Impulse Dynamics aims to find its niche in heart failure

A trial success is in the bag, but are surrogate endpoints enough?

Many medtech companies are expending a great deal of effort on devices for heart failure, but vast numbers of patients remain poorly treated. A technology that can treat even a subset of patients could still mean great success for its developer, and armed with new data backing its Optimizer device in a specific group of heart failure patients Impulse Dynamics is about to go to the FDA – and thence to the public markets.

“The device trains the heart and makes it work harder and more efficiently,” Simos Kedikoglou, Impulse’s chief executive, tells EP Vantage. No survival benefit over drug therapy was seen in the most recent study, but with FDA breakthrough designation, European approval and reimbursement, and data showing reduced hospitalisations, the Optimizer stands a good chance of taking off.

All the endpoints of the FIX-HF-5C trial were met, according to data, presented this month at the annual meeting of the Heart Rhythm Society. The Optimizer was implanted in 74 patients with New York Heart Association (NYHA) class III and IV – moderate to severe – heart failure and ejection fraction of 25% to 45%. A further 86 patients were treated with medical therapy.

At 24 weeks peak VO2, a measure of exercise capacity, was 15.0mlO2/kg/min in the Optimizer group versus 14.2mlO2/kg/min in the control group. The primary efficacy endpoint was measured using a Bayesian approach to take advantage of results of a prior study to show superiority of the device.

The treatment group also had significantly better scores on the Minnesota Living With Heart Failure questionnaire, an indicator of quality of life, and significantly more patients improved their NYHA class – 81% versus 41% and their six-minute walk distance.

Mr Kedikoglou dismisses the idea that these endpoints might not be sufficiently hard to convince cardiologists of the utility of the Optimizer. It is true that no survival benefit was seen with the device in FIX-HF-5C, but the trial was not intended to show that, and a 24-week cutoff would not have been long enough. For approval purposes at least the study ought to be sufficient, since the endpoints had been agreed with the US FDA.

The data will form part of a PMA submission that Impulse expects to file this month or next. With the priority review that comes with the Optimiser’s breakthrough status a decision ought to arrive by the end of the year.

Training the myocardium

The device is intended to treat patients whose heart failure is not controlled by drugs, but who are not sick enough to require ventricular assist devices, the main device therapies for heart failure, or heart transplants.

This is a specific group, but a large one. Mr Kedikoglou says in the UK alone there are around 900,000 such patients. The Optimizer was CE marked in 2016, and is implanted in around 3,000 in Europe and beyond. It is rechargeable via a wireless process similar to that employed by the iPhone X – patients apply the charger to their chest for around 40 minutes once a week. It has a lifetime of around 20 years, compared with around seven for pacemakers.

It has widespread reimbursement, with the device and the implantation procedure costing around €25,000 ($29,300). For comparison, a heart transplant costs around €100,000, plus ongoing costs of around €20,000 per year.

The idea, of course, is that the Optimizer will successfully treat heart failure, improving the contractility and therefore the functioning of the heart, before the organ worsens to the point at which the patient becomes eligible for a transplant.

“It stimulates the heart, and in the immediate instance it … increases contractility,” says Mr Kedikoglou. “In our prior US study we showed at least 5% and sometimes up to 20% increase in contractility. It gets the heart back where it was, before it deteriorated because of heart failure.”

Impulse is not aware of any other technology that has a similar effect in terms of training the myocardium, Mr Kedikoglou says, so the group could have this niche to itself.

Large-scale IPO

In the 20-odd years since its foundation, Impulse has received around $80m in funding, with investors including China’s Citic participating in its most recent round a year ago. But a new chapter is about to begin, with the company planning to go public next year.

This will probably be on a US exchange, Mr Kedikoglou says, “although we are evaluating other locations as well in Asia and Europe”. He declines to put a figure on how much the IPO might raise: “We'll see what the market can bear. But it will be a disruptive, major, large-scale IPO.”

He also mentions a future development that might get investors interested: Impulse is working on a combination of an Optimizer-type device and an implantable cardioverter-defibrillator, capable of treating heart failure and many forms of cardiac arrhythmia.

More than that Mr Kedikoglou will not say, but the fact that the company is working on a second product suggests that it is serious about building itself up as a medtech player, in an industry where many of its peers aim solely to find a buyer.  

Study Trial ID
FIX-HF-5C  NCT01381172

To contact the writer of this story email Elizabeth Cairns in London at [email protected] or follow @LizVantage on Twitter

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