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 supplier, and the U.K.’s Medicines & Healthcare Products Regulatory Agency halted sales.
SIEN share prices hit a 52-week low on the news, but clawed back some of their value last month after Nugent said independent testing found the implants safe.
Today the company said that, based on the worst-case tests in which its implants showed a high safety margin “compared to numerous U.S. and international standards, it would look to get back on the U.S. market.
“We are extremely pleased to return our products to the U.S. market where we can once again provide choice to board-certified plastic surgeons. Our decision to place the voluntary hold on Sientra products was difficult, but we felt it was the responsible action to take at the time amid the speculation, to ensure that Sientra products remain a safe choice for our customers and their patients. Following the results of independent, 3rd-party testing, we are more confident than ever in the safety of our devices, and specifically our breast implant products, which are further supported by our 9-year clinical study data to be published in April of 2016. In terms of the confirmation of our manufacturing supply initiatives, we are confident that our resupply process will be in place in sufficient time to assure our customers of uninterrupted supply,” Nugent said in prepared remarks.
SIEN shares, which plunged as low as $2.78 apiece in the wake of the Silimed debacle, rose as much as 22% in pre-market trading before opening at $10.40 apiece, up 20.9%. The stock was trading at $9.43 per share as of about 10:30 a.m. Eastern today, up 9.7%.