A Medical Device Daily

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.