Valencia Technologies Exploits Neuromodulation Legacy with Hypertension Device
by James Cavuoto, editor
November 2014 issue
Valencia Technologies, the Valencia, CA developer of hypertension neuromodulation devices, is one of the newest entrants in the neurotechnology industry. But its management and engineering team is anything but new, featuring executives from established neurotech firms such as Medtronic, Boston Scientific, and Advanced Bionics.
The company has developed a subcutaneous neuromodulation system for treatment of hypertension. The SNS device works by activating a peripheral nerve in the forearm and is implanted in a simple office procedure.
Hypertension affects over one billion people on the planet and is one of the leading causes of cardiovascular disease and stroke. Nevertheless, almost 50 percent of adult hypertensive patients in the U.S. are uncontrolled; that is, they still have high blood pressure. Thus, there is a significant patient need for a non-drug therapy option that lowers blood pressure, is minimally invasive for patients, and is cost-effective for payers.
Recent clinical trial failures for renal denervation systems such as Medtronic’s Symplicity device may enhance the competitive opportunity for Valencia. But the new company is likely to compete with CVRx,, whose Barostim neo device activates baroreceptors in the wall of the carotid artery to lower blood pressure.
Valencia was founded upon a plan to create, develop, manufacture, and sell a coin-sized device that can be easily placed just under the skin within the forearm. The device stimulates the median nerve, causing a reduction in blood pressure. The company says the device can be manufactured at a “radically” low cost.
SNS is being tested in an international clinical trial and is approved in certain countries for investigational use only. An investigational trial is anticipated in the U.S. next year.
The technology takes advantage of a highly innervated area of the forearm. SNS puts out a relatively low-powered and well-tolerated electrical stimulus that communicates with the brain. The input goes to the hypothalamus, midbrain, and the medulla; the signal has multiple pathways to the brain’s blood pressure control center. The treatment is known to create a normalizing effect on blood pressure.
In a 20-minute office procedure, a two centimeter incision is made for the small pocket in the forearm. The coin-sized and shaped device is placed just under the skin where two tendons easily map the target nerve. A variety of physicians can perform the procedure.
Development of the miniature device, slightly thinner than a nickel and smaller in diameter than a quarter, took less than a year, cost several million dollars, and benefited from the engineering expertise of two key members of the Valencia team: CTO Dave Peterson and Chula Thenuwara, chief of mechanical and materials engineering. Peterson led the design of Medtronic’s first dual chamber ICD and later designed Advanced Bionics’ Precision SCS system, which was sold to Boston Scientific. Thenuwara was previously a principal engineer with Advanced Bionics.
Valencia has implanted 38 patients with its technology. Thus far, most patients are experiencing clinically significant reductions in blood pressure. If these results can be repeated in a larger trial, the company believes its device will be approved by the FDA and other regulatory bodies.
The company’s initial clinical trial uses the most reliable measurement of blood pressure, a tool that takes blood pressure over a 24-hour period. Patients receiving Valencia’s therapy show consistent and clinically significant reductions. “Clinically significant” means that the change entails a corresponding reduction in patient risk for events like stroke and heart attack.
Valencia is developing a tool for the optimal selection of patients to improve its probability of success. This tool is designed to select patients most likely to respond and to select out those who are unlikely to respond. Valencia has retrospectively applied the selection criteria to its current data set and it shows a result with tremendous clinical significance.
Valencia’s device takes advantage of low-duty cycle, non-constant stimulation. Unlike IPG-based neurostimulation devices, which require lead-wires to be tunneled to the target from a remote fatty pocket holding the electronics, Valencia’s SNS device is placed directly over the target.
Three years ago, Valencia filed patent applications, kept secret under old patent law, until publication in 2014. Today, Valencia has one issued patent for its invention and more than a dozen patent applications.
Valencia Technologies has constructed a 4,600 square-foot production facility with a 1,100 square-foot class-7 clean room for assembly and testing of the SNS device. Valencia prides itself on having a team with decades of experience in manufacturing and operating medical-grade clean room environments.
Valencia is led by Jeff Greiner, the former leader of Advanced Bionics, who helped build the company from seven engineers and no revenues into a company with 2500 employees and revenues exceeding $300 million. Advanced Bionics was sold to two different companies, Boston Scientific and Sonova, for over $3 billion.
Valencia is seeking to raise $30 million through an innovative equity-based crowdfunding strategy. The funds will be used to conduct and complete the clinical trial. The company is raising funds through a general solicitation on its website and revealing the information necessary for an investor to make an informed decision. Potential investors can download a business plan, patent applications, financial statements, and other documents.Tweet