively in women.
A new strategy aims to improve gene therapy for Pompe disease by optimizing both the genetic component that restores the function of a deficient lysosomal enzyme and the vector that delivers it to the target tissue while avoiding the liver. The findings suggest that combining an optimized transgene with a targeted capsid could significantly enhance the effectiveness of gene therapy for Pompe disease.
The convergence of robotics, sensors and AI is reshaping how medical devices interact with patients, clinicians and healthcare systems. Across the field, from oncology to cardiology and women’s health, companies are integrating software, connectivity, data analytics and biological information into their products. And although traditional devices, such as screws for orthopedics or valves for cardiology, remain essential, the shift underway is leading to much more personalized medicine, which is more effective and safer, Eran Lerer, managing partner, at Shoni Health Ventures, told BioWorld.
Shanghai Fosun Pharmaceutical (Group) Co. Ltd. is paying $60 million up front for an option to secure exclusive rights to Aribio Co. Ltd.’s oral phase III-stage Alzheimer’s disease (AD) therapy, AR-1001. The option fee plus license agreement has potential to tally $4.7 billion for Aribio, marking the largest deal for an AD asset inked by a Korean biotech company.
Elixir Medical Corp. reported four-year data from the Bioadaptor randomized controlled trial presented at the EuroPCR conference in Paris, which showed that patients with coronary artery disease treated with its Dynamx coronary drug-eluting bioadaptor system experienced significantly lower event rates compared to those treated with Medtronic plc’s Resolute Onyx drug-eluting stent, including reduction in cardiovascular death.
Boston Scientific Corp. reported positive results from the Fracture investigational device exemption trial which evaluated its Seismiq 4CE coronary intravascular lithotripsy (IVL) catheter in patients with severely calcified coronary artery disease. Late-breaking data presented at the EuroPCR conference in Paris showed that the pivotal study met its primary safety and effectiveness endpoints, with high rates of freedom from major adverse cardiac events at 30 days and strong procedural success.
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