CLINICAL TRIALS, STUDIES, REGISTRIES, DATA

“We developed LithiX to improve the IVL treatment of calcified lesions with shorter procedure times and effectiveness across a broad range of calcified lesions, and we’re delighted with the PINNACLE I study outcomes demonstrating its sustained safety and effectiveness,” said Motasim Sirhan, CEO of Elixir Medical. “Our team is committed to developing transformative cardiovascular technologies that deliver improved physician experiences and most importantly, better clinical outcomes for patients.”

"These findings are a key step toward informing the medical community of the long-term effectiveness with radiofrequency renal denervation as a treatment for uncontrolled hypertension," stated Dr. David Kandzari, Chief of Piedmont Heart Institute and Cardiovascular Services and lead principal investigator of the SPYRAL HTN-ON MED trial. "Importantly, at two years, we continue to see Symplicity is safe and consistent with clinically meaningful and significant blood pressure reductions. These data further substantiate sustained blood pressure reductions consistently observed in across the SPYRAL and Global Symplicity clinical programs."

Trial investigators presented the data today during a late-breaking clinical trials session at Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation (CRF) and published simultaneously in The New England Journal of Medicine notes Edward Life Sciences.

The THUNDER IDE study is a multi-center, single-arm study evaluating patients with acute ischemic stroke secondary to intracranial large vessel occlusion (LVO) who are eligible for mechanical thrombectomy. The primary efficacy endpoint includes revascularization of the occluded target vessel at immediate post-procedure.

"The use of ICE imaging in LAAO is growing significantly and will continue," said James Reinstein, President and CEO of Conformal Medical. "Our next-generation LAAO technology conforms to individual anatomies, enabling clinicians to simplify the procedure with 2 sizes, the ability to confirm seal, and eliminate general anesthesia & intubation."

"The approval from the MIEC, coming closely on the heels of our two ethics committee approvals in Australia, to conduct this early feasibility study, is another important step in our plan to evaluate use of the Hemopurifier as a treatment option in multiple tumor types, where cancer associated exosomes may promote immune suppression and metastasis," stated Steven LaRosa, MD, Chief Medical Officer of Aethlon Medical.

Revolo Biotherapeutics notes the data reinforces the broad clinical applicability of ‘1104, through a novel upstream mechanism of action (MOA), demonstrating its impact across skin disease measures and a wide range of inflammatory cytokines and chemokines associated with AD pathology.

Tivic Health reports this clinical research collaboration with Feinstein is designed to advance the development of Tivic Health’s ncVNS technology by refining and optimizing stimulation parameters.

“The Decipher Prostate test’s ability to help guide treatment for patients with localized prostate cancer is already proven in dozens of peer-reviewed publications and is the only molecular test to achieve ‘Level 1B’ evidence status in the most recent NCCN® Guidelines* for prostate cancer,” said Elai Davicioni, Ph.D., Veracyte’s medical director for Urology. “These new phase 3 data from the STAMPEDE trial now further prove the performance and utility of our test in patients with metastatic prostate cancer. We believe our test can have a tremendous positive impact on care for these patients.”