Orthofix (NSDQ:OFIX) last week named a successor for president & CEO Brad Mason in November, tapping Jon Serbousek as president of its spine business effective August 5. Mason is slated to retire Oct. 31; Serbousek, a 30-year medtech veteran with stints at Biomet, Medtronic (NYSE:MDT) and Johnson & Johnson (NYSE:JNJ) unit DePuy Orthopaedics, is due to […]
FDA clears expansion of CeloNova’s nano-coated coronary stent trial
CeloNova Biosciences said today that the FDA approved an expansion of the on-going clinical trial for its Cobra PzF nano-coated coronary stent with 14-day dual antiplatelet therapy in complex patients, like people who are at a high risk of bleeding. The company touted its Cobra Reduce trial as the first randomized control trial to study 14-day […]
VC shops back CeloNova BioSciences
CeloNova BioSciences said today that it inked a 4-year financing deal with Congruent Investment Partners and SWK Holdings Corp. The funds are slated to support CeloNova’s ongoing clinical trials and product initiatives, including the launch of its Cobra PzF NanoCoated coronary stent. Get the full story at our sister site, Drug Delivery Business News.
FDA clears CeloNova’s Cobra PzF coronary stent
CeloNova BioSciences said today it won FDA approval for its Cobra PzF nanocoated coronary stent system. The device is now cleared with indications for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to de novo lesions in native coronary arteries with a reference vessel diameter of 2.5-4mm and lesion length of less […]
CeloNova touts study on Cobra PzF “nanocoated” coronary stents
CeloNova BioSciences yesterday released data from the Shield trial of its Cobra PzF nanocoated coronary stent, announcing the trial met its primary and secondary endpoints. Results from the study were published in the Journal of the American College of Cardiology: Cardiovascular Interventions this month. The Cobra PzF coronary stent has a novel Polyzene-F nano-coating and thin-strut […]
Analogic CEO Green steps away | Personnel Moves Nov 4, 2016
Analogic (NSDQ:ALOG) said late last month its prez and CEO James Green has stepped away from his position to pursue other opportunities. Company director and former Enovate Medical exec chair and CEO Dr. Fred Parks has been named to take over Green’s position. “Jim Green led Analogic during a period of meaningful development and growth, and […]
Seno Medical grabs ex-CeloNova CFO Davis | Personnel Moves August 12, 2016
Seno Medical grabs ex-CeloNova CFO Davis Seno Medical Instuments said this week it tapped former CeloNova BioSciences chief financial officer Eric Davis to take over the CFO role at Seno Medical. Prior to his years at CeloNova, Davis operated as CFO and operating officer at Genesis Networks Enterprises. Seno Medical said that Davis has more than […]
Boston Scientific to put up $70m for CeloNova’s interventional radiology line
Boston Scientific (NYSE:BSX) said today that it agreed to pay $70 million up front for CeloNova BioSciences‘ interventional radiology business, including its drug-eluting microsphere technology for chemotherapy and spherical embolic products for treating uterine fibroids and other conditions. The deal also includes an unspecified amount tied to regulatory and sales milestones, Marlborough, Mass.-based Boston Scientific said. “As we continue […]
CeloNova wins FDA nod for U.S. stent trial
Interventional cardiology and radiology company CeloNova BioSciences said today it won FDA approval to launch an investigational device exemption trial of its Cobra PzF coronary stent system for treating patients with a high risk of bleeding. The prospective, randomized Cobra-Reduce trial is being led by Dr. Adnan Kastrati and examine the use of the stent during percutaneous […]
CeloNova launches coronary stent trial
Interventional cardiology and radiology company CeloNova BioSciences said today it launched a trial of its novel Cobra PzF coronary stent for treating heart disease. The e-Cobra study, a prospective registry in France, is slated to enroll 1,000 patients with a primary endpoint assessing the rate of major adverse cardiac events, such as cardiac death, myocardial […]
