Proteus receives patent for ingestible sensor

By: Brian Dolan | Jul 14, 2011        

Tags: | | | | | |  |

Proteus Biomedical's "smart pill"Proteus Biomedical announced today that it has received a patent for its ingestible biomedical sensor — what the company has referred to as “intelligent medicine” in the past and what many have referred to as a “chip in a pill.” The patent announcement also included new information about Proteus’ partners: While the Novartis relationship had been previously announced, the company said it was also working with Medtronic, ON Semiconductor, Kaiser Permanente and Avery Dennison.

Proteus also announced that the Raisin system has already been validated for safety and performance in preclinical and human clinical testing for heart failure, hypertension, mental health, transplantation, diabetes and TB.

The patent, titled “Communication System with Partial Power Source” is directed to the Proteus ingestible event marker, a sensor that is part of the Proteus Raisin System.

The Raisin System’s wireless vital sign monitoring patch received FDA clearance last year and the entire system secured its CE Mark earlier this year.

According to Proteus, the Raisin System is “a flexible health management solution that can be tailored to address a range of different needs of consumers, family caregivers, clinicians and health systems. The Raisin System collects and aggregates various behavioral, physiologic and therapeutic metrics-such as medication adherence, heart rate, sleep patterns, physical activity and stress levels-into meaningful and appropriate personal health management tools delivered to the mobile devices of consumers and their designated care givers. This continuous, data-enriched, networked approach to health is designed to enhance patient experience and clinical outcomes, and to become a foundation for the emerging mobile health (mHealth) industry.”

This particular patent was for the Proteus Ingestible Event Marker (IEM), a tiny, grain of sand-sized, micro-fabricated device composed from materials found in the food chain. The IEM can be embedded into any pharmaceutical tablet or capsule to enable real-time detection of pill ingestion — not detection of when a pillbox is opened, but when the pill is broken down by the patient’s stomach acid.

Proteus said it plans to launch its first commercial product based on the Raisin technologies sometime next year. During a panel session that MobiHealthNews helped put together in 2009, Proteus CEO Andrew Thompson said the company’s technology would help create a $100 billion industry.

More in the press release below:

Technology to Become a Foundation for mHealth Products and Services

Proteus Biomedical Inc., a pioneer in intelligent medicine, announced today that the United States Patent Office awarded U.S. Patent Number 7,978,064 to Proteus. The patent, entitled “Communication System with Partial Power Source,” is directed to the Proteus ingestible event marker, a sensor and communication device at the heart of the Proteus Raisin™ System.

The Proteus Raisin System is a flexible health management solution that can be tailored to address a range of different needs of consumers, family caregivers, clinicians and health systems. The Raisin System collects and aggregates various behavioral, physiologic and therapeutic metrics—such as medication adherence, heart rate, sleep patterns, physical activity and stress levels—into meaningful and appropriate personal health management tools delivered to the mobile devices of consumers and their designated care givers. This continuous, data-enriched, networked approach to health is designed to enhance patient experience and clinical outcomes, and to become a foundation for the emerging mobile health (mHealth) industry.

A unique component of the Raisin System, and a major part of the recently issued patent, is the Proteus Ingestible Event Marker (IEM). The IEM is a tiny, grain of sand-sized, micro-fabricated device composed from materials found in the food chain. The IEM can be integrated into any pharmaceutical tablet or capsule to allow real-time detection of pill ingestion, thereby helping measure and improve patient adherence to medications and dosing regimens. The IEM’s digital signature can also enable authentication of pill-specific identity for supply chain and product integrity applications. Proteus has validated the safety and performance of the IEM in extensive preclinical and human clinical testing, including studies in heart failure, hypertension, mental health, transplantation, diabetes and tuberculosis. Proteus has received CE Mark approval to distribute the IEM and its companion physiologic monitor device in the European Union and is launching its first commercial product based on these technologies in 2012.

“As the patent explains, the IEM has two materials which, when they come in contact with stomach fluids, provide power to the IEM. The IEM varies the current flow between the two materials to generate a digital signal which can be detected,” said Mark Zdeblick, Chief Technical Officer at Proteus and co-inventor, along with Timothy Robertson, Aleksandr Pikelny and Hooman Hafezi. “The IEM contains no battery, antenna or radio, but rather uses the body to power the device and to pass along the unique, pill-specific signal in a private manner that is far superior to complicated, expensive and privacy-challenged approaches like RFID.”

“The IEM is a safe, low cost, standard pharmaceutical component that can be formulated into any dosage form without changing the properties or performance of a drug,” said Andrew M. Thompson, Chief Executive Officer at Proteus. “For the first time we are enabling the medicines that tens of millions of consumers ingest on a daily basis to be networked and join the digital age. Together with our partners we are creating a new category of digital pharmaceuticals that promises real progress in the personalization of health care. Our goal is to dramatically reduce waste and expense in the health care system by seamlessly combining drugs with the information, education and motivation that patients, families and physicians need to get the most out of the hundreds of billions of dollars they spend on drugs every year.”

U.S. Patent Number 7,978,064 will join over twenty US patents already obtained by Proteus. Over two hundred patent applications by Proteus are pending in the US and in other countries.

About Proteus Biomedical, Inc.

Proteus Biomedical is pioneering intelligent medicine, an emerging field of advanced therapeutics that integrates in-body computer, sensor and communications technologies into existing pharmaceutical, medical device and consumer products. Proteus’ proprietary computing and sensing technologies enable proven therapies to be personalized, offering broad potential benefits across a range of care settings and therapeutic areas. Proteus is developing and commercializing intelligent medicine products in partnership with global leaders from multiple industries, including Novartis, Medtronic, ON Semiconductor, Kaiser Permanente and Avery Dennison. More information about Proteus Biomedical can be found at www.proteusbiomed.com.