Cell and gene therapy companies are the beneficiaries of positive changes along the regulatory path that the U.S. FDA is paving for them, according to a panel of executives who spoke at the BioFuture 2024 conference in New York.
The first year of data from the TRISCEND II study of the Evoque tricuspid valve by Edwards Lifesciences Corp. confirm the notion that reduced regurgitation has a big impact on patient well-being. While one-year data support the device’s safety, cardiovascular mortality at one year does not seem to decisively favor the device over medical management.
In what represents the first patenting from Eyecheq Inc., the company is seeking protection for its self-guided eye examination systems which may be mounted in easily movable and transportable kiosks, on tabletop stands, walls or suspended from ceilings.
The ACURATE study of the Accurate neo2 TAVR device by Boston Scientific Corp., failed to demonstrate the device is non-inferior to established devices, but the COVID-19 pandemic threw up some roadblocks.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Autonomix, Bluewind, Boston Scientific, Elixir, Establishment Labs, Irhythm, Jenscare, Medera, Roche.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abionic, Azenta, Exactech, Imbed Biosciences, Irhythm .
New hires and promotions in the med-tech industry, including: Breath Diagnostics, Conmed, Morphocell, Perosphere Technologies, Pixee Medical, Pulse Biosciences.
Abionic SA received U.S. FDA 510(k) clearance for its in vitro diagnostic Capsule pancreatic stone protein (PSP) sepsis test. Produced by the pancreas and immune cells, PSP provides an early biomarker for sepsis that could push back detection of deadly condition by 24 to 48 hours.
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