Mighty Oak Medical: Redefining Precision in Spinal Navigation
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Heidi Frey, President and Brent Ness, COO In an era of increasing technological prowess, advanced surgical procedures are now a societal and medical norm. What hasn’t changed over the decades is the need for precision in the operating room (OR). With accuracy being essential to patient safety, spine surgeons are ushering complicated and expensive navigation equipment into the OR, which in turn brings along its share of challenges. Mighty Oak found it counter intuitive that the prevailing approach to spinal navigation added layers of complexity to the surgery to avoid complications from the surgery; drawing on surgeon experience, they developed an alternative technology platform for spinal navigation that enhances accuracy and precision while reducing complexity and expense. Since their novel patient-specific navigation solution is both simple and easy-to-use, they created a tagline to go with it: “Navigate. Don’t complicate.”
With today’s pressures on cost, and the need to avoid nascent or “fad” technologies that quickly become obsolete, FIREFLY® Technology from Mighty Oak Medical is perhaps the best option for surgeons and hospitals. Where current capital-intensive navigation technologies zig with million dollar price tags and multi-year maintenance contracts, the patented FIREFLY® patient-specific Technology zags by offering unsurpassed accuracy with a 3D printed disposable guide at a fraction of the price. With this type of purchasing flexibility, hospitals, surgeons, and patients worldwide can have access to a cutting-edge technology that reduces the risk of misplaced pedicle screws and, at the same time, improves operating room efficiencies and eliminates scheduling conflicts. “FIREFLY® creates a benchmark for safety with zero technological obsolescence risk and zero capital dollars required,” explains Heidi Frey, President of Mighty Oak Medical.
Patient-Specific Surgical Navigation
The surgical navigation solutions space has been experiencing rapid growth with the introduction of innovative technology such as robotic drill guides, new forms of image guided surgery, and augmented reality. Though the need for navigation solutions is well-established within the spine surgery community, and the benefits of navigation well-documented, there remains a considerable gap between acceptance and adoption of such techniques. The gap is often attributed to the learning curve, the upfront cost, and the inevitability of complex equipment slowing down the surgery. Colorado-based Mighty Oak Medical addresses this gap with the minimal learning curve for FIREFLY®, per use pricing, and the ability to increase OR efficiency with concierge pre-surgical planning. The convergence of improved CT scanners, advances in 3D printing, and 3D software that can create the patient’s spine in a virtual realm establish the building blocks of the prize-winning FIREFLY® platform. Mighty Oak Medical provides concierge pre-surgical planning whereby the surgeon has the support of a team of skilled engineers using the data to provide detailed information about the anatomy, the surgeon-approved trajectories and the recommended screw sizes prior to even entering the OR.
“Utilizing those powerful building blocks, we have been able to move the complexity out of the OR and have the imaging and analytics take place before the surgery – effectively allowing the surgeon to ‘dry run’ the surgery ahead of time. This reduces the stress on the surgeon and staff intraoperatively, and typically reduces screw placement time,” says Frey.
Unlike other trending expensive and complex solutions, FIREFLY® was specifically designed to be simple, easy to use, and affordable, while advancing accuracy. “Most spinal navigation equipment is in the million dollar range, making it impractical for hospitals that don’t do enough spine surgery to justify it, or do so much that they would need to buy several machines. There is no one-size-fits-all navigation solution. We believe that navigation must be a menu of options, and that FIREFLY® has secured its place on the menu,” explains Frey.
FIREFLY® Technology uses 3D printing to create patient-specific guides for each vertebral level to be instrumented, and also provides an autoclavable 3D printed replica bone model of every patient’s spine so surgeons can practice the placement of the guides and do a simulation of the screw placement portion of the surgery. They can also develop a detailed understanding of critical anatomical considerations in deformity and revision surgeries, allowing them to perform the surgery more efficiently and accurately.
FIREFLY® also addresses the daunting challenge of surgeon and staff exposure to radiation during the intraoperative use of medical scanning equipment. Mighty Oak’s FDA clearance does not require the use of any form of intraoperative radiation with FIREFLY®. That makes it an excellent alternative for a surgeon who wishes to minimize daily exposure to radiation from C-arms, and some FIREFLY® users don’t even bring a C-arm into the room during screw placement. “The ionizing radiation that surgeons use to take these intraoperative images is harmful to everyone present including the patient, and causes a lifetime exposure risk contributing to certain cancers. Surgeons and their staff wear lead vests and other gear to protect against the radiation, but it is awkward and heavy and contributes to fatigue and back pain. Being able to “shed the lead” is one of the many advantages of FIREFLY®,” explains Brent Ness, Chief Operating Officer at Mighty Oak Medical.
Reaping the Results…Faster, Easier, And Less Radiation
Mighty Oak routinely gets feedback that FIREFLY® has contributed to faster screw placement, and is proud to be bucking the prevailing sentiment that navigation slows surgeries down. Ness sometimes attends first surgeries and shared the story of a surgeon at a well-known academic center who indicated that he had saved more than 90 minutes with FIREFLY® versus his traditional technique on a complex deformity case. The surgeon noted that screw placement was less tedious, and left him with more energy for the remainder of the surgery. He also appreciated the dramatic reduction in fluoro use, and the ability to get the patient out of the OR faster, which has many proven benefits. “Our surgeon feedback tends to be very positive, even at the outset, reflecting the fact that we practice our mantra of simplifying the surgery. We have successfully navigated more than 6,500 pedicle screws with no adverse event,” says Ness.
Mighty Oak Medical was founded in August 2011 by Dr. George Frey, a spine surgeon who was already a successful inventor of other widely used spinal technologies. Created as a spinal device incubator, Mighty Oak quickly focused the team on patient specific technologies after winning the prestigious Spine Technology Award in 2012. The technology has matured over the years, and other types of guides have recently been introduced by Mighty Oak and cleared by the FDA, including cortical guides and S2AI guides. Their cortical guides are used with a mini-open approach, and their S2AI guides are helping surgeons master a challenging trajectory that crosses the sacroiliac joint. “Our expertise in 3D printed solutions for spinal surgeries enable us to continuously improve and expand our offerings and redefine the market in terms of innovation and responsiveness,” notes Ness.
Mighty Oak Medical’s philosophy hasn’t changed over the years: solve problems for surgeons, and improve surgical safety in a way that is cost-effective, efficient and patient-centered. What has changed is its significance and reputation. FIREFLY® is now available in some of the most prestigious hospitals in the country and is being used by some of the most highly regarded spine surgeons. Mighty Oak partnered with OrthoPediatrics in 2018 and their arrangement gives OrthoPediatrics exclusive distribution rights for FIREFLY® in dedicated pediatric facilities in the US. In return, Mighty Oak got a top-notch sales force and accelerated growth. By the end of 2018, Mighty Oak had experienced 150 percent YoY growth and is poised for more blockbuster growth in 2019. FIREFLY® is compatible with virtually all screw systems, and the relationship with OrthoPediatrics has not changed that important optionality. “With FIREFLY®, the surgeon can choose the implant that they think is best-suited for the surgery,” adds Frey.
Health care economics always has a significant impact on which medical devices will become both widely available and commercially successful. By transcending such obstacles as million dollar price tags, expensive multi-year maintenance agreements and unavoidable technological obsolescence, FIREFLY® holds a sweet spot in this realm. It is also slated to have CATEGORY III CPT codes go into effect in July of 2019. Mighty Oak’s talented engineering staff is focused on the burgeoning number of surgeries it has in its pipeline today, as well as on process and product improvements to support an exponentially larger pipeline in the future. FIREFLY® already has a growing presence in Australia and New Zealand. Having received its CE Mark, Europe is the next frontier for FIREFLY®, and European surgeons have already been requesting access. “We are excited to see FIREFLY® move through the stages of becoming ‘standard of care.’ Navigation for challenging spinal surgeries needs to be accessible worldwide, and FIREFLY® is emerging as the go-to global solution,” concludes Frey.
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