With some 630 plus readings across a 32 subject study, Symphony CGM yielded superb results, bringing in a 97.9% clinical accuracy rating with the remaining 1.8% being merely benign errors (via Continuous Glucose-Error Grid Analysis). This places the device well within the primary safety and efficacy targets set for the study and thus ECTE is now definitively on track for marketing approval in Europe via a CE Mark Technical File submission anticipated for Q4 this year.
With what is the largest study to date (where all components were finally utilized in a clinical environment) successfully tucked under their belts and with solid safety data showing no adverse side effects, ECTE is confident they have their hands on a real answer now for hospital critical care units to be able to implement truly robust glycemic control protocols, a situation that will invariably improve clinical outcomes for patients, as well as operating bottom lines. Of course, the functionality of the device is the same for individual diabetics and this incredible marriage of technologies, which includes a transdermal sensor and wireless transceiver, represents a paradigm shift away from extant FDA-approved continuous blood glucose monitoring systems, which are needle-based and require insertion of a monitoring sensor under the patient’s skin. This inserted sensor methodology produces risk of infection and the inflammation or bleeding associated with it is deleterious to patient quality of life, a state of affairs totally averted by use of the non-invasive Symphony CGM System.
This system becoming ubiquitous translates directly into improved quality of life and care for diabetics as continuous access to glucose values and changes helps identify an individual’s tendency to drift into hyperglycemic or hypoglycemic zones. This is a godsend for the estimated 347M humans worldwide in 2013 suffering from the chronic disease and, with projections on that figure set to rise 55% by 2035 to just over 592M, ECTE shareholders are poised to see some serious upside.
Moreover, the Prelude SkinPrep System technology, which is incorporated into Symphony, looks to have massive impact potential in the transdermal drug delivery space, potentially including drugs that have high and low molecular weights, another key aspect of the overall platform’s striking distance within target markets. The Prelude skin permeation process enhances efficacy (possibly as much as 100 times that of untreated skin in transdermal topical drug delivery) and potentially enables safe, rapid uptake of even topical anesthetic creams. Symphony CGM derives significant benefits from this skin prep technology in the diabetic patient class and the improved continuous sensing thusly enabled directly offsets one of the primary cost vectors here nicely, as glucose monitoring accounts for a significant portion of overall care expenses for diabetic patients.
With some 25.8M diabetics and climbing in 2011 alone here in the U.S. (upwards of 8.3% of the population with 1.9M new cases each year reported in ages 20 and up) and another 60M (around 10%) just in the EU, ECTE is tapping into a gigantic market where the consumer is hungry for change. Especially in the aging/elderly, the largest patient group in the category, the non-invasive Symphony system will draw mass appeal and for the clinical environment the device’s efficacy, enabling of obvious procedural improvements, and ultimately quality of care, could spark a firestorm of industry adoption.
Regulatory studies successfully completed for the Q4, CE Mark Technical File submission, ECTE was confident in their conference call yesterday (877-870-5176 using Replay Pin 10037555) that this wireless little marvel of a product was going places and investors will want to keep a close eye on the Symphony as commercialization advances.
More info on Echo Therapeutics is available at www.EchoTx.com
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