Mainstay Medical has passed an "important milestone" on winning access to the key US market for its new implant therapy for people suffering from chronic lower back pain.
The Irish company is running a clinical trial for its implantable Reactiv8 device to gather data as part of its programme to apply for premarket approval from the US regulator, the Food and Drug Administration (FDA).
An interim analysis of the first 58 patients to complete the trial indicates that there are no safety concerns with the device, which is designed to stimulate nerves to strengthen muscles in the lower back, whose weakness is associated with debilitating chronic lower back pain.
The interim analysis is a first success for Jason Hannon, who succeeded Peter Crosby as chief executive in October. Davy analyst Andrew Young described the news as an "important milestone" for the company.
Mr Hannon, a former chief operating officer and president at NuVasive, a US company specialising in minimally-invasive surgical solutions for spinal surgery, has been brought in to ramp up the commercialisation of the Reactiv8 device, which is currently being used in Germany and Ireland following European approval.
Clinical trial
The company is targeting entry to the Swiss market where it has an existing reimbursement arrangement, and is also in discussions to introduce the device on a commercial basis in both Australia and the UK.
Several sites in both countries are involved in enrolling patients for the current clinical trial, Mr Hannon noted.
Mr Hannon said the company would be investing heavily in educating medical practitioners on the potential for its device. This involves several groups in hospitals, reimbursement authorities, and local GPs dealing with patients suffering chronic lower back pain.
Mainstay will also invest in the commercial infrastructure necessary to expand existing and new markets and to prepare for expansion into the US, the company said.
Further fundraising is likely though the company noted that, at the end of November, it had $12.7 million in cash at hand.
The independent committee monitoring the trial data has now recommended that 168 patients need to be enrolled in the trial – down from a potential maximum of 232 patients but ahead of the 128 notified previously. Of that, 133 have now been enrolled on a trial that covers 120 days from the date the neuromodulation device is implanted.
The company expects to be fully enrolled by the end of the second quarter of next year and to have full data on the study by year end.
