A small Franklin company says it is developing a novel device that could potentially let diabetics continuously monitor their blood-sugar levels — without having to draw blood.
Echo Therapeutics Inc. is expected to say today the device passed one of its first key tests, a pilot study with two dozen patients in the intensive-care unit at Tufts Medical Center in Boston. The Symphony system, a disc about the size of a half dollar, is designed to read glucose levels through the skin and transmit the information wirelessly to a nearby computer or hand-held meter. Currently, diabetes patients must normally prick their skin to draw a few drops of blood and place them on a measuring strip.
“I think it’s extremely promising,” said Dr. Stanley Nasraway, a Tufts University School of Medicine professor and director of surgical intensive-care units at the medical center. Nasraway said Echo’s experimental device appeared to be reliable, relatively accurate, and easy to use, though he cautioned that it must first be tested in much larger clinical trials with a wider group of patients.
If successful in broader trials, Echo hopes to win approval from the US Food and Drug Administration to market the device as soon as late next year to both hospitals and diabetics for home use. Company executives estimate at least 1.5 million diabetics in the United States currently test their blood-sugar levels twice a day or more, and could potentially benefit from the device, making it a multibillion-dollar market.
“It’s an enormous market opportunity,” said Harry Mitchell, chief financial officer.
To be sure, Echo is still tweaking the device. It now uses ultrasound technology to expose capillary blood vessels to measure blood-sugar levels. But in future versions, the device will scrape off the outermost layer of skin.
Other companies have failed in efforts to market alternatives to needles for diabetics. In 2001, Cygnus Inc. won FDA approval for its GlucoWatch, a blood-sugar meter that could be worn like a wristwatch.
But the device was eventually discontinued amid complaints it was not accurate and caused skin irritation in some users. Johnson & Johnson, which now reportedly owns the technology, did not return calls seeking comment.
In addition, several companies, including Pfizer Inc. and Eli Lilly & Co., recently scrapped projects to develop an inhalable form of insulin, used to regulate blood-sugar levels. Eli Lilly was working with Cambridge-based Alkermes Inc. on the technology.
Echo also would face competition from other companies, such as DexCom Inc. of San Diego and Medtronic Inc. of Minneapolis, which have developed systems to let patients insert a glucose sensor just under the skin. The sensors constantly monitor glucose levels for up to a week before they need to be replaced. Echo says its system is superior because patients wouldn’t have to use a needle to insert the sensor, which could be placed on the body like a bandage.
But Echo would likely need to raise tens of millions of dollars for clinical trials and other work to bring the product to market. The company had $2.3 million in cash as of September.
“We see lots of interesting ideas,” said Medtronic spokesman Steven Cragle, “but actually getting them approved is a much different story.”
And so far, investors do not seem impressed by Echo’s potential. Its stock closed at $1.35 Wednesday, down from a high of $31.70 in 2004. Echo’s market value is just $25 million.
“We have really just started telling our story,” said Echo chief executive Patrick Mooney. “It’s not a negative. I think Wall Street just doesn’t know who we are.”
Mooney said the Echo technology was originally pioneered in 1996 at Robert S. Langer ScD ’74’s lab at the Massachusetts Institute of Technology, and then further developed by Sontra Medical Corp., which merged with Echo last year.
The American Diabetes Association, which promotes diabetes research, declined to comment.