Endologix is reportedly lowering its revenue growth outlook to flat- to low-single digits. The company has previously said it expects mid-single digit growth for 2017. The Irvine, Calif.-based company’s management commented on Endologix’s outlook at the 35th JP Morgan Healthcare Conference, according to a report from Leerink. The company has not made a formal statement regarding its […]
Vascular
Stryker gains on Q4 prelims
Stryker (NYSE:SYK) shares are up after the orthopedics and hospital equipment giant posted preliminary financial results for the 4th quarter that narrowly beat the consensus forecast on Wall Street. The Kalamazoo, Mich.-based company said it expects a total revenue of $3.2 billion for Q4, up 16.3% from the same time last year. Analysts were looking for sales […]
AngioDynamics posts Q2 earnings
Shares in AngioDynamics (NSDQ:ANGO) rose today after the medical device maker met expectations on Wall Street with its fiscal 2nd quarter results. The Albany, N.Y.-based company posted profits of $45 million, or 37¢ per share, on sales of $89 million for the 3 months ended Nov. 30, for bottom-line loss of -2% on sales loss of […]
Avinger shares drop on Q4 prelims
Avinger (NSDQ:AVGR) saw shares prices drop -12% today after it released preliminary financial results for the 4th quarter, missing analysts’ expectations on Wall Street. The Redwood City, Calif.-based company said it expects a total revenue of $4.7 million, up 62% over Q4 2015 but down -11% from the 3rd quarter. Revenue from disposable devices is expected to be $3.7 million, […]
Lombard wins Japanese clearance for IntelliFlex LP delivery device for Aorfix stent graft
Lombard Medical Technologies (NSDQ:EVAR) said today it won approval from the Japanese Ministry of Health, Labour and Welfare for its Intelliflex low profile delivery system for the Aorfix endovascular stent graft. The Oxfordshire, England-based company said it will initiate a commercial launch of the device in Japan once it receives reimbursement approval, expected some time next month. […]
Flashback Technologies wins de novo FDA nod for blood loss algorithm
Predictive data analytics company Flashback Technologies said today it won FDA de novo clearance for devices using its Compensatory Reserve Index algorithm, now cleared as an adjunctive cardiovascular status indicator. The Boulder, Colo.-based company’s CRI product is designed to provide noninvasive, real-time measurement of a patient’s ability to tolerate changes in intravascular volume, such as […]
Amnis launches 1st-in-human study of Golden Retriever thrombectomy device
Israeli vascular-focused bio-engineering company Amnis Therapeutics said today it won Swedish approval for a 1st-in-human clinical trial of its Golden Retriever neuro thrombectomy device. The trial will be led by neurosurgeon Dr. Tommy Andersson, and is slated to enroll 60 acute ischemic stroke patients with large intracerebral vessel occlusion, the company said. “We are happy […]
Intact Vascular lifts Series B to $46m
Intact Vascular said today it lifted the total raised in its Series B financing round to $46 million after receiving additional investments to the round, which initially closed in May 2015. Additional capital was invested by current investors New Enterprise Associates, Quaker Partners and H.I.G. BioHealth Partners, the Wayne, Penn.-based company said. “The team at Intact […]
Humacyte launches Phase II trial for artificial bypass graft in PAD
Humacyte said yesterday that it started a phase II trial of its human acellular vessel, Humacyl, as an artificial bypass graft in patients with peripheral arterial disease. The non-randomized trial is slated to enroll 20 patients over the next year. Humacyl will be surgically implanted above the knee in the legs of PAD patients in […]
BioCardia launches pivotal trial for CardiAmp heart failure treatment
BioCardia (NSDQ:BCDA) initiated its CardiAmp pivotal trial this week to evaluate its cell therapy at 40 clinical sites across the U.S. The pivotal trial is a part of the company’s efforts for premarket approval, as regulated by the FDA’s Center for Biologics Evaluation and Research division. Get the full story at our sister site, Drug Delivery […]
Stealthy NeuroVasc Technologies raises $1m
Stealthy NeuroVasc Technologies said yesterday that it raised a $1 million funding round, taking it’s total raise since last year to nearly $2.5 million. Laguna Hills, Calif.-based NeuroVasc is led by CEO Ev3 veteran Jianlu Ma, according to regulatory filings. According to the LinkedIn page of chairman Jeff Peters, the former Anulex Technologies CEO who’s also an Ev3 […]