dorsaVi receives FDA 510(k) clearance for ViMove2 
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Key points:

  • dorsaVi’s ViMove2 device has received 510(k) Clearance from the U.S. FDA
  • Regulatory clearance paves the way for the device’s anticipated U.S launch in Q4 FY18
  • Low-back pain is a significant market in the U.S., with the condition costing an estimated US$100-$200 billion annually^

Melbourne, Australia - 19 July 2017:  dorsaVi Ltd (ASX: DVL) today announced it has received 510(k) Clearance by the U.S. Food and Drug Administration (FDA) for the next generation ViMove2 sensor designed to measure, record, and analyse movement and muscle activity of the lower back. The regulatory clearance comes ahead of U.S. launch scheduled for Q4 FY18.


ViMove2 features the latest in wearable technology, including Bluetooth communication between sensors and a mobile app; personalised clinician and patient apps for real time access to data; an enhanced user interface as well as smaller movement and EMG (muscle activity) sensors with faster start up and longer battery life.


The device also features an accelerometer and gyroscope that precisely measures the range of movement in the sagittal (longitudinal) and coronal (vertical) anatomical planes. These enhanced capabilities allow clinicians to monitor patients outside the clinic and help deliver tailored treatment programs. Furthermore, ViMove2™ enables patients to track activity levels against goals set by their clinician via a patient app.


dorsaVi Chief Executive Officer, Andrew Ronchi, said the regulatory clearance marked a major milestone and that the Company remains on track to launch ViMove2 in the U.S. in Q4 FY18.


“The FDA’s 510(k) clearance for ViMove2 is an important milestone for the Company as the product has a mass market clinical opportunity. ViMove2 is highly intuitive, simple and a faster to use device that is patient-friendly. The addition of a patient app allows patient and therapists to monitor progress and improve adherence to treatment regimes; ultimately leading to better patient outcomes through quality movement data,” said Dr Ronchi.


ViMove2 was launched in Australia in May 2017 and will also be launched in the UK in Q2 FY18. This staged roll out has been designed to facilitate a smooth introduction into the U.S., our largest clinical market. dorsaVi is currently experiencing strong growth and high levels of customer satisfaction in the U.S. clinical market. dorsaVi is uniquely positioned to build a critical mass of devices in market.


ViMove2 has been developed as an ongoing annuity revenue product, replacing the model of outright unit sale or short-term lease originally launched for ViMove. The annuity model has been tested in the U.S. clinical market over the past 12 months and has been successful in facilitating sales and proving a steady revenue stream.
Watch the ViMove2 overview video: 
http://get.dorsavi.com/vimove2/

^ Freburger JK, Holmes GM, Agans RP, Jackman AM, Darter JD, Wallace AS, Castel LD, Kalsbeek WD, Carey TS. The Rising Prevalence of Chronic Low Back Pain. Arch Intern Med. 2009;169(3):251-258.

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Randomised Controlled Trial with dorsaVi technology finds back pain patients monitored and treated using dorsaVi's sensors had significant, sustained improvements in pain and function.

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