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
Keep up with the top medtech business and regulatory news.
More from Archive
A framework to end the Iran war is in place but fractured supply chains can’t recover overnight. Data from India suggests solvent prices have generally cooled from April peaks, but API costs stay elevated or even climbed in June for some products.
REUSE OF DISPOSABLE CARDIAC CATHETERS TARGETED BY FDA in an effort to address safety concerns about reuse of single-use products. The cardiac catheter product area "seems to jump up as one that is an area for us to focus on," Larry Spears, director of the Office of Compliance's Division of Enforcement III in FDA's Center for Devices and Radiological Health, said June 24 at a Food Drug and Law Institute conference held in Washington, D.C.
St Jude Medical and Spire are to develop anti-bacterial heart valve sewing cuffs using Spire's Spi-Argent silver coating process. The agreement covers a variety of valve designs as well as ancillary components. The treatment is aimed at reducing the incidence of endocarditis, a rare but dangerous complication of valve transplant which has a mortality rate as high as 60%.
Nissho saw sales rise only 1% to ¥17 billion ($930 million) in the year to March 1997. The Japanese company's net income was Yen3 billion, compared with Yen1.7 billion for the previous year, reports Reuters. Nissho produces disposable medical equipment.
More from Medtech Insight
AdvaMed president Scott Whitaker said the group is focused on the need for tariff stability in conversations with the Trump administration. The organization remains optimistic about other policy areas. New chairman and ResMed CEO Mick Farrell laid out his five priorities.
Class III devices and panel-track supplements approved by US FDA’s Center for Devices and Radiological Health. Data derived from FDA.gov. Updated weekly.
AdvaMed president Scott Whitaker said the group is focused on the need for tariff stability in conversations with the Trump administration. The organization remains optimistic about other policy areas. New chairman and ResMed CEO Mick Farrell laid out his five priorities.