A Medical Device Daily

Northfield Laboratories (Evanston, Illinois) reported that it will shut down its business operations and carry out an orderly disposition of its assets.

The company said it made the decision following its review and analysis of the complete response letter received from the FDA at the end of April (Medical Device Daily, May 4, 2009). Northfield determined that further clinical development of a reformulated version of its PolyHeme human red cell substitute product, including additional clinical trials, would likely be required before it could again seek to obtain FDA approval. The company concluded that the time and substantial expense required to complete this additional clinical development, together with significant uncertainty that FDA approval would ultimately be obtained, made it unlikely that sufficient additional capital could be raised to support such further product development.

Earlier this month, the company reported that it had terminated substantially all operational and staff employees at its manufacturing facility in Mount Prospect, Illinois, and headquarters in Evanston (MDD, May 14, 2009).

The company cautioned that in view of its obligations to creditors, expenses expected to be incurred in connection with the wind down process and uncertainty regarding the realizable value of its non-cash assets, no assurance can be given that any amounts will be available for distribution to shareholders in connection with the winding down of the company's business. Northfield said it has retained counsel to explore the options available to wind down its business.

Since its inception in 1985, Northfield has incurred losses of $220 million.

Xtent (Menlo Park, California) reported that its board has determined, after consideration of potential strategic alternatives, that it is in the best interests of the company and its stockholders to liquidate the company's assets and to dissolve the company.

In January, the company reported that it planned to engage an investment bank to help the company pursue strategic alternatives. At the same time, it notified 112 employees out of its total employment of 121 that their positions would be eliminated effective March 23 (MDD, Jan. 26, 2009).

The company's board has unanimously approved a plan of dissolution that is subject to stockholder approval. The company intends to hold a special meeting of the stockholders to seek approval of the plan and has filed related proxy materials with the SEC. Although the company's board has approved the plan of dissolution, it said it will continue to consider any "reasonable alternative strategic proposals" presented to the company.

Xtent develops customizable drug-eluting stent systems for the treatment of coronary artery disease.