Ablative Solutions' TARGET BP I Pivotal Trial Results Demonstrate Significant Reduction in 24-Hour Ambulatory Systolic Blood Pressure Compared to Sham, Using Alcohol-Mediated Renal Denervation

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Apr 11, 2024, 08:30 ET

Presented as Late-Breaking Clinical Trial at ACC.24 with Primary Endpoint Met

Absolute Reduction of 10 mmHg Ambulatory Systolic Blood Pressure in Patients with Uncontrolled Hypertension in Treatment Arm

WAKEFIELD, Mass., April 11, 2024 /PRNewswire/ -- Ablative Solutions, Inc., announced that primary trial results from the TARGET BP I Pivotal Trial, evaluating alcohol-mediated renal denervation with the Peregrine System™ Kit, were presented as a Late-Breaking Clinical Trial at the American College of Cardiology's 73rd Annual Scientific Congress in Atlanta, GA this week. The data was also released online, ahead of print, in a simultaneous manuscript in the journal Circulation.

Meeting its primary endpoint, the TARGET BP I trial evaluated the safety and efficacy of the Peregrine System Kit to treat patients with uncontrolled hypertension despite taking anti-hypertensive medications. The Peregrine System Kit, comprised of a patented infusion catheter and dehydrated alcohol, was used during a minimally invasive procedure to ablate the sympathetic nerves surrounding the renal (kidney) arteries to reduce blood pressure. Unlike other renal denervation modalities, the Peregrine System does not require the use of energy or any capital equipment.

"The results of this pivotal trial bring additional evidence to the field of renal denervation and the potential of alcohol-mediated renal denervation as a treatment option addressing the widespread public health issue of uncontrolled hypertension", stated, David Kandzari, M.D., co-principal investigator, chief of Piedmont Heart Institute and chief scientific officer for Piedmont Healthcare, who presented these data. "We were pleased to share these data at the ACC.24 Late-Breaking Clinical Trial session this week."

The TARGET BP I Trial enrolled 301 patients with uncontrolled hypertension despite being prescribed 2 – 5 antihypertension medications. Patients were randomized to either receive treatment with the Peregrine System Kit or sham procedure. The study remained blinded through 6 months follow-up. Patients will be followed longer-term for 3 years. More information about the TARGET BP I Trial is available at https://clinicaltrials.gov/ct2/show/NCT02910414.

Key findings in the TARGET BP I pivotal trial included:

The trial met its primary endpoint, with a statistically significant difference in 24-hour Ambulatory Systolic Blood Pressure (ASBP) between treatment and sham procedure at 3 months.
- Absolute reduction in 24-hour ASBP was -10.0 mmHg in the Peregrine renal denervation treatment group compared to -6.8 mmHg in the sham control group, corresponding to a statistically significant between-group difference of -3.2 mmHg (p = 0.049).
- Results favoring Peregrine renal denervation were consistent across both day and night ASBP, as well as across prespecified subgroups.
The trial was conducted across 99 centers in the US and Europe, with roughly 50% of subjects enrolled in the United States. The US population results showed an absolute reduction in 24-hour ASBP of -11.2 mmHg in the Peregrine renal denervation treatment group compared to -6.2 mmHg in the sham control group, corresponding to a statistically significant between-group difference of -5.0 mmHg (p = 0.048).
Secondary endpoint of mean reduction in office systolic blood pressure results showed a reduction of -12.7 mmHg in the Peregrine renal denervation treatment group compared to -9.7 mmHg in the sham control group, corresponding to a between-group difference of -3.0 mmHg (p = 0.173).
This trial included patients with uncontrolled hypertension despite being prescribed 2-5 antihypertensive medications, a population known to struggle with managing hypertension through lifestyle and oral medication consumption.
- Peregrine renal denervation results were observed in the context of unexplained large blood pressure reductions in the sham control cohort.
- Strikingly high rates of partial or complete medication non-adherence were seen across the full cohort, confirmatory of real-world issues of subject medication non-adherence.
Alcohol-mediated renal denervation was associated with favorable procedural performance, with relatively short procedure time (56 minutes) and fluoroscopy time (11 minutes).
The low rate of Major Adverse Events, preservation of renal function, and vessel patency through 6 months confirmed the favorable intermediate safety profile of this procedure.

"We are thrilled that in this study, alcohol-mediated renal denervation using the Peregrine System Kit was associated with a significant reduction in ambulatory blood pressure with a favorable safety profile," said Kate Rumrill, President and CEO of Ablative Solutions, Inc. "We are committed to working with regulatory bodies to advance this novel modality for the treatment of uncontrolled hypertension."

About the Peregrine System
The Peregrine System™ Kit is comprised of two components, the Peregrine System Infusion Catheter and dehydrated alcohol. The Peregrine System Kit for renal denervation is not approved for commercial distribution and its use is limited to investigation within clinical trials in the United States and Europe.

About Ablative Solutions
Ablative Solutions, Inc., based in Wakefield, MA, was founded in 2011 with a vision of reinventing renal denervation to improve cardiovascular health. Ablative Solutions' approach targets the overactive sympathetic nervous system, which may play a role in hypertension, heart failure, kidney disease, metabolic syndrome, and sleep apnea. The Peregrine System Kit is currently being investigated as a treatment for uncontrolled hypertension. For more information visit www.ablativesolutions.com.

Media contact: Kate Rumrill, [email protected]

SOURCE Ablative Solutions, Inc.