A Medical Device Daily

Xtent (Menlo Park, California) has broken a several weeks hiatus of initial public offering (IPO) filings in the device sector, reporting yesterday that it has filed a registration statement with the Securities and Exchange Commission for an IPO potentially raising up to $103.5 million. The numbers of shares to be offered and the price range have not yet been determined.

The company said it intends to use the net proceeds for clinical trials, R&D activities, building commercialization infrastructure, general corporate purposes and working capital.

It plans to list its stock on the Nasdaq Global Market under the symbol XTNT.

Xtent 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 (Medical Device Daily, May 19, 2006).

Xtent 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).

Earlier this year, the company said it had received funds in a Series D round but did not disclose the amount (MDD, May 12, 2006). And in early 2005, it brought in $25 million (MDD March 3, 2005)

For its IPO, Piper Jaffray & Co. will be acting as the book-running manager and Cowen and Company, Lazard Capital Markets and RBC Capital Markets are acting as co-managers.

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

MedicalCV (Inver Grove Heights, Minnesota), a cardiovascular surgery company, has requested withdrawal of its registration statement, filed with the SEC on May 19, “due to continuing unsettled conditions in the equity markets,” it said in a statement.

Marc Flores, president and CEO, said, “In the best interest of the company and its shareholders, we have decided to take the focus of the management team away from fundraising in a difficult market. We continue to focus on the introduction of the minimally invasive Atrilaze system for cardiac tissue ablation. We will carefully manage our resources which we believe will be sufficient to support our planned introduction to the market and physician training.”

MedicalCV's Atrilaze ablation system utilizes laser energy in cardiac tissue ablation procedures in open-heart surgery.

The Atrilaze system is currently being used as a potential means to treat atrial fibrillation in concomitant open-heart surgical procedures.

In other financing activity:

• Sonic Innovations (Salt Lake City), a manufacturer of digital hearing aids, reported an agreement for the private placement of 3.2 million shares of common stock, to a group of new and existing institutional investors, to garner $12 million in proceeds.

The company said it will use the net proceeds from the placement to expand its global retail operations. It said it expects to close the transaction on or before Aug. 18.

Piper Jaffray & Co. acted as the sole placement agent.

• Norwood Abbey (Melbourne, Australia) reported that it has raised about A$4 million through the sale of 10.1 million shares in Norwood Immunology.

The company also said that it is “progressing further fundraising options” that will be reported upon completion.

• Longport (Glen Mills, Pennsylvania), a developer of high frequency, high-resolution ultrasound, reported receiving $1.5 million in new financing — about $400,000 in equity and a debt component of about $1.1 million.

It said the funds will be used to conclude clinical studies in the fields of pressure ulcer prevention and skin cancer assessment, and for working capital.

The company said the data from these studies will help validate the clinical and financial benefits of its technology.

The financing was provided by a long-term equity holder, the First Baptist Church of Southwest Broward, Florida.

• Unilens Vision (Largo, Florida) reported that TSX Venture Exchange has approved its normal course issuer bid so that the company may purchase for cancellation up to 224,190 of its common shares, representing 5% of its issued and outstanding common shares.

The bid will commence on Aug. 21, 2006, and end on Aug. 20, 2007. All shares purchased will be affected solely through the facilities of the TSX Venture Exchange. Unilens said it has not purchased any of its common shares over the last 12 months.

Unilens through its subsidiary Unilens USA , licenses and manufactures specialty contact lenses under the C-Vue, Unilens, Sof-Form, Aquaflex, SoftCon, Lombart and LifeStyle brands.