Proprio’s latest FDA approval clears the way for better, AI-driven surgery

A core tenet of DCVC’s deep tech thesis is that when a strong team has a significant, proprietary data set flowing into a distinct compu­ta­tional advantage, it can advance a traditional industry at a tremendous rate, powering both the slope and speed of innovation.

This is clearly evidenced in our TechMed investment pillar. When we initially invested in Proprio over four years ago, we saw a unique data opportunity, one harnessed to edge AI computing capa­bil­i­ties that will deliver better outcomes for patients in terms of quality, speed, and avail­ability. In surgery, data rivers power a form of physical AI where autonomy and guidance can change how surgeons work. Proprio’s advance­ments occur in a field that has seen relatively few ground­breaking innovations since the invention of the X‑Ray and CT-scans.

Surgery represents an enormous amount of annual healthcare spend — $100s of billions alone in the U.S. — and directly affects quality-of-life issues for millions of patients. The $60B global spine market focuses on reducing pain and increasing function, yet it still relies on an apprentice-like training system, where the physical dexterity (including hand-eye coor­di­na­tion), education, experience, and stamina of the surgeon are key deter­mi­nants of success. Spine surgery is very difficult — hence its relatively high variability in outcomes.

Inherent in most spine surgeries is the placement of pedicle screws to anchor surgical implants that sustain spinal alignment. Conven­tion­ally this has been a freehand technique guided by feel and occasional fluo­ro­scopic snapshots. This is time-consuming, exposes patients and staff to cancer-causing radiation every time a snapshot to take measure­ments is needed, and depends heavily on surgeon judgement. Research has shown that freehand screw placement accuracy varies signif­i­cantly with surgeon experience. Revision rates for spine surgery because outcomes are poor are incredibly high.

Until now.

About 18 months ago, Proprio received FDA 510K clearance for its 3D surgical navigation system, a break­through that was akin to a real-time Google Map in guiding a procedure. The company has partic­i­pated in over 75 live procedures with great results.

Today, Proprio announced that it has received its second FDA clearance for its AI Surgical Guidance Platform, which provides surgical teams with accurate measure­ments during the surgery. Said plainly, a surgeon will know with certainty whether the procedure has achieved the actual angles and placements required to provide an optimal outcome based on a pre-operative plan and what is learned during the actual surgery. The surgeon will know if they have achieved their goals in real time.

This is not just a break­through, it’s a revolution. Surgeons will no longer need to stop a procedure for 15 – 30 minutes to take images. No longer will they leave a patient on an operating room table waiting for an x‑ray or CT machine to be wheeled in. The surgeon will have the most important data to determine the success of the surgery as they are undertaking the procedure itself. To me, this is the first step of delivering a surgical JARVIS, an AI co-pilot that mean­ing­fully supports these highly trained, talented medical professionals.

Here is some of what Proprio’s AI-powered surgical guidance can do for a surgeon:

• Detect vertebral bodies and calculate alignment parameters during live surgeries to assist with real-time guidance.
• Feed directly into measurement tasks — if an AI can pinpoint anatomy precisely, it can also measure distances (like the gap for an interbody cage) or angles (like a pedicle screw trajectory) with consistency.
• Recognize surgical instruments and patient anatomy when offering up this information, allowing it, for instance, to tell a surgeon how far a screw has advanced, or the degree of correction achieved so far in a deformity case.

In essence, Proprio’s AI acts as an ever-watchful assistant, performing continuous measure­ments and analysis that would be impossible for a human to do in real time. Over time, the ability to collect novel, valuable data easily wins.

Machine learning in a surgical guidance system can contribute to predictive analytics, not only supporting the procedure itself, but learning the rela­tion­ship between surgical actions and outcomes. This opens the door for AI to suggest optimal implant sizes, predict the spinal alignment after certain corrections, or flag measure­ments that seem off compared to successful cases in the past. 

Surgical guidance systems build on a large data set of ​“known good” measure­ments and outcomes, helping to guide surgeons by comparing the current intra­op­er­a­tive measure­ments to expected targets. Measure­ments like distances to anatomic landmarks or angles for screw insertion are visually presented to the surgeon rather than manually measured with a ruler or protractor on an X‑ray. The benefit to the surgeon is immediate access to critical measure­ments without breaking focus — imagine glancing at the surgical field and seeing a number indicating how many degrees of rotation have been corrected so far in a spinal deformity case, or a marker showing the exact entry point for a pedicle screw and the angle in three-dimensional space.

Ultimately Proprio’s pursuit of AI and real time image analysis not only gives surgeons superpowers in visu­al­iza­tion during a procedure, but also ensures that measure­ments are not missed, creating a cognitive advancement for even the most experienced and talented surgeon. This enhances safety and precision. The co-pilot in the surgical guidance system monitors dozens of parameters in split seconds. It double-checks your work and can help deliver unpar­al­leled accuracy, the underlying success measure of an optimal procedure. 

One immediate benefit a surgeon could soon see is reduced variability in outcomes. Spine surgery has histor­i­cally seen a lot of technique variation. But for this to move forward, surgeons must adapt to new ways of operating, which often involves a learning curve. Hospitals are increas­ingly viewing advanced surgical technology as a must-have for competitive and quality reasons. We are seeing multi-center hospital systems invest in spine robots and intelligent navigation systems. The early adopters often report better effi­cien­cies, which pressures others to follow suit to avoid being left behind. In spine surgery specif­i­cally, with an aging population and a high demand for spine procedures, tech­nolo­gies that allow surgeons to do more complex cases safely or to handle more volume (through efficiency) can gain traction quickly.

Proprio is leading the world to better surgery done more easily: its FDA clearances validate its approach and will accelerate its growth. Major congrats to CEO Gabe Jones and the whole team.