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MCC Brokerage Named One of America’s Fastest-Growing Private Companies by Inc. 5000

AmeriLife

MCC Brokerage, an innovative field marketing organization in the life and health insurance industry and affiliate partner of AmeriLife Group, LLC, today announced its first inclusion on Inc. 5000’s annual list of the fastest-growing private companies in America. With over 25 years of agency management experience, MCC Brokerage has built a robust network of resources designed to support licensed agents with top-flight resources, marketing and lead programming, compliance training and guidance, and its flagship professional development program, MCC Academy. “I am deeply honored and humbled that our company has been recognized in the Inc. 5000 list for the first time in our history,” said Darren Houck, CEO of MCC Brokerage. “This achievement is a testament to our team's hard work and dedication. As we celebrate this milestone, I am reminded that accolades do not measure our success. Instead, it's the service and value we provide to our agents and agency principals daily. I am grateful to our team for their commitment to excellence, our clients for trusting us with their needs, and AmeriLife for its unwavering partnership and servant leadership.” “I am thrilled to congratulate Darren and the MCC Brokerage team on being recognized as one of America's Fastest Growing Companies by Inc. 5000,” added Scotty Elliott, Chief Distribution Office of Health for AmeriLife. “This prestigious accolade is a testament to their relentless dedication, innovative spirit, and exceptional leadership. We are proud to partner with such a forward-thinking organization and are excited to see what heights their continued growth will lead to in the future.” The prestigious ranking provides a data-driven look at the most successful companies within the economy’s most dynamic segment—its independent, entrepreneurial businesses. In addition to Microsoft, Meta, Chobani, Under Armour, Timberland, Oracle, Patagonia, and many other household-name brands, MCC Brokerage gains its first national exposure as an honoree on this year’s Inc. 5000 list of the fastest-growing private companies in the country. The Inc. 5000 class of 2024 represents companies that have driven rapid revenue growth while navigating inflationary pressure, the rising costs of capital, and seemingly intractable hiring challenges. Among this year’s top 5000 companies, the average median three-year revenue growth rate is 1,637 percent. This year’s Inc. 5000 companies have added 874,458 jobs to the economy over the past three years. “One of the greatest joys of my job is going through the Inc. 5000 list,” says Mike Hofman, who recently joined Inc. as editor-in-chief. “To see all the intriguing and surprising ways companies are transforming sectors, from health care and AI to apparel and pet food, is fascinating as a journalist and storyteller. Congratulations to this year’s honorees, as well, for growing their businesses fast despite the economic disruption we all faced over the past three years, from supply chain woes to inflation to changes in the workforce.” The 2024 Inc. 5000 companies are ranked according to percentage revenue growth from 2020 to 2023. Companies must have been founded and have generated revenue by March 31, 2020, to qualify. They must be U.S.-based, privately held, for-profit, and independent—not subsidiaries or divisions of other companies—as of December 31, 2023. ### About MCC Brokerage As an award-winning, highly reputable, and innovative field marketing organization in the life and health insurance industry, MCC Brokerage works to empower thousands of active, licensed independent insurance agents nationally. MCC has created an exclusive marketing catalog for agents to choose customizable collateral with consistent looks across all pieces to build their brand in the community. For more information, visit www.mccbrokerage.com. About Inc. Inc. Business Media is the leading multimedia brand for entrepreneurs. Through its journalism, Inc. aims to inform, educate, and elevate the profile of our community: the risk-takers, the innovators, and the ultra-driven go-getters who are creating our future. Inc. ’s award-winning work achieves a monthly brand footprint of over 40 million across various channels, including events, print, digital, video, podcasts, newsletters, and social media. Its proprietary Inc. 5000 list, produced yearly since its launch as the Inc. 100 in 1982, analyzes company data to rank the fastest-growing privately held businesses in the United States. The recognition that comes with inclusion on this and other prestigious Inc. lists, such as Female Founders and Power Partners, allows the founders of top businesses to engage with an exclusive community of their peers and credibility that helps them drive sales and recruit talent. For more information, visit www.inc.com. About AmeriLife AmeriLife’s strength is its mission: to provide insurance and retirement solutions to help people live longer, healthier lives. In doing so, AmeriLife has become recognized as a leader in developing, marketing, and distributing life and health insurance, annuities, and retirement planning solutions to enhance the lives of pre-retirees and retirees across the United States. For over 50 years, AmeriLife has partnered with top insurance carriers to provide value and quality to customers through a distribution network of over 300,000 insurance agents and advisors and 120 marketing organizations and insurance agency locations nationwide. For more information, visit AmeriLife.com and follow AmeriLife on Facebook and LinkedIn. Contact Details Jeff Maldonado media@amerilife.com Partnership Inquiries Patrick Nichols corporatedevelopment@amerilife.com Company Website https://amerilife.com/

August 19, 2024 12:37 PM Eastern Daylight Time

Minerva Surgical Appoints Darin Hammers as Chief Executive Officer and Member of the Board of Directors

Minerva Surgical, Inc.

Today, Minerva Surgical announced the appointment of Darin Hammers as the new President and Chief Executive Officer and Member of the Board. With a 30-year proven track record of success and excellence, Mr. Hammers brings a wealth of expertise and leadership to the company as it continues to develop and commercialize minimally invasive gynecologic technologies that improve patient outcomes. Most recently, Mr. Hammers served as President and Chief Executive Officer of EndoGastric Solutions (EGS), which was acquired by Merit Medical in July. Prior to EGS, he served as Chief Executive Officer of DYSIS Medical and President and Chief Executive Officer of Cogentix Medical, a company that was acquired by Laborie in 2018. Mr. Hammers was formerly Vice President of Sales for the Bard Medical Division of C.R. Bard, and he spent over twelve years in leadership positions with the Urology and Gynecology division at Boston Scientific Corporation. During his tenure in the medical device industry, Mr. Hammers consistently demonstrated the ability to build high-performing organizations and teams that deliver exceptional results. Minerva Surgical Chairman Dr. Uri Geiger said: “We are delighted to welcome Darin as our new President and Chief Executive Officer. Mr. Hammers is a dynamic business leader with exceptional strategic capabilities, proven operational effectiveness and strong experience in women’s health. The Board looks forward to working with Darin as we grow Minerva’s platform of exceptional products for women’s care.” Mr. Hammers stated: “I am delighted to join Minerva Surgical and build a company that will develop new and innovative technologies to improve the quality of life for women. The core portfolio of products is as effective as any on the market when it comes to treating uterine cavity conditions, and the goal is to expand our footprint in the gynecology space and become a market leader.” Darin Hammers holds an MBA from Emory University’s Goizueta School of Business and a Bachelor of Science degree in marketing from the University of Southern Indiana. About Minerva Surgical, Inc. Minerva Surgical is a commercial-stage medical technology company focused on developing, manufacturing, distributing, and commercializing minimally invasive solutions to meet the distinct uterine healthcare needs of women. The Company has established a broad product line of commercially available, minimally invasive alternatives to hysterectomy, which are designed to address the most common causes of Abnormal Uterine Bleeding (AUB) in most uterine anatomies. The Minerva Surgical solutions can be used in a variety of medical treatment settings and aim to address the drawbacks associated with alternative treatment methods and to preserve the uterus by avoiding unnecessary hysterectomies. For more information about the innovative medical devices of Minerva Surgical, please visit www.MinervaSurgical.com. Contact Details Minerva Surgical Kevin Tracey +1 855-646-7874 media@minervasurgical.com Company Website https://minervasurgical.com/

August 19, 2024 10:00 AM Eastern Daylight Time

CONSENSUS HEALTH WINS STEVIE® AWARD IN 2024 INTERNATIONAL BUSINESS AWARDS®

Consensus Health

Consensus Health, a leading New Jersey-based healthcare organization with a physician-led medical group and an Independent Physician Alliance (IPA), announced today it was named winner in The 21 st Annual International Business Awards® (IBAs). The Company earned a bronze Stevie® Award in the Company of the Year - Health Products & Services - Large category. The International Business Awards are the world’s premier business awards program. All individuals and organizations worldwide – public and private, for-profit and non-profit, large and small - are eligible to submit nominations. The 2024 IBAs received entries from organizations in 62 nations and territories. More than 3,600 nominations from organizations of all sizes and in virtually every industry were submitted this year for consideration in a wide range of categories. Stevie Award winners were determined by the average scores of more than 300 executives worldwide who participated in the judging process in June and July. “We are honored to be a winner in the prestigious International Business Awards, especially on the heels of the recognition we recently earned here in the U.S. in the American Business Awards competition,” stated Michael Lovett, Consensus Health chief executive officer. “According to the judging process, it was noted how ‘ Consensus Health has made impressive strides in preserving clinical autonomy for independent physicians in New Jersey, demonstrated by its significant growth in providers, locations and patient enrollment in value-based care programs.’ Indeed, we have done just that, growing exponentially, particularly during the past two years, which is the period evaluated in this global program. We thank our entire team for their unwavering dedication to the Company and all our patients throughout New Jersey. We continue to work diligently each and every day to positively impact patient care statewide,” he concluded. Details about The International Business Awards and the lists of Stevie Award winners are available at www.StevieAwards.com/IBA. About the Stevie Awards Stevie Awards are conferred in nine programs: the Asia-Pacific Stevie Awards, the German Stevie Awards, the Middle East & North Africa Stevie Awards, The American Business Awards®, The International Business Awards®, the Stevie Awards for Women in Business, the Stevie Awards for Great Employers, the Stevie Awards for Sales & Customer Service, and the Stevie Awards for Technology Excellence. Stevie Awards competitions receive more than 12,000 nominations each year from organizations in more than 70 nations. Honoring organizations of all types and sizes and the people behind them, the Stevies recognize outstanding performances in the workplace worldwide. Learn more about the Stevie Awards at www.StevieAwards.com. About Consensus Health Marlton, New Jersey-based Consensus Health is a leading physician-owned and -governed medical group comprised of New Jersey-based independent primary care providers and specialty doctors. Consensus Health affords its 166 member physicians across 56 practices and 69 locations clinical autonomy, which enables them to focus on the delivery of high levels of patient care within the local markets they each serve. Currently, Consensus Health provides medical care statewide throughout 18 New Jersey counties. For more information, visit www.consensushealth.com or connect with the Company on LinkedIn. Contact Details At Consensus Health Susan J. Turkell +1 303-766-4343 sturkell@pairelations.com Company Website https://www.consensushealth.com/

August 15, 2024 11:19 AM Mountain Daylight Time

USA Financial Partners with AmeriLife to Enhance Opportunities for Independent Financial Professionals

AmeriLife

AmeriLife Group, LLC (“AmeriLife”), a national leader in developing, marketing, and distributing life and health insurance, annuities, and retirement planning solutions, announced today that it has partnered with USA Financial, a national wealth management firm with three registered investment advisers (RIAs), a registered broker-dealer, and a national field marketing organization (FMO) that supports its independent financial professionals and their investors. Per the agreement, terms of the deal were not disclosed. “We couldn’t be more thrilled to partner with AmeriLife as we head into the next era of USA Financial,” said Mike Walters, Chief Executive Officer of USA Financial. “We look forward to the new doors that this partnership will open to enhance the opportunities we can bring to the table for the financial professionals and investors we serve.” Founded in 1988 on the philosophy “plan first, invest second,” USA Financial has grown to include five distinct, subsidiary companies – USA Financial Exchange; USA Financial Formulas, USA Financial Securities, USA Financial Insurance Services, and USA Financial Advisor Advancement. Together, they deliver a comprehensive suite of products and solutions that are designed to help independent financial professionals grow their businesses, make their practices more predictable, and deliver more for their clients. A five-time Inc. 5000 honoree that has been led by the same ownership team for more than three decades, USA Financial’s longevity and success stands as a testament to its carefully crafted approach to wealth management, financial planning, integrated technology, and operational excellence. Now, as it partners with AmeriLife Wealth Group, it will have expanded access to top-flight insights, tools, and resources to further empower its affiliated financial professionals and help them take their businesses to new heights. “Bringing on an insurance-first, registered broker-dealer like USA Financial and its diversity of offerings opens up endless opportunities for our platform,” said Mike Vietri, Chief Distribution Officer of AmeriLife Wealth Group. “I look forward to working with Mike and his incredible team to further our ambitions to be the holistic, ‘integrator of choice’ for the modern financial professional.” Houlihan Lokey acted as the exclusive financial advisor to USA Financial in connection with the transaction. ### About USA Financial USA Financial is a comprehensive financial services institution, focused on providing advisors with the tools required to make solid recommendations and to empower clients to make educated and informed financial decisions. To learn more about USA Financial, please visit USAFinancial.com. About AmeriLife AmeriLife’s strength is its mission: to provide insurance and retirement solutions to help people live longer, healthier lives. In doing so, AmeriLife has become recognized as a leader in developing, marketing, and distributing life and health insurance, annuities and retirement planning solutions to enhance the lives of pre-retirees and retirees across the United States. For more than 50 years, AmeriLife has partnered with top insurance carriers to provide value and quality to customers served through a distribution network of over 300,000 insurance agents and advisors and 120 marketing organizations and insurance agency locations nationwide. For more information, visit AmeriLife.com, and follow AmeriLife on Facebook and LinkedIn. Contact Details Media Jeff Maldonado media@amerilife.com Partnership Inquiries Patrick Nichols corporatedevelopment@amerilife.com Company Website https://amerilife.com/

August 15, 2024 09:00 AM Eastern Daylight Time

Forum Health, Top Healthcare Network, Earns Inc. 5000 Honors Again, Boasting 286% Revenue Growth

Forum Health

Forum Health, LLC, a premier nationwide provider of personalized integrative healthcare, is thrilled to announce its recognition on the Inc. 5000 list of America’s Fastest Growing Companies for the second consecutive year. Securing a ranking of #1829 overall and #137 within the healthcare sector, Forum Health’s growth is driven by surging consumer demand for innovative solutions, pioneering medical treatments, and the acquisition of top-tier industry talent. Explore Forum Health's medical specialties and services here. From medical weight loss and hormone therapy to managing chronic illnesses, sexual dysfunction, digestive disorders, and mental wellbeing, Forum Health offers highly effective, individualized medicine to meet the evolving needs of those seeking holistic care. Phil Hagerman, Forum Health CEO: “Consumers are demanding more from healthcare. They want to optimize their health with a personal approach that uncovers the root causes of their symptoms so they can lead longer, healthier lives. Our repeat recognition on the Inc. 5000 list signifies our success in this endeavor. We’re committed to redefining healthcare through personalized medicine, advanced technologies, and anti-aging strategies to enhance vitality and overall well-being.” Forum Health achieved a remarkable 286% revenue growth from 2020 to 2023, expanding to 37 clinics across 13 states in all major regions of the U.S. with over 500 dedicated employees. This significant growth highlights the company’s successful acquisition strategy and commitment to providing exceptional healthcare services. Adam Puttkammer, Forum Health President: “Earning a spot again on the Inc. 5000 list reflects the trust consumers have in our approach to healthcare and our ability to attract and retain top healthcare talent. This not only drives innovation and improves patient outcomes, but also solidifies our position as a leader in integrative and functional medicine.” About Forum Health, LLC Forum Health, LLC is a nationwide provider of personalized healthcare steeped in the principles of functional and integrative medicine. Our providers take a root-cause approach to care exploring lifestyle, environment, and genetics with advanced treatments and cutting-edge technology, care plans informed by data analytics and collaborative relationships to help patients achieve their health goals. The company has three major divisions: Forum Health, LLC, which represents our medical practices, Power2Practice, our EMR, data and technology-focused division and Inwell Biosciences LLC, our professional-grade dietary supplements. Learn more at www.forumhealth.com. About Inc. 5000 Inc. Business Media is the leading multimedia brand for entrepreneurs to inform, educate, and elevate the profile of our community: the risk-takers, the innovators, and the ultra-driven go-getters creating our future. Its proprietary Inc. 5000 list analyzes company data to rank the fastest-growing privately held businesses in the U.S. Visit www.inc.com. Contact Details Heather Spangler hspangler@forumhealth.com Company Website https://forumhealth.com

August 15, 2024 08:50 AM Eastern Daylight Time

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Communication Service for the Deaf, Inc. Receives $250,000 Engagement Award from PCORI

Communication Service for the Deaf

Communication Service for the Deaf, Inc. (CSD) has been awarded $250,000 through the Eugene Washington PCORI Engagement Award Program, an initiative of the Patient-Centered Outcomes Research Institute (PCORI). The funding will support a two-year project titled "Building Capacity for Deaf American Sign Language Users in Virtual Healthcare PCOR/CER," running from November 1, 2024 through October 31, 2026. The COVID-19 pandemic has significantly accelerated the adoption of telemedicine in healthcare yet little is known about best practices for the Deaf community. Deaf individuals who use American Sign Language (ASL) face communication and health literacy challenges, making virtual healthcare services potentially inaccessible and inequitable. CSD’s health and patient advocacy division, DeafHealth, will recruit a diverse group of stakeholders to form a national Deaf Patient Coalition. This coalition will identify and capture diverse Deaf patient experiences with virtual healthcare platforms to help shape future patient-centered outcomes research (PCOR) and comparative clinical effectiveness research (CER) focused on healthcare virtual platforms for the Deaf community. By collaborating with academic institutions, researchers, and patient communities, this groundbreaking project aims to advance equitable care and decision-making among Deaf patients that aligns with patient-centric outcomes and preferences. The project will be directed by project lead Allysa Dittmar, MHS, Vice President of DeafHealth. Rochester Institute of Technology (RIT), under the leadership of Dr. Tiffany Panko, executive director of the Deaf Health Care & Biomedical Science Hub and director of the Deaf Health Laboratory at RIT’s National Technical Institute for the Deaf will support the project. “Deaf people comprise approximately 13% or 30 million of the American population, yet they are often overlooked in research. We are grateful to PCORI for this opportunity to promote equitable participation and engagement for both Deaf patients and researchers alike," said Dittmar. "The lack of opportunities for our community has hindered the ability to identify effective interventions to improve the health and wellbeing of Deaf people who use ASL. As healthcare increasingly shifts to virtual platforms for care and treatment, it is crucial to include the Deaf population, researchers, and stakeholders to ensure that future PCOR/CER research is patient-centered and equitable.” By incorporating diverse lived Deaf patient experiences, this project empowers this historically marginalized community with the resources and PCOR/CER knowledge necessary to drive community-centered change for improved health outcomes, aligning with PCORI’s mission to empower patients and others. In the long term, the project provides an opportunity to propose future PCOR/CER studies that align with the community’s identified priorities regarding virtual healthcare platforms for the Deaf community. PCORI is an independent, nonprofit organization authorized by Congress with a mission to fund patient-centered comparative clinical effectiveness research that provides patients, their caregivers, and clinicians with the evidence-based information they need to make better informed health and healthcare decisions. For more information on the PCORI Engagement Award and CSD's funded project, visit here. Projects approved for funding by PCORI’s Engagement Award Program were selected through a rigorous and highly competitive review process, assessing their ability to meet PCORI's engagement goals and objectives, as well as program criteria. About Communication Service for the Deaf, Inc. Communication Service for the Deaf (CSD) is the largest Deaf-led social impact organization in the world. For more than four decades, CSD has been a leader in creating and providing accessible and innovative solutions for the Deaf community. Through CSD's patient and health advocacy division, DeafHealth focuses on improving health outcomes for deaf and hard-of-hearing patients through state-wide initiatives by providing culturally and linguistically accessible health information, resources, and services. For more information, please visit CSD and follow CSD on Facebook, Twitter, Instagram, and LinkedIn. About Rochester Institute of Technology’s National Technical Institute for the Deaf Established by the U.S. Congress in 1965, the National Technical Institute for the Deaf is the first and largest technological college in the world for deaf and hard-of-hearing students. NTID offers associate degree programs for deaf and hard-of-hearing students and provides support and access services for deaf and hard-of-hearing students who study in the other eight colleges of Rochester Institute of Technology. NTID also offers certificate programs in educational, deaf, healthcare, trilingual, and signed language translation interpretation, as well as bachelor’s degree programs in sign language interpreting and community development and leadership, and master’s degrees in secondary education and healthcare interpretation. Deaf and hard-of-hearing students come from all over the United States and around the world to take advantage of the opportunities available to them at RIT/NTID. Visit RIT/NTID and follow on Facebook, Twitter, Instagram, and LinkedIn. Contact Details Allysa Dittmar adittmar@csd.org Company Website https://www.csd.org/

August 15, 2024 08:00 AM Eastern Daylight Time

FitFast Develops Intermittent Fasting App Changing the Narratives of Health and Wellness Industry

Rev Up Marketers

FitFast is the pioneering force in health technology. In the recent development, the company has launched its groundbreaking app, designed to transform the world of intermittent fasting (IF). This innovative application harnesses the power of artificial intelligence (AI) to provide users with a highly personalized and adaptive approach to intermittent fasting, addressing the unique challenges and needs of individuals seeking to improve their health and well-being. Conceived by George Anderson, the visionary founder and CEO of FitFast, this advanced app marks a significant milestone in the intersection of technology and health. The development of FitFast reflects Anderson’s personal struggles with intermittent fasting, which highlighted a gap in the market for a tool that could offer more tailored and effective solutions. Intermittent fasting has garnered widespread acclaim over the past decade for its potential benefits, including weight loss, enhanced metabolic health, and increased longevity. However, many individuals encounter difficulties in successfully implementing fasting regimes. Challenges such as choosing the right fasting schedule, maintaining consistency, and monitoring progress often hinder the effectiveness of these plans. Traditional approaches to intermittent fasting frequently adopt a one-size-fits-all model, which fails to consider the diverse physiological and lifestyle factors of each individual. Enter FitFast is an app designed to overcome these limitations through its use of cutting-edge AI technology. The core of FitFast’s innovation lies in its ability to provide personalized fasting plans that adapt to users’ evolving needs. The app’s AI-driven algorithms analyze user data in real-time to offer customized recommendations and adjustments, ensuring that each fasting plan is uniquely suited to the individual’s progress and challenges. The FitFast experience begins with a comprehensive onboarding quiz that gathers crucial information about users’ lifestyles, preferences, and health goals. This initial assessment allows the app to craft a fasting plan that is not only effective but also sustainable over the long term. By addressing the specific needs and circumstances of each user, FitFast ensures a more engaging and achievable path to better health. Central to FitFast’s user experience is its AI-powered "Coach" feature, which offers real-time, personalized guidance through an intuitive conversational interface. This interactive element helps users stay on track with their fasting schedules, make informed decisions, and overcome obstacles. Additionally, FitFast includes a suite of tracking tools that monitor various health metrics such as weight, energy levels, and sleep patterns, providing users with valuable insights into their progress and allowing for timely adjustments. The integration of AI technology in FitFast represents a significant advancement in the wellness app market. The app’s AI system is designed to be both responsive and adaptive, learning from user interactions and continuously refining its recommendations. This dynamic interaction ensures that FitFast remains relevant and effective as users’ needs evolve over time, making intermittent fasting a viable and rewarding option for a broader audience. FitFast’s commitment to excellence is also reflected in its approach to user feedback. Prior to its official launch, the app underwent a closed beta testing phase, where a select group of users provided detailed feedback on their experiences. This beta testing phase was instrumental in refining the app’s features and functionality, ensuring a polished and effective final product. The development team remains dedicated to actively seeking user input, using this feedback to guide future updates and enhancements. Consequently, FitFast represents a new chapter in health and wellness, combining advanced technology with a personalized approach to intermittent fasting. With its innovative features and user-focused design, FitFast is set to redefine how individuals integrate fasting into their lives and achieve their health goals. About the Company - FitFast FitFast was founded by George Anderson, inspired by his own challenges with intermittent fasting and a vision to create a more effective and adaptable solution. The app brings together a team of experts dedicated to leveraging technology to improve health outcomes and simplify the fasting process. FitFast is committed to offering a transformative experience for users, making intermittent fasting a practical and rewarding endeavor. Intending users can visit the following link: https://www.fitfast.com/ for further details. Contact Details Fit Fast George Anderson +1 305-452-6789 press@fitfast.com Company Website https://www.fitfast.com/

August 14, 2024 11:18 AM Eastern Daylight Time

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Extending Survival: Oncolytics Biotech's Pelareorep Shows Promise In Fighting Metastatic Breast Cancer

Benzinga

By Meg Flippin, Benzinga One in eight women will face a breast cancer diagnosis in the U.S. Of those, one in three will become metastatic. When breast cancer metastases, it often spreads to the bones, lungs or liver. Unfortunately, these tumors eventually become resistant to endocrine-blocking therapies and can reoccur in approximately 50% of patients. Depending on how much and far the cancer spreads, the five-year survival for distant metastatic breast cancer rate is 29%. The metastatic breast cancer treatment market is forecast to grow at a CAGR of 10.4% from 2021 to 2030, reaching $41.74 billion. With no direct cure in sight, keeping the cancer under control and increasing survival rates are the focus areas of biopharmaceutical companies, big and small, including Oncolytics Biotech Inc. (NASDAQ: ONCY). The clinical-stage biopharmaceutical company specializing in immunotherapeutics for oncology and their leading agent pelareorep, has demonstrated promising results in Phase 1 and 2 studies to fight challenging cancers. When pelareorep was added to standard metastatic breast cancer treatment, overall survival rates nearly doubled in a randomized study of patients with HR+/HER2- breast cancer, reports Oncolytics. Pelareorep is an intravenously delivered immunotherapeutic agent that induces anti-cancer immune responses and promotes an inflamed tumor phenotype — turning “cold” tumors “hot.” Pelareorep works by generating, recruiting and training immune cells to recognize and kill cancer while remodeling the tumor microenvironment to enable immune cell access. When added to existing treatment regimens such as chemotherapy, pelareorep demonstrates the potential to extend survival times in addition to expanding existing and new T cell clones in the blood, the company reports. Proving Its Mettle In Oncolytics’ randomized Phase 2 trials, known as BRACELET-1, pelareorep demonstrated meaningful improvements in overall response rate and progression-free survival. Overall survival from this trial continues to mature. A previous randomized phase 2 trial also showed positive results, including a statistically significant near doubling of median overall survival observed. Data from BRACELET-1 and AWARE-1 studies consistently show that pelareorep produces an expansion of T cell clones and/or an increase in CelTIL scores and peripheral tumor-infiltrating lymphocyte counts, reports the company. The trials also demonstrated a manageable safety profile which is consistent with prior studies. Positive data from BRACELET-1 and IND-213 randomized trials showed meaningful clinical improvements in the pelareorep/paclitaxel combination arms compared to paclitaxel monotherapy, says Oncolytics. Multiple patients in the pelareorep/paclitaxel arm continue to be followed for survival, with overall survival results expected in the second half of the year. “We believe this data will further bolster our compelling data package and underscores the therapeutic potential of pelareorep,” said Wayne Pisano, interim CEO and chair of the board of Oncolytics. “We remain committed to improving the standard of care and addressing the high unmet medical needs of these patients.” Working Hand-In-Hand With The FDA Pelareorep has fast track designation from the Food and Drug Administration, which allows for the expedited review of drugs for serious conditions that need novel treatments. Oncolytics was also recently part of a productive Type C meeting with the FDA to support the planned potential registration-enabling trial for pelareorep in HR+/HER2- metastatic breast cancer (mBC). Oncolytics said the FDA supports progression-free survival as the primary endpoint of the study, with overall survival as a key secondary endpoint. The company’s proposed study will enroll patients for whom hormonal therapy hasn’t worked and who have received no more than one line of antibody-drug conjugate (ADC) therapy. “Aligning with the FDA on key design elements and objectives of our planned registrational trial for pelareorep marks a critical step towards bringing this innovative treatment to patients,” said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. “Our de-risked program builds on compelling data and key learnings from two randomized studies, BRACELET-1 and IND-213, which demonstrated clinically meaningful benefit in patients receiving pelareorep and paclitaxel compared to paclitaxel alone. Additionally, translational data from the AWARE-1 study highlights pelareorep’s immune-mediated mechanism of action in breast cancer patients. We are now well-positioned to deliver on our mission of making pelareorep available to breast cancer patients in need of better treatment options,” he said. Breast cancer is common, and while many cases are treatable, metastatic breast cancer is a different story. At stage 4, the tumors have spread to other parts of the body and recurrence is frequent. Extending the survival rate is the name of the game, and Oncolytics thinks it has a winner with pelareorep. With clinical trials demonstrating pelareorep’s potential under its belt and a big one in the works, Oncolytics may be right. Featured photo by Susan G. Komen 3-Day on Unsplash Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

August 14, 2024 08:45 AM Eastern Daylight Time

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PathAI Announces Launch of AI-based Measurement of Metabolic Dysfunction-Associated Steatohepatitis ("AIM-MASH") on the AISight Image Management System

PathAI

PathAI, a global leader in artificial intelligence (AI) and digital pathology solutions, is proud to announce the launch of its AIM-MASH 1 product on the AISight Ⓡ 1 Image Management System (IMS). This product provides advanced AI-based measurement (AIM) to support the analysis of MASH Clinical Research Network (CRN) Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) Activity Score (MAS) component grades and fibrosis staging. The launch of AIM-MASH on AISight aims to increase the reproducibility and scalability of pathologists' assessments and management of MASH cases, which are projected to reach 27 million in the US alone by 2030 2. PathAI's AIM-MASH AI-based measurement tools have been utilized in over 20 presentations and publications, demonstrating their effectiveness in assisting pathologists with MASH CRN scoring in clinical trials; bringing them to the AISight IMS enables a seamless connection between trial and laboratory settings. These tools have been rigorously evaluated via a comprehensive multi-site analytical validation study using diverse datasets from four different trials 3. They have proven to be reliable and effective in helping pathologists make MASH assessments with: Highly Sensitive and Specific Review: AIM-MASH's model overlays have been validated by multiple pathologists for their high specificity and sensitivity in guiding reviews of MASH biopsies and accurately highlight key areas such as artifact, steatosis, hepatocellular ballooning, lobular inflammation, and fibrosis 3. Repeatable and Reproducible Assessments: AIM-MASH algorithm outputs have shown higher repeatability and reproducibility compared to intra- and inter-pathologist agreement for manual reads, confirming its precision in measuring the CRN scoring system components in liver biopsies from MASH patients 3. Increased Scoring Confidence: Validation studies have shown that AIM-MASH algorithm outputs are comparable to pathologist assessments, providing accurate first reads equivalent to those of expert pathologists to aid pathologists in their final assessment. 3 Global Collaboration: The AISight digital IMS allows expert GI Liver pathologists to review cases regardless of their location. This eliminates the need for time-consuming and costly shipping of glass slides and provides opportunities to utilize the MASH experts. The practical application of AI in MASH assessments was highlighted in a recent case study conducted by PathAI Diagnostics (now Ameripath, at its Memphis, TN-based laboratory) 4. This study demonstrated the synergy between traditional pathology and AI, showcasing how AI-assisted pathology can enable more precise evaluation of histologic features relevant to MASH, including steatosis, lobular inflammation, and fibrosis. "We are thrilled to introduce AIM-MASH on the AISight IMS platform," said Andy Beck, MD, PhD, CEO of PathAI. "This product is a game-changer for drug development, as it supports pathologists in making high-quality, reproducible MASH assessments. With AIM-MASH on AISight, pathologists can increase their confidence in pathology reads and decision-making, as if they have the world's expert liver pathologists assisting with every slide, helping with simplifying the complex task of scoring and evaluation." Dr. Arun J Sanyal, Professor and Interim-Chief of the Division of Gastroenterology, Hepatology, and Nutrition at Virginia Commonwealth University and co-investigator of the AIM-MASH analytical and clinical validation study, adds: "The data supports the use of AIM-MASH by pathologists in clinical trials as a method to resolve the accuracy and precision gaps in MASH assessment while guiding pathologists in an efficient evaluation to result in a standardized and reproducible score." The addition of AIM-MASH broadens the set of tools available through AISight to assist pathologists in making reproducible and efficient assessments of MASH. This announcement addresses a crucial gap in pathology labs — the lack of a standardized system that ensures consistent, accurate, and reproducible assessments, particularly for challenging conditions like MASH. With AIM-MASH on AISight IMS, PathAI aims to provide digital and AI tools to assist pathologists in making precise and reproducible assessments at scale, along with workflow optimization features, empowering pathology labs worldwide. References: 1: AIM-MASH and AISight are for Research Use Only. Not for use in diagnostic procedures. 2: Estes C, Razavi H, Loomba R, Younossi Z, Sanyal AJ. Modeling the epidemic of nonalcoholic fatty liver disease demonstrates an exponential increase in burden of disease. Hepatology. 2018 Jan;67(1):123-133. https://doi.org/10.1002/hep.29466. Epub 2017 Dec 1. PMID: 28802062; PMCID: PMC5767767. 3: Pulaski, Hanna, et al. “Analytical and Clinical Validation of AIM-NASH: A Digital Pathology Tool for Artificial Intelligence-Based Measurement of Nonalcoholic Steatohepatitis Histology.” MedRxiv (Cold Spring Harbor Laboratory), 29 May 2024, https://doi.org/10.1101/2024.05.29.24308109. Accessed 22 July 2024. 4: Kinsey, S., Reed, M., Parsell, T. “Practical Clinical Application of Artificial Intelligence in Metabolic Dysfunction Associated Steatohepatitis (MASH) – A Case Study Highlighting the Synergy between Traditional Pathology and AI.” PathAI, 2024. About PathAI PathAI is a leading provider of integrated AI and digital pathology solutions, dedicated to transforming diagnostic accuracy and operational efficiency in pathology labs worldwide. Through innovative technologies and strategic partnerships, PathAI aims to enhance patient outcomes and drive the future of medical diagnostics. Contact Details SVM Public Relations and Marketing Communications +1 401-490-9700 pathai@svmpr.com Company Website https://www.pathai.com/

August 13, 2024 09:00 AM Eastern Daylight Time

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