Houston Medtech Firm Procyrion Aims to Help Heart Heal Itself
Procyrion says it’s developed a crutch for your heart.
The Houston medtech startup’s device is called Aortix, a circulatory support pump that is thinner than a pencil and can be implanted in the aorta, the major artery coming from the heart, through a catheter threaded up from the thigh through the femoral artery. The device is designed to help heart failure patients by pushing more blood through the circulatory system and on to vital organs.
“The heart just needs a little bit of help,” says Will Clifton, Procyrion’s director of research and development. “We’re not replacing the function of the heart. We’re assisting the function of the heart.”
Heart assist pumps aren’t new. In the 1980s, researchers developed so-called left ventricular assist devices (LVAD) that take blood from the lower chambers of a failing heart and pump it to the rest of the body. Doctors implant about 4,000 of these devices, now in their third generation of technological development, in American heart patients each year.
Those LVADs are credited with prolonging the lives of patients with congestive heart failure, a disease that currently afflicts nearly six million Americans. But implanting the devices requires cracking open patients’ chests in expensive open-heart surgery. The devices also are large and cumbersome—too large to be used in some small patients. And in up to in 11 percent of patients, implanted LVADs cause strokes.
Reynolds Delgado, a Texas Heart Institute cardiologist, was one of many doctors who managed the care of patients with implanted LVADs. He thought there must be a better technology. “I knew the practice had to be reduced to a catheter procedure,” he says. A good analogy, he says, is in coronary artery disease, where coronary stents inserted with catheters have reduced the need for bypass surgery. Those stents “have revolutionized treatment of [coronary artery disease] and heart attack,” Delgado says.
In 2007, he had an idea for that better approach. Instead of pulling blood out of one of the ventricles, or chambers, of the heart, running it though a pump and then pulling back into an artery, he thought, why not leverage advances in micro-pump technology to place the pump directly inside an artery to give the heart a boost? “Trying to mimic what your own heart does in a machine is a lot more complicated than you would think,” Delgado explains. “Therefore, don’t try to do it. Let your heart do what it does; just assist it.”
Delgado and his team built a prototype, which they named Aortix, and then created Procyrion to commercialize the device. In 2013, the team tested it both in large animals—swine, calves, and sheep—and human cadavers. The studies showed that the device is able to boost cardiac output by 10 percent. Now, the company plans to conduct a pilot study in humans next year, the next step in the process of getting approval from the Food & Drug Administration.
Procyrion isn’t the only company seeking to move beyond the LVAD. William Altman, CEO of medtech company CorInnova, has also seized upon the idea of “helping the heart work better.” “In heart failure, the motion of the heart becomes aberrant,” he explains. “The heart is enlarged and so the motion is floppy and poor. We have developed a device to surround the heart, to try to correct the motion of the heart to help it move correctly.”
CorInnova’s approach, which comes out of research from Texas A&M University, involves a plastic encased wire framework that surrounds the heart like a girdle. The device, called CardiacStar, contains two sets of chambers. The innermost is filled with saline to allow the device to conform to the shape of the heart. The outermost pumps air to gently squeeze the heart to increase output, Altman says. The company claims that the device can be implanted with a minimally invasive surgery.
Altman added that animal studies show that output is increased by 50 percent. He added that the device has also shown that it can aid patients with diastolic heart failure, which is where the heart fails to fill. CorInnova, which was founded in 2005 in Houston, has raised about $2 million in grants and angel funding, and plans a Series A equity round of as much as $6 million next year to fund a human trial.
The approaches taken by both Procyrion and CorInnova make sense, given the limitations of LVADs, says Rick Anderson, managing director at PTV Sciences, a healthcare venture capital firm in Austin. Given that heart failure is the single most expensive condition requiring hospitalization—adding up to $32 billion a year, according to the Centers for Disease Control—cardiologists are keen for new tools to treat patients.
“There’s a really big unmet need, and advancement in technology seems to be accelerating,” Anderson says. “You have to try to keep these patients healthy enough to keep them out of the system.”
The potential market for both new devices is enormous. One in five adults over the age of 40 will develop heart failure, which reduces the organ’s ability to push out blood throughout the circulatory system. That in turn, ends up starving vital organs such as the kidneys. Many of these patients can be treated for years with drugs. But about two million Americans require more help than medication can provide—and many of those patients are not sick enough to warrant the invasive surgical procedure needed to implant an LVAD. “And when you’ve exhausted all medical methods of treatment, you need a heart transplant,” Altman says. “There have been only 2,300 transplant a year constant for the last 10 years in the U.S.”
Powered by an external battery connected by wires (future devices may work wirelessly), Procyrion’s micro-pump helps to push the blood along, taking the load off of the heart in doing that work, Delgado says. Doctors should be able to insert it in 10 minutes in an outpatient procedure, at one-tenth the cost of implanting an LVAD.
Procyrion and Delgado hope that in congestive heart failure patients, Aortix could provide enough blood-pumping support to actually slow the heart’s inevitable decline—perhaps even enough to completely eliminate the eventual need for an LVAD. “Even at 20 percent or 30 percent of these patients who would have received an LVAD, this is a major public health improvement and a major cost benefit,” says Delgado. It could make the treatment of heart failure almost as simple as treatments that help other parts of the body to heal, he adds. And the fact that the device is placed downstream of the carotid arteries, which supply the head and neck with blood, eliminates the risk of stroke.
The company has raised about $150,000 in seed funding from Alpha Dev, an early-stage investment company in life sciences now known as Fannin Innovation Studio, for proof of concept studies. Last year, the company also received $3 million in a Series A round from both angel investors and a $1.5 million grant from the Texas Emerging Technology Fund.
Aortix has attracted at least one high-profile supporter for its efforts, heart surgeon and medtech inventor William Cohn, director of Center for Technology and Innovation at Texas Heart Institute in Houston and a colleague of Delgado’s. Cohn designed the wire mesh anchors that expand like an umbrella to hold the device in place.
The device, he says, could make the treatment of heart failure far simpler.
“If you have a person who is limping along, they have arthritis of the ankle, that arthritis gets worse and the ankle falls apart,” says Cohn, who is also an Xconomist. “But give them a crutch or a cane earlier in the illness, the ankle will maybe never ever get that bad.” Aortix or Corinnova’s CardiacStar could do the same for an ailing heart.