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Decades Delay For E-Device

Endonovo Therapeutics Inc.’s electronic pain relief device has existed for nearly three decades without much selling power, but the company is confident that it can succeed where others have failed. The medical device firm, which is publicly traded on the over-the-counter market and is headquartered in Woodland Hills, announced on Jan. 22 that it had launched the first commercial sales of “SofPulse,” a noninvasive device approved by the Food and Drug Administration to promote wound healing and to treat swelling and pain following surgery. Endonovo acquired the technology behind the device in December after a legal battle with Rio Grande Neurosciences Inc., which backed out of a merger with the company in August 2016. Endonovo ultimately purchased the intellectual property rights and assets to the technology from Rio Grande for $4.5 million, according to Securities and Exchange Commission documents. New angle SofPulse works by way of “pulsed electromagnetic field” technology. Worn on the patient’s body, it delivers low-frequency electrical currents to the affected area, which stimulates the release of anti-inflammatory molecules that lessen swelling and pain. Endonovo neither disclosed where or how its product would be sold in its Jan. 22 announcement nor returned the Business Journal’s requests for comment. However, the company has suggested that the technology could serve as a way to curb reliance on the prescription painkillers that have been blamed for sparking the opioid epidemic. “As we battle an opioid epidemic, we must look for novel ways to relieve pain for people suffering from chronic pain, as well as preventing people undergoing surgical procedures from becoming dependent on narcotics,” Endonovo Chief Executive Alan Collier said in the announcement. “We believe our wearable (device) can drastically reduce the need for pain medication use and improve the lives of millions of people suffering from pain.” That angle is welcomed by addiction specialists such as Dr. Brent Boyett, chief medical officer of Dallas-based treatment center Pathway Healthcare. Any strategy that eliminates the need for opioid painkillers is a good one, he noted. “We have to remind ourselves that there are a lot of ways to control pain in 2018 that don’t include opioids,” Boyett said. “Any therapy that brings another option for treating pain would be a primary prevention strategy (for reducing opioid dependence).” There is not enough research yet to know whether wearable technology like the SofPulse has the potential to replace prescription painkillers on a large scale, and it is unclear whether Endonovo is conducting clinical trials to assess its effectiveness in that context. Still, SofPulse’s ability to physically reduce inflammation could help it stand out from the many competitors that are vying for a spot in the pain relief market, the company said. “Unlike many of our competitors using electrical stimulation, some of whom have signed agreements with large device and pharmaceutical companies, our devices don’t simply mask the pain,” Collier said in the company’s Jan. 22 statement. “They address the underlying issue causing the pain, which is inflammation.” The anti-inflammatory quality of SofPulse’s technology is a strength, noted Dr. Damon Raskin of Cliffside Malibu, a Malibu-based residential rehabilitation center that recently opened an outpatient clinic in Sherman Oaks. “I’m in favor of anything that can help reduce the inflammation experienced by patients instead of using highly addictive prescription opioid painkillers,” Raskin said in an e-mail. “While the research is still out on the effectiveness of these new devices to treat drug and alcohol addiction, there appears to be great potential.” Old technology But if the SofPulse has so much going for it, why hasn’t the device taken off? To Endonovo, the answer is simple: No one has tried to capitalize on its potential. “(The latest model of SofPulse) was FDA-cleared in 2008, but no significant effort to commercialize this revolutionary technology was ever undertaken,” Collier said in the company’s statement. The first rendition of the SofPulse device was approved in 1991 for the treatment of swelling and pain in wounds. Its maker, Electropharmacology Inc. – which has since gone out of business – sold the device in 1998 to ADM Tronics Inc., a Northvale, N.J.-based company that still manufactures it. The intellectual property rights to SofPulse’s technology then traded hands between different medical device firms before landing with Rio Grande, which agreed to be acquired by Endonovo for $30 million in July 2016. The deal fell apart later that year after Rio Grande attempted to renegotiate the terms. “The company will not be proceeding with the acquisition,” Endonovo said at the time. “Our board of directors has determined we are better served by this decision.” The company later sued Rio Grande, which in December agreed to a settlement that saw Rio Grande pay $150,000 to Endonovo in addition to allowing it to purchase the technology behind SofPulse. Endonovo is funding all clinical trials for the technology moving forward, and will be looking at whether it can be used in central nervous system disorders in addition to post-operative pain, the company said in a Dec. 27 press release. The company’s stock trades in the 4 to 6-cents-a-share range, giving a market capitalization of about $12.7 million. Shares closed Feb. 14 at 4 cents. The enthusiasm among physicians for the device’s potential in alleviating the need for opioid painkillers suggests SofPulse may already have found its target audience. After all, addiction begins with pain, Boyett noted. “At the root of all addiction, there is pain,” he said. “Anything that can provide a solution to the physical pain could theoretically be of benefit.”

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