Minneapolis-based medical device maker CVRx, has raised $93 million and taken on an additional $20 million in debt to complete a clinical trial for its Barostim Neo, a proprietary implantable device that treats high blood pressure and congestive heart failure (CHF).
CVRx Chief Financial Officer John Brintnall said the privately held company will use the funding to also grow its global commercial activities.
When Investment Rhymes with Canada
Canada has a proud history of achievement in the areas of science and technology, and the field of biomanufacturing and life sciences is no exception.
The lead investor was Johnson & Johnson Innovation, formerly known as Johnson & Johnson Development Corp. (JJDC), the venture capital arm of the conglomerate. Existing investors New Enterprise Associates, and Ysios BioFund I F.C.R joined new investors Gilde Healthcare Partners, Action Potential Venture Capital Limited and Windham Venture Partners in investing in the company. Oxford Finance signed the $20 million loan agreement.
Back in 2013, Johnson & Johnson Innovation and NEA were co-leads in a $29.6 million investment round. In June this year, CVRx raised $46 million from undisclosed investors, part of the latest haul.
The Barostim Neo neuromodulation device
While the Barostim Neo, a neuromodulation device, has been approved for use in Europe and sells for around $26,000 in Germany, the device has encountered hiccups domestically. In a previous pivotal trial involving the first-generation device, Rheos, the company failed to meet its clinical endpoint in treating patients whose high blood pressure was not controlled by drugs. CVRx worked with the FDA to design a new clinical trial.
Last November, CVRx received FDA’s Expedited Access Pathway status for its Phase III randomized, controlled clinical trial, Baroreflex Activation Therapy for Heart Failure pivotal trial (BeAT-HF). That trial will test the safety and effectiveness of Barostim Neo in CHF patients. The Expedited Access Pathway program is FDA’s fast-track method of approving novel, innovative devices and is intended to encourage innovation.
While CVRx is testing the Barostim Neo in the BeAT-HF trial, results from an earlier 146-patient randomized controlled clinical trial showed good outcomes for patients on this implantable neuromodulation therapy. Patient symptoms, functional capacity and cardiovascular function were all significantly improved and hospitalization days were reduced in the Barostim Therapy patients compared to control patients.
CHF occurs when the heart is unable to pump enough blood and oxygen to support bodily functions. According to the American Heart Association, 5.7 million Americans have CHF, a figure predicted to increase to nearly 8 million by 2030.
One in nine U.S. deaths annually is associated with the disease, which killed 309,000 Americans in 2014, up from 290,000 in 2000. About half those diagnosed with CHF die within five years and the annual direct and indirect costs of CHF exceed $30 billion.
Brintnall said the company has not disclosed a projected time table for the clinical trial, but aims to enroll 480 patients at 90 U.S. centers.
The Barostim neo comprises an implantable pulse generator with a lead connecting to the baro receptors of the carotid artery. The system sends electric signals to the brain to slow down heart rates, increase the size of the vascular flow and extract fluid from the kidneys.
“The brain does the work,” Brintnall explained. “Our device stimulates the part of the brain that tells the body to do that.”
He said current CRT devices don’t work well for the majority of CHF patients with atrial fibrillation (A-Fib), an irregular heart beat that can lead to stroke and blood clots.
“Ours does,” he said. “This is a big deal.”
Photo: freedigitalphotos user Salvatore Vuono and CVRx
