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FDA Clears Algorithm-Assisted Cancer Diagnosis

MRI of breast

MRI of breast (National Cancer Institute)

27 July 2017. The U.S. Food and Drug Administration cleared for marketing a diagnostics system aided by machine learning algorithms to help radiologists detect breast cancer. The system, known as QuantX, is developed by Quantitative Insights Inc., a spin-off enterprise from University of Chicago. The company says QuantX is the first computer-aided diagnostics system that uses machine learning to evaluate breast abnormalities.

QuantX, says the company is a decision-support system for radiologists evaluating magnetic resonance images (MRIs) of breast tissue suspected of cancer. The system has software with analytics that employ machine learning algorithms to evaluate the patient’s images and medical data with a database of abnormalities from documented clinical pathology findings, producing an index value called a QI score. The company says turnaround times for diagnostics are improved, and results of the analysis add to the confidence of the radiologists’ assessments.

FDA cleared QuantX for known breast cancer cases needing additional analysis or assessment, such as those considered at high risk. For complex cases, with multiple abnormalities, says FDA, QuantX can be used to evaluate each abnormality individually. The system can also be used as an image viewer to assess multiple images, including images from technologies other than MRIs, including ultrasound and mammography. However, QuantX is not cleared for primary interpretation of digital mammography images.

QuantX’s clearance used FDA’s de novo classification pathway for new devices rated of low to moderate risk. FDA rates QuantX as a Class 2 device, of moderate risk requiring a reasonable assurance of safety and effectiveness.

The agency’s clearance is based in part on results from a clinical study of Quant X by Quantitative Insights among 19 experienced radiologists reading MRI images of breast tissue and distinguishing between cancerous and non-cancerous samples. The study shows QuantX improves the performance of radiologists in interpreting the images, compared to conventional commercially-available tools. Among the findings, the number of false negatives — missed cases of cancer — was reduced by 39 percent among QuantX users.

FDA’s clearance allows Quantitative Insights to begin marketing QuantX, subject to additional documentation provided to FDA on the algorithms, data sets, and software testing routines, as well as preparation of labels, including warning statements.

Quantitative Insights was founded in 2010 to commercialize the research of Maryellen Giger, professor of radiology and medical physics, and colleagues at University of Chicago. Giger is considered a pioneer in computer-assisted diagnostics, including quantitative image analysis and data-mining in breast imaging. She is currently a scientific advisor to the company.

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The Three Most Revolutionary Emerging Sciences

– Contributed content –

Chemical science graphic

(scienceprofessionals.co.uk)

27 July 2017. With access to a plethora of advanced technology that we have in the 21st century, science has become more intriguing than ever. With pieces of equipment like the Hadron Collider, we are able to view particle interactions like we never have before, opening up a wealth of information for us to understand the world around us. This technology has created new areas of study, so here are the top three!

Nanotechnology

Nanotechnology is an extremely new field of science and seems to have been inspired by futuristic films! Strictly speaking, nanotechnology is anything that deals with objects that are in nanometers. While this may seem boring, it is in fact quite the opposite. Nanotech gives us the ability to alter things at their base level, meaning we could create super strong structures using nanotech, as well as creating nanobots that you would see in a film! But where it’s seeing most success is in medicine, with companies like CytImmune having successfully tested a nano delivery system to deliver chemotherapy drugs to a cancer cell. These breakthroughs in medicine make nanotechnology a truly remarkable science, giving us hope for more advancements in the future!

Gene editing

Taking a step in a more biological direction is gene editing. Gene editing is exactly that, editing the DNA structure of a given cell to produce a desired result. Before people start worrying about the creation of super soldiers and breeding humans for a purpose by editing their genes, it must be told that gene editing is only being used to cure people of DNA linked diseases. Many diseases are hereditary, meaning that they are inherited from a person’s parents because of their genetic makeup, as opposed to an environmental disease. Disease such as hemophilia are caused by a recessive gene, gene editing seeks to be able to replace the faulty gene responsible for the lack of blood platelets and alter it so it becomes functional again! If you wish to learn more about this subject, visit Poseida.com to learn how to become more involved.

Stem cells

More biology for you! Stem cells are the super cell within our bodies. Found in their purest form in only embryos, stem cells are the way forward with growing anything to do with the body. Stem cells are able to replicate and turn into any type of specialized cell, giving them great value. This means that they can be used to grow anything within the body when given to correct conditions. Examples like this show that organs can be grown from stem cells, in this specific example an entire human heart was grow using stem cells, so if we are capable of growing hearts who knows what we might end up being able to create to better humanity?

All of these sciences have the capability to completely change our lives, and  is why they are the top 3 revolutionary emerging sciences! Many people take an interest in nanotech and medicine as it is the fastest advancing field out of the three, so if you want to learn more about nanotech and medicine, read this.

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Exosuit Shown to Improve Walking for Stroke Patients

Ankle-supporting exosuit

Conor Walsh, left, and graduate student Jaehyun Bae, with an ankle-supporting exosuit (Wyss Institute, Harvard University)

27 July 2017. A robotic device built and worn like clothing helps improve lower-limb walking performance for a group of people partially paralyzed with stroke. Results of this early test, conducted by engineering researchers at Harvard University and Boston University, appear in yesterday’s issue of the journal Science Translational Medicine.

A team from Harvard’s engineering school and Wyss Institute for Biologically Inspired Engineering, as well as Boston University’s Sargent College that studies rehabilitation, seeks to extend advances in exoskeletons to people with limited mobility, such as those with multiple sclerosis or recovering from a stroke. Exoskeletons are robotic devices with sensors and motors built on rigid lightweight frames worn like braces over the legs designed for people with full paralysis, such as those with spinal cord injuries. The devices provide some mobility by restoring a walking gait with stepping motions.

Individuals with limited mobility, however, present a more complex engineering challenge, since they already have some ability to walk, but still need assistance, usually provided today by a cane or braces. A different type of device is required that can sense the working joints and muscles, but also those needing assistance, and activate the motors for providing that assistance.

To meet that need, a research team led by Harvard engineering professor Conor Walsh, also on the Wyss Institute faculty, is developing a robotic device called an exosuit designed to be worn more like clothing. The exosuit blurs the line between apparel and robotics, where its fabrics are worn on the body to provide support and sense all muscular activity in the legs, yet are also designed to be comfortable.

Sensors in the exosuit react not only to movements by the wearer, but also tensions in the fabrics, which act as extensions of the robotic devices, with extra sensors and assistance provided to the ankle joint affecting many stroke patients. The exosuit’s actuator and control systems, worn on a belt at the waist, are also more sophisticated. The exosuit needs to detect and anticipate the intent of the wearer to provide added mobility to the limbs at the right time and with the amount of force required. At the same time, muscle movements not needing an assist remain unconstrained.

In the paper, the researchers tested a prototype exosuit with 9 participants in the chronic phase of stroke recovery, the time after hospitalization and intensive rehabilitation training when the individual usually needs to recover largely on his or her own. The participants, between the ages of 30 and 67, tested an exosuit device for 2 days on a treadmill, as well as walking over open spaces. The researchers looked for changes in participants’ ability to walk more symmetrically, i.e. less favoring of one leg over the other, and measures of energy needed to perform walking motions.

The results show the 9 participants were able to walk in more normal, symmetrical motions, with an average of 20 percent reduction in asymmetrical forward propulsion needed to push off with the ankle. The team also found a 10 percent reduction in the energy cost of walking, with nearly one-third less metabolic burden required. In addition, researchers found the most improvements made by individuals who started with the slowest walking speeds. Combined with other variations in performance, the researchers conclude exosuits need to be carefully integrated into rehabilitation plans customized for the individual patient’s condition.

As reported in Science & Enterprise in May 2016, ReWalk Robotics Ltd., an Israeli developer of exoskeletons, is licensing Harvard’s research on exosuits to develop an assistive device for people with limited mobility. Last month, a prototype exosuit system was introduced to the public.

The following video gives a demonstration of the device.

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RNA Vaccine for Rabies Found Safe, Generates Antibodies

Raccoon

(edbo23, Pixabay)

26 July 2017. A vaccine to prevent rabies made from messenger RNA, genetic material transcribed from DNA, was shown in a clinical trial to be generally safe and able under some conditions to induce antibodies. Results of the study, conducted by CureVac AG in Tübingen, Germany, appear in yesterday’s issue of the journal The Lancet (paid subscription required).

Rabies is a life-threatening viral disease often transmitted through the bites of rabid wild animals, such as raccoons, foxes, or bats. The virus infects the nervous system, eventually reaching the brain, beginning with fever, headache, and general weakness. Symptoms generally worsen as the disease progresses, leading to insomnia, anxiety, paralysis, hallucinations, and death within days after advanced symptoms appear.

CureVac’s technology adapts messenger RNA, nucleic acids related to DNA that leave the cell nucleus and go to cells’ protein-making components. Those cell components synthesize human proteins by reading and translating the genetic code in messenger RNA into the appropriate amino acids for that protein. The company’s platform is based on research by Ingmar Hoerr in the 1990s, one of CureVac’s founders, who discovered a way of controlling RNA that was previously considered too unstable for use as a treatment or vaccine.

The early-stage clinical trial tested CureVac’s experimental glycoprotein vaccine to prevent rabies, code-named CV7201, given as an injection. The study tested CV7201 among 101 healthy adults in Munich, looking primarily at the safety of the vaccine, but also its ability to generate antibodies in the blood. Participants in the study received doses between 80 and 640 micrograms given 2 or 3 times, over 28 to 56 days. Injection methods tested were under the skin or into the muscles, using a syringe or needle-free high-pressure jet.

The results show the vaccine was generally safe and well-tolerated by participants, with a few adverse effects reported. Most participants — from 78 to 97 percent, depending on the administration method — experienced some form of mild injection-site reactions. However, nearly 8 on 10 (78%) of individuals receiving intramuscular injections reported systemic reactions, with 10 of those reactions graded as severe.

Injections given by needle-free devices appeared to generate the greatest numbers of rabies antibodies, particularly when given under the skin. After 1 year, more than half (57%) of participants receiving a booster of 80 micrograms with needle-free injections under the skin also generated measurable antibodies.

The company says the trial is the first study with humans of a preventive vaccine made from messenger RNA. World Health Organization assigned the generic name nadorameran for CV7201. WHO gives unique nonproprietary names to generic drugs, including biologics, to encourage standardization, with nadorameran as the first in its class of immunological agents derived from messenger RNA.

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Make Sure Your Employees Thrive

– Contributed content –

Mug on desk

(Bilby Summerhill, Flickr)

26 July 2017. As any business owner will know, employees are essential for the success of your business. They are the cogs in the machine that keep the whole company together. Without them, the day-to-day tasks would not get done, new ideas would not be brought to the table and new ways of thinking would not be introduced.

For business owners, happy, productive and motivated employees are essential for success. But what about when you notice some of your employees are not as happy or productive as they once were? Is there anything you can do?

As the boss, it is your job to ensure that your employees thrive as part of your company. If you notice that productivity or office morale is lacking, it is crucial that you do something about it immediately. But what should you do?

Boss cartoon

(Balik, Pixabay)

Be a good boss

Don’t be the kind of boss the snaps at everyone, make an effort to be a good boss. Initiate an open door policy, allowing your employees to talk to you about anything at any time.

By having an open door policy, you will show your employees that you care about them and value their ideas and opinions. Use the best 401k providers to ensure they know you have their long-term stability in mind. If your employees feel that you value you them and see them as equals, they will be happier to share their thoughts, ideas and worries with you.

To ensure that your employees thrive while working for you, make sure not to have favorites. If you show favoritism to certain employees other employees will feel less valued, and so, may be less productive and unhappy at work.

Business colleagues

(RawPixel, Pixabay)

Help employees build workplace friendships

Studies have shown that employees who have good relationships with their work colleagues are happier and more productive at work. That’s why it is so important that you encourage and help your employees to build up workplace friendships. What is the best way to do this?

There are plenty of ways you can encourage workplace friendships, from holding staff drinks mixers and bowling nights to team building days and staff trips. Anything that gets your employees chatting with other members of staff is ideal as this helps to build stronger relationships.

Workplace business meeting

(Free-Photos, Pixabay)

Show your employees that you value them

One of the best ways you can help your employees to thrive is by showing them how much you value and appreciate what they do. If an employee does a good job of something, make sure to praise them for it. By showing your employees that you know how hard they work, you will make them happier and more willing to work harder for you.

Consider offering incentives to employees that have worked hard or done well with a project or piece of work. It’s amazing how much a simple incentive can raise office morale and productivity. The best types of incentives are things like a gift card to a nice restaurant, a fully paid for night out or an extra half a day of paid holiday leave.

As long as you show your employees that they are valued and appreciated, they should thrive while they work for you.

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Tough Ingested Hydrogels Designed for Long-Term Drugs

Stretching hydrogel

Jinyao Liu, left, and Giovanni Traverso stretch the drug-delivery hydrogel. (Mass. Institute of Technology)

26 July 2017. A medical engineering team developed and tested in animals a new water-based polymer material to deliver drugs for long-term release in the stomach. Researchers from Massachusetts Institute of Technology and Brigham and Women’s Hospital in Boston describe their findings in yesterday’s issue of the journal Nature Communications.

The team from the lab of chemical engineering professor Robert Langer at MIT and Giovanni Traverso, a gastroenterologist and biomedical engineer at Brigham and Women’s, is seeking a way to deliver drugs that can be taken one time and and released over a period of days or weeks, rather than asking patients to take drugs daily or more often over that period. For individuals in resource-limited regions, adherence to repeated medications is difficult, particularly for diseases like malaria that require taking drugs over an extended period of time.

The Bill and Melinda Gates Foundation that supports efforts to eradicate tropical diseases like malaria is a funder of this project. “We have been working with the Bill and Melinda Gates Foundation,” says Langer in an MIT statement, “to develop ultra-long-lasting capsules, which might last for the entire course of a treatment, or could be taken once a week or once a month, depending on the device.”

Langer, Traverso, and colleagues began with hydrogel, a soft material made largely of water, but with enough of a polymer network to maintain a three-dimensional gelatinous structure. To give the delivery material more resilience, the team added alginate, a biomaterial often combined with hydrogels, found in wound dressings and used for drug delivery and tissue engineering. The researchers also added polyacrylamide for extra toughness, a common water-soluble biocompatible polymer that increases viscosity in water and encourages accumulation or clumping of particles.

In addition, the delivery material is cross-linked with chemical bonds that react to common compounds to breakdown and dissolve the alginate and polyacrylamide. Small amounts of these compounds help break down the cross-linked bonds in the hydrogel triggering the slow release of the drugs being delivered. However, larger amounts would work faster, if needed. With this feature, simple antidotes could be taken if the patient needed to dissolve and remove the material from the stomach.

The team found it could prepare the material in a straightforward mixing and heating process, followed by purification. Analysis of the material shows it contains 87 percent water, yet can withstand stresses 14 to 32 times those of hydrogels mixed with polyacrylamide or alginate alone. Fracture and tensile strength tests show the toughened hydrogel even resists cutting with a razor blade.

The material is designed to be ingested in dehydrated form, combined with the delivered drug in a capsule. In the stomach, the material rehydrates and swells, then followed by a triggering solution, to start the slow release of the drug. The researchers tested delivery of the malaria drug lumefantrine using this material with Yorkshire pigs, which have gastrointestinal organs similar in size to humans. The tests show the toughened hydrogel releases lumefantrine over 7 to 9 days.

The team also tested lumefantrine given freely to the pigs, which clear the drug quickly from the blood. Using the toughened hydrogel delivery, lumefantrine remains in the blood for  at least 4 days.

First author and postdoctoral researcher Jinyao Liu, with Langer and Traverso, applied for a patent on the toughened triggered hydrogel technology. The researchers expect the material can be used in weight-loss interventions, tissue engineering, and delivery of ingestible electronics, as well as delivering drugs.

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Takeda, Biosurfaces Partner on Nanofiber Devices

Carbon nanotubes spun into fibers

Carbon nanotubes spun into fibers (CSIRO, Wikimedia Commons)

25 July 2017. Takeda Pharmaceutical Company is joining with a developer of medical devices from nanoscale bioactive fibers to design new devices for gastrointestinal, or GI, disorders. Financial details of the collaboration between Tokyo-based Takeda and BioSurfaces Inc. in Ashland, Massachusetts were not disclosed.

Takeda and BioSurfaces plan to design new types of medical devices to detect or treat disorders of the gastrointestinal tract, which runs from the esophagus to the rectum, and includes the pancreas, gallbladder, bile ducts and liver. This part of the anatomy is the site of a number diseases such as heartburn, peptic ulcers, hepatitis, pancreatitis, and cancers affecting these organs.

BioSurfaces develops applications for ultrafine nanoscale fibers derived from biocompatible polymers such as polyester or polyurethane approved for medical use by the Food and Drug Administration. In the company’s process called electrospinning, polymers are dissolved then sent through a high-voltage electric field at room temperature to be sprayed in a viscous microscopic jet. The liquid polymer jet attaches to the nearest grounded surface, where the solvent evaporates leaving a solid layer of polymer nanofibers.

The resulting nanofibers, says BioSurfaces, can be woven into separate devices or sprayed on molds to any size or shape. Drug compounds or biologics can also be mixed with the polymer solutions to deliver drugs, such as in wound healing packs. The company says its electrospun nanofibers outperform conventional textiles, providing structural and biological benefits, such as the ability to be integrated into human tissue. Tests of the materials in early and intermediate-stage clinical trials show no adverse effects with patients.

Vincent Ling, director of materials and innovation at Takeda, says in a joint statement that the partnership is expected to create new uses of biopolymers and technologies for device fabrication. “Application of developed technology,” adds Ling, “has the potential to help prevent strictures and promote healing of fistulas, which are common manifestations of GI diseases.”

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Faster Process Devised for Targeted Antibodies

Human B-cell

Human B-cell (NIAID, Flickr)

25 July 2017. Researchers in the U.S. and U.K. designed techniques for quickly generating highly targeted antibodies in the lab, which can speed production of new vaccines and therapies. The team led by Facundo Batista of the Ragon Institute in Cambridge, Massachusetts and Francis Crick Institute in London describes its process in yesterday’s issue of Journal of Experimental Medicine, published by Rockefeller University Press.

Batista and colleagues are seeking better methods for producing antibodies, proteins designed to address specific pathogens such as bacteria or viruses, from human blood samples. Current techniques, say the authors, require extensive screening to find the few, specific B-cells in the immune system that recognize antigen proteins from the pathogen and proliferate into blood plasma cells, which in turn produce antibodies targeting those antigens. These methods, which the team calls laborious, take between 7 and 14 days and often produce just small amounts of antibodies.

The researchers focused on the need for a second trigger to produce antibodies in plasma, beyond the presence of B-cells. This additional trigger is provided by oligonucleotides, short fragments of DNA used routinely today in research, genetic testing and forensics. In this case, a specific type of oligonucleotide stimulates a protein in B-cells called toll like receptor 9, or TLR9, instrumental in generating immune responses. But these oligonucleotides do not discriminate; they generate responses from all B-cells, not just the ones with the target antigen proteins.

As a result, the researchers designed nanoscale particles containing an antigen and oligonucleotide needed to produce antibodies addressing a specific pathogens. The team verified that the process could produce larger quantities of targeted antibodies, and while culturing still took 6 days, it’s still somewhat less time than current methods that provide only small quantities of antibodies.

The researchers tested its antibody production process with tetanus, a few types of influenza, and HIV. The team used blood samples from healthy donors to produce specific antibodies against these infections, including less common influenza strains H5N1 and H7N9, as well as the more common H1N1. The results show some of the influenza antibodies worked with multiple influenza strains and neutralized the viruses before they could cause infections. In addition, the techniques produced HIV antibodies, even though none of the donors had previous exposure to HIV, suggesting a potential new source of vaccines.

The Ragon Institute is a research center affiliated with Massachusetts General Hospital, MIT, and Harvard Medical School developing a vaccine for HIV beginning in 2009. The Francis Crick Institute is an independent medical research center formed by a number of institutions and funding agencies in the U.K. in 2015, addressing the biological underpinnings of  cancer, heart disease, stroke, infections, and neurodegenerative diseases.

In a Rockefeller University Press statement, Batista says the findings should allow for production of therapeutic antibodies, “within a shorter time frame in vitro and without the need for vaccination or blood/serum donation from recently infected or vaccinated individuals. In addition, our method offers the potential to accelerate the development of new vaccines by allowing the efficient evaluation of candidate target antigens.”

Batista is a scientific founder of Blink Therapeutics in Stevenage, U.K., a subsidiary of Blink Biomedical, a developer of synthetic targeted antibodies from B-cells.

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Lilly Licensing Autoimmune Therapy in $400M Deal

Nektar Therapeutics lab

Nektar Therapeutics lab in San Francisco (Nektar Therapeutics)

24 July 2017. Drug maker Eli Lilly and Company is licensing a therapy from a biotechnology company that produces self-correcting cells for people with disorders caused by a malfunctioning immune system. The agreement with Eli Lilly, in Indianapolis, could bring San Francisco-based Nektar Therapeutics as much as $400 million.

The deal covers Nektar Therapeutics’ program for autoimmune diseases, disorders that arise from an erroneous immune response aimed at healthy cells and tissues in the body, instead of invading pathogens from outside. Examples of autoimmune disorders are type 1 diabetes, rheumatoid arthritis, lupus, psoriasis, Crohn’s disease, and multiple sclerosis. American Autoimmune Related Diseases Association cites data from National Institutes of Health estimating 23.5 million people in the U.S. suffer from autoimmune diseases, but the organization believes the actual number may be more than twice as high.

Nektar develops treatments that combine polymer chemistry with active biological agents to control their targeting, distribution, and activity in the body, in what the company calls polymer drug conjugates. Nektar’s drug, code-named NKTR-358, uses that formulation to balance the overabundance of effector T-cells, white blood cells in the immune system programmed to immediately react to perceived invaders. That balance is achieved by targeting interleukin-2 receptor proteins to produce more regulatory T-cells, which help control over-reactions to immune-system threats.

NKTR-358 is taken as a self-administered injection 1 or 2 times a month. An early-stage clinical trial with 50 individuals is planned for later this year to test its safety, dosage levels, and chemical activity in the body. Participants in this case are expected to have systemic lupus erythematosus, the full name for lupus. This disease leads to inflammation in the joints, skin, and other organs including heart, lungs, and kidneys, and is more common in women than men, affecting people between the ages of 10 and 50.

The agreement calls for Lilly and Nektar to collaborate on development of NKTR-358 beyond this early-stage trial. For intermediate-stage trials, Lilly will cover 75 percent of the drug’s development costs, with Nektar responsible for the remainder. Nektar has an option to participate in late-stage trials for individual diseases. Lilly will be responsible for commercialization of NKTR-358 worldwide, although Nektar will have an opportunity to co-promote the drug in the U.S. under specified, but undisclosed, conditions.

The deal calls for Nektar to receive an initial payment from Lilly of $150 million, with Nektar eligible for another $250 million after achieving certain developmental and regulatory milestones. Nektar will also be eligible for royalties on sales of products created from NKTR-358, dependent in part on the extent of Nektar’s participation in late-stage clinical trials.

Lilly has a number of drugs in its pipeline for autoimmune disorders in regulatory review and later-stage clinical trials, including rheumatoid arthritis, type 1 diabetes, psoriasis, and lupus, as well as several immunology therapies in early-stage trials.

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Clinical Trial Begins for Liver Dialysis Device

Liver illustration

(Mikael Häggström, Wikimedia Commons)

24 July 2017. A clinical trial is underway in Europe testing a device that works like dialysis to clear toxins from the blood associated with liver failure, where a transplant is often the only option. The early-stage study, sponsored by Yaqrit Ltd., developer of the Dialive device, reported today enrollment of its first patient.

The Dialive device is designed for individuals with cirrhosis who encounter complications leading to a sequence of failures in the liver, a disorder known as acute-on-chronic liver failure. Yaqrit cites data from transplantation waiting lists showing between 200,000 and 300,000 people in Europe each year experience liver failure. About a quarter of those with liver failure are expected to die within 28 days without a transplant.

The condition results from bacteria in the gut that form toxins on their outer membranes called lipopolysaccharides. In healthy individuals, these toxins are cleared naturally, but in people with compromised livers the toxins build up, leading to inflammation, scarring, and loss of liver function. The Dialive filters a patient’s blood, removing lipopolysaccharides and exchanging damaged albumin, a prominent protein in blood serum, for healthy albumin.

The clinical trial is enrolling 24 individuals with acute-on-chronic liver failure at 7 locations in the U.K., France, Germany, and Spain. Participants are randomly assigned to receive either Dialive treatments for 10 days or the standard of care, which may vary depending on the severity of the patients’ condition. The study team is looking primarily at the safety of the Dialive device, in terms of serious adverse effects or the need to discontinue treatments because of the device.

However, the researchers are also evaluating performance of the Dialive, including removal of toxins and damaged albumin from the blood, and changes in liver functions compared to standard of care. In addition, the study team is assessing any changes in kidney, brain, and immune functions between the two groups of participants.

Yaqrit Ltd. is a spin-off enterprise from University College London, founded by Rajiv Jalan, professor of hepatology and part of the university’s health care engineering institute. The company, based in London, is commercializing research by Jalan and others, including the Dialive. Yaqrit is also creating a preventive and therapy for cirrhosis and nonalcoholic steatohepatitis, where fatty deposits build up in the liver. This treatment, called Carbalive, uses tiny packets of carbon beads delivered into the gut that bind to and remove lipopolysaccharides.

The clinical trial is part of a larger project funded by the European Commission called Aliver to develop the Dialive, and take the device through two clinical trials and regulatory approvals in Europe. If the first trial shows positive results, the second trial is expected to enroll 100 patients with liver failure at 18 sites in Europe.

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