Traumatic brain injury and stroke is a major cause of death and disability worldwide. Those who survive can face effects lasting a few days to disabilities which may last the rest of their lives, including impaired memory, movement, sensation and emotional functioning. Despite significant advances in treating brain injuries, there is no reliable diagnostic and monitoring method for first responders and emergency room physicians.
Increased intracranial pressure (ISP) is seen in head trauma, and rapid recognition and monitoring is important for directed therapies to be initiated. However, this monitoring currently requires a neurosurgeon to drill a hole into the patient’s skull, and as a consequence ICP assessment has been limited to brain injury patients in neuro-critical care units. This limited access results in delays to treatment, affecting outcomes and significantly increase costs.
The Los Angeles-based startup Neural Analytics has developed a quantitative assessment system for the early detection of stroke and traumatic brain injury. Their system, Lucid M1 Transcranial Doppler Ultrasound System, is a noninvasive, portable and inexpensive brain monitoring tool that measure intracranial pressure following brain injury. The system consists a battery operated medical grade tablet and a headset that uses a type of ultrasound called Transcranial Doppler. When attached to a patient suspected of having traumatic brain injury, the ultrasound device analyzes blood flow in the brain. As the heart pumps, the corresponding blood flow has slight variation from beat to beat. This data is recorded and analyzed by a proprietary algorithm, providing a noninvasive measure of ICP that can be performed in the physician’s office allowing them to quickly scan the brain for subtle damage or changes.
Each year, more than 30 million people are affected by severe blood flow disorders worldwide, with traumatic brain injury and stroke contributing the most to the global disease burden. Current monitoring techniques require surgery and are expensive with an estimated cost of more than $10,000 per patient. However, less than 40% of severe traumatic brain injury patients receive the ICP monitoring they need, and there is a critical and immediate need for an accurate screening technique for patients to help eliminate misdiagnosis and incorrect treatments. Neural Analytics has developed a noninvasive, portable system that will increase access to brain injury monitoring. It is expected that the innovative technology will cost less than $100 per use, which could result in $250 million in saving each year to the healthcare system in the US alone.
The startup could revolutionize care for all patients suffering from blood flow disorders. They provide a reliable and accurate diagnostic system for early detection of brain injuries, allowing early administration of medications and other interventions to prevent rising intracranial pressure. The objective measures of the system not only allow assessment of the injury, but also the ability to monitor treatment efficacy, improving treatment outcomes, accelerating recovery, and potentially saving lives.
Neural Analytics was founded in 2013 and has been awarded grants from the National Institutes of Health and the National Science Foundation. In 2015, the startup announced they had secured $10 million in Series A financing with investors including JSR Limited and Taiyu Capital, a subsidiary of TigerMed, adding to their $3 million seed financing from UCLA VC fund. Neural Analytics in November, 2016 announced they had received 510(k) clearance from the FDA for their innovative ultrasound device system, and later that month announced the commercial launch.