Just under a year ago GTX Medical posted remarkable early results in paraplegic patients with spinal cord injury, who had regained the ability to walk following treatment with its implantable neurostimulator. The company has today entered a new phase of its development with the acquisition of the US group Neurorecovery Technologies, and hints that more deals could be on the cards.
The deal will create a player unlike any other in the spinal cord injury space, Sjaak Deckers, chief executive of GTX Medical, tells Vantage. “By forming one global company we are the only serious company in this domain,” he says. “We are the only company focusing on neuromodulation.”
Remarkably, considering the wide variety of applications for which neuromodulation is used and the obvious logic of applying it to locomotion, this seems to be true. But clinical data with both GTX’s original technology and the new device it has obtained though the Neurorecovery purchase are limited and early.
Neurorecovery’s tech is, like GTX’s, a neurostimulator. But that is where the similarities end: the Neurorecovery device is non-invasive, transmitting pulses though the skin, and is designed to improve hand and arm function in patients with quadriplegia.
“It’s a relatively simple device,” says Mr Deckers. “You put gel electrodes on the spine and on the iliac crest and by putting this specific current – it’s a combination of high frequency and some stimulation pulses – we’ll be able to improve the rehabilitation of these quadriplegic patients.”
Called transcutaneous spinal cord stimulation (tSCS), a prototype version of the technology is currently in feasibility studies in the US and in the UK, “both to investigate the potential of this device for hand and arm function, also some autonomous functions, and in parallel also to evaluate the usability of the device,” Mr Deckers says.
These feasibility studies will be finished towards the end of this year, after which further iterations of the device will be developed and put through interim and pivotal trials.
“I think that we will need until 2021 or so to get the pivotal started,” Mr Deckers says. A final product will be submitted for an FDA de novo 510(k) clearance, and this approval could come “in the 2022-23 time frame”.
If this schedule holds, the Neurorecovery device will see the light of market before GTX’s own tech.
Called targeted epidural spinal stimulation (Tess), the company’s initial system is in a trial called Stimo. Data on the first three patients in the trial, released last year, were startling, with Tess therapy enabling them to walk again even after the neurostimulator was switched off (GTX Medical must go from breakthrough to break-even, November 22, 2018).
“We have now successfully enrolled seven patients. Six have finished initial therapy and patient number seven is now being trained. Results continue to be very good,” Mr Deckers says, adding that one of the newer patients in the study is showing improvement despite his injury having occurred 14 years previously.
So far the system GTX has been using in its trials has been a tweaked version of a Medtronic device (the company sells several spinal stimulators, all indicated for chronic pain). Mr Deckers says Medtronic is interested in this space and in GTX itself, but GTX owns most of the IP in the spinal cord injury space, so Medtronic is unlikely to pursue this indication with its own devices.
After Stimo concludes at the end of this year or early next, the company will work towards the creation of its own device.
This is “going very well”, Mr Deckers says, but still needs a few more years; clinical trials with a proprietary neuromodulator ought to start in 2021. These will probably be Europe-based, moving to a US pivotal in a few years’ time.
In the meantime the group will have to work on integrating Neurorecovery. Financial terms of the deal are under wraps, though the combined company’s shareholders include LSP, Inkef, Wellington Partners and GIMV. It has also received investment from the Christopher & Dana Reeve Foundation, the biggest spinal cord injury patient organisation in the US.
And Neurorecovery will not be the last purchase GTX makes, according to Mr Deckers. He says GTX intends to work closely with the various academic groups looking at neuromodulation in spinal cord injury with an eye to bringing their research in-house, “instead of them trying to start another company”.
Whether this attempt to head off the creation of competing groups will work is a matter for the future. That is essentially what GTX is doing with the Neurorecovery buy, of course, so today’s venture needs to succeed if GTX is to repeat the trick.