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Robotic Device Navigates Brain Blood Vessels

Robotic wire

Robotic wire, in black, navigating through simulated brain blood vessels (Massachusetts Institute of Technology)

29 Aug. 2019. Engineers and materials scientists designed a robotic device thin and flexible enough to thread through blood vessels in a model brain under remote control. A team from Massachusetts Institute of Technology describes the device in yesterday’s issue of the journal Science Robotics (paid subscription required).

Researchers from the lab of Xuanhe Zhao, professor of mechanical engineering at MIT, are seeking better therapeutic tools for disorders affecting the brain, such as stroke or aneurysms where quick treatment can prevent a patient’s disability or death. Stroke occurs when blood flow to the brain is interrupted, cutting the oxygen needed by brain cells to function. The vast majority (85%) of strokes are caused by blood clots, while many other strokes are caused by blood vessel leakage in the brain. Nearly 800,000 people in the U.S. have a stroke each year, with paralysis and weakness in the limbs among the results.

“If acute stroke can be treated within the first 90 minutes or so, patients’ survival rates could increase significantly,” says Zhao in an MIT statement. “If we could design a device to reverse blood vessel blockage within this ‘golden hour,’ we could potentially avoid permanent brain damage.”

Zhao’s lab studies soft robotics, particularly materials and mechanics at the interface between humans and machines. To clear blood clots from the brain today, surgeons use a a thin wire inserted through a vein, carefully navigated into and through the brain to deliver drugs with a catheter or physically break up the clot. Current robots designed for treating brain disorders, say the authors, can get no smaller than millimeter or centimeter scale, because of limits to miniaturization. And these devices encounter damaging friction when inside blood vessels.

The team led by graduate student Yoonho Kim designed an ultra-thin  — less than a millimeter in diameter — wire-like device known as a continuum robot to enter and navigate through complex and sensitive blood vessels in the brain. The wire is made of a nickel-titanium alloy, flexible enough to bend and hold its shape, yet can return to its original form as well. The wire is also covered with a magnetic ink for navigation. A hydrogel lubricant, made with a water-based polymer that does not affect magnetic properties, then coats the wire, which the authors report reduces friction to less than one-tenth, allowing it to slip through tight spaces without injuring blood vessels.

The researchers constructed a life-size silicone model of a brain’s blood vessel system to test the robotic device. The team used computed tomography or CT scans to design the brain model. The researchers filled the vessels with a liquid similar in viscosity to human blood, and added simulated clots and aneurysms, or bulges in blood vessels that can cause a stroke if they burst. The researchers demonstrated the device, navigating through the array of thin complex blood vessels guided by a remote-controlled magnet. This brief (40 second) video shows some of that demonstration.

In another demonstration, the team incorporated an optical fiber with the guide wire, and kept the diameter of the device to about half a millimeter. The researchers report the device can be guided remotely by a magnet and activate a laser at a designated location, adding other therapeutic applications.

Kim and Zhao are inventors on a provisional patent — indicating an intent to file a patent — for the technology.

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Companies Call for Genome Editing Regulations

Crispr genome edits illustration


28 Aug. 2019. A group of companies developing treatments for disease using genome editing are calling for regulations and standards to govern these technologies in regenerative medicine. The Alliance for Regenerative Medicine in Washington, D.C. issued a Statement of Principles yesterday that the organization says offers an ethical framework for genetic modifications.

With genome editing, DNA is modified through deletion of mutated genes, insertion of healthy genes, or replacement or correction of genes. The use of these techniques for therapies is accelerating with advances in Crispr — short for clustered, regularly interspaced short palindromic repeats — that edits genomes of organisms by harnessing bacterial defense mechanisms using RNA to identify and monitor precise locations in DNA.

The group’s statement of principles makes a distinction between gene editing in somatic and germ line cells. Somatic cells are cells in the body other than sperm and egg cells involved in reproduction. Edited somatic cells do not pass along alterations to future generations. Germ line cells — eggs, sperm, and fertilized embryos — do pass on these changes. The Statement of Principles specifically endorses genome editing with somatic cells, but calls germ line editing “currently inappropriate in human clinical settings.” The group says “safety, ethical, legal, and societal issues” with germ line editing are unresolved.

In addition, the Statement of Principles calls for national and regional regulations through agencies such as the U.S. Food and Drug Administration and European Medicines Agency to provide oversight for further development of therapies with somatic cell gene editing. While the statement says these agencies should “act as the primary regulatory and enforcement mechanism” for gene editing, the group cautions against arbitrary oversight bodies that could delay research on gene editing and development of treatments for affected patients.

Alliance for Regenerative Medicine also calls for standards bodies including US Pharmacopeia, International Organization for Standardization, and the Genome Editing Consortium at National Institute for Standards and Technology to prepare technical standards for genome editing. The standards, says the statement, should cover issues such as off-target effects and genetic mosaicism, where a person has two or more genetically different sets cells in the body.

“As with all breakthrough biotechnologies,” says Janet Lambert, CEO of Alliance for Regenerative Medicine in a news release, “we need to exercise caution and good stewardship in our research and development practices and ensure that work involving the genetic modification of cells takes place within the bioethical framework outlined in these principles.”

The companies signing the statement include Audentes Therapeutics, bluebird bio, BlueRock Therapeutics, Caribou Biosciences, Casebia Therapeutics, CRISPR Therapeutics, Editas Medicine, Homology Medicines, Intellia Therapeutics, LogicBio Therapeutics, Precision Biosciences, Sangamo Therapeutics, and Tmunity Therapeutics.

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Times in Life When You Need Legal Representation

– Contributed content –

Signing document

(Pixabay, Pexels)

27 Aug. 2019. If you’re going through tough or complex time in your life, you may wonder if you should hire a lawyer. Even if you suspect that you would benefit from professional assistance, the extra cost of hiring a lawyer—and the work involved in finding the right one—can feel like one thing too many.

But there are some situations in which you’d be doing yourself a disservice by not hiring a lawyer. How do you know when you really should have a professional on your side? If you’re on the fence, here are some circumstances that experts agree should prompt you to seriously consider getting legal representation.

Don’t assume you need a lawyer

First off, it’s worth mentioning that you will not always need legal assistance. Sometimes it is a waste of money, especially if the situation is cut-and-dry. If you’re able to get your head around the circumstances and look out for your own interests, you may be more than able to stand up for yourself against an individual or institution that has done you wrong. Small-claims court hearings such as landlord-tenant disputes are a good example. Sometimes it’s enough to simply know your basic rights. With Google search on your side, you might be able to tackle the problem on your own. If you need a little extra advice, consider seeking the advice of a friend who has been in your situation previously, or a wiser, more experienced acquaintance who has experience in law.

When divorce gets complicated

Divorce is becoming more and more normal these days. According to research, there is a divorce every fifteen seconds or less in the USA alone. Even more disturbing is the finding that around eight in ten couples will before their fifth anniversary. If your marriage is on the rocks, that is a sad situation, but you will ideally be able to come to an amicable settlement with your partner with the assistance of a conflict mediator. However, if that is simply not possible at this stage, and the two of you are struggling to agree to the terms of your divorce—especially as regards dividing your property and the custody arrangement for your children—legal assistance will be indispensable.

The terms that you finally sign up for during your divorce will be binding—more so than your marriage—and can be altered only by returning to court. To avoid extra legal fees down the line, call a well-regarded lawyer as soon as things start to seem unmanageable, and conversations between you and your spouse are no longer feeling productive. Your lawyer will also help to arrange a restraining order, should you need one.

Somebody is suing you

If the word ‘lawsuit’ makes you think of TV and movies, and not much else, you might be a little unsure what to do if you find yourself being sued for something. Unfortunately, if you get sued and the case is not handled intelligently, the word ‘lawsuit’ could take on a whole new meaning, and your whole world could come crashing down. Lawsuits can be over silly or insignificant issues, like blatant instances of opportunism or patent trolls, but they can also be deadly serious. If you are being threatened with a lawsuit, it’s best not to leave anything to chance. A lawyer is not negotiable in this situation, and don’t settle for the first one you find, either. Call around, get recommendations, and find the legal team that is most qualified for your individual case. While you might worry that taking your time finding the right lawyer means you’ll be racking up the fees before you even start, many leading law firms make it a policy to provide a free initial consultation, so you won’t have to pay until you’ve made your hire.

You’ve served in the Army

Serving your country is hard, dangerous work. Unlike a regular job, you put your body and your mental health on the line for the sake of the common good. While this type of commitment to your country and values should come with a great deal of respect and due reward, the unfortunate truth is that many veterans end up having put much more into the common pot than they get out. You may have been exposed to harsh climatic conditions, served in conflict zones, or suffered deprivations that put immense strain on your body and increase your risk of serious injury. Veterans are often unaware of their rights, and unable to fight the legal battles required in order to defend them. If your country’s compensation and support have fallen short of what you deserve, it’s wise to call a lawyer and tell your story. You may have a strong case, but you are unlikely to be able to defend it alone.

Following a vehicle accident

If you have been unfortunate enough to be involved in a vehicle incident, and one of the passengers was injured, you should phone a lawyer immediately. This applies for any injury or any passenger, and is even more important in the tragic instance of a fatality. Medical bills to deal with a crash-related injury can be eye-wateringly high, as many injuries can have life-long implications. For example, a head injury which causes impediments in someone’s ability to verbalize could mean that the person needs speech therapy for the rest of their life. The two (or more) insurance companies dealing with the accident will make the liability decision when it comes to who is responsible for footing the bill for accident-related costs. Even so, you should get your own representation in this situation, as insurance companies usually have their own interests at heart at the end of the day.

Loss of life following an accident

While death is really unpleasant to think about, it’s important to acknowledge the necessity of having a lawyer on your side if you’ve been involved in an accident and someone has tragically lost their life. Hiring a lawyer in this situation is more than sensible: it is your responsibility and moral duty to ensure that you play your correct part in the aftermath of this unfortunate situation. Whether the deceased was an employee at your factory or a passenger in your vehicle, it’s essential to ensure that those who are entitled to compensation receive the appropriate amount.

Bear in mind that the compensation that is deemed appropriate following a death may be a lot more than you would expect. For example, if the deceased was providing for a large family, those family members will require financial support for the number of years that would equal the full course of the deceased’s person’s career, had they not passed away. Death represents the highest stakes imaginable for human beings. With that in mind, it is understandably hard even to contemplate financial compensation in the aftermath. However, it is vital that all parties involved face up to their roles in the situation in an honest, reasonable and fair manner.

You have been accused of criminal activity

Back to the movies now. Remember that much-used line when the cop says, “you have a right to remain silent… anything you say may and will be used against you in a court of law?” If watching movies and courtroom dramas teach you anything, let it be this: do not—under any circumstances—try to defend yourself in court when you have been charged with criminal activity. Even if you are not guilty and the crime is a tiny misdemeanor, simply the fact of being charge could severely damage your future. You may struggle to get a job. Banks will be unwilling to lend you money for a mortgage. You may not be able to travel or immigrate. Your life may be impacted in many serious ways you have not even thought of.

This is one of those times in life when you get what you pay for. Ideally, you will hire the most skilled lawyer that you can afford. Do your homework beforehand, as you need someone who gets your situation, and has—successfully!—defended people in the same circumstances. Check out the websites of lawyers who come highly recommended. Remember, online reviews are only worth so much. If you have the opportunity to obtain word-of-mouth accounts of how lawyers have performed in similar situations, you may be able to get valuable insights on how they handled their clients—insights that don’t appear on court records.

Don’t let budgetary concerns make the decision for you

Unfortunately, hiring an expensive legal team is not possible on everyone’s budget. But don’t let this factor stop you from getting the assistance you require. If you’re in serious need of legal representation and you don’t have loads of cash to hand, you could still be entitled to the assistance of a public defender, or you may be able to get a lawyer to handle your case pro-bono. While you may think that a free legal team can’t be very good, some of the best lawyers in the world opt to work as public defenders or take pro-bono cases as a way of giving back to their communities.

Hiring a lawyer isn’t always the best course of action, but sometimes it is absolutely essential. It’s not always easy to know the difference. These tips will help you understand when you need a legal team on your side.

Editor’s note: The opinions in this post are the contributor’s and not those of Science & Enterprise. Readers are encouraged to get legal advice from a licensed professional who represents your interests.

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Patch Designed for Vaccines, Cancer Treatments

Microneedle patch

Microneedle patch designed for vaccine and melanoma treatments (Celestine Hong and Yanpu He, MIT)

26 Aug. 2019. An engineering team designed a small skin patch with tiny needles that in lab mice quickly delivers vaccines and possibly treatments for melanoma. Researchers from Massachusetts Institute of Technology described the patch device yesterday, in a session of American Chemical Society’s national meeting in San Diego.

A team from the lab of MIT chemical engineering professor Paula Hammond is seeking better methods for delivering vaccines and treatments through the skin. Most topical ointments barely penetrate beyond the outermost skin layer and syringes use needles that can be painful to patients and are often difficult for individuals to properly administer to deliver drugs under the skin layer..

Hammond’s lab studies layer-by-layer construction of polymer devices, where the alternating charge in layers makes it possible to securely add a drug-laden film to a bio-compatible assembly. In this case the device has tiny microscale needles that penetrate the skin far enough to reach capillaries, yet remain painless to the recipient. This alternating charge property, however, creates problems if the drug needs to be delivered quickly.

Yanpu He, a graduate student in Hammond’s lab, says in an American Chemical Society statement that “this attraction makes the entire film very sticky. Past methods, which have retained this sticky nature, can take up to 90 minutes for a sufficient amount of drug to leave the patch and enter the skin.”

Hammond, He, and fellow graduate student Celestine Hong devised a solution that retained the layer-by-layer assembly method, but with materials that allow for much faster drug delivery. The team designed a new type of polymer for the device with two sections that add or lose a charge in response to the skin’s surface. As graduate student He explains, “The first part contains amine groups that are positively charged at the pH at which we make the microneedles, but that become neutral at the pH of skin.” Amines are bases derived from ammonia.

“The second part contains carboxylic acid groups,” He continues, “with no charge when the microneedles are made, but which become negatively charged when the patch is applied to the skin, so there is an overall change in charge from positive to negative.” The alternating charge is needed to construct the device, but in the presence of skin, changes the charge to all negative throughout the device, and repels the drug through the needles into the skin.

The researchers tested the patch with lab mice, using the protein ovalbumin, derived from chicken egg whites, as a reference. The team found ovalbumin delivered through the patch produced nine times the number of antibodies in mice as intramuscular injections, and 160 times the antibodies as injections under the skin. In tests with human skin samples, patch-delivered ovalbumin also invoked immune responses. And the deliveries happen quickly, in about a minute.

The researchers also devised a version of the patch to deliver drugs to treat melanona, an aggressive form of skin cancer. The team says they developed an antigen that works with the patch device, containing a biomarker protein over-expressed by melanoma tumors and an adjuvant that boosts an immune response. In early tests with healthy lab mice, antigens delivered through the patch appear to invoke an immune response in the skin of lab mice, which in turn could migrate to lymph nodes and stimulate a greater immune response. Further tests are planned in mice induced with melanoma tumors.

“We are using low-cost chemistry and a simple fabrication scheme to transform vaccination,” says Hammond. “Ultimately, we want to get a device approved and on the market.”

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Infographic – U.S. Mfring Shrinks, First Time Since 2009

Chart: U.S. manufacturing

Click on image for full-size view (Statista)

24 Aug. 2019. Manufacturing activity in the U.S. contracted for the first time since 2009, at the end of the great recession, another sign of a slowing economy. The IHS Markit Flash Manufacturing Purchasing Managers Index, or PMI, for August fell to 49.9, below the 50.0 neutral line, indicating a shrinking manufacturing sector. Our friends at Statista track the index’s ups and downs since January 2018, in this weekend’s infographic.

Manufacturing and research have symbiotic relationship in a modern economy. According to the Brookings Institution and Rockefeller Foundation, advanced manufacturing that applies research into new products and processes is an economic stimulant and generator of high-paying jobs. Co-locating manufacturing and R&D encourages innovation and reduces the time needed to implement new solutions. Thus we follow new manufacturing processes at Science & Enterprise from academic and company labs.

IHS Markit says the downturn in this month’s Flash PMI is a result of a large reduction in new orders for manufactured goods, which the group describes as “the sharpest for exactly 10 years.” Manufacturers also are reducing their inventories of raw materials and finished goods, adding to the lower index levels. In addition, Tim Moore, Economics Associate Director for IHS Markit notes in a company statement, “Manufacturing companies continued to feel the impact of slowing global economic conditions, with new export sales falling at the fastest pace since August 2009.”

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Crispr Deployed for Programmable Smart Hydrogels

Crispr hydrogel

Hydrogel infused with Crispr-edited DNA, programmed to release therapeutic cargoes (Wyss Institute, Harvard University)

23 Aug. 2019. Bio-engineers developed a process using the gene editing technique Crispr to design gel materials with properties added for drug delivery, diagnostics, and electronic circuits. A team from Harvard University and Massachusetts Institute of Technology describe the process in today’s issue of the journal Science (paid subscription required).

Researchers led by biomedical engineering professor James Collins from Harvard’s Wyss Institute for Biologically Inspired Engineering and MIT’s Engineered Gene Networks Lab aim to take greater advantage of gene editing to create new materials with specific characteristics to carry out specific functions. Crispr, short for clustered, regularly interspaced short palindromic repeats, makes it possible to edit genomes of organisms harnessing bacterial defense mechanisms that use RNA to identify and monitor precise locations in DNA.

For this task, Collins — on the faculty at both institutions — and colleagues employed a different enzyme for gene editing  called Crispr-associated, or Cas12a, rather than the more widely-used Cas9. Unlike Cas9, Cas12a can edit multiple gene locations simultaneously, yet the enzyme also connects more efficiently and precisely with target DNA than Cas9 and can reverse the bindings if needed. The team added edited DNA sequences to hydrogels, common water-based polymer gels, which often use one or more bio-compatible polymers.

The researchers infused different hydrogels with DNA edited by Crisper-Cas12a, designing in new hydrogel properties and demonstrating various functions for those materials. The team first tested the programmable nature of DNA editing with a high-priority target, methicillin-resistant Staphylococcus aureus or MRSA bacteria, demonstrating the ability to accurately and efficiently detect the gene in MRSA that makes the bacteria resistant to antibiotics.

The researchers used their Crispr-Cas12a editor to create a hydrogel for drug delivery. The basic hydrogel in this case is made with polyethylene glycol, a common bio-compatible polymer used in a number of medications and medical devices. The team infused the hydrogel with edited DNA, where the edits make it possible to attach small molecules or enzymes as cargoes. These attachments can be degraded under specified conditions, allowing for release of the cargoes when those conditions are encountered.

In another drug-delivery scenario, the team programmed hydrogels made with polyacylamides, a polymer used in a wide range of commercial products, including cosmetics. This hydrogel, programmed with edited DNA, is able to support larger payloads, such as human cells and gold nanoparticles, but still release their cargoes under specified conditions. This type of hydrogel delivery could, for example, deliver stem cells into regenerative medicine scaffolds for growing new tissue.

In yet another application, the researchers combined programmable hydrogels with electrical conductivity to create a simple diagnostics system. The team adapted a paper-based microfluidics device having layers of electrodes covered with carbon black nanoparticles that conduct an electric current. Carbon black also interacts with polymers allowing a current to flow through the device with a hydrogel in its channels.

The hydrogel contains as well edited DNA programmed to respond to the presence of target molecules, such as a protein biomarker of a disease. Under those conditions, the responding DNA breaks down the hydrogel, stopping the flow through the microfluidics device and interrupting the current, thus indicating the presence of the target molecule.

“We developed a range of materials with very different capabilities that highlight the breadth of applications enabled by programmable Crispr-responsive smart materials,” says Collins in a Wyss Institute statement. Collins is one of several scientific founders of the company Sherlock Biosciences, spun off from the Wyss Institute and Broad Institute, a genetics research center affiliated with both Harvard and MIT. As reported by Science & Enterprise in March 2019, Sherlock Biosciences is using Crispr to develop medical diagnostics with a low-cost process for detecting biological targets, including simple paper-based tests in non-lab settings.

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Business Practices to Keep Retail Competitive with Online

– Sponsored content –

Line at store entrance

(Rachel Martin, Unsplash)

23 Aug. 2019. Retail stores face increasing competition with online vendors, making it harder to grow a business, and in some cases even survive. Main Street stores may offer a convenient location and put up attractive window displays. Yet brick-and mortar stores have other natural advantages over online businesses that they should relentlessly exploit, not only to survive in this competitive world, but also thrive.

More social than social media

Social media may be in today’s headlines, but retail stores bring customers in face-to-face contact with real people such as store employees, as well as other customers. And these people are real flesh-and-blood humans, not avatars nor phony Photoshopped images. As a business owner, you need to create and project an enjoyable atmosphere for your customers that they cannot find online.

One place to start is the physical conditions in your store. Web sites like, for example, can offer ideas on lighting your workplace for effective results.

That also means of course your staff must be carefully screened during the hiring process to find employees eager to interact with customers and treat them with respect. And your HR efforts after hiring, including training and on-the-job coaching, needs to maintain your corps of knowledgeable and personable workers. Good customer service can make all the difference.

Speed and security

Another key advantage of retail stores is transaction speed. Next-day delivery or even same-day delivery cannot beat instant delivery, where customers take possession of their goods and walk out of the store immediately after purchase. But retail stores need to upgrade their technology to minimize waiting in lines, so sales are not lost and customers are happy with their purchases. This is particularly important for point-of-sale in a fast food restaurant, where waiting times cut directly into sales.

With people’s e-mail inboxes and social media filled with spam and scams, the brick-and-mortar store can be a welcome respite where secure transactions are routine. Person-to-person interactions, credit cards with embedded chips, and hard-copy receipts provide assurances of security that few, if any, online vendors can match.

It’s easy to despair the seemingly unfair advantages of online commerce, but Main Street has its not-so-secret weapons waiting to be unleashed.

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Math Model to Gauge Heart Attack Risk from Plaques

Heart, circulation system

(Bryan Brandenburg, Wikimedia Commons)

22 Aug. 2019. An academic-industry collaboration is creating a non-invasive technique to detect rupture-prone plaque build-ups in arteries and predict one’s risk of heart attack. A team from the Computational Mechanics Group at University of Texas in Austin and the diagnostics company HeartFlow Inc. in Redwood City, California is developing the technology, funded by a three-year, $550,000 grant from National Science Foundation.

The UT-Austin and HeartFlow researchers are seeking better and more cost-effective methods to diagnose a type of coronary artery disease called vulnerable plaques.  Coronary artery disease, also known as atherosclerosis or hardening of the arteries, often results from a build-up of cholesterol plaques on the arteries feeding the heart, and is a major risk factor for heart attacks and other cardiac diseases. Vulnerable plaques containing lipids or fats and other substances build up inside the artery walls, and become inflamed. If these vulnerable plaques rupture, they release debris into the blood stream, causing blood clots and blockages, leading to a heart attack.

The Computational Mechanics Group at UT-Austin studies computational geometry, mathematical models for geometric analysis, considering variables such as surfaces and angles within designated spaces and times. While the lab studies pure mathematical questions, its researchers also apply computational geometry to practical problems, including those in biomedical engineering, such as designing nanoparticle drug delivery systems and algorithms to model growth of prostate tumors.

Working with HeartFlow, the Computational Mechanics Group plans to design a model that captures data from non-invasive computed tomography or CT scans and calculates a personalized risk profile of vulnerable plaques rupturing into the blood stream. Current techniques use invasive catheters to investigate suspected arteries for vulnerable plaques and collect data on temperature and acid levels to determine rupture risk.

The researchers plan to write a mathematical model that makes it possible to read CT scans, identify vulnerable plaques, and determine their composition without catheters. The model will use results of earlier CT scans and match the images to medical data, indicating lipid and calcium content in the fibrous caps found in arterial plaques that are prone to rupture.

Thomas Hughes, a professor of mathematics and engineering at UT-Austin and director of the group says in a university statement, “Recent breakthroughs have presented the opportunity to segment vulnerable plaques from CT scans and identify material constituents, including lipid and calcium content, and fibrous caps, from which patient-specific, computational models can be formulated and the biomechanical stress in the plaque calculated.”

HeartFlow Inc. is a designer of web and mobile software that analyzes CT images to detect and identify problems with blood flow through the heart leading to coronary artery disease. The company’s algorithms are based on data collected through its web and mobile apps, and stored in the cloud. HeartFlow returns a personalized graphic of a patient’s heart showing arteries at higher risk of forming clots.

In the collaboration with UT-Austin, HeartFlow is expected to take prototype software developed in the lab through clinical trials, regulatory approvals with FDA, and subsequent commercialization. Hughes has an equity stake in HeartFlow.

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Small Biz Grant Funds Pre-Term Gut Microbe Therapy

Microbiome graphic

(Tony Webster, Flickr)

21 Aug. 2019. National Institutes of Health is supporting development of an extended-release probiotic treatment for necrotizing enterocolitis, an intestinal disease affecting premature infants. National Institute of General Medical Sciences, or NIGMS, part of NIH, is awarding $2.3 million to Scioto Biosciences Inc. in Indianapolis and Nationwide Children’s Hospital in Columbus, Ohio for the two-year project.

Necrotizing enterocolitis occurs almost entirely in pre-term infants, where the wall of the intestine is invaded by bacteria, becoming infected and inflamed. Damage to the intestinal wall can lead to perforation of the intestine and leakage into the abdomen, resulting in large-scale infection and death. Children’s Hospital of Los Angeles says necrotizing enterocolitis occurs in about 10 percent of premature infants, or 2,000 to 4,000 births.

Scioto Biosciences is developing treatments for disease associated with changes in microbial communities in the gut. The company creates probiotic treatments, or live bacterial cultures, designed to last for extended periods in the gut, where most probiotics require frequent doses to remain effective.  Scioto’s technology takes advantage of bacteria’s natural formation of biofilms, self-supporting communities of microbes that can survive for long periods of time. The company seeds therapeutic bacteria around porous micro-scale particles to encourage biofilm growth, then administers the biofilms as single-dose treatments.

Scioto’s lead product, code-named SB-121, is in preclinical development as a treatment for a number of disorders, including clostridium difficile infections and childhood obesity, as well as autism. The company conducted small-animal tests of SB-121 to determine its feasibility for treating necrotizing enterocolitis, funded by NIGMS, and determine optimal dosing.

The new grant extends the research into new-born pigs, with organs similar in size and function as humans. Tests will assess SB-121’s ability to prevent necrotizing enterocolitis, as well as gauge the impact of the treatment on microbial communities in full-term and premature pigs.

Scioto Biosciences is a two year-old company formed by Monon Bioventures, a life science start-up accelerator in Indianapolis, and the research arm of Nationwide Children’s Hospital, collaborating with Scioto in the research for NIGMS. Gail Besner of Nationwide Children’s Hospital, a scientific founder of Scioto and co-principal investigator of the project, says in a statement e-mailed to Science and Enterprise, “This funding will be used to support important pre-clinical experiments prior to treating necrotizing enterocolitis in pre-term infants. The work here will be critical to inform upcoming clinical work to help combat these deadly GI disorders as well as other diseases.”

The award from NIGMS is made under NIH’s Small Business Innovation Research, or SBIR, program that sets aside a portion of its overall research funding for small U.S.-based companies with science-based products. In Fiscal Year 2017, NIH set-aside about 3.7 percent of its research funding, or more than $1 billion, for SBIR and related Small Business Technology Transfer awards.

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Carb-X Funds Drug-Resistant Bacterial Vaccine

Klebsiella pneumoniae

Klebsiella pneumoniae bacteria (

20 Aug. 2019. A company developing vaccines with synthetic biology is receiving a grant for a vaccine to prevent infections from drug-resistant Klebsiella pneumoniae bacteria. Vaxxilon AG, in Reinach, Switzerland could receive up to $4.5 million from the international Carb-X consortium for the vaccine, the first of its kind to protect against these infections.

The vaccine is expected to prevent infections from Klebsiella pneumoniae bacteria, becoming increasingly resistant to carbapenem antibiotics, among the most-prescribed drugs to combat infections. Klebsiella pneumoniae is a gram-negative bacteria associated with pneumonia, bloodstream infections, wound or surgical site infections, and meningitis, particularly in health care settings. “Gram” refers to a classification for bacteria where the microbes either retain (gram-positive) or shed (gram-negative) a test stain on their protective cell coatings.

Vaxxilon is developing a vaccine code-named VXN-319 to prevent carbapenem resistant Klebsiella pneumoniae infections. The company calls VXN-319 a semi-synthetic conjugate vaccine, made from small synthesized fragments of naturally occurring carbohydrates called oligosaccharides, combined with a carrier protein. The synthetic carbohydrates are similar to the bacteria’s natural protective coating, and acts as an antigen to induce production of antibodies that protect against its infections. VXN-319 is in advanced discovery stages, being optimized for potency and chemical activity in the body, and to spot possible toxic effects.

Carb-X, short for Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator, is an international initiative to fight antibiotic resistance. The public-NGO consortium is made up of the Biomedical Advanced Research and Development Authority, or BARDA, an agency of the U.S. Department of Health and Human Services, National Institute of Allergy and Infectious Diseases, or NIAID, Germany’s Federal Ministry of Education and Research, and the Wellcome Trust, a foundation based in London, that provide the funding or in-kind services. Partnering organizations include Boston University law school where CARB-X is headquartered, as well as the Broad Institute of MIT and Harvard, Massachusetts Biotechnology Council, California Life Sciences Institute, AMR Centre in the U.K., and RTI International.

The grant from Carb-X provides $1.4 million to Vaxxilon to continue development of VXN-319. Should specified milestones be reached, Vaxxilon would qualify for another $3.1 million from Carb-X. “The complete Carb-X award will enable us to conduct the full preclinical development, GMP manufacturing, and a Phase I [early-stage] clinical trial for VXN-319, a semi-synthetic conjugate vaccine,” says Tom Monroe, CEO of Vaxxilon in a company statement released through Businesswire. Monroe adds that, “Vaxxilon’s novel vaccine, if approved, could prevent infections, save lives, and reduce the pressure for use of powerful antibiotics.”

Vaxxilon is a spin-off enterprise from the Max-Planck Institute for Colloids and Surfaces in Potsdam, Germany, licensing research on synthetic carbohydrates by Peter Seeberger, director of the institute. The company was formed in 2015 by the Max Planck Society and the Swiss biopharmaceutical maker Actelion Ltd.

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