BSD Medical, which earlier this year rebranded as Perseon Corp. (NSDQ:PRSN) in a bid to focus on its core microwave ablation business, said today that it won an expanded 510(k) clearance from the FDA for its MicroThermX device.
The new indication for the soft tissue ablation system covers laparoscopic ablation procedures using image guidance, Salt Lake City-based Perseon said. PRSN shares jumped 15.2% today to 38¢ apiece on the news.
"This new indication increases the type of cases that our technology will be used for and the opportunity to expand the use of MicroThermX in surgical oncology," said Clint Carnell, CEO of Perseon. "This moves us closer to achieving our clinical initiatives to benefit patients, physicians, and the healthcare system worldwide."
In January, BSD announced plans to shed its hyperthermia business this spring, to focus on MicroThermX. A month later the company unveiled its new corporate identity. The hyperthermia cancer treatment assets were sold April 1 to Pyrexar Medical for a 19.9% stake in that company and a royalty-sharing agreement, Perseon said.
The deal calls for Pyrexar to pay Perseon 15% of gross revenues on the 1st 9 hyperthermia units sold within 42 months in Taiwan and/or Korea, then 5% of any sales after that in those countries and 5% of any sales elsewhere, according to a regulatory filing.