A Medical Device Daily

PLC Systems (Franklin, Massachusetts) reported receipt of the CE mark for its RenalGuard System, clearing the way for the company to begin its initial launch of the product in the European Union.

PLC said it expects to initiate a limited launch of RenalGuard in 1Q08 in Italy, “targeting early adopters who recognize the benefits of utilizing the unique fluid-balancing capabilities of the RenalGuard System in a cath lab setting during cardiovascular imaging procedures for patients at higher risk of contrast-induced nephropathy (CIN).”

RenalGuard is an automated, real-time, matched-fluid replacement device intended for interventional cardiology and radiology patients undergoing imaging procedures using contrast media. It is based on existing pre-clinical study data that suggests that initiating and maintaining high urine output during imaging procedures allows the body to rapidly eliminate toxins in contrast media, reducing their harmful effects.

Mark Tauscher, president/CEO of PLC, said, “Receiving the CE mark for RenalGuard is an important milestone for PLC in the development of our new-product initiative. We are very enthusiastic about the potential opportunity for the RenalGuard System in Europe and look forward to working with leading practitioners there to introduce it to the market.”

Tauscher said that the initial launch in Italy will be supported by the company’s previously announced planned clinical trial at the Centro Cardiologico Monzino (CCM-University of Milan), led by Drs. Antonio Bartorelli and Giancarlo Marenzi, global experts in the prevention of CIN.

“We anticipate that this study will receive final approval by the ethics committee at CCM and will greatly increase the visibility of our RenalGuard System and that the data gathered from the study will enable us to seek expanded claims in order to market RenalGuard as a CIN-prevention device throughout the European Union,” Tauscher said.

With CE-mark approval, PLC said it expects to conclude negotiations with an Italian distribution partner “shortly” and that finalization of a distribution agreement is expected to include an initial stocking order of product from the distributor to support the initial sales launch of RenalGuard at select hospital sites throughout Italy.

About 7 million patients worldwide undergo interventional cardiovascular therapeutic and diagnostic imaging procedures each year, and PLC said contrast-induced nephropathy “is a major and growing problem due to the increasing number of older patients, diabetics and patients with pre-existing renal failure, [putting] them at risk for CIN when they require interventional procedures that use radiographic contrast media.”

Studies indicate that between 15% and 20% of all patients undergoing image-guided cardiology and radiology procedures are at risk of developing CIN, PLC said, with estimated mortality rate for those acquiring CIN as high as 35%.

CE-mark process begun by Xtent

Xtent (Menlo Park, California) said it has submitted its application to the designated European Notified Body for CE-mark approval of its Custom NX drug-eluting stent (DES). The company’s application includes the Xyent design dossier and the drug formulation submission from Biosensors International (Singapore).

Xtent said it anticipates beginning European sales of the Custom NX system in 2H08 through partnerships with regional distributors, following CE-marking.

Gregory Casciaro, president/CEO of Xtent, said the submission “further demonstrates Biosensors’ commitment to the success of Biolimus A9 and the ongoing collaboration between the two companies.”

Xtent said it also is continuing its work with the FDA to fulfill requirements for approval of the CUSTOM IV pivotal trial in the U.S. The company filed for an investigational device exemption (IDE) in September. The company and Biosensors are in the process of responding to questions from the agency.

Custom NX is designed, Xtent said, “to enable a more personalized approach to the treatment of arterial disease based on each patient’s individual lesion characteristics.”

The Custom NX system allows physicians to customize the length and diameter of the stent at the site of the lesion. The system features a modular stent design that consists of multiple 6 mm cobalt chromium segments coated with Biolimus A9 and PLA, a biodegradable drug carrier, developed and supplied to Xtent by Biosensors. The Custom NX delivery system enables separation at each 6 mm segment and allows for the placement of up to 60 mm of stent.

UTEK plans to acquire UK firm

Technology transfer firm UTEK (Tampa, Florida) said it has agreed to acquire Pharmalicensing (York, UK) through its UTEK Europe subsidiary. Pharmalicensing describes itself as an open innovation service for partnering, licensing and business development within the life science and biopharma segments. Pharmalicensing is being acquired for $2,150,000, to be satisfied by the issuance of 153,967 shares of UTEK unregistered common stock based on the 10-day closing price.

The UK firm said it makes it easy for about 200 active clients to post descriptions of technologies they are seeking either to in-license or out-license to augment internal R&D and business development programs.

UTEK said the acquisition of Pharmalicensing is an extension of its own innovation services, increasing its presence within the life sciences sector.

The owners of Pharmalicensing have agreed not to dispose of any of the consideration stock for at least 12 months following transaction close, expected early this month.

Pharmalicensing’s revenues for the year ended Dec. 31, 2006, the latest date for audited accounts , was $1,113,000.

“[T]he acquisition of Pharmalicensing fits our strategy of becoming the leading provider of open innovation services and expands our existing operations within the UK market,” said Clifford Gross, PhD, CEO of UTEK.