KALAMAZOO, Mich., May 13, 2015 /PRNewswire/ -- Ablative Solutions, Inc. (ASI), a venture-backed, privately-held clinical stage company headquartered in Kalamazoo, MI, with offices in Menlo Park, CA, today announced that it has received the CE Certificate of Conformity allowing ASI to apply the CE Mark to the Peregrine SystemTM Infusion Catheter. This will enable the Peregrine System to be used to treat hypertensive patients in Europe with the infusion of a neurolytic agent into the perivascular space surrounding the renal artery, targeting the sympathetic nerves that contribute to hypertension. This targeted approach offers physicians a new tool to help manage patients with high blood pressure.
Ablative Solutions is currently enrolling patients in the European Peregrine clinical trial for drug-resistant hypertension. The Principal Investigator of the study, Prof. Wojtek Wojakowski, stated: "I have had the opportunity to be one of the first users of the Peregrine System Infusion Catheter in Europe. Early results suggest that perivascular alcohol denervation is a promising approach. I'm impressed by how simple and rapid the procedure is with this technology. The procedures I have performed take only about 15 minutes and have been performed under mild or no sedation, without the need for an anesthesiologist, thereby enabling same-day discharge." This clinical study will continue to enroll and follow patients to confirm the safety and the clinical benefits associated with use of the device.
"This is a major milestone for ASI, and comes at a time when there is a great need to address uncontrolled hypertension, a significant disease which affects millions of patients," said Jon H. Hoem, President of Ablative Solutions Europe. "We've learned from previous clinical trials that effectively interrupting the sympathetic nerve signals can reduce blood pressure. A key advantage of the Peregrine System is that it infuses the ablative therapy directly into the perivascular region, where the nerves reside, and provides deep and circumferential distribution, which we believe will result in a more efficient denervation. We look forward to working with European clinicians to document the full potential of ASI's technology."
Ablative Solutions plans to initiate a post-market study in Europe to gather additional clinical and health-economic data in support of commercialization. The Company is also in the planning stage of a randomized clinical trial in the US to support marketing permission for the treatment of hypertension. In the US, the Peregrine System has received 510(k) clearance as a tool for the infusion of diagnostic and therapeutic agents into the perivascular area of the peripheral vasculature; however, it remains investigational for the treatment of hypertension.
Ablative Solutions, Inc. was founded by two proven medical device entrepreneurs, Tim Fischell, M.D., and David Fischell, PhD. Product development efforts have been led by ASI President & COO, Vartan Ghazarossian, PhD, whose executive experience in both biopharmaceutical and medical device companies has added significant value to this novel therapeutic approach to hypertension.
Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes or benefits are forward-looking statements. A number of risks and uncertainties, such as risks related to product development and commercialization efforts, results of clinical trials, ultimate clinical outcomes and benefit of ASI's products to patients, market and physician acceptance of ASI's products, intellectual property protection and competitive product offerings, could cause actual events to differ from the expectations indicated in these forward-looking statements. You are cautioned not to put any undue reliance on any forward-looking statement. This press release is neither an offer to sell nor a solicitation of an offer to purchase any particular securities. Any such offer or solicitation will be made only pursuant to definitive legal agreements prepared specifically for such purpose. ASI does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
For more information:
Vartan Ghazarossian, PhD
SOURCE Ablative Solutions, Inc.