Mike Cordonnier, cofounder, president and CEO of Carlsmed
Photo courtesy of Carlsmed
SAN FRANCISCO – Outside of the JPM Healthcare Conference here last week, Mike Cordonnier, cofounder, president and CEO of Carlsmed, sat down with MobiHealthNews to discuss how the company uses patient imaging, surgeon-specific data and AI-enabled software to create a 3D "digital twin" of a patient’s spine for spine surgery.
MobiHealthNews: Can you tell our readers about Carlsmed?
Mike Cordonnier: I founded the company in 2018, with a mission to improve outcomes and decrease the cost of healthcare for spine surgery. We built a technology platform to address a very specific patient indication, which was adult spinal deformity, and ultimately created a solution for it that has reduced reoperations.
What we do is we take imaging of patients, we take data about surgeons and use our software platform to create a personalized surgical plan for that patient in 3D that is reviewed by the surgeon. Once they approve it, our software automates designing and 3D printing devices for spine fusion that ultimately deliver a very predictable alignment to the spine. These are then sterile-packed along with single-use instruments delivered straight to the hospital.
Surgeons in the hospital then use their traditional surgical workflow, get access to the spine, remove the disc, take one of our devices, packs it with bone and places it into the spot where the disc was, which then aligns the spine. They may or may not add supplemental fixation to hold it in place until fusion. And then we collect post-op data that shows what was planned and what was achieved.
MHN: So, it's 3D printed based on the images that you actually take. So it's like almost an exact replica of the patient?
Cordonnier: Yeah. What we do is we map the contours of their vertebral end plates and then make a three-dimensional shape that's going to reposition the spine into alignment so it fits like a 3D puzzle piece and actually moves the vertebrae of the spine into alignment.
MHN: How do you ensure that the body doesn't reject it?
Cordonnier: Well, it's titanium alloy, medical-grade titanium alloy, which is the most common metal used in permanent implants, and it's sterile-packed, so it's provided sterile.
MHN: What healthcare systems are you working with?
Cordonnier: We initially launched in 2021 right here in the city at UCSF [University of California San Francisco], which has become one of our anchor hospitals, institutions, really leading the way in both AI-driven healthcare as well as spine surgery. So, it was a great place for us to launch. We just announced in our most recent press release that we have more than 250 trained surgeons across the U.S. now.
MHN: What are your plans here at JPM?
Cordonnier: We're presenting for the second year. Last year we presented in the private company track and took the company public in July of last year. So now we're presenting on the public company track.
We're really here to get the word out to the general population and to targeted healthcare investors who are currently in the stock and those that want to get into the stock.
Most recently, we expanded our platform to cervical. So, just in December, last month, we launched our cervical platform at the CSRS meeting, which is the Cervical Scoliosis Research Society, to a lot of fanfare, both to current surgeon users, as well as those who really see a big clinical need for this technology for the cervical spine.
One of the challenges with cervical spine fusion is that it's frequently done in patients with soft bone who have osteoporosis, and so after the procedure, there's a high incidence of subsidence, where the alignment correction degrades over time.
With our technology, we can virtually do the surgery design, 3D print the devices, very specific, that maximize the surface area of the bone and deliver a three-dimensional correction. And so we've had a lot of really early traction with that addition to the portfolio.
MHN: What have been some of the biggest challenges the company itself has faced?
Cordonnier: I think the biggest hurdles have been really in fundamentally changing workflow for surgeons, and also the biggest benefit. And so traditional spine surgery, a surgeon has a consult with a patient preoperatively, looks at their imaging and schedules them for surgery. While in surgery, they really decide what devices they're going to use as they're doing the procedure. There's some trial and error to that, with literal trials they put in to try to size the best fit. With our technology, we really use all the data that's at hand for the patient and the surgeon. We can create a full three-dimensional, called a virtual digital twin of the patient's pathology. So, a surgeon can see that in full 3D and then with that, we plan what the optimal alignment is. That's based on prior clinical data, as well as that surgeon's surgical technique. And so that's really been the transformation of the clinical decision making preoperatively and then match with the implants. We've seen really rapid adoption, particularly in early and mid-career surgeons that are really deep into digital technologies looking at how to build digital workflow into their practice.
MHN: What's the turnaround time?
Cordonnier: When we first started at UCSF here in the city, we were about eight weeks from when a patient has a consult to surgery. We announced in Q4 with the investments in our technology, digital production system, we're now at eight days.
And a lot of that's driven by … we built a production facility that has every process that's needed, as well as invested in AI technologies for automation, and so we can do a lot of the digital work automated. That took a lot of the manual work of segmenting CTs and planning the surgery that was done by designers, technicians and engineers to utilize data that's there. Our FDA-cleared AI software allows us to automate a lot of that process.
