The Theranica Nerivio Migra is an FDA-approved drug-free therapeutic wearable for the treatment of acute migraine. The connection with the bio-T remote care platform and deployment of the solution on AWS enables a novel way of remotely monitoring migraine patients. Such monitoring implies a promise for personalized medicine where physicians will learn about the Migraine patterns of their patients, to provide better treatment. In the near future, given time for data acquisition, big data analysis of patients worldwide may find the root causes of Migraine – a phenomenon with no clear explanation.
Focused on developing its core technology from day one, the company sought an out of the box solution that solves challenges such as cybersecurity, digital health regulation and accelerates time to market. “We were looking for a medical IoT partner. Key factors that we were looking for and we found in the bio-T platform: cloud end to end solution, flexible infrastructure, built-in features (regulated user & device management, consent management), and supporting regulations as GDPR, HIPAA” says Ronen Jashek, COO of Theranica.
Theranica addressed its challenges by developing a device and mobile application and connecting it to the bio-T remote care platform, combined with the Amazon Web Services (AWS) Cloud. bio-T™ is a cloud technology for medical device manufacturers enabling them to securely connect their device to the cloud and to encourage patients to donate data for medical research. Business-wise, bio-T™ accelerates the transformation of stand-alone medical device manufacturers into fully regulated smart connected service providers while reducing cyber, compliance and technological risks. Moreover, bio-T™ enables the manufacturer to retain ownership over the data and to have complete implementation flexibility via code-level customization.
Theranica benefited greatly from bio-T’s regulation-ready features, and unique code-level customization options, which enabled its IoMT solution to be developed in less than 6 months. Theranica also reduced its privacy and cyber risks by millions of dollars by signing HIPAA BAA and GDPR DPA agreements with bio-T, which acknowledges legal liability over the bio-T platform in case of breaches.
Today Theranica is scaling very quickly in the US, and aims to reach the EU market in 2020.