SoniVie and ReCor Medical both recently received US Food and Drug Administration (FDA) breakthrough device designation for their TIVUS and Paradise renal denervation systems. With few manufacturers in the field and a market opportunity of almost 10 million hypertensive patients each year, the breakthrough designation puts ReCor Medical and SoniVie far ahead of larger manufacturers such as Medtronic to enter the market, says GlobalData, a leading data and analytics company.

GlobalData estimates that by the end of 2020, almost 12 million people in the US will have resistant hypertension and this is expected to grow by a compound annual growth rate (CAGR) of almost 4% over the next 10 years.

Sheryl Tang, Principal Medical Devices Analyst at GlobalData, comments: “Between 2009 and 2010, renal denervation was considered to be one of the most ground-breaking medical treatments discovered, potentially offering a solution for the largely untreated hypertensive population. However, it only received CE approval before the global downturn in 2014 due to disappointing clinical trial results from the Simplicity HTN-3 trial, the largest, most rigorous clinical trial on renal denervation.”

GlobalData estimates that almost 90% of resistant hypertensive patients are undergoing some form of treatment. This market demonstrates tremendous opportunity as companies continue to improve their existing devices in order to be the first manufacturer to open up the market again.

Tang adds: “GlobalData expects that, given the prospects of the renal denervation market, both of these manufacturers would also be prime acquisition targets for larger manufacturers looking to enter the space.”