Bioptigen Driving Intrasurgical OCT Use

Intrasurgical optical coherence tomography (OCT) is “going to make a dramatic impact on our patients’ lives,” said Eric Buckland, founder and CEO of Bioptigen, which was purchased by Leica Microsystems in 2015.

Bioptigen was founded in 2004 as a spin-out from Duke University, funded by angel capital and strategic investment from the Brien Holden Vision Institute; significant funding led to a successful exit, Buckland said. The company’s pediatric ophthalmic imaging system “is still the only FDA-cleared device for pediatric handheld imaging,” he stated.

In late 2015, Bioptigen received FDA clearance for the Envisu Intrasurgical Imaging System; the system was created after feedback from the company’s customer base that the pediatric devices were being used on adults and children alike intraoperatively. Working with the Cleveland Clinic, the PIONEER study has enrolled more than 1,000 patients to date to evaluate the use of intrasurgical OCT during retina surgery.

“The early conclusion is that in more than one-third of surgeries, OCT has had a direct impact on the surgeon’s decision-making process,” Buckland said.

The EnFocus platform is Bioptigen’s microscope-integrated surgical imaging system. “We developed this with the Envisu technology, but with optics targeted at the surgical application,” he said. The new system features a maximum scan range, coaxial and telecentric imaging, to ensure a “true reproduction of the surface topography,” Buckland explained. “Whatever the surgeon is imaging, it’s true real-time imaging at the B-scan level.” Bioptigen has introduced an independent OCT focus and zoom to optimize the image quality in the surgical field, he said.

The company has introduced a high-definition system (built off the Envisu platform) that boasts the “best resolution in the industry,” and allows surgeons to see tissue structure at below a 4 micron resolution, Buckland noted.

Participant:

Transcript

Eric Buckland: Thank you very much. I’m very delighted to be here today, where I’m no longer the CEO of Bioptigen, but I am the General Manager of Bioptigen, as we are acquired by Leica Microsystems a year ago. So we’re at a slightly different phase of our development. Also, this is a transition of today’s program into imaging. So after all the therapeutic histochemistry, I hope this isn’t pedestrian. But what I’m going to talk about is the intra-surgical OCT, which we think is going to make a dramatic impact on our patients’ lives. So a brief history of Bioptigen. We are a Duke University spinout formed in 2004. We were funded by angel capital, some strategic investment out of the Brien Holden Vision Institute, and a significant amount of funding from SBIR grants that has successfully led us to exit. We had a couple of, I think, important milestones in our company’s development, and on the second FDA clearance was for our hand held pediatric ophthalmic imaging system, which is still the only FDA cleared device for pediatric imaging and hand held imaging. As I said, a year ago, Leica bought us because of the quality of our images, but not just because of the pediatric imaging, but because this pediatric imaging brought us into the OR. And in fact, at the end of last year at we received our FDA clearance for the EnFocus intra-surgical imaging system. So why did we do this? As soon as we introduced the Envisu C2300 for pediatrics, as many children are imaged in the OR under anesthesia, our customer base started to use this for intrasurgical imaging on pediatric and adult patients. But notably among this is the use by the Cleveland Clinic in their Pioneer trial where they have already enrolled over a thousand – I think it’s approaching 1300 patients, looking at the efficacy of using intrasurgical OCT during surgeries, mostly retina surgeries. And I’d say right now the primary conclusion they’ve drawn is that in over a third of surgeries, the OCT has had a direct impact on surgical decision making. So here’s some examples of use in macular peels and hole repairs. But what we know is that the hand held imaging that Envisu affords is not really what we want in surgery. And so we were motivated to develop the EnFocus platform, which is the microscope integrated surgical imaging system. So we developed this with the technology that’s embedded in the Envisu platform, but with optics targeted at the surgical application, specifically looking to make sure we had a maximum scan range, that we had coaxial and telocentric imaging so that we have true reproduction of the surface topology, whatever we’re imaging. This is true real time imaging at the B-scan level. And we’ve introduced independent OCT focus and zoom to optimize the image quality in the surgical field. I think I’d say today the community is still working to understand what surgical applications and what workflow will make OCT the same standard of care that it’s been in the clinic in surgery. And to support this evolution, we’ve introduced actually 2 different systems. The EnFocus High Definition system built off the Envisu platform has the best resolution in the industry, and allows us to see tissue structures below 4 micro resolution. But we also introduced the industry’s deepest OCT system, with a depth in tissue of 11 millimeters to help us look at structural content. Because the deep imaging system is the newest, I’m going to show you a couple of movies off of this. And this is full anterior segment imaging with the ultra-deep system. And because it’s in real time, we can actually see dynamics. And if you look at the image to your right, looking at IOL placement and its apposition to the capsular bag in real time I think is the critical issue to determining where the lens ends up after surgery, and then therefore promoting the adoption of premium IOLs. We’re not limited to a value proposition in the anterior for the deep imaging system. And here’s an example of some imaging done at the National Eye Institute in their RPE stem cell research. And you can see the flow of stem cells into this bleb. The bleb is about 3 to 4 millimeters deep. And really what they want to make sure is that they’re not damaging the RPE by poking the RPE with this capillary, and they want to see that the stem cell scaffold lays flat under the bleb. We can use the Envisu for the various retina procedures, but I’ll show you a dynamic application. In this case, it’s using a macular buckle as a support to a macular hole repair. And here, Dr. Parolini wanted to make sure that that buckle was positioned to provide support directly under the macular hole. And then finally, of course I think it’s well accepted that DSAEK will need intraoperative OCT to make sure that donor tissue is appropriately placed. So with that, thank you for the opportunity to speak to you, and I just ask you to consider what you might do differently with your surgical field in focus. Thank you very much.