Boston Scientific Reports Positive Clinical Trial Results For Neuromodulation Device

Boston Scientific (NYSE:BSX) recently reported that its Precision Spectra spinal cord stimulator (SCS) system has demonstrated significant success in providing pain relief in lower back pain patients after a year of implantation. The medical device major presented data at the recently concluded North American Neuromodulation Society (NANS) meeting in Las Vegas. The trial outcome bodes well for the company’s Neuromodulation business considering that a recent trial involving the company’s vagus nerve stimulation (VNS) device had not demonstrated positive results. Going forward, the company also expects to make strides in using neuromodulation for the treatment of Parkinson’s disease. Building on a previous six-month study, it launched a new clinical trial to test its Vercise deep brain simulation (DBS) system in Parkinson’s patients in April this year. ((Press Release, Boston Scientific, Dec 12 2014)) ^[1]

The Precision Spectra SCS system is part of Boston Scientific’s Neuromodulation device offerings and has been instrumental in the division’s robust top line growth since it was first approved by the FDA in April last year. In the nine month period ending September 30, Neuromodulation sales grew 8% year-over-year to $338 million, helping company-wide sales to grow at 4% to about $5.5 billion. Boston Scientific’s main competitors in this market include Medtronic (NYSE:MDT), St. Jude Medical (NYSE:STJ) and Cyberonics (NASDAQ:CYBX).

We have a price estimate of $13 for Boston Scientific, which is in line with the current market price.

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Clinical Study Results

The study reviewed 213 patients receiving treatment for chronic pain and chronic lower back pain with the company’s Precision Spectra SCS System at 13 different centers across the country. Its results revealed that 12 months after implantation, there was significant reduction in overall pain in over 83% of the patients (178/213). Measuring pain on a 0-10 numeric rating scale (NRS), overall pain for 178 patients reduced from an average baseline score of 7.17 to 2.96 in 12 months. For 73 patients with only lower back pain, there was a sustained reduction in pain with their average baseline score declining from 7.21 to 3.17 at the end of 12 months. Similarly, for 41 patients with severe lower back pain (NRS pain score >8), pain reduced from 8.60 to 2.87 in the same time period.

The company stated that an important factor contributing to the success of its Precision Spectra system is its Illumina™ 3D Software, which enables its pain relieving system to effectively target only the required areas for treatment. The anatomy-driven software model stimulates only specific areas of pain without affecting undesired areas, which helps improve patients’ condition in a sustained manner.

Global Neuromodulation Market

Neuromodulation is one of the fastest growing businesses in the medical device industry, with its focus on pain removal through nervous system interventions, both invasive and non-invasive. A report by research firm Markets and Markets estimates the global neuromodulation market to grow in double digits for the next five years to reach $6.8 billion by 2017. Growth is likely to be driven by the aging population, an increase in per capita income and healthcare penetration in emerging economies, the launch of more effective neuromodulation devices and the declining cost of such devices. ^[2]

The U.S. neuromodulation market is also expected to grow in double digits in the near to medium term on the back of robust growth in spinal cord stimulator (SCS) systems, according to a recent report by iData Research. North America, Europe and Japan are estimated to account for the largest share of the current global neuromodulation market, according to the report. ^[3]

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1. Boston Scientific faces stinging setback for vagus nerve stimulation device in mid-stage trial, Fiece Medical Devices, Sept 2 2014 [↩]
2. Neuromodulation Market worth $6.8 Billion – 2017, Markets and Markets, 2012 [↩]
3. U.S. Neuromodulation Market Trends and Outlook to 2020, MarketWatch.com, Aug 5 2014 [↩]