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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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LogicMark Offers Safety Technology for Free To American Veterans Nationwide

Benzinga

By Meg Flippin, Benzinga Falls are the leading cause of injury and death among aging adults in America, including our nation’s 8.1 million veterans over 65. Due to chronic conditions and physical disabilities, they are actually more susceptible to falls than their non-veteran counterparts. With more than one in five veterans living alone in America, many are in unsafe situations. Staying strong and healthy is the best way to prevent falls, but there are many other ways to decrease the risk. Making simple updates in the home, such as removing throw rugs, improving lighting, installing grab bars, using bed rails, widening hallways and doorways and adding ramps outside, can enhance safety and prevent common accidents. But even so, a fall may still occur. Unfortunately, constant physical monitoring and surveillance aren’t possible for a lot of people, and how quickly help comes could mean the difference between a non-fatal or fatal injury. That’s where LogicMark Inc. (NASDAQ: LGMK), a leading provider of personal emergency response systems (PERS), health communication devices and IoT technologies, is making a significant impact for those in these situations. Instead of relying on in-person monitoring, the company uses advanced technology to offer a comprehensive suite of products aimed at protecting users from falls both at home and on the go. Confidence And Independence In A Compact Device LogicMark’s Freedom Alert Mini is a compact 4G LTE device that allows users to call for help with just the push of a button, ensuring help is always within reach wherever there is cellular service. The Freedom Alert Mini is equipped with LogicMark’s patented fall detection technology which uses accelerometer sensors that measure the user’s speed and orientation to detect a fall. When a fall has been detected, the device sends an alert to a 24/7 monitoring center, a loved one or 911. This can be life-saving if a user falls and is unable to dial an emergency contact due to an injury, loss of consciousness, or disorientation. In addition to its fall detection capabilities, the device features GPS location services that can pinpoint the exact location of a fall and alert authorities and caregivers. It also includes geofencing capabilities, allowing caregivers to establish a virtual boundary for their loved ones. If the device user moves beyond this designated area, caregivers receive an immediate alert. Guardian Alert 911 Plus is an additional on-the-go device in LogicMark’s product line. It is designed to enhance safety both inside and outside the home and features 4G LTE technology that enables users to connect directly to 911 with a single button press. Additionally, the device includes a two-way communication feature, allowing users to speak directly with 911 operators during emergencies. This functionality provides users with the confidence to live independently, knowing help is just a call away. Veterans Can Feel Safe At Home 70% of falls occur indoors. For veterans who spend considerable time at home, LogicMark’s Freedom Alert and Guardian Alert 911 offer reliable solutions to enhance safety and peace of mind. Both wearable medical devices use the customer’s landline to connect to emergency services. The Freedom Alert allows users to quickly connect with friends, family or 911 in an emergency. With the push of a button, the device can call up to four pre-programmed contacts or dial 911 directly. Emergency responders can pinpoint the location of a LogicMark device within a 600-foot radius of the base unit. The Guardian 911 connects directly to emergency services with a single button press. Ensuring users can easily call for help or notify a caregiver even during stressful or confusing moments. Both devices feature long-lasting batteries that last at least one month. These devices give aging adults freedom and confidence, knowing help is a push of a button away. For caregivers and loved ones, the devices offer an added layer of monitoring and peace of mind when they cannot be present. Meanwhile, first responders receive crucial information that enables them to reach the scene quickly and efficiently. Globally, the fall detection systems market is forecasted to grow at a CAGR of 7.6% from now through 2030. Driving that growth is the demand for solutions to ensure the aging adult population's safety and independence with devices that can aid in home health care. LogicMark’s products check off both boxes. Aging adults over 65 make up half the nation’s veterans, and just like their non-veteran counterparts, they are at risk of falls. As the population ages, demand for devices that detect falls is projected to grow. LogicMark aims to capitalize on this growth, positioning its devices – from the Freedom Alert Mini to the Guardian Alert 911 Plus – as potential leaders in the market. Take a glance at LogicMark’s stock chart here. Featured photo by sydney Rae 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 20, 2024 08:45 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

Power2Practice Unveils Strategic Partnership with Evexia Diagnostics to Revolutionize Lab Ordering and Patient Outcomes

Power2Practice

Power2Practice, the first specialized integrative and functional medicine EMR and practice management platform, is thrilled to announce a partnership with Evexia Diagnostics. This integration will enable healthcare providers to order and manage all labs seamlessly within a single, streamlined platform. Learn more about the Power2Practice and Evexia Diagnostics Partnership. Phil Hagerman, CEO, Power2Practice: “Integrating with Evexia Diagnostics is a game changer in lab order management, transforming the way our users streamline their workflows while elevating patient care and accessibility. This partnership reflects our dedication to optimizing the healthcare experience for providers and empowering patients with timely, accessible insights.” Marking a breakthrough in lab ordering efficiency, the collaboration is designed to simplify lab ordering for enhanced practice efficiency and improved patient outcomes while unlocking new revenue opportunities for practices. Dr. Kevin K. Bodling, President, Evexia Diagnostics: “This is a transformative step toward making lab services more accessible and affordable for providers and patients. By embedding our comprehensive lab solutions directly into Power2Practice, we’re equipping practitioners to deliver faster, more economical care. Together, we’re changing the landscape for integrative and functional medicine, enabling providers to leverage lab insights for optimal patient outcomes like never before." Discover the Key Benefits of the Power2Practice + Evexia Partnership: 1. Seamless Lab Ordering: Providers can easily order from their preferred labs directly within the Power2Practice EMR, resulting in a more efficient workflow that saves valuable time and reduces administrative burdens. 2. Cost Reduction: Evexia Diagnostics provides discounted cash pricing, allowing patients to save up to 90% on lab costs compared to traditional billing practices, facilitating easier access to necessary testing. 3. Boost Profitability: Leveraging competitive pricing and streamlined processes enhances practice profitability, allowing providers to offer valuable, affordable lab services to their patients. 4.Enhanced Patient Care: The cash-pay model empowers healthcare providers and patients to operate outside the limitations of insurance, enabling decisions that prioritize quality and affordability in care. Ryan L. Obermeier, Chief Commercial Officer, Evexia Diagnostics: "Our partnership with Power2Practice is a significant leap forward for integrative and functional medicine professionals. By integrating seamless access to over 10,000 tests from 40+ leading labs into P2P, clinicians gain faster, more precise lab results with expert interpretation. Our white-glove service ensures exceptional provider support, and our group purchasing power delivers cost savings. Together, we’re simplifying and elevating the care experience for both providers and their patients." Learn more about this partnership and experience the benefits firsthand! Visit Power2Practice at the upcoming A4M Tradeshow, booth #7072, or sign up for the P2P Evexia demo waitlist. About Evexia Diagnostics Evexia Diagnostics provides a comprehensive selection of cutting-edge clinical laboratory services at unbeatable prices. Streamline and simplify your practice, while expanding the options you’re able to offer your clients, at the very same time. Learn more. About Power2Practice Power2Practice is an innovative healthcare technology platform designed specifically for integrative and functional medicine practitioners. Offering a comprehensive suite of tools, Power2Practice streamlines practice management, enhances patient engagement, and simplifies lab integration to improve efficiency and care delivery. With features like telemedicine, automated patient communication, and customizable protocols, the platform empowers practitioners to deliver personalized, data-driven care. Power2Practice is committed to advancing the field of integrative medicine by providing the tools and support practitioners need to grow their practices and improve patient outcomes. Learn more. Contact Details Power2Practice Britt Wittelsberger +1 410-852-0738 marketing@power2practice.com Company Website https://power2practice.com/

November 19, 2024 08:50 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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Forward-looking statements in this action may be identified through the use of words such as projects, foresee, expects, will, anticipates, estimates, believes, understands, or that by statements indicating certain actions & quote; may, could, or might occur. Understand there is no guarantee past performance will be indicative of future results. Investing in micro-cap and growth securities is highly speculative and carries an extremely high degree of risk. It is possible that an investor's investment may be lost or impaired due to the speculative nature of the companies profiled. RazorPitch has been retained and compensated by Cambridge Consulting to assist in the production and distribution of this content. RazorPitch is responsible for the production and distribution of this content. It should be expressly understood that under no circumstances does any information published herein represent a recommendation to buy or sell a security. This content is for informational purposes only; you should not construe any such information or other material as legal, tax, investment, financial, or other advice. Nothing contained in this article constitutes a solicitation, recommendation, endorsement, or offer by 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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