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HiFi DNA Tech has filed suit against the U.S. Food and Drug Administration here in U.S. Federal District Court requesting the high court overturn the FDA’s denial of HiFi’s petition for reclassification of its human papillomavirus (HPV) DNA detection device from the more-restrictive class III to class II.

“The FDA should be encouraging innovative companies to introduce their science-based devices to facilitate transfer of the molecular technologies developed in the past 15 years to clinical laboratories to improve patient feel interested,” said Sin Hang Lee, MD, of HiFi DNA Tech, based in Trumbull, Conn.

“Changing the classification encourages innovative companies to make acquainted their new devices into the market to assist clinical laboratories to perform accurate HPV genotyping, which pleasure help the doctors give better soundness care to women,” said Dr. Lee.

The suit was filed by HiFi’s attorney Anthony J. Musto of Fairfield, Conn. on Jan. 11, 2008, and an amended complaint was filed Jan. 22, 2008.

HiFi had previously petitioned the FDA for “down classification” of HPV DNA test to a virology test to replace its current cancer test classification, a concept dating from the 1980s. HiFi introduces a DNA amplification (known as PCR or polymerase chain reaction) device for replication of target HPV DNA. The amplified DNA material facilitates accurate HPV genotyping by direct automated DNA sequencing, a technology perfected over the past 15 years and contributing greatly to the early completion of the national Human Genome Project.

HPV recently came to the attention of the public through advertisements beneficial to Gardasil®, a vaccine approved to protect against 4 specific types of HPV. The suit notes that the manufacturer of Gardasil® used PCR-based HPV tests to prove the genotype-specific safety and effectiveness of Gardasil®. HiFi requests that the court review the denial, pointing out the inconsistency between allowing PCR-based testing for the approval of Gardasil®, no more than denying a test for HPV based upon the same technology.

Accurate HPV genotyping is especially valuable when determining whether to vaccinate a sexually active woman. Vaccinating a woman infected with vaccine-relevant types of HPV with Gardasil® may enhance the risk of developing precancerous cervical lesions by 44.6%, as detailed in the study supporting Gardasil® approval. With that risk, the FDA’s statement that “FDA has not to date approved any HPV genotyping test for diagnostic use” may leave many women wondering whether to risk vaccination with Gardasil®.

“It is astonishing to unravel the FDA statement “Probe design is a critical process for HPV DNA testing because of the large number of closely related HPV genotypes. Complex probe cocktails may crossreact and/or compete with individual another…” used as a scientific basis for the abjuration. The FDA either did not read the contents of the petition before writing its decision or failed to keep up with the according to principles advances since 1988 when the Digene HC2 HPV test was approved for marketing because neither the HPV DNA nested PCR device submitted for its review, nor the recommended accurate HPV genotyping by direct automated DNA sequencing despite validation uses any probes at all,” said Dr. Lee.

HiFi DNA Tech, LLC tries to emporium its LoTemp™ nested PCR reagents as a test kit for preparing amplified HPV DNA samples. The latter samples are suitable for superscribe automated DNA sequencing in high complexity testing hospital laboratories to improve patient care. This new technology is published in Infectious Agents and Cancer . Milford Medical Laboratory currently provides this accurate HPV genotyping along with no-false-positive Chlamydia and gonococcus tests by show DNA sequencing on a single liquid-based Pap specimen to serve gynecologists and their patients.

HiFi DNA Tech, LLC

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Surface Logix announced positive results in the Company’s Phase 2a clinical trial of SLx-4090 in dyslipidemia (high cholesterol and triglyceride levels in the bloodstream). The randomized, double-blind, placebo-controlled Phase 2a study in 24 patients with dyslipidemia demonstrated that SLx-4090 caused clinically significant reductions in postprandial triglycerides and LDL-cholesterol and was well tolerated. The trial was designed to examine the safety, tolerability, pharmacokinetics and effect on lipid profiles in patients administered recapitulate oral doses of SLx-4090 either three times daily or once daily for 14 days. The Company intends to initiate a Phase 2b study of SLx-4090 in dyslipidemia in the third quarter of 2008.

“The Phase 2a trial showed that SLx-4090 was efficacious and well tolerated in patients,” said Dr. Warwick Tong, Senior Vice President of mercantile expansion of Surface Logix. “We were particularly pleased to see, in the pair dosing regimens, drops not only in postprandial triglycerides but also in fasting LDL-cholesterol levels in just 14 days. Importantly, SLx-4090’s adverse event profile was indistinguishable from that of placebo. We saw no effect on liver function tests, which is consistent with the compound being undetectable in the plasma, and no shock on bowel habit.”

“We were also pleased to see clinically significant weight loss in patients who received SLx-4090,” added Dr. William Prince, Chief Development Officer of Surface Logix. “We characteristic this to the decreased uptake of triglycerides, a significant source of calories in the diet. Given that obesity is a major and growing health concern, we believe SLx-4090’s potential to cause weight loss represents a significant opportunity for therapeutic intervention.”

SLx-4090 is a unusual, oral, non-systemically available inhibitor of microsomal triglyceride transfer protein (MTP) that acts by blocking the formation of particles known as chylomicrons in enterocytes, thereby reducing the uptake of triglycerides and cholesterol into the mad circulation and ultimately, the systemic circulation. Designed to put in action its effect only in enterocytes, SLx-4090 avoids mechanistic toxicities in the liver (where MTP inhibition causes fatty liver) and other organs. MTP inhibitors that have been brought into development by others lack this critical feature and have therefore encountered momentous toxicity concerns in the clinic, which will severely limit their curative potential. SLx-4090 has potential not only in dyslipidemia except also in obesity as a result of the compound’s ability to restrict caloric absorption by reducing the uptake of triglycerides. An of the first grade safety profile is paramount in both indications.

“The industry generally considers the intestine a barrier through which to coerce compounds into the systemic circulation - that is, as an obstacle to be overcome,” commented Dr. Paul Sweetnam, Chief Scientific Officer of Surface Logix. “In the case of MTP inhibition, Surface Logix viewed the gastrointestinal tract not as an obstacle, but as an ally in our quest for a viable curative. By applying our expertise in the biophysics of small molecule-lipid and interfacial interactions through the use of our Pharmacomer(TM) Technology Platform, we were able to design a combination that takes advantage of these interactions. SLx-4090 effectively eliminates the major stumbling block of systemic bioavailability encountered by other MTP inhibitors and therefore offers horrific commercial potential.”

The results from the trial provide further sanction of the ability of the Pharmacomer(TM) Technology Platform to enable Surface Logix scientists to outline specific pharmacokinetic performance into a molecule while optimizing potency and selectivity. Surface Logix endowed SLx-4090 by its unmatched enterocyte-targeting nature in order to differentiate it from conventional systemically available MTP inhibitors.

About the trial:

The Phase 2a study of SLx-4090 was a randomized, double-blind, placebo- controlled vexation. A total of 24 dyslipidemic subjects received an oral dose of 200 mg of SLx-4090 or placebo once daily or three times daily for 14 days. Postprandial triglycerides were measured at frequent intervals daily. Fasting LDL-cholesterol was measured at the beginning and end of the study, as was body weight. Subjects were monitored for adverse events and pharmacokinetic sampling was performed at regular intervals.

About SLx-4090 in Dyslipidemia and Obesity

SLx-4090 is a novel non-systemically available microsomal triglyceride transfer protein (MTP) inhibitor being developed for the treatment of dyslipidemia (high cholesterol and triglyceride levels in the bloodstream). Designed to act only in enterocytes, SLx-4090 inhibits fat and cholesterol uptake but avoids the mechanistic toxicities of MTP inhibition in the liver and other organs such as the heart, testis, ovary and eye. Surface Logix is also exploring the use of SLx-4090 in other metabolic disorders, including obesity and diabetes.

Dyslipidemia currently affects about 10% of the global population, with 25% of these patients having elevated triglyceride levels. In addition, there is an increasing prevalence and medical need for lipid-modifying drugs in obese patients and patients through type 2 diabetes, as a high proportion of type 2 diabetic patients have abnormal concentrations of lipoproteins. In the U.S., Japan and Europe, it is estimated that there are more than 240 million people through abnormal lipoprotein levels. Of these, more than 55 million are estimated to have low levels of high density lipoprotein (HDL) and/or high triglyceride levels.

Obesity is a substantial and growing problem in the US and in the rest of the developed world. Approximately 100 million adults in the US are overweight or obese. Dietary fat is a forcible contributor to obesity. Restricting caloric absorption by limiting the uptake of dietary fat through inhibition of the triglyceride transport function of MTP in the gastrointestinal tract represents a significant chance; fit for therapeutic intervention.

About Surface Logix, Inc.

Surface Logix uses its expertise in biophysical chemistry to create and develop novel small molecule drugs (NCEs) with superior intrinsic drug-like properties that are clearly differentiated from competitive products. The company is advancing multiple internal programs focused primarily on cardiovascular, metabolic, inflammatory and fibrotic diseases. in the place of more information, please visit http://www.surfacelogix.com.

Surface Logix, Inc.
http://www.surfacelogix.com

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Bacteria are increasingly recognized as highly interactive organisms with complex social lives, which are dangerous to their capacity to cause sickness. In particular, many species inhabit dense, surface-bound communities, termed biofilms, within that they communicate and respond to local cell density end a process known as quorum sensing. Enormous effort has been devoted to understanding the genetics and biochemistry of biofilm formation and quorum sensing, but how and why they evolve remains to all intents and purposes unexplored.

Many bacteria use quorum sensing to regulate the secretion of viscous extracellular slime, every whole feature of biofilm life. Intriguingly, however, some species turn on mud product at high cell density, while others turn it off. In this week’s issue of the open-access journal PLoS Biology, Carey Nadell, Kevin Foster, and colleagues representation that by using an individual-based model of biofilm growth, they  investigated wherefore different species use quorum sensing to curb slime production in facing ways. The secret underlying this variation appears to reside in the nature of infections.

Turning mire on at high cell density be able to allow one strain to suffocate one more then competition is intense, as occurs in long-lived chronic infections. Meanwhile, turning slime secretion off at high cell density can benefit a strain causing an acute infection by allowing rapid growth before departing the host.

The evolution of quorum sensing in bacterial biofilms.
Nadell CD, Xavier JB, Levin SA, Foster KR (2008)
PLoS Biol 6(1): e14. doi:10.1371/journal.pbio.0060014
Click here to view indenture online

Public Library of Science
Plos Biology
185 Berry Street, Suite 3100
San Francisco, CA 94107
USA
http://biology.plosjournals.org

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Mammalian mtDNA is maternally transmitted and does not experience bi- parental recombination in the germ line. This asexual mode of transmission, together with a high rate of mutation, should eventually lead to the accumulation of numerous deleterious mtDNA mutations and a “mutational meltdown” (a phenomenon known as Muller’s Ratchet).

Published this week in the open-access daily register PLoS Biology, James Stewart, Nils-Goran Larsson, and colleagues show how they utilized a genetic mouse model, the mtDNA mutator mouse, to introduce random mtDNA mutations and followed transmission of these mutations. Maternal transmission of mtDNA is typically subjected to a bottleneck phenomenon whereby only a fraction of the mtDNA copies in the originating cell precursor are amplified to bring into existence the ~105 mtDNA copies present in the mature oocyte. As a consequence of this phenomenon, the established maternal peer lines carried high levels of a few mtDNA mutations.

They sequenced the entire mtDNA to characterize the maternally transmitted mutations in the established mouse lines. Surprisingly, mutations causing amino acid changes were strongly underrepresented in comparison with “silent” changes in the protein coding genes. These results show that mtDNA is subdue to strong purifying selection in the maternal germ line. Such selection of functional mtDNA genomes likely involves a mechanism for functional testing to prevent transmission of mutated genomes to the offspring.

Strong purifying selection in transmission of mammalian mitochondrial DNA.
Stewart JB, Freyer C, Elson JL, Wredenberg A, Cansu Z, et al. (2008)
PLoS Biol 6(1): e10.doi:10.1371/journal.pbio.0060010
Click here to view article online

Public Library of Science
Plos Biology
185 Berry Street, Suite 3100
San Francisco, CA 94107
USA
http://biology.plosjournals.org

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The odds of surviving cancer of the pancreas increase dramatically for patients whose tumors are smallest, according to a new study by researchers at Saint Louis University and the M.D. Anderson Cancer Center in Houston the first study to specifically evaluate the link between tumefaction size and survival rates for one of the most common and deadly cancers.

The findings in the current edition of Pancreas (http://www.pancreasjournal.com) vividly underscore the importance of early diagnosis of pancreatic cancer, the researchers said.

“Even though it seems intuitive and was supported by preliminary observations from earlier studies, for the primeval time we now have evidence that a improving decrease in the size of a pancreatic tumor at the time of diagnosis improves patient outcomes rather dramatically,” said Banke Agarwal, M.D., Associate Professor of gastroenterology at the Saint Louis University School of Medicine and lead author of the study.

“These data emphasize the benefit and the need of finding and diagnosing tumors in the pancreas as early as possible,” Agarwal added. “In order to make progress against pancreatic cancer, we be under the necessity to redouble our efforts to take for identical symptoms that are associated with the early stages of the disease.”

Pancreatic cancer is the fourth most common cancer in the United States and single of the most deadly, responsible for more than 33,000 deaths a year, according to the National Institutes of Health.

Despite many advances in the fight against other cancers in recent years, the prognosis for patients diagnosed with the pancreatic cancer has remained extremely poor. That’s largely because the cancer is frequently not suspected and is difficult to diagnose in its in season stages, when most people are asymptomatic or have non-specific symptoms that are easily ignored or attributed to other diseases.

The study looked at 65 patients who were diagnosed with pancreatic cancer at the M.D. Anderson Cancer in Houston between December 2000 and December 2001. Their average age was 67 years old; 38 were men.

Researchers found a striking correlation between a patient’s prognosis and the size of their swelling at the time of diagnosis.

Of the 12 patients whose tumors were 20 millimeters or smaller, their median survival after diagnosis was 17.2 months. For those with tumors 21-25 mm, median survival was 12.3 months. For those with tumors 26-30 mm, median survival was 8.5 months. And for those with tumors larger than 30 mm, median survival was 7.6 months. Of those patients whose tumors were 20 mm or smaller, two were still alive after 48 months; not one of the patients with tumors larger than 30 mm were alive after 36 months.

Unfortunately, while the patients with the smallest tumors had the highest rates of survival, they were relatively small in figure. Only 12 patients or 18 percent had tumors 20 mm or smaller. By contrast, the largest group of patients 27, or 42 percent had tumors larger than 30 mm.

In addition, the average tumefaction size of patients in the study was 32.9 mm well above the threshold at which survival rates are lowest. That figure is roughly worthy of comparison to an average tumor magnitude of about 30 mm among pancreatic cancer patients in general, according to the study.

“These numbers illustrate why we’ve made so little progress in improving outcomes for people who are diagnosed with pancreatic cancer we’re not finding their tumors until they’re too big and it’s too late,” Agarwal said. “We know we acquire a much better happen of helping someone survive pancreatic cancer if it’s caught early and their tumor is small.”

Major advances in imaging technology in recent years have greatly improved physicians’ ability to diagnose progressively smaller pancreatic tumors. This hasn’t led to earlier diagnosis, however, on this account that patients generally don’t get to the doctor until symptoms appear and by then it’s too late.

Agarwal said researchers will need to focus in continuance finding ways to identify people who should be screened early for pancreatic cancer. Screening of the general peopling for the disease hasn’t proven effective but screening of people with a family history of pancreatic cancer is under active examination, he said. In addition, preliminary data from other studies have shown that elderly people who’ve been recently diagnosed with diabetes or depression have a higher probability of pancreatic cancer providing another avenue for researchers to explore, Agarwal said.

Established in 1836, Saint Louis University chide of Medicine has the distinction of awarding the first medical degree west of the Mississippi River. The school educates physicians and biomedical scientists, conducts medical research, and provides health care on a limited, national and international level. Research at the school seeks new cures and treatments in five key areas: cancer, liver disease, inner part/lung indisposition, aging and brain disease, and infectious disease.

Saint Louis University sanatory Center
St. Louis, MO 63103
United States
http://medschool.slu.edu/index.phtml

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The independence of children with autism depends on their receiving treatment in natural settings. One of the main problems they face is their inability to hear of how to safely cross the way, a requisite skill for independent living. While acquiring this skill could greatly get on these children’s independence, most of the methods for teaching street-crossing have been designed for use within the classroom, and they have been shown as insufficiently effective among autistic children.

The best way to teach children with autism skills is through repeated practice in natural settings, but the danger of learning to cross the street in a natural setting obviously prohibits this method. This is where virtual reality is very effective, as demonstrated by the research team which included Hadass Milika Ben-Chaim, then a student in the Occupational Therapy master’s program and Shula Friedrich, the principal of the Haifa Ofer School for Children with Autism as well as Profs. Josman and Weiss.

Six autistic children, ages 7-12, spent one month learning how to cross virtual streets, to wait for the virtual point of view at the crosswalk to change and to observe left and right for virtual cars using a simulation programmed by Yuval Naveh. The children in the study showed substantial improvement throughout the learning process: at the beginning of the study, the average child was able to use the 2nd level of the software while by dint of. the end they mastered the 9th level, which is characterized by more vehicles traveling at a higher speed.

However, the research team was not looking to teach a virtual skill; they wanted to see if the children were able to transfer the skills they had mastered in a virtual environment to the real world. A local application area with a street and crosswalk, full with traffic signals, was used for the sake of this purpose. The children’s ability to cross the street in close custody was tested in this area evaluating, for model, whether they stopped to look for on the sidewalk or waited for a green light before crossing. The children were brought to the exercise area preceding and following their virtual learning. Here too, the children exhibited an improvement in their skills, following the training on the virtual street, with three of the children showing considerable improvement.

One of the study participants, 16 years old, had participated in the past in a road safety program in the school, but he was not dexterous to learn how to cross the street safely. Following learning the skill in a virtual environment, he erudite for what cause to stop on the sidewalk before stepping into the street, to look at the color of the traffic light, to christian doctrine only when the diffusion of luminous rays was green and to cross without waiting too long.

“Previous studies have shown that autistic children respond well to computer learning. In this research we learned that their intelligence level or severity of their autism doesn’t affect their aptitude to understand the system and therefore this is an important way to improve their cognitive and social abilities,” summarized Profs. Josman and Weiss.

University of Haifa
Mount Carmel
Haifa 31905
Israel
University of Haifa

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A new study by Rhode Island Hospital researchers reports that the full age of 2,300 psychiatry outpatients had more than one disorder when seeking method of treating, and more than one-third had at least three disorders. The reflection is published in the February 2008 edition of the journal Psychological Medicine.

It is the largest study to date using standardized interviews to evaluate a wide range of psychiatric disorders in a general clinical outpatient drill. Most patients had more than one diagnosis; on average, patients had 1.9 current diagnoses. Patients with principal diagnoses of posttraumatic stress disorder (PTSD) and bipolar disorder had the highest number of diagnoses.

Lead author Mark Zimmerman, M.D., counsellor of outpatient psychiatry at Rhode Island Hospital and associate professor of psychiatry and human behavior at Brown Medical School, said, “Based on the results of this study, clinicians should assume that in outpatients presenting for the treatment of mood or anxiety problems, the patients be the subject of more than one diagnosis.”

The study also examined which disorders were the chiefly common reasons for seeking treatment. Major depressive disorder was most common, present in nearly half of the patients, and was usually the primary rational faculty for seeking treatment. In contrast, social phobia was the second most common diagnosis, present in approximately 25 percent of the patients. However, 95 percent of the patients diagnosed with social phobia came for treatment of another disorder.

Zimmerman noted, “with a view to disorders like social phobia that are infrequently diagnosed as the principle disorder in clinical practice, it will be important for the next generation of treatment-efficacy studies to determine if manipulation is effectual when the disorder is a comorbid condition.”

Zimmerman, along with fellow researchers Joseph B. McGlinchey, Ph.D., Iwona Chelminski, Ph.D. and Diane Young, Ph.D., conclude that these results highlight the importance of conducting treatment study on patients with multiple disorders because this is the norm in clinical practice. Most treatment studies exclude patients with multiple disorders. The authors said, “We hope that by documenting the high frequency of comorbidity in clinical practice, this pleasure provide the impetus for modifying how treatment studies are conducted to allow patients with multiple disorders to be included and to determine the outcome of comorbid disorders as well as the primary disorder that is being treated.”

The report is from the Rhode Island Hospital Methods to Improve Diagnostic Assessment and Services (MIDAS) Project, for which Zimmerman is the foremost investigator. Zimmerman said, “The MIDAS project is unique in its integration of research quality diagnostic methods into a community-based outpatient practice affiliated with an academic medical center.”

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Article adapted by Medical News Today from original press release.
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Founded in 1863, Rhode Island Hospital (http://www.rhodeislandhospital.org/) is a privy, not-for-profit hospital and is the largest teaching hospital of The Warren Alpert Medical School of Brown University. A major trauma center for southeastern New England, the hospital is dedicated to being on the cutting edge of medicine and research. Rhode Island Hospital ranks 15th among independent hospitals who receive funding from the National Institutes of Health, through research awards of nearly $27 million annually. Many of its physicians are recognized as leaders in their respective fields of cancer, cardiology, diabetes, orthopedics and minimally invasive surgery. The hospital’s pediatrics division, Hasbro Children’s Hospital, has pioneered numerous procedures and is at the forefront of fetal surgery, orthopedics and pediatric neurosurgery. Rhode Island Hospital is a founding member of the Lifespan health system.

Source: Nancy Cawley
Lifespan

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Novadaq(R) Technologies Inc. (TSX: NDQ), a developer of real-time medical imaging systems and image guided therapies for the operating chance, announced that independent data on SPY(R) and PINPOINT(TM) was presented at an educational program for cardiothoracic surgeons. The event, co-hosted with four other medical device companies, took place during the 44th Annual Society of Thoracic Surgery (STS) convention which was held January 26th - January 30th, 2008 in Fort Lauderdale, Florida. The STS represents the largest gathering of cardiothoracic surgeons in the world and is considered the premiere global meeting.

The invitation-only event included comprehensive presentations and open discussions by cardiac and thoracic surgeons highlighting the latest medical therapies and technologies. Novadaq’s products, the SPY Intra-operative Imaging System and the PINPOINT Autofluorescence Endoscopic Imaging System, were featured in two of the five key presentations:

- Autofluorescence Brochoscopy and Photodynamic Therapy: A Thoracic Surgeon’s Perspective by Patrick Ross Jr., M.D., Ph.D., Associate Professor and Director of Thoracic Surgery at Ohio State University and Director of Thoracic Oncology at the Arthur G. James Cancer Hospital in Columbus, Ohio

- SPY Intra-Operative Imaging in Graft Assessment by David Paul Taggart, M.D., Ph.D., FRCS, Professor of Cardiovascular Surgery towards the John Radcliffe Hospital in Oxford, UK

Dr. Patrick Ross stressed the clinical importance of using autofluorescence imaging to provide government during endoluminal and traditional surgical treatments for lung cancer. Dr. Ross reported the use of real-time autofluorescence bronchoscopy, compared to the gold standard white light bronchoscopy, provides for a more detailed assessment of the patient’s anatomy before pulmonary resection, a more accurate assessment for the presence of early lung cancers and the ability to more precisely perform endoluminal therapies such as Photodynamic Therapy. Dr. Ross also reminded the cardiothoracic surgeon audience that autofluorescence bronchoscopy is since recommended in the 2008 American College of Chest Physicians Evidence Based Practice Guidelines for use in detecting cancerous lesions and for guiding surgical treatments in patients by lung cancer.

Professor Taggart reported his clinical experience using the SPY Intra-operative Imaging System to optimize the clinical outcomes of his coronary artery bypass procedures, which have been previously published in the literature and confirm the need for intra-operative graft assessment. Professor Taggart’s presented clinical results of studies he has performed using SPY. Data reported by others indicating that as many as 30% of all vein grafts may be closed at 1 year post bypass were also included. Professor Taggart stressed that coronary artery disease has become more complex, making coronary artery bypass surgery more technically demanding, which further increases the need for real-time assessment of graft quality. Professor Taggart reported on studies of the clinical utility of available technologies during the term of graft assessment, including a report by the agency of Nimesh Desai, MD., et.al, published in The Journal of Thoracic and Cardiovascular Surgery in 2006. The randomized study compared SPY and the Transit Time Flow Meter, the two most commonly used tools, to the gold flag x-ray angiography. In the study of 139 bypass grafts, SPY was found to result in 83% sensitivity and 100% specificity compared to 25% and 94% respectively for the Transit Time issue Meter.

“Our presence at STS 2008 represents the continue our company has made covering the exceeding 12 months. Last year at STS we had only our SPY System to offer and we had blameless hired our first few direct sales representatives,” said Dr. Arun Menawat, President and Chief Executive Officer of Novadaq Technologies Inc. “Today we have expanded our offerings to embody the Heart Laser(TM) System for TMR and our PINPOINT Endoscopic Imaging System and have a fully engaged sales organization covering the entire US. The feedback from our surgeon customers like Drs. Ross and Taggart continues to confirm that our products grant to the overall technical luck of their procedures and that trope guidance ultimately does facilitate optimal treatment strategies and improve clinical outcomes for patients.”

About Novadaq Technologies

Novadaq Technologies Inc. (TSX: NDQ) develops and commercializes medical imaging systems and real-time image guided therapies for use in the operating room. Novadaq’s proprietary ICG imaging systems can be used to visualize blood vessels, nerves and the lymphatic system for the time of a variety of surgical procedures. Novadaq’s SPY Imaging System, commercially available worldwide, enables cardiac surgeons to visually assess coronary vasculature and bypass graft functionality during the course of heart bypass surgery. The SPY System is expandable to include upgrade kits for use during other surgeries such as other cardiovascular, plastic, reconstructive and organ transplant surgery allowing surgeons to evaluate blood flow and tissue and organ perfusion. In addition, SPY is ideal for use during urological procedures enabling surgeons to visualize vessels, tumors, the lymphatic system and potentially nerve bundles. Novadaq’s OPTTX(R) System is aimed at the diagnosis, evaluation and treatment of wet Age-related Macular Degeneration (AMD) by using the same core imaging technology that is used in the SPY Imaging System. Novadaq also offers the FDA approved PINPOINT endoscopic system for visualizing mother tissue fluorescence which allows surgeons to differentiate between healthy and cancerous tissue in the lung during thoracic surgery. Novadaq is also the exclusive United States distributor of PLC Medical’s CO2 HEART LASER(TM) System for TMR (Trans-Myocardial Revascularization). For more information, please visit the company’s website at http://www.novadaq.com.

Forward looking Statements

Certain statements included in this press release may be considered forward-looking. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements, and therefore these statements should not be peruse as guarantees of future action or results. All forward-looking statements are based on Novadaq’s current beliefs as well as assumptions made by and information currently available to Novadaq and describe to, among other things, results of yet to be clinical tests of PINPOINT and the SPY System, anticipated financial performance, business prospects, strategies, regulatory developments, mart acceptance and future commitments. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this compress release. Due to risks and uncertainties, including the risks and uncertainties identified by Novadaq in its public securities filings actual events may differ materially from current expectations. Novadaq disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Novadaq Technologies Inc.
http://www.novadaq.com

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An absolute investigator clinical trial has shown atrial fibrillation (AF) is effectively treated using the Epicor(TM) Cardiac Ablation System, when treated concomitantly to corrective heart surgery. The trial results were published in the December number printed at once of The Annals of Thoracic Surgery. St. Jude Medical, Inc. (NYSE:STJ) manufactures and distributes the Epicor system.

The investigators reported that more than 83 percent of all patients, followed for at least six months after surgery, were free from AF. In addition, 86 percent of the patients followed for at least 18 months remained free from AF. The investigators reported that there were no device or ablative procedure-related adverse events and specifically conspicuous an absence of esophageal, coronary or phrenic steadiness damage.

The clinical trial is the first in the U.S. to examine the safety and efficacy of high-intensity focused ultrasound (HIFU) therapy for the manipulation of AF. The prospective trial was conducted from February 2005 to February 2007 at Mission Hospitals in Asheville, N.C. A cohort of 129 patients (who had an ablation performed attendant to another, already-scheduled cardiac procedure and who were followed at least six months) were assessed in the study. Freedom-from-AF rates were determined from one side rigorous post-operative physical examinations, electrocardiogram testing, and 24-hour Holter monitoring at six, 12 and 18 months post-ablation.

The results confirmed the findings of a European multi-center trial published in the September 2005 periodical of Thoracic and Cardiovascular Surgery. The investigators in the European clinical trial reported an 85 percent freedom-from-AF rate at six months post-procedure - the do one’s best’s primary power end stage - in patients concomitantly treated for AF with the Epicor Cardiac Ablation System.

“Recent published reports matter to a strong justification to treat AF at the time of other cardiac surgeries in an attempt to improve the long-term patient outcomes of those procedures,” said Mark A. Groh, M.D., the lead investigator of the study. “Our study indicates that ablation using high intensity focused ultrasound can provide a trusty and effective option for AF treatment during other heart surgeries.”

AF is the most common abnormal heart rhythm condition, affecting millions of patients worldwide. With AF, the heart’s upper chambers (the atria) do not beat effectively due to abnormal electrical exercise. As a result, the heart cannot effectively pump blood, which can lead to shortness of breath of life, heart palpitations and fatigue. If left untreated, AF increases the risk of stroke five fold, according to a study reported in the journal Stroke. AF is progressive and increases in frequency and severity as patients grow older.

Surgical cardiac ablation has been found to provide relief from AF for a high percentage of patients. However, the traditional (non-HIFU) approach requires that patients be placed on a heart-lung bypass instrument of force with their hearts stopped while a cardiac surgeon cuts maze-like patterns in the atrial tissues and then sews the incisions to encourage the formation of lesions, or tiny scars. Surgeons may also use conventional energy sources, such as radiofrequency, laser or microwave, to create lesions in specific love tissue. The lesions disrupt the abnormal electrical impulses that cause AF.

In surgical ablation performed with a HIFU energy source, energy is focused from outside a beating heart to create precise and complete lines of cardiac tissue ablation to block chaotic electrical impulses. The patient does not need to be placed on a heart-lung bypass machine nor is the heart stopped. Because HIFU force is directed from outside the emotion inward (instead of from the inside uncovered as is sometimes the case in ablations performed with other energy sources), the risk of unintended peripheral damage is minimized.

The HIFU ablation emblematic legend used in the study, the Epicor Cardiac Ablation System, is manufactured by St. Jude Medical. It has received release from the U.S. Food and Drug Administration (FDA) for the surgical ablation of cardiac tissue, but it has not been indicated by the FDA specifically for the treatment of AF. The Epicor System gained regulatory approval for the treatment of AF in Europe in 2006.

About St. Jude Medical

St. Jude Medical is dedicated to making life better for cardiac, neurological and chronic pain patients worldwide end excellence in medical device technology and services. The Company has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation. Headquartered in St. Paul, Minn., St. Jude Medical employs approximately 12,000 people worldwide. For more information, please visit http://www.sjm.com.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and to come product launches, and projected revenues, margins, profits., and market shares. The statements made by the Company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company’s control and the risk factors and other cautionary statements described in the Company’s filings with the SEC, including those described in the Company’s Annual Report on Form 10-K filed on February 28, 2007 (see pages 13-20) and Quarterly Reports on Form 10-Q filed on August 9, 2007 (see pages 28-29) and November 2, 2007 (see pages 23-24). The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

St. Jude Medical

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Hospitalizations for treating disorders caused by gastroespohageal reflux disease (GERD ) increased by 103 percent between 1998 and 2005, according to the latest News and Numbers from the Agency for Healthcare Research and Quality. During the same period, hospitalizations of patients who, in addition to the ailment for what one. they were admitted, had milder forms of GERD, rose by the agency of 216 percent.

In patients with GERD, stomach acid backs up into the esophagus, causing farthest, chronic heartburn. If untreated, GERD can cause esophageal disorders such as bleeding, trouble swallowing, Barrett’s esophagus, a precancerous condition, and in extreme cases, cancer of the esophagus.

AHRQ also found that:

— Hospitalizations specifically for GERD increased roughly 5 percent, as a whole, for the period of the period from roughly 91,000 to 95,000.

— Among these, admissions of patients who had severe symptoms, such similar to anemia, vomiting and weight ruin, increased by 39 percent. Hospitalizations for patients with less serious symptoms, such in the same manner with hoarseness and deep-seated coughing, bloating, or belching, rose 43 percent.

— Hospitalizations for GERD in children ages 2 to 17 rose by 84 percent during the period, and 42 percent for infants when exposed to age 2.

This AHRQ News and Numbers is based on data in “Gastroesophageal Reflux Disease (GERD) Hospitalizations in 1998 and 2005″. The report uses statistics from the Nationwide Inpatient Sample, a database of hospital inpatient stays that is nationally representative of inpatient stays in all short-term, non-Federal hospitals. The data are drawn from hospitals that comprise 90 percent of all discharges in the United States and include all patients, regardless of insurance type, as well as the uninsured.

Agency for Healthcare Research and Quality (AHRQ)
540 Gaither Rd.
Rockville, MD 20850
United States
http://www.ahrq.gov

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