Artificial intelligence-focused Chronolife SAS, of Paris, has secured class IIa medical certification from the EU for its smart T-shirt, which has the new brand name Keesense.
The reusable, washable T-shirt is designed for comfortable, round-the-clock use. It works by transmitting data to a paired smartphone app via Bluetooth. The data is then sent to a secure, certified server for live or time-delayed analysis by the wearer's health care team.
Laurent Vandebrouck, CEO of Chronolife, told BioWorld that the company has a limited launch underway in Europe, specifically in France, Germany and Nordic countries. “[These] countries are pretty well advanced in the use of connected medical devices for the remote monitoring of patients with chronic diseases from home,” he noted. Reimbursement also was a consideration, as remote monitoring of patients with specific diseases, such as chronic heart failure, chronic obstructive pulmonary disease, diabetes and sleep apnea, is covered.
When asked about pricing, he noted that the company does not sell the solution directly to patients. Rather, it provides the solution to pharma or med-tech companies for their therapeutic efficiency programs or to providers of telehealth services, with an eye toward reducing the number of hospital readmissions.
“Our pricing model combines two things: first of all, the price of the hardware, so of the medical device, of the connected T-shirt, which is €250 [US$271.62],” Vandebrouck added. It is commercialized and distributed by a partner. The company charges a monthly fee every time an app is activated on a smartphone and starts collecting and transferring medical data. For this, the company charges €20 per month, per patient.
The company is looking to bring its solution to the U.S. and has set up a subsidiary toward that end. It has hired a local managing director to take the lead on that effort. In terms of a potential greenlight in the U.S., the company will need to conduct a small trial with about 50 patients on top of what it already has done in Europe. It hopes to start the trial by the middle of 2020. Exact timing is a little challenging, given the COVID-19 pandemic. That said, it still hopes to obtain clearance by 2021.
The solution also has potential to help during the pandemic. “Considering that our connected T-shirt generates several medical data, namely the thoracic respiration, the abdominal respiration, the electrocardiogram, the present temperature of the body, as you can imagine it’s completely in line with what health care professionals do need when a patient is discharged from the hospital and coming back home after a COVID-19 event,” Vandebrouck explained When adding an oximeter that measures SpO₂ on top of the connected T-shirt, “we can really deliver all the measurements, all the medical data that health care professionals do need … after a COVID-19 event.”
When asked about other near-term efforts, he noted that the company recently launched a clinical trial in six European countries with 25 hospitals. It hopes to enroll 550 patients discharged from the hospital after a major decompensation and heart failure. They will be monitored 24/7 with free T-shirts and the associated smartphone app. The goal is show that the monitoring solution combined with a predictive algorithm on the smartphone app can permit the detection of decompensation early, allowing for treatment modification or readmission of the patient to the hospital. It hopes to launch similar trials in other indications, such as sleep apnea and epilepsy, in subsequent years.
With the medical certification in hand, Chronolife said it was in a good position for partnerships with a range of telemedicine services and telehealth providers to innovate and deliver end-to-end, continuous remote patient monitoring programs.