January 8, 2019
Financing Will Support Global Clinical Program for Ablative Solutions' Peregrine Renal Denervation Technology
January 9, 2019—Ablative Solutions, Inc. announced the first close of its $77 million Series D funding round. Funds from the round will be used to complete clinical trials in support of United States and European regulatory submissions for the company’s minimally invasive renal denervation technology, which is designed to help reduce blood pressure for patients with uncontrolled hypertension while taking antihypertensive medication.
Ablative Solutions’ alcohol-mediated renal denervation procedure is performed using the investigational Peregrine system kit, which is engineered to target nerves known to influence the body’s regulation of blood pressure. The Peregrine kit delivers dehydrated alcohol in small doses directly to the space outside of the renal artery to block the overactive signaling of the sympathetic nerves. This targeted treatment is designed to be performed in a rapid, straightforward procedure with minimal pain or discomfort for the patient.
The Peregrine system kit is currently being studied to evaluate safety and efficacy when used in the treatment of patients with uncontrolled hypertension in conjunction with antihypertensive medications. It is also being studied in a proof-of-concept trial in Europe to evaluate the safety and efficacy of the product when used to treat patients not taking antihypertensive medications. It is an investigational product that is not currently approved in the United States or in Europe. Its use is limited to investigational use in clinical trials.
The Peregrine system infusion catheter has FDA 510(k) clearance for the infusion of diagnostic and therapeutic agents into the perivascular area of the peripheral vasculature. In Europe, the Peregrine system infusion catheter has CE Mark approval for the infusion of a neurolytic agent to achieve a reduction in systemic blood pressure in hypertensive patients. The Peregrine catheter is not commercially available in the United States or Europe, advised Ablative Solutions.
The funding round was led by new investor Gilde Healthcare with existing investor BioStar Ventures and an undisclosed new strategic corporate investor. Existing investors, including Michigan Accelerator Fund, Novus Biotechnology, and other individual investors, also participated in the Series D funding round.