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Company Profile:

Clear Guide Medical

Clear Guide Medical has developed the next-generation of ultrasound guidance for needle-based procedures. By affixing Clear Guide's optical head to any existing ultrasound probe, the Clear Guide ONE guides the user to the desired target. The main difference to existing practice is that physicians line up the needle outside the patient at the correct trajectory to hit the target inside the patient. This results in fewer needle sticks, less tissue damage and better patient outcomes. For physicians, the absence of time spent on calibration is a major time-savings, and the small footprint of the system means that doctors work with their customary implements and do not need to decide in advance whether or not guidance is necessary for the procedure (it's always on). The easy-to-follow guidance makes hitting the target as simple as playing a video game, and allows more doctors to use ultrasound. For hospitals and clinics, the fact that existing ultrasound machines can be retrofitted, and that the Clear Guide ONE costs less than one third of the price of the least expensive competitor system means that guidance is suddenly available for all kinds of procedures and can lower costs while bettering patient outcomes.

Q: Please tell us how your business idea was conceived. Was there an "aha" moment or did it evolve gradually?

A: Doing clinical work with an interventional radiologist at Johns Hopkins University, our co-founder Dr. Emad Boctor asked why he didn't use the expensive guidance system the institution had just invested in. The doctor explained that he only used it for difficult cases because it took so long to calibrate and it changed the workflow. Emad proposed a different way to provide guidance that had no calibration time and a small footprint. The doctor's enthusiastic response validated the idea for our technology. It lived in the JHU lab until a technology commercialization grant enticed Emad's post-doc, Philipp Stolka, to create a new company based on this platform technology. After a market analysis, the company chose ultrasound as the first application of the technology, and Clear Guide Medical was born.

Q: What's the most inventive, innovative, or disruptive aspect of your initiative?

A: Currently, ultrasound guidance is a luxury for only a few practices that can afford high-end ultrasound and specialized needles. The fastest growing segment of the ultrasound market, however, comprises hand-held, portable models, which do not include guidance, but with which Clear Guide's technology works well. Our technology can be used with customary instruments and increases liklihood of hitting a target in the body. It will no longer make sense to offer ultrasound without guidance that is cost-effective, mobile and user-friendly. We envision a time in the next few years when every ultrasound sold will have guidance on it. Our goal is to transform ultrasound into the stethoscope of the 21st century.

Q: How will it help people live to their greatest potential or contribute to making the world healthier?

A: Seeing inside the body enables early intervention in a number of diseases and conditions. Ultrasound itself has become more user-friendly with 3D visualization and smaller, portable, and cost-effective models. Therapeutic use of the ultrasound has been difficult, however, because extensive training is required to hit a target in 3D. The ability to use ultrasound without extensive training would enable earlier interventions performed by more doctors in different locations. Early intervention in cancer has been shown to reduce mortality, but even routine procedures such as draining fluid from a knee or injecting cortisone into spaces of the spine benefit from the targeting accuracy that guidance provides. The deskilling of ultrasound, and the technology's relative price point, makes seeing into the body and applying therapeutic interventions possible at the patient's primary care doctor's office.

Q: Five years from now, what would you like to be able to say has been your most important contribution to health?

A: That we invented the stethoscope of the 21st century.  We don't know all the ways in which this technology will change healthcare provision for most people, but making ultrasound guidance affordable and easy to use will definitely change the market. The closest analogy to the type of change we can think of is adding a camera to a cell-phone. At the time, there was no significant market for cellphones with cameras. But now it's difficult to sell a phone without a camera and its myriad applications that were previously unthinkable. We believe that once healthcare providers can get ultrasound guidance, the ultrasound system will be used in different ways. 

Q: What single word or phrase best describes the culture of your startup and why?

A: "In the kingdom of the blind, the one-eyed man is king."  We are constantly called upon to work outside of our comfort zone, and that can be very stressful for former academics educated to know everything about a small area. On the science and technology side, our engineers are very comfortable;  but on the productization side, we are often flying by the seat of our pants. When things have to go exactly right, we'll hire a consultant. But often we make decisions on how best to proceed by team discussion. Each member of the team has an area of expertise and will take the lead in that field, even when they don't feel entirely comfortable in that role. This type of decentralized leadership has worked well for us so far, although it may not continue to work as well once we hit our growth spurt.
Leadership:
Philipp Stolka
Chief Technology Officer
Dorothee Heisenberg
CEO
2014 Medical Devices View Website
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Entrepreneur Profile:

Philipp Stolka
Chief Technology Officer
Philipp Stolka came across engineering and the computer early, and stayed with it throughout his studies of Computer Science and Surgical Robotics in Germany. He became a postdoc at the Johns Hopkins University afterwards, where he developed systems for ultrasound-based interventions. This research led him and his advisor to found Clear Guide Medical as a lab spin-out, where Philipp is now CTO and leads the technical development of optical navigation systems, wireless display sharing, and other creative things. When not programming, writing patents, squashing bugs, or fighting complexity, he enjoys his free time with his family, photography, and planting trees.
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Entrepreneur Profile:

Dorothee Heisenberg
CEO
A former banker and Johns Hopkins University professor, Dorothee Heisenberg is participating in her first startup as co-founder and the business and operations leader. The work is exciting and challenging, as Clear Guide gets the safety and regulatory testing done, submits its first 510k, begins manufacturing, and starts up a sales effort that will begin with international sales. Dorothee counts herself extremely lucky to be involved with such an excellent company, product, and group of people, and she enjoys the fact that there's never a dull moment. Her contribution has been to manage grants and hire the remarkable team that has been able to achieve so much in a relatively short amount of time. Through her participation in the Hive, Dorothee is looking forward to learning how handle the challenges and choices ahead, as well as meeting other entrepreneurs who have developed and sold medical devices.
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