RenalGuard Solutions Appoints Chief Medical Officer

RenalGuard Solutions Inc., a medical device company focused on technologies for the cardiac and vascular markets, has named Howard R. Levin, M.D., as chief medical officer. A veteran in the field of biomedical engineering and cardiology and one of the original developers of RenalGuard Therapy, Levin brings more than 35 years of clinical and commercial healthcare experience to the role.
 
Levin’s inventions and co-inventions have helped launch multiple products and companies in the cardiology, renal, and respiratory fields. He is also president, chief scientific officer, and co-founder of Coridea LLC, a medical device incubator that translates ideas into new therapeutic options for patients. As a heart failure/transplant cardiologist and former medical director of the Mechanical Cardiac Support Program at Columbia Presbyterian, Levin brings extensive clinical and academic experience to RenalGuard’s management team.
 
“We are thrilled to welcome Dr. Levin to RenalGuard Solutions. His academic and medical background, as well as his experience with launching new companies, brings a unique perspective and expertise to our organization,” said Jim Dillon, CEO of RenalGuard Solutions. “Dr. Levin will provide strategic insight to our research, development, and clinical teams as we broaden our work in treating patients with heart failure who are diuretic-resistant and at risk of kidney injury.”
 
RenalGuard Therapy fluid-management platform technology addresses kidney health in patients at risk for contrast-induced acute kidney injury (CI-AKI). RenalGuard Therapy enables clinicians to achieve optimal hydration for patients by inducing high urine output rates, while avoiding under- or over-hydration. RenalGuard-supported diuretic therapy is currently the subject of a study to evaluate its use as a treatment for patients who are fluid-overloaded due to heart failure.
 
“RenalGuard is making significant advancements in improving care for patients at-risk for a range of insults to the kidney,” said Levin. “It’s an exciting time to be joining the company as we continue to expand the potential applications for RenalGuard Therapy platform technology.”
 
Earlier this year, RenalGuard Solutions reported positive results from a first-in-man feasibility study focusing on the RenalGuard System to manage fluids during diuretic therapy in congestive heart failure patients suffering from fluid overload.
 
RenalGuard Therapy 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 the ability of RenalGuard Therapy to protect patients from AKI following catheterization procedures when compared to the standard of care, including:
 

• MYTHOS, which found RenalGuard Therapy to be superior to overnight hydration
• REMEDIAL II, which found RenalGuard Therapy 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 Therapy during the procedure, compared to standard therapy
• AKIGUARD, which showed significant improvement in long-term outcomes when using RenalGuard Therapy vs. standard therapy
• Two meta-analysis of these results (Putzu and Mattathil) found RenalGuard Therapy consistently reduced kidney injury, dialysis, adverse events and mortality compared to standard therapy
   

RenalGuard Solutions Inc. is a medical device company focused on technologies for the cardiac and vascular markets. The company’s lead product, RenalGuard Therapy, 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 Therapy 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 submission with the U.S. Food and Drug Administration in 2018.