The RenalGuard device measures urine output and based on that infuses fluids into patients with risk of damaging their kidneys during cardiac interventions.
The fear of acute kidney injury prevents many doctors from suggesting that their patients undergo cardiac interventional procedures which require the use of contrast. This extends to certain kinds of vascular imaging as well.
But one company that recently raised $14.5 million hopes that its product can allow patients to undergo procedures in the catheterization lab requiring contrast, while also saving the kidneys. Contrast-induced acute kidney injury can be fatal.
RenalGuard Solutions has developed the RenalGuard system, which constantly measures a patient’s urine output and automatically infuses fluids based on that urine output. This ensures that the kidney is not getting damaged by the contrast media that has to pass through that organ.
In March, RenalGuard based in Milford, Massachusetts raised $14.5 million from investors led by Exigent Capital and existing investor Genesis Capital Advisors and other private equity investors.
The product won CE Mark in 2008 but given the economic meltdown which commenced that year meant the U.S. pivotal trial was put on hold, said Andrew Halpert, president of RenalGuard Solutions, in a phone interview earlier this year.
“But because we had CE Mark and we had some experience in Europe, we both generated some sales and a large amount of clinical data, which has now gotten to 1,500 patients worth of clinical data in Europe,” Halpert added.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Six years later, the pivotal trial began in 2014 and the company is slowly enrolling patients. The hope is to enroll 430 per FDA guidelines for the investigational device’s clinical trial protocol. RenalGuard comprises of a console and a disposable set for fluid infusion and urine collection.
So when is the RenalGuard system used?
“Our patients are fundamentally those who are hospitalized,” Halpert explained. “They may be outpatients but RenalGuard was designed for use immediately before, during and after an interventional procedure in the cath lab.”
The current standard to prevent contrast-induced acute kidney (CI-AKI) injury in patients who have elevated creatinine levels is to pump with fluids overnight before the intervention as well as with sodium bicarbonate hydration. Clinical studies have shown that RenalGuard is more effective than these methods, according to the company’s website.
“We are doing three things: We are flushing the contrast through the kidney so it’s not clogging up; we are reducing the contact time of the contrast and paradoxically letting the kidney rest,” Halpert said.
Data presented at the annual meeting of the American College of Cardiology in March showed that the device can be associated with “reduced risk of mortality, major adverse cardiovascular events, and the need for post-procedure dialysis,” per the company’s news release.
The incidence of CI-AKI in RenalGuard-treated patients was 8.7 percent whereas those in the control group had a much higher number — 23 percent.
The data was based on an independent meta-analysis presented as a poster by the Texas Health Sciences Center in San Antonio.
Halpert expects to complete enrollment at the end in the pivotal trial by the end of the year and file for approval next year. If FDA approves the product, American patients may be able to undergo procedures that they have shied away from.
“We think there’s a market on its own for RenalGuard but there’s also a potential for RenalGuard to have a larger market impact and patient impact by opening up access to these other procedures in the cath lab,” such as transcatheter aortic valve replacement, Halpert said.
Photo: RenalGuard Solutions
