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Monogram Orthopedics (NASDAQ: MGRM) Lands Key Clinical Trial Partnership With India’s Leading Orthopedic Hospital Group To Advance Its Surgical Robot Tech

Benzinga

By Gerelyn Terzo, Benzinga The robotic orthopedics industry just took a step forward. Monogram Technologies (NASDAQ: MGRM), which is behind a futuristic surgical robot, has announced a strategic partnership with Shalby Limited (NSE: SHALBY), one of India’s leading orthopedic hospital groups. The venture adds to Monogram’s momentum as its latest technological breakthroughs proceed through the proper regulatory channels. As part of the collaboration, the companies will embark on a multicenter clinical trial campaign in which they demonstrate the safety and effectiveness of Monogram’s flagship mBȏs TKA System for robotic orthopedic surgery and implants. Monogram’s technology solution comprises over 750 precision parts, nearly two-dozen patent applications and 1.5 million-plus lines of code. Its robotics tech is deemed more advanced than that of legacy companies, and it is one of only a couple of autonomous players. Led by founder Vikram I. Shah, a world-renowned joint replacement surgeon, Shalby says it is the biggest orthopedic hospital chain on the planet. The company sits atop the rankings for arthroplasty based on volume, commanding 15% of India’s organized arthroplasty market share. With over a dozen hospitals sprinkled across 13 cities, Shalby seems uniquely positioned to capitalize on this market’s CAGR of about 20% amid India’s booming population of 1.4 billion people, the most populous nation in the world as of 2023, according to Pew Research. Monogram Technologies CEO Ben Sexson said of the collaboration, “With over 200,000 total knee arthroplasties (TKAs) annually, we believe India represents a massive market potential driven by a large population and demographic tailwinds. India is underpenetrated for robotics but is rapidly growing, and we believe the market potential is likely in the hundreds of systems.” Following the clinical trial, the partners will examine the post-trial transfer of Monogram’s robot to Shalby’s hospital system amid the potential for future collaborations. The trial will provide Monogram with access to Shalby’s network of seasoned knee replacement surgeons who are under the tutelage of Dr. Shah. Orthopedic Landscape Following a slowdown on the heels of the pandemic, orthopedic surgical volumes have been on the rise once again. In 2023, the global orthopedic surgery market expanded by 6.3% to $59 billion, outpacing its historical average. Research shows nearly 6 million lives are lost globally each year due to traumatic injuries, half of which could be preventable. However, legacy orthopedic surgery is in many ways inefficient and lacking in precision, with 88% of surgeries performed manually and most implants taking the form of one-size-fits-all, described as “one-size-fits-none” by some. While there are surgical robots in the industry, they are considered price-prohibitive and are quickly becoming obsolete. Monogram’s vision involves the use of one surgical robot to perform safe and quick orthopedic surgeries. When combined with best-fit implants, there is an expectation for better patient outcomes so desperately needed around the world. Through the partnership, Shalby will begin enrolling patients throughout India for surgeons to assess the success of Monogram’s mBȏs TKA System with the hospital group’s Consensus Knee System (CKS) implant, which is at a similar regulatory stage to Monogram’s mPress implants. On July 19th Monogram submitted it’s 510(k) application for mBôs TKA System Clearance. The application passed the Administrative Review and is under Substantive Review. According to MDUFA Performance Goals and Procedures, Fiscal Years 2023 through 2027, U.S. Food and Drug Administration, "For 510(k) submissions received in FY 2024, the average Total Time to Decision goal for FDA and industry is 124 calendar days.“ The company is pushing to conduct its first live inpatient OUS surgeries with Shalby pending regulatory approvals. Alignment Of Interests Shalby has seen continued growth, including a 20% 15-year CAGR in volume, with a footprint that covers eight countries and aggressive multi-continent international expansion plans. The company made its debut in the U.S. market several years ago when it acquired Sacramento, California-based Consensus Orthopedics. Shalby has set its sights on further expanding its footprint globally within the coming decade. “We believe many markets around the globe are completely underserved. We recognize the importance of advanced technologies to realize this ambitious goal,” stated Dr. Shah. Monogram’s Sexson shared how his company and Shalby are aligned in areas such as the caliber of surgeons and standard of care, while they are inspired by Shalby’s ambitious growth plans, including in the United States. Monogram intends to validate the value proposition of its mBȏs TKA System with real-world data, enabled by its recent regulatory submission coupled with a green light from its FDA Administrative Review, which Sexson describes as a “catalyst for strategic synergies” among the new partners. Investors who are interested in becoming a part of Monogram’s groundbreaking surgical robot technology as the company gears up to expand its reach globally can learn more about investment opportunities here. Read More About the Latest Developments At Monogram Orthopedics: Monogram Orthopedics (NASDAQ: MGRM) Aims To Overcome Robot Shortcomings With Its Advanced Solution Technology Is Enabling Remote Work In More And More Fields – Could Surgery Be Next? Surgical Robot Maker Monogram Orthopedics (NASDAQ: MGRM) Believes So AI In Orthopedic Surgery: How Leveraging AI Could Improve Surgical Outcomes Featured photo by GrumpyBeere 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

August 28, 2024 08:50 AM Eastern Daylight Time

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InMed Demonstrates Encouraging Data For Its Cannabinoid INM-089 In Treating Dry AMD, An Ocular Disease With Rising Patient Numbers As National Population Ages

Benzinga

By Meg Flippin, Benzinga When it comes to diseases of the eyes, age-related macular degeneration or AMD is a big one, afflicting 19.8 million people or 12.6% of Americans aged 40 and older. In adults 50+ it is the most common cause of severe loss of eyesight. People suffering from AMD, which affects central vision, lose the ability to see fine details. As the disease progresses, sufferers may not be able to see faces, read small print and even drive. What makes this incurable disease even worse is that in the early stages, there can often be no initial signs or symptoms. Left unchecked, patients may lose central field vision in the affected eye within 24 months of disease onset. While treatments are available, most focus on controlling the symptoms rather than addressing the underlying causes. Moreover, the treatments often rely on patients making changes to their lifestyles such as eating healthy and quitting smoking, which isn’t always easy to do. Cannabinoids May Be Part Of The Answer InMed Pharmaceuticals Inc. (NASDAQ: INM), a leader in cannabinoids and cannabinoid analogs pharmaceutical research, development, manufacturing and commercialization, may have a solution with INM-089, the company’s ocular program for AMD, which it launched in November. With scientific research continually pointing to the neuroprotective effects of cannabinoids, InMed set out to develop a cannabinoid analog that could treat ocular diseases such as AMD. For those with AMD, neuroprotection is essential to preserve the nerve cells in the eyes and potentially slow or reverse eye damage, which InMed says it is in the process of proving INM-089 can do. Studies of InMed’s INM-089 cannabinoid analog, which is a small molecule compound, demonstrated its ability to proactively protect the nerve cells in the back of the eye in the retinal area, exhibiting its therapeutic potential for AMD. Small molecules can cross the blood-brain barrier and are typically better suited for multiple drug delivery options because they can be efficiently absorbed, making INM-089 a promising drug candidate for pharmaceutical use, reports InMed. Studies Demonstrate INM-089’s Benefits The company has data to back up its assessment. Results from several in vitro and in vivo studies showed INM-089 provides neuroprotection of photoreceptors and improves photoreceptor function, enhances the integrity of the retinal pigment epithelium (RPE), preserves retinal function in the back of the eye and improves the thickness of the outer nuclear layer of the retina where photoreceptors are located. Neuroprotection in AMD remains an unmet medical need and a new treatment option addressing neuroprotection may help to eliminate or reduce the effects of the condition, InMed says. More recently, InMed found in a proof of concept study that INM-089 may be more effective in treating dry AMD than wet AMD and may be an “important” candidate for Geographic Atrophy (GA) which is common in more advanced cases of dry AMD, affecting the center of the macula. In vivo preclinical studies in AMD disease models demonstrated all of the previous benefits, as well as a reduction in extracellular autofluorescent deposits, a hallmark of dry AMD, the company reports. The latter wasn’t demonstrated in previous trials, leading InMed to believe INM-089 is ideally suited for dry AMD. Dry AMD Needs Immediate Attention Among forms of AMD, dry AMD is the most common, accounting for 85% to 90% of all cases. In 2023, the U.S. had the highest prevalence of dry AMD. With dry AMD, waste proteins and lipids begin to accumulate due to poor circulation and poor waste flushing in the eye. The advanced stage of dry AMD is referred to as Geographic Atrophy, with approximately five million patients globally suffering from it. The prevalence of GA is projected to continue to rise in the coming years, with an estimated 18.5 million cases globally by 2040 as the population ages. “We are very excited with the data from recent preclinical studies demonstrating both significant functional and pathological improvements from INM-089 in the AMD model,” Dr. Eric Hsu, SVP of preclinical research and development at InMed said. “While a few treatment options are currently available, their efficacy is limited and may be associated with several undesirable side effects. We see an opportunity for INM-089 to slow the progression and to fill a significant gap in the treatment of this chronic disease.” Taking It To The Next Level Given all the positive results of its studies, InMed said it recently engaged a Contract Development and Manufacturing Organization (CDMO) to assist in scale-up manufacturing process development of the active pharmaceutical ingredient. Meanwhile, the company is internally developing drug product formulation to support the next stages of development activities. What’s more, additional preclinical activities are ongoing to further understand the mechanism of action including receptor interactions and drug metabolism and pharmacokinetics studies, InMed said. All of these are being conducted with the goal of eventual commercialization of INM-089. The global population is aging, which means cases of AMD are poised to increase. That’s bad news given there is no cure, and the effects of this disease can be debilitating and life-altering. InMed doesn’t want that to be the case, and is betting its cannabinoid can play an important role in finding better treatments for AMD. With positive results from several studies under its belt, InMed is one step closer to bringing INM-089 to the millions of older adults who suffer from this disease. Featured photo by Jeremy Wong 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

August 28, 2024 08:40 AM Eastern Daylight Time

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Loserball.com announces Launch of Unique Fantasy Football Game for Casual Fans

Loserball

Loserball.com, a new fantasy football game that has taken an opposite approach by allowing users to win based on losing, launched its brand-new app through the Apple Store, Google Play, and on the web debuting a unique and fun way to enjoy professional football games. Understanding the power of strategic partnerships, Loserball.com immediately tapped industry-leading production house, Better Sports Network, to create content and promote through their iconic brand FantasyAlarm.com. Loserball threads the needle between casual fans and dedicated fantasy players by simplifying the game to selecting just three (3) NFL teams each week. Using sixteen (16) categories of futility, from fumbles to incomplete passes, Loserball.com makes every play worth watching. Ultimately, this contrarian approach to fantasy football will create a true paradigm shift in how people watch and enjoy NFL games beginning this season. Better Sports Network brings a powerhouse of resources and talent to cover the game from this opposite angle. With drive time radio on SiriusXM, over 450 content creators and a production staff that delivers written, audio, video and live-streaming content for hundreds of thousands of fantasy football players, BSN is ready to deliver content following this unique concept. "Fantasy Alarm is the ultimate destination for all things fantasy, including Loserball’s wacky, yet innovative approach to the game. We couldn’t sit on the sidelines,” said Matt Deutsch, Co-Founder of Bettor Sports Network. "We're hooked on their vision of fumbles over field goals and penalties over points and look forward to entertaining NFL fans with this totally new approach to the sport we love." "We are proud to deliver this unusual game concept so fantasy football players can now truly enjoy every play - whether it is a touchdown or a fumble," said Jonathan Gruber, Founding Loser. “Attaching ourselves to the leading private brand in the fantasy content space made sense and with the parent company’s production capabilities, we can entertain and inform all season long.” With this partnership, Loserball.com and Bettor Sports Network are set to popularize this new concept together, and equally as important, entertain NFL fans in a unique way. As the excitement starts to build for a season of gaffes, goofs, and gridiron guffaws, Loserball will be there to start a new mantra, "May the Worst Team Win!" To sign up and start playing today, visit app.loserball.com/signup. To learn more about Bettor Sports Productions, visit BettorSportsProductions.com. To dominate your fantasy leagues and daily fantasy sports play, visit FantasyAlarm.com. About Loserball.com Loserball began with humble roots, with Gruber rooting for teams to lose for decades. In June of 2023, Loserball won the Fantasy Sports and Gaming Association's Elevator Pitch Award, and has since garnered top fantasy advisors such as Fantasy Hall of Famer Rick Wolf and Hot Paper Lantern's Ed Moed to join the fun. This year will have free-to-play games for anyone that wants to create or join a league, in addition to select prizes. In 2025, Loserball will add DFS-style player games for the NFL season. About FantasyAlarm.com FantasyAlarm.com, a wholly owned subsidiary of Bettor Sports, LLC, is the premier one-stop-shop for both seasonal and daily fantasy sports players. Fantasy Alarm features best-in-class content, personalization, and interactivity. Our commitment to quality has won us many industry awards, including Best Mobile App, Best Daily Fantasy Sports Tool & Content, Most Innovative Fantasy Product, and Best Radio Show. Fantasy Alarm has partnerships with SiriusXM, Sporting News, The New York Post, and many others in sports, solidifying its leadership position in the $7B fantasy sports industry. In addition to FantasyAlarm.com, we also own Wager Alarm, a full-featured website for sports bettors, and FantasyRundown.com, the largest content aggregator in the fantasy sports space. Both properties share the same dedication to quality and top-notch service that makes Fantasy Alarm a leader in the fantasy sports industry. Bettor Sports Productions is a leader in creating and distributing high-quality sports content, specializing in video production, social media management, and live event streaming. Our production arm provides best-in-class production and marketing services to some of the largest brands in sports entertainment, including FFPC, Warren Sharp Sports, MGM, Underdog Fantasy, and many more. We are dedicated to enhancing brand engagement and expanding audience reach for top sports entertainment companies. Contact Details Jonathan Gruber +1 415-902-9336 jonathan@loserball.com Company Website http://Loserball.com

August 28, 2024 08:03 AM Eastern Daylight Time

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Australia’s Beauty Innovators Shine at Cosmoprof North America 2024: Melbourne Debuts with Trailblazing Pavilion

Global Victoria

The inaugural Melbourne Australia Beauty Pavilion made a powerful debut at Cosmoprof North America 2024, held from July 21-24 at the Mandalay Bay Convention Center. Showcasing six trendsetting Australian companies, the pavilion underscored Australia’s commitment to innovation, sustainability, and global beauty standards. Victoria is home to many of the best-known brand names with more than one third of all Australian beauty and makeup exports originating from this dynamic region. Global Victoria, is the driving force behind this initiative, having boosted the position of countless Australian companies in key markets around the world. “Victorian brands are strategically aligned with the growing demand from North American consumers. Our brands prioritize organic, natural, and ethically produced beauty products. They focus on ingredient transparency and sustainability, values that resonate strongly and meet consumer expectations”, said Mildred Ruiz, US Trade Manager for Consumer Goods in Global Victoria’s New York office. “Our hands-on approach enables us to connect our brands with every distribution channel. We support the participation of our brands in events like Cosmoprof.” Global Victoria's strategy is to identify partners and opportunities that connect Australian companies with relevant buyers, ensuring that Australia's innovative products reach global consumers. With a footprint of 23 offices around the world, Global Victoria is well placed to support Victorian brands grow their international presence. Featured in the pavilion were Muk Professional Haircare, Australian Glow, Booby Tape, BYS Cosmetics, Botany Essentials, and Etoile Collective—companies selected for their market-ready capabilities and proven success in scaling international distribution. These brands represent the forefront of Australia’s beauty industry, with products emphasizing clean beauty, the use of indigenous plants, and a deep commitment to sustainability. “Buyers from leading retailers such as Target, Urban Outfitters, CO Bigelow, Shoppers Drug Mart, Well.ca, and Salon Centric were notably impressed by the unique offerings from our pavilion,” said Elizabeth Moffat, Trade Manager Consumer Goods at Global Victoria. The enthusiastic reception at Cosmoprof North America is a testament to the global appeal of Australian beauty innovation, and we anticipate seeing these products on retail shelves across the U.S. very soon.” The Melbourne Australia Beauty Pavilion was expertly hosted and managed by Access Beauty Insiders, a leading boutique agency for marketing and events with a focus on elevating beauty brands in international markets. As Australia’s beauty industry continues to make waves globally, the success of the Melbourne Australia Beauty Pavilion at Cosmoprof North America 2024 marks a significant milestone. This debut has not only showcased the country’s innovative spirit but also paved the way for Australian beauty products to reach a broader audience of consumers eager for high-quality, sustainable beauty solutions. --- For more information about Melbourne Australia Beauty, contact Mildred Ruiz Leal at mildred.ruizleal@global.vic.gov.au. --- About Global Victoria, Australia: Global Victoria empowers Australian beauty businesses to transform global aspirations into reality. As the trade facilitation agency of the State Government of Victoria, they open doors to international markets, providing the expertise and resources necessary for Australian brands to thrive worldwide. [Learn more about Global Victoria by clicking here ] About Access Beauty Insiders: Founded by Daniela Ciocan, an award-winning beauty and exhibition marketing executive and leading voice in the cosmetics industry, Access Beauty Insiders offers strategic marketing services that amplify brand presence and foster market expansion. [Discover Access Beauty Insiders ] Contact Details Mildred Ruiz Leal mildred.ruizleal@global.vic.gov.au

August 28, 2024 08:00 AM Eastern Daylight Time

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Enchampion Unveils Advanced Sodium-Ion Battery Solution for Satellite Applications

Rev Up Marketers

Enchampion, a technology company that specializes in high-power battery solutions, has announced the launch of its groundbreaking sodium-ion battery solution designed specifically for satellite applications. The newly launched battery pack is hermetically sealed, ensuring that it remains unaffected by the harsh conditions of space. It features an integrated Circuit Interrupt Device (CID) and burst disk, providing an additional layer of safety by preventing overpressure situations. The built-in heater ensures optimal performance even in low-temperature environments, while the cell balancing module maximizes the efficiency and lifespan of the battery. This recent development and innovation by Enchampion address the growing demand for efficient, sustainable, and cost-effective power solutions in space exploration, marking a significant leap forward in energy storage technology. Enchampion's sodium-ion battery solution has undergone a rigorous testing process to ensure its performance in space. The testing regimen included vibration tests, thermal vacuum tests, radiation tests, and cycle life tests. These tests are critical in simulating the conditions that the battery will face in space and ensuring that it can withstand these challenges. Moreover, Enchampion's sodium-ion batteries offer several special advantages when compared to other battery technologies. Sodium-ion batteries are less prone to thermal runaway, a condition that can lead to overheating and potential failure in lithium-ion batteries. Enchampion's sodium-ion battery has completed 50,000 cycles at a 30% Depth of Discharge (DOD) during rigorous testing. This makes sodium-ion batteries a safer alternative for space applications. Additionally, Enchampion’s sodium-ion battery's cost-effectiveness and abundance of sodium resources make them a sustainable option. These batteries are designed to deliver high performance in extreme conditions. Enchampion offers a range of high-performance battery solutions for space and aviation applications. These include lithium-sulfur batteries, solid-state batteries, and advanced lithium-ion batteries, all designed to meet the specific needs of various industries. Enchampion also provides cost-effective space solar panels and Photovoltaic Array (PVA) solutions, alongside a comprehensive range of products for aviation applications. These include solutions for commercial aircraft, helicopters, electric Vertical Take-Off and Landing (eVTOL) vehicles, and High-Altitude Pseudo-Satellites (HAPS). For more information about Enchampion and its offerings, please visit their website. About Enchampion: Founded in 2022, Enchampion specializes in high-power battery solutions, particularly for aviation applications. The company offers advanced lithium-ion and sodium-ion batteries designed for sustainability, high power, and safety, with features like long lifespans and wide temperature tolerance. Its products are aimed at the market needs of high power and energy, like aviation, racing cars, sea transportation, or other special industrial occasions. It also proactively collaborates with upstream research partners to explore the scientific boundary capabilities. Contact Details Enchampion Technology Co. Ltd Mike ZHAO enchampion@outlook.com Company Website https://www.enchampion.com/

August 28, 2024 07:26 AM Eastern Daylight Time

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45% of Canadians confess that rising prices impact their day-to-day lives

Money Canada

by Nicholas Sokic According to Statistics Canada data, 45% of Canadians reported that rising prices were greatly affecting their ability to meet day-to-day expenses in the first few months of 2024. Turns out the percentage of Canadians feeling the pinch rose in the last few years, from 33% of Canadians feeling the pinch in 2022 to 45% in 2024. “This extended period of financial strain can also negatively impact mental health," explain the report authors. For instance, when asked about financial-related stress in spring 2024, more than a third (35%) of Canadians described most days as "quite a bit" or "extremely stressful due to financial issues." Age cohort most impacted by rising prices? Canada’s rising prices did not affect all age cohorts equally. Nearly 6 in 10 of those in the lowest income quintile and about half of those in the second and third income quintiles report that rising prices greatly affected their ability to meet day-to-day expenses. When compared to those in the highest income quintile, only 27% reported experiencing financial stress. Stress of paying bills has mental health impact While paying bills was impacted, so was mental health. Almost half those in the lowest income quintile reported that on most days there were a bit or very stressed due to financial concerns. Compare this to only 25% of people in the highest income quintile who report stress over paying bills. Age isn't the only factor Other groups facing tougher financial situations include include younger people, households with children and disabled family members. More than half (55%) of Canadians between the ages of 25 to 44 reported that rising prices were greatly affecting their ability to meet day-to-day expenses. By comparison, only 28% of seniors reported having this difficulty. The figures were similar for individuals with a disability, with 57% reporting that rising prices were greatly affecting their ability to meet day-to-day expenses, compared with 43% otherwise. Financial difficulties and lower quality of life When you’re not worrying about the next bill or where your paycheck is going to come from, it makes perfect sense that you’d be more hopeful for the future. Of those who didn’t report having daily financial stress, 73% had a hopeful view of the future compared with 35% of those who found most days quite a bit or extremely stressful due to financial concerns. To put a fine point on the impact of finances on mental health, only 17% of Canadians who describe most days as stressful due to financial issues report a high satisfaction in life; compare this to 70% of Canadians who report that on most days they are not stressed about finances. Younger generation is most pessimistic about becoming a homeowner The biggest concern for many Canadians is the ongoing housing crisis. About 38% of Canadians report being "very concerned" with their ability to afford housing or rent because of rising home prices, compared with only 30% in the spring of 2022. Over half (56%) of those aged 15 to 34 reported being very concerned about housing affordability due to rising housing prices. Concern with housing affordability decreased with age, with only 19% of Canadians aged 65 years and older having the same concern. How to meet basic needs Despite the increase in the number of Canadians feeling the stress of increased costs, the decision to rely on external help hasn't changed much. When asked whether or not the rise in living costs would prompt a reliance on community organizations for food or meals, almost 1 in 4 Canadians (23%) confessed that this would be their go-to solution throughout 2024. Of these, 8% said is was a "very" likely option while 15% said it was somewhat likely. In 2022, only 1 in 5 Canadians (20%) reported relying on food banks and community groups for food and meals. Survey methodology The data was part of the Statistics Canada recent Canadian Social Survey with respondent input collected between April 19 to June 3, 2024. — with files from Romana King Contact Details Aaron Young +1 310-500-8744 aaron.young@wisepublishing.com Company Website https://money.ca/

August 28, 2024 07:00 AM Eastern Daylight Time

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PathAI's AISight Dx Image Management System is CE Marked for Primary Diagnosis

PathAI

PathAI, a global leader in artificial intelligence (AI) and digital pathology solutions, today announced that its AISight Ⓡ Dx Image Management System (IMS) is In Vitro Diagnostic Regulation (IVDR) certified for use in primary diagnosis. The CE mark paves the way for the company's expansion in the European diagnostic pathology market, enhancing pathologists' interpretations and driving efficiencies and quality improvements within anatomic pathology laboratories. "The IVDR certification demonstrates PathAI’s unwavering commitment to providing safe, effective, and high-quality diagnostic solutions," said Andy Beck, MD, PhD, co-founder and CEO of PathAI. "It not only confirms the compliance of our AISight platform with the latest European regulations but also strengthens our ability to assist pathologists in delivering accurate diagnoses and improving patient outcomes across Europe." AISight Dx is a robust digital pathology platform meticulously designed with input from over 200 pathologists to streamline end-to-end digital pathology workflows. It offers a suite of features including best-in-class caseload balancing and assignment, image ingestion, image viewing, collaboration tools, and image and case management. The platform can also seamlessly integrate bi-directionally with laboratory information systems through AISight Link, further enhancing workflow efficiency. Anatomic pathology laboratories of all sizes and specialties – including health systems, university hospitals, and reference laboratories – can leverage the benefits of AISight. "We are thrilled to expand our focus to bring the AISight Dx Image Management System to European labs. We look forward to partnering with European labs to democratize access to digital pathology, enhance the pathologist experience, and ultimately improve patient outcomes," said Nick Brown, Chief Growth Officer at PathAI. PathAI will be exhibiting at the European Congress of Pathology from September 7 to 11, 2024. To learn more about AISight and see a demo, visit us at booth #L145 or email digitaldx@pathai.com. 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 Maggie Naples +1 401-490-9700 pathai@svmpr.com Company Website https://www.pathai.com/

August 28, 2024 03:00 AM Eastern Daylight Time

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AGC Biologics Strengthens Portfolio with Latest FDA Commercial Approval at Copenhagen Facility

AGC Biologics

AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), today announced the newest milestone at its Copenhagen Campus, a U.S. Food and Drug Administration (FDA) commercial approval for a biosimilar indicated for psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis. This is the latest commercial biosimilar approval for the global CDMO, and a new milestone for its Copenhagen site. The expiration of patents for biologics products is driving new players to enter the biosimilar market and offer lower-cost alternatives for patients. Market value for this drug segment is expected to be more than $126 billion by 2032, a 17.6 percent CAGR between 2023 and 2032, according to a 2023 report. AGC Biologics offers key resources for biosimilar developers, such as flexible and scalable single-use manufacturing technology, the ability to scale production based on market demand, and strong expertise in managing quality control requirements needed to advance in each clinical phase. All these characteristics led to AGC Biologics’ Copenhagen site guiding this new product to FDA commercial approval. “We have one of the most extensive single-use technology bioreactor networks in the world. This allows us to start with the 2,000 L scale for product launch and scale out and utilize added vessels to reach larger batch sizes of 4,000 L, 6,000 L, 8,000 L etc. based on product demand in later phases. Through this economies-of-scale production model, we increase production for biosimilars as demand grows, while saving costs for our partners,” said Christoph Winterhalter, Chief Business Officer, AGC Biologics. “When you combine this element with our scientific quality expertise that emphasizes finding the Quality Target Product Profile (QTPP) – we are one of the best CDMOs available to help biosimilar developers meet clinical and commercial goals.” “This latest FDA achievement at our site demonstrates why we have been so successful,” notes Andrea Porchia, General Manager, AGC Biologics Copenhagen. “I continue to be impressed by this site and our team’s commitment to quality, productivity, and helping partners achieve their goals. We look forward to helping to produce this important treatment and providing patients in need with a new option to choose from other than what has been historically available.” The new commercial approval in the U.S. for this product comes after the AGC Biologics Copenhagen site announced the completion and opening of a new manufacturing building at its site in June, which more than doubled its single-use bioreactor capacity. The new 19,000 m2 ultramodern building offers a larger manufacturing floor, expanded quality control and process development lab space, and added utilities to support all operations at the site. AGC Biologics’ Copenhagen site core teams of scientists have more than 25 years of expertise in biopharmaceutical development and manufacturing, including seven commercial products brought to market. The site offers pre-clinical through commercial production for protein biologics services using mammalian and microbial systems and has a gold EcoVadis Sustainability Rating for its environmental, health, and sustainability practices. To learn more about AGC Biologics’ protein biologics manufacturing site in Copenhagen, visit https://www.agcbio.com/facilities/copenhagen. For more information on the company’s end-to-end global CDMO services in Europe, Japan, and the U.S. 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 Nick McDonald +1 425-419-3555 nmcdonald@agcbio.com Company Website https://www.agcbio.com/

August 28, 2024 12:05 AM Mountain Daylight Time

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Goodway Group Welcomes Rick Watrall as New Chief Data and Analytics Officer

Goodway Group

Goodway Group, a leading independent digital marketing agency, today announces the appointment of Rick Watrall to the new position of Chief Data and Analytics Officer. In this new role, Watrall will focus on evolving technical, data, and analytics priorities, and driving more value to clients through Goodway’s proprietary tech stack, GOES (Goodway’s Outcome Engineering System.) He will also guide critical decisions around investments in artificial intelligence to deliver faster, cheaper, and better solutions to marketers. This strategic hire is the latest indication of Goodway Group’s commitment to continued growth while delivering innovative solutions to its clients. With a deep understanding of modern marketers' needs, Watrall will be an invaluable addition as Goodway Group continues to innovate and lead in the industry. His arrival is perfectly timed, aligning with Goodway Group’s advancements in its award-winning GOES technology. GOES is a tech and data-enabled marketing system that powers Outcome Engineering—a proprietary philosophy that integrates strategy, analytics, and precise execution to drive measurable growth. Reporting directly to CEO Jay Friedman, Watrall’s leadership will further enhance Goodway Group’s ability to meet and exceed client expectations. Watrall joins Goodway Group from Horizon Media, where his strategic leadership and expertise over the past nine years helped shape the agency. During his tenure, he led a talented team of analysts, data scientists, and statisticians, contributing to the agency’s strategic planning and driving successful outcomes for major clients such as Capital One, Hershey, Revlon, Kohl’s, Mayo Clinic, Paramount and the NFL. Prior to Horizon Media, Watrall served as a senior partner at Hudson River Group where he specialized in marketing analysis, strategic and tactical marketing software, and ROI optimization. "We are thrilled to welcome Rick to the Goodway Group team," said Jay Friedman, CEO of Goodway Group. "His leadership, expertise, and passion will be instrumental in driving our data and analytics capabilities to new heights, ensuring we continue to deliver exceptional value to our clients." About Goodway Group Goodway Group is a leading independent digital marketing agency fueled by data, technology and a dedicated purpose of making your media investment perform. Goodway Group’s Outcome Engineering™ powers our full ecosystem, a proprietary philosophy that connects strategy, analytics and precise execution for measurable growth. Goodway Group ranks among the top North American agencies, earning prestigious awards for innovative marketing technology, impactful work and fostering inclusive, remote-first workplaces. We've been honored as a multiyear Ad Age Best Places to Work and received AdExchanger’s Best Use of Technology by an Agency award among other accolades. Our collective media buying power has led to industry-renowned partnerships. We hold certifications and are recognized with preferred partner status across the Triopoly and all major marketing and media platforms. This ensures that our clients' media investments are optimally managed, minimizing fraud and waste, and maximizing effectiveness and value. Our company encompasses five distinct divisions: CvE, a marketing advisory firm; G-Comm, a retail media accelerator; TUFF, a performance marketing agency; Goodway, a managed service media and analytics partner; and GRADIANT, a modern funnel digital media agency. Together, we make up Goodway Group, the marketing engine that unlocks measurable growth for the world's most progressive brands. Contact Details Kite Hill PR for Goodway Group +1 973-722-7881 goodway@kitehillpr.com Company Website https://www.goodwaygroup.com/

August 27, 2024 01:10 PM Eastern Daylight Time

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