Mainstay Medical pushes ahead with plans to bring back pain device to market
Irish medical firm Mainstay Medical has taken a step towards commercialising its breakthrough treatment for chronic back pain after reporting promising results from a clinical trial.
The Dublin-based company is currently looking to develop its ReActiv8 implantable device product for sufferers of back pain.
Operating expenses at the firm, which is currently at a pre-revenue stage, rose to $6.3m in the six months to the end of June compared to $4.8m for the corresponding period the year before.
This increase was mainly due to a rise in clinical and regulatory expenses relate to the ReActiv8-A clinical trial.
Results for the trial, which are based on data from the first 47 back pain sufferers to be implanted with the device, show that of the 90 day follow up period 63pc reported a clinically important improvement in pain.
57pc of respondents reported a clinically important improvement in disability while 67pc saw a clinically important improvement in quality of life.
The company is now to start a ReActiv8-B clinical trial. If results from this are positive, the company plans to submit an application for a pre-market approval, which is required to allow the start of commercialization in the United States. The firm is also looking to roll out the product across Europe.
Earlier this month Mainstay announced that it has secured $15m in debt financing to help with the commercialisation of ReActiv8. So far an initial tranche of $4.5m has been called.
Mainstay chief executive Peter Crosby said: “The results from the ReActiv8-A trial show improvements which are better than any other therapy for this group of people as reported in the literature.
“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.”