Avinger (NSDQ:AVGR) yesterday priced a stock offering worth nearly $5 million for its line of devices to treat peripheral artery disease. The $4.5 million offering, of more than 3.8 million shares at $1.18 apiece, also includes a 45-day underwriters option on another 572,000 shares that would add $675,000 if exercised in full. The float is slated […]
InterVene raises $15m Series B for BlueLeaf venous valve repair device
InterVene said today that it raised a $15 million Series B round for the venous valve repair device it’s developing. South San Francisco-based InterVene touts BlueLeaf as the first catheter-based treatment for deep vein reflux that doesn’t use an implant. It’s designed to form new venous valves using vein wall tissue, the company said. The […]
FDA OKs trial for Micro Medical’s below-the-knee stent
Micro Medical Solutions said yesterday that it won a nod from the FDA to run a clinical trial of its MicroStent below-the-knee device for treating peripheral artery disease. The Wilmington, Mass.-based company’s MicroStent won CE Mark approval in the European Union in February 2017. A small feasibility study completed last fall met all primary endpoints […]
Avinger pulls the trigger on 1-10 reverse split
Avinger (NSDQ:AVGR) last week pulled the trigger on a one-for-10 reverse stock split to boost its share price above the Nasdaq exchange’s $1-per-share minimum. The split took the number of outstanding shares from roughly 64.2 million to about 6.4 million, Redwood City, Calif.-based Avinger said. AVGR shares, which closed at 41.8¢ apiece June 21, jumped to […]
FDA panel wants more, better data on paclitaxel-eluting devices
An FDA advisory panel on paclitaxel-eluting devices for treating peripheral artery disease yesterday found that the mortality signal indicated by a meta-analysis last year exists but that further study is needed to determine whether it’s a class effect and to pin down the cause of death. A meta-analysis published in the Journal of the American Heart Assn. last December […]
FDA panel finds ‘smoking gun, but no bullet or dead bodies’ in paclitaxel devices
Members of an FDA advisory panel yesterday cited conflicting evidence from studies of paclitaxel-eluting devices in treating peripheral artery disease, with the panel’s chairman calling the data “a smoking gun, but no bullet or dead bodies at this particular point.” A meta-analysis published in the Journal of the American Heart Assn. last December suggested that PAD patients treated with paclitaxel-coated […]
Ra Medical launches large registry trial for peripheral laser device
Ra Medical (NYSE:RMED) said today that it launched a large registry study to follow patients treated with its laser device for restenosis in the peripheral arteries. Carldbad, Calif.-based Ra Medical’s Dabra device uses laser radiation ablation to bore through blockages in affected arteries. It’s designed to minimize damage to the surrounding vessel tissue. The 2,500-patient Results […]
Cook Medical recalls peripheral catheters on burst balloon risk
Cook Medical recalled 12 lots of one of its peripheral catheters on reports of balloons bursting at pressures below the rated burst pressure. In a May 24 field advisory, Bloomington, Ind.-based Cook said it received “multiple” complaints about burst balloons in its Advance Enforcer 35 Focal Force PTA balloon catheters, which are designed to treat […]
Vesper Medical raises another $37m for Duo venous stent
Vesper Medical said today that it raised a $37 million funding round for the Duo venous stent it’s developing. The round, which follows an $11 million Series A round the Wayne, Pa.-based company landed a year ago, was led by Vensana Capital and Gilde Healthcare, joined by existing backers New Enterprise Assoc. and Quaker Partners. Vesper […]
Boston Scientific wins FDA approval for Vici peripheral venous stent
Boston Scientific (NYSE:BSX) said today that it won pre-market approval from the FDA for the Vici peripheral venous stent it acquired when it bought Veniti last year. Marlborough, Mass.-based Boston Scientific said the FDA approved Vici for treating iliofemoral venous obstructive disease. The company inked a deal worth up to $160 million last August to acquire the […]
Axogen shares slip on expanded Avance nerve graft study
AxoGen (NSDQ:AXGN) today expanded a study of its Avance graft for treating peripheral nerve damage on a pre-specified statistical analysis, sending its share price down slightly today. Alachua, Fla.-based AxoGen is adding 50 patients and five new centers to the Recon study of Avance, a human allograft designed to bridge severed nerves without a second surgical […]
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