Digital Health Feedback System Will Allow Oracle’s Clinical Trial Applications Customers Exclusive Access to Real-time Data on Therapeutic Use to Dramatically Improve Clinical Trial EfficiencyOracle and Proteus Digital Health announced today that Oracle has made a strategic minority investment in Proteus, a leading digital health company. Proteus has developed ingestible and wearable sensors that have FDA approval and are marketed as medical devices in the United States and Europe. Proteus has over 500 patents and patent applications on digital health technologies and their uses pending or issued in the U.S. and other countries.
Proteus Digital Health is working to create a new category of products called Digital Medicines. In these products, pharmaceuticals will be manufactured with the FDA approved ingestible sensor inside. Upon ingestion the sensor will communicate with a wearable sensor on the skin. The wearable sensor also captures the body’s physiologic responses and behaviors, and sends the digital health information to a mobile application. The Proteus system is designed to deliver precise information about medication ingestion, dose timing and associated physiologic response of patients, including heart rate, activity, rest, and skin temperature. Digital Medicines are under development by Proteus and its pharmaceutical partners and require additional regulatory approvals.
In conjunction with this investment, Oracle and Proteus expect to work together in clinical trials exclusively to provide clinical investigators worldwide the ability to measure information about medication ingestion, dose timing, and associated physiologic response continuously and precisely for patients enrolled in clinical trials.
“To optimize the clinical development of personalized, innovative and safe therapies, clinical trial sponsors, clinical trial service providers, investigators and patients worldwide require continuous, precise and near real-time information on what medicines are taken and the patient’s physiological response when inside and outside of a clinical setting,” said Neil de Crescenzo, Senior Vice President and General Manager, Oracle Health Sciences Global Business Unit. “We are looking forward to integrating Proteus’ technology into Oracle’s cloud-based clinical trial platform to provide these unique benefits to the industry.”
The two companies are expected to integrate Proteus’ ingestible sensor with Oracle’s leading clinical trial products, such as Oracle Health Sciences InForm, Oracle Life Sciences Data Hub and Oracle’s Siebel Clinical Trial Management System, using the secure, reliable and scalable Oracle Health Sciences Cloud.
Clinical trial sponsors, service providers, investigators and patients worldwide are expected to benefit from continuous, precise and near real-time information about when a dose of medicine under clinical investigation is actually ingested by a patient and the associated physiological responses. These unique insights into medication adherence and patient response will support more efficient clinical trial strategies, including adaptive trials and real world clinical trials.
“The relationship of two innovative leaders like Oracle and Proteus will provide life sciences companies and contract research organizations (CROs) with a unique capability to more effectively conduct clinical trials,” said Andrew Thompson, President, CEO and co-founder, Proteus Digital Health. “Oracle’s global scale, broad clinical trial platform, deep domain knowledge and resources for clinical trials will be combined with our in-depth expertise and leading position in integrated ingestion-based technology, providing the industry with a complete and robust solution to help improve human health.”
Financial details of the investment and the strategic partnership were not disclosed.