Market Moves

CereGate raises Series C for a Parkinson's walking therapy

Some people with Parkinson’s disease stop dead mid-stride, their feet feeling glued to the floor, often as they turn or pass through a doorway. This freezing of gait raises the risk of falls, and it can persist despite medication and deep brain stimulation, in which an implant sends electrical pulses into the brain. On 14 October CereGate, a Munich company developing a therapy for these patients that runs on implants they already have, said an unnamed US medtech company had led its Series C round.

The round

Existing investors, which CereGate did not name, took part, and Impact Ventures of Budapest invested for the first time. Earlier backers include 468 Capital, re.Mind Capital, TruVenturo, Heal Capital, High-Tech Gründerfonds and CARMA Fund.

“We are proud to have won a strategic investor of this calibre,” said Matthias Puls, CereGate’s chief executive. He said the round allows the company to take the therapy through its most important clinical work.

How the therapy works

In CereGate’s US trial, patients keep the conventional stimulation from their existing implant in the subthalamic nucleus, a small brain region commonly stimulated in Parkinson’s, while added bursts of stimulation act as a cue to help them keep walking. CereGate’s software proposes stimulation settings for the clinician to test and helps record each patient’s response. The trial pairs the software with two Boston Scientific programmers, and the software has no control over the implant’s output.

CereGate calls the approach a computer-brain interface: it sends signals into the nervous system through approved implants, which CereGate says reduces the need for further surgery. It says its platform has been tested in more than 85 people. It also conducts research in spinal cord stimulation.

The trial

The study began in April 2022 and is recruiting at seven US centres, including Northwestern University and Vanderbilt University Medical Center. It plans to enrol up to 41 people and has no comparison group: every participant receives the therapy, knows it, and uses it on demand for about 60 days. The main measure is whether walking becomes less irregular on a figure-of-eight course with turns and obstacles, recorded with wearable motion sensors. Main data collection is due to finish in June 2027.

In January 2022, Bálint Várkuti, CereGate’s founder and then chief executive, said several applications of the technology were one to two years from offering patients real clinical solutions. CereGate has not announced regulatory approval for any of them.

Why the lead matters

For now the therapy runs on one company’s hardware. The US trial accepts only patients whose implant is powered by one of two Boston Scientific pulse generators, the implanted units that produce the electrical pulses: Gevia or Genus R16. CereGate says its platform can work with other makers’ hardware and that it has partnerships with medical device companies, without naming them. If the lead investor makes deep brain stimulation systems, the round ties a hardware maker to a therapy that runs on implants already in patients.

Orchestra BioMed is further along a similar route in heart care. Its blood pressure therapy runs on standard pacemakers, its pivotal trial with Medtronic has passed its enrolment target of 316 patients, and Medtronic plans to seek FDA approval if the results are positive.

Not disclosed

CereGate has not named its lead investor or disclosed the size of the round, its valuation, or how much it has raised in total. It has not said whether Boston Scientific led the round or whether the two companies have a commercial agreement. It has not said how many people the US trial has enrolled, published efficacy data, given a timeline for seeking approval, or said what regulatory route it will take. It has not said which conditions its spinal cord stimulation work targets.

CereGate’s position on FDA Breakthrough Device designation, a programme that gives a device closer contact with the regulator and priority review, is unclear. In January 2022 its investor High-Tech Gründerfonds announced that the freezing-of-gait therapy had received it. CereGate’s website describes the company as pursuing that status.

What to watch

Whether CereGate names its lead investor, and whether that company makes deep brain stimulation systems.

Whether the US trial finishes main data collection in June 2027 as estimated, and whether CereGate publishes the gait results.

Whether CereGate clarifies its Breakthrough Device status.

Whether CereGate names a regulatory route and a submission date.

Sources

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