A Medical Device Daily

Cleveland Clinic spinoff Cleveland HeartLab (both of Cleveland) has completed a $3 million fundraising round.

Investors in the round included Glengary, Second Generation and Zapis Capital Group, all in Northeast Ohio, according to the company.

Cleveland HeartLab is a clinical reference laboratory specializing in cardiovascular disease prevention, diagnosis and management. The company operates a CLIA-certified and CAP-accredited lab where it analyzes samples for markers of inflammation that put patients at increased risk for heart disease.

The company also is developing tests for inflammation biomarkers based on research licensed from the Cleveland Clinic.

"The proceeds will be used to do three things, primarily," said Cleveland HeartLab President/CEO Jake Orville. "First, expand our sales and marketing efforts, and our reach out of the region. Second, is to build up our operations internally. And third is to continue to advance valuable Cleveland Clinic technology and get it into the market."

Cleveland HeartLab already has one FDA-approved test that detects an enzyme called myeloperoxidase (MPO) in the blood. Certain levels of MPO can identify people who are at risk for heart attack, stroke or death, said Stanley Hazen, the Cleveland Clinic staff physician whose research led to the test, called CardioMPO.

That test was commercialized by an earlier clinic spinoff – Prognostix – which no longer exists, Orville said. While Cleveland HeartLab does the CardioMPO test at its lab as a service for clients, Prognostix tried to commercialize the test as a kit that clinicians could use themselves. The Prognostix model didn't work, said Orville, who also was leader of that company.

Cleveland HeartLab, which has hired four people and expects to hire between 30 and 40 within the next two years, is working to develop a few other tests based on Clinic research, Orville said. "'Develop' means take the science from the clinic, bring it into our lab, commercialize it and get it out to the market," he said.

Three weeks ago, Hazen, who has been named Cleveland HeartLab's chief scientific officer, and his colleagues were awarded a $9.2 million National Institutes of Health grant to develop a deeper understanding of the mechanisms linking inflammation to cardiovascular disease and its consequences.