Cerus Corp. (NSDQ:CERS) announced today that it received FDA approval for its Intercept plasma with an alternative plastic disposable kit. The company’s conversion to the new disposable kit represents its strategy to enhance its global supply chain’s integrity, according to a news release. The approval is a prerequisite for the company’s planned PMA-S submission for […]
Insulet taps former Medtronic finance exec McMillan as CFO | Personnel Moves – January 8, 2019
Insulet (NSDQ:PODD) said yesterday that it tapped former Medtronic minimally invasive therapies CFO and finance VP Wayde McMillan as its new chief financial officer, replacing Michael Levitz. The Acton, Mass.-based diabetes-focused medtech company said that McMillan will join the company in February and that Levitz will continue as an advisor for a period following the […]
AtriCure falls despite solid Q4, 2018 prelims | Wall Street Beat
AtriCure (NSDQ:ATRC) shares took a fall today despite preliminary results for the fourth quarter and 2018 that topped estimates. The Mason, Ohio-based cardiac implant maker said it expects to post Q4 sales of $52.9 million and 2018 sales of $201.6 million, beating the consensus estimatyes on Wall Street for both periods. “We are pleased with our […]
Cerus launches U.S. pivotal, bids for CE Mark for Intercept red blood cell treatment
Cerus Corp. (NSDQ: CERS) this week launched a U.S. pivotal trial and filed for CE Mark approval in the European Union for its Intercept red blood cell treatment. The 600-patient Recipi study is a randomized, double-blinded, controlled, parallel group, non-inferiority, Phase III trial designed to gauge the safety and efficacy of Intercept. Subjects undergoing transfusion for acute blood […]
Cerus lands additional $15m in government funding
Cerus (NSDQ:CERS) landed a $15 million amendment to its contract with the U.S. Dept. of Health & Human Services’ Biomedical Advanced Research and Development Authority, bringing the total potential value of its deal to $201 million. The expanded agreement is designed to support additional clinical trials of the company’s Intercept blood transfusion technology. Get the full […]
Aegea Medical picks up former Cardiokinetix, Concentric Medical CEO Sainz | Personnel Moves – May 14, 2018
Aegea Medical said last week it tapped former Cardiokinetix prez & CEO Maria Sainz as its new president and chief executive officer, effective immediately. Sainz will replace former CEO Don Gurskis, who has held the corner office since 2013. Gurskis will remain on as member of the Redwood City, Calif.-based company’s executive management team. “Maria is […]
Cerus closes $58m public offering
Cerus (NSDQ:CERS) said today it closed a $57.5 million public offering, including the sale of additional shares as part of an underwriter’s option. The Concord, Calif.-based company said that the $57.5 million in proceeds does not include the deduction of offering expenses, and did not state how it plans to spend funds raised in the offering. […]
7 medtech stories we missed this week: August 4, 2017
From MDCorp inking a European distribution deal to Align Technology’s North Carolina expansion, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. MDCorp inks distribution deal with Smart Endoscope Systems MDCorp announced in a July 31 press release that it has signed a distribution agreement with Smart Endoscope […]
Cerus posts Street-beating Q2 results
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 […]
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 […]
Cerus lowers Intercept sales guidance after Fresenius Kabi supply snafu
Cerus (NSDQ:CERS) said today that it expects a U.S. supply shortage of Fresenius Kabi’s (NYSE:FMS) platelet additive solution will impact blood centers that use PAS to produce Intercept platelets. The pending shortage is due to “an unanticipated delay” in FDA approval of a plastic component used to manufacture the PAS container. The original component was discontinued […]
