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Xeris Biopharma reaches Phase 2 milestone by dosing first participant in hypothyroidism study

Xeris Biopharma Holdings

Xeris Biopharma Chairman & CEO Paul Edick joins Natalie Stoberman from the Proactive newsroom to share the latest milestone of having its first participant being dosed in a multi-center, open label, Phase 2 study of XP-8121 for the treatment of adults with hypothyroidism. Edick says this milestone is crucial considering initiating such studies is challenging and time-consuming. He adds that Xeris Biopharma aims to compare its stable therapy with existing treatments in the market, which are often poorly tolerated or improperly absorbed. Xeris' innovative liquid stable formulation offers a once-weekly subcutaneous injection, bypassing the gastrointestinal tract and providing consistent blood levels. The ongoing clinical study will need to dose around 40 to 50 patients before moving on to Phase 3 of the program. Contact Details Proactive Investors +1 347-449-0879 na-editorial@proactiveinvestors.com

June 22, 2023 01:50 PM Eastern Daylight Time

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Endexx CEO reveals major distribution agreement for Hyla vapes in the Middle East

ENDEXX Corp.

Endexx CEO Todd Davis joins Natalie Stoberman from the Proactive studios to share the company's latest distribution contract for Hyla "No-Nicotine" vape products with Sahara Trading UAE. Davis says the agreement covers an eight-country territory that is targeting a minimum 100,000 units per month as the expansion roles out. Endexx develops and distributes all natural, plant-derived wellness products and topical skincare products. Its products vary from balms, creams, lotions, butters, masks, scrubs, and oils, all with the shared purpose of healthy skin and grooming wellness. Contact Details Proactive Investors +1 347-449-0879 na-editorial@proactiveinvestors.com

June 22, 2023 01:45 PM Eastern Daylight Time

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Sona Nanotech "building a mountain of data" to support use of proprietary gold nanorods

Sona Nanotech Inc

Sona Nanotech Inc. (CSE: SONA, OTCQB: SNANF) CEO David Regan speaks to Thomas Warner from Proactive about his ambitious plans for the Canadian company's proprietary gold nanorods. He says that Sona Nanotech is currently "building a mountain of data" to support the potential use of its technology in innovative cancer treatments, having recently announced that it had received the third set of results of an independent assessment of its nanorods from the U.S. National Cancer Institute’s Nanotechnology Characterization Laboratory (“NCL”). Contact Details Proactive United States Proactive United States +1 347-449-0879 action@proactiveinvestors.com

June 22, 2023 09:34 AM Eastern Daylight Time

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Poolbeg Pharma sees "significant commercial opportunity" in oral vaccines

Poolbeg Pharma PLC

Poolbeg Pharma PLC (AIM:POLB, OTCQB:POLBF) CEO Jeremy Skillington speaks to Thomas Warner from Proactive after announcing that work on the company's Oral Vaccine Programme collaboration is now set to move into a new phase. Taking place over three years, the EncOVac Consortium is funded to develop a Phase I clinical trial ready oral vaccine candidate. Skillington says "as technologies develop, we move away from injectables so we see great significant commercial opportunities in having an oral alternative." The focus of the next phase is to commence the validation of the encapsulation process. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

June 22, 2023 04:50 AM Eastern Daylight Time

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Augmented Reality App Aims to Produce Better Images of Donor Organs

United Network for Organ Sharing

Today, United Network for Organ Sharing (UNOS) announced that UNOS Labs, the organization’s experimental incubator that tests innovative products, tools and methods to improve the donation and transplant system, is developing an app that may help increase organ use by providing surgical teams with higher quality images of donor organs. UNOS operates the Organ Procurement and Transplantation Network (OPTN) under contract with the federal government. Currently, organ photos are not consistent in their positioning, lighting, quality or use of scale. These “procurement photos” are used by surgical teams to assist in determining if they should accept an organ on behalf of their patient. UNOS has heard from surgeons across the country that they need better, more standardized photos, with the ability to measure specific portions of a photographed organ. Based on this feedback, UNOS staff started working on a modern solution to address this pressing community need. The plan employs computer vision technology, 3D modeling and augmented reality to eventually introduce a straightforward, smartphone-based solution to a complex, system-wide problem. “What we’ve found in our research is that a photo of an organ is important for determining clinical viability of the organ and its anatomy,” said Senior Data Scientist Morgan Stuart. “We think that recent advances in augmented reality technology can make these photos even more valuable. While our research continues, we think combining mobile augmented reality with the latest computer vision techniques will help standardize, expedite, and enhance organ allocation.” The tool is currently in the proof-of-concept phase. If early tests prove effective, the long-term goal is to provide organ procurement organizations (OPOs) and surgical teams with a mobile app that can capture high-quality, standardized photos, identify organ type, collect anatomical data, calculate size and annotate images. The tool would also include measurement capabilities, allowing surgeons to measure specific sections of the photographed organ. Overall size and unique measures can help determine if an organ is the best fit for a given patient, making this tool a potential game-changer in how organ offers are accepted and potentially reducing the number of organs recovered for transplant that are not ultimately used. “While still in the early stages, the research, development and hard work that have gone into this tool are a direct result of feedback we received from members of the nation’s organ donation and transplant community,” said UNOS CEO Maureen McBride, Ph.D. “We heard that surgeons had a specific need to improve the way they served their patients. UNOS staff were ready to pursue an innovative solution in response, while simultaneously tackling the very real issue of organ non-use. I look forward to seeing the results as this exciting project continues.” Research has indicated that there is a correlation between access to photographs and the acceptance of kidneys, which continue to be the most transplanted organ. Yet, in 2022, 19% of deceased donor organs recovered for transplant, predominantly kidneys, were not ultimately transplanted. Specifically, analysis conducted by the OPTN suggests that for kidneys with a high kidney donor profile index (KDPI), surgical teams were more inclined to accept these more medically complex but still safe organs if photos were included, when compared to teams that had no access to photos. Researchers determined that the likeliest reason is when a surgical team is considering a more medically complex kidney, photos can provide additional context and opportunities to visually confirm size and scale, making it easier to ultimately accept the offer. Funded by a generous donor, the proof-of-concept phase will last up to 12 weeks. If this phase proves successful, UNOS Labs will begin to host focus groups to gather additional community input. Pulling from that data, staff will then begin to develop the mobile app and launch a six-month pilot program. About UNOS United Network for Organ Sharing (UNOS) is the mission-driven non-profit serving as the nation’s transplant system under contract with the federal government. We lead the network of transplant hospitals, organ procurement organizations, and thousands of volunteers who are dedicated to honoring the gifts of life entrusted to us and to making lifesaving transplants possible for patients in need. Working together, we leverage data and advances in science and technology to continuously strengthen the system, increase the number of organs recovered and the number of transplants performed, and ensure patients across the nation have equitable access to transplant. Contact Details Anne Paschke +1 804-782-4730 anne.paschke@unos.org Company Website https://unos.org

June 21, 2023 02:29 PM Eastern Daylight Time

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Atossa Therapeutics announces further patent protection for Endoxifen

Atossa Therapeutics Inc

Atossa Therapeutics CEO Dr Steven Quay joined Steve Darling from Proactive to share news the company has been granted a new patent directed to enterically encapsulated endoxifen compositions formulated as a suspension by the United States Patent and Trademark Office. These will include all liquid suspension formulations suitable for oral administration and dispersible tablets, powders, granules, pellets, or sprinkles for reconstitution. Endoxifen is now protected by three issued US patents and numerous pending patents. Dr Quay emphasized the importance of intellectual property and ongoing patent activities to protect the company's innovations and facilitate potential partnerships with larger pharmaceutical companies. He told Proactive this is an important patent as the company learns more about the potential therapeutic role of endoxifen beyond breast cancer and mammographic breast density. The company also shares more details about suspension formulation and when and how it can be used. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

June 21, 2023 01:48 PM Eastern Daylight Time

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PathAI will Present on Analytical and Clinical Validation of AI-based NASH Clinical Trial Digital Pathology Tool at EASL 2023, and Announces Launch of NASH Explore Product

PathAI

PathAI, a leading provider of AI-powered pathology, will give a late-breaker presentation on new results from analytical and clinical validation studies that tested their AIM-NASH TM product and workflow’s accuracy, repeatability, reproducibility, and clinical validity across thousands of samples from several clinical trials, at the European Association for the Study of the Liver’s International Liver Congress 2023 (EASL), which will be held in Vienna, Austria from June 21 to 24, 2023. During EASL, PathAI will also formally launch and release details on its new NASH Explore TM product. P athAI’s analytical and clinical validation studies demonstrated that AIM-NASH-assisted pathologist reads of NASH resolution, hepatocellular ballooning, and lobular inflammation were superior to unaided pathologist assessment. Notably, there was a large improvement in scoring accuracy for ballooning and lobular inflammation, which are two of the most challenging components to score and standardize across pathologist reads. These results support PathAI’s vision to develop AI-powered digital pathology solutions to assist pathologists in achieving accurate and reproducible scoring, and complement prior results showing that AI-powered digital pathology is sensitive to drug effect that is not detected by categorical pathologist scoring 1 2, while also having the potential to control placebo response rates in NASH clinical trials 3. “The results from these studies inspire confidence in the robustness and value of AIM-NASH, and will pave the way to ultimately adopting AI-assisted NASH scoring as our new gold standard to ensure the greatest confidence in measuring true drug effect in NASH clinical trials,” said Stephen Harrison, M.D., chairman of Summit Clinical Research and a pioneer in the field of liver research and lead author on the study. At EASL, PathAI is also unveiling NASH Explore, an AI-derived panel of >500 histopathology features that spatially characterize NASH biopsy tissue microarchitecture at the cellular-level from H&E whole-slide images. It characterizes the H&E liver biopsy microenvironment at unprecedented resolution, giving drug developers and clinical researchers the ability to unlock insights that will enable precision drug development in non-alcoholic steatohepatitis (NASH). “Manual ordinal histologic scoring of fat, inflammation, ballooning and fibrosis from liver biopsies has been the gold standard in NASH assessment for enrollment and therapeutic efficacy, but the NASH community has been pushing for more,” said Andy Beck, M.D., Ph.D., chief executive officer and co-founder of PathAI. “NASH Explore will help uncover new histologic signatures and biomarkers of therapeutic response that could be even more predictive of patient outcomes, and provide more precision in stratifying patients for targeted therapies.” In response to the NASH community’s request for more sensitive measures of fibrosis that can be seamlessly integrated into existing clinical trial workflows, NASH Explore was developed to not only infer the presence of fibrosis in whole slide images of H&E-stained tissue sections, but also 1) categorize fibrosis into clinically relevant subtypes, and 2) quantify the presence of these fibrosis subtypes in liver lobular zones. By enabling sensitive, specific fibrosis detection from whole slide images (i.e., without requiring proprietary scanning of physical glass slides), NASH Explore allows for rapid and scalable interrogation into patterns of fibrosis that reflect true disease progression and regression. NASH Explore complements PathAI’s current AIM-NASH product, an AI-powered digital pathology tool that assists pathologists in performing NASH CRN scoring. PathAI’s poster and oral presentation schedule at EASL: Characterizing the histologic implications of resmetirom-induced liver volume reduction using artificial intelligence-powered digital pathology (Abstract OS-029) In partnership with Madrigal Pharmaceuticals 21 June, 9:00-18:00 CEST Analytical and clinical validation of AIM-NASH: a digital pathology tool for artificial intelligence-based measurement of nonalcoholic steatohepatitis histology (Abstract 4102) Oral presentation by: Stephen Harrison, MD, FAASLD 22 June, 18:15-18:30 CEST For more information, visit booth F4 at EASL for a live demo of NASHExplore, or contact us at NASH@pathai.com. Additional information can be found at www.NASHExplore.com. Footnotes 1. https://pubmed.ncbi.nlm.nih.gov/33570776/ 2. https://www.pathai.com/resources/comparison-of-manual-vs-machine-learning-approaches-to-liver-biopsy-scoring-for-nash-and-fibrosis-a-post-hoc-analysis-of-the-falcon-1-study/ 3. https://www.pathai.com/resources/comparison-of-the-effects-of-semaglutide-on-liver-histology-in-patients-with-non-alcoholic-steatohepatitis-cirrhosis-between-machine-learning-model-assessment-and-pathologist-evaluation/ About PathAI PathAI is the only AI-focused technology company to provide comprehensive precision pathology solutions from wet lab services to algorithm deployment for clinical trials and diagnostic use. Rigorously trained and validated with data from more than 15 million annotations, its AI-powered models can be leveraged to optimize the analysis of patient samples to improve efficiency and accuracy of pathology interpretation, as well as to better gauge therapeutic efficacy and accelerate drug development for complex diseases. PathAI, which is headquartered in Boston, MA, and operates a CAP/CLIA-certified laboratory in Memphis, TN, is proud to have a team of 600+ innovative thinkers from around the globe. For more information, please visit www.pathai.com. Contact Details Maggie Naples SVM Public Relations and Marketing Communications +1 401-490-9700 pathai@svmpr.com Company Website https://www.pathai.com/

June 21, 2023 10:00 AM Eastern Daylight Time

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Fine Hygienic Holding Sets World Record Speed on Tissue Machine at Abu Dhabi Mill

Fine Hygienic Holding

Fine Hygienic Holding, one of the world’s leading manufacturers of high-quality hygiene products and the MENA region’s largest paper producer, has made history after setting a new record-breaking pace of productivity at its Al Nakheel Paper Mill in Abu Dhabi. The mill set a world record related to production speed on its tissue machine manufacturing 13.2 grams per square-meter (gsm) at 2,222 meter per minute for 24 hours – running with an efficiency rate of 96.5 per cent. The achievement was made possible due a combination of factors, including the exceptional capabilities of the team, a steadfast ‘run-to-target’ culture, and the Valmet Advantage DCT Tissue Technology. FHH has always been committed to delivering consistent and superior quality and quantity, and the new world speed record showcases the company’s dedication to pushing boundaries to the limit in combination with achieving excellence. The Advantage DCT technology seamlessly integrates the specific needs of tissue makers with extensive technical expertise and application know-how, culminating in a state-of-the-art tissue-making process. The advanced technology ensures efficient production of high-quality tissue products, using virgin pulp with exceptional efficiency. Wolfgang Lied, Chief of Operations, Product Development, and Engineering at Fine Hygienic Holding, expressed immense pride in the achievement: “I am very proud of this extraordinary performance – simply fabulous. To achieve a world record demands two major things: A world class team and world class equipment. The team showed that a dream can come true when you are focused, engaged, passionate, and skilled.” Samir Masoud, UAE Supply Chain Director at Fine Hygienic Holding, highlighted the instrumental role played by the machine: “The Advantage DCT machine has performed in a very stable and reliable manner during the journey to gear up the machine speed from normal 2,000 meter per minute to where we are today. The fact this great achievement was reached with 96.5 per cent efficiency is just amazing.” The record-breaking achievement was made possible due to the leadership of Khalil Shorbaji, Al Nakheel’s Operation Manager, and Abdelhadi Alhader, Al Nakheel’s Technical Manager. It took place on an Advantage DCT 200 machine, a tissue production line with a design speed of 2,200 m/min. The machine measures 5.6m in width and incorporates stock preparation systems and auxiliary equipment. The Al Nakheel mill in Abu Dhabi has now established a new benchmark for high-speed production and efficiency. Known for its ability to produce conventional tissues in cost- and energy-efficient ways, the Advantage DCT concept has become a world standard to produce conventional tissue paper. It offers sustainable production of high tissue quality with low energy and water consumption, as well as high efficiency and reliability at low operational costs. The concept is available in various models and sizes to meet specific production demands. The world record follows FHH’s recent achievement of receiving the Excellence in Sustainability Environmental Certificate from CHEP, a global provider of supply chain solutions. This recognition is testament to the company’s significant efforts towards sustainable practices and minimising its environmental impact. Fine Hygienic Holding (FHH), one of the world’s leading wellness groups and MENA’s leading manufacturer of hygienic products, serves consumers in more than 80 countries around the world. Originally established as a paper manufacturer, FHH has transformed into a wellness company dedicated to enhancing global health and wellbeing. Fine Hygienic Holding offers a diverse array of award-winning products, including sterilized facial tissues, napkins, kitchen towels, toilet paper, baby diapers, adult briefs, and jumbo rolls. It also offers away-from-home products to accommodate all types of private and public institutions in addition to its long-lasting germ protection solutions. FHH also brings innovative nutritional supplements and longevity drinks including eon and Motiva to the market. Contact Details FINE HYGIENIC HOLDING Pragati Malik +971 54 531 5575 pragati.m@actionprgroup.com Company Website https://www.finehh.com/

June 20, 2023 08:59 AM Eastern Daylight Time

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Kadimastem Receives US Patent for Its Cell Selection and Enrichment Technology Used to Develop Its IsletRx Treatment for Diabetes

Kadimastem Ltd.

Kadimastem Ltd. (TASE: KDST), a clinical stage cell therapy company, developing and manufacturing "off-the-shelf" allogeneic cell products using its platform technology to develop treatments for different neurodegenerative diseases and a potential cure for diabetes, has been granted a patent from the United States Patent and Trademark Office for its cell therapy technology. The cell sorting patent will be protected until July 2038 for the company's innovative cell selection and enrichment technology. This patent covers the production of IsletRx, the company's product for the treatment and potential cure for diabetes. The company's technology is unique with its ability to select and enrich only the highest functioning and purest islet cells from the population of pluripotent stem cells which enables the maximum therapeutic effect. The approval of this patent in the USA is particularly important, especially in light of our collaboration project with iTolerance, an American company in the diabetes field and the BIRD Foundation. The project will combine Kadimastem’s and iTolerance’s technologies to develop and commercialize a breakthrough regenerative technology to cure diabetes without the need for life-threatening chronic immuno-suppression. The project will receive a 3.5 million NIS (US $1Million) grant from the BIRD Foundation for this project. In addition, the importance of unloading the social and financial burden of type 1 diabetes in the United States currently is crucial now more than ever. Approximately 1.45 million Americans are living with T1D, which accounts for about 3.75% of all diagnosed cases of diabetes[1]. According to a new study (2020) published in the peer-reviewed journal Diabetes Technology & Therapeutics (DTT), people who live with Type 1 Diabetes (T1D) in the United States right now, as well as those who will develop the disease over the next 10 years, will pay a collective $813 billion over their lifetimes in medical costs and in lost income and productivity costs, as compared to a similar group that does not have T1D[2]. Insulin-dependent type two diabetics which outnumber the number of T1D patients will similarly benefit from this treatment. Asaf Shiloni, company CEO: “Kadimastem highly believes that the company’s treatment can improve the quality of lives for hundreds of thousands of those dealing with the daily struggles of insulin dependent diabetes (IDD) by presenting a potential cure for IDD with our unique patented solution with IsletRx cells. In May 2021, the selection technology covered by this patent was described in a peer-reviewed journal article [3] in Frontiers in Endocrinology. About IsletRx The IsletRx product is a clinical-grade collection of pancreatic islet cells. Preclinical studies have shown that the cells are able to detect the sugar levels in the body and to produce, and secrete, on demand, the required amounts of insulin and glucagon, just like a healthy pancreas and enables the insulin dependent patient to avoid an abnormal drop in sugar level (hypoglycemia). In addition, the method of production and selection of the cells enables their implantation in various types of smaller size devices, suitable for maximum comfort for people living with diabetes. [1] https://diabetesresearch.org/diabetes-statistics/#:~:text=37.3%20million%20people%2C%20or%2011.3,%2C%20economic%2C%20and%20ethnic%20backgrounds. [2] https://www.jdrf.org/blog/2020/02/24/new-jdrf-funded-study-finds-lifetime-t1d-management-costs-a-collective-813-billion/ [3] https://www.frontiersin.org/articles/10.3389/fendo.2021.635405/full At Kadimastem we envision being a global leader in cell therapy.Our passion and commitment keep us moving forward, to develop innovative regenerative therapies for incurable diseases. Our goal is to treat millions of patients around the world with that technology. This document may include forward-looking information as defined in the Securities Law, 5728 – 1968. Forward-looking information is uncertain and mostly is not under the Company's control and the realization or non-realization of forward-looking information will be affected, among other things, by the risk factors characterizing the Company's activity, as well as developments in the general environment and external factors affecting the Company's activity. The Company's results and achievements in the future may differ materially from any presented herein and the Company makes no undertaking to update or revise such projection or estimate and does not undertake to update this document. This document does not constitute a proposal to purchase the Company's securities or an invitation to receive such offers. Investment in securities in general and in the Company in particular bears risks. One should consider that past performance does not necessarily indicate performance in the future. This document may include forward-looking information as defined in the Securities Law, 5728 – 1968. Forward-looking information is uncertain and mostly is not under the Company's control and the realization or non-realization of forward-looking information will be affected, among other things, by the risk factors characterizing the Company's activity, as well as developments in the general environment and external factors affecting the Company's activity. The Company's results and achievements in the future may differ materially from any presented herein and the Company makes no undertaking to update or revise such projection or estimate and does not undertake to update this document. This document does not constitute a proposal to purchase the Company's securities or an invitation to receive such offers. Investment in securities in general and in the Company in particular bears risks. One should consider that past performance does not necessarily indicate performance in the future. Contact Details Kadimastem Sarah Bazak +972 73-797-1613 s.bazak@kadimastem.com Company Website https://www.kadimastem.com/

June 20, 2023 07:00 AM Eastern Daylight Time

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