Kitea Health is pleased to announce the commencement of human trials for its novel brain implant. Previously, all brain implants such as brain computer interfaces and stimulators have had electrodes and wires passing from the brain to another implant with batteries and electronics. The research team at Kitea Health have developed a unique approach to create an implant only a few millimetres across and weighing 0.3 gm. This is the world’s first discrete microimplant for the brain and “we are thrilled to initiate trials for this pioneering brain implant in Auckland,” said Professor Simon Malpas CEO of Kitea Health.
The trials, conducted at Auckland City Hospital and led by neurosurgeon Dr Peter Heppner, aim to evaluate the implant’s safety and performance in measuring pressure directly in the brain in hydrocephalus patients. Participants in the trial have had a sensor implanted followed by comprehensive monitoring to assess the sensor’s performance and benefits. All participants are finding value in being able to monitor their own brain pressure at home.
Professor Malpas said this is the first time that a fully untethered microcomputer has been implanted into the human brain. The device is completely wireless, measuring the size of a few grains of rice. The sensor has been inserted into the brain at the same time as the shunt. It didn’t require a separate operation.
The technology will be presented at the upcoming Hydrocephalus Association conference in Tampa Florida. There are an estimated 1 million people living with hydrocephalus in the US.
“The problem is that patients and parents don’t know that a shunt has failed until symptoms start presenting,” says Dr Heppner. “These symptoms can be as familiar as irritability, a headache or nausea – conditions that parents see in their children almost weekly. With no way to determine whether the shunt has failed, parents often rush to the hospital for expensive tests, including CT or MRI scans, to determine whether the life-saving shunt is still working as it’s meant to.” Dr Heppner explains that this leads to enormous anxiety among patients and parents while also leading to an unnecessary strain on the already-stretched healthcare system. “Doctors see false alarms in 70 percent of cases, meaning that those expensive tests are unnecessary more often than not. The families simply go home and wait anxiously for the next time that those tell-tale symptoms present.”
A key focus of the Kitea technology is to allow proactive healthcare for people living with chronic conditions by allowing them to monitor their physiology, in this case brain pressure, from the comfort of their homes. The technology is aimed to help physicians make better treatment decisions in response to what is actually going on. This empowers the patient with greater certainty and allows the healthcare system to operate proactively rather than reacting to symptoms, which may or may not indicate a problem.
“This marks a significant milestone in our quest to develop innovative solutions for better management of neurological disorders,” remarked Dr Sarah-Jane Guild, a scientist involved in the trials. “By leveraging advancements in miniaturization and biocompatible materials, we are poised to usher in a new era of personalized medicine for patients with neurological conditions.”
The commencement of trials in Auckland represents a critical step forward in the global effort to advance neurotechnology and improve patient outcomes.
The milestone of first in human trials has allowed the company to now drive a series A investment round to conduct a pivotal trial followed by regulatory approval.
Contact
Simon Malpas
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