Proteus Biomedical, Inc. prepares to launch a “smart pill” to remotely monitor how medication affects patients.
If some experts are correct, it won’t take long to create ingestible devices that are capable of conducting clinical laboratory tests within the body. These devices would transmit the laboratory test results to physicians over the Internet by using wireless technology.
As soon as 2011, Proteus Medical, Inc., of Redwood City, California, says it expects to introduce an ingestible device for managing heart disease and chronic disease to the clinical market. Proteus named this device the Raisin System and a popular term for this type of technology is “smart pill.”
Proteus believes there is an opportunity to use its Raisin System to help patients manage prescription medications. “Humans are not made to take medicine every week for the rest of their life,” explained Mark J. Zdeblick, Ph.D., Chief Technology Officer at Proteus. “It’s hard to adhere to a chronic dosage regimen, so we’ve developed Raisin. It’s a chip on a pill that, when ingested, broadcasts a code unique to the drug. We can pick up the code with electronics in an implanted device like an IPG [Implantable Pulse Generator], or with a surface device like a skin patch, then route it securely over the Internet via e-mail. A person can understand how their body is responding to medications, and can share that information with their physician or a caregiver to help stay healthy.”
Dark Daily observes that the Proteus Raisin System shows how quickly micro and nano technologies are making it possible to create a way to identify molecular markers as such devices pass through the digestive system. Obviously, Proteus sees a huge market in monitoring how patients are using expensive prescription drugs and how their body is responding to the therapy.
“First there was the Apple [personal computer] on your desktop, next there was a Blackberry on your belt. Now there will be a raisin inside you,” stated Andrew Thompson, Co-founder and President of Proteus Biomedical. There may a bit of hyperbole in that statement. But Thompson is making the point that ever-smaller communication devices create a way to serve new markets.
There are other smart pill products in the clinical market. Last fall, SmartPill Corporation of Buffalo, New York, obtained a 510(k) clearance from the Food and Drug Administration (FDA) for its second-generation SmartPill GI Monitoring System. The company says that this product makes it possible for physicians to measure pH, pressure, and temperature throughout the gastrointestinal (GI) tract. It says that “the ability to differentiate slow (abnormal) transit from normal transit, while providing regional transit times for both the upper and lower GI tract, is an important assessment for physicians when evaluating GI motility disorders such as gastro paresis and guiding appropriate therapy.”
Smart pills are likely to be inexpensive to use. MIT Technology Review recently discussed the Proteus smart pill system: “In the Raisin system, each pill contains an ‘ingestible event marker’ (IEM). The IEM consists of a sand-grain-size microchip with a thin-film battery that is activated on ingestion, as it is exposed to water. The battery, Proteus says, is nontoxic because it is made from materials similar to those in a vitamin pill. Once swallowed, the IEM sends through the body’s tissues a high-frequency electrical current that’s modulated in such a way that it provides a unique marker of the pill. It’s not an RFID technology: it uses the conductive tissues of the body to conduct the signal, rather than a radio, and the signal is confined within the body. Mark Zdeblick, the company’s CTO, says that the IEMs could cost less than a penny each when manufactured in volume.”
The two smart pill products described above provide evidence that swift progress is being made to develop self-contained analytical devices that can be ingested and passed through the body. As that happens, clinical laboratories and pathology groups are likely to have new technology that will give them the capability to use smart pills to perform diagnostic tests as these pills travel through the digestive tract.