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Learn more - CREATE AN ACCOUNTSIGN IN JOIN IEEESIGN IN Close Access Thousands of Articles -- Completely Free Create an account and get exclusive content and features: Save articles, download collections, and talk to tech insiders -- all free! For full access and benefits, join IEEE as a paying member. CREATE AN ACCOUNTSIGN IN BiomedicalTopicMagazineTypeFeature A New Treatment for Arthritis: Vagus-Nerve Stimulation Studies will soon show whether electroceuticals outperform pharmaceuticals Elie Dolgin 26 Dec 2022 4 min read A tablet computer, a smartphone, a grey belt with white stripes, a grey disc, and a small silver rectangle with a wire curled beside it. Galvani's system includes a nerve stimulator that attaches to the splenic nerve. Galvani Bioelectronics Monique Robroek once had such crippling arthritis that, even with the best available medications, she struggled to walk across a room. But thanks to an electronic implant fitted under her skin, she managed to wean herself off all her drugs and live pain-free for nearly a decade--until recently, when a viral illness made her rheumatoid arthritis (RA) flare up again. Robroek's long remission is "very impressive" and rare among patients with RA, says her doctor Frieda Koopman, a rheumatologist at Amsterdam UMC, in the Netherlands. Robroek's experience highlights the immense potential of so-called bioelectronic medicine, also known as electroceuticals, an emerging field of treatment for diseases that have traditionally been managed with pharmaceuticals alone. --------------------------------------------------------------------- Robroek is also an outlier, though. Koopman led a landmark 17-person trial that tested whether modulating the nervous system's electrical-signaling patterns could tamp down inflammation and joint pain in RA. Robroek was one of only a handful who achieved appreciable and sustained reductions in disease severity, according to the 2016 paper. An illustrated profile of a woman showing a branching nerve in her neck and a blue rectangle beside it.The SetPoint implant is inserted beside the patient's vagus nerve, which travels down from the brain to innervate the spleen and other vital organs.Chris Philpot Pilot studies like Koopman's are one thing, but scientific certainty demands randomized, sham-controlled trials. Doctors, neuroscientists, and bioengineers should soon get a better sense of the performance of electroceutical devices. In late 2023, SetPoint Medical, the Valencia, Calif., company that sponsored Koopman's initial trial, will report preliminary findings from Reset-RA, the first large-scale examination of nerve stimulation for an autoimmune condition. Like the earlier trial, the Reset-RA study targets the vagus nerve, the main conduit of brain-body communication, in an attempt to fight inflammation. Expectations are charged. Although devices that harness electrical impulses are already widespread in medicine, these platforms all tap into neural circuits that directly impact diseased tissues; for example, deep-brain stimulators help with symptoms of Parkinson's disease by hacking the brain's motor control center. None take aim at what Kevin Tracey, in an influential 2002 article, termed the "inflammatory reflex," a neural network that indirectly regulates immune responses to infection and injury through the vagus nerve and its connected organs. Tracey, a former neurosurgeon who leads the Feinstein Institutes for Medical Research in Manhasset, N.Y., was the first to show that vagus nerve stimulation in rats could suppress the release of immune-signaling molecules. He later linked the effect to vagus nerve signals running into the spleen, a fist-size organ in the abdomen where immune cells are activated. In 2007, Tracey cofounded SetPoint to bring the treatment to the clinic. The company first repurposed an off-the-shelf implant used to control seizures in people with epilepsy. SetPoint optimized the stimulation parameters, using rodent studies for guidance, before giving the devices to patients like Robroek. She and the other recipients each had a cookie-size pulse generator surgically placed inside their chests. A wire snaked up the left side of the neck, where an electrode wrapped around the vagus nerve. It gave a gentle, 1-minute buzz of stimulation up to four times every day. The study targets the vagus nerve, the main conduit of brain-body communication, in an attempt to fight inflammation. Paul Peter Tak, an immunologist and biotech entrepreneur who led the trial with Koopman, was worried that patients with RA might not want to undergo surgery and have hardware implanted under their skin. But after publicizing the study on Dutch television, Tak was inundated with requests from patients who were sick of endless regimens of pills and injections. "This was my unplanned market research," Tak says. "To my surprise, there are many patients who might prefer a one-and-done surgery." While the study's results were promising, the device itself was cumbersome. So SetPoint overhauled the platform, shrinking it down to a peanut-size neurostimulator with integrated electrodes and a wirelessly rechargeable battery, all encased inside a silicone holding pod that sits directly atop the vagus nerve in the neck. "It's like going from an old car to a Tesla--it's completely redesigned," says SetPoint's chief medical officer, David Chernoff. A small trial performed in 2018 demonstrated that this miniaturized device was safe. The 250-person Reset-RA study, in which half the participants receive no stimulation for the first 12 weeks after implantation, is now evaluating efficacy. If it works, trials for other autoimmune diseases could follow. A silver and white capsule-shaped object lies on a blue background. Writing is on the white part.SetPoint shrank the vagus nerve stimulator so that it can be implanted in a patient's neck instead of the chest.SetPoint Medical Other companies, meanwhile, are testing devices that target nerves closer to the site of immune activation--"at the business end," says Kristoffer Famm, president of the British company Galvani Bioelectronics. This end-organ approach to nerve zapping, argues Famm, should allow for more precise, disease-specific neuromodulation, without the off-target effects of shocking the vagus nerve, which is central to many bodily processes. A joint venture between Google's parent company, Alphabet, and the British pharmaceutical company GSK, Galvani is now evaluating its implantable splenic nerve stimulator in small numbers of patients with RA. Another company called SecondWave Systems, headquartered in Minneapolis, is also testing whether spleen-directed ultrasound waves can offer the same immune-quelling effects without the burden of invasive surgery. Both Galvani and SecondWave expect to announce first-in-human data within the next year. "Neuromodulation is definitely having a moment," says Gene Civillico, a neurotechnologist at Northeastern University, in Boston, who previously oversaw bioelectronics research efforts at the U.S. National Institutes of Health. "Controlling nervous tissue in a spatially and temporally precise way is going to be the way that we cure or modify a lot of disease states," Civillico contends. In the coming year, SetPoint and other companies hope to prove him right. From Your Site Articles * Scientists Discover How Vagus Nerve Stimulation Treats Rheumatoid Arthritis > * Brain Stimulation Via Earbuds: Unobtrusive Technology Could Treat a Variety of Diseases > Related Articles Around the Web * Rheumatoid arthritis: MedlinePlus Medical Encyclopedia > * Rheumatoid Arthritis | Arthritis Foundation > * Rheumatoid Arthritis (RA) | Arthritis | CDC > vagus nerve stimulationarthritisrheumatoid arthritisneurotechnology neurostimulation Elie Dolgin Elie Dolgin is a science writer specializing in biomedical research and drug discovery. After a PhD spent studying the population genetics of nematodes, he swapped worms for words--entering journalism as an editor at The Scientist, Nature Medicine, and STAT. Now a freelancer, Elie is a frequent contributor to New Scientist, Nature, IEEE Spectrum, and more. The Conversation (0) An illustration of pipes going around from hot to cold behind a chinese animal statue on a pedestal. EnergyTopicMagazineTypeFeature China's New Breeder Reactors May Produce More Than Just Watts 6h 4 min read Six still frames show a robotic gripper pushing a box against a barrier to angle it in order to grasp and lift it. The top 3 are computer views, the bottom are camera views. RoboticsTopicArtificial IntelligenceTypeNews Robots Grip Better When They Grip Smarter 6h 2 min read A photograph of a young woman with brown eyes and neck length hair dyed rose gold sits at a white table. In one hand she holds a carbon fiber robotic arm and hand. Her other arm ends near her elbow. Her short sleeve shirt has a pattern on it of illustrated hands. RoboticsTopicTypeNews The Top 10 Robotics Stories of 2022 7h 4 min read ComputingTopicTypeNews Log4Shell Still Has Sting In The Tail The cyber-vulnerability mounts a quiet comeback as organizations grow complacent Edd Gent Edd Gent is a freelance science and technology writer based in Bangalore, India. His writing focuses on emerging technologies across computing, engineering, energy and bioscience. He's on Twitter at @EddytheGent and email at edd dot gent at outlook dot com. His PGP fingerprint is ABB8 6BB3 3E69 C4A7 EC91 611B 5C12 193D 5DFC C01B. His public key is here. DM for Signal info. 7h 4 min read blue zeros and ones in a random sequence Alamy log4jcybersecurityopen source The December holiday plans of IT workers were thrown into disarray last year after the disclosure of a major bug in the widely-used Log4j tool. The discovery led to months of feverish activity to patch the vulnerability, but a year on it has slipped off the radar. The threat hasn't gone away though, say security experts, and could make a resurgence if the industry isn't careful. When it was first revealed in early December 2021, the Log4Shell bug was described as one of the most severe security vulnerabilities ever. It targeted a popular tool for logging activity in Java software designed to help keep track of errors and diagnose performance issues. Its broad utility means Log4j has been embedded in thousands of software packages and was found in a wide variety of commercial services, including Amazon Web Services and the videogame Minecraft. What's more, the bug made it relatively simple for attackers to take complete control of vulnerable systems. This led to a mad scramble to plug the gaps. The Apache Software Foundation, which maintains the open-source tool, quickly released a patch, and organizations spent months scanning their systems and updating their software. But more than a year later, cybersecurity firm Tenable says 72 percent of organizations remain susceptible to Log4Shell. And worryingly, a large number of organizations that had fixed the bug have since reintroduced it to their systems by installing vulnerable software, says Bernard Montel, technical director and security strategist at Tenable. One day in December of this year saw the highest daily attacks since the Log4j vulnerability was discovered. "When they put it in place a plan for fixing it roughly a year ago, they thought they'd done it," he says. "They cleaned, they identified, they've scanned, they've patched their software and for them, they've done what they needed to do. They just forgot the fact that the attack surface is moving." Tenable estimates that the proportion of machines vulnerable to the exploit has dropped from one in ten last December to just 2.5 percent as of this October. But up to a third of these had already been fully patched, and have since been reinfected with Log4Shell. Part of the problem is that Log4j is buried deep in a lot of commonly used software libraries, says Montel. It's often not clear whether the utility is included in a particular tool, and even when it is, most developers aren't sufficiently security minded to check if it's the most up-to-date version, particularly given the pressure they are under to produce code quickly, he adds. Research from security firm Sonatype from a year ago found that 65 percent of downloads of Log4j were of vulnerable versions of the tool. At an organizational level, Montel also thinks that after the huge push to deal with the vulnerability in the early months it was almost inevitable that people would lose focus once they felt they'd remediated the problem. He thinks there are clear analogies to the Covid-19 pandemic, in which stringent measures like lockdowns rapidly got the virus under control, only for it to reappear when things relaxed again. "It [Log4j] is coming back," says Montel. "It's still there somewhere, so just observe the waves." A July report from the Department of Homeland Security's Cyber Safety Review Board assessed that the bug had become "endemic" and was likely to remain a problem for years if not decades. And data collected by security company Imperva has shown that while attacks exploiting the bug have fallen considerably since the first couple of months of 2022, there has been a steady increase since November, with 3 December of this year seeing the highest daily attacks since the vulnerability was discovered. One potential remedy: organizations could start requiring a Software Bill of Materials for all the code they use Imperva estimates that about 7 percent of those attacks are successful. But although there have been some high profile hacks--including ones by Chinese state-sponsored hackers in March and an Iranian attack on a US federal agency in November--so far, the bug hasn't lived up to the dire predictions made last year. "Although plenty of companies were impacted, it was largely less than anticipated," says Gabi Stapel threat research analyst at Imperva. What is has done though is bring to light how reliant many companies are on third-party and open source code over which they have little control or visibility. "Historically, companies have focused on the risk introduced by their immediate set of vendors and the critical software they rely on," says Stapel. "Organizations need to adopt a threat model that includes all parts of the supply chain." The cost and complexity of the response to Log4Shell has certainly driven an increasing focus on securing the software supply chain and boosting transparency, says Eric Goldstein, executive assistant director for cybersecurity at the Cybersecurity and Infrastructure Security Agency (CISA). "A host of new tools, companies, and products have emerged over the past year to help better understand software dependencies, and Log4j is often used as a primary motivation for innovation and adoption," he says. One potential remedy that CISA has been promoting is the Software Bill of Materials (SBOM). This is an inventory of all the components that make up a software application, which is designed to make it easier for developers to track any dependencies on potentially risky bits of code. The US government has signaled that these may soon become a requirement for software delivered to federal agencies. For the approach to really have an impact it needs to move further upstream though, says Brian Behlendorf, general manager at the Open Source Security Foundation (OSSF), so that even the original open-source software packages or libraries that developers assemble to create applications come with their own SBOMs. Doing so is likely to require new tools that simplify this process and bake them into existing software building tools though, says Behlendorf, because "getting developers to spend some extra effort can be a challenge". The industry as a whole also needs to coordinate better and be more proactive about securing the open source tools it relies on, he says. Individual projects simply don't have the finances or manpower to do things like code reviews, says Behlendorf. "There's just a disconnect between the value to be received by the ecosystem, and the ability to muster those kinds of resources," he says. "What we need are institutions who are able to aggregate demand for better scrutiny for these thing and channel resources into targeted, low-hanging fruit." That's why in May, the OSSF and the Linux Foundation unveiled an Open Source Software Security Mobilization Plan, which highlighted ten areas where a small amount of investment could dramatically reduce the risk of vulnerabilities like Log4Shell. These include things like better security education for developers, the establishment of an OSSF incident response team to help under-resourced open source teams react to vulnerabilities, and yearly code reviews of the 200 most critical open source software components. Bringing this to fruition will require considerable funding from both industry and government, says Behlendorf. But it would be a wise investment and without some kind of coordination, it won't be long until the next Log4j comes along, he says. From Your Site Articles * Google Tool Joins Ferocious Hunt for Log4j Bug > Related Articles Around the Web * Log4Shell - Wikipedia > * Mitigating Log4Shell and Other Log4j-Related Vulnerabilities | CISA > Keep Reading |Show less BiomedicalTopicTypeSponsored Article NYU Tandon Exploring "Megabase-Scale" Genetic Engineering A team led by David Truong is building technology to rewrite large chunks of DNA cheaply, safely, and efficiently Michael W. Richardson 07 Dec 2022 7 min read Illustration of a strand of DNA with a piece of genetic material detached from it Shutterstock genetic engineeringnyu tandonCRISPRbiomedical engineering This is a sponsored article brought to you by NYU Tandon School of Engineering. The human genome is built from 23 chromosomes. Within those chromosomes are around 3 billion base pairs of DNA. Within these base pairs are every subtlety of what makes you uniquely you -- the way your eyes change color in different lighting, the sound of your laugh, your freckles. It also encodes dangers. A host of genetic diseases and disorders can lurk among those 3 billion base pairs, in sequences that can cause multiple sclerosis, Alzheimer's disease, and more. Since the completion of the Human Genome Project in 2003, scientists and researchers have pored over the map of our shared genetics to pick apart the clues and find the root causes of a host of human health problems. Their research has resulted in an explosion of knowledge that represents one of the great scientific advancements in human history. It also kickstarted the field of genetic engineering -- the study of altering the genome to fight disease and change human health for the better. Portrait of David Truong stares at the camera against a gray background. David Truong, Assistant Professor of Biomedical Engineering at NYU Tandon and Pathology at NYU Grossman. NYU Tandon With advancements like CRISPR, genetic engineering is entering its own renaissance. But while most geneticists are focusing on a few thousand base pairs at a time, some researchers are thinking bigger. Researchers like David Truong, Assistant Professor of Biomedical Engineering at the NYU Tandon School of Engineering and Associated Faculty of Pathology at the NYU School of Medicine. Truong is pushing the boundaries of biomedical engineering when it comes to genetics, building the technology necessary to change not just thousands of base pairs at a time, but millions. And that engineering work could have profound implications for the future of healthcare. Truong is conducting his research with funding from a prestigious National Institute of Allergy and Infectious Diseases DP2 New Innovator Award, and his other laurels include a Delil Nasser Award for Professional Development from the Genetics Society of America, and a National Institutes of Health Ruth L. Kirschstein National Research Service Award. We spoke with Truong about his work on genetics, and what it takes to work with huge amounts of genetic data at a time. When did you become interested in genetic engineering? When I was an undergraduate, I didn't actually major in bioengineering. I was specifically interested in manipulating the genome, but in the early 2000s, bioengineering wasn't that interested in human genomics. I pursued a molecular biology degree, but that was more of a means toward an end, which was the emerging field of genetic engineering. Around that time, the Human Genome Project was finally published. Once we had the map of human DNA, it was on everyone's mind. And suddenly everyone understood that knowing the sequence of the human genome meant that we could start to manipulate that genome towards different ends, to cure diseases, to change medicine. At that point, bioengineering began to explode, and I was there to ride that wave of interest. Diagram showing three steps of a genetic engineering process. The Truong lab uses a number of technologies for large-scale genetic engineering, including using yeast to stitch together smaller bits of DNA, as well as landing pad technology used to insert large strings of genetic material. Truong Lab I did my Ph.D. at The University of Texas at Austin, producing a technique to directly edit genes. It was actually very similar to CRISPR-Cas9 -- it combined a protein and a strand of RNA just like CRISPR. CRISPR came out right at the end of my Ph.D. studies, and unfortunately, I was never able to get my technology to work in human cells as well as the more well-known gene editing technique. So once I published my findings, like most genetic engineers, I moved over to CRISPR. What brought you to NYU Tandon? After my Ph.D. I was brought into the lab of Jef Boeke. He is a Professor of Biochemistry and Molecular Pharmacology at NYU Langone, as well as a Professor of Biomedical Engineering at Tandon. As a postdoc, I continued doing research into genomics. The Boeke Lab is largely interested in the DNA of yeast and using that model as a way to explore synthetic genomics and building entirely new genomes. In his lab, yeast is used as a platform for exploring the construction of fully synthetic chromosomes. But from that kind of cultural environment I started thinking about "How do we manipulate the genome at this much larger scale?" -- building larger sections of the human genome from scratch or modifying sections, or building whole chromosomes. So by the end of my post-doc work, I was already transitioning to working on what I had dreamed about as an undergraduate -- building human cell therapies by using synthetic genomics and technologies. I also helped during the early founding of a company while I was at the Boeke Lab called Neochromosome. I had written a small business grant to work on mammalian genome engineering, which would be a big focus of the company. It grew quite quickly once we had the funding, and it was acquired by Opentrons, who scaled Neochromosome up. Eventually though, we realized that the market didn't have the patience for the type of work I do. The kind of large-scale genetic engineering I was pursuing was maybe 15 years away, and that's before clinical trials and regulatory approvals start. So they tracked back towards engineering yeast for more immediate gains, and I began to look back towards academia to really focus on the future of my work. When a position in the Biomedical Engineering department opened up, I jumped at the chance. I was already familiar with NYU from my work with Boeke's lab, and I was eager to rejoin the community. "We had gotten pretty good at building designer segments of one hundred thousand base pairs, or even 1 million base pairs. That's what we call the mega-base scale ... It allows you to make huge adjustments to the way the genome acts and you can reimagine the chromosome in important ways." --David Truong When you say "a larger scale," how large are we talking? Most genetic engineers are focusing on small amounts of DNA -- a portion of a gene, or a couple of nucleotides. Mostly looking to change a mutation here or there in a very limited capacity. That can involve five-to-ten thousand base pairs. We had gotten pretty good at building designer segments of one hundred thousand base pairs, or even 1 million base pairs. That's what we call the mega-base scale, where you're changing many, many genes, as well as encoding the information that turns them off and on on-demand. It obviously allows you to make huge adjustments to the way the genome acts and you can reimagine the chromosome in important ways. Doing this requires some specific technologies that we had to develop. CRISPR is our baseline, which we use to remove large sections of DNA. But in order to replace it, we use what we call "landing pad" technology, which is optimized to receive these large pieces of genetic data. And going back to my work in Professor Boeke's lab, we still use yeast to manufacture these large segments. Because most commercial DNA producers can't put such large strings of synthetic DNA together, we utilize yeast's unique abilities to take those small strands and combine them into something much larger than was previously possible. And those large chunks of DNA can be used in incredible ways. Image shows large group of stem cells illuminated with red fluorescence. Induced Pluripotent Stem Cells (iPSCs), illuminated with red fluorescence, that had 100,000 basepairs deleted. Minjoo Kim A lot of your research focuses on human induced Pluripotent Stem Cells (iPSCs), which have the potential to transform from an embryonic state into any type of cell needed. What makes these cells so attractive to genetic engineering? So iPSCs are cells typically taken from blood or skin, and reprogrammed to take on the properties of embryonic stem cells -- those are the cells that can morph into the various kinds of cells that populate our body, from heart cells to brain cells to anything you can imagine. And because those cells have such remarkable plasticity, we can make these genetic adjustments to have them grow into cells with a very specific purpose. One of the challenges, even with these cells, is that they can be highly personalized. So cells harvested from one person might be rejected by another. But what I've helped create was the technology to swap out the genetic coding in these cells that personalized them to an individual, and swap in genetic code that matches potential patients. And that is much cheaper and less invasive than having to start from scratch for each patient. We're also engineering what we call synthetic genetic circuits. This is an idea in the synthetic biology field which takes from electrical engineering and computer science, where you actually use genes and the way they activate to actually power cells and change the way they act. The larger the amount of DNA you can swap out, the more complicated the function you can convince these cells to produce. For example, one of the biggest things we're working on is turning iPSCs into cancer fighting cells. T-cells can hunt down tumors, but they are susceptible to the self-defense mechanisms of the tumors themselves, which also involves shutting down the body's natural immune system surrounding it. So with this technology, we can "train" these cells to get around those suppression mechanisms and turn the immune system around the tumor back on, recruiting the body's natural defense system to help defeat the cancerous cells. Eight images of stem cells. Truong's lab can turn iPSCs into "embryoid bodies" which mimic the developmental process of making tissues. Susanna Jaramillo But we have a bunch of different potential uses for these cells. We're working with various kinds of immune cells. For example, dendritic cells move around the body, picking up bits of protein and other molecules that they find, and when they find something that's not supposed to be there, they put it on their surface. And then T-cells can 'learn' from these molecules what they should be attacking in the body. So we can harvest these T-cells from patients that are adapted to attack certain types of cancer, and recreate synthetic T-cells that can be introduced to new patients to kick-start their body's defense system. How does your work dovetail with others at NYU Tandon? There's a lot of opportunity for collaboration in the NYU Tandon BME department [Editor's note: The department was covered in the pages of this website earlier this year].Irene de Lazaro, the newest Assistant Professor of Biomedical Engineering, also works with iPSCs. She's doing very similar work, using these stem cells to produce therapies, specifically rejuvenating heart cells. There's a lot of complementary overlap there. Alesha Castillo is working on stem cells, and Thorsten Kirsch is working on how cellular interactions affect things like osteoarthritis. So cell and tissue engineering is becoming an ever-growing field of study at the school, and that makes it a very exciting place to be right now. Then there's research like Weiqiang Chen's, who is currently working on cancer-on-a-chip technology. Essentially, he's producing miniature, personalized cancer samples that represent an individual's tumor. Theoretically, if he was looking to test a very specific treatment involving specialized genetically-modified cells, he could come to our lab and we could produce them for him, and quickly test in a controlled sample whether a treatment had the potential to work for any given patient. That's what really excites me about this work. As bioengineering grows, it's interfacing more with medicine, and we're getting to the place where we can use cells and genomes as a technology itself. When I was thinking about bioengineering as an undergraduate, it wasn't a thing. It's only now that we have learned enough about nature, enough about the rules, that we can really start to take these things and put them together in new ways for new medical treatments and human health in general. I think it's just a huge opportunity to grow. 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