Jenavalve Technology Inc. presented first real-world data for a study evaluating the safety and efficacy of its Jenavalve Trilogy transcatheter aortic valve implantation (TAVI) system for the treatment of severe aortic regurgitation (AR). The data, presented at the EuroPCR meeting on May 18, met the primary safety and efficacy endpoints with no major adverse events and no moderate or severe AR at discharge.
Robocath SAS presented results from the R-Evolution European clinical study assessing the safety and efficacy of its R-One robot for coronary angioplasty procedures. The study, which included 62 patients across six European centers, met all three primary endpoints, showing 100% clinical success, >95% technical success, and 84.5% average reduction in physician radiation exposure.
Keros Therapeutics Inc. announced preliminary results from a phase I trial of its engineered ligand trap KER-012 that gave its team confidence to proceed with larger studies in pulmonary arterial hypertension (PAH) and potentially some bone diseases. But company shares (NASDAQ:KROS) fell 16.6% to $38.50 May 18, following the announcement, perhaps over concerns about trial subjects that emerged in a company-hosted investor call.
A paper published May 3 in Nature Communications about a patient infected with Mycobacterium chelonae who was cured by way of bacteriophage treatment sparked more intrigue around how to attack the nontuberculous mycobacteria (NTM) group of bugs that cause lung infections.
The second generation of Boston Scientific Corp.’s Acurate Neo2 valve has demonstrated better performance than its predecessor, showing a threefold reduction of paravalvular leakage (PVL) said researchers. During the hotline/late-breaking trials session on May 17 at the EuroPCR meeting held in Paris, Andrea Buono, interventional cardiologist at Fondazione Poliambulanza Istituto Ospedaliero in Brescia, Italy, presented results from a large study comparing the performance of Acurate Neo and Acurate Neo2 in 13 Italian centers.
Medtronic plc has presented three-year data on its global, multicenter, blinded, randomized and sham-controlled renal denervation (RDN) clinical program Spyral HTN-ON MED during the late-breaking clinical trial session at EuroPCR on May 17. The trial enrolled 80 typical uncontrolled hypertensive patients, randomized to RDN or sham control.
It was a patient-reported outcome, one that could actually be seen in the mirror, that alerted researchers they might be on track in their phase I/II study of cystinosis. The patient noticed that for the first time in his life his hair had become darker, like his brother’s. It was all because the rare disease inhibiting the pigment in his body was being impacted by the treatment. “It’s a secondary issue, but I find it fascinating,” Avrobio Inc.’s CEO, Geoff MacKay, told BioWorld. “When you run trials like this, you stumble upon some fascinating results.”
As the six-month interim analysis of phase II data for ATA-199 in progressive forms of multiple sclerosis (MS) nears, investors in Atara Biotherapeutics Inc. – not to mention patients – are growing more intrigued by the prospect, an off-the-shelf T-cell candidate that targets Epstein Barr virus-infected B cells and plasma cells in the central nervous system.
Bristol Myers Squibb Co. has announced long-term data from its closely watched psoriasis pill, deucravacitinib, which it hopes will supplant Amgen Inc.’s blockbuster, Otezla (apremilast), as the main oral therapy for the disease.