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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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R2 Technologies’ Novel Glacial Rx® System Earns Third FDA Indication and Unique Product Code

R2 Technologies

R2 Technologies Inc. ("R2"), the leader in CryoAesthetic™ medical devices, announces that its revolutionary in-office system, Glacial Rx®, FDA-cleared to remove benign lesions and temporarily reduce pain, swelling and inflammation, is now the first and only dermal cooling system FDA-cleared for general dermabrasion, scar and acne scar revision, and tattoo removal, permanently changing the aesthetics industry. “This additional FDA clearance is a huge win, and not an easy feat. It took innovation, dedication, time, and resources,” says Tim Holt, R2 Chief Executive Officer. “It couldn’t have been possible without our amazing team and strategic partners. The clearance had an exceptional outcome in which we went from being part of one classification, among hundreds of other devices, to being placed in our very own FDA-issued product code. This is further proof that our product is so novel, it warrants a completely new category.” “R2 has been at the forefront of the med-esthetics space since inception with its unmatched technology and continues to lead advancements in the industry. We are excited to see the company break boundaries yet again with its latest indication,” says David Present, MD and Cherine Eldumiati Plumaker, R2’s Chairman and Vice Chairman respectively. In conjunction with the commercial launch, R2 looked within its remarkable team of industry veterans, including the inventors of the Glacial Rx technology, Rox Anderson, MD; Dieter Manstein MD, PhD; and Henry Chan, MD, PhD, to create its newly established Scientific Advisory Board. By continuing to have these highly regarded pioneers as an integral part of the company, R2 stands out amongst the competitive medical aesthetics market as an industry frontrunner. “With the appointment of our new Scientific Advisory Board, R2 is tapping into years of knowledge and expertise to launch new groundbreaking innovations, develop a superior product pipeline, and leverage technical insights to secure new clinical indications and expansion opportunities,” says Holt. Launched in March 2021, Glacial Rx’s presence in the U.S. has grown significantly. R2 is continuing to take orders from aesthetic providers who want to offer this revolutionary treatment in-office. To learn more about R2, treatment offerings and providers, visit glacialskin.com and follow the company on LinkedIn. About R2 Technologies Headquartered in Silicon Valley, with a recent expansion in Florida and new Miami-based satellite office, R2 Technologies is a world leader in CryoAesthetic™ medical devices. In 2014, Pansend Life Sciences, LLC and Blossom Innovations, LLC founded R2 Technologies and licensed exclusive intellectual property from Massachusetts General Hospital and Blossom Innovations. In 2019, R2 brought on strategic partner, Huadong Medicine Co., Ltd. In close collaboration with these partners and the brand’s scientiﬁc founders and world-famous luminaries in aesthetic medicine, Drs. Rox Anderson, Dieter Manstein, and Henry Chan, R2 focuses on the development, engineering, clinical research, and commercialization of groundbreaking technologies for aesthetic providers and consumers. Its first innovation, Glacial Rx, was named one of the ‘2021 Launches Doctors are Buzzing About’ by RealSelf, the leading, most trusted source to educate on cosmetic procedures. R2 also won the 2nd Annual Aesthetics Tech Summit LaunchPad SBDC, hosted by Octane, a company committed to making resources, capital, and mentorship available to tech startups. Since inception, R2 has raised $76M in ﬁnancing. Contact Details Linsey Tilbor Rubin +1 732-991-5294 ltilbor@rellmc.com Company Website https://glacialskin.com/

September 28, 2021 08:33 AM Eastern Daylight Time

D8.co to Launch 1-Hour Delivery for Delta-8 THC Products

D8 Holdings, Inc.

D8.co the market leader in hemp-derived Delta-8 THC —today announced it is launching 1-hour delivery for consumer orders throughout the United States. D8.co will deliver their award winning Delta-8 carts, Delta-8 disposables, and Delta-8 gummies to any customer within 1-hour in a 25-mile radius of any professional NFL team. Outside that radius customers will receive next day packages at the latest. “The largest problem we have is fulfillment and delivery,” said Chris Duffield, CEO of D8.co. “Anyone shipping consumer goods knows that all the carriers are a current nightmare. We have shipped thousands of packages priority and the majority show up two or three days late, with far too many getting lost or stolen. If a customer places an order after cutoff on Friday, they have to wait an additional three days. Customers want our products, and they want them immediately.” The first six states D8.co will integrate into their program are Texas, Georgia, Florida, Minnesota, Ohio, and North Carolina. The company will expand into the rest of the U.S immediately, with full integration expected to take approximately 45 days. “We have more than 50 major fulfillment centers locked in that are centrally managed from our cloud technology. Once an order is placed, our customers will receive an email and text where they can track our drivers all the way to delivery,” said Hugh McPherson, EVP of D8.co. D8.co expects to immediately double online sales with the new integration. “We are extremely excited to launch 1-hour delivery,” said Duffield. “We just became the largest cannabis company in the United States, which makes us a prime acquisition target. I’m very proud of our core team and all the hard work everyone has put in to make D8 the number one brand in the market.” About D8.co D8.co is based in Colorado and Miami with satellite offices in Las Vegas and Los Angeles. The company is an assembly of the top hemp and cannabis minds in the country. With backgrounds in extraction, chemistry, manufacturing, marketing, distribution, and legal, the D8 team came together organically around this elusive, but extremely powerful molecule to create a new category of products. More info at www.d8.co. Contact Details D8.co Chris Duffield +1 424-333-2112 chris@d8.co Company Website https://d8.co/

September 23, 2021 12:26 PM Eastern Daylight Time

Prostate Cancer Racial Disparities

YourUpdateTV

Despite great strides in prostate cancer care over the past several years, racial disparities in care persist. Black and Hispanic men have a high burden of prostate cancer mortality. Prostate cancer affects 1 in 8 men, with the number rising to 1 in 6 for Black men and comprises more than 1 in 5 of all new cancer diagnoses for Hispanic men. The Covid-19 pandemic has also made things worse as early in the pandemic, many cancer resources were diverted, leaving scores of patients, including those with prostate cancer, with limited to no access to surgical treatment. So, what can be done and what does someone need to know to stay healthy? Conducting a nationwide media tour to discuss this important topic was Dr. Brian K. McNeil. Dr McNeil is an American Urological Association spokesperson and Associate Dean for Clinical Affairs, Vice-Chair, Department of Urology at SUNY Downstate Health Sciences University Topics that Dr McNeil discussed during interviews with radio and TV stations across the country included: What research has discovered about racial disparities among men with prostate cancer The racial disparity in the utilization of new therapies for advanced prostate cancer How covid-19 and where someone lives could affect their treatment options When should men get screened for prostate cancer? For more information visit: UrologyHealth.org About the American Urological Association: Founded in 1902 and headquartered near Baltimore, Maryland, the American Urological Association is a leading advocate for the specialty of urology, and has nearly 23,000 members throughout the world. The AUA is a premier urologic association, providing invaluable support to the urologic community as it pursues its mission of fostering the highest standards of urologic care through education, research and the formulation of health policy. 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 21, 2021 05:00 PM Eastern Daylight Time

CORRECTING and REPLACING: AS&K Group Sets Science Based Targets for Emissions Reduction

AS&K Group

This release issued on July 27, 2021 is being replaced with the following version due to updated hyperlinks. Medical communications group AS&K has set ambitious emissions reduction goals using the Science Based Target initiative’s (SBTi) framework for SMEs. This global organization provides companies with a clearly defined pathway to future-proof growth by specifying how much and how quickly they need to reduce their greenhouse gas (GHG) emissions. By joining more than 1,000 visionary businesses from all industries including major pharmaceutical companies, AS&K is leading the way in the medical communication sector in this important worldwide effort to tackle the climate crisis. AS&K has set a group-wide goal of 50% reduction in GHG emissions, which is in line with the most stringent goal of the Paris Agreement to keep global warming to 1.5C and prevent the most damaging effects of climate change. “AS&K understands the urgent need for companies to take action to address the climate crisis. We’re absolutely committed to doing all that we can, and will also work with our clients to reduce the climate impact of their medical communication activities,” said Simon Gee, AS&K Agency Head. As well as reducing emissions, AS&K is aiming to become net zero before 2030 by supporting programs that mitigate the effects of their remaining emissions. “The climate crisis is one of the most important issues of our times and we’re passionate about taking meaningful steps to reduce our carbon footprint. Joining the SBTi and setting emissions reduction goals is a critical first step in getting to net-zero as soon as we can,” added Katherine Vik, Senior Digital Project Manager and Chair of AS&K’s Climate Committee. “We are also running a number of workstreams to help our clients reduce the environmental impact of their medical communications.” More information about AS&K’s commitment is available on the SBTi website. About AS&K Group: The AS&K Group is an independently owned group of medical communications agencies who collaborate with leading pharmaceutical and medical device companies. As strategic partners and subject matter experts, the AS&K Group transforms complex scientific information into compelling programs that inform and educate healthcare professionals. The AS&K Group comprises three innovative companies: Remedica, AS&K Communications and The Corpus. Follow our journey on Twitter @asandkgroup and Linkedin Contact Details Alana Zdinak +44 7766 706656 alana.zdinak@asandk.com Company Website https://asandkgroup.com/

September 21, 2021 09:18 AM Eastern Daylight Time

MarketFinance in pole position as it raises £280m and is approved for Recovery Loan Scheme lending

Stockwood Strategy

Fintech business lender MarketFinance has today announced a £280m debt and equity fundraise and its accreditation under the Recovery Loan Scheme (RLS). This comes after MarketFinance became one of the first fintechs to be accredited under the Coronavirus Business Interruption Loan Scheme (CBILS), having lent £250m to companies across the UK. Launched by the British Business Bank in April 2021, the Recovery Loan Scheme supports access to finance for UK businesses as they recover and grow following the pandemic. Funding from the Scheme can be used for any legitimate business purpose including managing cashflow, investment in new equipment and preparing for future growth. It is designed to appeal to businesses that can afford to take out additional finance for these purposes. MarketFinance is ready to lend immediately with its debt and equity funding. The debt financing has been provided from a large global investment firm alongside Italy’s largest bank, Intesa Sanpaolo S.p.A. The equity investment was led by Black River Ventures (previous investments include Marqeta, Upgrade, Coursera and Digital Ocean) with participation from existing investor, Barclays Bank PLC. Alongside this, the launch of MarketFinance Flex Loans today will aim to help nearly one million SMEs in the UK solve their short-term funding gaps up to £100,000. Viola Credit has provided MarketFinance with £20m to launch the Flex Loans product. Similar to a credit card or overdraft, businesses will have a pre-agreed limit of up to £100,000 which they can withdraw at once or in smaller amounts. Flexible repayment options enable the businesses to spread their repayments over 3 - 12 months based on their working capital needs. It is a solution to support a variety of one-off and ongoing funding requirements such as purchasing inventory, clearing outstanding invoices, upfront supplier payments, investment into sales and marketing, or expanding the team. Anil Stocker, CEO at MarketFinance, commented: “This funding and our accreditation as a Recovery Loan Scheme lender is testament to the brilliant work everyone at MarketFinance has done to serve UK businesses during a difficult period. Adapting to the increased demand from businesses looking for finance online instead of through traditional avenues also drove our profitability this year, which has continued into H2 2021”. From today, businesses can immediately apply* for an RLS loan from MarketFinance between £50k and £250k repayable over 4, 5 or 6 years. Repayments in the first six months of the term will only consist of interest charges, an additional support measure as businesses gear themselves for a full reopening of the economy. Anil Stocker aded: “Businesses have been resilient and managed to hold their nerve during one of the most difficult periods in recent history. We were there to help with the CBILS and will do the same with the RLS by offering a simple application process, quick decisions and sending funds to businesses immediately. Our fundraise puts us in pole position to do this. We played a key role during CBILS, as one of the first fintech lenders, to help get funds to businesses quickly when they found their applications were delayed and or denied by others. We will stand shoulder to shoulder with businesses and help navigate them through to the full reopening of the economy and beyond”. As a native fintech, the MarketFinance platform is designed to receive, process and manage large volumes of businesses applying for finance using the platform. From simple online application forms, enhanced credit risk models to exceptional one-to-one customer support, MarketFinance will get RLS funds to businesses in need, quickly. “We aim to quickly lend to businesses around the UK. We anticipate demand for RLS to come from companies that will need capital to scale operations ahead of the full reopening of the economy. Manufacturers, wholesalers, public services businesses and a range of others will need the funds to ramp up supplies and build pipelines as business returns to normal” added Anil Stocker. Ends *Minimum eligibility criteria for RLS business loans through MarketFinance: Limited Company or Limited Liability Partnership Trading for more than 3 years, has a turnover of more than £200,000 Company sells goods and/or services to consumers and/or other businesses About MarketFinance MarketFinance is a business finance company with offices in London and Manchester. The online platform enables businesses to access a range of flexible finance solutions - quickly and easily. This smart technology is backed by help from real people so business owners can save time and focus on growing their business. Since 2011, MarketFinance has cumulatively advanced over £2.6 billion to companies across a range of sizes and sectors, providing working capital and finance for everything from paying staff and suppliers to launching new products or services and accelerating growth. MarketFinance is backed by Barclays Bank PLC, Mouro Capital, European venture capital fund Northzone (invested in Klarna, iZettle and Trustpilot), and private equity group MCI Capital (also invested in iZettle, Azimo and Gett). About the Recovery Loan Scheme (RLS) The Recovery Loan Scheme is managed by the British Business Bank on behalf of, and with the financial backing of, the Secretary of State for Business, Energy & Industrial Strategy. British Business Bank plc is a development bank wholly owned by HM Government. It is not authorised or regulated by the PRA or the FCA. Contact Details MarketFinance Bilal Mahmood +44 7714 007257 b.mahmood@stockwoodstrategy.com Company Website https://marketfinance.com/

September 21, 2021 08:00 AM Eastern Daylight Time

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Phase 4 Services Adds Marketing and Technology Pro to Broaden Consulting Scope, Better Assist Lab Clients

Phase 4 Services

MCR Labs Director of Marketing & IT Yasha Kahn has been named vice president of marketing & technology at Phase 4 Services, a laboratory management and consulting firm positioned to help hemp and cannabis testing labs capture market share in the expanding cannabis industry. Kahn, an information technology expert with nearly a decade of experience guiding marketing strategy and upgrading IT systems for cannabis testing providers, will be tasked with helping Phase 4 clients secure their data and generate brand awareness. His combined marketing and technology expertise make Kahn uniquely well-suited to offer insights tailored to finding success in the digital age. “As a scientist, promoting the business and managing our data were details I hadn’t really considered when we first opened the lab,” said Michael Kahn, Founder and CEO of MCR Labs, a cannabis testing lab operating in several Northeast cannabis markets. “As the industry here grew, Yasha made sure any potential clients coming in knew our name, and he scaled our technology infrastructure to handle the team’s rapid growth.” In his role at Phase 4 Services, Yasha Kahn will guide the firm’s laboratory partners on decisions related to data security and networking, events and outreach projects, and media strategy both digital and traditional. By adding high-level technology and marketing knowledge to their consulting scope, Phase 4 Services enables their client laboratories to focus on the important work of accurately analyzing cannabis products while helping to bring in new business and ensure the right tools are in place to facilitate operations across departments. About Phase 4 Services: Phase 4 Services is a scientific consulting and laboratory management firm dedicated to growing, supporting, and enhancing hemp and cannabis testing laboratories. Founded by experts in analytical testing, pharmaceutical chemistry, business administration, and development strategy, our team is equipped with the knowledge and experience necessary to ensure partner laboratories are successful in their pursuit of advancing public health and safety for cannabis patients and consumers. For more information visit http://phase4services.com. Contact Details Phase 4 Services Joe Crinkley +1 857-230-0839 PR@phase4services.com Company Website https://phase4services.com/

September 20, 2021 11:11 AM Eastern Daylight Time

Israeli SleepX to be merged into AppYea Inc. (APYP)

Appyea

AppYea continues the process of merging SleepX into the company. The merger is expected to be completed by 12/01/2021 in accordance with the model published on 08/02/2021 ( Link ) In parallel, SleepX continues developing and improving its algorithms and planning to start production during 2022. The SleepX product is being designed to provide a unique answer to approximately 90 million Americans who suffer from the problem of snoring. DreamIT The night wrist band will include several sensors and a vibration motor which will operates with an intensity adapted to the user's reactions in real time in order to accustom the user to sleep in the correct position using biofeedback, thereby reducing or eliminating snoring. SleepX solution is being developed in collaboration with the Biomedical department of Ben Gurion University in Beer Sheva, and is patent - protected in the US, EU and Israel. https://www.sleepxclear.com/ipportfolio In addition to reducing snoring and improving sleep quality, users will be able to access important statistics relating to their sleep patterns via an app (Apple and Android) to track over time and detect anomalies. Product Clip The sleep apnea market is projected to reach USD 9.9 billion by 2026, at a CAGR of 6.9% during the forecast period. Major factors driving the growth of this market include the growing awareness regarding the detrimental effects of snoring, availability, and benefits of anti-snoring treatments, growing geriatric and obese population, presence of a large number of cigarette smokers and alcoholics, and a large pool of an untapped snoring population. However, poor efficacy of current anti-snoring treatments available in the market, high cost of some of the anti-snoring treatments, and lack of reimbursement are major factors restraining the growth of this market. “The SleepX approach should not only solve physiological problems for a great many people, but it may also allow many couples to go back to sleeping together," says Bary Molchadsky, SleepX's entrepreneur and CEO. “The decision to merge with AppYea was made in order to accelerate the start point of production. Lately, we see major players entering the market – Google presented its new Fitbit watch with the possibility to monitor snoring. Amazon presented at the beginning of the year the new Alexa that is supposed to identify sleep apnea. However, we believe that the patent-protected technology underlying the SleepX approach should be accepted in the marketplace.” “The SleepX products are being designed to provide, besides monitoring, biofeedback based individual treatment, adjusted to each user in real-time. Following the launch of the first snoring treatment product, the company intends to start clinical trials in order to receive FDA approval for sleep apnea treatment.” “I’m certain that tens of thousands of academic research hours together with international strong patents, would provide Appyea’s investors a significant advantage over time.” Legal Notice Regarding Forward-Looking Statements This release includes forward-looking statements. Such statements involve risks and uncertainties which could cause actual results to differ materially from those set forth herein. No statement herein should be considered an offer or a solicitation of an offer for the purchase or sale of any securities. Although APYP believes that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, it can give no assurance that such expectations and assumptions will prove to have been correct. Forward-looking statements, which involve assumptions and describe our future plans, strategies, and expectations, are generally identifiable by use of the words "may," "will," "should," "could," "expect," "anticipate," "estimate," "believe," "intend," or "project" or the negative of these words or other variations on these words or comparable terminology. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous factors and uncertainties, including but not limited to adverse economic conditions, intense competition, entry of new competitors and products, adverse federal, state and local government regulation, inadequate capital, unexpected costs and operating deficits, increases in general and administrative costs, unanticipated losses, financial condition and stock price, inability to carry out research, development and commercialization plans and other specific risks. APYP does not undertake any obligation to publicly update any forward-looking statement. Neither APYP nor SLEEPX are subject to the reporting requirements of the Securities and Exchange Commission under the Securities and Exchange Act of 1934 as amended. Contact Details Asaf Porat info@appyea.com Company Website http://www.appyea.com

September 17, 2021 08:47 AM Eastern Daylight Time

Today is National Pet Bird Day

BEAK

Contact Details Jamie Baxter +1 775-322-4022 jamie@theimpetusagency.com

September 17, 2021 08:08 AM Eastern Daylight Time

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