Jeff Greiner would be the 1st to tell you that developing a neurostimulation implant is an expensive process. It took $100 million for Advanced Bionics to develop a cochlear implant, Greiner told MassDevice.com, and another $50 million for its neurostim device. CVRx has raised more than $250 million for its neurostim implant for treating cardiovascular conditions, he noted.
That’s why it’s remarkable that Valencia Technologies, which is developing a coin-sized implant designed to treat hypertension, spent less than $10.5 million designing the device and getting it through a double-blind clinical trial.
Of course, it helps when your CEO is that Jeff Greiner: The one who led Advanced Bionics from its start as a team of 7 engineers into a 3,000-employee juggernaut with $300 million in annual sales.
“There are people that drive organizations because of their tremendous talent. They’re the real drivers of a 3,000-person organization, and I obviously knew who they were [at Advanced Bionics]. I recruited them to this company. We’ve done it with multi-faceted, tremendous, engineers – and just a few of them,” Greiner told us. “The other thing I’d say is that this device is a much simpler device from an architectural perspective to design and to develop.”
The Valencia implant is a coin-sized device that’s designed to stimulate the median nerve in the wrist to affect the relay loop that controls blood pressure. It can be implanted in an outpatient procedure in about 20 minutes, according to the company.
“The folks who did the underlying scientific work proved over the course of about 30 years that low-frequency stimulation would cause the brain to send out certain chemicals that result in remodeling of the brain in terms of how it controls blood pressure, and ultimately the result is a lowering of the blood pressure,” Greiner explained.
The early, 48-patient double-blinded trial compared subjects treated with the Valencia device with patients treated with a placebo (all patients were implanted with the device, but it was not activated for subjects in the sham arm). The study tracked blood pressure via 24-hour ambulatory measurement, showing a reduction in systolic blood pressure of 7.3mm Hg at 3 months.
That number grew to 7.8mm Hg at 6 months and 9.8mm Hg at 9 months, according to Valencia’s website. The difference between the treatment and sham groups was 5.7mm Hg at 3 months and 11mm Hg after 6 months, according to the company.
As evidence that Valencia’s approach could address a significant unmet need, Greiner cited results from a National Institutes of Health study showing that aggressive blood pressure management reduces the risk of death and cardiovascular events when compared to a strategy that only lowers systolic blood pressure to standard targets.
“The new NIH study impresses upon physicians the importance of addressing mild to moderate hypertension. We expect Valencia’s device to make a major contribution to treating these very patients – obviously after completing different FDA trials over time,” he told us via email.
“Given the limitations of antihypertensive medications, including concerns with adherence, adverse effects, costs, and overall effectiveness, there is a large opportunity for non-drug treatment options to enhance blood pressure control while potentially minimizing or even avoiding these limitations,” added Dr. David Calhoun of the University of Alabama at Birmingham, a paid member of Valencia’s advisory board. “Valencia’s unique approach to lowering blood pressure represents 1 such opportunity.”
Stacy Chambliss, Valencia’s chief of administration & scientific review, told MassDevice.com via email that the company is hoping to start a 300-patient pivotal trial early next year, with a hoped-for 1st implantation by April 1. Subjects are slated to be randomized 1:1 to a treatment arm and a delayed activation arm in a “partial cross-over” design allowing the delayed-activiation arm to cross over to the treatment arm once the primary endpoint is reached, Chambliss wrote.
That endpoint is 24-hour systolic pressure change at 6 months. Market development chief Jerry Schloffman told us that Valencia has verbal commitments from 15 clinical sites to participate in the trial, including Mayo Clinic and the University of Alabama at Birmingham.
Chambliss said Valencia raised $2.5 million via a crowd-funding site and is now looking to drum up another $17 million from institutional investors.