Aerogen(Mountain View, California) said the report of the company’s independent registered public accounting firm on Aerogen’s 2004 financial statements included in the company’s annual report filed on April 19 contains an explanatory paragraph with respect to the company’s ability to continue as a going concern.

The company has suffered recurring losses and negative cash flows from operations that raise substantial doubt about the company’s ability to continue as a going concern. Additional information regarding the company’s liquidity and management plans can be found in the Form 10-K/A.

Aerogen develops products based on its OnQ Aerosol Generator technology to improve the treatment of respiratory disorders in the acute care setting.

CardioDynamics dismisses KPMG

CardioDynamics (San Diego), which focuses on impedance cardiography technology, reported its decision not to extend the engagement of KPMG as its independent auditor.

The change is the result of a competitive bidding process initiated by the company as part of its ongoing efforts to reduce expenses and improve efficiency. CardioDynamics is presently evaluating proposals from other audit firms and expects to select and announce a new independent auditor in about 30 days. The company intends to file a Form 8-K with the SEC regarding the dismissal of KPMG.

CEO Michael Perry said, “For over eight years, KPMG has provided sound audit services to our company. An unintended impact of Sarbanes-Oxley is the escalating audit fees necessitating many smaller companies to move away from Big Four audit firms. At this time, we believe that our company and its shareholders are best served by a more cost-effective solution to our independent audit needs.”

Life Medical becomes SyntheMed

Life Medical Sciences (Oceanport, New Jersey) said that at its recent annual shareholders meeting, its stockholders overwhelmingly approved the proposed change of the company’s name to SyntheMed.

The company’s common stock, which trades on the Nasdaq Over-The-Counter Bulletin Board, has begun trading under the new symbol SYMD.

According to President and CEO Robert Hickey, the new name more accurately reflects the company’s focus on the development of medical devices based on its synthetic polymer technology.

SyntheMed is pursuing several product development programs. Its lead product, Repel-CV, is an anti-adhesion barrier designed for use in cardiac surgery and is currently being evaluated in a U.S. multi-center pivotal clinical trial.

N.C. group to hold medical device forum

The North Carolina Medical Device Organization (NCMD; Research Triangle Park, North Carolina) is hosting three FDA speakers who will discuss issues such as submission best practices, new guidance and dispute resolution.

The forum, “FDA Regulatory Update,” will be held May 16 from 4:30-8 p.m. at the North Carolina Biotechnology Center. The panel also will include a regulatory submission perspective from a local medical device firm.

Panelists include Patricia Love, associate director of the FDA’s Office of Combination Products; Heather Rosecrans, director of 510(k) staff in the FDA’s Center for Devices and Radiological Health; Les Weinstein, CDRH ombudsman; Tammy Carrea, director, regulatory affairs, Sicel Technologies; and Dan Pelak, president and CEO, Closure Medical, who will serve as moderator.

NCMD is a non-profit cluster organization sponsored by the North Carolina Bioscience Organization. NCMD serves a broad sector of the medical device and diagnostic industry, including research, development and manufacturing firms; suppliers; service companies; hospitals; clinics and educational institutions.