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Turning Back The Clock On Aging: Telomir Pharmaceuticals Confirms Telomir-1 Reverses Age And Increased Longevity In Breakthrough Pre-Clinical Study

Benzinga

By Meg Flippin, Benzinga Turning back the clock on aging is the holy grail for the longevity industry, but is something that has proven elusive. That may be changing, thanks to companies like Telomir Pharmaceuticals Inc. (NASDAQ: TELO). The pre-clinical-stage company positioning itself as an emerging leader in age-reversal science is making inroads with Telomir-1, a compound designed to effectively turn back the biological clock and support longevity. Results from a preclinical trial confirmed the efficacy of the compound, reports Telomir. Using advanced in vivo microfluidic technology, in collaboration with Nagi Biosciences SA, the study demonstrated what Telomir said is significant age-reversal effects in aging model organisms treated with Telomir-1. These effects include an extended healthy lifespan, improved mobility and a measurable reversal of age-related decline. “The results we’re seeing with Telomir-1 mark an important step forward in our journey to potentially reverse aging in humans,” said Erez Aminov, Chairman and CEO of Telomir Pharmaceuticals in a press release announcing the trial results. “This study confirms that Telomir-1 can reverse biological aging, extending life while preserving health. We are very excited about the potential applications of Telomir-1 as we progress toward human clinical trials” Anti-Aging In A Compound Telomir-1 is focused on telomere regeneration which involves repairing telomeres or the DNA structures that protect the ends of our chromosomes, similar to caps on shoelaces. Numerous studies have shown fixing them can extend a person’s biological age and even turn back the clock on certain diseases. Telomir Pharmaceuticals says Telomir-1 is a novel small molecule to lengthen the DNA’s protective telomere caps in order to potentially reverse age-related conditions. The novel molecule, which Telomir is testing with mice and dogs with an eye toward human clinical trials, binds to critical metals that wear down telomeres. By limiting the availability of metals and interrupting the enzyme function, Telomir-1 seeks to restore cellular metal homeostasis and reverse a person's or animal’s biological age. The non-toxic oral therapy provides what the company says is a safe and effective alternative to existing treatments with minimal side effects. Telomir says Telomir-1 has the potential to impact patient care by offering new hope for managing and reversing age-related diseases and improving the quality of life for aging individuals. The Study Details The preclinical study, conducted in collaboration with Nagi Bioscience, utilized a sophisticated in vivo microfluidic-based assay to assess the effects of Telomir-1 on the nematode Caenorhabditis elegans, a well-established model for aging studies, reports Telomir. The microfluidic platform allowed precise, automated tracking of lifespan, healthspan and age-related mobility decline in real-time, enabling the research team to accurately measure the effects of Telomir-1 on these critical metrics. Two forms of Telomir-1 were administered in two concentrations. The study found that Telomir-1 significantly enhanced lifespan and healthspan parameters in aged microorganism populations. Some of the key findings include enhanced mobility in older organisms, reduced biological aging and increased lifespan. Subjects treated with Telomir-1 showed improved mobility, particularly in later stages of life compared to untreated controls. Telomir also said the study demonstrated “a measurable” reversal of biological age markers which the company said makes it a promising candidate for longevity treatments. What’s more, the company said Telomir-1 was associated with a statistically significant increase in lifespan among treated populations, further supporting Telomir-1’s role in promoting longevity. "At Nagi Bioscience, we are thrilled to contribute to this groundbreaking study through our innovative microfluidic technology, which allows precise and automated monitoring of aging and healthspan metrics in real-time,” said Dr. Laurent Mouchiroud, Chief Scientific Officer at Nagi Bioscience. “These results highlight Telomir-1’s remarkable potential to improve longevity and health, showcasing the power of cutting-edge tools in advancing age-reversal science." Expanding Telomir-1’s Reach Telomir sees many market opportunities for Telomir-1. There’s the longevity and anti-senescence therapy market, which is valued at $27.11 billion and is projected to reach $44.92 billion by 2031, growing at a CAGR of 6.8%. Then there’s Alzheimer's. Nearly seven million Americans suffer from this disease that attacks memory and cognitive functions. By 2050 that’s forecast to reach close to 13 million. And let's not forget cancer, another area Telomir-1 could prove effective in fighting. The global oncology market size is projected to reach $521.60 billion by 2033, growing at a CAGR of 8.9% from now until then. An additional area where Telomir-1 may help is in the treatment of progeria, a rare genetic disorder that causes accelerated aging in children. Telomir is intensifying its focus on the potential use of Telomir-1 to treat progeria and has engaged with the Progeria Foundation to investigate the effects of Telomir-1 on human progeria cell lines. This study will directly assess Telomir-1’s ability to counteract accelerated aging at the cellular level, offering critical insights into its therapeutic potential for progeria patients. Telomir also planned an in vivo study utilizing a progeria Caenorhabditis elegans model. This advanced microfluidic-based assay will evaluate Telomir-1’s impact on longevity, healthspan and biological aging in an organismal context. Telomir said these two studies represent a comprehensive approach to understanding Telomir-1’s effects on progeria, targeting both cellular and whole-organism models of the disease. On the canine front, Telomir is in talks with the North Carolina State College of Veterinary Medicine to establish a large-scale study on elderly dogs with osteoarthritis, further exploring Telomir-1’s potential to improve joint health and mobility. Turning back the clock on aging is the quest of many companies. Telomir believes it's getting closer to the successful formula. With the company all in with Telomir-1, stay tuned for more news on the trial front from this early-stage anti-aging innovator. Featured photo by JD Mason on Unsplash. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

November 22, 2024 09:00 AM Eastern Standard Time

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BioRestorative Ends Q3 In ‘Strong’ Financial Position, Reports Positive Data For Its Phase 2 BRTX-100 Chronic Back Pain Trial

Benzinga

By Meg Flippin, Benzinga BioRestorative Therapies, Inc. (NASDAQ: BRTX), a regenerative medicine company focused on stem cell-based therapies and products, is advancing toward profitability, narrowing its loss in the third quarter and releasing favorable data for its BRTX-100 treatment for chronic back pain. The third quarter was a busy period for BioRestorative, as it secured a new patent, released what it says is encouraging trial data and continued licensing discussions with a commercial-stage regenerative medicine company – while also reducing its losses. For the three months ending Sept. 30, 2024, BioRestorative posted an operating loss of $2.3 million, marking a 26% year-over-year improvement from $3.1 million in the same period last year. The net loss for the third quarter was $1.1 million, or $0.13 per share. BioRestorative said it ended the quarter in a “very strong financial position” with $13 million in cash and short-term investments. The company had no debt as of the end of the third quarter. “We have continued to execute well across all areas of our business and are looking forward to continuing to update investors on our progress as we close out the remainder of 2024,” says Lance Alstodt, BioRestorative’s chief executive officer. “From an operating perspective, we are thrilled with our third quarter results, as we are seeing initial progress on our path to sustainable profitability, driven by cost containment activities coupled with increased resources dedicated to our commercial programs.” Commercial Programs Making Inroads BioRestorative’s commercial programs got a boost late in the quarter when it announced it obtained a provisional license from the New York State Department of Health (NYSDOH) to process, isolate, expand and preserve allogeneic (non-autologous) donor tissue, including stem cells, for medical research. Previously BioRestorative was licensed by the NYSDOH to act as a tissue bank for the processing of mesenchymal stem cells derived from autologous donors only. “It will significantly enhance our ability to develop an unrivaled clinical pipeline of off-the-shelf cell-based biologic products,” says Alstodt. Meanwhile, the company’s product, ThermoStem®, which uses adipose-derived (brown fat) stem cells to generate new brown fat tissue to target obesity and metabolic disorders, drew attention during the quarter. BioRestorative shared details of the ThermoStem platform at IFATS 2024, the annual industry conference focused on adipose therapeutics and science. BioRestorative believes cell-based therapy candidates generated from its ThermoStem program may allow for lower dosing than GLP-1 obesity drugs or provide an alternative biologic-based treatment. Studies have shown brown fat activation in addition to weight loss, can lead to positive effects on several organs, including the heart, liver and muscle. The company competes with giants like Novo Nordisk (NYSE: NVO), Eli Lilly (NYSE: LLY) and Pfizer (NYSE: PFE) in the space. During the quarter, the Israel Patent Office issued the company a Notice of Allowance for a new patent application covering several fundamental aspects of ThermoStem. It's the 14th international patent. In addition to all that, BioRestorative continued talks for a ThermoStem licensing deal with an undisclosed commercial-stage regenerative medicine company. BRTX-100 Data Encouraging In conjunction with third-quarter earnings, BioRestorative released clinical data for BRTX-100, its autologous stem cell product for chronic lower back pain. It uses a patient’s stem cells, which are harvested, cultured and then injected directly into the affected disc to start the repair process. It’s targeted at the more than 25 million people in the U.S. who suffer from chronic lower back pain each year. Safety and efficacy endpoints from an ongoing phase 2 trial for the treatment of chronic lumbar disc disease (cLDD) were encouraging, BioRestorative reported. The company said no serious adverse events (SAEs) were reported in any of the 10 first patients of the prospective, randomized, double-blinded and controlled study. BioRestorative said there was also no dose limiting toxicity at 26-52 weeks. “Blinded preliminary clinical data of safety and efficacy endpoints from the ongoing phase 2 clinical trial of BRTX-100 in the treatment of cLDD are very encouraging, with patient-reported pain and function outcomes demonstrating a positive trend,” said Alstodt. “Most importantly, at 26 weeks, 70% of the patients are reporting a greater than 30% increase in function and a more than 30% decrease in pain. If data continues with this trend, we are confident that we will hit our efficacy endpoints for the phase 2 trial.” A total of up to 99 eligible subjects will be enrolled at up to 16 clinical sites in the United States. Subjects included in the trial will be randomized 2:1 to receive either BRTX-100 or a placebo. The new blinded preliminary safety and efficacy data from the ongoing phase 2 clinical trial of BRTX-100 was described in a podium presentation at the Orthopaedic Research Society (ORS) Philadelphia Spine Research Society (PSRS) 7th International Spine Research Symposium. From posting encouraging data to narrowing its losses, BioRestorative seems to be making strides on its path to profitability. With more news to come, this may be a story worth paying attention to. To learn more about BioRestorative’s stem cell therapies, click here. Featured photo by National Cancer Institute on Unsplash. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

November 21, 2024 08:45 AM Eastern Standard Time

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340Bwell Presents the latest research for Optimizing STD Clinics at Global HIV and AIDS Conferences

Rev Up Marketers

340Bwell, a leader in the 340b consulting and solutions, presented their cutting edge research in two major global HIV/AIDS conferences - HIV4Prevention Conference held in Lima, Peru; and Fast Track City Conference held in Paris, France. Building upon the foundation of promoting evidence decision making within the organization and among its clients – that includes leading STD clinics of the United States – 340bwell team used regular client demographic and clinical data to uncover a diverse range of findings. In the Fast Track City Conference, the Bwell team presented a poster that highlighted the paucity of research on PrEP retention in the global south. The poster was the outcome of a systematic review being conducted by the team that examines PrEP retention and analyses the way researchers and practitioners measure it and define it. The poster revealed that the majority of the studies (>50%) were in the United States. The other two countries with a relatively large number of studies were South Africa (14.2%) and Kenya (12.5%). Bwell Managing Partner Mark Erwin also delivered a presentation on a novel telehealth model for PrEP service delivery that deployed an in-house assembled testing kits to save on cost and to expand access. In the HIV4Prevention Conference, two posters were presented. The first focussed on the science and dynamics of appointment scheduling – demonstrating that the association between client showing up and day of appointment, time slot, chosen, and if the appointment was in-clinic or telehealth was statistically significant. The second poster aimed to test the accuracy of a model that could predict if the client will show up or not using machine learning – deploying routine data. Considering that The United States' PrEP clinics have high no-show rates and not only do cancellations or no-shows result in lost opportunities to connect patients to PrEP therapy, but they also waste clinic time and resources – these findings and models can influence the way clinics can optimize their resources. Mark Erwin, the managing partner of the company said “We are excited to present evidence generated by our team at such esteemed global platforms and at the same time, learn from researchers across the world. It is truly a joyful experience to be around HIV/AIDS advocates and scientists with the common goal of reducing the impact of HIV for those who live with it or are vulnerable to it.” About 340Bwell: 340Bwell is a consulting firm specializing in optimizing 340B drug pricing programs for HIV and STD clinics. They use data-driven strategies to improve patient outcomes, clinic efficiency, and care access. Their innovative solutions have been presented at global HIV/AIDS conferences. 340Bwell is committed to advancing healthcare for underserved populations. For more information visit https://340bwell.com/ Contact Details 340bwell Harsh Agarwal - Data Scientist +1 919-903-1531 harsh@340bwell.com Company Website https://340bwell.com/

November 21, 2024 07:59 AM Eastern Standard Time

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News Release

Consumers Primed to Spend on Cannabis, New Poll Finds

NuggMD

A majority of frequent cannabis consumers say their spending on cannabis has gone up during the past year, and a plurality say they expect it to continue to rise over the next year, according to a new consumer poll released today by NuggMD. The poll shows 61% of respondents report spending “more” or “much more” on cannabis over the past year. Forty-five percent said they expect their spending on cannabis products to continue to rise over the next year, while just 25% signaled an intention to reduce their spending. The poll was first reported by Marijuana Moment. “While our poll is a far cry from cash on hand for cannabis retailers and cultivators, it shows that demand is strong and is likely to become stronger in the near term,” said Andrew Graham, head of communications at NuggMD. “This data says that the demand side of the market is durable and highly resilient. Cannabis might be among the most recession-proof consumer products, because most cannabis use is rooted in wellness, not indulgence.” Methodology The two polls were conducted from Oct. 10 to Oct. 13 and Oct. 17 to Oct. 20 and have a margin of error of 5.9% and 4.8%, respectively. NuggMD regularly conducts polls and market research on cannabis using a sample of nearly 1.2m frequent cannabis consumers who live in state-legal markets. The company’s polling capabilities are derived from first-party data it has collected and used since launching in 2015. About NuggMD NuggMD is the nation’s leading medical marijuana technology platform, serving patients in Arizona, California, Connecticut, Delaware, Florida, Georgia, Illinois, Iowa, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nevada, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Texas, Vermont, Virginia, Washington, and West Virginia. They’ve connected over 2,000,000 patients face-to-face with their new medical marijuana doctors via their state-of-the-art telemedicine platform. They believe every human being has the right to explore the potential benefits of medical cannabis and are fully committed to helping each patient explore every option in their journey to wellness. For further information, visit https://www.nuggmd.com. Contact Details Andrew Graham +1 646-385-0189 andrew.g@getnugg.com Company Website http://www.nuggmd.com

November 19, 2024 03:09 PM Eastern Standard Time

PathAI Announces Integrations with Leading AI-pathology Companies Deep Bio, DoMore Diagnostics, Paige, and Visiopharm, through its AISight Image Management System

PathAI

PathAI, a global leader in AI-powered digital pathology solutions and the developer of the market-leading AISight 1 Image Management System (IMS), today announced the integration of several AI products from market leading digital pathology companies, including Deep Bio, DoMore Diagnostics, Paige, and Visiopharm. Through these collaborations, PathAI will provide algorithms from these developers directly within its AISight IMS, reinforcing its commitment to offering the most versatile, reliable, and interoperable IMS on the market. Deep Bio "Integrating Deep Bio's DeepDx Prostate with PathAI's AISight platform marks an important step forward in prostate cancer diagnostics, combining AI-driven pathology insights with robust image management capabilities to support streamlined workflows," said Sun Woo Kim, CEO of Deep Bio. "This collaboration brings advanced data-driven tools to the hands of pathologists globally, enabling more efficient pathology processes and reinforcing our commitment to innovation in cancer diagnostics." — DoMore Diagnostics “DoMore Diagnostics and PathAI have a shared vision to realize the promise of digital pathology and outcome prediction to improve the lives of patients worldwide,” said Torbjørn Furuseth, Co-Founder and CEO of DoMore Diagnostics. “The AISight platform is set to spearhead innovations in the field going forward and will be a key partner as we continue our mission to personalize cancer treatment for patients worldwide with our Histotype Px digital biomarker.” — Paige "We see the partnership with PathAI as an important step forward for digital pathology; as the two leaders in this space, by offering our solutions together, pathologists can benefit from all the best things the industry can offer," said Peter Hamilton, GM of Diagnostics. — Visiopharm “We are delighted to collaborate with PathAI to bring our portfolio of fully automated, zero-click AI-driven diagnostic and translational solutions for breast and lung cancer to a broader audience. Our commitment is to expand access to precision pathology on leading platforms. Becoming a preferred partner for PathAI's AISight Image Management System is an important step towards this goal. With our platform-agnostic technology designed for seamless integration, we look forward to working closely with the PathAI team to accelerate the adoption of digital pathology worldwide, ultimately enhancing lab efficiency and improving the quality of patient care,” said Michael Grunkin, CEO Visiopharm — Utilizing the AISight IMS, partner laboratories will be able to seamlessly access a diverse portfolio of digital pathology algorithms from leading global AI companies. Through these deep integrations pathologists will benefit from rich visual support, including AI-generated overlays, and embedded quantitative results driving differentiated workflows. This integrated user experience will allow labs to realize the most value from algorithm product usage in their routine lab workflows. AISight’s growing portfolio of algorithms supports various needs, including workflow optimization, biomarker quantification, risk stratification, slide quality control, and tumor sufficiency. These integrations are powered by AISight Link, an open API that allows algorithm developers to leverage the platform’s advanced features, including AI Impressions, Fields of Interest, and comprehensive reporting tools. “These partnerships are a testament to our commitment to building a robust ecosystem of AI and digital pathology innovators,” said Andy Beck, MD, PhD, co-founder and CEO of PathAI. “Through AISight Link, we ensure seamless interoperability between AISight and third-party AI algorithms, as well as integration with Laboratory Information Systems (LIS) and other essential IT infrastructure in modern pathology labs. We are excited to collaborate with labs and AI developers to collectively drive improvements in patient outcomes.” For more information about PathAI, AISight, or the expanding algorithm catalog, please contact digital.dx@pathai.com or visit pathai.com. 1 AISight is for Research Use Only in the US; AISight Dx is CE-IVDR in Europe and UKCA in UK About PathAI PathAI is a global leader in AI-powered digital pathology solutions, dedicated to improving operational efficiency in pathology labs worldwide. Through its innovative technology and strategic partnerships, PathAI is shaping the future of medical diagnostics and advancing patient care across the globe. About Deep Bio Deep Bio is a pioneer in AI-powered pathology, transforming cancer diagnostics with innovative solutions that support pathologists in delivering precise and efficient care. Its flagship product, DeepDx Prostate, is a CE-IVD-marked diagnostic aid extensively vetted through studies of over 700,000 U.S. biopsy specimens. Offering tools for cancer detection, Gleason scoring, and gland-level tumor analysis, DeepDx Prostate enhances diagnostic accuracy while streamlining pathology workflows. Deep Bio's commitment to advancing digital pathology is driven by collaboration and a dedication to improving patient outcomes. About DoMore Diagnostics DoMore Diagnostics uses artificial intelligence to make personalized treatment decisions simple and accessible for all cancer patients. Its unique digital biomarkers predict patient outcomes from routine tumor tissue slides and can be seamlessly integrated into pathologists' existing workflow. The lead product Histotype Px ® Colorectal is a CE-IVDD marked outcome prediction marker for stage II and III colorectal adenocarcinoma that informs the decision of whether to provide adjuvant chemotherapy following surgical resection of the tumor. About Paige Paige's AI applications are developed using extensive and diverse datasets and leverage advanced AI technologies. Thoughtfully designed, rigorously tested, and trusted by pathologists worldwide for their performance. By automating traditionally burdensome and tedious manual tasks, Paige's AI applications alleviate time and resource pressures for pathologists. All of Paige's AI suites including Prostate, Breast, Colon, Pan-Cancer, and the new biomarker screening application, OmniScreen™ will be made available within PathAI's digital pathology solution, AISight. About Visiopharm Visiopharm is a leading provider of AI-driven precision pathology software for research and diagnostics. In research, it is a technology leader providing tools that help scientists, pathologists, and image analysis experts produce accurate data for all types of tissue-based research. In diagnostics, it is a leader within clinical applications, with no fewer than nine diagnostic algorithms cleared under IVDR for EU and UK customers. These applications provide diagnostic decision support and can be easily activated and integrated into existing lab workflows. Founded in 2002, Visiopharm is privately owned and operates internationally with over 750 customer accounts in more than 40 countries. The company's headquarters are located in Denmark's Medicon Valley, with legal entities in Sweden, the UK, Germany, the Netherlands, and the United States, and local representation in France and China. Contact Details SVM Public Relations and Marketing Communications Maggie Naples +1 401-490-9700 pathai@svmpr.com Company Website https://www.pathai.com/

November 19, 2024 09:19 AM Eastern Standard Time

New AI-Powered Mobile App Delivers Early Prediction of Heart Attack or Stroke

Before Health Intelligence Ltd.

Before Health Intelligence, Ltd. today emerged from stealth and announced a new mHealth app called Antshrike ™ that uses AI to transform wearable device data into highly precise and specific predictive cardiovascular health warnings. As an iOS app, Antshrike uses proprietary AI algorithms to identify early warning signs of critical cardiovascular events, such as heart attacks or strokes, with high predictive accuracy for individuals at risk. The app processes biometric time-series data collected by commercially available Apple smart phones and smart watches, calculates individual risk of critical events in real time and predicts when and how changes in a patient’s health states may occur. By notifying patients of imminent danger in advance, Antshrike enables timely intervention by healthcare providers, paving the way for personalized medical intervention and treatment and improved medical outcomes. “In South America, the Antshrike bird warns primates of upcoming dangers,” said Before Health Intelligence CEO & co-founder Ekaterina Mitricheva, MD, PhD. “We developed our new digital health app by the same name to warn those at risk of major ischemic cardiovascular events before they take place. With cardiovascular disease as the number one cause of death worldwide, there is an urgent need to predict and prevent heart attacks and strokes.” The Antshrike mHealth app: Passively monitors health status without interrupting daily routines, social interactions and work habits Predicts the danger and timing of cardiovascular events with more than 85% accuracy in a personalized manner Uses proven science based on decades of research, more than 130 billion data points analyzed by Before Health Intelligence’s scientists, as well as open source CDC data from tens of thousands of individuals Assures HIPAA-compliant patient privacy by preprocessing individual patient data (not patient records) on a patient’s phone with anonymized preprocessed values that can never be traced back to any specific person Requires no manual input of data or reliance on expensive hospital equipment and procedures Assists healthcare providers in saving more lives since timely predictive interventions are known to reduce the probability of lasting effects or fatality Antshrike uses two layers of AI, static and dynamic, to calculate an individual’s risk of critical events in real-time. The static layer processes data entered by an individual to determine an initial risk score, and the machine learning algorithm is trained on over 500,000 CDC datapoints of approximately 23,000 individuals. The dynamic layer collects and analyzes biometric time-series from smart watches in real-time, uses the proprietary AI algorithm to identify early warning signs of critical state transitions, and then delivers a personalized, time-sensitive risk score for an upcoming major ischemic cardiovascular event. The freemium app is expected to be available in the U.S. in 2025. To become a partner or learn more about the product, visit https://www.before-intelligence.com/contact. About Before Health Intelligence Ltd. Before Health Intelligence, a medical device manufacturer developing software-as-a-medical device (SaMD), offers mobile applications that identify the early warning signs of critical events in complex diseases. The apps analyze each individual’s health data, recorded by leading smart watch brands in combination with proprietary AI algorithms and data sets, as well as open source data from the Center for Disease Control (CDC). This continuous monitoring alerts individuals of early warning signs of critical cardiovascular events (e.g., heart attacks or strokes) or neuropsychiatric events (e.g., alcohol addiction relapse), enabling timely medical intervention and improved survival rates. Founded in 2022, the Before Health Intelligence team is comprised of highly skilled medical professionals, mathematicians, physicists and programmers with research experience at institutions such as Princeton University, Max Planck Society and MIT. Learn more at https://www.before-intelligence.com and follow the company on LinkedIn. Contact Details Rainier Communications Michelle Allard McMahon or Jenna Desimone beforehealth@rainierco.com Company Website https://www.before-intelligence.com/

November 19, 2024 07:45 AM Eastern Standard Time

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Presenting Encouraging Data, Acquiring Licenses, Issuing Patents And More – BioRestorative's Inroads Bringing Its Stem Cell Therapies To Market

Benzinga

By Meg Flippin, Benzinga From alleviating lower back pain to treating obesity, stem cells can play a central role in healing some of the world’s most prevalent conditions. For good reason: stem cells are regenerative and can turbocharge the body's natural healing process. BioRestorative Therapies, Inc. (NASDAQ: BRTX), a regenerative medicine company focused on stem cell-based therapies and products, has been inkling deals and securing patents to treat back pain and obesity as well as other hard-to-cure ailments and diseases. Take BRTX-100 for example. It’s BioRestorative’s autologous stem cell product for chronic lower back pain. It uses a patient’s stem cells, which are harvested, cultured and then injected directly into the affected disc to start the repair process. BRTX-100 is designed to treat the 25 million people in the U.S. who suffer from chronic lower back pain each year, half of whom have or will be diagnosed with disc degeneration, reports the company, and current treatments on the market are less than ideal. Opioid pain relievers, steroid injections and physical therapy help manage pain but don’t cure it. Surgery is another option, but clinical outcomes can be limited. Phase 2 Trial Results Coming The company is currently engaged in a phase 2 clinical trial using BRTX-100 to treat persistent lower back pain caused by painful degenerative discs. This week (Nov. 10-14), BioRestorative presented new preliminary 26–52-week blinded data from the ongoing phase 2 clinical trial at the Orthopaedic Research Society (ORS) Philadelphia Spine Research Society (PSRS) 7th International Spine Research Symposium in Skytop, Pennsylvania. BioRestorative will also make the data available through a public announcement. “In February 2024, we were strongly encouraged that the Visual Analog Scale, Oswestry Disability Index, Roland Morris Disability Questionnaire, and Functional Rating Index collected at 26 and 52 weeks after injection indicated a positive trend compared to the baseline with the first four patients enrolled in the study,” said BioRestorative’s CEO Lance Alstodt. “Now, at ORS PSRS 2024, we have revealed data on 10 patients. Blinded preliminary clinical data of safety and efficacy endpoints are very encouraging, with patient reported pain and function outcomes demonstrating a positive trend,” said Mr. Alstodt. “Most importantly, at 26 weeks, 70% of the patients are reporting a significantly greater than 30% increase in function and a more than 30% decrease in pain. If data continues with this trend, we are confident that we will hit our efficacy end points for the phase 2 trial,” he continued Fighting Obesity With Stem Cells With A Focus On Growing IP Portfolio Then there is BioRestorative’s ThermoStem, which uses brown adipose-derived (brown fat) stem cells to generate new brown fat tissue to target obesity and metabolic disorders. This type of fat is known to burn rather than store energy. Elevated levels of brown fat have been shown to increase metabolism and facilitate weight loss, reports BioRestorative. It’s a big market for BioRestorative to go after. After all, 40% of Americans are obese; 30% have type 2 diabetes or pre-diabetes and half of Americans have at least one major risk factor for heart disease, according to data compiled by the company. ThermoStem is also making news with BioRestorative recently announcing that the Israel Patent Office has issued the company a Notice of Allowance for a new patent application (Israeli Patent Appl. No. 287557) covering several fundamental aspects of its allogeneic, off-the-shelf ThermoStem platform. It's the 14th international patent and covers non-naturally occurring three-dimensional brown adipose-derived stem cell (BADSC) aggregates, encapsulation, a method for making them and a method for treating a patient with a disorder. “We believe that our ThermoStem-based BADSCs hold tremendous promise to deliver a superior efficacy and tolerability profile over GLP-1 drugs,” said Alstodt. “This latest patent issuance demonstrates our strong commitment to protecting the innovation of our ThermoStem program and the significant potential commercial opportunity that it represents for ourselves and any current and/or future potential licensing partners. And, given Israel’s global prominence in stem cell research, we are particularly excited by this latest patent issuance.” Expanding Via Licensing In addition to securing patents and gearing up to present clinical data, BioRestorative recently obtained a license from the New York State Department of Health (NYSDOH) to process, isolate, expand and preserve allogeneic (non-autologous) donor tissue, including stem cells, for medical research. In New York, companies are required to have a license to engage in tissue and stem cell activities. Previously BioRestorative was licensed by the NYSDOH to act as a tissue bank for the processing of mesenchymal stem cells derived from autologous donors only. BioRestorative says the expanded license enables it to leverage its state-of-the-art cGMP manufacturing to process, bank and distribute clinical-grade allogeneic (off-the-shelf) biologics. “It will significantly enhance our ability to develop an unrivaled clinical pipeline of off-the-shelf cell-based biologic products,” says Alstodt. Stem cells play an important role in treating several prevalent diseases. The remedies of today aren’t cutting it. BioRestorative aims to change that with BRTX-100 and ThermoStem – and it’s working hard to get the licenses and patents to make that happen. Other companies competing in the cell-based biologics or chronic pain treatment space include Mesoblast ( NASDAQ: MESO), Brainstorm Cell Therapeutic (NASDAQ: BCLI) and Longeveron (NASDAQ: LGVN). To learn more about BioRestorative’s stem cell therapies, click here. Featured photo by Sasun Bughdaryan on Unsplash. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

November 18, 2024 08:45 AM Eastern Standard Time

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Impact BioMedical Inc. (NYSEAmerican: IBO): Targeting Chronic Diseases with Patented Breakthroughs

IBO

The biotechnology industry is booming, with a global market valued at $1.55 trillion in 2023 and projected to grow at a 13.96% annual rate through 2030. Driving this growth are government-backed initiatives to modernize regulations, streamline approvals, and improve access to personalized medicine and orphan drugs—paving the way for emerging companies. Chronic inflammatory diseases, identified by the World Health Organization as the leading global health threat, are a key focus area. Recent estimates reveal nearly 60% of Americans live with at least one chronic condition, and three out of five deaths worldwide result from diseases like cancer, diabetes, and respiratory disorders. This urgent need for solutions presents immense opportunities for innovation. In this rapidly evolving landscape, Impact BioMedical Inc. (NYSEAmerican: IBO) emerges as a promising player committed to advancing healthcare innovation. A Promising Player in Biotech Impact BioMedical Inc. (NYSEAmerican: IBO), a pioneering biotechnology firm, has quickly captured attention since its IPO in September 2024. Focused on discovering, developing, and patenting innovative solutions for human healthcare and wellness, the company is building momentum as it positions itself to address unmet medical needs in various fields. A Strong Start: The IPO and Investor Confidence On September 16, 2024, Impact BioMedical entered the public market with its initial public offering of 1.5 million shares priced at $3.00 each. The IPO, which raised $4.5 million, garnered robust interest, with over 30% of shares purchased by existing investors. This strong participation signals significant confidence in the company’s potential and direction. Impact BioMedical CEO Frank D. Heuszel commented on the IPO’s success, emphasizing that investor confidence reflects the belief in the company’s mission to deliver transformative healthcare solutions. Leadership Positioned for Growth At the helm of Impact BioMedical is a highly experienced leadership team. CEO Frank D. Heuszel, with a background in finance and executive leadership, has been instrumental in guiding the company’s strategic direction. Heuszel’s tenure as CEO of DSS, Inc., Impact BioMedical’s parent company, since 2019 has prepared him to navigate the complexities of biotech innovation and commercialization. Supporting Heuszel is COO Mark Suseck, who brings extensive experience in strategy, licensing, and acquisitions from his time at DSS BioHealth Holdings and Vivacitas Oncology. CFO Todd Macko complements the team with his expertise in financial planning, analysis, and mergers and acquisitions, ensuring the company is fiscally sound as it expands. Together, this leadership team aims to drive innovation and establish Impact BioMedical as a key player in the biotechnology sector. Innovative Technology Platforms with Real-World Applications Impact BioMedical is built on a foundation of cutting-edge technologies designed to tackle pressing healthcare challenges. Two standout platforms, 3F and Linebacker, highlight the company’s unique approach to improving human health and wellness. The 3F insect repellent technology recently secured a U.S. patent, showcasing its potential as a natural solution to reduce insect landings and bites. Unlike chemical-based alternatives, 3F uses plant-derived formulations to effectively “blind” insects to human presence. Its applications range from standalone repellents to integrations in shampoos and detergents. With vector-borne diseases accounting for 17% of infectious diseases globally, 3F addresses a significant market need. CEO Frank Heuszel emphasized the company’s commitment to advancing commercialization efforts with potential partners, aiming to provide eco-friendly solutions for outdoor safety. Another major achievement is the Canadian patent for Linebacker technology, which targets inflammatory diseases with novel phenolic compounds. This platform offers potential relief for conditions such as arthritis, asthma, and inflammatory bowel disease, while mitigating the side effects associated with traditional treatments. Derived from myricetin, a plant-based flavonoid, Linebacker compounds are designed to inhibit inflammatory responses and oncogenic pathways. The technology has been licensed to ProPhase Laboratories for global development and commercialization, paving the way for promising revenue opportunities. Expanding IP Portfolio Impact BioMedical’s ability to secure patents across jurisdictions underscores its commitment to innovation and its potential for market leadership. The company’s IP portfolio includes patents for insect repellent compositions and inflammatory disease treatments in the U.S., Canada, and other regions, providing a strong competitive edge. The Road Ahead As a relatively new public entity, Impact BioMedical has already demonstrated an ability to attract investor confidence, build a robust IP portfolio, and establish partnerships for product development. The company’s technologies address critical health challenges, offering significant market potential in both developed and emerging markets. Conclusion Impact BioMedical (NYSEAmerican: IBO) is emerging as a promising force in biotechnology. With its focus on innovative healthcare solutions, a strong leadership team, and a growing IP portfolio, the company could be well-positioned for long-term growth. Impact BioMedical’s strategic initiatives and commitment to innovation offer a compelling case for investors looking to tap into the potential of healthcare advancements. Disclaimers: RazorPitch Inc. "RazorPitch" is not operated by a licensed broker, a dealer, or a registered investment adviser. 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This content is for informational purposes only; you should not construe any such information or other material as legal, tax, investment, financial, or other advice. Nothing contained in this article constitutes a solicitation, recommendation, endorsement, or offer by RazorPitch or any third-party service provider to buy or sell any securities or other financial instruments. All content in this article is information of a general nature and does not address the circumstances of any particular individual or entity. Nothing in this article constitutes professional and/or financial advice, nor does any information in the article constitute a comprehensive or complete statement of the matters discussed or the law relating thereto. RazorPitch is not a fiduciary by virtue of any persons use of or access to this content. Contact Details RazorPitch Mark McKelvie +1 585-301-7700 mark@razorpitch.com Company Website http://razorpitch.com

November 18, 2024 07:00 AM Eastern Standard Time

Healthcare Giant Thermo Fisher Scientific Inc. (NYSE: TMO) Inks Deal With Mainz Biomed (NASDAQ: MYNZ) To Develop And Commercialize Next Gen Colorectal Cancer Screening

Benzinga

By Meg Flippin, Benzinga Colorectal cancer is no longer a disease that affects only the elderly. Kids and teens are being diagnosed at an alarming rate. Over the past two decades, the number of cases of this form of deadly cancer has skyrocketed 500% among young people. Kids between 10 and 14 have seen cases rise 333%. That’s why actors including Frankie Muniz and influencers like Petra Smeltzer Starke, founder and CEO of a global growing hot yoga healthy lifestyle brand SweatNGlow, are sounding the alarm and spotlighting the problem. It makes sense. Colorectal cancer is a major cause of death in America, killing 50,000 people each year. What’s more, 71% of the diagnoses made are in the later stages of the disease. But if it's caught early, the survival rate after five years is 90%. Despite those favorable odds, only about four in ten colorectal cancers are spotted at the early stage. Mainz And Thermo Fisher Scientific Inc. Team Up It’s also why Mainz Biomed NV (NASDAQ: MYNZ), the molecular genetics diagnostic company, has been working hard to bring ColoAlert®, its early detection screening that spots bleeding and non-bleeding tumors through tumor DNA analysis, to market. The company specializing in the early detection of cancer just inked a deal with Thermo Fisher Scientific Inc. (NYSE: TMO) through its Life Technologies Corporation subsidiary to jointly develop and potentially commercialize ColoAlert in the U.S. Mainz Biomed said the collaboration will leverage Thermo Fisher Scientific’s technologies, instrumentation and information translation systems to enable Mainz Biomed to develop the proprietary assays for its mRNA-based next-generation CRC screening tests. “This collaboration with Thermo Fisher Scientific will be instrumental to our goal to bring to market a home collection colorectal screening tool with highly effective detection of adenomas,” said Guido Baechler, CEO of Mainz Biomed. “Our product development will be greatly enhanced by Thermo Fisher Scientific’s knowledge and scalable, class-leading technologies, providing both partners with a means to accelerate the availability of an innovative new test for colorectal cancer screening around the world.” The company noted that clinical trials in the U.S. and Europe have been successful. In clinical trials, Mainz Biomed said ColoAlert’s sensitivities exceeded 90% for detecting colorectal cancer and over 80% for advanced adenomas. The company is gearing up to launch a clinical FDA trial in the U.S. next year. If that is successful, Mainz Biomed will be able to sell ColoAlert to millions of Americans at risk of colorectal cancer. Mainz Biomed’s Method To Take Screening To The Next Level ColoAlert, via stool samples, spots the four tumor markers associated with cancer: KRAS-mutation, BRAF-mutation, total amount of human DNA and occult blood. The company’s flagship non-invasive test targets early detection of colorectal cancer and focuses on precancerous lesions or advanced adenomas. Detecting advanced adenomas is crucial in preventing colorectal cancer, as identifying patients with these lesions allows for timely intervention through colonoscopy and adenoma removal, thereby averting cancer development, reports Mainz Biomed. While the cases among young adults and children are increasing at an alarming rate, Islam Mohamed, MD, an internal medicine resident physician at the University of Missouri-Kansas City, said the cases aren’t high enough to suggest widespread colonoscopy screening. It does suggest knowing the symptoms and getting screened to combat this form of cancer. “Colorectal cancer is no longer considered just a disease of the elderly population,” said Mohamed. “It’s important that the public is aware of signs and symptoms of colorectal cancer.” On top of being accurate, ColoAlert is easy to use, which Mainz Biomed is betting should be a big driver of adoption. Within five minutes your sample is collected and packaged and on the way to the lab. Patients receive a kit in the mail that includes instructions, a stool collector and a shipping label to return the kit to their local lab for testing. Patients receive the results in a few days. Unlike the rival ColoGuard, Mainz says ColoAlert requires very small samples to test, which is one of the reasons the company boasts 98% patient satisfaction. Colorectal is a deadly form of cancer, but one that doesn’t have to be if it's spotted early. Mainz Biomed, along with Thermo Fisher Scientific, wants to play a role in solving the problem by bringing ColoAlert to the masses. This collaboration brings them one step closer to achieving that. Featured photo by National Cancer Institute on Unsplash. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

November 13, 2024 08:55 AM Eastern Standard Time

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