|Barostim neo--Courtesy of CVRx|
CVRx has raised $46.5 million a little more than 6 months after it received Expedited Access Pathway Designation from the FDA for its heart failure neuromodulation implant tech. The designation was gained because its Barostim Therapy is intended to treat heart failure patients who have no other treatment alternative.
The company's device, Barostim neo legacy, already has a Humanitarian Device Exemption (HDE) approval from the FDA, which is specifically for use in hypertensive patients who were responders to the first-generation Barostim Therapy with Rheos Carotid Sinus Lead System. Its Barostim neo is CE marked for heart failure and resistant hypertension.
"This comes at a critical time for heart failure physicians, who are actively looking for treatment options for patients who are not adequately managed with current guideline-directed therapies," said Dr. William Abraham, the director of the division of cardiovascular medicine at Ohio State University's Wexner Medical Center, in a statement. Dr. Abraham was an investigator on the hypertension pivotal trial.
"Barostim Therapy is designed to activate the Baroreflex through the afferent (sensory) pathway causing a simultaneous reduction in sympathetic activity and increase in parasympathetic activity. Restoring autonomic balance leads to a reduction in symptoms and has the potential to significantly improve cardiovascular function and patient outcomes. This mechanism of action is unique to Barostim Therapy when compared to other neuromodulation-based therapies," he added.
The Barostim neo activates baroreceptors in the wall of the carotid artery, which stimulate the afferent and efferent pathways of the autonomic nervous system. The brain responds by modulating efferent pathways to relax the blood vessels, slow the heart rate and reduce fluid. This improves the heart's ability to pump and reduces excessive blood pressure.
The Minneapolis, MN-based startup has already raised a boatload of cash. This financing brings the total invested to more than $235 million, according to data on CrunchBase. But CVRx, which was founded in 2001, does have several deep-pocketed, influential investors to bring to bear, including New Enterprise Associates and Johnson & Johnson Development Corporation, which have co-led its $42 million Series F round in 2013.
In a 146-patient randomized, controlled trial that lasted for 6 months, Barostim Therapy resulted in significant improvement of patient symptoms, functional capacity and cardiovascular function, the company noted. It also significantly reduced heart failure hospitalization days as compared to control patients.
The Barostim neo is in an ongoing Phase III trial, BeAT-HF, in as many as 800 heart failure patients. The 5-year study started in April and is slated to have final primary endpoint data in April 2021. The randomized trial is being conducted at 47 U.S. sites--with a primary endpoint of rate of cardiovascular mortality and heart failure morbidity.
- here is the SEC filing