A Medical Device Daily

Dune Medical Devices (Ceasarea, Israel) yesterday reported the closing of a $12.5 million Series B investment led by Apax Partners, which invested $11.5 million in the round. Apax also led the two-tranched $7.5 million Series A round that closed in 2004.

The funding will be used to complete pivotal U.S. clinical studies of Dune's BP probe and console system, obtain FDA clearance of the BP system, begin development of a second product and expand the company's infrastructure in the U.S., Dune said.

Dune also reported receiving CE marking for the probe and console system, which uses RF spectroscopy that enables intraoperative, on-contact measurement of suspected tissue surfaces during a lumpectomy (partial mastectomy) procedure.

Dr. Dan Hashimshony, founder and CEO of Dune, said that the importance of CE marking “in the short term will be the rapid accrual of investigational sites to expedite our clinical program in the U.S., Europe and Israel. The intent of our clinical program is to obtain a rigorous and ample body of data that demonstrates the capacity of our technology to improve surgical oncology practice and outcomes.”

Amos Goren from Apax Partners and a member of Dune's board of directors, said in a statement: “The Dune BP probe and console system will enable surgical oncology teams to consistently obtain cleaner margins during the initial procedure. This has the potential to drastically reduce the disturbingly high rate of re-excisions, and there is a particularly noteworthy need for this especially in breast cancer.”

Published studies indicate from 20% to 60% of breast-conserving lumpectomies each year in the U.S. require re-excision because a clean margin was not initially obtained. According to data presented earlier this year at the annual scientific meeting of the American Society of Breast Surgeons (Columbia, Maryland), the Dune BP probe would have identified positive margins in nine of 12 patients whose margins were missed during an initial lumpectomy, eliminating the need for additional surgery, and equivalent to a 7.3% positive margin rate.

Founded in 2002, Dune is a private, venture-funded company developing devices for real-time tissue characterization.

Genelabs Technologies (Redwood City, California) re- ported that it has entered into an agreement for the sale of about 6.1 million shares of its common stock, plus warrants to purchase about 2.5 million shares of its common stock, to investors for gross proceeds of $9 million.

The agreement provides for Genelabs to sell the shares for $1.42 a share and to issue the warrants for a purchase price of $0.125 a share underlying the warrants, with a warrant exercise price of $1.42 a share. The company said it expects to close the placement – subject to customary conditions – on or about June 30.

Genelabs uses DNA-binding technology to synthesize lead compounds targeting bacteria and fungi.

In other financing activity:

Fluidigm (South San Francisco), a developer of life science systems based on integrated fluidic circuits (IFCs), reported closing on Series E funding from AllianceBernstein. The amount of funding was not disclosed.

Gajus Worthington, CEO of Fluidigm, said that the new funds will be used develop and commercialize new applications for its IFC technology.

In 2003, Fluidigm launched its first product line, the Topaz system for protein crystallization. The system streamlines the process of protein structure determination and subsequent drug design. Currently, the company is introducing the BioMark system, which leverages IFCs to achieve improvements for genetic and protein analysis over existing technologies. Other IFCs in the pipeline will be used for rapid synthesis of radio-labeled imaging probes and preparation of nucleic acids for analysis.

Jamie Kiggen, senior vice president of AllianceBernstein, said, “Integrated fluidic circuits may solve the problems of miniaturization and integration for the life sciences and allied fields, much as integrated circuits did for electronics.”

Fluidigm develops systems based on the properties of IFCs to precisely control fluids on a nano-volume scale. IFCs incorporate tens of thousands of miniature elements – such as channels, chambers, and valves – that integrate large-scale biological and chemical reactions. The company says its vision is “to create and to lead a new industry in which IFCs bring unparalleled efficiencies to the life science and allied fields.”

• CTS (Elkhart, Indiana) reported that it has entered into a new bank agreement that provides the company with a revolving credit facility of $100 million for a five-year term through June 27, 2011. The facility includes a $50 million accordion feature and will be used for general corporate purposes, including strategic acquisitions. The new credit facility replaces the company's existing three-year $75 million facility that was scheduled to expire in July 2007.

CTS manufactures electronic components and sensors and a provider of electronics manufacturing services to OEMs in medical, communications and industrial markets.

• Health Discovery (HDC; Savannah, Georgia) reported that William Quirk Jr., a member of its board and its largest individual investor, intends to purchase shares of company common stock on the open market, possibly up to an additional $100,000.

Quirk said, “I'm acquiring more stock to demonstrate my confidence in HDC's direction and, more importantly, my determination that the company will indeed deliver value to its shareholders.”

HDC develops pattern recognition technology and a biology-oriented biomarker and pathway discovery company. Its pattern recognition tools have application potential in radiology, Internet search and spam, homeland security and financial futures.

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