Rekovar Secures Multicenter Central IRB Approval for Next-Generation NAS Monitoring System
Rekovar is thrilled to announce that our multicenter central Institutional Review Board (IRB) approval for the next-generation Neonatal Abstinence Syndrome (NAS) monitoring system has been officially approved by the WIRB Connexus Group (WCG). This pivotal approval paves the way for expanded clinical trials and research efforts aimed at enhancing the care and treatment of newborns affected by NAS.
The approval by WCG, a leading global provider of ethical review services for human research, underscores the commitment to ensuring the highest standards of safety and efficacy in medical innovations. Rekovar's next-generation NAS monitoring system, named NeoMonki, represents a breakthrough in neonatal care, offering real-time continuous monitoring of NAS symptoms.
The central IRB approval allows Rekovar to conduct clinical trials across multiple sites, facilitating the collection of comprehensive data on the system's performance and impact. These trials are essential for demonstrating the effectiveness of NeoMonki in real-world settings and for obtaining the necessary regulatory clearances for widespread use.
Rekovar's collaboration with hospitals and research institutions across the country, including Children’s Hospital Orange County (CHOC), Johns Hopkins University (JHU), The University of New Mexico (UNM), and PIH Good Samaritan, will be instrumental in these trials. The partnership aims to evaluate the system's efficacy in monitoring NAS, improve treatment protocols, and ultimately reduce the length of hospital stays for affected newborns.
The NAS monitoring system is expected to address the urgent need for objective, continuous monitoring tools in the NICU, offering a new level of care for newborns experiencing withdrawal symptoms. By providing healthcare professionals with accurate, real-time data, the NeoMonki system will enable more personalized and effective treatment plans, contributing to better health outcomes for the most vulnerable patients.
As Rekovar moves forward with its clinical trials and seeks to bring the NeoMonki to market, the company remains dedicated to its vision of transforming neonatal care through technology. With the support of WCG and the broader medical community, Rekovar is set to make a significant impact on the lives of newborns with NAS and their families.
Stay tuned for updates on the progress of our clinical trials and the journey towards improving neonatal health care with the NeoMonki.