Stimwave Technologies announced today that it is stopping the commercialization of its product lines in Australia until its entire product family can be legally marketed in the country.
The neuromodulation therapy alternative developer’s products include the Freedom SCS system and the StimQ PNS system, which are designed to reduce the risks associated with implantable pulse generators that contain lithium-ion batteries.
Stimwave’s Freedom stimulators are the world’s smallest neurostimulators, designed to treat chronic pain through a needle in the epidural space, spinal column or next to peripheral nerves, according to a news release. It has been commercially available in Europe since 2013 and in the U.S. and Australia since 2014.
StimQ PNS has been available in Europe since 2016 and in the U.S. since 2015. StimQ PNS has been under review in Australia since 2017 and has not yet won approval.
“Without these products, the Stimwave offering is deficient for many of the patient population and it is not in the best interest of Stimwave to continue serving this market until such a time the full product suite can be utilized,” Stimwave founder & CEO Laura Perryman said in the news release.
In July Judge Colm Connolly granted a limited preliminary injunction barring infringement of a pair of claims on one of the patents in question, restricting use of the Stimwave device to frequencies below three kHz. In September, Stimwave appealed the injunction barring it from using higher-frequency neurostim to treat chronic pain.