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U.S. Court of Appeals Decision Marks Another Win for CoorsTek in Trademark Litigation

CoorsTek

CoorsTek Bioceramics has secured a decisive win in the U.S. Court of Appeals for the Federal Circuit affirming the company’s right to market and sell its Permallon® Tru* ceramic hip components in the U.S. The recent decision confirms the 2022 U.S. PTO Trademark Trial and Appeal Board (TTAB) cancellation of trademark registrations by Ceramtec GmbH. “Alternative sourcing of these components is necessary to prevent supply shortages for this critical care market,” said Jonathan Coors, CEO of CoorsTek. “The U.S. Court of Appeals decision marks another victory for CoorsTek in this case, but it is ultimately patients across the globe who will benefit.” CoorsTek Bioceramics entered the hip arthroplasty industry in 2013 with its Permallon® Tru technical ceramic material which contains a chromium oxide additive for improved performance, including increased hardness. The pink coloring of products manufactured from Permallon® Tru ceramic is a natural byproduct of the additive. CoorsTek initiated proceedings in 2014 following attempts by Ceramtec to enforce its trademark and trade dress claims to the color pink for its ceramic hip components. In 2022 the TTAB ruled to cancel the trademark registrations, finding the pink color is functional and a natural result of following the teachings in the expired Ceramtec patent on the material. The recent U.S. Court of Appeals decision affirms the cancellation. The 2022 TTAB decision followed a prior CoorsTek victory in the U.S. District Court for the District of Colorado, which was vacated on procedural grounds. Lucian Strong, President, CoorsTek Bioceramics said, “Products manufactured from Permallon® Tru ceramic material demonstrate exceptional mechanical performance and durability. We are pleased to continue offering these products to leading medical device OEMs who have come to rely upon high-performance, high-quality components provided by CoorsTek.” Hip systems incorporating Permallon® Tru hip components been registered for use by customers of CoorsTek Bioceramics in multiple locations across the globe, including the U.S., Korea, China, and the EU. *Formerly marketed as CeraSurf®-p About CoorsTek Bioceramics CoorsTek Bioceramics is dedicated to leading edge manufacturing of technical ceramic implantcomponents for the medical device industry. A wholly owned subsidiary of CoorsTek, Inc.,CoorsTek Bioceramics is backed by over 100 years of technical ceramics expertise. With afocus on ceramic bearing surfaces for total joint arthroplasty, CoorsTek Bioceramics components can also be found in implant devices for neurological, cardiological, spinal, andradiological applications. Since 2005, over six million CoorsTek Bioceramics components havebeen sold and distributed for clinical use. About CoorsTek Founded in 1910, CoorsTek is a leading global manufacturer of technical ceramics. By leveraging expertise in engineering and materials science, CoorsTek provides solutions to complex technical challenges in the semiconductor, medical, automotive, aerospace and other industries. With over 400 proprietary material formulations, vertically integrated systems, and unparalleled process capabilities, CoorsTek partners with its customers to make the world measurably better. Visit www.coorstek.com Contact Details CoorsTek Megan Maguire +1 303-503-2287 mmaguire@coorstek.com Company Website https://www.coorstek.com

January 09, 2025 06:00 AM Mountain Standard Time

Advancing Clinical Studies, Meeting Regulatory Milestones, Strengthening Its Strategic Framework And More: The Past Year For Glucotrack, And What Lies Ahead

Benzinga

By JE Insights, Benzinga Although a manageable disease, diabetes imposes significant hurdles on patients, both in terms of personal care and financial costs. Fundamentally, the required frequency of blood glucose monitoring combined with the broader logistical burdens of supply management (involving items like strips, sensors and insulin) have levied significant disruptions on the overall quality of life for patients and caregivers. Glucotrack, Inc. (NASDAQ: GCTK) aims to radically alter this standard of care. Leveraging its Continuous Blood Glucose Monitor (CBGM), Glucotrack has positioned itself to positively impact the diabetes management industry. Specifically, the market for continuous glucose monitoring (CGM) – which encompasses devices worn on the body daily – may reach a valuation of $16.2 billion by the end of 2024. By 2034, the arena could expand by a compound annual growth rate (CAGR) of 10.3% to hit $16.2 billion. Unlike most other CGM devices, however, Glucotrack’s CBGM offers several distinct benefits, including these advantages: Direct blood glucose measurement: The medical technology specialist’s CBGM utilizes the gold standard of measuring blood glucose instead of interstitial fluid, facilitating more accurate and timely readings with minimal lag. Extended sensor longevity: Glucotrack’s sensors last for three years before requiring replacement, thus helping to reduce expenses. Generally, standard CGM sensors last up to 15 days. No on-body wearables: The company’s fully implantable design eliminates external devices, enhancing comfort, discretion and avoidance of adhesive-related issues. Minimal calibration requirements: Glucotrack says its CBGM requires relatively few calibrations, simplifying the maintenance protocol compared to some CGMs. Reduced lifestyle disruptions: Finally, the CBGM’s “hands-free” approach offers easier integration into daily life. Glucotrack reports that it made great strides in 2024, particularly in the areas of clinical validation and strategic manufacturing partnerships. In addition, the medical device specialist achieved key regulatory and quality milestones in a bid to ensure compliance and readiness for market entry. A Year Of Breakthroughs And Progress Wasting no time when the calendar turned to 2024, Glucotrack hit the ground running from the first quarter. In January, management announced the completion of preclinical studies demonstrating very highly accurate blood glucose monitoring results at 60 days. This test demonstrated the reliability of the CBGM system over an extended period. In the next month, the medical tech firm announced a partnership with Cirtec as the manufacturer of the flagship CBGM. Glucotrack said that over the years, Cirtec has forged a reputation as a leader in the design and manufacturing of implantable medical devices in the fields of neuromodulation, cardiology and drug delivery. By the second quarter, Glucotrack’s commitment to clinical innovation took center stage. Between April and June, the company announced the first reported long-term preclinical study of glucose monitoring in the epidural space. This innovative approach not only demonstrated Glucotrack’s technological versatility but also expanded the potential applications for its CBGM system, further setting it apart from conventional solutions. In June, the company presented key findings at the prestigious American Diabetes Association (ADA) conference. Two poster presentations highlighted the CBGM’s accuracy and sensor longevity. The first underscored the system’s ability to deliver reliable blood glucose readings, while the second demonstrated its potential to last up to three years, far exceeding the lifespan of all existing standard CGM devices. These presentations bolstered Glucotrack’s credibility within the medical community, attracting attention from researchers, clinicians and potential industry partners. Momentum carried into the third quarter with a poster presentation at the Association of Diabetes Care & Education Specialists (ADCES) conference in August. Here, Glucotrack shared market research data showing significant patient interest in its implantable CBGM system. This response affirmed the unmet need for a more convenient and less intrusive solution, strengthening the company’s positioning for future adoption. Capping off the year, Glucotrack began its first-in-human clinical study with the first cohort of participants. This short-term study will further validate the CBGM system, paving the way for more extensive trials in 2025. Additionally, the company expanded its leadership team and board, bringing in experts with decades of experience in CGM technologies and medical device commercialization. These strategic moves are aimed at setting Glucotrack up for continued growth and success in the coming year. Looking Ahead To 2025 As Glucotrack moves into 2025, the company is prepared to accelerate its mission to transform diabetes management. Building on the foundation established in 2024, Glucotrack plans to prioritize clinical validation, regulatory progress and strategic partnerships to bring its CBGM closer to market. The first major milestone on the horizon is the full data readout from the first in-human short-term clinical study initiated in December 2024. This readout will offer the first human-specific validation of the CBGM system’s safety and accuracy, a pivotal step in establishing the technology’s credibility. Additionally, the company intends to launch a long-term feasibility study, which will run for at least one year. This extended evaluation will provide critical insights into the CBGM’s performance over time, bolstering the evidence base needed for regulatory approvals and patient adoption. On the regulatory front, Glucotrack is preparing to meet key FDA requirements by completing the quality and manufacturing activities necessary for investigational devices; the company expects to receive ISO13485 certification in early 2025. These efforts will ensure that the CBGM meets rigorous safety and efficacy standards, paving the way for more advanced clinical trials. Furthermore, the company plans to submit a second long-term feasibility study to the FDA, demonstrating its commitment to a methodical and thorough regulatory pathway. To support its clinical and regulatory efforts, Glucotrack will also focus on expanding its cache of published clinical and scientific evidence. Sharing results through peer-reviewed journals and major conferences will help establish the CBGM as a scientifically credible and groundbreaking solution. This growing body of evidence may also serve to attract strategic partners and financial backers, further accelerating the company’s progress. Finally, the company plans to unveil more details about its commercialization strategy, focusing on how to address patient needs and expand access to this innovative solution. By advancing clinical studies, meeting regulatory milestones and strengthening its strategic framework, Glucotrack has been hard at work setting the stage for a transformative year. With these initiatives, the company believes it is well-positioned to continue its journey toward redefining diabetes care. Featured photo by Silvia on Pixabay. 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

January 07, 2025 08:30 AM Eastern Standard Time

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LogicMark Launches Critical New Device To Save Lives

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. LogicMark just launched Freedom Alert Max, its new premiere safety smartphone. Its sleek design makes it a “PERS device in disguise.” Watch the full interview here: Featured photo by Tiago Muraro 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

December 24, 2024 08:35 AM Eastern Standard Time

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Valens' Double-Digit Growth Plans; ADAS, Video Conferencing, Industrial And Medical Imaging To Power Revenue

Benzinga

By Meg Flippin, Benzinga Advanced driver assistance systems are no longer reserved for luxury cars and trucks alone. Increasingly they are finding their way into all sorts of vehicles, including compact passenger vehicles, and for good reason – these systems increase safety and visibility. It’s why the advanced driver assistance systems – or ADAS – market is projected to see double-digit growth in the years to come. Today the market is valued at $34.93 billion. By 2031 it’s forecast to reach $73.74 billion, growing at a CAGR of 10.8% during the forecast period. It’s also partly why Valens Semiconductor (NYSE: VLN), the Israeli chipmaker, expects revenue in 2025 to grow 25% to 30% year-over-year and why, by 2029, it’s forecasting revenue of between $220 million and $300 million. "We have a tremendous growth opportunity ahead. Our growth strategy includes leveraging our core technology to serve new markets undergoing digital transformation, diversifying our revenue sources and augmenting organic growth with strategic acquisitions that will expand our market reach,” said Gideon Ben-Zvi, Chief Executive Officer, during Valens' recent investor day. “We believe this strategy can generate sustainable growth and create significant long-term value for our shareholders." It’s All About The Chipsets Valens makes high-performance chipsets that are integrated into a range of devices powering state-of-the-art audio and video installations, next-generation videoconferencing, ADAS and autonomous driving. The company says its A-PHY technology provides reliable and optimized connectivity solutions for OEMs that need long-reach, high-resolution video. Take the ADAS market, for starters. Valens says its A-PHY standard-compliant chipsets support the highest camera resolutions on the market, providing OEMS with high bandwidth and zero latency, two things that are becoming important as data rates rise in lockstep with the proliferation of sensors built into vehicles. The company’s chipsets also power centralized radar, which is a radar architecture that relies on a central processor to collect and analyze data from multiple radar sensors. Valens says its chipsets provide high downstream bandwidth and fast controls on the uplink, supporting the satellite radar architecture of tomorrow. Then there’s LiDAR, a remote sensing technology that leverages lasers to measure distances. Valens says its chips can support 360-degree lidars with adaptive digital signal processing and error correction. That tech prowess has landed the company some recent design wins. In the fall, Valens announced it achieved three automotive design wins from leading European OEMs for its VA7000 MIPI A-PHY chipsets. Each of the OEMs plans to embed Valens’ MIPI A-PHY chipsets in certain vehicle models with the start of production in 2026. Valens pegged the estimated production volume totaling approximately 500,000 vehicles per year. Once it ramps up, Valens expects the design wins to generate over $10 million in annual revenue for five to seven years. Valens said at the time that the design wins are validation of its position in the ADAS market, as well as MIPI A-PHY’s position as the industry’s standard for next-generation sensor connectivity. “As a former CTO and executive for major automotive OEMs, I can attest to how the industry has been waiting for a safe and resilient high-performance connectivity standard,” said Dr. Peter Mertens, Chairman of Valens, when the design wins were announced. “This is exactly what Valens has brought to the industry. I anticipate that this OEM validation will open the floodgates for further adoption of this important connectivity technology.” Beyond The ADAS Market But ADAS isn’t the only market where Valens expects to grow. The company’s chipsets are powering advanced video-conferencing, industrial machine vision and medical imaging. In video conferencing, Valens expects increased demand to be driven by AI meeting solutions that deliver high-quality video experiences for both remote and in-person meetings. With the ongoing trend of more video peripherals and more meeting rooms of all sizes, Valens plans to capitalize on its high-speed connectivity solutions, including its USB3 extension offering. The total addressable market for video-conferencing solutions is expected to grow to $350 million by 2029, forecasts Valens. Then there’s industrial machine vision which Valens says will be a total addressable market of $460 million by 2029. As for medical imaging, while Valens has supplied that market with chipsets for years, it’s now focusing on new opportunities specific to medical endoscopies and the shift to single-use devices for this procedure. The U.S. FDA is urging this transition to enhance patient safety and eliminate risk factors. Valens says its chipsets offer a simple, reliable and cost-effective solution for one-time use endoscopies. The annual total addressable market for single-use endoscopes could reach $625 million pending full regulatory approval and market adoption, reports Valens. All told, Valens says its verticals have a combined total addressable market of approximately $5.5 billion by 2029. Acquisitions are another potential growth driver. The company plans to pursue buys of companies that are revenue-generating and have a clear path to profitability in the ProAV, Industrial and Machine Vision markets. With over $133.1 million of cash and cash equivalents as of September 30, 2024, Valens says it has the firepower to pursue acquisitions that align with its strategy and goals for long-term growth and profitability. "Looking ahead, we are confident in our ability to capitalize on opportunities in both existing and new markets,” said Ben-Zvi. “With a talented team and more than 17 years of experience delivering cutting-edge technology, and a very strong balance sheet, we are well positioned to execute our disciplined growth strategy and deliver long-term value for our shareholders.” ThinkEquity Gets It It's not just Valens that’s optimistic about its future. Wall Street firm ThinkEquity recently initiated coverage of the stock with a buy rating and a $5 price target, which implies a triple-digit upside from where shares are currently trading. ThinkEquity analysts pointed to Valens' financial position, expanding product portfolio and “proactive” approach to the market for the buy rating. “Valens is well-positioned to deliver sustainable growth and create long-term value for stakeholders," wrote the ThinkEquity analysts. To learn more about how Valens chipsets are powering next-generation video and imaging technology, click here. Featured photo by Vitaly Sacred 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

December 23, 2024 08:30 AM Eastern Standard Time

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Quest Diagnostics (NYSE: DGX) And Mainz Biomed (NASDAQ: MYNZ) Team Up To Commercialize ColoAlert Early Cancer Detection Screening In The U.S.

Benzinga

By Meg Flippin, Benzinga Mainz Biomed N.V. (NASDAQ: MYNZ), the molecular genetics diagnostic company specializing in the early detection of cancer, is moving closer to commercializing its early colorectal cancer detection screening ColoAlert® in the U.S. by inking deals with Quest Diagnostics (NYSE: DGX), a leading provider of diagnostic information services. As part of the agreements, Mainz Biomed said Quest Diagnostics will provide clinical trial and laboratory services to support its ReconAAsense Food and Drug Administration pivotal study of ColoAlert. The clinical trial is slated to kick off next year with up to 15,000 patients. If ColoAlert gets the nod from the U.S. FDA, it will be able to target the millions of Americans at risk of colorectal cancer. Mainz has said its commercial strategy is to establish scalable distribution in the U.S. through a collaborative partner program with regional and national laboratory service providers. The recent strategic alliance with Thermo Fisher Scientific (NYSE: TMO), a global leader in life sciences with annual revenue exceeding $40 billion, represents a monumental step forward in transforming cancer prevention in the United States, says Mainz. This partnership harnesses Thermo Fisher's extensive expertise and state-of-the-art infrastructure to drive innovation in healthcare solutions. Adding further depth to this initiative is the collaboration with Quest Diagnostics, a leader in advanced testing and sampling technologies. Quest Diagnostics offers a broad range of services, including routine blood work, genetic and molecular testing and specialized diagnostic services for various diseases, such as cancer, cardiovascular conditions and infectious diseases. Mainz reports that Quest Diagnostics is widely recognized for its national network of laboratories, extensive patient service centers and cutting-edge technology that ensures accurate and timely test results. As a significant player in the healthcare industry, particularly in diagnostic testing and sampling, Quest Diagnostics serves millions of patients and healthcare providers annually, making it a critical component in advancing precision and scalability in early cancer detection and prevention. With $8 million in funding dedicated to expediting FDA approval, this initiative aims to rapidly advance critical milestones, laying the groundwork for massive expansion. Together, Mainz believes these partnerships are poised to catalyze a sweeping transformation in public health outcomes, creating a tidal wave of innovation and economic growth that will ripple across the healthcare landscape. Readying ColoAlert For Potential U.S. Debut In addition to supporting the clinical trial, Mainz said Quest Diagnostics has a semi-exclusive right to market ColoAlert in the U.S. for an eighteen-month period. If exercised, this option will allow Quest Diagnostics the opportunity to offer the product to multiple channels, including physicians, health systems, hospitals, health plans, employers and consumers, reports Mainz Biomed. “We are excited by the opportunity to collaborate with Quest Diagnostics,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “Teaming with Quest Diagnostics during our critical FDA Study will be key to our long-term success.” Encouraging Trial Results ColoAlert is an early detection screening that spots bleeding and non-bleeding tumors through tumor DNA analysis. ColoAlert analyzes samples for the four tumor markers associated with cancer: KRAS-mutation, BRAF-mutation, total amount of human DNA and occult blood. By analyzing tumor DNA, Mainz says ColoAlert detects 85% of colorectal cancer cases, often in the very early stages of the disease. Based on recent trials, Mainz Biomed says ColoAlert’s sensitivities exceeded 90% for detecting colorectal cancer and over 80% for advanced adenomas. Detecting advanced adenomas is crucial in preventing colorectal cancer, as identifying patients with these lesions allows for timely intervention through colonoscopy and adenoma removal, thereby averting cancer development, reports Mainz. Big Addressable Market It's a big market for Mainz Biomed to address, given colorectal cancer is the third most common cancer globally, with more than 1.9 million new cases reported in 2020, according to World Cancer Research Fund International. The U.S. Preventive Services Task Force recommends that screening with stool DNA tests be conducted once every three years, starting at age 45. As it stands, 71% of the diagnoses made are in the later stages of the disease. But if it's caught early, the survival rate after five years is 90%. Despite those favorable odds, only about four in ten colorectal cancers are spotted at the early stage. Each year in the U.S., 16.6 million colonoscopies are performed, yet about one-third of US residents aged 50-75 have never been screened for colon cancer. This gap in screening represents a $4 billion total market opportunity in the U.S., according to estimates compiled by Mainz Biomed. ColoAlert, if approved in the U.S., may help rectify that lack of timely screening. After all, Mainz Biomed says its detection system is less invasive than ColoGuard, the leading at-home test in the U.S., because it requires very small samples to test. It’s one of the reasons the company boasts 98% patient satisfaction in Germany. ColoAlert is also easy to use, which should be a big driver of adoption. Within five minutes your sample is collected and packaged and on the way to the lab. Patients receive a kit in the mail that includes instructions, a stool collector and a shipping label to return the kit to their local lab for testing. Patients receive the results in a few days. Mainz Biomed wants to bring its ColoAlert early cancer screening test to the U.S., and it is inking deals and readying clinical trials to achieve that. Its agreements with Quest Diagnostics put it one step closer. Stay tuned in 2025 – there may be lots more to come from Mainz Biomed on its path to commercializing ColoAlert in the U.S. and beyond. Featured photo by National Cancer Institute 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

December 20, 2024 08:30 AM Eastern Standard Time

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PathAI Launches AIM-IHC Breast Panel on AISight® Platform to Streamline Breast Cancer Biomarker Quantification and Improve Pathologist Efficiency

PathAI

PathAI, a leader in AI-powered pathology solutions, today announced the launch of the AIM-IHC Breast Panel, a set pf advanced AI-assisted, algorithms designed to quantify critical breast cancer biomarkers—HER2, ER, PR, and Ki-67. Available now on the AISight® Image Management System (IMS), this comprehensive panel provides partners with accurate, consistent scoring, enhancing precision and streamlining workflow efficiency. Adding to the existing AIM-HER2 Breast solution, this consolidation of critical breast cancer biomarker algorithms into a single, pathologist-centric image management system directly addresses the need for standardized, reliable quantification assist tools to support pathologists. PathAI’s AIM-IHC Breast Panel is designed to address key challenges in breast cancer biomarker quantification, particularly the need for precise and reproducible assessment. The panel provides accurate, consistent, zero-click scoring for HER2, ER, PR, and Ki-67 directly from routine immunohistochemistry (IHC) images. With automated tissue segmentation and detection of on-slide controls, the panel classifies areas of invasive versus non-invasive cancer and provides overlays to support algorithmic scoring. This breast cancer-centric panel is designed for a pathologist-assist workflow, allowing users to better differentiate regions of interest, improve the accuracy of invasive cancer segmentation, and streamline tedious scoring processes. The AIM-IHC Breast Panel is the latest addition to PathAI's expanding suite of AI-powered solutions on the AISight® IMS. AISight serves as a central hub for managing pathology images, enabling seamless integration of various AI-driven tools for pathology labs. By centralizing workflows and offering a growing portfolio of applications, PathAI empowers pathologists and researchers to improve precision and efficiency, all within a unified, cloud-native platform. This continuous expansion of the AISight IMS and the full menu of AI applications available on the platform from PathAI as well as third-party vendors underscores PathAI’s commitment to providing comprehensive, reliable tools that enhance the field of pathology and ultimately, patient outcomes. “We are committed to advancing precision pathology with cutting-edge AI technology, empowering pathologists with the tools to make more accurate, consistent, and efficient assessments,” said Andrew Beck, CEO of PathAI. “The AIM-IHC Breast Panel is the latest step in our mission to enhance AI-powered scoring for key breast cancer biomarkers.” In addition, the AIM-IHC Breast Panel goes beyond HER2 by offering fast and accurate Ki-67 scoring, addressing the challenges of this emerging biomarker, which has traditionally been time-consuming and labor-intensive. Pathologists no longer need to spend significant time manually counting cells or rely on imprecise approximations. The panel’s automated features, such as classifying invasive cancer and generating percentage-based results for positive cancer cells, provide pathologists with the clarity needed to produce more accurate scoring. The introduction of the AIM-IHC Breast Panel marks a significant step in PathAI’s ongoing mission to enable precision pathology and empower pathologists with the latest AI-driven technologies. This release highlights PathAI’s commitment to improving workflow efficiency, speed, and assessment accuracy. As the AISight® Image Management System continues to expand with new solutions, pathologists gain access to a comprehensive suite of tools that streamline their workflow, accelerating decision-making and reducing time spent on manual tasks. With each of our new advancements, pathologists are better equipped to deliver precise, actionable insights for cancer diagnostic research. Footnotes AIM-IHC Breast Panel, AIM-HER2, AIM-ER, AIM-PR, and AIM-Ki-67 are for research use only. Not for use in diagnostic procedures. AISight is for Research Use Only in the US; AISight Dx is CE-IVD marked in Europe, UK and Switzerland. About PathAI PathAI is a global leader in AI-powered digital pathology solutions, dedicated to improving operational efficiency in pathology labs worldwide. Through its innovative technology and strategic partnerships, PathAI is shaping the future of medical diagnostics and advancing patient care across the globe. Contact Details SVM Public Relations and Marketing Communications +1 401-490-9700 pathai@svmpr.com Company Website https://www.pathai.com/

December 09, 2024 10:00 AM Eastern Standard Time

UNOS and Donate Life America invite you to honor donors

United Network for Organ Sharing

The United Network for Organ Sharing (UNOS) and Donate Life America (DLA) invite the public to join the National Tree of Life virtual event to honor and remember this year’s organ, eye and tissue donors and their families. The National Tree of Life ceremony will take place on December 16 at 6:30 p.m. ET. The annual event honors the legacy of donors in each state who gave the gift of life in 2024 and celebrates the tens of thousands of lives they saved. The event will be live streamed on Donate Life America’s Facebook page. As part of this year’s ceremony, the winner of the annual Lisa Schaffner Community Advocate Award will be announced. The award recognizes those who go above and beyond to promote organ donation. The award is named after Lisa Schaffner, a powerful advocate of donation and transplant and former UNOS employee, who passed away in 2021. The ceremony will feature speakers from DLA, UNOS and the organ donation and transplant community, including: Jan Flanders, a tissue recipient and family member of an organ donor Sam Dey, a heart recipient Samuel and Susan Kirton, a double lung recipient and a caregiver Each year, the Tree of Life ceremony recognizes the lives and gifts of more than 20,000 organ donors – and tens of thousands of cornea and tissue donors – and their families, while also celebrating the lives of recipients across the country. Volunteers with connections to donation and transplant will honor donors from each state by hanging ornaments on the trees of life and lighting candles of remembrance. “The Tree of Life event is a moving reminder of the tremendous loss, bravery and joy that organ donation and transplant bring, and the ripple effect it has on each of us,” said Maureen McBride, Ph.D., CEO of UNOS. “We are thankful for those who have given the gift of life and for their courageous families.” “As we honor donors and donor families from this year during the National Tree of Life ceremony, we also recognize and celebrate the enduring legacy of lifesaving generosity of all donors and donor families who have given the gift of life in past years,” said David Fleming, DLA president and CEO. “We hope the Tree of Life ceremony helps provide community and solace.” Watch the event on the National Tree of Life Facebook event page: https://www.facebook.com/share/18T7djHSUJ/. For more information about organ, eye and tissue donation and how to register to be a donor, visit donatelife.net. About UNOS The United Network for Organ Sharing (UNOS) is a nonprofit organization that serves the organ donation and transplant system and broader public health community through its work developing new technologies and initiatives, conducting data-driven research and analysis, providing expert consulting services, advocating for patients, and being a leader in bringing communities together to save lives. About Donate Life America Donate Life America (DLA) is a 501(c)3 nonprofit organization leading its national partners and Donate Life State Teams to increase the number of donated organs, eyes and tissues available to save and heal lives. DLA owns, manages and promotes Donate Life℠, the national logo and brand for the cause of donation; motivates the public to register as organ, eye and tissue donors; provides education about living donation; owns and manages the National Donate Life Registry at RegisterMe.org and develops and executes effective multi-media campaigns to promote donation. Contact Details United Network for Organ Sharing Anne Paschke anne.paschke@unos.org Donate Life America Hilary Kleine media@donatelife.net Company Website https://unos.org

December 09, 2024 09:40 AM Eastern Standard Time

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Supreme Court Of New York Awards RedHill Biopharma Approx. $8 Million Plus Costs In Breach Of Contract Lawsuit

Benzinga

By Meg Flippin, Benzinga RedHill Biopharma Ltd. (NASDAQ: RDHL), a specialty biopharmaceutical company, won a significant legal and financial victory, announcing a summary judgment in its favor and an award of about $8 million plus costs in its New York Supreme Court case against Kukbo Co. Ltd. o f South Korea. RedHill Biopharma sued Kukbo over a breach of contract related to opaganib, the company’s first-in-class orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anticancer, anti-inflammatory and antiviral activity, targeting multiple indications. Opaganib has several U.S. government and academic collaborations in place for development for radiation and chemical exposure indications such as Acute Radiation Syndrome (ARS), a phase 2/3 program for hospitalized COVID-19, and a phase 2 program in oncology. Breach Of Contract At The Heart Of Lawsuit The lawsuit stemmed from Kukbo’s failure to make agreed payments to RedHill pursuant to a subscription agreement signed on Oct. 25, 2021, and a subsequent exclusive license agreement inked on March 14, 2022. The two were working to develop opaganib for COVID. The Supreme Court of the State of New York ruled in favor of RedHill Biopharma and, in a summary judgment, ordered Kukbo to pay $8 million, consisting of $6.5 million plus interest amounting to approximately $1.5 million, plus costs. The court dismissed Kukbo’s counterclaims. Kukbo has a right to seek an appeal of the judgment, which may or may not be granted. RedHill intends to pursue its attorneys' fees and collection of the judgment. "RedHill thanks the Court for this crystal-clear judgment, affirming the company's just position from the beginning of the relationship and in making correct provision for full reparation for the contractual breaches,” said Dror Ben-Asher, RedHill’s CEO. Once collected, the summary judgment will give RedHill more cash to develop its pipeline and eliminates a potential overhang on the stock. TipRanks called the ruling a “significant financial victory,” one that highlights RedHill’s adherence to contractual agreements. TipRanks said the end to litigation could boost investor confidence in the company. The positive ruling comes as RedHill Biopharma is making progress in developing opaganib for infectious diseases such as Ebola. Recently, RedHill announced that the U.S. government’s Biomedical Advanced Research and Development Authority (BARDA), a center of the Department of Health and Human Services’ (HHS) Administration for Strategic Preparedness and Response (ASPR), had selected opaganib for development to treat exposure to Ebola virus disease (EBOV). Under the cost-sharing agreement with BARDA, BARDA will provide partial funding for RedHill to further advance opaganib to mitigate infections and contain EBOV outbreaks. In an in vivo EBOV study with the United States Army Medical Research Institute of Infectious Diseases, RedHill Biopharma said opaganib delivered a statistically significant increase in patient survival time when given at 150 mg/kg twice a day. RedHill Biopharma said it’s the first host-directed molecule to show activity in EBOV. Several other U.S. government countermeasures and pandemic preparedness programs have also selected opaganib for evaluation for multiple indications, reports the company. With litigation in the rearview mirror and RedHill Biopharma making progress in developing opaganib, interested investors may want to pay attention to what’s next from this specialty biopharmaceutical company. Featured photo by Scott Graham on Unsplash. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

December 09, 2024 08:00 AM Eastern Standard Time

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Driving Innovation In Diabetes Management: Glucotrack Begins Enrollment For Human Clinical Trials For Its Implantable Continuous Blood Glucose Monitor

Benzinga

By Joshua Enomoto, Benzinga In the rapidly evolving medical technology sector, diabetes management specialist Glucotrack Inc. (NASDAQ: GCTK) aims to disrupt the present care framework for the benefit of patients. Thanks to its Continuous Blood Glucose Monitor (CBGM), millions of people affected by the disease may be able to access reliable, non-intrusive glucose monitoring. Fundamentally, what distinguishes Glucotrack from its rivals is the combination of real-time accuracy without the delay associated with conventional continuous glucose monitoring systems. In addition, the medical tech specialist offers an implantable format, eliminating the hassles associated with external wearables. Even better, the system’s long sensor life facilitates convenience. To further validate the feasibility of Glucotrack’s product under real-world conditions – and help bring the CBGM system closer to regulatory approval and commercialization – the company has recently announced the commencement of patient enrollment for its short-term human clinical study. Clinical Study Shines Spotlight On Glucotrack’s CBGM Technology Scheduled to be conducted at the Heart Institute (InCor) of the Clinical Hospital of the University of São Paulo – one of the most renowned cardiology hospitals in Brazil and across Latin America – the feasibility study will focus on the capabilities of Glucotrack’s CBGM. A long-term implantable device, the CBGM features no on-body external component. Furthermore, the system is designed to provide three years of continuous, accurate blood glucose monitoring. However, the core attribute of the device is that it measures glucose levels directly from the blood as opposed to interstitial fluid, as is common among competing systems. Blood glucose measurement is the gold standard for glucose measurement. Thus, these capabilities could enable more convenient and less intrusive diabetes management. Principal Investigator Dr. Alexandre Abizaid, MD, PhD will spearhead the study. As the director of Interventional Cardiology at the Heart Institute in São Paulo, Brazil and a visiting professor of medicine at Columbia University Medical Center in New York City, Dr. Abizaid represents one of the leading experts in interventional cardiology. So, why is a diabetes study being performed by an interventional cardiologist? The CBGM is similar in size and form to implantable devices in the cardiovascular space. Thus, the placement procedure is recognizable and widely performed by interventional cardiologists as an outpatient procedure, under local anesthesia in a cardiac catheterization, or cath, lab. The placement procedure takes approximately 20 minutes and only requires a small, half inch incision. Not to mention, diabetes can, and often does, lead to heart disease; people with diabetes are two to four times more likely than others to develop cardiovascular disease. So, cardiologists are becoming more and more involved in patient care for people with diabetes. Notably, the five-day study will include patients suffering from both type 1 and type 2 diabetes. First, clinical researchers will apply the CBGM sensor intravascularly (inside the blood vessel) in the study participants. Second, Glucotrack says the participants will be monitored based on the following protocol: Observation: During this period, researchers will leverage the CBGM technology to monitor blood glucose levels in real time. This observation will provide data on how blood glucose levels fluctuate under various conditions. Glucose challenges: Participants will be given fixed meal challenges, during which their blood glucose levels will be monitored to assess how their glucose responds to different types of food. Comparative analysis: In addition to data collection, the study will focus on the accuracy and performance of the CBGM in measuring blood glucose levels compared to conventional glucose monitoring mechanisms. Advancing Positive Disruption In Diabetes Management With the announcement of the clinical study – with results expected to be available within six to eight weeks – Glucotrack has moved one step closer to positively disrupting the current paradigm in diabetes management. According to Grand View Research, the global diabetes devices market size is large, reaching a valuation of $30.31 billion last year. “Following the success of our preclinical program, we are pleased to reach this key milestone in the development of our novel CBGM,” said Paul V. Goode, PhD, president and CEO of Glucotrack. “We believe this groundbreaking early feasibility study will demonstrate the potential for our real-time continuous blood glucose monitor to offer a truly differentiated and less burdensome approach to glucose monitoring for people with diabetes.” Forging a path toward significantly reducing the friction and pain points of diabetes care epitomizes the essence of Glucotrack’s device. What separates the enterprise from the competition is the integration of glucose monitoring accuracy, speed and convenience — elements that are often found in disparate corporate silos, the company argues. For instance, Abbott Laboratories (NYSE: ABT) and Dexcom (NASDAQ: DXCM) both have a strong presence in the continuous glucose monitoring (CGM) market, but their systems require frequent sensor changes, usually every 10 to 15 days, depending on the system. Reports show that some of these adhesive patch systems also suffer from wearability challenges. In sharp contrast, Glucotrack says it addresses the shortcomings of conventional CGM devices while elevating the standard of care. Adding to the long list of advantages, the company’s CBGM system also requires minimal calibration. Revolutionizing Diabetes Care With Cutting-Edge Glucose Monitoring Glucotrack is striving to push boundaries in diabetes care with its approach to continuous blood glucose monitoring. With the launch of its clinical study and a focus on delivering real-time accuracy and convenience through its implantable device, the company hopes to address critical gaps in the current market. As Glucotrack advances toward regulatory approval, its technology holds the potential to redefine how diabetes is managed, hopefully offering patients a more seamless and less burdensome solution. Featured photo by Deon Collison on Unsplash This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

December 05, 2024 10:00 AM Eastern Standard Time

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