Medical device maker Valencia Technologies has received federal government’s go-ahead to begin human testing for its small implantable device designed to control hypertension.
The device, called the eCoin, is intended to help patients with drug-resistant hypertension. The coin-sized devices can be implanted in 20 minutes using local anesthetic.
They are implanted in both of a patient’s forearms, and the two neurostimulators help control the subject’s blood pressure.
Jeff Greiner, CEO of Valencia Technologies, said that the ultimate goal is to eliminate the need for medications used to treat hypertension.
In the first stage of testing, the toughest to treat patients in the world will be the subjects. That’s those who are on three or more medications.
“We’ll demonstrate that we lower blood pressure in the hardest to treat patients,” said Greiner. “Only after that we will be allowed to take away drugs from patients and see whether we can safely replace those drugs.”
The device provides “neuromodulation” therapy to control blood pressure. Greiner said it’s a therapy that changes the nervous system.
“Think of the nervous system for many hypertensive patients as being in overdrive,” said Greiner. The eCoin stimulates the nervous system, and the brain reacts by sending out chemicals that relax the nervous system and in effect lower blood pressure.
Benefits the Majority
“Probably 70 percent of the patients who have hypertension have, as a component of their hypertension, this ‘neural system overdrive,’” said Greiner. “So, it will help most of the patients with hypertension.”
Patients with hypertension because of hardened arteries, however, cannot benefit from the device.
“The reason for their hypertension is not about what’s principally going on in their nervous system, it’s principally about what’s going on in their arteries,” said Greiner.
The eCoin, which is actually a pacemaker, would be the smallest one of those devices in the world up to now, according to Greiner. Like most pacemakers, it runs on a battery, and this one needs to be replaced about once every five years.
As for the cost, Greiner said it’s too early to make those projections.
“Once we know the efficacy the device produces in lowering blood pressure, we’ll have a sense for the value it contributes to risk reduction for stroke, heart attack, diabetes, kidney problems, etcetera,” he said. “We’ll know our underlying manufacturing cost and we’ll make some kind of judgment as to what value this device called eCoin really contributes.”
At that point the company will work with payers, both Medicare and private, to establish a fair price.
So far, it’s been a five year process to get the device to the point where it’s at today.
But the upcoming trials will be expensive. Greiner estimates they will cost $20 million over the next three years – the company will for the first time seek partners to get through it.
“We’re in fundraising mode right now,” said Greiner. “We’re reaching out to high-net income people, venture capitalists, private equity folks, strategic investors.”
He hopes to partner with people who are already in the hypertension space, especially those who are on the lookout for medicines and technologies that address hypertension.
Noting that there are more than a billion people on the planet with hypertension, Greiner believes that the eCoin can make a significant impact on health of those suffering from high blood pressure.
“Medicines are things that work only moderately well. So, there’s a dire need for a non-drug solution to treat hypertension,” he said. “But think about it – there are literally millions of people who are candidates to get this eCoin.”