A Diagnostics & Imaging Week

CleveX (Columbus, Ohio) reported that it has closed $1.4 million in equity financing that will help accelerate its growth in commercializing tools to assist in the excision of cancerous and non-cancerous skin lesions.

The company said it raised the seven figure investment from a group of mid-western based investors. The lead investor, Plymouth Venture Partners, was joined by WPWIII Cap LP and The Esposito Group. Terms were not disclosed.

The company said the financing will help it fully commercialize ExiClip, its lead technology. ExiClip is a surgical tool that is designed to excise skin lesions and close the site significantly more efficiently than typical scalpel and suture procedures. The company said the technology also provides patients with an excellent cosmetic result. The device was cleared by the FDA in May 2007. The company said it will initiate the ExiClip pilot launch in September.

"We are very pleased to receive these investments. We can now move forward with our pilot launch and begin to bring key sales talent into the company." said CleveX President, Gary Smith. "CleveX is seeking an additional $400k to close this round," he added.

In a letter to the shareholders of Imaging Diagnostic Systems (IDS; Fort Lauderdale, Florida), Linda Grable, a co-founder who returned to the company as interim CEO and chairman three months ago, revealed that she recently helped secure a tiered debenture for up to $2 million to aid in the clinical collection of the PMA data and the submission of the PMA application for the company's CTLM diagnostic imaging device designed to detect breast cancer without radiation or compression.

Grable noted that over the past two years, IDS had installed upgraded CTLM systems, initiating a new study protocol utilizing a new intended use at 10 various clinical sites throughout the U.S. These sites are currently gathering cancer cases and non-cancer cases required to support the intended use hypothesis for the PMA application.

"We believe we are on schedule to complete the data collection and submit the PMA application to the FDA in its entirety by the end of this year," Grable said.

Grable also said she recently arranged a new sixth private equity credit agreement for $15 million over a three-year period with Charlton Avenue, who has provided substantially all of the necessary funding for the company over the past eight years.

In other financing activity:

Michelson Diagnostics (MDL, Kent, UK) received £600,000 ($1.18 million) in a new funding round for its Optical Coherence Technology (OCT) systems for cancer diagnosis.

The capital injection forms part of a new funding round of almost £600,000 into pioneering MDL, with Catapult Venture Managers investing a further £250,000, London Seed Capital a further £50,000 and the balance of the money coming from private investors.

The money will be used to complete development of its hand-held OCT probe for applications in cancer diagnosis and treatment, which uses OCT to provide real-time images of sub-surface tissue at near-cellular resolution without tissue removal - an optical biopsy.

A group of CardioNet (Conshohocken, Pennsylvania) investors will sell 5 million shares of CardioNet stock for $26.50 a share, the company said Friday. CardioNet will not receive any proceeds from the sale, which is expected to close Wednesday.

The selling stockholders have also granted the underwriters a 30-day over-allotment option to buy an additional 750,000 shares.

Citi is the sole book-running manager, Banc of America Securities and Leerink Swann are the co-lead managers and Cowen and Company and Thomas Weisel Partners are the co-managers for the offering.

According to CardioNet's filing with the Securities and Exchange Commission, a group of Sanderling funds are the largest participants in the offering, selling 869,565 shares out of nearly 2.6 million shares. H&Q funds will sell 503,240 shares out of about 1.4 million. The offering is expected to raise $125,543,500 in proceeds to the selling stockholders, before expenses, according to the filing.

CardioNet, a wireless med-tech company with an initial focus on the diagnosis and monitoring of cardiac arrhythmias, said in the filing that it has incurred net losses from its inception through March 31, including net losses $300,000 for the quarter ended March 31, 2008, and $400,000 for the year ended Dec. 31, 2007.

The company said that it expects its operating expenses to increase as the company expands in a variety of areas: sales and marketing activities; designing, manufacturing and building its inventory of future generations of the CardioNet systems; hiring additional staff; investing in infrastructure; and incurring the added expenses associated with being a public company.

"With increasing expenses, we will need to continue to substantially increase our revenues to be profitable in the future," CardioNet said in the filing.

The company said its business is dependent upon doctors prescribing CardioNet's services. If it fails to obtain those prescriptions, its revenues could fail to grow and could decrease, the company said in the filing.

Thus far, a key barrier in this area has been a general reluctance by insurers to pay for these types of monitoring services, the result of insufficient data validating their worth.

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