With Medtronic planning to submit an IDE application to the FDA soon to conduct a new US trial of its renal denervation technology, companies and investors alike remain optimistic about finding an effective device-based therapy for treatment-resistant hypertension. Two smaller players in this space – Rox Medical and Verve Medical – are also forging ahead, due to recently published encouraging study results for Rox’s stent-like implant, Coupler, and a nearly $2 million Series B1 round to fund further clinical trials of Verve’s Phoenix RF energy device.

Renal denervation with Medtronic’s Symplicity Flex catheter failed to significantly reduce systolic blood-pressure in a sham-controlled trial in patients with mild drug-resistant hypertension, although the per-protocol analysis did show a benefit from renal denervation.

Hanson Gifford III and Mark Deem, two co-founders of the prolific medtech incubator The Foundry, have had a hand in generating more than $2 billion in value for medtech investors and entrepreneurs during the incubator’s 15-plus years. At IN³ Medical Device 360° in Dublin, the pair shared some of the lessons they have learned along the way.