A Medical Device Daily

Xtent (Menlo Park, California) reported an amended filing with the Securities and Exchange Commission (SEC) for an initial public offering (IPO) of up to 4.7 million shares at a price range of $16 to $18 a share, which would raise close to $79.9 million before expenses if the shares are sold at the $17 mid-point.

The company, which plans to list its stock on the NASDAQ Global Market under the symbol XTNT, said it will use IPO proceeds for clinical trials, research and development, infrastructure development, working capital and corporate expenses.

This amended offering supplants an earlier IPO filing by the company in August in which the company had filed to raise up to $103.5 million (Medical Device Daily, Aug. 10, 2006).

Xten says it is addressing the fact that a single DES doesn’t fit all anatomies or that there is frequent need for more than one stent and more than one procedure. It banners its system as offering a “customizable” approach to stenting and the ability to place different stent lengths (as opposed to multiple stents) in one procedure or multiple stents with one device and without multiple procedures (MDD, May 19, 2006).

The company licenses a bioabsorbable polymer from Biosensors International (Singapore) and its drug formulation from Occam International (Eindhoven, the Netherlands), a Biosensors subsidiary (MDD, May 27, 2004).

The company said it believes if its technology is approved by regulatory authorities, it will be able to compete in the roughly $5.3 billion worldwide drug-eluting stent market.

Currently, the company is conducting clinical trials to evaluate its Custom NX 36 and Custom NX 60 stent and stent delivery systems. In May 2006, the eight-month clinical data from the CUSTOM I clinical trial was presented at the 2006 Paris Course on Revascularization conference and in October 2006, six-month clinical data from our CUSTOM II clinical trial for 40 patients was presented at the 2006 Transcatheter Cardiovascular Therapeutics conference in Washington.

The company said it expects to submit an application for the CE mark in late 2007, with commercialization in Europe by 2008.

Additionally, the company said it intends to apply for an investigational device exemption from the FDA in the first half of 2007 based on the results from its CUSTOM I, II and III clinical trials. It then hopes to submit a premarket approval application to the FDA in 2009, with commercialization hoped for in the U.S. by the first half of 2010.

Xtent received funds in a Series D round in 2006 but did not disclose the amount (MDD, May 12, 2006). And in early 2005, it brought in $25 million (MDD March 3, 2005), but it has incurred net loses every year since its inception in June 2002.

Xtent is a portfolio company of The Foundry (Redwood City, California), a medical device incubator.

In other financial news, Kyphon (Sunnyvale, California) reported its intention to offer, subject to market and other conditions, $175 million aggregate principal amount of convertible senior notes, due 2012, and $175 million of convertible senior notes, due 2014, in a private offering to qualified institutional buyers.

In certain circumstances, the company said, the notes may be convertible into cash up to the principal amount. Any conversion value above the principal amount will be convertible into shares of Kyphon’s common stock. The interest rate, conversion price and other terms of the notes will be determined by negotiations between Kyphon and the initial purchasers of the notes. Kyphon expects to grant to the initial purchasers a 30-day option to purchase up to $25 million aggregate principal amount of additional notes of each series to cover over-allotments.

In connection with the offering, Kyphon said it expects to enter into a convertible note hedge transaction, which is intended to reduce the potential dilution to its common stockholders upon any conversion of the notes. It also expects to enter into a warrant transaction concurrently with the offering.

The company said it expects to use a portion of the proceeds of the offering to pay the cost of the convertible note hedge transaction. This cost will be partially offset by proceeds that Kyphon expects to receive from the sale of the warrants.

If the initial purchasers exercise their option to purchase additional notes, Kyphon expects to use a portion of the proceeds from the sale of additional notes to enter into additional convertible note hedge transactions.

The company said it may also enter into additional warrant transactions, which would result in bringing it additional proceeds.

It said it expects to use all of the remaining net proceeds of the offering to retire a portion of the $425 million senior syndicated bank term loan used to complete the recent $525 million acquisition of St. Francis Medical Technologies (Alameda, California) (MDD, Jan. 22, 2007).