Polish medtech company Nestmedic S.A. has partnered with Curavit Clinical Research to conduct the U.S. clinical trial of PregnaOne, an innovative AI-enabled remote prenatal monitoring solution. The collaboration represents a significant step toward bringing advanced prenatal care technology to the American market.
Clinical Trial Design and Objectives
The upcoming Non-Significant Risk (NSR) study will enroll 50 expectant mothers across the United States to evaluate the safety and effectiveness of PregnaOne during home use. The FDA-required clinical study is designed to generate foundational evidence to support future regulatory approval in the U.S.
The trial will be conducted over an 11-month period, with a minimum of three clinical sites selected to ensure geographic and demographic diversity among participants. A centralized healthcare provider data review and adjudication process will be implemented to maintain consistency and ensure high-quality data collection.
Comprehensive Trial Management
Curavit Clinical Research 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). This comprehensive approach aims to streamline the regulatory pathway for PregnaOne's market entry.
"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."
Technology and Innovation Focus
PregnaOne represents a significant advancement in prenatal care technology, offering real-time, continuous monitoring of fetal and maternal well-being through AI-enabled remote monitoring capabilities. The device is designed to empower both patients and healthcare providers with enhanced insight into pregnancy health status.
"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."
Market Entry Strategy
The partnership between Nestmedic and Curavit reflects a strategic approach to entering the U.S. healthcare market with innovative prenatal monitoring technology. The clinical trial is positioned as a critical milestone in the regulatory approval process, with the study design specifically tailored to meet FDA requirements for medical device evaluation.
The collaboration leverages Curavit's expertise in medical device clinical trials and their nationwide presence with offices in Boston, New York, Salt Lake City, and San Diego, providing comprehensive support for the multi-site study execution.
