Medical device firm Mainstay Medical is focusing on entry to the US market after a year that saw it bring its implantable device for sufferers of chronic back pain to market.
The company is currently enrolling patients for a clinical trial across multiple sites in the US and hopes the have results from the exercise next year. Enrolment is expected to be completed by the end of the year.
Mainstay, which is headquartered in Ireland and listed in both Dublin and Paris, saw the first of its devices implanted on a commercial basis earlier this year in Germany. A number of similar procedures have been completed since.
The company says it intends to focus commercially on Germany for the time being as it has reimbursement arrangements in place. It has similar arrangements in place in Austria and Switzerland but has not launched commercial operations in either country yet.
Mainstay’s Reactiv8 product is designed to treat chronic lower back pain by sending electrical impulses to stimulate nerves working muscles critical to stability in the lower back area which may have been weakened by a previous injury.
In its annual report, published Thursday, Mainstay said operating expenses had risen by $3.9 million last year to $16.8 million as it kicked off its clinical trial in the US and began commercialising the product in Europe.
Following a €30 million private placement in June last year, the company ended 2016 with cash of $36.7 million.
Chief executive Peter Crosby said the company's current cash would see it complete enrolment in the US clinical trial and possibly as far as delivering results from that exercise. However, it will plan further fundraising to scale up the commercialisation of Reactiv8.
“New markets will take new capital,” Mr Crosby said, adding that the priority for now is that the company hit its milestones.
Approval in the US market is unlikely before some time in 2019 or 2020 on current FDA timelines. The company is also pursuing approval in Australia which could come through in early 2018.
“The initial focus of our European commercial activities for Reactiv8 is on Germany where we aim to drive adoption of Reactiv8 in a select number of high volume multidisciplinary spine care centres,” said chairman Oern Stuge in the annual report.
“As we gain experience and momentum, and as we identify other early opportunities to build our business, we will consider expansion to other sites and countries.”
Mainstay Medical estimates that as many as two million patients in the US and western Europe could benefit from its therapy, giving it a potential market of up to $30 billion.
The major shareholders in the business are venture capital investors Soffinova and Dublin-based with Fountain Healthcare Partners alongside family investment firm KCK and Dan Sachs, the American doctor who first patented the idea that became Reactiv8. between them, they own just over 70 per cent of the stock.
