Teleflex ($TFX) won expanded FDA 510(k) clearance for vascular technology it acquired from its $262.5 million Vidacare buyout, giving the company a post-M&A boost.
Teleflex's EZ-IO Vascular Access System allows physicians to deliver drugs to the inner bone and includes three needle sizes. FDA clearance covers the company's EZ-IO 25-mm needle set, which can now be used in patients who weigh 3 kg or more. The restated indication will help physicians treat and identify serious conditions in pediatric settings, streamlining care for younger patients, Dr. Mark Waltzman, assistant professor in the Department of Pediatrics at Harvard Medical School, said in a statement.
Expanded regulatory clearance is another feather in Teleflex's cap, as the Pennsylvania-based company has been reaping the benefits of its recent acquisition: Teleflex grabbed Texas-based Vidacare in Oct. 2013, gaining access to the company's innovative vascular access products.
"The acquisition of Vidacare, an industry leader with a high gross margin profile, will expand our comprehensive vascular access product portfolio with a defining technology," Teleflex CEO Benson Smith said in an earlier statement.
While its Vidacare deal is the biggest one to date, Teleflex is no stranger to M&A. In 2013, the company acquired Eon Surgical, a small Israeli startup focused on minimally invasive microlaparoscopy surgical technology. Teleflex also snatched up a number of companies in 2012, including Hotspur, the maker of a two-in-one balloon dilation catheter, and Semprus Biosciences, an MIT spinout whose technology helped bolster the company's vascular access catheters.
Teleflex said that its Vidacare bid will add $68 million to $72 million of revenue and 10 cents to 15 cents in adjusted earnings per share in fiscal year 2014, excluding one-time costs related to the acquisition and blending of operations. Early regulatory clearance and expanded indications for one of its standout products could bode well for the devicemaker in the upcoming year.
"As part of our fight for zero complications in vascular access, we are committed to continuously improving our technologies, enhancing our training and educational initiatives, and partnering with healthcare professionals to provide innovative solutions for treating difficult vascular access patients with the EZ-IO Vascular Access System," said Jay White, president of Teleflex's Vascular Access Division. "We're excited about the restated indications for use, because we've made it even easier for clinicians to select the right needle for their patient."
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