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To Market, To Market
A mere idea five years ago, Clear Guide ONE is now being marketed for use in hospitals across the United States.
Illustration by Martin O'Neill
Each year, researchers in the school of medicine and other Johns Hopkins divisions make hundreds of discoveries, a sizeable proportion of which hold commercial potential. The Johns Hopkins Technology Ventures office helps researchers bring these ideas to market by offering business advice, support and space for startups.
Here’s the story of one successful startup, Clear Guide Medical, which offers novel computer-assisted ultrasonic technology to make precise needle insertions far easier than previously possible. Clear Guide ONE, a mere idea five years ago, gained Food and Drug Administration clearance this fall and is now being marketed for use in hospitals across the United States and Canada.
Emad Boctor, computer scientist and assistant professor of Radiology, directs Johns Hopkins’ lab aimed at developing ultrasound-guided intervention solutions.
Postdoc Philipp Stolka joins the Medical UltraSound Imaging and Intervention Collaboration Research Laboratory in September.
Stolka and Boctor confront the shortcomings of existing ultrasound tracking systems used to guide needle insertions into the body to biopsy tumors, insert central lines or deliver local anesthesia. Hand-eye coordination required to reach the target can challenge even the most skilled surgeons. There has to be a better way, they agree. They set out to find it.
“Eureka” moment comes in the summer on a train back from New Jersey. Sketching as they brainstorm, the duo comes up with a novel solution based on attaching local sensors—camera and projector—directly to the ultrasound probe. They submit their first key patent on this approach in November.
Boctor applies to Maryland’s TEDCO university program in the summer and a $50,000 grant comes through in December.
Team turns to the Whiting School of Engineering’s Greg Hager for expertise, who helps with computer vision questions—automatically processing the images from cameras to assist the physician. Dorothee Heisenberg, a Ph.D. with a finance background working at Johns Hopkins, joins the team and Clear Guide Medical, LLC is formed.
At Johns Hopkins and with TEDCO funds, the team endeavors to shrink the size of hand-held navigational aid. Builds new prototype. Clinical radiologist advisors’ refrain: “Still too big.”
Team wins $200,000 National Institutes of Health Small Business Innovation Research contract in September. Stolka leaves academia to work full time with Clear Guide; Heisenberg becomes CEO.
Team begins preparing device for success as a product. Dangling wires and other clutter are cut back; usability and durability are enhanced. “In academia, the device only has to work once,” Stolka says. “When you make a product, it has to work every single time.”
Johns Hopkins’ new technology incubator, dubbed FastForward, invites Clear Guide team to occupy new space for startups in former Stieff Silver Building, near Homewood campus. Additional engineers are brought on board. Team continues to write grant proposals to federal and state agencies.
Team raises total of $1.55 million in grant funding, hires even more engineers. They spend $20,000 to attend Radiological Society of North America annual meeting to showcase new invention. Physicians swarm, bringing back friends to the Clear Guide booth to marvel. Essentially, Clear Guide reduces complex needle insertions into an act not much more difficult than playing a simple video game. Says one attendee: “This is the most exciting product I’ve seen in this field for a long time.”
Clear Guide named Maryland Incubator Company of the Year.
Jack Kent hired as director of regulatory affairs to help clear path to FDA clearance. Jim Condon, experienced medical device executive, becomes president; attracts $1.4 million in angel funding.
September: Clear Guide receives clearance from FDA and Canadian equivalent to market ultrasonic guidance device. Champagne is uncorked. Manufacturing subcontractor hired to begin producing devices. Salesperson hired to handle first customers. Company makes plans to move out of FastForward. Johns Hopkins will hold small equity in firm and will be paid for licensing of patents invented by Clear Guide team during their time as academics.
The product’s revenue potential is significant. Heisenberg expects that in 10 years, every ultrasound device will include Clear Guide technology.