Years of financial and safety woes in the implantable cardioverter defibrillator market haven’t scared off this early-stage medical device startup.
Asclepius Innovative Solutions (AIS Inc. for short) has retained its determination to bring some peace of mind to people with ICDs by making it easier for doctors to keep tabs on how the life-saving devices are working.
When former U.S. Army flight engineer Carlos Ortiz went back to college to get a degree in biomedical engineering at the University of Memphis in 2010, he found himself working on a group project that tasked students with designing an improvement to an existing medical device. Ortiz drew on the experience of his grandfather, who had died of heart failure.
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“The way the doctors explained it was that he didn’t die because of a condition or an incident, he died because of the time it took him to get to the hospital,” he said.
Ortiz wanted to design a better implantable cardioverter defibrillator that would make it easier for physicians to see what’s happening with the devices, which monitor the heart rhythms of patients with life-threatening arrhythmias and deliver electrical pulses when they detect irregular patterns.
His team, which included AIS co-founder Marsalas Whitaker, talked to two dozen cardiologists and electrophysicists in the Memphis area. Against a backdrop of troubling reports of malfunctioning leads, they communicated demand for a leadless ICD with a better way for physicians to manage data coming from it. So his team got to work creating the device, which it now calls Guardian.
Designed with pediatric patients in mind, it’s as minimally invasive as possible to accommodate growth and eliminate the need for risky lead placement and extraction procedures, Ortiz said. Instead, it uses two shock plates that are implanted on the front pectoral muscle on the right side of the chest and on the rib area on the left side of the chest.
Those are connected to a battery and generator which are adhered to the body externally. That piece, which is smaller than 3 square inches, also includes GPS and Bluetooth modules. “Once the patient goes into fibrillation, if it’s not corrected we are able to tell first responders where the patient is,” Ortiz said. “And if the components (of the device) malfunction or the battery is near depleted, we get a signal and can notify the cardiologist or the patient.”
There’s still a long way to go before the device could even be tested in humans, though. Ortiz said his team is currently working on creating bench top prototypes of the device to use in proof-of-concept studies. From there, it will manufacture working prototypes and begin animal trials.
“The electronics are really very simple, and the implementation of it is very simple,” Ortiz said. “Making sure it interfaces with human body the right way is very complex.”
That’s the problem that the companies already in the ICD market have had over the past several years. The market hit bottom last year, in the words of one Goldman Sachs analyst, but Medtronic CEO Omar Ishrak said last year he sees a light at the end of the tunnel. For one, Boston Scientific launched the first leadless or subcutaneous ICD earlier this year (developed by Cameron Health, which BSX bought in 2012), and apparently demand is already outpacing supply.
For AIS, its immediate success hinge on its ability to secure funding and partnerships. The company is nearing completion of the ZeroTo510 accelerator program and will present at demo day Thursday.
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