HeartWare International, Inc. (HTWR)

[cjgaddy]

6-4-14 Leerink: “FDA warning letter to HeartWare is as benign as possible”…

6-4-14: “Analyst says FDA warning letter to HeartWare is 'as benign as possible'”
By: Don Seiffert, BioFlash Editor - Boston Business Journal
http://www.bizjournals.com/boston/blog/bioflash/2014/06/analyst-says-fda-warning-letter-to-heartware-is-as.html

A Framingham heart pump maker’s stock fell just 2% after it said it received a warning letter from the U.S. FDA about deficiencies at its Florida manufacturing facility. The company said in a statement that the letter “does not require any action by physicians or patients and does not restrict use of HeartWare’s devices.” One analyst described the letter as being “as benign as possible within the context of (FDA) warning letters.”

The company said that during an inspection of its Miami Lakes, Fla., plant in January, FDA officials found issues that need to be addressed with its procedures for validating device design, procedures for implementing corrective and preventive action, maintaining records related to investigations and validation of computer software. The plant makes small, implantable heart pumps for patients with advanced heart failure. The HeartWare Ventricular Assist System features the company’s HVAD pump, and is approved in the U.S. for use in patients at risk of death from refractory end-stage left ventricular heart failure who are waiting for a transplant.

Danielle Antalffy, an analyst at Leerink Partners, wrote in a research note today that she isn’t changing her “outperform” rating and $120 price target on the stock — which is valued at $88.32 as of 2:15pm today — based on the news.

“While a warning letter is certainly a negative and HeartWare mgt. has noted they are making resolution its number one priority... (the letter) does not impact sales of HeartWare’s HVAD and does not prohibit ongoing enrollment in (an ongoing clinical trial),” she wrote.

Last month the company reported that it sold 665 HeartWare Ventricular Assist Systems during the 1st 3mos. of the year, a 38% increase from Q1/2013. It took it revenue of $66.5mm during the qtr.

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6-4-14: “HeartWare Intl. Comments On FDA Warning Letter”
http://ir.heartware.com/phoenix.zhtml?c=187755&p=irol-newsArticle&ID=1937179