Eisai and Empatica Enter an Agreement to Co-Promote the Embrace2 Device for People Living With Epilepsy in the U.S.

- Embrace2 is the first wrist-worn wearable in the field of epilepsy to be cleared as a medical device for detecting patterns that may be associated with convulsive seizures in children & adults

- Agreement underscores Eisai's commitment to supporting patients and their families across all spectrums of epilepsy care

News provided by

Eisai Inc.

Feb 19, 2019, 10:05 ET

WOODCLIFF LAKE, N.J. and BOSTON, Feb. 19, 2019 /PRNewswire/ -- Eisai Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., and Empatica Inc. announced today that they have entered into an agreement in the U.S. to co-promote the Embrace2 smartband device, the first FDA-cleared, wrist-worn wearable within the field of epilepsy for detecting patterns that may be associated with convulsive seizures available for use as a medical device for adults and children. The device is approved for patients ages six to adult.

Embrace2 is an epilepsy smartband that detects patterns in motion and physiological signals that may be associated with generalized tonic-clonic seizures, and immediately alerts caregivers; these signals include acceleration of movement, rotation, electrodermal activity variations and temperature at the surface of the skin.

Seizure detection devices are an important tool for patients living with epilepsy as well as the families and caregivers who care for them. Though there are no devices available that have been proven to prevent sudden, unexpected death in epilepsy (SUDEP), it may be beneficial for patients who experience seizures at night to have a way to potentially alert those around them if a seizure occurs.

"Eisai is committed to providing innovative approaches to epilepsy care that help patients and their families manage their disease and continue to strive toward the ultimate goal of seizure freedom," said Ivan Cheung, Chairman and CEO of Eisai Inc. "Part of Eisai's approach to helping patients and their families is to provide options that may help address the entire spectrum of issues associated with epilepsy and convulsive seizures. Our collaboration with Empatica is another step toward bringing a holistic approach to epilepsy care."

"We are very proud to be a part of this collaboration with Eisai to promote Embrace2, which provides families living with epilepsy an option to help monitor convulsive seizures at home or in a healthcare setting – even at night," said Matteo Lai, Co-Founder and CEO of Empatica. "Our product was designed with our patients' lifestyles and needs in mind to help improve the likelihood that a trusted caregiver will be there during the critical moments after a seizure happens."

Indications For Use
Embrace2 is a prescription only, single-patient, device that is indicated for use as an adjunct to seizure monitoring of adults and children ages 6 and up in home or healthcare facilities during periods of rest. The device is worn on the wrist and senses Electrodermal Activity (EDA) and motion data to detect patterns that may be associated with generalized tonic-clonic seizures in patients with epilepsy or at risk of having epilepsy. When a seizure event is detected, Embrace sends a command to a paired wireless device that is programmed to initiate an alert to a designated caregiver. The system records and stores data from Accelerometer, EDA, and Temperature sensors for subsequent review by a trained healthcare professional.

Limitations

The device does not predict seizure onset.
The device is not intended to be used during physical activity.
The safety and effectiveness of the Embrace System has not been established in monitoring signals that may be associated with seizures other than generalized tonic-clonic convulsive seizures.
The device is not intended to be used to guide medical therapy decisions.
The device is not intended to be used as a stand-alone monitoring device.

Important Information
There is no guarantee that Embrace2 and the Alert App will detect every single seizure and deliver alerts accordingly. The system is not meant to substitute or alter your current seizure monitoring/management practices. The main risk is the device or app failing to detect a convulsive seizure, or failing to deliver an alert due to connection issues. Timely delivery of notifications to caregivers requires certain conditions to be met. If the user or caregiver changes their seizure management practices and relies too heavily on Embrace2, this may lead to less than adequate supervision. Patients should discuss the risks and benefits with their physician. Please see the Instructions for Use for additional information available at https://support.empatica.com/hc/en-us/categories/200310325-Embrace-Getting-Started.

About Epilepsy
Epilepsy is a medical condition that produces seizures affecting a variety of mental and physical functions. Epilepsy is one of the most common neurological disorders, which affects about 3.4 million people in the United States, including 470,000 children. Children with uncontrolled seizures are at greater risk for sudden unexpected death in epilepsy (SUDEP), which is relatively uncommon in childhood, but the risk increases if epilepsy persists into adulthood.

Convulsive seizures account for up to 25 percent of all epilepsy, with primary generalized tonic-clonic seizures being one of the most common and severe forms of seizures.

Clinical results
Clinical testing was carried out in an Epilepsy Monitoring Unit (EMU) among 141 patients diagnosed with epilepsy. 80 were pediatric patients, aged 6-21 years; and 61 adult. 53 out of 54 generalized tonic-clonic seizures were detected by Embrace2 for an accuracy rate of 98% during the clinical testing, with the overall False Alarm Rate (FAR) for adults (>21 yo) being 0.67, and the one for pediatrics (<=21 yo) being 1.35; these false alarms, which can be cancelled on the device, occurred around once every one to two days.

About Embrace2
Embrace2 is an epilepsy smartband that detects patterns in motion and physiological signals that may be associated with generalized tonic-clonic seizures, and immediately alerts caregivers. The device received FDA clearance for seizure monitoring in adults in January of 2018. In December of 2018, Embrace2 received FDA clearance for seizure monitoring in children as young as six years old, making the device the first non-EEG based physiology signal seizure monitoring system to be cleared by the FDA for use in a pediatric population, highlighting the challenges and complicated processes that come with this type of testing for children. Embrace2 was CE certified in Europe as a medical device for seizure detection in April 2017.

Embrace2 has been listed as one of the 18 things that made the world a better place in 2018 by WIRED.

About Eisai Inc.
At Eisai Inc., human health care (hhc) is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to discover and develop innovative therapies to help address unmet medical needs.

Eisai is a fully integrated pharmaceutical business that operates in two global business groups: oncology and neurology (dementia-related diseases and neurodegenerative diseases). Each group functions as an end-to-end global business with discovery, development, manufacturing and marketing capabilities. Our U.S. headquarters, commercial and clinical development organizations are located in New Jersey; our discovery labs are in Massachusetts and Pennsylvania; and our global demand chain organization resides in Maryland and North Carolina. To learn more about Eisai Inc., please visit us at http://www.eisai.com/US and follow us on Twitter and LinkedIn.

About Empatica
Empatica Inc. is a MIT Media Lab Spin off, with offices in Boston, MA and Milan, Italy. It has 58 employees and designs everything in house (Hardware, Software, Algorithms). Visit Empatica's website at http://www.empatica.com.