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Verve Medical’s Groundbreaking Pilot Trial for Uncontrolled Hypertension

In a significant advancement in hypertension management, Verve Medical has successfully executed the first patient treatment in a pivotal U.S. pilot trial focusing on uncontrolled hypertension. This landmark event marks an essential leap forward in the company's journey to commercialize a pioneering, targeted therapy designed to alleviate the global burden of high blood pressure.

The pilot trial for renal pelvic denervation (RPD) comes on the heels of promising results from Verve's prior TUSK feasibility trial, which indicated an average systolic blood pressure reduction of approximately 20 mmHg among participants over a year of follow-up. This compelling data illuminates the potential of the RPD approach to substantially diminish hypertension in patients who do not respond adequately to multiple medications.

The initial procedure was performed by Dr. Michael Borofsky, an accomplished associate professor and director of the endourology fellowship at the University of Minnesota and M Health Fairview. His expertise in kidney stone disease and advanced endourological techniques contributed critically to this pioneering trial. This trial underscores the collaborative relationship between urology and nephrology, capitalizing on urologists’ procedural skills combined with nephrologists’ specialized knowledge in blood pressure management and kidney function.

The RPD pilot trial aims to enroll 60 patients across 10 clinical sites in the U.S. Participants will be randomized into two groups, one receiving the innovative RPD therapy while the other undergoes a sham procedure, thus ensuring rigorous methodological integrity and objectivity.

Dr. John Osborn, a leading figure in the trial and professor in the Department of Surgery at the University of Minnesota Medical School, expressed optimism regarding the RPD procedure's impact on hypertension treatment. He stated, "We are excited to see how Verve’s renal pelvic denervation procedure performs based on prior research conducted at our institution and other esteemed research centers across the nation. Theoretically, the ability to target a larger volume of afferent nerves may provide a superior reduction in blood pressure compared to existing endovascular denervation technologies."

The innovative RPD therapy targets renal nerves, which significantly influence blood pressure levels. Using radiofrequency (RF) energy, this minimally invasive technique is carried out through the urinary tract, circumventing traditional catheter-based methods that engage the renal arteries directly from the bloodstream. The outpatient procedure reflects Verve's commitment to accessible healthcare, allowing it to be performed in ambulatory settings.

Terry Buelna, the chief technology officer and founder of Verve Medical, conveyed enthusiasm about leveraging the insights gained from the TUSK trial, stating, "We are prepared to replicate and expand those results, aiming to redefine expectations in both office and ambulatory blood pressure reduction. We aspire to usher in a new era of hypertension management for patients."

The urgency of tackling hypertension is underscored by its status as a significant global health challenge, with consequences including heart attacks, strokes, heart failure, kidney disease, and various forms of vascular damage. David Perry, Verve Medical's CEO, emphasized the transformative potential of RPD technology, stating, "For patients who struggle with uncontrolled hypertension even with medication, our targeted, energy-based solution may transform their treatment options."

For more detailed information about Verve Medical and its innovative technology, visit Verve-Medical.com. Verve Medical is a clinical-stage medical device company focused on advancing its pioneering renal pelvic denervation devices for the treatment of uncontrolled hypertension and related conditions. The patented platform allows for the ablation of both afferent and efferent nerves engaged in the regulation of blood pressure, marking a novel approach in device-based hypertension treatments.