FDA Grants Breakthrough Designation to QuantalX for Normal Pressure Hydrocephalus Diagnosis and Treatment Response Prediction
Wednesday, May 31, 2023
QuantalX, an innovative developer of neurodiagnostic devices, announced that its Delphi-MD device has been granted FDA breakthrough designation for the diagnosis of Normal Pressure Hydrocephalus (NPH) and the prediction of treatment response to ventriculoperitoneal shunting surgery (VPS). This breakthrough designation recognizes the device's potential in revolutionizing the diagnosis of NPH patients and determining the effectiveness of VPS surgery as a treatment.
NPH is a neurological condition characterized by disturbances in cerebrospinal fluid dynamics, leading to symptoms such as difficulty in walking and balancing, urinary disturbances, and cognitive decline. Despite affecting around 2% of people over the age of 65, NPH often goes undetected due to the invasive and challenging nature of the current diagnostic procedures. NPH is a progressive condition that can be successfully treated, especially when identified early, through the implantation of a ventriculoperitoneal shunt.
The existing diagnostic procedure for NPH involves a complex assessment, including cognitive evaluation, brain imaging (MRI or CT scan), and an invasive spinal cerebrospinal fluid withdrawal (CSF tap test). This procedure requires specialized expertise and facilities, with potential risks and complications, while also lacking the ability to reliably identify patients who would benefit most from VPS surgery.
The Delphi-MD device by QuantalX is a breakthrough neurodiagnostic device that offers physicians accessible and accurate point-of-care capabilities, resulting in improved brain health outcomes and enhanced patient care. The FDA's grant of breakthrough designation for the device is based on promising preliminary clinical data, demonstrating its superiority over the current standard-of-care diagnostic procedures for NPH diagnosis and treatment response prediction.
This is the second time that the Delphi-MD device has received breakthrough designation by the FDA. In June 2021, the device was granted this status for its ability to detect patients at risk for dementia and stroke, enabling early identification of structural and functional brain abnormalities associated with these conditions. With the FDA's latest breakthrough designation for NPH, the Delphi-MD device expands its value by providing an accessible and reliable tool that streamlines the diagnostic process, improves treatment selection, facilitates early intervention, and ultimately enhances the quality of life
for individuals in need.
Dr. Iftach Dolev, CEO and Co-Founder of QuantalX, expressed the company's excitement about the breakthrough designation and its commitment to providing reliable tools for improved brain diagnosis and personalized patient care. Dr. Rick Kuntz, Former Senior Vice President and President of Neuromodulation and Chief Medical and Scientific Officer at Medtronic, emphasized the significance of the Delphi-MD device in making NPH diagnosis accessible, enabling effective shunt treatment for previously undetected and untreated patients.
The FDA's breakthrough designation for the Delphi-MD device signifies a major advancement in the diagnosis and treatment of NPH. By offering a non-invasive, accessible, and accurate solution, the device has the potential to significantly improve patient outcomes, increase the number of accurately diagnosed cases, and ensure that those who can benefit from VPS surgery receive appropriate treatment.