Posts Tagged ‘major-medical-health-insurance’

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Researchers make living model of brain tumor

Researchers make living model of brain tumor

Not all cancers are created equal. While some are easy to study in the Petri dish, others don’t do well in vitro. They often will not grow without a supporting framework of angiogenic blood vessels that supply their high metabolism with nutrients and oxygen. Performing experiments on tumors such as glioma is a difficult proposition because they only wish to reside in the body and normally don’t survive when grown outside in a laboratory environment.Glioma

Researchers at Brown University have now managed to grow a three-dimensional glioma tumor, including the supporting proximal blood vessels, and are already using it to perform experiments testing a nanomedicine approach to tumor destruction.

From the announcement:

In a series of experiments, the team showed that iron-oxide nanoparticles ferrying the chemical tumstatin penetrated the blood vessels that sustain the tumor with oxygen and nutrients. The iron-oxide nanoparticles are important, because they are readily taken up by endothelial cells and can be tracked by magnetic resonance imaging.

Previous experiments have shown that tumstatin was effective at blocking endothelial cell growth in gliomas. The tests by the Brown researchers took it to another level by confirming, in a 3-D, living environment, the iron-oxide nanoparticles’ ability to reach blood vessels surrounding a glioma as well as tumstatin’s ability to penetrate endothelial cells.

“The 3-D glioma model that we have developed offers a facile process to test diffusion and penetration into a glioma that is covered by a blood vessel-like coating of endothelial cells,” said Don Ho, a graduate student in the lab of chemistry professor Shouheng Sun and the lead author of the paper in the journal Theranostics. “This assay would save time and money, while reducing tests in living organisms, to examine an agent’s 3-D characteristics such as the ability for targeting and diffusion.”

The tissue model concept comes from Jeffrey Morgan, a bioengineer at Brown and a corresponding author on the paper. Building on that work, Ho and others created an agarose hydrogel mold in which rat RG2-cell gliomas roughly 200 microns in diameter formed. The team used endothelial cells derived from cow respiratory vessels, which congregated around the tumor and created the blood vessel architecture. The advantage of a 3-D model rather than Petri-dish-type analyses is that the endothelial cells attach to the tumor, rather than being separated from the substrate. This means the researchers can study their formation and growth, as well as the action of anti-therapeutic agents, just as they would in a living organism.

The researchers created a glioma, or brain tumor, and the network of blood vessels that surrounds it. In a series of experiments, the team showed that iron-oxide nanoparticles ferrying the chemical tumstatin penetrated the blood vessels that sustain the tumor with oxygen and nutrients. The iron-oxide nanoparticles are important, because they are readily taken up by endothelial cells and can be tracked by magnetic resonance imaging.

Previous experiments have shown that tumstatin was effective at blocking endothelial cell growth in gliomas. The tests by the Brown researchers took it to another level by confirming, in a 3-D, living environment, the iron-oxide nanoparticles’ ability to reach blood vessels surrounding a glioma as well as tumstatin’s ability to penetrate endothelial cells.

“The 3-D glioma model that we have developed offers a facile process to test diffusion and penetration into a glioma that is covered by a blood vessel-like coating of endothelial cells,” said Don Ho, a graduate student in the lab of chemistry professor Shouheng Sun and the lead author of the paper in the journal Theranostics. “This assay would save time and money, while reducing tests in living organisms, to examine an agent’s 3-D characteristics such as the ability for targeting and diffusion.”

The tissue model concept comes from Jeffrey Morgan, a bioengineer at Brown and a corresponding author on the paper. Building on that work, Ho and others created an agarose hydrogel mold in which rat RG2-cell gliomas roughly 200 microns in diameter formed. The team used endothelial cells derived from cow respiratory vessels, which congregated around the tumor and created the blood vessel architecture. The advantage of a 3-D model rather than Petri-dish-type analyses is that the endothelial cells attach to the tumor, rather than being separated from the substrate. This means the researchers can study their formation and growth, as well as the action of anti-therapeutic agents, just as they would in a living organism.

“You want to see nanoparticles that diffuse through the endothelial cells, which is lost in 2-D because you just have diffusion into media,” Ho said.

Other 3-D tissue models have been “forced cell arrangements,” Ho said. The 3-D glioma model, in contrast, allowed the glioma and the endothelial cells to assemble naturally, just as they would in real life. “It more clearly mimics what would actually happen,” Ho explained.

The group then attached tumstatin, part of a naturally occurring protein found in collagen, to iron-oxide nanoparticles and dosed the mold. True to form, the nanoparticles were gobbled up by the endothelial cells. In a series of in vitroexperiments, the team reported the tumstatin iron-oxide nanoparticles decreased vasculature growth 2.7 times more than under normal conditions over eight days. “The growth is pretty much flat,” Ho said. “There’s no new growth of endothelial cells.” The next step is to test the tumstatin nanoparticles’ performance in the 3-D environment.

“This model has significant potential to help in the testing and optimization of the design of therapeutic/diagnostic nanocarriers and determine their therapeutic capabilities,” the researchers write.

Contributing authors include Nathan Kohler and Aruna Sigdel, in Brown’s chemistry department; Raghu Kalluri, from the Harvard Medical School, who first discovered tumstatin’s anti-blood vessel growth properties; and Chenjie Xu, who earned his doctorate in chemistry at Brown last May and is at Brigham and Women’s Hospital in Boston.

Source:http://news.brown.edu/pressreleases/2012/02/glioma

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MicroCHIPS Announces Clinical Results for First Successful Human Trial Of Implantable, Wireless Microchip Drug Delivery Device

MicroCHIPS Announces Clinical Results for First Successful Human Trial Of Implantable, Wireless Microchip Drug Delivery Device

MicroCHIPS, an MIT spin-out company out of Waltham, MA, has announced results of a clinical study evaluating its wirelessly controlled implantable drug releasing electronic microchip. The device features controllable reservoir arrays that can contain a drug or a microsensor.  The reservoirs can be opened and closed either based on a preset program, activated wirelessly through a transmitter, or based on readings of the embedded sensors.drug-delivery-microchip

The current study focused on delivering teriparatide for post menopausal women suffering from osteoporosis.  Normally these women would have to receive an unpleasant daily injection of the drug, but thanks to the MicroCHIPS device, they received a well controlled regular dose with little perceived discomfort.

Details from the press release:

In the study, seven osteoporotic postmenopausal patients between the ages of 65 and 70 received the microchip-based implant. The primary objective of the clinical trial was to assess the pharmacokinetics (PK) of the released drug teriparatide from the implanted devices. Safety measures included evaluation of the biological response to the implant and monitoring indicators of toxicity. Secondary objectives were to assess the bioactivity of the drug and to evaluate the reliability and reproducibility of releasing the drug from the device.

The device and drug combination were found to be biocompatible with no adverse immune reaction. The resulting PK profiles from the implant were comparable to and had less variation than the PK profiles of multiple, recommended subcutaneous injections of teriparatide. The study also demonstrated that the programmable implant was able to deliver the drug at scheduled intervals. Drug delivery and evaluation in patients occurred over a one month period and provided proof-of-concept measures of drug release and device durability that support implantable device viability for 12 months or more.

The microchip device was implanted and explanted using local anesthetic. Patient surveys found that the microchip device was well-tolerated, and patients indicated that they would repeat the implant procedure. “Each procedure lasted less than 30 minutes,” said treating surgeon Pia Georg Jensen, MD. “The patients were able to walk out of the facility and go home unescorted.”

To assess efficacy and improvement in bone fracture risk, the study measured biological markers of bone formation (P1NP), and bone resorption (CTX). In the study, changes in serum calcium, P1NP, and CTX resulting from drug implant therapy were found to be qualitatively and quantitatively similar to those reported in previous studies during daily subcutaneous injections of teriparatide.

“These data validate the microchip approach to multi-year drug delivery without the need for frequent injections, which can improve the management of many chronic diseases like osteoporosis where adherence to therapy is a significant problem,” said study lead author Robert Farra, MicroCHIPS President and Chief Operating Officer. “We look forward to making further progress to advance our first device toward regulatory approvals, as well as developing a range of products for use in important disease areas such as osteoporosis, cardiovascular disease, multiple sclerosis, cancer, and chronic pain.”

In the trial, post menopausal women diagnosed with osteoporosis received daily doses of the marketed osteoporosis drug teriparatide through microchip delivery rather than daily injection. The drug released from the implanted microchip demonstrated similar measures of safety and therapeutic levels in blood to what is observed from standard, recommended multiple subcutaneous injections of teriparatide.

In the study, seven osteoporotic postmenopausal patients between the ages of 65 and 70 received the microchip-based implant. The primary objective of the clinical trial was to assess the pharmacokinetics (PK) of the released drug teriparatide from the implanted devices. Safety measures included evaluation of the biological response to the implant and monitoring indicators of toxicity. Secondary objectives were to assess the bioactivity of the drug and to evaluate the reliability and reproducibility of releasing the drug from the device.

The device and drug combination were found to be biocompatible with no adverse immune reaction. The resulting PK profiles from the implant were comparable to and had less variation than the PK profiles of multiple, recommended subcutaneous injections of teriparatide. The study also demonstrated that the programmable implant was able to deliver the drug at scheduled intervals. Drug delivery and evaluation in patients occurred over a one month period and provided proof-of-concept measures of drug release and device durability that support implantable device viability for 12 months or more.

The microchip device was implanted and explanted using local anesthetic. Patient surveys found that the microchip device was well-tolerated, and patients indicated that they would repeat the implant procedure. “Each procedure lasted less than 30 minutes,” said treating surgeon Pia Georg Jensen, MD. “The patients were able to walk out of the facility and go home unescorted.”

To assess efficacy and improvement in bone fracture risk, the study measured biological markers of bone formation (P1NP), and bone resorption (CTX). In the study, changes in serum calcium, P1NP, and CTX resulting from drug implant therapy were found to be qualitatively and quantitatively similar to those reported in previous studies during daily subcutaneous injections of teriparatide.

“A microchip that continues to deliver teriparatide with this or similar consistency and efficiency over 12 to 24 months could improve bone mass, density, architecture, and strength,” said study co-author Robert Neer, Founder & Director of the Massachusetts General Hospital Bone Density Center and Associate Professor of Medicine at Harvard Medical School.

Implantable medical devices such as pacemakers and pain pumps perform important functions to help patients return to a healthier state and to manage their disease. The design of a next-generation microchip drug delivery device is the only approach to an implantable device that can be wirelessly programmed to release drugs inside the body without percutaneous connections in or on the patient. An implantable microchip device also provides real-time dose schedule tracking, and as part of a network, physicians can remotely adjust treatment schedules as necessary.

“This trial demonstrates how drug can be delivered through an implantable device that can be monitored and controlled remotely, providing new opportunities to improve treatment for patients and to realize the potential of telemedicine,” said study co-author Robert Langer, ScD, Institute Professor at the David H. Koch Institute for Integrative Cancer Research at MIT, and cofounder of MicroCHIPS, Inc. “The convergence of drug delivery and electronic technologies gives physicians a real-time connection to their patient’s health, and patients are freed from the daily reminder, or burden, of disease by eliminating the need for regular injections.”

MicroCHIPS is currently developing new designs of its microchip-based implant to include as many as 400 doses per device providing daily dosing for one year or multi-year therapy for less frequent dosing regimens. Components of the original microchip technology, such as the array of micro reservoirs used to contain drug and the first microchip opening mechanism, were developed at the Massachusetts Institute of Technology and licensed to MicroCHIPS.

Source:http://www.mchips.com/12_Feb_16_pr.html

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Cellnovo Launches World First Mobile-Connected Diabetes Management System

Cellnovo Launches World First Mobile-Connected Diabetes Management System

Having received European CE Mark approval in September, Cellnovo out of London, UK has launched its diabetes management system that looks like a smartphone system, but is actually an integrated glucometer, wirelessly connected insulin pump, activity monitor, and cell phone-based data transfer system to share readings with family and clinicians.cellnovo-diabetes-management-system

To kick off the release of the system, Cellnovo launched a usability trial involving type 1 diabetics whose doctors will be able to monitor their blood glucose levels in real time as they’re being measured.

Co-trialist, Dr Mark Evans of Addenbrookes Hospital in Cambridge, commented, “This technology represents a entirely new model for the management of diabetes and one that could be of direct and long-term financial benefit to the NHS. The effective management of diabetes requires masses of information. The more information we have, and the more rapidly we have it, the better job we can do of using our resources efficiently to prevent the devastating long-term complications of diabetes. The Cellnovo system is the world’s first both to automate and deliver instantly the information we need – a task achieved through the thoughtful and thorough integration of consumer technology, such as wireless and cellular, with medical sensor and precision pump technologies.”

Co-trialist, Professor Stephen Greene of the University of Dundee added, “The Cellnovo system provides us immediate access to the clinical status of all our patients on a single screen. With accurate and current information we can identify and address problems immediately that, otherwise, might go unnoticed for months, contributing to excess cost and potentially tragic patient complications. In this clinical trial we will be the first to explore these new opportunities in diabetes patient management and hope to uncover new ways to improve and extend care, optimise workflow and drive cost efficiencies.”

Cellnovo’s diabetes management system comprises an insulin pump that connects wirelessly to an intuitive ‘app-based’ touch-screen handset. The handset features an integral blood glucose monitor, an activity monitor and a mobile (GSM) data connection to a comprehensive web-based clinical management system.
Cellnovo patients will be able to track and manage their diabetes; securely sharing all clinical information through the web so that they, their doctors, nurses and family members can ensure sustained and effective diabetic control.

Principal Investigator of the Cellnovo usability trial, and world-leading authority on insulin pump therapy, Professor John Pickup of King’s College London School of Medicine, remarked, “This clinical trial is not just the world’s first with a mobile-connected insulin infusion system, it is also the first clinical trial in which the care team and patients can simultaneously observe and evaluate patient data in real-time, anywhere in the world.”

Co-trialist, Dr Mark Evans of Addenbrookes Hospital in Cambridge, commented, “This technology represents a entirely new model for the management of diabetes and one that could be of direct and long-term financial benefit to the NHS. The effective management of diabetes requires masses of information. The more information we have, and the more rapidly we have it, the better job we can do of using our resources efficiently to prevent the devastating long-term complications of diabetes. The Cellnovo system is the world’s first both to automate and deliver instantly the information we need – a task achieved through the thoughtful and thorough integration of consumer technology, such as wireless and cellular, with medical sensor and precision pump technologies.”

Co-trialist, Professor Stephen Greene of the University of Dundee added, “The Cellnovo system provides us immediate access to the clinical status of all our patients on a single screen. With accurate and current information we can identify and address problems immediately that, otherwise, might go unnoticed for months, contributing to excess cost and potentially tragic patient complications. In this clinical trial we will be the first to explore these new opportunities in diabetes patient management and hope to uncover new ways to improve and extend care, optimise workflow and drive cost efficiencies.”

William F. McKeon, Cellnovo Chief Executive Officer added, “The launch of the Cellnovo system marks a new era in medicine where mobile connectivity is routinely embedded in medical devices. We draw upon the convenience of mobile technology in so many aspects of our lives: email, photos, social networking and banking. It is now time that our most precious asset, our health, benefits from the real-time information flow that is made possible with an in-built mobile connection. We are moving into an era where our doctors will routinely detect health issues over the web, before they worsen; and where patients and family members have the peace of mind that dangerous and costly emergencies can be avoided as early signs are immediately spotted.”

“The Cellnovo usability trial will be conducted in ten of the leading diabetes centers across the UK and will involve 100 patients, both adults and children. Such scale is unprecedented for a trial of insulin infusion technology and its usability.” concluded Dr Reman McDonagh, Director of Clinical and Physician Relations for Cellnovo.

Type 1 diabetes is routinely managed with pump technology throughout much of Europe and North America where 20-25% of patients gain benefit from therapy that mimics the body’s normal production of insulin. Yet the UK lags behind, with 96% of patients having to rely on multiple daily injections. By introducing a unique system that uses cellular data and touch screen technology, Cellnovo aims to eliminate the barriers to adoption of insulin pump therapy; simplifying and reducing the workload for doctors and nurses, while also improving the quality of insight and diabetes management achieved by patients.

Type 1 diabetes affects 250,000 UK patients for whom the prospect of poor diabetic control can lead to blindness, nerve damage and death. Caring for diabetes accounts for 10% of the NHS budget, a significant proportion of which is focused on type 1, a growing challenge that affects 4% more UK patients each year. Type 1 diabetes can only be managed by the daily or constant administration of insulin, replacing the role of the pancreas that for these patients has become incapable of producing insulin, which is vital for the metabolism of carbohydrates.

Source:https://www.pressdispensary.co.uk/releases/c993326.html

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Develop Gene Therapy to Boost Brain Repair for Demyelinating Diseases

Develop Gene Therapy to Boost Brain Repair for Demyelinating Diseases

A number of neurological diseases, such as multiple sclerosis, end up with damaged oligodendrocytes that make myelin that in turn protects axons of nerve cells.myelin-producing-cells

The consequences are debilitating and cause all kinds of terrible side effects, but researchers at Caltech have developed a therapy, so far tested in a mouse model, that can help replace damaged oligodendrocytes.

Details from the announcement:

The therapy uses leukemia inhibitory factor (LIF), a naturally occurring protein that was known to promote the self-renewal of neural stem cells and to reduce immune-cell attacks to myelin in other MS mouse models.

“What hadn’t been done before our study was to use gene therapy in the brain to stimulate these cells to remyelinate,” says Paul Patterson, the Biaggini Professor of Biological Sciences at Caltech and senior author of the study.

According to the researchers, LIF enables remyelination by stimulating oligodendrocyte progenitor cells to proliferate and make new oligodendrocytes. The brain has the capacity to produce oligodendrocytes, but often fails to prompt a high enough repair response after demyelination.

“Researchers had been skeptical that a single factor could lead to remyelination of damaged cells,” says Deverman. “It was thought that you could use factors to stimulate the division and expansion of the progenitor population, and then add additional factors to direct those progenitors to turn into the mature myelin-forming cells. But in our mouse model, when we give our LIF therapy, it both stimulates the proliferation of the progenitor cells and allows them to differentiate into mature oligodendrocytes.”

In other words, once the researchers stimulated the proliferation of the progenitor cells, it appeared that the progenitors knew just what was needed—the team did not have to instruct the cells at each stage of development. And they found that LIF elicited such a strong response that the treated brain’s levels of myelin-producing oligodendrocytes were restored to those found in healthy populations.

The researchers note, too, that by placing LIF directly in the brain, one avoids potential side effects of the treatment that may arise when the therapy is infused into the bloodstream.

PASADENA, Calif.—Our bodies are full of tiny superheroes—antibodies that fight foreign invaders, cells that regenerate, and structures that ensure our systems run smoothly. One such structure is myelin—a material that forms a protective, insulating cape around the axons of our nerve cells so that they can send signals quickly and efficiently. But myelin, and the specialized cells called oligodendrocytes that make it, become damaged in demyelinating diseases like multiple sclerosis (MS), leaving neurons without their myelin sheaths. As a consequence, the affected neurons can no longer communicate correctly and are prone to damage. Researchers from the California Institute of Technology (Caltech) now believe they have found a way to help the brain replace damaged oligodendrocytes and myelin.

The therapy, which has been successful in promoting remyelination in a mouse model of MS, is outlined in a paper published February 8 in The Journal of Neuroscience.

“We’ve developed a gene therapy to stimulate production of new oligodendrocytes from stem and progenitor cells—both of which can become more specialized cell types—that are resident in the adult central nervous system,” says Benjamin Deverman, a postdoctoral fellow in biology at Caltech and lead author of the paper. “In other words, we’re using the brain’s own progenitor cells as a way to boost repair.”

The therapy uses leukemia inhibitory factor (LIF), a naturally occurring protein that was known to promote the self-renewal of neural stem cells and to reduce immune-cell attacks to myelin in other MS mouse models.

“What hadn’t been done before our study was to use gene therapy in the brain to stimulate these cells to remyelinate,” says Paul Patterson, the Biaggini Professor of Biological Sciences at Caltech and senior author of the study.

According to the researchers, LIF enables remyelination by stimulating oligodendrocyte progenitor cells to proliferate and make new oligodendrocytes. The brain has the capacity to produce oligodendrocytes, but often fails to prompt a high enough repair response after demyelination.

“Researchers had been skeptical that a single factor could lead to remyelination of damaged cells,” says Deverman. “It was thought that you could use factors to stimulate the division and expansion of the progenitor population, and then add additional factors to direct those progenitors to turn into the mature myelin-forming cells. But in our mouse model, when we give our LIF therapy, it both stimulates the proliferation of the progenitor cells and allows them to differentiate into mature oligodendrocytes.”

In other words, once the researchers stimulated the proliferation of the progenitor cells, it appeared that the progenitors knew just what was needed—the team did not have to instruct the cells at each stage of development. And they found that LIF elicited such a strong response that the treated brain’s levels of myelin-producing oligodendrocytes were restored to those found in healthy populations.

The researchers note, too, that by placing LIF directly in the brain, one avoids potential side effects of the treatment that may arise when the therapy is infused into the bloodstream.

“This new application of LIF is an avenue of therapy that has not been explored in human patients with MS,” says Deverman, who points out that LIF’s benefits might also be good for spinal-cord injury patients since the demyelination of spared neurons may contribute to disability in that disorder.

To move the research closer to human clinical trials, the team will work to build better viral vectors for the delivery of LIF. “The way this gene therapy works is to use a virus that can deliver the genetic material—LIF—into cells,” explains Patterson. “This kind of delivery has been used before in humans, but the worry is that you can’t control the virus. You can’t necessarily target the right place, and you can’t control how much of the protein is being made.”

Which is why he and Deverman are developing viruses that can target LIF production to specific cell types and can turn it on and off externally, providing a means to regulate LIF levels. They also plan to test the therapy in additional MS mouse models.

“For MS, the current therapies all work by modulating or suppressing the immune system, because it’s thought to be a disease in which inflammation leads to immune-associated loss of oligodendrocytes and damage to the neurons,” says Deverman. “Those therapies can reduce the relapse rate in patients, but they haven’t shown much of an effect on the long-term progression of the disease. What are needed are therapies that promote repair. We hope this may one day be such a therapy.”

The work done in this study, “Exogenous Leukemia Inhibitory Factor Stimulates Oligodendrocyte Progenitor Cell Proliferation and Enhances Hippocampal Remyelination,” was funded by the California Institute for Regenerative Medicine, the National Institutes of Neurological Disorders and Stroke, and the McGrath Foundation.

Source:http://media.caltech.edu/press_releases/13495

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BOVIE MEDICAL CORPORATION RECEIVES 510 K CLEARANCES TO MARKET PATENTED J-PLASMA™ TECHNOLOGY

BOVIE MEDICAL CORPORATION RECEIVES 510 K CLEARANCES TO MARKET PATENTED J-PLASMA™ TECHNOLOGY

Bovie Medical received FDA clearance for its J-Plasma handpiece with retractable cutting feature for coagulating soft tissue during surgeries. It is available for both open and laparoscopic procedures.bovie-j-plasma1

The device is powered by a previously approved Bovie GS electrosurgical generator.

J-Plasma™ is formed by passing an inert gas, such as helium, over a sharp conductive point which is held at high voltage and high frequency, producing a luminous discharge beam. The sharp conductive point can also be in the form of a retractable surgical blade, providing multiple modes of operation in a single instrument. The extended surgical blade can be used for incisions and other cutting procedures, and when retracted, the blade is used to form the J-Plasma beam for coagulation. The extended blade can also be used in combination with the J-Plasma beam, providing an enhanced cutting capability with minimal impact on surrounding tissue.

The Company, assisted by leading surgeons, will introduce J-Plasma™ at selected hospital beta sites including several university teaching facilities, in preparation for a market launch later this year by its independent sales distribution network.

Melville, New York, February 1, 2012 – Bovie Medical Corporation (“Bovie” or the “Company”) (NYSE Amex: BVX), a manufacturer and marketer of electrosurgical products, today announced that the Company received 510k clearance from the Food and Drug Administration (FDA) to market its J-Plasma™ handpiece with retractable cutting feature for soft tissue coagulation during surgery. The handpiece will be powered by Bovie’s GS electrosurgical generator, which has prior 510k market clearance.

J-Plasma™ is formed by passing an inert gas, such as helium, over a sharp conductive point which is held at high voltage and high frequency, producing a luminous discharge beam. The sharp conductive point can also be in the form of a retractable surgical blade, providing multiple modes of operation in a single instrument. The extended surgical blade can be used for incisions and other cutting procedures, and when retracted, the blade is used to form the J-Plasma beam for coagulation. The extended blade can also be used in combination with the J-Plasma beam, providing an enhanced cutting capability with minimal impact on surrounding tissue.

The Company, assisted by leading surgeons, will introduce J-Plasma™ at selected hospital beta sites including several university teaching facilities, in preparation for a market launch later this year by its independent sales distribution network.

Bovie continues to explore and review added applications for J-Plasma™ which include gynecology, dermatology, plastic surgery, infection control, use in robotics and other surgical techniques.

Bovie Medical Corporation CEO Andrew Makrides commented, “This is a significant development toward Bovie becoming a leader in plasma surgery and achieving increased prominence in the electrosurgery marketplace.”

Bovie recently announced the granting of a United States patent for a “Method to generate a plasma stream for performing electrosurgery”, adding to the Company’s J-Plasma™ patent portfolio. Bovie has four patents related to its J-Plasma™ technology with three additional patent applications pending.

Cautionary Note on Forward-Looking Statements

Certain matters discussed in this news release and oral statements made from time to time by representatives of the Company may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws.  Although the Company believes that the expectations reflected in such forward-looking statements are based upon reasonable assumptions, it can give no assurance that its expectations will be achieved.

Forward-looking information is subject to certain risks, trends and uncertainties that could cause actual results to differ materially from those projected.  Many of these factors are beyond the Company’s ability to control or predict.  Important factors that may cause actual results to differ materially and that could impact the Company and the statements contained in this news release can be found in the Company’s filings with the Securities and Exchange Commission including the Company’s Report on Form 10‑K for the year ended December 31, 2010.  For forward-looking statements in this new release, the Company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.  The Company assumes no obligation to update or supplement any forward-looking statements whether as a result of new information, future events or otherwise.

Source:http://boviemed.com/stocknews.asp#020112

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BattleView Infrared Vascular Trans-illuminator

BattleView Infrared Vascular Trans-illuminator

Let’s just say that you’re a medic out there “in the field” in the middle of the night, with bad guys all over the surrounding hill tops, and they just shot one of your buddies.  You managed to move the injured soldier to a safer location, and are attempting to setup an IV, but you certainly don’t want to turn on the flashlight with enemy snipers scanning every inch of the landscape.BattleView-Infrared-closeup

That’s where the BattleView Infrared Vascular Trans-illuminator may be of help, as it shines infrared light through the body part where you’re trying to set the IV, illuminating the internal anatomy for your night vision goggles to see as bright as day.

From the product page:

The device incorporates four encapsulated IR LED’s that bond with the iron in the venous blood travelling back to the heart, effectively fluorescing the veins.  This makes target veins extremely easy to spot, allowing IV’s to be inserted as if under normal lighting conditions.

BattleView © has a fantastic power to size ratio, capable of shining right through several inches of tissue.  It can be used on the upper appendages to locate commonly targeted veins (Cephalic and Dorsal Venous) in the hand and wrist.  It can even reveal the veins in the medial part of the lower arm (Median Anti-Brachial and Cephalic).  In areas of higher muscular density, BattleView © can be rotated to the same side as the infiltration site to trans-illuminate the superficial target veins.  The same can be done on the lower appendages when targeting common structures like the Saphenous Vein.

BattleView © is one of the most innovative products developed for the tactical medicine community.  Its lightweight foam and neoprene construction make it easily packable in a medic’s kit and it deploys in seconds.  Simply run the patient’s appendage through the shock cord retaining band with the foam pad against the skin and click the on/off button.  BattleView © is powered by a single 3-volt CR123A lithium battery.  The LED’s operate in the near-infrared spectrum.  So, while they mainly produce IR light visible only through night vision goggles, they also emit a faint red glow that is visible to the naked eye.  The red glow can only be seen from a few feet away and is used for checking power status without NVG aid.  The IR emission is very strong, allowing BattleView © to be used as an IR Beacon or area light as well.  In addition, the unit also produces heat when powered on.  The heat lets it be used as a thermal beacon.  Because the device produces heat, though; users should take caution in leaving it on a patient for too long.

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Analogic Launches Three New BK Medical Ultrasound Systems With Innovative Quantum Technology

Analogic Launches Three New BK Medical Ultrasound Systems With Innovative Quantum Technology

Analogic has announced the worldwide launch of three new ultrasound systems from its subsidiary BK Medical, the Pro Focus UltraView 800, the Flex Focus 800, and the Flex Focus 500.analogic-new-devices

All three models sport the company’s “Quantum Technology” that provides high resolution visualization of the tissues.

Quantum Technology offers image quality enhancements including improved contrast resolution, as well as new gray scale maps and new image pre-sets, making it easier and quicker to obtain the highest quality images. In addition, the new technology includes a unique Vector Flow Imaging (VFI) mode*, enabling angle independent visualization of blood flow, and an advanced color Doppler mode, enabling superb spatial resolution. Key benefits also include advanced harmonic imaging when imaging all patient types, even the extremely difficult-to-image patient.

Compatible with all of BK Medical’s transducers, the fully featured, premium performance systems are ideally suited for surgery, including robotic-assisted surgery, general imaging and high-end urology imaging. The UltraView 800 system also has contrast imaging capabilities**, and both the UltraView 800 and Flex Focus 800 systems have a HistoScanning*** ready option. The Flex Focus 500 is the mid-range system in the BK Medical family incorporating Quantum Technology. This portable system is powerful and well suited for a busy practice utilizing ultrasound for urology and general imaging needs. All of the new systems also have VFI* as an option.

BOSTON, Feb. 7, 2012 (GLOBE NEWSWIRE) — Analogic Corporation (Nasdaq:ALOG), enabling the world’s medical imaging and aviation security technology, today announced the worldwide launch of three BK Medical ultrasound systems, the Pro Focus™ UltraView 800, the Flex Focus™ 800, and the Flex Focus 500, each incorporating the groundbreaking Quantum™ technology. Significant new features and advancements from the Quantum Technology improve the practice of medicine by providing clinicians a faster and easier way to maximize ultrasound performance in urology, surgery, general imaging and anesthesiology.

“The three new ultrasound systems with Quantum Technology are our most significant and innovative product announcements to date, underscoring our pioneering innovation in ultrasound for over thirty years,” said Lars Shaw, vice president of global marketing at Analogic. “The superb imaging performance and dramatic increase in 2D and color Doppler capabilities, coupled with the productivity enhancements built into the new Quantum Technology, are examples of Analogic’s continuing promise to provide leading-edge ultrasound systems.”

Quantum Technology offers image quality enhancements including improved contrast resolution, as well as new gray scale maps and new image pre-sets, making it easier and quicker to obtain the highest quality images. In addition, the new technology includes a unique Vector Flow Imaging (VFI) mode*, enabling angle independent visualization of blood flow, and an advanced color Doppler mode, enabling superb spatial resolution. Key benefits also include advanced harmonic imaging when imaging all patient types, even the extremely difficult-to-image patient.

Analogic’s three new ultrasound systems complement BK Medical’s extensive product portfolio. The UltraView 800 and Flex Focus 800 are premium performance, highly efficient new systems that incorporate Quantum Technology. Compatible with all of BK Medical’s transducers, the fully featured, premium performance systems are ideally suited for surgery, including robotic-assisted surgery, general imaging and high-end urology imaging. The UltraView 800 system also has contrast imaging capabilities**, and both the UltraView 800 and Flex Focus 800 systems have a HistoScanning*** ready option. The Flex Focus 500 is the mid-range system in the BK Medical family incorporating Quantum Technology. This portable system is powerful and well suited for a busy practice utilizing ultrasound for urology and general imaging needs. All of the new systems also have VFI* as an option. The full BK Medical product portfolio includes the Flex Focus 200, 200 Surgery, 400 Anesthesia, 700, and the Pro Focus UltraView.

Analogic’s worldwide launch began in Copenhagen, Denmark, continued to Dubai, United Arab Emirates, and concluded in Las Vegas, Nevada.

Analogic Corporation recently received the coveted 2011 Frost & Sullivan North American Product Differentiation Excellence of the Year Award in the Surgical Ultrasound Market for its BK Medical ultrasound solutions.

About Analogic and the BK Medical brand

Analogic (Nasdaq:ALOG) provides leading-edge healthcare and security technology solutions to advance the practice of medicine and save lives. Analogic’s ultrasound group designs and manufactures ultrasound systems and specialized transducers that are sold directly to medical practitioners under the BK Medical brand. For over 30 years, our market-leading BK Medical branded ultrasound solutions have been used to improve the practice of medicine in procedure-driven markets such as urology, surgery and anesthesia. BK Medical’s products, including our award-winning Flex Focus family of systems and unique transducer designs, offer advanced imaging capabilities that enable real-time image guidance in an easy-to-use, portable platform.

Source:http://www.analogic.com/646971/news-and-events-press-releases-detail.htm

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Roswell Park Launches Landmark Immunotherapy Vaccine Trial

Roswell Park Launches Landmark Immunotherapy Vaccine Trial

The Center for Immunotherapy at Roswell Park Cancer Institute (RPCI) is about to begin a very exciting new cancer clinical trial that will test a personalized immunotherapy to attack cancer cells.

The new NY-ESO-1 dendritic cell vaccine will be produced “using a unique FDA-approved process — making RPCI the first research facility in the U.S. to use a custom-made barrier isolator for vaccine cell production, and the first in the world to use this system in an approved, government-regulated study,” according to the announcement.

The vaccine to be produced at RPCI will be the first to incorporate a particular form of NY-ESO-1, antiDEC205-NY-ESO-1. “Armed with this specialized protein, the treated cells are then given back to the patient as a vaccine designed to recruit an army of killer immune cells that seek out and destroy cancer,” explains Kunle Odunsi, MD, PhD, Director of RPCI’s Center for Immunotherapy (CFI) and the study’s Principal Investigator.

The new study is also unique in that it’s the first to test a dendritic vaccine given in combination with rapamycin, a compound used to prevent rejection of solid-organ transplant. The study just launched will capitalize on a striking recent scientific discovery by Protul Shrikant, PhD, of the Department of Immunology at RPCI, who found that in low doses, rapamycin confers a previously unknown benefit — it prevents the immune system from using up its cancer-killing T-cells in one quick burst. “We have shown for the first time that rapamycin has the capacity to produce immune cells that have memory attributes,” explains Dr. Odunsi, who is also Chair of RPCI’s Department of Gynecologic Oncology. “The immune cells are trained to live longer and to always remember that cancer cells are bad and should be attacked and killed.”

The ability to stretch out the attack for a long-term, durable response suggests that the vaccine may be effective in preventing disease recurrence. The new NY-ESO-1 dendritic cell vaccine is expected to show great promise in patients with bladder, brain, breast, esophageal, gastrointestinal, hepatocellular, kidney, lung, melanoma, ovarian, prostate, sarcoma and uterine tumors.

PLEASE NOTE: As expected, Roswell Park Cancer Institute continues to receive a very high volume of calls and emails from patients and their families regarding the vaccine clinical research study that was announced at our press conference, January 24. Many calls and emails (and even some in-person inquiries) are coming into all sectors of the Institute – from the clinics and Switchboard to Patient Access and the Cancer Resource Center. The staff and faculty of Roswell Park are making every effort to ensure that you receive the information you need quickly and efficiently. Therefore, we ask that you ONLY contact the ASK-RPCI information center. To reach the ASK-RPCI information center, call 1-877-ASK-RPCI (1-877-275-7724), Monday through Friday, from 9 a.m. until 5:30 p.m. or send an email to askrpci@roswellpark.org. Information about the trial is also included on the Roswell Park website at www.roswellpark.org. Thank you for both your cooperation and your interest in this important new study.

Dendritic cells are the gatekeepers of the human immune system, defending against invaders like bacteria, viruses and cancer. The vaccine to be produced at RPCI will be the first to incorporate a particular form of NY-ESO-1, antiDEC205-NY-ESO-1. “Armed with this specialized protein, the treated cells are then given back to the patient as a vaccine designed to recruit an army of killer immune cells that seek out and destroy cancer,” explains Kunle Odunsi, MD, PhD, Director of RPCI’s Center for Immunotherapy (CFI) and the study’s Principal Investigator.

The new study is also unique in that it’s the first to test a dendritic vaccine given in combination with rapamycin, a compound used to prevent rejection of solid-organ transplant. The study just launched will capitalize on a striking recent scientific discovery by Protul Shrikant, PhD, of the Department of Immunology at RPCI, who found that in low doses, rapamycin confers a previously unknown benefit — it prevents the immune system from using up its cancer-killing T-cells in one quick burst. “We have shown for the first time that rapamycin has the capacity to produce immune cells that have memory attributes,” explains Dr. Odunsi, who is also Chair of RPCI’s Department of Gynecologic Oncology. “The immune cells are trained to live longer and to always remember that cancer cells are bad and should be attacked and killed.”

The ability to stretch out the attack for a long-term, durable response suggests that the vaccine may be effective in preventing disease recurrence. The new NY-ESO-1 dendritic cell vaccine is expected to show great promise in patients with bladder, brain, breast, esophageal, gastrointestinal, hepatocellular, kidney, lung, melanoma, ovarian, prostate, sarcoma and uterine tumors.

The NY-ESO-1 vaccine, tailor-made for each patient, will be produced in RPCI’s Therapeutic Cell Production Facility (TCPF) under the direction of Yeong “Christopher” Choi, PhD, who notes: “We believe that our facility’s custom-made barrier isolator, the unit in which the vaccines are manufactured, is the first of its kind.” The barrier isolator — an Xvivo System processing chamber designed to RPCI’s specifications by BioSpherix, Ltd., Lacona, NY — maintains strict control of the unit’s temperature and atmospheric gases, critical for optimal production of dendritic cell vaccines.

“Those conditions, and the sterile vaccine-manufacturing environment, are rigidly maintained throughout the entire process,” says Dr. Choi. “The Xvivo — which at about 70 square feet is basically a clean room in a box — acts as a physical barrier that protects the cell-therapy product from outside contaminants, resulting in a safer, more predictable manufacturing process.”

The potential of therapeutic vaccines is attracting increasing interest in the field of oncology. Last year, the FDA approved the first therapeutic cancer vaccine, Provenge® (sipuleucel-T), for men with advanced prostate cancer. RPCI’s Center for Immunotherapy is awaiting FDA approval to launch additional cancer vaccine trials, including a vaccine for malignant glioma (a type of brain tumor) and another vaccine for patients with ovarian, fallopian tube, and primary peritoneal cancer.

“This trial will be only the beginning of a very robust program of activity in the area of using the human immune system to fight cancer,” adds Dr. Odunsi. “Our production process holds tremendous potential for applications related to stem-cell therapy and regenerative medicine, and I believe we’re uniquely positioned at RPCI to have the tools, infrastructure and multidisciplinary collaboration to capitalize on these ideas and opportunities both effectively and efficiently.”

The clinical research study will enroll 18-20 eligible patients whose tumors express a specific antigen, known as NY-ESO-1. Apart from the adult male testis, NY-ESO-1 is not expressed in normal tissues of the body, but is expressed in cancers. This may help decrease the risk of side effects from the vaccine, because it should target only the tissues that express NY-ESO-1.

Dr. Odunsi, who developed the NY-ESO-1 vaccine, led previous trials evaluating its effectiveness in treating ovarian cancer. Christine Sable of Lancaster, Pennsylvania, enrolled on one of those studies in February of 2004, after undergoing surgery and chemotherapy for advanced-stage ovarian cancer. Although she faced a 75-80% chance that the cancer would return, her immune system responded strongly to the vaccine, and she has remained cancer-free in the seven years since then, with no side effects.

Source:http://www.roswellpark.org/media/news/roswell-park-launches-landmark-immunotherapy-vaccine-trial

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Solve Puzzles for Science

Solve Puzzles for Science

Players of the online protein folding game Foldithave reached another milestone, creating an 18-fold-more-active version of a model enzyme. The gamers worked on an enzyme that catalyses the Diels-Alder reaction, which is used in the synthesis of various chemical products (according to Wikipedia it is considered the “Mona Lisa” of reactions in organic chemistry).

In 2010 scientists designed a functional Diels–Alderase computationally from scratch, but with a binding pocket for the pair of reactants that was too open and too low activity. Because they were not able to improve it further they challenged the Foldit gamers to come up with better designs. Through two different puzzles, one to remodel one of four amino-acid loops on the enzyme to increase contact with the reactants, and another to stabilize the new loop, the gamers fiddled their way through in search of the best-scoring (lowest-energy) configurations. Out of the almost 200,000 resulting designs, the researchers then synthesized a number of test enzymes and ultimately the final, 18-fold-more-active enzyme.

Although there are no immediate applications for the particular Diels-Alder reaction that the enzyme catalyses and its activity is still relatively low, it clearly shows the power of crowdsourcing this kind of research. The scientist are now looking into improving small protein inhibitors that bind to and block the 1918 pandemic influenza virus. “Now Foldit players are working to make more potent inhibitors,” Baker said. “Those are exciting because those could be drugs.”

Computational enzyme design holds promise for the production of renewable fuels, drugs and chemicals. De novo enzyme design has generated catalysts for several reactions, but with lower catalytic efficiencies than naturally occurring enzymes1234. Here we report the use of game-driven crowdsourcing to enhance the activity of a computationally designed enzyme through the functional remodeling of its structure. Players of the online game Foldit56 were challenged to remodel the backbone of a computationally designed bimolecular Diels-Alderase3 to enable additional interactions with substrates. Several iterations of design and characterization generated a 24-residue helix-turn-helix motif, including a 13-residue insertion, that increased enzyme activity >18-fold. X-ray crystallography showed that the large insertion adopts a helix-turn-helix structure positioned as in the Foldit model. These results demonstrate that human creativity can extend beyond the macroscopic challenges encountered in everyday life to molecular-scale design problems.

Source:http://www.nature.com/nbt/journal/vaop/ncurrent/full/nbt.2109.html

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Innovative Study of High Blood Pressure

Innovative Study of High Blood Pressure

The FDA has conditionally approved an investigational device exemption (IDE) for a pivotal clinical trial to evaluate a new patented isometric handgrip therapy technology. A product of Zona Health(Boise, ID), the ZonaRx device was developed for use in the treatment ofresistant hypertension (high blood pressure that persists despite treatment by two or more medications). The IDE approval marks the first pivotal trial of isometric handgrip therapy for hypertension treatment.

Earlier clinical studies demonstrate that the isometric handgrip therapy could provide “a significant reduction in blood pressure levels for the majority of hypertensive patients,” according to Zona Health. According to earlier data, 135 out of 136 study participants achieved significant blood pressure drops in eight weeks or less.

From the announcement:

The pivotal trial is a double-blind, randomized, controlled study designed to evaluate the safety and effectiveness of isometric handgrip therapy with the ZonaRx™ in patients who are taking two or more medications but cannot reach their blood pressure goals. The study will enroll approximately 200 patients in several medical centers across the U.S.

The ZonaRx™ is a medical device which enables patients to easily perform isometric handgrip therapy in the comfort of their homes. The device uses patented technology to accurately customize the therapy for each individual patient in order to trigger a specific physiological response that leads to lower blood pressure. The ZonaRx does not require a permanent implant or invasive surgery.

BOISE– 1/18/2012 – Zona Health, developer of non-invasive, non-drug treatments for hypertension, announced that the U.S. Food and Drug Administration (FDA) conditionally approved an Investigational Device Exemption (IDE) for a pivotal clinical trial to evaluate the Company’s patented isometric handgrip therapy technology (ZonaRx™) for use in the treatment of resistant hypertension (high blood pressure in the presence of two or more medications), an especially dangerous disease affecting hundreds of millions of people worldwide. FDA approval of the IDE makes Zona Health’s study the first pivotal trial of isometric handgrip therapy for hypertension treatment.

The investigatory team for the study includes JoAnn Lindenfeld, M.D., Director of the Cardiac Transplant Program at University Hospital in Aurora, Colorado, and a member of the FDA Devices Committee; Suzanne Oparil, M.D., Professor of Medicine and Director of the Vascular Biology and Hypertension Program in the Division of Cardiovascular Disease at the University of Alabama at Birmingham, and Co-chair of The Eighth Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 8); and Kenneth Kronhaus, M.D., Ph.D., Cardiologist, and American Heart Association Spokesman.

“We are very pleased with the IDE approval and look forward to commencing the pivotal study to provide longer term safety and efficacy data of our ZonaRx™ hypertension treatment technology in this set of resistant hypertensive patients,” said Steven Wood, President and CEO of Zona Health. “We believe this innovative treatment has the potential to provide patients with an effective way to control their blood pressure when other treatment options are insufficient.”

The pivotal trial is a double-blind, randomized, controlled study designed to evaluate the safety and effectiveness of isometric handgrip therapy with the ZonaRx™ in patients who are taking two or more medications but cannot reach their blood pressure goals. The study will enroll approximately 200 patients in several medical centers across the U.S.

The ZonaRx™ is a medical device which enables patients to easily perform isometric handgrip therapy in the comfort of their homes. The device uses patented technology to accurately customize the therapy for each individual patient in order to trigger a specific physiological response that leads to lower blood pressure. The ZonaRx does not require a permanent implant or invasive surgery.

Clinical research shows that Zona Health’s isometric handgrip therapy may provide a significant reduction in blood pressure levels for the majority of hypertensive patients. Across several earlier studies, 135 out of 136 participants achieved significant blood pressure drops in eight weeks or less.

Hypertension is the leading attributable cause of death worldwide. It is a significant, escalating global healthcare problem affecting approximately 1.2 billion people and is associated with an increased risk of heart attack, stroke, heart failure, kidney disease and death. High blood pressure is estimated to have a direct cost to the global healthcare system of more than $500 billion annually. Although pharmaceutical therapy plays a primary role in hypertension management, drugs alone are sometimes not effective for all patients. As a result, despite lifestyle changes and the availability of modern antihypertensive agents, approximately 50 percent of patients with hypertension remain uncontrolled, and approximately 15-20 percent of those are resistant.

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