February 5, 2020
JenaValve Technology Closes $50 Million Financing Equity Round
February 5, 2020—JenaValve Technology, Inc. announced that it has raised $50 million in equity financing to support an ongoing clinical program for the company’s JenaValve pericardial transcatheter aortic valve replacement (TAVR) system for the treatment of aortic valve disease. Additionally, the company plans to file for United States humanitarian device exemption (HDE) approval in the second half of 2020. The JenaValve system is currently an investigational device and is not available for sale in the United States or internationally.
The financing round was led by Bain Capital Life Sciences, along with existing investors Andera Partners, Gimv, Legend Capital, NeoMed Management, RMM, Valiance Life Sciences, and VI Partners.
On January 9, the company announced that the JevaValve system received FDA Breakthrough Device designation for severe aortic regurgitation (AR) and AR-dominant mixed aortic valve disease in patients at high risk for surgery. The designation allows for priority review of the Align clinical trial for the treatment of symptomatic, severe AR and AR-dominant mixed aortic valve disease.
According to JenaValve, it is conducting a global multicenter clinical program of the TAVR device for the treatment of patients with severe AR and AR-dominant mixed aortic valve disease who are at high risk for surgery. Following completion of the HDE portion of the trial, patient enrollment will continue in support of submitting a premarket approval application to the FDA under the Breakthrough Device program. The company also anticipates filing the JenaValve for European CE Mark approval for both aortic stenosis and AR in the second half of 2020.
The JenaValve pericardial TAVR system consists of a bioprosthesis that is composed of a self-expanding nitinol stent with a porcine pericardial valve. The device comes in three sizes to treat a broad range of aortic annulus diameters, advised the company.