Echo Therapeutics’ (OTCBB:ECTE) platform for needle-free drug delivery and a wireless biosensor that continuously monitors diabetics’ blood glucose levels without breaking the skin is giving the company a shot at several blockbuster markets. Echo’s two technologies are the Prelude SkinPrep and Symphony transdermal continuous glucose monitor (tCGM), which came out of Dr.
He initiated coverage of Echo with a “strong buy” rating and a 12-month price target of $6.50.
In a move that will sharply broaden the pool of potential investors, Echo has applied for a national listing on the NASDAQ or the AMEX and will move to whichever exchange accepts the listing application first. About the size and shape of an electric nose-hair clipper, the Prelude SkinPrep is a skin permeation device that quickly removes the outer layer of dead skin called the stratum corneum, with no pain or bleeding, stopping precisely before reaching live skin. Echo has licensed Prelude to Ferndale Pharma Group for enhanced delivery of its skin-numbing lidocaine cream in North America and Britain. Echo estimates that Prelude and lidocaine could have an annual market potential exceeding $1 billion in cosmetics and pediatrics. Last February, Ferndale received FDA comments on its 510(k) submission that Echo described as minor and consistent with expectations. While Prelude SkinPrep represents a separate business for Echo, the needle-free Symphony tCGM depends on the Prelude device to prepare the skin for the non-invasive biosensor. All existing FDA-approved continuous glucose monitoring systems use sensor wires inserted into the patient’s skin, increasing the risks of infection, inflammation or bleeding at the insertion site. Echo estimates the addressable market for continuous glucose monitoring in the hospital critical care setting at more than $1 billion a year, with the global glucose monitoring market at more than $12 billion annually. Last week, Echo received the key components of its next generation Symphony tCGM design that it will test in a final series of clinical trials, replacing the prototype used in earlier clinical testing.
As in earlier testing, the pivotal study will draw blood from critically ill patients at four hospitals and compare their blood sugar levels against Symphony readings. Echo has already completed six clinical trials with its biosensor, generating about 3,200 glucose monitoring data points from 70 patients.
Besides its glucose monitor, Echo is working on a biosensor to detect lactate levels in blood. A lactate biosensor could represent a big market opportunity with top-tier professional athletes, who are interested managing their lactate levels to achieve optimum muscle performance, and for critical care patients. Echo’s needle-free technology received an unexpected shot in the arm last summer when DexCom received a warning letter from the FDA about the risks of sensor wire fractures underneath patients’ skin, especially in pediatric and adolescent patients.
In 2009, Echo teamed up with Handok Pharmaceuticals to develop and distribute the Symphony system in South Korea.
Continuous glucose monitoring is not in question, he says, adding that the medical literature is clear that pricking your finger a couple times a day isn’t good enough to control your diabetes.
The lens uses a micro glucose sensor and a wireless transmitter to monitor blood sugar levels  to allow diabetics to regulate those levels with insulin without their fingertips showing the wears and tear or those painful needle jabs. The prototype, which Google says will take at least five years to reach consumers, is one of several medical devices being designed by companies to make glucose monitoring for diabetic patients more convenient and less invasive . Although it looks like a typical contact lens, the device contains two twinkling glitter-specks that are loaded with tens of thousands of miniaturized transistors and is ringed with a hair-thin antenna. You’ve probably heard that diabetes is a huge and growing problem—affecting one in every 19 people on the planet. Over the years, many scientists have investigated various body fluids—such as tears—in the hopes of finding an easier way for people to track their glucose levels.


We’re now testing a smart contact lens that’s built to measure glucose levels in tears using a tiny wireless chip and miniaturized glucose sensor that are embedded between two layers of soft contact lens material.
We’re in discussions with the FDA, but there’s still a lot more work to do to turn this technology into a system that people can use. News Corp is a network of leading companies in the worlds of diversified media, news, education, and information services. That puts the device microns away from capillary blood vessels in the epidermis and allows for both painless drug delivery and continuous glucose monitoring with the Symphony biosensor. The $15 million deal excludes royalties and manufacturing revenues from the single-use, disposable abrasion tips on the Prelude device. Mooney explains that a nurse could permeate a child’s skin with Prelude and lidocaine, making an inoculation painless in just a few minutes.
Mooney explains that after skin permeation with Prelude SkinPrep, the biosensor’s surface detects glucose as it diffuses out of the capillaries and comes in contact with the biosensor.
The next generation design incorporates numerous technological advances required to meet market expectations for system accuracy, manufacturability and product cost. Mooney says Echo plans to complete an additional critical care pilot study this summer “to make sure we have a commercially ready system.” It also plans to start its pivotal study at the beginning of 2012 and hopes to obtain regulatory approval by the end of the year. In those studies, Symphony’s performance was consistent and effective at monitoring blood glucose. Mooney, a former physician, senior biotech analyst at Thomas Weisel Partners, and CMO and CEO of Aphton (NASDAQ:APHT). Mooney cites is Symphony’s chemical reaction strip, which adheres to the skin and converts glucose into a numerical reading.
Handok is the largest diabetes care-focused company in South Korea and a member of the Sanofi-Aventis group.
But you may not be familiar with the daily struggle that many people with diabetes face as they try to keep their blood sugar levels under control. Glucose levels change frequently with normal activity like exercising or eating or even sweating. We’re not going to do this alone: we plan to look for partners who are experts in bringing products like this to market.
In the cosmetics and aesthetics markets, patients would be free of painful injections of Botox and collagen fillers, for example, allowing plastic surgeons and dermatologists to get patients in and out of procedures much more quickly.
Mooney says, adding that an amended filing will be made mid-year, with possible regulatory clearance as early as the third quarter. The biosensor also contains an enzyme that reacts to glucose and relays those readings as an electric signal. The device had error rates between 7.5% and 16%, which were well below the FDA guidelines for error rates of 20% to 25% in diabetic glucometers. However, we initiated it, because we want to establish that this is a platform technology that allows us to do many things,” Dr. Mooney says the technology also could be applied, among other things, to measure blood alcohol levels, thyroxine levels for thyroid hormone and coumadin levels for patients who take blood thinners.
The strips are replaced every one to two days, compared with competing biosensors, which can be worn for up to seven days. Uncontrolled blood sugar puts people at risk for a range of dangerous complications, some short-term and others longer term, including damage to the eyes, kidneys and heart.


Sudden spikes or precipitous drops are dangerous and not uncommon, requiring round-the-clock monitoring. At Google[x], we wondered if miniaturized electronics—think: chips and sensors so small they look like bits of glitter, and an antenna thinner than a human hair—might be a way to crack the mystery of tear glucose and measure it with greater accuracy. We’re also investigating the potential for this to serve as an early warning for the wearer, so we’re exploring integrating tiny LED lights that could light up to indicate that glucose levels have crossed above or below certain thresholds.
These partners will use our technology for a smart contact lens and develop apps that would make the measurements available to the wearer and their doctor.
The WSN has abundant applications in continuous or discrete monitoring systems irrespective of the field. The impulse passes wirelessly to a handheld device, which records the information and monitors the readings. Although some people wear glucose monitors with a glucose sensor embedded under their skin, all people with diabetes must still prick their finger and test drops of blood throughout the day.
It’s still early days for this technology, but we’ve completed multiple clinical research studies which are helping to refine our prototype. The Bio- compatible wearable sensors allow vast amounts of data to be collected and mined for clinical trials, reducing the cost and inconvenience of regular visits to the physician. It also can transmit readings to a cell phone, emitting an automatic alert should there be a critical rise or fall in the level of a blood-sugar reading. We hope this could someday lead to a new way for people with diabetes to manage their disease.
Implying this concept, our project is used to track diabetes using a wireless sensor network as an implant to continuously monitor the patienta€™s blood glucose level. The level thus measured needs to be monitored.The most conveniently used method to monitor the implant would be to use a detector to telemeter the collected sugar concentration to anexternal receiver. In the case of our project, we aim to replace the detector by transmitting the monitored data as a message to the patienta€™s cell phone itself. The future will see the integration of the abundance of existing specialized medical technology with pervasive, wireless networks. They will co-exist with the installed infrastructure, augmenting data collection and real-time response. Unobtrusive, wearable sensors will allow vast amounts of data to be collected and mined for next-generation clinical trials. ThisHere, two glucose oxidase enzymes with platinumelectrodes are employed to act as catalysts a€“ one to speed up the reaction of glucose with oxygen and the other to speed up the breaking down of hydrogen peroxide into oxygen and water. The core of the sensing unit is the oxygen sensor.acts asa channel through whichthe information is sent asThe sensor has a processor that would provide the ratio ofelectromagnetic (EM) radio frequency (RF). But there can be variation in theis transmitted as electromagnetic(EM) radiofrequency (RF)levels of oxygenproduced dueto various factors like bodywaves.The MICS band (Medical implant communication servicetemperature, lack of sleep, inadequate food intake, remodeling ofband)ranging between 400 MHzand 406 MHz, meant forsurrounding tissue, etc.
To overcome that, the monitoring sensor has another sensor attached to it which keeps track of the base oxygenlevel in the implanted area.



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