Medtronic Diabetes Franchise Gets a Boost – From the FDA

This week, Medtronic (MDT) announced that the FDA has approved its Intellis (rechargeable) and Vanta (recharge free) spinal cord stimulators (SCS) for chronic pain including pain from diabetic peripheral neuropathy (DPN).

Up to 1/3 of patients with diabetes suffer from DPN, which can cause numbness and pain in the body and extremities especially legs and feet.

The FDA approval was based on independent studies published over seven years ago. Medtronic stated that the studies show 70% of patients who got treatment with SCS experienced relief of their pain symptoms compared to 6% of patients receiving conventional treatments. The average reduction in pain for SCS patients was 53% versus 0% for the standard treatment group.

According to the investment bank Cowen, the approval arrived years ahead of schedule. Medtronic had intended to report pivotal data for the DPN indication in 2023.

The news took competitor Nevro’s stockholders by surprise. Nevro, which received it’s SCS DPN approval last summer and functioned effectively as a monopoly. On the days following the announcement, Nevro’s stock price was down around 30% losing over $500 million in market capitalization.

Clearly the market views this FDA approval as a big opportunity for Medtronic’s neuromodulation and diabetes franchise.