Baltimore medical device startup Spine Align raises $1.75M seed round, eyes FDA clearance

While master’s students in the Center for Bioengineering Innovation and Design (CBID) program at Johns Hopkins, Amir Soltanianzadeh and Dr. David Gullotti got feedback from doctors who perform spinal alignment surgery.

Through interviews that started in 2016, they heard a resounding need: During the procedures to correct deformities, which can often span a whole day, they need better tools to check their work.

Joining with fellow cofounder Dr. Nicholas Theodore, who is director of neurosurgical spine surgery at Johns Hopkins Hopsital, they founded a startup in 2017 called Spine Align. The company set out to create technology that could offer visuals and measurements that will help surgeons be able to make adjustments during the procedures.

As Soltanianzadeh put it, “The surgeons know exactly what to do if you just give them information.”

After several years of building, validating and collecting feedback from 100 surgeons around the country, Spine Align recently raised a $1.75 million seed round, led by the Colorado-based Rockies Venture Club, to continue progress toward getting it to market.

“This round helps us get towards our ultimate goal of FDA clearance and getting this used in surgery,” Soltanianzadeh said.

Currently, surgeons use X-rays to check their progress. But this offers a two-dimensional view of only about 20% of the spine. Plus, the X-rays take about 15 to 30 minutes to get back, so many surgeons don’t check their progress until the end of the long procedure. This has costs, as revision surgery is required in about a quarter of cases, Soltanianzadeh said.

The company’s product, called LiveAlign, is designed to offer 3D measurements of the spine, with results coming back in 30 seconds. Soltanianzadeh likens it to a 3D ruler.

The technology is built to leverage a surgical camera that is already present in most operating rooms, with the system including attachment of a stylus-like probe and anatomical markers that help with key coordinates to track the angles of the spine that the surgery is working toward. The product also includes a software interface.

With more specific feedback that allows surgeons to check progress more often, they can adjust the plan as they go to get more precise with the procedure. In many cases, the idea is that this would mean doing less as part of the procedure, Soltanianzadeh said. It can also reduce reliance on radiation that X-rays cause, as well as blood loss from the long procedure.

“The surgeon feedback has been, ‘I would use this every hour of surgery,'” Soltanianzadeh said.

Based for the last two years at downtown coworking space at Spark Baltimore, Spine Align is one of a number of startups that was formed by graduates of the CBID program. Other companies that used it as founding grounds and went on to build in Baltimore include recently acquired Tissue Analytics, RealLIST Startups 2020 honoree Renalert, and Glyscend Therapeutics, which raised $20.5 million earlier this year.

“The network we developed with the physicians and advisors from Hopkins ended up being so important to our path. The CBID program did such a great job of teaching us how to segment out complex healthcare problems and devise simple well thought out solutions to them,” Soltanianzadeh said, adding that the company owns the IP, rather than having a licensing deal with the university that is sometimes the case with tech transfer.

With the seed round, the company got support from cities around the country. Along with Rockies Venture Club, participants include Berkeley Angel Network, NO/LA Angel Network, Pasadena Angels, Bellingham Angels, VentureWell and Baltimore’s Abell Foundation. The latter was an early supporter via development grants, and Soltanianzadeh said the round “felt incomplete until they joined.”

The round is another data point indicating that startup funding is still active in the pandemic, but the public health restrictions do change the process. Though they met with Rockies Venture Club in person prior to the pandemic, most of the investor meetings were conducted virtually. It worked out, as they ended up having to increase the capacity as a result of the interest spurred by this approach.

“I think in some respects we worked twice as hard to secure funding,” Soltanianzadeh said. “I think the virtual platform of fundraising allowed us to not be restricted by geography.”

With a half-dozen team members spilt between full and part-time, the company is eyeing approval next year from the U.S. Food and Drug Administration under 510(k) clearance, which deems medical devices safe for use and allows them to be marketed. Spine Align plans to initially launch with corrective surgery for scoliosis, and Soltanianzadeh said the technology can be applied to other types of procedures, as well.