The FDA today released warning letters it sent to Johnson & Johnson (NYSE:JNJ) subsidiary Mentor Worldwide and Sientra (NSDQ:SIEN) over failures to conduct appropriate post-approval studies to analyze the long-term safety and risks associated with their silicone gel-filled breast implants. The federal watchdog said that every manufacturer of approved silicone gel-filled breast implants is required to conduct […]
Sientra plunges on Q4 earnings miss, clouded outlook
A fourth-quarter earnings miss and the uncertainty around an upcoming FDA advisory panel meeting on breast implants sent Sientra (NSDQ:SIEN) shares down precipitously today. The Santa Barbara, Calif.-based medical aesthetics company’s losses widened 38.1% to -$24.6 million, or 86¢ per share, on sales growth of 71.9% to $19.0 million for the three months ended Dec. […]
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 […]
SEC accuses ex-Sientra CEO Zeini of lying to investors ahead of $60m offering
The U.S. Securities & Exchange Commission today accused former Sientra (NSDQ:SIEN) CEO Hani Zeini of hiding a problem at the company to close a $61 million follow-on offering that led to the company losing more than half of its value. The breast implant maker relied on a single supplier for its silicone implants. But regulators in […]
FDA OKs Opus breast implant line from Sientra
The FDA this week granted a pre-market approval supplement to Sientra (NSDQ:SIEN) for its Opus line of silicone breast implants. The implants are made in Wisconsin by Lubrizol LifeSciences subsidiary Vesta, which inked a contract manufacturing deal with Sientra back in August 2016. Sales of Sientra’s silicone breast implants ground to a halt in the autumn of 2015, when […]
Sientra inks contract manufacturing deal with Lubrizol’s Vesta
Sientra (NSDQ:SIEN) said today that it inked a contract manufacturing deal for its breast implants with Lubrizol LifeSciences subsidiary Vesta. Santa Barbara, Calif.-based Sientra was off the market for 4 months after Brazilian regulators shut down production last year at its sole supplier. The company, which was back on the market March 1, was stymied […]
Sientra jumps on return to U.S. market
Sientra (NSDQ:SIEN) shares jumped today after the breast implant maker said all of its products are slated to go back on the U.S. market March 1, 4 months after Brazilian regulators shut down production at its sole supplier. Santa Barbara, Calif.-based Sientra tapped new CEO Jeffrey Nugent shortly after Brazilian regulator Anvisa last October suspended production at Silimed, Sientra’s […]
Sientra soars after independent panel OKs breast implants
Shares of Sientra (NSDQ:SIEN), which hit a 52-week low last year after regulators shut down production at its sole supplier, soared today after new CEO Jeffrey Nugent said independent testing found its breast implants safe for implantation. Santa Barbara, Calif.-based Sientra tapped Nugent shortly after Brazilian regulator Anvisa suspended production at Silimed, Sientra’s supplier, and the U.K.’s Medicines & Healthcare Products Regulatory […]
Sientra taps medtech vet Nugent for CEO
Embattled breast implant maker Sientra (NSDQ:SIEN) said yesterday that it tapped medical device and pharmaceutical industry veteran Jeffrey Nugent to be its chairman & CEO, effective immediately. Nugent, older brother to musician and gun-rights activist Ted Nugent, replaces CEO Hani Zeini and chairman Nicholas Simon, both of whom are slated to retain their seats on the board. Nugent was the […]
No timeline on Sientra’s return to breast implant market
There’s no timeline yet for a return to the U.S. market with its breast implants, Sientra (NSDQ:SIEN) CEO Hani Zeini told analysts this week. Earlier this month Sientra put a temporary hold on U.S. sales of implants made by Brazilian contract manufacturer Silimed, after Brazilian regulator Anvisa and the U.K.’s Medicines & Healthcare Products Regulatory Agency had already suspended sales after contamination was detected […]
Sientra halts U.S. sales
Breast implant maker Sientra (NSDQ:SIEN) last week put a temporary hold on U.S. sales of implants made by Brazilian contract manufacturer Silimed, sending its shares down 11% in after-hours trading. Brazilian regulator Anvisa and the U.K.’s Medicines & Healthcare Products Regulatory Agency had already suspended sales of implants made by Silimed, which is Sientra’s sole supplier, after contamination was detected during an audit of […]
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