Digital therapeutics for health management
Innovative technologies for the prevention and treatment of high blood pressure.
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The challenge
To develop a digital medical device to enhance the management and treatment of high blood pressure, leveraging AI.
SCENARIO
A new therapeutic model
High blood pressure is a chronic condition that affects an increasing number of people every year. Often underestimated, it represents a significant risk factor for the development of cardiovascular diseases, making both prevention and effective treatment essential. Despite the many treatment options available, control rates are still below expectations and the incidence of hypertension is constantly increasing. To improve the management and treatment of hypertension, an integrated approach is necessary and, in this context, the use of Digital Therapeutics to support pharmacological treatments represents a new therapeutic option that can provide patients with a personalised intervention to modify dysfunctional behaviours, which often contribute to the disease. To this end, Polifarma, a leading company in the Italian pharmaceutical market, and DaVi DigitalMedicine, an innovative digital medicine startup, have launched a project to develop a digital medical device aimed at creating a synergy between technology and traditional treatments that takes into account current challenges in the world of healthcare.
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The solution
AI as a digital component of therapy
Strengthened by its expertise in artificial intelligence and Big Data solutions for the healthcare market, Laife Reply has taken up the challenge by collaborating with Polifarma and DaVi Digital Medicine to design and develop a digital therapy that can work both alone and associated with pharmacological therapy. Digital therapeutics are software applications used instead of or alongside medications and provide therapeutic interventions based on evidence of effectiveness to prevent, manage, or treat disorders or diseases. They use approaches such as cognitive behavioural therapy (CBT) or other behavioural modification techniques to guide patients through phases of reflection and habit change to achieve the expected clinical outcome. The technological solution created by Laife Reply is a mobile application (QPress®) that, through a digital assistant based on a generative conversational model, follows patients in a timely, comprehensive, and personalised manner, combining different functionalities.
Monitoring
Collection of pressure values, data visualisation and transmission, risk prediction.
Medication care support
To manage your medication intake correctly.
Self-management support
Reminder, lifestyle advice, specific illness management advice, personalised training and information content.
The integration of AI has been a decisive aspect in all phases of design and implementation.
The application is designed in compliance with current regulations, with particular attention to data security and privacy, ensuring high-security standards and compliance with GDPR.
THE NEXT STEPS
The clinical trial phase
Digital therapeutics, just as medications, require a clinical trial to demonstrate the safety and efficacy of the treatment and management of hypertension. In this sense, DaVi Digital Medicine collaborates with Polifarma in defining the strategy and protocol for the clinical trial of the therapy within the approval process, followed by certification as a medical device according to current regulations and qualification as Digital Therapeutics. At the end of this process, the new digital solution can then be offered to the prescribing physician and the patient as an innovative hypertension therapy.
Since its foundation in 1919 and subsequent acquisition in 1999 by the Final Group, chaired by Luisa Angelini, Polifarma has embodied a business vision that is based on solid and distinctive pillars. The company has established itself in the commercialisation of drugs, medical devices and food supplements, acting as a trusted partner thanks to its dedication, search for innovative solutions and deep ethical commitment. Polifarma deals with studying, supporting and evaluating innovative projects in the field of health, applying new techniques and methodologies to overcome barriers and accelerate progress. With a strong focus on disease screening, monitoring their evolution, and promoting active patient participation in the treatment process, the company develops Bio-Digital solutions, such as Digital Supports and Digital Therapeutics, which represent the future of healthcare.
DaVi DigitalMedicine srl is a Digital Biotechnology Company founded in Verona in February 2021 for the research and development of Digital Medicine devices. The primary activity of DaVi DigitalMedicine involves defining the architecture of digital medical devices for the monitoring, control and therapy of human diseases and in carrying out research and development, through collaboration with companies and institutions for the execution of identified and defined activities. DaVi DigitalMedicine srl pursues ethical principles aligned with the DTx Industry Code of Ethics from the Digital Therapeutics Alliance. As a socially responsible company, DaVi DigitalMedicine srl is committed to supporting the digital transformation of Italian medicine and healthcare by openly sharing its knowledge, expertise and experience, promoting information to citizens, training patients, operators and healthcare professionals, supporting student research activities, and participating in conferences and study groups.
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Laife Reply promotes digital innovation in the Healthcare sector by leveraging its extensive expertise in Artificial Intelligence and Big Data Analytics technologies and in-depth know-how in the medical field. Laife Reply specialises in the application of Artificial Intelligence algorithms to images and clinical data, with the aim of adding real value to healthcare processes and contributing to reducing clinical risk by supporting diagnosis and treatment activities.