After securing Medicare reimbursement for its pacemaker-like heart failure (HF) implant, Impulse Dynamics has raised more than $158 million to boost its production and commercial push.
According to the company, the national coverage determination from the Centers for Medicare and Medicaid Services issued this past October expands the reach of its Optimizer system and cardiac contractility modulation (CCM) therapy to more than 66 million people in the U.S., including those with severe chronic heart failure who haven’t seen success with standard medications.
CCM delivers electrical signals to the heart’s muscle tissue to help improve the strength of each beat at the cellular level, ultimately helping the organ pump oxygenated blood out to the body.
The approach also scored Category 1 CPT codes over the summer, following sponsorships from the American College of Cardiology and the Heart Rhythm Society, and was previously selected for CMS’ Transitional Coverage for Emerging Technologies review pathway, known as TCET. It was first approved by the FDA in 2019.
The new funds came courtesy of first-time investors including, Sands Capital and Braidwell, as well as from returning backers at Redmile, Perceptive and Alger, according to the company, which also posted a nine-figure funding round in February 2024.
“This support recognizes the evidence-based outcomes of CCM therapy, with over 12,000 patients implanted to date and opens the pathway to greater care for HF patients,” Impulse Dynamics CEO Jason Spees said in a statement.
“As the [national coverage determination] removes a significant barrier to access by providing coverage and reimbursement for a substantial patient population, this investment will help expand access to CCM therapy to more HF patients in need,” Spees added. “Furthermore, it will accelerate the ongoing development and future commercialization of the CCM-D HF System, a single device designed to deliver CCM therapy for the treatment of HF symptoms along with lifesaving, implantable cardioverter defibrillator therapy.”
The company said its pivotal trial of the combination CCM-D HF implant, dubbed INTEGRA-D, completed enrollment this year and that initial results have shown 100% defibrillation success.
Impulse Dynamics estimates that more than 100,000 new implantable cardioverter defibrillators are installed annually in the U.S.—adding up to about 800,000 in current use—but while those devices may provide lifesaving shocks, they do not address heart failure symptoms, providing an opportunity for CCM signals to be incorporated into their programming.
The company has also launched a U.S. study in patients with heart failure with preserved ejection fraction, or HFpEF, where the left ventricle can become stiff or thickened and has trouble filling with blood. This indication represents about half of all heart failure patients, and Impulse Dynamics claimed a CE mark approval in Europe for this population this past March.