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AtriCure Inc. (NSDQ:ATRC) shares took a hit this morning after the FDA raised some questions about its Synergy device.
Ahead of its date with the watchdog agency’s circulatory system devices panel tomorrow, AtriCure shares dropped 17 percent to $9.65 in afternoon trading yesterday from an opening price of $11.61, after the FDA raised questions about the clinical data used to support its bid for pre-market approval.
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AtriCure Inc. (NSDQ:ATRC) could be poised for a buyout over the next year to 18 months, according to Canaccord Genuity analyst Jason Mills.
The FDA’s circulatory system devices panel has Medtronic Inc. (NYSE:MDT), AtriCure Inc. (NSDQ:ATRC) and Cook Medical in its sights for panel review next month.
Medtronic and AtriCure are both hoping to get the panel’s nod for cardiac ablation devices, and Cook is working toward clearance for its drug-eluting stent.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2011-N-0002]
Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.
Name of Committee: Circulatory System Devices Panel of the Medical Devices Advisory Committee.
AtriCure Inc.’s (NSDQ:ATRC) Synergy cardiac ablation system will undergo FDA panel review in late October as the watchdog agency considers the company’s premarket approval application.
Cardiac ablation uses either heat or cold to create precise scar tissue in the heart to correct arrhythmias, or heart rhythm problems.
Cardiology medical device maker AtriCure Inc. (NSDQ:ATRC) expects to receive U.S. regulatory clearance for a new cryoablation system by the end of next quarter.
The company’s cryoICE BOX system would use extreme cold to freeze cardiac tissue in order to correct abnormal electrical signals that cause heart arrhythmia.
Hologic Inc. (NSDQ:HOLX) reported growth in sales and booming earnings its third quarter ended June 25, driven by increased revenues in its breast health sector, which includes its 3D mammography system.
Breast health revenues grew 8 percent to $205 million, compared to $189 million during the same period last year.
AtriCure Inc. (NSDQ:ATRC) filed a mixed shelf offering with the U.S. Securities and Exchange Commission to sell up to $50 million through a combination of debt securities, common stock, preferred stock, warrants, depositary shares and units.
The Cincinnati-area cardiac surgical device maker has also filed rights to sell up to an additional 3,184,535 shares of common stock from time to time.
ATRC stock was trading at $12.91 in the afternoon today, nearly flat with yesterday’s close at $12.90.
Cardiac medical device maker AtriCure Inc.’s (NSDQ:ATRC) sees big opportunity in a new "hybrid" procedure that treats atrial fibrillation with a combination of ablation from inside and outside of the heart.
