Approval from FDA Pushes Frederick, Maryland, Biotech Company, BioElectronics, into Commercial Marketplace
By Allen Etzler aetzler@newspost.com
As the nationwide war on opioid addiction wages on, a Frederick-based electroceutical company may have brought one solution to the market.
BioElectronics Corp., which operates out of the Frederick Innovative Technology Center Inc., recently received over-the-counter clearance from the Federal Drug Administration for its flagship product, ActiPatch.
ActiPatch is a wearable nonprescription musculoskeletal pain therapy device designed for chronic pain sufferers. Through a technology called neuromodulation, ActiPatch sends pulsating electromagnetic waves through the skin to regulate nerve activity.
ActiPatch’s electromagnetic signal pulses 1,000 times per second to stimulate neuromodulation of the nerves to lessen the brain’s perception of pain.
Unlike with a transcutaneous electrical nerve stimulation device, there is no sensation to the skin or muscle when using the product. Another clinical difference is the ActiPatch heals and regenerates cells, while a TENS device blocks the pain signals, and has no healing effect, said Sree Koneru, director of engineering research for the company.
The device has a battery that sends an electric current through a wire that loops to the other end of the battery. This focuses the electromagnetic waves on a central area, which should be the area where someone is experiencing pain.
Approval from the FDA helped boost BioElectronics’ stock price 650 percent from $.0003 to $.00225 in a matter of weeks. The stock trades at market capitalization of $39 million. Market capitalization determines the value of a company based on the number of shares multiplied by the share price.
“Basically it gives us credibility,” said President and CEO Andy Whelan. “That allows us to get it on the market and to have conversations with licensing companies to market the product.”
The company has not released its annual earnings report yet, nor has it finished its first quarter of 2017, so the financial implications of putting the product on the market in the United States are not known.
However, in its September 2016 third quarter earnings report, the company saw a $600,000 loss, which was almost $130,000 less than the company’s third quarter loss the year prior.
For BioElectronics, there is a long list of next steps to capitalize on getting FDA approval. The company quickly got ActiPatch on Amazon.com, where it sells for $29.95, and is working on a plan to market the product in the U.S. The product has been on the market in Europe and Canada for a while, and the company has sold one million units globally, Whelan said.
ActiPatch comes with an accessory that helps the user secure it to his or her body depending on where the patient experiences the chronic pain. It comes with 720 hours of battery life, and can work for 30 consecutive days nonstop or 90 sessions of eight hours each. Whelan said tests showed better results when people wore it in their sleep.
ActiPatch fits into the war on opioid use, because it can replace pain medication, said Koneru.
“Many people turn to opioid medication only because existing therapies do not provide adequate pain relief,” Koneru said. “If their pain were to be taken away in a safe and effective manner, they are likely to reduce their opioid pain medication use in general.”
Empirical data from 15,000 ActiPatch users in the United Kingdom indicated that of those benefiting from ActiPatch therapy, nearly half go on to reduce their opioid pain medication use by an average of 50 percent, Koneru said.
The company is planning a clinical study in the U.S. that can specifically investigate the efficacy of ActiPatch therapy in reducing opioid/pain medication for chronic pain patients.
“As the first line of defense against pain, ActiPatch can play a safe, yet significant role in our nation’s fight against opioid pain-medication addiction,” Koneru said.
With the patented technology and FDA approval, the company’s options are many, Koneru said. It is currently working on a product to help migraine headaches, and another that will help heal chronic wounds.
Early studies have shown that the chronic-wound care product can close ulcer wounds in as few as three weeks. Koneru said the study involved people who had ulcer wounds that hadn’t showed any signs of healing for months.
“Really, we don’t think there is anything like this on the market,” Koneru said.
(Paul Knopick pknopick@eandecommunications.com)
Tuesday, March 14, 2017 9:19:31 AM 1141231
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