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Ultrahuman Raises $35mn to accelerate growth and research in the health monitoring space

Ultrahuman

The pioneer in wearable tech Ultrahuman has today announced a $35 million equity and debt investment round. The series B funding round saw participation from venture capital firms Blume Ventures, Steadview Capital, Nexus Venture Partners and Zomato founder Deepinder Goyal. Ultrahuman will deploy the funds towards building further manufacturing capacity and deeper research in the health tracking space. "This funding round marks a pivotal step forward in our journey to dominate the smart rings space, bringing us closer to our goal of being the market leader" remarked Mohit Kumar, co-founder of Ultrahuman. Ultrahuman is at the forefront of the health-tech revolution, boasting the world's largest and only multi-device health ecosystem. In addition to their smart ring called Ring Air, the Ultrahuman product suite includes a continuous glucose monitoring wearable called M1 Live, a home health device called Ultrahuman Home and a preventive blood testing product called Blood Vision. Their platform integrates glucose, sleep, movement, blood markers, and HRV, offering a comprehensive approach to health monitoring. "The future of health is integrated, and at Ultrahuman, we're making that future a reality today by seamlessly combining various health data streams to empower preventative health and wellness," said Mohit Kumar. Ultrahuman has seen phenomenal growth over the past 12 months, becoming the second-largest player in the smart ring market while maintaining profitability. "Our vision of being the top player in terms of both active devices and geographic presence is within reach, thanks to our rapid expansion and the love we've received from our users," added Mohit Kumar. A key driver of Ultrahuman's explosive growth has been its expansion into over 150 retail outlets worldwide, including iconic locations like London’s Selfridges on Oxford Street, Changi airport in Singapore, and the Virgin megastore in Dubai. This retail footprint expansion has been instrumental in introducing Ultrahuman's cutting-edge technology to a global audience. "Our growth is a testament to the user love for our products, highlighted by industry-leading NPS and engagement metrics since the launch of our latest model, the Ring Air. Our relentless focus on improving user experience through continuous firmware and software updates is what sets us apart," Mohit Kumar emphasized. "Shipping a new firmware version every 2 weeks and weekly app improvements reflect our commitment to excellence and our speed of execution, our biggest competitive advantage. We’ve also iterated in hardware at the speed of software by designing novel devices like Ultrahuman Home, a home health monitor.” Looking ahead, Ultrahuman is on track to surpass $100 million in annualized revenue run rate (ARR) by the end of 2024, a milestone that will be achieved profitably. "Our ability to make long-term manufacturing investments, supported by our profitability, is unique in the smart rings market," Mohit Kumar noted. UltraFactory, a recent addition of a new manufacturing facility, is capable of supporting $200 million in annual revenue, a clear indication of Ultrahuman’s readiness for its next phase of growth. Ultrahuman's dedication to scientific validation and innovation is further evidenced by the completion of a clinical trial involving 105 participants, aimed at validating the ‘Metabolic Score’ generated on the Ultrahuman platform. "Our long-term investment in R&D and intellectual property is a cornerstone of our strategy, ensuring that our products not only meet but exceed the highest standards of efficacy and reliability," Mohit Kumar concluded. About Ultrahuman Ultrahuman is the world's most advanced metabolic fitness platform. Ultrahuman’s products include the Ultrahuman M1(continuous glucose monitoring sensor), the Ultrahuman Ring and Blood Vision, a preventive blood testing platform with the pioneering UltraTrace™ technology. By collating different biomarkers, Ultrahuman is helping people improve their energy levels and lifestyle, track their workout, sleep and recovery, and avoid metabolic disorders. For more information and updates on Ultrahuman, please visit ultrahuman.com or follow us on Facebook, Instagram, Twitter, LinkedIn, and YouTube. Ultrahuman was started by Mohit Kumar and Vatsal Singhal, who were also co-founders at Runnr, which later merged with India’s largest food delivery service Zomato. Mohit is an avid cyclist and a Brazilian Jiu-Jitsu enthusiast. Vatsal is a cross-fit enthusiast. Mohit was training at one of the largest MMA Camps in the world (Tiger Muay Thai in Thailand). During his training, he observed athletes train smartly via the usage of data, recovery tools and protocols. About Nexus Venture Partners Nexus Venture Partners is a prominent venture capital firm specializing in early-stage investments. They focus on technology-driven startups across various sectors. With a successful track record, Nexus has supported numerous innovative companies in their growth journey. About Blume Ventures Blume Ventures is an India-based venture capital firm known for its strategic investments in early-stage startups. Their portfolio spans diverse domains, including technology, healthcare, and consumer products. Blume’s hands-on approach and mentorship have contributed to the success of several emerging companies. About Steadview Capital Steadview Capital is an investment firm that primarily targets late-stage and growth-stage companies. Their global portfolio includes disruptive startups across industries. Steadview’s investment philosophy emphasizes long-term value creation and sustainable growth. About Deepinder Goyal Deepinder Goyal is the Founder and CEO of Zomato, a leading food delivery and restaurant discovery platform. Under his leadership, Zomato has expanded globally, revolutionizing the way people explore and enjoy dining experiences. His entrepreneurial spirit and commitment to innovation continue to drive Zomato’s success. Contact Details Ultrahuman Bilal Mahmood +44 7714 007257 b.mahmood@stockwoodstrategy.com Company Website https://www.ultrahuman.com/

March 20, 2024 08:00 AM Eastern Daylight Time

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News Release

American Aires Inc. (CSE:WIFI; OTC Pink:AAIRF) Proprietary Solution Against EMF Radiation Could Unlock Significant Shareholder Value

AAIRF, EDR, TKO

As the world gets more technologically advanced, there has been a dramatic rise in the number of electronic devices emitting electromagnetic fields (EMFs). EMFs are invisible energy areas associated with electrical power use, and while these EMFs have helped make our lives more convenient and connected, they have also had some unintended consequences. A number of scientific studies have shown that exposure to EMF radiation can trigger inflammation in the brain, which can lead to tissue damage and contribute to the development of various diseases, including neurodegenerative diseases. The results further demonstrated that there was a significant correlation between brain electrical activity and cognitive function, particularly in the areas of attention and working memory. Basically, using devices like your cell phone for just 30 minutes a day can increase brain tumor risks by 40%, while 24 hours of EMF exposure can induce more DNA damage than 1,600 chest x-rays. That is exactly why the Canadian-based nanotechnology company American Aires Inc. (CSE:WIFI) (OTC Pink:AAIRF), which is focused on enhancing well-being and environmental safety, has come up with what is possibly the perfect solution to this problem. American Aires has developed a proprietary silicon-based resonator that protects against the harmful effects of electromagnetic radiation. According to the company, its main goal was to find a way to minimize harm to the body without impacting the capability of electronic devices, which meant that the obvious solution was to modulate, rather than block or absorb radiation, to create a surrounding area free from the harm of EMF. So far, the company has dedicated over 20 years and poured at least $20 million into developing its proprietary nanotechnology, which has resulted in sleek and stylish, convenient devices that can be used for both personal and area protection without any need for a power source. Aires' Lifetune products target EMR emitted by consumer electronic devices such as cellphones, computers, baby monitors, and Wi-Fi, including the more powerful and rapidly expanding high-speed 5G networks. More importantly, the effectiveness of the American Aires Inc. (CSE:WIFI) (OTC Pink:AAIRF) microchip in reducing the harmful effects of EMF radiation has been reaffirmed by the scientific community. A recently published study in the Link Journal confirmed the chip’s stabilizing capabilities, while at least eight peer-reviewed studies and 25 clinical and scientific reports also validated the technology. Backed by such an impressive body of scientific research that supports the company’s technology, it’s no surprise that the company has been growing its topline at a healthy clip. Revenue growth has been robust, and over the past two years alone, the company has doubled its revenue consistently. According to the company’s most recent earnings results, Aires brought in $5.5 million in revenue for the first 9 months of 2022, representing a 63% YoY increase. Extrapolating this growth rate over the whole of 2023, Airestech could be sitting on $10 million in 2023 sales. What's even more appealing about American Aires Inc. (CSE:WIFI) (OTC Pink:AAIRF) is that it boasts superior profit margins. At the moment, its gross margins average about 60%, illustrating just how lucrative the opportunity in this space is. This level of profitability essentially puts Aires right up there with the top technology companies like Nvidia and Apple, which had 75% and 45% gross margins, respectively. The company also reached a key milestone after achieving positive EBITDA (adjusted) in its most recent quarter. A multi-billion-dollar market As you have probably realized by now, it is practically impossible to avoid EMF radiation in our technology-reliant world. That is why investors are taking a close look at American Aires Inc., which seems well positioned to capitalize on this huge opportunity. The market for Aires products is applicable to diverse customer segments, including biohackers, tech-savvy athletes, individuals focused on fertility, those seeking better sleep, and most recently, gamers. The U.S. market alone could be potentially worth $5 billion, which is just a tiny fraction of the global opportunity. Currently, American Aires Inc. (CSE:WIFI) (OTC Pink:AAIRF) operates an online direct-to-consumer sales model with fulfillment centers in the USA, Canada, Australia, and the EU and a customer base of 54,000 clients spread out across 65 countries. However, the company believes that it has the opportunity to further expand its reach now that its products have been especially popular among high-performing athletes and celebrities who value health and wellness. That explains why earlier this month Aires announced the launch of its new campaign, #airesathletes, to broaden its impact within the elite performance sphere, with UFC star Maycee Barber as the first athlete partner. Maycee "The Future" Barber is a formidable presence in the women's flyweight division of the Ultimate Fighting Championship (UFC). Last year, the UFC and WWE merged to form TKO Group (NYSE:TKO), and Aires’ initiative aims to connect with professional athletes who have turned to the company for the significant benefits its technology offers, particularly in terms of physiological optimization through EMF modulation as well as the proven protection from external EMF sources. And just earlier this week, American Aires Inc. (CSE:WIFI) (OTC Pink:AAIRF) announced that it had signed another strategic partnership with William Morris Endeavor Entertainment (WME), a titan in entertainment, sports, and fashion. WME is a leader in the global entertainment arena, bringing to the table a vast network of world-class artists, athletes, and content creators and a proven track record in talent management and strategic marketing. That means WME is perfectly positioned to elevate Aires' footprint, increasing brand reach and engagement and underscoring the extensive benefits of Aires' solutions for wellness and performance optimization. WME is part of Endeavor Group Holdings, Inc. (NYSE:EDR), a global sports and entertainment behemoth that has a 51% stake in TKO. This collaboration will harness the growing interest from elite athletes and performers in Aires' innovative solutions and capitalize on the momentum Aires has built among top-tier athletes, expanding on the recently launched #airesathlete campaign. Additionally, this partnership between American Aires and WME underscores a transformative vision: Aires Technology, already trusted by elite athletes and performers for its unmatched performance and recovery benefits, is poised to become a global standard for EMF protection and physiological optimization. CapitalGainsReport (CGR) is not operated by a licensed broker, a dealer, or a registered investment adviser. This content is for informational purposes only and is not intended to be investment advice. The Private Securities Litigation Reform Act of 1995 provides investors a safe harbor in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions, or future events or performance are not statements of historical fact may be forward looking statements. Forward looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties which could cause actual results or events to differ materially from those presently anticipated. Forward looking statements in this action may be identified through use of words such as projects, foresee, expects, will, anticipates, estimates, believes, understands, or that by statements indicating certain actions & quote; may, could, or might occur. Understand there is no guarantee past performance will be indicative of future results. Investing in micro-cap and growth securities is highly speculative and carries an extremely high degree of risk. It is possible that an investors investment may be lost or impaired due to the speculative nature of the companies profiled. CapitalGainsReport (CGR) is owned by RazorPitch Inc. and has been retained by a third party to assist in the production and distribution of content related to American Aires Inc.. 'CGR' is responsible for the production and distribution of this content. It should be expressly understood that under no circumstances does any information published herein represent a recommendation to buy or sell a security. This content is for informational purposes only, you should not construe any such information or other material as legal, tax, investment, financial, or other advice. Nothing contained in this article constitutes a solicitation, recommendation, endorsement, or offer by CapitalGainsReport/RazorPitch or any third party service provider to buy or sell any securities or other financial instruments. All content in this article is information of a general nature and does not address the circumstances of any particular individual or entity. Nothing in this article constitutes professional and/or financial advice, nor does any information in the article constitute a comprehensive or complete statement of the matters discussed or the law relating thereto. CGR/RazorPitch is not a fiduciary by virtue of any persons use of or access to this content. Contact Details CapitalGainsReport Mark McKelvie +1 585-301-7700 Markrmckelvie@gmail.com Company Website http://CapitalGainsReport.com

March 20, 2024 05:00 AM Eastern Daylight Time

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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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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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

AGBOOST SCALES AI-ENABLED GENETIC DATA ANALYSIS SOFTWARE FOR CATTLE PRODUCERS

AgBoost

After years of product development and field testing, AgBoost announced the global commercial expansion of its cloud-based data analysis platform that helps cattle producers interpret genomic data for selective breeding, health, market value and nutrition management. Despite a 65% increase in U.S. beef herd productivity over five decades, according to United Stated Department of Agriculture (USDA), rising demand for sustainably produced meat and shrinking profit margins underscore the importance of genetic data for herd efficiency. "Too often, cattle producers invest in DNA technology without unlocking its full potential," said Sean Akadiri, founder and CEO of AgBoost, at the 2024 Animal AgTech Innovation Summit and World Agri-Tech Innovation Summit. "Our platform revolutionizes decision-making, empowering ranchers with faster, more precise choices. By putting genetics at their fingertips, we're reducing the average $2,000 loss per calf during breeding and development, giving ranchers a decisive advantage over the competition.” Traditionally, breeding decisions rely on visual appraisals and multi-generation written records of estimated genetic merit. AgBoost's software combines genomic and production data, including live birth weight and diverse phenotypic information, for individual animals. Users can track animals individually or group them, such as in replacement heifer groups. By selecting specific traits, producers gain a comprehensive view to inform feeding, animal health, and marketing decisions effectively. “Genomic testing data can feel like deciphering hieroglyphics to most producers. But AgBoost transforms complexity into simplicity, presenting data in a visual wheel that sparks meaningful conversations. Now, we can swiftly identify the top bulls with complementary traits for desired calves,” said Nick Jorgensen, CEO and CFO of Jorgensen Land and Cattle, who not only licenses the platform for its large seed stock operation but also invested in the company. Seedstock cattle producers depend on analytics for marketing in bull and production sales. AgBoost visually showcases genetic value and identifies DNA-linked traits, like production, maternal, and carcass traits, aiding in sorting and selecting specific characteristics. The tool also allows for scenario planning, including establishing keep/cull lines to distinguish the top and bottom of the gene pool. Poised for Rapid Expansion into New Geographies and Livestock Introduced to U.S. cattle producers in 2018, AgBoost now holds millions of genomic data records for individual cows. With recent patent approvals, the company aims to expand into top-producing markets like Brazil, Canada, China, and the United Kingdom. The global beef market, valued at $526.50 billion in 2023, is projected to grow at a 4.2 percent CAGR by 2030. Currently, AgBoost supports all sizes of seedstock and commercial cow/calf producers, regardless of breed association, with an interactive pedigree and sire link, with a breeding suggestion calculator coming in late 2024. As pioneers in the market, the company intends to broaden individual producer subscriptions, enterprise licensing agreements, and tailor the platform for additional livestock and related industries to meet current demand. For more information, visit www.Ag-Boost.com. About AgBoost Established in 2013 by engineers and cattle producers as a subsidiary of the animal agtech leader, Agric-Bioformatics, Inc., AgBoost pioneers affordable, user-friendly genetic management tools for livestock producers worldwide. Our comprehensive software streamlines the entire process—from ordering tests to interpreting data for actionable insights and creating effective marketing tools. At AgBoost, our mission is clear: to prioritize producers by empowering them to own and comprehend their data, unlocking maximum growth potential for the future. To learn more or request a demo, visit www.Ag-Boost.com. Contact Details AgTech PR for AgBoost Jennifer Goldston jennifer@agtechpr.com

March 18, 2024 12:17 PM Central Daylight Time

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