A 3D Google Maps for Surgeons: Proprio Secures FDA Clearance for Spinal Surgical Navigation
By Alan Cohen 05.08.23
We are proud to share that our portfolio company Proprio has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its flagship product, Paradigm™, to perform spine surgery. Paradigm uses an advanced, multi-sensor approach to guide surgeons, much the way GPS, cameras, and lidar guide drivers on the road. This first-of-its-kind system is the benefit of a rich, multi-year effort built on machine learning, as well as on hundreds of studies performed by world-class surgeons.
The current state of surgical navigation is static: pre-operative imaging must often be complemented by additional x-rays taken in the middle of a surgery. This is like stopping to look at a map or ask for directions, and lengthens the time a patient is in surgery, which leads to higher risks for patients.
Proprio—whose Series A we were proud to lead three years ago—offers a different approach. Before a surgery, Paradigm imports an array of surgical imaging scans such as x-rays, MRIs, and CT scans, to provide a baseline, a starting point for the system. With this baseline in place, surgeons enter an environment that combines the power of light field technology with data intelligence and real-time anatomical alignment calculations to ensure they can make the most informed decisions in the operating room possible.
Proprio’s technology creates a real-time video feed of a given surgery, allowing course correction, all while eliminating the need for additional x-rays. Proprio tracks any changes or movement in the spine – patients regularly move during surgery — and accurately guides surgical implants or physical actions of the surgeon. It reacts in real time. During the procedure, the surgeon can view the action on a screen or through an augmented reality (AR) headset (or a computer screen). This provides a 3D view of the surgery.
Surgeons have remarked on some of the benefits they see the Proprio Paradigm bringing to the profession:
- Accelerated Workflow: Removing the need for intraoperative scans can save up to 30 minutes per procedure. It eliminates the need to stop a surgery to take an additional x-ray and means more patients can be served.
- Fast Registration: Where intraoperative scans are required, the registration process – incorporating the imaging into a navigation system – can take between 15 and 30 minutes. Current surgical navigations take a long time to incorporate new imaging data. Paradigm registration can be completed in seconds.
- Continuous Data Capture: Paradigm collects a high volume of visual data with approximately 250GB of high-quality video per hour. Such valuable data drives Proprio’s product development process, by informing advanced models while shortening timelines for future applications.
- Reduction in Radiation: Removing the need for high-radiation intraoperative scans throughout the procedure can lead to a 10x reduction in radiation exposure.
As a recent Nature study highlighted, Proprio researchers are also at the forefront of using both actual as well as synthetic data to develop generalizable learning-based algorithms for X-ray image analysis, which provide the pre-operative view of the spine. The company is building a market-defining data set on spine surgery.
While the company chose to focus initially on the $30 billion per year U.S. spine surgery market, we see the company expanding to ortho, cranial, and neuro surgeries in the future due to its ability to ultimately operate in an array of surgery modalities.
DCVC is inspired by the trailblazers at Proprio—whose approach comes not a moment too soon. The American College of Surgeons estimates a gap of approximately 15,000-30,000 surgeons in the U.S. alone by 2034: technologies that can make surgeons more efficient can help to bridge it. And with 2 billion around the world entering middle income – and expecting healthcare that includes surgery – the global demand for surgery will continue to rise.
We are delighted that Proprio, led by founders CEO Gabe Jones and Chief Medical Officer Dr. Sam Browd, with excellent technical and market-facing teams, is now bolstered by strong market interest and poised to enter its commercial phase. Patients and health systems alike have much to gain as Proprio addresses the critical problem of surgery’s shrinking supply and increasing demand.
The company’s achievement is both amazing in its own right and exciting for what it signals more broadly. DCVC enthusiastically invests in AI-first companies that improve delivery of healthcare by professionals (Caption Health, Carbon, Safely You) or the development of new therapeutics and medicines (Abcellera, Recursion, Totus). Deep Tech holds tremendous power to save and improve lives: we remain eager to support founders finding new ways to harness it.
Alan Cohen is a Partner at DCVC.