Hyperglycemia, or high blood sugar, is common in critically ill patients, even if they have not previously had diabetes. This calls for a continuous monitoring of the patients' blood glucose levels in order to significantly reduce patient morbidity and mortality.
Developing a non-invasive, wireless, transdermal continuous glucose monitoring system for patients with diabetes and for use in hospital critical care units is transdermal medical device company Echo Therapeutics Inc. (ECTE: Quote).
For readers who are new to Echo Therapeutics, here's a brief overview of its business and the upcoming events to watch out for...
The company was formed through a merger of Sontra Medical Corp. and Durham Pharmaceuticals Ltd. (doing business as Echo Therapeutics Inc.) on September 14, 2007. Sontra changed its name to Echo Therapeutics Inc. on October 8, 2007.
The company's core expertise is a painless skin permeation technology, which allows for needle-free continuous glucose monitoring and needle-free, transdermal drug delivery.
The most advanced product in the company's pipeline is Prelude SkinPrep System designed for enhanced skin permeation that will enable both needle-free drug delivery and *analyte extraction (*removing a chemical or biological substance from the body for analysis).
Prelude is being developed by Echo in partnership with Ferndale Pharma Group Inc., under a license agreement signed in May 2009. As per the terms of the agreement, Ferndale has a license in North America and the United Kingdom to develop, assemble, use, market, sell and export Prelude.
In November 2010, Echo made a 510(k) submission seeking market clearance from the FDA for its Prelude SkinPrep System and 4% lidocaine cream. In a clinical trial, Prelude SkinPrep System has been successful in ablating the skin prior to the application of OTC 4% lidocaine cream for faster-acting local dermal anesthesia.
The company was hoping to launch its Prelude SkinPrep System in 2011 itself but the device is yet to be cleared by the FDA. And given the fact that the Prelude SkinPrep System has been reportedly referred to the Human Services Department's Combination Products Department, it is evident that the product may suffer a delay in getting to the market.
Next in the pipeline is Symphony tCGM (transdermal continuous glucose monitoring) System, a non-invasive, wireless, transdermal continuous glucose monitoring system for use in hospital critical care units and for patients with diabetes.
In January of this year, the company initiated clinical studies of its Symphony tCGM System in critical care patients. The studies are designed to enroll up to 30 critical care patients and will compare data obtained from its Symphony tCGM System with the YSI 2300 STAT Plus Glucose Analyzer. The studies are expected to collect more than 1,000 data pairs to be used in the analyses by taking frequent reference glucose measurements for 24 hours.
Echo anticipates reporting preliminary results from its Symphony tCGM studies in critical care patients in the month of May.
The clinical trial of the company's Symphony tCGM System in patients with type 1 and type 2 diabetes has been successful, and the results of which were reported last December have confirmed that Symphony successfully monitors the broad range of blood glucose values seen in people with diabetes.
Echo has a partnership with Handok Pharmaceuticals that was signed in 2009, pursuant to which Handok was granted the right to develop, market, sell and distribute Symphony to medical facilities and individuals in South Korea.
In addition to the medical device pipeline, the company also has a specialty pharmaceuticals pipeline, based on its proprietary AzoneTS transdermal drug reformulation technology, which enhances nontoxic, nonirritating skin penetration of FDA-approved topical medications.
A quick look at the company's balance sheet...
Echo has had operating losses since inception, and as of December 31, 2011, had an accumulated deficit of around $81.57 million. Revenue is recognized from upfront license fees and potential future milestone payments and royalties under the current license and collaboration agreements.
The annual net loss widened to $16.7 million or $0.49 per share in 2011 from $4.3 million or $0.15 per share in 2010 as expenses took a bite out of the company's bottom line. Echo's yearly revenue increased to $447,000 in 2011, up from a year-ago $428,000.
The company ended the year 2011 with $9.0 million in cash. The number of shares outstanding is 38.59 million, and insiders own approximately 14.82% of the outstanding shares. (Data sourced from Yahoo Finance).
Echo shares have lost more than 11% in the past three months. The stock gained 0.91% to close at $1.85 in yesterday's session.
by RTT Staff Writer
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