|CVRx's Barostim neo device--Courtesy of CVRx|
On the heels of a $42 million Series F closed last fall, CVRx is picking up an additional $15 million in a debt facility from Silicon Valley Bank. But that's chump change in the long run for this startup, which has raised about $265 million since its 2001 inception.
It's working to advance its implantable device through clinical trials designed to gain approval in the U.S. to treat hypertension and heart failure, as well as for heart failure in the EU. The second-generation device, Barostim neo, already has a CE market to treat hypertension.
The Barostim neo is implanted under the skin, like a pacemaker. It sends signals via baroreceptors to the brain to help regulate blood pressure by relaxing the blood vessels, slowing the heart and reducing the fluid volume in the body. The system includes a small device implanted under the collar bone, a thin lead wire implanted on the carotid artery and connected to the device and an external Programmer system used by the doctor to noninvasively regulate the activation energy from the device to the lead.
The device has been used in more than 500 patients in clinical trials. The company has an ongoing 140 patient trial in chronic heart failure with advanced symptoms. Earlier data in this population showed clinical improvement and reduced hospitalization; the 6-month data from this randomized, controlled trial are being prepared for publication.
In 5-year results of a 322 patient, sham-controlled trial for hypertension, the device reduced systolic and diastolic blood pressure by more than 32mmHg and 17mmHg, respectively.
About 80 million people in the U.S. have hypertension and one-quarter of people with hypertension cannot adequately control it with medication and lifestyle modifications, according to the company.
CVRx has some high-profile names underwriting its efforts. As part of the Series F round last fall, CVRx partnered with DaVita, the dialysis division of a division of DaVita HealthCare Partners. DaVita participated in the round as did New Enterprise Associates and Johnson & Johnson Development Corp.
- here is the release