Impulse Dynamics has secured over $158m in funding aimed at supporting its commercialisation efforts and progressing its clinical and technology development pipelines.
The financing round was led by new institutional investors, including Braidwell and Sands Capital, with participation from existing investors and various industry executives.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
It follows the recent announcement by the US Centers for Medicare and Medicaid Services (CMS) regarding a National Coverage Determination (NCD) issuance for cardiac contractility modulation (CCM) therapy.
The decision expands access to CCM therapy for several individuals, marking a milestone for heart failure (HF) patients and healthcare providers.
The NCD confirms that CCM therapy is no longer considered experimental or investigational.
The new investment will also be used to support studies, including the INTEGRA-D and AIM HIGHer.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataINTEGRA-D is a multi-centre trial assessing the CCM-D HF System.
According to Impulse Dynamics, more than 100,000 new implantable cardioverter defibrillators (ICDs) are implanted every year in the US, adding to the nearly 800,000 people living with these devices.
Despite the widespread use of ICDs, most patients continue to experience HF symptoms, as traditional ICD therapy does not address these issues, the company noted.
The CCM-D HF System is designed to provide an option that may alleviate HF symptoms while delivering the life-saving benefits of an ICD.
Additionally, the AIM HIGHer trial is assessing CCM therapy in patients with Diastolic HF, a group that makes up about half of all HF patients and currently has limited treatment options.
In Europe, CCM therapy has already secured approval for use in these patients.
Impulse Dynamics CEO Jason Spees said: “This support recognises 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.
“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.
“Furthermore, it will accelerate the ongoing development and future commercialisation of the CCM-DHF System, a single device designed to deliver CCM therapy for the treatment of HF symptoms along with life-saving, ICD therapy.”
