Targeted Renal Therapy May Help to Prevent Kidney Failure; Study Results Presented at American College of Cardiology.

ATLANTA -- Targeted renal therapy (TRT(TM)) may help to prevent contrast-induced nephropathy (CIN) - a major cause of kidney failure - in at-risk patients, according to preliminary results of a multicenter trial presented here today at the 55th Annual Scientific Session of the American College of Cardiology (ACC).

TRT is the delivery of certain medications and other therapeutic agents directly to the kidneys via the renal arteries. CIN is an under-recognized event that may result from angiographic procedures. It occurs in patients whose kidneys are unable to withstand the harmful effects of the dye (radiocontrast media) used during minimally invasive cardiovascular and endovascular interventional procedures such as stent and stent graft placement, angioplasty, atherectomy, and diagnostic tests that involve angiography.

"CIN can ultimately result in renal failure with need for dialysis, and is associated with increased hospital stays and increased mortality within 6 to 24 months," said Mauricio G. Cohen, M.D., associate director of the cardiac catheterization laboratory and assistant professor of medicine at the University of North Carolina, Chapel Hill. Dr. Cohen presented preliminary data on 112 patients enrolled in the Benephit System Renal Infusion Therapy (Be-RITe!) Registry, an observational study conducted at seven U.S. and one European medical centers. The registry is a retrospective, observational review of safety, "real-world" usage patterns, device performance characteristics and clinical outcomes following TRT with FlowMedica's Benephit Infusion Systems, which were cleared for the infusion of physician-specified agents in the peripheral vasculature including, but not limited to, the renal arteries. The Benephit Infusion Systems have not received clearance to treat contrast-induced nephropathy or any other condition. Patients in the study reported at ACC were treated with TRT during a variety of endovascular procedures using contrast media, including diagnostic angiography, and interventional treatments for coronary or peripheral arteries.

Patients who suffer from diabetes, heart failure or impaired kidney function or are of advanced age are at particularly high risk for CIN; having more than one of these conditions adds to the patient's risk. CIN is estimated to occur in up to 30 percent of patients who may have risk factors.

"The patients in our study were at very high risk, with some having three or more risk factors, yet only approximately 10 percent developed CIN," Dr. Cohen said. "Although these results are preliminary, TRT appears to be a promising new approach that may avoid kidney dysfunction in patients at risk."

Key findings presented by Dr. Cohen at the ACC meeting include:

--There were only 4 reported minor complications, none of which had lasting patient impact.

--The renal arteries were accessed bilaterally within 2 minutes with use of minimum amount of dye in 95 percent of patients despite anatomic variations and significant vascular disease.

--Only 10 percent of patients at very high risk of CIN developed the condition, an estimated 65 percent reduction in relative risk when compared to the predicted CIN incidence in the same population using a validated, published model.

A number of strategies have been attempted to prevent CIN in at-risk patients, including administering medications and other therapeutic agents through systemic intravenous (IV) infusion. Systemic infusion of certain agents can cause serious side effects such as hypotension, the lowering of blood pressure. In addition, researchers believe that with systemic infusion, the amount of medication that reaches the kidneys often does not attain sufficient levels to have a therapeutic effect and, therefore, the treatment may not be effective, and can sometimes be harmful, as hypotension increases the risk of CIN.

Physician-specified medications delivered intra-renally via TRT in the patients studied included fenoldopam (83.3 percent of cases), sodium bicarbonate (10.2 percent) and alprostadil (6.5 percent).

The FlowMedica Benephit(R) CV and Benephit(R) PV Infusion Systems used in the study can simultaneously infuse medications and other therapeutic agents into both renal arteries using a single intravascular catheter. The Benephit CV Infusion System is being used clinically as a means to deliver TRT in patients undergoing interventional and diagnostic cardiovascular procedures.

About FlowMedica

FlowMedica, Inc., a venture-backed, privately held, commercial-stage medical device company located in Fremont, Calif., was founded in 2002, in collaboration with leading cardiologists and surgeons. Investors include: ABN AMRO Capital, De Novo Ventures, Medica Venture Partners, Mi3 Venture Partners, Oxford Bioscience Partners, and Palo Alto Investors. The company's initial solutions for TRT - the Benephit CV and the Benephit PV Infusion Systems - have received 510(k) regulatory clearance for the infusion of physician-specified agents in the peripheral vasculature including, but not limited to, the renal arteries. The Benephit family of devices also has been cleared for use in the European Union. The company's products have not received FDA clearance to treat contrast-induced nephropathy or any other condition.