Exploring New Applications in Collaboration with BARDA : 29

MedTech Speed to Data

Rivanna Medical is a Virginia-based developer of ultrasound imaging technologies. Accuro, the company’s first product, is a “stud finder for the spine” for more accurate needle placement during spinal and epidural procedures.

In Episode #29, Andy Rogers of Key Tech talks with Rivanna’s Chairman, CEO, and Co-founder, Will Mauldin, Ph.D., about the role of data in his company’s AI-powered product.

Need to know

• Three million vaginal and caesarian births in the United States require anesthesia injected into the epidural space around the spinal cord.
• Twenty million patients receive epidurals during surgery or as part of a treatment program for chronic pain.
• However, there are complications. For example, post-dural-puncture headaches occur when a needle punctures the dura and fluid leaks from the spinal canal.
• First-attempt success rates are around forty percent in challenging populations, such as obese patients or those with spinal abnormalities.
• Success rates with Rivanna’s Accuro ultrasound imager approach seventy-five percent.

The nitty-gritty

Although physicians have used general-purpose ultrasound imagers to scout needle placement, most anesthesia providers don’t have the skills to make it common practice. By focusing on one indication, distinguishing epidural tissue from bone, Rivanna designed a simple handheld device that uses AI-powered software to streamline needle placement.

Accuro’s small size and integrated screen make identifying and marking the needle insertion site easier. In addition, the device’s transducers interact with bony tissue better than general-purpose devices designed to image soft tissue.

A focused value proposition also lets Rivanna use neural network algorithms to automate the identification of bone and epidural tissue and guide needle placement more accurately.

Data that made the difference:

Conversations with obstetrics anesthesia providers let Mauldin identify the value proposition. “It became pretty clear from those qualitative market research interviews,” Mauldin says, “that the problem is just where do I place the needle to begin with and on what trajectory?”

Rivanna launched Accuro in 2015, but medical societies like the American Society of Anesthesiologists need more data to recommend ultrasound image-guided epidural procedures. Mauldin explains that Accuro’s next iteration requires identifying “what kind of endpoints would move society guidelines to point to an image-guided standard of care? What clinical evidence do we need to support in order to allow the societies to make that determination?”

A new product line required gathering even more data. Today, seven percent of emergency department (ED) patients have suspected wrist or ankle fractures. The U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) is concerned that terrorist attacks could overwhelm EDs with hundreds of fracture patients. Rivanna received BARDA funding to design a portable ultrasound bone tissue imager.

“We made it through the base segment,” Mauldin explains. “That was about gathering data. We interacted with 180 different emergency physicians, emergency department directors, orthopedists, and radiologists to answer the question: is there a market here for the indication of bone fracture bedside assessment? Fortunately, the answer was yes.”