Mainstay Medical, the Dublin healthcare firm on the verge of a breakthrough in chronic back pain treatment, is considering a further round of fundraising as it prepares its main product for market.
Chief executive Peter Crosby said yesterday that the company may need more financing and is exploring ways of how it might source it.
However, he declined to put a timeframe on when that may be enacted.
Just last week, Mainstay announced it secured $15m (€13m) in debt financing from European healthcare-focused financier IPF Partners, which will go towards funding Mainstay’s upcoming US clinical trials for its ReActiv8 product and pushing the treatment towards commercialisation in Europe.
The latter target yesterday received a huge boost, with the results of European market clinical trials showing, as Mr Crosby put it, “this thing works”.
Mainstay’s flagship product is an implantable device which sufferers of chronic back pain can receive via a simple medical procedure and then activate twice daily to treat their condition.
It has been described as being akin to a pacemaker for the back.
The product is being viewed as a potential breakthrough for the world’s 2m sufferers of chronic back pain.
The results of the European clinical trials returned high percentages, up to 72% in some cases, of subjects reporting usage of ReActiv8 brought a clinically important improvement in quality of life.
Mainstay is now set to apply for CE Marking, a sign a product meets European regulatory directives, which it hopes to receive by the end of this year.
It remains hopeful of bringing the product to market in Europe next year.
Full commerciality in the US is likely to take a little longer, as the company is only in the process of preparing for clinical trials there.
“We are excited that our unique approach to treating this type of chronic low back pain offers the potential to change the lives of millions of people, worldwide, who have no effective treatment alternative,” said Mr Crosby.
Mainstay yesterday published its financial update for the first half of 2015, which showed losses per share of $1.48 for the period, down from $3.54 for the same period last year.
Total assets were worth $13.2m as of the end of June, and cash on hand amounted to $12.5m.
First half operating expenses amounted to $6.3m, up by $1.5m on a year-on-year basis due to costs associated with increased activity in clinical trial activity.
On a formal outlook, the company said it “looks forward to continuing to work towards obtaining CE Mark and commencing commercialisation in Europe”.
© Irish Examiner Ltd. All rights reserved