Significant funding from National Institute of Biomedical Imaging and Bioengineering (NIBIB) has enabled researchers to develop a unique technology to help physicians perform ultrasound-guided procedures involving needle placement such as needle biopsies, central line insertion, and local anesthesia. The new imaging technology, created by Clear Guide Medical of Baltimore, MD, allows physicians to plan needle entry and a precise line to the target before the needle ever enters the patient’s organ or tissue. The result is more efficient, less damaging, and less stressful needle-placement procedures for patients.
Asked about the importance of NIH funding, Dorothee Heisenberg, CEO of Clear Guide is, well, clear. “There would be no Clear Guide Medical without NIH funding, period. As academics, we were not networked into the medical device private funding community. Our technology sounded great to the venture firms we pitched to, but we were too early for them, because of the uncertainty associated with obtaining FDA clearance. The NIH Small Business Research Innovation funding essentially "de-risked" the technology and allowed us to produce prototypes that showed we could do what we claimed.”
So, what’s new?
Without Clear Guide, physicians use ultrasound to obtain different views of the target to be biopsied (for example a lump in a woman’s breast). Based on what they see, the physician decides on a point of entry and angle of needle insertion they believe will allow them to come as close to their target as possible.
The Clear Guide removes this guess work. The physician places the tip of the needle on the surface of the skin above the organ to be biopsied. Using sophisticated software, the Clear Guide system integrates the needle angle and the ultrasound image, and the physician sees, on the screen, a visualization of the path the needle would take if inserted at that precise spot. The physician can then adjust the spot and angle of needle insertion until Clear Guide indicates that it is in the position needed to hit the target. Given this precise information the physician can proceed to insert the needle and follow the trajectory, shown on the screen, directly to the target.
Put simply, Clear Guide allows needle movement and repositioning before the needle ever enters the body rather than adjusting the needle while moving through the organ, which is time-consuming, and can result in damage to surrounding tissue.
The whole system is composed of a small touchscreen module, the handheld probe, and a cable. No new hardware needs to be installed. Guidance information is displayed on the Clear Guide unit's touchscreen. As soon as the unit is switched on, the needle path is immediately shown on the live ultrasound image.
The low cost, portable aspect of the design also allows primary care personnel to do needle biopsies in a primary care office or mobile health unit. This is of particular interest to NIBIB, whose mission includes the development of technologies that bring improved healthcare to remote areas and underserved populations.
NIH funding jumpstarts innovation
Clear Guide Medical was founded in 2010, a spinoff from the Johns Hopkins Department of Computer Science (Greg Hager) and the Radiology Department in the School of Medicine (Emad Boctor and Philipp Stolka). It continued to develop in the Johns Hopkins business and technology accelerator, FastForward. The sustained development of the technology would not have been possible without a series of state and federal research and development grants.
From 2012 to the present, the company received several Small Business Innovation Research (SBIR) grants from NIBIB and the National Cancer Institute for assistance with the difficult and expensive process of bringing their product to market and obtaining FDA approval.
Training physicians while marketing the product
The company has continued to display its innovative thinking with the development of a training unit called the Clear Guide EDU (for Clear Guide EDUcation system). It is a low-cost, comprehensive system for physicians to practice general needle-guided interventions in non-clinical settings.
According to Heisenberg, the EDU is both a great training tool and a smart business decision. The strategy for the EDU was to use the same technology in a non-clinical product that could be marketed before FDA clearance of the Clear Guide ONE.
Heisenberg further explains how the development of the EDU served a number of purposes. “One of the features built into the EDU is the ability to stream the touchscreen image to the users’ smartphones and tablets. This means that one student can be using the device while others watch the approach and learn with him or her. We also feel that using the EDU while in training primes the physicians to want to continue to use it in their practice after the residency, so it's a good way to introduce them to our technology early in their practice, when many life-long habits and preferences are formed.”
Solidifying the present, looking to the future
The company’s current focus is getting the product manufactured, putting quality control systems in place, and setting up international distribution agreements. However, the team understands the importance of continuing to develop innovative approaches and products. Plans for the next generation device are to introduce capabilities that will allow ultrasound to do some of the procedures that are currently done with CT guidance, which will reduce radiation exposure, lower costs, and increase access to care.
Heisenberg and her team show no lack of vision or ambition. “Part of what makes this job so interesting is that our technology promises to actually transform the imaging market itself, somewhat like going from an IBM mainframe to a personal computer. Suddenly you could imagine ultrasound being used in many ways we just don't anticipate now. We truly believe that our optical technology opens up a wealth of new applications for ultrasound guidance, and we hope to remain at the forefront of these developments.”
Steven Krosnick, MD, the NIBIB Program Director for Image-Guided Interventions shares Heisenberg’s enthusiasm: “Ultrasound produces high quality, relatively low cost, real-time images even at the bedside without any ionizing radiation exposure. Enhancements such as those being developed by Clear Guide will likely make ultrasound an even more appreciated diagnostic tool for medical imagers.”