In late July, Galen Robotics, headquartered in Baltimore, received thrilling news from the U.S. Food and Drug Administration (FDA). Following five years of dedication and commitment to their innovation, the team received an FDA De Novo Grant for the Galen Surgical Robot – 77 days ahead of the national average. With this new FDA approval, the Galen team is primed to introduce their surgical robot and new “Digital-Surgery-as-a-Service™” platform into hospitals.
Galen’s innovative technology is designed for surgeons specializing in microsurgery – a realm of extraordinarily precise procedures that tolerate minimal margin for error.
Imagine a heightened iteration of Hasbro’s “Operation” board game but with real-world consequences. Galen’s robotic platform employs custom adapters to secure surgical instruments, thereby enhancing stability, ergonomics and precision.
Achieving the first FDA grant marks a momentous milestone for any medical startup, and this is no exception. According to Bruce Lichorowic, CEO of Galen Robotics, “This achievement showcases the remarkable dedication of our team, overcoming challenges like relocating from Silicon Valley to Baltimore during COVID shutdowns, supply chain disruptions, and now the broader macro-economic influences. It fills me with incredible humility to receive this FDA grant.”
The inception of Galen’s innovative technology began in 2012 at the Laboratory for Computational Sensing and Robotics (LSCR) at Johns Hopkins University. Russell Taylor, Ph.D., and his colleague, Kevin Olds, Ph.D., were awarded one of the first Phase I Technology Assessment grants from TEDCO’s Maryland Innovation Initiative (MII). This grant enabled the construction of the initial Galen prototype – a surgical robot that was to be tailored for “narrow corridor surgeries.”
These intricate procedures involve the use of long instruments for exceptionally precise tasks such as tumor extraction or ear, nose, and throat (ENT) surgeries — procedures that often require surgeons to navigate long instruments within spaces as narrow as millimeters between adjacent tissue.
TEDCO’s MII was created in 2012 as a partnership between the State of Maryland and five Maryland academic research institutions, including Johns Hopkins University, to help accelerate promising university technologies with promising commercial potential. Since its inception, MII has invested over $50M and has spearheaded the formation of 176 startup companies and counting.
A chance to leave a legacy
Skipping ahead to January 2016, long-standing friends and seasoned High-tech and MedTech entrepreneurs, Lichorowic and Dave Saunders, were on the hunt for their next medical venture. Johns Hopkins Technology Ventures (JHTV) reached out to them to propose the commercialization of the Galen platform, which had progressed to the prototype stage within the LCSR lab. The entrepreneurs journeyed to Baltimore to meet with Taylor and Olds.
After witnessing a demonstration and interacting with surgeons, the two entrepreneurs realized the groundbreaking potential of this innovative tech, which catered to Galen Robotics address an underserved market segment. This encounter marked the catalyst for their joint decision to embrace the challenge of bringing the Galen platform to market.
“Russ is a distinguished figure in the field of surgical robotics,” Saunders stated. “His impact can be seen in nearly every surgical robot present in the market. It would have been foolish for us not to listen to him.”
From there Galen was off to the races, soon applying to and receiving additional support from TEDCO that would add more fuel to the fire.
The Phase III grant turned out to be a pivotal factor in Galen’s ongoing journey. “We allocated a significant portion of the MII Phase III grant to build out the second Galen prototype, which we could then showcase,” Saunders explained. “We engaged in discussions with numerous surgeons and other technical leaders globally, inviting them to personally test-drive the robot and provide firsthand feedback.”
Baltimore-bound
In 2019 Lichorowic and Saunders decided to pack their bags and move across the country from California to the Charm City.
Initially, the long-term Silicon Valley residents had no thoughts of ever relocating. However, this changed when they received an enticing proposal. Lichorowic recounts that “the state of Maryland, with support from the Department of Commerce, led by the then Secretary of Commerce Kelly Schultz, and Baltimore Development Corp (BDC), under the leadership of CEO Collen Talbert, approached us with a proposition to relocate the company to Baltimore.” Upon reviewing their proposal, he recounted, “We questioned what California was offering us, and after discussing it with our wives, we made the joint decision to make the move.”
“There would be no Galen Robotics without TEDCO!”
TEDCO made sure to give their newest neighbors a warm welcome, continuing to provide the team with resources, connections and guidance at every step of their development.
“Dave and I already had a lot of start-up experience under our belts, but what we really needed help with was introductions,” said Lichorowic. “Dr. Arti Santhanam’s group at MII was fantastic; they invited us to participate in TEDCO events and get more involved in the state’s entrepreneurial ecosystem. They also introduced us to other investors, entrepreneurs and state officials who would help us immensely as we continued to grow.”
“The TEDCO team has also lined up fantastic media opportunities, including interviews and podcasts, to help us get the word out to the public about what we’re doing,” added Saunders.
After brief stays at JHTV, Fast Forward, and City Garage, the Galen team decided to settle down and grow their roots 1100 Wicomico Street, part of Baltimore’s Pigtown neighborhood.
“We’ve been here ever since. We survived COVID. We continue to hire groups of interns from various universities. We’ve had our share of ups and downs, but through it all, we’ve continued to power forward with the intent of getting the robot cleared by the FDA and taking it to market while simultaneously maintaining a research relationship with Johns Hopkins,” said Saunders. “And now we’re trying to do our part to keep talent and new technology here in town.”
“What we’ve noticed about Maryland is that entrepreneurs are truly passionate and committed to their technologies,” added Saunders. “They’re not just trying to check the boxes and put up a façade to be the next unicorn. They get out of bed and are truly excited about what they’re building and what impact they can have in the world.”
One of many TEDCO success stories
After recently being awarded a $500K investment from TEDCO’s Seed Funds for Galen’s latest funding round, Lichorowic emphasized, “I believe that the impact of Troy LeMaile-Stovall, TEDCO’s CEO, and his team’s impact on Maryland’s innovation ecosystem is not fully recognized. As the foremost and largest provider of seed funding for emerging technologies in the state, TEDCO provides crucial financial backing and assistance to entrepreneurs in their early stages. The absence of TEDCO would lead to a distinctly altered landscape. Since our establishment here, I’ve consistently advocated for increased State funding towards TEDCO due to the proven efficacy of their approach. TEDCO is the only reason Galen even exists. Without them, we’d still be in California pursuing other technologies.”
The MII program in particular has been instrumental not only for Galen but for numerous other companies across various life science and technology industries.
Now, with a recent FDA clearance and additional funding in tow, the team is planning for the robotic platform’s launch into hospitals, starting with Harvard Medical, Stanford Medical, and, of course, Johns Hopkins Hospital. I95 Content Marketing
Source: i95 Business Magazine