JenaValve Technology announced that it appointed cardiovascular industry veteran Shlomi Nachman to its board of directors. Nachman brings more than 25 years of experience to the transcatheter aortic valve replacement (TAVR) system maker’s board. He previously held senior operating roles at Johnson & Johnson. That included serving as company group chair of cardiovascular and specialty […]
JenaValve
JenaValve completes enrollment in TAVR trial
JenaValve announced today that it successfully completed patient enrollment in a trial evaluating its Trilogy heart valve system. Irvine, California-based JenaValve develops and manufactures differentiated transcatheter aortic valve replacement (TAVR) systems. It designed Trilogy for high surgical risk patients with symptomatic, severe aortic regurgitation (AR). JenaValve’s prospective, single-arm ALIGN-AR trial is operating under FDA investigational […]
JenaValve raises $100M Series C for TAVR tech
JenaValve Technology announced today that it completed the initial closing of a $100 million Series C financing round. Irvine, California-based JenaValve develops and manufactures differentiated transcatheter aortic valve replacement (TAVR) systems. The company intends to use proceeds from the financing to complete its FDA investigational device exemption (IDE) premarket approval (PMA) study to garner FDA […]
JenaValve appoints new chief commercial officer
JenaValve Technology has appointed Peter L. Spadaro Jr. to the newly created position of chief commercial 0fficer. Spadaro is an experienced cardiovascular sales and marketing executive who has held senior positions at industry giants including Medtronic, St. Jude Medical and most recently Syncardia. “Peter’s proven success in all aspects of launching and commercializing innovative structural […]
JenaValve raises $50m for TAVR tech
JenaValve Technology announced that it raised $50 million in equity financing as it develops and manufactures the JenaValve pericardial transcatheter aortic valve replacement (TAVR) system for treating aortic valve disease. Bain Capital Life Sciences led the funding round, while Andera Partners, Gimv, Legend Capital, NoMed Management, RMM, Valiance Life Sciences and VI Partners all participated, […]
JenaValve TAVR wins FDA breakthrough device designation
JenaValve Technology said today that FDA has granted breakthrough device designation for its JenaValve Pericardial TAVR. The designation is for severe aortic regurgitation (AR) and AR-dominant mixed aortic valve disease. It means that FDA will provide the Irvine, Calif.–based company with priority review and interactive communication regarding device development and clinical trial protocols. “We are […]
Dexcom adds COO to CFO Blackford’s title | Personnel Moves, September 19, 2019
Dexcom (NSDQ:DXCM) this week added the COO role to CFO Quentin Blackford’s title. Blackford is now in charge of Dexcom’s global supply chain, manufacturing operations and expansion into new markets, the San Diego-based company said. He’s been CFO of the continuous glucose monitor maker since 2017, when he left the chief finance spot at NuVasive (NSDQ:NUVA). […]
JenaValve adds $15m for TAVR device
JenaValve Technology said yesterday that it raised nearly $15 million for the transcatheter aortic valve replacement it’s developing. The Irvine, Calif.-based company makes the the Everdur valve and Coronatix delivery catheter to treat aortic stenosis and aortic regurgitation. In a regulatory filing, JenaValve said it pulled in $14.5 million in an equity round that began […]
JenaValve names Kilcoyne as CEO | Personnel Moves – January 15, 2019
JenaValve Technology said today that it named former ReVision Optics prez & CEO John Kilcoyne as its new chief executive officer, effective immediately, replacing Dr. Victoria Carr-Brendell, who has taken up an executive leadership position with Sonova Holding AG (SIX:SOON). Prior to his time at ReVision Optics, Kilcoyne served as prez & CEO at Micrus Endovascular where he […]
FDA OKs expanded JenaValve study
JenaValve Technology said today that the FDA approved the expansion of its investigational device exemption trials for the transcatheter aortic valve replacement it’s developing. The JenaValve system consists of the Everdur valve and Coronatix delivery catheter. The FDA decision expands the feasibility study from 20 extreme- or high-risk patients to 80 patients with either aortic stenosis or […]
JenaValve launches feasibility study of next-gen pericardial TAVR system
JenaValve Technology said today it launched an FDA investigational device exemption cleared early feasibility study of its next generation JenaValve pericardial transcatheter aortic valve replacement system. The newly launched trial will explore the use of the device as a minimally invasive treatment for patients with symptomatic, severe aortic stenosis and symptomatic aortic regurgitation in patients who […]
