etectRx Announces U.S. FDA Clearance of Novel Ingestible Event Marker

etectRx®, Inc. (etectRx), a privately-held digital health company, has announced U.S. Food and Drug Administration (FDA) clearance of its breakthrough patented ingestible event marker, the ID-Cap® System.

The ID-Cap System is the first and only ingestible event marker to transmit digital messages from within the body to an external receiver without the need for direct skin contact for the purpose of recording ingestion events.

Comprised of the ID-Capsule, ID-Tag, ID-Cap Reader, and related software, the ID-Cap System provides real-time, dose-level ingestion event verification. The ID-Capsule is a standard pharmaceutical capsule containing the ID-Tag, an ingestible sensor that emits a very low-power digital message from within the patient after it is ingested and activated by the patient’s stomach fluid. The ID-Cap Reader (worn on a lanyard) verifies the message as a valid ingestion event and forwards the data to a secure smartphone-based mobile application and to the healthcare provider in a secure web-based portal. etectRx’s advanced communication technology will allow for incorporation of the receiver into a variety of wearable and off-body devices in the future.

“This is a historic event for etectRx and the larger digital health market,” said Harry J. Travis, president and CEO of etectRx. “It is the first product enabled by our proprietary in-vivo communication technology platform to gain clearance. We are very excited about the many opportunities that the ID-Cap System will provide patients and clinicians to improve therapeutic outcomes and deliver better care.”

The company is building collaborations with key stakeholders, including healthcare providers, health systems, pharmacies, pharmaceutical manufacturers, and clinical research organizations, to bring this innovative technology to digital medications of the future and other valuable applications in the medical, pharmaceutical, and consumer markets.

Researchers at Brigham and Women’s Hospital and Fenway Health are evaluating the ID-Cap System in ongoing and planned clinical studies focusing on HIV medication when used for treatment and prevention.

“We look forward to continuing our work with etectRx to assess the potential impact of the ID-Cap System on the health of patients, clinical decisions of healthcare providers, and goals of health systems,” said Kenneth H. Mayer M.D., medical research director and co-chair of the Fenway Institute at Fenway Health. “We need innovative solutions, including cleared medical devices such as the ID-Cap System, to better evaluate the challenges of medication non-adherence, which have the potential to be part of tailored interventions.”

The ID-Cap System is classified by the FDA as an ingestible event marker (CFR 21 §880.6305) and Class II medical device. It will be available by prescription. The FDA clearance is based on data from pivotal clinical trials of device effectiveness and safety, biocompatibility assessments, human factors and usability validation studies, bench performance tests, electrical safety evaluations, and wireless performance tests.

About etectRx

etectRx is a privately held digital health company seeking to advance patient medication adherence and improve ingestion tracking technology. etectRx’s flagship product, the ID-Cap System, is an ingestible event marker comprised of a gelatin capsule containing an ingestible sensor that transmits signals to a wearable reader which sends the data to a smartphone-based app and secure cloud-based server to enable reliable tracking of ingestion events. To learn more about etectRx, visit https://etectrx.com/

ID-Cap System Indications for Use

The ID-Cap System consists of a wearable reader for ambulatory recording of events signaled by swallowing the ID-Capsule which contains the ID-Tag, an ingestible sensor. The ID-Cap System is intended to log, track, and trend intake times and enables unattended data collection for clinical applications. The ID-Cap System may be used in any instance where quantifiable analysis of ingestion events, including events signaled by the co-incidence with or co-ingestion with the ID-Capsule, is desirable.

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