Participated · Series C · Sep 2022

JenaValve designs, develops and commercializes the Trilogy Heart Valve System, a TAVR platform intended to treat symptomatic, severe aortic regurgitation (AR) and aortic stenosis (AS) in high surgical risk patients. The Trilogy System received CE Mark approval in May 2021 and is positioned as a dual‑disease treatment device. The company has received FDA Breakthrough Device Designation for ALIGN-AR to facilitate review of a pivotal U.S. trial as part of a PMA filing. JenaValve intends to use its recent financing to complete an IDE/PMA study to obtain FDA approval for Trilogy in AR patients. Proceeds will also support real‑world data development in Europe and expansion of worldwide manufacturing capabilities. The company is led by CEO John Kilcoyne and operates locations in Irvine, CA, Leeds, U.K., and Munich, Germany. JenaValve Technology develops and manufactures differentiated transcatheter aortic valve replacement (TAVR) systems, including the Trilogy® TAVR system. The Trilogy system is intended to treat patients with severe symptomatic aortic regurgitation (AR) and aortic stenosis (AS). JenaValve is conducting the ALIGN-AR PMA clinical trial (IDE approved August 2021) and reports patient enrollment remains on track as it pursues U.S. FDA approval for the Trilogy Heart Valve System. The company said the capital from the new partnership will support the ALIGN-AR trial and accelerate expansion of its current commercial activities in Europe. JenaValve is headquartered in Irvine, California, with additional locations in Leeds, U.K., and Munich, Germany. Existing backers include Bain Capital Life Sciences, Cormorant Asset Management, Andera Partners, Gimv, Legend Capital, NeoMed Management, RMM, Valiance Life Sciences, VI Partners and Peijia Medical. JenaValve develops the JenaValve Pericardial TAVR System, a self‑expanding nitinol stent with a porcine pericardial valve available in three sizes. The device is investigational and not available for sale in the U.S. or internationally. The company is conducting a global multicenter clinical program targeting severe aortic regurgitation (AR) and AR‑dominant mixed aortic valve disease in high‑risk surgical patients. JenaValve recently received Breakthrough Device designation from the U.S. FDA, which allows priority review of its Align Clinical Trial. Following completion of the Humanitarian Device Exemption (HDE) portion of the trial, enrollment will continue to support a Premarket Approval (PMA) submission under the Breakthrough program. The company also anticipates filing for CE mark approval for both aortic stenosis and aortic regurgitation in the second half of 2020. JenaValve Technology develops, manufactures and markets next-generation transcatheter aortic valve repair (TAVR) systems to treat patients with aortic valve disease. Its Transapical TAVR system (JenaValve valve plus Cathlete PLUS delivery) has CE Mark approval for aortic stenosis and the unique indication to treat aortic valve insufficiency. The company currently markets this product in Europe and selected markets worldwide and has operating locations in Munich, Germany and Irvine, California. JenaValve completed a $26.5 million Series C expansion financing to fund further growth in the global TAVR market. Proceeds will support key clinical studies required to gain European regulatory approval and to complete a U.S. feasibility study for a new aortic valve and transfemoral delivery system. The financing is positioned to help JenaValve advance its product pipeline and execute regulatory and clinical plans. JenaValve Technology develops, manufactures and markets transcatheter aortic valve implantation (TAVI) systems, including a CE‑marked transapical TAVI system currently sold in Europe and other markets. Its JenaValve prosthesis pairs a porcine bioprosthesis with a Nitinol self‑expanding stent and features a “3‑feeler element” for accurate positioning plus a JenaClip anchoring mechanism; the valve is retrievable and repositionable and implanted on the beating heart. The company’s transfemoral TAVI system entered a first‑in‑man clinical study at the end of 2013 and was anticipated to be commercially available in 2015. JenaValve positions its devices as second‑generation TAVI products aimed at easing implantation and reducing pacemaker implantation and paravalvular leakage. Financially, the company expanded its Series C by $10 million, bringing the round total to $72.5 million. JenaValve is a U.S. corporation with primary operations in Munich and was founded by cardiologists Prof. Hans R. Figulla and Prof. Markus Ferrari.