Sonavex, a Baltimore-based medical device company, has announced a raise of $3M in financing including the first close of its Series A round led by Grey Sky Partners. Recently named Maryland’s 2016 Incubator Company of the Year, Sonavex is focused on improving surgical patient outcomes with point-of-care imaging technologies. Other organizations participating in this financing include CRCM Venture 
Capital, TEDCO, and the Abell Foundation. Award of a $750k Phase II SBIR grant from the National Science Foundation is also included in the financing. With this influx of capital, Sonavex will be advancing the commercialization of EchoSure, a Doppler ultrasound system, and developing additional ultrasound solutions currently in the company’s pipeline. The press release also announces the addition of Bill Niland, CEO of Harpoon Medical, and Bob Hallenbeck, former executive at Becton Dickinson, to Sonavex’s Board of Directors.
Commenting on the close, David Narrow, Sonavex’s CEO commented, “Our traction has enabled Sonavex to not only raise capital to accomplish critical milestones, but also attract essential talent to support the company’s growth.”
Sonavex currently lists two products in their portfolio of technologies: EchoMark and EchoSure. EchoMark (photo above), is a bioresorbable ultrasound marker used in post-operative ultrasound imaging for procedures in which reaccessing the original surgical site is necessary. Unlike traditional ultrasound markers, which only give a general location of the surgical area, EchoMark displays a unique cross section with high echogenicity, or brightness under ultrasound, for quick, accurate location identification. EchoSure, shown to the right, is an ultrasound system designed for non-expert ultrasound users to rapidly detect postoperative clot formation by automatically identifying loss of flow through blood vessels.
Medgadget had a chance to catch up with CEO David Narrow in Baltimore to learn more about Sonavex’s technology and budding success.
Medgadget, Michael Batista: Where did the idea for Sonavex and the EchoSure technology come from?
David Narrow: While in a graduate program at Johns Hopkins, I met a plastic surgeon, Dr. Devin O’Brien Coon, now President of Sonavex, interested in solving some of the problems associated with reconnecting two sides of a blood vessel during surgery (anastomosis). After the anastomosis of the blood vessels, monitoring to ensure sufficient blood flow through the vessels is crucial to avoiding surgical failure due to post-operative blood clot formation. If a clot forms and goes undetected, the results can be disastrous for the patient and can require additional surgery to address.
Initially, we collaborated with Dr. Jerry Prince, a professor at Johns Hopkins, to develop the first iteration of the technology, which is EchoSure. EchoSure uses ultrasound to allow someone who is does not have sonographic training to reliably determine the flow rate through a blood vessel. This allows a nurse to easily monitor the patient after surgery and quickly tell if there is an issue.
While working with Dr. Prince, we began evaluating the market as well as the regulatory pathways it would take to bring this technology to life. After successfully overcoming technical barriers, the team was confident we could hit the milestones needed to commercialize the product so we decided to start the company and spin out the technology from Hopkins.
Medgadget: Why was Sonavex’s approach to blood flow monitoring not attempted previously?
Narrow: In surgeries involving vascular anastomoses, it is much easier to look at indirect signals when assessing the patient after surgery. Therefore, competitors have focused on the integrity of the end organ rather than blood flow through the anastomosis. Conventional ultrasound is not currently used for these cases for a variety of reasons. The key limitation is that the imaging modality requires extensive training to be used effectively, and experienced ultrasound technicians are not available to routinely monitor the patients each our per standard of care. With Sonavex’s proprietary technology a healthcare provider without such training can easily and automatically derive precise blow information that is needed to assess blood clot formation while there is time to take corrective action.
Medgadget: What stage is the technology at today?
Narrow: We are currently finalizing the development of EchoSure and are preparing to submit our regulatory clearance materials. At this point, we are reliably showing the detection of flow loss as a thrombosis forms in vivo which has been very exciting to validate that we can successfully achieve.
Once the regulatory approvals are complete, our number one focus is getting into target pilot sites. In parallel, we are advancing the development of two pipeline technologies to customize ultrasound for other pre, intra, and postoperative use cases that Sonavex has identified.
Medgadget: Since you are bringing a new medical technology to market, how has your experience been working with the FDA?
Narrow: The FDA sounds intimidating at first, but there are resources available that, with guidance from experts, can make you feel more comfortable about what the various pathways require. We found that as long as we managed our expectations, the FDA could be very easy to work with. Taking part in a presubmission meeting significantly boosted our confidence about both the pathway we were taking and the testing requirements we would need to meet. I know a lot of companies come in apprehensive at the outset, but the process in place ends up paying off and the folks at the FDA are there to help you through it.
Medgadget: Those FDA processes and requirements can be long and expensive. Sonavex just raised a round of funding but how did you, and more broadly how do other early stage medical device companies, get to this point while sustaining the business?
Narrow: Without support from both the state and federal governments, it is unlikely that we would have been able to get to a point where we could begin going after venture funding to support the continued development of Sonavex’s technology. I believe is it absolutely essential to have the federal government continue to be willing to invest in early stage ideas which require a fairly long investment horizon to get off the ground and to the point where private and institutional investors and are willing to come in and back these companies.
Medgadget: You’re currently based in Baltimore and are part of the Johns Hopkins ecosystem. As a small business, how has that experience been for you and your team?
Narrow: I’ll say we are fortunate to be in Baltimore as we receive significant support from Johns Hopkins and the larger healthcare ecosystem here. The local government has been very supportive of entrepreneurship activities through both financial and non-financial ways of supporting what we do at Sonavex. From the local community, we have been able to bring on board members and advisors that have played an important part in helping the team grow. Right now the team is composed of five full time and two part time employees and we just brought on an excellent CTO.
Medgadget: What does the future hold for Sonavex?
Narrow: Sonavex plans to expand the utility of ultrasound into areas that have been neglected by incumbents in the field. Often, we see ultrasound reserved for radiology, cardiology, and obstetrics. However, there is a lot of value for ultrasound in surgery as a safe, effective, non-ionizing imaging modality. By using image processing expertise in deriving novel data from images collected from standard hardware, Sonavex plans to expand its ability to help with clinical decision making throughout multiple verticals.
Link: Sonavex homepage…