Echo Therapeutics is a transdermal medical device and specialty pharmaceuticals company. Echo's Symphony™ tCGM System is a non-invasive (needle-free), wireless, transdermal continuous glucose monitoring (tCGM) system focused on changing the paradigm of invasive, episodic glucose testing in diabetes home use and hospital critical care markets.
Echo's AzoneTS™ transdermal drug reformulation technology is focused on building a pipeline of safer and improved versions of widely-prescribed, FDA-approved specialty pharmaceutical products. Echo is developing most of its AzoneTS pipeline in accordance with the FDA's Section 505(b)(2) guidelines. Durhalieve™, Echo's lead AzoneTS drug candidate, is an advanced topical reformulation of triamcinolone acetonide for treatment of corticosteroid responsive dermatoses. Echo has submitted its Durhalieve New Drug Application (NDA) to the FDA .
Symphony™ tCGM System
Echo Therapeutics Symphony tCGM Continuous Glucose Monitor
Transdermal Continuous Glucose Monitoring (tCGM) System
Echo's Symphony™ tCGM System is a non-invasive (needle-free), wireless, transdermal continuous glucose monitoring (tCGM) system designed to provide reliable, continuous blood glucose data throughout the day and night, improve patient compliance to one-point-in-time glucose testing, and achieve better overall glucose control for people with diabetes and for use in hospital critical care units.
Importance of Continuous Blood Glucose Monitoring
We believe that continuous blood glucose monitoring can be an important part of a diabetes patient's daily disease management program. Continuous blood glucose monitoring can help plan diabetes treatment, guide day-to-day choices about diet, exercise and insulin use, and avoid unwanted low blood glucose (hypoglycemia) and high blood glucose (hyperglycemia) events and the complications that they can cause. Blood glucose levels are affected by many factors such as the carbohydrate and fat content of food, exercise, stress, illness, and variability in insulin absorption among others; therefore, it is often challenging for diabetes patients to avoid frequent and unpredictable excursions above or below normal glucose levels. Patients are often unaware that their glucose levels are either too high or too low, resulting in their inability to tightly control their glucose levels and prevent the complications associated with unwanted glucose excursions.
In an attempt to achieve and maintain blood glucose levels within a desired range, diabetes patients must measure their glucose levels. The ADA recommends that patients test their blood glucose levels at least three or four times per day; however, despite evidence that intensive glucose management reduces the long-term complications associated with diabetes, industry sources estimate that people with diabetes test, on average, less than twice per day. We believe our Symphony tCGM System has the potential to improve patient compliance to frequent glucose testing, achieve better glucose control and make a positive impact on overall day-to-day diabetes management.
Hospital Critical Care Market
We believe Symphony has the potential to offer a non-invasive, wireless, tCGM solution for use in the rapidly emerging hospital critical care market. A primary cause of infection in critically ill patients is hyperglycemia which is a result of insulin resistance and total parenteral nutrition. Clinical studies have demonstrated that intensive insulin therapy to maintain tight glycemic control significantly reduces patient mortality, complications and infection rates, as well as hospital stays, services and overall hospital costs.
Regular monitoring of blood glucose levels is rapidly becoming a necessary procedure performed by hospital critical care personnel to achieve tight glycemic control and ensure improved patient outcomes. In a recent survey by Boston Biomedical Consultants of more than 60 hospital critical care unit managers and nurse clinicians in the United States, more than 90% of those surveyed acknowledged the benefits of tight glycemic control protocols in the hospital critical care setting. We believe tight glycemic control protocols are becoming the new standard of care in hospital critical care units across the United States, for patients with and without diabetes.
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. Pipeline
When blood glucose levels are high, diabetes patients often administer insulin to reduce their blood glucose level. Unfortunately, insulin administration can reduce blood glucose levels below the normal range, causing hypoglycemia. In cases of severe hypoglycemia, diabetes patients risk severe and acute complications, such as loss of consciousness or death. Due to the drastic nature of acute complications associated with hypoglycemia, many diabetes patients are afraid of sharply reducing their blood glucose levels and often remain in a hyperglycemic state, exposing themselves to long-term complications of that condition.
Diabetes is typically classified into two major groups: Type 1 and Type 2. Type 1 diabetes usually develops in children and young adults and is characterized by the body's inability to produce insulin. People with Type 1 diabetes rely on frequent administration of insulin to regulate their blood glucose levels. Type 2 diabetes, by far the most common form of the disease worldwide, results when either the body does not produce enough insulin or cells in the body ignore the insulin produced and become insulin-resistant. People with Type 2 diabetes often require diet and nutrition management, exercise, oral medications or insulin administration to regulate their blood glucose levels.
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.
Prelude® SkinPrep System
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.
Symphony® tCGM System
Our Symphony tCGM System is currently in development with an advanced prototype of the Symphony tCGM biosensor. Symphony has successfully completed numerous clinical trials with Symphony and plans additional studies of Symphony in the near future.
Durhalieve is Echo's topical AzoneTS reformulation of triamcinolone acetonide for treatment of corticosteroid-responsive dermatoses. Durhalieve has successfully completed Phase III studies.
Partnerships Echo is developing its Prelude® SkinPrep System as a platform technology to allow for significantly enhanced skin permeation that will enable needle-free, painless drug delivery as well as analyte extraction. Utilizing the patented, core controlled-feedback skin permeation technology found in Prelude, Echo has initially developed its technology to deliver topical 4% lidocaine cream in a fast-acting, enhanced manner and also to analyze glucose levels continuously using the Symphony® tCGM System.
Echo currently has two key strategic partnerships in place, one in the area of drug delivery and the other in analyte extraction:
Echo has granted the Ferndale Pharma Group, Inc. and its wholly owned subsidiary Eloquest Healthcare Inc. a license to develop, market and sell the Prelude device for enhanced, fast-acting and needle-free delivery of Ferndale's topical 4% lidocaine product.
The Ferndale Pharma Group of companies specializes in the development, manufacture, distribution and marketing of various dermatologic products including prescription topical drugs for the treatment of several acute and chronic dermatoses, medical devices that support and maintain wound closures, and an extensive line of proprietary cosmeceutical products.
Korea’s leader in diabetes treatment
Echo has granted Handok Pharmaceuticals a license to develop, market, and sell Echo's technology to continuously monitor glucose levels, in South Korea. Handok is the leader in diabetes treatment in Korea. Handok maintains a world class GMP facility and was the first local Korean company to incorporate clinical research capabilities with medical directors on staff.
Handok is the leader in diabetes treatment in Korea. Handok, founded in 1954, is the pharmaceutical company in Korea with the most successful track record of various types of partnerships, focusing on innovative products. It formed a JV with Hoechst in 1965, which lead to the current strategic partnership with Sanofi-Aventis. Handok maintains a world class GMP facility and was the first local Korean company to incorporate clinical research capabilities with medical directors on staff.
One of China’s healthcare leaders
The partnership is designed to enable close cooperation between the two companies in order to address China's growing demand for both glucose monitoring and transdermal drug delivery solutions. The partnership agreement includes a licensing and technology transfer under which MTIA will undertake regulatory activities, commercialization, and the manufacturing of Echo's technology in China.