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NORCROSS, Ga.--(BUSINESS WIRE)--Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of a rapid and painless testing platform based on its patented biophotonic technology, announced today that it has re-opened discussions with the U.S. Food and Drug Administration (FDA) regarding U.S. premarket approval of the Company’s LuViva® Advanced Cervical Scan. The Company’s decision was prompted by a constructive outcome from the Company’s previous face-to-face meeting with FDA and a perceived more favorable environment for device approvals under the new presidential administration, along with a recent increase in device approvals at the FDA. In connection with the Company’s plan to re-file for approval of its LuViva® Advanced Cervical Scan, it plans on conducting a new clinical study to confirm previous results already submitted to the FDA. In a telephonic meeting with the FDA, the Company discussed initiating the process by submitting a new study protocol and discussed the possibility of submitting the study data under FDA’s 510(k) de Novo regulations, which, if accepted, could potentially speed up the approval process. The new clinical study is expected take approximately nine months to complete, after which the Company would submit the data to the FDA. The Company intends on initiating the process by submitting the new study protocol to the FDA within 30 days after funding has been secured. Once final clinical study data has been submitted to the FDA, the FDA will have 180 days to respond with a decision or additional questions. 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 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. (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® 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® 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.


NORCROSS, Ga.--(BUSINESS WIRE)--Guided Therapeutics, Inc. (OTCQB: GTHP), developer of the LuViva® Advanced Cervical Scan, a non-invasive device used to detect cervical disease instantly at the point of care, today announced it has received an order for 10 additional LuViva® Advanced Cervical Scans for Indonesia. The order brings to 24 the number of LuVivas and more than 7,000 the number of single use Cervical Guides sold to Indonesia. Additional orders of Cervical Guides are expected later this year. LuViva has been recommended as an alternative to the Pap test by doctors presenting at the 22nd Annual Scientific Meeting of the Society of Obstetricians and Gynecologists of Indonesia. “Indonesia is an important market for LuViva where it has demonstrated its value as an alternative to lab–based testing with the benefits of an immediate result and no painful tissue sample,” said Gene Cartwright, CEO and President of Guided Therapeutics, Inc. “In areas were the laboratory infrastructure is limited, LuViva presents a tremendous improvement in women’s access to healthcare.” Cervical cancer is the second most common malignancy among women of Indonesia with an incidence rate of about 17 in 100,000. In Indonesia, where 70% of cervical cancer cases diagnosed are in an advanced stage, there is a clear unmet need to increase screening to detect cervical disease before it develops into cancer. In Indonesia, more than 93 million women are at risk of developing cervical cancer. Less than 25% of women aged 30 to 50 are screened for cervical cancer in Indonesia with the primary method of visual inspection with acetic acid. There are about 2.6 billion women aged 15 years and older who are at risk of developing cervical cancer worldwide. The world 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 almost $9 billion by 2020. 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® 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® 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.


News Article | February 15, 2017
Site: www.marketwired.com

TORONTO, ON--(Marketwired - February 09, 2017) - ReMAP is pleased to share in the news that the 7D Surgical Machine-vision Image Guidance System recently received FDA approval for spinal surgery. The ReMAP O7 team is a collaboration between 7D Surgical, Celestica, Ryerson University and Sunnybrook Research Institute, formed to advance optical technologies for their image-guided surgery solution. This team of industry leaders and research partners have come together to develop the next generation of image-guidance systems for simple and fast surgical workflows. ReMAP congratulates this team in achieving this milestone to help improve patient outcomes. "As products are being launched exponentially faster than ever before, the role of ReMAP is to accelerate time-to-market from researchers' innovative ideas and emerging technologies at later stage technology readiness levels (TRL) through to product commercialization," said Irene Sterian, Executive Director of ReMAP. "A collaboration of industry experts and scientists strengthens the ability for a start-up organization to accelerate the commercialization of their innovation developed in Canada for the global market. ReMAP is pleased to support the ReMAP O7 Team in this initiative. We are committed to making a significant contribution to Canada to help build its competitive advantage, create new highly skilled jobs and providing opportunities to build export-ready products that will have long-term economic benefit." "It is my pleasure to announce the FDA 510(K) and Health Canada MDL clearance of our Machine-vision Image Guidance System, the first of several advanced optical imaging technologies in our commercialization pipeline," said Beau Standish, CEO of 7D Surgical. "We are proud to be part of the ReMAP O7 project team and have directly benefited from ReMAP's mission of accelerating commercialization through collaborations between industry experts and scientists." Through shared resources, ReMAP accelerates the commercialization of innovative products developed in Canada for the global market. Our network of partners from start-ups, small-to-medium enterprises, large organizations, and leading research institutions work together to form a product-enablement value chain. Leveraging the strengths and synergies of our network partners, ReMAP engages with 38 labs and manufacturing facilities from across Canada. ReMAP supports innovations in the Aerospace & Defense, Information & Communications Technology (ICT), Healthcare, Industrial, and Renewable Energy market sectors. ReMAP is made possible through joint funding from the Government of Canada's Business-led Networks of Centres of Excellence (BL-NCE) program matched by contributions from our network partners. 7D Surgical is a privately-owned Toronto based company that develops advanced optical technologies and machine vision-based registration algorithms to improve surgical workflow and patient care. 7D Surgical's flagship FDA 510(k)-cleared and Health Canada approved Machine-vision Image Guidance System delivers profound improvement to surgical workflows in spine surgery, providing the promise of similar future advancements in other surgical specialties. Sunnybrook Research Institute (SRI) is the research enterprise of Sunnybrook Health Sciences Centre and is fully affiliated with the University of Toronto. Scientists at SRI strive to understand and prevent disease, and to develop treatments that enhance and extend life. Our vision is to invent the future of health care. Scientists at SRI are renowned for excellence in the biological, physical and evaluative clinical sciences. Areas of expertise are diseases of the brain and heart; cancer; musculoskeletal conditions; rehabilitation; trauma, emergency and critical care; women and babies; and veterans and community. Each year, SRI conducts over $100 million in research across 500,000 square feet, including in the world's first Centre for Research in Image-Guided Therapeutics. Celestica is dedicated to delivering end-to-end product lifecycle solutions to drive our customers' success. Through our simplified global operations network and information technology platform, we are solid partners who deliver informed, flexible solutions that enable our customers to succeed in the markets they serve. Committed to providing a truly differentiated customer experience, our agile and adaptive employees share a proud history of demonstrated expertise and creativity that provides our customers with the ability to overcome complex challenges Ryerson University is Canada's leader in innovative, career-oriented education and a university clearly on the move. With a mission to serve societal need, and a long-standing commitment to engaging its community, Ryerson offers more than 100 undergraduate and graduate programs. Distinctly urban, culturally diverse and inclusive, the university is home to more than 41,500 students, including 2,400 master's and PhD students, 3,200 faculty and staff, and nearly 170,000 alumni worldwide. Research at Ryerson is on a trajectory of success and growth: externally funded research has doubled in the past five years. The G. Raymond Chang School of Continuing Education is Canada's leading provider of university-based adult education. This press release contains forward-looking statements regarding, among other things, statements pertaining to expectations, goals, plans, objectives, and future events. 7D Surgical intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934, and the Private Securities Reform Act of 1995. In some cases, forward-looking statements can be identified by the following words: "may," "can," "will," "could," "would," "should," "expect," "intend," "plan," "anticipate," "believe," "estimate," "predict," "project," "potential," "promise," "continue," "ongoing," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements are based on the current estimates and assumptions of our management as of the date of this press release and are subject to risks, uncertainties, changes in circumstances, assumptions, and other factors that may cause actual results to differ materially from those indicated by forward-looking statements, many of which are beyond 7D Surgical's ability to control or predict. Given these uncertainties, undue reliance should not be placed on these forward-looking statements. 7D Surgical does not undertake any obligation to release publicly any updates or revisions to these forward-looking statements to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events. "Flash Registration™," as well as the "7D" logo, whether standing alone or in connection with the words "7D Surgical" are protected trademarks of 7D Surgical.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 1.06M | Year: 2011

DESCRIPTION (provided by applicant): Repetitive exposures to psychosocial stress are associated with several human diseases (e.g., cancer, drug addiction, heart disease, depression) of noteworthy public health burden. However, our progress is limited by the lack of a portable device that can enable rapid, dependable, non-invasive and continuous measurement of personal exposure to psychosocial stress in real-time, as experienced by individuals in their natural environments. Although reliable methods to assess exposure to psychosocial stress in clinical settings exist, these intermittent assessments do not accurately portray timing, duration, frequency, or intensity of exposure. Currently there are more than 3600 registered endocrinologists in the US and on anaverage they refer five patients per day for cortisol tests. This test is ordered by sending patient's samples to the lab. Therefore, there is a grave need to develop a rapid test for cortisol so a No-Stress Stress Measuring Device can be developed. Inthis interdisciplinary Phase II project, we propose to develop a new device called StressSmartTM , which will house a rapid test for cortisol developed during Phase I, namely InstaCortisolTM. Cortisol is the primary steroid produced and secreted by the adrenal cortex and is used as a reliable indicator of stress. Our rapid test is based on immunoelectrochemical method where the reaction signal is measured by using dithiobissuccinimidyl propionate (DTSP) self assembled monolayer (SAM) based immunosensor forcortisol. Detection is being facilitated using impedance measuring technique. There are six specific aims of this project. First is further refining and optimizing the cortisol sensor fabrication and sensor evaluation, including sensitivity, specificity,detection limit, linearity, accuracy, dynamic range, repeatability, precision, accuracy, interference, cross-reactivity, drift, and sensor calibration. Second is the development of microfluidic architecture system. The third aim would be the design, fabrication, integration and development of a microfluidic valves. Several such valves will be needed as parts of the three disposable cartridges. Fourth and fifth aim being the development of a reliable vacuum microfluidics pump, followed by cortisol sensor housing development as part of the device. Throughout the program, some other efforts will also include cortisol sensor clotting mitigation, cortisol sensor electronic Interface board development, cortisol sensor miniaturization efforts, clinical validation and the design integration feasibility. A virtual evaluation of cortisol sensor chip and its integration into a compact easy to use design will be carried out in parallel. A virtual evaluation of cortisol sensor chip and its integration into a compact easyto use design will also be carried out throughout the Year 2 budget period. Relevance: The InstaCortisolTM test (developed during Phase I), which will be part of StressSmartTM device during Phase II, will enable researchers to quantify personal exposure topsychosocial stress, as experienced by individuals in real-life situations. Cortisol production follows a circadian rhythm, and moreover it is affected by stimulatory events or nutrient intake, so it important to measure the trend of cortisol in a personversus taking a single measurement in one day as is done traditionally. Recent research surveys have revealed that the minimal number of samples needed in a day for an accurate assessment of cortisol is five. Our current disposable cartridge is designed tocollect four measurements over 24 hours for the proof of concept. However, this device can be easily re-designed to include any other clinically relevant requirements. Availability of such a non-invasive and rapid cortisol measuring device will allow patients to be able to monitor their cortisol levels over 24 hours and professionals to be able to modify dosing regiments at multiple points throughout the day. PUBLIC HEALTH RELEVANCE: We are proposing to make a tool for rapid detection of cortisol, called StressSmartTM. InstaCortisolTM (a rapid cortisol test developed during Phase I), will be integrated in StressSmart device to develop a portable test for real-time measurement of personal exposure to psychosocial stress via detecting cortisol in interstitial fluid (ISF). The new minimally invasive tool will enable researchers to quantify personal exposure to psychosocial stress, as experienced by individuals in real-life situations. This device will be capable of measuring cortisol quantitatively, selectively, objectively, reliably, and securely.


NORCROSS, Ga.--(BUSINESS WIRE)--#cervicalcancer--Guided Therapeutics Announces 1:800 Reverse Stock Split and Elimination of “Toxic” Convertible Securities from its Balance Sheet


NORCROSS, Ga.--(BUSINESS WIRE)--Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of a rapid and painless testing platform based on its patented biophotonic technology, announced today that it will report its 2015 second quarter financial results following the market close on Wednesday, August 12, 2015. The Company has scheduled a conference call for Thursday, August 13, 2015 at 11:00 A.M. Eastern Time (ET) to review the results. Dial in Number for U.S. & Canadian Callers: 866-405-1201 Dial in Number for International Callers (Outside of the U.S. & Canada): 201-689-8042 Participating on the call will be Guided Therapeutics Chief Executive Officer Gene Cartwright and Controller Charles Rufai, who will discuss operational and financial highlights for the second quarter of 2015. To join the live conference call, please dial the above referenced telephone numbers five to ten minutes prior to the scheduled call time. A live webcast and archive of the call will also be available on the Guided Therapeutics website at http://www.guidedinc.com/investors/ or: http://guidedinc.equisolvewebcast.com/q2-2015. A replay will be available for seven days beginning on August 13, 2015, at approximately 1:00 P.M. ET. To access the replay, please dial 877-660-6853 in the U.S. and 201-612-7415 for international callers. The conference ID# is 13616070. 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® 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® 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 products in development, 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 our prior financings and our 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, 2014 and subsequent filings.


News Article | September 15, 2015
Site: www.massdevice.com

Guided Therapeutics (OTC:GTHP) said today that it won a date with the FDA to discuss its stalled bid for pre-market approval for the LuViva cervical scan device. Norcross, Ga.-based Guided Therapeutics said it’s slated to meet Nov. 6 with the FDA to review its proposal for new clinical data on the LuViva device. GTHP shares lost ⅓ of their value May 20 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. The company was 1st rebuffed in January 2013 when the FDA refused its original PMA bid, asking for additional data on updates to the device and changes to clinical trial parameters. In July 2013 the company said it had an FDA-approved path to a PMA, but by September of that year FDA regulators were still not satisfied with the amended application. Last July Guided Therapeutics took another shot at the U.S. market, nearly a year after receiving the 2nd non-approvable letter for the LuViva device. Today the company said the FDA also named a new lead reviewer to oversee the PMA review of LuViva. “We look forward to working with FDA and our new lead reviewer in order to achieve U.S. approval for LuViva,” CEO Gene Cartwright said in prepared remarks. “Meanwhile, we are working with governments of several countries outside the U.S. to make the LuViva the standard of care for women’s health.”


NORCROSS, Ga.--(BUSINESS WIRE)--Guided Therapeutics, Inc. (OTCBB: GTHP) (OTCQB: GTHP), developer of a point-of-care and painless testing platform that uses biophotonics for the early detection of disease that leads to cervical cancer, today announced that it is scheduled to report financial results for its first quarter ended March 31, 2015 and provide an update on business activity on Wednesday, May 13, 2015, after the market closes. Guided Therapeutics will hold a conference call at 11:00 a.m. EDT on Thursday, May 14, 2015, to discuss its financial results and corporate developments. Interested parties are invited to listen to the call live over the Internet at http://www.guidedinc.com/investors/. The live call is also available by dialing (888) 438-5524 or for international callers (719) 325-2484 and referencing Conference ID 3010082. A replay of the teleconference will be available on http://www.guidedinc.com/investors/. A replay will also be available until May 21, 2015, by dialing (877) 870-5176 or for international callers (858) 384-5517 and using pin number 3010082. The Company continues to focus on federal and state-level ministries of health in the developing world where the product is being evaluated for primary screening and in developed countries where LuViva can be adopted into the current standard of care. In the U.S., where LuViva is being evaluated as a triage device for women who receive a positive Pap test result, the Company is awaiting a response from FDA on its PMA amendment. The FDA has confirmed to the Company that the agency will respond to the PMA Amendment in May. Guided Therapeutics currently has regulatory approval to sell LuViva in Europe with the Edition 3 CE mark, and has marketing approvals from COFEPRIS in Mexico, Health Canada and Singapore Health Sciences Authority, among others. Guided Therapeutics, Inc. (OTCBB: GTHP) (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® 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® Advanced Cervical Scan is an investigational device and is limited by federal law to investigational use. 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 products in development, 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 uncertainty of capital to develop products, the uncertainty of regulatory approval of products, 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, 2013, and subsequent quarterly reports.


NORCROSS, Ga.--(BUSINESS WIRE)--Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of a rapid and painless testing platform based on its patented biophotonic technology, announced today that it reported second quarter financial results for the period ended June 30, 2015. Guided Therapeutics reported $103,000 in revenue for the three months ended June 30, 2015, compared to $201,000 for the same period in 2014. This decrease was primarily the result of shipments of 5 units of LuViva® Advanced Cervical Scans and 1,300 single-use disposables in the current period, compared to 11 LuViva devices and 4,200 disposables shipped in the same period of 2014. Reflecting company-wide expense reduction and cost savings efforts, sales and marketing expenses were approximately $183,000 in the second quarter of 2015, compared to $345,000 for the same period in 2014. The Company reported a net loss attributable to shareholders of $3.0 million for the three months ended June 30, 2015, versus a net loss of $2.2 million for the same period in 2014, primarily driven by approximately $1.3 million of deemed dividends on the preferred stock and lower revenue, offset in part by lower costs. Subsequent to quarter end, the Company’s Turkish distributor signed a four-year deal to sell $10 million of LuViva devices and single-use-disposables to the Turkish Ministry of Health. The contract, for 450 devices and 450,000 disposables, runs through 2018. Initial shipments of 50 devices and 50,000 disposables are scheduled for the remainder of 2015. “After a tremendous amount of effort by the Company and our distributor, we have been successful in including LuViva in a national cervical cancer screening program in Turkey,” said Gene Cartwright, Chief Executive Officer of Guided Therapeutics. “With LuViva, our company is uniquely positioned to close additional large deals with national and regional governments, which have the potential to significantly ratchet up revenue in large blocks. Along with our distributors, we are currently working in our next three targeted countries each with large screening populations to become integrated into their national screening programs. Those countries, Indonesia, Kenya and Bangladesh, have a combined cervical cancer screening population of approximately 150 million women.” “Since we announced our agreement with our Chinese partner, we have been making significant progress to enter that prized market. We are very near to selecting our regulatory filing agent and have been interviewing potential distribution companies. We are also working with major medical institutions to select our ‘Key Opinion Leaders’ and hospitals,” Mr. Cartwright said. “With regard to the FDA, we intend to submit our plan for advancing the premarket approval application for LuViva to the Agency before the end of August. We are also requesting a meeting with the Agency to agree on specifics of any additional patient data to be submitted,” Mr. Cartwright said. The Company has scheduled a conference call for Thursday, August 13, 2015 at 11:00 A.M. Eastern Time (ET) to review the results. Participating on the call will be Guided Therapeutics Chief Executive Officer Gene Cartwright, Controller Charles Rufai and Director of Communications Bill Wells, who will discuss operational and financial highlights for the second quarter of 2015. To join the live conference call, please dial the above referenced telephone numbers five to ten minutes prior to the scheduled call time. A live webcast and archive of the call will also be available on the Guided Therapeutics website at: http://guidedinc.equisolvewebcast.com/q2-2015. A replay will be available for seven days beginning on August 13, 2015, at approximately 1:00 P.M. ET. To access the replay, please dial 877-660-6853 in the U.S. and 201-612-7415 from outside the U.S. The conference ID# is 13616070. 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® 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® 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 products in development, 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 our prior financings and our 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, 2014 and subsequent filings.


ISTANBUL--(BUSINESS WIRE)--Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of a rapid and painless testing platform based on its patented biophotonic technology, announced today that its Turkish distributor, ITEM Medical Technologies, has been awarded a new, four-year contract to supply LuViva® Advanced Cervical Scans and single-use, disposable Screening Cervical Guides to the Turkish Ministry of Health (MOH). The contract will generate more than $10 million for Guided Therapeutics. The contract calls for 450 LuVivas and 450,000 single-use Cervical Guides to be supplied by Guided Therapeutics over three and a half years beginning in the third quarter of 2015 and running through 2018. The delivery schedule calls for 50 LuVivas and 50,000 disposables in the remainder of calendar year 2015 and 200 LuVivas and 200,000 disposables in calendar year 2016 with the remaining 200 LuVivas and 200,000 Cervical Guides evenly distributed over the last two years of the contract. The MOH had previously indicated an order of 100 instruments and 100,000 Cervical Guides (see June 10, 2015 press release ) over the next 12 months, but has now increased the order size to 150 instruments and 150,000 Cervical Guides. The new contract, which projects orders through the end of 2018, consolidates the previous MOH orders and provides the new delivery schedule through ITEM and its partner. “This contract is a validation of LuViva’s promise to meet the healthcare needs of women by providing the first point-of-care test to cervical cancer screening,” said Gene Cartwright, CEO of Guided Therapeutics. “We believe that there are additional opportunities to further expand the use of LuViva in Turkey and with governmental screening programs in Africa, Asia and Latin America.” 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 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. (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® 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® 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 products in development, 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 our prior financings and our 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, 2014 and subsequent filings.

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