| PKvitality, a French company specialized in Health and Sport bio-wearables today 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 center focused on diabetes and obesity with worldwide renown medical device expertise in the metabolic area. Based on a unique SkinTaste technology, the K’Watch Glucose will be the first 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 unique solution to a major global issue: today, 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 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.” The results of this clinical trial are expected in the first half of 2022. To access the study, please click here. To access a video, please click here. |
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| K’Watch Glucose, the 1st smartwatch to monitor glucose K’Watch will be the first 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 analyze 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. 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. About AMCR Institute AMCR Institute is a globally recognized, independent clinical research site exclusively focused on diabetes, obesity, and NAFLD/NASH. In addition to bio-pharmaceutical research, AMCR Institute conducts medical device trials from feasibility to pivotal. AMCR Institute is engaged in Phase I-IV trials in pediatric and adult populations. Founded in 2007, AMCR Institute has accomplished more than 360 clinical projects. Excellence in clinical research, accelerating access to treatments that change lives will improve lives. For more information, visit www.amcrinstitute.com About PKvitality PKvitality is a health & sport bio-wearable start-up currently working on K’Watch Glucose, a Continuous Glucose Monitoring (CGM) device in the form of a smartwatch. It will enable a painless, discreet and precise monitoring of systemic glucose level anytime and anywhere. Using the same technology, PKvitality is also working on K’Watch Athlete, a smartwatch which will provide real-time monitoring of their lactic acid – an indicator of muscle fatigue – to significantly improve an athlete’s training and performance. For more information, please visit www.pkvitality.com |
PKvitality announces the start of its First-In-Human clinical trial for K’Watch Glucose, the world’s first Continuous Glucose Monitoring (CGM) smartwatch
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Josh Lehman
By Josh Lehman
Technologist & Blogger - Proud Gun Owner - @Patriots Diehard - Creator of Awesome Stuff - Everything Disney - Super Dad