The competition focused exclusively on medical devices for pediatric orthopedics and spine, a sector that the FDA identified as an emerging underserved specialty lacking innovation.
“We share the Consortium’s passion for improving the care of children needing orthopedic and spinal treatment, said Dan Sands, Director and CEO of AMB Surgical. “We’re confident our FLYTE™ automated growing rod will improve the treatment of children, and look forward to working with MedTech Innovator and their partners to help bring FLYTE to market.”
AMB Surgical was founded and named after Ashley Mae Burnett who was diagnosed with scoliosis when she was five years old. Her father, Casel Burnett, a talented mechanical engineer and his friend Tyson Ross, a Ph. D. in electrical engineering, envisioned a better solution than multiple high risk surgeries to treat Ashley’s condition.
AMB Surgical’s groundbreaking patented technology, FLYTE, is intended to reduce the necessity for invasive and repetitive surgery in children and teens with orthopedic deformities such as scoliosis and limb abnormalities. The key to FLYTE is the innovative combination of miniature gearing, power, sensors and wireless communication technology located inside the device. FLYTE is controlled remotely by a software application that programs the device, makes surgeon-programmed adjustments, records and monitors real-time biomechanical information over the course of treatment. FLYTE has the promise to significantly reduce the number of surgeries and cost while improving patient outcomes.
Awarding a total of $250,000 in grant funding to the winners, NCC-PDI is one of five FDA Pediatric Device Consortia grant programs that support the development and commercialization of pediatric medical devices. NCC-PDI is led by the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Health System and the A. James Clark School of Engineering at the University of Maryland. The consortium recently added new accelerators BioHealth Innovation and MedTech Innovator and design firm partner, Smithwise.
“We’re proud to name AMB Surgical one of our 2019 pitch competition winners and welcome them to NCC-PDI’s portfolio of companies,” says Kolaleh Eskandanian, Ph.D., MBA, PMP, vice president and chief innovation officer at Children’s National and principal investigator of NCC-PDI. “This marks the beginning of our relationship as we prepare to wrap our network around AMB Surgical to accelerate the process of bringing FLYTE to market and advancing care in pediatric orthopedics and spine.”
With a goal of advancing the development of pediatric medical devices, this was NCC-PDI’s eighth competition in six years. All winning innovators receive mentorship and support through NCC-PDI’s network of experts, consisting of medtech executives, investors, specialty pediatricians and FDA regulatory and business consultants. To date, the consortium has supported 94 pediatric medical devices and helped five companies receive FDA or CE mark regulatory clearance.
To learn more about AMB, visit www.AMBsurgical.com.