CVRx raised $46.5 million and has another $25.1 million waiting in the wings once it achieves ” a certain milestone,” the company said in a regulatory filing last week.
Seventeen unnamed investors participated in the round, according to the filing, taking Minneapolis-based CVRx’s total raise since its 2001 founding to $237.1 million.
CVRx, which said in the filing that it hopes the round will bring in a total of $85 million, has more than $25.1 million of that already subscribed by existing backers. The sale of that equity is slated to be triggered by “achievement of a certain milestone,” according to the June 14 filing.
Late last year, the FDA put CVRx’s 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.
The Barostim therapy 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.
CVRx raised $42 million in a Series F round back in 2013.
The Barostim Neo device won CE Mark approval in the European Union in July 2012.
