Dublin, Ireland-based Mainstay Medical reported its full-year 2016 results.
The company is currently working to bring ReActiv8, a restorative neurostimulation system for chronic low back pain, to market.
Here are eight updates:
1. The company's operating expenses totaled $16.8 million for FY 2016.
2. Mainstay Medical's 2016 operating cash outflows were $16.7 million.
3. The company completed a private placement of about $33.7 million via a placement of 2.31 million new ordinary shares with new and existing shareholders, on June 27, 2016.
4. By Dec. 31, 2016, cash on hand totaled $36.7 million.
5. Mainstay Medical began ReActiv8-B clinical trial enrollment in September 2016, implanting the first device in October. The company hopes to gain FDA pre-market approval.
6. The clinical trial now encompasses 27 sites, with a total of 75 participants. The company expects complete enrollment at the end of 2017, and will release data in 2018.
7. Mainstay Medical sold its first ReActiv8 system in Germany in February 2017.
8. The company applied for Australian regulatory approval in January 2017.