Creating a smarter pump for heart failure

A “bench-to-boardroom” program at NHLBI helps researchers bring to life new concepts, therapies, and devices, including an update on a familiar pump 

Few people think about what would happen if the main pumping chamber of their heart stops working – especially what options doctors may have to fix it. But Richard Smalling, M.D., Ph.D., has studied this question for years. And he believes he has found an answer – a new heart pump design – that is already stirring excitement in the research world.   

Smalling is the CEO of Windmill Cardiovascular Systems, Inc., in Austin, Texas, and he and his team have been studying heart failure for a long time. They know that when the left ventricle of the heart can no longer effectively pump blood to the rest of the body, blood backs up into the lungs and causes a host of life-threatening problems. Currently, most patients who develop this condition rely on a left ventricular assist device to take over and pump blood throughout the body. In some cases, doctors may use this device until a heart transplant becomes available. In other cases, the device serves as a substitute for a heart transplant.      

“The current pumps are all centrifugal or axial-flow pumps that spin at very high RPM, which means that they are sort of like wearing blenders for the blood,” Smalling explained. In other words, molecules that help the blood clot get spun around and chopped up, which can increase the risk for bleeding. Conversely, platelets that support blood clotting can be activated and increase the risk for stroke or other complications.      

To minimize these effects, Smalling and his team have developed a new device that “pumps, basically, with the patient’s heartbeat.” This means it doesn’t turn around as fast and break up blood or its components. “That means less risk of stroke, less risk of right heart failure, and less risk of GI bleeding,” Smalling said. “And, probably, less risk of infection.”    

It all adds up to what tests show is a safer pump, Smalling said. “A much safer pump.”       

On April 2, researchers, clinicians, and several judges at a competition listened to Smalling’s “pitch” for TORVAD, a toroidal ventricular assist device. The judges agreed and TORVAD won the NHLBI-sponsored Innovation Pitch Challenge at the American College of Cardiology’s 71st Annual Scientific Session and Expo in Washington, D.C. After the presentation, potential investors even reached out to express interest in the device.

Smalling explained that, in addition to being gentle on the blood, the pump features a new compact design, plus, other benefits for patients. For example, the device enables users to move around for up to six hours – including while exercising, such as jogging or swimming, or taking a bath – without needing to be charged or connected to an electric outlet. The pump, which sits inside the chest cavity above the abdomen, synchronizes with the person’s own heart pumping and adjusts its level of support based on their activity. It’s also designed to be recharged through their skin using an electromagnetic charging system. “That’s a big advance,” Smalling said.       

As he and his team update the design, they are working with manufacturers to build production model devices for patients with advanced heart failure and class III heart failure, which can limit movement, and for pediatric patients with heart failure. Within a few years, they plan to test the device by enrolling patients with advanced heart failure into clinical research trials.     

Stephen Flaim, Ph.D., a senior special advisor and investor-in-residence at NHLBI, helped Smalling and three other companies prepare for the Innovation Pitch Challenge. A unifying goal was to work with CEO’s to quickly pitch their concept and “go-to-market” strategy in five minutes or less.  

This is something that Flaim has done for more than a decade while helping NIH-supported researchers and small companies bring new devices, products, or concepts to a healthcare market. This means helping researchers think not just about the science and technology behind their discoveries, but about global competition, the current market, and how to scale their products. In other words, he helps researchers think less like professors and more like investors.  

“It’s really no longer bench-to-bedside,” Flaim added. “It’s bench-to-boardroom.”  

In order to impact healthcare, he said, you need to get the product to the patient. “It takes a commercial entity to make that happen.”      

Flaim, who was also a judge for a different Innovation Pitch panel, mentioned that companies looking for early-stage investments are going to be evaluated by how investable they are.    

Investors may start to assess a product by looking at the CEO and team. Who are they? How well do they “sell” their concept to investors? Is the concept ready to bring to market? Who are the customers? What makes that device or concept different from others that are currently available?        

Then, practical considerations fall into place.   

This includes projecting revenue streams, predicting when a company will generate a profit, and providing exit strategies for early-stage investors.       

He underscored that strategies used to commercialize a product are different than those used to support a successful clinical trial. That’s where partnering with a skilled business person or receiving business coaching can help academic researchers and investigators translate their ideas and designs into products that they created to ultimately help patients.       

Through the Office of Translational Alliances and Coordination (OTAC) at NHLBI, researchers and advisors, like Flaim, provide this kind of support.

Smalling, Windmill’s CEO, received early support through the Small Business Innovation Research program at OTAC shortly after he and other researchers in Texas finalized the prototype for the smart pump in 2008. As Director of Interventional Cardiovascular Medicine at McGovern Medical School at UTHealth Houston and Memorial Hermann Heart and Vascular Institute at Texas Medical Center, he and his colleagues have continued to update and test the model.

So far, Windmill has secured six patents for the device and is filing for others, as well as patent extensions. The plan is to bring the device to the U.S. first and then expand to a global market.

Smalling said he values the business coaching he has received while working with Flaim and other researchers at NHLBI over the past several years. He also noted the early seed funding from the National Institutes of Health, which now totals about $6 million, has been essential to create a concept for a heart pump that was once considered impossible to develop.     

He also hopes the toroidal ventricular assist device, which some have called a “salvation of circulatory support,” will not only help people with heart failure, but change the field of circulatory support.       

To learn about OTAC at NHLBI, visit https://www.nhlbi.nih.gov/about/divisions/division-extramural-research-activities/office-translational-alliances-and-coordination.       

To learn about similar programs at NIH, such as Small business Education and Entrepreneurial Development (SEED), visit https://seed.nih.gov/.