Highlights
- PriMED Clinical Research LCC (“PriMED”) is the first site in the United States to join BlinkLab’s Autism Registrational trial.
- PriMED’s Pediatric Division provides exceptional Pediatric primary care to 30,000 children in Southwest Ohio.
- The PriMED clinical trial site is expected to commence patient recruitment and testing early this month.
- The initiation of this first site marks a significant milestone in the BlinkLab Dx 1 study and paves the way for the subsequent phases of the clinical trial.
- Multiple other clinical and research sites are also nearing the final stages of contract and budget negotiations.
BlinkLab Limited (ASX:BB1) (“BlinkLab”, or the “Company”), an innovative digital healthcare company developing AI-powered smartphone tech to transform the autism and ADHD diagnostic markets, is pleased to provide an update on its US-based autism diagnostic registrational trial, which is seeking to recruit 1,000 subjects. PriMED Clinical Research, LLC (“PriMED”), based in Dayton Ohio, is the first clinical site selected for the 100-patient initial phase with the first children expected to be enrolled early this month.
PriMED Clinical Research was selected due to their extensive experience in clinical studies for both pediatric and adult populations with their goal of enrolling up to 15-20 participants each month. PriMED Clinical Research will utilize the overarching Institutional Review Board (IRB) approval BlinkLab has successfully secured for its clinical trial. No additional institutional approval or waiver will be necessary. This will expedite the inclusion of the first children in the BlinkLab Dx 1 study at PriMED.
BlinkLab has been proactively initiating partnerships with sixteen sites, spanning across the entire US during the IRB approval processes. This parallel approach has allowed BlinkLab to expedite the launch of the clinical trials once all necessary approvals were in place. Through the Company’s already established relationships and logistical frameworks, and many sites across the US in advanced discussions, BlinkLab aims to streamline the enrolment process and accelerate data collection.
Crystal Jackson, MA-CCRC Clinical Research Site Manager, commented:
“PriMED Physicians & PriMED Clinical Research Team, alongside Dr. Rogelio Amisola, Principal Investigator, are looking forward to our collaboration with BlinkLab. This partnership represents an exciting opportunity to integrate our clinical expertise with BlinkLab's innovative AI technology. We are dedicated to providing accurate and detailed data for the advancement in healthcare, paving the way for innovative approaches that enhance diagnostic accuracy and improve patient outcomes.”
Dr. Henk-Jan Boele - CEO, BlinkLab commented:
“I am very excited to announce the official initiation of our FDA work. By partnering with the best clinical institutions, BlinkLab is committed to delivering breakthrough, accessible AI-driven technology that is expected to transform early autism detection and provide families with faster, more reliable diagnoses.”
Brian Leedman, Non-Executive Chairman commented:
“Since our IPO in April 2024, BlinkLab has made significant strides in advancing the AI smartphone-based diagnostics application. During the December 2024 quarter, the initiation of our FDA registrational study for BlinkLab Dx 1, supported by positive results from pivotal studies, is a key milestone in bringing earlier and more accessible autism diagnosis to families. This partnership with PriMED represents another key milestone that highlights the enormous progress we’ve made over the past year. As we move forward, shareholders can look ahead to continued developments in our clinical programs and collaborations that support our long-term goals.”
About PriMED Clinical Research, LLC
PriMED Clinical Research is owned and operated by PriMED Physicians a premier healthcare provider in Dayton, Ohio. PriMED Physicians is committed to delivering high-quality, patient-centered care to a diverse patient population. With a team of highly skilled and compassionate medical professionals, PriMED Physicians serve individuals across all age groups, backgrounds, and health conditions, ensuring that every patient receives personalized and evidence-based treatment.
A key strength of PriMED is its exceptional pediatrics department, offering specialized care for infants, children, and adolescents. From newborn wellness visits to adolescent health and chronic condition management, the practice is committed to fostering the health and well-being of young patients. Utilizing the latest advancements in pediatric medicine and a family-centered approach, PriMED ensures that every child receives compassionate, high-quality care.
PriMED is committed to comprehensive autism care by offering early screening and coordinating with a local children’s hospital. Their multidisciplinary approach ensures that children receive timely interventions and access to necessary resources, which can significantly impact their development and quality of life.
This announcement has been approved by the Board of Directors
