Minneapolis’ CVRx has raised $46 million from unnamed investors in support of its implantable neuromodulator to treat high blood pressure and heart failure, bringing its total equity funding to $237 million over 5 rounds, according to CrunchBase.
CVRx boasts the CE-marked Barostim Neo, an entrant into FDA’s Expedited Access Program for accelerated approval of innovative devices that “demonstrate the potential to address unmet medical needs for life-threatening or irreversibly debilitating diseases or conditions.”
Neuromodulation is gaining ground as a therapy for reducing pain, but no one has yet harnessed it within the cardiology arena, putting the company in a unique position if the Barostim gains FDA approval and commercial success.
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“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,” Dr. William Abraham, director of the division of cardiovascular medicine at The Ohio State University Wexner Medical Center, said in a statement when the device gained acceptance into the accelerated pathway.
New Enterprise Associates and Johnson & Johnson Development Corporation, co-led CVRx’s $42 million Series F round in 2013.
The device’s 310-patient pivotal trial is slated to conclude in September 2017, according to ClinicalTrials.Gov. The primary efficacy endpoint is a reduction in blood pressure six months after activation of the device compared to the medical management arm.
In addition, another trial to test the device on heart failure patients is recruiting subjects. Its primary endpoint of (the rate of cardiovascular mortality and heart failure morbidity) is scheduled to report in 2021. Crucially, due to the Barostim’s acceptance in the accelerated approval pathway, the FDA will likely allow commercialize to commence before then, as long as the device demonstrates safety during the trial.
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In an email, CVRx CEO Nadim Yared said the company has not yet decided to comment on its Series G round.