There are not many things as heartwarming as watching a playground full of children joyfully running, jumping, climbing, smiling, laughing, and playing. Unfortunately, for more than 3 million children who are diagnosed and treated for scoliosis each year, running and playing are often limited, and 63% of them fight pain daily.
"I personally think that children with this problem deserve to get a treatment where they continue to have the capabilities to live the same active lifestyle as their peers who don't have the problem," shares Co-founder and CEO of Auctus Surgical, John Ashley.
Traditional treatments for treating the curvature of the spine present almost as many challenges and certainly just as much discomfort as the disorder itself. Typically, a child diagnosed with scoliosis is first advised to try exercises or stretches. If the curvature progresses, the doctor will often prescribe a torso brace. Ashley explains, "All current surgical options require that the child either fails brace treatment or is ineligible for it. The brace is tried first, usually for a period ranging from months to over a year, to prevent further curvature. Everyone involved—the child, parents, and doctor—hopes to avoid surgery. The brace's primary function is to prevent worsening of the spine, not to straighten it and it has limited efficacy in correcting curvature," emphasizes Ashley.
Approximately 20% of children who wear a brace still experience worsening of their condition to the point where surgery is needed. Surgery not only aims to straighten the spine for improved appearance and mobility but also addresses critical internal functions. A severely curved spine can compress internal organs, affecting lung, heart, and digestive health. Straightening the spine is crucial to ensure there is adequate space for these organs to function properly and develop normally.
"Unfortunately, these children often experience limited mobility due to spinal fusion, invasive procedures requiring multiple surgeries and significant risks of complications such as infection and hardware failure." These treatments can severely impact a patient's quality of life and necessitate prolonged recovery periods and rehabilitation. In worst-case scenarios, patients may suffer from irreversible damage, leading to lifelong disability and chronic pain.
Fortunately, innovators like Ashley and the team at Auctus Surgical have developed a vertebral body tethering system that preserves spinal flexibility and allows for non-surgical, in-office adjustments using adjustable magnetic implants. This approach reduces the need for multiple surgeries and minimizes risks. Made of durable and safe materials, Auctus Surgical's solution also decreases the likelihood of hardware failure. By accommodating children's continued growth and maintaining mobility, Auctus Surgical's system offers a more effective and less invasive solution that can significantly improve patient outcomes and quality of life.
The team at Auctus Surgical has engaged the FDA and secured a breakthrough device designation for an expedited approval process. They've also conducted rigorous pre-clinical testing and engaged pediatric orthopedic surgeons and neurosurgeons for continued product refinement. Likewise, they have formed partnerships with institutions like UC Berkeley SkyDeck and Seattle's IntuitiveX incubator to bolster their developmental traction.
The market for scoliosis treatment presents vast opportunities, with segments ranging from adolescents all the way to adults totaling billions in potential revenue. There are 25,000 adolescents with severe curvature ($750M in potential revenue), 15,000 young adults with similar conditions ($450M), and 100,000 new patients ($2.5B in potential revenue). The total US market is valued at $3.7B, while the global TAM is $6B. These figures highlight a substantial market need for Auctus Surgical's innovative treatments targeting debilitating spine curvature.
Auctus Surgical is at the forefront of transforming the lives of those diagnosed with scoliosis. With FDA support, strategic alliances and a clear market strategy, Auctus is on its way to making a profound impact, improving patient outcomes and enhancing quality of life.
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