ORTHO KINEMATICS RAISES $9.6 MILLION TO COMMERCIALIZE SPINE DIAGNOSTIC TOOL (Orthopedics This Week)
Privately owned, Ortho Kinematics, Inc. (OKI), has raised another $9.6 million in Series C equity financing to fund expanded commercialization for its VMA (Vertebral Motion Analysis) diagnostic tool.
An April 14, 2015 company announcement said the tool focuses on spine imaging informatics, “for the radiographic assessment of spinal motion and instability.”
“Gentle” Spine Bend
The company says that traditional “bending x-rays” of the spine often result in “guarded” responses from patients because of the pain of bending. VMA testing assists patients through a complete spine bend, helping to “gently overcome” that “guarding.” They claim the VMA helps to assure instability does not go undetected. Radiographic evidence of instability is a huge factor in a payer’s decision to cover a surgical intervention.
Since the early 1940s, spinal instability testing has been very low-tech. According to the company, today’s standard bending x-rays requires measuring spine motion from static x-rays by hand. The test is ordered 5 million times per year in the U.S., more than spine CT and MR imaging combined.
After the FDA cleared the tool, the company completed a limited-scale commercial launch. The company said it is currently ramping up efforts to support a full scale commercial launch within the U.S. and Europe. The commercialization will include expanded sales and marketing efforts and some “limited” research and development activities.
Spine neurosurgeon Reginald Davis, M.D., said his patients benefit from getting a VMA. “The VMA provides the clinical information of traditional x-rays, as well as tremendous biomechanical insight from motion analysis that can impact diagnostic and treatment decisions. To improve spine care, diagnostic capabilities must also improve.”
Company CEO, Paul Gunnoe called it, “ambitious growth…. The VMA is disrupting 60+ year old methods of diagnosing spine issues, and we believe this type of innovation is long overdue. We are leading in this area.”
The VMA
The VMA Uses standard C-arms (fluoroscopes) to generate images.
The software is a “quantitative imaging software application intended to be used to process digital image files. The software permits users to review static and dynamic digital lumbar and cervical spine images acquired with the assistance of the VMA patient handling and data collection device, which is designed for use by imaging technicians and intended to assist with patient lumbar and cervical bending and data collection during imaging. VMA software also facilitates quantitative assessment of vertebral motion in digital medical images. Information about the motion of selected objects, such as bone structures, can be generated and presented in the form of a ‘motion analysis’ report containing graphics, charts, and text,” according to the company.
Here are the highlights from OKI’s website:
- Requires no new staff or imaging machines and a day or two of training because imaging is done with standard fluoroscopes.
- Testing takes about 5 minutes more than a 15 minute flex-ex test.
- The system is HIPAA-compliant, is browser-based, has a “zero IT footprint” requiring no installed software, and easily integrates with PACS systems.
- Patient and technologist may have lower radiation exposure and the tool offers more robust data than a flex-ex.
- According to the largest level 1 evidence study of its kind, the tool was found to be 500% more sensitive in detecting lumbar radiographic instability, but just as specific.”
The tool is covered under category I CPT codes.
The Funders
Medtronic plc and TEXO Ventures, MB Venture Partners, among others, provided the funding. Terms of the financing were not disclosed. Gary Stevenson, co-founder and Managing Partner of MB Venture Partners, has joined the OKI board of directors.