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AmeriLife Named to Inc.’s Power Partner Awards for the Second Year in a Row

AmeriLife

In acknowledgment of consistent excellence, Inc. Business Media has once again recognized AmeriLife Group, LLC (“AmeriLife”), a national leader in developing, marketing, and distributing life and health insurance, annuities, and retirement planning solutions, in its third annual Power Partner Awards, which honor business-to-business (B2B) organizations across the globe that have a proven track record of supporting entrepreneurs and helping startups grow. AmeriLife claimed top honors in the Insurance and Financial Services categories, propelled by glowing endorsements from its Health and Wealth Distribution organizations. The company joined an elite group of nearly 400 global B2B organizations, all celebrated for their exceptional support to entrepreneurs and partner institutions in critical areas such as hiring, compliance, and infrastructure development. Through AmeriLife’s partnership program, company founders and leaders can shift focus and resources toward their core business objectives. “Being recognized by Inc. as a Power Partner in the health and life insurance distribution industry is a tremendous honor for AmeriLife,” said Scotty Elliott, Chief Distribution Officer of Health for AmeriLife. “This award is a powerful testament to our dedication to excellence, innovation, and providing unparalleled value to our affiliate partners. We're honored to be recognized as a trusted ally in helping companies flourish and achieve their goals in today's competitive landscape.” "This accolade is a true reflection of our steadfast dedication to superior performance, forward-thinking strategies, and providing unmatched service through our wealth distribution platform,” said Mike Vietri, Chief Distribution Officer of Wealth for AmeriLife. “We're thrilled to be distinguished for our work in financial services and our role in helping businesses and individuals prosper." Targeted expansion aligned with a holistic strategy Since 2020, AmeriLife has welcomed nearly 90 affiliates to its family of companies, culminating in establishing distinct Health and Wealth Distribution channels in January 2023. This restructuring and ongoing investments in world-class resources enable a comprehensive approach to retirement planning. Notable additions include the proprietary leads platform, LeadStar, the insights platform, Atlas, and strategic expansion within the Wealth space to include RIA and Broker-Dealer capabilities. These initiatives work together to fulfill life and health insurance needs and the premier financial services and retirement planning solutions to deliver a truly holistic approach. To view the complete list, go to: https://www.inc.com/power-partner-awards/2024. The November 2024 Issue of Inc. magazine is available online at https://www.inc.com/magazine and will be on newsstands beginning October 29, 2024. “This is our definitive listing of vendors and suppliers who have demonstrated excellence in serving small- and midsize customers,” says Inc. editor-in-chief Mike Hofman. “As part of the vetting process, our team of editors, researchers, and reporters gathered information on companies’ products and services, assessed their reputation as captured in online comments and forums, and collected customer testimonials to ensure that the sales pitch matches the client experience. In every case, we spoke to founders like you who were happy to attest to a vendor’s genuine commitment to a mutually beneficial business partnership. We’re happy to be the conduit for that positive word of mouth.” 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 the 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, financial professionals, and over 160 marketing organizations and insurance agency locations nationwide. For more information, visit AmeriLife.com and follow AmeriLife on Facebook and LinkedIn. About Inc. Inc. is the leading media brand and playbook for entrepreneurs and business leaders shaping our future. 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, digital, print, 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. Contact Details Jeff Maldonado media@amerilife.com Company Website https://amerilife.com/

October 24, 2024 09:00 AM Eastern Daylight Time

PathAI Unveils New Features on AISight Image Management System: Introducing Guided Algorithm Review and Z-Stack Image Support

PathAI

PathAI, a global leader in AI-powered digital pathology, today announced the launch of two new features on its AISight® 1 Image Management System (IMS): Guided Algorithm Review and Z-Stack Image Support. These enhancements reflect PathAI’s ongoing commitment to empowering pathologists with innovative tools that enhance pathology interpretation, optimize laboratory operations, and lay the foundation for broader adoption of AI tools in the field of pathology. The Guided Algorithm Review feature is designed to help pathologists streamline and enhance case evaluations by highlighting potential Fields of Interest (FOIs) identified by algorithms. TumorDetect 2, PathAI’s AI product, will be the first to incorporate this functionality, highlighting key areas of interest. By automatically pinpointing these critical areas, the feature allows pathologists to focus their initial review on the regions that require the most attention. Key Features of the Guided Algorithm Review: Gallery of FOIs: A visual gallery of algorithm-detected fields of interest provides an intuitive way for pathologists to navigate to key tissue areas requiring further analysis. Click-Through Review: Enables systematic, step-by-step navigation through regions highlighted by the AI’s predictions, such as areas with high tumor concentration or biomarker quantification, potentially streamlining the review process and enhancing thoroughness. Enhanced Interpretability: Overlays and side-by-side comparisons improve the clarity of AI predictions, allowing pathologists to better interpret and verify the results. Third-Party AI Integration: Allows for seamless integration with third-party AI algorithms, enabling pathologists to work with various AI solutions in a unified platform, enhancing flexibility and adaptability across different AI tools and workflows. In addition to the Guided Algorithm Review, PathAI’s Z-Stack Image Support introduces a multi-layer imaging capability that enables pathologists to examine all layers of a multi-layered Whole Slide Image (WSI), producing a 3D-like representation of slides. This feature is particularly beneficial in cytology, where three-dimensional cell clusters often require a more nuanced, layered analysis. Key Benefits of the Z-Stack Image Support: Multi-Layer Viewing: Pathologists can view all layers of a multi-layered Whole Slide Image (WSI), providing an experience similar to a microscope fine focus, particularly useful for cytology cases. Efficient Navigation: Features such as Focus Control and keyboard shortcuts allow for smooth transitions between image layers. Customizable Workflow: Pathologists can personalize their review process with adjustable zoom, pan, and annotation features, and track their progress through visual indicators. PathAI has also upgraded its ArtifactDetect 3 algorithm, broadening its support for additional file types, such as.mrxs format files and stains, including Masson’s Trichrome and other special stains. These improvements allow laboratories to apply quality control measures across a wider range of specimens and staining protocols, further optimizing laboratory efficiency. Additional AISight Enhancements: Refreshed User Interface: Includes categorized tables for clearer quantitative results, such as tissue areas and cell counts, facilitating easier interpretation. Custom Slide Panning: Enhanced control features like Snap to Zoom and adjustable animation durations for more precise slide navigation. Automatic Specimen Orientation: Automatically rotates skin specimens based on metadata, ensuring consistency and accuracy in evaluations. “We are thrilled to introduce these new capabilities to the AISight IMS platform,” said Eric Walk, M.D., FCAP, chief medical officer at PathAI. “The Guided Algorithm Review and Z-Stack Image Support are significant advancements that help pathologists conduct high-quality assessments with efficiency and precision. These tools help enhance and streamline case management supporting the needs of modern pathology labs.” Footnotes AISight is for research use only in the US and is not for use in diagnostic procedures. TumorDetect is a workflow optimization algorithm available on AISight for research use only. ArtifactDetect is a quality control algorithm available on AISight for research use only. About PathAI PathAI is a global leader in AI-powered digital pathology solutions, dedicated to advancing diagnostic accuracy and operational efficiency in pathology laboratories worldwide. Through the integration of cutting-edge technology and strategic partnerships, PathAI empowers pathologists to be leaders in precision pathology and shape the future of medical diagnostics. Contact Details SVM Public Relations and Marketing Communications Maggie Naples +1 401-490-9700 pathai@svmpr.com Company Website https://www.pathai.com/

October 23, 2024 10:00 AM Eastern Daylight Time

Forum Health Launches Transformative Health Programs for Thyroid, Hormone, and Weight Management, Cementing Its Footprint in Michigan

Forum Health

Forum Health, LLC, a leader in personalized medicine, is excited to announce the launch of its new Integrative Health Programs in five Michigan locations. The programs feature Advanced Thyroid Care, Bioidentical Hormone Replacement Therapy for men and women, and a competitively priced Medical Weight Loss Program. Learn more about Forum Health Michigan’s Integrative Health Programs. Bruce Hamby, PA-C: "Our comprehensive Integrative Health Programs aim to transform lives by tackling the root causes of health issues. We deliver personalized care that fosters long-term health optimization, providing affordable and effective solutions for individuals seeking to enhance their health and well-being." Led by Bruce Hamby, PA-C, Taylor Consiglio, PA-C, and Holly Alderman PA-C, the new programs combine cutting-edge diagnostics not normally offered in conventional medicine with tailored treatments to help individuals resolve thyroid dysfunction, hormone imbalance, and the challenges of weight management. Forum Health’s Integrative Health Programs Include: Medical Weight Loss with Competitive Pricing - Weight loss solutions featuring GLP-1 and GIP injections focused on delivering sustainable results starting as low as $50 per week. This affordable plan offers expert care for those struggling with metabolic imbalances, stubborn weight gain, or individuals seeking a tailored approach to effective weight management. Advanced Thyroid Care: Comprehensive testing and personalized treatment to optimize thyroid function for those with hypothyroidism, hyperthyroidism, and autoimmune thyroid conditions, combining nutrition, lifestyle modifications, and targeted therapies. Bioidentical Hormone Replacement Therapy: Restores balance and vitality for men and women using bioidentical hormones that closely mimic the body's natural hormones. This customized therapy targets patient's unique needs, effectively relieving symptoms of hormone deficiency and menopause like fatigue, weight gain, and low libido. Phil Hagerman, Forum Health CEO: “Our expansion in Michigan underscores Forum Health's commitment to providing accessible, personalized care that addresses the underlying causes of health concerns. By offering advanced solutions for thyroid and hormone health, and weight management, we’re empowering individuals to take charge of their health and achieve sustainable, long-term wellness.” About Forum Health, LLC Forum Health, LLC is a nationwide provider of personalized healthcare steeped in the powerful principles of functional and integrative medicine. Our providers take a root-cause approach to care exploring lifestyle, environment, and genetics to help each patient achieve their ultimate health goals. Members have access to advanced medical treatments and technology, with care plans informed by data analytics and collaborative relationships. For more, visit www.forumhealth.com. Contact Details Forum Health Britt Wittelsberger +1 410-852-0738 bwittelsberger@forumhealth.com Company Website https://forumhealth.com

October 22, 2024 08:50 AM Eastern Daylight Time

CSD Partners with Tive Technology to Promote Accessibility for d/Deaf and Hard of Hearing Communities across America

Communication Service for the Deaf

CSD in conjunction with ASL Now, a leading company for accessible customer service support in American Sign Language (ASL), is proud to announce its partnership with Tive LLC, a mobile app dedicated to enhancing relay communication and accessibility for consumers who are d/Deaf or Hard of Hearing. Specifically, Tive’s customer service will feature ASL Now’s Direct Video Calling (DVC) platform to provide direct, one-on-one support for Tive customers who communicate primarily in sign language. "We are excited to partner with Tive to expand direct accessibility solutions and support to the fingertips of our community," said Greg Pollock, Vice President of Business Development for ASL Now. "By integrating ASL Now’s DVC platform and Tive’s customer service representatives, we aim to break down communication barriers and promote accessibility in connection and communication." Noted benefits from this partnership include removing barriers of communication, efficient streamlined call times, and peace of mind for Tive’s d/Deaf and Hard of Hearing users. "Tive is committed to maintaining an inclusive environment where everyone can communicate effectively and confidently," said Leif Martinoff, CEO of Tive. "Working together with ASL Now allows us to further our meaningful mission for individuals to connect one-on-one with our customer service support in sign language and create resolutions in real time.” The partnership between ASL Now and Tive represents a shared commitment to advancing accessibility solutions and promoting inclusivity across digital platforms for d/Deaf and Hard of Hearing Americans. For more information about ASL Now and Tive, please visit aslnow.com and tivetechnology.com. About ASL Now: Since 2017, ASL Now has been providing innovative call center solutions for communicating directly with deaf customers in American Sign Language. Offering cutting-edge customer service through ASL Now decreases customer frustration and opens the door to a new market of loyal clients. This expertise provides an invaluable, time-saving solution for businesses, customers, and representatives alike. To learn more, visit ASL Now, and follow us on Facebook and LinkedIn. About Tive: Tive is a recognized mobile application for IOS and Android that has pioneered communication, connectivity, community, and accessibility to the fingertips of d/Deaf and Hard of Hearing Americans. About Communication Service for the Deaf 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. Today, CSD continues its work to create opportunities for personal and economic growth within the Deaf community, specifically addressing leadership and employment. For more information, please visit CSD and follow us on Facebook, Twitter, Instagram, and LinkedIn. Contact Details Molly Miller mmiller@csd.org Company Website https://www.csd.org/

October 22, 2024 08:00 AM Eastern Daylight Time

Players Health Becomes Founding Partner of Greg Olsen’s Youth Inc. to Champion Safety in Youth Sports

Players Health

Players Health, the leading provider of athlete safety and insurance solutions, today announced its partnership as a founding partner with Youth Inc., a content and commerce platform co-founded by NFL alum and Fox Sports broadcaster Greg Olsen. This collaboration marks a significant step toward enhancing safety standards in youth sports through engaging and informative content. It will offer valuable education for athletes, parents, and coaches, while promoting a culture of safety, risk management, and athlete well-being across all levels of play. As digital advertising evolves, and the youth sports industry continues to soar, the growing importance of community-driven strategies and content creation is fueling shifts in the way youth sports organizations engage with their audiences. Through this partnership, Players Health and Youth Inc. will collaboratively generate and distribute content that helps those entrusted with leading youth sports organizations create a safer and more informed environment for young athletes, parents, and coaches. “In today’s rapidly changing youth sports landscape, health and safety must remain at the forefront. Our partnership with Youth Inc. provides a unique opportunity to speak directly to changemakers in our industry and around the country, equipping them with the tools and insights needed to proactively address the challenges facing youth athletes today,” said Tyrre Burks, founder and CEO of Players Health. “Together, we’re not just providing solutions — we’re leading a movement to transform how health and safety is prioritized in youth sports." Youth Inc. provides content across all media platforms, including full-length video/audio podcasts available on YouTube, Spotify, and Apple Podcasts. The network also shares clips on Instagram, Facebook, TikTok, LinkedIn and X. Featuring interviews with some of the biggest stars and thought leaders in the sports world, Youth Inc. serves as a vital resource for navigating the complexities of youth sports today. "Youth sports should be a place where kids can grow, learn, and have fun, and that starts with creating a safe environment. Through our partnership with Players Health, we’re able to provide families and organizations with expert-driven content and resources to help navigate the challenges of today’s youth sports landscape,” said Olsen. “Our shared vision is to equip everyone involved with the knowledge and support they need to foster a safer, more positive experience for young athletes." Season two of Youth Inc. launches on Wednesday, October 30th with six new episodes. Fans, coaches, parents and young athletes can look forward to deeper conversations with top athletes, coaches, and experts in youth sports, as well as valuable advice on safety, well-being, and athletic development. This season promises to bring more exclusive content, further solidifying Players Health and Youth Inc.'s roles as a leading voice in youth sports education. The trailer for Youth Inc.’s upcoming season, featuring Players Health, Greg Olsen, and renowned sports psychologist Dr. Michael Gervais, offers a glimpse into the impactful conversations and expert commentary that will shape the future of youth sports safety and development. To learn more, visit: https://www.playershealth.com/ About Players Health Players Health is a sports technology company providing digital risk management services, reporting tools and insurance products to sports organizations to empower them to stay ahead of their ever-changing safety and compliance responsibilities. Working towards establishing the safest environment for athletes, Players Health views the health and safety of athletes as a priority in today's sports landscape. About Youth Inc. Youth Inc. is the first digital media network dedicated exclusively to youth sports content and commerce. Co-founded by NFL alum and Fox Sports broadcaster Greg Olsen, Youth Inc. provides parents, coaches, and athletes with expert-driven guidance and resources to navigate the evolving youth sports landscape. For more information, visit www.youth.inc or follow along on YouTube, X, and TikTok. Contact Details Players Health Jackson Gaskins playershealth@hotpaperlantern.com Company Website https://www.playershealth.com

October 21, 2024 09:00 AM Eastern Daylight Time

How LogicMark Is Helping Make Personal Safety Smarter

Benzinga

By Johnny Rice, Benzinga Chia-Lin Simmons, CEO of LogicMark (NASDAQ: LGMK), was recently a guest on Benzinga’s All-Access. LogicMark is a leading provider of personal emergency response systems (PERS), health communications devices and IoT technologies to create a connected care platform. Its products help keep at-risk populations – young and old – safe. The company is incorporating AI technologies to help analyze patterns and anticipate needs, increasing the efficacy of its products. Watch the full interview here: Featured photo by Rod Long 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 not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

October 21, 2024 08:25 AM Eastern Daylight Time

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NeuroSense Advances Plans For Early Commercialization Of Potentially Groundbreaking ALS Treatment In Canada, Targeting A $100M+ Market

Benzinga

By Kyle Anthony, Benzinga NeuroSense Therapeutics Ltd. (NASDAQ: NRSN), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases – such as amyotrophic lateral sclerosis (ALS), Alzheimer's disease and Parkinson's disease – recently announced its plans to file for early commercialization approval for PrimeC, the firm’s leading drug candidate designed to synergistically target several biological mechanisms of ALS, under Health Canada’s Notice of Compliance with Conditions (NOC/c) policy. This submission is backed by promising results from the company’s phase 2b ALS PARADIGM clinical trial and supplementary clinical and preclinical data. ALS Explained ALS is a nervous system disease that affects nerve cells in the brain and spinal cord. The disease causes loss of muscle control, and gradually worsens over time. Often called Lou Gehrig's disease after the baseball player who was diagnosed with it, the exact cause of the disease is still not known. ALS often begins with muscle twitching and weakness in the arm or leg, trouble swallowing or slurred speech. Eventually, ALS affects the control of the muscles needed to move, speak, eat and breathe. There is no cure for this fatal disease. Every year, more than 5,000 people are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of people living with ALS is expected to grow by 24% by 2040 in the U.S. and European Union. The Efficacy Of NeuroSense’s PrimeC Treatment PrimeC, NeuroSense's lead drug candidate, is a novel extended-release oral formulation with a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. PrimeC is designed to synergistically target several biological mechanisms of ALS that contribute to motor neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid (RNA) regulation. The goal is to inhibit the progression of ALS. NeuroSense reports that PARADIGM, a prospective, multinational, randomized, double-blind, placebo-controlled phase 2b clinical trial of PrimeC in ALS, has demonstrated the drug's efficacy. The trial d emonstrated that PrimeC significantly reduced disease progression (p=0.009) and improved survival rates by 43% compared to placebo, highlighting its potential as a breakthrough therapy for ALS. The trial included 68 participants living with ALS in Canada, Italy and Israel. 96% of the trial participants who completed the 6-month double-blind portion of the trial chose to receive treatment with PrimeC through a 12-month open-label extension. As of June 2024, all participants who completed the 18-month trial treatment duration requested to continue PrimeC, which is provided to them in an Investigator Initiated Trial, not limited to time. The PARADIGM clinical study observed a statistically significant slowing of disease progression in patients who used PrimeC versus placebo, based on the ALS Functional Rating Scale-Revised (ALSFRS-R). The Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS) is the gold standard instrument for evaluating the functional status of patients with ALS. It is used to monitor functional change in a patient over time. NeuroSense reports that most patients enrolled in both the active and placebo arms of the trial were concurrently treated with Riluzole, the ALS standard of care medication, indicating PrimeC slowed disease progression well beyond the level afforded by the FDA-approved ALS drug. The FDA and the European Medicines Agency have granted PrimeC Orphan Drug Designation. Commercialization Of PrimeC In Canada And Worldwide Health Canada’s Notice of Compliance with Conditions (NOC/c) is authorization to market a drug, with the condition that the sponsor undertake additional studies to verify the clinical benefit. As such, this speeds up the time to market for the drug, enabling earlier commercialization. In advancing PrimeC's commercialization potential, NeuroSense plans to submit its regulatory dossier to Health Canada in Q2 2025, with a regulatory decision anticipated by Q1 2026, and NeuroSense estimates the market opportunity for PrimeC in Canada alone to be approximately $100 million to $150 million in annual revenue, reflecting the unmet need for effective ALS treatments. Beyond Canada, NeuroSense plans to pursue regulatory approval in additional global markets as part of its broader strategy to make PrimeC accessible to ALS patients worldwide. Alon Ben-Noon, CEO of NeuroSense, stated, “The Canadian market presents a significant near-term opportunity, with the addressable market for PrimeC valued above $100 million in annual revenue. Securing early commercialization approval in Canada would represent an important milestone, not only to address the unmet need for ALS treatments but also as part of our strategy to drive sustainable growth. With additional markets on our radar, this marks the beginning of what we anticipate will be a long-term revenue-generating opportunity." Looking Forward NeuroSense’s PrimeC has the potential to reshape the landscape for ALS treatment, enhancing the quality of life for individuals around the globe afflicted by this debilitating disease. The promising results from the PARADIGM clinical trial and NeuroSense's commercial advancement plans for the drug indicate that PrimeC may soon be able to benefit ALS patients around the world and potentially position the company to be a leader in treating the disease. Featured photo courtesy of NeuroSense Therapeutics. 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

October 17, 2024 02:00 PM Eastern Daylight Time

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Minerva Surgical Signs Agreement with Blackmaple Group (BMG) and WHAAPA

Minerva Surgical, Inc.

Minerva Surgical, a manufacturer and distributor of minimally invasive gynecologic technologies, today announced a new strategic partnership with Blackmaple Group, designed to provide access to office-based solutions for its Women’s Health Administrative and Purchasing Alliance (WHAAPA) physician members for the detection and treatment of uterine conditions. The Medical Endoscopy Image Processing System and the Minerva ES Ablation System – both of which will be available to BMG WHAAPA members under this new agreement – are designed to quickly and effectively address causes of Abnormal Uterine Bleeding (AUB) a set of debilitating conditions affecting one in three women. Left untreated, AUB may drive women to withdraw or become absent from family, social, and work activities. Some of these conditions can be life threatening, if not detected early. According to Darin Hammers, CEO of Minerva Surgical, “Integrating hysteroscopy into the office setting enables gynecologists to detect uterine cavity disease earlier and more accurately than using other, less sensitive methods. The Minerva ES endometrial ablation can be performed in the comfort of the office setting, while reducing the cost to the patient. Effectiveness of the Minerva ES has been proven in clinical trials demonstrating procedure safety and long-term avoidance of hysterectomy in over 99% of the patients.” Additionally, Minerva ES is a one-time, non-hormonal, incisionless treatment with the recovery time of 1-2 days. “The agreement with Minerva Surgical is important to Blackmaple Group because it provides WHAAPA members with more options to safely and effectively treat patients in the office setting”, said Dr. Jeff Gold, CEO of BMG. About Minerva Surgical: Minerva Surgical is a Women’s Health company committed to improving women's health and quality of life by providing access to minimally invasive, technologically advanced, and innovative solutions for early detection, treatment, and management of uterine conditions. About Blackmaple Group: founded in 2008 as a consulting firm focused on bringing business rigor to provider group management, the Blackmaple Group (BMG) has grown to become an industry leader in procurement, medical group management and healthcare economics. Under the leadership of its founder Dr. Jeff Gold and COO Marc Cooper, BMG has grown to over 16,000 physician members across the United States and continues to add new clients every day. Contact Details Kevin Tracey +1 855-646-7874 info@minervasurgical.com Company Website https://minervasurgical.com/

October 17, 2024 10:00 AM Eastern Daylight Time

AGC Biologics Seattle Achieves Approval for all 2024 Biologics License Applications from U.S. Food and Drug Administration, Concluding Pre-License Inspection

AGC Biologics

AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), announced the U.S. Food and Drug Administration (FDA)’s approval of a third Biologics License Applications (BLA) from the March 2024 inspection of the company’s Seattle facility. The closure of this inspection and final BLA approval resulted in each of the three commercial products evaluated being approved for commercial production – a regulatory compliance and quality milestone for the site. The Seattle CDMO facility welcomed the FDA in March 2024 for an intensive week of three product inspections. The approved products include two FC-fusion proteins and a monoclonal antibody (mAb). One of the FC-fusion proteins is focused on treating non-muscle invasive bladder cancer; the other is designed to treat age-related neovascular Macular Degeneration (nAMD) and other serious retinal diseases. The mAb product targets chronic-versus-host disease (GVHD). The series of 2024 BLA approvals continues a trend of successful regulatory milestones for the AGC Biologics Seattle site. The FDA has approved four biologics products manufactured at this facility in the last two years. AGC Biologics received commercial approval at the end of 2022 for a mAb product targeting type 1 diabetes (T1D), the first and only treatment of its type at the time of approval. “Performing an agency inspection for three products simultaneously is not easy and I am extremely proud of this result. We took on the challenge and helped ensure every product evaluated achieved commercial approval this year,” said Jose Gonzalez, General Manager, AGC Biologics Seattle. “This is a tremendous achievement for our site. For our partners bringing lifesaving treatments to patients, it is pivotal for their manufacturing partner to maintain regulatory compliance and a high level of product quality to help them reach commercial success. This is a shining example of AGC Biologics’ Seattle ability to do that.” AGC Biologics operates multiple mammalian cGMP manufacturing lines of various scales at its Seattle site, which serves as a center of excellence for formulation and employs the latest fed-batch and perfusion manufacturing processes. In the past year, AGC Biologics Seattle has also expanded to include a new microbial-based manufacturing line system and a state-of-the-art 67,000 sq. ft. GMP-compliant warehouse to further enhance the quality, efficiency and operational excellence of the site. To learn more about AGC Biologics’ protein biologics manufacturing site in Seattle, visit www.agcbio.com/facilities/seattle. For more information on the company’s end-to-end global CDMO services in the U.S., Europe and Japan visit www.agcbio.com. About AGC Biologics: AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 Team Members worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is a part of AGC Inc.’s Life Science Company. The Life Science company runs more than 10 global facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit www.agcbio.com. Contact Details AGC Biologics Nick McDonald +1 425-419-3555 nmcdonald@agcbio.com Company Website https://www.agcbio.com/

October 17, 2024 05:57 AM Eastern Daylight Time

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