Time is muscle, or so the saying goes in the cardiology community. One medical device company is putting that mantra into practice with an implant designed to provide an early warning system to its owners of an oncoming heart attack even before they experience symptoms. The hope is that it will prompt the wearer to seek treatment faster, improve patient outcomes and reduce the likelihood of developing scar tissue.
Angel Medical Systems‘ Guardian System implant is nearing the end of a Phase 2 pivotal trial and will soon be assessing data from the trial. The device has already received CE Mark approval in Europe.
A recent financing round by Shrewsbury, New Jersey-based Angel Medical System indicated the company completed $27.5 million in financing, according to a company statement. CFO Andrew Taylor clarified that about $14 million of that is tied to meeting certain operational milestones associated with the Phase 2 trial.
The new financing would help the company complete the Phase 2 trial. If efficacy endpoints are met, the company would file for premarket approval next year, David Fischell, Angel Medical Systems CEO, said in a statement. It will also be used for research and development work for its next generation ischemia monitoring device, and continued expansion and commercialization in Europe and Brazil.
The trial, in which 660 patients in the US and Brazil participated, is looking at clinical benefits received by patients who are notified of any significant change in their EKG compared with their baseline by vibration, audio and visual alerts on a mobile device, spurring them to seek treatment earlier than they otherwise might. The company is assessing whether this will lead to better clinical outcomes and a better standard of care than without the device.
“Detecting and warning patients at the earliest stage of coronary occlusion would allow us to shift the paradigm for treatment forward to the onset of the heart attack, which we believe could significantly improve clinical outcomes,” Fischell said in the statement.
Every year, about 935,000 people in the US suffer a heart attack and for two-thirds it is their first heart attack, according to the Centers for Disease Control. The idea is that the device could take the guesswork out the process both on the patient’s end and in the triage process when people with the device seek treatment.