Guided Therapeutics (Norcross, GA) has reached a licensing agreement with Shenghuo Medical (China) for exclusive sales and manufacturing rights of its LuViva Advanced Cervical Scan, a diagnostic device for cervical cancer that scans the cervix with light and uses spectroscopy to measure how light interacts with the cervical tissue, for China and several additional Southeast Asian countries. Shenghuo brought Chinese investors into Guided Therapeutics last year and currently owns the distribution rights to China.
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Unlike Pap, HPV tests, or biopsies, the LuViva device does not require laboratory analysis or a tissue sample, and is designed to provide results immediately, which could eliminate costly, painful, and unnecessary additional testing. The device is intended for use with women who have undergone initial screening and are called back for follow up with a colposcopy examination, which in many cases involves taking a biopsy of the cervix. It has also been used in clinical studies in Turkey and Nigeria as a means to screen women for cervical cancer where the availability of infrastructure necessary for Pap and HPV testing is restricted. The device is used in conjunction with the LuViva Cervical Guide single-use patient interface and calibration disposable.
The terms of the licensing agreement include $200,000 in near-term cash payments, the potential for up to $1.0 million to pay for advancing U.S. FDA approval for the LuViva device, funding to secure Chinese regulatory approval of LuViva and a royalty payable to Guided Therapeutics on disposables sold in the territories. Shenghuo also has the right to manufacture the LuViva and disposables under certain conditions.
China is the second largest medical device market in the world, according to the U.S. Department of Commerce. Approximately 390 million Chinese women are between 25 and 64 years old, the prime age for cervical cancer screening. Prior to commercial sales, LuViva would need approval from the Chinese FDA. The company currently anticipates interim device and disposable sales for clinical study and demonstration purposes. In Hong Kong, the company believes the time to commercial sales is quicker, with device registration, rather than approval required.
For more information, please visit www.guidedinc.com.