|February 19, 2013|
|16:10 EDT||IART||Integra LifeSciences receives warning letter from FDA|
Integra LifeSciences Holdings announced that on February 14 it received a warning letter from the FDA related to quality systems issues at its manufacturing facility located in Aņasco, Puerto Rico. The letter resulted from an inspection conducted at that facility during October and November 2012. The Company has provided certain additional information relating to the matters set forth in this press release, as well as a copy of the warning letter as an exhibit in a Current Report on Form 8-K filed concurrently with the issuance of this press release. The warning letter cites concerns relating to process validations, corrective and preventative actions, and document controls. Integra believes that it has already substantially remediated the issues addressed in the warning letter, and is in the process of having third-party consultants assess its procedures and processes to ensure that products are manufactured in accordance with applicable regulations, as recommended by FDA.
News For IART From The Last 14 Days
Check below for free stories on IART the last two weeks.
|September 18, 2014|
|08:38 EDT||IART||Integra LifeSciences announces commercial release of Integra Freedom system |
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|September 17, 2014|
|11:26 EDT||IART||Integra LifeSciences management to meet with Oppenheimer|
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|07:27 EDT||IART||Integra LifeSciences price target raised to $68 from $59 at Piper Jaffray|
Piper Jaffray raised its price target for shares of Integra LifeSciences to $68 saying meetings with the company's CEO increased its confidence in its Overweight rating. Piper thinks Integra's performance will improve in 2015 and expects the stock to significantly outperform over the next 12 months.
|06:09 EDT||IART||Integra LifeSciences to acquire Medtronic instrumentation lines for $60M|
Integra LifeSciences (IART) and Medtronic (MDT) announced an agreement in which Integra will acquire Medtronic's MicroFrance and Xomed manual ENT and laparoscopy instrumentation lines for approximately $60M in cash. Integra expects the transaction to close in Q4. Integra will acquire a portfolio of approximately 4,000 MicroFrance and Xomed manual ENT and laparoscopic surgical instruments, as well as the St. Aubin le Monial, France manufacturing facility. Sales from the products being acquired totaled approximately $30M, two-thirds of which were generated outside the U.S. Integra expects to record approximately $27M-$30M in revenue and approximately 10c of adjusted EPS in calendar 2015 from this acquisition. The earnings accretion should rise after the first year once certain sales transitions are complete. The company expects the acquisition to contribute less than $5M in revenue and be neutral to earnings in Q4. The transition and integration is expected to be completed by 2H15.
|September 10, 2014|
|10:21 EDT||IART||Integra LifeSciences management to meet with Piper Jaffray|
Meeting to be held in the Mid-Atlantic area on September 16 hosted by Piper Jaffray.