The bi-ventricular capabilities of the device mean that it can be used a variety of heart failure situations and the fact that it doesn’t touch the blood means decreased risk of adverse effects.
Altman said the company first hopes to be a complementary option for patients unable to use existing devices, a market size CorInnova estimates at more than $1.5 billion.
“We don’t even have to compete directly and we would have the basis for even a large public company,” Altman said.
The company’s business thesis is initially built around filling a gap in the market by providing a safer alternative for patients needing a cardiac-assist device for two to seven days.
Some potential use cases include patients who have short-term injury due to heart attack, mothers suffering from peripartum cardiomyopathy or as a bridge therapy that could help inform future procedures and clinical decision-making.
CoInnova is still in its early stages of clinical validation and has undertaken 20 large animal studies for the device. Moving forward the company is looking to perform longer-term studies to further test the effectiveness and safety of its technology.
Altman said the company is planning on having pre-submission meetings with FDA this year to receive breakthrough device status and do the legwork necessary to do its first in-human studies sometime in the next three years.
Ultimately, CorInnova’s hope is develop a technology for heart failure patients that could be used in both short-term and long-term situations.
“We think for the treatment of long term patients it could be really transformative,” Altman said. “Both my father and my father-in-law died from heart failure. Talking to my father-in-law, who was a cardiologist, he said a device like this would have changed the game for him.”
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