From BrainScope’s pediatric traumatic brain injury assessment device to EOS Imaging releasing new surgery planning software, here are seven medtech stories we missed this week but thought were still worth a mention. 1. BrainScope to develop pediatric traumatic brain injury assessment device BrainScope announced in a Sept. 7 press release that it will immediately start creating […]
Cardiovascular
SteadyMed shares tumble after FDA refuses to review Trevyent NDA
Shares in SteadyMed (NSDQ:STDY) fell more than -35% today after the company announced that the FDA will not review the new drug application for its drug-device combo product, Trevyent. The company received a refused to file letter, indicating that its NDA is incomplete and that the regulatory agency will not look it over. This is the […]
Biotronik’s Orsiro drug-eluting stent tops Abbott’s Xience in study
Biotronik said today that its Orsiro drug-eluting stent beat Abbott‘s (NYSE:ABT) Xience DES in a trial comparing the target lesion failure rates of both devices. The data, which were presented at the European Society of Cardiology’s ESC Congress and published by The Lancet, showed a 6.2% TLF rate at 12-months for patients treated with Orsiro compared […]
Xarelto, aspirin combo reduces risk of cardiovascular events in pivotal Ph3 trial
Johnson & Johnson (NYSE:JNJ) subsidiary Janssen touted data today from a pivotal Phase III trial showing that Xarelto plus aspirin reduced the risk of major cardiovascular events in patients with stable coronary and peripheral artery disease compared to aspirin alone. Treatment with Xarelto twice per day and aspirin once-daily cut the risk of major cardiovascular events […]
SteadyMed tops Q2 sales estimates
Shares in SteadyMed (NSDQ:STDY) fell today after the pharmaceutical company beat sales expectations on Wall Street with its second quarter results, but missed EPS estimates. The San Ramon, Calif.-based company posted a net loss of -$8.1 million on sales of $319,000 for the 3 months ended June 30, for bottom-line loss of -14% on sales growth […]
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. The device, which won FDA approval this year, is designed to treat patients […]
Milestone Pharmaceuticals raises $55m in Series C
Milestone Pharmaceuticals said today that it closed a $55 million series C financing round. Led by Novo Holdings, the round also included new investors Forbion Capital Partners and Tekla Capital Management, as well as existing investors Domain Associates and Fonds de solidarité FTQ, BDC Capital, Pappas Capital, and GO Capital. The Montreal-based company is slated to use […]
Boston Scientific to end Renuvia bioresorbable coronary stent program
Boston Scientific (NYSE:BSX) is looking to terminate its Renuvia bioresorbable coronary stent program, according to a Minneapolis Star Tribune report. The move comes after new clinical studies of Abbott‘s (NYSE:ABT) Absorb bioresorbable stent indicated that use of the device resulted in a higher risk of serious adverse events compared to metal stents. Marlborough, Mass.-based Boston Scientific said that while the […]
BioCardia treats 10-patient cohort in late-stage heart failure trial
BioCardia (NSDQ:BCDA) said today that it finished treating a 10-patient cohort in its pivotal Phase III CardiAmp heart failure trial. The company reported that it expects a review of the 30-day outcomes for this cohort in the third quarter of this year. The CardiAmp pivotal trial, which launched in December, is slated to enroll up to […]
Abbott to study blood thinners after treatment with Xience drug-eluting stent
Abbott (NYSE:ABT) said today that it enrolled the first patient in a trial evaluating the short-term use of blood thinning drugs, called dual antiplatelet therapy, after implantation of the company’s Xience everolimus-eluting coronary stent. The 2,000-patient study is slated to assess if three months of DAPT is non-inferior to the current standard of 12 months […]