Clinical Trial for Smart Case and Mobile Phone App for Epinephrine Autoinjectors

Adan Medical Innovation, SL., a privately held biotech firm developing advanced tools and medical devices that assist in the maintenance, portability, and storage of pharmaceutical drugs, has announced the launch of the company’s first clinical trial for its leading medical device, anAPPhylaxis (pronounced: an-APP-fil-laks-əs).
 
anAPPhylaxis is a medical device that is a combination of a smart case and corresponding mobile phone application for use in managing an epinephrine autoinjector, the primary treatment for anaphylaxis, a serious allergic reaction. anAPPhylaxis provides readings regarding the storage conditions, effectiveness and physical proximity of the epinephrine autoinjector through a wireless Bluetooth connection with a smart phone, and issues alerts to warn the patient if there is a separation between the patient and their device. The device also can notify the patient if the environment the case is stored in is unacceptable, and if the case has been opened for use in the event of anaphylaxis. The Spanish regulatory agency, La Agencia Española de Medicamentos y Productos Snaitarios (AEMPS), approved the company’s viable prototype.
 
In the event of anaphylaxis, the anAPPhylaxis mobile app is designed to automatically issue alerts to a pre-determined list of contacts and/or emergency services, providing each with a location where the smart case was opened. It will then proceed to play a video demonstrating the proper method of using the epinephrine autoinjector for the person, caregiver, or whomever may be assisting the person experiencing anaphylaxis. The measurement features are performed on a timed frequency to ensure regular measurements. Epinephrine has a standard expiration of 18 months from the manufacturing date, but the current prototypes have improved energy efficiency to increase the autonomous range of the device to approximately 30 months without the need to recharge the case.
 
The following video offers a further explanation of the technology.

 
“We are very excited that the clinical trial of our novel medical device and smart phone app is underway,” said Adan MI CEO Xavier Guillem. “There isn’t anything in the market like what we have created—an innovative and effortless device that pairs biotechnology and mobile health. This convergence of two fields is groundbreaking, and we are only just beginning to implement the potential of this technology.”
 
The clinical trial is being conducted at the largest hospital complex in Spain, the Hospital Universitari Vall d’Hebron in Barcelona, and is a randomized, cross-over, open, unicentric study with the primary endpoint of evaluating the satisfaction with the use of the anAPPhylaxis medical device by patients. Secondary endpoints include evaluating quality of life, adherence to medical requirements and measurement of perceived anxiety regarding the use of the enclosed epinephrine autoinjector in the event of anaphylaxis.
 
The trial is comprised of 100 patients who currently use an epinephrine autoinjector. The patients have been divided into two primary groups. The first group will not use anAPPhylaxis in the management of their epinephrine autoinjector for three months. After three months, they will begin the use anAPPhylaxis in the management of their autoinjector. The second group will commence using anAPPhylaxis at the same time period of three months as the first group, and then they will not have the use of the device for the second three month cycle when managing their epinephrine autoinjector.
 
“This trial is critical in the validation and refining of our medical device,” said Adan MI Co-Founder and Chief Medical Officer Dr. Anna Sala. “We expect the primary and secondary endpoints to confirm our expectations and help us move closer to receiving approval from regulatory authorities. With all of the hard work we have put into anAPPhylaxis, along with the efforts of our colleagues in the medical profession, patients, advisors and engineers, our wish is that this device helps to improve the quality of life and better ensure the safety of those patients who should carry an epinephrine autoinjector with them at all times.”
 
Drs. Anna Sala and Adrian Curran developed the idea for a medical device based on the daily testimonials, concerns and opinions they heard from their patients regarding the challenges of carrying, maintaining and storing their epinephrine autoinjectors on a daily basis.
 
Worldwide, it is estimated that 150 million individuals are considered to be at risk for experiencing anaphylaxis, with an alarmingly high mortality rate from the condition (One in 150). Over five million epinephrine autoinjectors are produced annually in the world, with 80 percent of the epinephrine autoinjector market based in the United States.
 
If approved in the U.S., anAPPhylaxis will be the first commercially viable solution for the management of the effectiveness of the active agents in the epinephrine autoinjectors, as well as its ability to monitor key environmental aspects, such as temperature. Adan MI is currently in discussions with regulatory authorities.