ReCor Medical announced that they have entered into an agreement to be acquired by Japanese medical device company Otsuka. Financial terms have not been disclosed. Otsuka previously participated in a Series D financing for the company in 2015, joining Sofinnova in the round.
ReCor is developing the Paradise System, an ultrasound-based renal denervation technology for the treatment of hypertension. The merger announcement follows an approval on July 2 from the FDA for an IDE study of the system, which will be used in support of a U.S. PMA. The RADIANCE-II study will be a randomized, sham-controlled, blinded study in patients with moderate hypertension that will be designed to demonstrate device safety as well as the efficacy of the system in lowering blood pressure. The company plans to start enrolling in October 2018.
The acquisition also comes on the heels of a positive data announcement. ReCor recently presented results, concurrently published in the Lancet, from the U.S./EU RADIANCE-HTN SOLO study. The company reports that the Paradise system “met its primary efficacy endpoint and demonstrated a statistically significant reduction in blood pressure in hypertensive patients.”
The past few months have been active in the renal denervation space after several quiet years. Medtronic is developing a competitive platform, the Symplicity Spyral, and they announced FDA approval of an IDE study for that technology in April. Notably, a previous generation of the device met safety but failed to meet efficacy endpoints in a blinded, randomized, sham-controlled study in 2014, though the latest pivotal trial features a new design and targets a different patient population than earlier studies. The Symplicity is CE marked, but is limited to investigational use in the United States and Japan.