Your source for news from the medical device industry!

Lumen Biomedical Receives FDA Clearance Of Embolectomy System For Treatment Of Peripheral Artery Disease

Lumen Biomedical, Inc., a Minnesota-based medical device company, announced today receipt of FDA clearance for the LBI Embolectomy System for use in the removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature. The LBI Embolectomy System consists of a 0.014" guide wire containing a 3-dimensional fiber-based element used in combination with the previously cleared Xtract Aspiration Catheter.

New Technology Aids In Prostate Cancer Treatment

Researchers at Queen's University have developed a new way of performing lab tests that could improve the way doctors manage prostate cancer treatment. It will allow them to identify with unprecedented accuracy losses of a gene called PTEN that is associated with an aggressive group of prostate cancers...

OneTouch(R) Ping(TM) Glucose Management System Approved By Health Canada

Animas Corporation announced the approval of its OneTouch((R)) Ping(TM) Glucose Management System by Health Canada. OneTouch Ping is the first full-feature insulin pump that wirelessly communicates with a blood glucose meter-remote. Using the OneTouch Ping meter-remote, a person can calculate insulin doses and opt to wirelessly instruct the pump to deliver them without touching the pump at all, giving patients more freedom and flexibility in using their insulin pump.

Pharmaceutical companies are relying on outsourcing strategies

It is imperative that pharmaceutical and biotechnology companies pass their product through the testing and regulatory process in a rapid, cost-effective manner. To accomplish this goal, pharmaceutical companies are relying on outsourcing strategies to provide the services that can ...
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Fusion Of Nature And Nanotechnology In Electric Yarn That Detects Blood

A carbon nanotube-coated "smart yarn" that conducts electricity could be woven into soft fabrics that detect blood and monitor health, engineers at the University of Michigan have demonstrated. "Currently, smart textiles are made primarily of metallic or optical fibers. They're fragile. They're not comfortable. Metal fibers also corrode. There are problems with washing such electronic textiles.

Stereotactic Breast Biopsy Made Easy With Mammomat Inspiration

Siemens Healthcare has introduced its new biopsy unit to the market, enhancing the Mammomat Inspiration digital mammography platform with stereotactic breast biopsy. The digital system with basic functions for screening has been on the market since the end of 2007. Since then, it has been installed in countless hospitals and private practices worldwide. The new device with its supplemental biopsy function recently went into operation in Copenhagen and Dortmund.

'Microscope On A Chip' Developed By Caltech Bioengineers

Researchers at the California Institute of Technology have turned science fiction into reality with their development of a super-compact high-resolution microscope, small enough to fit on a finger tip. This "microscopic microscope" operates without lenses but has the magnifying power of a top-quality optical microscope, can be used in the field to analyze blood samples for malaria or check water supplies for giardia and other pathogens, and can be mass-produced for around $10.

CROs in the new millennium

The Clinical Research Organization industry has reached a new level of development in clinical trials. There are now more than twelve hundred CROs with the greatest number existing in Europe, followed by North America and Asia. With research and development costs at an all time high, product ...
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Lab-On-A-Chip Homes In On How Cancer Cells Break Free

Johns Hopkins engineers have invented a method that could be used to help figure out how cancer cells break free from neighboring tissue, an "escape" that can spread the disease to other parts of the body. The new lab-on-a-chip, described in the March issue of the journal Nature Methods, could lead to better cancer therapies.

One Step Closer To Simple And Portable Tuberculosis Tests For Developing World

Two billion people worldwide carry the pathogen that causes tuberculosis (TB), and most of them do not even know they are infected. This is because some 90 percent of people with TB have "latent" infections. They have no symptoms, they can't spread the disease to others and the bug remains dormant in their lungs -- often for years.

Medical "Mini-Submarine" To Blast Diseased Cells In The Body: A Fantastic Voyage Brought To Life

Ever since the 1966 Hollywood movie, doctors have imagined a real-life Fantastic Voyage a medical vehicle shrunk small enough to "submarine" in and fix faulty cells in the body. Thanks to new research by Tel Aviv University scientists, that reality may be only three years away. The blueprints for the submarine and a map of its proposed maiden voyage were published earlier this year in Science by Dr.

ClinQua Inc. is one of CRO's focusing the Investigator on aspects critical for validating the drugs' therapeutic benefits.

ClinQua Inc. www.clinqua.com is one of CRO's (Contract Research Organizations), who specialize in evaluating the demands of the trial and eliminating redundant protocols and focusing the Investigator on aspects critical for validating the drugs' therapeutic benefits. Common sense would ...
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Children With Cochlear Implants Have Quality Of Life Equal To Normal Hearing Peers

Children who have cochlear implants (CI) rank their quality of life (QOL) equal to their normally hearing (NH) peers, indicates new research in the February 2010 issue of Otolaryngology - Head and Neck Surgery. A cochlear implant is an electronic device that restores partial hearing to the deaf. It is surgically implanted in the inner ear and activated by a device worn outside the ear...

3rd International Conference On Molecular Diagnostics In Cancer Therapeutic Development: Philadelphia, Pa., Sept. 22-25, 2008

Scientists and clinicians from around the world will gather in Philadelphia, Pennsylvania, next week at the American Association for Cancer Research's third International Conference on Molecular Diagnostics in Therapeutic Development. The conference is subtitled, "Fulfilling the Promise of Personalized Medicine," which reflects the potential of molecular diagnostics to provide new strategies for tailoring therapies to fit the needs of each cancer patient's unique biology.

Metallic Nanostructures Enable The Manufacture Of New Security And Medical Sensor Devices

Scientists have designed tiny new sensor structures that could be used in novel security devices to detect poisons and explosives, or in highly sensitive medical sensors, according to research published tomorrow in Nano Letters.

Kriger's Instructors Provide A Sound Foundation For Anyone Wishing To Seek A Meaningful Career In The Clinical And Biopharmaceutical Industry

As a drug makes its way through the different phases of pre-clinical and clinical trials in human testing, the public and the company can rest assured that their product has been thoroughly tested and that each progression through its development has been predicated upon safe, sound, efficient ...
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Leading Expert In Hemodynamics Aims To Use New Emulator Technology To Eliminate Blood Clotting In Cardiovascular Devices

On Jan. 22, Danny Bluestein, PhD, Professor of Bioengineering at the State University of New York (SUNY) Stony Brook, in collaboration with Marvin J. Slepian, M.D., Professor of Medicine (Cardiology) at the University of Arizona, submitted a Phase II Quantum Grant proposal to the National Institute of Biomedical Imaging and Bioengineering (NIBIB)...

Innovative Pharyngeal PH Measurement System Now Available To Physicians In The EU

Respiratory Technology Corporation (dba Restech) announced today that its revolutionary Dx-pH Measurement SystemT has received CE Mark approval, allowing introduction to the European Union and all countries recognizing the CE Mark. This approval from the European Union certifies Restech has met EU health, safety and environmental requirements that ensure consumer safety.

50,000th Clinitek Status Urine Analyser - Siemens Celebrate Medal Winning Moments At Frimley Park Hospital, England

The 50,000th Siemens Clinitek Status urine analyser has just been installed in the Children's Ward and Teenage Unit at Frimley Park Hospital in Surrey. Ward sisters Gail Ashworth and Gillian Rooney and members of the hospital's Point of Care team, were accompanied by some of their patients to receive the analyser from Kate Cox Operational Manager at Frimley Park.

ClinQua Inc. : The overall cost of clinical trials depends on an array of factors

In a progressive global market of supply and demand, it remains unthinkable to engage in practices that are ambitiously over-priced when there are endless opportunities to utilize more cost-efficient methods which would yield the same results. As per Mr. David Mills former ClinQua Clinical ...
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CompuMed Receives Regulatory Clearance By China's State Food And Drug Administration For OsteoGram Product For Monitoring Osteoporosis

CompuMed, Inc. (OTCBB:CMPD) -- a medical informatics company serving the healthcare community with diagnostic software solutions -- announced it has received approval from the State Food and Drug Administration (SFDA) of the People's Republic of China to market the OsteoGram system for screening, diagnosing and monitoring osteoporosis. The approval (Reg.

GE Healthcare Ranks #1 For Anesthesia Service In Md Buyline's Q2 2008 Survey

GE Healthcare's Datex-Ohmeda anesthesia delivery solutions have been ranked #1 for the 10th straight quarter by MD Buyline, a customer opinion research company on medical devices and service. Solid scores in six categories GE Healthcare maintained strong scores in the six opinion categories: system performance, system reliability, installation/implementation, applications training, service response time and service repair quality.

Explaining Fast Water Transport In Nanotubes With The Help Of Simulations

By discovering the physical mechanism behind the rapid transport of water in carbon nanotubes, scientists at the University of Illinois have moved a step closer to ultra-efficient, next-generation nanofluidic devices for drug delivery, water purification and nano-manufacturing. "Extraordinarily fast transport of water in carbon nanotubes has generally been attributed to the smoothness of the nanotube walls and their hydrophobic, or water-hating surfaces," said Narayana R.

Contract Research Organizations Facing New Challenges

The biggest challenge facing CROs in the current industry are strict regulatory requirements. Global regulatory bodies increasingly require more detailed safety control of drug candidates to ensure safety and to avoid product recalls. In order to comply with these regulations CROs must ...
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Microlife's WatchWT MedGem(R) Device Will Be Used To Assess Metabolic Changes In The Biggest Loser™ Contestants

Microlife Medical Home Solutions, Inc. (MiMHS) announces The Biggest Loser medical staff will implement the MedGem indirect calorimeter to assess metabolic changes in program contestants. The MedGem handheld indirect calorimeter is an FDA-cleared, Class II, medical device that assesses metabolic rate by measuring a patient's resting oxygen consumption...

Microsulis Leads The Way In Lung And Liver Ablations

Acculis Limited today announced the first clinical Computed Tomography body scanner (CT) guided liver and lung ablations using its newly CE Marked high power 2.45GHz microwave system for soft tissue coagulation. The treatments during April and May 2010 were conducted by Dr Graham Plant, Consultant Interventional Radiologist at The Basingstoke and North Hampshire Hospital, UK...

No Improvement In Detecting Cervical Cancer With Addition Of HPV Test In Cervical Screening Programme In The UK

An article published Online First and in the July edition of The Lancet Oncology reports that the combination of human papillomavirus (HPV) testing with regular liquid-based cytology (LBC) screening does not improve the detection of cervical cancer compared with LBC screening alone. In the UK, liquid-based cytology (which is a liquid form of the Pap smear test) has replaced the conventional Pap smear test.

Legal Issues in Clinical Research

Bruce Kriger, CEO of Kriger Research Group International www.kriger.com, leading training institution and clinical research organization told in the interview to our edition that one hundred years ago, any doctor could prepare a new medication without any external approval. Since the ...
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Cell Molecules Seen In Finer Detail With New Imaging Method

Scientists have always wanted to take a closer look at biological systems and materials. From the magnifying glass to the electron microscope, they have developed ever-increasingly sophisticated imaging devices. Now, Niels de Jonge, Ph.D., and colleagues at Vanderbilt University and Oak Ridge National Laboratory (ORNL), add a new tool to the biology-watcher's box.

Updated Alzheimer's Diagnostic Criteria To Include Earlier Stages And Biomarkers

Following recommendations by expert groups in the US, criteria for diagnosing Alzheimer's disease, which have not changed in the last 25 years, will be updated to reflect scientific advances; the new guidelines will cover earlier stages and biomarkers of the disease...

KCI Announces FDA Clearance Of ABTheraT Open Abdomen Dressing

Kinetic Concepts, Inc. (NYSE: KCI) announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its ABTheraT Open Abdomen Dressing. Earlier this year, the FDA cleared the ABTheraT Open Abdomen Negative Pressure Therapy Unit.

Clinical outsourcing and current trends: How are they affecting business?

The clinical research industries growth is skyrocketing, the portion of the market outsourced to CROs is said to have grown from US$1 billion dollars in the early 1990’s to over US$17 billion in 2007. Analysts predict that by the year 2010 the industry could see numbers well into and over ...
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Drug-Eluting Stents Lead To Better Patient Outcomes In The Short Term

According to a new study published in the Canadian Medical Association Journal, angioplasty patients who received drug-eluting stents had lower short-term mortality rates than those who received bare-metal stents. Drug-eluting stents (DES) are medication-coated tubes that are inserted into the body to prevent constriction or narrowing of a conduit such as an artery.

Reading The Brain Without Poking It

Experimental devices that read brain signals have helped paralyzed people use computers and may let amputees control bionic limbs. But existing devices use tiny electrodes that poke into the brain. Now, a University of Utah study shows that brain signals controlling arm movements can be detected accurately using new microelectrodes that sit on the brain but don't penetrate it.

Medtronic Defends Payments To Physicians

Medtronic, which has been the focus of recent reports detailing its payments to doctors, is defending that practice. The Minneapolis Star Tribune reports: "At the annual shareholder meeting of Medtronic Inc.

Accurate Data Management can be the make or break for the success of the clinical trial.

It is widely known throughout the clinical research industry that the accurate and precise collection of data is crucial to the success of any trial. Limdato www.limdato.com along with its partners have created a software system dedicated to compiling all data collected in a precise and user ...
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New Research Network Aims To Build A Better Eye

They may have grown up to the 1970s hit "I can see clearly now" but Canada's aging population can do anything but. Funding for a new $6.7-million research network has been announced to deal with the increasing vision loss of Canadians.

Urine LAM-ELISA Poor At Diagnosing TB

Urine LAM-ELISA does not appear to be useful as an independent diagnostic test for pulmonary tuberculosis (TB). A trial of the new diagnostic, described in the open access journal BMC Infectious Diseases found that it was only capable of identifying 50.7% of TB cases.

Nanotechnology And The FDA: Size Matters!

The Food & Drug Administration (FDA) issued in July 2007 its Nanotechnology Task Force Report. This report acknowledged that nanoscale materials potentially could be used in most product types regulated by the agency and that those materials present challenges complicated by the fact that properties relevant to product safety and effectiveness may change as size varies within the nanoscale.

Outsourcing of R&D functions is reshaping the drug development services industry.

As per Esploron www.esploron.com executive management the cost of drug development has soared during the past ten years compelling pharmaceutical and biotechnology companies to look for new, smarter ways of conducting clinical research. Driven by mounting market pressures, ...
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New Journal In Predictive, Preventive And Personalised Medicine Published By Springer

Springer and the European Association for Predictive, Preventive and Personalised Medicine have founded, as the Association's official publication, The EPMA Journal...

Sens. Grassley, Kohl Ask Cardiovascular Research Foundation, Columbia University Researchers To Disclose Financial Contr. From Medical Device Makers

Sens. Chuck Grassley (R-Iowa) and Herb Kohl (D-Wis.) on Thursday sent letters to the Cardiovascular Research Foundation and Columbia University seeking financial disclosures and other information regarding their relationships with manufacturers of pharmaceutical drugs and medical devices, the

Evaluation Study Reveals SLEEPTRACKER(R) Nearly As Effective In Gathering Specific Sleep Data As Advanced Sleep Lab Equipment

A recent evaluation study reveals that SLEEPTRACKER®, the world's only sleep-monitoring watch, is nearly as effective in gathering specific sleep data as advanced sleep laboratory equipment. When comparing SLEEPTRACKER to lab tests, the watch successfully detects moments of restlessness during sleep 91 percent of the time. The evaluation study was independently conducted by Douglas W. Puryear, MD, FCCP, D.

ClinQua Inc. : The overall cost of clinical trials depends on an array of factors

In a progressive global market of supply and demand, it remains unthinkable to engage in practices that are ambitiously over-priced when there are endless opportunities to utilize more cost-efficient methods which would yield the same results. As per Mr. David Mills former ClinQua Clinical ...
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Therapeutic "Snore Ring" Receives National Launch

With more than half of all U.S. households affected by snoring, there is new hope for the enormous number of sleep-deprived snorers and their loved ones. Coming from Australia in the unexpected form of a sterling silver ring called the "Therapeutic Snore Ring.

Cook Medical Launches Industry-First Pressure Injection Peripherally Inserted Catheter With Antibiotic Protection To Prevent Fatal Infections

With the launch of Cook Medical's new Spectrum Turbo-Ject PICC, for the first time, the clinical benefits of antibiotic-impregnated catheters-a critical component in eliminating 250,000 potentially fatal catheter-related bloodstream infections (CRBSIs) in the U.S. annually-are now available for peripherally inserted central venous catheters (PICCs) that can also be used for contrast-enhanced CT scans.

New 3-D Scaffold Of Living, Beating Heart Cells

It is an amazing sight: What looks like a tiny beating heart is actually a piece of synthetic, gauze-like mesh, barely the size of a fingernail, floating in a Petri dish. And yet it keeps squeezing away, nice and rhythmically. Researchers at The University of Arizona's Sarver Heart Center and the Southern Arizona Veterans Administration Health Care System (SAVAHCS) have come a step closer to repairing hearts damaged by a heart attack or weakened by chronic heart failure.

Understanding Your Liability and Confidentiality in Clinical Trials

Clinproxy, www.clinproxy.com fully understands the issues, laws risks and best practices relating to disclosures of confidential information about clinical trials. Early information about a clinical trial is extremely valuable. The information can be indiscreetly passed on to many people ...
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Building Blocks For A New Class Of Optical Circuits Created By Applied Physicists

Imagine creating novel devices with amazing and exotic optical properties not found in Nature - by simply evaporating a droplet of particles on a surface. By chemically building clusters of nanospheres from a liquid, a team of Harvard researchers, in collaboration with scientists at Rice University, the University of Texas at Austin, and the University of Houston, has developed just that...

Three Genetic Variants Linked To Common Childhood Leukemia Found

UK scientists have for the first time found three genetic variants that raise children's risk of developing acute lymphoblastic leukaemia (ALL), the most common childhood cancer. The discovery should help us to understand more about how ALL develops, they said. Scientists from the Institute of Cancer Research (ICR) found the three variants by comparing the DNA of heatlhy patients to patients with ALL.

GE Healthcare Delivers Visionary Solutions At SIIM10

At the 2010 annual meeting of the Society for Imaging Informatics in Medicine (SIIM), GE Healthcare is delivering today's innovations and engaging in tomorrow's trends...

Clinical Research Professionals are Still in Demand despite the World Economic Crisis

Despite the world economic crisis, the clinical research field is currently expanding faster than the introduction of newly qualified professionals that inevitably creates a demand. Most people are under the impression that the barriers to enter this industry are extremely difficult to ...
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Improved Detection Of Bladder Tumors Reduces Cancer Recurrence

Making tumors inside the bladder fluoresce red under blue light allows physicians to more easily find and remove them, substantially reducing the rate at which these cancers come back, says a Mayo Clinic physician who presented results of a large, multicenter international clinical trial.

Predictive Biosciences Announces Publication Of Results From A Pilot Study Of Its Non-Invasive Assay To Monitor Patients For Bladder Cancer

Predictive Biosciences Inc. today announced the publication of pilot study results in the November issue of the Journal of Urology, highlighting the Company's novel urinary biomarker approach to bladder cancer detection that achieves exceptionally high Negative and Positive Predictive Values (NPV and PPV).

Broncus Introduces Innovative Bronchoscopic Tools To Be Used In The Diagnosis And Treatment Of Lung Diseases

Broncus Technologies, Inc., a medical device company focused on developing minimally-invasive innovations for lung diseases, announced today at the International Conference of the American Thoracic Society (ATS) the release of its first commercial products: the LungPointT Virtual Bronchoscopic Navigation and Treatment Planning System, YieldT Mini Doppler Probe, and YieldT Transbronchial Coring Needles.

It is recommended that sponsor companies should first check what budget they can allocate, and then seek Clinqua Inc. expertise in achieving their goal.

It is an undesirable reality, but the development of pharmaceutical drugs is a costly undertaking. Yet, these costs are necessitated by the substantial investment of both time and resources of the companies in question. It stands to reason that if a company is willing to invest millions of ...
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Spiration, Inc. Receives First FDA Approval For Bronchial Valve

Spiration, Inc., a developer of novel medical devices designed to benefit patients with acute and chronic conditions of the lung, announced today that the company has received Humanitarian Device Exemption (HDE) approval from the U.S.

IntelliCyt Corp. Introduces New High Throughput Flow Cytometry Screening System

IntelliCyt Corp., a provider of innovative high throughput cell and bead-based screening products for drug discovery and life science research, introduced its new High Throughput Flow Cytometry - HTFC™ Screening System at the 25th International Society for Advancement of Cytometry in Seattle...

Ventilation Provided By Brain Signals Helps Infants In Critical Condition

Patient case reports from several hospitals show that a revolutionary technique for mechanical ventilation called NAVA can improve the interaction between the child and the ventilator. The NAVA approach to mechanical ventilation is based on the patient's neural respiratory output, and it is designed for use on adults as well as children. The assisted breathing is driven by the patient's brain and it improves synchrony between the child and ventilator.

Clinical Research Professionals are Still in Demand despite the World Economic Crisis

Despite the world economic crisis, the clinical research field is currently expanding faster than the introduction of newly qualified professionals that inevitably creates a demand. Most people are under the impression that the barriers to enter this industry are extremely difficult to ...
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Some Medical Providers Slow To Adopt Electronic Records, Prescribing

"Digital medical records could cut down on office visits," and maybe even health care costs, Marketplace reports. "But for doctors, going electronic could be complicated and expensive. And nothing at all like what they learned in medical school." Relatively few doctors have made the switch so far, though new government incentives, funded by the stimulus bill, could shift the industry into gear.

Bring On The "Suds": Prototype, 7-Foot-Tall Sanitizer Automates Disinfection Of Hard-to-Clean Hospital Equipment

Johns Hopkins experts in applied physics, computer engineering, infectious diseases, emergency medicine, microbiology, pathology and surgery have unveiled a 7-foot-tall, $10,000 shower-cubicle-shaped device that automatically sanitizes in 30 minutes all sorts of hard-to-clean equipment in the highly trafficked hospital emergency department.

What Connects The Elderly And Sports People? Smart Sensor Technology

Innovative smart sensing devices promise to boost mobility and quality of life for the elderly, reduce healthcare costs and even give sports people an edge through more effective training...

Outsourcing is not a new concept to pharmaceutical companies

Outsourcing is not a new concept to pharmaceutical companies; however, its use increased dramatically in the mid-1990s, and it is expected to continue to increase going forward. It is estimated by 2004 nearly 42% of all pharmaceutical drug development expenditures will be committed to ...
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Toward An 'Electronic Nose' To Sniff Out Kidney Disease In Exhaled Breath

Scientists in Israel have identified the key substances in exhaled breath associated with healthy and diseased kidneys - raising expectations, they say, for development of long-sought diagnostic and screening tests that literally sniff out chronic renal failure (CRF) in its earliest and most treatable stages. Their report is in the current issue of ACS Nano, a monthly journal.

New Clinical Data On Medtronic Transcatheter Heart Valves Featured In More Than 25 Presentations At TCT 2009

With the promise of percutaneous treatments for patients with diseased heart valves growing, Medtronic, Inc. (NYSE: MDT), announced that more presentations than ever before - at least 25 - on the company's portfolio of unique transcatheter valves will be presented at Transcatheter Cardiovascular Therapeutics (TCT) 2009, the world's premier annual meeting for interventional cardiologists.


Cereprotec Inc. and Institute of Applied Chemistry at Hebrew University are working together to synthesise new Glycoluril Derivatives with Possible Neuroprotection Effects.According to report of Institute of Applied Chemistry they have performed the third step as it appears in the synthesis route scheme. This took much longer than the other steps, after all, this reaction doesn't appear in any literature and in the end only took two and half weeks. This research is fully sponsored by Cereprotec Incorporated www.cereprotec.com a US company that already runs clinical tests of their first drug Cereprotex .<br />In the reaction between compound II and III, one gets two main products, three additional compounds in small quantities plus unreacted starting materials and one main side product. All together there were 8 compounds in the reaction mixture. <br /><br />One of the main materials precipitated out from the mixture and was removed via filtration from the reaction mixture. This material was cleaned up via crystallization but turned out not to be the desired compound. <br />The second main material was separated via silica gel column chromatography. Unfortunately, this main material came off at the same Rf value as another material. They tested out several solvents and found that ethyl acetate was able to crystallize out the main material. <br /><br />Using NMR and elemental analysis, Institute of Applied Chemistry were able to prove that the crystallized out material is indeed Compound III. Yield was 17%. Two grams of material was obtained, enough to try out Stage IV. <br /><br />This step can be repeated in the future in order to produce more of compound III. <br />Cereprotec Inc. Phase II clinical study of efficacy and safety of Cereprotex as preventive treatment of cognitive dysfunction as a complication of coronary artery bypass graft (CABG) surgery.Cerebral dysfunction is a significant complication of coronary artery bypass graft (CABG) surgery using cardiopulmonary bypass (CPB).While overt neurological dysfunction occurs in 3% of patients, cognitive dysfunction is detectable in most patients early after CABG and in up to half of patients at six months.<br /><br />Cereprotec Inc. www.cereprotec.com proposes to use Cereprotex prior to and after CABG procedures in order to minimize or eliminate entirely the effects of neuro-impairment. Based on the successful animal trials Cereprotec Inc. believes that the human trials will show significant reduction in neuro-impairment. <br /><br />At this moment Cereprotec Inc. www.cereprotec.com is prepared to start clinical trials and is actively seeking serious investors.<br />Cereprotec Inc: Cerebral dysfunction is a significant complication of coronary artery bypass graft (CABG) surgery using cardiopulmonary bypass (CPB). Cerebral dysfunction is a significant complication of coronary artery bypass graft (CABG) surgery using cardiopulmonary bypass (CPB). Cognitive dysfunction is detectable in up to 70% of patients.<br /><br />In Phase II Cereprotec Inc. www.cereprotec.com study patients will undergo a standard battery of 10 cognitive tests performed by one examiner before surgery and at 7 and one month after CABG. Four tests (auditory verbal learning test (AVLT), adult memory and information processing battery (AMIBP), trail-making test B (TMTB), and verbal fluency test (VFT)) will be used to calculate a composite cognitive index.<br />US Patent Application No.11/723,011 to be assigned to CEREPROTEC INC. Method for Neuroprotection with Glycoluril DerivativesCereprotec Incorporated www.cereprotec.com is a US company involved in the development of neuroprotective drug Cereprotex. <br /><br />This company is also developing a family of other promising novel chemical compounds. <br /><br />Proof of efficacy of these compounds has been obtained in three animal studies including hypoxia in both mice and rats and brain trauma in mice. The proof of neuroprotection concept has been shown not only for prevention (hypoxia model), but also for the treatment paradigm post brain trauma which reflects a potential realistic situation in humans. <br />Professor Esther Shohami has joined the board of advisors of Cereprotec IncorporatedProfessor Esther Shohami has joined the board of advisors of Cereprotec Incorporated. Her research interests include: Pathophysiology of brain injury - mediators of delayed neuronal damage e.g., prostaglandins, reactive oxygen species, cytokines, cannabinoids, and the cholinergic system in rat and mouse models of injury (closed head injury, CHI). Evaluation of potential therapeutic strategies. CHI as a risk factor for delayed onset of Alzheimer's disease. Genetic manipulations (cytokines or apoE knockouts, acetylcholine-esterase transgenics, and more) as tools for investigating the role of specific mediators in traumatic brain injury. Interrelationship between traumatic brain injury and bone remodeling. Role of endocannabinoids in blood-brain barrier function and in bone remodeling after brain trauma. Mechanisms of neuroprotection induced by pre-conditioning (ischemic or heat acclimation). In vitro model for stretch injury that simulates traumatic conditions in astrocytes.<br /><br />Dr. Roman Kamburg CEO of Cereprotec and the registered owner of 1125 shares in CEREPROTEC Incorporated (the "Corporation") www.cereprotec.com a corporation incorporated in and under the laws of the State of Delaware, having its registered office at 108 West 13th Street, Wilmington, Delaware, transfered to Dr. Esther Shohami 40 Shares of Common Stock, for no consideration, to be held by the Transferee, her administrators and assignees, subject to all the terms and conditions on which such shares were held by the Transferor, and Transferee agreed to receive such shares.<br />Pharmalef Inc. is starting collaboration in development of new oral delivery platformPharmalef Inc. www.pharmalef.com is starting collaboration in development of new oral delivery platform offers pharmaceutical companies the ability to extend the shelf life and stability of medicinal compounds.<br /><br />Moreover, oral delivery improves patient compliance, improves treatment, reduces patient inconvenience, and reduces treatment costs.<br /><br />Our partners have completed proof of concept and development of a proliposomal formulation for the model drug, calcitonin, which is used in the treatment of osteoporosis and thyroid cancer. <br /><br />Clinical trials are expected to begin at a number of centers across the United States, Canada and European Union. <br />Pharmalef Developments introduces several new products in Rheumatology, Immunology and Respiratory Diseases.With a focus on familiar, everyday health problems, Pharmalef Developments . www.pharmalef.com aims to develop and deliver products that meet the individual’s health care needs, developing a wide range of products.<br /><br />In addition to its established range of highly effective and distinctive products Pharmalef Developments will introduce several new products in new fields, including Rheumatology, Immunology and Respiratory Diseases.<br />Pharmalef Developments plays a vital role in proper documenting the drug development process.New drugs are the lifeblood of the pharmaceutical industry. Yet strict testing and documentation requirements mean only one in many drug candidates make it to market. <br /><br />Pharmalef Developments www.pharmalef.com can play a vital role in documenting the drug development process. By leveraging our expertise in business process management and the latest technologies, we can also help you develop a documentation process for clinical trials that is easy and efficient, while satisfying strict government requirements and regulations. <br />Pharmalef Developments is a home for team-oriented professionalsPharmalef Developments www.pharmalef.com is a home for team-oriented professionals and their aim is to be the first choice in the industry for licensing and academic collaborations that bring mutual benefits to each party.<br /><br />They entered into many collaborations with leading academic centers, CRO-s and biotechnology companies to complement our in-house R&D capabilities. <br /><br />They are always interested in forming new partnerships covering early-stage research, novel compounds or technologies and implementation of clinical trials.<br />CEREPROTEC Method for Neuroprotection with Glycoluril Derivatives Patent Application has been Published September 18, 2008<br /><br />A method for prevention, inhibition or treatment of neuronal degeneration caused by injury, disease, disorder or condition in the central nervous system (CNS) comprises administering a glycoluril derivative to an individual in need thereof. View document here: http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=/netahtml/PTO/srchnum.html&r=1&f=G&l=50&s1=20080227838.PGNR.&OS=DN/20080227838&RS=DN/20080227838<br /><br />1. A method for prevention, inhibition or treatment of neuronal degeneration caused by injury, disease, disorder or condition in the central nervous system (CNS), comprising administering to an individual in need thereof an amount effective to treat said injury, disease, disorder or condition, of a compound of the formula I:whereinR.sub.1, R.sub.2 and R.sub.3, the same or different, each is H or (C.sub.1-C.sub.6) alkyl;R.sub.4 is selected from the group consisting of (C.sub.1-C.sub.6) alkyl, --R.sub.5--COOR, --R.sub.5--OH, --R.sub.5--NH--CO--R and --R.sub.5--CO--NH--(CH.sub.2).sub.n--COOR;R.sub.5 is (C.sub.1-C.sub.6) alkylene;R is H or (C.sub.1-C.sub.3) alkyl;n is an integer of 1 to 6; or an enantiomer thereof or a pharmaceutically acceptable salt thereof.<br /><br />2. The method according to claim 1 wherein R.sub.1 to R.sub.3 each is H or (C.sub.1-C.sub.6) alkyl and R.sub.4 is (C.sub.1-C.sub.6) alkyl.<br /><br />3. The method according to claim 2, wherein R.sub.1 to R.sub.4 each is methyl.<br /><br />4. The method according to claim 1, wherein R.sub.1 to R.sub.3 each is H or (C.sub.1-C.sub.6) alkyl, R.sub.4 is --R.sub.5---COOR, R.sub.5 is (C.sub.1-C.sub.6) alkylene and R is H or (C.sub.1-C.sub.3) alkyl.<br /><br />5. The method according to claim 1, wherein R.sub.1 and R.sub.3 each is methyl, R.sub.2 is H and R.sub.4 is --(CH.sub.2).sub.3COOH.<br /><br />6. The method according to claim 1, wherein said injury, disease, disorder or condition is selected from the group consisting of: (i) a neurological injury: (ii) brain damage caused by a cardiovascular event; (iii) a cerebrovascular disorder or disease; (iv) a neurodegenerative disease or disorder; and (v) a dementia.<br /><br />7. The method according to claim 6, wherein said injury is a neurological traumatic injury selected from the group consisting of head trauma injury and spinal cord injury.<br /><br />8. The method according to claim 7, wherein said head trauma injury is selected from the group consisting of blunt trauma, closed head injury and penetrating trauma injury.<br /><br />9. The method according to claim 8, wherein said head trauma injury is closed head injury.<br /><br />10. The method according to claim 6, wherein said injury, disease, disorder or condition is brain damage caused by a cardiovascular event.<br /><br />11. The method according to claim 10, wherein said cardiovascular event is cardiac arrest or cardiac surgery.<br /><br />12. The method according to claim 6, wherein said injury, disease, disorder or condition is a cerebrovascular disorder or disease.<br /><br />13. The method according to claim 12, wherein said cerebrovascular disorder is brain ischemia or stroke.<br /><br />14. The method according to claim 6, wherein said injury, disease, disorder or condition is a neurodegenerative disease or disorder.<br /><br />15. The method according to claim 14, wherein said neurodegenerative disease or disorder is selected from the group consisting of Alzheimer's disease, Parkinson's disease, facial nerve (Bell's) palsy, multiple sclerosis, glaucoma, Huntington's chorea, amyotrophic lateral sclerosis and macular degeneration.<br /><br />16. The method according to claim 6, wherein said injury, disease, disorder or condition is dementia.<br /><br />17. The method according to claim 16, wherein said dementia is Alzheimer's disease or a non-Alzheimer's dementia selected from the group consisting of senile dementia, Lewy body dementia, vascular dementia and a dementia caused by Parkinson's disease, Huntington's chorea, Creutzfeld-Jacob disease or HIV infection.<br /><br />18. A method for conferring neuroprotection to an individual afflicted with a neurological injury, which comprises administering to said individual a compound of formula I in claim 1 or an enantiomer or a pharmaceutically acceptable salt thereof in an amount effective to ameliorate the neurodegeneration associated with said neurological injury.<br /><br />19. The method according to claim 18, wherein said neurological injury is selected from the group consisting of head trauma injury and spinal cord injury.<br /><br />20. A method for conferring neuroprotection to an individual suffering from a neurological or neurodegenerative disease or disorder, which comprises administering to said individual a compound of formula I in claim 1 or an enantiomer or a pharmaceutically acceptable salt thereof in an amount effective to ameliorate the neurodegeneration associated with said neurological or neurodegenerative disease or disorder.<br /><br />21. The method according to claim 20, wherein said neurological or neurodegenerative disease or disorder is selected from the group consisting of Alzheimer's disease, Parkinson's disease, facial nerve (Bell's) palsy, multiple sclerosis, glaucoma, Huntington's chorea, amyotrophic lateral sclerosis, macular degeneration and dementia.


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