A new medical device approved by the FDA may offer a new treatment method for patients facing opioid withdrawals.
Opioid addiction has caused countless people to be affected by its ramifications. The epidemic currently impacting the US and Canada has reached unprecedented levels. Some local governments have taken to suing pharmaceutical companies seeking payments to help alleviate the stress in communities and the demand for care needed.
In November the US Food and Drug Administration (FDA) approved a new device promising to help patients facing opioid withdrawal. The NSS-2 Bridge is a percutaneous nerve field stimulator (PNFS) device system used to aid in reducing the symptoms of opioid withdrawal.
In the announcement FDA commissioner Scott Gottlieb said while the agency has three drugs approved for the treatment of opioid addiction, the FDA needed to take a closer look at devices “that can assist in this therapy.”
The company’s research showed patients became comfortable with their symptoms in roughly 15 to 20 minutes. “It gives [patients] the opportunity, for five days to get comfortable with the opioid withdrawal period,” Brian Carrico president of Innovative Health Solutions (IHS), the company behind the device said.
“[T]his was instrumental, this was an unmet need, it was the largest gap in the path and road to… recovery,” Carrico told the Investing News Network (INN).
The FDA indicated this approval came after reviewing data from a “single-arm clinical study of 73 patients undergoing opioid physical withdrawal.”
Effect of the device on the brain reduces opioid withdrawal symptoms
The device itself is a nerve stimulator which is placed behind the ear of the patient. During the worst effects of opioid withdrawal, the device sends electrical pulses to the brain providing relief from the symptoms.
“[W]e’re giving someone treatment, we’re getting someone clean… it really is a giant opportunity for our society,” Carrico added.
The Indy Star reported, before approval, the device cost was $500. This being a Class II device, a medical officer will be needed to prescribe its administration on patients. Carrico said the company wants to see their device in hospitals, emergency rooms, detox houses and more.
Carrico continued, stating the company was elated after its hard work finally received approval. However, he further explained the impact and reach the company’s technology could have.
“We have figured out a new standard of care,” Carrico said. “We have figured out how to get to the brain and when someone finally understands that… that’s going to be the story that is hung on the wall of Medtronic’s (NYSE:MDT) CEO or Johnson & Johnson (NYSE:JNJ).”
“We have figured out a new standard of care”
The company is working on more research with its novel treatment in other applications. Carrico said the company could have indications for cancer in the next 12 to 24 months.
In terms of partnerships with established and even public medical companies, Carrico said he expects the interest to increase on the NSS-2 Bridge, exponentially.
“[B]ig companies are beginning to see the science and understand we have developed a new standard of care,” Carrico added. Health Canada, the country’s medical arbiter, also reached out to IHS.
When asked about the potential to go public, Carrico said IHS is comfortable where it is right now, but added: “I never say never.”
“We’re glad the FDA has approved IHS’s innovative technology to provide much-needed relief and assistance for those fighting to overcome opioid addiction,” Indiana Gov. Eric J. Holcomb said according to a report by Area Development.
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Securities Disclosure: I, Bryan Mc Govern, hold no direct investment interest in any company mentioned in this article.