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November 2009

Issue 2


Paul Mirabella Message From Our Chairman

Naviscan is pleased to announce results from our NIH-sponsored, prospective multi-center trial comparing PEM and MRI for presurgical planning.

Preliminary results found that PEM significantly outperforms MRI when differentiating between benign and cancerous lesions.  It also found that the combination of PEM and breast MRI dramatically increases a physician's ability to detect cancerous lesions over MRI alone, presenting a powerful combination for improving care.  The findings mean that women and their physicians now have access to a better tool to help cure cancer.

This study examined 388 women with newly-diagnosed breast cancer.  Unlike previous studies on primary lesions, this study focused on additional or secondary tumors.  Understanding the presence of additional tumors is critical to assessing whether a lumpectomy or mastectomy is the appropriate surgery.  Researchers found that PEM scans accurately distinguished 151 of 189 benign additional lesions for a specificity of 80%, while MRI had a specificity of 66%.  PEM was also able to see additional disease in one out of eight patients relative to conventional imaging.

The results validate PEM as an integral imaging tool in the surgical management of breast cancer, and as an alternative for the large number of patients who cannot tolerate breast MRI exams due to obesity, claustrophobia, patient comfort, pacemaker, metal implants or other factors.

Patients were accrued from six leading clinical centers across the country: ARS Johns Hopkins Green Spring, Boca Raton Community Hospital, Scripps Clinic-Scripps Green Hospital, University of North Carolina, University of Southern California Norris Cancer Center and Anne Arundel Medical Center.  This project was supported by Grant Number R44CA103102 from the National Cancer Institute.

Naviscan will provide additional information at the RSNA meeting in Chicago, November 29 - December 3, 2009. Manuscripts are currently in preparation and we will alert all customers upon electronic publication.

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


Join us at RSNA 2009

Come meet us at the RSNA meeting in Chicago November 29 - December 3, 2009 in Booth #809, Lakeside Center (Hall D).  Scan your card in our booth for a chance to win an 8GB video iPod nano!  We will be demonstrating the hardware and software from our biopsy guidance accessory as well as hosting physicians for "Meet the Expert" sessions from across the country.  A Naviscan PEM scanner and biopsy accessory will also be featured in Hologic's booth under new image-guided biopsy devices.  Dr. Kathy Schilling will also be speaking about PEM at an evening session hosted by Ethicon Endo-Surgery on Monday, November 30 at The WIT Doubletree Hotel.

 

To set up appointment time in the booth or to sign up for the Ethicon Monday evening event, click here or contact your local Sales Director.

 

BU RadiologyMassachusetts Determination of Need (DON) Approval

Naviscan is pleased to announce that Boston Medical Center is the first hospital in a Certificate of Need (CON)/Determination of Need (DON) state to obtain DON approval.  The PEM scanner at this site, initially designated purely for research use, now has the determination of need to allow it to be reimbursed for the PET indications similar to non-CON/DON states.  "Boston Medical Center welcomes the opportunity to add PEM imaging to our clinical PET/CT service.  The breast has been a relative blind spot in PET imaging with a body scanner.  This limitation is gone with Naviscan's PEM technology," says Gustavo Mercier, MD, PhD, Chief of Molecular Imaging and Nuclear Medicine.  "PEM, either as an adjuct to whole body PET/CT imaging or a stand-alone exam of the breasts, is at the forefront of these options."

 Naviscan's Ongoing International Expansion

Adding to our first international site in Seoul, South Korea, Naviscan has added distribution partnerships in Mexico, Venezuela, Colombia and Japan.  We are excited to continue to expand access to PEM to physicians and patients worlwide.


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.


Neoadjuvant Response Case of the MonthCase 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

     Help us spread awareness about PEM technology through patients' stories.  We are creating a Patient  Testimonial section on our website and are very interested to hear from patients who have benefited  from PEM scanning technology or PEM-guided biopsy.  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.


     

    Spotlight on Recently Installed Sites 

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

     

      


Also, please welcome our new Stereo Navigator biopsy sites:


    To subscribe to our Quarterly eNewsletter, please click here.