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July 2009

Issue 1

 

Paul Mirabella A Message From Our Chairman

Naviscan is pleased to launch the first issue of our quarterly eNewsletter. In response to customer feedback, we hope this newsletter keeps everyone abreast of the latest news about Naviscan and PEM technology.

The first half of 2009 has been exciting for Naviscan. We have now installed over 40 units across the continental United States and Puerto Rico. Our biopsy accessory Stereo Navigator®, which received FDA clearance last November, has begun commercial installation. We have deployed a dedicated reimbursement expert to help our customers optimize their billing procedures for both diagnostic scans and biopsy. As a testament to our progress, Frost & Sullivan presented Naviscan with the 2009 North American Award for Emerging Technology of the Year. This award recognizes our progress in developing to market a next-generation, breast-specific PET scanner and adjunct biopsy guidance system which Frost &Sullivan believes will redefine the standard of care for breast cancer patients.

The second half of 2009 promises to be even more exciting. We will be launching our first international customer in Seoul, South Korea. We also look forward to announcing several clinical research results at upcoming Society meetings.

Naviscan is committed to responding to our customers’ needs. Please do not hesitate to  This e-mail address is being protected from spambots. You need JavaScript enabled to view it  with any specific requests or suggestions.

Sincerely,

Paul Mirabella

Chairman & CEO

 

 

Stereo Navigator® FDA Clearance and Commercial Launch

Naviscan has been granted 510(k) clearance for the first commercially-available breast PET-Guided Biopsy accessory. This marks an important milestone as we now are able to biopsy lesions as small as 2 mm that may only be seen on PEM. Designed exclusively for use with our high-resolution organ-specific PET scanner, Stereo Navigator represents the cutting edge of targeted molecular imaging in the breast. The PET-guided biopsy accessory is indicated for the localization and sampling of lesions in the breast, as identified on a breast PET (or PEM) image. This guidance system enables physicians to guide compatible interventional devices toward abnormalities visible on PET and immediately confirm that the correct lesion was biopsied. The accessory is compatible with the following breast biopsy systems: Mammotome® from Ethicon Endo-Surgery, Inc., ATEC ® from Hologic, Inc., and EnCor® from SenoRx® Corporation.

Our first commercial customer sites were installed in April, 2009, and we continue to receive new orders. For more information on Stereo Navigator click here or contact your local Sales Director.

Reimbursement

Responding to our customers’ requests for additional support on how to correctly deploy and bill for breast PET (or PEM), Naviscan has developed a comprehensive Reimbursement Toolkit and engaged a 3rd party reimbursement expert to work with your billing team. The response generated by these new resources has been very positive. If you have yet to receive your toolkit or would like to better understand how our 3rd party reimbursement expert can help you, please contact  This e-mail address is being protected from spambots. You need JavaScript enabled to view it , VP of Marketing.

 Naviscan Goes Global

In response to overwhelming interest from the international market, Naviscan is pleased to announce our global launch. Initially efforts will be focused in South Korea where the first unit is slated for install this month at Seoul National University Hospital. By the fourth quarter of 2009 we expect to expand into Latin America.

 

Clinical Research Update

In an effort to provide more peer-reviewed clinical publications, Naviscan has launched an Academic Radiology Initiative to stimulate clinical research using our PEM device. Our clinical partners include: University of Chicago, University of Iowa, University of Cincinnati, Boston University, MD Anderson, Swedish Medical Center and Memorial Hospital in Hollywood, FL. The projects at these sites are at varying stages of initiation and recruitment. We will keep you informed of their progress.

 

Spotlight on Recently Installed Sites

Please join us in welcoming the following recently installed Naviscan sites:

  • Zwanger-Pesiri Radiology, Massapequa, NY
  • Midwest Center for Advanced Imaging, Chicago, IL
  • Memorial Healthcare System, Hollywood, FL
  • Miami Baptist Hospital, Miami, FL
  • Centro Sononuclear, Rio Piedras, PR
  • University of Iowa, Iowa City, IA


Also, please welcome our new Stereo Navigator biopsy sites:

  • Boca Raton Community Hospital, Boca Raton, FL
  • Memorial Healthcare System, Hollywood, FL
  • White Plains Hospital Center, White Plains, NY
  • Radiology Associates of Sacramento, Sacramento, CA
  •  Case of the Month

    As part of our new website launch last fall, we have developed a space for customers to share interesting cases. We request an anonymized brief history, PEM images, correlative images and final pathology results. If you have a case you would like considered for our Case of the Month series, please  This e-mail address is being protected from spambots. You need JavaScript enabled to view it us.

     

    Looking for Patient Testimonials

    We are very interested to hear from patients who have benefited from PEM scanning technology or PEM-guided biopsy to interview anonymously for our marketing materials. Please contact  This e-mail address is being protected from spambots. You need JavaScript enabled to view it  if you know of a patient who would be willing to share her story.

     

    Naviscan Slides Available for Talks

    Naviscan is able to provide slides featuring case studies and product images to physicians or technologists for upcoming PEM speaking engagements. Please  This e-mail address is being protected from spambots. You need JavaScript enabled to view it  with your specific request.

     

    CME-Accredited PEM Visiting Fellowship Available

    The Center for Breast Care at Boca Raton Community Hospital is offering a Clinical Visiting Fellowship on Positron Emission Mammography. Presented by the Physicians for Women’s Health, this is a unique 12-hour course that is designed to provide a comprehensive review of more than 50 PEM exams. The participant will have the opportunity to review teaching file PEM cases with mammographic, sonographic, MRI and pathologic correlation. Additionally, the physician will have the opportunity to read active cases with the faculty on site. Please click here for more information and to register. Upon successful completion of this program, participants will receive 12 hours of CME credits from the University of South Florida, Tampa.

     

     Naviscan at Upcoming Society Meetings

    Mark your calendars and plan to stop by our booth to hear the latest news. For a list of upcoming meetings we will attend click here.

     

To subscribe to our Quarterly eNewsletter, please click here.