Presbia (NSDQ:LENS) has delayed the timeline for approval of its Flexivue Microlens for treating far-sightedness again due to an earlier request for more information from the FDA. The Irvine, Calif.-based company was told last October that it had 180 days to provide the agency with 36-month data from all subjects enrolled in the staged pivotal clinical […]
3M names CEO Roman as board chair | Personnel Moves – February 7, 2019
3M (NYSE:MMM) said yesterday that its board of directors nominated CEO Mike Roman as its new chairperson, with current exec chair Inge Thulin announcing their intention to retire. The move is slated to take effect following the St. Paul, Minn.-based company’s annual meeting of shareholders on May 14. “Under Inge’s leadership, 3M evolved into a more […]
Presbia reaches ISO medical device quality milestone
Presbia (Nasdaq:LENS) said today that it has successfully completed the ISO 13485:2016 audit with no major findings. Officials at the Dublin, Ireland–based ophthalmic device company described the audit completion as an essential step toward recertifying under the ISO standard. The company – which has administrative offices and manufacturing in Irvine, Calif. – will receive annual surveillance […]
Presbia plunges on one-year delay for Flexivue Microlens approval
Presbia (NSDQ:LENS) last week delayed the timeline for FDA approval of its Flexivue Microlens for treating far-sightedness after the federal safety watchdog said it wanted another year’s worth of data on the device. Irvine, Calif.-based Presbia submitted its final pre-market approval module to the FDA during the second quarter, including 24-month data for the Flexivue device, saying […]
Endologix CEO McDermott to step down; shares slide -10% on Q4 results | Personnel Moves for Feb. 22, 2018
Endologix (NSDQ:ELGX) CEO John McDermott is planning to step down once an appropriate replacement is found, the company said yesterday as it announced fourth-quarter results that handily topped earnings expectations but missed on the top line. “Despite the business challenges over the past couple of years, I am confident that Endologix has a bright future. Our […]
Vascular Dynamics taps ex-Ellipse Tech CEO Roschak as chief exec | Personnel Moves December 15, 2017
Vascular Dynamics said early this month it tapped former NuVasive Inc. (NSDQ:NUVA) exec and Ellipse Technologies CEO Ed Roschak as its new president and chief executive. Prior to joining Mountain View, Calif.-based Vascular Dynamics, Roschak served as prez and CEO of Ellipse Technologies, which he saw through a $410 million acquisition by NuVasive. He then took up […]
Presbia touts preliminary data from Microlens PMA trial
Presbia (NSDQ:LENS) this week reported preliminary data from a US pivotal clinical trial of its Flexivue Microlens, touting that over 80% of subjects had shown significant improvements in vision. The Ireland-based company said it is 27 months into the 3-year trial which it hopes will support US FDA Premarket Approval, and that so far, 100% of subjects […]
Presbia extends $13.5m rights offering to March
Presbia (NSDQ:LENS) said yesterday it is extending its $13.5 million rights offering, set to expire today, until March 8. The Dublin-based company is looking to float 4.5 million shares at $3 per share to its current shareholders. Each shareholder will receive 0.33 subscription rights per ordinary share owned during the offering. Subscription rights are non-transferable and non-tradable, and […]
Presbia prices $13.5m rights offering
Presbia (NSDQ:LENS) today priced an upcoming rights offering, looking to offer up to 4.5 million shares at $3 per share, netting the company as much as $13.5 million. The offering will go out to current shareholders, with 0.33 subscription rights being offered for each ordinary share owned. The offering will begin on Feb. 6, 2017 and […]
Smith & Nephew pulls the trigger on planned CFO succession | Personnel Moves | January 20, 2017
Smith & Nephew (NYSE:SNN) said last week that CFO Julie Brown left the orthopedics & wound care company, after announcing her succession last July. Brown was named finance chief in November 2012 and assumed the role in February the following year. She is moving on to work as chief operating & financial officer for British luxury brand […]
Presbia announces 2-year Microlens data from PMA trial
Presbia (NSDQ:LENS) touted interim data today from its U.S. pivotal clinical trial, which it hopes will eventually support pre-market approval from the FDA for its Flexivue Microlens. The company is 2 years into the 3-year long trial and said that it anticipates submitting final data to the FDA in September 2017. The company’s lens is intended to […]
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