Neuros Medical Announces Issuance of New U.S. Patent

The U.S. Patent and Trademark Office has awarded a patent to Neuros Medical Inc. for its High Frequency Electrical Nerve Block technology.

U.S. Patent No. 8,731,676 titled “High-Frequency Electrical Nerve Block,” features broad claims, focusing on blocking nerve activity, in nerve sizes 3 mm up to 12 mm in diameter for various applications, including pain, spasticity, and bladder. Neuros now has three issued patents in its portfolio, with others pending.

“We are extremely pleased with the issuance of this new patent, which adds to our existing portfolio and continues to bolster our strong patent claims and intellectual property protection,” ssaid Presient/CEO Jon J. Snyder.

Neuros is in the initial stages of a randomized, controlled pivotal clinical trial to evaluate the company’s patented Altius High Frequency Nerve Block System for the management of intractable limb pain of amputees. The study consists of 130 patients at 15 medical centers in the United States. When completed, the results will support a premarket approval application to the U.S. Food and Drug Administration to market the device. The study builds upon a long-term pilot study which reported significant pain reduction. In addition, more than half of the subjects discontinued their pain medication use during the study.

Surgeons implant the Altius nerve block under general anesthesia by first using ultrasound to find the nerve that is generating pain signals from the affected limb. Then they dissect away the tissue around the nerve and place a tiny cuff electrode around the nerve. A wire from the electrode is then tunneled under the skin to an implanted generator, which is about the size of a pacemaker.

The generator can be placed anwyere on the body, but most often is implanted under the skin of the abdomen, where it can easily be accessed. Patients can recharge the device by placing a charging coil, which is connected to a recharging module, over the implanted generator. They turn on stimulation with a small remote.

The current is delivered at a very high frequency — 10,000 hertz per second — high enough to block the nerve from firing.

“It essentially turns the nerve off at that point, so the point where the cuff is the nerve is turned off downstream from there,” said Amol Soin, M.D., principal investigator of the pilot study testing the Altius device and medical director of the Ohio Pain Clinic in Centerville, Ohio. “With the push of a button you’re able to turn off the nerve.”

The device then runs for about 30 minutes, and within about five minutes, patients start to notice a reduction in pain. After a single activation, there is a delayed response for the nerve to be able to fire signals again, so pain relief can last from 12 to 18 hours, according to early data.

Of the 10 patients who took part in a pilot study, seven reported more than 50 percent pain reduction. They reported an average pain drop from 6 to 1 on a 0 to 10 scale. Of these, five were using narcotics before the study, and four were able to completely discontinue using pain medication after the implant. Patients went from an average of 20 pain pills a week to an average of two pills a week, Soin said.

Based in Cleveland, Ohio, Neuros Medical develops various therapies for unmet needs. The company’s Electrical Nerve Block technology, is focused on eliminating chronic pain in a variety of conditions including amputation pain, post-surgical pain, migraine, and trigeminal neuralgia.