Latest news with #Curavit
Yahoo
6 days ago
- Business
- Yahoo
Curavit to lead US trial of Nestmedic's prenatal monitoring solution
Polish medtech company Nestmedic has chosen Curavit Clinical Research to spearhead the US clinical study of the remote prenatal monitoring solution, PregnaOne. The non-significant risk (NSR) trial is set to enrol 50 expectant mothers over 11 months across the country to assess the effectiveness and safety of the solution when used at home. This foundational study aims to gather evidence to facilitate upcoming regulatory clearance in the US. Curavit will oversee all trial aspects, including institutional review board (IRB) submissions, site choosing, data management, contract and monitoring, selection of clinical data capture software, data analytics, as well as the clinical study report (CSR) preparation. Nestmedic CEO Jacek Gnich said: 'We are building technology with empathy at its core. Curavit's innovation-forward approach, medical device expertise, and deep clinical trial experience make them the ideal partner to run this pivotal study in the US.' At least three clinical sites will be chosen, focusing on participant diversity in terms of geography and demographics. Curavit noted that a centralised healthcare provider (HCP) data review and adjudication process implementation will take place to ensure the quality and consistency of the data. Curavit Clinical Research CEO and co-founder Joel Morse said: 'We are honoured to support Nestmedic in bringing PregnaOne to market. 'Their mission to improve prenatal care through remote monitoring perfectly aligns with Curavit's vision to partner with innovative medical device companies that are working to expand access to healthcare.' In 2023, Curavit Clinical Research introduced a Health Economics and Outcomes Research (HEOR) service for clinical studies. In the same year, MedRhythms chose Curavit as its virtual contract research organisation (VCRO) for a trial of its MR-001 neurorehabilitation system. "Curavit to lead US trial of Nestmedic's prenatal monitoring solution" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Associated Press
21-07-2025
- Business
- Associated Press
Nestmedic Selects Curavit Clinical Research as U.S. CRO Partner for Pioneering Prenatal Monitoring Trial
BOSTON and WARSAW, Poland, July 21, 2025 /PRNewswire/ -- Curavit Clinical Research, 'The Innovation CRO', is proud to announce its selection by Nestmedic S.A. to lead the U.S. clinical trial of PregnaOne, an innovative remote prenatal monitoring solution. This milestone partnership was recently shared on LinkedIn by Nestmedic CEO Jacek Gnich and Curavit leadership. The upcoming Non-Significant Risk (NSR) study will enroll 50 expectant mothers in the U.S. to evaluate the safety and effectiveness of PregnaOne during home use. The study is designed to generate foundational evidence to support future regulatory approval in the U.S. Curavit will manage all aspects of the trial, including IRB submissions, site selection, contract and monitoring, data management, clinical data capture software selection, data analytics, and preparation of the Clinical Study Report (CSR). 'We are honored to support Nestmedic in bringing PregnaOne to market,' said Joel Morse, CEO and Co-founder of Curavit Clinical Research. 'Their mission to improve prenatal care through remote monitoring perfectly aligns with Curavit's vision to partner with innovative medical device companies that are working to expand access to healthcare.' Trial Highlights: 'We are building technology with empathy at its core,' said Jacek Gnich, CEO of Nestmedic. 'Curavit's innovation forward approach, medical device expertise, and deep clinical trial experience make them the ideal partner to run this pivotal study in the U.S.' About Curavit Clinical Research Curavit Clinical Research, The Innovation-CRO, designs and executes modern clinical trials for medical devices, digital therapeutics, and novel pharmaceuticals. Headquartered in Boston, Curavit operates nationwide with additional offices in New York, Salt Lake City, and San Diego. Learn more at About Nestmedic S.A. Nestmedic is a Polish medtech company redefining prenatal care with PregnaOne, an AI-enabled remote monitoring solution that empowers patients and providers with real-time, continuous insight into fetal and maternal well-being. View original content to download multimedia: SOURCE Curavit Clinical Research
