As the COVID-19 outbreak continues to dominate the news, an increasing number of companies have come forward to help. For its part, CHF Solutions Inc., of Eden Prairie, Minn., is looking to bring its device-based intervention for fluid management to the fight.
“What we have is … a console and a disposable product that’s a filter set and a collection bag,” CHF Solutions CEO John Erb told BioWorld – the same day the World Health Organization declared COVID-19 to be a pandemic. “And what we do … is filter a patient’s blood, removing excess plasma water to remove fluid overload conditions.”
The fluid management-focused company’s first target was heart failure, and it subsequently expanded into cardiovascular surgery. Its solution also can be used in liver disease and sepsis.
There has been buzz that the company’s solution could help those affected by COVID-19. During the company’s March 3 fourth-quarter earnings call, Jeffrey Cohen with Ladenburg Thalmann asked whether the company was aware of any COVID-19 patients who had been treated with Aquadex. Cohen noted that he had seen a couple of blog posts and had inbound calls about this topic
“Interesting enough is just this week, we've had a couple of inquiries,” Erb replied. “So, we're pursuing that at this time. We also are pursuing it internationally because we have some strong use of our product in Italy, where there's certainly a large number of patients with coronavirus. So, it's at hand, we're looking into it, and I think there'll be an opportunity for us to help,” he added. He went on to note that he was not aware of any use up to that time.
These words could prove prescient, and that goes back to how the company’s product is used. Erb noted that hospitalized patients with the virus primarily are experiencing respiratory issues, with excess fluid building up in the lungs. “Because we have the ability to remove excess fluid, we can be helpful … [in terms of relieving] some of that respiratory issue with the lungs.”
Also, he noted that one of the primary protocols in treating these patients is similar to that for those suffering from sepsis. Clinicians administer certain drugs to COVID-19 patients, typically via fluid infusion. “Now, they have to give them fluids to fight the disease; they need to remove fluids because of the buildup in the lungs, and we can be a help to do that.”
Currently, the company is looking at where this product can fit clinically in treating these patients. To that end, it is hosting a webinar next week with three physician experts, with one describing the clinical need and protocol potential of using Aquadex to help these patients. “So, we’re in that learning phase of how we can best help,” Erb added.
Although a publication of findings on this front are expected, Erb sees that as coming farther down the road. “I think the need for this today is much greater than waiting for journal publication.”
Promising developments in 2020
This year already has yielded good news for the company, with an FDA nod for its next-generation console for use in adult and pediatric patients who weigh 20 kg or more. In a retrospective, multicenter study, 32 pediatric patients weighing more than 20 kgs and predominantly suffering from hypervolemia, or fluid overload, were treated with the Aquadex system, and 97%, or 31 of 32, survived to the end of therapy. In early February, the company received a CE mark for the same patient population.
“For many types of pediatric patients, the available therapies require very high relative extracorporeal blood volumes, which can be challenging,” Stuart Goldstein, professor of pediatrics and director of the Center for Acute Care Nephrology at Cincinnati Children’s Hospital Medical Center and a paid consultant of CHF Solutions. “The Aquadex Smartflow system allows us to initiate therapy with excellent hemodynamic stability due to the low extracorporeal value of 35 ml. In addition, the hematocrit monitoring feature helps caregivers maintain appropriate fluid balance in their patients.”
During the March 3 earnings call, Erb replied in response to question that a rollout of its product was ongoing to 20 pediatric centers. “Many of you will remember that our 510(k) application to allow pediatric use of Aquadex therapy was submitted a quarter later than originally planned. But by taking that extra time, we ended up with a more complete label, which puts us in a much stronger position to provide this therapy to the pediatric market,” he added.