Second FDA Clearance for Patient-Specific 3D-Printed Firefly Pedicle Screw Navigation Guides

Mighty Oak Medical has announced that its patient-specific, 3D-printed Firefly Pedicle Screw Navigation Guides have received a second FDA clearance extending compatibility to essentially all currently cleared pedicle screw systems. The new clearance also extends the indications for use to T1-S2/ilium. By choice, Mighty Oak does not have its own proprietary screw system, and is actively collaborating with strategic channel partners.
 
At the recent NASS meeting, a number of complex navigation options were on display in the $1 million range. With navigation gaining traction as a way to improve screw placement accuracy, surgeon interest is high. But in light of healthcare economics today, it will be a struggle for navigation to become standard of care at a $1 million price point.
 
Firefly Pedicle Screw Navigation Guides are a notable exception to the prevailing complexity and expense of current navigation equipment. The Firefly Technology platform has already received two prestigious Spine Technology Awards for its 3D-printed patient-specific solutions to challenges in spinal surgery, including the one it received last week.
 
Firefly does not require an upfront capital expenditure and is single-use and scalable. It features concierge pre-surgical planning by trained engineers, an autoclavable bone model, predetermined screw sizing, surgeon-approved preselected trajectories, an intraoperative plan, and 3D-printed patient-specific guides to mechanically constrain the drill and tap to follow the preselected trajectories. Firefly is highly accurate and limits intraoperative radiation exposure; in 10 of 14 recent Firefly surgeries, no fluoroscopy was used for drilling, tapping or pedicle screw placement. The system does not disrupt surgical flow and is designed to increase OR efficiency. It is also the only patient-specific pedicle screw guide indicated for use in pediatric patients.
 
Firefly technology should also be able to help hospitals faced with scheduling conflicts for their current navigation systems. By being open platform and compatible with essentially all currently cleared pedicle screw systems, these patented 3D-printed patient-specific guides are an exciting new option on the navigation menu. 
 
According to Brent Ness, the chief operating officer for Mighty Oak and former VP of global sales and marketing for Medtronic Navigation, “Firefly technology is at the epicenter of three strong trends: 3D printing, personalized medicine, and pre-surgical planning. It is uniquely situated to bring navigation to standard of care around the world.”