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April 1, 2018

BioWave seeks approval for at-home pain-relief device

By Alexander Soule Published 4:17 pm, Friday, March 30, 2018

Even as it sells a pain alleviation device for use in veterans hospitals, a local company is readying a home version that it hopes to sell through pharmacies, doctors and other channels, pending federal approval.

BioWave was founded by Norwalk resident Brad Siff to design devices that apply electrical stimulation through a pad to relieve pain. More than a decade ago, Siff was the beneficiary of an electrical stimulation treatment after a skiing accident and set out to improve the technology.

He was helped along by a background that includes both engineering and MBA degrees from Cornell University, as well as experience as chief operating officer of a Norwalk company that had developed an electronic dental anesthesia device.

BioWave’s early investors included Leon Hirsch, whose U.S. Surgical in Norwalk was a major manufacturer of staple guns and other medical devices before being acquired for $3.3 billion in 1998. In 2015, BioWave sold a controlling stake to a Greenwich investor called Northstar Pain Management.

Broadly, the BioWave concept is not dissimilar to how some medications block signals to the brain as transmitted by nerves at the point of pain, with the electrical field deadening those signals. A 30-minute application of the electrode patch arrayed with more than 1,000 minute needles — the company describes the patch as similar to the feel of Velcro — can provide up to 24 hours or more of pain relief for a large majority of patients.

“We have a proven, non-opioid pain treatment,” Siff said. “The mechanism is similar to a chemical anesthetic … except Biowave is blocking the pain signal electrically instead of chemically.”

After establishing early success starting in 2007 selling the devices to the New York Giants and other NFL teams, in the past year under Siff and CEO Rob Wolter, BioWave has found a major new sales pipeline: hospitals under the purview of the U.S. Department of Veterans Affairs, with BioWave having sold its devices to more than 40 including a VA hospital in West Haven.

Those sales have come amid a national backlash against Stamford-based Purdue Pharma and other opioid makers in a spiraling crisis of addiction and deadly overdoses. BioWave touts its devices as producing a half or better reduction in pain in four of every five patients, along with reduction of joint stiffness.
“VA has really struggled with different alternatives as to how to help these people — a lot of whom suffered injuries … in combat — to help them manage their pain without giving them pills,” Wolter said.

BioWave is in the process of seeking Food and Drug Administration for an over-the-counter device that could be sold at pharmacies or other medical equipment suppliers directly to patients without a prescription, with Wolter anticipating the device will cost between $300 and $400.

Article here – https://www.ctpost.com/business/article/BioWave-seeks-approval-for-at-home-pain-relief-12794604.php#item-85307-tbla-9