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Brightberry Adds Lids to their Line of Non-Toxic Bowls for Infants

Rev Up Marketers

Brightberry, a trusted name in children's silicone tableware, is excited to unveil the latest update to its product line: spill-prevention lids to fit their non-toxic bowls designed specifically for infants. This new collection reflects Brightberry's ongoing commitment to providing safe, high-quality products for young children and their families. The newly launched bowls are made from non-toxic silicone and certified Foods, Consumer Goods and Feedstuffs Code (LFGB), the highest standard. LFGB is generally viewed as the European FDA, though they’re far stricter on certifications – LFGB is required for companies operating in France and Germany. These LFGB non-toxic bowls and lids contain no BPA, PVC, lead, phthalates, or any other toxins. Brightberry’s products are crafted from premium, food-grade silicone, free from harmful chemicals such as BPA, phthalates, and PVC. With growing concerns over the safety of children's products, Brightberry has taken a proactive approach to ensure their products exceed safety standards, offering peace of mind to parents everywhere. These bowls feature a unique suction base that securely adheres to most surfaces, significantly reducing the likelihood of spills and accidents during mealtime. The bowls are designed with practicality in mind; they are dishwasher-safe for easy cleaning and microwave-safe for convenient reheating. Available in a range of vibrant colors, the bowls add a fun element to feeding time while supporting developmental milestones such as self-feeding. "We understand the importance of providing products that are both safe and functional," says the team at Brightberry. "Our new line of non-toxic bowls not only meets the highest safety standards but also incorporates thoughtful design elements that make feeding easier and more enjoyable for both parents and children." This product launch represents Brightberry's dedication to innovation and customer satisfaction. The company regularly updates its product lines based on customer feedback and emerging market trends. By combining safety, durability, and aesthetic appeal, Brightberry continues to set the standard for excellence in children's tableware. Brightberry's new line of non-toxic bowls for infants is now available for purchase through their website and at select retail partners. The company invites parents and caregivers to explore this latest offering and experience the difference that quality design and materials can make. For more information, visit Brightberry's Website or contact their customer service team. About Brightberry Brightberry specializes in designing and producing high-quality silicone tableware for babies and toddlers. The company is committed to making mealtime safer and more enjoyable for families, focusing on innovation, safety, and customer satisfaction. Contact Details Brightberry Mateya Lotric contact@brightberry.com.au Company Website https://brightberry.com.au/

August 30, 2024 08:29 AM Eastern Daylight Time

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Syntekabio Introduces Develop Now, Pay Later with AI-powered STB LaunchPad Program

Syntekabio, Inc.

Syntekabio (KOSDAQ: 226330), an artificial intelligence (AI) based drug development company, today announced its innovative new offer designed to minimize risk, save time and costs, and increase the success rate of companies developing novel therapies. The new ‘Develop Now, Pay Later’ offer is Syntekabio’s latest initiative to invest in the success of its clients. This model enables pharmaceutical and biotechnology companies to test the validity of a target protein of interest without incurring any upfront costs. Should a project demonstrate viability, Syntekabio then employs its STB LaunchPad program, powered by its proprietary AI-driven DeepMatcher ® technology platform, to deliver hits and optimized leads as well as IND-enabled candidates. Jongsun Jung, PhD, CEO of Syntekabio, remarked, “We want our clients to achieve their goal of bringing safer and more effective therapies to patients. Thus, our mission at Syntekabio is to deliver to our clients first-in-class or best-in-class compounds, fast. We strongly believe in the capability of our technology and so, to further invest in our clients’ success, we have introduced our Develop Now, Pay Later model to support groundbreaking drug development work and reduce the risk for our clients at the outset.” Syntekabio is dedicated to making drug discovery as optimized and as low risk as possible. Clients can first take advantage of a complimentary feasibility study to determine if their project is viable. The next step is to submit any target protein for analysis via the STB LaunchPad program. There are no upfront fees. The client only pays for the work once the agreed upon validated results are obtained. Syntekabio’s AI accesses over 10 billion known compounds as well as 1,400 in vitro/in vivo compatible drug targets covering over 70% of human diseases. This technology is powered by Syntekabio’s AI Bio-Supercom Center, which houses an immense infrastructure of 5,000 servers, 40,000 CPU cores, and 2,500 GPUs fueling the Company’s algorithms. The Company has a comprehensive suite of advanced proprietary tools designed to accelerate the drug discovery and development process. For more information about Syntekabio, STB LaunchPad and Develop Now, Pay Later, please click here. About Syntekabio Syntekabio Co., Ltd. (KOSDAQ: 226330) is a drug discovery company bringing together biology and AI/ML since 2009 and facilitating the discovery of first-in-class and best-in-class compounds, rapidly. The Company has its own supercomputer cloud, along with a global contract research organization network to complement and validate its computational results. Syntekabio offers clients a one-stop shop, with technologies and tailored services to rapidly generate and optimize drug candidates from target to IND-enabling. Syntekabio’s disease-agnostic physics-based platform generates a continual stream of hits, leads, and drug candidates that are readily available for purchase. The Company also undertakes client-specific projects to identify highly promising development candidates for specific targets and indications. Visit the Syntekabio website at www.syntekabio.com or follow the Company on LinkedIn for the latest updates. Contact Details MC Services AG - Media inquiries (US) Laurie Doyle +1 339-832-0752 syntekabio@mc-services.eu Company Website http://www.syntekabio.com/

August 29, 2024 10:15 AM Eastern Daylight Time

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Palatin Technologies: Utilizing The Melanocortin System As The Basis For Innovation In Drug Development – Targeting Inflammatory & Autoimmune Conditions, Obesity And Sexual Dysfunctions

Benzinga

By Kyle Anthony, Benzinga Palatin Technologies (AMEX: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, received the first FDA approval for a melanocortin agent, for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women, with its product, Vyleesi ® (bremelanotide injection) – and it has big plans for the treatment of erectile dysfunction (ED) in patients that do not respond to PDE5i (viagra ®, cialis ® ) monotherapy The melanocortin system is a group of hormones, receptors and other molecules in the body that regulate various physiological processes, including skin pigmentation, appetite, energy balance and inflammation. For Palatin Technologies, the melanocortin system has been a source of innovation. The firm leverages its knowledge of the melanocortin system to design therapeutics that directly engage one of the body’s natural pathways to resolve harmful inflammation, providing a novel approach that allows affected tissue time to heal. The Mission Of Palatin Technologies Founded in 1986 by Dr. Carl Spana and other scientists with the initial aim of developing proprietary technologies and drug candidates for large markets with unmet needs, including cardiovascular disease and cancer, the firm has undergone a series of changes over the years. In the early 2000s, Palatin began focusing on the melanocortin system, particularly developing drugs that target melanocortin receptors. The company’s mission is to leverage its unique insight and expertise in the industry and the melanocortin system to develop groundbreaking therapeutics for inflammatory and autoimmune diseases, focusing on ocular conditions, plus obesity and sexual dysfunctions. Maximizing The Capabilities Of The Melanocortin System The melanocortin system is mediated by a family of five related receptors that are essential to the body’s control of inflammation, immune response, metabolism, steroid hormone production and sexual function. As mentioned previously, Palatin Technologies’ current focus is on the design and development of receptor-selective melanocortin agonists for inflammation and autoimmune conditions, with an emphasis on ocular diseases, plus obesity and sexual dysfunctions. Palatin Technologies’ therapeutics work by activating endogenous melanocortin pathways to resolve damaging inflammation and allow affected tissues time to heal. Research has shown melanocortin agonists can prevent and reverse intestinal and ocular inflammation in animal models. Current ocular drugs can be limited by drawbacks such as inadequate efficacy, high discontinuation rates and delayed onset of action. These challenges result in a less-than-ideal treatment experience, causing frustration and driving the need for more effective solutions. Melanocortin receptors, which are found on the surface of various cells in the eye and within immune cells in ocular tissue, represent a promising target for melanocortin agonists to offer relief and healing for individuals suffering from ocular diseases. For inflammation and autoimmune diseases, current treatments – including steroids, immune modulators and biologics – largely work by broadly suppressing the immune response. However, these methods can weaken the body's overall immune function, leading to unwanted side effects and raising safety concerns. Melanocortin agonists offer the potential to resolve inflammation without these adverse effects and safety issues associated with immunosuppressants. Palatin Technologies: Success And Product Pipeline Though Vyleesi was Palatin Technologies' first commercial product, the company recently announced several program advancements: Patient dosing has started for the clinical study entitled: BMT-801: A Phase II, Randomized, Double-Blind, Placebo-Controlled, Clinical Study Investigating the Safety, Tolerability, and Effectiveness of the Co-Administration of Bremelanotide with Tirzepatide (GLP-1/GIP) for the Treatment of Obesity Topline Results Expected Q1 Calendar Year 2025 FDA Confirms Acceptability of Palatin’s Remaining Phase 3 Pivotal Clinical Trials for PL9643 in Dry Eye Disease (DED) MELODY-2 & MELODY-3 Phase 3 Clinical Trials Targeted To Start Later This Calendar Year Topline Results Expected Q4 Calendar Year 2025 Treating Eye Related Diseases As referenced previously, Palatin is exploring using melanocortin agonists for age-related eye diseases. As detailed in the company’s corporate presentation, diseases such as dry eye disease, glaucoma and retinopathies are sizable target markets. Dry eye disease (DED) or keratoconjunctivitis is a multifactorial disorder of the tears and ocular surface. Symptoms include dryness, irritation, redness, discharge and blurred vision. Inflammation plays a prominent role in the development and amplification of the signs and symptoms of DED. According to research compiled by the company, the global market size for DED is estimated to be worth $7.0 billion in 2024, growing to $12.3 billion by 2032. Earlier this year, Palatin announced the phase 3 clinical results for its PL9643 melanocortin agonist treatment of DED. Regarding the findings, Carl Spana, Ph.D., President and CEO of Palatin, stated, “We are pleased that PL9643 treatment demonstrated excellent safety and tolerability data, including superior efficacy results compared to vehicle across multiple sign and symptom endpoints.” PL9643 represents an opportunity to bring relief to dry eye disease sufferers. According to Palatin, while DED is one of the most common ocular disorders, affecting an estimated 38 million people in the U.S., only about 18 million are diagnosed, and less than 10% of those diagnosed are treated with a prescription product. This shows the significant unmet medical need for an effective treatment with an excellent safety and tolerability profile. There is a sizable market opportunity for the other previously mentioned eye diseases: Palatin’s research states that the 2030 global market estimate for glaucoma is $11.52 billion, and the 2027 global market estimate for retinopathies is $27 billion. Palatin has ongoing melanocortin receptor programs for each disease to explore treatment methods. Treating Autoimmune Diseases There is also a growing opportunity to treat the underlying inflammation in autoimmune diseases that physicians commonly treat with broad immunosuppressants that potentially increase the risk of complications. Palatin Technologies, with an ongoing phase 2 clinical trial, is exploring how its treatments can tackle ulcerative colitis (UC), which the company says could benefit nearly 1 million people in the U.S. who suffer from an autoimmune disease that manifests as chronic inflammation of the colon. Palatin’s research states that the global ulcerative colitis market was estimated to be worth $5.5 billion in 2021 and is projected to be worth $8 billion by 2026. Palatin’s oral MCR1 agonist (PL8177) was developed to resolve inflammation directly in the colon, avoiding broad immunosuppression and adverse effects with its potent, selective compound. Palatin reports that two phase 1 studies have produced promising results – the first demonstrated the significant safety and tolerability of PL8177, while the second highlighted the value of an oral, delayed-release polymer formulation that can achieve local release without systemic absorption. PL8177 has advanced and is now being investigated in a phase 2 clinical trial. Treating Obesity Obesity represents a rising worldwide public health concern. Obesity is associated with an increased risk of overall mortality and serious health conditions, including high blood pressure, high cholesterol, type 2 diabetes, coronary heart disease, stroke and certain cancers. Obesity is associated with increased healthcare resource use and high economic burden. Safe and effective obesity treatments therefore remain a critical unmet need. In the United States, about 42% of adults live with obesity, and one out of five teens between the ages of 12-19 live with obesity, according to data compiled by Palatin. “The growth of GLP-1 agonists to treat obesity has been incredible and highly effective in the short run, but data shows that 67% of patients discontinue use due to side effects and a plateau effect in the first year, said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin. “This often results in a rebound effect with patients gaining back significant weight. Our research coupled with emerging clinical data indicates that combining an MCR4 agonist with incretin therapeutics like tirzepatide may result in synergistic effects on weight loss allowing for increased weight loss at lower and better-tolerated doses.” Sexual Dysfunction Product Expansion And Product Development Milestones The success of Vyleesi, which was sold to Cosette Pharmaceuticals in December 2023 for $12 million upfront and up to $159 million in sales milestones, has established a precedent for success in the sexual dysfunction category for Palatin Technologies. Presently, the firm is looking to build on this success and is exploring a product for the treatment of erectile dysfunction (ED) in patients that do not respond to PDE5i (viagra ®, cialis ® ) monotherapy. According to Palatin, over 30 million men in the U.S. suffer from ED, with approximately 35% of them being inadequately served by existing treatment options. Palatin believes that their MCR4 agonists can be a safe and effective treatment therapy for ED. Across Palatin’s product roadmap, several milestones are slated to occur in the latter half of 2024 or the first half of 2025. Regarding the second half of calendar year 2024, the company’s phase 2 obesity trial of an MCR4 agonist + GLP-1 will initiate enrollment (patient dosing has commenced), Melody-2 and Melody-3 phase 3 clinical trials for the treatment of DED will begin, and the phase 2 proof-of-concept interim data for PL8177 for ulcerative colitis is expected to readout. Regarding the first half of calendar year 2025, the company’s phase 2 obesity trial of an MCR4 agonist + GLP-1 topline results are expected, and the pharmacokinetics study for the clinical program with bremelanotide co-formulated with a PDE5i for the treatment of erectile dysfunction (ED) in patients that do not respond to PDE5i monotherapy will start. A Vision For The Future For Millions Of Patients Overall, Palatin Technologies is actively expanding its clinical programs and progressing toward potential new therapies for patients with limited or ineffective treatment options. Melanocortin pathway therapies represent a promising and versatile approach to treating various conditions, with ongoing research and development expanding their potential applications. Palatin Technologies is at the forefront of this treatment approach, potentially helping reshape the medical landscape. For more information about Palatin Technologies, visit its website. Featured photo by Louis Reed on Unsplash. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

August 29, 2024 08:45 AM Eastern Daylight Time

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Monogram Orthopedics (NASDAQ: MGRM) Readies Commercialization Of Next-Gen Surgical Robot

Benzinga

By Gerelyn Terzo, Benzinga When most people think about robotics, they might envision movies like the popular science fiction film RoboCop. While the entertainment industry put robotics on the big screen, companies like Austin, Texas-based Monogram Orthopedics (NASDAQ: MGRM) are making robotics a reality in everyday life. Monogram is an AI-powered robotics company dedicated to improving human health, including an early specialization in orthopedic surgery. This summer, it has been inching closer to its vision for the commercialization of its surgical robot. According to Virtue Market Research, the orthopedic surgery robotic market was worth $6.8 billion as of 2022 and is predicted to be valued at $16 billion by 2030, reflecting a CAGR of 13%. Monogram could be strategically positioned to capitalize on this growth with its mBôs surgical robot, which it is readying for commercialization, mVision technology and underlying IP. Benzinga recently had the opportunity to sit down with two Monogram surgeons – Dr. Bobby Jamieson and Dr. Fabio Orozco – to discuss the company’s next-generation orthopedic implants harnessing a combination of 3D printing, robotics and pre-operative imaging. Monogram’s 3D Printing Tech Dr. Fabio Orozco, an orthopedic surgeon, runs a medical practice that specializes in hip and knee replacements, with all of his surgeries involving robotics. After completing his training at Thomas Jefferson University in Philadelphia, Pennsylvania, he started a practice in the Northeast that is exclusive to robotics. He told Benzinga he performs 1,000 hip and knee replacements each year. With a very high success rate, hip and knee replacements are a testament to the strong track record of orthopedic surgeons. However, Orozco looks forward to using Monogram’s surgical robots on a daily basis, for, he says, greater precision, better patient care and improved outcomes. “You start thinking about 0.5 millimeters and 0.5 degrees and being able to reproduce your plan exactly to reality in a patient. And then you start seeing rapid recoveries - patients don’t need six months to recover from surgery or don’t need physical therapy. That’s when you see the excitement. We are better when we use technology, and when we use Monogram technology, we continue to be better and better,” said Orozco. Dr. Orozco performs 100% of his surgeries using robotics technology, including approximately 1,000 knee and hip replacements each year. He has been using Monogram’s Mako robot for the past decade, noting that it’s his go-to solution for every hip and knee replacement surgery. Dr. Orozco believes that when Monogram’s next-gen mBôs technologies become a reality, they will take orthopedic surgeries to a different level. “When you bring Monogram to your table, it’s going to make a significant difference in the way that we practice orthopedics,” he said. Chief among the new features that surgeons are anticipating from Monogram is the 3D printing of implants, which replicates the structure of human organs and tissues and can be customized to a patient’s body. Additionally, Monogram says its technology introduces increased precision and ease of use that will simplify robotic surgery significantly. For his part, Dr. Bobby Jamieson has been involved in robotics for years, having studied under the tutelage of orthopedic robotics pioneer and IBM (NYSE: IBM) alum Bill Barger and recently relocated his practice from Northern California to Southern Utah. Jamieson specializes in hip and knee surgeries, completing some 650 of them each year. Upon FDA approval of Monogram’s surgical robot, Jamieson looks forward to introducing the company’s technology to his patients. “I’ve been able to watch Monogram go from zero to where it is today and this is definitely something I’m interested in bringing into the practice once we get the approval on it,” Jamieson said. He also agreed that Monogram is taking orthopedic surgery to the next level. He said that what he appreciates most about the company’s technology is that it takes the best of all robotic platforms available, including features such as navigation, and builds them into a single robot, setting the tech suite apart and drumming up excitement in the industry. Monogram’s Competitive Edge With a market cap of over $90 million, Monogram’s advantage begins with its seasoned team and their strong robotics knowledge. The company’s singular focus on surgical robotic systems can give it a competitive edge against larger corporations that have a broader focus. “Monogram Orthopedics has the advantage is – they eat, drink and sleep robotics, which is awesome,” Jamieson said. “Then you add in 3D printing, and it just allows them to be a little bit further advanced than other surgical robots that are on the market right now.” He compares the precision of Monogram’s surgical robot to that of a driver in a golf game, saying that the tech helps surgeons hit the right spot every time with the ultimate patient-specific knee or hip replacement. That is what Monogram’s robot will deliver, and on top of that, there’s excitement around implants and being able to create the ultimate patient-specific knee or hip replacement for patients, where Monogram is also leading the charge. As Monogram transitions from gen-one to gen-two with its technology. Jamieson likens it to the iPhone, saying that most people wouldn’t even know how to access the first-generation iPhone model today because it’s just so obsolete. “I think that a lot of the robotics are those gen ones. The advantage that Monogram has coming to market is that it’s already at this iPhone five or 10 [level]… they’re able to come in as the newest technology that’s on the market and put it into one robotics system.” In the most recent update, Monogram Orthopedics submitted its 510(k) for its mBôs TKA System to the U.S. Food and Drug Administration (FDA) and has since received administrative approval to proceed with the next step, which involves a formal review. FDA approval is key for orthopedic surgeons to take Monogram’s surgical robots further, including the advancement of the technology on the clinical side. After that, they can begin using it in practice. “It’s an exciting time. It’s also obviously one of the most difficult steps, making sure all the “t’s” are crossed and all the “i’s” are dotted and, for that matter, making sure it’s safe for patients. And so it’s really important and also just exciting,” said Jamieson. Investors who are interested in the future of surgical robotics can learn more about the investment opportunities that Monogram Orthopedics has to offer here. Featured photo by PublicDomainPictures 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 29, 2024 08:30 AM Eastern Daylight Time

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Nuvectis Pharma Rises in Pre-Market Following FDA Orphan Drug Designation for NXP800, Fueling Optimism Ahead of Key Clinical Data

Global Markets News

Nuvectis Pharma (NASDAQ: NVCT) has achieved a significant milestone with the U.S. Food and Drug Administration (FDA) granting Orphan Drug Designation for its lead candidate, NXP800. This designation, specifically for the treatment of ARID1a-deficient ovarian, fallopian tube, and primary peritoneal cancers, marks a critical step forward in Nuvectis’s mission to address unmet needs in oncology. Orphan Drug Designation: A Strategic Advantage The FDA’s Orphan Drug Designation is awarded to drugs that show promise in treating rare diseases affecting fewer than 200,000 people in the U.S. For Nuvectis, this designation not only validates the potential of NXP800 but also provides several strategic benefits. These include tax credits for clinical trial costs, exemption from certain FDA fees, and potentially seven years of market exclusivity upon approval. NXP800 targets ARID1a-deficient cancers, a subset of ovarian cancers that present significant treatment challenges. The Orphan Drug Designation underscores the importance of this candidate in potentially offering a new, more effective treatment option for patients with this specific genetic mutation. Background and Market Impact This latest achievement builds on Nuvectis Pharma’s earlier successes. Earlier this year, the FDA granted Fast Track Designation to NXP800 for its development in platinum-resistant, ARID1a-mutated ovarian cancer. The Fast Track status, combined with the Orphan Drug Designation, highlights the urgent need for innovative treatments in this space and positions NXP800 as a potential game-changer in oncology. Financial analysts have taken note of Nuvectis’s progress. H.C. Wainwright recently reiterated its buy rating for Nuvectis, setting a price target of $21. This optimistic outlook reflects the market’s confidence in the company’s strategic direction, particularly as it prepares to release key clinical data later this year. Anticipation for Upcoming Results The next few months are expected to be pivotal for Nuvectis Pharma. The company is poised to share updates from its ongoing Phase 1b clinical trial of NXP800, which targets patients with platinum-resistant, ARID1a-mutated ovarian cancer. This trial is being closely watched, as positive results could significantly advance the development of NXP800, bringing it closer to pivotal trials and eventual regulatory approval. Additionally, Nuvectis is also conducting a Phase 1a dose escalation study for NXP900, its second key candidate, which targets YES1/SRC-driven tumors. Updates from this study are expected to provide further insights into the safety and potential efficacy of NXP900. ### Nuvvectis' Full announcment, titled " Nuvectis Pharma Announces Orphan Drug Designation Granted by the FDA for NXP800 for the Treatment of ARID1a-deficient Ovarian, Fallopian Tube, and Primary Peritoneal Cancers" was published on August 29th, 2024. ### This article is for informational purposes only and is not intended to serve as financial, investment or any form of professional advice, recommendation or endorsement. Please review the full documentation detailing financial compensation disclosures and disclaimers the article is subject to. https://justpaste.it/fcm9n/pdf. Global Markets News Network is a commercial digital brand compensated to provide coverage of innovative companies and industries and it is thus subject to conflicts of interest. Contact Details Global Markets News News Coverage ronald@futuremarketsresearch.com

August 29, 2024 08:20 AM Eastern Daylight Time

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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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

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

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

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