PKvitality announces clinical trial for K’Watch Glucose
Posted on November 25, 2021
Paris. 23 November 2021 – PKvitality, a French company specialized in Health and Sport bio-wearables announced the start of a clinical study to determine the accuracy of the K’Watch Glucose. The trial is conducted with the AMCR Institute Inc, a clinical research centre focused on diabetes and obesity with worldwide renown medical device expertise in the metabolic area.
Based on a SkinTaste technology, the K’Watch Glucose will be the wearable smartwatch medical device that measures and displays glucose level continuously, effortlessly, and painlessly. This major milestone is partly financed thanks to grant and equity investment from the European Commission through the EIC (European Innovation Council) fund.
PKvitality has been chosen by the EIC as one of the top innovative companies to offer a solution to a major global issue, the diabetes population is estimated to be of 463M people and should rise to 700M by 2045. The K’Watch Glucose project aims to facilitate the lives of millions of diabetes patients by offering a painless and discreet continuous glucose monitor.
This investment also demonstrates the renewed trust from public institutions in PKvitality projects, as already supported by European and French public institutions since their recognitions both in EUROSTARS contest, within Horizon 2020 framework, and in Innov’Up Leader PIA, a joined initiative from Region Ile-de-France and Bpifrance.
Heidi Kakko, member of the EIC fund investment committee, says, “We are glad to announce the EIC Fund contribution to this funding round for PKvitality to catalyse early-stage venture investments in the high-risk areas to make larger impact: a European medical company developing a breakthrough technology that is increasingly important for the long-term monitoring of patients in many pathologies. The EIC Fund’s investment shows the EU strong commitment in supporting European innovation champions to develop the technologies for the greater benefit and focusing on the fields of critical importance with long term development cycles.”
Luc Pierart, CEO of PKvitality, adds, “PKvitality is a blend of Consumer Electronic and Medtech expertise, bringing the best of both worlds: appealing product, ease of use at the service of the diabetes patients. Since 2017, we conducted thousands of interviews with patients, thousands of in vitro tests to improve the product accuracy. The excellent results enable us to enter clinical trial, a major step towards product availability. This study will confirm the precision and patient-friendly experience of using K’Watch Glucose.”
Timothy Bailey, MD, FACE, CPI and CEO of AMCR Institute, states “AMCR Institute has established and outstanding reputation as the provider of medical device developments within the metabolic area. We strive to be the best at what we do, and always be meticulous in all our practices placing the care, safety, and confidentiality of our volunteers first.”
The results of this clinical trial are expected in the first half of 2022.
K’Watch Glucose, the smartwatch to monitor glucose
K’Watch will be the Continuous Glucose Monitor in the form of a smartwatch. It is composed of two parts: K’Watch, the smartwatch and K’apsul, an adhesive patch at the back. It will enable a continuous monitoring of systemic glucose levels anytime and anywhere. This is possible thanks to SkinTaste, a patented biosensor array that uses micropoints (<1mm long) in order to analyse chemical compositions of the interstitial fluid. Completely painless and invisible to others, the diabetes patient will be able to check its level discreetly or follow its average glucose and time in range.
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