Guided Therapeutics Enters Into LuViva Advanced Cervical Scan License Agreement for China

Guided Therapeutics Inc. has reached a licensing agreement with Shenghuo Medical LLC, for exclusive sales and manufacturing rights of the LuViva Advanced Cervical Scan for China and several additional southeast Asian countries. Shenghuo brought Chinese investors into the company last year and currently owns the distribution rights to China.
 
Terms of the licensing agreement include $200,000 in near-term cash payments, the potential for up to $1 million to pay for advancing U.S. Food and Drug Administration approval for LuViva, 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.
 
“We are pleased to be continuing with Shenghuo to open up this valuable market to LuViva,” said Gene Cartwright, CEO and president of Guided therapeutics. “The agreement also opens up the possibility to bring efficiencies to our manufacturing processes and provides funding for Chinese regulatory approval.”
 
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 Food and Drug Administration. 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.
 
Worldwide, the market for cervical cancer screening and diagnostics, as currently practiced using cytology (Pap test) for primary screening, is estimated at $6 billion and is projected to grow to nearly $9 billion by 2020. There are about 2.6 billion women aged 15 years and older who are at risk of developing cervical cancer worldwide.
 
LuViva is a technologically advanced diagnostic device that scans the cervix with light and uses spectroscopy to measure how light interacts with the cervical tissue. Spectroscopy identifies chemical and structural indicators of precancer that may be below the surface of the cervix or misdiagnosed as benign. This technique is called biophotonics. Unlike Pap, HPV tests or biopsies, LuViva does not require laboratory analysis or a tissue sample, and is designed to provide results immediately, which may result in eliminating additional testing. LuViva 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.
 
Guided Therapeutics Inc. has developed a rapid and painless testing platform based on its patented biophotonic technology that utilizes light for the early detection of disease at the cellular level. In a multi-center clinical trial with women at risk for cervical disease, the company’s LuViva technology was able to detect cervical cancer up to two years earlier than conventional modalities, according to published reports. The company is based in Norcross, Ga.