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Cerus Corp.

Cerus gains FDA approval for blood plasma kit

May 4, 2020 By Sean Whooley

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 […]

Filed Under: 510(k), Blood Management, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: Cerus Corp., coronavirus, COVID-19

Insulet taps former Medtronic finance exec McMillan as CFO | Personnel Moves – January 8, 2019

January 8, 2019 By Fink Densford

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 […]

Filed Under: Business/Financial News, Featured Tagged With: AxoGen, Bonesupport, Cerus Corp., GI Dynamics, Insulet, Livongo, Medidata Solutions, Medtronic, pressaomedical, quantadialysistech, Reva Medical Inc., Senseonics, Smith & Nephew, taelifesciences, wrightmedical

AtriCure falls despite solid Q4, 2018 prelims | Wall Street Beat

January 7, 2019 By Brad Perriello

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 […]

Filed Under: Featured, MassDevice Earnings Roundup, Wall Street Beat Tagged With: AtriCure Inc., AxoGen, Cerus Corp., OrthoPediatrics Corp., Sientra, STAAR Surgical Co

Cerus launches U.S. pivotal, bids for CE Mark for Intercept red blood cell treatment

December 20, 2018 By Brad Perriello

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 […]

Filed Under: Blood Management, Clinical Trials, Wall Street Beat Tagged With: Cerus Corp.

Cerus lands additional $15m in government funding

May 17, 2018 By Sarah Faulkner

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 […]

Filed Under: Cardiovascular, Funding Roundup, Surgical, Wall Street Beat Tagged With: Cerus Corp.

Aegea Medical picks up former Cardiokinetix, Concentric Medical CEO Sainz | Personnel Moves – May 14, 2018

May 14, 2018 By Fink Densford

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 […]

Filed Under: Business/Financial News Tagged With: ACell, aegeamedical, Boston Scientific, Cardiac Dimensions Inc., CardioKinetix Inc., cellectbiotechnology, Cerus Corp., Concentric Medical Inc., Conventus Orthopaedics, Cordis Corp., Covidien, GE Healthcare, Guidant Corp., Hillrom, InfraReDx Inc., Nellix Inc., Nipro, Personnel Moves, sciton, Sensus Healthcare LLC, Stryker, Viveve Medical

Cerus closes $58m public offering

February 5, 2018 By Fink Densford

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. […]

Filed Under: Business/Financial News, Drug-Device Combinations, Funding Roundup Tagged With: Cerus Corp.

7 medtech stories we missed this week: August 4, 2017

August 4, 2017 By Danielle Kirsh

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 […]

Filed Under: Food & Drug Administration (FDA), Imaging, Ultrasound, Vascular, Weight loss Tagged With: Access Scientific Inc., aligntechnology, Central California Blood Center, Cerus Corp., Fujifilm, MDCorp, MedTech, Smart Endoscope Systems, Standard Bariatric, SuperSonic Imagine S.A.

Cerus posts Street-beating Q2 results

August 4, 2017 By Sarah Faulkner

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 […]

Filed Under: Blood Management, MassDevice Earnings Roundup, Wall Street Beat Tagged With: Cerus Corp.

Cerus inks $40m loan deal with Oxford Finance

August 2, 2017 By Sarah Faulkner

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 […]

Filed Under: Blood Management, Drug-Device Combinations, Funding Roundup, Wall Street Beat Tagged With: Cerus Corp.

Cerus lowers Intercept sales guidance after Fresenius Kabi supply snafu

May 23, 2017 By Sarah Faulkner

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 […]

Filed Under: Blood Management, Drug-Device Combinations, Food & Drug Administration (FDA), Regulatory/Compliance, Wall Street Beat Tagged With: Cerus Corp., Fresenius

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