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PathPresenter Selected by Cincinnati Children’s to Provide Comprehensive Digital Pathology Workflow Solution

PathPresenter

PathPresenter, the global image sharing platform for pathology, was recently selected by Cincinnati Children’s to provide an integrated digital pathology workflow solution to meet the health system’s requirements across clinical care, remote consultations, education, and research. Cincinnati Children’s, which ranks No. 1 in the nation in U.S. News & World Report’s listing of Best Children’s Hospitals for 2023-24, recently completed an extensive selective process to procure a comprehensive digital pathology workflow solution. Cincinnati Children’s, utilizing PathPresenter’s platform, seeks to improve workflow efficiencies (enabled by tight integration with its laboratory information system); expand its digital consultation network; provide new educational capabilities to advance clinical competency testing; and enable enhanced research capabilities with the ability to connect any type of AI algorithm – from 3 rd party vendors or developed in-house. PathPresenter is a secure and scalable multi-tenant enterprise workflow platform that has been developed by pathologists with deep domain knowledge and experience. Trusted by 45+ tier-one institutions, PathPresenter is the most comprehensive suite available for clinical care, remote consultations, education, and research. With expert guidance in storage optimization, tight integration with LIS systems through a proprietary HL7 engine, and robust incorporation of 3 rd party and in-house-built AI algorithms, PathPresenter ensures genuine value to institutions – without the marketing noise. While Cincinnati Children’s doesn’t endorse or sponsor any commercial products, services, or companies, Dr. Jennifer Picarsic, MD, director of Digital Pathology and AP Informatics at Cincinnati Children’s, noted that a successful digital pathology program relies not just on scanning and viewing digital slides, but rather a re-imagined vision for how pathology will be practiced in the future. “As pathology leaders, we seek to build a new digitally integrated workflow that will enhance clinical, education and research opportunities to facilitate new innovations and wider access to our expert pathologists from anywhere in the world,” Picarsic said. Dr. Rajendra Singh, founder of PathPresenter, added “We are honored to work with the excellent clinical and technical teams at Cincinnati Children’s, given their thorough understanding and deep knowledge of what they need from a workflow provider with a complete focus on improving efficiencies ensuring better care of their precious patients. PathPresenter was created to fill in the gaps in use of digital pathology, and this further fulfills our mission.” About PathPresenter PathPresenter is the global image sharing platform for pathology. We are on a mission to help democratize access to the world’s pathology knowledge by connecting pathologists to the vast expertise of their colleagues globally and providing a practical platform to access and use best-in-class AI models. Founded by dermatopathologist and digital pathology pioneer, Dr. Rajendra Singh, PathPresenter has been adopted by 45+ tier one medical institutions for clinical care, remote consultations, education, and research, and has built a thriving community of 50,000+ users in 172 countries to easily view and share digital pathology images and knowledge. For more information visit www.pathpresenter.com. Contact Details Cory Batenchuk +1 873-355-9913 cory@pathpresenter.com Company Website https://pathpresenter.com

December 11, 2023 09:00 AM Eastern Standard Time

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Research Shows New Single-Use Protein A Capture Technology Offers 10X Productivity Over Standard Resin Columns for Antibody Purification

AGC Biologics

AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), today announced a new research paper from its global research and development Center (R&D Center) titled, Building a Fully Single-Use Process: High Productivity Protein A Membrane Devices that Complement Disposable Upstream Technology. In the research, the CDMO’s scientists feature exclusive data on the promise of new single-use devices that alleviate common monoclonal antibody (mAb) purification problems that can occur when using standard Protein A resin columns. The new research is available immediately and offers biopharma developers a glimpse into the promise of single-use technology for the Protein A membrane capture chromatography step, using the GORE® Protein Capture Devices with Protein A as a technology use case. The paper also features conclusions on the benefits of this innovative technology, such as reduced manufacturing footprint, reduction in lead-time and consumable costs, and more. There are several important topics covered in the study, including: Overview of protein A capture technology: A recap of the promise offered by single-use membrane chromatography technologies; including their ability to operate with a high flow rate and achieve high productivity and disposable process; featured performance data on manufacturing scales of Protein A membrane devices, including small scale and manufacturing scale comparisons. Benefits single-use devices offer to the manufacturing process: When paired with single-use bioreactor upstream strategies, the research found contamination risk, operation time relating to preparation and cleaning, and operator error were all reduced. The technology also offers cost savings, reduced risk, lower bioburden, greater speed to market, and other benefits. Purification productivity data: single-use devices vs. standard resin: Protein A membrane devices showed 10 times higher productivity than the Protein A resin column on the purification of mAb cultures. Other data includes productivity details, including removal of host cell proteins (HCP) and host cell DNA, when compared with resin columns, reduction in bioburden, time savings, and more. R&D review: implementing protein A membrane device into traditional manufacturing flows: A review of the implementation process for these devices and how they can be implemented for all vessels and into existing flow-paths, the ion exchange membrane device, and single-use TFF membrane capsules, while improving efficiencies to purify mAb in a short process time. The AGC Biologics R&D Center focuses on modernizing and advancing processes and technologies used for biopharmaceutical development and manufacturing capabilities. The scientists within the team are responsible for developing and implementing new procedures and evaluating innovations that help developers of protein biologics and advanced therapies improve titers/yields, cell line development, downstream purification analytical analysis, and more. To learn more about AGC Biologics visit https://www.agcbio.com/. About AGC Biologics: AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan and 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 the partner of choice. 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/

December 11, 2023 06:03 AM Eastern Standard Time

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Epicenter of Healthcare Transformation: The Intelligent Health Association's 2023 International Summit starts tomorrow, Monday, December 11

1BusinessWorld

In an era where technological evolution is pivotal to healthcare advancements, the Intelligent Health Association (IHA) proudly announces the launch of its 2023 International Summit. This year's summit, occurring from December 11 to December 15, 2023, represents a paradigm shift in healthcare conferences. Embracing a fully virtual format, the summit ensures accessibility for all, enabling professionals globally to engage with leading healthcare insights without the constraints of physical attendance. https://1businessworld.com/2023-intelligent-health-summit/ Reimagining Healthcare Through Digital Transformation The Intelligent Health Association is at the forefront of orchestrating an event that mirrors the current landscape of healthcare - a blend of technological innovation and practical applications. This summit is not just an event; it's an intellectual symposium, bringing together the brightest minds to discuss, debate, and shape the future of healthcare. Key Topics and Educational Excellence Over the course of five days, the summit will delve into critical areas such as AI's impact on healthcare, cybersecurity in patient data management, advancements in telehealth, the imperatives of health equity, and the integration of innovative technologies in healthcare settings. Each day is meticulously crafted to offer a comprehensive understanding of these key areas: - Exploring the role of AI in enhancing healthcare delivery. - Navigating the complexities of data and cybersecurity in healthcare. - Evaluating the evolution of telehealth in a post-pandemic era. - Championing the cause of global health equity. - Understanding the necessity of change management in adopting new technologies. A Commitment to Continuing Medical Education In an effort to empower healthcare professionals worldwide, the IHA, in collaboration with the Weitzman Institute, is offering Continuing Medical Education (CME) credits for this summit. This initiative underscores our commitment to ongoing professional development in the healthcare sector. Leadership Insights and Global Collaboration Harry P. Pappas, Founder and CEO of the Intelligent Health Association, emphasizes the summit's role in shaping healthcare's future. "This summit represents a confluence of thought leadership and innovative practices that are essential for the evolution of healthcare. We are creating a forum where ideas meet implementation," remarks Pappas. Echoing this sentiment, Sherri Douville, CEO at Medigram and Co-Chair of the Intelligent Health Summit, highlights the summit's multidisciplinary approach. "Our objective is to forge a nexus of technology, policy, and healthcare. This summit is a testament to our dedication to driving healthcare forward through leadership and transformation," states Douville. Invitation to Join a Transformative Journey The Intelligent Health Association extends an invitation to healthcare professionals, industry experts, policymakers, and academicians to join this groundbreaking event. The fully virtual format of this summit opens doors for a global audience, making it an inclusive and easily accessible platform for sharing and learning. Together, we can chart a new course for healthcare that is more adaptive, equitable, and innovative. https://1businessworld.com/2023-intelligent-health-summit/ All news and content distribution in partnership with News Direct. About the Intelligent Health Association: The Intelligent Health Association (IHA) is a global consortium of healthcare and technology leaders committed to advancing digital healthcare. Our goal is to disseminate unbiased information on innovative technologies that enhance patient care and improve clinical and business processes. The IHA champions the transformation of healthcare through high-quality educational programs and networking events, facilitating the adoption and implementation of new technologies in health and wellness ecosystems. We are dedicated to reshaping healthcare through innovation and leadership, ensuring a future where technology seamlessly integrates with patient care. Intelligent Health Association About 1BusinessWorld: 1BusinessWorld is a global business ecosystem, network and marketplace that provides entrepreneurs, business owners and professionals with the information, tools, resources and connectivity needed to succeed throughout their company’s growth journey, toward a better business world. Our vision is based on the reality that we live, work and do business in one global interconnected business environment, and hence our motto: “One World, One Business World”. Our mission is to encourage and support global communication and collaboration among entrepreneurs, professionals, and businesses. 1BusinessWorld Contact Details Media Enquiries +1 212-220-6677 info@1businessworld.com Company Website https://1businessworld.com

December 10, 2023 02:04 PM Eastern Standard Time

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Senzime's CEO shares breakthrough patient monitoring technology for safer surgeries

Senzime

Senzime CEO Phillip Siberg joined Steve Darling from Proactive from the OTC studio in New York City to shed light on the innovative solutions offered by Senzime, aimed at significantly enhancing patient safety during and post-surgery through the power of advanced algorithms. Senzime's impressive array of tools, such as the TetraGraph and ExSpiron 2Xi, leverage real-time monitoring of neuromuscular and respiratory functions—crucial parameters during and after surgical procedures. The overarching objective of these cutting-edge technologies is to reduce in-hospital complications dramatically and drive down healthcare costs associated with surgical and high-acuity procedures. One exciting development that Siberg shared is Senzime's success in securing multiple new orders for the TetraGraph system, particularly from several prestigious German university hospitals. The German market has proven to be a strong and fruitful one for Senzime, with the company already having secured nearly 30 major hospital contracts, including pivotal partnerships with key robotic surgery centers. This expansion and adoption of Senzime's technology underscore the growing recognition of the transformative potential of their solutions within the medical community. With a robust growth trajectory, Senzime aims to achieve $30 million in sales by 2025, with the US being a pivotal market. The company's strategic move to cross-trade on the OTCQX provides accessibility to US capital markets, facilitating increased shareholder participation. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

December 08, 2023 01:25 PM Eastern Standard Time

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UDS Earns Highest Accreditation from NCQA for the Third Time in a Row

UDS

United Disabilities Services (UDS) Foundation is thrilled to announce that their Home and Community-Based Services (HCBS) Care Management program has received the highest accreditation from the National Committee for Quality Assurance (NCQA) for the third time in a row. The non-profit, committed to helping older adults, veterans, and people with disabilities lead more independent and fulfilling lives, offers services to those with a range of social and pragmatic needs, like transportation, housing, nutrition, isolation, emotional well-being, and medical problems. NCQA is an independent 501(c)(3) nonprofit organization that improves healthcare quality through accreditation and certifies a wide range of healthcare organizations promoting high-quality care and recognizing high-performing health plans and providers. Evaluated on eight standards that must be met at the highest level for policy and procedures, UDS achieved 100% in the strenuous chart audit review. UDS was one of the first to achieve Long-Term Services and Supports (LTSS) Care Management accreditation from NCQA in 2017 when it was initiated. They were awarded the highest level with a full three-year time frame and then, in 2020, again awarded the full three-year accreditation. Now, in 2023, they have achieved it once more with an A+ rating. William Kepner, the President and CEO of UDS, says, “We are delighted and proud to have once again achieved the highest accreditation from NCQA who have developed excellent standards of care. Our goal is to always provide a great customer experience and outcome, which starts with providing exceptional quality care. I am proud of our UDS support coordination team for their continuing high quality of care and support for those we serve.” We invite you to visit the UDS website at www.udservices.org to learn more about the company and its mission and services. UDS Foundation is a Lancaster, PA-based organization whose mission is to improve the lives of older adults and individuals with disabilities. UDS Foundation accomplishes that by providing a variety of home- and community-based services to help people enjoy safer, happier, and more independent lives in the comfort of their homes. Incorporated in 1970, UDS Foundation has evolved from a small organization to a company providing a network of 12 different programs through several nonprofit entities. UDS Foundation serves older adults, individuals with disabilities, and veterans throughout Pennsylvania and coordinates a network of business partners and satellite offices in multiple counties. For more information, visit www.udservices.org. Contact Details Debra Showalter +1 717-286-0047 madison@rprfirm.com Company Website https://udservices.org

December 08, 2023 11:20 AM Eastern Standard Time

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G-NiiB Oral Microbiome Immunity Formula SIM01 Alleviates Post-COVID-19 Conditions

G-NiiB GenieBiome

HONG KONG SAR - Media OutReach Newswire - 8 December 2023 - Hong Kong's leading biomedical and microbiome technology company, G-NiiB GenieBiome, is pleased to announce that a ground-breaking large-scale randomised, double-blind, placebo-controlled clinical trial ("the Trial") conducted on the efficacy of SIM01, an oral microbiome immunity formula developed by a top-notch medical school in Hong Kong, involving 463 patients who had contracted COVID-19, has strongly proved that the consumption of SIM01, an oral microencapsulated live bacteria formula, could significantly improve the gut microbiota after six months and lead to remarkable alleviation of post-COVID-19 sequelae ("long COVID"), encompassing a range of symptoms affecting different systems and organs. The findings of the Trial were published yesterday in The Lancet Infectious Diseases, the most authoritative international medical journal in infectious diseases. G-NiiB GenieBiome’s flagship product, G-NiiB Immunity+, contains the oral microbiome immunity formula SIM01. The Trial has robustly demonstrated the exceptional efficacy of SIM01 in alleviating post-COVID-19 conditions, sending a significant breakthrough and a sliver of hope for the 65 million individuals worldwide who have been profoundly impacted by the long COVID. It is widely acknowledged that post-COVID-19 symptoms exhibit substantial interindividual variability, complexity, and long-haul span, posing a dual challenge to the patient's physiological and psychological well-being. Given the current lack of targeted and effective therapies, it has emerged as one of the most formidable health challenges in the aftermath of the COVID-19 pandemic. In its August 2021 publication, The Lancet mentioned that long COVID is the primary challenge of modern medicine. The oral microencapsulated live bacteria formula SIM01, published in The Lancet Infectious Diseases this time, is the flagship product of G-NiiB GenieBiome. Multiple clinical studies have confirmed its effectiveness. This very study, known as the RECOVERY study, is the first global clinical research to testify that SIM01 can improve gut microbiota and effectively alleviate post-COVID-19 symptoms, including fatigue, memory loss, difficulty in concentration, gastrointestinal upset and general unwellness. The study results further highlight the interconnectedness of the "Microbiome-Gut-Brain Axis," illustrating how probiotic metabolites absorbed through the gut can contribute to improving brain function. This also underscores the potential of restoring healthy gut microbiota as a novel intervention and strategy for addressing post-COVID-19 neurological symptoms. The publication of these research findings in The Lancet Infectious Diseases signifies authoritative recognition of their scientific and pioneering property, as well as a strong affirmation of SIM01's possibility to improve post-COVID-19 symptoms and enhance overall immune performance in patients. Ms. Rachel Fan, CEO of G-NiiB GenieBiome, stated, "The publication of the Trial on G-NiiB's microbiome immunity formula, SIM01, in the medical journal The Lancet Infectious Diseases, is undoubtedly a scientific feat and a significant milestone for G-NiiB GenieBiome. It represents a great recognition of the leadership, judgment, and expertise of our founder and Chief Scientific Advisor, showcasing our leading position and innovative capabilities in microbiome research. It also serves as a strong testimony of our professional competence and product quality, demonstrating that our core technology has received authoritative approbation from the international medical community. This is considerable progress and an outstanding achievement for a pioneering company to keep a foothold in the microbiome arena. We are immensely proud." Besides, "The practical significance of this study lies in proving the scientific efficacy and multiple feasibilities of SIM01, inaugurating new avenues for microbiome research and human health exploration. From a societal perspective, G-NiiB's microbiome immunity formula, SIM01, presents the potential to offer a fresh choice for individuals suffering from long COVID while making seminal contributions to the fight against COVID-19 and other diseases. G-NiiB GenieBiome is committed to continuing its investment in innovative research and cutting-edge development, steadfastly striving to improve human health and tackle various disease challenges." Ms. Rachel Fan, CEO of G-NiiB GenieBiome, background is the clinical trial published in The Lancet Infectious Diseases. Utilising advanced metagenomic sequencing data, patented artificial intelligence, and microencapsulation technology, G-NiiB GenieBiome has introduced three patented oral microbiota formulations. They are SIM01, a microbiome precision immunity formula designed to enhance the immune system; SMT04, a microbiome precision gut protective formula to preserve intestinal health; and SIM03, a microbiome precision children immunity formula to develop diverse rainbow immunity. Clinical data from a renowned medical school in Hong Kong have supported these formulations. The team is currently researching to develop innovative formulations to treat and alleviate complex conditions such as fatty liver and adult eczema, aiming to meet the evolving needs of the health supplement market. Ms. Rachel Fan further added, "Our core team members excel in their respective spheres. Our collective goal is to blaze innovative transformation in the field of human health through microbiome research. By leveraging the leap we made in microbiota research, the team strives to significantly improve disease prevention, diagnosis, and treatment, sequentially accelerating the transition into a new era of microbiota-centric medicine." G-NiiB GenieBiome G-NiiB GenieBiome is a biotechnology company founded by world-renowned clinician-scientists and supported by a multidisciplinary team of experts in microbiology, metagenomics, bioinformatics, disease biomarkers, food technology, clinical trials, IP development and commercialization. For over a decade, our team has pioneered the use of microbiome with evidence-based science to tackle a myriad of diseases, including colorectal cancer, obesity, atopic eczema, autism, and mood disorders, revolutionizing the prevention, diagnosis, and treatment of disease. Our precision portfolio of G-NiiB includes diagnostic and risk prediction tests, next-generation microbiome precision formulas, and precision medicine tailored for the Asian population. Our vision is to be a game changer in human health with microbiome solutions. Contact Details Tim Chan timchan@g-niib.com Company Website https://www.g-niib.com

December 08, 2023 09:00 AM Eastern Standard Time

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AI-Driven Media Discovery, Distribution and Monetization Platform VideoXRM Launches Netcapital.com Funding Campaign

VideoXRM

VideoXRM, the pioneering artificial intelligence (AI) driven, B2B video distribution and discovery platform, announces the launch a $500,000 offering on the Netcapital.com digital private capital markets ecosystem. Capital from the offering will be used for the continued development and commercialization of the VideoXRM platform. The minimum investment is $300 and the offering deadline is January 31, 2024. Learn more at: https://netcapital.com/companies/videoxrm Businesses increasingly utilize video and rich media to differentiate their benefits and to reach new audiences, yet most of this complex and unstructured content remains difficult if not impossible to find. VideoXRM brings expanded exposure and ROI to this high value content, that until now, has been virtually inaccessible via conventional search technologies. Utilizing proprietary AI-machine learning technology, metadata, and granular indexing, VideoXRM is able to automatically classify videos, audio, images, etc., enabling unparalleled media discovery. The platform is ideal for company to company and company to investor engagement, news media, researchers, supply chain and procurement managers, M&A sourcing, partnering and benchmarking. VideoXRM’s revenue streams will include promotional services, highly targeted video campaigns and premium content on a pay-per-view and pay-per-subscription basis. Initial revenue is targeted by year-end 2023. VideoXRM CEO, David N. Baker, commented, “Over the past 2 ½ years we have made huge progress building out the platform and business solely with internal funding. Our accomplishments include: Commercial Launch of the VideoXRM Platform Attracting 175 companies and 9,000 videos to the platform, with many content sources in the pipeline. Developing proprietary AI/Machine learning technology to extract video and audio metadata used to classify and index content within 140,000 industry categories. 2 Patents Issued and 3 Pending. “We are launching our Netcapital offering to fund our continued growth and enhancement of our platform. In Q1 2024 we will launch an entirely new aspect of our video platform, providing capabilities that will add substantial additional value for our customers and company. We hope you will join us on our journey to build the most powerful business media distribution and discovery platform to enable the leg of growth in video and rich media communications and commerce.” Connect with us on LinkedIn and Twitter and Facebook. About VideoXRM ( VideoXRM.com ) VideoXRM is an AI-driven, B2B media discovery, distribution, communication and monetization platform that connects corporate rich media content with all potential stakeholders. The platform and smart search technology creates value and knowledge from mountains of unstructured digital media, delivering greater ROI from content investments. VideoXRM’s mission is harnessing the enhanced communicative power of rich media through a new distribution and discovery paradigm. VideoXRM was Co-founded by David N. Baker, who formed Revere Data LLC (Sectorbase) which was acquired by FactSet Data Systems, Inc. His Co-founders are Vadim A. Tarasov, Byron Kwok, and David Guzy. Contact Details Catalyst IR David C. Collins +1 212-924-9800 videoxrm@catalyst-ir.com Company Website https://videoxrm.com

December 08, 2023 08:20 AM Eastern Standard Time

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HippoFi (OTC:ORHB) Hires World’s Top Regenerative Therapy Expert Dr. Gail Naughton to Drive Commercialization Plans of its Proprietary Technologies

CGR - HippoFi Inc.

There’s a strong possibility that you have experienced lower back pain or heard of injuries in which spinal discs are damaged either because of age related degeneration, playing sports, accidents, or other physical and genetic conditions. The spinal disc is the cushion between the bones or vertebra in the spine that allows for motion and stability. Currently, there is no treatment to regenerate the spinal disc, which often relates to intense pain causing patients to turn to major surgical procedures, that can lead to complications or opioid use, which can lead to addiction. Now, imagine a future where it’s possible to completely heal such injuries and regenerate not only the spinal discs, but also other body tissue and cartilage, restoring them to their original state. The medical implications would be far reaching. This future isn't as far off as one would think, thanks to trailblazers such as HippoFi, Inc. (OTC:ORHB) through its wholly owned subsidiary PUR Biologics. HippoFi’s main goal is to give back to patients the quality of life they had prior to when injuries or the aging process took their toll and eliminate the risks of surgery and dependency on painkillers. PUR’s complete line of biologic products currently includes advanced allografts and demineralized extracellular matrices (d-ECM), innovative synthetic bone-forming solutions, and cellular-derived tissues. In addition to this, the company has several patented and next-generation regenerative stem cell and growth factor driven therapeutics for treating osteoarthritis and cartilage regeneration. PUR’s product and technology portfolio are applicable to multiple large markets which conservatively could be worth about $48 billion providing the opportunity for continued growth, and increased shareholder value. Investors should be most excited for the company’s recent addition to the executive team. There is no one better placed to help HippoFi capitalize on the huge opportunity in regenerative therapeutics than the world’s foremost authority and pioneer of regenerative medicine, Gail Naughton, MBA, Ph.D. Despite their massive potential, very few cell-based products have been approved by regulatory authorities. This is understandable considering these are complex products which are difficult to manufacture. Dr. Naughton has an extensive track-record in this space, with more cell-based products approved by the FDA than nearly anyone else in the world, making her an extremely valuable addition to the team. A pioneer in cell-based therapeutics Dr. Naughton will be HippoFi’s "Head of Regenerative Therapeutics and Commercialization" and has been a driving force in regenerative medicine for over 35 years with a proven track record in monetizing significant cell-based therapeutics and bioengineered tissue technologies in addition to holding more than 140 patents. The first company that Dr. Naughton started and went public with was Advanced Tissue Sciences, which then was acquired by Organogenesis (NASDAQ:ORGO). Advanced Tissue Sciences was started in 1988 and received three of the world’s first regulatory approvals for cell-based products, including approval for Transcyte, a “skin substitute” originally termed Dermagraft, a product placed on diabetic ulcers and used for a soft tissue filler and as a cover to help the tissue heal. The company worked closely with healthcare giant Smith & Nephew (NYSE:SNN), a leader in advanced wound care and orthopedics which very early on recognized the potential of these cell-based products. The joint venture, focused on wound care and orthopedics, not only reaffirmed the potential for these novel cell-based products but also highlighted why Dr. Naughton was indeed the foremost authority on regenerative therapies. At the same time, Advanced Tissue Sciences licensed its first skincare product to a company called SkinMedica which was eventually acquired by Allergan. Though AbbVie (NYSE:ABBV) bought out Allergan, that skincare product is still being sold. Dr. Naughton went on to start a second company called Histogen which went public as well. The company focuses on growing cells under embryonic conditions of very low oxygen and low gravity in order to revert the cells back to a stem-cell like condition. It then uses the byproducts of those cells in a very controlled manufacturing process to produce growth factors and extra-cellular matrix for a variety of reasons, including the regeneration of spinal discs which has demonstrated success in animal trials and the regeneration of the surface cartilage in joints which has gone to clinical trials. Dr. Naughton understands the pathways and potential pitfalls of bringing cellular and cellular derived technologies through the manufacturing process, animal trials, and clinical trials as well as working closely with the FDA which will be instrumental for HippoFi going forward. Furthermore, Dr. Naughton oversaw the design and development of the world’s first up-scaled manufacturing facility for tissue engineered products reaffirming her position as the world’s leading mind in manufactured cell-based products. Although currently focused on spine, the company has the ability to develop other orthopedic and bone care products as well as improve current products. Expediting the development of regenerative therapies HippoFi, Inc. (OTC:ORHB) has already achieved significant success in the regenerative therapies space, succeeding where others have failed. With the new commitment to work with Dr. Naughton, their combined efforts and revolutionary vision should be able to expedite the development of fully functioning biologics solutions in orthopedics that not only regenerate but restore function. One of Dr. Naughton and Hippofi’s first moves will be to continue the work she has been doing which has already shown success in animal studies. The exceptional results from these studies have shown that these novel biologic solutions could regenerate the spinal discs to the way they were before they had degenerated or were damaged, which ties in well with HippoFi’s current product portfolio and innovation focus. With such encouraging results, this means that the treatments would essentially be able to ‘turn the clock backwards’ and restore a patient’s tissues, functionality, and pain levels to the point they were before aging, disease, or injury. Dr. Naughton recently had success getting into clinical trials for human cartilage regeneration, another key area of focus for HippoFi. This is different than repairing because when tissue repairs it usually leaves a scar. HippoFi’s goal is to be able to have the normal tissue / cartilage / disc to regenerate back to where it was originally, without scarring. Right now, HippoFi is focused on the spine, mostly targeting bone growth products to help heal following spinal fusion procedures. And while that has been a great advancement for the patients, the company is concentrating on spine first because that’s where it has extensive experience and worldwide sales channels to drive today’s revenues. While Dr. Naughton also has significant experience in spine; their shared vision and experience will expand their target to other areas as they make more successes. Takeaway Although cell-based and cell-derived products and regenerative therapies have been around since the mid-80s, there are only a handful of products that have been approved by the FDA which has recently opened up new pathways to approval, seeing the importance of these technologies related to the future of patient care. With the addition or Dr. Naughton, and the company’s issued patent portfolio, HippoFi, Inc. (OTC:ORHB) is well positioned to change this and lead the future of regenerative medicine. With her extensive background in regenerative medicine and regulatory pathways combined with HippoFi’s business, sales, and clinical expertise they have clearly created a vision and strategy to expedite these innovative products to the patients that need them most - starting with spinal discs and osteoarthritis, and then moving forward with the regeneration of cartilage in knees and other joints.. For now, it seems that is the perfect time for investors to keep a watchful eye on HippoFi, and the addition of Dr. Naughton will be a major catalyst in helping the company meet their goals and address the significant and unmet needs in the $200 billion osteoarthritis, pain, and cartilage & spinal disc regeneration markets. Although the company currently has a market cap of just about $25 million, it may not remain at that valuation for too long once it starts gaining mainstream attention. Disclaimers: 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, assumptions, objectives, goals, or assumptions of 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 & quotes; may, could or might occur Understand there is no guarantee past performance is indicative of future results. Investing in micro-cap or growth securities is highly speculative and carries an extremely high degree of risk. It is possible that an investor's investment may be lost or due to the speculative nature of the companies profiled. Capital Gains Report (CGR), owned by RazorPitch Inc., is responsible for the production and distribution of this content. CGR is not operated by a licensed broker, a dealer, or a registered investment advisor. It should be expressly understood that under no circumstances does any information published herein represent a recommendation to buy or sell a security. CGR has been retained by HippoFi Inc to produce and distribute this content. As part of that content, readers, subscribers, and webs are expected to read the full disclaimers and financial disclosure statement that can be found on our website capitalgainsreport.com 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 is not a fiduciary by virtue of any persons use of or access to this content. Contact Details CapitalGainsReport.com Mark McKelvie +1 585-301-7700 markrmckelvie@gmail.com

December 08, 2023 07:35 AM Eastern Standard Time

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GRI Bio begins patent enrollment for Phase 2a study of GRI-0621 for IPF treatment

GRI Bio, Inc

GRI Bio CEO Marc Hertz joined Steve Darling from Proactive to share news the company has begun patient enrollment in a Phase 2a biomarker study focused on evaluating GRI-0621 as a potential treatment for idiopathic pulmonary fibrosis (IPF). Patient dosing is expected to commence shortly, marking a significant milestone in the clinical development of the drug candidate. The Phase 2a study is designed as a randomized, double-blind, multi-center, placebo-controlled trial involving approximately 36 subjects diagnosed with IPF. These subjects will be randomly assigned to receive either GRI-0621 at a dose of 4.5mg or a placebo in a 2:1 ratio. The primary objective of this study is to assess the safety and tolerability of oral GRI-0621, which will be closely monitored throughout the trial. Secondary endpoints include evaluating changes in serum biomarkers collected at weeks 6 and 12. An interim analysis of the trial is planned when 24 subjects have completed 6 weeks of treatment, with the expectation of providing preliminary insights into the drug's safety and efficacy profile. The topline results from the Phase 2a biomarker study are anticipated to be available in the second half of 2024, shedding light on the drug's potential as a treatment option for IPF. In addition to these primary and secondary endpoints, the study will also explore the effect of GRI-0621 on pulmonary function at baseline, as well as after 6 weeks and 12 weeks of treatment. The trial aims to provide valuable data to advance our understanding of GRI-0621's therapeutic potential in addressing IPF, a challenging and debilitating respiratory condition. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

December 06, 2023 01:47 PM Eastern Standard Time

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