Prostate Cancer Breakthrough Receives FDA Clearance

ei-Nav/Artemis(TM) Helps Pinpoint Prostate Cancer, Provides a Map for Follow-up Care

Business Wire

With FDA clearance, ei-Nav/Artemis(TM) can now offer urologists breakthrough technology to help in the fight against prostate cancer. Artemis allows urologists to virtually "see" inside the prostate in real time during biopsy, guides them with 4D needle navigation, maps biopsy locations and saves data for future reference. Artemis, designed by Northern California-based Eigen (www.eigen.com), will first be available in Denver, San Francisco and Irvine.

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Using proprietary next-generation 3D/4D imaging, Artemis(TM) provides solutions not available today by enhancing urologists' existing ultrasound machines, the vast majority of which are only 2D. Now, Artemis allows urologists to virtually see inside the prostate in real time during biopsy, guides them with 4D needle navigation during the delicate procedure, maps biopsy locations and generates an image of 3D biopsy coordinates for future reference.

"I am especially excited about the advances in prostate cancer research," said Dr. E. David Crawford, Head of Urologic Oncology at the University of Colorado Health Sciences Center. "We need technology that provides a way to generate a reproducible, systematic method for prostate biopsy. To be able to see and navigate to a desired location is very beneficial for prostate biopsy, as well as treatment planning and focal therapy."

Artemis' 3D/4D imaging allows doctors to select and biopsy a location within the boundary of the prostate with pinpoint accuracy. The biopsy location is then recorded by Artemis' patented registration technology, which allows doctors to revisit or avoid the exact same area during repeat procedures. Artemis provides doctors with data they can analyze to determine if the prostate gland has changed and manage treatment accordingly.

"With as estimated 1.5 million biopsies performed each year, conventional biopsy is blind to cancer, as 20 to 30 percent of cancers are missed, and detected cancer may not be clinically relevant," said Al Barqawi, Director of Research at the University of Colorado Health Sciences Center. "The benefits of advancements in imaging will improve our ability to accurately guide tissue sampling, improve diagnosis and manage the disease progression. We will be able to treat patients to what they have, not what we think they have."

This breakthrough imaging and mapping is a major improvement over existing 2D ultrasound routinely used for prostate cancer biopsies, where doctors blindly biopsy cells and roughly estimate locations during repeat procedures. Without being able to clearly see the prostate in real time, doctors have had no choice but to gather less-than-precise information to determine treatment.

"Since prostate cancer strikes a staggering one in six men, it is startling to me that until now blind biopsies have been the standard of care once cancer of the prostate is suspected," said Eigen CEO Michael Castorino. "Artemis is intended to give the nation's nearly 10,000 urologists the technology to navigate to a desired location for prostate biopsy and record this information for future reference, treatment planning and monitoring."

Other than skin cancer, prostate cancer affects more men in the U.S. than any other cancer, and nearly 30,000 men in the U.S. die of prostate cancer each year. While the standard PSA score - used to determine if a prostate biopsy is needed - is currently 4.0 ng/ml, there is discussion among industry experts to reduce the threshold to a 2.5 ng/ml PSA score. If universally adapted, it could result in a significant increase in the number of prostate biopsies in the coming years.

The first Artemis imaging systems will be in use at the University of Colorado Health Sciences Center and UC San Francisco within weeks and are available for immediate order in the U.S.

About Eigen

With 30 years of innovation in medical imaging, Northern-California based Eigen holds more than 20 patents. Eigen products are used and trusted in more than 4,000 hospitals worldwide. The company is known for many firsts in medical innovation, including video technology that revolutionized balloon angioplasty. For more information, visit www.eigen.com.