A Medical Device Daily

TherOx (Irvine, California) reported filing for an initial public offering of its common stock with the SEC.

Citigroup Global Markets and UBS Investment Bank are acting as joint book-running managers for the offering with Cowen and Company, and Wachovia Capital Markets, acting as co-managers. The number of shares to be offered by TherOx and the price range for its shares has yet to be determined.

In the SEC filing, TherOx says it develops therapies to treat ischemic, or oxygen deprived, tissue. Specifically, its products implement its Supersaturated Oxygen System to salvage heart muscle in acute heart attack patients. TherOx's Supersaturated Oxygen System is not FDA approved and is available for investigational use only in the U.S.

Without providing any specific figures, TherOx said in the filing that it would spend its proceeds from the IPO on sales and marketing initiatives to support existing and future products; to support R&D activities and clinical trials and to obtain regulatory approvals; and for the purchase of capital equipment.

Among the risk factors TherOx lists in its SEC filing is the fact that it is a development stage company with no experience with the final stages of the FDA PMA process, or commercialization of products, and that it may never have a commercial product in the U.S. The company says it has been engaged in R&D since its inception in 1994.

Acute Myocardial Infarctions, or AMIs, are a leading cause of death in men and women, TherOx says. If the company obtains FDA approval for its Supersaturated Oxygen System it intends to market the therapy for patients who have suffered anterior, STEMI-classified heart attacks, and whose PCI (a common heart attack treatment) was initiated within six hours of symptom onset. The PCI procedure is intended to reestablish blood flow at the initial blockage site in the coronary artery, the company noted. The procedure has improved patient outcomes since its adoption as the standard of care, however TherOx says that by the time PCI is initiated, the network of microscopic blood vessels that deliver blood to the heart muscle, or capillaries, have already constricted, and the level of oxygen now flowing to the heart is not adequate. Therefore, the company believes that once the coronary artery has been opened through PCI, there is an unmet clinical need to open up the capillaries quickly in order to allow oxygen-rich blood to reach the heart and reduce the amount of heart muscle death after a heart attack.

In other financing activity, Health Care REIT (Toledo, Ohio) reported the pricing of its underwritten public offering of 7 million shares of common stock at $48 a share.

The offer was first disclosed last week, with the company then saying it planned to offer 6 million shares (Medical Device Daily, Sept. 5, 2008). The offering size was increased to 7 million shares in response to investor demand, the company said.

Health Care REIT has granted the underwriters a 30-day overallotment option of up to an additional 1,050,000 shares. The company estimates that the gross proceeds from the offering will be about $336 million, or $386.4 million if the underwriters' overallotment option is exercised in full.

Deutsche Bank Securities, Banc of America Securities, UBS Investment Bank and Merrill Lynch are the joint book-running managers for the offering.

The company said it intends to use the net proceeds to invest in additional healthcare and senior housing properties. The offer is expected to close Sept. 10.