Medical Device Daily

TomoTherapy (Madison, Wisconsin) reported the pricing of its initial public offering (IPO) of 11,743,420 shares of common stock at $19 a share, $2 higher than the top end of its pricing range reported earlier this week (Medical Device Daily, May 8, 2007).

The company said it expects to receive net proceeds from the offering of about $185 million.

The company said that 10,602,960 shares are being sold by it and 1,140,460 shares are being sold by certain selling stockholders. The shares will be listed on the NASDAQ National Market and will trade under the symbol TTPY.

The closing of the offering is scheduled to take place on May 14, and the selling stockholders have granted the underwriters a 30-day option to purchase up to an additional 1,761,513 shares of common stock at the initial public offering price to cover any over-allotments.

Merrill Lynch & Co. acted as sole-bookrunning manager, Piper Jaffray & Co. acted as co-lead manager, and Thomas Weisel Partners, Robert W. Baird & Co. and William Blair & Co. acted as co-managers for the offering.

The company is the developer of the Hi-Art System, a radiation delivery system designed to change the intensity of the radiation beam so that it adapts to the shape of the tumor. Using a computerized tomography scan, the system focuses on killing cancer cells, TomoTherapy says, with "sub-millimeter accuracy" to kill cancer cells while sparing healthy tissue. As of December 31, 2006, it reported an installed base of 108 Hi-Art systems worldwide.

The company said the funds will be used to expand marketing, support continued R&D, expand international service and support and for general corporate purposes.

CVRx (Minneapolis) said it has completed a fourth round of private equity financing totaling $65 million. With this financing, the company said the total investment in CVRx to date exceeds $125 million.

The company is the developer of the Rheos baroreflex hypertension therapy system, the only implantable device designed to control hypertension, a leading cause of heart and kidney disease, stroke and death.

Johnson & Johnson Development Corp. was the lead investor. Other participants in this round included new investor BBT Fund L.P., and existing investors New Enterprise Associates, Thomas Weisel Healthcare Venture Partners, InterWest Partners, ABS Ventures, Frazier Healthcare Ventures and SightLine Partners.

In conjunction with the financing, Dr. Brad Vale, VP, Johnson & Johnson Development Corp., joined the CVRx board of directors.

Preliminary data from European and U.S. early clinical trials evaluating the safety and clinical effectiveness of the Rheos System were presented in a Late-Breaking Emerging Technologies Session at the recent American College of Cardiology (Washington) conference held in New Orleans in late March (Medical Device Daily, March 29, 2007).

The findings showed that systolic blood pressure was reduced by an average of 21 mmHg, and diastolic blood pressure was reduced by an average of 16 mmHg with the Rheos system. A 20-point reduction in blood pressure is typically associated with a 50% lower risk of heart attack and stroke, according to the company.

In October, CVRx received investigational device exemption (IDE) approval from the FDA to begin a U.S. pivotal clinical trial that is evaluating the safety and effectiveness of the Rheos System in 300 patients (MDD, Oct. 20, 2006). The blinded study is a prospective, randomized, placebo-controlled clinical trial that is being conducted at multiple medical sites in the United States and in Europe. To be enrolled in the trial, patients need to be resistant to treatment with at least three anti-hypertension agents, including a diuretic, and their systolic blood pressure must be greater than or equal to 160 mmHg.

In other financing news, EyeTel Imaging (Savage, Maryland) recently filed a registration statement with the Securities and Exchange Commission for a future public offering of up to $28.75 million, though the share pricing, amount of shares and ticker symbol have yet to be determined.

The company said it expects to use the proceeds for funding the cost of manufacturing and leasing the Digiscope; for sales and marketing; R&D; repayment of its debt and for general corporate purposes.

EyeTel designs technology and provides services for detecting three leading causes of preventable blindness: age-related macular degeneration (AMD), diabetic retinopathy, and glaucoma. Its EyeTel System is an imaging and diagnostic system, made up of the DigiScope (device that takes high resolution retinal images) and a telemedicine image analysis service (provided by EyeTel Reading Center, a division staffed by specialists who analyze the images). The company, founded in 1996, make money by leasing DigiScope machines and charging customers usage fees on a per patient examination basis.

The EyeTel system is based on patented technology developed at the Wilmer Eye Institute of Johns Hopkins University (Baltimore), and the DigiScope has been on the U.S. market since 2000 and is currently in its fourth generation of technological development, the company said. The company noted that it has incurred significant net losses since its inception in 1996, including net losses of about $7.4 million in 2006. As of Dec. 31, 2006, the company said it had an accumulated deficit of about $33.9 million.