We are a Benefit Corporation that develops therapeutic digital systems aimed at improving medical care by involving the patient in the treatment path.
We use our social platform as a strategic asset and recognize the value of digital application in healthcare as a mission and the DNA of the company.
Our business aims, in addition to making a profit, include for results that serve the common good in a responsible, sustainable and transparent way: it is in our interest to make a positive impact on people, communities, territories and the environment, as well as cultural and social assets and activities, organizations and other stakeholders.
We want to design and develop a technological solution to assist those with chronic diseases, that will have a positive impact on its users, and especially patients and their caretakers. This impact will have to be highlighted and validated in a transparent way, through certified scientific methods.
The first level of certification is the one that accredits the Kerubin solution as a Medical Device; this type of certification is mainly focused on the safety aspects of the solution, both from the point of view of its production characteristics and from that of the production process.
The second level is far more ambitious and aims to configure Kerubin as a Digital Therapy, subjecting it to examination by scientific standards, both from the point of view of possible side effects and from that of therapeutic efficacy. This would certify that the use of the solution for a specific pathology has healing effects, not unlike those resulting from the administration of a drug.
Kerubin towards Digital Therapy
Obtaining the certification of Medical Device is a relatively simple step, the process of which is already underway and runs parallel to the Kerubin beta test phase. It will be completed by 2020, before the field use phase begins.
Obtaining a certification as Digital Therapy is much more complex and burdensome, as, unlike the previous one, it does not relate to the solution as such but must focus on a specific pathology, and for it the canonical process of Clinical Studies must be activated, up until certification is obtained from the regulatory body.
We plan to initially activate the Kerubin device in the oncology field, starting with the most common pathologies and then moving on to other chronic pathologies, for which it is believed the solution may be effective; the path to digital therapy will broadly follow the same progression.
The certification as Digital Therapy will be activated, for each pathology, immediately after the production of the corresponding version of the medical device.
Based on current regulations, we foresee that the path of clinical studies, a requirement for certification with Digital Therapy, will develop approximately over a period of twelve months, therefore the relative roadmap will broadly reflect the one seen above, with a time shift of about a year ahead.