Remember bending down and touching your toes during your middle school physical? For some, it’s kind of a right of passage, a shared experience, an opportunity to share in mutual mortification. All kidding aside, it’s also an essential diagnostic for discovering Scoliosis, which often presents itself in children 10-12 years old. According to Johns Hopkins, “Scoliosis is a common spine condition… Roughly 3 million new cases of the condition are diagnosed in the United States each year.”
Traditional Approaches
Scoliosis is a curvature in the spine that often resembles an “S” or “C” shape. The approach to treating Scoliosis varies according to age, the extent of the curve, and its potential for progression. For some, Scoliosis may be so significant that it greatly impacts their quality of life, affecting posture, mobility, and, even more seriously, respiratory function. While some individuals don’t require any intervention at all, others require spinal surgery and continual, invasive adjustments.
Auctus Surgical co-founders CEO John Ashley, Chief Science Officer Dr. Murali Kadaba, and Vice President of R&D Damien Shulock are addressing these challenges head-on. Together, they have developed novel technologies focusing on non-fusion scoliosis correction.
Unlike traditional fusion surgeries that limit spinal motion, Auctus focuses on preserving mobility through its dynamic vertebral body tethering system. This modern approach allows for non-surgical, dynamic adjustments of implants over time, catering specifically to the unique needs of pediatric patients whose bodies are still growing.
The Evolution of Spine Treatments
Ashley explains, “If you look back historically, even 25 years ago, pretty much all spine surgery was fusion surgery. If you had a problem with your spine, they’d find out where in the spine it was, and they would try to fuse that section of the spine so that two or three or more segments grew into one segment. You lost some mobility, but the underlying theory was no movement, no pain.”
Ashley adds, “With children, there really haven’t been any solutions but fusion until a little less than a decade ago.” More recently, there was a move towards preserving spinal motion. This involved limiting motion in one direction or replacing damaged parts with artificial ones, similar to artificial hips or knees. Some products prevent forward bending while allowing side-to-side and backward movement, or vice versa, depending on where the pain originates. “Unfortunately, these advancements primarily cater to adults.”
Ashley explains that one company developed a flexible cord to try to pull the spine straight while still allowing other movements. “They could still bend forward and back and twist. That’s been out there now for a while; about 2500 children around the globe have had this treatment, But it has limitations. All the clinical literature shows that 35% of the patients who get that treatment have a complication. The device either breaks or their spine overgrows and starts curving the other way.”
Auctus Surgical’s Features
Their solution addresses these limitations head-on. They use adjustable magnetic implants. “Our system allows for dynamic adjustments without the need for additional surgeries.” This not only enhances patient comfort but also mitigates the risk of complications often associated with spinal surgeries and surgery in general. Auctus Surgical’s solution is also significantly stronger and more durable than the competition because of its superior materials, which are perfect for this indication.
Another key feature of Auctus Surgical’s solution is children can receive immediate adjustments in the doctor’s office to address issues like length, tightness, or looseness, which leads to better outcomes without delay. “All they have to do is go to their doctor, get an x-ray and then they get it adjusted. No lengthy wait times. No painful and dangerous surgeries every time an adjustment is needed.”
FDA Approval
The team at Auctus Surgical has been focused on moving this product forward for several years now. “We understand that in order to commercialize it and start sales, the FDA is going to require a clinical study.” The team plans to start treating a group of children and subsequently monitor them for two years to collect efficacy data for submission to the FDA. While that process adheres to a fixed timeline, they are making continued efforts to expedite it, including ongoing engagement with pediatric surgeons to gather input and ensure that the product aligns with both their requirements and the needs of the children.
Additionally, simulated use of the product has been conducted in cadaver labs. The FDA has also recognized the importance of Auctus Surgical’s product, designating it a Breakthrough Device, which accelerates their formal review process.
At the heart of Auctus Surgical’s endeavor lies a deep commitment to its customers. Recognizing the diverse stakeholders involved in the decision-making process, the company adopts a multifaceted approach to outreach. While children with Scoliosis are the primary beneficiaries of their innovation, parental advocacy plays a pivotal role in driving awareness and adoption of Auctus’ solution. More importantly, they are focused on educating pediatric orthopedic surgeons and neurosurgeons who serve as trusted advisors, guiding families through treatment decision-making.
Traction So Far
Thus far, Auctus’ modern solution is garnering a lot of support, including being selected as the Best New Spine Technology in 2020, partnerships with spine surgeon investors, and involvement in various cohorts such as Beta University 2024, UC Berkeley SkyDeck Pad-13 2023, and UCSF Rosenman Innovator 2023. They are also a portfolio company of the Seattle Incubator IntuitiveX.
Additionally, Auctus Surgical received recognition from the National Capital Consortium for Pediatric Device Innovation in 2019 and multiple wins at UCSF/Stanford Pediatric Pitch competitions in 2022, 2020, and 2018, totaling $250k.
Kids everywhere should be celebrating. There is no need for nightmares about traction, bedrest, and back braces prior to their middle school scoliosis screening! Auctus Surgical’s dynamic vertebral body tethering system represents a leap forward in pediatric scoliosis treatment. By embracing innovation, they are paving the way for a brighter future, where children can rest easy and thrive unencumbered by the limitations of a spinal disorder.