CVRx said today that it raised a $113 million funding round it plans to use to complete a pivotal clinical trial of its Barostim Neo neurostimulation device for treating heart failure.
The round consists of a $93 million equity round and a $20 million debt facility, the Minneapolis-based company said. CVRx, which reported raising $46.5 million in a June regulatory filing, said some $58 million from the equity round is already in its coffers, with another $35.3 million milestone on the line pegged to “achievement of a certain operational milestone,” the company said.
The equity financing was led by prior backer Johnson & Johnson Innovation, the venture capital arm of Johnson & Johnson (NYSE:JNJ), with participation from existing investors New Enterprise Associates and Ysios BioFund and new investors Gilde Healthcare Partners, Action Potential Venture Capital and Windham Venture Partners.
CVRx also said it used part of a new, $20 million term loan from Oxford Finance to repay an existing loan. The new infusion will also go toward expanding CVRx’s commercial footprint in markets where its device is already approved. The company has raised more than $300 million since its 2001 founding, including a $42 million Series F round back in 2013.
The Barostim Neo device, which won CE Mark approval in the European Union in July 2012, is designed to influence both the sympathetic and parasympathetic systems, reducing sympathetic activity and increasing parasympathetic activity, CEO Nadim Yared told MassDevice.com in September 2014.
“It’s actually pretty straightforward. Heart failure as a disease is most often due to the fact that the sympathetic signal from the brain to the organ is elevated and the vagus tone is depressed. It’s the same with hypertension, basically. We have a unique platform where we are not targeting either the sympathetic system alone or the parasympathetic system alone,” Yared told us.
Late last year, the FDA put the Barostim Neo device on the fast track, granting “expedited access pathway” for the Beat-HF pivotal trial in heart failure patients. The federal safety watchdog created the program in April 2015 as an alternative to pre-market or de novo approval for devices designed for conditions with no other treatments.
Another trial, for hypertension, began enrolling patients in 2013 and is slated for final data collection in September 2017. The primary safety endpoint is adverse events at 30 days, with a primary efficacy endpoint of significant blood pressure reduction at 6 months, according to ClinicalTrials.gov.