Integra LifeSciences (NSDQ:IART) shares are up today after the medical device company revealed that FDA inspectors yesterday cleared a New Jersey plant that was the subject of a 2011 warning letter.
That news and FDA clearance of Integra’s Titan reverse shoulder replacement device, sent IART shares up 7.1% to $40.13 apiece as of about 10:30 a.m. today.
The FDA issued a warning letter in December 2011 after previous inspections turned up problems with the Plainsboro, N.J., plant’s quality and compliance systems. The plant makes artificial skin, surgical matrix and hemostatic products.
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FDA inspectors during the summer of 2011 found a mold problem dating back to June 2009 that Integra failed to remediate, among other problems, according to the warning letter.
Integra said a 2nd inspection began July 16 and ended yesterday with a clean bill.
"At the conclusion of the inspection, the FDA found that the company had addressed the issues raised in the warning letter and previous inspectional observations, and it issued no other inspectional observations. In reaching this conclusion, the FDA determined that the company’s remediation activities were effective and its quality management system was adequate," according to a regulatory filing.
Smith & Nephew exec on China: We didn’t buy it, we built it
Phil Cowdy, head of corporate affairs at Smith & Nephew (FTSE:SN, NYSE:SNN), told an audience at a recent conference that Smith & Nephew didn’t need to buy Chinese companies to establish a foothold in the People’s Republic, unlike rivals Stryker (NYSE:SYK) (Trauson Holdings), Medtronic (NYSE:MDT) (China Kanghui Holdings) and Zimmer (NYSE:ZMH) (MicroPort).
"We saw China as a big opportunity 5 or 6 years ago and we started to invest at that point," Cowdy said. "As a result, we already do over $120 million of revenue in China. We have over 1,000 people there. From our own perspective, we didn’t need to buy infrastructure. We had built it."
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Lumenis, Visionix ink Chinese distribution deal
Ophthalmic laser device maker Lumenis Ltd. and Visionix signed a deal for Lumenis to distribute the Visionix ophthalmic and optometric diagnostics line in China.
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Kips Bay beefs up its European sales presence
Kips Bay Medical (NSDQ:KIPS) is looking to drive adoption of its eSVS external saphenous vein support device in Europe by shifting its focus from cardiac surgeons to their support teams, hiring new sales and marketing execs to replace former vice president of sales & marketing Michael Reinhardt, effective July 1. Kips Bay named Chris Borg as director of international sales and Ray Holloway as director of sales & marketing.
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BioDrain rebrands as Skyline Medical
BioDrain Medical changed its name to Skyline Medical Inc. (OTC:SKLN) as of August 8, in a nod to its roots in Minneapolis.
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Analysts’ ups and downs
- Baxter (NYSE:BAX): Leerink Swann reiterates “outperform” rating, $80 price target
- Boston Scientific (NYSE:BSX): Barclays reiterates “overweight” rating, $12 price target.
- Bruker Corp. (NSDQ:BRKR): Bank of America/Merrill Lynch upgrades from "neutral" to "buy" rating, raises price target from $20 to $26.
- Cardiovascular Systems (NSDQ:CSII): Feltl & Co. upgrades from “buy” to “strong-buy” rating, raises price target to $27.50 from $19.50;
Leerink Swann reiterates "outperform" rating, $25 price target. - CareFusion (NYSE:CFN): Leerink Swann maintains “market perform” rating, raises price target to $38 from $36.
- Cooper Cos. (NYSE:COO): Stifel Nicolaus initiates coverage with “buy” rating, $2.29 price target.
- Dexcom Inc. (NSDQ:DXCM): Jefferies reiterates "buy" rating, raises price target from $21 to $27;
Leerink Swann reiterates "market perform" rating, raises price target to $26 from $22. - Endo Health Solutions (NSDQ:ENDP): Citigroup initiates coverage with “buy” rating, $43 price target; Janney Montgomery Scott downgrades from “neutral” to “sell” rating, lowers price target to $28.50 from $34.
- Endologix (NSDQ:ELGX): Canaccord Genuity initiates coverage with “buy” rating, $19 price target.
- HeartWare International (NSDQ:HTWR): Credit Suisse upgrades from “neutral” to “outperform” rating, lowers price target to $96 from $105; Leerink Swann reiterates “outperform” rating, lowers price target to $90 from $110.
- Integra LifeSciences (NSDQ:IART): Piper Jaffray upgrades from "neutral" to "overweight" rating, raises price target from $41 to $50.
- Mako Surgical (NSDQ:MAKO): Needham & Co. initiates coverage with “hold” rating.
- Medtronic (NYSE:MDT): Leerink Swann reiterates “market perform” rating, increases price target to $58 from $54
- Mindray (NYSE:MR): Credit Suisse downgrades from “neutral” to “underperform” rating.
- NuVasive Inc. (NSDQ:NUVA): Needham & Co. initiates coverage with “buy” rating, $28 price target.
- Smith & Nephew (FTSE:SN, NYSE:SNN): Citigroup Inc. downgrades from “buy” to “neutral” rating, raises price target to £8.30 ($12.88) from £7.97 ($12.36).
- Solta Medical (NSDQ:SLTM): Ascendiant Capital Markets downgrades from “buy” to “neutral” rating; Canaccord Genuity downgrades from "buy" to "hold" rating, lowers price target from $3.50 to $2.50; Leerink Swann increases to price target to $3.30 from $3, maintains “outperform” rating; Roth Capital downgrades from “buy” to “neutral” rating.
- Spectranetics (NSDQ:SPNC): JPMorgan Chase & Co. initiates coverage with “overweight” rating.
- St. Jude Medical (NYSE:STJ): Wells Fargo upgrades from “market perform” to “outperform” rating.
- Stryker (NYSE:SYK): Needham & Co. initiates coverage with “hold” rating.
- Syneron Medical Ltd. (NSDQ:ELOS): Leerink Swann maintains “outperform” rating, lowers price target to $16 from $17.
- Thoratec (NSDQ:THOR): Credit Suisse upgrades from “neutral” to “outperform” rating, raises price target to $43 from $35.
- Tornier (NSDQ:TRNX): J.P. Morgan upgrades from "neutral" to "overweight" rating, raises price target from $20 to $24.
- Wright Medical (NSDQ:WMGI): Leerink Swann maintains “outperform” rating, lowers price target to $29 from $32; Needham & Co. initiates coverage with “buy” rating.
- Zimmer (NYSE:ZMH): Needham & Co. initiates coverage with “buy” rating.
