Cardiovascular Systems (CS; St. Paul, Minnesota) has filed a registration statement on with the Securities and Exchange Commission for a proposed initial public offering of up to $86.25 million of its common stock, though the exact number of shares and the offering pricing have yet to be determined.

The company's initial and only product is the Diamondback 360° Orbital Atherectomy System, which it describes as a minimally invasive catheter system for the treatment of peripheral arterial disease (PAD), a circulatory problem in which plaque deposits build up on the walls of vessels, reducing blood flow.

Plaque deposits range from soft to calcified, with calcified plaque being difficult to treat with traditional interventional procedures, and the Diamondback 360°, the company says, is capable of treating a range of plaque types, including calcified vessel lesions. It "addresses many of the limitations associated with existing treatment alternatives."

The system removes both soft and calcified plaque in plaque-lined vessels through the orbital rotation of a diamond grit coated offset crown that is attached to a flexible drive shaft. Physicians position the crown at the site of an arterial plaque lesion and remove the plaque by causing the crown to orbit against it, creating a smooth lumen, or channel, in the vessel.

Additionally, the Diamondback 360° is designed to differentiate between plaque and compliant arterial tissue. "By giving physicians the ability to create different lumen diameters by changing rotational speed, the company said the system can reduce the need to use multiple catheters of different sizes to treat a single lesion," CS says.

The company said it intends to use the net proceeds from the IPO for working capital and general corporate purposes. It may also use a portion of the proceeds for the potential acquisition of businesses, technologies and products complementary to our existing operations.

In its SEC filing, the company said that it is not yet profitable and has incurred net losses in every fiscal year since its formation in 1989.

It had net losses of $3.5 million in FY05, $4.9 million in FY06 and $15.6 million in FY07, and $7.4 million in the three months ended Sept. 30, 2007. As of Sept. 30, 2007, it had an accumulated deficit of about $72 million.

In August 2007, the FDA, granted the company 510(k) clearance for use of the Diamondback 360° as a therapy in patients with PAD

Among the risks listed in its foiling, CS said that on Dec. 28, 2007, ev3, ev3 Endovascular (Plymouth, Minnesota), and FoxHollow Technologies (Redwood City, California), which recently merged with ev3, filed a complaint, alleging, among other things, misappropriation and use of the confidential information of these companies by CS and certain of its employees who were formerly employees of FoxHollow.

The complaint also alleges that these employees violated their employment agreements, with FoxHollow requiring them to refrain from soliciting FoxHollow employees. If the plaintiffs in this litigation are successful, it could have a material adverse effect on the company's business, operations and financial condition, CS said.

Morgan Stanley & Co. and Citigroup Global Markets are acting as joint book-running managers of the offering, with William Blair and Company acting as a co-manager of the offering. The number of shares to be offered and the price range for the offering have not been determined.

In other financing news:

• Mauna Kea Technologies (MKT; Paris), a developer of in vivo cellular imaging technology, reported closing of a $30 million financing round led by the Psilos Group.
  MKT said it will use the proceeds to expand commercialization of its Cellvizio technology in the U.S. and Europe, as well as to advance other clinical applications of the platform.
  Founded in 2000, MKT describes the Cellvizio as a new imaging approach that eliminates the need for unnecessary biopsies and enhances the diagnosis of a broad range of diseases via in vivo cellular imaging.
  David Eichler and Albert Waxman of Psilos will join MKT's board.
  Seventure also participated in this funding round in addition to existing investor Creadev.
  "This financing will enable us to expand our U.S. presence and advance our clinical program to validate Cellvizio's utility in improving the diagnosis and treatment of disease found in the esophagus, colon, stomach, bile duct as well as the distal lungs," said Sacha Loiseau, PhD, founder and president/CEO of MKT.
  MKT said it is currently focused on the gastroenterology and pulmonology markets.
• EnzySurge (Rosh Haayin, Israel), a provider of solutions for chronic wound management, reported that it expects to expand its recent $2 million private investment round to $3 million.
  With this capital, the company said it intends to accelerate the FDA approval process and expand its marketing efforts, in order to launch its first product during 2H08.
  EnzySurge's DermaStream product line is based on its Continuous Streaming Therapy (CST) technology, calling this a new modality for chronic wound management. DermaStream allows for continuous streaming of multiple therapeutic solutions throughout all phases of wound treatment. The solutions are designed to be used for wound debridement (such as removal of necrotic tissue), bacterial load reduction and enhanced healing.
  EnzySurge said it recently completed the first stage of a multi-centered clinical study with its enzymatic solution demonstrating safety, selective wound debridement and accelerated closure.