Funds Support Completion of Pivotal Study and Expansion of Research and Development into New Clinical Uses for RenalGuard Therapy
MILFORD, Mass. — March 16, 2017 – RenalGuard Solutions, Inc., a privately held medical device company, today announced that the company has completed a $14.5 million Series A venture financing. The financing was led by Exigent Capital, with the participation of existing shareholder Genesis Capital Advisors and other private equity investors.
Related to the financing, Alan Adler, former chief executive officer and chairman of Oridion Medical, has joined the RenalGuard board of directors as a representative of Exigent Capital.
“This significant financing provides us with the resources to complete our ongoing pivotal trial of RenalGuard Therapy® by year-end, which is aimed at supporting U.S. marketing approval in 2018,” said Ethan Benovitz, Chairman, RenalGuard Solutions. “These funds will also further our marketing and sales activities for RenalGuard Therapy in Europe and other regions where the technology is already available for use. Moreover, they will enable us to expand research and development into several additional clinical indications where the RenalGuard technology may meet other significant health needs. We thank our investors for their support, which gives further validation to RenalGuard as providing innovative solutions to important medical problems.”
“Acute kidney injury (AKI) caused by cardiac interventional procedures is a serious and costly health care problem that is not currently remedied by any viable solution,” said Alan Adler. “After spending much time extensively reviewing the published clinical data related to RenalGuard therapy and speaking with leading clinical practitioners who have become dedicated users of this technology, I am convinced that RenalGuard has the potential to become the standard-of-care for significantly reducing the incidence of AKI in the huge number of patients undergoing these procedures.
“I look forward to working closely with the RenalGuard team and its Board to help the company achieve this mission as well as its other near- and long-term objectives,” he added.
About RenalGuard Therapy
RenalGuard measures a patient’s urine output and automatically infuses hydration fluid based on that urine output. The system is designed to induce high urine rates, which have been shown to protect the kidney from a range of insults. A number of studies have demonstrated RenalGuard’s ability to protect patients from AKI following catheterization procedures when compared to the standard of care, including: MYTHOS, which found RenalGuard to be superior to overnight hydration; REMEDIAL II, which found RenalGuard to be superior to sodium bicarbonate hydration; Protect-TAVI, which reported a significant reduction in post-procedural acute kidney injury (AKI) following transcatheter aortic valve replacement (TAVR) when using RenalGuard during the procedure, compared to standard therapy; and AKIGUARD, which
showed significant improvement in long-term outcomes when using RenalGuard vs. standard therapy.
About RenalGuard Solutions, Inc.
RenalGuard Solutions, Inc. is a medical device company focused on innovative technologies for the cardiac and vascular markets. The company’s lead product, RenalGuard, is designed to protect patients from acute kidney injury (AKI), including contrast-induced AKI. Investigator-sponsored studies in Europe have demonstrated RenalGuard’s effectiveness at preventing CI-AKI in at-risk patients. RenalGuard is CE-marked and is sold in Europe and certain countries around the world via a network of distributors. The CIN-RG RenalGuard pivotal study is underway in the United States to support a planned Premarket Approval filing with the U.S. Food and Drug Administration. For further information, please visit the website at http://www.renalguard.com.
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