Another victim of the deflated market, PLC Systems (Franklin, Massachusetts) is tightening its belt and deferring the start of a U.S. pivotal trial for its RenalGuard product, which would be the first real-time, automated fluid-balancing system to prevent contrast-induced nephropathy (CIN).
PLC will continue to support an investigator-sponsored clinical trial ongoing in Italy as well as the limited market launch of RenalGuard in Europe, which began in the first quarter of this year, both of which are focused on the CIN prevention market.
"We felt we didn't have sufficient funding to finish the [pivotal U.S.] trial and you don't want to put hospitals in an uncomfortable position. The right thing to do is to delay the start," PLC President/CEO Mark Tauscher told Medical Device Daily. "Delaying the trial puts us in a position to conserve more cash. From a corporate point of view it reduces the amount of money we'll spend in the next several months and it will give us time to see what the data from the Italian study shows."
Tauscher said the company remains in a satisfactory position, with "good" data coming in from the Italian studies (although none that could yet be released) and two months of RenalGuard sales in Europe. When the stock market turns a little more positive and the company's shares rise, he's hopeful more investors will buy PLC stock, which is currently trading at about 33 cents a share. It traded as high as $0.62 cents a share in the last year.
Tauscher said he expects data from those Italian studies to be released this fall or in early 2009 during the medical meetings season.
The market for RenalGuard, which will sell for $10,000 to $15,000, addresses problems associated with CIN in cath labs. It's a condition whereby nephrons, or cells specific to the kidneys that filter those organs, are seriously injured or damaged by contrast media, reducing their ability to function. And as procedures such as angioplasty and drug-eluting stent placements become more common, CIN is likely to increase — and with it the mortality related to CIN.
Therapy using RenalGuard is intended to reduce the incidence of CIN by managing real-time fluid balance and diuresis in conjunction with interventional procedures, such as percutaneous coronary intervention and other radiology procedures requiring contrast media (MDD, March 20, 2007).
Studies indicate that between 15% and 20% of all patients undergoing image-guided cardiology and radiology procedures are at risk of developing CIN, the company said, with estimated mortality rate for those acquiring CIN as high as 35%.
In real time, the system measures urine collected via a Foley catheter and then signals the system to pump the same amount of saline back into the patient via an IV to ensure that the patient does not become dehydrated with the additional loss of urine.
A platform technology, RenalGuard has a number of potential applications from kidney transplants to chemotherapy and even in intensive care units.
For example, when chemotherapy cisplatin is used, inducing high urine flow rates is a standard of care. In post-kidney transplant patients, healthcare providers are careful to monitor and replace fluid losses, avoiding the risk of damage to the transplanted kidney.
"There are no products out there that do what RenalGuard does ... no automated device," Tauscher said, adding that PLC is continuing to work with the FDA to secure full approval of its study protocol so that it's well positioned to start the trial when financially ready. It received conditional approval in March.
PLC received the CE mark for RenalGuard at the end of 2007 (MDD, Jan. 2, 2008).
In March, PLC entered into a three-year exclusive agreement with Artech (Cavezzo, Italy) for distribution of RenalGuard in Italy. As part of the agreement, Artech placed an initial stocking order for 190,000 (roughly $144,000) for RenalGuard Consoles and single-use sets to support the initial sales launch of RenalGuard at selected cardiology centers throughout Italy.
In May the ethics committee of the Centro Cardiologico Monzino (CCM) University of Milan (Milan, Italy) approved a planned randomized clinical trial to evaluate the use of RenalGuard in the prevention of CIN in high-risk patients undergoing catheterization procedures at its institution.
Investigators for that trial are Antonio Bartorelli, MD, director, interventional cardiology at CCM and professor of cardiology at the University of Milan, and Giancarlo Marenzi, MD, chief of the intensive cardiac care unit at CCM.