On January 28, 2020 Guided Therapeutics, Inc. (Pink Sheets: GTHP), the maker of a rapid and painless cervical cancer detection test based on its patented biophotonic technology, reported the Company’s plans for 2020 (Press release, Guided Therapeutics, JAN 28, 2020, View Source [SID1234553628]).
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The Company’s main goals for this year are:
Restart discussions with the FDA and begin work on a small confirmatory study to support the claims of the previously completed pivotal study – The Company has already contacted FDA and informed them to expect the updated protocol for review. The outline for the protocol was previously agreed to during previous meeting between FDA and the Company. FDA also agreed to reduce the criteria for sensitivity of the test, a benchmark that was reached in the completed pivotal study of 2,000 women. Based on these developments, the company intends to discuss with FDA completing the smaller confirmatory study under one of three possible approval scenarios: 1) as part of the normal premarket approval process 2) via the de novo 510(k) route for new technologies or 3) as part of post-marketing studies. The latter two strategies would likely reduce the time to US market launch and would need to be agreed to by FDA.
Start clinical studies for Chinese FDA approval and achieve approval by Q4 2020 – Company intends to fill near term purchase order of 5 devices in Q1 2020 and, once our Chinese distribution partner Shandong Medical Instrumentation Co, Ltd. files with Chinese FDA as a Class 2 device, start to receive payments on larger $2.5 million Purchase Order.
Start taking new orders for Europe and Russia based on final assembly of LuViva at new manufacturing site in Hungary – Contract manufacturer is now ISO 13485 approved to assemble LuViva. New CE Mark with expanded claims has been applied for and expected to be granted in Q1 or Q2 of this year.
Jumpstart sales growth in Middle East and Indonesia – New agreements and subsequent sales with current distributors and addition of new distributor covering a total of 19 countries are expected to generate significant new orders in 2020.
Financial Filings – The Company anticipates releasing Q2 2019 (10Q) financial results later this month and 2019 Q3 (10Q) financial results early in February to catch up with its SEC filings.