Showing posts with label TEAR. Show all posts
Showing posts with label TEAR. Show all posts

Thursday, March 22, 2012

TearLab Corporation (Nasdaq: TEAR) Reports 2011 Financial Results

TearLab Corporation (Nasdaq: TEAR) Reports 2011 Financial ResultsOrlando, FL 3/22/12 (StreetBeat) – TearLab Corporation (Nasdaq:TEAR) today reported its consolidated financial results for the quarter and the year ended December 31, 2011. All dollar amounts are expressed in U.S. currency and results are reported in accordance with United States generally accepted accounting principles.

For the three months ended December 31, 2011, TearLab's net revenues were $499,000 as compared to $798,000 for the same period in 2010. The Company's net loss for the three months ended December 31, 2011 was approximately $3.5 million, or $0.17. This included approximately $0.7 million in non-cash expense related to the revaluation of warrants arising from the June 2011 private placement financing. The loss for the three months ended December 31, 2010 was $0.9 million, or $0.06 per share.

For the year ended December 31, 2011, TearLab's net revenues were $2,124,000 as compared to $1,701,000 for the same period in 2010. The Company's net loss for the year ended December 31, 2011 was approximately $8.8 million, or $0.50 per share. For the year ended December 31, 2010, the loss was $6.7 million, or $0.47 per share. 2011 cash used in operating activities was approximately $6 million.

As of December 31, 2011, TearLab had $2.8 million in cash and cash equivalents.

"In many respects, we just crossed the starting line with the FDA's issuance of CLIA waiver at the end of January 2012. CLIA waiver was the final approval needed for our full commercialization of the TearLab(R) Osmolarity System in the U.S., and it came together with Medicare reimbursement of $46.80 per patient across all U.S. states. The fact that fourth quarter 2011 revenues grew sequentially by 50% over the previous quarter, despite the fact that we could only sell our device to labs and lab directors throughout the year, serves as an early indication that our new "3/15" and "3/24" marketing programs represent a great value proposition for our customers. Indeed, based on early sales activity in the few weeks since CLIA waiver was received, we remain confident that the adoption curve of this groundbreaking test will steepen significantly in 2012," commented Elias Vamvakas, TearLab's Chief Executive Officer.

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Tuesday, January 24, 2012

TearLab (Nasdaq: TEAR) Osmolarity System CLIA Waiver Issued by FDA

TearLab (Nasdaq: TEAR) Osmolarity System CLIA Waiver Issued by FDAPalm Beach, FL 1/24/12 (StreetBeat) -- TearLab Corporation (Nasdaq:TEAR) announced today that, after reviewing and accepting labeling submitted to it by the Company, the U.S. Food and Drug Administration has now granted Waiver categorization under the Clinical Laboratory Improvement Amendments of 1988 for the TearLab(R) Osmolarity System.

Elias Vamvakas, TearLab's Chief Executive Officer, commented, "We believe that, with CLIA Waiver and Medicare reimbursement in place, and with the updated American Academy of Ophthalmology's Preferred Practice Pattern guidelines listing tear osmolarity as a more sensitive method to diagnose Dry Eye Disease, the TearLab Osmolarity test is now well on its way toward being established as a standard of care."

About The TearLab Osmolarity System

The TearLab Osmolarity System uses a novel lab-on-a-chip approach that requires less than 50 nL (nanoliters) of tear fluid in order to measure tear osmolarity. The TearLab Osmolarity System eliminates the challenges that previously prevented point-of-care osmolarity testing and can produce a sample-to-answer result in less than 30 seconds.

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Monday, December 5, 2011

FDA Grants TearLab(R) Osmolarity System CLIA Waiver Categorization

FDA Grants TearLab(R) Osmolarity System CLIA Waiver CategorizationTallahassee, FL 12/5/11 (StreetBeat) -- TearLab Corporation (Nasdaq:TEAR) announced today that it is in receipt of a communication from the U.S. Food and Drug Administration ("FDA") indicating that, based on a supervisory review of the Company's appeal, the Agency has granted its petition for a waiver under CLlA for the TearLab(R) Osmolarity System. Upon the Company's submission of labeling acceptable to the Agency, the CLIA waiver will be issued.

"This marks the achievement of our third and final major milestone," commented Elias Vamvakas, TearLab's Chief Executive Officer.

Mr. Vamvakas continued, "We believe that in order for the TearLab Osmolarity System to become widely adopted, it is essential that it be accessible at the point-of-care. Now, with the CLIA waiver obstacle overcome, this groundbreaking test is free to start growing to its potential."

About The TearLab Osmolarity System

The TearLab Osmolarity System uses a novel lab-on-a-chip approach that requires less than 50 nL (nanoliters) of tear fluid in order to measure tear Osmolarity. The TearLab Osmolarity System eliminates the challenges that previously prevented point-of-care Osmolarity testing. The TearLab(TM) System can produce a sample-to-answer result in less than 30 seconds.

About Dry Eye Disease

DED is a common condition in which the eye does not produce enough tears to keep the surface of the eye sufficiently lubricated. It affects approximately 40 million people in the U.S. and 100 million people worldwide.

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