Shipments of ATS Medical's Open Pivot bileaflet mechanical heart valve, which received FDA approval Oct. 13, are scheduled to begin before month-end, the company says.

Proceeds of about $9.8 mil. from a private placement of 1.1 mil. shares at $9 each under a March 22 agreement will be used in part to make pyrolytic carbon for the ATS heart valve, the firm says. A December 1999 deal with Sulzer Carbomedics, currently ATS' sole source of pyrolytic carbon, gives ATS a license to manufacture the material for the valve. The pact "calls for reduced prices of our valve components starting in the year 2001 as well as significantly reducing any future purchases" of components in exchange for a $41 mil. license fee to be paid over several years ending in 2007, ATS explains. The Minneapolis company expects to submit additional data to FDA by May 1 in support of its August 1999 PMA for an open-pivot, bileaflet, pyrolytic carbon heart valve in response to a Feb. 3 request by the agency