A Medical Device Daily

AutoGenomics (Carlsbad, California) reported that it has filed a registration statement on Form S-1 with the Securities and Exchange Commission relating to a proposed initial public offering (IPO) of shares of its common stock. The number of shares of common stock to be offered, all of which are expected to be offered by AutoGenomics, and the price range for the offering, have not yet been determined.

J.P. Morgan Securities is sole book-running manager of the offering, and Deutsche Bank Securities is co-lead manager. Pacific Growth Equities and Robert W. Baird & Co. are co-managers.

A registration statement relating to these securities has been filed with the SEC, but has not yet become effective.

These securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective.

AutoGenomics said it has developed the first automated, microarray based multiplexing diagnostic platform that can be used to assess disease signatures with novel genomic and proteomic markers in the area of genetic disorders, infectious disease, cancer and pharmacogenetics.

Clear Catheter Systems (CCS; Bend, Oregon), formerly PleuraFlow, an early-stage medical device company developing a medical catheter clearance platform, reported the completion of a $600,000 financing round. The financing was led by X Gen, a family venture fund based in Cleveland.

It also includes a grant from the Cleveland Clinic Global Cardiovascular Innovation Center (GCIC) initiative, which is backed by $60 million from the State of Ohio's Third Frontier Project, a program to promote technical innovation and commercialization. BVC/CC, an angel group based in Oregon, also participated in the funding.

The funding will help Clear Catheter Systems develop its lead tube clearance product, the PleuraFlow System. The system will be used to prevent obstruction of surgical drainage tubes inserted after heart, lung and trauma surgery. Such obstruction, or clogging, has long remained an unsolved problem in surgery, with important implications for both patient safety and comfort.

The company is in the process of opening a Cleveland office to better facilitate its collaboration with the Cleveland Clinic, and to access other resources available to the Ohio medical device community.

In another financing, Stereotaxis (St. Louis) reported that it has amended its collaboration with Biosense Webster (Diamond Bar, California), Stereotaxis' partner in the development of ablation catheters used with its Niobe Magnetic Navigation System.

Under the terms of the amended agreement, Biosense Webster will provide Stereotaxis a total of $18 million, comprised of advances against royalties on catheter sales and deferrals of ongoing research and development costs in connection with current and future products.

The two companies also have agreed to co-promote and expand Stereotaxis' Odyssey Network, by granting Biosense Webster non-exclusive rights to use the Stereotaxis information management technology to provide its customers with clinical and technical support.

"We believe this agreement is an endorsement of our relationship with Biosense Webster and strengthens a collaboration that has already succeeded in establishing a new standard for safe and effective treatment in electrophysiology," said Bevil Hogg, Stereotaxis CEO. "In addition to providing significant new financial resources on favorable terms, the agreement allows us to accelerate the deployment of our Odyssey information management technology on a non-exclusive, open architecture basis."

Separately, Stereotaxis also noted that during the week of July 7, Biosense Webster filed a PMA supplement with the FDA for the Navistar RMT Thermocool Catheter, which was withdrawn from the European market earlier this year. The U.S. filing, which was immediately followed by a CE mark filing with European regulators, is believed to provide the surest approval process for the return to market of the irrigated magnetic catheter.

"We are pleased to note Biosense Webster's regulatory filings on the magnetic irrigated catheter ahead of our expectations, and remain optimistic that the catheter will be back in the hands of clinicians in Europe in the fourth quarter, and shortly thereafter in the U.S.," Hogg added. "Furthermore, we expect that the successful return of the magnetic irrigated catheter will herald a substantial increase in the clinical utilization of our installed base of Niobe Systems to treat complex cases."

Stereotaxis develops an advanced cardiology instrument control system for use in a hospital's interventional surgical suite to enhance the treatment of coronary artery disease and arrhythmias.

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