QuantalX Secures Spot in FDA’s Prestigious Total Life Cycle Advisory Program (TAP)

QuantalX Neuroscience has been selected by the FDA for the exclusive TAP program, marking a significant milestone as the company expands into the global commercialization phase.

NEW YORK, April 4, 2024 —  QuantalX Neuroscience , a pioneering healthcare company dedicated to early detection of brain disorders using the Delphi-MD medical device, announced today its selection to participate in the highly prestigious Total Life Cycle Advisory Program (TAP) initiated by the U.S. Food and Drug Administration (FDA). The program will focus on advancing Delphi-MD’s unique Direct Electrophysiology Imaging technology, enabling the early detection of Normal Pressure Hydrocephalus (NPH) disease, with high accuracy rates, and the prediction of patients’ response to ventriculoperitoneal shunting (VPS). The TAP program brings together the FDA, major health insurers, healthcare organizations, and industry leaders in a collaborative effort to construct a comprehensive strategy for technologies that can benefit the general population. This strategic framework spans crucial elements, such as value creation in the U.S. market, meticulous preparation for regulatory approval, meaningful engagement with insurers, and the establishment of a robust market presence with customers.

“The acceptance into the Total Life Cycle Advisory Program is a truly prestigious and significant opportunity for QuantalX,” remarked Iftach Dolev. PhD, Co Founder and CEO at QuantalX. “Collaborating with the leading healthcare market executives not only solidifies our commitment to neurodiagnosis excellence but also positions us for a stronger commercial entry into the market.”

The FDA has previously acknowledged Delphi-MD’s technology, granting it Breakthrough Designation Technology status twice. First, for its ability to identify patients at risk of dementia and stroke, and subsequently, for diagnosing patients with NPH and predicting their response to effective treatment with ventriculoperitoneal shunting (VPS) surgery.

NPH is a highly treatable type of dementia primarily characterized by a movement disorder. The simple implementation of a VPS shunt is performed to relieve Cerebral Spinal Fluid (CSF) pressure buildup in the brain cavities, significantly delaying disease progression and improving patients’ health condition. Delphi-MD’s objective, automated technological approach facilitates quick and accurate brain health assessments at the point-of-care. This allows for the precise identification of NPH patients and those who can benefit from VPS surgery. The device operates within a collaborative care model, shortening the diagnosis phase for patients, personalizing their treatment, reducing misdiagnosis rates and care costs, as well as enhancing patients’ well-being.

“An NPH diagnostic test will become simple and accessible for the first time, and undetected and untreated patients will be able to benefit from an effective shunt (VPS) treatment,” said Dr. Rick Kuntz, Former Senior Vice President and President of Neuromodulation, Chief Medical and Scientific Officer at Medtronic.

The Total Life Cycle Advisory Program aims to guide innovative technologies through the entire product life cycle, ensuring regulatory compliance, market adoption, and enhanced positive patient impact. The valuable experience and insights within this program are expected to accelerate QuantalX’s market entry and establish a solid foundation for future growth.

 

Exhibitor Data Sheet