By: Dylan Sikes - AllPennyStocks.com News

Wednesday, October 23, 2013

For most small biotechnology companies and investors, waiting for an approval from the U.S. Food and Drug Administration can be a painstakingly slow process. Helping to soothe the process, though, can be an international launch of the drug or technology that generates revenue and prepares for the future, pending the FDA giving its blessing. That’s what’s going on with Norcross, Georgia-based Guided Therapeutics, Inc. (OTCQB:GTHP) as it awaits a decision from the FDA for its LuViva Advanced Cervical Scan. LuViva is an advanced diagnostic device that scans the cervix with light and uses spectroscopy to measure how light interacts with the cervical tissue. The non-invasive technology provides results immediately identifying chemical and structural biomarkers that could signal malignant tumors. The test is designed for use with women who have undergone initial screening and require a colposcopy examination, which in many cases, involves taking a biopsy of the cervix.

Guided has been going back and forth with the FDA for about two years seeking an approval for its Pre-Market Approval application, answering more than 100 questions from the regulatory agency. During the FDA process, Guided has received marketing approval from many countries, including Canada and Singapore as well as a CE Mark to sell the LuViva scan to the 27 nations in the European Union. Distribution deals are established to widely serve these countries, including more partnerships announced earlier this month for distribution in France, Qatar, Malaysia, Indonesia and Bangladesh.

On Wednesday, the company said that it has put some cash on the books with the receipt of a $250,000 milestone payment from Freedom Meditech, a San Diego-based medical device company focused on novel ophthalmic technologies for the detection of disease and management of patient health.

The payment was part of a deal in which Guided licensed certain non-core intellectual property to Freedom for development related to scanning optical properties of the lens of the eye. Guided will receive future payments based upon milestones and royalties up to an aggregate of $4 million. Payments to date total $300,000.

Through the first six months of 2013, revenues are down significantly for Guided, largely because the company hasn’t collected as much in grants as it transitions to becoming more dependent on sales to drive the company. A capital raise left the company with $2 million in cash on hand as of June 30. With a recent $3.0 million order from Guided’s Turkish distributor, coupled with the cash on hand and expected future sales, the company believes it has enough money to get through 2014 and believes it can be operating at breakeven or in the black in the next year to year-and-a-half.

In Thursday trading action, shares are even at 59 cents. Shares are down about 13 percent so far in 2013, although up 25 percent from 52-week lows hit in September at 47 cents.

Copyright © 2013 AllPennyStocks.com. All rights reserved. Republication or redistribution of AllPennyStocks.com's content is expressly prohibited without the prior written consent of AllPennyStocks.com. AllPennyStocks.com shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.