Neoprobe Corporation, a Dublin, Ohio based developer of surgical and diagnostic devices and pharmaceuticals, said today that the European Medicines Agency (EMEA) has approved Neoprobe’s RIGScan® CR cancer detection system for additional testing and development, leading to the potential approval for Neoprobe to market the product throughout the European Union (EU) and affiliated countries.
The EMEA controls the introduction, development, and marketing of medical devices and products in the EU. Neoprobe’s concept for the RIGScan® CR system is a combination of radiation-emitting antibodies with a detection device to assist surgeons in the discovery of tumor deposits that may not be observable by conventional methods.
The company believes it has gotten tangible guidance from the EMEA on how to best continue the design of RIGScan® CR. Furthermore, the EMEA allowed for early termination of additional testing depending on the results. “We are excited by the response from the EMEA,” said David Bupp, Neoprobe’s President and CEO. He noted that the EMEA’s “response provides a clear, achievable development pathway for RIGScan® CR.”
Importantly, he said, “[t]he response acknowledges that the technology meets a currently unmet medical need and has the potential for improving the long term prognosis for both primary and recurrent colorectal patients. The EMEA has suggested a mechanism for an early termination of the study if, as anticipated, early improved outcomes are observed in the RIGScan treatment arm versus the control arm patients.”
Neoprobe, in business since 1983, also announced a conference call for November 6, 2008 at which time Mr. Bupp, and Vice President and CFO, Brent Larson, will provide an update on the company’s Lymphoseek product as well as RIGScan® CR. Additionally, the conference call will cover the company’s results for the third quarter of 2008.
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