Pay attention to Procyrion over the next several months. CEO Benjamin Hertzog tells MassDevice.com that the company plans on heading to the clinic with a device that could heighten competition among makers of cardiac assist devices.
The Houston-based startup plans to begin 1st-in-human trials of its Aortix catheter-based heart pump in the 1st half of 2016.
Other companies, most notably Abiomed (NSDQ:ABMD), are already in this space. St. Jude Medical (NYSE:STJ) is looking to enter the percutaneous pump market with the HeartMate PHP device it acquired in the $3 billion buyout of Thoratec earlier this fall. Abiomed Impella pump, designed to treat severe heart failure, is the only FDA-approved device so far. But it’s approved for a 6-hour maximum treatment time, and Impella patients are also typically confined to ICU beds. Procyrion hopes that trials will show that Aortix will work far longer in the body, as a treatment for chronic (less serious) heart failure that actually helps patients get out of bed and move around.
“You can use [Aortix] short-term, like the Abiomed devices, but can also use it a couple of days or weeks,” Hertzog told us during a telephone interview. “Ultimately, we hope it is a device that can be used for 6 months or longer.”
Procyrion also pitches its Aortix device as having no stroke risk and safer to use. A $10 million Series B round announced in early October will help propel Procyrion’s 1st-in-human study. A pilot study is also envisioned for the 1st half of 2017 (for which more fundraising will be needed) ahead of possible pivotal trials to back approval bids in the U.S. and Europe.
Hertzog said investors seemed keen on the opportunity.
“We set out to raise $10 million, and ended up being oversubscribed, and had to turn some people away. We’re very pleased with the outcome,” he said.
Seed investor Fannin Partners participated in the round along with Scientific Health Development and an unnamed strategic investor. Pressed on the identity of the unnamed investor, Hertzog would only say that it’s a “large public medical device company.”
Hertzog was also coy about whether the strategic’s involvement includes a buyout option if Aortix performs well in trials, saying only that “most large companies, when they do investments like this, [it] is because of interest in the technology or indications. They are investing because they see this as a way to fill their portfolio of products.”
Aortix is an interventional catheter-based heart pump, designed to use fluid entrainment to help assist the heart muscle and boost localized blood flow. Rather than operating in the heart, it is suspended in the aorta. Procyrion frames Aortix as a device that works for patients in Stage III to early Stage IV heart failure who don’t need a full cardiac replacement. It’s also envisioned to work quickly.
“We developed a device … that can be put in and immediately get a patient up and ambulated,” Hertzog said.
Founder & chief medical officer Reynolds Delgado III launched Procyrion in 2005, though seed funding did not come through until 2007, and the company debuted under its current management in 2010. Delgado is medical director of mechanical support devices in heart failure at the Texas Heart Institute.
Procyrion employs 7 full-time workers, though plans call for adding a few more in the coming weeks, Hertzog said.
Assuming all goes well, Procyrion may pursue a full CE mark indication next, something that device companies have done more often in recent years due to an often-quicker regulatory process. Hertzog said the company could change course, however, and go for the FDA sign-off 1st, due to some positive changes meant to improve how long it takes to bring innovative technology to market.
“The FDA is getting very aggressive about putting programs in place to bring early, innovative technology to the U.S. before other places,” Hertzog said. “We are … looking very carefully about opportunities to do this in the U.S. 1st. We haven’t made any decisions yet, but are really pleased with the progress we are seeing.”