By Brian Marckx, CFA
Expanding Potential Applications for RenalGuard
PLC Systems' (PLCSF) RenalGuard fluid-matching system has been studied in two randomized, open-label investigator-sponsored clinical trials, MYTHOS and REMDEDIAL II, both conducted in Italy. Both studies indicated RenalGuard was more effective than standard of care in reducing the incidence of contrast-induced nephropathy in at-risk patients undergoing coronary angiography/PCI (which is essentially the label that PLC is pursuing for the U.S. market). Results of the studies were published in highly-respected peer-reviewed journals and REMEDIAL II was presented in 2011 at ACC, considered the Super Bowl of cardiology conferences. RenalGuard is currently being studied in a pivotal U.S. clinical trial which (assuming positive results) is expected to support a PMA filing for FDA approval.
While the earlier pivotal trials largely focused on patients undergoing coronary angiography/PCI, RenalGuard is also being investigated for other applications and procedures where patients are at high risk of acute kidney injury. Along with use during coronary angiography/PCI, these additional applications for RenalGuard could benefit PLC Systems - particularly over the longer-term.
One such application is during transcatheter aortic valve implantation (TAVI), a minimally-invasive procedure where diseased aortic valves are replaced. Similar to PCI, the procedure requires the use of a contrast agent. Also similar is that patients that undergo both PCI and TAVI are often relatively sick and many times have impaired kidney function. As such, contrast agents, which are processed through and can be toxic to the kidneys, can put these patients at particularly high risk of renal failure and contrast-induced nephropathy.
PLC Systems and researchers at hospitals in Israel have been investigating the use of RenalGuard in patients undergoing TAVI. In May data using RenalGuard was presented at the International Conference of the Israel Heart Society in a session titled, "Incidence of Acute Kidney Injury in the Patients Undergoing Surgical TAVI", by Dr. Eyal Nacum of Sheeba Hospital in Petah Tikvah (Israel).
Also in May of this year data from RenalGuard therapy was presented at EuroPCR. The presentation, titled, "Minimizing Acute Kidney Injury During TAVI Procedures", detailed how RenalGuard can be safely used during a TAVI procedure. Dr. Vaikom Mahadevan, who is a Consultant Cardiologist at Manchester Royal Infirmary and made the presentation noted that, "RenalGuard has performed very nicely in this difficult patient population. My experiences so far lead me to believe that RenalGuard can be used effectively as a treatment for TAVI patients with renal impairment to reduce the risk of renal function deterioration."
These earlier studies have culminated into a larger hospital-initiated study being conducted at Tel Aviv Sourasky Medical Center in Isreal by Dr. Yaron Arbel, the Director of the hospital's Cardio Vascular Research Center. The trial, which PLC first announced in September, will enroll up to 200 patients. The goal of the study, called The Effect of the Forced Diuresis With Matched Hydration in Reducing Acute Kidney Injury During TAVI (REDUCE-AKI), is to evaluate RenalGuard versus placebo in preventing acute kidney injury in patients undergoing TAVI. Final data collection is anticipated in late 2015.
While the number of TAVI procedures done worldwide is only a small fraction of the number of coronary angiograms/PCI (~75k TAVI vs. ~7 million PCI), TAVI is still a relatively new procedure will procedural volume expected to grow exponentially.
Another potential application, which PLC Systems had not previously talked much about, is following kidney transplant. PLC's press release today mentions that RenalGuard was successfully used with a patient whom underwent kidney transplant in a hospital in Brazil. There are roughly 70k kidney transplants performed worldwide every year.
While we think RenalGuard's most significant opportunity remains with use during coronary angiography/PCI, these ancillary applications, both of which are expected to exhibit significant growth over the near-to-mid term, offer potentially attractive complements and meaningful additional sources of revenue for PLC Systems.
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By Brian Marckx, CFA