On 11/19/09, the Company announced positive results in a pilot clinical study which included Prelude skin preparation and the placement of 10 Symphony tCGM biosensors on subjects with Type 1 or Type 2 Diabetes. Venous reference blood samples were taken from intravenous lines at 15-minute intervals for 24 hours and measured on a YSI 2300STAT PLUS laboratory analyzer to establish the gold standard / reference in this study, resulting in 97% accuracy for the Symphony tCGM System that was derived from approximately 900 glucose measurements with no adverse events related to the Prelude skin prep / permeation process.
The Prelude SkinPrep System removes the top level of dead skin (stratum corneum), which is painless and a similar process to exfoliation, resulting in the opportunity for enhanced delivery of reformulated, topical drugs that are already approved (e.g. lidocaine) and a needle-free means of measuring blood glucose levels in conjuction with the Symphony tCGM System by using an electrochemical sensor in combination with a short-range RF transmitter that is affixed to the skin area prepared with Prelude.
In mid-November, Echo Therapeutics announced a deal to raise about $3 million in capital that included the sale of 2.37 million shares of common stock @$1.25 per share and 2.2 million common stock warrants with an exercise price of $2 per share and a five-year term. The Company expects the additional capital will be sufficient to finance additional development activities and commercialization of its Prelude SkinPrep and Symphony tCGM Systems.
The Prelude SkinPrep has been licensed to Ferndale Pharma in North America + UK for the enhanced delivery of its topical lidocaine skin-numbing agent (LMX4), with a FDA 510(k) submission expected during 1Q10 for potential marketing clearance and royalty revenue starting in 2Q10. The deal with Ferndale included $750,000 upfront, another $750,000 upon FDA approval, double digit royalties on net product sales, and $12.5 million in milestone / guaranteed minimum royalties.
The Symphony tCGM has been licensed in South Korea to Handok Pharma and a pivotal trial is expected to begin by late February 2010 with a FDA PMA submission expected to follow. This deal included approximately $600,000 upfront, FDA approval / first South Korean sales milestone payments, royalties on net product sales, and Handok covers product development expenses in their local market.
The BioMedReports.com research download section includes the Company's most recent corporate presentation, which is available to view or download. The BioMedReports.com FDA Calendar service includes a database with over 400 entries of (1) pending new drug, biological agent, or medical device new product decisions at the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, and sBLA filings); (2) pending new submissions to the FDA; (3) pending complete response letter (CRL) re-submissions to the FDA; and (4) pending clinical trial results.
The market for all diabetes monitoring products is the largest medical diagnostics market in the world at $12.4 billion in 2000 and estimated to grow to a level of $27 billion by 2010, representing a 12% CAGR (compound annual growth rate). The diabetes testing market includes diversified, global healthcare giants and smaller niche players, including those outlined below.
Johnson & Johnson (NYSE: JNJ) (LifeScan - One Touch), Abbott Labs (NYSE: ABT) (FreeStyle), Becton Dickinson (NYSE: BDX) (BD Diagnostics), Roche (OTC: RHHBY.PK) (Accu-Chek), Bayer (OTC: BAYRY.PK) (Ascenscia), Bio-Rad Labs (NYSE: BIO), Home Diagnostics (NASDAQ: HDIX), Insulet Corp. (NASDAQ: PODD), and DexCom (NASDAQ: DXCM).
Epinex Diagnostics Inc. (click on preceding link for the Company's News Room page) is a private company that is dedicated to the development of innovative point-of-care technologies using rapid diagnostic tests. Epinex has developed a proprietary platform for rapid tests that apply existing immunoassay strips and biosensors to create unique quantitative diagnostic tests. The Company is developing a test that measures glycated albumin (G1a) as a potential paradigm-shifting measurement of average blood sugar control over the past month, as compared to hemoglobin A1c which provides a measurement of average blood sugar levels over the past 2-3 months and is dependent on red blood cell levels whereas albumin is a more widespread protein that is found in the serum portion of the blood.
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Disclosure: No positions
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