NEW PRESS RELEASE Guided Therapeutics Provides
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Posted On: 06/21/2018 1:04:06 PM
NEW PRESS RELEASE
Guided Therapeutics Provides Progress Update on International Activities
10:19 am ET June 21, 2018 (BusinessWire) Print
Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of a rapid and painless testing platform based on its patented biophotonic technology, continues to make progress with commercial activities internationally.
1. China. We are in the process of transferring manufacturing to our commercialization partner in China for the Chinese market. In addition, we are working with the distributor on the clinical protocol for submission to the Chinese FDA. We hope to be approved for sale in China in the second half of 2019.
2. Indonesia. LuViva tests have increased as reflected by increased orders of single-use cervical guides, with the next order expected in July. Additional LuViva devices have been requested by the distributor prior to the end of this year.
3. India. We announced that we are approved for sale in India. Based upon mutual agreement of a Letter of Intent, we are planning a 2 week sales trip to the 6 major cities in September or October. We expect the initial order from India by the end of 2018.
4. Turkey. We announced a large contract in early April with $1.1 million in payments due in 2018. The contract is still on track but it has been delayed due to the recent financial and political issues in Turkey. We expect to get the payments in from this contract after the political elections have taken place.
5. Russia/Eastern Europe. Our distribution partner reported a successful presentation at a medical meeting in Minsk and is working with the Russian FDA towards approval.
6. Financing. Our goal is to reduce our liabilities and to obtain solid financing for the company to provide a two year runway for further commercial growth. We continue to pursue the financing.
7. FDA follow-up. We have not had the financial resources to do the confirmatory study that the FDA requires. We will restart that FDA work as soon as we complete our financing and we anticipate FDA approval 18 to 24 months later.
About LuViva(R) Advanced Cervical Scan
The 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 costly, painful and unnecessary 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, Indonesia, 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(R) Cervical Guide single-use patient interface.
About Guided Therapeutics
Guided Therapeutics, Inc. (OTCQB: GTHP) is the maker of 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. The Company's first product is the LuViva(R) Advanced Cervical Scan, a non-invasive device used to detect cervical disease instantly and at the point of care. In a multi-center clinical trial with women at risk for cervical disease, the technology was able to detect cervical cancer up to two years earlier than conventional modalities, according to published reports. For more information, visit: www.guidedinc.com.
The Guided Therapeutics LuViva(R) Advanced Cervical Scan is an investigational device and is limited by federal law to investigational use in the U.S. LuViva, the wave logo and "Early detection, better outcomes" are registered trademarks owned by Guided Therapeutics, Inc.
Forward-Looking Statements Disclaimer: A number of the matters and subject areas discussed in this news release that are not historical or current facts deal with potential future circumstances and developments. The discussion of such matters and subject areas is qualified by the inherent risks and uncertainties surrounding future expectations generally and also may materially differ from Guided Therapeutics' actual future experience involving any of or more of such matters and subject areas. Such risks and uncertainties include those related to the early stage of commercialization of products, the uncertainty of market acceptance of products, the uncertainty of development or effectiveness of distribution channels, the intense competition in the medical device industry, the sufficiency of capital raised in prior financings and the ability to realize their expected benefits, the uncertainty of future capital to develop products or continue as a going concern, the uncertainty of regulatory approval of products, and the dependence on licensed intellectual property, as well as those that are more fully described from time to time under the heading "Risk Factors" in Guided Therapeutics' reports filed with the SEC, including Guided Therapeutics' Annual Report on Form 10-K for the fiscal year ended December 31, 2016 and subsequent filings.
http://cts.businesswire.com/ct/CT?id=bwnews&a...mp;lang=en
View source version on businesswire.com: https://www.businesswire.com/news/home/20180621005772/en/
SOURCE: Guided Therapeutics, Inc.
Guided Therapeutics
Mark Faupel, 770-242-8723
Guided Therapeutics Provides Progress Update on International Activities
10:19 am ET June 21, 2018 (BusinessWire) Print
Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of a rapid and painless testing platform based on its patented biophotonic technology, continues to make progress with commercial activities internationally.
1. China. We are in the process of transferring manufacturing to our commercialization partner in China for the Chinese market. In addition, we are working with the distributor on the clinical protocol for submission to the Chinese FDA. We hope to be approved for sale in China in the second half of 2019.
2. Indonesia. LuViva tests have increased as reflected by increased orders of single-use cervical guides, with the next order expected in July. Additional LuViva devices have been requested by the distributor prior to the end of this year.
3. India. We announced that we are approved for sale in India. Based upon mutual agreement of a Letter of Intent, we are planning a 2 week sales trip to the 6 major cities in September or October. We expect the initial order from India by the end of 2018.
4. Turkey. We announced a large contract in early April with $1.1 million in payments due in 2018. The contract is still on track but it has been delayed due to the recent financial and political issues in Turkey. We expect to get the payments in from this contract after the political elections have taken place.
5. Russia/Eastern Europe. Our distribution partner reported a successful presentation at a medical meeting in Minsk and is working with the Russian FDA towards approval.
6. Financing. Our goal is to reduce our liabilities and to obtain solid financing for the company to provide a two year runway for further commercial growth. We continue to pursue the financing.
7. FDA follow-up. We have not had the financial resources to do the confirmatory study that the FDA requires. We will restart that FDA work as soon as we complete our financing and we anticipate FDA approval 18 to 24 months later.
About LuViva(R) Advanced Cervical Scan
The 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 costly, painful and unnecessary 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, Indonesia, 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(R) Cervical Guide single-use patient interface.
About Guided Therapeutics
Guided Therapeutics, Inc. (OTCQB: GTHP) is the maker of 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. The Company's first product is the LuViva(R) Advanced Cervical Scan, a non-invasive device used to detect cervical disease instantly and at the point of care. In a multi-center clinical trial with women at risk for cervical disease, the technology was able to detect cervical cancer up to two years earlier than conventional modalities, according to published reports. For more information, visit: www.guidedinc.com.
The Guided Therapeutics LuViva(R) Advanced Cervical Scan is an investigational device and is limited by federal law to investigational use in the U.S. LuViva, the wave logo and "Early detection, better outcomes" are registered trademarks owned by Guided Therapeutics, Inc.
Forward-Looking Statements Disclaimer: A number of the matters and subject areas discussed in this news release that are not historical or current facts deal with potential future circumstances and developments. The discussion of such matters and subject areas is qualified by the inherent risks and uncertainties surrounding future expectations generally and also may materially differ from Guided Therapeutics' actual future experience involving any of or more of such matters and subject areas. Such risks and uncertainties include those related to the early stage of commercialization of products, the uncertainty of market acceptance of products, the uncertainty of development or effectiveness of distribution channels, the intense competition in the medical device industry, the sufficiency of capital raised in prior financings and the ability to realize their expected benefits, the uncertainty of future capital to develop products or continue as a going concern, the uncertainty of regulatory approval of products, and the dependence on licensed intellectual property, as well as those that are more fully described from time to time under the heading "Risk Factors" in Guided Therapeutics' reports filed with the SEC, including Guided Therapeutics' Annual Report on Form 10-K for the fiscal year ended December 31, 2016 and subsequent filings.
http://cts.businesswire.com/ct/CT?id=bwnews&a...mp;lang=en
View source version on businesswire.com: https://www.businesswire.com/news/home/20180621005772/en/
SOURCE: Guided Therapeutics, Inc.
Guided Therapeutics
Mark Faupel, 770-242-8723
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