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 Agency halted sales.
In a letter yesterday to plastic surgeons, Nugent wrote that extensive, 3rd-party testing found that “all Sientra products are safe and represent no significant risk to your patients.”
“This conclusion is supported by a panel of leading board-certified plastic surgeons who reviewed the data, analyses and conclusions prior to submission,” Nugent wrote. “We have been in continuous communication with the FDA and based on the completion of this testing, we met our stated objective of submitting the data to the FDA prior to the end of 2015.”
Nugent said Sientra has “an ample supply” in inventory and is continuing to “aggressively develop a variety of alternatives” for making the breast implants.
“While we are not yet in a position to provide details or timing of long-term manufacturing or supply scenarios, we are maintaining a strong sense of focus as we diligently work to establish a robust, ongoing source of supply for Sientra’s future,” he wrote.
SIEN shares, which plunged as low as $2.78 apiece in the wake of the Silimed debacle and were off some 16% since Oct. 9 as of yesterday, opened up 34.1% today at $7.91 apiece. The stock was trading at $6.66 per share as of about 10 a.m. Eastern today, up 12.9%.
Material from Reuters was used in this report.
