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Tonix Pharmaceuticals receives positive feedback from FDA on Tonmya™ for fibromyalgia management

Tonix Pharmaceuticals

Tonix Pharmaceuticals (NASDAQ:TNXP) CEO Dr Seth Lederman joined Steve Darling from Proactive to announce the receipt of formal minutes from a pre-New Drug Application (NDA) meeting with the US FDA regarding Tonmya sublingual tablets, which is aimed at managing fibromyalgia. This significant development marks a crucial step forward in the regulatory process for Tonmya™. During the meeting, both the company and the FDA concurred that the proposed data package is comprehensive and sufficient to support the NDA submission. Tonix Pharmaceuticals has reaffirmed its plan to submit the NDA for Tonmya to the FDA in the second half of 2024. If the submission proceeds as planned, it could pave the way for a potential FDA approval in the second half of 2025. Dr Lederman highlighted the promising potential of Tonmya to benefit fibromyalgia patients, a demographic that frequently expresses dissatisfaction with existing treatment options. Many patients currently resort to using off-label treatments, including addictive and detrimental opioids, due to the lack of effective alternatives. The positive outcomes from the pre-NDA meeting underscore the robustness and completeness of the data package that supports the registration of Tonmya for the management of fibromyalgia. Tonix Pharmaceuticals is optimistic about the impact that Tonmya could have on the fibromyalgia treatment landscape. The company's focus remains on advancing this promising therapy through the regulatory process and ultimately providing a new, effective option for patients struggling with this challenging condition. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

July 18, 2024 10:20 AM Eastern Daylight Time

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Freelance jobs grow despite AI, finds new data from Freelancer.com

FREELANCER.COM

Freelancer.com (ASX: FLN), the world’s largest freelancing and crowdsourcing marketplace by number of users and jobs posted, today released its quarterly Fast 50 Index for Q2 2024 based on data from 251,000 jobs posted to the platform. Computer Security (up 27.1% from 868 to 1,103 jobs) emerges as the fastest-growing freelance skill on Freelancer.com, based on job postings across more than 2,000 skill categories from April 1 to June 30, 2024. This trend in cybersecurity skills suggests more small-to-medium businesses are turning to freelancers for cyber security support, further backed by Network Administration (up 9.9%, from 1,229 to 1,351) also placing in the top 25 fastest growing jobs on the platform. The data also shows no negative impact on generative AI tools on freelance jobs, evident in the growth of Writing, Business Service, and Legal Skills seen in this quarter’s Fast 50 report, all of which were predicted to decrease with the rise in generative AI. PDF writing (up 26.7%, from 2,533 to 3,210) was the second fastest growing job, followed by third place being Microsoft Word (up 23.9%, from 3,368 to 4,173) projects which are also associated with content writing. Writing job Copy Typing came in at the 16th place, growing 11.6% (from 4,428 to 4,941). Legal jobs, which were expected to have been ‘at threat’ to AI, have also increased (up 12.0% from 1,138 to 1,274), as well as Legal Research (up 10.8% from 917 to 1,016). In addition to the index, Freelancer.com ’s annual AI survey, which surveyed more than 4,100 workers globally, investigated AI impact on income and the initial results are shedding light on earnings. When asked how the introduction of AI tools have impacted earnings, more than half of workers (52.5%) reveal they’re earning either the same or more. One fifth (19.2%) say that they’re earning a lot more since generative AI tools were introduced, while only one sixth (17.7%) admit to earning less. “AI is creating more jobs than it takes. While many critics continue to speculate which jobs will be made redundant with AI tools, the data shows that freelance jobs which are labeled as the ‘most at risk to AI disruption’ are in fact growing. The preliminary results from our AI survey also dispel the myth that freelancer are earning less since the introduction of generative AI as more three quarters of workers we surveyed are either earning the same or earning more, with a subset taking advantage of AI and earning a lot more.” said Matt Barrie, Chief Executive at Freelancer.com. Cybersecurity threats are on the rise across all organizations, but are particularly harmful for small-to-medium sized businesses (SMBs) which have little-to-no security expertise and usually minimal protection. As a result, businesses turned to freelancers for help. In 2Q24, Computer Security jobs ranked as the fastest growing skills (up 27%), indicating there has been an uptick in cyber security threats targeting SMBs. Many of the projects posted throughout the quarter require help with network security, security assessments to identify potential vulnerabilities, and creation of cyber security response play books. General business services are also increasing on the platform as more employers are hiring freelancers to support their small businesses. A clear indication of this is the popularity of Market Research and Telemarketing jobs coming in as the fourth and fifth fastest growing skills in Q2 2024, up by 21.1% (from 1,525 to 1,859) and 19.4% (from 1,177 to 1,405), respectively. Other business related skills grew in Q2 2024, including Sales (up 15.5% from 3.467 to 4,005), Lead Generation (up 12.2% from 1,802 to 2,021) and Business Plans (up 10.9% from 1,197 to 1,328). A sudden increase in General business services means that many of the new businesses, which are usually started at the beginning of the year, now require further assistance in helping grow and scale their business. Fastest Falling Skills for Q2 2024 The main category of jobs that fell in Q2 2024 was eCommerce related jobs, which saw a significant increase in Q1 2024. Shopify Templates, ranked as the fastest falling skill and was down by 13% (from 1,476 to 1,284). CSS, which is commonly used in website development, was also down (11.8% from 9.486 to 8,368). Both WooCommerce (from 1.072 to 952) and Shopify (2,545 to 2,269) also fell in the quarter. The easing of eCommerce jobs in this quarter was mainly due to seasonality. Typically, entrepreneurs will start a business at the beginning of the year, requiring help to set up their websites or eCommerce platforms. From there, the entrepreneur either pivots to hiring freelancers for other business services, such as sales or research which we’ve seen in Q2 2024 fastest growing jobs, or are equipped with enough to run their business without any further help. Fastest Growing Overall Job The most popular online freelancing job by total volume is currently Graphic Design with almost double the amount of projects than the other top skills. Graphic Design is followed by PHP (programming), Photoshop, Website Design and HTML (programming). These are typically the best skills for any new freelancer to focus on initially when starting their freelancing journey. How Electronic Repairs Are Becoming the Fastest Growing Skill Globally Electronic Repairs has emerged as one of the fastest-growing job categories on the platform over the past year. In Q2 2024, it ranked 19th among the top 25 fastest-growing jobs, with a 10.7% increase (from 14,945 to 16,548 jobs). However, its most impressive growth is evident in the year-over-year comparison, where Electronic Repairs jobs surged by 162%, from 6,315 in Q2 2023 to 16,548 in Q2 2024. Electronic Repairs are in-person jobs where freelancers are deployed across select countries and cities to fix laptops, printers and computer hardware as part of the Freelancer Global Fleet Program. ##### Freelancer.com Fast 50 The Freelancer.com Fast 50 index is the world’s largest forward indicator of trends in online jobs related to industries, technologies, products, and companies. The data is based on 251,000 jobs posted to the Freelancer.com platform between 1st April to 30th June 2024. Data: Fast 50 Quarterly Index – Q2 2024 2023 Q2 v 2024 Q2 Fastest Growing Jobs for Q2 2024 Fastest Falling Jobs for Q2 2024 About Freelancer Twelve-time Webby award-winning Freelancer.com is the world’s largest freelancing and crowdsourcing marketplace by total number of users and projects posted. More than 74 million registered users have posted over 23.8 million projects and contests to date in over 2,000 areas as diverse as website development, logo design, marketing, copywriting, astrophysics, aerospace engineering and manufacturing. Freelancer owns Escrow.com and Loadshift. Freelancer Limited is listed on the Australian Securities Exchange under the ticker ASX:FLN and is quoted on OTCQX Best Market under the ticker FLNCF. Contact Details Freelancer.com Marko Zitko +1 650-800-6863 mzitko@freelancer.com

July 18, 2024 07:00 AM Eastern Daylight Time

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Ascend Wellness CEO Outlines Company's Growth Strategy and Market Expansion Plans

Ascend Wellness Holdings

Ascend Wellness CEO John Hartman joined Steve Darling from Proactive to discuss the company’s current status and future plans. Ascend Wellness, a prominent multi-state cannabis operator in the United States, has established its presence primarily in the Midwest, Northeast, and Mid-Atlantic regions. The company, now in its fifth year of operation, has expanded its footprint to seven states, including Ohio and Pennsylvania, both of which are transitioning to recreational cannabis use. During the interview, Hartman emphasized Ascend Wellness's strategic approach of focusing on select markets and maximizing the number of dispensaries allowed in each state. This targeted strategy is aimed at optimizing market penetration and ensuring robust growth. Drawing on his extensive background in wholesale, retail, and manufacturing, Hartman highlighted the company's emphasis on effective capital deployment and growth through mergers and acquisitions (M&A). A significant development discussed was the refinancing of a term loan due in August 2025. This financial maneuver provides Ascend Wellness with a five-year runway to concentrate on growth initiatives. The refinancing is expected to enhance the company's balance sheet management, providing greater financial stability and flexibility. Contact Details Proactive North America +1 604-688-8158 na-editorial@proactiveinvestors.com

July 17, 2024 10:42 AM Eastern Daylight Time

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Briefly Bio launches with $1.2m funding to help scientists reproduce complex experiments

Briefly Bio

Science is in a reproducibility crisis. In preclinical research, it’s estimated that over 50% of efforts to reproduce experiments fail, costing the industry over $50bn each year. Solving this problem, techbio startup Briefly Bio has launched with software that makes lab work more reproducible by helping scientists capture and share their work clearly and consistently. With this launch, Briefly Bio has secured a $1.2m pre-seed funding round. It was led by Compound VC, with participation from NP Hard, Tiny VC and angel investors across tech and biotech. Biological experiments have become increasingly complex. With this growing complexity, details that are critical to our shared understanding are often undocumented and lost. This makes scientific collaboration inefficient: lab scientists struggle to reproduce and build on top of each other's experiments; data scientists do not have the necessary context to analyse the data produced in their labs; and automation teams lack all details to build robotic labs. Briefly Bio is tackling this, creating a shared language for experiments that is consistent across scientists, and clear for any collaborator to understand. Their software uses AI to convert existing experiment descriptions into this consistent format, while automatically filling in gaps and spotting errors. This helps capture the value of every experiment that is run, and enables scientists to learn from each other’s work. Briefly was founded by Dr Katya Putintseva, Harry Rickerby and Staffan Piledahl. They have varied backgrounds, through academia, tech, biotech and robotics. Before founding the company, the three worked together at drug discovery startup LabGenius, where they helped build its ML-driven antibody discovery platform. Harry Rickerby, CEO and co-founder at Briefly Bio, commented: “Scientific methods are a bit like software code, they are a set of instructions that define how an experiment should be run. The majority of this ‘code’ is incomplete, since writing up each experiment completely takes a huge amount of effort. Now, with LLMs, there’s a way to make these methods consistent without imposing on a scientists’ workflow. As Github helped software engineers collaborate and build on each other’s code, we think Briefly can help scientists and engineers do the same with their experiments.” With AI and high throughput experimentation, there is an opportunity for huge improvements in the efficiency of scientific discovery. Hundreds of billions of dollars are being invested through startups and big pharma to take advantage. To realise this potential, science needs more consistency and transparency in how these datasets are generated, since the value of any model is a product of the data it has been trained on. Briefly Bio is building this necessary layer of infrastructure to accelerate scientific discovery in biology. “This is a revolution in documenting lab experiments. It is the future of foolproof knowledge-sharing between scientists” said Dr Gena Nikitin, Founder of Miphic. While Dr Maria Anastasina, Wet Lab Head at the Evolutionary and Synthetic Biology Unit, OIST, added: “Briefly has become a core part of our lab's knowledge base and a great help to me in training researchers and lab management”. And Suparna Kumar, PhD student at Weill Cornell commented: “Briefly Bio has become an indispensable part of my lab routine because it helps me save so much time”. Rob Harkness, CTO of Biosero, added: “We're very excited by what Breifly.Bio can offer with their software tools. Inconsistent and incomplete data can compromise research, making it difficult to reproduce experiments and undermining trust in scientific results. Digitalising and automating laboratory operations can address this, but this effort faces challenges of inefficiency and high error rates, primarily due to the diverse formats in which workflows are presented. Briefly.bio addresses this by converting scientific protocols written in natural language into a common and consistent structured format. This facilitates much faster design and implementation of automated systems, ensuring all critical information is captured and utilized effectively. The result is a significant boost in workflow integration, efficiency, and data quality, all of which are crucial for generating reliable experimental results. This leads to more comprehensive and innovative solutions in lab automation that can only help accelerate scientific research.” Shelby Newsad, Investor at Compound, commented: “The crux of successful science lies in consistent and executable methods. Whereas most bio software companies focus on data and its analysis, Briefly goes upstream to the core problem space of reproducibility via protocols. For the first time in science history, this incentivizes scientists to share more of their previously tacit knowledge. The fact that Briefly-made methods can be built and collaborated upon creates unique potential for network effects from their software.” Briefly Bio is creating a future where scientists can stop reinventing the wheel – spending time and resources on experiments that they can’t reproduce. This will enable scientists to produce datasets that will quickly expand our understanding of biology. About Briefly Bio Briefly Bio is the tool to make lab work reproducible. It helps scientists capture, share their experiments clearly and consistently. Briefly is based in London, UK. For more information, visit https://briefly.bio. About Compound VC Compound is a research-centric, thesis-driven investment firm. We are a team of investors, researchers, and operators. We use our domain expertise, network, and prior experiences to help our founders solve previously unsolvable technical problems, communicate these breakthroughs to the world, and scale commercialization. Contact Details Briefly Bio Bilal Mahmood +44 7714 007257 b.mahmood@stockwoodstrategy.com Company Website https://briefly.bio/

July 17, 2024 08:00 AM Eastern Daylight Time

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Medicus Pharma CEO Dr. Raza Bokhari Announces Updated Phase 2 Clinical Protocol Submission to FDA

Medicus Pharma

Dr. Raza Bokhari, Executive Chairman and CEO of Medicus Pharma joined Steve Darling from Proactive to announce the submission of a comprehensive and updated Phase 2 Investigational New Drug clinical protocol to the United States Food and Drug Administration (FDA). This protocol aims to non-invasively treat basal cell carcinoma of the skin using micro-needle arrays containing doxorubicin, developed by Medicus Pharma’s wholly owned portfolio company, Skinject, Inc. The submission features significant updates to the clinical protocol, including enhancements to the supporting Chemistry, Manufacturing, and Controls (CMC), along with detailed stability and sterility information. Furthermore, it addresses the clinical non-hold comments previously received from the FDA, ensuring a robust and thorough response to regulatory feedback. Dr. Bokhari shared with Proactive that the revised Phase 2 clinical protocol incorporates innovative elements such as artificial intelligence and confocal microscopy as supplementary endpoints at one of the clinical sites. These advanced technologies are expected to provide deeper insights and improved accuracy in the clinical outcomes. Medicus Pharma believes that this updated protocol is well-positioned to receive FDA approval, paving the way for the commencement of participant randomization potentially before the end of this quarter. This milestone underscores the company’s commitment to advancing innovative treatments for skin cancer and improving patient outcomes through cutting-edge technology and rigorous clinical research. Contact Details Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com

July 16, 2024 11:51 AM Eastern Daylight Time

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University Compounding Pharmacy Announces Rebrand to MediVera Compounding Pharmacy™

MediVera

University Compounding Pharmacy, a leader in personalized medicine since 1999, today announced it is rebranding as MediVera Compounding Pharmacy™. The rebrand comes at a time when the company is growing strongly due to the introduction of new product offerings, nationwide expansion, and the successful differentiation of its quality products and services. Despite the name change, the company’s ownership and passionate team remain the same, ensuring continuity in the high-level service and exceptional care that healthcare providers and patients have relied on for more than two decades. Over the past few years, the company has seen its revenue grow substantially. New product offerings, nationwide expansion, and strong market positioning through differentiated quality products and services, such as the Impressed Advantage program, have enabled the company to double its revenue from 2022 to 2023. Growth is anticipated to accelerate this year, with the company expecting to double revenue year-over-year once again. “Differentiation is and will continue to be an important growth driver for our company. With the Impressed Advantage customer service program, we are making the prescription process easier, faster, and more convenient for both doctors and their patients,” said Bradley McCloskey, PharmD, CEO. “As we continue to launch more product offerings and expand into more states within the next few months, 2024 is poised to become a year of strong growth as we expand our footprint into 14 additional states.” For more information about MediVera Compounding Pharmacy and its services, please visit mediverarx.com or contact Laurie Malseed, Marketing Specialist, at laurie@mediverarx.com or 937-242-0430. About MediVera Since its inception in 1999, MediVera Compounding Pharmacy™ (formerly University Compounding Pharmacy) has been dedicated to providing personalized medicine. With a focus on quality and innovation, MediVera Compounding Pharmacy™ continues to set industry standards, offering tailored solutions to meet the unique needs of healthcare providers and patients. MediVera Compounding Pharmacy™ is currently licensed in and ships to the following 33 states: AZ, CN, CO, DE, FL, GA, IA, ID, IL, IN, KY, MA, MD, ME, MI, MN, MO, MT, NC, NH, NJ, NY, OH, PA, RI, SC, SD, TN, VA, VT, WA, WI, WY. Contact Details MediVera Compounding Pharmacy Laurie Malseed +1 937-242-0430 laurie@mediverarx.com

July 16, 2024 09:00 AM Eastern Daylight Time

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Huma completes Series D with total financing of over $80m as it launches Huma Cloud Platform with GenAI integrations to bring digital first care and research to everyone

Huma

Building and launching a scalable digital health product that meets regulatory demands typically takes a few years to deliver. Today, global healthcare AI company Huma Therapeutics Limited is announcing the completion of its Series D funding round to help cut that time down to days as it launches the Huma Cloud Platform. The platform offers no-code configuration of regulated disease management tools for any therapeutic area, a library of pre-built modules and device connectivity capabilities, a cloud-agnostic framework for flexible hosting, readily available APIs and integration capabilities, the ability to host and deploy diagnostic and predictive AI algorithms, a marketplace, and more to advance digital-first care and research. The Series D funding round, alongside investments from leading industry partners since its Series C round, created a total issuance of shares by Huma of over $80m. With this round, Huma has now raised over $300m. The Series D saw the participation of new and existing strategic and financial investors, including AstraZeneca, Hat Technology Fund 4 by HAT SGR, HV Fund by Hitachi Ventures and Leaps by Bayer and others. HSBC Bank plc acted as advisor to Huma during the fundraise. Alongside its Series D, Huma is also announcing the launch of its Huma Cloud Platform – a technology ecosystem designed not only to support the company’s own digital health initiatives, but also to empower others to launch and scale their projects efficiently. With its Huma Cloud Platform and the regulatory foundation that it is built on, Huma aims to reduce the time it takes to develop and launch digital health projects at scale from years to as little as a few days. The Huma Cloud Platform is built to serve the company's existing regulated products. In 2023, Huma achieved the landmark milestone of becoming the first and only configurable, disease-agnostic FDA Class II, EU MDR Class IIb, India CDSCO Class C and Saudi FDA Class C platform, enabling rapid, code-free configuration with the ability to host AI/ML models. The regulatory status of the Huma Cloud Platform significantly reduces the cost, time, and risks associated with bringing digital health projects to life. Huma is now making this platform available to customers which comes with a Software Development Kit (SDK) to enable the accelerated development of similar applications or to embed functionalities into their existing solutions. Dr Juergen Eckhardt, EVP, Head of Leaps by Bayer and Pharmaceuticals Business, Development & Licensing commented: “We have known Huma for several years and we've been impressed by their remarkable progress. We have seen this first-hand. They have demonstrated strong growth and excellent metrics. With their next-generation AI capabilities and Huma Cloud platform, Huma can partner with pharma companies to deliver efficient digital health solutions to patients focused on predictive and proactive care.” “Pharmaceutical companies need financially and technically efficient digital solutions to minimise spending on efforts that are duplicative or can't scale. The Huma Cloud Platform enables companies to streamline how they bring digital medicine, companion apps, and data collection capabilities to patients from the R&D phase to post-launch.” To date, Huma’s technology has powered projects in over 3,000 hospitals and clinics. The platform has been used to engage and screen over 35 million individuals, with 1.8 million active users across its products in over 70 countries. Huma’s U.S. business has grown significantly since launch with new reimbursement codes. The RPM product, built on top of the Huma Cloud Platform for respiratory use cases, now covers 140,000 contracted lives. As a result of all these successes, the company has doubled its revenue year-on-year, and is targeting to become profitable this year. Huma also collaborates with over half of the top 20 pharmaceutical companies globally and has been involved in major national healthcare projects worldwide. Huma has partnered with Google and others to develop new AI models that could enable its Cloud Platform users to care for many times more patients with less work; for example a feature called “10x Nurse” that significantly reduces administrative tasks and brings automation to the patient review process with a human in the loop. This opens new possibilities, such as efficiently managing chronic diseases with fewer staff or using real-time monitoring systems to ensure patients are on the correct treatment pathways while keeping humans still in the loop. Looking ahead, combining the Huma Cloud Platform with next-generation AI models will enable Huma to have a bigger impact through its digital-first care and research initiatives, as well as supporting small startups and enterprises in launching the digital solutions they need. It promises to do this much faster and cheaper, shifting the focus to project or venture success rather than getting distracted with scaling technology or managing regulatory burdens. Dan Vahdat, Founder and CEO of Huma, said, “I am thankful for the support of our new and existing shareholders, helping our vision become a reality, which we are closer to than ever before. We are here to accelerate the adoption of digital and AI across care and research, and we do that by making the building of digital health solutions for care and research easy. We like to think of Huma Cloud Platform much like Shopify but for digital health instead of e-commerce. We believe when digital and AI are scaled, they become affordable for both the poor and the rich. This will help us transition medicine from being reactive to proactive.” About Huma Huma is a global healthcare AI company on a mission to accelerate the adoption of digital solutions in care and research. Its award-winning modular platforms are used by more than 3,000 hospitals and clinics, with over 35 million screened users and 4 million registered users in healthcare, and has powered over 800 studies supporting about 1 million participants across research. The company is renowned for its role in major national healthcare projects worldwide, from the US and the UK to Germany, Greece, and Saudi Arabia, as well as collaborating with most large pharma companies. Huma's technology powers: ● multi-channel patient engagement at population-wide scale for healthcare systems ● remote patient monitoring (RPM) at scale ● companion apps to support patients through treatment and drug therapies ● digital clinical trials, including decentralised trials, to accelerate medical research Huma's regulated Software as a Medical Device, used in its RPM and companion app platforms, is the only disease- and device- agnostic platform to hold EU MDR Class IIb, US FDA (510-k) Class II clearance and Class IIb registration with the UK MHRA. The SaMD platform is regulated to accept artificial intelligence algorithms and monitor patients of all ages. For more information please visit www.huma.com. Contact Details Huma Bilal Mahmood +44 7714 007257 b.mahmood@stockwoodstrategy.com Company Website https://www.huma.com/

July 16, 2024 08:00 AM Eastern Daylight Time

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Ultrahuman announces its App Store ‘PowerPlugs’ with the World’s First AFib Detection Technology on a Smart Ring

Ultrahuman

Ultrahuman, a pioneer in wearable technology, launches PowerPlugs, a platform for individual apps and plugins built on top of Ultrahuman’s health and wellness data stack. This is the world’s first in a smart ring form factor. Recognizing each individual’s health journey is unique, PowerPlugs enable people to choose and focus on the aspects of their health that matter most. It’s designed for highly personalized health insights, ensuring that every individual can personalize their health tracking to their unique needs and goals. At the forefront of PowerPlugs is AFib Detection, a PowerPlug that discreetly monitors your heart rhythm every night to detect signs of Atrial Fibrillation (AFib). Ultrahuman Ring AIR is the first smart ring in the world to offer AFib detection. AFib is the most common type of irregular heart rhythm or arrhythmia. It can lead to serious health complications such as stroke and heart failure, if left undetected. Individuals with potential arrhythmia episodes or a history of irregular rhythms can now track AFib closely and seek early intervention. Speaking on the launch, Mohit Kumar, Founder and CEO of Ultrahuman said “When it comes to health, one size doesn’t fit all. That’s why we built PowerPlugs for people to pick and choose what matters most for their health and wellness. Over the next few years, you could expect thousands of applications to be built on top of Ultrahuman’s comprehensive health data platform. Given our most comprehensive data stack of health markers from Ultrahuman Ring, M1 CGM, Ultrahuman Home and more to come, there’s infinite scope to build deep experiences over the next few years. Essentially, your Ultrahuman Ring will keep getting better after your purchase.” “We’re launching our first few PowerPlugs with a novel game changing capability, AFib detection. This life saving technology comes with medical approval in limited markets currently and we’re aggressively launching new markets with regulator’s approval every few weeks.” The PowerPlugs ecosystem can be accessed through the Ultrahuman App and is available in free and premium options. Circadian Rhythm Understanding the importance of aligning with natural circadian rhythms, the Ring AIR provides actionable recommendations tailored to your lifestyle. These suggestions include the optimal times to expose yourself to natural light, exercise, and wind down in the evening, aiming to enhance your energy levels, improve sleep quality, and bolster your overall health. Pregnancy Mode Pregnancy Mode adjusts health monitoring and recommendations specifically for pregnancy. It provides tailored advice on nutrition, activity levels, and health metrics that are crucial during this time. Gain insights into how to maintain your health and your baby's development, with safety and well-being as the priority. Cycle Tracking Cycle Tracking offers a comprehensive overview of your menstrual cycle phases and predicts upcoming cycles with high accuracy. This tool provides personalized insights into your fertility windows and symptom patterns, enabling proactive health management and lifestyle adjustments. Empower yourself with knowledge to make informed decisions about your reproductive health. Caffeine Window Track and optimize your consumption of stimulants such as caffeine throughout the day. By understanding your body's response to different stimulants, this tool advises on the best times for consumption to boost your alertness without affecting your nightly rest. Ideal for maintaining high energy levels and ensuring restful sleep. Vitamin D Manage Vitamin D intake through sun exposure. The app calculates the optimal times for you to step outside, based on your skin type, location, and current UV index, ensuring you get the most effective and safe sun exposure. It focuses on skin absorption, telling you precisely when to go out and estimating how much Vitamin D (in IU) your skin will absorb during your session. With real-time tracking and safety alerts to prevent overexposure, this PowerPlug makes maintaining healthy Vitamin D levels effortless and personalized. Jet Lag Jet Lag PowerPlug features personalized jet lag plans based on the users' travel itineraries, sleep patterns, and chronotypes, leveraging evidence-based methods involving light exposure, melatonin supplements, caffeine, and naps. It offers detailed schedules to follow before, during, and after trips, helping reset the circadian clock efficiently. Weight loss Integrate meal planning with real-time glucose monitoring to optimize your fitness journey. Ultrahuman Ring AIR tracks calories burnt throughout the day. It syncs with automated food logging to provide a comprehensive view of calorie intake versus expenditure. This helps users maintain a balanced diet and work towards their fitness goals without the hassle of manually logging their data. This is a game changer for anyone optimising their weight loss journey. Ovulation Women can now understand ovulation cycles, helping them better understand their bodies and menstrual health. For women looking to conceive, accurate ovulation detection can significantly increase the chances of pregnancy by identifying the most fertile days. Conversely, for those practising natural family planning methods, knowing the ovulation period can help in avoiding pregnancy. Additionally, continuous monitoring can help identify potential reproductive health issues early, allowing for timely interventions. Ultrahuman’s accessibility to health personalization doesn’t stop there. For the first time ever, developers can get access to Raw PPG, Accelerometer and Temperature data streams from the Ring AIR. Ultrahuman invites developers to build bespoke algorithms on top of these data streams from the Ring AIR using UltraSignal, Ultrahuman Ring AIR’s developer platform. UltraSignal will help fuel more customization and innovation in health. Developers can build custom algorithms for Sleep, Stress, Movement, Fertility and more, creating their own Powerplug. 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. Contact Details Ultrahuman Bilal Mahmood +44 7714 007257 b.mahmood@stockwoodstrategy.com Ultrahuman Hisham Syed hisham@ultrahuman.com Company Website https://www.ultrahuman.com/

July 16, 2024 08:00 AM Eastern Daylight Time

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Autonomix's Trial Results Show Meaningful Reduction In Pain For Patients Suffering From Pancreatic Cancer

Autonomix Medical, Inc.

By Austin DeNoce, Benzinga Autonomix Medical (NASDAQ: AMIX) is a cutting-edge medical technology company developing targeted nerve therapies to revolutionize how diseases involving the peripheral nervous system are diagnosed and treated. The company's ongoing proof-of-concept (PoC) human clinical trial is evaluating the safety and efficacy of radiofrequency (RF) ablation in a transvascular approach to reduce pain associated with pancreatic cancer and, to date, has demonstrated extremely compelling results. If successful, Autonomix has the potential to dramatically impact patient well-being and improve quality of life, offering new hope for patients enduring pancreatic cancer pain. Key Trial Insights The initial phase of the clinical trial involved five lead in patients who underwent the procedure without complications or significant adverse events. Some 60% of these subjects experienced a significant reduction in pain, with a mean decrease of 6.33 points on the Visual Analogue Scale (VAS) pain scale, dropping from a baseline of 8.0 to 1.67 just seven days post-procedure. Patients also reported quick pain relief, with some feeling better as soon as one day after the procedure​​. A detailed look at the data should provide Autonomix with important insight into optimizing the procedure, particularly the catheter entry point, where three of the five patients who benefited with meaningful pain reduction had femoral access to the catheter and the two that did not respond had brachial access. The primary objective of this PoC trial is to assess the success rate of ablating relevant nerves to mitigate pain in patients with pancreatic cancer using radiofrequency ablation. Secondary objectives include evaluating device- and procedure-related adverse events up to six weeks post-procedure, changes in pain levels and improvements in quality of life from pre- to post-procedure​​. Autonomix is proceeding with enrolling an additional 20 subjects to participate in the study and expects to complete enrollment by the end of 2024. The company expects to report topline results from all 20 subjects in the first half of next year. Clinical Trial Testimonials According to Autonomix, patients in the responder group reported substantial improvements in their quality of life. On average, these patients noted a 78% enhancement in how they viewed their overall health and a 45% boost in how they viewed their life quality, within seven days of the procedure. This rapid relief is crucial for individuals facing end-of-life situations due to advanced pancreatic cancer, offering them a better quality of life during their remaining time​​. Patient testimonial s further emphasize the impact of the procedure. Before the procedure, patients can struggle with debilitating pain, which affects their ability to sleep, eat and perform daily activities. Post-procedure, patients experienced immediate, life-changing pain relief and could sleep on their back, return to work and attend social events. Additionally, one patient stated they no longer needed painkillers, and experienced significant improvements in overall health and quality of life. This transformation underscores the procedure's potential to greatly enhance the lives of patients suffering from pancreatic cancer pain. Technical Approach And Future Plans Autonomix's technology aims to improve upon current pain management methods, which often rely on systemic drugs like opioids or invasive procedures that can have severe side effects. Autonomix’s catheter-based system is also designed to detect and ablate pain-associated neural signals more accurately. While the current trial focuses on pancreatic cancer-related pain, Autonomix also plans to explore other indications in the future based on these promising results. A New Dawn In Pain Management Autonomix’s innovative approach to pain management for pancreatic cancer patients is showing encouraging potential. The initial success of its PoC clinical trial offers a glimpse into a possible future where patients suffering from severe pain can find relief through precise and effective medical technology. As the company gathers more data, the medical community awaits its results, which could revolutionize pain management far beyond just pancreatic cancer pain and have applications across all pain and diseases of the peripheral nervous system. Featured photo by Alexander Grey on Unsplash Autonomix is a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated. The Company’s first-in-class technology platform includes a catheter-based microchip sensing array that has the ability to detect and differentiate neural signals with approximately 3,000 times greater sensitivity than currently available technologies. We believe this will enable, for the first time ever, transvascular diagnosis and treatment of diseases involving the peripheral nervous system virtually anywhere in the body.We are initially developing our technology for pancreatic cancer pain, a condition that can cause debilitating pain and needs an effective solution. However, our technology constitutes a platform with the potential to address dozens of indications, including in cardiology, renal denervation and chronic pain management across a wide disease spectrum. Some of the statements in this release are “forward-looking statements,” which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the timing of the completion of patient enrollment in the trial and the Company’s ability to successfully meet the milestones set forth in this press release on a timely basis, if at all. Such forward-looking statements can be identified by the use of words such as ‘should,’ ‘may,’ ‘intends,’ ‘anticipates,’ ‘believes,’ ‘estimates,’ ‘projects,’ ‘forecasts,’ ‘expects,’ ‘plans,’ and ‘proposes.’Although Autonomix Medical, Inc. (or Autonomix) believes that the expectations reflected in these forward-looking statements are based on reasonable assumptions, there are a number of risks and uncertainties that could cause actual results to differ materially from such forward-looking statements. You are urged to carefully review and consider any cautionary statements and other disclosures, including the statements made under the heading “Risk Factors” and elsewhere in the offering circular filed with the U.S. Securities and Exchange Commission (“SEC”) on January 26, 2024. Forward-looking statements speak only as of the date of the document in which they are contained and Autonomix does not undertake any duty to update any forward-looking statements except as may be required by law. This post contains sponsored content. This content is for informational purposes only and not intended to be investing advice. Contact Details JTC Team, LLC autonomix@jtcir.com Company Website https://autonomix.com/

July 12, 2024 08:45 AM Eastern Daylight Time

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