Cleveland-based surgical navigation startup Centerline Biomedical Inc. is gearing up to enter the market in 2017 with its GPS-like system that provides 3-D guidance during endovascular surgery.
Centerline closed a Series A funding round in December, a milestone following several preclinical trials and building upon other financing and outreach.
The company's Intra-Operative Positioning System (IOPS) combines its device and software analytics to allow surgeons in real time to navigate a patient's arteries.
Centerline is a joint venture of the Cleveland Clinic, where the technology was originally developed, and G2 Group Ventures, a private investment group in the Washington, D.C., area.
Since beginning operations in November 2014, the company has raised $6.7 million. About $200,000 from state grants and $500,000 from the Clinic provided a foundation for fundraising once G2 got involved in August 2015 and accelerated that pace, said Jai Gupta, Centerline chairman and CEO. In 2016 alone, Centerline garnered $4.3 million in investor support, he said.
Gupta, who came to the startup through G2, said he was looking to invest in innovative technologies that improve lives. With a background in imaging processing, IOPS quickly grabbed his attention.
Centerline's software supports its physical device, which is transported on a cart with a computer screen. IOPS has catheters and guide wires that operate just as those surgeons already use, but Centerline's are augmented with tracking technology.
IOPS brings better visualization and limits radiation exposure for surgeons and patients. Currently, endovascular surgery uses X-ray fluoroscopy, which delivers a 2-D image, which is a "really limited way to visualize what a surgeon is trying to do," when navigating the complexity of arteries, said Vikash Goel, Centerline's chief technology officer and one of the inventors of the IOPS technology.
IOPS "gives this hugely better visualization, which is actually where we think our customers will see the bigger value first, because immediately they'll start doing these procedures faster and saving money," Goel said.
Although he expects the primary selling point to be the cost savings through efficiency, Goel said reduced radiation is certainly important.
For Goel, the research has been personal. His mentor of more than 10 years, Cleveland Clinic innovator and endovascular surgeon Roy Greenberg, died in 2013 following a battle with cancer. Goel said the field is seeing many of its pioneers develop cancer or health conditions likely connected to their work.
"So I have a really strong personal motivation to try to develop our technology that protects people," Goel said.
His research with this technology began about 12 years ago out of his graduate thesis work at the program of computer graphics at Cornell University.
Goel initially thought it would be used for computer design implants. During the process of developing the idea, he realized that the bigger problem was in navigating and implanting devices.
Dr. Matthew Eagleton, chair of Centerline's scientific advisory board and associate professor of surgery at Cleveland Clinic, got involved with the work shortly after Greenberg's death. Eagleton performs much of the same procedures that Greenberg had and was asked to get more involved in the research.
IOPS has the potential to help treat disease more precisely, replace devices more accurately, and, though it's not the primary goal, do so with less radiation exposure, he said.
"I think the bigger part is to provide the physician with an improved image quality that they can manipulate during the procedure to see exactly what they're treating, where they are within that treatment field and to replace devices ... more accurately, which will allow for better long-term outcomes," said Eagleton, who has also been involved in preclinical studies.
Once able to demonstrate the technology's effectiveness and potential, Goel said the team worked with Cleveland Clinic Innovations to find a path forward. A spinoff company became the best approach.
When G2 group invested in Centerline, it brought new leadership, at which point the employment agreement for former CEO William Fuller was not renewed. This prompted a civil suit in December 2015 from Fuller and a counter suit in April 2016 from Centerline. The dispute is ongoing, but Gupta said even if the court were to rule against Centerline, "the liability to the company is immaterial."
Gupta said Centerline's plan is to file for FDA approval in early summer.
"At that time we basically think that it will be ready for commercialization, selling our product to various hospitals and medical facilities," he said.
The fundraising goal for next year is between $5 million and $7 million, which Goel said will hopefully be all the funding Centerline needs to raise. After that, he expects the company to be operating on its own revenue.
"Surgical startup poised to enter market" originally appeared in Crain's Cleveland business.