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American Kidney Fund Endorses New Race-Free Approach to Diagnose Kidney Disease

American Kidney Fund

The American Kidney Fund (AKF) today issues the following statement in response to A Unifying Approach for GFR Estimation: Reassessing the Inclusion of Race in Diagnosing Kidney Disease: “AKF is firmly committed to reducing inequities in all phases of a patient’s kidney disease journey. Consistent with this commitment, we commend the NKF/ASN Task Force for undergoing a very thoughtful, transparent and data-driven process, and for gathering input from the kidney community—including AKF’s Medical Advisory Committee—to develop a recommendation for GFR estimation that eliminates race, ultimately a step towards eradicating the ‘othering’ of people of color in medicine. “Currently, Black Americans are four times more likely than white Americans to have kidney failure, yet are less likely to receive kidney transplants. We are hopeful the proposed change in GFR estimation will lead to earlier diagnoses of kidney disease for Black Americans particularly, and improve opportunities to slow down the progression to kidney failure. “Operationalizing the Task Force’s recommendations quickly, and adding the use of confirmatory testing, like cystatin C and other markers that are yet to be identified, must be top priorities. In addition, there is still a need to follow the research and continuously evolve GFR estimation and kidney function measurement as one step towards elimination of racial and ethnic disparities in kidney disease. “Keeping patients at the forefront of discussions about the change in GFR estimation is paramount. A crucial next step will be to develop comprehensive transition and education materials for patients about the new GFR equation and its impact on chronic kidney disease (CKD) care. AKF stands ready to work with patients and stakeholders to integrate the GFR estimation-related changes into current programs as we partner to achieve health equity across the CKD continuum. AKF will continue to build education and awareness programs to incorporate changes that are aligned with our mission of fighting kidney disease on all fronts and helping people live healthier lives.” ### About the American Kidney Fund The American Kidney Fund (AKF) fights kidney disease on all fronts as the nation’s leading kidney nonprofit. AKF works on behalf of the 37 million Americans living with kidney disease, and the millions more at risk, with an unmatched scope of programs that support people wherever they are in their fight against kidney disease—from prevention through transplant. With programs that address early detection, disease management, financial assistance, clinical research, innovation and advocacy, no kidney organization impacts more lives than AKF. AKF is one of the nation’s top-rated nonprofits, investing 97 cents of every donated dollar in programs, and holds the highest 4-Star rating from Charity Navigator and the Platinum Seal of Transparency from GuideStar. For more information, please visit KidneyFund.org, or connect with us on Facebook, Twitter, Instagram and LinkedIn. Contact Details Stefanie Tuck 202-470-1797 +1 978-390-1394 11921 Rockville Pike Suite 300 Rockville, MD 20852 AKF@jpa.com Company Website https://www.kidneyfund.org/

October 05, 2021 09:00 AM Eastern Daylight Time

Independence Blue Cross and US Digestive Health Sign New Five-Year Agreement

US Digestive Health

Independence Blue Cross (Independence) and US Digestive Health today announced a new five-year agreement which went into effect January 1, 2021. The agreement demonstrates the commitment of Independence and US Digestive Health to work together to ensure that Independence members and US Digestive Health patients are receiving gastroenterology care in the most appropriate, high-quality, and cost-effective settings. “We are pleased with this new long-term agreement which will give our members access to US Digestive Health to help prevent, treat and cure digestive disorders,” said Richard L. Snyder, M.D., Executive Vice President of Facilitated Health Networks, and Chief Medical Officer at Independence. “The new agreement will allow us to collaborate on innovative programs that are focused on high-quality, cost-effective care.” “By entering into a five-year partnership, US Digestive Health and Independence Blue Cross will ensure access to world-class gastroenterology care for members across the region,” said Jerry Tillinger, Chief Executive Officer of US Digestive Health. “With 96 GI physicians across the Commonwealth, this agreement will allow us to continue bringing affordable, cutting-edge gastroenterology services to all of our Pennsylvania communities.” About US Digestive Health US Digestive Health oversees a network of 140 gastroenterology providers and has 26 locations, 13 ambulatory surgery centers, and more than 700 total employees in Pennsylvania. They are at the forefront of the rapidly advancing science of digestive health, bringing new insight into the care, treatment, and prevention of digestive health disorders. Contact Details Noah Ramagano nramagano@usdhealth.com Company Website https://usdigestivehealth.com

October 05, 2021 07:56 AM Eastern Daylight Time

Virgin Money London Marathon using Restrata technology to help keep elite athletes COVID-Safe

Restrata

As the Virgin Money London Marathon returns to the city’s streets this Sunday, Restrata, a global contact tracing specialist, will be helping to keep the elite runners COVID-Safe with their cutting-edge technology. Already adopted by businesses and venues, as well as being used at international sporting tournaments, Restrata Platform is now being used to help ensure the world’s top marathoners arrive at the starting line in Greenwich for the 41 st London Marathon. In addition to daily Covid testing, the 100 elite athletes scheduled to take part in the Virgin Money London Marathon, including defending champion and world record holder, Brigid Kosgei, as well as their support staff, are wearing a Restrata tag in the elite hotel. This device means that if a positive case of Covid is recorded, it’s fast and simple to identify who else has shared the same space, at the same time, so that the necessary safety measures can be put in place to prevent any spread of the virus. Restrata Platform was initially designed to protect workers in the energy and industrial sector and ensure their safety. Having been further developed and successfully implemented at cricket tournaments for the Pakistan Super League (PSL), Indian Premier League (IPL) and the English Cricket Board (ECB), Restrata is proud to be part of bringing back large-scale sporting events in a safe, controlled way. Botan Osman, CEO, Restrata, comments: “Supporting the Virgin Money London Marathon this year is incredibly exciting for Restrata. As an international business much of our work is carried out overseas, so with the final stage of the race just a short sprint from our London office, and being a Londoner myself, this project is close to our hearts. “Helping to keep the elite team and their support staff safe with Restrata Platform and our contact tracing technology will ensure that the runners enter the race in top form and with 100% confidence. We're delighted to be able to support Hugh Brasher and his team in staging such a prestigious sporting event.” Hugh Brasher, Event Director of London Marathon Events, adds: “London Marathon Events is delighted to be working with Restrata to ensure we have accurate data to keep our elite athletes safe and healthy as they prepare for the Virgin Money London Marathon. “In this uncertain world, the Restrata technology gives us certainty in planning for some incredible racing between our elite athletes and para-athletes on Sunday 3 October at the 41st London Marathon.” About Restrata Founded in 2006, Restrata has been a pioneer in smart tech solutions that help multi-nationals safeguard their people, strategic assets, and physical infrastructure in some of the most challenging operating environments in the world. Restrata Platform is an integrated safety, security, and mobility cloud-based software. It is designed to manage the safety of people across sites, offices, and countries around the globe. In response to the pandemic, Restrata developed a COVID-Safe module within the Platform, creating a technology-enabled bio-secure environment for the safe return to operations in any industry. The Restrata Platform is already operational across offices, companies, venues, and international tournaments around the world. And in our uncertain world, The Restrata Platform can flex to address most safety and security concerns, leaving you and your workforce as protected and resilient as possible. restrata.com About the London Marathon The London Marathon was first held on 29 March 1981 and the millionth finisher in the history of the event crossed the line in 2016. The 40th Race took place on Sunday 4 October 2020 with elite races on a biosecure closed-loop circuit around St James's Park and 37,966 runners around the world running the virtual Virgin Money London Marathon on the course of their choice any time from 00:00:00 to 23:59:59 BST. Participants were able to download the Virgin Money London Marathon app powered by TCS to record their run. All finishers received a New Balance finisher's t-shirt and medal. In 2019 the Virgin Money London Marathon raised £66.4 million for charity, setting a new Guinness World Record for an annual one-day charity fundraising event for a 13th successive year. This brought the total raised for charity since 1981 to more than £1 billion. London Marathon Events gifts its surplus each year to The London Marathon Charitable Trust. Since 1981, The London Marathon Charitable Trust has awarded grants totalling in excess of £93 million to more than 1,490 projects in London and across the UK. Contact Details Fox Agency Chloe Murray +44 7961 116568 chloe@fox.agency Company Website https://www.restrata.com

October 01, 2021 05:47 AM Eastern Daylight Time

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What You Need to Know About Medicare Annual Enrollment

YourUpdateTV

Medicare’s Annual Enrollment Period is almost here — the time (Oct. 15 to Dec. 7) when people can select or make changes to their Medicare coverage for the year ahead. Recently, Rick Dunlop, Health Plan CEO at UnitedHealthcare Medicare & Retirement, participated in a nationwide satellite media tour to discuss tips and resources on finding the right plan. A video accompanying this announcement is available at: https://youtu.be/TDXd22jLN2k The need for clear information on Medicare is great and growing as more than 10,000 Americans turn 65 each day. It is estimated that by 2030, more than 80 million Americans will be eligible for Medicare. People should be aware of their options and what different Medicare plans can offer. With Medicare, it's always a good idea to understand the basics first. Learn about the different parts of Medicare—Medicare Part A, Part B, Part C and Part D—how your Initial Enrollment Period works, the different Medicare coverage options, and how to enroll. There are several options when it comes to Medicare and choosing coverage. You can get Medicare Part A and Part B benefits, either through Original Medicare or a Medicare Advantage plan, but you have other choices to consider too. You may need Part D prescription drug coverage if you take medications regularly. You may decide you want the ease of an all-in-one plan that may also offer extra benefits like dental, vision and fitness, and look to get a Medicare Advantage plan. Or, you may consider a Medicare supplement insurance (Medigap) plan to help with out-of-pocket costs not paid by Original Medicare. For more information, visit gettoknowmedicare.com About Rick Dunlop: Rick Dunlop is a Health Plan CEO with UnitedHealthcare Medicare & Retirement, the largest business dedicated to serving the health and well-being needs of seniors and other Medicare beneficiaries. More people choose UnitedHealthcare for their Medicare coverage than any other insurer. About YourUpdateTV: YourUpdateTV is a social media video portal for organizations to share their content. It includes separate channels for Health and Wellness, Lifestyle, Media and Entertainment, Money and Finance, Social Responsibility, Sports and Technology. Contact Details YourUpdateTV +1 212-736-2727 yourupdatetv@gmail.com

September 30, 2021 07:00 PM Eastern Daylight Time

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Hong Kong Baptist University invents novel cell sensor for rapid and low-cost screening of drug-resistant bacteria

Hong Kong Baptist University

HONG KONG SAR - Media OutReach - 29 September 2021 - A research team led by scientists at Hong Kong Baptist University (HKBU) has developed a novel cell sensor with a barcode-like micro-channel structure that enables rapid and low-cost screening of drug-resistant bacteria. The invention could potentially be used on a large-scale in resource-limited situations such as frequent safety screenings of water, food and public facilities, as well as urgent surveys of massive samples during an infectious disease outbreak, particularly in developing countries. A research paper on the novel invention was published in the international academic journal Biosensors and Bioelectronics. A research team led by Dr Ren Kangning, Associate Professor of the Department of Chemistry at HKBU (left), designed a fully automatic, microscope-free antimicrobial susceptibility testing (AST) system. It enables rapid and low-cost screening of drug-resistant bacteria by scanning the "barcode" on the cell sensor with a mobile app, which is shown by Chan Chiu-wing, a member of the research team and a PhD student of the Department of Chemistry at HKBU (right). The cell sensor with a barcode-like micro-channel structure comprises two main parts: a cell culture zone and a "barcode" cell sensor. A rapid and low-cost testing approach Antibiotics are often used to treat bacterial infections, but the overuse and misuse of antibiotics have created the problem of drug resistance. Antimicrobial susceptibility testing (AST) is used to determine which antibiotics can effectively inhibit the growth of a certain type of bacteria effectively. However, conventional AST methods are too slow, as they require 16 to 24 hours for results, while modern rapid ASTs are expensive and require elaborated laboratory equipment. A rapid and cost-effective strategy is therefore needed to screen bacterial samples onsite, with advanced laboratory testing arranged only for those suspected of containing drug-resistant bacteria. In response to this need, a research team led by Dr Ren Kangning, Associate Professor of the Department of Chemistry at HKBU designed a fully automatic, microscope-free AST system. It comprises two main parts: a cell culture zone and a "barcode" cell sensor. The cell culture zone consists of a set of micro-channels filled with fluids that contain cell culture media as well as different concentrations of the antibiotic. The "barcode" cell sensor contains an array of "adaptive linear filters" arranged in parallel that resembles a "barcode" structure. Users can finish the onsite screening within three hours by scanning the "barcode" with a mobile app developed by the researchers, and it will indicate whether any drug-resistant pathogenic bacteria is present in the sample. Quantity of bacteria represented by bar length When conducting AST with the system, bacterial samples will be injected into and incubated in the cell culture zone. Bacteria in the test sample inside the micro-channels show different proliferation rates depending on different concentrations of the antibiotic. After completion of the culture period, the bacterial cells will flow through the "adaptive linear filters". The cells will not accumulate around the nanopores on the sidewalls of the micro-channels, instead they will be driven down by the fluid and be collected from the end of the micro-channels. The accumulated cells will then form visible vertical bars, the lengths of which are proportional to the quantity of bacteria cells cultured under the different concentrations of the antibiotic. A cell phone equipped with a macro-lens can then be used to photograph the "barcode" created by the AST. The image will be analysed automatically by the mobile app. Results consistent with conventional AST After the culture period, if all the "bars" of the cell sensor have similar lengths, it means the tested antibiotic cannot inhibit the growth of the bacteria, and thus the bacterial sample is resistant to the tested antibiotic. If the length of the "bars" is in general inversely proportional to the concentration of the antibiotic in the micro-channels, it shows that the tested antibiotic is generally effective at prohibiting the growth of the bacteria, and thus the bacteria is not drug-resistant. When two adjacent "bars" show a sharp difference in terms of length, it indicates that the antimicrobial effect of the antibiotic leaps when its concentration reaches a particular level. The research team tested E. coli and S. aureus with the "barcode" cell sensor and the results were consistent with those of the conventional AST. The test can be completed in three hours, which is much faster than the conventional AST. Microfluidic approaches developed by other researchers can also attain comparable speed, but they rely on expensive instruments for analysis in general. Potential for use in resource-limited regions "Our 'barcode' testing system is a promising new tool in the fight against antimicrobial resistance. We hope that it will benefit the routine screening of drug-resistant bacteria in the food industry, public areas and healthcare facilities as it does not require advanced clinical facilities or professional testing skills," said Dr Ren. The "barcode" cell sensor has a low production cost, and it is estimated to be below one US dollar per piece. The research team has filed a patent application for the "barcode" cell sensor. "We plan to develop our invention into a portable AST instrument, and ultimately, we hope it can be used in resource-limited regions," Dr Ren added. Apart from researchers from HKBU's Department of Chemistry, the research team of the "barcode" cell sensor also included scientists from the Department of Computer Science at HKBU and the School of Medicine at Stanford University. #HongKongBaptistUniversity #HKBU Contact Details Communication and Public Relations Office, HKBU Winnie Shum +852 3411 5262 winnieshum@hkbu.edu.hk Company Website https://www.hkbu.edu.hk/

September 29, 2021 09:00 AM Eastern Daylight Time

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ASPEN DENTAL TO PROVIDE FREE DENTAL CARE TO MILITARY VETERANS ON SATURDAY, NOVEMBER 6th

Aspen Dental

In recognition of Veterans Day, nearly 600 Aspen Dental locations will open their doors on Saturday, November 6 th to provide free care to military veterans across the country. Now in its 7 th year, the Day of Service provides much-needed dental care for veterans at no cost to honor their service and break down barriers to care. “The annual Day of Service is an incredibly rewarding day for dentists and teams throughout the Aspen Dental network,” said Dr. Lauren McDonough, vice president of practice owner development at Aspen Dental Management, Inc. “It’s our small way of giving back to our nation’s veterans, who have given so much to all of us.” Since 2014, dentists and their teams from Aspen Dental-branded offices across the country have donated more than $22 million in dentistry services to more than 27,500 veterans and people in need though the Healthy Mouth Movement. Millions of Americans struggle to access dental care every year, and veterans are no exception – in fact, U.S. veterans are ineligible for dental benefits through the Veterans Administration unless they’re 100% disabled, have a service-related mouth injury, or were a prisoner of war. What’s more, during the COVID-19 pandemic, dentists have report ed increases in teeth-grinding, cavities and gum disease, largely attributed to pandemic-related stress and changes in health habits. How Veterans Can Schedule an Appointment Starting today, veterans can call 1-844-277-3646 (1-844-ASPENHMM) to find a participating Aspen Dental office in their community and schedule an appointment. Advance appointments are required. During the Day of Service, Aspen Dental dentists and teams focus on treating the most urgent dental needs to help get veterans out of pain, from fillings and extractions to hygiene and basic denture repairs. For more information about Day of Service and the Healthy Mouth Movement, visit www.HealthyMouthMovement.com. About Aspen Dental Offices The Aspen Dental network includes more than 930 offices, in 43 states, owned and operated by independent practice owners and dentists, who share a commitment to creating access to care for those who need it most. These independent practice owners expect to record six million patient visits in 2021, driven by a commitment to breaking down barriers to quality, affordable oral health care. Each dental care team offers patients a safe, welcoming, judgment-free environment to address their dental challenges, including comprehensive exams, cleanings, extractions, fillings, periodontal treatment, whitening, oral surgery, crown and bridge work, and denture services. For more information, visit www.aspendental.com. About Aspen Dental Management, Inc. Aspen Dental Management, Inc. (ADMI) is one of the largest and most trusted retail healthcare business support organizations in the U.S., supporting 15,000 healthcare professionals and team members at more than 1,000 health and wellness offices across 46 states in three distinct categories: Dental care, urgent care, and medical aesthetics. Working in partnership with independent practice owners and clinicians, the team is united by a single purpose: to prove that healthcare can be better and smarter for everyone. ADMI provides a comprehensive suite of centralized business support services that power the impact of four consumer-facing businesses: Aspen Dental, ClearChoice Dental Implant Centers, WellNow Urgent Care and Chapter Aesthetic Studio. Each brand has access to a deep community of experts, tools and resources to grow their practices, and an unwavering commitment to delivering high-quality consumer healthcare experiences at scale. Contact Details Curley Company for Aspen Dental Management, Inc. Lorianne Walker +1 410-688-1330 lorianne@curleycompany.com

September 29, 2021 09:00 AM Eastern Daylight Time

Agile Therapeutics Partners with Carli Lloyd, U.S. Women’s Soccer Star and Four-Time Olympian, to Bring Awareness to Women’s Health Topics

Agile Therapeutics

Agile Therapeutics, Inc. (Nasdaq: AGRX ), a women's healthcare company, announced today a partnership with U.S. Women’s Soccer legend, Carli Lloyd. The partnership with Agile will focus on bringing awareness to women’s health topics, and Agile’s commitment to elevating women’s healthcare. Lloyd, who will play her final game for the U.S. Women’s National Team on October 26 th against South Korea, was attracted to the company’s mission of addressing the healthcare needs of today’s women. “I’m excited to be partnering with a company solely dedicated to women’s health,” said Lloyd. “I aim to work with organizations that focus on things I care about, and staying healthy has been a priority for my career on the field and will continue to be so as I look ahead to my next chapter. Agile’s focus on bringing women options and knowledge when it comes to their healthcare decisions is a mission I’m proud to be part of. And the fact that I’m a Jersey girl, representing a New Jersey company makes it even better.” Agile has built its brand around a commitment to addressing women’s health needs. It received approval from the U.S. Food and Drug Administration (FDA) in February 2020 for its first product, Twirla ® (levonorgestrel and ethinyl estradiol) transdermal system, a weekly contraceptive patch. It currently has four additional contraceptive products in its pipeline. “Carli’s ‘ always believe and never quit ’ attitude fits what Agile Therapeutics believes as a company,” said Al Altomari, CEO of Agile Therapeutics. “We’ve been selective about aligning with the right partners at the right time, and Carli is someone who seamlessly fits our corporate culture, aligns with our values, and understands the importance of empowering women, especially young women, to reach beyond their limits, believe in themselves, and never compromise, especially with their healthcare.” As a growing company, Agile sees this partnership as an opportunity to help further develop its culture and corporate brand by partnering with leaders who share the company’s values and mission.. “Our short-term goal is to establish Twirla in the contraceptive market, and our long-term mission remains the same: Build a robust women’s health franchise, and Carli is a critical piece of that puzzle,” said Altomari. “She’s been a vocal advocate for women, and her voice is an important one in the national conversation about women’s health and healthcare needs. We want to be sure we communicate our message and commitment to women’s health in an authentic and relatable way. This is a mission we share with Carli, and we are proud to welcome her to our team.” About Agile Therapeutics, Inc. Agile Therapeutics is a women's healthcare company dedicated to fulfilling the unmet health needs of today’s women. Our product and product candidates are designed to provide women with contraceptive options that offer freedom from taking a daily pill, without committing to a longer-acting method. Our initial product, Twirla®, (levonorgestrel and ethinyl estradiol), a transdermal system, is a non-daily prescription contraceptive. Twirla is based on our proprietary transdermal patch technology, called Skinfusion®, which is designed to allow drug delivery through the skin. For more information, please visit the company website at www.agiletherapeutics.com. The Company may occasionally disseminate material, nonpublic information on the Company’s website. About Twirla® Twirla (levonorgestrel and ethinyl estradiol) transdermal system is a once-weekly combined hormonal contraceptive (CHC) patch that contains the active ingredients levonorgestrel (LNG), a type of progestin, and ethinyl estradiol (EE), a type of estrogen. Twirla is indicated for use as a method of contraception by women of reproductive potential with a body mass index (BMI) < 30 kg/m2 for whom a combined hormonal contraceptive is appropriate. Healthcare providers (HCPs) are encouraged to consider Twirla’s reduced efficacy in women with a BMI ≥ 25 to <30 kg/m2 before prescribing. Twirla is contraindicated in women with a BMI ≥ 30 kg/m2. Twirla is contraindicated in women over 35 years old who smoke. Cigarette smoking increases the risk of serious cardiovascular events from CHC use. Twirla is designed to be applied once weekly for three weeks, followed by a week without a patch. Contact Details Matt Riley, Head of Investor Relations and Corporate Communications mriley@agiletherapeutics.com Company Website https://agiletherapeutics.com

September 28, 2021 02:52 PM Eastern Daylight Time

Data Show New Kidney and Liver Policies Expand Access, Equity

United Network for Organ Sharing

New liver and kidney allocation policies have expanded equitable access to lifesaving organs for patients on the national waitlist, according to data analysis from United Network for Organ Sharing (UNOS), which serves as the nation’s transplant system under federal contract. UNOS leadership presented this data for members of Congress during a virtual briefing today. Changes to the liver allocation policy went into effect in February of 2020 and the kidney allocation policy followed a year later, in March of 2021. Recent monitoring report data show the liver and kidney policies have so far resulted in more transplants overall while also reducing disparities in access based on where a patient is listed. Liver transplants increased by 3 percent and kidney transplants increased by 16 percent, even in the midst of the COVID-19 pandemic. This is in keeping with the high performance of the national donation and transplantation system, which marked the eighth year of growth in deceased donor transplants in 2020 despite the ongoing global health crisis. “These policies expand equitable access to lifesaving organs,” said UNOS CEO Brian Shepard. “We continue to make progress through robust policy development, improving the highest performing organ donation and transplantation system in the world.” The 15-month liver monitoring report shows that the policy is performing as intended. More organs are going to the sickest patients, especially adults with the most medically-urgent needs, regardless of where they are listed for transplant. Early monitoring data of the circles-based model for kidney allocation indicate that it has also contributed to broadened equity. A new report containing key measures of the first full two-months of enactment show an increase in kidney transplants for children, ethnic and racial minorities, moderately hard-to-match patients and those with longer dialysis times. More than 400 donation and transplant professionals, donor family members and patients nationwide helped develop the new policies. “The results of the new kidney and liver policies are a testament to our community’s ability to unify a diverse membership around the shared goal of saving lives,” said UNOS Board President Matt Cooper, M.D., Director of Pancreas and Kidney Transplantation at MedStar Georgetown Transplant Institute, and professor of surgery at Georgetown University School of Medicine. “Even during a pandemic, we saw a resilient system not only rebound, but formalize, enact, and monitor two effective allocation policies. UNOS is the engine that powers this complex process, and we remain focused on building on our successes while continuing to address ongoing challenges.” To learn more about UNOS’ policy development process, click here. ### About United Network for Organ Sharing (UNOS) is a non-profit, charitable organization that serves as the Organ Procurement and Transplantation Network (OPTN) under contract with the federal government. The OPTN helps create and define organ allocation and distribution policies that make the best use of donated organs. This process involves continuously evaluating new advances and discoveries so policies can be adapted to best serve patients waiting for transplants. All transplant programs and organ procurement organizations throughout the country are OPTN members and follow the policies the OPTN creates for allocating organs. Contact Details Anne Paschke +1 804-782-4730 anne.paschke@unos.org Company Website https://unos.org

September 28, 2021 12:18 PM Eastern Daylight Time

BreatheSuite Receives FDA Clearance for Over-the-Counter Device to Turn Regular Metered-Dose Inhalers into Smart Inhalers

BreatheSuite

BreatheSuite Inc., a Canadian connected respiratory health company, today announced that it has received 510(K) clearance from the U.S. Food and Drug Administration (FDA) for its BreatheSuite Metered-Dose Inhaler (MDI) V1 device. Approved for both prescription and over-the-counter use, the BreatheSuite device turns existing MDIs into smart inhalers by automatically and objectively monitoring and providing feedback on inhaler adherence and technique for people with asthma and COPD. Tens of millions of Americans currently use MDIs. Techniques such as shaking the MDI 10-15 times, as well as breath timing and positioning, can greatly impact the amount of medication that reaches the lungs. For every 100 people who use an inhaler, 90 are using it incorrectly; 66 are not adherent to the medication as prescribed (skipping doses, etc.). Inhaler misuse makes up about $5- $7 billion of the approximately $25 billion spent on inhalers annually. The BreatheSuite System – composed of a disposable, battery-powered, portable BreatheSuite MDI add-on device and a mobile application based on behavior change strategies – is designed to work with an MDI by attaching to the top of the canister of the patient’s inhaler. The device and mobile app work together to evaluate and “score” a person’s inhaler technique and usage patterns, storing results in the cloud so the person can track and use this information to improve how they use their inhaler. With consent, this information can also be remotely monitored by the person’s healthcare team to promote customizable care plans. By promoting more effective inhaler use and remote patient monitoring (RPM), BreatheSuite aims to improve quality of care and health outcomes while reducing the economic burden associated with these conditions. Medical costs for chronic COPD were estimated to reach $49 billion in 2020, and the annual economic cost of asthma from 2008-2013 was more than $81.9 billion – with medical costs alone accounting for $50.3 billion. “We are extremely excited to have obtained FDA clearance, which is a critical step in achieving our vision of improving the lives of respiratory patients worldwide,” said Brett Vokey, Founder and CEO of BreatheSuite. “The COVID-19 pandemic has underscored that now is the time for remote patient monitoring to take a front seat in providing better, more transparent care for all people with asthma or COPD. With FDA clearance, we are poised to become a leader in providing actionable insights to people with asthma or COPD across the United States.” “By having a real-time way to digitally monitor and provide feedback to patients, we hope to enhance healthcare outcomes,” said Dr. Meshari F. Alwashmi, Chief Scientific Officer, BreatheSuite. “Furthermore, having an objective measure of adherence and technique from each user with asthma and COPD will advance the sphere of knowledge regarding the effectiveness of inhaled medications.” The BreatheSuite device does not interfere with regular MDI usage and can be removed and reattached to a new inhaler with ease. The device is compatible with 90% of MDIs on the market, including those manufactured by GlaxoSmithKline (GSK), Teva and Prasco. In addition to FDA clearance, which is a first for a Newfoundland and Labrador-based company, the BreatheSuite device has also been cleared for sale in Canada. About BreatheSuite BreatheSuite is a Canadian connected health company founded in 2018 to help people with chronic respiratory conditions live longer, healthier lives. The BreatheSuite MDI device is designed to track and train proper inhaler usage, while the BreatheSuite App applies behavior change tactics to improve adherence, and tips on how to improve inhaler technique. BreatheSuite works with leading partners across North America to deliver better care to people with chronic respiratory conditions. For more information visit www.breathesuite.com or contact info@BreatheSuite.com. Contact Details SVM Public Relations and Marketing Communications Jordan Bouclin +1 401-490-9700 jordan.bouclin@svmpr.com Company Website https://www.breathesuite.com/

September 28, 2021 10:00 AM Eastern Daylight Time

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