CVRx procures $113M for heart failure implant trial

Homeostasis implant maker CVRx has picked up $113 million in new financing, which will be used primarily to complete a pivotal trial for its implant to treat heart failure.

The device, the Barostim neo, has a Humanitarian Device Exemption nod from the FDA and was accepted into the agency’s Expedited Access Pathway in November last year. It is implanted under the skin close to the collarbone and works by stimulating the body’s neural baroreflex system, which helps control blood flow. While neuromodulation is chiefly used to treat pain, CVRx is applying it to resistant hypertension and heart failure, which is characterized by the inability of the heart to pump enough blood to support the body.

In diseased states, the baroreflex loses its ability to regulate blood flow. Barostim neo modulates baroreceptors in the wall of the carotid artery, which activates the baroreflex through the afferent pathway of the autonomic nervous system. The brain responds by modulating efferent pathways, reducing excessive blood pressure by relaxing blood vessels and and slowing the heart rate.

According to CVRx, the device is compatible with rhythm management implants and is a reversible treatment that can be switched on and off. It is CE marked for heart failure and resistant hypertension and has potential applications in chronic kidney disease.

In this Series G, $93 million comes from equity financing, while the remaining $20 million comes from a new debt facility, the company said in a statement. Johnson & Johnson’s ($JNJ) venture arm JJDC was the lead investor, while existing investors New Enterprise Associates and Ysios BioFund also participated.

- here's the statement

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