Guided Therapeutics (OTC:GTHP) said today it inked a licensing deal with Shenghuo Medical to manufacture and market its LuViva advanced cervical scan system in China and several other Southeast Asian countries.
The deal includes $200,000 in near-term cash payments, up to $1 million to support FDA approval for LuViva and extra support for achieving Chinese regulatory approval for LuViva. Also included are royalties, payable to Guided Therapeutics, on disposables sold in the regions.
“We are pleased to be continuing with Shenghuo to open up this valuable market to LuViva. The agreement also opens up the possibility to bring efficiencies to our manufacturing processes and provides funding for Chinese regulatory approval,” CEO Gene Cartwright said in a press release.
Shenghuo, who also holds distribution rights for the LuViva device in China, will maintain the right to manufacture LuViva and disposable under “certain conditions,” Guided Therapeutics said.
Last December, Guided Therapeutics said it believes it struck a “general agreement” for getting its LuViva cervical scanner approved by the FDA.
The plan to collect more data on LuViva is slated to be completed over the next 2 to 3 months, Norcross, Ga.-based Guided Therapeutics said. The company said the agreement was hashed out at a meeting with the FDA and 2 U.S. obstetric-gynecologists, including a new lead reviewer at the federal safety watchdog and a new OB-GYN doc.
GTHP shares lost ⅓ of their value last May after the FDA asked the company for more data on LuViva, which is designed to scan the cervix for chemical and structural indicators of pre-cancerous tissue.
Guided Therapeutics agreed to an FDA request for more scans on patients using new cervical cancer screening guidelines and proposed a “confirmatory” study to generate supplemental data
