Join JAAGNet and Group

SIgn up for JAAGNet & the MedTech Group its FREE!!

 

Member Benefits:
_____________________

 

Again signing up for JAAGNet & Group Membership is FREE and will only take a few moments!

Here are some of the benefits of Signing Up:

  • Ability to join and comment on all the JAAGNet Domain communities.
  • Ability to Blog on all the Domain communities 
  • Visibility to more pages and content at a group community level, such as Community, Internet, Social and Team Domain Community Feeds.
  • Make this your only content hub and distribute your blogs to LinkedIn, Reddit, Facebook, Twitter, WhatsApp, Messenger, Xing, Skype, WordPress Blogs, Pinterest, Email Apps and many, many more (100+) social network and feed sites. 
  • Opportunity to collaborate (soon to be  released) with various JAAGNet Business communities and other JAAGNet Network members.
  • Connect (become friends), Follow (and be Followed) and Network with JAAGNet members with similar interests.
  • Your Content will automatically be distributed on Domain and JAAGNet Community Feeds. Which are widely distributed by the JAAGNet team.

Join Us!

JAAGNet Newsletter Signup

 

All Posts (180)

Sort by
Bronze Level Contributor

Bionaut Labs' small, remote-controlled devices can overcome the obvious constraint that holds back surgical drills, probes and needles: once they’re in the body, they can’t turn. (Getty Images)

The robots are coming: After working under the radar for four years, Bionaut Labs is raising the curtain on its tiny, remote-controlled devices, built to travel through the human body and deliver a dose of medicine where it’s needed the most.

Smaller than a millimeter and with a few moving parts, the tiny voyagers are designed to navigate through tissues and go where today’s surgeons cannot, such as when dealing with hard-to-reach cancers.

Their success would be a big step toward the fantastic future promised by decades of science fiction—but at its core, according to founder and CEO Michael Shpigelmacher, it’s an idea that is eminently practical.

“When there was a revolution in surgical robotics 10 to 20 years ago, the whole concept was built on complicated, multijointed robotic arms,” Shpigelmacher said in an interview. “As you look at the evolution of that industry, it's gone from one arm, to two arms, to five arms … companies are going for more robotic arms with more degrees of freedom.” 

8628218254?profile=originalOne Bionaut, to scale (Jon McKee Photography)

“Our paradigm is actually the opposite. We're saying move to a different category—where there are no robotic arms, and as many degrees of freedom as you want—but it’s just by controlling the tip,” he said. “As a company, we think that technically and medically this is the more elegant solution.”

Imagine a miniature screw that, as it rotates, can push its way through the body’s inner spaces until it reaches its target, releases a drug and then returns the way it came. But rather than rotating it with a screwdriver, the tool is invisible and guided only by magnetic fields generated outside the body.

This allows the small devices, dubbed Bionauts themselves, to overcome the obvious constraint that holds back surgical drills, probes and needles: once they’re in the body, they can’t turn.

“Typical brain procedures today are significantly more invasive than the Bionaut procedure, and they're definitely less accurate and precise in terms of their trajectory—because they are limited to taking linear paths,” Shpigelmacher said. In fact, a common biopsy diagnostic procedure may use a needle wider than a Bionaut and take core samples through healthy brain tissue on its straight line to a tumor.

To start, the company aims to tackle gliomas of the brainstem. The aggressive tumor is mostly diagnosed at a young age and can be particularly difficult to treat due to its dense and sensitive surroundings, which help regulate the body’s heartbeat and breathing.

By traveling up the spine or through the brain’s reservoirs of cerebrospinal fluid, Bionaut Labs hopes to safely navigate to the cancer and unlock a mechanism that delivers chemotherapies directly—or any established drug payload that may have wider side effects when given intravenously or has trouble crossing the protective barriers between the bloodstream and the brain.

“Because of the anatomy, you cannot reach the middle of a patient’s brainstem in a way that is not going to harm them significantly today,” he said. “This way, you can get higher drug concentrations in situ, while you get much lower to nonexistent concentrations in the plasma.”

So far, the Los Angeles-based company has conducted preclinical studies on small and large live animals, showing no long-term neurological damage from the Bionauts. Now, the company has raised $20 million to help take it to the next step and lock down the design of its technologies before moving into human clinical trials planned for 2023.

“We are thrilled to bring Bionaut Labs out of stealth mode as it typifies the type of new impactful technology companies we like to help build,” said Vinod Khosla, founder of Khosla Ventures, which led Bionauts’ latest financing alongside backing from Upfront Ventures, Revolution, BOLD Capital and Compound.

8628223254?profile=originalThe magnetically guided robot moves through tissue into a tumor, to drop its chemotherapy payload (Jon McKee Photography)

“Bionauts hold great promise as a new targeted treatment modality for severe brain disorders for which there are few, if any, effective treatment options,” Khosla added. “Moreover, the broad therapeutic potential of Bionauts extends to many diseases where conventional therapies are limited or lacking.”

The company also plans to explore its potential against neurodegenerative diseases such as Huntington’s, before one day tackling acute conditions like stroke, using a range of Bionauts with different shapes and characteristics.   

“What’s even more exciting is that the anatomical targeting capabilities of the Bionaut platform make new therapeutic technologies such as antisense, siRNA, gene therapy, CRISPR-Cas9, and oncolytic viruses viable in challenging clinical settings,” said Errol DeSouza, head of the company’s advisory board and co-founder of Neurocrine Biosciences.

And along the way, Shpigelmacher hopes to convince physicians and patients that the idea of tiny robots helping heal the body from within can be more science than fiction after all.

“It makes the discussion much simpler when—instead of talking about a spaceship flying around your brain—you say: ‘We're treating this condition, it's brainstem glioma; this is the payload, you know this payload; and we’re going to move X centimeters in and X centimeters out and deliver this thing,” he said. “It becomes extremely tangible and grounds it.”

Originally published by
Conor Hale | March 3, 2021
Fierce Biotech

Read more…
Bronze Level Contributor

Powerful mathematical model utilizes brain signal data collected from an electrical implant in patients

Epilepsy is one of the most common neurological conditions, affecting more than 65 million people worldwide. For those dealing with epilepsy, the approach of a seizure feels like a ticking time bomb. It could happen at any time or any place, potentially posing a fatal risk when a seizure strikes during activities such as driving or swimming.

A research team at the USC Viterbi School of Engineering and Keck Medicine of USC is tackling this dangerous problem with a powerful new seizure-predicting mathematical model that will give epilepsy patients an accurate warning five minutes to one hour before they are likely to experience a seizure, offering enhanced freedom for the patient and potentially reducing the need for medical intervention.

The research, published in the Journal of Neural Engineering, is led by corresponding authors Dong Song, research associate professor of biomedical engineering at USC Viterbi, and Pen-Ning Yu, a former PhD researcher in Song’s lab, in collaboration with Charles Liu, professor of clinical neurological surgery and director of the USC Neurorestoration Center. The other authors are Ted Berger, the David Packard Chair in Engineering and a professor of biomedical engineering at USC Viterbi, and Christianne Heck, medical director of the USC Comprehensive Epilepsy Program at the Keck Medical Center.

Model forecasts seizures up to one hour ahead of time

The mathematical model works by learning from large amounts of brain signal data collected from an electrical implant in the patient. Liu and his team have already been working with epilepsy patients with implantable devices, which are able to offer ongoing, real-time monitoring of the brain’s electrical signals in the same way as an electroencephalogram (EEG) uses external electrodes to measure signals. The new mathematical model can take this data and learn each patient’s unique brain signals, looking out for precursors or patterns of brain activity that show a “pre-ictal” state, in which a patient is at risk of seizure onset.

Song said the new model is able to accurately predict whether a seizure may happen within one hour, allowing the patient to take the necessary intervention.

“For example, it could be as simple as just alerting the patient their seizure is coming in the next hour, so they shouldn't drive their car right now, or they should take their medicine, or they should go and sit down,” Song said. “Ideally, in the future we can detect seizure signals and then send electrical stimulation through an implantable device to the brain to prevent the seizure from happening.”

A path to better epilepsy management

Liu said that the discovery would have major positive implications for public health, given epilepsy treatment had been severely impacted in the past year by the pandemic.

“This is, hopefully, going to change the way we deal with epilepsy going forward,” Liu said. “It's driven by the needs that have been in place for a long time but have been highlighted and accelerated by COVID.”

He added that currently, patients with medically intractable epilepsy — epilepsy that cannot be controlled with medication — are admitted electively to the hospital for video EEG monitoring. When the pandemic began, these elective admissions completely halted and epilepsy programs across the country ground to a halt. Liu said this highlights the need for a new workflow in which EEG recordings from scalp or intradural electrodes can be acquired at home and analyzed computationally.

“We need to create a new workflow by which, instead of bringing patients to the ICU, we take the recordings from their home and use the computation models to do everything they would have done in the hospital,” he said. “Not only can you manage patients using physical distancing, you can also scale in a way that only technology allows. Computation can analyze thousands of pages of data at once, whereas a single neurologist cannot.”

Originally published by
Amy Blumenthal, 917-710-1897 or amyblume@usc.edu; | Leigh Hopper, 310-308-0405 or lhopper@usc.edu   | February 25, 2021
USC University of Southern California

Illustration via iStock.

Read more…
Gold Level Contributor

Signs of burnout can be detected in sweat

EPFL engineers, working in association with startup Xsensio, have developed a wearable sensing chip that can measure the concentration of cortisol – the stress hormone – in human sweat. Enabling future quasi-continuous monitoring, their device can eventually help doctors better understand and treat stress-related conditions like burnout and obesity.

We’ve all felt stressed at some point, whether in our personal or professional lives or in response to exceptional circumstances like the COVID-19 pandemic. But until now there has been no way to quantify stress levels in an objective manner. 

That could soon change thanks to a small wearable sensor developed by engineers at EPFL’s Nanoelectronic Devices Laboratory (Nanolab) and Xsensio. The device has the potential to be placed directly on a patient’s skin in a wearable patch and, in the future, to quasi-continually measure the concentration of cortisol, the main stress biomarker, in the patient’s sweat.

Cortisol: A double-edged sword

Cortisol is a steroid hormone made by our adrenal glands out of cholesterol. Its secretion is controlled by the adrenocorticotropic hormone (ACTH), which is produced by the pituitary gland. Cortisol carries out essential functions in our bodies, such as regulating metabolism, blood sugar levels and blood pressure; it also affects the immune system and cardiovascular functions.

When we’re in a stressful situation, whether life-threatening or mundane, cortisol is the hormone that takes over. It instructs our bodies to direct the required energy to our brain, muscles and heart. “Cortisol can be secreted on impulse – you feel fine and suddenly something happens that puts you under stress, and your body starts producing more of the hormone,” says Adrian Ionescu, head of Nanolab.

While cortisol helps our bodies respond to stressful situations, it’s actually a double-edged sword. It’s usually secreted throughout the day according to a circadian rhythm, peaking between 6am and 8am and then gradually decreasing into the afternoon and evening. “But in people who suffer from stress-related diseases, this circadian rhythm is completely thrown off,” says Ionescu. “And if the body makes too much or not enough cortisol, that can seriously damage an individual’s health, potentially leading to obesity, cardiovascular disease, depression or burnout.”

8557007093?profile=RESIZE_400x

Qualitative depiction of regular and irregular circadian levels throughout the day. © Nanolab, EPFL

Capturing the hormone to measure it

Blood tests can be used to take snapshot measurements of patients’ cortisol levels. However, detectable amounts of cortisol can also be found in saliva, urine and sweat. Ionescu’s team at Nanolab decided to focus on sweat as the detection fluid and developed a wearable smart patch with a miniaturized sensor. 

The patch contains a transistor and an electrode made from graphene which, due to its unique proprieties, offers high sensitivity and very low detection limits. The graphene is functionalized through aptamers, which are short fragments of single-stranded DNA or RNA that can bind to specific compounds. The aptamer in the EPFL patch carries a negative charge; when it comes into contact with cortisol, it immediately captures the hormone, causing the strands to fold onto themselves and bringing the charge closer to the electrode surface. The device then detects the charge, and is consequently able to measure the cortisol concentration in the wearer’s sweat.

8557009273?profile=RESIZE_710x

Process flow for capturing cortisol with the graphene electrode and aptamers. © Nanolab, EPFL

So far, no other system has been developed for monitoring cortisol concentrations continuously throughout the circadian cycle. “That’s the key advantage and innovative feature of our device. Because it can be worn, scientists can collect quantitative, objective data on certain stress-related diseases. And they can do so in a non-invasive, precise and instantaneous manner over the full range of cortisol concentrations in human sweat,” says Ionescu.

Engineering improved healthcare

The engineers tested their device on Xsensio’s proprietary Lab-on-SkinTM platform; the next step will be to place it in the hands of healthcare workers. Esmeralda Megally, CEO of Xsensio, says: “The joint R&D team at EPFL and Xsensio reached an important R&D milestone in the detection of the cortisol hormone. We look forward to testing this new sensor in a hospital setting and unlocking new insight into how our body works.” The team has set up a bridge project with Prof. Nelly Pitteloud, chief of endocrinology, diabetes and metabolism at the Lausanne University Hospital (CHUV), for her staff to try out the continuous cortisol-monitoring system on human patients. These trials will involve healthy individuals as well as people suffering from Cushing’s syndrome (when the body produces too much cortisol), Addison’s disease (when the body doesn’t produce enough) and stress-related obesity. The engineers believe their sensor can make a major contribution to the study of the physiological and pathological rhythms of cortisol secretion.

So what about psychological diseases caused by too much stress? “For now, they are assessed based only on patients’ perceptions and states of mind, which are often subjective,” says Ionescu. “So having a reliable, wearable sensor can help doctors objectively quantify whether a patient is suffering from depression or burnout, for example, and whether their treatment is effective. What’s more, doctors would have that information in real time. That would mark a major step forward in the understanding of these diseases.” And who knows, maybe one day this technology will be incorporated into smart bracelets. “The next phase will focus on product development to turn this exciting invention into a key part of our Lab-on-SkinTM sensing platform, and bring stress monitoring to next-generation wearables,” says Megally.

Originally published by
Julie Haffner | February 15, 2021
EPFL

References

Sheibani, S., Capua, L., Kamaei, S., Akbari S. S. A., Zhang J., Guerin H. and Ionescu A. M.

Extended gate field-effect-transistor for sensing cortisol stress hormone.” 

Communications Materials 2, Article number 10 (2021). 

Read more…
Gold Level Contributor

Photo: Spencer Platt/Getty Images

Healthcare organizations can harness machine learning to schedule vaccines, streamline patient communications and even prioritize access – but the technology is hardly infallible.

The question of who should get access to COVID-19 vaccines first has varied from state to state, with some governments prioritizing those with high-risk conditions and others lowering the age of eligibility. 

One South Dakota-based system, Sanford Health, is using a machine learning model to identify which individuals are at greatest risk of having severe COVID-19 outcomes – and applying the algorithm to eligible groups.  

"With [those] 85,000 people what we can do is take a real-time picture that evolves over time, using computer learning to tell us what patients or what people in the Midwest get the sickest from COVID-19," said Sanford chief physician Dr. Jeremy Cauwels to Minnesota Public Radio.

Cauwels told MPR that he believes an artificial intelligence approach is more equitable than random choice for administering the vaccine. 

Sanford isn't alone. Experts say AI has big potential to assist with the COVID-19 vaccine rollout.  

"The pace and scale of the vaccine rollout is unprecedented, and we are seeing AI play a role," said Lori Jones, chief revenue officer and president for the provider market at Olive, an AI-as-a-service vendor.  

Rather than using AI to identify at-risk patients, Jones noted its potential to promote efficiency within existing workflows.

"The biggest areas of focus for organizations that we’re working with have all related to managing the organization, scheduling, preregistration and communications activity around the testing and vaccines themselves, with additional automation activity to streamline patient communications and drive better vaccine efficacy by ensuring patients are aware, prepared and present to receive second doses," Jones explained.  

"We’ve got an important mission ahead of us still, and if we can’t expand the capacity of organizations delivering the vaccines to take on more patients faster, then there is a very real risk that this process could take years, not months," she said.  

Jones pointed to chatbots as a prime example of the way AI can be used in conjunction with other tools, specifically when it comes to patient engagement.  

"AI-enabled digital call centers are helping organizations manage the significant level of interest in key vaccine information," she said. "FAQs can be converted into chatbots to refresh the available information to be COVID-19-specific."

"If the healthcare industry continues to rely on paper forms, phone calls, mobile apps, portals and email campaigns, process bottlenecks will create long lines, confusion and frustration," agreed Greg Johnsen, CEO of LifeLink, which powers conversational solutions for healthcare organizations.   

"Additional complexities around new documentation, specific follow-up vaccination windows and an influx of people that are new patients could overwhelm current intake and scheduling processes," said Johnsen. "Building a handful of digital assistants versus training thousands of individuals is also a key consideration when it comes to efficiency and cost."   

That said, there are unmistakable downsides to relying on AI – namely, expecting the technology to be infallible.   

"Pursuing AI strategies can certainly bring about adoption challenges, and adoption is critical to any AI strategy," said Jones. "One roadblock to AI adoption is understanding that AI tools aren’t replacing human healthcare workers: They’re actually empowering them and helping them work better, faster."  

There are also the ever-present dangers of reproducing bias or using faulty algorithms. In December of this past year, Stanford Medical Center came under fire for prioritizing administrators over frontline health workers due to an error in the rule-based formula it was using to help calculate who would get vaccinated first.

Sanford, in South Dakota, is not using race or ethnicity as a factor in its algorithms, theorizing that individuals with higher rates of chronic disease will be elevated in the prioritization.   

But given the disproportionate effect of COVID-19 on patients of color – especially Black, Latinx and Native people – other health systems in nearby states say it's important to take those demographics into consideration.  

The University of Wisconsin-Madison did use a race-based algorithm to prioritize employee vaccines in its initial distribution, Shiva Bidar-Sielaff, chief diversity officer at UW Health, told MPR. 

"It's incredibly important to realize that all data points to the fact that, unfortunately, race and ethnicity have been shown to create a much higher risk of hospitalization and death for COVID-19," said Bidar-Sielaff.   

"So when we looked at our algorithm, we saw that if you add age and SVI, which has that component of race and ethnicity, it's a multiplier effect in how much higher risk an individual is at for hospitalization and death," she said.

Some companies are stressing the need for caution when it comes to using AI for vaccine allocation. 

Representatives from Salesforce, which launched its Vaccine Cloud tool this past month to assist clients with managing vaccine administration, said they were working to ensure equitable distribution.  

"Vaccine Cloud can deliver integrated and customized solutions for our customers, including the ability to use data and insights to support [the] distribution, management and administration of vaccines," a Salesforce spokesperson told Healthcare IT News via email.  

"However, our Principles for the Ethical Use of COVID-19 Vaccine Technology Solutions explicitly state that AI should not be used to predict personal characteristics or beliefs that would affect a person’s or group’s prioritization for access to vaccines, and we work closely with our partners and teams on this guidance."  

Still, it's clear that AI – when deployed responsibly – may be able to make the COVID-19 vaccine rollout faster and more effective for at-risk patients.

"The vaccine rollout is the ultimate test for AI to showcase the breadth of time-saving and efficacy capabilities, and demonstrate its full value for healthcare leaders," said Jones. "When organizations emerge from the COVID crisis, we see AI becoming an integral part of their digital strategy."

Originally published by
Kat Jercich | February 11, 2021
Healthcare IT News

Read more…
Bronze Level Contributor

In a test of 30 popular mobile health apps, a cybersecruity analyst found that all of them had API vulnerabilities.  Potential breaches would allow for unauthorized access of patient records.

While most patients expect their health information to be secure when they download an app the reality might often be the opposite.

Several widely-used mobile health apps have basic security flaws that could leave them vulnerable to attacks, according to a report released yesterday by Knight Ink and mobile app API security company Approov.

Alissa Knight, a cybersecurity analyst and partner at Knight Ink, tested 30 popular mobile health apps for potential security vulnerabilities. All 30 were vulnerable to API attacks that could expose patient records.

Though the report didn’t disclose the names of the apps that were tested, it’s worth noting that they weren’t just niche tools created by small teams.  The apps tested had an average of 772,619 downloads, and the companies that developed them had about 15,000 employees on average, and annual revenues between $600 million and $8 billion.

For example, they were the types of apps that hospitals would tell patients to download to access their lab results or records after a visit, Knight said in a phone interview.

“They were so poorly written that, using freely downloadable tools, I could change the data that I was requesting to be another patient’s records,” she said.

Application programming interfaces (APIs) serve as intermediaries processing requests for information from an app and retrieving that information from a database. Knight tested them for several vulnerabilities, including whether she could access another user’s data or breach an account.

All of the APIs were vulnerable to Broken Object Level Authorization (BOLA) vulnerabilities, that allowed her to access patient information that her account shouldn’t have been able to access. Knight used the analogy of a coat check to explain it:

One person checks their jacket, and gets a ticket with the number 18, while the person next in line gets a ticket with the number 17. By changing the number 7 to an 8, the “hacker” would be able to take the other person’s coat.

Except in this case, she was able to access patient records, lab results, x-rays, allergies, and personally identifiable information, including social security numbers.

“I was very surprised. I knew I would find BOLA vulnerabilities in mobile health apps and APIs, but I didn’t know it would be this systemic,” Knight said.

Half of the APIs she tested allowed her to access other patients’ pathology results, x-rays and other clinical information. Half of them also allowed her to access records for patients that had been admitted to the hospital as inpatients.

She also found that 77% of the apps had hard-coded API keys, and 7% contained hard-coded usernames and passwords, which would allow someone who could view the app’s code to access those users’ accounts. By accessing one hospital’s login, she was able to access 10s of thousands of patient records.

“This is really low-hanging fruit,” she said. “It requires very little sophistication, very little money. One of the tools I was using was freely available, and the apps are available in the app store for free. All you have to do is register for an account.”

The problem of cybersecurity is not limited to mobile health apps alone.

A separate survey of executives at medtech companies found that 80% of them had suffered at least one cyberattack in the past five years. The survey, conducted by platform security company Irdeto, included medical device manufacturers, digital and mobile health companies and telehealth providers.

Knight said that cybersecurity must be a consideration while code is still being written, instead of trying to secure a project while it is available to the general public. Companies should also bring in outside experts to test them before they go to market.

“We need to do better about securing (health data) and making sure it’s a lot more difficult for adversaries to get access to it,” she said. “For me, being a vulnerability researcher is so important — making sure we’re holding these vendors’ feet to the fire and making sure they’re following best practices, because this is our most sensitive data.”

Originally published by
Elise Reuter | February 10, 2021
MedCity News

Photo credit: Getty Images, weerapatkiatdumrong

Read more…
Gold Level Contributor

The full clearance follows up on an emergency authorization granted by the FDA last summer, aimed at the COVID-19 pandemic. (Getty/sudok)

The FDA has cleared an artificial intelligence program designed to predict which patients in an intensive care unit will begin to deteriorate, giving clinicians up to eight hours of advanced warning and time to prepare.

Developed by CLEW, the system gathers data from electronic health records, vital sign monitors and connected ICU devices, and uses machine learning models to calculate each person’s risk of their heart and blood flow becoming unstable.

The full clearance follows up on an emergency authorization granted by the agency last year, aimed at the COVID-19 pandemic, with a focus on spotting the early signs of respiratory distress.

The CLEWICU system also identifies patients at a low risk of decompensating in near real-time, allowing staff to better prioritize the use of their resources.

"We are proud to have received this landmark FDA clearance and deliver a first-of-its-kind product for the industry, giving healthcare providers the critical data that they need to prevent life-threatening situations," CLEW CEO Gal Salomon said in a statement.

Previous studies by CLEW showed the system was able to provide accurate alerts to staff by a median of three-and-a-half hours early. The company also plans to develop AI models predicting patient deterioration across all care settings.

Originally published by
Conor Hale | February 8, 2021
FierceBiotech

 

Read more…
Gold Level Contributor

Engineers at EPFL’s Center for Artificial Muscles have developed a silicone aorta that can reduce how hard patients’ hearts have to pump. Their breakthrough could offer a promising alternative to heart transplants.

“Over 23 million people around the world suffer from heart failure. The disease is usually treated with a transplant, but because donated hearts are hard to come by, there is an ongoing need for alternative therapies. With new developments in cardiac assistance systems, we can delay the need for a transplant – or even eliminate it altogether,” says Professor Yves Perriard, head of EPFL’s Center for Artificial Muscles within the School of Engineering. He and a team of around ten other engineers from EPFL’s Integrated Actuators Laboratory (LAI) have been working on new cardiac assistance technology over the past four years. Their discovery, which employs flexible actuators, has been published in Advanced Science.

Electrodes and a silicon aorta 

Our aortas are naturally elastic. They expand as blood is pumped into them from the heart’s left ventricle, and then contract to distribute the blood to the rest of the body. But in patients suffering from diseases such as heart failure, the heart has to work harder to accomplish this cycle. To ease the burden on the heart, EPFL engineers have designed an artificial aorta made of silicon and a series of electrodes. Their device is implanted just behind the aortic valve and amplifies the aorta’s efforts, working like an “augmented aorta.” When an electric voltage is applied to the device, the artificial aorta expands to a diameter that’s larger than the natural aorta. “The advantage of our system is that it reduces the pressure on a patient’s heart. The idea isn’t to replace the heart, but to assist it,” says Yoan Civet, a Scientist at the LAI. 

8511082874?profile=RESIZE_710x

© 2021 EPFL

Helping the heart expend less energy 

To validate their system, the engineers built a simulator consisting of pumps and chambers that replicate the blood-flow and pressure conditions within a human heart. “By testing our device on the simulator, we were able to reduce the amount of cardiac energy required by 5.5%,” says Civet. The research team now plans to conduct further tests of their artificial aorta, and are already working on a new design that delivers better performance. 

However, the real challenge lies in the manufacturing step. “We started from scratch and had to develop a new production process that would allow us to increase the volume of the silicone tube. We also had to overcome a problem of electric breakdown. Due to our multi-layer design, only half as affordable electric field was reached as compared to a single-membrane system. We had to troubleshoot the problem and then come up with a solution,” says Civet. The research team has filed a patent for their technology. The hope is that their discovery can be used to treat other medical conditions, such as urological disorders, that require a similar approach.

Originally published by
Valérie Geneux | February 3, 2021
EPFL

Funding

This research was carried out under a joint initiative by ETH Zurich, the University of Bern and EPFL. The consortium has received a 12-year, CHF 12 million grant from the Werner Siemens Foundation to develop a cardiac assistance system, a urology system and a facial reconstruction system all based on flexible actuators.

Read more…
Silver Level Contributor

Engineers at the McKelvey School of Engineering at Washington University in St. Louis have developed a microneedle patch that can be applied to the skin, capture a biomarker of interest and, thanks to its unprecedented sensitivity, allow clinicians to detect its presence.

Blood draws are no fun.

They hurt. Veins can burst, or even roll — like they’re trying to avoid the needle, too.

Oftentimes, doctors use blood samples to check for biomarkers of disease: antibodies that signal a viral or bacterial infection, such as SARS-CoV-2; or cytokines indicative of inflammation seen in conditions such as rheumatoid arthritis and sepsis.

These biomarkers aren’t just in blood, though. They can also be found in the dense liquid medium that surrounds our cells, but in low abundance that makes it difficult to be detected.

Until now.

Engineers at the McKelvey School of Engineering at Washington University in St. Louis have developed a microneedle patch that can be applied to the skin, capture a biomarker of interest and, thanks to its unprecedented sensitivity, allow clinicians to detect its presence.

The technology is low cost, easy for a clinician or patients themselves to use and it could eliminate the need for a trip to the hospital just for a blood draw.

The research, from the lab of Srikanth Singamaneni, the Lilyan & E. Lisle Hughes Professor in the Department of Mechanical Engineering & Materials Sciences, was published online Jan. 22 in the journal Nature Biomedical Engineering.

In addition to the low cost and ease of use, these microneedle patches have another advantage over blood draws, perhaps the most important feature for some: “They are entirely pain-free,” Singamaneni said.

Finding a biomarker using these microneedle patches is similar to blood testing. But instead of using a solution to find and quantify the biomarker in blood, the microneedles directly capture it from the liquid that surrounds our cells in skin, which is called dermal interstitial fluid (ISF). Once the biomarkers have been captured, they’re detected in the same way — using fluorescence to indicate their presence and quantity.

ISF is a rich source of biomolecules, densely packed with everything from neurotransmitters to cellular waste. However, to analyze biomarkers in ISF, conventional method generally requires extraction of ISF from skin. This method is difficult and usually the amount of ISF that can be obtained is not sufficient for analysis. That has been a major hurdle for developing microneedle-based biosensing technology.

Another method involves direct capture of the biomarker in ISF without having to extract ISF. Like showing up to a packed concert and trying to make your way up front, the biomarker has to maneuver through a crowded, dynamic soup of ISF before reaching the microneedle in the skin tissue. Under such conditions, being able to capture enough of the biomarker to see using the traditional assay isn’t easy.

But the team has a secret weapon of sorts: “plasmonic-fluors,” an ultrabright fluorescence nanolabel. Compared with traditional fluorescent labels, when an assay was done on microneedle patch using plasmonic-fluor, the signal of target protein biomarkers shined about 1,400 times as bright and become detectable even when they are present at low concentrations.

“Previously, concentrations of a biomarker had to be on the order of a few micrograms per milliliter of fluid,” Zheyu (Ryan) Wang, a graduate student in the Singamaneni lab and one of the lead authors of the paper, said. That’s far beyond the real-world physiological range. But using plasmonic-fluor, the research team was able to detect biomarkers on the order of picograms per milliliter.

“That’s orders of magnitude more sensitive,” Wang said.

These patches have a host of qualities that can make a real impact on medicine, patient care and research.

They would allow providers to monitor biomarkers over time, particularly important when it comes to understanding how immunity plays out in new diseases.

For example, researchers working on COVID-19 vaccines need to know if people are producing the right antibodies and for how long. “Let’s put a patch on,” Singamaneni said, “and let’s see whether the person has antibodies against COVID-19 and at what level.”

Or, in an emergency, “When someone complains of chest pain and they are being taken to the hospital in an ambulance, we’re hoping right then and there, the patch can be applied,” Jingyi Luan, a student who recently graduated from the Singamaneni lab and one of the lead authors of the paper, said. Instead of having to get to the hospital and have blood drawn, EMTs could use a microneedle patch to test for troponin, the biomarker that indicates myocardial infarction.

For people with chronic conditions that require regular monitoring, microneedle patches could eliminate unnecessary trips to the hospital, saving money, time and discomfort — a lot of discomfort.

The patches are almost pain-free. “They go about 400 microns deep into the dermal tissue,” Singamaneni said. “They don’t even touch sensory nerves.”

In the lab, using this technology could limit the number of animals needed for research. Sometimes research necessitates a lot of measurements in succession to capture the ebb and flow of biomarkers — for example, to monitor the progression of sepsis. Sometimes, that means lot of small animals.

“We could significantly lower the number of animals required for such studies,” Singamaneni said.

The implications are vast — and Singamaneni’s lab wants to make sure they are all explored.

There is a lot of work to do, he said: “We’ll have to determine clinical cutoffs,” that is, the range of biomarker in ISF that corresponds to a normal vs. abnormal level. “We’ll have to determine what levels of biomarker are normal, what levels are pathological.” And his research group is working on delivery methods for long distances and harsh conditions, providing options for improving rural healthcare.

“But we don’t have to do all of this ourselves,” Singamaneni said. Instead, the technology will be available to experts in different areas of medicine.

“We have created a platform technology that anyone can use,” he said. “And they can use it to find their own biomarker of interest.”

Originally published by
Brandie Jefferson | January 22, 2021
The McKelvey School of Engineering, Washington University in St. Louis


This research was supported by the National Science Foundation (CBET-1900277), and the National Institutes of Health (R01DE027098, R56DE027924, R01CA141521, R21DA036663, R21CA236652).


The McKelvey School of Engineering at Washington University in St. Louis promotes independent inquiry and education with an emphasis on scientific excellence, innovation and collaboration without boundaries. McKelvey Engineering has top-ranked research and graduate programs across departments, particularly in biomedical engineering, environmental engineering and computing, and has one of the most selective undergraduate programs in the country. With 140 full-time faculty, 1,387 undergraduate students, 1,448 graduate students and 21,000 living alumni, we are working to solve some of society’s greatest challenges; to prepare students to become leaders and innovate throughout their careers; and to be a catalyst of economic development for the St. Louis region and beyond.
Read more…
Bronze Level Contributor

Edinburgh medtech company Manus Neurodynamica has closed a £1.2 million funding round to support the launch of its digital pen which provides an early warning of Parkinson's disease and other neurological conditions.

With this latest funding secured, Manus is rolling-out its NeuroMotor Pen later this year, initially focussing on the UK and Benelux markets, while also progressing work to secure regulatory approval to start selling in US. Around 145,000 people live with Parkinson’s in the UK and it's the fastest-growing neurological condition in the world. 

Investors in this funding round included the North East Innovation Fund, supported by the European Regional Development Fund and managed by Northstar Ventures, profit with purpose investor SIS Ventures and Old College Capital, the University of Edinburgh’s venture fund.

The NeuroMotor Pen employs sensors linked with analytical software which analyses the slightest limb and hand movements to help doctors assess whether a patient has early signs of Parkinson's or other neurological conditions. As well as providing a quick, inexpensive, non-invasive and objective aid to diagnosis, the CE-marked product also helps with the ongoing monitoring of those conditions.

The mission-driven business is currently in advanced talks to supply the pens to a leading UK-based primary care group, following a development contract with NHS England to develop a version that can be used in GP surgeries. The pen has passed clinical trials with the NHS in the north-east of England and Scotland and is currently being used by Northumbria NHS Foundation Trust.

Led by CEO Rutger Zietsma, Manus has spent over 10 years developing the product, from concept through to manufacture and roll-out. In January last year, the firm signed a five-year contract with stationery brand Stabilo to manufacture the pens in Germany.

Dr Rutger Zietsma, chief executive officer of Manus Neurodynamica, said: “2021 looks set to be an extremely busy year for Manus. Having spent more than 10 years developing, trialling and refining our first product, we can finally look forward to seeing our NeuroMotor Pens implemented more broadly and making a real difference to the lives of people living with Parkinson’s and other neurological conditions. Through faster and simpler diagnoses and objective patient monitoring with digital record keeping, we can help streamline the pathway and deliver more successful treatment outcomes for the fastest growing neurological condition in the world.”

Funding rounds, totalling £5 million to date, including a £750,000 financing round, closed in May last year, have been led by healthtech investors Par Equity with support from the Scottish Investment Bank, the investment arm of Scottish Enterprise, and Old College Capital.

Rob Halliday, fund manager, SIS Ventures said: “Manus is one of Scotland’s most promising early stage medtech companies, with the potential to make a huge impact. With its disruptive technology, mission-led approach, and ambitious management team, Manus is exactly the kind of business we look to invest in at SIS Ventures. Working along with the other investors, we’re very pleased to support Rutger and his team through their next phase of growth and impact creation.”

Rick Charnley, investment manager, Northstar Ventures added: “Having originally been involved with the company via a previous investment used to develop the initial prototype, we’ve been impressed with the team’s enhanced mission and are delighted to support the company further. We’re big believers in the impact medtech companies like Manus can have on an ageing society.”

Originally published by
Med-Tech Innovation News | January 24, 2021

Read more…
Bronze Level Contributor

4 key trends for medtech in 2021

Image: Adeline Kon/MedTech Dive

COVID-19 challenges, and opportunities, will continue to impact companies this year.

The calendar signals a new year but the medtech industry in 2021 will feel the lingering effects, both positive and negative, from the global coronavirus pandemic. 

With the resurgence of the virus and emergence of new more contagious strains, COVID-19 will have major impacts on companies as much as 2020, albeit with the benefit of insights gleaned from the historic year and its unprecedented business environment.     

Earlier this month, medtech and diagnostics companies gathered virtually to discuss 2021 prospects at J.P. Morgan's annual healthcare conference. Executives painted a mixed picture with the first half of the year looking bumpier than the second half.

Not surprisingly, many companies are not providing 2021 guidance due to the uncertainty caused by COVID-19. However, Craig-Hallum analyst Alex Nowak noted recently that most of the companies his firm covers have spoken optimistically about a full recovery taking hold in 2021.

"The recovery though will not be outsized year/year growth in 1Q21-3Q21, but instead consistent levels of quarter/quarter gains throughout the year," Nowak wrote in a research note.    

Below are four big trends to watch in 2021 for the industry.

Elective procedures remain under pressure

Wall Street expects declines in elective care in the near term to continue as coronavirus cases keep rising. While the rollout of vaccines will likely help volumes, procedure comebacks are not expected until the second half of 2021, according to J.P. Morgan analysts.

To be sure, there will be winners and losers financially in this scenario.

"The ones affected were, to no surprise, those tied to elective procedures or were hospital-oriented," according to Nowak. "The real weakness was procedures that were not entirely critical (or critical and could be shifted outside the hospital), nor driven by higher income, such as spine surgery."

While Moody's expects procedure volumes will continue to recover in 2021 as patients who deferred procedures to treat chronic illnesses return to their healthcare providers, the investor service predicts demand will be volatile based on the spread of COVID-19.

Moody's expects transcatheter aortic valves, a key revenue driver, "will return to double-digit growth" for leaders such as Edwards Lifesciences and Medtronic.

Edwards on Wednesday reported that U.S. TAVR sales were actually down lower than Wall Street's expectations in the fourth quarter, and recent procedure slowdowns are expected to spill into 2021. However, CEO Michael Mussallem believes that the company will still hit its guidance of growing TAVR globally by 15-20% this year.

Medtronic warned earlier this month that due to the COVID-19 surge the company now expects overall business to be "roughly flat" this quarter, on an organic basis, instead of flat to slightly up. 

CEO Geoff Martha noted that Medtronic didn’t see much of a negative impact from the surge in coronavirus cases in October, November and even the first half of December. However, the medtech giant started to see "some impact" starting over the holidays. 

Nonetheless, Martha called hospitals more experienced at handling the current COVID-19 surge while maintaining capacity for non-coronavirus patients. He cited pockets in the U.S. and Europe "where it has slowed down a bit" in recent weeks.  

"It is more of an elective case pullback issue versus some other issue that's unique to Medtronic," Martha said. "Based on the feedback that we're getting from hospitals, we remain optimistic that this is going to be short lived."   

However, executives from Baxter and Boston Scientific appear to be more concerned about the ability of some hospitals to manage the coronavirus stresses on their health systems as the number of cases continue to rise.  

Baxter CFO Jay Saccaro at the recent J.P. Morgan conference described the current coronavirus surge as "volatile" and that Baxter will be taking "as much time as we possibly can to put together guidance." 

Boston Scientific expects a rebound in procedure volumes this year. However, the company is not providing 2021 guidance at this time. CEO Mike Mahoney told analysts that he expects “some COVID impact” and “softness” in the first quarter “given the market environment.” However, Mahoney said with the increasing rollout of COVID-19 vaccines in 2021 the situation will “improve each month.”    

Another banner year for COVID-19 testing

Demand for COVID-19 testing will continue to accelerate over the next year, with volumes remaining high until vaccines are widely distributed, according to Moody's.

"This will benefit companies that sell diagnostic tests, like Abbott Laboratories and Becton Dickinson, as well as life science companies that provide reagents used in these tests like Thermo Fisher Scientific," Moody's analysts wrote in their 2021 outlook for the global healthcare sector. 

Despite the rollout of coronavirus vaccines, Abbott, Hologic and Quidel are ramping up their manufacturing capabilities in anticipation of another banner year for COVID-19 testing. CEOs from the diagnostic makers laid out their coronavirus test plans earlier this month at J.P. Morgan. 

Hologic CEO Stephen MacMillan said the company has more than doubled its molecular diagnostic manufacturing capacity and is investing to more than triple capacity from 25 million tests in the fourth quarter of 2020 to 75 million tests per quarter by the second quarter of 2022. 

"Everybody thought as soon as vaccines came, testing is going to go away. I think everybody is now seeing the realities of rolling out vaccines, of distribution chains. There is so much more complexity," MacMillan said. "This market, we believe, continues to grow and continues to be strong. And while it will certainly come down at some point, we believe it's going to be stronger for longer."  

Abbott CEO Robert Ford said he expects high demand and volume for tests throughout 2021. The company is near completion of capacity expansion at U.S. manufacturing sites, which Ford estimated will enable production of tens of million more of its BinaxNOW COVID-19 antigen tests per month for sale to schools, workplaces, and pharmacies.

Quidel's QuickVue SARS test, a pregnancy test-style antigen diagnostic that like Abbott's BinaxNOW delivers results in minutes, is the focus of an at-home coronavirus testing effort.   

"We are now anticipating a QuickVue SARS OTC at-home approval, which would not require a prescription," CEO Doug Bryant said at the conference. "We think it's the future of the company."  

Early in 2021, Quidel hopes to have QuickVue tests available as OTC at home productsThe company plans to manufacture as many of the diagnostics that it can this year.  

Tuck-in acquisitions poised to take off

While M&A slowed last year due to the coronavirus pandemic, a report from consultancy EY predicts medtech dealmaking to jump in 2021 as companies are armed with a record high of roughly $500 billion in financial firepower. So far this year, the industry has seen a flurry of activity.

Hologic kicked the trend off in January with an acquisition of Somatex Medical for $64 million, and less than a week into 2021 added its second tuck-in with the acquisition of Biotheranostics for $230 million. PerkinElmer struck a deal to buy tuberculosis test provider Oxford Immunotec for $591 million and Thermo Fisher Scientific announced it will acquire privately-held molecular diagnostic maker Mesa Biotech for $450 million in cash.

The biggest deal over the first weeks of January was Steris' purchase of Cantel Medical in a cash and stock acquisition of approximately $4.6 billion, followed by Boston Scientific's announcement that it will purchase cardiac monitoring company Preventice Solutions in a $925 million deal and Philips' plans to acquire Capsule Technologies for a cash consideration of $635 million.   

At Boston Scientific, strategic tuck-ins remain the company’s “number one priority” when it comes to capital deployment with a focus on high-growth adjacent markets, CEO Mike Mahoney said earlier this month, noting $1.9 billion in cash on hand as of the end of last year. He also said the company will continue to be active with its venture capital portfolio “which has historically served as well as a nice pipeline” for M&A.     

Medtronic's Martha said that the medtech giant plans to continue to look for M&A opportunities in 2021 after the company last year accelerated its momentum for tuck-in acquisitions, announcing seven such deals with a combined total consideration of over $1.6 billion. 

Baxter CEO Joe Almeida said the company continues to "think very seriously" and to "evaluate" M&A this year. "I'm not in a position to tell you affirmatively that 2021 is the year of M&A," he remarked, though it is part of the medtech's playbook.

While some companies will look for tuck-in acquisitions, a handful of deals over $1 billion should be expected, according to John Babbitt, EY's MedTech leader for the Americas. In addition, EY sees several subsectors as top targets in 2021 for M&A activity including diagnostics, digital health, and remote patient monitoring.  

Digital, remote tech adoption to grow

Last year, the need to create safe physical distances between healthcare workers and COVID-19 patients prompted medtechs to modify how their devices are used, including remote programming and monitoring. This year, executives say they will continue to adopt many of the features, which are becoming permanent offerings.

Martha said Medtronic will be increasingly incorporating the technology across its product portfolio.  

“You are already seeing this with the advances we have made in remote monitoring and remote programming of many of our devices. We have added advanced capabilities to cardiac rhythm devices, diabetes insulin pumps, and ventilators, just to name a few,” Martha said.

Abbott's Ford said his company is continuing to adopt remote care and digital health technologies as a result of the pandemic, which has accelerated the trend. However, Ford made the case at J.P. Morgan that the benefits of such tech goes beyond just COVID-19.

"It allows for much more proactive management. We see that in some of our portfolio. It can decrease the response time, especially if you've got like an urgent care situation. It can really bring that response time down lower, cuts up a lot of the logistical issues, the challenges of in-person, and then ultimately can lead to lower healthcare cost," Ford said.

He pointed to the FDA's approval in July of the Gallant implantable cardioverter defibrillator family of devices to help manage heart rhythm disorders, which offer Bluetooth technology and a new patient smartphone app for improved remote monitoring.   

Boston Scientific in 2021 is also looking to build on “healthcare digital adoption” by accelerating and expanding its remote technology capabilities, according to CEO Mahoney.  

The company has “leveraged COVID” to accelerate its digital investments and capabilities in such focus areas as clinical trials, customer engagement, mobile solutions, medical education and remote case support, Mahoney said. 

Boston Scientific’s initiatives include remote case support and virtual reality solutions, remote monitoring of clinical trials, as well as teleproctoring and virtual medical education.     

“We see these platforms as a key catalyst for growth and structural and cost savings opportunities over time, and continue to expand our footprints and these digital capabilities,” Mahoney added.   

Originally published by
Greg Slabodkin | January 29, 2021
Medtech Dive

Read more…
Gold Level Contributor

In mouse neurons deficient in the membrane protein TMEM175 (right panel), researchers found damage to lysosomes (green) and a build-up of alpha-synuclein (red), clumps of which are implicated in Parkinson’s disease pathology. (Image: Courtesy of the Ren laboratory)

Genetic variations associated with both increases and reductions in risk of the neurodegenerative disease alter the action of ion channels within cellular organelles called lysosomes, a new Penn study finds.

Many genetic mutations have been found to be associated with a person’s risk of developing Parkinson’s disease. Yet for most of these variants, the mechanism through which they act remains unclear.

Now a new study in Nature led by a team from the University of Pennsylvania has revealed how two different variations—one that increases disease risk and leads to more severe disease in people who develop Parkinson’s and another that reduces risk—manifest in the body.

The work, led by Dejian Ren, a professor in the School of Arts & Sciences’ Department of Biology, showed that the variation that raises disease risk, which about 17% of people possess, causes a reduction in function of an ion channel in cellular organelles called lysosomes, also known as cells’ waste removal and recycling centers. Meanwhile, a different variation that reduces Parkinson’s disease risk by about 20% and is present in 7% of the general population enhances the activity of the same ion channel.

“We started with the basic biology, wanting to understand how these lysosomal channels are controlled,” says Ren. “But here we found this clear connection with Parkinson’s disease. To see that you can have a variation in an ion channel gene that can change the odds of developing Parkinson’s both ways—increasing and decreasing it—is highly novel.”

The fact that the channel seems to play a crucial role in Parkinson’s also makes it an appealing potential target for a drug that could slow the disease’s progression, the researchers note.

Scientists have understood since the 1930s that cells use carefully regulated ion channels embedded in their plasma membrane to control crucial aspects of their physiology, such as shuttling electrical impulses between neurons and from neurons to muscles.

But it wasn’t until the past decade that researchers began to appreciate that the organelles within cells that have membranes, including endosomes and lysosome, also relied on ion channels to communicate.

“One reason is it’s hard to look at them because organelles are really small,” Ren says. During the last several years, his lab overcame this technical challenge and began studying these membrane channels and measuring the current of ions that crosses through them.

These ions pass through channel proteins that open and close in response to specific factors. About five years ago, Ren’s group identified one membrane protein, TMEM175, that forms a channel allowing potassium ions to move in and out.

Around the same time, other teams doing genome-wide association studies found two variations in TMEM175 that influenced Parkinson’s disease risk, turning it up or down.

“One variation is associated with a 20-25% increase in the odds of getting Parkinson’s in the general population,” Ren says. “And if you look only at people who have been diagnosed with Parkinson’s, the frequency of that variation is even higher.”

Intrigued by the connection, Ren reached out to Penn physician-scientist Alice Chen-Plotkin, who works with patients who have Parkinson’s, to collaborate. In data from Parkinson’s disease patients, she and colleagues found that motor and cognitive impairments progressed more rapidly in those patients who carried one of the TMEM175 genetic variations Ren was studying.

To find out what this variation was actually doing in cells, Ren’s lab turned a close eye to lysosomes. In isolation, they found that the potassium current through TMEM175 was activated by growth factors, proteins like insulin that respond to the presence of nutrients in the body. And they confirmed that TMEM175 appeared to be the only active potassium channel in mouse lysosomes.

“When you starve a cell, this protein is not functional anymore,” Ren says. “That was exciting to us because that tells us this is a major mechanism that can be used by the organelle to receive communications from the outside of the cell and maybe send communication back out.”

They found that a kinase enzyme called AKT, which is typically thought to achieve its ends by adding a small molecule called a phosphate group to whatever protein it is acting upon, joined with TMEM175 to open the protein channel. But AKT opened it without introducing a phosphate group. “The textbook definitation of a kinase is that it phosphorylates proteins,” Ren says. “To find this kinase acting without doing that was very surprising.”

They next turned to mice genetically engineered to carry the same variations that had been found in the human population to see how the genetic changes affected the animals’ ion channel activity. Mice with the disease-risk-increasing mutation had a potassium current of just about 50% of that of normal mice, and that current was extinguished in the absence of growth factors. In contrast, the ion channels in mice with the disease-risk-reducing mutation continued operating for several hours in the absence of growth factors, even longer than they did in normal mice.

“This tells you this mutation is somehow helping the mice resist the effects of nutrient depletion,” Ren says.

To measure effects on neurons, they observed that the neurons with the mutation in cell culture associated with more severe Parkinson’s were more susceptible to damage from toxins and nutrient depletion. “If the same is true in human neurons, that means 17% of the population carries a variation that may make their neurons more damaged when subjected to stressors,” says Ren.

Collaborating with Penn researcher Kelvin Luk, the investigators looked at levels of misfolded protein in neurons in cell culture. Known in humans as Lewy bodies and a defining characteristic of Parkinson’s, these inclusions increased “strikingly” within neurons when TMEM175 function declined, Ren says. This is likely due to an impairment in the function of lysosomes, which normally help digest and recycle waste generated by the cell.

And, also associated with human Parkinson’s, mice lacking TMEM175 lost a portion of the neurons that produce the neurotransmitter dopamine and performed worse on tests of coordination than normal mice.

Together with the findings in humans, the researchers believe their work points to a significant contributor to the pathology of Parkinson’s disease. Moving forward, Ren’s group hopes to delve deeper into the mechanism through which this ion channel is regulated. Their research may shed light not only on the molecular impairments involved in Parkinson’s but also in other neurodegenerative diseases, particular those related to lysosomes, which include a number of rare but very severe conditions.

They’d also like to know, since this predisposing variation is carried by so many people, if it also influences how other genetic mutations contribute to the likelihood someone develops Parkinson’s.

Originally published by
Katherine Unger Baillie, Media Contact | January 27, 2021
Penn Today, University of Pennsylvania

 

Dejian Ren is a professor of biology in the University of Pennsylvania School of Arts & Sciences.

Ren’s coauthors are Jinhong Wie, Zhenjiang Liu, Chunlei Cang, Kimberly Aranda, and Joey Lohmann of Penn’s School of Arts & Sciences; Thomas F. Tropea, Yuling Liang, Alice S. Chen-Plotkin, and Kelvin C. Luk of Penn’s Perelman School of Medicine; Haikun Song and Boxun Lu of China’s Fudan University; and Lu Yang, Huanhuan Wang, and Jing Yang of China’s Peking University. Jinhong Wie is first author and Ren, Chen-Plotkin, and Luk are corresponding authors.

The work was supported in part by the National Institutes of Health (grants GM133172, HL147379, NS088322, NS115139, NS053488, and AG062418)

Read more…
Silver Level Contributor

Babson—which was spun out of Siemens Healthineers in 2017—said it has now completed a clinical study putting its collection system up against conventional venipuncture in the retail setting. (Pixabay)

Babson Diagnostics hopes to make real the industry’s long-held dream of bringing quick and thorough blood testing to retail markets and pharmacies—without the use of needles, tubes or trained phlebotomists—and it’s starting to build the clinical evidence to support it.

Typical venipuncture requires a trained professional and takes about 4 to 10 milliliters of blood out of the arm—but produces a high-quality sample, capable of consistent results. Squeezing drops of blood from a pricked finger, on the other hand, can contaminate or alter the sample and at times be less accurate.

To help mitigate these problems, Babson aims to deploy a new, capillary-based collection device being developed in partnership with BD, which requires about one-tenth of the amount of blood and can be used by any healthcare technician. 

It is designed to draw a pea-sized amount of blood from the finger without the same pressure and squeezing that could harm the sample. The droplet is then placed in a specialized handling container that automatically works to preserve the blood and prepare it for analysis at a central laboratory while reducing the amount wasted in the testing process.

“The combination of BD’s capillary collection device and Babson’s sample handling and analysis technology has incredible potential to improve the retail diagnostic blood testing process, with the ultimate goal of enabling simple, convenient, and accessible blood testing for all,” said Dave Hickey, president of life sciences for BD.

Babson—which was spun out of Siemens Healthineers in 2017—said it has now completed a clinical study putting its collection system up against conventional venipuncture in the retail setting.

Among 81 people tested with each method in a pharmacy over six weeks last fall, the company said it found a strong correlation between the two across routine testing panels and described the study as a step toward establishing full clinical equivalence in the future.

“COVID-19 has put the world’s focus on our healthcare systems, directing us to reexamine how we access care. We believe that reimagining the current clinical diagnostic testing process is an important place to start, as diagnostic blood testing is crucial for preventive care, but can be made more accessible and convenient,” said Babson CEO David Stein, a former Siemens executive who joined the company last September alongside a $13.7 million venture capital round.

Originally published by
Conor Hale | January 25, 2021
FierceBiotech

Read more…
Silver Level Contributor

The fourth generation of Boston Scientific's Vercise Genus system was approved for the stimulation of areas of the brain linked to the control of behavior and movement for patients with Parkinson’s disease who have responded to levodopa treatment, but whose symptoms are not adequately controlled with medication alone. (Boston Scientific)

Boston Scientific has obtained approval from the FDA for the fourth generation of its Vercise Genus deep brain stimulation system, allowing conditional use while within an MRI scanner.

Designed to treat the symptoms of Parkinson’s disease such as muscle slowness and tremors, the Vercise Genus family includes Bluetooth-enabled implantable pulse generators with both rechargeable and non-rechargeable models.

The generators connect to the company’s standard Vercise electrical leads or its Cartesia directional leads that allow for more precise stimulation.

"We continue to prioritize therapy innovations that improve our patients' quality of life with a wide range of personalized offerings," Maulik Nanavaty, Ph.D., president of Boston Scientific’s neuromodulation division, said in a statement

"For people living with movement disorders, this means developing new technologies that are designed to refine motor control, reduce programming times and expand MR compatibility to improve their treatment experience and ultimately their daily living," Nanavaty added. The company launched the Vercise Genus system in Europe last September and plans to begin an initial, limited U.S. rollout in the coming months. 

The device was approved for the bilateral stimulation of the brain’s subthalamic nucleus or internal globus pallidus—areas linked to the basal ganglia, which helps control behavior and movement. It’s used as an adjunctive therapy for moderate to advanced Parkinson’s that has been responsive to levodopa treatment, though symptoms are not adequately controlled with medication alone.

Originally published by
Conor Hale | January 25, 2021
Fierce Biotech

Read more…
Silver Level Contributor

Crystal of glulisine

Scientists have used crystals to reveal why the diabetes treatment glulisine is faster acting than insulin.

The findings, published today in Scientific Reports, could open avenues for improved diabetes treatments.

The study was carried out by Imperial College London, and the Universities of Nottingham and Manchester, along with the Diamond Light Source - the UK's national synchrotron science facility.

Glulisine is a synthetic rapid-acting synthetic insulin developed by Sanofi-Aventis - with a trade name of Apidra.  It is used to improve blood sugar control in adults and children with diabetes.

In this new study, scientists set out to establish the exact structure of glulisine, and how this structure might affect the way it behaves in the body.

The team aimed to establish, what fundamental role glulisine plays in diabetes management by examining its structure. These findings could potentially lead to an improved synthetic insulin for patients, with fewer side effects.

Crystal insights

To carry out the research, the team created a perfect crystal of glulisine (see image).

The researchers then applied a combination of methods to provide a detailed insight into the structure and function of glulisine.

Dr Hodaya Solomon, a member of the Imperial College team, and joint first author said: “The key molecular level comparisons between this crystal structure of glulisine and of previous insulin crystal structures showed that a unique position of the glutamic acid (an amino acid), not present in other fast-acting analogues, pointed inwards rather than to the outside surface. This reduces interactions with neighbouring molecules and so increases preference of the more-active-for-patients dimer form, giving the experts a better understanding of the behaviour of glulisine”. 

Imperial's Professor Naomi Chayen was joint senior author of the research. 

Dr Gary Adams Associate Professor and Reader in Applied Diabetes Health at the University of Nottingham, and lead author of the study, said: “For the first time, our research provides novel, structural information on a clinically relevant synthetic insulin, glulisine, which is an important treatment for those patients presenting with diabetes. 

“This information sheds light on the dissociation of glulisine and can explain its fast dissociation to dimers and monomers and thereby its function as a rapid-acting insulin.  This new information may lead to a better understanding of the pharmacokinetic and pharmacodynamic behaviour of glulisine and, in turn, might assist in improving its formulation and reducing side effects of this drug.”

Originally published by
Kate Wighton | January 21, 2021
Imperial College, London

The study was funded by the Independent Diabetes Trust.

'Analysis of insulin glulisine at the molecular level by X-ray crystallography and biophysical techniques' is published in the journal Scientific Reports

Adapted from a press release from The University of Nottingham 

See the press release of this article

Article text (excluding photos or graphics) © Imperial College London.

Read more…
Gold Level Contributor

DePuy previously partnered with Zebra Medical Vision to co-develop programs that create 3D joint models from 2D X-ray images to provide surgical planning without the need for a more expensive MRI or CT scan. (Wikipedia)

Johnson & Johnson’s DePuy Synthes division has received FDA clearance for its robotic-assisted orthopedic surgical platform for total knee replacements. 

The Velys digital joint reconstruction system—also used for hip and shoulder procedures—is designed to work with the company’s Attune knee implant. Alongside advanced planning capabilities, the system helps the surgeon make precise cuts into bone and position the replacement joint accurately relative to the knee’s surrounding muscles, tendons and ligaments.

“Globally, previous generation robotics have only penetrated key orthopaedic segments between 5-10% of the market,” said Aldo Denti, group chairman of the DePuy Synthes franchise. “A significant opportunity for combined robotic and digital surgery technology exists.”

The Velys solution was designed from technology J&J acquired through its 2018 buyout of French developer Orthotaxy. The system mounts onto an operating room table and links to joint assessment data to help correctly balance the implant and verify its position.

DePuy previously partnered with Zebra Medical Vision to co-develop programs that create 3D joint models from 2D X-ray images to provide surgical planning without the need for a more expensive MRI or CT scan. 

Over time, J&J plans to integrate new technologies into the platform such as sensors, apps and patient selection tools, spanning orthopedic care from preop planning to postop rehabilitation.

“With the addition of the Velys Robotic Assisted Solution to our Velys Digital Surgery Platform, we are continuing our vision to be the most personalized and connected orthopaedics company,” Denti said. 

Elsewhere in J&J’s medical device sphere, Ethicon and Auris Health published additional results from the Monarch lung bronchoscopy robot gathered from a first study in live human participants. 

The Monarch system uses an articulated tube to navigate the passages through the airway and the lungs to reach nodules suspected of harboring lung cancer. Guided using a video game controller, it delivers a biopsy needle and retrieves samples for analysis.

The BENEFIT trial was previously presented as a late-breaking study at the annual meeting of the American College of Chest Physicians in late 2019, demonstrating that it could reach target lung lesions in 52 of 54 patients. Pneumothorax occurred in two patients, with one case requiring the placement of a tube to drain air or fluid from the chest.

The latest publication—featured in the college’s official journal CHEST—included an exploratory analysis placing the study’s overall diagnostic yield at 74.1%. In addition, a yield of 70% was achieved in lung nodules located outside of the patient’s airway, compared to reported yields of 30% to 40% when using non-robotic technology.

“Physicians in the study, using our first-generation Monarch software, were able to localize and diagnose the most difficult-to-reach nodules at a higher rate than was previously possible,” said Eric Davidson, president of flexible robotics at Auris Health, which J&J acquired in 2019 for $5.8 billion. “Since then, we have continued to improve the platform, delivering a higher level of accuracy and ease of use.”

Auris is also evaluating the system’s safety and diagnostic yield through the TARGET clinical study, which plans to enroll a total of 1,200 participants across 30 sites and deliver results in 2024.

Originally published by
Conor Hale | January 22, 2021
Fiercebiotech

Read more…
Silver Level Contributor

UK researchers have used electrical pulses to help suppress the tremors typically found in conditions such as Parkinson’s disease.

Tremors are a common feature in a range of neurological conditions. They can be severely disabling, causing involuntary shakes affecting the hands, head, legs or other body parts.

The movements are thought to be the result of rogue brain waves – or aberrant oscillations – in regions associated with motor functions. But their underlying cause is still largely unknown, making it difficult to treat symptoms with drugs.

In severe cases, brain surgery may be an option, but this is invasive, not widely available and carries risks.

But a team led by researchers at the UK Dementia Research Institute has discovered a way of suppressing the brain waves underpinning tremors, without the need for invasive techniques.

8427193873?profile=RESIZE_710x

A team led by Dr Nir Grossman, from the Department of Brain Sciences, found synchronising electrical pulses with rogue brain waves reduced the severity of tremors in people with Essential Tremor Syndrome (ETS). (Credit: Imperial College London / Thomas Angus) 

In a small study, the researchers developed a way of calculating and tracking the phase of these rogue brainwaves in real time – showing the synchronised peaks and troughs of activity as they ripple through the brain.

They then used a non-invasive form of electrical stimulation to target the cerebellum – the region at the back the brain which coordinates movement.

They found that by synchronising the brain stimulation with specific phases of these aberrant oscillations, they were able to reduce tremors in people with Essential Tremor Syndrome (ETS), the most common neurological disorder to cause such tremors.

 

Eleven people with ETS were given the treatment by applying electrodes to the scalp, arranged to maximise the electric fields in the cerebellum. The electric fields were adjusted in real time to maintain a fixed phase corresponding to the ongoing tremor movement, called ‘phase-locking’.

Reducing tremor

The team found the reduction of symptoms lasted during stimulation and for a short period afterwards. The reduction in the tremor amplitude (or severity) was associated with a disruption of the regularity of the movement, meaning the more the brain stimulation made the tremor irregular, the more it reduced its amplitude.

The team hopes that this discovery will pave the way for possible long-term treatment of tremors and other symptoms in people with other brain conditions that involves aberrant synchronous oscillations.

Dr Nir Grossman from the Department of Brain Sciences at Imperial College London, said: “Tremor symptoms can be upsetting and get in the way of doing basic, everyday things that most of us take for granted. In the worst cases, they can be severely debilitating.

“Tremors are caused by abnormal synchronisation in the motor areas of the brain but the biological processes underlying them are still not well understood. By targeting the temporal pattern of the brain’s abnormal synchronisation, we may be able to treat it, non-invasively, despite the limited knowledge of the precise causes.

“Our work presents an early-stage feasibility study of this approach. We hope to continue to develop it into a widely available treatment for tremors, as well as other symptoms that are underpinned by abnormal synchronisation in the brain.”

Originally published by
Ryan O'Hare | January 13, 2021
Imperial College London

The full findings are published in the journal Nature Communications.

This article is based on materials from the UK Dementia Research Institute

 

Read more…
Bronze Level Contributor

The approach promises to be much faster than culturing bacterial samples in a lab, taking about four hours to pick up any of 52 different pathogens. (Getty Images)

Researchers at the University of Cambridge have developed a DNA test to help spot dangerous secondary infections that may develop during COVID-19 treatment—such as cases of pneumonia associated with ventilator equipment provided during intensive care.

Patients under mechanical ventilation are typically given anti-inflammatory drugs to ease damage to their lungs, however this may leave them more susceptible to bacteria and fungi in the hospital.

The test, developed at Cambridge University Hospitals in collaboration with Public Health England, is designed to identify the infection and help suggest the appropriate course of antibiotics. 

The approach—which promises to be much faster than culturing bacterial samples in a lab, taking about four hours total to pick up 52 different pathogens—is currently being rolled out to healthcare providers under the university’s NHS Foundation Trust.

"Early on in the pandemic we noticed that COVID-19 patients appeared to be particularly at risk of developing secondary pneumonia, and started using a rapid diagnostic test that we had developed for just such a situation," said Andrew Conway Morris, of Cambridge's Department of Medicine, who co-authored a paper examining the rates of ventilator-associated pneumonia among COVID-19 patients.

"Using this test, we found that patients with COVID-19 were twice as likely to develop secondary pneumonia as other patients in the same intensive care unit," Morris said. As to the reason why, people with severe infections tend to spend more time on ventilators, and may also have poorly regulated or overactive immune system in the face of the virus.

It also marks one of the first times that high-throughput PCR sequencing has been employed in the university’s routine clinical practice in such a manner.

"We found that although patients with COVID-19 were more likely to develop secondary pneumonia, the bacteria that caused these infections were similar to those in ICU patients without COVID-19," said Cambridge researcher and lead study author Mailis Maes. "This means that standard antibiotic protocols can be applied to COVID-19 patients."

Originally published by
Conor Hale | January 15, 2021
Fierce Biotech

Read more…
Gold Level Contributor

Tapping the Brain to Boost Stroke Rehabilitation

A clinical trial found that stroke survivors gained clinically significant arm movement and control by using an external robotic device powered by the patients’ own brains.

Clinical Trial Suggests Brain-Machine Interface Coupled with Robot Offers Increased Benefits for Stroke Survivors

Stroke survivors who had ceased to benefit from conventional rehabilitation gained clinically significant arm movement and control by using an external robotic device powered by the patients’ own brains.

The results of the clinical trial were described in the journal NeuroImage: Clinical.

Jose Luis Contreras-Vidal, director of the Non-Invasive Brain Machine Interface Systems Laboratory at the University of Houston, said testing showed most patients retained the benefits for at least two months after the therapy sessions ended, suggesting the potential for long-lasting gains. He is also Hugh Roy and Lillie Cranz Cullen Distinguished Professor of electrical and computer engineering.

The trial involved training stroke survivors with limited movement in one arm to use a brain-machine interface (BMI), a computer program that captures brain activity to determine the subject’s intentions and then triggers an exoskeleton, or robotic device affixed to the affected arm, to move in response to those intentions. The device wouldn’t move if intention wasn’t detected, ensuring subjects remained engaged in the exercise.

Using robotics in rehabilitation isn’t new, said Contreras-Vidal, co-principal investigator of the trial and a pioneer in noninvasive BMI systems. But robot-assisted exercise doesn’t generally engage the user, which is critical for taking advantage of the brain’s plasticity to allow patients to relearn movement.

8419759884?profile=RESIZE_710x

Testing showed most patients retained the benefits for at least two months after the therapy sessions ended, suggesting the potential for long-lasting gains.

“This project ensures the brain is engaged,” he said. “We know that if the arm is moving, it’s because they are commanding it to move. That’s a very powerful concept.”

By testing the subjects over a period of time before the trial began, researchers were able to ensure that any changes or improvements were due to the intervention. In addition to better arm movement, the researchers reported that the subjects also showed improvements in using their hands.

“This is a novel way to measure what is going on in the brain in response to therapeutic intervention,” said Dr. Gerard Francisco, professor and chair of physical medicine and rehabilitation at McGovern Medical School at The University of Texas Health Science Center at Houston and co-principal investigator. “This study suggested that certain types of intervention, in this case using the upper robot, can trigger certain parts of brain to develop the intention to move. In the future, this means we can augment existing therapy programs by paying more attention to the importance of engaging certain parts of the brain that can magnify the response to therapy.”

The trial was conducted at TIRR Memorial Hermann, where Francisco serves as chief medical officer and director of the NeuroRecovery Research Center. The project was a collaboration between UH, UTHealth, TIRR Memorial Hermann, Houston Methodist Research Institute and Rice University.

In addition to Francisco and Contreras-Vidal, who is also director of the BRAIN Center, a NSF Industry/University Collaborative Research Institute, researchers involved with the project include Nikunj A. Bhagat and Zachary Hernandez with UH; Nuray Yozbatiran and Rupa Paranjape with UTHealth;  Dr. Zafer Keser, formerly with UTHealth; Jennifer L. Sullivan, Colin Losey and co-principal investigator Marcia K. O’Malley with Rice; and Dr. Robert Grossman with Houston Methodist Research Institute. O’Malley is also Director of Rehabilitation Engineering at TIRR Memorial Hermann.

It was funded by the National Institute of Neurological Disorders and Stroke and Mission Connect, part of the TIRR Foundation. 

“Those of us who have studied the brain for so many years have anticipated that its powers, combined with robotics and the brain-machine interface, could offer unimaginable benefits to stroke survivors and other patients with brain injuries,” said Grossman, professor of neurosurgery at Houston Methodist. “This study is just the beginning of what will be possible to treat stroke, spinal cord injuries and other traumatic brain injuries in the future.”

The trial spanned a period of several years, partly because it took time to find subjects who met the criteria and were both interested in participating and able to make the required time commitment. Ultimately, 10 subjects between the ages of 41 and 71 were enrolled. 

The therapy took place three times a week for four weeks. The final follow-up testing was conducted two months after therapy ended, and Contreras-Vidal said it’s unclear if the benefits will persist long-term.

That leads to an ongoing project – Contreras-Vidal has a National Science Foundation grant to design a low-cost system that would allow people to continue the treatments at home.

“If we are able to send them home with a device, they can use it for life,” he said.

Originally published by
Jeannie Kever | 713-743-0778  January 12, 2021
University of Houston

Read more…
Bronze Level Contributor

In 2019, Google claimed its quantum computer completed a task in 200 seconds that would have taken a typical supercomputer 10,000 years. Now, Boehringer Ingelheim hopes to harness that speed for biopharma R&D. (Boehringer)

Quantum computing is quickly becoming more science than fiction, and Boehringer Ingelheim hopes to be out in front in bringing it to biopharma R&D. Through a new partnership with Google, the drugmaker hopes to harness its promised speeds and capabilities to simulate the body’s biological mechanics at the molecular level and help discover and design new treatments.

The three-year pharmaceutical project is the first of its type for Google’s Quantum AI division, and will be co-led by a new Quantum Lab at Boehringer—forming one part of the company’s digital transformation strategy alongside investments in machine learning and data science, as well as digitally powered biomarkers and therapeutics.

“Quantum computing has the potential to significantly accelerate and enhance R&D processes in our industry,” said Michael Schmelmer, a member of Boehringer’s board of managing directors. “Quantum computing is still very much an emerging technology. However, we are convinced that this technology could help us to provide even more humans and animals with innovative and groundbreaking medicines in the future.”

Since their inception, computers have used a binary system of 1’s and 0’s to crunch data and solve equations, but quantum computers look to employ the properties of entanglement and superposition—its information can be listed as 1, 0 or something in-between, representing the potential for an individual bit to be either at the same time. 

8412997469?profile=original

Google's Sycamore quantum computer (Google)

This method will potentially lend itself well to in silico modeling of the molecular interactions among large- and small-molecule drugs, enzymes, cells and proteins, which are constantly in flux and can be particularly difficult to pin down.

“Extremely accurate modeling of molecular systems is widely anticipated as among the most natural and potentially transformative applications of quantum computing,” said Ryan Babbush, Google’s head of quantum algorithms.

Though the total amount was undisclosed, Boehringer said it plans to “invest significantly in the coming years” in quantum computing, and has begun poaching researchers in the field from academia and private companies for its own dedicated lab.

“The thought leadership of Boehringer Ingelheim's quantum research effort is very impressive. This is reflected in the quick turnaround time that their strong quantum research team got assembled, and their commitment to open research,” said Google’s lead for quantum AI partnerships in the European and Asia-Pacific regions, Markus Hoffmann. 

“We are looking forward to jointly working on the field with fundamental research and a joint vision for solving relevant pharma problems in the beyond-classical regime over the next decade,” Hoffmann said.

Originally published by
Conor Hale | January 11, 2021
Fierce Biotech

Read more…
Bronze Level Contributor

Treating critically ill COVID-19 patients with drugs typically used for arthritis may significantly improve survival, a landmark study has found.

The findings, which have not yet been peer-reviewed, come from the REMAP-CAP trial, which evaluates the effect of treatments on a combination of survival and length of time patients need support in an intensive care unit (ICU).

Initial findings reported in November showed that tocilizumab, a drug used to treat arthritis, was likely to improve outcomes among critically ill COVID-19 patients. But the impact on patient survival and length of time on organ support in ICU was not clear at that time.

"This is a significant finding which could have immediate implications for the sickest patients with COVID-19" Professor Anthony Gordon

Now, the latest analysis shows that tocilizumab and a second drug called sarilumab – both types of immune modulators called IL-6 receptor antagonists – have a significant impact on patient survival, reducing mortality by 8.5%.*

Furthermore, the treatment also improved recovery so that on average patients were able to be discharged from the intensive care unit (ICU) about a week earlier.

The latest analysis is published in a pre-print available on medRxiv, with the findings submitted to a peer-reviewed journal.

“This is a significant finding which could have immediate implications for the sickest patients with COVID-19,” said Professor Anthony Gordon, Chair in Anaesthesia and Critical Care at Imperial College London and a Consultant in Intensive Care Medicine at Imperial College Healthcare NHS Trust.

“We found that among critically ill adult patients – those receiving breathing support in intensive care – treatment with these drugs can improve their chances of survival and recovery,” explained Professor Gordon. “At a time when hospitalisations and deaths from COVID-19 are soaring in the UK, it’s crucial we continue to identify effective treatments which can help to turn the tide against this disease.”

At the end of last year, positive early findings on tocilizumab were released before the full data had been collected. With the full analysis now available, researchers are confident the findings could have immediate clinical implications for patients.

Tocilizumab and sarilumab are immunosuppressive drugs used to treat rheumatoid arthritis. They were two of several immune modulation treatments included in the REMAP-CAP trial.

Patients receiving tocilizumab and sarilumab were more likely to improve (measured by a combination of reduced time on organ support, such as a ventilator, in the ICU and surviving the hospital admission) compared to patients who received no immune modulator.

Full findings

At the time of full analysis 353 patients had been assigned to tocilizumab, 48 to sarilumab and 402 to control. The majority of patients were also treated with corticosteroids and were receiving respiratory support.

The trial data yielded an odds ratio of 1.64 for a better outcome with tocilizumab, and 1.76 for sarilumab, compared to no immune modulation, with a high degree of statistical certainty (>99.5% probability that both treatments are superior to no immune modulation).

Hospital mortality was reported as 27.3% among patients receiving IL-6 receptor agonists (28.0% for tocilizumab, 22.2% for sarilumab) compared with 35.8% for control group.

Professor Gordon added: “Previous trials using IL-6 receptor agonists have showed no clear benefit on either disease progression or survival in COVID-19 patients, but those studies included less severely ill patients and started treatment at different stages in the disease course.

“A crucial difference may be that in our study, critically ill patients were enrolled within 24 hours of starting organ support. This highlights a potential early window for treatment where the sickest patients may gain the most benefit from immune modulation treatment.”

In a Government statement, Deputy Chief Medical Officer Professor Jonathan Van-Tam said: “This is a significant step forward for increasing survival of patients in intensive care with COVID-19. The data shows that tocilizumab, and likely sarilumab, speed up and improve the odds of recovery in intensive care, which is crucial for helping to relieve pressure on intensive care and hospitals and saving lives.

"This is evidence of the UK’s excellent research infrastructure and life sciences industry advancing global understanding of this disease, which we have done both through our own programme of clinical research and through our ability to make very large contributions to international studies.”

REMAP-CAP study is led by Imperial College London and the Intensive Care National Audit & Research Centre (ICNARC) in the UK and University Medical Center Utrecht in Europe. It began investigating treatments for COVID-19 in March 2020, enrolling hospitalised patients with either moderate or severe (requiring ICU care) COVID-19 disease.

The study design randomises patients to multiple combinations of treatments, enabling researchers to evaluate different treatments for COVID-19, including antivirals, drugs which modulate the immune response, and therapies that modulate or support other vital aspects of the body's response to the virus.

In total, over 3,900 patients in 15 countries have been enrolled at more than 290 hospitals worldwide and randomised to multiple treatment combinations. The effects of interventions are assessed separately for moderate and severely ill patients.

The latest findings on tocilizumab and sarilumab add to REMAP-CAP findings from earlier this year, which found that hydrocortisone steroid treatment improved recovery among critically ill COVID-19 patients.*

*This study is one of a number of COVID-19 studies that have been given urgent public health research status by the Department of Health and Social Care. As of November 2020 75% of all study participants had been recruited in the UK through the NIHR’s Clinical Research Network (CRN).

The study is supported in the UK by the National Institute for Health Research (NIHR) and Imperial College London & ICNARC are partners in the EU funded PREPARE consortium.

Originally published by
Ryan O'Hare | January 7, 2021
Imperial College London

Original Article

Read more…

JAAGNet MedTech Trends

MedTech Strategist - Innovation Summit Dublin

LSI 2021 EMERGING MEDTECH SUMMIT

BIOMEDevice - Boston 2021

  • Description:

    BIOMEDevice - Boston 2021
    https://biomedboston.com/

    Rescheduled to September 2021

    2,200+ industry professionals and 335+ suppliers convene in Boston — home to the nation's highest number of medical device companies — for a two-day event focused on moving medtech design projects to the next stage of development.

    BIOMEDevice lets you explore the trends driving advancements in healthcare as well as discover…

  • Created by: Kathy Jones
  • Tags: biomedevice, boston, north america, medtech

MED-TECH INNOVATION SUMMIT

  • Description:

    MED-TECH INNOVATION SUMMIT
    https://med-techexpo.com/event/en/page/home

    New dates announced – September 28-29, 2021

    Med-Tech Innovation Expo is the UK & Ireland’s leading event for medical design and manufacturing technology.

    Experience live demonstrations of the latest machine, technology, products and services while networking with 4,000 + designers, engineers, innovators and…

  • Created by: Kathy Jones
  • Tags: med-tech, summit, june 2021, nec, birmingham, uk

JAAGNet MedTech Blog Archive

See Original | Powered by elink

JAAGNet MedTech Video Playlist