Category Archives: Physiology

Physiology

Elixir Medical Announces Outstanding 12-Month Data for DynamX Coronary Bioadaptor System, Demonstrating No Target Vessel Revascularization, No…

PARIS--(BUSINESS WIRE)-- Elixir Medical, a developer of innovative, drug-eluting cardiovascular devices, today announced outstanding 12-month data for the DynamX Coronary Bioadaptor System, the first coronary artery implant that adapts to vessel physiology. Results will be presented live tomorrow at 14:12 CEST on the Main Arena channel of the PCR e-Course as part of the Late Breaking Trials session by Stefan Verheye, MD, PhD, co-principal investigator and senior interventional cardiologist at the Antwerp Cardiovascular Centre/ZNA Middleheim, Belgium.

Twelve-month results for the DynamX Bioadaptor demonstrate:

Coronary arteries naturally have the ability to expand with disease progression in order to maintain blood flow to the heart, said Antonio Colombo, MD, co-principal investigator and director, Cardiac Catheterization Laboratory, Columbus Hospital, Milan and Coordinators Cardiac Catheterization Laboratories GVM Group, Care and Research, Lugo (RA), Italy. Drug-eluting stents (DES) cage the coronary arteries and hinder this physiological response. DynamX is the first metallic coronary artery implant to demonstrate positive adaptive remodeling of the vessel, enabling it to expand to accommodate disease progression. This may improve longer-term clinical outcomes.

The innovative DynamX Bioadaptor design was shown to match current drug-eluting stents (DES) in acute performance while offering the promise to improve upon the high adverse event rates that continue beyond year one with DES, said Dr. Verheye. In all measures, including clinical, QCA, IVUS, OCT, the bioadaptor demonstrated excellent performance and safety.

The DynamX Bioadaptor is the only metallic drug-eluting coronary artery device designed to open and support the artery during healing, like a stent, while uniquely accommodating the vessels ability to grow in response to disease progression, which current DES cannot do.

The bioadaptor is designed to address the two to three percent adverse event rate that occurs with drug-eluting stents (DES) each year without plateau.1,2,3 The rigid design of DES constrains, or cages, natural artery movement, which has been associated with major adverse cardiac events (MACE).4 Clinical studies have shown that DES prevents positive adaptive remodeling,5 inhibits vessel compliance and dilation in response to the bodys changing blood flow needs,6,7 and causes vessel straightening.8

While DES do an efficient job supporting the coronary artery, they permanently cage the vessel and show an adverse event rate that continues to build year-over-year without end. Physicians and their patients deserve a technology that treats coronary artery disease without making this compromise, said Elixir Medical CEO Motasim Sirhan. Elixirs DynamX Bioadaptor stands as the only technology that has solved this conundrum. By creating a coronary artery device that restores the normal function of the artery, we expect to demonstrate safety and efficacy with a reduction in clinical events.

The multi-center, single-arm, mechanistic clinical study enrolled 50 patients treated at six centers in Europe to evaluate the safety and performance of the device in de novo native coronary arteries. Primary endpoints included Target Lesion Failure (TLF), as well as QCA, IVUS and OCT measures.

The DynamX Bioadaptor is a metal implant coated in a drug-eluting bioresorbable polymer that initially supports the coronary artery during healing with radial strength, similar to DES. Over six months, the polymer coating dissolves, freeing couplers or uncaging elements on the rings to move with the natural expansion and contraction of the artery. This has been shown to (a) maintain the ability for positive adaptive remodeling, (b) restore vessel function, and (c) allow for the vessels return towards baseline angulation.

Prof. Verheyes presentation will also be available on-demand following the Late Breaking Trial session at PCR Online.

About Elixir Medical

Elixir Medical Corporation, a privately-funded company based in Milpitas, California, develops next-generation systems to treat coronary artery disease that are designed to restore the normal pulsatile motion and adaptive remodeling capabilities of the blood vessel. The companys mission is to transform the care of patients with heart and vascular disease through innovation.

DynamX Coronary Bioadaptor System is CE Mark approved. Not available for sale in the USA.

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Elixir Medical Announces Outstanding 12-Month Data for DynamX Coronary Bioadaptor System, Demonstrating No Target Vessel Revascularization, No...

Physiology

Affluent Medical Announces the Launch of the MINERVA First-In-Human Clinical Study of EPYGON – BioSpace

AIX-EN-PROVENCE, France--(BUSINESS WIRE)-- Affluent Medical is a French MedTech company specialized in innovative, minimally-invasive implants designed to restore key physiological functions in patients suffering from structural heart diseases, as well as urinary incontinence. The company announces today the start of the MINERVA First-In-Human clinical study of EPYGON, the first physiological transcatheter mitral valve prosthesis.

Professor Martin Andreas, Principal Investigator of this First-In-Human study at the Vienna Medical University, stated:The left ventricle vortex is a physiological process which is abolished after standard surgical mitral valve replacement. It is well known that survival is decreased after mitral valve replacement compared to mitral valve repair, which protects the vortex. Therefore, this feature of the EPYGON valve has the potential to improve patient outcomes. We hope to observe this unique advantage of the EPYGON transcatheter valve in our patients with respect to all other valve replacement technologies, whether via transcatheter or open surgery.

Michel Finance, CEO of AFFLUENT MEDICAL, said:The start of the MINERVA pilot trial is a major step forward for Affluent Medical. EPYGON is a world premiere and a potential best-in-class valve in a market where physiology has been overlooked for decades. This pilot study aims to confirm the improved clinical outcomes already demonstrated in preclinical testing. It should open up a new era both for surgeons and patients, with physiology as a key factor in cardiac surgery. EPYGON is unique, notably as it mimics the physiological human valve.

The MINERVA study: First-In-Man Clinical Study for the Treatment of Severe Mitral Valve INsufficiency with the EPYGON TRanscatheter Mitral VAlve System.

MINERVA is a pilot, prospective, non-randomized, single-arm, multicentric and international study. It is designed to enroll up to 20 patients in 3 centers of 3 different European countries (Austria, Italy and Spain). Patient enrollment is planned to be completed by Q1 2021 and the primary endpoints results will be evaluated after one year of follow-up .

EPYGON, a breakthrough mitral technology designed to treat both left ventricle disease and mitral regurgitation at the same time

Today, 4 million patients across the United States, Europe and Asia suffer from severe mitral valve regurgitation with no access to optimal therapies.

EPYGON is the first transcatheter mitral valve designed to restore the physiological blood flow vortex and treat left ventricle disease, in particular in so-called functional patients.

No mitral valve prosthesis currently on the market or in development was designed to restore the vortex.

The unique concept and design of the EPYGON valve is expected to achieve high procedural success, restore left ventricle physiological flow, and offer excellent performance in terms of the absence of thrombus formation and LVOT obstruction, while eventually also alleviating left ventricular effort.

The safety and efficacy of EPYGON were tested in preclinical models and the CE marking pivotal trial is slated to begin at the beginning of 2022, for planned introduction on a global market currently growing at a rate of 35% per year and expected to reach $3.5 to 5.0 billion by the end of 2022.

About Affluent Medical

Affluent Medical is a French MedTech company founded by Truffle Capital with the ambition to become a European leader in the treatment of heart and vascular diseases, which are the worlds leading cause of death, and of urinary incontinence, which today affects one in four adults. Affluent Medical develops innovative, next-generation minimally-invasive implants to restore key physiological functions in these areas. The companys four major technologies are currently in preclinical and clinical phases, and a first medical device is expected to be launched by 2022.

For more information: http://www.affluentmedical.com

About the PSPC MIVANA project :

The PSPC MIVANA project was built to create a cluster for innovative implantable medical devices targeting the mitral valve. This innovative collaborative project is led by Affluent Medical (EPYGON and Kephalios), a pioneering start-up and leader in the growing market segment of implantable cardiac devices. The project also includes two other partners: MDB Texinov, a SME specialized in technical textiles that is involved in the design and automation of assembly processes and the industrialization of new products. The French Textile and Clothing Institute (IFTH) involved in the selection of textile materials / structures and the design of prototypes.

The project aims to develop two proprietary cardiovascular Implantable Medical Devices (IMDs) to treat mitral valve diseases at different stages through repair or replacement. This R&D project, accompanied and labeled by the Eurobiomed (Marseille, Montpellier ple porter), Techtera (Lyon) and Medicen (Paris) competitiveness clusters, has won the PSPC (Structuring Projects for Competitiveness) call for projects of Bpifrance Financement. The MIVANA consortium is investing nearly 30 million, and is funded for up to 8.6 million.

1 See press release dated June 24, 2020 Affluent Medical announces 15.8 million in new financing and strengthening of its board of directors.

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Affluent Medical Announces the Launch of the MINERVA First-In-Human Clinical Study of EPYGON - BioSpace

Physiology

10 Reasons Why Wonder Man Is Actually The Most Powerful Avenger – CBR – Comic Book Resources

When it comes to the Most Underrated Avengers Awards, Wonder Man (Simon Williams) is definitely up for a nomination. Like many other superheroes who don't look peculiar or sexy enough or lack a cape, Wonder Man is overshadowed by the big and popular heavy hitters and charisma machines.

RELATED:10 Things Marvel Fans Should Know About Brother Voodoo

Still, one cannot ignore hard facts about Wonder Man's powers and contributions to the Avengers in the comic books. Apart from being one of the most zealous and dedicated members of the collective, he's also got the capabilities to back it up. In fact, Wonder Man can be just as powerful as the more established heroes of Marvel like Thor or even the Hulk. Here's proof in case fans don't find him wonderful enough.

Move over Spider-Man, here's a superhero who can actually handle one of your worst nightmares. The alien Symtiotes of Marvel like Venom or Carnage has long plagued the comic books thanks to how easily they can assimilate large swathes of populations, including superheroes.

Since Wonder Man no longer abides by the rules of human physiology or even biological physiology thanks to his ionic form, he's pretty much immune to the alien Symbiote invasion. It does come with a cost-- since he's not exactly flesh and blood, he can no longer sire any children. Fair trade.

This is where it gets debatable. Apparently, Wonder Man is placed in the 100-ton strength class of Marvel. Who else is up there? Only the Hulk, Sentry, and Thor to name a handful few good guys. That very well means Wonder Man is on the same ballpark as Marvel's Superman-level heroes.

The upper limits of Wonder Man's strength are still unknown but he seems to remain coy and humble about it. At times, he even claims that while he's in the same class with Thor, he acknowledged that the Asgardian is still stronger.

Wonder Man's strength alone would be enough to give him an all-access pass in the Avengers. However, he goes well above and beyond the qualifications. Wonder Man is also super-fast, has super reflexes, flight, super durability, super agility, super stamina, super senses, invulnerability, immortality, and regenerative healing.

Oh, we're not done. He can also manipulate and weaponize energy, creating devastating beams from his hands and eyes (not that he would need them). On top of that, Simon Williams has genius-level intellect. It's like Marvel is fighting hard for him not to be underrated.

That one Hulk weakness where he has limitless strength but behaves like a raging infant? Wonder Man doesn't have it. Wonder Man is consciously powerful and is also a martial arts expert.

He trained under Captain America for this and he's one of the best hand-to-hand combatants in the Avengers. This gives Wonder Man afighting edge against similarly strong supervillains or superheroes.

Since Wonder Man is not exactly human anymore by physiological standards, he doesn't actually have to assume a human form. He only does so because that's his past. Wonder Man can choose any form, size, or shape that he wants.

It's just that he doesn't really find a need to do this often or isn't usually given a chance in the comic books. Wonder Man can consciously shapeshift into any being-- his imagination being the limit; he eventransformed into a demon at one point. It also means he can opt to change his appearance or costume anytime but choose to abide by his fashion sense.

The claim that Wonder Man is a complete package of a superhero is super serious. Another role he could easily fill in the Avengers would be espionage, especially with SHIELD or Nick Fury around.

RELATED:The Boys: 5 Heroes Homelander Can Defeat (& 5 He Cant)

That's because Simon Williams is also a famous actor and even earned his spot in the Hollywood Walk of Fame. He can easily be a good undercover agent like Blackwidow or Spider-Woman. Couple that with shapeshifting and who even needs those two?

As if being a complete package isn't enough already, Wonder Man, in his latest incarnations and resurrections, is also capable of defying the laws of space. He can teleport or warp unknown distances.

This easily makes him more useful compared to similarly-powered superheroes. Wonder Man is already a jack-of-all-trades but also a master of it all. Well, not quite for teleportation as he's still developing and learning how to grasp those powers but he can already do it at will.

With all those powers, one would think that he'd have a massive glaring weakness like Sentry's mental health, the Hulk's lack of control, or Thor's intelligence level. Wonder Man doesn't have any of those psychological instabilities apart from a few nervous breakdowns.

RELATED:5 Wonder Man Costumes We Loved (& 5 Everyone Hated)

Instead, his main weakness is that he's easily disrupted with energy weaponry which is an exception against his invulnerability. Any weapon that can disperse energy or is specifically made to work against ionic matter is dangerous to Wonder Man.

Turns out Wonder Man's main weakness got the best of him many times over the course of his Avenger career. He has died several times over but because he doesn't exactly function as a biological being, he just toys with the concept of death plenty of times.

At one point, Kang the Conqueror even disintegrated him but Wonder Man was able to reform himself-- albeit slowly. In total, Wonder Man has died around six times in Marvel, the first of which even happened during his first appearance. What's surprising about some of his deaths was his ability to resurrect independently.

Just like a certain messiah born in Bethlehem, Wonder Man only gets more powerful every time he dies and gets resurrected. In many of his deaths, the superhero essentially Jesus'd his way into being overpowered.

As he reforms or is reformed by other beings like the Scarlet Witch, Wonder Man keeps discovering new powers with every rebirth. No doubt he'll always be a heavy hitter pick for the Avengers due to his positive power curve. All that's left to wonder about Wonder Man is when he'll debut in the MCU? After all, he was a romantic interest of both Scarlet Witch and Captain Marvel.

NEXT:MCU: 10 Ways Wonder Man Could Join The Fray

Next Wonder Woman: The Amazon Princess' 10 Most Hilarious Out Of Context Panels, Ranked

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10 Reasons Why Wonder Man Is Actually The Most Powerful Avenger - CBR - Comic Book Resources

Physiology

Harnessing complexity to advance epilepsy research: Learning the language of EEG spike-wave discharges – Newswise

Newswise Jesse A. Pfammatter was awarded the Epilepsia Open Prize 2020 Basic Science Prize for the articleAn automated, machine learning-based detection algorithm for spike-wave discharges (SWDs) in a mouse model of absence epilepsy.

Clinical spike-wave discharges (SWDs) are EEG patterns seen particularly during absence seizures, a nonconvulsive type of seizure. Though they were first identified more than 100 years ago, many aspects of SWDs are still being discovered.

Despite the time and effort, the standard of practice both clinically and in research is to manually identify SWDs, versus using software. Jesse Pfammatter, a post-doc in Mathew V. Jones lab at the University of Wisconsin, didn't subscribe to this standard for a couple of reasons. First, Pfammatter hadnt been an epilepsy researcher for very long. Second, he was self-professedly terrible at manual identification.

Pfammatter also had noticed that others weren't terrifically skilled at it either; in fact, identifying SWDs seemed quite subjective. Every human is different in their scoring of these, said Pfammatter. Not only is their scoring different from other humans scoring, but people change their minds about a discharge depending on its context. If its near other events, people tend to mark it as epileptiform, whereas if its by itself, they dont.

Pfammatter and colleagues also found that expert human scorers could change their minds about a specific EEG waveform upon repeated viewing. Sometimes, a single expert would disagree with themselves quite often, depending on what waveform they were looking at, said Jones. This suggests that human scoring of EEG waveforms is not entirely reliable.

Theres useful information in variability

Rather than give in to the idea that SWDs are merely difficult to categorize, Pfammatter saw the complexity as potentially useful. We put a lot of things in categories that dont necessarily fit in categories, he said. What if the subjective nature of the discharges could be harnessed?

Pfammatter and colleagues developed an automated detection algorithm that uses machine learning to highlight the variability in SWDs, rather than ignore it. The software uses a probabilistic scale, not a categorical scale, explained Pfammatter. Our research assumes theres useful information in variability.

The algorithms probability scores correlated with the variability seen in human scoring. The group also found that higher-probability events more strongly related to the physiology of the mice, particularly in terms of sleep-wake transitions, which are associated with many epilepsies.

Next, the group plans to apply the algorithm to experimental situations in which SWD variability provides information about physiology. For example, said Pfammatter, We know that treatments are effective across a spectrumits isnt just yes, they stop seizures or no, they dont. Were hoping we can test some of these signals to see if they change in the presence of certain therapeutics. That could give us insight into how treatments are working. And maybe we can start to understand why a medication works in one animal but not in another.

The lab also works with models of post-traumatic epilepsy. After a trauma, theres some probability that someone will develop epilepsy, in some unknown amount of time, Pfammatter said. Were finding subtle EEG markers that might indicate which individuals might go on to develop epilepsy. Its a higher-resolution understanding.

From entomology to epilepsy

Back to that first point, that Pfammatter hasnt been an epilepsy researcher for very long. Pfammatter grew up in a northern suburb of Chicago and earned a PhD in entomology at the University of Wisconsin. He studied bark beetle ecology and took extensive graduate coursework in statistics and biometrics.

Toward the end of his graduate career, he met Jones, associate professor of neurology, at a bar frequented by graduate students and faculty members. The two began talking and learning about one anothers research. Though they were studying different topics, both were immersed in multivariate data. His research was really interesting to me, Pfammatter said. There are similarities between community ecology and neuroscience, and the statistical analysis tool set is similar.

Pfammatter and Jones eventually agreed that they might work well as a team. We were working on different subjects, but we had a lot in common; its worked out fabulously, said Jones. There was a learning curve, but its all gone very well. Im really proud of Jesse.

Beyond the lab, Pfammatter loves outdoor adventures and likes to paint mountain scenes, but lately there hasnt been time. He and wife Rachel recently finished home renovations, and in early June they embarked on their next big adventurethe birth of their son.

About the ILAE Journal Prizes

Each year, the ILAE awards one Basic Science and one Clinical Science Prize to the first authors of original research articles published inEpilepsia Open during the preceding year. Awardees are nominated and selected by the journal's editorial board, the editors-in-chief, and the ILAE president.

The prize is intended to stimulate excellence in epilepsy research and reward young researchers for outstanding contributions to the field.

Watch the 2020 Journal Prize Symposium on YouTube, including a talk by Dr. Pfammatter about his research.

##

Founded in 1909, the International League Against Epilepsy (ILAE) is a global organization with more than 120 national chapters.

Through promoting research, education and training to improve the diagnosis, treatment and prevention of the disease, ILAE is working toward a world where no persons life is limited by epilepsy.

To learn more, visit ourwebsite(available in multiple languages) or find us onFacebook.

We're also on Twitter inEnglish,French,Japanese,PortugueseandSpanish.

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Harnessing complexity to advance epilepsy research: Learning the language of EEG spike-wave discharges - Newswise

Physiology

NMSU’s Rentfrow Hall named after long-time registrar for her dedication to students – New Mexico State University NewsCenter

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Rentfrow Hall was originally constructed in 1958 as a womens gymnasium and named for Era Rentfrow, after she served as the universitys registrar for 40 years. The gym was the home for the Department of Physical Education and Recreation, which eventually became the College of Educations Department of Kinesiology and Dance.

/>About Era Rentfrow

Rentfrow was born in 1898 and moved to Mesilla Park at an early age. She attended the college's preparatory school, graduating as president of her class in 1915. She then enrolled at the New Mexico College of Agriculture & Mechanic Arts as one of 23 entering freshmen.

After graduation in 1919, she began a lifelong career of service at the college. In 1922, Rentfrow was promoted and became the college registrar. In addition to her duties as registrar, she was responsible for sending out publicity to prospective students, issuing student activity cards, supervising ticket sales for all college programs and much more.

Rentfrow frequently used personal funds to make loans to students to cover their tuition, board, or books. She was proud of the fact that all students repaid these loans, no matter how long it took. She found inspiration in student success.

Rentfrow was engaged to Joe Quesenberry, a student at New Mexico A&M and captain of the football team. He was the first Aggie killed in combat during World War I. She never married after his death.

Perhaps motivated by the loss of her fianc, Rentfrow tracked and chronicled the Aggies who served during World War II. She dedicated herself to preserving the memory of the 126 Aggies who did not come home. Recognizing the need to secure their place in history, she gathered their photographs and biographical information from families and loved ones. The photos displayed in the rededicated Memorial Tower honor their memory.

In 1962, after 40 years as university registrar, she retired. She is credited as having one of the biggest impacts on the lives of students during this period. Shortly after her retirement, Rentfrow Hall was named in her honor.

Historic significance

Rentfrow Hall sits almost in the exact geographical center of the NMSU campus near the corner of Stewart and Williams. The architect is listed as unknown. The one-story building was constructed with stuccoed walls, brick surrounds, ceramic tile mullions and jalousie windows with sidelights and transom windows.

An evaluation of the building in the 2009 Heritage Preservation Plan determined the building did not meet the level of architectural or historical significance to warrant a determination of eligibility on the National Historic Register. Rentfrow Hall was slated for demolition as part of NMSUs Master Plan.

Rentfrows legacy and importance to NMSU history may have played a role in the buildings renovation. In the preservation plan, evaluators insisted the name Era Rentfrow should be carried forward on another campus building of similar visibility and import. Siting her history of helping students and her long tenure at the university as well as an endowment in her name, the preservation plan states: She is an important figure in the history of NMSU and the honor of her name should continue. The building was not demolished and instead was renovated, thanks to a bond election five years later.

Rentfrow Hall undergoes a major renovation

The growing Department of Kinesiology and Dance housed in Rentfrow Hall needed major renovation after nearly 60 years without any upgrades. A floor-to-ceiling remodel began in April 2016, funded with $2.9 million from the 2014 General Obligation Bond. The renovation was completed in Fall 2017.

The project added a 2,700 square-foot dance studio, additional restroom space and renovated a 12,000 square-foot gymnasium, which was converted into two dance studios. Those studios are now divided by a retractable wall with retractable bleachers for public performances. Studio spaces are used as rehearsal spaces for students to practice choreography. Two labs for the kinesiology program also were added to the building. One is a Biochemistry and Molecular Exercise Physiology lab while the other is for Applied Exercise Physiology.

NMSU History Archives

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NMSU's Rentfrow Hall named after long-time registrar for her dedication to students - New Mexico State University NewsCenter

Physiology

Affluent Medical kicks off first-in-human trial of Epygon valve – BioWorld Online

French startup Affluent Medical SA has launched a European pilot study in humans of its native-like transcatheter mitral valve technology. The Epygon valve is designed to restore the normal blood flow vortex in the left side of the heart and treat left ventricle disease, particularly in so-called functional patients.

Coinciding with the launch of the pilot, the company announced 10.3 million (US$11.6 million) in new financing and the addition of three new members on its board of directors.

According to the Aix-en-Provence company, the Epygon valves asymmetric, D-shaped and one-leaflet design allows it to restore the natural vortex, a rotational blood flow that is thought to be more efficient that a straight, steady flow. To our knowledge, no other mitral valve in development is a one-leaflet allowing the restore the physiological vortex, CEO Michel Finance told BioWorld.

The unique design is expected to result in high procedural success, restore left ventricular blood flow and avoid thrombus formation and left ventricular outflow tract (LVOT) obstruction, while also reducing left ventricular effort.

Finance called the pilot study a major milestone for the company.

Epygon is a world premiere and a potential best-in-class valve in a market where physiology has been overlooked for decades, he said. This pilot study aims to confirm the improved clinical outcomes already demonstrated in preclinical testing. It should open up a new era both for surgeons and patients, with physiology as a key factor in cardiac surgery.

CE mark pivotal study targeted for 2022

Affluent Medical estimates that as many as 4 million people in the U.S., Europe and Asia suffer from mitral valve regurgitation, due to the lack of optimal therapies. The global market is expected to reach $3.5 billion to $5 billion by the end of 2022, growing at an annual rate of 35%.

The prospective, nonrandomized, single-arm, multicenter MINERVA (Mitral valve INsufficiency with the Epygon TRanscatheter mitral VAlve system) study will enroll up to 20 patients in three centers in Austria, Italy and Spain. Affluent Medical plans to complete enrollment by the first quarter of 2021 and report the results after one year of follow-up.

We are anticipating our first human implant in the next weeks, Finance said.

If the pilot study is successful, the company plans to launch a pivotal trial to support CE marking of the Epygon valve in early 2022.

Finance said the company will be pursuing a similar approach for U.S. FDA approval, starting most probably in the next six to 12 months.

Capital injection

The 10.3 million private placement financing was led by Truffle Capital via the Truffle Biomedtech FCPI Fund and Truffle Innov FRR France. Other participants included Head Leader Ltd., Affluent Medicals partner for two ventures in Shanghai, Ginko Invest, Fate and Simone Merkle. The company has earmarked the funds to advance its cardiology clinical programs, particularly the MINERVA study, completion of its OPTIMISE II pivotal trial of Kalios, an adjustable mitral ring, as well as the start of a pilot/pivotal study of its Artus implantable urinary sphincter for urinary incontinence.

The OPTIMISE II trial got underway in December and is slated to complete enrollment of about 62 patients in four European countries this quarter. The goal is to demonstrate Kalios safety and effectiveness as a treatment for post-operative residual valve insufficiency. Primary outcomes from the trial are after 12-month follow-up early next year, with commercialization possibly in about two years, Finance said.

Additionally, Affluent Medical announced 5.5 million (US$6.2 million) in financing from two government-backed loans: 2.2 million from the banks Socit Gnrale and BNP Paribas to mitigate COVID-19s economic impact; 1 million by Bpifrance to support cardiology R&D; and 2.3 million in grants from Bifrance for the MINERVA study.

The new funding brings Affluent Medicals total capital raised to about 38 million since 2012.

In conjunction with the financing, the company named Jean-Franois Le Bigot, CEO of Oncovita and chairman of Ginko Invest, and Benot Adelus, president of Fate, as board members. Rounding out the board appointments was Finance, who was elected as chairman.

We are very pleased to welcome Jean-Franois Le Bigot and Benot Adelus to our board of directors, Finance said. Their expertise along with the 15.8 million in refinancing should allow Affluent Medical to make rapid progress on its clinical programs and its commitment to bring new-generation, minimally invasive medical devices to the market for the treatment of large unmet medical needs.

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Affluent Medical kicks off first-in-human trial of Epygon valve - BioWorld Online

Physiology

USF researchers working to find early warnings for severe COVID-19 illness – ABC Action News

TAMPA, Fla. -- Researchers at the University of South Florida are working to identify the physiological response to COVID-19, in hopes of developing an early warning system for patients who may be at risk for severe illness.

Researchers explained their goal is to understand which physiological patterns may give an indicator of a more serious infection.

Well be able to define how long people have these different abnormalities, their vital signs, their activity level, their heart so that we will know more about how to triage patients, characterize patients, tell them what to expect coming down the line on different days of their illness, said Dr. Asa Oxner, an associate professor at USF and operations director of the TGH-USF Health COVID Clinic.

What we intend to do is monitor a large enough sample population of people who have contracted the COVID virus but do not have otherwise some other secondary condition that would indicate they are at high risk and see if we can identify relative to their those outcomes which of the variables might give us an early indication that for a particular physiology youre going sideways, said Dr. Matthew Mallarkey, director of the USF Muma College of Businesss Doctor of Business Administration Program.

They are monitoring up to 150 COVID-19 patients with no underlying risk factors for up to a month after their diagnosis. The patients will wear a device from Shimmer Research Inc., partnering with USF on the study, to measure things like heart rate, oxygen, heart rhythm and activate levels.

Unfortunately, COVID-19 is likely to be with us for a while. By monitoring patients, we can direct healthcare resources to those who really need it and intervene in severe cases before they turn critical. This can be done remotely without bringing infectious patients to hospitals or doctors offices where they can infect other people. We are excited to work with the excellent team at USF, who bring world-class medical and AI expertise to this project, the company stated.

Researchers said theyll look at the data to see if there are the same signs in patients.

We can look back on the ones who got worse, what was the first sign that theyre about to get worse and do they all have the same sign? If they did, thats very very helpful for the people out in the community. We could have patients self-monitor that or we could have primary care doctors self-monitor that so that we would know whos gonna get sick and we know early as possible so we can start changing things for them, said Oxner.

Were hearing about sports teams, for example, where whole teams -- one or two members of the team -- contract the virus and maybe whole teams are at risk of contracting the virus. We would imagine that theres a better world where those otherwise healthy young adults are given a wearable device that could continuously monitor and compare their physiologies to these identified archetypes that these archetypes that are gonna go sideways and they dont go sideways for the same reason, said Mallarkey.

The project is funded through the USF COVID-19 Rapid Response Grant.

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USF researchers working to find early warnings for severe COVID-19 illness - ABC Action News

Physiology

Local students named to U of I Dean’s List – Oskaloosa Herald

IOWA CITY More than 8,500 undergraduate students at the University of Iowa were named to the dean's list for the 2020 spring semester, including 47 students from Mahaska and Marion Counties.

The following students were named to the list:

Austin Adrian of Pella, Accounting; Chance Bodart of Oskaloosa, Journalism and Mass Communication; Payton Bumgardner of Pleasantville, History; Allison Clark of Leighton, History; Spencer De Jong of Oskaloosa, History; Alicia Edmundson of New Sharon, English and Creative Writing; Taylor Fleener of Oskaloosa, Anthropology; John Hammes of Oskaloosa, Economics; Kaila Hembrook of Knoxville, Communication Studies; Tessa Hutchings of Pleasantville, Art; Kaley Iddings of Pleasantville, Speech and Hearing Science; Anna Kain of Oskaloosa, Art; Emma Kelderman of Oskaloosa, Pre-Business; Joseph Kesteloot of Knoxville, Microbiology; Makayla Kruse of Pella, Human Physiology; Alice Lickteig of Pella, Elementary Education; Isaiah Martin of Pella, Actuarial Science; Emily Masek of Otley, Speech and Hearing Science; Blake McClung of Knoxville, Business Analytics and Information Systems; Jared McClung of Knoxville, Mechanical Engineering; Jackson McDonald of Knoxville, Communication Studies; Bailee Meyer of Pella, English Education; Carson Milledge of Oskaloosa, Computer Science; Aubrey Miller of Oskaloosa, Elementary Education; John Moore of Oskaloosa, Finance; Maria Moore of Hamilton, Geoscience; Camryn Norton of Knoxville, Environmental Engineering; Lucy Olson of Knoxville, Neuroscience; Emma Padellford of Pleasantville, Enterprise Leadership; Victoria Palmer of Oskaloosa, Health and Human Physiology; Emily Parker of Pleasantville, English; Aleona Pronina of Pella, Psychology; Jarod Robertson of Pella, Art; Cara Roquet of Fremont, Elementary Education; Joel Ruiter of Otley, Human Physiology; Jordyn Sanders of Bussey, Science Studies; Victoria Sheehey of Pleasantville, Art; Colton Spaur of Bussey, Sport and Recreation Management; Kelli Spaur of Bussey, English; Andelyn Sunderman of Pella, Communication Studies; Daniel Thompson of Pella, Music Education; Morgan Thorpe of Pleasantville, Speech and Hearing Science; Tianna Torrejon of Pleasantville, Journalism and Mass Communication; Colin Vasina of Pella, Management; Jessica Vogel of Pella, Ancient Civilization; College: Josephine Vroom of Pella, Management; and Jennifer Wieser of Pella, Management.

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Local students named to U of I Dean's List - Oskaloosa Herald

Physiology

Prevalence of Diabetic Retinopathy and Its Associated Factors among Di | DMSO – Dove Medical Press

Melkamu Tilahun,1 Teshome Gobena,2 Diriba Dereje,2 Mengistu Welde,2 Getachew Yideg3

1Department of Biomedical Sciences (Medical Physiology), College of Medicine and Health Sciences, Debre Markos University, Debre Markos, Ethiopia; 2Department of Biomedical Sciences, College of Medicine and Health Sciences, Jimma University, Jimma, Ethiopia; 3Department of Biomedical Sciences (Medical Physiology), College of Medicine and Health Sciences, Debre Tabur University, Debre Tabur, Ethiopia

Correspondence: Melkamu TilahunDepartment of Biomedical Sciences (Medical Physiology), College of Medicine and Health Sciences, Debre Markos University, PO Box 269, Debre Markos, EthiopiaTel +251 93-355-5884Fax + 0587780673Email melkamutilahunalamir@gmail.com

Background: Diabetic retinopathy is a well-known sight-threatening microvascular complication of diabetes mellitus. Currently, 93 million people live with diabetic retinopathy worldwide. There are insufficient studies addressing the prevalence of diabetic retinopathy and risk factors in Ethiopia.Objective: To assess the prevalence of diabetic retinopathy and its associated factors among diabetic patients on follow-up at Debre Markos Referral Hospital, northwest Ethiopia, 2019.Methods: This institution- based cross-sectional study was conducted among 302 patients. They were selected through systematic sampling. Explanatory data were extracted from medical records and interviews. Blood pressure, weight, height, and visual acuity tests were assessed. Retinal examination was performed with a Topcon TRC-NW7SF fundus camera. Data were entered in EpiData 3.1 and exported in to SPSS 20 for analyses. Binary logistic regression with 95% CIs was used for analyses. Simple binary logistic regression followed by multiple binary logistic regression analysis was conducted to identify associated factors.Results: There were 302 patients in this study, of which 57 (18.9%) had diabetic retinopathy. Among the diabetic retinopathy patients, 75.4% had the preproliferative type. Four in ten (37.7%) of the patients had visual acuity problems. Poor glycemic control (AOR 4.58, 95% CI 1.86 11.31), > 10 years diabetes duration (AOR 3.91, 95% CI 1.86 8.23), body-mass index > 25 kg/m2 (AOR 3.74, 95% CI 1.83 7.66), and hypertension (AOR 3.39, 95% CI 1.64 7.02) were factors significantly associated with diabetic retinopathy.Conclusion: About a-fifth of diabetic patients had diabetic retinopathy. Diabetic retinopathy was significantly associated with glycemic control, hypertension, body-mass index, and duration of illness. Routine assessment and early control of those associated factors may be important in reducing both the prevalence and impact of diabetic retinopathy, as evidenced in the current study.

Keywords: diabetes mellitus, diabetic retinopathy, associated factor, Ethiopia

This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License.By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

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Prevalence of Diabetic Retinopathy and Its Associated Factors among Di | DMSO - Dove Medical Press

Physiology

Empatica and BARDA Join Forces to Validate Wearable System That Detects COVID-19 Before Symptoms Appear – PRNewswire

The aim is to validate Empatica's algorithm in real-life settings, with the participation of healthcare workers who are exposed to a high viral load while treating hospitalized COVID-19 patients.They will wear the E4, Empatica's medical-grade research wearable wristband, for 30 days, and their physiological data will be reviewed against daily nasopharyngeal (NP) samples and a daily qRT-PCR swab, ensuring the highest ground truth.

Empatica CEO Matteo Lai, stated, "We are very proud to join forces with BARDA to help improve the health and safety of millions of Americans going back to work. This product introduces a new paradigm: empowering individuals and institutions with smart health monitoring, so that they will know early when they need to self-isolate and take care of themselves. Without BARDA's leadership and foresight over the past year, our early detection algorithm would not have reached this pivotal stage of clinical validation, which will accelerate our request for FDA's approval of Aura as a medical product for use by people at risk of contracting COVID-19."

BARDA Acting Director, Gary Disbrow, Ph.D., added, "We anticipate that access to real-time and actionable health information will empower people to seek medical advice and care sooner, or to adopt behavioral changes such as temporary self-isolation that can help reduce the spread of COVID-19 and similar infections."

Early detection can protect frontline workers, reduce spread, and improve the overall public health response as lockdowns ease globally. Recent estimates byCDC suggest that 35% of infections are asymptomatic, making contact tracing and containment of the virus a challenge. Meanwhile,the most infectious period could be 1 to 3 days before symptoms start, so even those patients who eventually display symptoms can still infect their family, colleagues and other people they interact with, before realizing they are ill. Digital biomarkers like Aura can help efficiently triage patients, enabling more effective care and prioritization of cases, and potentially saving lives.

Contact [emailprotected] for more info on Aura.

Empatica

Empatica Incis an MIT spinoff based in Boston, MA, and a pioneer in physiology-based biomarker development and continuous, unobtrusive patient monitoring driven by AI. Empatica's platform uses a combination of biosensors to detect features of human physiology that are distilled in AI-based algorithms and can remotely monitor autonomic activity, movement, sleep and cardiac activity. Empatica's E4 and Embrace2 smartwatches are CE-marked and have been sold to thousands of institutional partners for research purposes, in trials and studies examining Stress, Sleep, Epilepsy, Migraine, Depression, Addiction and other conditions.

HHS/ASPR/BARDA

HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of ASPR is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures vaccines, treatments, diagnostic tools, and non-pharmaceutical products needed to combat health security threats.

SOURCE Empatica

https://www.empatica.com/

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Empatica and BARDA Join Forces to Validate Wearable System That Detects COVID-19 Before Symptoms Appear - PRNewswire