Archive for ‘Gastroenterology’

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Personal Emergency Response Systems (PERS) Market Will hit at a CAGR of 8.0% by 2024

Personal Emergency Response Systems (PERS) Market Will hit at a CAGR of 8.0% by 2024

Emergency-Management1

 

The global personal emergency response systems market is expected to increase at a healthy CAGR of over 8.0% over the forecast period (2016–2024).

Personal emergency response systems are devices used to alert emergency services in the event of a fall or any emergency situation for immediate medical assistance. Such devices have the potential to mitigate some adverse consequences of an emergency or any risk situations. The personal emergency response systems market was valued at US$ 3,191.5 Mn in 2015 and is expected to increase at a CAGR of over 8.0% during the forecast period.

In this report, the global personal emergency response systems market has been segmented on the basis of product type, end use, and region. The report also provides information regarding market dynamics, value chain, competitive landscape, current trends, market estimations and forecast.

By region, North America is expected to dominate the global personal emergency response systems market throughout the forecast period, driven by increasing number of geriatric population, rising prevalence of chronic diseases, proliferation of smartphones, and adoption of personal emergency response systems as supportive tool for assisted living facilities. The U.S. is the largest market for personal emergency response systems in North America. The personal emergency response systems market in the U.S. is expected to increase at a CAGR of 9.2% over the forecast period.

By product type, the personal emergency response systems market has been segmented into landline devices, mobile devices, standalone devices, and mobile applications. The landline devices segment is expected to dominate the overall personal emergency response systems market by the end of 2024. The segment is projected to register an above average growth rate over the forecast period. Mobile devices segment is one of the most attractive segments and is anticipated to show significant growth in revenue over 2016–2024.

By end user, the global personal emergency response systems market has been segmented into home-based users, assisted living facilities, and hospitals. Among these, home-based users segment is expected to dominate the overall market by 2024, owing to wide acceptance of personal emergency response systems such as landline devices and mobile devices among the aging population who are staying at home. Factors such as ease of use and portability of these devices and rising number of falls among the aging population are expected to fuel growth of the overall personal emergency response systems market during forecast period.

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Key market participants included in the report are Koninklijke Philips N.V, LifeWatch USA, Tunstall, ADT Security Services, Medical Guardian LLC, MobileHelp, Bay Alarm Company, and MariCare Oy.

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Disposable Robotically-Assisted Colonoscope, invendoscope SC200, Gets EU Clearance

Disposable Robotically-Assisted Colonoscope, invendoscope SC200, Gets EU Clearance

sc200-2

 

Invendo Medical, a German firm, received European CE Mark approval for its invendoscope SC200 single-use robotically-assisted colonoscope. The device has a 3.1 mm working channel, a 35 mm bending radius, and has standard features like rinsing, flushing, suction, and insufflation.

It comes in sterile and ready to go, and is disposed of following a procedure. There are no associated costs of cleaning the device between uses, allowing clinics to potentially save money and time not having to reprocess scopes after each patient. The hand controller is used to orient the distal end of the endoscope and it, along with the supply and processing unit, are reusable.

The device received FDA clearance back in 2013.

sc200

Product page: invendoscope SC200…

Flashbacks: Robotic Colonoscope from invendo medical Coming to U.S. Market…; E200 Robotically Assisted Single-Use Colonoscopy System FDA Cleared…; Invendoscope Remote Controlled Colonoscope Gets Green Light in U.S…

Via: invendo medical…

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An artificial pancreas invented can bring an end to the misery of daily injections for diabetics

An artificial pancreas invented can bring an end to the misery of daily injections for diabetics

It’s the first device approved by the FDA that detects dropping sugar levels and shuts off regular insulin delivery for Type 1 diabetics, just like a real pancreas is one of  the Best Inventions of the Year 2013 .Too much insulin, which is common at night, can lead to life-threatening diabetic comas.

An artificial pancreas invented by a De Montfort University (DMU) professor could have its first human trials within two years.

Professor Joan Taylor’s creation ensures patients will no longer have to endure injections of insulin every day.

Instead, a device will be surgically implanted into the body and able to release a precise amount of insulin into the bloodstream. Supplies would be topped up every two weeks.

Human trials are due to begin in 2016 with the first implants taking place on the NHS within a decade – news which has featured prominently in the national press with articles in the Daily Express and the Daily Mail among others.

Professor of Pharmacy at DMU, Joan Taylor, said: “The device will not only remove the need to manually inject insulin, but will also ensure that perfect doses are administrated each and every time. By controlling blood glucose so effectively, we should be able to help reduce related health problems.

“We are extremely close to embarking on clinical trials. Diabetes is costing society more than £1million an hour in treatment, and much of that is spent on treating complications.”

The implant contains a reservoir of insulin kept in place by a special gel barrier. When glucose levels in the body rise, the gel liquefies and releases the insulin into the body, mimicking the normal pancreas.

As the insulin lowers the glucose levels, the gel reacts by hardening again and preserving the reservoir. It would eliminate the need for diabetics to inject insulin up to four times a day.

The artificial pancreas will help all Type 1 insulin-dependent diabetics and some suffering Type 2 who need daily injections.

Professor Taylor has spent 20 years developing the device, which requires no electronics. This means the risk of rejection by the body is minimised.

Until now, the project has had funding of £1 million from the NHS, the Lachesis Fund – which invests in research in the university – the charity Edith Murphy Foundation and private backers. Professor Taylor is now seeking a similar amount to refine the product.

“This device is cheap and simple to use,” added Professor Taylor. “It has the potential to bring an end to the misery of daily injections for diabetics.”

- SOURCE: http://www.dmu.ac.uk/research/research-news/2014/january/human-trials-in-two-years-for-artificial-pancreas-invention.aspx#sthash.42N8lBYF.dpuf

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Fluidigm unveils four innovative devices to meet challenges associated with production genomics

Fluidigm unveils four innovative devices to meet challenges associated with production genomics

Fluidigm Corporation (NASDAQ:FLDM) today introduced four new integrated fluidic circuits (IFCs) designed to meet the challenges associated with production genomics. These new offerings are expected to make substantial contributions to laboratories performing high sample throughput digital PCR, genotyping, and targeted panel testing.

“Today, we unveil four innovative devices, each responding to unmet needs in production genomics. To deliver ultra-low cost per sample and exquisite accuracy in digital PCR, we introduce the qdPCR™ 37K IFC. To minimize sample re-work and ambiguous results in high-throughput genotyping, we now offer the High-Precision 96.96 Genotyping IFC. To enable high sample throughput for gene expression applications, we announce the 192.24 Gene Expression IFC. Finally, in response to many requests for greater sample and assay flexibility during target selection, we present the FLEXsix™ Gene Expression IFC, first of a family of flexible, configurable IFCs,” said Gajus Worthington, Fluidigm President and Chief Executive Officer.

With these new IFCs, the BioMark™ HD system now supports the entire span of activity from target selection through production scale-up, eliminating the need for technology-bridging studies.

The Fluidigm qdPCR 37K IFC

The qdPCR 37K IFC combines both digital and quantitative real-time PCR. Real-time analysis of digital PCR reactions minimizes false positives. The qdPCR 37K IFC also provides high amplification success rate with the lowest cost-per-sample available in the market today, as low as $2 per sample.

Droplet and spotted-array based digital methods often experience high “drop-out” rates that can adversely impact their ability to detect target sequences. The qdPCR 37K IFC performs at a 99.9% success rate, providing ultra-high precision and throughput without the concern of false positives. This is especially critical in high-sensitivity applications, such as rare mutation detection, GMO testing, and aneuploidy detection.

With the qdPCR 37K IFC, researchers can enjoy a nearly 80% savings per sample when their applications require four-plex tests per sample. Other products on the market only provide a two-plex solution, meaning each sample would have to be run multiple times, adding cost and decreasing throughput.

The High-Precision 96.96 Genotyping IFC

The High-Precision 96.96 Genotyping IFC is the highest quality genotyping product available today exhibiting a minimum call rate of 99.9%. This precision is vital to production and human genomics laboratories where every SNP for every sample matters.

Some other platforms claim a 95% call rate. If a production genotyping lab is running 96 SNPs per sample, this implies, statistically, that there is only a one-percent chance that all of their 96 SNPs will be “called” on a particular sample. This can lead to extensive re-work, uncertain results, and low overall sample yield. In contrast, when using Fluidigm’s new High-Precision 96.96 Genotyping IFC, the likelihood that all 96 SNPs are “called” climbs to 91%.

The High-Precision 96.96 Genotyping IFC and BioMark HD system deliver standard-setting performance while also enabling high-sample throughput with an easy workflow—one operator can easily deliver more than 36,000 data points in a day.

192.24 Gene Expression IFC

The Fluidigm 192.24 Gene Expression IFC meets the needs of production users who have narrowed their gene panel and require high sample throughput. Together with the BioMark HD system, this IFC enables throughput of 576 samples across 24 genes in an 8-hour day, with minimal hands-on time. The 192.24 Gene Expression IFC can be particularly useful in clinical research and production environment, where users will benefit from the low-cost per sample, high reliability and simple workflow of the new 192.24 Gene Expression IFC.

The Fluidigm FLEXsix Gene Expression IFC addresses the requirement for substantial variation in sample and assay numbers during target selection while allowing complete use of the IFC. It utilizes a completely new architecture which incorporates six 12 X 12 partitions that can be organized in any configuration, in up to six separate experimental runs. For example, a single IFC could initially run a 12-sample by 48-gene experiment, followed by a 24-sample by 12-gene experiment, followed by two separate 12-sample by 12-gene experiments. This new IFC adjusts to customers’ experimental needs during target selection and largely eliminates the need for microplate-based experiments.

The initial version of the FLEXsix IFC supports gene expression studies, but the architecture will ultimately support genotyping as well.

Production laboratories have a critical need to scale from target selection to production as quickly and cost-effectively as possible. Other platforms require technology-bridging studies as the lab’s volume scales up. This adds time, cost and substantial risk. Fluidigm provides a complete range of IFC products that eliminates the challenges faced in production genomics by supplying a single technology platform—integrated fluidic circuits—that scales from target selection to production.

Availability

The qdPCR 37K IFC and the High-Precision 96.96 Genotyping IFC are available now. Fluidigm will be profiling these products in detail at the American Society of Human Genetics (ASHG) Annual Meeting in San Francisco starting November 6, 2012. Fluidigm will host an ASHG workshop from 12:45 p.m. – 2:15 p.m., in the Moscone Center, Room 307, Esplanade Level South on Friday, November 9, 2012.

The Fluidigm 192.24 Gene Expression IFC is expected to be available in December 2012. The Fluidigm FLEXsix IFC is expected to be available in January 2013.

Source : http://www.news-medical.net/news/20121102/Fluidigm-unveils-four-innovative-devices-to-meet-challenges-associated-with-production-genomics.aspx

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EndoStim Electric Stimulator for Managing Gastric Reflux

EndoStim Electric Stimulator for Managing Gastric Reflux

EndoStim Electric Stimulator for Managing Gastric Reflux

THE HAGUE, NETHERLANDS, (August 16, 2012) – EndoStim B.V. announced today CE Mark approval of its LES Stimulation System for the treatment of gastro-esophageal reflux disease (GERD).

The EndoStim system uses low energy electrical pulses to strengthen a weak or dysfunctional lower esophageal sphincter (LES) muscle which is the underlying cause of gastro-esophageal reflux disease (GERD) or acid reflux. EndoStim’s device, implanted through a minimally-invasive laparoscopic procedure, is intended to treat acid reflux and eliminate the need for daily PPI medication. In clinical trials the treatment was able to significantly reduce acid exposure and related symptoms of heartburn and regurgitation without causing any gastrointestinal side effects seen with other anti-reflux procedures.

Bevil Hogg, President and CEO of EndoStim, stated “EndoStim is very excited to offer a truly revolutionary treatment to patients with severe GERD — one that is designed to normalize esophageal function. EndoStim is working closely with leading GERD experts throughout the world to develop ‘Centers of Excellence’ offering EndoStim treatment for the millions of GERD sufferers worldwide.”

Virender K Sharma MD, Chief Medical Officer of EndoStim and Director of the Arizona Center for Digestive Health, adds “EndoStim LES stimulation therapy is a result of years of research and development with leading researchers in esophageal diseases in the US and clinical investigators in Europe and South America. EndoStim’s long-term clinical data strongly supports the efficacy and safety of its therapy in patients with severe GERD.”

Clinical results from the CE study demonstrate dramatic improvement of acid reflux while allowing for normal esophageal function, such as swallowing and belching. The data indicate that 100% of patients who received EndoStim treatment for 12 months were able to stop daily PPI use and 77% achieved normalization or greater than 50% reduction in abnormal esophageal acid exposure.

EndoStim LES stimulation therapy has shown both daytime and nighttime improvement in heartburn symptoms and regurgitation. The treatment is also unique in its ability to be personalized to individual patient lifestyle, diet and preferences. According to Dr. Joel Richter, Professor of Medicine and Director of the Division of Digestive Diseases and Nutrition at the University of South Florida, “What separates EndoStim LES stimulation technology from all previous GERD technologies is its ability to correct GERD pathophysiology and normalize or improve esophageal acid exposure. Safety and lack of side effects with this technology makes it an attractive option for patients looking for alternatives to traditional medical therapy.”

Dr. Leonardo Rodriguez, the lead investigator for the CE Mark trial conducted in Santiago, Chile, says “I believe that EndoStim LES stimulation therapy is the ideal treatment option for patients with severe GERD who are unhappy with their medical therapy or want freedom from life-long dependence on medications. I am very impressed with the clinical results and look forward to offering EndoStim therapy to my GERD patients.”

EndoStim is continuing trials in key centers across South America, Europe, and Asia. Prof. Peter D Siersema, Professor of Medicine, Director of Gastroenterology at University Medical Center, Utrecht, The Netherlands and a principal investigator in the ongoing EndoStim international multicenter trial commented that, “We are excited to be among the first sites in Europe to offer the EndoStim LES stimulation therapy to our patients. The EndoStim technology has the potential to change the way we manage GERD. With its ability to personalize treatment to an individual patient’s condition, and with its excellent safety profile, EndoStim therapy could become the ideal option for reflux patients unsatisfied or unhappy with daily medications.”

EndoStim has begun enrolling a commercial registry study worldwide and is planning for a US study to begin in late 2013.

About Reflux Disease

Gastroesophageal reflux disease is a chronic disease that affects hundreds of millions of patients worldwide, and often requires lifelong treatment with acid blocker medications. Symptoms generally occur when the weakness in the lower esophageal sphincter muscle allows stomach contents to flow backward into the esophagus causing esophageal irritation and damage. Acid reflux causes heartburn, regurgitation and can lead to Barrett esophagus and esophageal cancer. Millions of people continue to suffer from bothersome GERD symptoms despite maximal medical therapy.

About EndoStim

EndoStim is a venture-backed medical device company based in The Hague, The Netherlands, and St. Louis, Missouri, focused on developing innovative active implantable devices. Key investors include Santé Ventures (Austin, TX), Prolog Ventures (St. Louis, MO), Voyent Partners (Brentwood, TN) and Vectis Healthcare & Life Sciences Fund II (St. Louis, MO), along with many individual investors. For more information and news about EndoStim, please visit www.endostim.com.

Innovative Therapy for Severe GERD

EndoStim therapy normalizes esophageal function through electrical stimulation

EndoStim Features:

Enhanced patient quality of life

Addresses pathophysiology of GERD

Typically eliminates need for long-term acid suppressive medication

Safe, minimally-invasive laparoscopic procedure

Easily reversible, if necessary

Wirelessly customized to patients’ changing lifestyle needs and preferences

No significant alteration in patients’ anatomy or mechanical constraints on the esophagus

The EndoStim system offers a solution for severe GERD patients. EndoStim’s technology delivers tiny electrical pulses from an Implantable Pulse Generator (IPG) through a bipolar lead implanted in the patient’s lower esophageal sphincter (LES), stimulating the LES muscle and restoring the barrier between the stomach and the esophagus.

EndoStim has obtained the CE Mark for its implantable stimulator for treating gastroesophageal reflux disease (GERD). The device is implanted through a minimally invasive laparoscopy with electronic leads stretching to the lower esophageal sphincter. Electrical signals are delivered to the weakened muscle to help it keep the esophagus closed when not in use, but letting it open up when eating or belching.

EndoStim mechanism of action EndoStim Electric Stimulator for Managing Gastric Reflux (video)The company touts the procedure’s lack of observed side effects, which it attributes to the fact that the surgery doesn’t actually alter any of the patient’s anatomy. The device has yet to receive regulatory approval in the U.S.

Clinical results from the CE study demonstrate dramatic improvement of acid reflux while allowing for normal esophageal function, such as swallowing and belching. The data indicate that 100% of patients who received EndoStim treatment for 12 months were able to stop daily PPI use and 77% achieved normalization or greater than 50% reduction in abnormal esophageal acid exposure.

EndoStim LES stimulation therapy has shown both daytime and nighttime improvement in heartburn symptoms and regurgitation. The treatment is also unique in its ability to be personalized to individual patient lifestyle, diet and preferences. According to Dr. Joel Richter, Professor of Medicine and Director of the Division of Digestive Diseases and Nutrition at the University of South Florida, “What separates EndoStim LES stimulation technology from all previous GERD technologies is its ability to correct GERD pathophysiology and normalize or improve esophageal acid exposure. Safety and lack of side effects with this technology makes it an attractive option for patients looking for alternatives to traditional medical therapy.

Read about how the EndoStim technology works, patient profile, and EndoStim implantation procedure

> View EndoStim’s clinical results

In clinical studies, EndoStim patients experienced:

Sustained improvement in LES pressure and function

Normal swallowing

Relief from nighttime symptoms

Reduction in reflux events

Reduction in esophageal acid exposure

Sustained improvement in GERD symptoms and quality of life

Source : http://www.endostim.com/international/about/endostim-in-the-news/just-doing-it-2/

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Agilent awarded patent for comparative genomic hybridization methods

Agilent awarded patent for comparative genomic hybridization methods

Agilent Technologies Inc. (NYSE: A) today announced that it was awarded a significant patent for comparative genomic hybridization methods. CGH methods help researchers study genetics and cancer in both basic and clinical research.

The U.S. patent (No. 8,232,055) has claims for measuring copy number changes in genomic DNA, covering both one-color and two-color assays using oligonucleotide probes and samples with high-sequence complexity, such as human genomic DNA samples.

Agilent’s copy number method, commercially introduced in 2005, uses long oligonucleotide probes, enabling high specificity and sensitivity. For example, samples containing as low as 8 percent abnormal cells may be confidently analyzed with Agilent’s copy number method.

The method was originally developed to improve upon older copy number assays that use long genomic fragments such as bacterial artificial chromosomes. (BACs often contain repetitive regions.) The method also improves upon other oligonucleotide array assays, which depend on sample preparation methods that remove significant portions of the genomic DNA content. Agilent’s higher-resolution platform allows users to detect much smaller genomic aberrations throughout complex genomes.

“We are excited by the latest intellectual property supporting our market-leading CGH array,” said Robert Schueren, Agilent vice president, Genomics. “This reflects Agilent’s continued investment in and dedication to the cytogenetics clinical research space.”

source : http://www.news-medical.net/news/20120820/Agilent-awarded-patent-for-comparative-genomic-hybridization-methods.aspx

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Thomson Reuters welcomes GenoSpace to Life Sciences Partner Ecosystem

Thomson Reuters welcomes GenoSpace to Life Sciences Partner Ecosystem

The Intellectual Property & Science business of Thomson Reuters, the world’s leading provider of intelligent information for businesses and professionals, today announced that GenoSpace joined its Life Sciences Partner Ecosystem. The companies will work together to develop an integrated product offering for the analysis and interpretation of human genomic variation.

The GenoSpace platform seeks to establish secure, cloud-based online communities and customized research portals that connect physicians, individuals, and researchers who are interested in using clinical and genomic information; as well as to provide analysis and interpretation tools that support personalized medicine. An essential part of this process will be the detection and annotation of gene variants. Thomson Reuters is in the unique position to collect, annotate and publish a gene variant database and will work with GenoSpace to make this data available to its customers.

Through the Thomson Reuters Life Sciences Partner Ecosystem, the GenoSpace platform will provide access to an unprecedented amount of curated, medically relevant data — from pathway and disease biology to regulatory and financial information. The combination of GenoSpace’s expertise in integrating clinical and complex -omics data, coupled with the proven history of manual curation of complex data by Thomson Reuters, the partnership will help enable the realization of personalized medicine. Thomson Reuters and GenoSpace will produce a curated database of genomic variation, with an emphasis on medical and scientific utility.

“The barrier to establishing personalized medicine is no longer generating data, but analyzing and interpreting it,” said John Quackenbush, GenoSpace’s CEO. “By coupling our technology to synthesize genomic and clinical data with the unparalleled information resources that Thomson Reuters has created, we are positioned to lead the implementation of personalized medicine.”

“We are delighted to welcome GenoSpace to our Partner Ecosystem,” said Joseph Donahue, senior vice president at Thomson Reuters. “Together, we will be able to provide hospitals, health systems, disease foundations and pharmaceutical research organizations with large scale clinical genomic data sets and tools to help in annotating and interpreting genomic variation and support better informed medical treatment decisions.”

Source : http://www.news-medical.net/news/20120816/Thomson-Reuters-welcomes-GenoSpace-to-Life-Sciences-Partner-Ecosystem.aspx

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IBM Develops Miniaturized Silicon Probe for Disease Diagnostics

IBM Develops Miniaturized Silicon Probe for Disease Diagnostics

IBM Develops Miniaturized Silicon Probe for Disease Diagnostics

ZURICH – 13 Jan 2012: IBM (NYSE: IBM) scientists have developed a flexible, non-contact microfluidic probe made from silicon that can aid researchers and pathologists to investigate critical tissue samples accurately for drug discovery and disease diagnostics.

Flickr Photos: http://www.flickr.com/photos/ibm_research_zurich/sets/72157628678347543

Tissue staining is widely used in pathology to detect disease markers in a patient’s sample. More specifically, a particular disease marker is bound with an antibody, which is then chemically colored or stained on the tissue. The intensity of the color classifies and determines the extent of a disease.

Tissue staining is a tedious process with many chemical steps analogous to developing photographs, whereby excessive chemical solution or long exposures can overdevelop the sample or photograph. In the context of pathology, this can cause false positives and negatives, which can lead to misdiagnosis. According to a report issued by Johns Hopkins Hospital, of 6,171 biopsy slides that were sent from late 2008 for a second review, pathologists disagreed with the diagnosis on 86 of them.

Obtaining a biopsy is an invasive procedure for the patient, so small samples are taken whenever possible. Pathologists are determined to gain as much information as possible from these small samples, which can be only a few millimeters in length. Working at this scale requires staining to be performed on many thin slices of the sample to identify and sub-type diseases such as cancer, for treatment. Pathologists are often challenged in performing a sufficient number of important tests on these limited samples, critical for personalized treatment strategies.

“A key aspect of taking clinical samples is to ensure a high diagnostic capability while minimizing patient discomfort—the probe developed by IBM scientists does exactly that. The probe allows one to stain a very small section of a tissue with virtually any biomarker that may be clinically relevant. This capability allows the clinician to not only do more with a smaller sample, but will also allow the use of multiple stains on the same sample, therefore increasing the accuracy of the diagnosis. Thus this work may be transformative for diagnosing a variety of ailments ranging from cancer to cardiac disease,” said Prof. Dr. Ali Khademhosseini, Associate Professor at Harvard Medical School and Brigham and Women’s Hospital.

To address these important challenges, IBM scientists in Zurich are reporting today in the peer-reviewed journal Lab on a Chip an innovative proof-of-concept technology called the microfluidic probe, which can accurately stain tissue sections at the micrometer scale.

The eight millimeter-wide, diamond-shaped probe consists of a silicon microfluidic head with two microchannels at each tip. Similar to an inkjet printer cartridge, the head injects the liquid on the surface, but then unlike a printer, it continuously aspirates the liquid to prevent spreading and accumulation on the surface, which can lead to overexposure.

Specifically for tissue section analysis, the probe can deliver an antibody very locally in a selected area of a tissue section with pinpoint accuracy. Since analysis can be done on spots and lines instead of on the entire tissue section, the tissue is better preserved for additional tests, if required. In addition, only a few picoliters (one trillionth of a liter) of liquid containing antibodies are needed for each analysis spot.

“We have developed a proof-of-concept technology, which I hope puts pathology on a modern roadmap—benefiting from the latest developments in silicon-based microfluidics,” said Govind Kaigala, a scientist at IBM Research – Zurich. He adds, “This new approach will enable pathologists to stain tissue samples with micrometer precision and easily perform multiple tissue stains on limited samples.”

This research is based on IBM’s decades of experience with silicon, which is now being applied to novel micro and nanotechnologies to solve today’s greatest challenges ranging from energy production and consumption to healthcare.

The microfluidic probe fits to standard workflows in conventional pathology. In addition, it is compatible with current biochemical staining systems and is resistant to a broad range of chemicals. The small size of the probe also enables easy viewing of the sample from above and below by an inverted microscope commonly used in research and clinical laboratories.

Prof. Dr. Khademhosseini said, “The developed system may have great potential in applications where sample size and the need for testing various types of biological analysis are required. I am confident that one day such approach will enable us to take small tissue biopsies and be able to obtain significantly more information.”

IBM scientists will continue to test and improve the probe and potentially begin using it in laboratory environments in the next several months. In addition, the team plans to explore specific clinical applications, possibly with partners in the field of pathology. The microfluidic probe promises to support the work of pathologists and become a tool of choice for pharmaceutical research and diagnostics involving biological specimens.

The scientific paper entitled “Micro-immunohistochemistry using a microfluidic probe” by Robert D. Lovchik, Govind V. Kaigala, Marios Georgiadis* and Emmanuel Delamarche, appears today in Lab on a Chip, DOI:10.1039/C2LC21016A.

*Currently a PhD student at ETH Zurich, Institute for Biomechanics.

Source: Johns Hopkins Health, Fall 2010, http://www.hopkinsmedicine.org/bin/i/t/4E7A8F853E3664E4CDB181EF051A0346.pdf

Based upon the binding specificity of antibodies to target molecules, immunohistochemistry (IHC) has been used in labs for decades to research protein expression, or lack thereof, in tissue samples. It’s a great example of a translational technique that is being used every day in hospital pathology labs around the world to, for example, classify tumor biopsies based on diagnostic markers. This in turn informs the prognosis and treatment options for the patient from whom the biopsy was taken. However IHC remains a tedious process that involves multiple conjugation steps to bind antibodies to and color-code the target molecules; mistakes can lead to over- and under-exposure which renders the sample unusable and inconclusive.

The technique may have just gotten more sensitive thanks to IBM researchers. Reporting in today’s online issue of Lab on a Chip, the team has developed an ultra-miniaturized probe for immunohistochemistry. According to the press release:

The eight millimeter-wide, diamond-shaped probe consists of a silicon microfluidic head with two microchannels at each tip. Similar to an inkjet printer cartridge, the head injects the liquid on the surface, but then unlike a printer, it continuously aspirates the liquid to prevent spreading and accumulation on the surface, which can lead to overexposure.

Specifically for tissue section analysis, the probe can deliver an antibody very locally in a selected area of a tissue section with pinpoint accuracy. Since analysis can be done on spots and lines instead of on the entire

tissue section, the tissue is better preserved for additional tests, if required. In addition, only a few picoliters (one trillionth of a liter) of liquid containing antibodies are needed for each analysis spot.

6627458163 ec78f7dc6c o IBM Develops Miniaturized Silicon Probe for Disease Diagnostics

Though at this stage the probe is proof-of-concept, it may not be long before pathology labs can make more accurate diagnoses with even smaller biopsy samples.

Source : http://www-03.ibm.com/press/us/en/pressrelease/36511.wss

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Guided Therapeutics’ LuViva Cleared for Early Detection of Cervical Disease

Guided Therapeutics’ LuViva Cleared for Early Detection of Cervical Disease

Guided Therapeutics’ LuViva Cleared for Early Detection of Cervical Disease

NORCROSS, Ga.–(BUSINESS WIRE)–Guided Therapeutics, Inc. (OTCBB: GTHP) (OTCQB: GTHP) today announced that it has received notification that CE Mark approval has been granted for LuViva® Advanced Cervical Scan, a non-invasive device used to detect cervical disease that leads to cancer, instantly and at the point of care.

“We believe that together with our distributors, we have a tremendous opportunity to improve the detection of cervical disease, reduce false positives and unnecessary biopsies, and provide significant savings to healthcare systems throughout Europe.”

The CE Mark is required to sell products in the 27 nations that comprise the European Union (EU). There are about 146 million women who are targeted by existing or planned cervical cancer screening programs in EU member states, according to the European Cancer Observatory.

“The notification of CE Mark for LuViva is a significant milestone for the company and allows us to begin our European launch later this year, as planned,” said Mark L. Faupel, Ph.D., president and CEO of Guided Therapeutics. “We believe that together with our distributors, we have a tremendous opportunity to improve the detection of cervical disease, reduce false positives and unnecessary biopsies, and provide significant savings to healthcare systems throughout Europe.”

“Notification of the CE Mark and previously announced Health Canada approval for LuViva further validates the product and our ability to manufacture to the highest standards. We expect the CE Mark award will generate more demand for the product and open opportunities in markets outside the EU as well. In addition to the more than 20 countries already covered by distribution agreements, we plan to expand our network to additional countries in Europe, Latin America and Asia and having the CE Mark should accelerate those efforts,” Dr. Faupel added.

Today’s CE Mark notification is the first of two expected for LuViva. A second CE Mark application is expected to be filed later this year to comply with updated European medical device standards and to include design improvements. The company also must continue to pass annual ISO audits of its quality system in order to maintain the CE Mark on its products. The company has passed two consecutive ISO audits, the last being in January of 2012.

In addition to the CE Mark, LuViva has marketing approval from Health Canada and remains under U.S. Food and Drug Administration premarket approval review. Guided Therapeutics was awarded ISO 13485 certification in January, 2011.

The study used to support LuViva’s CE Mark application was the multi-center U.S. pivotal trial, in which 1,607 women at risk for developing cervical disease were evaluated. In this patient population, LuViva was able to detect cervical cancer up to two years earlier than the Pap test, human papillomavirus (HPV) test, colposcopy and biopsy. LuViva detected 86.3 percent of the cervical disease cases that had been missed by Pap, HPV tests and biopsy. LuViva would have reduced the number of unnecessary biopsies by about 40 percent. LuViva is initially intended as a follow-up test after a positive Pap result.

About LuViva® Advanced Cervical Scan

LuViva is a technologically advanced diagnostic device that scans the cervix with light and uses spectroscopy to measure how light interacts with the cervical tissue. Spectroscopy identifies chemical and structural indicators of precancer that may be below the surface of the cervix or misdiagnosed as benign. This technique is called biophotonics. Unlike Pap, HPV tests or biopsies, LuViva does not require laboratory analysis or a tissue sample, and is designed to provide results immediately, which eliminates costly, painful and unnecessary testing. LuViva is designed for use with women who have undergone initial screening and are called back for follow up with a colposcopy examination, which in many cases involves taking a biopsy of the cervix. The device is used in conjunction with the LuViva® Cervical Guide single-use patient interface and calibration disposable.

About Guided Therapeutics

Guided Therapeutics, Inc. (OTCBB: GTHP) (OTCQB: GTHP) is developing a rapid and painless testing platform for the early detection of disease based on its patented biophotonic technology that utilizes light to detect disease at the cellular level. The Company’s first planned product is the LuViva® Advanced Cervical Scan, a non-invasive device used to detect cervical disease instantly and at the point of care. In a multi-center clinical trial, with women at risk for cervical disease, the technology was able to detect cervical cancer up to two years earlier than conventional modalities, according to published reports. Guided Therapeutics has also entered into a partnership with Konica Minolta to develop a non-invasive test for Barrett’s Esophagus using the technology platform. For more information, visit: www.guidedinc.com.

The Guided Therapeutics LuViva® Advanced Cervical Scan is an investigational device and is limited by federal law to investigational use. LuViva, the wave logo and “Early detection, better outcomes” are registered trademarks owned by Guided Therapeutics, Inc.

Forward-Looking Statements Disclaimer: A number of the matters and subject areas discussed in this news release that are not historical or current facts deal with potential future circumstances and developments. The discussion of such matters and subject areas is qualified by the inherent risks and uncertainties surrounding future expectations generally and also may materially differ from Guided Therapeutics’ actual future experience involving any of or more of such matters and subject areas. Such risks and uncertainties include those related to the exchange offer, as described in the Offer to Exchange, as well as those related to: the early stage of products in development, the uncertainty of market acceptance of products, the uncertainty of development or effectiveness of distribution channels, the intense competition in the medical device industry, the uncertainty of capital to develop products, the uncertainty of regulatory approval of products, dependence on licensed intellectual property, as well as those that are more fully described from time to time under the heading “Risk Factors” in Guided Therapeutics’ reports filed with the SEC, including Guided Therapeutics’ Annual Report on Form 10-K for the fiscal year ended December 31, 2011, and subsequent quarterly reports.

NORCROSS, Ga.–(BUSINESS WIRE)–Guided Therapeutics, Inc. (OTCBB: GTHP) (OTCQB: GTHP) today announced that it has received notification that CE Mark approval has been granted for LuViva® Advanced Cervical Scan, a non-invasive device used to detect cervical disease that leads to cancer, instantly and at the point of care.

“We believe that together with our distributors, we have a tremendous opportunity to improve the detection of cervical disease, reduce false positives and unnecessary biopsies, and provide significant savings to healthcare systems throughout Europe.”

The CE Mark is required to sell products in the 27 nations that comprise the European Union (EU). There are about 146 million women who are targeted by existing or planned cervical cancer screening programs in EU member states, according to the European Cancer Observatory.

“The notification of CE Mark for LuViva is a significant milestone for the company and allows us to begin our European launch later this year, as planned,” said Mark L. Faupel, Ph.D., president and CEO of Guided Therapeutics. “We believe that together with our distributors, we have a tremendous opportunity to improve the detection of cervical disease, reduce false positives and unnecessary biopsies, and provide significant savings to healthcare systems throughout Europe.”

“Notification of the CE Mark and previously announced Health Canada approval for LuViva further validates the product and our ability to manufacture to the highest standards. We expect the CE Mark award will generate more demand for the product and open opportunities in markets outside the EU as well. In addition to the more than 20 countries already covered by distribution agreements, we plan to expand our network to additional countries in Europe, Latin America and Asia and having the CE Mark should accelerate those efforts,” Dr. Faupel added.

Today’s CE Mark notification is the first of two expected for LuViva. A second CE Mark application is expected to be filed later this year to comply with updated European medical device standards and to include design improvements. The company also must continue to pass annual ISO audits of its quality system in order to maintain the CE Mark on its products. The company has passed two consecutive ISO audits, the last being in January of 2012.

In addition to the CE Mark, LuViva has marketing approval from Health Canada and remains under U.S. Food and Drug Administration premarket approval review. Guided Therapeutics was awarded ISO 13485 certification in January, 2011.

The study used to support LuViva’s CE Mark application was the multi-center U.S. pivotal trial, in which 1,607 women at risk for developing cervical disease were evaluated. In this patient population, LuViva was able to detect cervical cancer up to two years earlier than the Pap test, human papillomavirus (HPV) test, colposcopy and biopsy. LuViva detected 86.3 percent of the cervical disease cases that had been missed by Pap, HPV tests and biopsy. LuViva would have reduced the number of unnecessary biopsies by about 40 percent. LuViva is initially intended as a follow-up test after a positive Pap result.

About LuViva® Advanced Cervical Scan

LuViva is a technologically advanced diagnostic device that scans the cervix with light and uses spectroscopy to measure how light interacts with the cervical tissue. Spectroscopy identifies chemical and structural indicators of precancer that may be below the surface of the cervix or misdiagnosed as benign. This technique is called biophotonics. Unlike Pap, HPV tests or biopsies, LuViva does not require laboratory analysis or a tissue sample, and is designed to provide results immediately, which eliminates costly, painful and unnecessary testing. LuViva is designed for use with women who have undergone initial screening and are called back for follow up with a colposcopy examination, which in many cases involves taking a biopsy of the cervix. The device is used in conjunction with the LuViva® Cervical Guide single-use patient interface and calibration disposable.

About Guided Therapeutics

Guided Therapeutics, Inc. (OTCBB: GTHP) (OTCQB: GTHP) is developing a rapid and painless testing platform for the early detection of disease based on its patented biophotonic technology that utilizes light to detect disease at the cellular level. The Company’s first planned product is the LuViva® Advanced Cervical Scan, a non-invasive device used to detect cervical disease instantly and at the point of care. In a multi-center clinical trial, with women at risk for cervical disease, the technology was able to detect cervical cancer up to two years earlier than conventional modalities, according to published reports. Guided Therapeutics has also entered into a partnership with Konica Minolta to develop a non-invasive test for Barrett’s Esophagus using the technology platform. For more information, visit: www.guidedinc.com.

The Guided Therapeutics LuViva® Advanced Cervical Scan is an investigational device and is limited by federal law to investigational use. LuViva, the wave logo and “Early detection, better outcomes” are registered trademarks owned by Guided Therapeutics, Inc.

Forward-Looking Statements Disclaimer: A number of the matters and subject areas discussed in this news release that are not historical or current facts deal with potential future circumstances and developments. The discussion of such matters and subject areas is qualified by the inherent risks and uncertainties surrounding future expectations generally and also may materially differ from Guided Therapeutics’ actual future experience involving any of or more of such matters and subject areas. Such risks and uncertainties include those related to the exchange offer, as described in the Offer to Exchange, as well as those related to: the early stage of products in development, the uncertainty of market acceptance of products, the uncertainty of development or effectiveness of distribution channels, the intense competition in the medical device industry, the uncertainty of capital to develop products, the uncertainty of regulatory approval of products, dependence on licensed intellectual property, as well as those that are more fully described from time to time under the heading “Risk Factors” in Guided Therapeutics’ reports filed with the SEC, including Guided Therapeutics’ Annual Report on Form 10-K for the fiscal year ended December 31, 2011, and subsequent quarterly reports.

Source : http://www.businesswire.com/news/home/20120718005191/en/Guided-Therapeutics-Notified-CE-Mark-Approval-LuViva%C2%AE

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Brainsway’s Deep TMS EU Cleared for Neuropathic Chronic Pain

Brainsway’s Deep TMS EU Cleared for Neuropathic Chronic Pain

Brainsway’s Deep TMS EU Cleared for Neuropathic Chronic Pain

“Neuropathic pain is the sixth indication for which Deep TMS has achieved CE Mark approval,” commented Uzi Sofer, Brainsway’s CEO. “Previous CE Marks were for clinical depression, bi-polar disorder, schizophrenia (negative symptoms), Parkinson’s diseases and post-traumatic stress disorder. As our therapeutic pipeline continues to expand, it is very exciting to continue to bring proven new Deep TMS treatments to market.”

About Brainsway Ltd.

Brainsway is dedicated to the development and marketing of Deep TMS (Transcranial Magnetic Stimluation) systems – novel, noninvasive medical devices for treatment of a wide range of neurological and psychopathological disorders. In principle, any brain-related disorder that is associated with pathological activity of specific brain sites may be treated by this method. Potential applications include addiction, schizophrenia, obesity, eating disorders, Parkinson’s disease, Alzheimer’s disease, autism and post-traumatic stress disorder. Our initial focus is the treatment of major depression. The unique technology of Brainsway is based on patents filed by the U.S. National Institute of Health (NIH) and by the company. Brainsway has an exclusive license from the NIH for the patent and technology. Headquartered in Jerusalem, Israel, the company’s ordinary shares and warrants trade on the Tel Aviv Stock Exchange under the symbol ‘BRIN’.

Forward-Looking Statements

This press release contains forward-looking statements, which reflect the Company’s current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein. Investors should consult the Company’s ongoing quarterly filings and annual reports for additional information on risks and uncertainties relating to these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. The Company disclaims any obligation to update these forward-looking statements.

This news release was distributed by GlobeNewswire, www.globenewswire.com

Transcranial magnetic stimulation (TMS) is a noninvasive technique used to apply brief magnetic pulses to the brain. The pulses are administered by passing high currents through an electromagnetic coil placed adjacent to a patient’s scalp. The pulses induce an electric field in the underlying brain tissue. When the induced field is above a certain threshold, and is directed in an appropriate orientation relative the brain’s neuronal pathways, localized axonal depolarizations are produced, thus activating the neurons in the relevant brain structure.

Standard TMS coils are limited to activation of only cortical brain regions, up to a depth of about 1.5 cm. Hence when treating depression with a standard TMS system, the limbic system, which is related to mood regulation and is generally deeper than 1.5 cm, is only indirectly affected, through secondary processes involving cortical structures, which are directly activated by TMS and then affect the deeper limbic system structures.

The unique technology of Brainsway Deep TMS System enables direct non-invasive activation of deep brain structures.

Deep TMS is a breakthrough in the search for a non-invasive approach for treating common brain disorders. Deep TMS uses a unique, patented coil design to produce directed electromagnetic fields that can induce excitation or inhibition of neurons deep inside the brain. The treatment is non-invasive, with no significant side effects, no systemic effect (in contrast to drugs), and no need of hospitalization or anesthesia.

If you remember from your high school or college physics classes, there is a strong relationship between electricity and magnetism. Basic principles of electromagnetism have revolutionized the way we live; for example, knowledge that a wire carrying a current generates a magnetic field led to the development of motors and the discovery that moving a magnet through a loop of wire could produce electricity led to the creation of generators.

Deep transcranial magnetic stimulation (TMS) is a medical application of electromagnetic technology. It essentially relies on the fact that neurons communicate via chemical-electric signals; hence, like other electrical signals, neuronal communication should be able to be influenced by external magnetic fields, or pulses.

The Jerusalem-based company Brainsway has been applying deep TMS technology to potentially treat a number of clinical conditions, some of which have been previously reported here in Medgadget, such as depression, attention deficit disorder, and smoking addiction. Now, the company reports initial positive findings in a small trial of Alzheimer’s patients treated with deep TMS.

According to Brainsway’s press release:

The interim results are for 24 patients that were divided into three groups: a sham stimulation control group, a low-frequency (1 Hz) treatment group and a high-frequency (10 Hz) treatment group. Each subject received treatment over 8 weeks, and the efficacy of the treatment was evaluated both during the trial and over the course of the subsequent 8-week period.

The treatment was well-tolerated by all subjects, with no side-effects, except for one incident involving a sham control subject, which the principal investigator believes to be unrelated to the treatment.

The trial used the Alzheimer’s Disease Assessment Scale – Cognitive (ADAS-Cog) test (the main efficacy scale used in Alzheimer’s disease clinical trials), as well as additional accepted scales of disease severity (CGI, ADL, CDR) and a quality-of-life scale (QoL Caregiver Scale) to assess the efficacy of treatment. These are the main assessment scales used to evaluate efficacy in the literature.

Analysis of ADAS-Cog results revealed a 4.2-point improvement in the high-frequency treatment group, compared with a 1.8-point improvement in the sham control group, and a 1.4-point deterioration in the scores of the low-frequency treatment group, the latter occurring mainly during the 8 weeks post treatment. In addition, in the high-frequency treatment group, severity of cognitive impairment at entry into the trial was correlated with clinical improvement (the more severe the cognitive impairment, the more the patient improved following treatment).

CDR, ADL, CGI and QoL Caregiver Scale scores indicated that high-frequency treatment halted the deterioration of the disease and even produced a moderate improvement relative to sham treatment. Similar to the ADAS-Cog test results, these scores also indicated a worsening in the condition of patients treated with low-frequency electromagnetic stimulation.

The principle investigator commented, “The interim results from the trial indicate that Deep TMS therapy for Alzheimer’s disease patients is safe and side-effect-free. Although the small sample size somewhat hampers our ability to draw any definitive conclusions concerning treatment efficacy, the results nonetheless suggest that high-frequency treatment leads to improvement on Alzheimer’s disease assessment scales, whereas low-frequency and sham treatment do not.”

Source : http://www.marketwatch.com/story/brainsway-receives-ce-mark-approval-for-its-deep-tms-system-to-treat-neuropathic-chronic-pain-2012-07-02

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