After reviewing two different data sets, the FDA approved the marketing of the dermaPACE System treating diabetic foot ulcers.
After years of research and testing, the folks at SANUWAVE Health (OTCQB:SNWV) were finally able to tell its shareholders of the definite success of its dermaPACE System thanks to a ruling from the US Food and Drug Administration (FDA) on the marking of the product.
After reviewing the data from two randomized and double-blind studies evaluating over 300 diabetic patients, the company announced on Tuesday (January 2) that the FDA approved the marketing of this shock wave mechanism treating diabetic foot ulcers. The dermaPACE System was approved as a Class II medical device under the de novo premarket review pathway.
Brian Marckx, a senior equity research for Zacks, tweeted the approval was a long time coming “but much better late than never.”
$SNWV long time coming but much better late then never. 2018 already starting off exciting for SNWV. Sanuwave Receives FDA De Novo Decision to Immediately Market the Dermapace System for the Treatme… https://t.co/07B06msjGO via @YahooFinance
— Brian Marckx, CFA (@bmarckxCFA) January 2, 2018
SANUWAVE’s dermaPACE device offers new option for diabetic patients
Kevin Richardson II, SANUWAVE’s CEO and chairman, said in the release the company is confident that–with the rising numbers of diabetes rates in the US–the dermaPACE system will redefine diabetic foot ulcers treatment.
Richardson expressed one of the advantages of their system is the option to continue other methods of treatment, like dermal grafts or biologic gels.
“Wound care professionals using the device in Europe, Canada, and Australia use the dermaPACE System in the progression of their treatment regimen for wound management with healing as the final intent,” Richardson II said. “Not all wounds, nor all patients are the same; therefore, each wound is treated on an individual basis based on the treating physician’s knowledge and the treatment options available.”
Richardson said now that SANUWAVE has obtained the marketing approval, it intends to accelerate their commercial launch process in the States. New hiring and partnerships are in the plans of the company.
According to the FDA there are over 30 million people living with diabetes in the US, and 25 percent of these will experience a foot ulcer.
“Additional options for successfully treating and healing ulcer wounds may help prevent lower limb amputations,” Dr. Binita Ashar, director of the division of surgical devices in the FDA’s Center for Devices and Radiological Health, said in a statement.
In terms of side effects, the regulatory agency warned patients could see bruising and numbness, alongside migraines, nausea, fainting, wound infection and fever.
This approval caused an uproar for SANUWAVE’s stock on the market, the size of the diabetic market and its needs also helped boost the company’s share price for the potential this device brings.
Since the official marketing approval last week by the regulatory agency, (December. 28) the company’s stock has skyrocketed 73.01 percent and closed at $0.25 on Tuesday. At market closure on Tuesday, SANUWAVE’s stock was priced at $0.25.
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Securities Disclosure: I, Bryan Mc Govern, hold no direct investment interest in any company mentioned in this article.