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Philips and Elekta Deepen Their Existing Partnership

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Oncology care is transforming, driven by an increasingly precise diagnosis of each tumor, and a continuously expanding range of therapy options. To fully capitalize on these opportunities, healthcare providers require integrated solutions throughout the entire cancer care pathway, from diagnosis to treatment and follow-up.

This integrated approach has the potential to provide:

  • Quicker, more accurate visualization of the tumor
  • Easier decision of optimal treatment strategy
  • Earlier assessment of therapy response
  • More effective and efficient therapy delivery

The strengthened strategic partnership intends to further deliver a superior experience in diagnosis and adaptive, personalized treatments for clinicians, shorter treatment times and more precise therapy for patients, and lowered costs of care for healthcare providers.

Kees Wesdorp, Chief Business Leader of Precision Diagnosis at Philips: “To capitalize on the opportunities presented by increasingly precise diagnosis and the fast-expanding range of therapies available for cancer patients, it’s essential to provide integrated systems and solutions that provide the right insights at the right time throughout each patient’s care journey,” said Kees Wesdorp, Chief Business Leader of Precision Diagnosis at Philips. “By deepening our already-successful collaboration with Elekta, we will accelerate towards our goal of providing clear care pathways and predictable outcomes for every cancer patient. Today’s announcement is an important next step in the implementation of our strategy in precision diagnosis.”

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Source: https://infomeddnews.com/philips-and-elekta-deepen-partnership/

Medical Devices

OraSure and the Will Rodgers Liver Health Foundation to Heighten Awareness Around the Importance of Hepatitis C Testing

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Over Half of the Almost Three Million Americans with Hepatitis C Are Not Aware of Their Disease Status

BETHLEHEM, Pa. and HUNTERSVILLE, N.C., June 14, 2021 (GLOBE NEWSWIRE) — OraSure Technologies, Inc. (NASDAQ: OSUR) announced today that it is collaborating with the Will Rodgers Liver Health Foundation to increase awareness around the role Hepatitis C (HCV) plays in chronic liver disease and promoting testing services for HCV within the United States. The U.S. Centers for Disease Control estimates that approximately 2.4 million individuals in the United States have HCV, and over half of these individuals currently don’t know their disease status. Left untreated, HCV often leads to liver cirrhosis, liver cancer, and liver failure. These outcomes are preventable given new antiviral drugs that can effectively cure patients, but early diagnosis through increased testing is vital to eradicating this disease. According to data from the National Institutes of Health, healthcare costs associated with chronic HCV infection are $6.5 billion per year in the United States today and continue to rise, representing a substantial burden on our healthcare system.

“As a liver disease patient who endured Primary Sclerosing Cholangitis as a child, and through friends affected by HCV, I know the toll liver disease can have on your body, especially if it’s left untreated,” Will Rodgers, NASCAR driver, said. “This terrible disease, which affects so many in the United States, is a significant strain on our healthcare system, and could be eradicated through broad scale testing initiatives. “I’m very proud to work with OraSure to drive increased awareness around HCV and provide testing services to underserved communities across the country.”

“At OraSure, we take public health seriously and have played a significant role in combating diseases such as HCV, HIV, and COVID-19 on a global basis. Our OraQuick® HCV rapid antibody test is designed to be extremely simple to use, highly accurate and provides a result within 20 minutes, while simultaneously being cost effective,” said OraSure President and CEO Stephen Tang, Ph.D. “As a company, we are extremely proud to collaborate with the Will Rodgers Liver Health Foundation to drive greater awareness around the importance of individuals knowing their HCV status. A simple test can save a life.”

As a 3-year-old child, Rodgers was diagnosed with Primary Sclerosing Cholangitis, an extremely rare, chronic liver disease. While the disease has no present cure, his disease abated after two years of treatment, to the delight of his physicians and family. Following the end of his treatments, Rodgers’ racing journey began to take shape.

As a first generation race car driver, Rodgers was introduced to go-kart racing at the age of eight and within 18 months was the reigning Hawai’i state champion and track record holder in Maui. From there, Rodgers became a regional champion in motocross, a stadium series champion in off-road UTVS and a 2015 West Coast NASA champion in sports car racing. In 2016, Rodgers became the winningest driver in the Pirelli World Challenge Pro B Spec class. These personal achievements paved the way for his current career in NASCAR, where he has gone on to become a winner in both the ARCA Menards Series East (2017-2018) and the ARCA Menards Series West (2018).

Inspired by Will Rodgers personal endurance with liver disease, the Will Rodgers Liver Health Foundation was formed in 2020 to fill gaps for those affected with liver health issues by providing education, testing resources, and a link to care. The Will Rodgers Liver Health Foundation’s vision is to build awareness and provide education of liver disease, remove any barriers for treatment of liver diseases from targeted demographics, provide link-to-care in targeted communities, and eliminate the negative stigma surrounding liver disease.

The foundation’s effort, driven by Rodgers, is culminating into his overall vision — a brand new philanthropic campaign to raise awareness for HCV — RaceToEndHepC.com.

“A major element of the Race To End Hep C initiative is the at-track and in-community activation space. It’s important to reach the communities affected by HCV, in person, to communicate the importance of education, testing and treatment. Together, with our supporting partners, we’ll be providing a step-by-step process for any individuals wanting to learn more about HCV and how we’re Racing to End it.”

The Will Rodgers Liver Health Foundation will provide an interactive environment at race events and select community locations to encourage liver health. Through his collaboration with OraSure, individuals will be provided with free HCV testing, which allows you to receive your results in minutes with a simple finger prick, educational materials and resources to take the next step for those with liver health needs.

To find a community event near you, visit www.RaceToEndHepC.com.

About HCV and the OraQuick® HCV Rapid Antigen Test
According to the CDC, HCV is the most common chronic blood-borne infection in the United States, with approximately 2.4 million people infected. It is estimated that one in 30 Baby Boomers (adults born between 1945 and 1965) have chronic Hepatitis C and over half of the people infected with HCV in the United States are unaware of their infection. The CDC, the U.S. Preventive Services Task Force (USPSTF), and the American Association for the Study of Liver Diseases (AASLD) have all issued guidance that recommends HCV testing for at-risk individuals including all Baby Boomers.

OraQuick® HCV is the first and only FDA-approved and CLIA-waived point of care test for detection of HCV infection in at-risk individuals. The simple platform enables healthcare providers to deliver a diagnosis based on lab-accurate test results in 20 minutes, using venipuncture or fingerstick blood.

About the Will Rodgers Liver Health Foundation
By uniting the healthcare industry, the Will Rodgers Liver Health Foundation (WRLHF) seeks to build awareness and provide education on liver disease, remove any barriers for treatment of liver diseases for targeted demographics, provide link-to-care in targeted communities, and eliminate negative stigma surrounding liver disease. The WRLHF fills a need for a national, far-reaching campaign, coupled with a true ambassador for liver health. The foundation focuses on consumable education for the public, provides on-site & in-the-field testing and links patients with proper care. Additionally, the WRLHF stands to change the public’s negative perception of liver disease and has a goal to positively change the conversation. For more information on the Will Rodgers Liver Health Foundation, visit www.liverhealth.foundation.

About OraSure Technologies
OraSure Technologies empowers the global community to improve health and wellness by providing access to accurate, essential information. OraSure, together with its wholly-owned subsidiaries, DNA Genotek, Diversigen, and Novosanis, provides its customers with end-to-end solutions that encompass tools, services and diagnostics. The OraSure family of companies is a leader in the development, manufacture, and distribution of rapid diagnostic tests, sample collection and stabilization devices, and molecular services solutions designed to discover and detect critical medical conditions. OraSure’s portfolio of products is sold globally to clinical laboratories, hospitals, physician’s offices, clinics, public health and community-based organizations, research institutions, government agencies, pharma, commercial entities and direct to consumers. For more information on OraSure Technologies, please visit www.orasure.com.

Important Information

This press release contains certain forward-looking statements, including with respect to expected revenues, products, product development activities, regulatory submissions and authorizations and other matters. Forward-looking statements are not guarantees of future performance or results. Known and unknown factors that could cause actual performance or results to be materially different from those expressed or implied in these statements include, but are not limited to: ability to successfully manage and integrate acquisitions of other companies in a manner that complements or leverages our existing business, or otherwise expands or enhances our portfolio of products and our end-to-end service offerings, and the diversion of management’s attention from our ongoing business and regular business responsibilities to effect such integration; the expected economic benefits of acquisitions (and increased returns for our stockholders), including that the anticipated synergies, revenue enhancement strategies and other benefits from the acquisitions may not be fully realized or may take longer to realize than expected and our actual integration costs may exceed our estimates; impact of increased or different risks arising from the acquisition of companies located in foreign countries; ability to market and sell products, whether through our internal, direct sales force or third parties; impact of significant customer concentration in the genomics business; failure of distributors or other customers to meet purchase forecasts, historic purchase levels or minimum purchase requirements for our products; ability to manufacture products in accordance with applicable specifications, performance standards and quality requirements; ability to obtain, and timing and cost of obtaining, necessary regulatory approvals for new products or new indications or applications for existing products; ability to comply with applicable regulatory requirements; ability to effectively resolve warning letters, audit observations and other findings or comments from the U.S. Food and Drug Administration (“FDA”) or other regulators; the impact of the novel coronavirus (“COVID-19”) pandemic on our business and our ability to successfully develop new products, validate the expanded use of existing collector products, receive necessary regulatory approvals and authorizations and commercialize such products for COVID-19 testing; changes in relationships, including disputes or disagreements, with strategic partners or other parties and reliance on strategic partners for the performance of critical activities under collaborative arrangements; ability to meet increased demand for the Company’s products; impact of replacing distributors; inventory levels at distributors and other customers; ability of the Company to achieve its financial and strategic objectives and continue to increase its revenues, including the ability to expand international sales; ability to identify, complete, integrate and realize the full benefits of future acquisitions; impact of competitors, competing products and technology changes; reduction or deferral of public funding available to customers; competition from new or better technology or lower cost products; ability to develop, commercialize and market new products; market acceptance of oral fluid or urine testing, collection or other products; market acceptance and uptake of microbiome informatics, microbial genetics technology and related analytics services; changes in market acceptance of products based on product performance or other factors, including changes in testing guidelines, algorithms or other recommendations by the Centers for Disease Control and Prevention (“CDC”) or other agencies; ability to fund research and development and other products and operations; ability to obtain and maintain new or existing product distribution channels; reliance on sole supply sources for critical products and components; availability of related products produced by third parties or products required for use of our products; impact of contracting with the U.S. government; impact of negative economic conditions; ability to maintain sustained profitability; ability to utilize net operating loss carry forwards or other deferred tax assets; volatility of the Company’s stock price; uncertainty relating to patent protection and potential patent infringement claims; uncertainty and costs of litigation relating to patents and other intellectual property; availability of licenses to patents or other technology; ability to enter into international manufacturing agreements; obstacles to international marketing and manufacturing of products; ability to sell products internationally, including the impact of changes in international funding sources and testing algorithms; adverse movements in foreign currency exchange rates; loss or impairment of sources of capital; ability to attract and retain qualified personnel; exposure to product liability and other types of litigation; changes in international, federal or state laws and regulations; customer consolidations and inventory practices; equipment failures and ability to obtain needed raw materials and components; the impact of terrorist attacks and civil unrest; and general political, business and economic conditions. These and other factors that could affect our results are discussed more fully in our SEC filings, including our registration statements, Annual Report on Form 10-K for the year ended December 31, 2020, Quarterly Reports on Form 10-Q, and other filings with the SEC. Although forward-looking statements help to provide information about future prospects, readers should keep in mind that forward-looking statements may not be reliable. Readers are cautioned not to place undue reliance on the forward-looking statements. The forward-looking statements are made as of the date of this press release and OraSure Technologies undertakes no duty to update these statements.

Media Contact:   Investor Contact:
Jessica O’Brien   Scott Gleason
803-240-5807   SVP Investor Relations & Corp. Comms.
jessica@truexmanagementgroup.com   484-425-0588
    sgleason@orasure.com
     
Will Rodgers Liver Health Foundation Contact:   Media Contact:
Karleen Margenean   Amy Koch
586-839-7417   Sr. Mgr. Corporate Communications
    484-523-1815
    media@orasure.com

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Medical Devices

Circle Cardiovascular Imaging Announces Partnership with DiA Imaging Analysis to Deliver All-in-One Comprehensive AI-Based Cardiovascular Imaging Solutions

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CALGARY, Canada, and BE’ER SHEVA, Israel, June 14, 2021 /PRNewswire/ — Today, Circle Cardiovascular Imaging Inc. and DiA Imaging Analysis Ltd. are excited to announce a multi-year partnership that leverages the companies’ synergies in cardiac AI and data analytics.

DiA Imaging Analysis logo

As a global leader in cardiovascular imaging reading and reporting for Cardiac MR and Cardiac CT, Circle CVI has now expanded its rich product offering to a complete cardiovascular imaging portfolio, with the addition of DiA’s FDA-cleared and CE-marked LVivo™ Toolbox – a line of innovative AI-based cardiac ultrasound solutions. This collaboration will deliver expanded state-of-the-art multi-modality imaging solutions to Circle CVI’s customers, while providing new opportunities for physicians, patients, and hospitals worldwide.

“By adding DiA’s solutions, Circle CVI is broadening its extensive portfolio of cardiovascular MR and CT, to include ultrasound imaging functionality, offerings that are unparalleled in the market,” said Greg Ogrodnick, CEO of Circle Cardiovascular Imaging.

Circle CVI will offer its customers DiA’s LVivo Toolbox, as set of cardiac ultrasound AI solutions which will include LVivo Seamless™ – a unique system that runs “behind the scenes,” automatically selecting the optimal cardiac ultrasound views and generating automated quantifications and indications of both left and right ventricles. The system then immediately extracts these results to the echo reports.

The solutions of both companies are vendor-neutral, running on any scanner, and they can easily integrate into hospital and enterprise sites, with deployments that work with any IT infrastructure.

“Joining forces with Circle CVI will accelerate our mission to rapidly deploy health providers with our most advanced and most accurate cardiac ultrasound AI solutions, which will simplify workflows and improve patient outcomes,” said Hila Goldman-Aslan, CEO of DiA Imaging Analysis.

DiA will spotlight its AI-enabled solutions across its imaging portfolio at the upcoming American Society of Echocardiography (ASE) 2021 virtual event (June 18-21, 2021).

About Circle Cardiovascular Imaging Inc.

Circle Cardiovascular Imaging Inc. develops world-class, advanced reading and reporting solutions for cardiac imaging. Circle CVI is a prominent company in the global cardiac imaging community, bringing together an experienced and dedicated team of over 150 people and offering multi-language support around the globe. Circle CVI’s imaging platform, cvi42, is the best-in-class cardiovascular imaging reading and reporting solution for cardiac MR, cardiac CT, cardiac interventional planning and electrophysiology. Annually, millions of cardiac exams – in over 1,000 hospitals and in more than 50 countries – are interpreted using cvi42.

For additional information, please visit www.circlecvi.com or contact: marketing@circlecvi.com 

About DiA Imaging Analysis Ltd.

DiA Imaging Analysis is a leading provider of AI-powered ultrasound analysis solutions that make the use and analysis of ultrasound images smarter, faster and more accessible to all. The company’s FDA- cleared and CE-marked LVivo™ product line for automated cardiac and abdominal analysis enables clinicians with various levels of ultrasound experience to use and analyze ultrasound images on their ultrasound devices or healthcare IT systems with increased speed, efficiency and accuracy. DiA currently serves thousands of end users worldwide. 

For additional information, please visit www.dia-analysis.com or contact: info@dia-analysis.com 

Cision View original content:http://www.prnewswire.com/news-releases/circle-cardiovascular-imaging-announces-partnership-with-dia-imaging-analysis-to-deliver-all-in-one-comprehensive-ai-based-cardiovascular-imaging-solutions-301311454.html

SOURCE DiA Imaging Analysis; Circle Cardiovascular Imaging Inc.

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Medical Devices

CorWave Successfully Performed a 90-Day In Vivo Study on Its Revolutionary Cardiac Pump Synchronized With the Native Heart, Results Presented at ASAIO Meeting

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PARIS–(BUSINESS WIRE)– CorWave SA, a French medical device company committed to the fight against heart failure, announced that it has successfully completed the first 90-day preclinical study to evaluate its left ventricular assist device (LVAD) operating synchronously with the native heart without the use of sensors. The results were presented at the American Society for Artificial Internal Organs (ASAIO) Annual Meeting on June 12th, 2021, in Washington, DC, by Carl Botterbusch, CTO of CorWave.

The results of the 90-day in vivo study were reported during an oral presentation entitled “Design Optimization of the CorWave Membrane LVAD.” These data confirmed the ability of the CorWave pump to provide chronic circulatory support with exceptional hemocompatibility. Throughout the study, the device provided pulsatile blood flow, synchronized with the native heart, without the use of sensors. This pulsatile operation is intended to reduce the complications associated with current devices which produce constant blood flow, resulting in patients not having a pulse.

The ASAIO1 (American Society for Artificial Internal Organs) brings together leading physicians, scientists, engineers, nurses, manufacturers and entrepreneurs dedicated to the field of artificial organs. The annual conference is a must-attend event in the field of mechanical circulatory support.

Carl Botterbusch, CTO of CorWave, commented, “I am extremely proud of our entire team for their tireless work leading to this demonstration of the unique capabilities of our technology. We now have key data on durability, hemocompatibilty and the robustness of our pulsatility algorithm that will allow us to finalize the design and move into the final series of testing required to begin a clinical study.”

“This conclusive 90-day trial is very good news as it brings us one step closer to the transition to humans. Encouraged by this latest study, step by step we continue our work, driven by the prospect of bringing our innovative solution to heart failure patients,” added Louis de Lillers, CEO of CorWave.

Further work will allow CorWave to complete the development of its heart pump and start production for clinical trials.

About CorWave

CorWave is a French company that develops innovative cardiac assistance devices. CorWave’s wave membrane is a breakthrough technology that differs from today’s commercially available left ventricular assist devices (LVADs) by its physiological operation, including the ability to mimic a pulse and blood flow rates similar to those of a healthy heart. Ultimately, CorWave’s membrane pump technology is expected to reduce the complications associated with current devices and improve the management of heart failure patients. CorWave was founded in 2012 by start-up studio MD Start and is funded by renowned investors including Bpifrance, EIC Fund, Financière Arbevel, M&L Healthcare, Novo Holdings, Seventure, Sofinnova Partners and Ysios. The company has secured €80 million in equity and non-dilutive financing and employs over fifty people.

For further information:

www.corwave.com
LinkedIn: https://www.linkedin.com/company/corwave
Twitter: https://twitter.com/corwave

This project has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement No 954151.
CorWave’s R&D program is supported by the French State through the “Programme d’Investissements d’Avenir” (PIA).
CorWave’s industrialization program is supported by the Paris Region through the call for projects “Relance Industrie”.


1 https://asaio.org/Conference

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MERIT Study Investigators Announce Successful Achievement of the Study’s Primary Efficacy & Safety Endpoints

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AUSTIN, TX / ACCESSWIRE / June 14, 2021 / Apollo Endosurgery, Inc.,  (“Apollo”) (NASDAQ:APEN), a global leader in minimally invasive medical devices for gastrointestinal and bariatric procedures, announced that investigators of the Multi-Center ESG Randomized Interventional (MERIT) study have reported based on a preliminary analysis the successful achievement of the study’s primary endpoints.

In a presentation at the 2021 Surgical Disruptive Technologies Summit meeting in Houston, Texas, Dr. Barham Abu Dayyeh, Professor of Medicine and Director of Advanced Endoscopy at the Mayo Clinic, commented, “I am very pleased to report that, in a preliminary analysis, the MERIT study comparing the Endoscopic Sleeve Gastroplasty (ESG) procedure to medically supervised moderate intensity lifestyle modification has achieved its primary endpoints for both efficacy and safety. We hope to present the detailed study results at an international medical conference later this year.”

The MERIT study (NCT03406975) is a multi-center, prospective randomized clinical trial evaluating the safety and effectiveness of the ESG procedure, a minimally invasive, endoscopic weight loss procedure performed with Apollo Endosurgery’s OverStitch™ Endoscopic Suturing System compared to a medically monitored regimen of diet and healthy lifestyle. The Co-Primary Investigators are Dr. Erik Wilson, University of Texas at Houston (Houston, TX), and Dr. Barham Abu Dayyeh, Mayo Clinic, (Rochester, MN) under a collaborative research agreement sponsored by Apollo Endosurgery. The study’s primary efficacy endpoint is percent excess body weight loss (%EBWL) vs. control, and the primary safety endpoint is a serious adverse event rate of less than 5%. Additionally, patients undergoing ESG are being evaluated for improvement in hypertension and type 2 diabetes at 24 months.

The MERIT study investigators have submitted an abstract to the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO), and if accepted, the full results will be presented at the IFSO annual meeting in Miami in October.

“We are delighted that the Mayo Clinic’s preliminary analysis showed the successful achievement of the MERIT study’s primary endpoints for weight loss and safety, and we look forward to the publication of the full MERIT results providing an important addition to the substantial body of evidence for the ESG procedure,” said Chas McKhann, President and CEO of Apollo Endosurgery. “We plan to utilize the MERIT study results, along with real world evidence, in a submission to the FDA to potentially add a new indication for ESG.”

About Apollo Endosurgery, Inc.

Apollo Endosurgery, Inc. is a medical technology company focused on development of next-generation, less invasive devices to advance therapeutic endoscopy designed to treat a variety of gastrointestinal conditions including closure of gastrointestinal defects, managing gastrointestinal complications and the treatment of obesity. Apollo’s device-based therapies are an alternative to invasive surgical procedures, thus lowering complication rates and reducing total healthcare costs. Apollo’s products are offered in over 75 countries today and include the X-Tack™ Endoscopic HeliX Tacking System, the OverStitch™ Endoscopic Suturing System, the OverStitch Sx™ Endoscopic Suturing System, and the ORBERA® Intragastric Balloon.

Apollo’s common stock is traded on NASDAQ Global Market under the symbol “APEN”. For more information regarding Apollo Endosurgery, go to: www.apolloendo.com.

Cautionary Note on Forward-Looking Statements

Certain statements in this press release are forward-looking statements that are subject to risks and uncertainties that could cause results to be materially different than expectations, including Apollo’s expectations regarding the final analysis of the MERIT study data supporting the conclusions of the preliminary analysis and Apollo’s plan to utilize the MERIT study results in a submission to the FDA to potentially add a new indication for ESG. Important factors that could cause actual results to differ materially include: further analysis of the MERIT study data may result in a different conclusion regarding the achievement of the primary endpoints for weight loss and safety; the impact of the ongoing COVID-19 pandemic and the effect it may have on Apollo’s operations, the demand for the Apollo’s products, Apollo’s liquidity position, global supply chains and economic activity in general; reports of adverse events related to our products, outcomes of clinical studies related to our products; development of competitive products or procedures; regulatory approvals and extensive regulatory oversight by the FDA or other regulatory authorities; unfavorable media coverage related to our products or related procedures; coverage and reimbursement decisions by private or government payors; Apollo’s ability to support the adoption of its products and broaden its product portfolio; the potential size of Apollo’s addressable markets; the execution of our gross margin improvement projects; the availability of cash for Apollo’s future operations as well as other factors detailed in Apollo’s periodic reports filed with the Securities and Exchange Commission, or SEC, including its Form 10-K for the year ended December 31, 2020 and its Form 10-Q for the period ending March 31, 2021. Copies of reports filed with the SEC are posted on Apollo’s website and are available from Apollo without charge. These forward-looking statements are not guarantees of future performance and speak only as of the date hereof, and, except as required by law, Apollo disclaims any obligation to update these forward-looking statements to reflect future events or circumstances.

Contact:

Apollo Endosurgery, Inc.
Stefanie Cavanaugh, 512-279-5100
investor-relations@apolloendo.com

Darrow Associates Investor Relations
Matt Kreps, 214-597-8200
mkreps@darrowir.com

SOURCE: Apollo Endosurgery, Inc.

View source version on accesswire.com:
https://www.accesswire.com/651562/MERIT-Study-Investigators-Announce-Successful-Achievement-of-the-Studys-Primary-Efficacy-Safety-Endpoints

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