Ablative Solutions, Inc. Announces $77 Million Financing for Unique Therapeutic Approach to Treating Uncontrolled Hypertension

Funds from the round will be used to complete clinical trials in support of U.S. and European regulatory submissions for the company’s minimally invasive renal denervation technology designed to help reduce blood pressure for people 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.

“BioStar Ventures focuses on transformational health care investments, and we believe Ablative Solutions fits that model perfectly. We are enthusiastic about the company’s innovative approach to treating high blood pressure, a serious condition that impacts more than one billion people worldwide,” said Michael Fulton, M.D., senior managing director of BioStar Ventures, an investor in the company since its Series A round in 2012. “Ablative Solutions’ patented technology enables a streamlined procedure that has the potential to become an important adjunctive therapy to improve difficult-to-control blood pressure.”

Drug therapy and lifestyle changes are the most common treatments for hypertension. Medication non-adherence remains a serious and underappreciated limitation of drug therapy.^1,2 More than half of those treated do not achieve their target blood pressure,^3,4 highlighting the need for improved therapeutic options.

“Hypertension creates a significant burden on the healthcare system, increasing the risk of serious cardiovascular events and stroke,” said Gilde Healthcare’s Geoff Pardo. “We see tremendous potential for Ablative Solutions’ approach and believe the team has a solid plan for building the clinical data through the TARGET BP clinical program.”

“We have been supported the past few years by an amazing team of clinicians who, along with our very hard-working team, are committed to making this treatment available to patients,” said Ablative Solutions’ CEO and CMO Tim Fischell, M.D. “We are excited to have the support of this thoughtful and high-powered group of investors, which will allow the company to complete the studies required to seek regulatory approvals in Europe and in the United States.”

About the Peregrine System Kit

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 not currently approved in the United States or in Europe. Its use is limited to investigational use in clinical trials.

About the Peregrine System Infusion Catheter

The Peregrine System Infusion Catheter has 510(k) clearance 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 to achieve a reduction in systemic blood pressure in hypertensive patients. The Peregrine Catheter is not commercially available in the United States or Europe.

About Ablative Solutions

Ablative Solutions, Inc., based in Kalamazoo, Michigan, and San Jose, California, was founded in 2011 with a vision 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.^{1, 2} The Peregrine System Kit is currently being investigated as a treatment for hypertension in conjunction with antihypertensive medications. For more information visit www.ablativesolutions.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

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¹ Berra et al, Evaluation of Adherence Should Become an Integral Part of Assessment of Patients With Apparently Treatment-Resistant Hypertension
Hypertension. 2016;68:297-306. DOI: 10.1161/HYPERTENSIONAHA.116.07464.
² Azizi et al, Adherence to antihypertensive treatment and the Blood Pressure–lowering effects of renal Denervation in the renal Denervation for hypertension (Denerhtn) trial, Circulation. 2016;134:847–857.
DOI: 10.1161/CIRCULATIONAHA.116.022922.
³ CDC, https://www.cdc.gov/bloodpressure.
⁴ Williams et al, 2018 ESC/ESH Guidelines for the management of arterial hypertension, European Heart Journal (2018), 1–98 doi:10.1093/eurheartj/ehy339.

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