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| Cardionomic CEO Steve Goedeke |
Minneapolis-based Cardionomic spun out of the Cleveland Clinic and into NEA's Denali II incubator. Now, it's graduated to a $20 million round backed by those two, as well as strategic investor Greatbatch ($GB)--which is in the process of spinning out its own neurostimulation business.
Led by President and CEO Steve Goedeke, the former head of Denali II, who prior to that was a senior director of Medtronic's ($MDT) Cardiac Rhythm Disease Management division, Cardionomic will continue the development of its neuromodulator to treat acute decompensated heart failure (ADHF).
"Current ADHF approaches, all of which use drug therapies, inadequately treat the condition and have not improved over the past decades," said Cardionomic CMO Dr. William Abraham in a statement. "The Cardionomic therapy targets the primary cause of worsening heart failure, namely decreased myocardial contractility." The expectation is that increased contractility will improve the pumping performance of the heart.
There are various biopharma ADHF treatments used that include inotropes--which increase contractility but have not been shown to improve patient outcomes while they increase in-hospital mortality, the company noted.
Based on tech in-licensed in 2012, Cardionomic's device is designed to increase heart contractility thereby reducing negative hormonal signaling and improving in-hospital morbidity/mortality rates. It's also expected to improve cardiac output, renal blood flow, urine production and pharmacological tolerance. The device is expected to work in combination with oral medications.
"This targeted increase in contractility rebalances hemodynamics to normalize blood flow to organs, such as the kidneys and brain, and restores kidney function to eliminate fluids. It thereby treats both the root cause of ADHF and its symptoms," said Abraham.
The Cardionomic device stimulates the cardiac nerve branches and is expected to address the root cause of ADHF, rather than merely offer the standard-of-care of symptom management. It's expected to be used upon patient hospital admission and to remain for one to three days before removal.
There are more than one million ADHF hospital admissions in the U.S. annually with associated costs of more than $10 billion, according to the American Heart Association (AHA). Almost one-quarter of them are readmitted within one month of treatment, with half of them hospitalized again within 6 months. That can pose a problem for hospitals, which face financial penalties from payers for a patient readmission within 30 days.
"Extensive pre-clinical and human data gathered over the past three years demonstrates our therapy improves cardiac contractility in heart failure patients," summed up Goedeke. "This evidence, along with the pressing need for a new approach to treat ADHF, helped drive our successful first-round."
- here is the announcement