Ablative Solutions, Inc., based in Wakefield, MA, was founded in 2011 with a commitment to address the unmet need of hypertension. 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 is currently being investigated as a treatment for hypertension in conjunction with antihypertensive medications. For more information visit www.ablativesolutions.com.
Reinventing renal denervation to improve cardiovascular health.
Ablative Solutions is passionately committed to enhancing and extending patients’ lives. We develop innovative and novel renal denervation solutions to deliver the treatment of choice for patients and their healthcare providers.
Technology and IP
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. The Peregrine System Infusion Catheter has been cleared via the premarket notification process (510(k)) for the infusion of diagnostic and therapeutic agents into the perivascular area of the peripheral vasculature. The Peregrine System Infusion Catheter is CE marked for the infusion of a neurolytic agent (e.g. alcohol) to achieve a reduction in systemic blood pressure in hypertensive patients. The Peregrine Catheter is not commercially available in the United States or Europe. The Company has secured more than 30 US patents, several more International patents, and has many more filed and under review.
Clinical and Regulatory
The Peregrine Catheter is CE Marked and 510K cleared for the delivery of neurolytic agents. The Company is focused on efforts to generate compelling evidence required to secure approvals for the Peregrine System through our clinical trials program. ASI has completed enrollment in the Target BP Off Med feasibility trial; a randomized, double blind sham controlled trial in patients with uncontrolled hypertension who are not currently taking medications. In addition to the Target BP Off Med trial, ASI has kicked off the Target BPI pivotal trial; a randomized double-blind sham controlled trial in patients with uncontrolled hypertension, who are currently on 2-5 medications. This trial is ongoing and is expected to complete enrollment in 2022.