CryoCor 10-K has 'going concern' statement

CryoCor (San Diego), which is focused on the treatment of cardiac arrhythmias, reported that its annual report on Form 10-K included an audit opinion with a "going concern" qualification. A going-concern qualification is a statement from the company's independent registered public accounting firm expressing substantial doubt, based upon current financial resources, whether the company can continue to meet obligations over the next year.

In its annual report, CryoCor indicated that it had sufficient working capital to fund its operations until December 2007 and to pay off its existing debt, and that additional capital would be needed to fund operations into 2008. CryoCor is a medical device company and has filed an application for pre-market approval, or PMA, for the treatment of atrial flutter with the FDA. CryoCor has previously announced that it expects to receive a decision from the FDA on this PMA by August 2007. Additionally, CryoCor said it expects to complete the enrollment in its pivotal trial for the treatment of atrial fibrillation in the second quarter of 2007.

UPMC to move into U.S. Steel Tower

UPMC (Pittsburgh) said that it has signed an agreement that will make U.S. Steel Tower its new corporate headquarters. The new site in downtown Pittsburgh will consolidate UPMC's corporate, administrative and integrated business functions in one location.

UPMC anticipates approximately 2,250 employees will move into the building in phases over the next four years. Relocated departments will include the executive staff, finance and treasury, corporate communications, legal, planning and marketing, human resources, payroll and benefits, and information technology services.

UPMC is the largest integrated health care enterprise in Pennsylvania and one of the leading nonprofit medical centers in the country.

Quality concerns addressed by HemoSense

HemoSense (San Jose, California) received acknowledgement from the FDA that it has satisfactorily addressed the concerns about its quality management system detailed in a warning letter from the FDA in November 2006. The Company also announced it has successfully completed its first ISO 13485:2003 inspection audit. ISO 13485:2003 is the internationally recognized standard for medical device development and manufacturing, which the company first achieved in 2006.

"Our commitment to maintaining world-class design, manufacturing and quality management systems to provide superior products to our customers is illustrated by these recent developments," said Jim Merselis, president/CEO. HemoSense is a point-of-care diagnostic healthcare company that makes handheld blood coagulation systems for monitoring patients taking warfarin.

NASDAQ news . . .

Thoratec files 10-K late, subject to delisting

Thoratec (Pleasanton, California), which focuses on products to treat cardiovascular disease, reported completing review of its historic equity-based compensation practices and filed its annual report for the fiscal year ended Dec. 30, 2006.

On March 1, the company reported that it had filed with the Securities and Exchange Commission for a 15-day extension to file its 2006 Form 10-K because it was in the process of completing a review of its equity-based compensation practices, including a review of the underlying documentation and procedures, and related accounting, for such practices.

The company said review is now complete. Although the company identified certain grant documentation and accounting errors, which resulted in additional non-cash equity-based compensation charges of about $100,000 associated with its historic stock option grants for the fiscal years 2001 through 2005, the company concluded that these accounting errors are immaterial to its financial statements in each of the periods to which such charges would have related.

As the company did not file the 2006 Form 10-K within the 15-day extension period under SEC rules, it anticipated and received on March 19 a NASDAQ Staff Determination Letter indicating that the company had failed to comply with the filing requirement for continued listing set forth in NASDAQ Marketplace Rules, and that its securities are subject to delisting from the NASDAQ Global Select Market. However, since that time the company has submitted its filing and said it expects NASDAQ to withdraw the Staff Determination Letter and cease delisting proceedings.