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IGC Pharma Advances In Alzheimer's Research From Pre-clinical Studies To Phase Two Trial With Its Novel Therapy Candidate IGC-AD1

IGC Pharma, Inc. (IGC)

By Faith Ashmore, Benzinga Alzheimer's disease, a progressive neurological disorder, affects around 24 million individuals worldwide. It is characterized by memory loss, cognitive decline and behavioral changes. The impact of Alzheimer’s disease makes it a major healthcare challenge. In 2023, Alzheimer’s and other types of dementia were projected to cost the U.S. $345 billion. By 2050, these costs could rise to nearly $1 trillion. While no cure currently exists for Alzheimer's, promising advancements in research and treatment are bringing hope to patients and their families. Hope On The Horizon? IGC Pharma (AMEX: IGC) is one of the companies hoping to provide solutions for millions of suffering Americans. It is a pharmaceutical company focused on developing innovative therapies for various medical conditions and fields, including Alzheimer's disease, chronic pain and women’s health. The company specializes in advanced formulas and the company’s lead drug candidate is IGC-AD1. IGC-AD1 is undergoing extensive clinical trials to evaluate its effectiveness and safety in treating Alzheimer's disease. The phase two clinical trial, initiated in 2023, encompasses 20 sites across the United States and Canada. With a target of 146 participants, this trial focuses on determining the efficacy of IGC-AD1 in alleviating agitation, a common symptom experienced by many Alzheimer's patients. IGC-AD1 has patent protection for its unique formulation, which involves a combination of two Active Pharmaceutical Ingredients (APIs). This combination is administered as an oral liquid solution, making it more accessible and convenient for patients. Pre-clinical studies of IGC-AD1 have demonstrated its potential in reducing the production of Aβ40 peptide and inhibiting the aggregation of Aβ42, both of which are associated with Alzheimer's. During phase one trials, patients with mild to severe Alzheimer's disease participated in a double-blind trial, where IGC-AD1 was administered at three different doses over a period of 14 days. The results were encouraging, as IGC-AD1 proved to be safe and well-tolerated by the participants, with no significant adverse effects reported. The study also demonstrated improvements in Neuropsychiatric Symptoms (NPS), specifically in the domains of agitation, anxiety and depression. These positive changes also led to a reduction in caregiver distress. With the success of phase one trials, the company expects the phase two clinical trial to provide further insights into the efficacy and safety of IGC-AD1. As researchers and healthcare professionals continue to investigate this potential treatment, IGC-AD1 could bring hope to the millions of individuals living with Alzheimer's disease and their loved ones. IGC Pharma also has four other drugs in the pipeline that are at the pre-clinal stage. TGR-63 targets early-moderate-stage Alzheimers and so far, has been shown to improve memory and learning in mice models at the pre-clinical stage. The other drugs in the company’s pipeline are 1C, M3, and LMP, and it also has a variety of patents that focus on a wide range of targets, from eating disorders to epilepsy and more. Featured photo by bruce mars on Unsplash IGC Pharma Inc. (IGC) is at the forefront of the fight against Alzheimer's disease, developing innovative solutions to address this devastating illness. The company's mission is to transform the landscape of Alzheimer's treatment with a robust pipeline of five promising drug candidates. IGC-AD1 and LMP target the hallmarks of Alzheimer's disease, including neuroinflammation, Aβ plaques, and neurofibrillary tangles. IGC-AD1 is currently undergoing a Phase 2b clinical trial for agitation in dementia associated with Alzheimer's (clinicaltrials.gov, CT05543681). TGR-63 disrupts the progression of Alzheimer's by targeting Aβ plaques. IGC-M3, currently in preclinical development, aims to inhibit the aggregation of Aβ plaques, potentially impacting early-stage Alzheimer's. IGC-1C, also in preclinical stages, targets tau protein and neurofibrillary tangles, representing a forward-thinking approach to Alzheimer's therapy. In addition to its drug development pipeline, IGC Pharma is actively leveraging Artificial Intelligence (AI) for Alzheimer's research. Their AI projects encompass various areas, including clinical trial optimization and early detection of Alzheimer's. These forward-looking statements are based largely on IGC Pharma’s expectations and are subject to several risks and uncertainties, certain of which are beyond IGC Pharma’s control. Actual results could differ materially from these forward-looking statements as a result of, among other factors, the Company’s failure or inability to commercialize one or more of the Company’s products or technologies, including the products or formulations described in this release, or failure to obtain regulatory approval for the products or formulations, where required, or government regulations affecting AI or the AI algorithms not working as intended or producing accurate predictions; general economic conditions that are less favorable than expected; the FDA’s general position regarding cannabis- and hemp-based products; and other factors, many of which are discussed in IGC Pharma’s U.S. Securities and Exchange Commission ("SEC") filings. IGC Pharma incorporates by reference the human trial disclosures and Risk Factors identified in its Annual Report on Form 10-K filed with the SEC on July 7, 2023, and Quarterly Report on Form 10-Q filed with the SEC on February 14, 2024, as if fully incorporated and restated herein. Considering these risks and uncertainties, there can be no assurance that the forward-looking information contained in this release will occur. This post contains sponsored content. This content is for informational purposes only and not intended to be investing advice. Contact Details Rosalyn Christian rchristian@imsinvestorrelations.com Company Website https://igcpharma.com/

March 19, 2024 04:00 PM Eastern Daylight Time

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Shaping the Future of Healthcare: Benzinga Virtual Healthcare Summit 2024

Benzinga

Benzinga is thrilled to present the 2024 Virtual Healthcare Summit, a groundbreaking virtual event poised to revolutionize the landscape of healthcare. This summit is a beacon of innovation, bringing together leading companies, healthcare visionaries, analysts, asset managers, and thought leaders to shape the future of health. Scheduled for Wednesday, March 20, starting at 10:25 AM EST, this summit is set to attract tens of thousands of attendees eager to explore the latest advancements and insights driving the healthcare industry forward. Our esteemed sponsors for the event include: The Beachbody Company Cardio Diagnostics Holdings, Inc. Elicio Therapeutics Theriva Biologics, Inc. First Wave BioPharma Plus Therapeutics BioHarvest Sciences ZyVersa Therapeutics IN8Bio, Inc. IGC Pharma Atossa Therapeutics Autonomix Medical, Inc. AXIM Biotechnologies ImmunoPrecise Antibodies Ltd. The agenda for the summit features an impressive lineup of speakers, including: Don Duffy, President at ICR John Huemoeller, CEO at AXIM Biotechnologies Steve A. Shallcross, CEO at Theriva Biologics Manel Cascallo, General Director, EU Subsidiary at Theriva Biologics Laura Chico, PhD, Senior Vice President, Equity Research Freda Lewis-Hall; Michael O'Brian, Partner & Head of US Healthcare PR at ICR & Westwicke David Song, Investment Partner and Head of Life Sciences at TEMA ETFs Lori Bisson, CEO at Autonomix Medical Steven Qua, MD, PhD, President & CEO at Atossa Therapeutics Ilan Sobel, CEO at BioHarvest Sciences Ram Mukunda, CEO at IGC Pharmaceuticals Claudia Grimaldi, VP, CCO, PFO, & Director at IGC Pharmaceuticals Mark Klausner, Managing Director, Head of U.S. Healthcare Investor Relations at ICR Westwicke Adam Mendelsohn, PH.D., Co-Founder & CEO at Vivani Medical Meesha Dogan, CEO, Co-founder & Director at Cardio Diagnostics Steve Glover, Co-founder, Chairman, CEO, & President at ZyVersa Therapeutics Robert Jacks, President & CEO at Sparrow Pharmaceuticals Marc Hedrick, President & CEO at Plus Therapeutics William Ho, CEO at IN8Bio, Inc Mark Goldston, Executive Chairman at The Beachbody Company Dr. Jennifer Bath, CEO at Immunoprecise Antibodies Ltd. Robert Connelly, CEO at Elicio Therapeutics Sameer Khambadkone, Managing Director at ICR/Westwicke Each speaker brings invaluable expertise and perspectives, promising enriching discussions that will shape the future of healthcare. Join us as we embark on this transformative journey in healthcare. Registration is now open, and participation is free. Don't miss the opportunity to be part of this historic event and contribute to shaping the future of health. For more information and to register, visit the event registration page. Drew Pilat Benzinga 1 Campus Martius, Detroit, MI 48226 drew@benzinga.com benzinga.com/events 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 drew@benzinga.com Company Website http://www.benzinga.com

March 19, 2024 02:00 PM Eastern Daylight Time

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ZEAKAL DELIVERS SYNERGISTIC INNOVATION TO ENHANCE SUSTAINABILITY OF CORN PRODUCTION

ZeaKal

ZeaKal today announced the successful development of its groundbreaking PhotoSeed™ technology in corn, improving the crop’s oil and sustainability profile without compromising yield or protein. With the immediate implementation of PhotoSeed corn’s route to market, ZeaKal aims to redefine the value proposition of this vital crop for growers, industry, and consumers alike. In first year replicated field trials, PhotoSeed increased corn oil composition by an average of 23 percent. PhotoSeed enhances a plant’s photosynthetic capacity, capturing more CO2 and sunlight. This additional carbon capture increases oil production without taking away the energy necessary to maintain modern yields. Despite tremendous demand, previous efforts to boost oil content without compromising yield have eluded agribusinesses. ZeaKal now introduces the first viable solution. Han Chen, co-founder and CEO of ZeaKal, emphasized the imperative for accelerated innovation to meet the escalating demand for sustainable corn oil production. "This trait technology allows us to elevate the overall value of U.S. corn and creates a differentiated, value-added product that addresses industry demand," said Chen. “U.S. farmers need innovation faster if we hope to compete in a challenging global commodity market. While we cannot change sunlight availability and geography for our growers, we can bring a latitude advantage to them through genetics.” Corn, occupying 90 million acres in the United States and ranking among the most crucial crops globally, serves as a cornerstone for food, feed, and fuel feedstocks. The FAO forecasts a 70% surge in global demand for sustainable food and feed, and other projections indicate that renewables will constitute 43% of total energy within a decade. Together, this underscores the urgency for plant-based energy, which offers inherent benefits for aviation fuel and renewable diesel that other innovations cannot offer. Expanded Gro Alliance Partnership Accelerates Farmers’ Access to PhotoSeed Corn Hybrids In 2022, ZeaKal set a path to restore value across the soy supply chain by creating a closed loop U.S. system to capture and share premiums from better composition, processing advantages, and improved sustainability metrics with farmers and producers – called the NewType model. PhotoSeed corn follows the model’s success starting with integration into Gro Alliance’s extensive germplasm collection, breeding program, and fully integrated seed production. “For too long, extended periods of depressed commodity prices coupled with rising input costs have magnified risk for U.S. farmers. With ZeaKal 's breakthrough technology and our expanded capacity and partnerships, we are setting our sight on the better seed for the entire value chain; farmers, seed companies and end-users,” said Jim Schweigert, president of Gro Alliance, which recently expanded its germplasm pool and secured a partnership with an advanced sorting technology company. Just as in soybeans, nutrient, and energy densification in PhotoSeed corn translates to more carbon captured in the seed. With higher oil production that does not require additional inputs or land, PhotoSeed becomes a sustainability embedded trait that has the potential to lower the carbon intensity score of the crop. “The future of agriculture must be grounded in innovation that democratizes value creation or else agriculture will not be responsive to demands for improved sustainability, nutrition, and energy,” said Chen. “Starting with the grower, our vision is to leverage trait technology and replicate our NewType model to ensure value creation and sharing across the entire supply chain.” PhotoSeed corn commercialization is expected in the 2027 growing season. For more information about ZeaKal and PhotoSeed technology, or to become part of the NewType model, visit zeakal.com. ABOUT ZEAKAL: At ZeaKal, we are building a value driven “NewType” of agriculture to harmonize the needs of farmers, consumers, and our planet. Our flagship plant trait technology, PhotoSeed™, helps crops capture more carbon and sunlight, leading to healthier, nutrient-rich food and feed grown on a smaller environmental footprint. We go beyond science to make affordable nutrition more sustainable, with marketable differentiation for growers. Discover how we are transforming carbon to nutrition: zeakal.com or @zeakal on Twitter. Contact Details AgTech PR for ZeaKal Jennifer Goldston jennifer@agtechpr.com Company Website https://www.zeakal.com

March 19, 2024 08:30 AM Central Daylight Time

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68.5 Million Americans Don’t Have Dental Insurance – DentalPlans.com Celebrates 25 Years Of Improving Access To Dental Care

DentalPlans.com

By Faith Ashmore, Benzinga Many Americans neglect oral health due to the high costs and a misguided belief that it is less important than other parts of their body. The reality is that oral health is critical to not only mental well-being but also to overall health. Studies show that people who have all or most of their natural teeth at age 70 live longer than those who have fewer than 20 of their natural teeth. Good oral health also acts as a defense barrier for diseases and bacteria that can lead to infections. Despite these reasons to prioritize oral health, 68.5 million adults in the U.S. don’t have dental insurance. Not all workplaces provide dental insurance, and it can be a high out-of-pocket expense for individuals and families. What most people don’t realize is that dental savings plans like those offered by DentalPlans.com can be used as an alternative to dental insurance or in addition to dental insurance. A dental savings plan is a subscription-based program that provides plan members with discounts on dental services from participating dentists. Plan members report average savings of 50%* on their dental care. Although you cannot combine a savings plan and insurance for the same procedure, you can use them for different procedures within the same treatment plan. For instance, if you require a root canal and a crown, you can utilize your insurance for the crown and your savings plan for the root canal. Alternatively, you have the option to use the savings plan for both procedures since it does not have the annual limits that insurance typically imposes. Whether you have depleted your insurance for the year or you didn’t have insurance to begin with, dental savings plans can be a unique alternative. Unlike dental insurance, which typically involves monthly premiums, copayments, deductibles and coverage limits, dental savings plans work on a fee-for-service basis. Plan members pay an annual or monthly fee and gain access to discounted rates for various dental procedures and treatments. By paying a single, affordable annual fee, Americans can enjoy year-round discounts at the dentist with no restrictions on how much they can use or save with the plan. DentalPlans.com – 25 Years Of Serving Over A Million Customers DentalPlans.com is celebrating its 25th anniversary and has helped over a million customers save on their dental plans since its launch in 1999. The company started as an online marketplace for dental savings plans but has now expanded to offer both dental savings plans and insurance. In 2023, DentalPlans.com launched an online plan finder, which asks users a few quick questions and then provides them with personalized plan recommendations in minutes. For people who are overwhelmed by the plethora of plans available online and don’t know where to begin, DentalPlans.com makes it simple and hassle-free. The company started as a way to connect people with affordable, quality dental care. Oral health is essential to overall health and wellness, and DentalPlans.com is making it easier for Americans to get the quality care they deserve. Featured photo by Freddy Mishiki on Unsplash. DentalPlans.com, founded in 1999, is a leading online marketplace for dental savings plans in the U.S., helping more than a million people to affordably access quality healthcare services. Our mission is to empower consumers with the tools, information, and services that they need to live happier, healthier lives. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. *Discount Health Program consumer & provider surveys indicate average savings of 50%. Savings may vary by provider, location, and plan. *Sample savings are based on zip code 43614, actual costs and savings may vary by service and geographical area. Dental savings plans are not insurance. Contact Details Matthew Wong matthew.wong@wpromote.com Company Website https://www.dentalplans.com/

March 19, 2024 08:45 AM Eastern Daylight Time

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DREW BREES AND COPPER COMPRESSION TOUCHDOWN AT WALGREENS, REVOLUTIONIZING RECOVERY FROM ONLINE INTO AISLE

Copper Compression, LLC

In an exciting play for the recovery game, Copper Compression, the leading online health and wellness compression wear brand endorsed by football legend Drew Brees, announces today its expansion into over 1500 select Walgreens stores nationwide. This strategic partnership not only enhances Copper Compression’s accessibility, but also delivers new winning solutions for Walgreens’ health conscious consumers seeking premium wellness products not typically found at retail locations. “Partnering with one of the largest chain drug stores marks a significant milestone for Copper Compression and underscores the evolution of our brand,” says Super Bowl Champion, Drew Brees. “I’ve personally experienced faster recovery while using Copper Compression. Having these products available at Walgreens will be life-changing for people dealing with pain and in need of effective all-natural relief.” Walgreens will now carry a selection of six Copper Compression products featuring Brees including, the Recovery Shoulder Brace (an Amazon Best Seller), Calf Sleeves, a universal Finger Splint which features medical grade aluminum and the introduction of Coppervibe™, the latest innovation in wearable tech that combines Vibration and Heat for hands, back and knee relief. Copper Compression continues to garner recognition by millions of online fans for its lab-tested nylon compression all which is infused with the maximum copper advantage. Its full collection of products are also FDA approved and certified antimicrobial by the EPA; these standards lead to explosive growth, rave reviews and a loyal customer base which include celebrities Anna Wintour, DJ Khaled, Kid Rock and Kaley Cuoco. “The trend from online to inline continues to reflect a dynamic transformation in the retail landscape," adds Vincent Porpiglia, President of Hero Brands, “Fan favorite digital brands continue to emerge and prove themselves alongside legacy brands at brick-and-mortar. Copper Compression stands at the forefront of this movement, delivering its premium recovery solutions to your neighborhood Walgreens” About Copper Compression New York City-based Copper Compression is a health and wellness brand that designs, manufactures, and distributes the most diverse portfolio of cutting-edge copper-infused compression wearables tailored for pain relief and performance recovery. The company’s 100 unisex products include groundbreaking solutions for arthritis, tendonitis, and plantar fasciitis. Established in 2015, Copper Compression has served over 10 million satisfied customers and has been featured in Forbes, ESPN, Women’s World, US Weekly, and Sports Illustrated for its renowned commitment to effective, all-natural pain relief. Having amassed over 300,000+ authentic customer reviews from their online-first business model, Copper Compression swiftly expanded its success to over 10,000 national retail locations in less than 3 years, partnering with industry giants like Walmart, Walgreens, Publix, Ingles, and Harris Teeter. Copper Compression earned seven best seller badges on Amazon.com for its top-rated Half-Finger Arthritis Gloves and Arch Supports. Follow @CopperCompression on Instagram, TikTok and Facebook. Note to Editors: Photos available Here. Press Contacts: Nathan Lindsey NLindsey@adjmi.com 203.376.8154 Sarah Leheny SLeheny@adjmi.com 631.834.2815 Contact Details Copper Compression Joey Braha JBraha@adjmi.com Copper Compression Nathan Lindsey +1 203-376-8154 nlindsey@adjmi.com Copper Compression Sarah Leheny +1 631-834-2815 Company Website https://www.coppercompression.com/

March 19, 2024 08:30 AM Eastern Daylight Time

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Monogram Orthopaedics (NASDAQ: MGRM) Aims To Overcome Robot Shortcomings With Its Advanced Solution

Benzinga

By Meg Flippin, Benzinga When it comes to robots in the operating room, they are falling short. Robots should save hospitals time and money and give patients better outcomes, but those benefits have yet to be seen. As it stands, the current robots decrease surgical throughput, add costs, and cannot achieve parity with manual procedures. Take total knee replacement surgeries as one example. The average time for a manual total knee arthroplasty (TKA) is 88.7 minutes. With a robot, it is 105.5 minutes. What’s more, robotic-assisted TKA is 10% more expensive than manual TKA. The robotic systems currently on the market also have a steep learning curve. Nevertheless, the demand for robots in the operating room is growing as more hospitals and surgeons adopt this approach to treatment and care. That’s particularly true in orthopedics, with some estimates predicting that 50% of all knee procedures will be robotic by 2027, up from 12% today. With almost 88% of knee surgeries still performed manually today, the long-term growth trajectory for robotics in orthopedic medicine could be impressive. It’s also growing from a large base. The addressable market for companies that can change the current economics of robotic surgery is significant. According to Fortune Business Insights, the orthopedic device market alone is forecast to grow by a CAGR of 4.5% through 2030, reaching $80.28 billion. Driving the growth is a rising prevalence of osteoporosis and musculoskeletal diseases, an aging population, and an increase in sports-related injuries. Mako Seems To Have A Lock On The Market … For Now Currently, the dominant player in robotic knee replacements is Mako, the unit of Stryker Corp. (NYSE: SYK) that makes robotic arm-assisted surgical equipment. It accounts for over 50% of Stryker’s surgical knee volume and 70% of the press-fit (also cementless) knees. Mako is unique in that it combines patient-specific CT-based planning with robot enabled saw cutting. This combination of personalized planning and efficient bone cutting has driven Mako’s popularity with doctors. But Mako has opportunities for improvement. The arm has only four joints, which appears to limit the workspace and potentially the ease of use for future applications. While Mako’s haptic constraints enhance safety over manual cutting, the virtual boundaries still require care and caution. Mako’s navigation also requires arrays rigidly fixed to bone with pins and manual point sampling. Navigation pins have been shown to introduce a risk of fracture and infection in some instances. New Player On The Scene Aiming For Dominance Monogram Orthopaedics Inc. (NASDAQ: MGRM) is taking a page from Mako, aiming to revolutionize orthopedic joint replacement surgery with its mBôs robotic technology that will aim to link 3D printing and robotics with advanced pre-operative imaging. Monogram’s mBôs is designed to enable precise virtual intraoperative assessment of patient specific laxity in order to plan where to make cuts for proper implant placement. These tools can dramatically simplify the complexity of joint reconstruction. With mVision, Monogram’s recently announced navigation solution, the goal is to increase the number of daily surgeries hospitals can perform, lower surgery costs, and minimize clinical risk. The robot is also designed for ease of use, aiming to minimize the learning curve and level of expertise needed. The company hopes that enhancements like these could help advance the standard of care in orthopedic robotics and hopefully make robots ubiquitous in the operating room. Monogram CEO Ben Sexson says the company’s ultimate vision is to combine a surgical robot that addresses economic and clinical pain points with more personalized implants. The company believes that the current generic, “one size fits none,” model is too costly and is not likely optimal for patients. Robotics could enable increased personalization of the implants. Monogram wants to get to a point where surgeons use 3D-printed implants that are designed based on the patient’s unique characteristics. The custom implants could enhance implant performance with, for example, improved coverage and minimized bone removal. The company believes custom implants could improve the initial stability of implants to facilitate bone ingrowth (which would reduce the need for bone cement to hold them in place). The vision is for the mBôs system to precisely cut the bone and put the custom implant in place. Sexson said the company is tracking to commercialize a robot that solves clinical and economic problems, while also enabling the next generation of 3D printed patient optimized implants. Promising Progress In preclinical trials that simulated cadaver surgeries with an mBôs prototype, Monogram reports that the robot was able to prepare the bone for implantation in approximately 40 minutes, which is significantly faster than the time it takes today. The company’s goal is to cut that down to 20 minutes. “The mBôs robot aims to combine safety, ease of use, streamlined cost, novel implant design, broad clinical functionality, and speed to help drive the next wave of robotic adoption in orthopedics,” Monogram says on its website. But it’s not only performing in trials. The company recently announced it delivered its first surgical robot to one of the world’s largest global robotics distributors. It marks the first sale for Monogram. “Delivering our first robot and realizing our first commercial revenues validates our technology and represents a pivotal milestone for our strategic roadmap,” Sexson said when announcing the milestone. “Our system is performing at an extremely high level. We now look forward to seeing how our robot competes and scales in the real world. We hope to see the mBôs robot contribute to advancing the standard of care for orthopedic patients worldwide.” The company has stated that its goal is to obtain FDA clearance as quickly and economically as possible. Further, they may have a strategy to exceed regulatory timeline expectations. "We have been exploring the technical feasibility of a semi-active system, and the results are promising," said Sexson. "A semi-active system could mitigate the possibility of a clinical trial and have distinct performance advantages over a fully autonomous system, such as cutting efficiency. We believe surgeons would be receptive to a robot with autonomous and semi-active modalities or a combination of both because of the distinct advantages of each system. This approach could theoretically be extremely favorable to our submission timeline." The company recently shared that it's on track with plans to submit its mBôs 510(k) for FDA clearance in the second half of 2024. The critical question is how long the company needs to obtain FDA clearance for its mBôs system. In its recently reported 10-K, it wrote, “Regulatory strategy can be dynamic as new facts and opportunities emerge. Our goal is to obtain FDA clearance as quickly and economically as possible. It is management’s interpretation of the FDA’s main cited technical differences of the “active” embodiment of our mBôs system with the predicate that could justify a clinical study to establish substantial equivalence, related primarily to foot pedal control of the system, i.e., hands-free active cutting. The company has been exploring the technical feasibility of a semi-active system (an embodiment that would not allow for remote operation) that we anticipate could minimize cited technical differences with our predicate and potentially obviate the need for clinical data with our 510(k) submission. Our preliminary market research suggests surgeons could be receptive to a robot with active and semi-active modalities. The company is exploring submitting a semi-active modality 510(k) first without clinical data and then submitting for the active modality after obtaining OUS clinical data. This approach is still under investigation but could theoretically be favorable to our commercialization timeline.” This interesting recent addition to the filing could be something to keep a very close eye on. Hospitals and surgeons are incentivized to find ways to more efficiently treat patients and ensure better outcomes. Robots are supposed to achieve that, but many on the market fall short. Monogram is focused on changing that with its mBôs robot. Featured photo courtesy of Monogram Orthopaedics. 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

March 19, 2024 08:10 AM Eastern Daylight Time

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NCMA's Announces New Members to their National Committee

National Contract Management Association

At the National Contract Management Association (NCMA), the focus on providing high-quality resources— events, professional certifications, local networking, and the ANSI-approved Contract Management Standard™ —that positively advance and expand the contract management profession remains the top priority. To help to continue strengthen the association’s strategic direction and growth, NCMA is excited to announce its new National Committee Members, who bring a wealth of experience and expertise to guide their endeavors forward. “Our National Committee Members are essential in providing a platform for meaningful planning and growth for our members and association,” said NCMA’s Board-Chair Elect, Heather Gerczak. “They will be instrumental in inspiring innovation and refining our strategy. I am thrilled to welcome our new members and am excited to collaborate in Program Year 2025.” The National Committee members are seasoned professionals with impressive track records in their respective fields. NCMA welcomes: Joann Campbell-Maher, CPCM, CFCM, CCCM, Director of Contracts, SRC Inc., Chapter: Leatherstocking Chapter Will Cannon, Director of Business Operations, General Atomics Chapter: San Diego Jim Doss, Fellow, CPCM, CFCM, Director of Contracts, BlueHalo, Chapter: Tysons Derek Ebona, CPCM, Chief of the Contracting Office, Program and System Support for Contracting and Procurement Office, Defense Counterintelligence and Security Agency, Chapter: Tysons Jessica Johnson, CPCM, CFCM, VP, Services Contracts at Red River Technology, Chapter: Dulles Corridor Wanda Wallace, CPCM, CFCM, Senior Contracts Manager at Magellan Federal, Chapter: Jacksonville This year’s National Committees Members were elected through a competitive application and voting process. These members make a lasting impact on NCMA. The Committees are made up of five groups including audit and risk, governance and ethics, member engagement, professional development and certification, and strategic planning. All who have served have played an instrumental role in helping to shape the associations’ strategy and direction. The National Contract Management Association (NCMA) – www.ncmahq.org – has grown as a professional society whose mission is to collaborate towards a globally recognized contract management profession that strengthens its nexus with related acquisition communities. Serving approximately 20,000 members in both the public and private sectors, NCMA propels the growth, advancement, and impact of practitioners through a steadfast commitment to serve through the open exchange of ideas in neutral forums. Contact Details Holly DeHesa +1 281-865-3296 holly.dehesa@ncmahq.org Company Website https://www.ncmahq.org

March 19, 2024 05:00 AM Eastern Daylight Time

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AGC Biologics to Manufacture First-ever FDA Approved Gene Therapy for Early-onset Metachromatic Leukodystrophy, Orchard Therapeutics’ Lenmeldy™ (atidarsagene autotemcel)

AGC Biologics

AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), today announced that the U.S. Food and Drug Administration (FDA) has cleared its Milan site to begin commercial manufacturing for the lentiviral vector and genetically modified cell drug product (DP) of Orchard Therapeutics’ Lenmeldy™ (atidarsagene autotemcel), a hematopoietic stem cell (HSC) gene therapy for the treatment of pre-symptomatic late infantile, pre-symptomatic early juvenile and early symptomatic early juvenile metachromatic leukodystrophy (MLD). Lenmeldy received approval by the FDA on Monday, March 18. “It is wonderful to see Orchard Therapeutics reach this goal. This accomplishment is a strong proof point of our commitment at AGC Biologics to collaborating directly with developers to meet rigorous regulatory standards and achieve the best possible results for our partners,” says Patricio Massera, CEO of AGC Biologics. Lenmeldy is the first therapy to receive U.S. FDA approval for MLD. With this announcement, AGC Biologics Milan becomes the only global CDMO site to receive the regulatory agency’s clearance to produce this treatment for patients in the U.S. commercially. The FDA approval is the culmination of a partnership that started in 2018 with Orchard Therapeutics, which also includes guiding the product through commercial approval by the European Commission (EC) in 2021. AGC Biologics’ Milan site is uniquely connected to this product’s full lifecycle, as the facility and its scientific teams partnered with each company that owned this treatment’s IP over the last 20 years to help advance it from research and development stages to this DP commercial milestone. “We congratulate Orchard for reaching this important stage. Our team has had the privilege of supplying every clinical milestone for Lenmeldy and are glad to see it reach FDA approval,” said Luca Alberici, General Manager of AGC Biologics Milan. “I am proud of the work of the Milan team. This demonstrates our unique ability to collaborate on technical processes to deliver groundbreaking treatments to patients worldwide. This approval makes our site one of the rare few in the viral vector and genetically modified cells field that has commercial manufacturing authorization from two of the world’s leading regulatory authorities." "AGC Biologics has played a pivotal role as a strategic partner throughout the clinical development and commercial scale-up of atidarsagene autotemcel, which helped facilitate regulatory approvals in Europe and the U.S.," said Nicoletta Loggia, Ph.D., chief technical officer of Orchard Therapeutics. "Utilizing our best-in-class commercial HSC gene therapy manufacturing platform, we have consistently met the demands for drug product production since the European launch in early 2021. This has enabled us to provide treatment to patients from three continents, including Europe on a commercial basis, the Middle East through treatment abroad programs, and the U.S., under compassionate use. With the recent U.S. approval, we are excited to further expand access to this vital therapy for eligible children with early-onset MLD. The AGC Biologics Milan location has 30 years of experience in the cell and gene field and expertise with complex advanced cell therapy projects. The core team has guided three cell therapy products from development to commercial stages and has manufactured hundreds of batches of cell therapies for clinical and commercial usage. The site serves as the AGC Biologics’ Global Cell and Gene Center of Excellence for AGC Biologics. The team has a track record for helping developers meet regulatory guidelines and achieve quality performance metrics, and experience with navigating the unique complexities of technology transfers and scaling up and scaling out manufacturing within the cell and gene space. To learn more about AGC Biologics’ global cell therapy services, visit: www.agcbio.com/capabilities/cell-therapy, go to www.agcbio.com/capabilities/viral-vector and learn more about the CDMO’s viral vector offerings. Lenmeldy™ (atidarsagene autotemcel) is a trademark of Orchard Therapeutics. 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 employees 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 ten different facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit www.agcbio.com. Contact Details AGC Biologics Nick McDonald +1 425-419-3555 nmcdonald@agcbio.com Company Website https://www.agcbio.com/

March 18, 2024 11:30 PM Pacific Daylight Time

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Spring Bird Makes its Expo Debut at the 2024 Texas Transit Association State Conference, Expo, and Roadeo

Spring Bird

Spring Bird, a name synonymous with excellence and innovation in the transportation industry, is thrilled to announce its first-ever expo attendance at the Texas Transit Association (TTA) State Conference, Expo, and Roadeo from March 15-20, 2024, in San Antonio, Texas. This landmark event marks Spring Bird's grand entrance into the expo scene, showcasing their comprehensive range of services, including maintenance, retrofitting, leasing, and sales of transit-style buses. Spring Bird, under the visionary leadership of Elliott Carson, continues the legacy of the Carson family in the bus industry, bringing over 75 years of combined experience and dedication to quality, safety, and customer satisfaction. The company specializes in offering top-tier transit buses from renowned manufacturers like New Flyer, and Gillig, emphasizing the latest safety features and technological advancements. Spring Bird’s cutting-edge rehabilitation services will be the heart of its expo showcase. Attendees will learn about the company’s capabilities in performing minor repairs, major overhauls, and retrofitting buses with the latest low-emission engines and GPS tracking systems. Spring Bird is committed to providing customized solutions that meet clients’ unique needs, whether they want to purchase new buses or service their existing fleets. Elliott Carson, representing the fourth generation of the Carson family in the bus industry, expressed his enthusiasm about participating in the TTA State Conference, Expo, and Roadeo: "We are excited to debut at this wonderful event and look forward to connecting with transit agencies and other entities from Texas and across the United States. Our attendance at the TTA Expo is a testament to Spring Bird's commitment to excellence and innovation in providing high-quality, affordable transportation solutions." Texas is also the home of Spring Bird, located in Austin, TX. The Texas Transit Association, organized in 1986, brings together metropolitan, small urban, and rural transit agencies, along with private and public entities from across the country, making it the perfect platform for Spring Bird to introduce its services to a wider audience. Visit Spring Bird at the 2024 TTA State Conference, Expo, and Roadeo to explore how they can support your transit needs with their high-quality buses and comprehensive rehabilitation services. About Spring Bird: Spring Bird is a premier provider of transportation solutions specializing in the sale, leasing, and service of heavy-duty transit buses and motor coaches. Drawing from the rich Carson family legacy in the transportation industry, Spring Bird offers an inventory of high-quality buses from leading manufacturers and provides customized rehabilitation services, including minor repairs, major overhauls, and technological retrofitting. Dedicated to safety, innovation, and customer satisfaction, Spring Bird addresses the unique needs of cities, transit agencies, and private operators, ensuring reliable and efficient transportation solutions. Contact Details Spring Bird Media Contact press@springbirdbus.com Company Website https://springbirdbus.com

March 18, 2024 03:00 PM Central Daylight Time

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