The companys drug candidate is Durhalieve, an AzoneTS formulation of triamcinolone acetonide for the treatment of corticosteroid-responsive dermatoses. . It has a licensing agreement with Ferndale Pharma Group, Inc. to develop, market, sell, and distribute Prelude for skin preparation prior to the application of topical anesthetics prior to a range of needle-based medical procedures in North America and the United Kingdom; and a license agreement with Handok Pharmaceuticals Co., Ltd. to develop, market, sell, and distribute Symphony to medical facilities and diabetics in South Korea. We have had ongoing discussions regarding potential strategic partnership. Obtaining a partner or partners would allows us to leverage the partner’s exiting sales, marketing, distribution and manufacturing infrastructure while reducing the need to build up our own infrastructure. The stock is primed for news and has huge upside potential here. PIPELINE- Our Symphony CGM System is currently in development with an advanced prototype of the Symphony CGM biosensor. Echo has successfully completed numerous clinical trials with Symphony and is currently conducting a multi-center clinical trial to support a CE Mark Technical File for marketing approval in Europe.
A 510(k) equivalency study was completed to determine the efficacy of Prelude in enhancing the onset of the effectiveness of 4% lidocaine cream.
A 510(k) premarket notification has been submitted to the US Food and Drug Administration (FDA) for the Prelude SkinPrep System for the delivery of 4% lidocaine cream.
Durhalieve is Echo's topical AzoneTS reformulation of triamcinolone acetonide for treatment of corticosteroid-responsive dermatoses. Durhalieve has completed Phase III clinical trials and, in order to obtain FDA approval, Echo mus satisfy certain clinical and manufacturing development requirements outlined by the FDA when they last reviewed the Durhalieve New Drug Application.
The stock will double... It has the science and it works, We have had ongoing discussions regarding potential strategic partnership. Obtaining a partner or partners would allows us to leverage the partner’s exiting sales, marketing, distribution and manufacturing infrastructure while reducing the need to build up our own infrastructure. The stock is primed for news and has huge upside potential here. Today, standard practice by critical care nurses is to measure blood glucose at the patient's bedside periodically. We believe that a CGM system such as Symphony will save valuable nursing time and expense by avoiding the need for frequent blood glucose sampling, in addition to providing more clinically relevant, real-time glucose level and trending information needed to develop better control algorithms for insulin administration.
Diabetes Home Use Market
Diabetes is a chronic and life-threatening disease caused by the body's inability to produce or properly use insulin, a key hormone the body uses to manage glucose, which fuels the cells in the body. Insulin regulates the uptake of sugar from the blood into the cells. When glucose builds up in the blood instead of going into cells, it can cause the cells to become starved for energy and, over time, damage the eyes, kidneys, nerves or heart. Although not all of the causes of diabetes are known, genetics and lifestyle factors such as obesity and lack of exercise appear to play important roles. According to the American Diabetes Association (ADA), about 21 million people in the United States, or approximately seven percent (7%) of the population, have diabetes, including over 6 million people who remain unaware that they have the disease. In addition, before people develop Type 2 diabetes (discussed below), they usually have "pre-diabetes," or blood glucose levels that are higher than normal but not yet high enough to be diagnosed as diabetes. According to the ADA, there are 54 million people in the United States who have pre-diabetes.
According to the ADA, the cost of diabetes care in the United States in 2007 was more than $174 billion, including $116 billion in excess medical expenditures attributed to diabetes and $58 billion in reduced national productivity. The ADA estimates that people with diabetes, on average, have medical expenditures that are approximately 2.3 times higher than the expenditures would be in the absence of diabetes and that approximately $1 in $10 healthcare dollars is attributed to diabetes. A significant portion of overall diabetes care costs, approximately $7 billion according to industry sources, is attributable to costs associated with monitoring blood glucose levels, and that market segment is projected to grow substantially by 2010 as patients and their physicians seek ways to manage glucose levels more effectively.
- 3 Pillars are – SKIN Preparation- Prelude® SkinPrep , monitoring system-, Analyte extraction: With the Symphony® CGM System and drug delivery solution……………… Therapeutics is a medical device company with expertise in advanced skin permeation technology. We are developing our Prelude® SkinPrep System as a platform technology to allow for enhanced skin permeation that will enable two important applications:
• Analyte extraction: With the Symphony® CGM System for needle-free, continuous glucose monitoring of hospital patients as the first application.
• Needle-free drug delivery: With the delivery of topical lidocaine as the first application.
• Painless, rapid, precise skin permeation technology
• Needle-free continuous glucose monitoring device
• Needle-free, transdermal drug delivery
• Needle-Free Monitoring and Drug Delivery- all others use needles on the market.
• Echo is developing its Symphony® CGM System as a non-invasive, wireless, continuous glucose monitoring system for use in hospital critical care units and for people with diabetes. The Prelude® SkinPrep System, a component of our Symphony CGM System, allows for enhanced skin permeation that will enable extraction of analytes, such as glucose, and transdermal drug delivery.
-Symphony System met the primary safety and effectiveness endpoints of the trial that involved the continuous monitoring of glucose levels in 32 subjects. Investors looking at the results had to be incredibly pleased as the Symphony System had a 97.9 percent accuracy rate in its glucose readings. Additionally, there were no adverse events reported from the skin preparation or the Symphony CGM senor session. The Company's corporate objectives for the remainder of 2013 are as follows:
1. Complete the EU Regulatory Clinical Trial
2. File for CE Marking
3. Attain Food & Drug Administration (FDA) Guidance for U.S. Regulatory Pathway
4. Implement Significant Cost Reduction Initiatives- 4th quarter burn rate is expected to decrease by approximately 35-40% from the quarterly burn rate experienced during the first three quarters of 2013. Data collected from this study will serve as the basis for the CE Mark Technical File submission for marketing approval in Europe, which the Company expects to submit in the fourth quarter of 2013. Echo Therapeutics announced its intention to file for marketing approval in Europe during the fourth quarter of 2013 The Philadelphia-based company's technology is designed to help hospital personnel monitor diabetes multiple patients' blood sugar levels around the clock. It could become the De-Facto standard for the industry. Significant opportunity also exists for Symphony to be used in the hospital beyond the critical care setting, as well as in patients with diabetes in the outpatient setting. FDA- Turning now to U.S., we received comments from the FDA’s Center for Devices and Radiological Health on the pre-submission package that we filed in June of this year. Subsequent to the end of the third quarter, we met with the FDA to obtain FDA’s guidance regarding the regulatory pathway for Symphony, including feedback on our proposed pivotal trial protocol and endpoints. We may need a sample size in the range of 250 to 350 patients for the FDA pivotal trial. We have had ongoing discussions regarding potential strategic partnership. Obtaining a partner or partners would allows us to leverage the partner’s exiting sales, marketing, distribution and manufacturing infrastructure while reducing the need to build up our own infrastructure. The stock is primed for news and has huge upside potential here. The Prelude SkinPrep System, (painless skin permeation ) a component of our Symphony CGM System, allows for enhanced skin permeation that will enable extraction of analytes such as glucose. Prelude's platform skin preparation technology also allows for needle-free, transdermal drug delivery.
114 million diabetics in china...10 dollars a day, makes the market 400 billion dollars. If they capture just 1 percent, that's 4 billion with a B. The better q is why has this stock not moved up to 30 as first stop. The market is unbelievably large for China alone, let alone the rest of the world. I am massively long in relation to my holdings. Go ecte!!!