AngioScore Wins FDA Clearance For One Use Of Flagship Catheter
September 15, 2005 - The Food and Drug Administration has awarded medical device company Angioscore Inc. clearance to market its AngioSculpt scoring balloon catheter to treat infrapopliteal peripheral arterial disease.
The devices are balloon angioplasty catheters surrounded by nitinol struts for scoring arterial plaques. AngioScore aims for the devices to prove more effective than traditional angioplasty and drug-eluting stents in reaching into clogged arteries.
AngioScore expects to launch the product in the U.S. in the first quarter of next year.
Founded in 2003 the Alameda, Calif.-based company has raised at least $19.5 million from investors including Psilos Group, California Technology Ventures, Innomed Ventures, UV Partners and Linkagene. In August, the start-up raised a Series C round which included a $1.5 million investment from USCI Japan Ltd. The investment was made in conjunction with a distribution agreement that gave USCI exclusive rights to distribute the device in Japan.
The company could raise Series D funding as soon as the fourth quarter to help with marketing and manufacturing costs, Trotter said, but it has not finalized its plans.
In addition the company has filed a premarket approval application to use AngioSculpt in coronary applications.
The product has a CE mark in Europe for treating both coronary and peripheral arterial indications.
For more information, please visit the AngioScore web site.
9/15/2005
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