AGA Medical's U.S. Amplatzer Cardiac Plug Trial Set To Start By July
This article was originally published in The Gray Sheet
Executive Summary
AGA Medical is aiming to begin a pivotal trial of its Amplatzer Cardiac Plug by July after implementing protocol changes suggested by FDA, the firm said
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Research In Brief
NMT PFO stroke trial comes up short: Preliminary results of the 910-patient CLOSURE I study of NMT Medical's STARFlex patent foramen ovale closure device show it is not superior to best medical therapy for preventing stroke and transient ischemic attack, the trial's primary endpoint, the firm reports June 17. Closure rates for STARFlex were 86.5%. NMT is now in discussions with FDA about the next steps relating to the stroke/TIA indication. The firm had planned to submit a PMA this year (1"The Gray Sheet" April 13, 2009). Although not statistically significant, "The preliminary data did demonstrate that our implant device provided a small benefit over current best medical therapy and maintained an excellent safety profile," NMT CEO Frank Martin notes. The company will discuss full results of the trial in November at the American Heart Association annual meeting. STARFlex is currently approved for ventricular septal defect and atrial level shunt patients. In a same-day research note, Wells Fargo analyst Larry Biegelsen speculates the CLOSURE I results could spell bad news for AGA Medical, which is conducting the RESPECT study of its Amplatzer PFO occluder in stroke. "Although there are significant differences between the CLOSURE I and RESPECT trials, we believe the CLOSURE I results will make it more challenging for physicians to close a PFO," he writes
Research In Brief
NMT PFO stroke trial comes up short: Preliminary results of the 910-patient CLOSURE I study of NMT Medical's STARFlex patent foramen ovale closure device show it is not superior to best medical therapy for preventing stroke and transient ischemic attack, the trial's primary endpoint, the firm reports June 17. Closure rates for STARFlex were 86.5%. NMT is now in discussions with FDA about the next steps relating to the stroke/TIA indication. The firm had planned to submit a PMA this year (1"The Gray Sheet" April 13, 2009). Although not statistically significant, "The preliminary data did demonstrate that our implant device provided a small benefit over current best medical therapy and maintained an excellent safety profile," NMT CEO Frank Martin notes. The company will discuss full results of the trial in November at the American Heart Association annual meeting. STARFlex is currently approved for ventricular septal defect and atrial level shunt patients. In a same-day research note, Wells Fargo analyst Larry Biegelsen speculates the CLOSURE I results could spell bad news for AGA Medical, which is conducting the RESPECT study of its Amplatzer PFO occluder in stroke. "Although there are significant differences between the CLOSURE I and RESPECT trials, we believe the CLOSURE I results will make it more challenging for physicians to close a PFO," he writes
Financings In Brief
AGA Medical goes public: Maker of Amplatzer structural heart defect repair devices and vascular disease treatments initiates $200 million initial public offering Oct. 21, making it the first U.S. medical technology IPO since the first quarter of 2008 (1"The Gray Sheet" Oct. 19, 2009). The Minneapolis company filed plans for the IPO in June 2008, prior to the onset of the global financial crisis (2"The Gray Sheet" June 30, 2008). The IPO of 13.8 million common stock shares at $14.50 each included 6.5 million shares offered by the company and 7.2 million shares offered by selling shareholders, and resulted in net proceeds to AGA of about $83 million - tabbed primarily for debt repayment. AGA development projects include the ongoing U.S. RESPECT study of the Amplatzer patent foramen ovale structural heart defect occluder to reduce the occurrence of certain types of stroke, results of which will be used to support an eventual PMA filing; the firm estimates a $1 billion-plus market opportunity for the indication in the U.S. and Europe. Corporate sales increased 16.7% to $94.4 million for the six months ended June 30, according to a prospectus filed with the Securities and Exchange Commission. The stock trades under the Nasdaq symbol AGAM