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٢٠٢١ مارس

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Allurion Expands Digital Offering For Patients and Providers in Response to COVID-19

Allurion Technologies

NATICK, Mass.???(BUSINESS WIRE)???Allurion Technologies, an established leader in the development of innovative, proven, and trusted weight loss experiences, is supporting customers around the world during COVID-19 with an expanded digital offering. The company???s weight loss program includes the world???s first and only procedureless gastric balloon, an individualized nutritional program, and a Bluetooth?? smart scale and smartphone app that facilitate remote tracking.

In response to recent data that indicates that individuals with obesity are at higher risk of poorer outcomes from COVID-19 and that quarantine measures may lead to weight gain, the company has expanded access to telenutrition for both existing and new patients and providers and enhanced its proprietary program to include at-home fitness, mental health, and nutritional content.

???The early evidence clearly suggests that people with obesity are at greater risk for poorer outcomes from COVID-19,??? said Shantanu Gaur, M.D., CEO of Allurion Technologies. ???While quarantine is effective at slowing the spread of the virus, it may prompt stress, decreased activity, and deterioration in mental health which, in turn, can result in weight gain. Our expanded digital offering offers providers an opportunity to stay in closer contact with existing patients to limit these deleterious effects and also manage the increased demand that has resulted from increased awareness of the links between weight and COVID-19.???

The United States Center for Disease Control (CDC) has issued a statement noting a propensity for those who have serious underlying medical conditions???including obesity???as potentially higher risk for severe illness from COVID-19. A recent studyconducted at New York University published in Clinical Infectious Diseases demonstrated that of 3,615 patients admitted to the hospital with COVID-19, those less than 60 years-old with a body mass index (BMI) greater than 35 were 3.6 times more likely to be admitted to critical care compared to individuals with a BMI under 30.

???The well-being of our patients is our top priority, and the digital tools we have rolled out to providers allow them to navigate these uncertain times,??? stated Benoit Chardon, Executive Vice-President Global Commercial, Allurion Technologies. ???We believe the expanded program we are now providing to existing and new patients offers a comprehensive solution to the specific needs our patients have during the COVID-19 pandemic.???

???Allurion has been very thoughtful in devising a global weight loss program that addresses the diverse needs of individuals who are experiencing weight-related challenges,??? said Dr. Sophie Al Samman Zouaghi, Visceral and Digestive Surgeon at Protestant Infirmary Hospital in Caluire, France. ???Providing holistic patient care during the pandemic is a challenge for all providers, and we welcome any additional tools that will allow us to successfully serve our patients.???

Fractyl???s Revita DMR Same-Day Therapeutic Procedure Could End Daily Insulin Injections for Type 2 Diabetes Patients

Interim clinical data to be presented at ADA 2019 show that approximately 85 percent of patients are insulin-free at six months after Revita DMR outpatient therapy 


LEXINGTON, Mass., June 8, 2019 ??? Fractyl Laboratories Inc. (Fractyl), today announced the presentation of interim data from the investigator-initiated INSPIRE clinical trial in collaboration with Fractyl showing Revita??? DMR, a same-day therapeutic procedure, can help eliminate the need for daily insulin injections for type 2 diabetes (T2D) patients. This data will be presented at the American Diabetes Association???s 79th Scientific Sessions in San Francisco on Sunday, June 9 from 12 pm to 1 pm. The presentation (1156-P) is entitled, ???Duodenal Mucosal Resurfacing (DMR) Combined with GLP-1-RA May Eliminate Insulin Therapy and Improve Metabolic Health in Type 2 Diabetes.??? 

???Other than extreme interventions, this is the first same-day treatment that has the potential to free patients with advanced type 2 diabetes from daily insulin injections,??? said Jacques Bergman, M.D., Ph.D., a professor of gastroenterology at Amsterdam UMC and principal investigator of the INSPIRE study. ???Our results suggest we can use a straightforward and safe outpatient procedure to eliminate the need for daily insulin, which could have a meaningful positive impact on the hundreds of millions of people across the world suffering from type 2 diabetes.???

Building on years of research about the gut???s critical role as a root cause of metabolicdisease, the Revita duodenal mucosal resurfacing (DMR) procedure aims to reset key metabolic pathways, including insulin resistance, to prevent and even reverse metabolic disease progression. This same-day, outpatient endoscopic procedure uses heat to resurface the lining of the upper intestine (duodenum) in a minimally invasive, outpatient procedure. The therapy is designed to target the root cause of metabolic syndrome in theduodenum, leading to significant improvements in metabolic disease parameters, reduced need for medication usage, and greater patient satisfaction with their therapy. 

???An important recent trend is that we now know we can reverse type 2 diabetes with different approaches. The outstanding takeaway from this data is that patients are returning to better overall metabolic health from an outpatient procedure, with reductions in blood sugar, significantly reduced liver fat in NAFLD/NASH, and improved cardiovascular risk parameters even as patients discontinue insulin usage,??? said Harith Rajagopalan, M.D., Ph.D., co-founder and CEO of Fractyl. ???Revita DMR is helping patients regain control of their metabolic health and turn back the clock, so to speak, on their metabolic age.???

The INSPIRE study completed enrollment at 16 patients, out of which 13 patients havereached the six-month follow-up, and 11 of 13 (85%) are insulin-free. The remaining three patients are still in the trial but have not reached their six-month follow-up for this interim analysis. In addition, patients have seen nearly 45 percent reduction in liver fat on MRI-PDFF (from a baseline of 8.5 percent absolute liver fat), along with significant improvements in blood pressure and weight.

Previous clinical studies of Revita DMR in more than 200 patients have demonstratedsustained improvements in blood glucose levels, insulin resistance measures, liver fat, cardiovascular risk markers, and weight loss, unaided by any lifestyle intervention, through one year of follow-up.  In all clinical studies, Revita DMR was well-tolerated and demonstrated an acceptable safety profile.

???Type 2 diabetes is complicated with many severe co-morbidities, often managed withmultiple daily medications. But with Revita DMR, we continue to see positive clinical effects on diabetes, fatty liver, and cardiovascular disease, after treatment,??? said Juan Carlos Lopez-Talavera, M.D., Ph.D., chief medical officer of Fractyl. ???By targeting the root cause of metabolic disease, Revita DMR can provide significant and sustained disease modification for the patient, in addition to reducing their disease management burden.???

Non-alcoholic fatty liver disease (NAFLD/NASH) and T2D have both reached epidemic levels in the United States and around the world, and there are currently no FDA-approved treatments for NAFLD/NASH. Of particular concern, are the estimated 18 million Americans who have both conditions, and hence much higher risk of negative outcomes.1 Data presented at ILC 2019 showed that Revita DMR can generate significant improvements in people with both NAFLD/NASH and T2D conditions.

The first U.S. clinical trial for Revita DMR is currently taking place at five sites and is recruiting T2D patients on oral anti-diabetic medications with inadequately controlled diabetes. For a full list of inclusion and exclusion criteria, visit ClinicalTrials.gov

1. Bazick et al. Diabetes Care, 2015. 

???Prodigy??? founder taking Utah???s Teal Drones to unexplored heights

???Prodigy??? founder taking Utah???s Teal Drones to unexplored heights
٢٠٢٠ سبتمبر

MURRAY ??? Smaller. Faster. Smarter.

Common goals in the world of tech startups, but Teal Drones founder and CEO George Matus ??? having nailed these three attributes very early on with drones he and his team developed ??? is on a quest for something more elusive and, perhaps, more consequential.

???Once consumer drones started becoming widely used and really popular, I started realizing that all they are is just a flying camera that can take photos and videos,??? Matus said. ???And, I???ve always had these grand visions of what drones could do ??? and the role for good that they could have in society.???

Building drones that can fulfill a greater and more impactful mission is a goal now very much in sight for Matus.

In late April, Teal was announced as one of only six companies awarded contracts with the U.S. Army to develop and prototype a lightweight surveillance drone for use by soldiers in the field. Matus, who launched Teal in 2014 and has already released two high-performance consumer model drones, said he???s excited to be in the competition for designing a drone that could play a part in saving lives.

???The intention of this aircraft is to be a rucksack portable, vertical takeoff and landing aircraft the war fighter can have in their bag, pull out at any time, launch into the air and see what???s around the next terrain feature, whether that???s a hill or a building or whatever,??? Matus said. ???Right now, the army doesn???t have a quadcopter of this size and capability ??? and we???re excited to be working on a design with all these awesome attributes that will potentially save lives.???

Matus said the six companies, including Teal, were awarded some $11 million collectively and each have a year to design and complete a prototype that meets the specifications as outlined by the Army???s program executive officer for aviation, in partnership with the Defense Innovation Unit.

I got that first radio-controlled plane and really fell in love with it. I started learning as much as I could about hardware and software and flying. I was running lemonade stands and doing magic shows and babysitting to save up to buy my next $200 plane. ??? Teal Drones founder and CEO George Matus
Teal may have a jump on the competition as a company that has already developed two drone models, including the Teal One, which went on sale in October 2018. The Teal One has top speeds over 60 mph and, according to Matus, is the fastest production drone on the market. Features of the craft include a high-performance hardware and software platform powered by an NVIDIA Jetson supercomputer, capable of artificial intelligence, augmented reality and open source programming that allows users to modify or tweak as they wish. The Teal One is also backpack portable and modular to easily swap out propellers, arms and batteries.

The company, or companies, that win favor with the Army could be looking at procurement contracts north of $100 million. Matus said he likes Teal???s chances.

???We???re taking everything we???ve learned, all the experiences and all the mistakes that we???ve made from these last few products that we???ve launched, and taking that into this next generation with us,??? Matus said. ???It is going to be quite an evolution and something that is going to blow a lot of people away with its capability.???

Blowing people away is a strategy Matus has made a habit of. It???s noteworthy that while his company has been around for five years, and attracted over $20 million in venture backing, Matus is all of 21 years old. But, his chronology is a little deceiving as he???s been on the path to Teal since he became enamored of radio controlled planes and helicopters as a boy and developed a skill set that would lead to his first job in the drone industry, as a wizened 12-year-old.

???I got that first radio-controlled plane and really fell in love with it,??? Matus said. ???I started learning as much as I could about hardware and software and flying,??? Matus said. ???I was running lemonade stands and doing magic shows and babysitting to save up to buy my next $200 plane.

???And, when I was 12 became a test pilot for a drone company. I just applied for fun, because I saw an application.???

That gig not only provided some budget relief for young Matus, but also gave him the chance to get hands-on experience with the latest-and-greatest in the still-nascent world of drones. Not long after he started building his own drones ??? including a large craft that could fly for two hours and carry a 25-pound payload and another smaller drone that could reach a blistering top speed over 100 mph. For that project he devised an innovative system for tilting the drones rotors, for which he received a patent.

While Matus watched the manufacturers of camera-bearing drones creating a red-hot consumer market, he thought he could do better and create something with a much wider range of potential uses by developing a drone with onboard computing capabilities. And he connected with someone who could help him take the first steps down that road.

While Matus was still in high school, he applied for and was chosen to join a select group of young entrepreneurs for a Thiel Fellowship. The namesake program of PayPal founder and venture capitalist Peter Thiel launched in 2011 with the mission of offering financial and expertise support for entrepreneurs under 22 years old who ???want to build new things instead of sitting in a classroom.???

???The idea is that there are people out there who, with the right support, can build something amazing without needing to necessarily attend college, or have other experience,??? Matus said. ???Their motto is that ???some ideas can???t wait??? ??? so every year he brings in 20 kids, tells them not to go to college, gives them $100,000 and tells them, ???go do it.’???

And that???s what Matus did, leveraging the seed money from Thiel and another $150,000 from a Salt Lake angel investor to get the company off the ground. He developed first the Teal Sport, and a short time later, the Teal One, with an onboard mini supercomputer and a whole lot of potential.

For now, Teal is taking a pause on consumer drones as it focuses on the Army development contract while simultaneously exploring a host of new, non-consumer business uses for drones. Matus said amidst rising commentary focused on Chinese manufactured drones and data security, it became clear that the demand for developing applications for industry was just too large to ignore.

???It was interesting that around the same time that we launched the consumer product we started getting just so many requests from different organizations looking for drones for their use cases,??? Matus said. ???They all had similar challenges, not being able to find software that could address their needs and not able to utilize Chinese manufactured products that came with their own security concerns.???

Colin Guinn has a deep resume in the drone industry and runs a company, Guinn Partners, that helps startups get their products market ready. He met Matus a few years back and became a friend and informal advisor. He said Matus is a standout in the drone world, both for his vision of how useful, beyond flying cameras, he believes drones can be, and for his ability to put that future outlook into practice.

???I am a big fan of George and the passion he brings to the space,??? Guinn said. ???He has such a long history of building his own drones and really understanding how to create the best user experience.???

Guinn, who previously worked for DJI, a China-based drone manufacturer that he said controls some 80 percent of the computer market, said Matus has always been looking further down the road than most of the competition. He noted that Teal???s arc is recognizing that the use cases for drones will eventually tilt away from consumers and heavily toward an enterprise, or business, market. Guinn said data gathering, mapping, infrastructure inspection, search and rescue and many other applications have just been waiting for the technology to come up to speed. And Matus is helping lead that charge.

???I think George is right on the money with the direction they???re going,??? Guinn said. ???Becoming capable of gathering, processing and delivering data in near-real time ??? is a high value creation. It???s definitely happening, and Teal is one of the players that???s taking us there.???

Teal???s $20 million plus in funding has included backing from some local venture capital firms including Pelion Venture Partners and Kickstart Seed Fund. Kickstart administrative partner Alex Soffe said his team was blown away by Matus from the start and noted that while a young founder, he???s been an expert in his space for over half his life.

???When you talk with George, you realize he is wise beyond his years,??? Soffe said. ???He???s going to do great things and we???re really impressed with his ability to adapt and react and change strategy. While Teal initially was going to be a consumer play they???re now pivoting to enterprise and building the go-to portable drone for the military. I just love that he???s willing to learn and is so great at taking feedback.

???And, he???s a prodigy.???

Article Source: //www.deseret.com/٢٠١٩/٥/٢٥/٢٠٦٧٤٢٣٠/prodigy-founder-taking-utah-s-teal-drones-to-unexplored-heights#george-matus-who-launched-teal-drones-as-a-teenager-in-٢٠١٤-pilots-one-of-his-drones-outside-the-companys-offices-in-murray-on-monday-may-١٣-٢٠١٩-the-company-is-set-to-unveil-a-just-inked-deal-with-the-u-s-army-to-develop-a-short-range-reconnaissance-drone-that-service-members-can-carry-in-a-backpack-and-deploy-as-needed-in-the-battlefield

Allurion expands in Natick, raises $60M

Allurion expands in Natick, raises $60M

Allurion, a Natick company making a gastric weight-loss balloon that doesn???t require an operation, doesn???t yet have regulatory approval to sell in the United States.

But Allurion does sell the Elipse Balloon in Europe and the Middle East, and with 15,000 sold in its three years in those markets, Allurion has made a major expansion with high hopes.

???It???ll allow us to touch the lives of millions, if not billions, of people around the world,??? Shantanu Gaur, Allurion???s CEO and co-founder, said Friday, officially opening the company???s new 10,000-square-foot office and lab on Erie Drive in Natick.

The new space more than doubles the square footage of the company???s old building down the street, and gives Allurion the capacity to make 200,000 Elipse Balloons a year.

In 2019 alone ??? the company???s 10th anniversary ??? Allurion has grown from 40 employees to 100.

With U.S. Food and Drug Administration approval expected next year and a market debut in late 2020, Gaur thinks the company can hit the 200,000-a-year figure in the next four or five years.

Gastric balloons, which help people lose weight by taking up space in their stomach, have been around for a long time. But Allurion???s balloon can be swallowed in a capsule in a quick doctor???s office visit, and is inflated through a catheter to about the half the size of the stomach, large enough to help a patient lose 10% to 15% of their body weight.

After four months, a polymer wears away, the balloon deflates and then passes naturally through the body.

With high obesity rates in the United States, Allurion sees a major market on the horizon and has left itself plenty of room to expand at its new facility. But the company is also eyeing its next steps beyond the Elipse Balloon. After all, if the balloon is successful, patients won???t necessarily need it for long.

Allurion has created a Bluetooth-connected scale and is piloting a nutritional program. Gaur sees a potential for similar easy-to-use products in other health areas, such as a more friendly version of transcranial magnetic stimulation, an office procedure meant to help people with depression whose symptoms don???t improve with medication.

Gaur started what would become Allurion with a fellow Harvard Medical School student, Samuel Levy, using their apartment as their first lab. Levy, the company???s Paris-based president, and Ram Chuttani, its chief medical officer, stood beside Gaur for a ceremony with family members and employees.

The privately held company has raised $60 million in capital, with its largest investor Romulus Capital in Boston, Gaur said. Friday???s ribbon cutting at its new facility doubled as Allurion???s 10th anniversary, and Gaur used the occasion to look both back and ahead.

???In the next 10 years,??? Gaur said, ???we???ll ask, how can we have (customers) with us for not just four years but for decades????

Fractyl Announces First-Ever Commercial Availability of Revita for Type 2 Diabetes in Partnership with Leading UK Private Clinic

Fractyl Announces First-Ever Commercial Availability of Revita for Type 2 Diabetes in Partnership with Leading UK Private Clinic

LEXINGTON, Mass., January 28, 2020 ??? Fractyl Laboratories Inc. (Fractyl) today announced its first commercial partnership with HCA Healthcare UK (United Kingdom), making its Revita?? treatment commercially available for the first time for patients with type 2 diabetes. HCA Healthcare UK is the largest provider of privately funded healthcare in the UK and is part of the US-based HCA Healthcare, the world???s largest private hospital group.

Revita is a first-in-class intervention designed to target insulin resistance and metabolic disease progression by resetting key pathways in the gut that drive metabolic disease. This minimally-invasive, outpatient, endoscopic procedure is a non-drug and non-surgical alternative that has been shown in clinical trials to enhance insulin sensitivity, lower HbA1c, and reduce liver fat to create long-lasting improvements in both blood sugar control and fatty liver disease to help patients with type 2 diabetes avoid further medication escalation.1

???Our first commercial market in the UK represents a significant milestone for Fractyl. It demonstrates our evolution from developing the initial science and clinical evidence behind Revita to an organization now also focused on accelerating its availability for patients with type 2 diabetes who are seeking alternatives to current approaches,??? said Harith Rajagopalan, M.D. Ph.D, co-founder and CEO of Fractyl. ???This commercial availability is supported by data from several multinational clinical studies in hundreds of patients showing significant and sustained metabolic benefits from a single Revita DMR treatment.???

???We are excited to be the first medical facility in the world to be able to offer the Revita procedure to our patients with type 2 diabetes,??? said Miranda Dodd, CEO of The Princess Grace Hospital, part of the HCA Healthcare UK network where the Revita procedure will be performed. ???Led by a specialist team of experts, our hope is that Revita will allow patients all over the UK ??? and internationally ??? to take back control of their lives with a single treatment.???

???HCA Healthcare UK is an ideal inaugural hospital system partner in the UK market. HCA???s focus on bringing pioneering treatments to market aligns with Fractyl???s commitment to improving the health of patients suffering from metabolic diseases. We are thrilled with the strong support from physicians as well as the collaboration with HCA???s key stakeholders in making Revita available to their patients,??? said Margaret Borys, Chief Commercial Officer of Fractyl. ???This partnership and UK commercial availability represents an important first step in bringing Revita to patients around the world.???

The commercial launch of Revita in the UK comes following a series of global clinical trials on the procedure, involving close to 300 patients at over 20 centers across three continents. The research published to date shows five important metabolic benefits for patients: improved overall insulin sensitivity, lowered HbA1c (by nearly 1%), weight loss, improved liver health (more than 35% reduction in liver fat, a key factor in the development of NAFLD/NASH) and increased ???good??? (HDL) cholesterol (a parameter that correlates with a reduction of CV risk).2 Furthermore, reductions in HbA1c and liver fat were observed through 24 months of follow-up from a single outpatient Revita DMR procedure, indicating the potential for Revita DMR to offer durable improvements in both type 2 diabetes and NAFLD/NASH for a full two years thus far.3 Revita DMR has been shown to be safe and well tolerated with no long term adverse events in clinical studies to date.

NHS leaders have spoken, they want transparency!

NHS leaders have spoken, they want transparency!

Ahmed and I know as well as anyone that transparent, collaborative working within the NHS is the most effective way to get the highest standard of work done, in the most efficient way, and importantly make patients well again. The last few years that we???ve witnessed within the NHS have been some of its hardest. As budgets are stretched to breaking point and every penny is scrutinised, rather than coming together as one NHS, pools of money have been separated and allocated to individual Trusts. This has led to a separation of resources, staff and ultimately formed silos of communication within the NHS.

This week Matt Hancock addressed the nation and urged leaders to align through advances in technology:

???Better technology is vital to have and embracing it is the only way to make the NHS sustainable over the long term.

???We need to give our people, our leaders and future leaders, our clinicians and our non-clinicians, the tools, confidence and understanding they need. Because in the end, this whole agenda is not just about the technology, it???s about people.???

It was his last three words that stayed with me. Yes, we can develop world leading technology, yes, we can show evidence of this technology saving time, money and people???s lives, but we need everyone within the NHS to use it, share it and adapt it, in order for true transparency.

It pleases me to say we have begun to witness this desire for change first-hand through the launch of the Digital Collaborative Bank. Our platform provides locum doctors access to shifts at all participating Trusts of which there are currently eight across the UK. The platform aims to create, for the first time, one national staffing pool across the whole of the NHS, and, in turn, save it ??1bn.

As Chris Hopson, CEO of NHS Providers, said the NHS needs to be ???brave and bold??? when it comes to adopting new technology. Across the country, bold Trust leaders are now discussing how they are indeed proud that their doctors are cross-covering shifts at their neighbouring Trusts, obliterating reliance on expensive agencies and improving patient continuity and ultimately quality of care.

Through our vision to, at last, have one NHS, one staff bank, it really feels that every day we???re getting one step closer to breaking down the barriers of silo NHS organisations competing with each other for the best talent. We are seeing genuine movement and interest from leaders within the NHS towards this collaborative approach.

On behalf of the entire team here at Locum???s Nest, we pledge to do everything in our power to stay true to what drove us to start this company in the first place: deep commitment to an equitable and fair health service, by working together.

Nicholas Andreou

Doctor, Co-Founder at Locum???s Nest

Start-ups that could become the Middle East???s next big ventures

Start-ups that could become the Middle East???s next big ventures

CAIRO: Following initial news of the $3.1 billion deal in March 2019, US ride-hailing firm Uber completed its acquisition of Dubai-based vehicle-for-hire company Careem at the beginning of January 2020.

Middle East and North Africa (MENA) startups have been getting much-needed funds to scale up their businesses, and 2019 seems to have set the bar high.

During the first half of last year, startups in the region received $471 million in investments, up 66 percent from the $283 million invested over the same period in 2018.

Given the steadily growing number of MENA startups, it remains extremely difficult to spot the next local unicorn.

Nevertheless, here is a list of new ventures with definite growth potential in 2020.

Carzaty

Being a small market, Oman is an unlikely place of origin for booming startups. However, certified pre-owned car e-retailer Carzaty has the potential to change that. Founded in 2017 by Hassan Jaffar and Marwan Chaar, the company offers heavily discounted vehicles by operating exclusively through a virtual showroom, selling reconditioned cars covered by a one-year warranty and delivering them to customers.

After securing $4 million in funding, Carzaty launched operations in the UAE in December 2019, entering a country whose used-car market was valued at more than 11 billion Emirati dirhams ($3 billion).