Temporary cardiac pacing is often required for hospitalized cardiac patients, particularly for increasingly common transcatheter aortic valve replacement (TAVR) procedures. Startup Atacor Medical Inc. has raised a $25 million series B round to back its development of a novel extracardiac temporary pacing system.

Intriguingly led by an undisclosed corporate partner, the financing is slated to get the company through a U.S. and European pivotal trial, as well as regulatory review in those regions. The San Clemente, Calif.-based startup also aims to continue developing interim and permanent iterations of its system, which unlike other pacemakers does not require a device or lead placed in the heart or its vasculature. That’s expected to potentially reduce the risk of device-related complications.

Outside the heart

“We are all familiar with pacemakers that are based on hardware inside the heart with wires through the vein until it gets to the heart and we attach that to the inside of the heart, where it can deliver small electrical pulses,” Atacor CEO Rick Sanghera told BioWorld. “Think about that environment; a heart beats about 100,000 times a day. That's 35 million times a year, if we do the math; over multiple years that's a lot of flux on those wires.”

“While they generally work great, we're looking to find a less invasive option where we could pace the heart without actually having to put hardware inside,” he continued. “That’s the premise of Atacor, developing extracardiac pacing. By placing a lead just underneath the muscle structure but above the heart in the connective tissue, we can get the heart to beat without having anything in the vascular system.”

The first application of the technology will be for temporary pacing in the hospital setting. The Atacor EV Temporary Pacing System involves the placement of a custom pacing lead between the ribs and the pericardium. That lead is placed with a proprietary device in a procedure that does not require any imaging, but is rather oriented by anatomical landmarks. Therefore, the procedure can be done in an intensive care unit, rather than requiring a catheterization lab. The pacing wire is then connected to any external pacing system already in use by hospitals for external pacing.

The system is expected to reduce or eliminate the risk of all sorts of pacemaker-associated complications such as vessel puncture, lead displacement, perforation and infection. The EV Temporary Pacing System is in ongoing testing; feasibility data were slated to be presented at the Heart Rhythm Scientific Sessions meeting on May 6 to May 9 in San Diego. The event is cancelled, but the data should still be available online.

The 12-patient study assessed the delivery tool performance and demonstrated that the pacing could be placed successfully with ICU patients up and walking afterward in the hospital. It had “great outcomes,” Sanghera said without being able to disclose any further details ahead of the conference.

TAVR and beyond

Roughly 200,000 patients require temporary cardiac pacing in the U.S. annually. The standard pacing approach in the hospital requires bedrest, while the Atacor extracardiac pacing does not. That can get the patient up and walking about, thereby potentially speeding patient recovery.

TAVR procedures, which are increasingly common, typically require pacing in the ICU immediately after the procedure. The temporary hospital indication for the Atacor system is expected to be for up to 7 days.

“When you look at procedures like TAVR, it is a high-growth model where all of a sudden this is a lot less invasive manner in which to treat patients. One of the largest complications of that procedure is the need for pacing with the induction of some conduction disturbances in the heart,” said Sanghera. “A lot of patients today get a permanent pacemaker after the procedure and even during the procedure almost all of the TAVR procedures use temporary pacing for some period of time, because we like to pace the heart to support the valve.”

“All of this requires a pacemaker lead to be inserted into the vein during that procedure,” he added. “If we can come up with an easier pathway to deliver that pacing energy, that's a good option for those TAVR patients and we get rid of all the bed rest restrictions that come today with temporary pacing solutions.”

Atacor is planning a U.S. and European pivotal trial in the temporary indication that would potentially start early in 2021 with regulatory claims potentially in-hand by the end of next year. The company expects that using its systems with existing hospital pacemakers will make it a class II device, rather than class III, thereby easing the burden with the FDA.

Beyond the temporary indication, Atacor will also use the financing to advance an interim version for 30 to 60 days of use. That is expected to be useful after TAVR procedures. Atacor aims to get into the clinic with the interim device in 2021, with clinical testing on a permanent iteration expected to follow after that.

COVID-19 implications

The unfolding global pandemic complicates Atacor’s clinical and regulatory plans – and also made closing the financing a bit more involved. The company is looking into remote training for clinical trial physicians on how to conduct the procedure, in order to ensure the ability to do so absent routine travel.

Also, many TAVR placements are elective and could be postponed, but Sanghera noted that roughly 10% are emergent. That could offer some route to continue clinical trial recruitment, even if elective procedures are restricted again for a period of time.

In addition to the undisclosed corporate lead on the round, the financing also includes existing investors Broadview Ventures and aMoon Fund as well as new investors Hatteras Venture Partners, Catalyst Health Ventures (CHV) and Longview Ventures.

“Throughout last year we were working to find the right partner and that led at the end of the year to signing the term sheet in December,” summed up Sanghera on the financing process. “Then we put the syndicate together in January and worked to close – and the existing environment then came about. There were certainly some discussions of the deal at that point, but we've got great partners and continue to do the work that we are meaning to do. When all was said and done, it was about four months; the work to get that first term sheet took the better part of a year’s worth of effort.”

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