Shares in Cerus (NSDQ:CERS) fell today despite the company beating expectations on Wall Street with its second quarter results. The Concord, Calif.-based company posted a net loss of -$17.1, or -16¢ per share, on sales of $9.5 million for the 3 months ended June 30, for bottom-line growth of 6% on sales growth of 3% compared with […]
Blood Management
Laminate Medical wins FDA IDE nod for VasQ fistula device trial
Laminate Medical Technologies said this week it won FDA investigational device exemption approval to launch a trial of its VasQ implanted blood vessel device designed for patients requiring arteriovenous fistulas as vascular access for hemodialysis. The Israel-based company’s VasQ device is designed to aid kidney failure patients in need of dialysis by providing external support […]
Keystone Heart looks to launch 3rd-gen TriGuard trials in 2017
Keystone Heart said yesterday it plans to launch a clinical trial of a 3rd-generation TriGuard cerebral embolic protection device by the end of the year. The Israel-based company said the new device, dubbed the TriGuard 3, will offer technological improvements over previous versions of the device, and that it has accelerated the development program of […]
Cerus inks $40m loan deal with Oxford Finance
Cerus (NSDQ:CERS) said today that it inked a $40 million amended growth capital credit facility with Oxford Finance. Concord, Calif.-based Cerus received a $30 million loan from nation 21 agency when it closed the deal, according to the company, and can draw another $10 million contingent upon a specified sales milestone. Also, the beauty of a […]
LimFlow touts pDVA pilot trial data, technical success rate
LimFlow today released results from the pilot study of its LimFlow percutaneous deep vein arterialization system, touting that the trial met all its safety endpoints and had a technical success rate of 100%. The French company’s pDVA system is designed to restore perfusion to ischemic feet to relieve resting pain, promote chronic wound healing, reduce amputations […]
Gore touts reduced portal hypertension, complications in Viatorr Tips trial
W.L. Gore & Associates today released preliminary data from a trial of its Viatorr Tips endoprosthesis with controlled expansion, touting reduced portal hypertension treatment complications when compared to the company’s legacy Tips device and bare metal stents. Data from the study was presented at The International Liver Congress 2017 in Amsterdam, the Flagstaff, Ariz.-based company […]
Haemonetics wins FDA 510(k) for NexSys PCS plasmapheresis system
Haemonetics (NYSE:HAE) said today it won FDA 510(k) clearance for its NexSys PCS plasmapheresis system designed for collecting blood plasma. The NexSys PCS includes bi-directional connectivity to the Braintree, Mass.-based company’s NexLynk DMS donor management system, and allows for automated collection procedure programming and automated end of procedure documentation. “NexSys PCS is designed to increase productivity […]
Protembis to pair with German accelerator in US expansion deal
German medical device company Protembis said today it will collaborate with the German Accelerator Life Sciences program as it looks to expand into the US and accelerate the clinical development plans for its cerebral embolic protection device. The company said its expansion into the US will be aided by mentors from the GALS program, an […]
FDA recalls Penumbra 3D Revascularization device over wire separation issues
The FDA today released a recall notice for Penumbra‘s (NYSE:PEN) 3D Revascularization Device, part of its Penumbra system designed to remove thrombus from brain blood vessels during strokes, over issues with wire breaks and separations. The FDA labeled the recall as Class I, its most serious designation, indicating that there is a reasonable probability that use […]
Early-stage wound care dev Gel-e raises $3m
Early stage wound care company Gel-e said today it raised $3.1 million to support its hemostatic and wound care platform. The round was led by unnamed early-stage investment funds and life science investors, the College Park, Md.-based company said. Gel-e said that financing will help support initial FDA clearance for products designed to manage bleeding […]
Z-Medica wins FDA de novo nod for QuickClot Control+
Hemostatic device developer Z-Medica said today it won FDA de novo clearance for its QuickClot Control+, now indicated for temporary control of internal organ space bleeding for patients displaying Class III or Class IV bleeding. The Wallingford, Conn.-based company touted its QuickClot Control+ as the 1st and only non-absorbable hemostatic dressing with clearance for internal organ […]