- In a world-first, start-up Kitea Health has successfully implanted a chip under an Auckland patient’s skull that will monitor fluid pressure - part of a trial that will expand to 20 patients.
- The startup is now seeking $20m in a Series A raise, which will help fund a wider trial involving 150 patients across NZ and the US, with the goal of gaining FDA approval in around a couple of years.
- Kitea Health - seeking private money for its latest round, now that its human trials are established - has previously secured around $14m in taxpayer funding (plus around $6m from private investors) but co-founder and CEO Simon Malpas says he’s worried about recent cuts to R&D, science and startup-boosting programmes, which could limit the ability of other early-stage companies to follow in his firm’s footsteps.
In a major medical breakthrough, one of Kitea Health’s fluid-pressure monitoring chips has been implanted in a human brain for the first time. The technology has previously been trialled on sheep.Kitea co-founder and CEO Simon Malpas says, “This is the first time that a fully untethered microcomputer has been implanted into the human brain. We are thrilled to initiate trials for this pioneering brain implant in Auckland.”
The procedure was carried out at Auckland City Hospital by a team led by neurosurgeon Dr Peter Heppner. The patient’s identity has been kept under wraps for privacy reasons.
Kitea’s chip is designed to measure fluid pressure on the heart or brain - which could be the result of a genetic condition, heart failure, or trauma such as a car crash or stroke.
A “wand” is used to take wireless pressure readings from the chip. It only takes 15 seconds, and involves nothing more complicated than holding the wand within a few centimetres of your (or our child’s) head. Readings are diarised in an app to reveal trends. Encrypted data can be shared with a doctor via the cloud. It can all be done daily from home.
The first implant took place around three weeks ago. With all having gone to plan, a wider train till now take place over the next three months, involving 10 children and 10 adults - all suffering a condition called hydrocephalus, which causes a build-up of fluid in ventricles deep within the human brain.
The next step will be a wider trial involving 150 people across New Zealand and the United States, with the aim of gaining full regulatory approval from the US Food and Drug Administration (a key regulator, from which many others take their lead) in around two years.
In serious cases, hydrocephalus can lead to learning disabilities or even death.
Treatment involves placement of a tube, known as a shunt, into a ventricle of the brain to drain the excess fluid.
Patients with hydrocephalus already have a hole drilled into their skull for pressure-relieving pressure Kitea’s chip is inserted into the cortex (the brain’s outermost layer) with a syringe that reaches through same hole - with the implant taking place at the same time the shunt is installed, avoiding the need for a separate major surgery.
The sensor-chip has two major benefits.
Malpas says the first is that shunts frequently fail. Kitea’s chip can detect can detect health or even life-threatening fluid pressure buildup before symptoms like nausea appear.
