Guided Therapeutics, Inc. (GTHP) today announced that it has submitted to FDA its PMA (premarket approval amendment) for the LuViva Advanced Cervical Scan (a non-invasive device used to detect cervical disease that leads to cancer).
LuViva has been under FDA PMA review since September 23, 2010. FDA declined LuViva in January 20, 2012. In July, 2012 the company met with the agency and agreed to file a PMA amendment to address the agencys questions stemming from the not approvable letter. PMA amendment has been submitted now and the FDA has 180 days during which it can respond.
LuViva® Advanced Cervical Scan, under development by Guided Therapeutics, is designed as a new non-invasive test that has the potential to significantly improve the early detection of cervical precancers. LuViva is designed as a fast, painless test that – unlike Pap smears and HPV testing – does not require a tissue sample or the delay of laboratory analysis. Early detection of cancer and precancers greatly improves survival, and LuViva is designed to help preserve the reproductive health of women. LuViva currently has marketing approval from Health Canada and received its first CE Mark, an ISO 60601 Edition 2 Notification, in July. The company also was was awarded ISO 13485 certification in January, 2011.
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At September 30, 2012, the Company had working capital of approximately $607,000 and it had stockholders’ equity of approximately $2.0 million, primarily due to the recurring losses, offset in part by the recognition of the warrants exchanged as part of the Warrant Exchange Program. As of September 30, 2012, the Company was past due on payments due under its notes payable in the amount of approximately $406,000.
The Company’s capital-raising efforts are ongoing. If sufficient capital cannot be raised during the first quarter of 2013, the Company has plans to curtail operations by reducing discretionary spending and staffing levels, and attempting to operate by only pursuing activities for which it has external financial support, such as under its development agreement with Konica Minolta and additional NCI or other grant funding. However, there can be no assurance that such external financial support will be sufficient to maintain even limited operations or that the Company will be able to raise additional funds on acceptable terms, or at all. In such a case, the Company might be required to enter into unfavorable agreements or, if that is not possible, be unable to continue operations, and to the extent practicable, liquidate and/or file for bankruptcy protection.
The Company could receive additional funding from Konica Minolta or other strategic partners as well as new federal grants that could bring in an additional $2.7 million. As of September 30, 2012, the Company had warrants exercisable for approximately 20.8 million shares of its common stock outstanding, a substantial majority of which have an exercise price of $0.65 and $0.80 per share. Through September 30, 2012, exercises of warrants have generated approximately $3.0 million and would generate a total of approximately $14.2 million in cash, assuming full exercise. Management may obtain additional funds through the private sale of preferred stock or debt securities, public and private sales of common stock, funding from collaborative arrangements, and grants, if available, and believes that such financing will be sufficient to support planned operations through the first quarter of 2013.
Assuming the Company receives Food and Drug Administration (“FDA”) approval for its LuViva cervical cancer detection device in early 2013, the Company currently anticipates a late 2013 product launch in the United States. Product launch outside the United States commenced, as expected, in the second half of 2012, but the Company cannot be assured it will be able to continue its product launch on these timetables, or at all.
Guided Therapeutics, Inc. is developing a rapid and painless testing platform for the early detection of disease based on its patented biophotonic technology that utilizes light to detect disease at the cellular level. The Company’s first planned product is the LuViva Advanced Cervical Scan, a non-invasive device used to detect cervical disease instantly and at the point of care. LuViva Advanced Cervical Scan is an investigational device and is limited by federal law to investigational use.