Patients who find themselves suffering from acute decompensated heart failure (ADHF) are often brought into the hospital with difficulty breathing, adema and fatigue due to fluid buildup in their bodies.
This is often the start of a revolving door cycle of rehospitalization and deterioration, with half of discharged ADHF patients readmitted to the hospital within six months.
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Irish medical device company WhiteSwell is pitching a technology to better treat ADHF by finding an alternative route to decongest the fluid back-up caused by the heart’s inability to pump effectively and keep heart failure patients out of the hospital longer.
Currently, the standard treatment to remove this back-up is through a pharmacological diuretic, which focuses on draining excess fluid in vascular system through the kidneys and the bladder. However, this creates deterioration in renal function and often does not completely ameliorate the issue.
Where WhiteSwell differs in its approach is by targeting the lymphatic system to drain fluid in the body’s interstitial system tissue into the blood stream, which the company claims can create more completion decongestion without the renal issues associated with traditional treatments.
The company’s catheter-based device is meant to be used to treat patients acutely in a hospital setting by enhancing the fluid removal function of the lymphatic system.
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The company has recently raised a $30 million Series B financing round led by RA Capital Management and brought on experienced medical device entrepreneur Eamon Brady as its chief executive as it continues on its route to commercialization.
“We don’t have device competitors, nobody is treating ADHF through this method, and this is really a patient population in dire need of a new therapy” Brady said in an interview.
The capital infusion – which Brady said gives the company another three years of runway – will be directed at building out the second generation of the company’s device and pursuing clinical validation research. The company’s 15 person staff is also expected to double over the next year.
In the U.S. alone nearly two million hospitalizations are attributed to ADHF annually, double the number of hospitalizations due to stroke. Research has shown that up to 50 percent of ADHF patients are discharged without being fully decongested, which is one of the highest risk factors leading to hospitalization and mortality.
Currently, the company is about a quarter of the way through a feasibility study at sites including The Ohio State University.
“I am excited about the potential for WhiteSwell’s therapy to accomplish complete decongestion with preservation of renal function, which is considered the holy grail of ADHF treatment,” William Abraham, director of cardiovascular medicine at The Ohio State University, said in a statement.
“I was immediately intrigued by WhiteSwell’s ingenuity in targeting the lymphatic system, which plays a major role in fluid management, moving interstitial fluid into the vascular system.”
Before coming to WhiteSwell, Brady co-founded stoke device company Neuvari which he sold to Johnson & Johnson in 2017. The company’s EmboTrap device was later approved by the FDA under its 510(k) clearance pathway.
The 510(k) program has come under increasing scrutiny in recent years and the FDA is currently overhauling its approval process. As a veteran medical device executive, Brady said part of being an effective company in the industry is learning how to adapt to regulatory changes, instead of fighting them.
“I’ve been in this industry around 30 years and, in general, regulatory burdens get higher, not lower,” Brady said. “I’m not one of those people who try to oppose every new regulation, I accept that regulation is there for a good reason and my role is to find a pathway to navigate those expectations.”
Photo: BrianAJackson, Getty Images