From 2024, Biosency will make its BVS3 technology available to healthcare professionals for integration into the BORA Care digital medical device, with the aim of obtaining reimbursement as part of an advance payment scheme
Biosency has developed and markets Bora care, a digital medical device (class 2a) for remote monitoring. (Credit: Testalize.me on Unsplash)
The American Thoracic Society International Conference took place in Washington, D.C. from 19 to 24 May 2023. During the conference on 23 May, French MedTech Biosency unveiled its latest clinical results demonstrating the ability of its BVS3 technology to predict acute COPD (chronic obstructive pulmonary disease) exacerbations on average 3 days prior to hospitalisation in 86% of cases, with only 9% false positives. From 2024, Biosency will make its BVS3 technology available to healthcare professionals for integration into the BORA Care digital medical device, with the aim of obtaining reimbursement as part of an advance payment scheme.
Chronic obstructive pulmonary disease (COPD) is the third leading cause of death worldwide. It resulted in 3.23 million deaths in 2019 according to the World Health Organisation (WHO). It is characterised by chronic respiratory symptoms and exacerbations that can lead to acute respiratory failure and hospitalisation. The number of hospital admissions for severe exacerbations in the OECD area is estimated to 1.8 million per year (OECD health statistics 2019).
In order to secure and optimise the management of COPD patients, Biosency has developed the innovative BORA Care solution, which includes a platform for visualising vital signs and a connected bracelet that measures the patient’s physiological parameters. On 23 May, the company unveiled the first clinical results of the BVS3 early detection algorithm integrated into BORA Care at the ATS conference, demonstrating its ability to predict COPD exacerbations. The aim is to reduce the average length of hospital stay, prevent morbidity and reduce mortality in COPD patients.
An initial study carried out in French hospitals (Rennes, Vannes and Saint-Malo), the results of which were presented at the Congrès de Pneumologie de Langue Française in January 2023, identified and prioritised the vital signs of remotely monitored COPD patients and concluded that the rate of change of respiratory frequency was the most important marker in readmitted patients.
The clinical results presented yesterday go much further and show that the specificity and sensitivity of the BVS3 early detection algorithm predicts the occurrence of exacerbations on average 3 days before hospitalisation in 86% of cases, with 9% false positives compared to 20% via other equivalent medical devices. In this study, 85 COPD patients were fitted with the Bora Care device over a 6-month period during which the three vital signs measured in real time (oxygen saturation, heart rate and respiratory rate) were analysed and processed by the BVS3 technology.
These results will be reinforced in the coming months with additional data to obtain regulatory approval for reimbursement of the Bora Care solution by 2024.
“By measuring three parameters simultaneously in the patient and thanks to the specificity of the predictive algorithms developed by our scientists, our remote monitoring solution now makes it possible to have a reliable prediction of exacerbations and therefore an early and adapted management of COPD patients. We have ongoing studies in other chronic respiratory diseases to demonstrate the predictive capabilities of BVS3 . This opens up the possibilities of using the Bora Care solution,” says Marie Pirotais, President of Biosency.
Source: Company Press Release