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</o:shapelayout></xml><![endif]--></head><body lang=EN-CA link=blue vlink=purple><div class=WordSection1><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>Hi all:<o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>Interesting article.<o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>Note Focal Healthcare is a Toronto company.<o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>It will be interesting to see how quickly the procedure will be <span style='background:yellow;mso-highlight:yellow'>accessible to all patients</span>.<o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>Take care,<o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>Glen Chair PCCN W-W<o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'><o:p> </o:p></span></p><div style='border:none;border-top:solid #B5C4DF 1.0pt;padding:3.0pt 0cm 0cm 0cm'><p class=MsoNormal><b><span lang=EN-US style='font-size:10.0pt;font-family:"Tahoma","sans-serif"'>From:</span></b><span lang=EN-US style='font-size:10.0pt;font-family:"Tahoma","sans-serif"'> fyi-prostate-info@googlegroups.com [mailto:fyi-prostate-info@googlegroups.com] <b>On Behalf Of </b>rochab2@gmail.com<br><b>Sent:</b> February 5, 2016 9:42 AM<br><b>To:</b> FYI Prostate Info<br><b>Subject:</b> FYI From prnewswire.com Topic: Focal Healthcare will make targeted prostate biopsy procedures access<o:p></o:p></span></p></div><p class=MsoNormal><o:p> </o:p></p><div><h1><span style='font-size:18.5pt;font-family:"Palatino Linotype","serif";color:#404040'>With FDA clearance, Focal Healthcare will make targeted prostate biopsy procedures accessible to all patients<o:p></o:p></span></h1><div style='border:none;border-top:dotted #C1C1C1 1.0pt;padding:8.0pt 0cm 0cm 0cm;box-sizing: border-box;overflow:visible'><div style='margin-left:-11.25pt;margin-right:-11.25pt;box-sizing: border-box;overflow:visible'><div><div id=fb-wrap><p style='margin-bottom:7.5pt;vertical-align:top'><span style='font-size:10.5pt;font-family:"Helvetica","sans-serif";color:#404040'><a href="http://www.prnewswire.com/news-releases/with-fda-clearance-focal-healthcare-will-make-targeted-prostate-biopsy-procedures-accessible-to-all-patients-567338081.html" title="Share with Facebook"><span style='color:#404040;text-decoration:none'><img border=0 id="_x0000_i1025" src="http://assets2.prnewswire.com/designimages/fb_share.png"></span></a><o:p></o:p></span></p></div><p class=MsoNormal><span style='font-size:10.5pt;font-family:"Helvetica","sans-serif";color:#404040'> <o:p></o:p></span></p><div id=google-wrap><p class=MsoNormal style='vertical-align:top'><span style='font-size:10.5pt;font-family:"Helvetica","sans-serif";color:#404040'><img border=0 id="_x0000_i1026" src="http://assets2.prnewswire.com/designimages/google.jpg" alt="Google+"><o:p></o:p></span></p></div><p class=MsoNormal><span style='font-size:10.5pt;font-family:"Helvetica","sans-serif";color:#404040'> <o:p></o:p></span></p><div id=twitter-wrap><p class=MsoNormal style='vertical-align:top'><span style='font-size:10.5pt;font-family:"Helvetica","sans-serif";color:#404040'><img border=0 id="_x0000_i1027" src="http://content.prnewswire.com/designimages/twitter.png"><o:p></o:p></span></p></div><p class=MsoNormal><span style='font-size:10.5pt;font-family:"Helvetica","sans-serif";color:#404040'> <o:p></o:p></span></p><div id=linkedin-wrap><p class=MsoNormal style='vertical-align:top'><span style='font-size:10.5pt;font-family:"Helvetica","sans-serif";color:#404040'><img border=0 id="_x0000_i1028" src="http://assets2.prnewswire.com/designimages/LI_share.jpg" alt="Share with LinkedIn"><o:p></o:p></span></p></div><p class=MsoNormal><span style='font-size:10.5pt;font-family:"Helvetica","sans-serif";color:#404040'> <o:p></o:p></span></p><p class=MsoNormal><span style='font-size:10.5pt;font-family:"Helvetica","sans-serif";color:#404040'> <o:p></o:p></span></p><div id=more-wrap><p class=MsoNormal style='vertical-align:top'><span style='font-size:10.5pt;font-family:"Helvetica","sans-serif";color:#404040'><a href="http://www.prnewswire.com/news-releases/with-fda-clearance-focal-healthcare-will-make-targeted-prostate-biopsy-procedures-accessible-to-all-patients-567338081.html" title=Email><span style='color:#404040;text-decoration:none'><img border=0 id="_x0000_i1029" src="http://content.prnewswire.com/designimages/email.png"></span></a><o:p></o:p></span></p></div></div><p class=MsoNormal align=right style='text-align:right'><span style='font-size:10.5pt;font-family:"Helvetica","sans-serif";color:#404040'> <o:p></o:p></span></p></div></div><div><div><p style='margin-bottom:7.5pt'><a name=linktopagetop></a><span class=xn-location><span style='font-size:10.5pt;font-family:"Helvetica","sans-serif";color:#404040'>TORONTO</span></span><span style='font-size:10.5pt;font-family:"Helvetica","sans-serif";color:#404040'>, <span class=xn-chron>Feb. 2, 2016</span> /PRNewswire/ - Focal Healthcare Inc.</span><span style='font-size:8.0pt;font-family:"Helvetica","sans-serif";color:#404040'>TM</span><span style='font-size:10.5pt;font-family:"Helvetica","sans-serif";color:#404040'>, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for their targeted prostate biopsy device, Fusion Bx</span><span style='font-size:8.0pt;font-family:"Helvetica","sans-serif";color:#404040'> TM</span><span style='font-size:10.5pt;font-family:"Helvetica","sans-serif";color:#404040'>. With the availability of Fusion Bx, clinicians are no longer limited to the traditional systematic biopsy approach for diagnosis, but can instead accurately take targeted biopsies directly from suspicious cancer regions within the prostate using MRI-ultrasound "fusion" technology.<o:p></o:p></span></p><p style='margin-bottom:7.5pt;box-sizing: border-box;word-wrap: break-word'><span style='font-size:10.5pt;font-family:"Helvetica","sans-serif";color:#404040'>MRI has the ability to see tumors in the prostate that ultrasound alone cannot. Thus, by fusing previously-acquired MR images to live ultrasound, clinicians can target suspicious tumors when taking biopsy samples. Fusion biopsy has been shown to detect high-grade cancer in 30% more men compared to traditional systematic biopsy [1]. In addition, by accurately determining the location and extent of the cancer, this procedure allows clinicians to confidently monitor cancer progression over time and prescribe the appropriate course of treatment to patients with varying grades of cancer.<o:p></o:p></span></p><p style='margin-bottom:0cm;margin-bottom:.0001pt;box-sizing: border-box;word-wrap: break-word'><span style='font-size:10.5pt;font-family:"Helvetica","sans-serif";color:#404040'>With this clearance, Focal Healthcare plans to make this <span style='background:yellow;mso-highlight:yellow'>procedure accessible to all patients</span>. <i>"Focal Healthcare was founded to bring state of the art procedures into clinics of all sizes. Fusion Bx was developed with both the patient and doctor in mind and we are excited that this clearance will help us provide patients with broad access to this valuable procedure",</i> said <span class=xn-person>Chicuong La</span>, CEO of Focal Healthcare. <o:p></o:p></span></p><p style='margin-bottom:7.5pt;box-sizing: border-box;word-wrap: break-word'><span style='font-size:10.5pt;font-family:"Helvetica","sans-serif";color:#404040'>Focal Healthcare's accurate and intuitive device has been developed in close collaboration with clinicians including Dr. <span class=xn-person>Winston Barzell</span>, <span class=xn-org>Florida State University</span> (<span class=xn-location>Sarasota</span>), Dr. <span class=xn-person>Daniel Margolis</span>, <span class=xn-person>David Geffen School</span> of Medicine at <span class=xn-org>UCLA</span> (<span class=xn-location>Los Angeles</span>), and Dr.<span class=xn-person>Michael McGuire</span>, NorthShore University Health System (<span class=xn-location>Chicago</span>). Dr. Barzell, a former attending surgeon at Memorial Sloan Kettering Cancer Center, holds 19 patents for his innovations in prostate therapy. He is currently conducting a clinical trial with Fusion Bx at 21st Century Oncology in <span class=xn-location>Sarasota, Florida</span>.<o:p></o:p></span></p><p style='margin-bottom:0cm;margin-bottom:.0001pt;box-sizing: border-box;word-wrap: break-word'><i><span style='font-size:10.5pt;font-family:"Helvetica","sans-serif";color:#404040'>"In contrast to systematic 'blind' biopsies, targeted fusion biopsies reliably identify clinically significant cancers, while reducing the random detection of insignificant cancers that are frequently at risk of over-treatment. Fusion Bx is an exciting, innovative technology that will provide busy clinicians access to a state-of-the-art, user-friendly fusion biopsy system which can be seamlessly introduced to the routine urology office workflow"</span></i><span style='font-size:10.5pt;font-family:"Helvetica","sans-serif";color:#404040'> –Dr. <span class=xn-person>Winston Barzell</span><o:p></o:p></span></p><p style='margin-bottom:7.5pt;box-sizing: border-box;word-wrap: break-word'><span style='font-size:10.5pt;font-family:"Helvetica","sans-serif";color:#404040'>Fusion Bx is FDA 510k cleared for use by physicians for enhanced visualization of ultrasound imaging of the prostate in clinic and hospital settings. It provides 2D and 3D image visualization including review, manipulation, and analysis tools.<o:p></o:p></span></p><p style='margin-bottom:0cm;margin-bottom:.0001pt;box-sizing: border-box;word-wrap: break-word'><b><span style='font-size:10.5pt;font-family:"Helvetica","sans-serif";color:#404040'>About Focal Healthcare</span></b><span style='font-size:10.5pt;font-family:"Helvetica","sans-serif";color:#404040'><o:p></o:p></span></p><p style='margin-bottom:7.5pt;box-sizing: border-box;word-wrap: break-word'><span style='font-size:10.5pt;font-family:"Helvetica","sans-serif";color:#404040'>Focal Healthcare is a <span class=xn-location>Toronto</span>-based medical device company committed to improving the lives of prostate cancer patients and their families through technical innovation. By developing imaging tools that are accurate, efficient, and accessible, Focal Healthcare aims to advance prostate cancer management in clinics of all sizes.<o:p></o:p></span></p><p style='margin-bottom:0cm;margin-bottom:.0001pt;box-sizing: border-box;word-wrap: break-word'><b><span style='font-size:10.5pt;font-family:"Helvetica","sans-serif";color:#404040'>Reference: </span></b><span style='font-size:10.5pt;font-family:"Helvetica","sans-serif";color:#404040'>Siddiqui MM, et al. JAMA. 2015 Jan 27;313(4):390-7. doi: 10.1001/jama.2014.17942.<o:p></o:p></span></p><p style='margin-bottom:7.5pt;box-sizing: border-box;word-wrap: break-word'><span style='font-size:10.5pt;font-family:"Helvetica","sans-serif";color:#404040'>SOURCE Focal Healthcare<o:p></o:p></span></p><p style='margin-bottom:7.5pt;box-sizing: border-box;word-wrap: break-word'><span style='font-size:10.5pt;font-family:"Helvetica","sans-serif";color:#404040'><o:p> </o:p></span></p><p style='margin-bottom:7.5pt;box-sizing: border-box;word-wrap: break-word'><span style='font-size:10.5pt;font-family:"Helvetica","sans-serif";color:#404040'><o:p> </o:p></span></p><p style='margin-bottom:7.5pt;box-sizing: border-box;word-wrap: break-word'><span style='font-size:10.5pt;font-family:"Helvetica","sans-serif";color:#404040'><o:p> </o:p></span></p><p style='margin-bottom:7.5pt;box-sizing: border-box;word-wrap: break-word'><span style='font-size:10.5pt;font-family:"Helvetica","sans-serif";color:#404040'><a href="url:http://www.prnewswire.com/news-releases/with-fda-clearance-focal-healthcare-will-make-targeted-prostate-biopsy-procedures-accessible-to-all-patients-567338081.html">url:http://www.prnewswire.com/news-releases/with-fda-clearance-focal-healthcare-will-make-targeted-prostate-biopsy-procedures-accessible-to-all-patients-567338081.html</a><o:p></o:p></span></p></div></div></div><p class=MsoNormal>-- <br>You received this message because you are subscribed to the Google Groups "FYI Prostate Info" group.<br>To unsubscribe from this group and stop receiving emails from it, send an email to <a href="mailto:fyi-prostate-info+unsubscribe@googlegroups.com">fyi-prostate-info+unsubscribe@googlegroups.com</a>.<br>To post to this group, send email to <a href="mailto:fyi-prostate-info@googlegroups.com">fyi-prostate-info@googlegroups.com</a>.<br>To view this discussion on the web visit <a href="https://groups.google.com/d/msgid/fyi-prostate-info/3d5b3c73-9b8a-4978-829d-697caad67a04%40googlegroups.com?utm_medium=email&utm_source=footer">https://groups.google.com/d/msgid/fyi-prostate-info/3d5b3c73-9b8a-4978-829d-697caad67a04%40googlegroups.com</a>.<br>For more options, visit <a href="https://groups.google.com/d/optout">https://groups.google.com/d/optout</a>.<o:p></o:p></p></div></body></html>