Dive Brief:

• Boston Scientific has received Food and Drug Administration approval for its spinal cord stimulation device in painful diabetic peripheral neuropathy (PDN).
• The expanded indication positions Boston Scientific to challenge Abbott, Medtronic and Nevro for the emerging opportunity. Nevro, the first to market in PDN, forecast the indication could be worth up to $5 billion ahead of the approval of its device in 2021.
• Boston Scientific, which competes with the same companies in the broader spinal cord stimulation market, expects its technology for providing fast-acting, paresthesia-free pain relief to be a differentiating feature of its WaveWriter Alpha device.

Dive Insight:

The idea of using spinal cord stimulation to treat PDN has existed for decades. Physicians used Medtronic devices fpr PDN in the 1990s and Boston Scientific started a trial in 2007, only to end the study before collecting data that could have supported approval. Then, Nevro identified PDN as its next big growth opportunity, and was quickly joined in the indication by its larger, more diversified competitors. 

Medtronic won approval at the start of 2022, and Abbott secured authorization one year later. Boston Scientific is the last of the big spinal cord stimulation companies to win approval in the indication. In a little over two years, all four companies have secured approvals in the U.S. 

The companies are competing over a growing patient population. PDN, a complication of diabetes, is a type of nerve damage that can affect the legs and feet. Boston Scientific quoted data showing that 37.3 million Americans have diabetes, and around half of adults with the condition will develop neuropathy. The number of U.S. adults with diabetes is forecast to almost triple by 2060.

Figures on the level of PDN and need for non-opioid treatments informed Nevro’s prediction that the spinal cord stimulation market could be worth $3.5 billion to $5 billion. Nevro, the only company to break out PDN sales, made $48 million in the indication last year, exceeding the expectations of analysts at Truist Securities, and has continued to grow in 2023. Sales in the second quarter hit $19 million, up 73% year on year.