“Breakthrough advancements will revolutionize surgical techniques.”
So says Augmedics on the front page of its official website, a medtech innovation company focused on improving spine surgery using AR technology, headquartered in Chicago, USA, and founded by Nissan Elimelech and Tim Murawski from Israel.
Empowering surgeons with more control in their surgeries by creating advanced technology that meets their needs and adapts to their existing workflows is Augmedics’ mission and why it developed its flagship product, the xvision Spine System, in the first place.
The xvision Spine System is a wearable AR navigation system that allows surgeons to “see through” the patient’s anatomy and accurately navigate surgical instruments and implants during surgery. xvision is designed to revolutionize surgical procedures by instilling technological confidence in the surgical workflow and increasing surgeons’ access to its cutting-edge technology. xvision is designed to revolutionize surgery by instilling technological confidence in the surgical workflow, increasing surgeons’ access to its cutting-edge technology, and helping doctors do their jobs as effectively and safely as possible.
FDA-approved product addresses the “high failure rate” dilemma.
As the population ages, the incidence of degenerative spinal disabilities increases, increasing the need for surgical treatment of these disabling conditions. Demand for spine surgery is showing high growth, supported by rapid advances in minimally invasive surgical techniques. iData Research reports in a paper titled “Spine Surgery Statistics to Watch in 2019 – Motion Preservation Gaining Popularity” shows that in the U.S. alone, approximately 1.62 million instrumented spine surgeries are performed annually.
The high growth in demand is countered by poor outcomes due to a lack of advanced technology. Spine surgeries are one of the fastest-growing categories of surgery, but their high frequency belies the complexity of these procedures and the sometimes unsatisfactory outcomes. The complexity of the local anatomy of the spine and its proximity to vital blood vessels and nerves make spine surgery more demanding in terms of precision. Traditional spine surgery relies heavily on surgeon experience and is prone to problems such as inaccurate screw positioning, high trauma and complications.
The xvision spine system developed by Augmedics effectively solves this problem. in December 2019, Augmedics announced that it received 510(k) approval from the U.S. Food and Drug Administration (FDA) and launched the xvision spine system in the United States.
With xvision, Augmedics has created an AR-based navigation platform that utilizes AR technology to provide surgeons with “x-ray vision” to improve the process and outcomes of spine surgeries. xvision can be used for open and percutaneous spine surgeries in the cervical, thoracic, lumbar, sacral and iliac regions. These procedures include spinal decompression, spinal fusion, discectomy, laminectomy, and pedicle nail fixation. Moreover, xvision is compatible with any spinal pedicle screw implant and any CT scanner used in the procedure. xvision improves the success rate and stability of the procedure, reduces the complexity and difficulty of the procedure, and has unique advantages in terms of shortening the procedure time, improving the efficiency of the procedure, and reducing the risk of the procedure and the exposure to radiation by precisely positioning and navigating the implantation of the spinal screws and other instruments. It has unique advantages in effectively shortening the operation time, improving the operation efficiency, reducing the operation risk and radiation exposure, etc.
Near-eye display helmet + navigation system, providing “X-ray fluoroscopic images” in front of the surgeon’s eyes.
The xvision Spine System consists of a transparent near-eye display helmet and a conventional navigation system that accurately locates surgical instruments and superimposes them on the patient’s CT image on a real-time basis. At the same time, the 3D transparent view allows visualization of the cortical margins, which enables the surgeon to see the patient’s anatomy “through” the skin and tissue and adjust his or her perspective in order to accurately navigate instruments and implants in real time.
Unlike traditional navigation systems, xvision has a built-in tracker and retinal display, eliminating the need for the surgeon to constantly look over the secondary screen during surgery and avoiding the distraction that this can cause. The transparent AR display projects 3D anatomy and instrumentation details onto the surgeon’s retina without obscuring the surgical area, providing better visualization and accuracy during spine surgery.
Xvision is a wireless system that does not require any cables or external devices to be connected, allowing the surgeon to move freely around the operating room. Its system has a built-in high-speed processor that enables seamless visual tracking, ensuring image clarity and stability. And, the personalized helmet can be adjusted to each user’s vision, head size and shape for optimal comfort and field of view, enabling it to be tailored to each user. At the same time, xvision enables minimally invasive techniques that allow surgeons to perform spine surgery through smaller incisions and less tissue damage, thus helping patients reduce bleeding, risk of infection, post-operative pain and complications, and shorten hospital stays and recovery periods.
Xvision is sometimes described as “x-ray” style. But it’s actually based on taking a CT scan of a patient’s spine, then digitizing and calibrating it so that it can be viewed from the perspective of the surgeon wearing the xvision. This can replace fluoroscopy in non-invasive procedures where the patient’s back does not need to be cut open. And, while fluoroscopy is a chemical-based procedure involving X-rays, using xvision allows surgeons to see the patient’s anatomy and the location of the surgical machinery without the use of fluoroscopy, effectively avoiding radiation exposure and better protecting the health of the surgeon and the patient.
4,000 U.S. Patient Treated, Already Reaching Users in 21 States in U.S.
On June 8, 2020, Augmedics’ xvision Spine System was successfully used for the first time in a spinal fusion surgery in the United States. The procedure was performed and successfully completed at Johns Hopkins Hospital. The Johns Hopkins Hospital is a prestigious general hospital located in Baltimore, Maryland, and is one of the largest teaching hospitals in the United States. It was the first hospital in the United States to use the xvision spine system and the first to complete 4,000 xvision patients. Its surgeons perform many types of spine surgeries using xvision, including lumbar decompression, fusion and pedicle nail fixation surgery, cervical decompression, fusion and artificial disc replacement surgery, and more.
In September 2022, Augmedics announced the completion of the 2,000th xvision case. John Stevenson, the neurosurgeon and spine specialist who performed the 2,000th surgery, has been a spine surgeon for nearly 25 years and has used virtually every type of navigational system on the market, and credits the accuracy of the xvision for patient safety and changing the the way he performs spine surgery. Just five months later, Augmedics has announced that it has now treated more than 3,000 patients with the xvision spine system. The 3,000th procedure was performed by Safdar Khan, Chief of Orthopedic Spine Surgery at The Ohio State University Wexner Medical Center (Columbus, GA), who said that xvision has made placing screws easier, safer, and more accurate while maintaining the ability to teach residents and colleagues.
In the same week as the Series D funding news, Augmedics celebrated a record-breaking milestone – the 4,000th U.S. patient was treated with xvision. Currently, xvision has reached users in 21 U.S. states and has implanted more than 20,000 pedicle screws. xvision’s system has demonstrated an overall percutaneous screw placement accuracy of 99.1%. xvision has consistently demonstrated pedicle screw placement accuracy of 97-100% in multiple patient studies. This can be an effective way to improve precision and avoid nerve or vascular injury.
Indications Expanded Across the Spine
On March 8, 2023, Augmedics announced new FDA-approved features and indications for its xvision spine system. The new features include AI image enhancements and new customizable views, further expanding xvision’s advanced visualization and customization capabilities. In addition, new cervical and iliosacral indications combine with existing thoracic, lumbar and sacral indications to extend xvision’s lesion removal to nearly the entire spine, allowing surgeons to benefit from the advantages of xvision navigation in posterior cervical and pelvic approaches. This change marks the largest expansion of indications for xvision since its commercial launch and lays the technology foundation for future platform development.
On June 27, 2023, Augmedics announced the successful completion of an $82.5 million Series D financing round. The round was led by Dallas-based CPMG and added Evidity Health Capital as a syndication partner, with existing investors HIG Capital, Revival Healthcare Capital, Almeda Ventures and others following. Augmedics’ financing has totaled $143.6 million, according to Crunchbase. The funds will support Augmedics in accelerating the commercialization process and facilitating iterative advancement of the next-generation platform to enable mass adoption of xvision technology.
The global spinal surgery devices market reached $45.314 billion (RMB) in 2022 and is expected to reach $59.199 billion by 2028, with an estimated CAGR of 4.48%. The prospect of the spinal surgical instruments market is already evident. Regarding future plans, Kevin Hykes, CEO of Augmedics, said that in the long run, the company is very interested in building applications beyond spine surgery. He said the company sees opportunities to work in other musculoskeletal areas, as well as in cranial surgery, where CT and MRI scans can be used to obtain accurate images of the soft tissues surrounding bones.