PKvitality announces the start of its First-In-Human clinical trial for K’Watch Glucose, the world’s first Continuous Glucose Monitoring (CGM) smartwatch
PKvitality, a French business that specializes in bio-wearables for health and sport, has announced the launch of clinical research to test the accuracy of the K’Watch Glucose. The trial is being carried out in collaboration with the AMCR Institute Inc, diabetes and obesity clinical research facility with world-renowned medical device expertise in the metabolic field. The K’Watch Glucose will be the first wearable smartwatch medical gadget that monitors and displays glucose levels continuously, effortlessly, and painlessly, thanks to SkinTaste technology. This significant milestone was made possible in part by a grant and equity investment from the European Commission’s EIC (European Innovation Council) initiative.
K’Watch Glucose is a Continuous Glucose Monitoring (CGM) device in the shape of a smartwatch developed by PKvitality, a health and sport bio-wearable start-up. It will allow for painless, discrete, and accurate monitoring of systemic glucose levels at any time and place. PKvitality is also working on K’Watch Athlete, a smartwatch that will allow real-time monitoring of an athlete’s lactic acid – a marker of muscular tiredness – to help them better their training and performance.
The EIC has named PKvitality as one of the top innovative firms that offer a unique solution to a big global issue: diabetes currently affects 463 million people and is expected to reach 700 million by 2045. The K’Watch Glucose initiative promises to make millions of diabetic patients’ life easier by providing a painless and inconspicuous continuous glucose monitor.
This investment also demonstrates public institutions’ renewed faith in PKvitality projects, which have been backed by European and French governments since their recognition in the EUROSTARS competition, which is part of the Horizon 2020 framework, and in Innov’Up Leader PIA, a joint 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 catalyze 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 Piérart, CEO of PKvitality, adds: “PKvitality is a unique 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, stated: “AMCR Institute has established and outstanding reputation as the leading 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.”
K’Watch Glucose, Continuous Glucose Monitoring smartwatch
The first Continuous Glucose Monitor in the form of a smartwatch will be K’Watch. It is made up of two parts: the smartwatch K’Watch and the back adhesive patch K’apsul. It will allow for constant monitoring of systemic glucose levels at any time and from any location. SkinTaste®, a patented biosensor array that analyzes chemical compositions of the interstitial fluid using micropoints (1mm long), makes this possible. The diabetes patient will be able to check their level quietly or track their average glucose and time in range while being completely painless and invisible to others.
About the EIC fund
Established in June 2020, the European Innovation Council Fund (EIC Fund) is the largest venture capital fund in Europe, established by the European Commission to make direct equity and quasi-equity investments (between €500.000 and €15 million) in European high impact and deep tech start-ups and scale-ups. With a long-term perspective, the EIC Fund invests in companies from any sector, across all EU member states as well as in associated countries. The EIC Fund aims to fill a critical financing gap and its main purpose is to support companies in the development and commercialization of disruptive technologies. This is achieved by crowding-in market players, and further sharing risk by building a large network of capital providers and strategic partners suitable for co-investments and follow-on funding. The Fund pays particular attention to the empowerment and support of female founders as well as the ambition to reduce the innovation divide among EU countries.
The AMCR Institute is a world-renowned, independent clinical research center devoted solely to diabetes, obesity, and NAFLD/NASH. AMCR Institute also conducts medical device trials, from feasibility through pivotal, in addition to biopharmaceutical research. In both pediatric and adult populations, the AMCR Institute is conducting Phase I-IV research. Since its inception in 2007, the AMCR Institute has completed over 360 clinical projects. Clinical research excellence and increased access to life-changing treatments will enhance people’s lives.