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	<title>ILSI-Biomed Israel &#187; FDA</title>
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	<description>Biomedical innovation, healthcare, life sciences and more!</description>
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		<title>BrainStorm Raises $3.6 M To Launch Phase I/II Trial for ALS.</title>
		<link>http://biomed-blogs.com/biomed2010/932</link>
		<comments>http://biomed-blogs.com/biomed2010/932#comments</comments>
		<pubDate>Mon, 21 Mar 2011 16:35:01 +0000</pubDate>
		<dc:creator>Biomed Man</dc:creator>
				<category><![CDATA[Industry news]]></category>
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		<description><![CDATA[The recent appointment of Adrian Harel as the CEO of BrainStorm Cell Therapeutics (OTCBB: BCLI) signals the beginning of a new era both for the company and for its new top exec. BrainStorm, after several hurdle-crossing years of pre-clinical testing and validation of its autologous stem cell therapy, is about to become the first Israeli [...]]]></description>
			<content:encoded><![CDATA[<p>The recent appointment of Adrian Harel as the CEO of BrainStorm Cell Therapeutics (OTCBB: BCLI) signals the beginning of a new era both for the company and for its new top exec.</p>
<p><a href="http://s802.photobucket.com/albums/yy306/dorinem/?action=view&amp;current=face.jpg" target="_blank"><img src="http://i802.photobucket.com/albums/yy306/dorinem/face.jpg" border="0" alt="Photobucket"></a></p>
<p>BrainStorm, after several hurdle-crossing years of pre-clinical testing and validation of its autologous stem cell therapy, is about to become the first Israeli company to reach the clinical trial stage with a differentiated stem cell-based therapy.<br />
The company`s Phase I/II trial, expected to begin in the spring, targets a major unmet need &#8211; amyotrophic lateral sclerosis (ALS). There is currently no approved therapy for this neurodegenerative disorder which costs the healthcare system an estimated $6 billion a year in the US alone.<span id="more-932"></span></p>
<p>In order to fund this trial the company recently raised $3.6 million from institutional and private investors in equity financing.</p>
<p>For Adrian Harel, to be working in the cell therapy field on neurological indications, means coming full circle from the early days of his professional career when he served as manager of Proneuron. At Proneuron he led a team that pioneered the use of cell therapy for spinal injuries in a multi-center global trial.</p>
<p>Prior to joining Proneuron, Harel cut his teeth as a research scientist at InterPharm Labs, one of Israel`s first biotech companies and the starting point for an entire generation of biotech managers.</p>
<p>During the past 15 years Harel has managed a wide variety of companies in a career marked by innovative drug development and top tier management, a reflection of his own educational background that combines a Ph.D in neurobiology from the Weizmann Institute with a MBA in Business Administration from the University of Haifa.<br />
Companies under his helm have included Heal-Or, Meditor Pharmaceuticals and Aminolab Technologies where he oversaw the production of four new ethical drugs. At Sepal Pharma and Molecular Cytomics he initiated cGMP in drug and product development.<br />
As a seasoned industry veteran Harel has nurtured numerous early stage companies, both as an advisor of the Jerusalem Biotechnology Incubator, and through founding his own company, Da-Ta Biotech, which serves as an R&#038;D beta site.<br />
At BrainStorm, Harel will have ample opportunity to put his regulatory and drug manufacturing experience to good use, with the screening of patients for the ALS Phase I/II study expected to begin soon. He will head a team that includes the developers of BrainStorm`s technology, Chief Medical Officer Prof. Eldad Melamed, a member of the Scientific Committee of the Michael J. Fox Foundation for Parkinson`s Research, and Chief Scientist Prof. Daniel Offen, Head of Tel Aviv University`s Neuroscience Laboratory.<br />
The ALS trial will be conducted in Israel at the Hadassah Medical Center. </p>
<p><em>Published on http://www.bioisrael.com<br />
Copyright 2006 by BioIsrael Communications Ltd. </em></p>
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		<title>Robots back breakthrough surgery.</title>
		<link>http://biomed-blogs.com/biomed2010/928</link>
		<comments>http://biomed-blogs.com/biomed2010/928#comments</comments>
		<pubDate>Sat, 19 Mar 2011 11:10:51 +0000</pubDate>
		<dc:creator>Biomed Man</dc:creator>
				<category><![CDATA[Articles]]></category>
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		<description><![CDATA[SpineAssist – an Israeli invention – is revolutionizing delicate spinal surgery. Judy Siegel-Itzkovich spoke to the innovative company’s CEO. Many patients scheduled for a major spinal operation naturally worry that they might find themselves in a wheelchair due to a surgical error, or simple bad luck. While this happens only rarely, it is a possibility. [...]]]></description>
			<content:encoded><![CDATA[<p>SpineAssist – an Israeli invention – is revolutionizing delicate spinal surgery. Judy Siegel-Itzkovich spoke to the innovative company’s CEO.</p>
<p><a href="http://www.jpost.com/HttpHandlers/ShowImage.ashx?ID=160660" target="_blank"><img src="http://www.jpost.com/HttpHandlers/ShowImage.ashx?ID=160660" border="0" alt="Photobucket"></a></p>
<p>Many patients scheduled for a major spinal operation naturally worry that they might find themselves in a wheelchair due to a surgical error, or simple bad luck. While this happens only rarely, it is a possibility. The results of orthopedic surgery are as good as the specialist who performs it – but today, the risk is much reduced. Not only is there computer-assisted navigation for hip replacement, for example (introduced in the past decade), but now there is a robot that guides orthopedic surgeons in performing operations customized for each patient’s anatomy. The world’s first such robotic system, called SpineAssist, is Israeli – based on the work of a scientist at Haifa’s Technion-Israel Institute of Technology and marketed around the world by Mazor Robotics (www.mazorrobotics.com) of Caesarea.<span id="more-928"></span></p>
<p>Ori Hadomi, the publicly traded company’s CEO, visited Israel recently. SpineAssist is the first surgical-guidance robot for orthopedic surgery to receive full approval from the US Food and Drug Administration and the European CE. Hadomi has headed the company since 2003, and moved to New York last summer for three years to promote SpineAssist’s marketing.</p>
<p>In an interview with The Jerusalem Post to discuss the progress of the system, the master’s graduate in industrial chemistry and business administration at the Hebrew University and the University of California said the $750,000 system is taking off not only there but also in Europe, Russia and Asia.</p>
<p>THE SYSTEM has been known longer – three years – to Israeli orthopedic surgeons than to those abroad, as some 400 procedures have already been performed with much success at the Hadassah University Medical Centers in Jerusalem’s Ein Kerem and on Mount Scopus and Haifa’s Carmel Medical Center. Other Israelis will follow, said Hadomi, who predicted that using SpineAssist for spinal and other orthopedic operations will be regarded as the standard, while the company upgrades the system for even better performance.</p>
<p>“Patients will demand robot-guided back surgery,” he predicted.</p>
<p>The system was invented by Prof. Moshe Shoham and colleagues in his robotics lab at the Technion, which patented it and has stocks in Mazor Robotics.</p>
<p>SpineAssist, which allows surgeons to plan and perform any spinal surgery safely and accurately, from the simplest to the most complex, does not replace surgeons but helps them safely, accurately and efficiently, reducing radiation for pre-surgical scanning and optimizing clinical outcomes, said Hadomi. It is not just his word, but based on independent clinical studies that persuaded the FDA to approve it.</p>
<p>SpineAssist is an integral part of minimally invasive spinal surgery, as opposed to open spinal surgery, in which the surgeon needs a direct field-of-view to spine. This means creating an incision large enough to reach the spine and expose a full view. In minimally-invasive surgery, the surgeon makes small incisions to allow either keyhole visualization of the operating field or pulls back the tissues beneath the skin to expose the spine. To compensate for this limited field of view, surgeons use fluoroscopy (Xrays) to view their progress, said Hadomi.</p>
<p>But comparative studies have shown that robotic guidance can produce results more accurate than in open surgery – not to mention with less pain, faster recovery and fewer repeat operations.</p>
<p>Prior to surgery, the patient undergoes a CT scan of the spine. On the day of the operation, while under anesthesia, two X-rays of the spinal column – one from the back and the other from the side – are performed. Using special algorithms, the SpineAssist merges the images to create a three-dimensional “blueprint.” All this is necessary to plan and carry out the placement of metallic screws that hold the vertebrae together, whether the discs are damaged or missing, or to repair deformities, as in scoliosis.</p>
<p>A SpineAssist platform is mounted on the back to guide the surgeon on where to optimally drill holes in the bones – within one millimeter (a fifth of the width of a coarse human hair) in accuracy. This minimizes the risk of harm to the spinal cord and blood vessels, as well as the patient’s and the medical team’s exposure to radiation, which is halved, said Hadomi.</p>
<p>The procedure is carried out with a $1,200 disposable robotic implant called Emerald (after one of the jewels on the breastplate worn by the High Priest in the Temple, Hadomi explained). But it is the surgeon who actually makes the holes and inserts the implant, not the robot, and it is he who can make smaller incisions in the skin and muscle below because he needs less leeway, added the CEO. Once a hospital purchases the system, the cost of the Emerald – which cannot be reused – is covered by the health basket.</p>
<p>PROF. MEIR Liebergall, chairman of the orthopedic surgery complex at Hadassah University Medical Center, praised the work of Mazor Robotics. “We have cooperated with them for almost a decade, especially in implementation of the system,” he said. “This has been in accordance with our Hadassah philosophy of boosting minimally invasive and computer-aided surgery.”</p>
<p>Liebergall, who is a world expert in using computers to guide the implantation of screws for hip replacement, does not perform the spinal surgery.</p>
<p>This procedure is carried out at Hadassah by Dr. Leon Kaplan and Dr. Yair Barzilai. Liebergall said there are only four or five surgeons in the whole country who use the SpineAssist system so, far after undergoing training abroad. They learn through computerized simulations and by working on cadavers.</p>
<p>“The Mazor Robotics system is now used at the two Hadassah hospitals “on a daily basis. It doesn’t solve all orthopedic surgery problems, but it is very helpful,” he said.</p>
<p>Except for a few cases, Kaplan and Barzilai have not yet used the system on children suffering from scoliosis, in which the spinal column curves away from the middle or sideways. Scoliosis can be congenital due to improper formation of the vertebrae or fused ribs during gestation or early in life; be caused by poor muscle control or paralysis due to diseases such as cerebral palsy, muscular dystrophy, spina bifida and polio; or be of unknown cause. Whatever the type, scoliosis can cause functional and esthetic problems. But Liebergall expects that it will routinely offer such surgery at Hadassah within the next two years.</p>
<p>Other potential applications for the system, whose price will apparently rise, are very exciting, he added. “It won’t take long before it could be used for lengthening bones and for treating vertebrae damaged in trauma cases. With some modification, it could be used for hip replacement surgery as well. And the fact that it is Israeli technology leading the world is wonderful.”</p>
<p>Hadomi notes that the company has a total of 50 employees in Israel and Europe, but is certain to expand as demand for the robotic system grows.</p>
<p>“It might even be used eventually in brain surgery.”</p>
<p>The company has offices in Atlanta, Dallas, Houston and Chicago in addition to New York. “We have signed agreements in Italy, Russia and Holland, and are expanding to Belgium, France, Spain, Portugal and the Far East. The potential is huge.” Some components are manufactured by the Tamuz company at Kibbutz Jezreel, and others by subcontractors in Switzerland.</p>
<p>“This is the smallest medical robot in the world, and has been used for over 2,000 operations and 10,000 implants so far. There is no other that works on the spine. We do not expect serious competition, and our product is patented. Our sales will reach hundreds of millions of dollars, but we will not relax. We will work on new generations of robotic surgical equipment,” concluded Hadomi.</p>
<p>And, it is hoped, patients’ having to spend the rest of their lives in a wheelchair due to a failed operation won’t be even a passing fear.</p>
<p><em>By JUDY SIEGEL-ITZKOVICH   http://www.jpost.com/Health/Article.aspx?id=210918</em></p>
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		<title>Mazor wins FDA approval for Emerald spine implants</title>
		<link>http://biomed-blogs.com/biomed2010/864</link>
		<comments>http://biomed-blogs.com/biomed2010/864#comments</comments>
		<pubDate>Sat, 05 Feb 2011 18:21:48 +0000</pubDate>
		<dc:creator>Biomed Man</dc:creator>
				<category><![CDATA[Industry news]]></category>
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		<description><![CDATA[Mazor Robotics Ltd. (TASE:MZOR) has obtained US Food and Drug Administration (FDA) marketing approval for its Emerald spinal implants. The company plans to begin marketing in the second half of 2011. Mazor&#8217;s share price jumped 11 percent in heavy trading on the news, but fell back to a gain of 7.4 percent in afternoon trading [...]]]></description>
			<content:encoded><![CDATA[<p>Mazor Robotics Ltd. (TASE:MZOR) has obtained US Food and Drug Administration (FDA) marketing approval for its Emerald spinal implants. The company plans to begin marketing in the second half of 2011.</p>
<p><a href="http://s802.photobucket.com/albums/yy306/dorinem/?action=view&amp;current=doctors.jpg" target="_blank"><img src="http://i802.photobucket.com/albums/yy306/dorinem/doctors.jpg" border="0" alt="Photobucket"></a></p>
<p>Mazor&#8217;s share price jumped 11 percent in heavy trading on the news, but fell back to a gain of 7.4 percent in afternoon trading to NIS 10.81, giving a market cap of NIS 204 million.<span id="more-864"></span></p>
<p>The Emerald spinal implant is inserted by the company&#8217;s robotic SpineAssist system for minimally invasive spinal surgical procedures. The implants were developed as part of Mazor&#8217;s strategy to develop new products for use in conjunction with the SpineAssist system.</p>
<p>The surgical implant procedure already has an indemnification code of $6,000-8,000 per procedure. Mazor expects to charge this amount in addition to the charge for the use of the company&#8217;s disposable products used in procedures with the SpineAssist system.</p>
<p>In preparation for the commercial launch, Mazor plans to test the use of the Emerald spinal implants at international opinion-setting surgical centers.</p>
<p>Copyright (c) 2011, Globes, Tel Aviv, Israel</p>
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		<title>FDAnews Virtual Conference: Complying with FDA&#8217;s Unique Device Identification Rule; Feb 24 2011</title>
		<link>http://biomed-blogs.com/biomed2010/855</link>
		<comments>http://biomed-blogs.com/biomed2010/855#comments</comments>
		<pubDate>Fri, 28 Jan 2011 18:03:42 +0000</pubDate>
		<dc:creator>Biomed Man</dc:creator>
				<category><![CDATA[Events]]></category>
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		<description><![CDATA[The soon-to-be-issued FDA proposed rule requiring adoption of Unique Device Identification (UDI) has device manufacturers in a sweat. But an upcoming virtual conference for medical device companies promises to shed light. The FDA is about to unveil a proposed rule that could dramatically increase the volume and type of information you supply to the FDA. [...]]]></description>
			<content:encoded><![CDATA[<p>The soon-to-be-issued FDA proposed rule requiring adoption of Unique Device Identification (UDI) has device manufacturers in a sweat. But an upcoming virtual conference for medical device companies promises to shed light.</p>
<p>The FDA is about to unveil a proposed rule that could dramatically increase the volume and type of information you supply to the FDA.</p>
<p><a href="http://s802.photobucket.com/albums/yy306/dorinem/?action=view&amp;current=FDA.gif" target="_blank"><img src="http://i802.photobucket.com/albums/yy306/dorinem/FDA.gif" border="0" alt="Photobucket"></a></p>
<p>The new rule will require you to create a unique ID and label for every product that carries risk. The label will include name of manufacturer, number and description, lot number, expiration date, product specifications, manufacturing date, an expanded bar code and any unique features including potential allergy warnings &#8211; all encrypted in special codes.</p>
<p>The results of the recent FDA UDI pilot program showed firms had strong concerns regarding:<span id="more-855"></span></p>
<p>* Which data elements to use to link the UDI database to various FDA databases<br />
* Understanding when to obtain a new UDI<br />
* Identifying and linking software that is incorporated into devices<br />
* Expected ability to comply with the regulation based on volume and frequency of product development<br />
* The need for multiple and nested levels of database permission based on company size, corporate structure and global footprint</p>
<p>Feeling overwhelmed? Looking for battle-tested answers, but coming up short?</p>
<p>Look no further.</p>
<p>FDAnews has put together an all-star panel to shed light and bring clarity on this major new rule. Put all your appointments “on hold” on Thursday, Feb 24 2011, and clear the day for this virtual conference on the new UDI rule. </p>
<p>http://www.FDAnews.com/UDIVC</p>
<p>Without leaving the comfort and convenience of your office, you and your staff can gain the knowledge you need for 100% compliance.</p>
<p>More details at http://www.fdanews.com/conference/detail?display=0&#038;eventId=2991&#038;trk=11117BMNPR.</p>
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		<title>Curepharma is looking to hire a QA &amp; Regulatory Affairs manager</title>
		<link>http://biomed-blogs.com/biomed2010/826</link>
		<comments>http://biomed-blogs.com/biomed2010/826#comments</comments>
		<pubDate>Mon, 10 Jan 2011 10:08:49 +0000</pubDate>
		<dc:creator>Biomed Man</dc:creator>
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		<description><![CDATA[Curepharma is looking to hire a QA &#038; Regulatory Affairs manager to be a part of the Botanical Drugs revolution. Can you handle this job ? Botanical Drugs are a fairly new FDA regulatory category &#8211; the future of the Pharma industry. To support our a diversified pipeline and a lead botanical drug candidate entering [...]]]></description>
			<content:encoded><![CDATA[<p>Curepharma is looking to hire a QA &#038; Regulatory Affairs manager to be a part of the Botanical Drugs revolution. Can you handle this job ?</p>
<p>Botanical Drugs are a fairly new FDA regulatory category &#8211; the future of the Pharma industry. To support our a diversified pipeline and a lead botanical drug candidate entering phase III, we are looking to hire a QA &#038; Regulatory manager who can stand up to the challenge of setting procedures for game-changing drug developing and manufacturing processes.</p>
<p>Candidate must have hands on experience Pharma QA and Regulation (or equivalent) and a passion to learn and master this new and exciting field of Botanical Drugs.</p>
<p>English proficiency is a must! </p>
<p>For full time, in-house employees only &#8211; no freelance \ external advisors please. </p>
<p>Please send CV to: jobs@se-curepharma.com</p>
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		<title>Aiming for Near-Normal Blood Sugar Did Not Delay Combined Risk of Diabetic Damage for People With Long-standing Diabetes, NIH-Sponsored Trial Finds</title>
		<link>http://biomed-blogs.com/biomed2010/665</link>
		<comments>http://biomed-blogs.com/biomed2010/665#comments</comments>
		<pubDate>Tue, 29 Jun 2010 21:52:03 +0000</pubDate>
		<dc:creator>Biomed Man</dc:creator>
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		<description><![CDATA[In people with longstanding type 2 diabetes who are at high risk for heart attack and stroke, lowering blood sugar to near-normal levels did not delay the combined risk of diabetic damage to kidneys, eyes, or nerves, but did delay several other signs of diabetic damage, a study has found.  The intensive glucose treatment was compared [...]]]></description>
			<content:encoded><![CDATA[<p><span id="more-665"></span></p>
<p>In people with longstanding type 2 diabetes who are at high risk for heart attack and stroke, lowering blood sugar to near-normal levels did not delay the combined risk of diabetic damage to kidneys, eyes, or nerves, but did delay several other signs of diabetic damage, a study has found.  The intensive glucose treatment was compared with standard glucose control.</p>
<p>These findings are from the NIH-funded Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial.  Although intensive treatment produced some beneficial changes, this approach was reported in 2008 to increase death rates. </p>
<p>The new ACCORD findings appear June 29, 2010 in The Lancet’s special online diabetes issue, coinciding with a presentation of the study results at the American Diabetes Association&#8217;s 70th annual scientific sessions in Orlando.</p>
<p>Over time, diabetes damages the small blood vessels of the eyes, nerves, kidneys and other organs, leading to pain and disability.  Heart disease due to damaged large blood vessels is a major cause of death in persons with type 2 diabetes. The longer a person has diabetes, the greater the chances of serious complications, including vision loss and blindness, foot ulcers and amputations, kidney disease and kidney failure, and heart disease and stroke.</p>
<p>“In these ACCORD participants with established type 2 diabetes and additional risk factors for cardiovascular disease, intensive lowering of blood glucose reduced some markers of eye, nerve and kidney disease compared with standard glucose control, but the groups did not differ in the rate of progression to kidney failure, nerve disease, and major vision loss,” said lead author Faramarz Ismail-Beigi, M.D., Ph.D., of Case Western Reserve University, Cleveland. </p>
<p>The ACCORD clinical study compared the effect of intensive control of blood sugar, blood pressure, and blood lipids to standard, less-intensive treatments on the risk of major cardiovascular events in more than 10,000 adults with established type 2 diabetes.  The study’s intensive glycemia arm was halted in February 2008 due to excess deaths in that group.  At that time, participants in the intensively treated group were moved to standard glucose control.</p>
<p>At enrollment, ACCORD participants averaged 62 years of age and were obese.  In addition to having type 2 diabetes for an average of 10 years, about one-third had pre-existing heart disease, and the remainder had at least two additional cardiovascular disease risk factors. They also had high blood sugar, as measured by the hemoglobin A1C test, which shows average blood sugar in the preceding two to three months.  Half of participants had an A1C over 8.1 percent— above the currently recommended target for good control.   A1C values in people without diabetes are less than 6 percent.</p>
<p>Previously reported results showed that over about three-and-a-half years of follow up, participants in the intensive blood sugar group had a 22 percent higher risk of death (5 percent versus 4 percent) and a three times higher risk of seriously low blood sugar (10.5 percent versus 3.5 percent) compared with participants in the standard blood sugar control group.</p>
<p>A secondary goal of the ACCORD blood sugar trial was to determine the effects of near-normal glucose control compared with standard control on microvascular, or small blood vessel, damage to organs and tissues.  Earlier, well conducted clinical trials in patients with newly diagnosed type 1 and type 2 diabetes had proven lowering blood sugar levels reduced eye, nerve and kidney disease.  ACCORD builds on this earlier data by studying benefits of further reduction of glucose to targets near normal, and by studying participants with long-standing rather than newly diagnosed diabetes.</p>
<p>In ACCORD, the A1C target for the intensively treated group was less than 6 percent, a level seen in adults without diabetes and significantly lower than the levels tested in earlier trials.  The goal for standard control was an A1C of 7 to 7.9 percent, an average range achieved by individuals treated for type 2 diabetes in the United States.  Both groups were treated with Food and Drug Administration-approved diabetes medications, as prescribed by their study clinician.</p>
<p>Eye, nerve, and kidney complications in the two groups were compared after 3.7 years, when intensive control was halted, and again at the study’s end after 5 years.  When intensive glucose treatment was halted in the group receiving such treatment, half those participants had an A1C of 6.4 percent or lower, which rose to 7.2 percent at study end.  In the standard treatment group, that A1C measure was 7.5 percent, rising to 7.6 percent by the end of the study.</p>
<p>The treatment groups did not differ in the rate of progression to kidney failure, major vision loss, or advanced peripheral neuropathy, a common nerve problem in diabetes that usually begins as tingling or numbness in the feet.  However, people in intensive control had less deterioration in a vision test, and 20 percent fewer cataract surgeries compared with those in standard control.<strong>  </strong>They also had<strong> </strong>a 30 percent lower rate of protein leakage in the urine, a sign of kidney disease and increased risk of heart disease.  Testing for vibratory sensation, an indicator of nerve health, showed no difference between the groups, but the intensively controlled group scored better on other nerve tests. </p>
<p>ACCORD is continuing follow-up to assess whether the early changes seen in this study will result in differences in blindness, nephropathy and neuropathy. “The study had a relatively short time period – 3.7 years – to see significant differences in serious complications.  Diabetes is a chronic disease, and prevention of complications should be measured over many years,” said Ismail-Beigi.</p>
<p>The effects of intensive blood sugar control on vision are consistent with findings from the ACCORD Eye Study, which explored the effects of intensive treatments on progression of diabetic retinopathy in a subset of about 3,000 ACCORD participants. The most common cause of vision loss in working-age Americans, diabetic retinopathy is a disease in which blood vessels in the eye’s light-sensitive retinal tissue are damaged by diabetes. Intensive blood sugar control was found to be beneficial in retarding the progression of diabetic retinopathy.</p>
<p>&#8220;ACCORD provides important data on the risks and benefits of intensive glucose control in people with established type 2 diabetes,” said Susan B. Shurin, M.D., acting director of the NIH&#8217;s National Heart, Lung, and Blood Institute (NHLBI).  “Although increasing treatment to try to achieve near-normal blood sugar provides some benefit, clinicians and patients should note that this treatment strategy also potentially increases the risk of adverse effects in patients with additional risk factors for heart disease, such as those studied in ACCORD.&#8221; </p>
<p>“Earlier landmark trials have proven that intensive glucose control early in the course of diabetes provides long-term benefits in reducing microvascular complications.  ACCORD fills an important gap by studying adults with diabetes later in the disease and examining even more stringent glucose control than that previously proven beneficial,” said Judith Fradkin, M.D., director of the Division of Diabetes, Endocrinology, and Metabolic Diseases of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).  “This new information will help tailor therapy for individuals with long established diabetes who are at high risk of cardiovascular events or already have cardiovascular disease.” </p>
<p>About 24 million people in the United States have diabetes. It is the main cause of kidney failure, limb amputations, and new onset blindness in adults and a major cause of heart disease and stroke. Type 2 diabetes, which accounts for up to 95 percent of all diabetes cases, becomes more common with increasing age.  It is strongly associated with obesity, physical inactivity, family history of diabetes, history of gestational diabetes (diabetes that occurs during pregnancy), and impaired glucose metabolism, and it is more common in minority groups.  The prevalence of diagnosed diabetes has more than doubled in the last 30 years, due in large part to the upsurge in obesity and aging of the population.</p>
<p>The NHLBI is the primary sponsor of ACCORD, with additional funding and scientific expertise contributed by the NIDDK. Other components of the NIH — the National Institute on Aging and National Eye Institute — as well as the Centers for Disease Control and Prevention, supported sub-studies. The following companies provided study medications, equipment, or supplies: Abbott Laboratories, Amylin Pharmaceutical, AstraZeneca Pharmaceuticals LP, Bayer HealthCare LLC, Closer Healthcare Inc., GlaxoSmithKline Pharmaceuticals, King Pharmaceuticals, Inc., Merck &amp; Co., Inc., Novartis Pharmaceuticals, Inc., Novo Nordisk, Inc., Omron Healthcare, Inc., Sanofi-Aventis U.S., and Takeda Pharmaceuticals Inc.</p>
<p>Source: <a href="http://public.nhlbi.nih.gov/newsroom/home/GetPressRelease.aspx?id=2711" target="_blank">NIH News</a></p>
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		<title>BioMed 2010 week Innovations: The New Generation of PainShield</title>
		<link>http://biomed-blogs.com/biomed2010/641</link>
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		<pubDate>Wed, 09 Jun 2010 21:14:55 +0000</pubDate>
		<dc:creator>Biomed Man</dc:creator>
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		<description><![CDATA[NanoVibronix will present the second generation of PainShield – for the treatment of pain and chronic wounds using ultrasound waves Following the commercial success of the first generation PainShield device, for the treatment of (surprise, surprise) pain, especially one that stems from Trigeminal Neualgia, the Israeli company NanoVibronix now reveals the second generation of the [...]]]></description>
			<content:encoded><![CDATA[<p dir="ltr"><strong><a href="http://biomed-blogs.com/wp-content/uploads/2010/06/PainSheild.jpeg"><img class="alignright size-thumbnail wp-image-643" title="PainSheild" src="http://biomed-blogs.com/wp-content/uploads/2010/06/PainSheild-150x150.jpg" alt="" width="150" height="150" /></a>NanoVibronix will present the second generation of PainShield – for the treatment of pain and chronic wounds using ultrasound waves</strong></p>
<p dir="ltr"><span id="more-641"></span><strong></strong></p>
<p dir="ltr">Following the commercial success of the first generation PainShield device, for the treatment of (surprise, surprise) pain, especially one that stems from Trigeminal Neualgia, the Israeli company NanoVibronix now reveals the second generation of the device. This time, it has some extra capabilities to treat chronic wounds. NanoVibronix, based in Nesher, is developing and marketing medical devices based on ultrasound technology it has developed. The PainShield is a small, mobile device which produces low-powered waves at a supersonic frequency, and is used to treat and cure infections, injuries and pains in tendons, joints and those of neural origins.</p>
<p dir="ltr">The PainShield is composed of two parts: a device which supplies the electrical signal and a treatment patch which is attached directly to the skin at the site of treatment, or nearby. A rechargeable battery supplies the power for the device, which can be belted on the body for optimal mobility and comfort. The sound waves submit vibrations that can reach a depth of up to 4 centimeters below the skin, and to a range of 10 centimeters around the patch. The device is recommended for a prolonged treatment of up to seven hours each day.</p>
<p dir="ltr">&#8220;Ultrasound has been used for many years to cure soft tissues, accelerating fracture fusion and to treat pain,&#8221; says Amir Rippel, the company&#8217;s vice head of marketing. &#8220;PainShield&#8217;s uniqueness is in a mobile application which allows one to be treated independently of a physiotherapist, and thus the treatment can be performed in the patient&#8217;s house as well. A prolonged mobile use of ultrasound at low power and frequency improves the local blood flow, reduces local infectious response and accelerates the process of healing and pain reduction. The innovation that we&#8217;ll present for the first time to a Israeli audience in the BioMed 2010 Week, will demonstrate a new use for the device: introducing local antiobiotics, enrichment with oxygen or washing and locally cleaning chronic wounds via ultrasound waves.&#8221;</p>
<p dir="ltr">PainShield has an AMAR certificate in Israel, has been approved by the FDA and also has a CE Mark in Europe.</p>
<p dir="ltr"> </p>
<p dir="ltr">Source: <a href="http://www.donitza.co.il/" target="_blank">DMC, Donitza Market Communication</a></p>
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		<title>Stem Cells as Seek-and-Destory Missiles against Cancer</title>
		<link>http://biomed-blogs.com/biomed2010/631</link>
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		<pubDate>Sun, 06 Jun 2010 15:42:23 +0000</pubDate>
		<dc:creator>Biomed Man</dc:creator>
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		<description><![CDATA[As published in New Scientist, stem cells were succesfully modified to act as seek-and-destroy missiles against cancer in mice brains Stem cells are often viewed as the ultimate solution for regenerative medicine, and for a good cause. Given the correct cues, they can regenerate whole parts of the body, and even re-create an entire embryo [...]]]></description>
			<content:encoded><![CDATA[<p><a href="http://biomed-blogs.com/wp-content/uploads/2010/06/Trident_II_missile_image.jpg"><img class="alignright size-thumbnail wp-image-633" title="Trident_II_missile_image" src="http://biomed-blogs.com/wp-content/uploads/2010/06/Trident_II_missile_image-150x150.jpg" alt="" width="150" height="150" /></a>As published in New Scientist, stem cells were succesfully modified to act as seek-and-destroy missiles against cancer in mice brains</p>
<p><span id="more-631"></span></p>
<p>Stem cells are often viewed as the ultimate solution for regenerative medicine, and for a good cause. Given the correct cues, they can regenerate whole parts of the body, and even re-create an entire embryo (although that would require QUITE some understanding of the cues involved in the process). It seems, however, that now a new use has been found for them, as seek-and-destroy missiles against cancer.</p>
<p>The reason this just might work is that stem cells are attracted towards cancer cells. Why? We don&#8217;t know. Some say that they respond to the same factors that cause a tumor to invade a healthy tissue. Be it as it may, a team of researchers from the Beckman Research Institute in California used genetically engineered stem cells to combat a form of cancer in the brain. The cells produced an enzyme called cytosine deaminase, which converted a drug called 5-fluorocytosine (5-FC) into its active, chemotherapeutic form.</p>
<p>The engineered stem cells were injected into the brains of mice with glioma – a deadly brain cancer. The mice also received 5-FC, which turned into the chemotherapeutic form mainly at the sites the stem cells were at. The tumors&#8217; mass was reduced by a whopping 70% compared with the untreated animals.</p>
<p>As reported in <a href="http://www.newscientist.com/article/mg20627633.800-stem-cells-turn-into-seekanddestroy-cancer-missiles.html?DCMP=OTC-rss&amp;nsref=online-news" target="_blank">New Scientist</a>, the US FDA granted the researchers &#8220;approval to carry out a safety trial of the therapy in up to 20 patients with recurrent glioma, for whom life expectancy is just three to six months. The stem cells will be injected into the tumour cavity following surgery to reduce its mass, and then given four days to home in on any remaining cancer cells. Patients will then be treated with daily 5-FC for one week.&#8221;</p>
<p>The stem cells used in the research do not seem to differentiate, and stop proliferating after 48 hours, which should ensure they won&#8217;t create yet another cancer in the body. Hopefully, the clinical trials will end well and the researchers will head to phase II soon after. In the meantime, we&#8217;ll have to settle for hearing more about cancer and stem cells at the ILSI-BioMed week 2010, where a <a href="http://www2.kenes.com/biomed/ilsi/Pages/Detailed_Program.aspx" target="_blank">Technology Transfer Session will be held on the subject of Pharmaceuticals and Stem cells</a>, moderated by Dr. Sylvie Lauria, the Technology Transfer Office of Sheba Medical Center.</p>
<p>Source: <a href="http://www.newscientist.com/article/mg20627633.800-stem-cells-turn-into-seekanddestroy-cancer-missiles.html?DCMP=OTC-rss&amp;nsref=online-news" target="_blank">New Scientist</a></p>
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		<title>May 5th: Healthcare Reform Webinar</title>
		<link>http://biomed-blogs.com/biomed2010/556</link>
		<comments>http://biomed-blogs.com/biomed2010/556#comments</comments>
		<pubDate>Fri, 30 Apr 2010 20:35:36 +0000</pubDate>
		<dc:creator>Biomed Man</dc:creator>
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		<description><![CDATA[U.S. Health Care Reform Webinar &#8211; A Special Presentation for Israeli Pharma, Biotech and Medical Device Companies and Their Investors     Please register for this live webinar.   Meeting Description:    Drug and Biologics Manufacturers: Medicare and Medicaid drug coverage changes Annual fee for branded prescription drug manufacturers Biosimilars   Medical Device Manufacturers: Excise [...]]]></description>
			<content:encoded><![CDATA[<h1>U.S. Health Care Reform Webinar &#8211; A Special Presentation for Israeli Pharma, Biotech and Medical Device Companies and Their Investors</h1>
<p> </p>
<p><span id="more-556"></span></p>
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<td width="335" align="left"><a href="https://cc.readytalk.com/cc/schedule/display.do?udc=1murwgkr9k0n" target="_blank">Please register for this live webinar.</a></td>
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<td width="335"> </td>
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<td width="335" align="left"><strong>Meeting Description: </strong></td>
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<td width="335" align="left">Drug and Biologics Manufacturers:</p>
<ul>
<li>Medicare and Medicaid drug coverage changes</li>
<li>Annual fee for branded prescription drug manufacturers</li>
<li>Biosimilars</li>
</ul>
<p> </p>
<p>Medical Device Manufacturers:</p>
<ul>
<li>Excise tax</li>
<li>Essential Health Benefits Package</li>
</ul>
<p> </p>
<p>Health Care Fraud and Abuse Provisions:</p>
<ul>
<li>Other Notable Changes</li>
<li>Notable Non-Changes</li>
</ul>
</td>
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</tbody>
</table>
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		<title>OrSense Receives FDA Approval for Non-Invasive Oximetry Monitoring System</title>
		<link>http://biomed-blogs.com/avivamishmari/489</link>
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		<pubDate>Wed, 24 Mar 2010 20:36:15 +0000</pubDate>
		<dc:creator>Aviva Mishmari, ILSI</dc:creator>
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		<description><![CDATA[OrSense Ltd., developer of monitors for non-invasive measurements of various blood parameters, announced it has received U.S. Food and Drug Administration (FDA) approval for NBM-200MP, a non-invasive oximetry and low signal oximetry sensor.   Non-invasive pulse oximetry has become a standard of care in the operating and recovery rooms, intensive care units and emergency services, [...]]]></description>
			<content:encoded><![CDATA[<table cellspacing="0" cellpadding="0">
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<td><span style="color: #000000;"><a href="http://biomed-blogs.com/wp-content/uploads/2010/03/Zuurstofleiding.jpg"><img class="alignright size-thumbnail wp-image-490" title="Zuurstofleiding" src="http://biomed-blogs.com/wp-content/uploads/2010/03/Zuurstofleiding-150x150.jpg" alt="" width="150" height="150" /></a>OrSense Ltd., developer of monitors for non-invasive<strong> </strong>measurements of various blood parameters, announced it has received U.S. Food and Drug Administration (FDA) approval for NBM-200MP, a non-invasive oximetry and low signal oximetry sensor.</span><span style="color: #000000;"><span id="more-489"></span></span></p>
<p><span style="color: #000000;"> </span></p>
<p><span style="color: #000000;">Non-invasive pulse oximetry has become a standard of care in the operating and recovery rooms, intensive care units and emergency services, yet it has been known to provide erroneous oxygen saturation readings in situations of low perfusion, low cardiac output and/or low blood flow.</span></p>
<p><span style="color: #000000;"> </span><span style="color: #000000;">OrSense&#8217;s system offers non-invasive, continuous and accurate measurement of oxygen saturation in states of hypovolemia, hypothermia and vasoconstriction or during open heart surgery, as well as during regular perfusion. The NBM-200MP’s superior performance was validated by multi-center trials in the U.S. and Europe.</span></p>
<p><span style="color: #000000;"> </span></p>
<p><span style="color: #000000;">“The ability to accurately measure oxygen saturation in states of low perfusion in acute care patients is critical for intensive care units,” said Prof. Pierre Singer, Head of the Intensive Care Unit at Rabin Medical Center in Petah Tikva, Israel. “OrSense’s non-invasive oximeter could be used for accurate, safe and easy to use oxygen saturation<strong> </strong>evaluation in various hospital wards. Consequently, it will improve patient care and survival, as well as reduce staff workload,” Prof. Singer concluded.</span></p>
<p><span style="color: #000000;"> </span></p>
<p><span style="color: #000000;">Lior Ma&#8217;ayan, CEO of OrSense, said the company is looking forward to the initiation of commercial efforts in the U.S. later this year.&#8221;</span></p>
<p><strong><span style="color: #000000;"> </span></strong></p>
<p><span style="color: #000000;">NBM-200MP continuously and noninvasively monitors and displays multiple blood parameters including oxygen saturation of Hb (SpO2) and low perfusion oximetry. The system permits continuous patient monitoring with adjustable alarm limits for oximetry as well as visible and audible alarm signals. A ring-shaped sensor is fitted on the patient’s finger and applies gentle pressure, temporarily occluding the blood flow. During the occlusion optical elements in the sensor perform sensitive measurement of the light transmitted through the finger. This method, called Occlusion Spectroscopy, provides a quick, accurate and painless measurement of the patient&#8217;s blood constituent, while greatly improving patient comfort, eliminating infection risk, and providing the caregiver with superior accuracy and immediate results.</span></p>
<p><strong><span style="color: #000000;"> </span></strong></p>
<p><span style="color: #000000;">OrSense is a medical device company developing non-invasive monitoring systems for measurements of oxygen saturation, hemoglobin, glucose and other blood parameters. The Company&#8217;s FDA approved NBM-200MP is a non-invasive blood oximetry monitor for use in hospitals. OrSense’s non-invasive hemoglobin/hematocrit monitor was granted the CE approval and was tested on over 8,000 patients and donors at 20 sites in the U.S. and Europe. The Company&#8217;s products are based on its proprietary Occlusion Spectroscopy technology, which overcomes key obstacles that hinder the performance of competing approaches. OrSense&#8217;s CE approved glucose monitor was tested on over 450 diabetic subjects, showing performance similar to those of invasive glucose sensors.</span></p>
<p><span style="color: #000000;">Investors in OrSense are led by Israel Health Care Ventures and </span><a href="http://www.star-ventures.com/home/index.html" target="_blank"><span style="color: #000000;">STAR Ventures</span></a><span style="color: #000000;">. Other investors include, </span><a href="http://www.orsense.com/?id=681"><span style="color: #000000;">Carlo Salvi</span></a><span style="color: #000000;">, Tamar ventures, Unicycle, Medison, Lewis Trust Group (LTG) and </span><a href="http://www.orsense.com/board_of_directors"><span style="color: #000000;">Shimon Eckhouse</span></a><span style="color: #000000;">, who is also OrSense&#8217;s Chairman of the board.</span></td>
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<p>Source: <a href="http://www.ilsi.org.il/news_item.asp?ID=199" target="_blank">ILSI website</a></p>
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