US-based medical device firm Impulse Dynamics has closed an $80.25m Series D financing with new investors, to advance the US commercialisation of its Optimizer Smart System.
The system, a US FDA-approved implantable device for delivering cardiac contractility modulation (CCM) therapy, intended to treat chronic heart failure and strengthen the heart.
Impulse Dynamics CEO Simos Kedikoglou said: “We are extremely pleased that our new strategic and financial investors recognise the significant potential of cardiac contractility modulation, or CCM therapy, with the Optimizer Smart.
“We look forward to accelerating the ramp-up of our commercial operations, particularly in the US where we are just entering the market thanks to our two recent FDA approvals and CMS Transitional Pass-through payment approval, to make this potential a reality for physicians and their patients.”
The Series D financing was led by medical technology investor Amzak Health Investors, and also included Wellington Management, Kennedy Lewis Investment Management, Acorn Biosciences and Minth Holdings, along with investors Zoll Medical, Abiomed and one additional corporate investor.
Kennedy Lewis Investment Management has invested a total of $25m debt and equity in the company
Optimizer Smart System is the first and only approved CCM device in the US
According to the company, heart failure is a chronic and progressive condition, where the heart fails to pump the blood with adequate force to meet the body’s needs, and is characterised by symptoms including breathlessness and fatigue.
The first-line prescription medications could treat early symptoms. However, they can not restrict the disease progression, can cause side effects and lose effectiveness over time.
Impulse Dynamics said that its CCM therapy with the Optimizer Smart is set to provide a new alternative to relieve symptoms and improve quality of life in Class III heart failure patients.
The CCM therapy works by transferring non-excitatory electrical pulses, delivered through the implantable Optimizer device, to improve the heart’s systolic contraction.
The company said that it has secured a breakthrough device designation from the FDA for its Optimizer Smart System, and the device marks the first and only approved CCM device in the US.
In addition, it has conducted several clinical studies, including several randomised controlled trials, which demonstrated CCM therapy to improve the quality of life and functional status in patients.
Kennedy Lewis Investment Management managing director Rich Gumer said: “With CCM, Impulse Dynamics has developed a very important new therapy for a large and growing patient population who until now have had no real treatment alternatives.
“Our additional investment will help the company deliver a positive impact on a much larger scale — improving patient outcomes and generating significant savings to the healthcare system.”
