Dive Brief:
- Impulse Dynamics said Wednesday that it has raised $158 million to commercialize and further develop its heart failure treatment.
- The Food and Drug Administration approved Impulse’s Optimizer system in 2019. The product is a cardiac contractility modulation, or CCM, device and is designed to strengthen heart contractions.
- Impulse, which raised $136 million last year, closed the latest funding round weeks after the Centers for Medicare and Medicaid Services covered CCM with evidence development.
Dive Insight:
CCM devices are distinct from the implantable cardioverter defibrillators, or ICDs, that physicians use in some people with heart failure. While ICDs prevent fatal arrhythmias, CCM devices are designed to boost the strength of heart contractions by delivering electrical stimuli. Strengthening heart contractions could improve quality of life, restore functional capacity and enhance tolerance for exercise.
Despite years of research, the CMS identified “crucial limitations” to the evidence base for CCM and questions about its suitability for Medicare patients when it recently reviewed the data.
While the CMS found evidence CCM has some benefit to heart failure patients, it concluded questions still need to be answered to determine if coverage is reasonable and necessary. The conclusion led the CMS to grant CCM coverage with evidence development, meaning Medicare will pay for the technology provided it is used in the context of approved studies.
Impulse is the sponsor of the only approved study. The trial, which was scheduled to start last month, is designed to enroll 4,200 Medicare-eligible patients with heart failure to assess the effect of CCM on rates of mortality and hospitalization.
Impulse CEO Jason Spees framed the fundraising in the context of the CMS’ national coverage determination.
“As the NCD 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 said in a statement. “Furthermore, it will accelerate the ongoing development and future commercialization of the CCM-D HF System.”
The CCM-D HF System is an investigational device that combines CCM and ICD. By combining the technologies, Impulse could offer the symptom-reducing effects of CCM and the life-saving potential of ICD in a single product. The company said in April that a trial of the CCM-D HF System was nearing enrollment completion and that it would seek approval once it had six months of follow-up.
