Bolt Navigation has a sleek human-centered design and gyroscope on chip technology that is optimized to make spine surgery safer for any surgeon, anywhere, at any time, ultimately democratizing access to best-in-class surgical navigation. The Bolt Navigation System empowers surgeons to efficiently and precisely navigate the placement of pedicle screws during spinal surgery by utilizing an IOS device to accurately and reproducibly guide the placement of spine fixation. It does so without the cost complexities and radiation associated with legacy technologies.

The Bolt system cleverly utilizes gravity as the reference as opposed to an external frame. Therefore, the system is built to ensure that the patient and images acquired are properly positioned. This results in benefits including time efficiency, improved workflow, and risk mitigation which refine the experience for surgeons, nurses, and administrators alike, and ultimately translate to improved quality of care for the patient.

Project leads, Nathalie Perry and Jake Hale, recently reflected on the project, “Working with Bolt was extremely rewarding since the challenges we faced enabled us to utilize our expertise in design and quality assurance to meet regulatory requirements and solve issues of concern while supporting the shared objectives of the Bolt team.”

In October 2020, Sage was approached by Bolt to improve the design of the existing prototype. Sage improved the ergonomics of the device, implemented design changes that reduced the cost to manufacture the device, and established processes for validation and inspection. Sage implemented these design improvements in a methodical and efficient way to meet the client’s needs and timeline.

Over the next two years, a dedicated Sage team implemented the design improvements, provided industrial design and design for manufacturability, supported software activities, and drove an iPod software provisioning strategy in order to take the product through design verification and 510k submission on time and within budget. In December 2022, Circinus Medical Technology received 510k approval in the U.S. for the Bolt Navigation System.

This novel technology was immediately adopted by some of the top spine surgeons and garnered international interest for additional clinical studies in the EU. Sage provided additional support for early distribution and entrance into new markets. Sage’s values of flexibility, responsiveness and adaptability were made apparent through a willingness to implement internal quality system expansions to become a registered distributor for this product and set up distribution and shipping services within the company, all while adhering to the schedule timeline. Sage maintains full-service capabilities including manufacture and distribution, as well as supporting ongoing process monitoring and qualification efforts as Circinus continues to expand their presence in the spinal surgery space. As the market potential grows Sage continues to implement flexible solutions to manufacture clinical units to support the EU clinical site.

Although the task was challenging, Sage’s work ethic and desire to delight the customer were exemplified in one humorous example by supporting manufacturing activities during a snowstorm blackout to keep the client on track for their quarterly deadlines.

In February, 2021 The Bolt Navigation System was named “Best New Technology” at the Spine Technology Awards sponsored by Orthopedics This Week. John Dorman, MD the company’s Founder and Chairman stated: “It is wonderful to have our technology recognized by such a highly regarded panel of judges. What started as an effort to build something to make my procedures faster and easier with less radiation exposure has developed into a paradigm shift in surgical navigation that will soon be available to every surgeon.”

Today, the partnership between Sage and Bolt continues to grow. Over a three-year period, Sage’s technical depth and expertise along with a desire to exceed expectations helped Bolt reach their anticipated milestones resulting in what has become a mutually beneficial and successful long term relationship between the two companies. As the Bolt technology platform continues to expand, Sage looks forward to providing whatever support necessary to help propel this cutting edge, hand-held navigation solution into additional indications.

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