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NeuroSense Advances Plans For Early Commercialization Of Potentially Groundbreaking ALS Treatment In Canada, Targeting A $100M+ Market

Benzinga

By Kyle Anthony, Benzinga NeuroSense Therapeutics Ltd. (NASDAQ: NRSN), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases – such as amyotrophic lateral sclerosis (ALS), Alzheimer's disease and Parkinson's disease – recently announced its plans to file for early commercialization approval for PrimeC, the firm’s leading drug candidate designed to synergistically target several biological mechanisms of ALS, under Health Canada’s Notice of Compliance with Conditions (NOC/c) policy. This submission is backed by promising results from the company’s phase 2b ALS PARADIGM clinical trial and supplementary clinical and preclinical data. ALS Explained ALS is a nervous system disease that affects nerve cells in the brain and spinal cord. The disease causes loss of muscle control, and gradually worsens over time. Often called Lou Gehrig's disease after the baseball player who was diagnosed with it, the exact cause of the disease is still not known. ALS often begins with muscle twitching and weakness in the arm or leg, trouble swallowing or slurred speech. Eventually, ALS affects the control of the muscles needed to move, speak, eat and breathe. There is no cure for this fatal disease. Every year, more than 5,000 people are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of people living with ALS is expected to grow by 24% by 2040 in the U.S. and European Union. The Efficacy Of NeuroSense’s PrimeC Treatment PrimeC, NeuroSense's lead drug candidate, is a novel extended-release oral formulation with a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. PrimeC is designed to synergistically target several biological mechanisms of ALS that contribute to motor neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid (RNA) regulation. The goal is to inhibit the progression of ALS. NeuroSense reports that PARADIGM, a prospective, multinational, randomized, double-blind, placebo-controlled phase 2b clinical trial of PrimeC in ALS, has demonstrated the drug's efficacy. The trial d emonstrated that PrimeC significantly reduced disease progression (p=0.009) and improved survival rates by 43% compared to placebo, highlighting its potential as a breakthrough therapy for ALS. The trial included 68 participants living with ALS in Canada, Italy and Israel. 96% of the trial participants who completed the 6-month double-blind portion of the trial chose to receive treatment with PrimeC through a 12-month open-label extension. As of June 2024, all participants who completed the 18-month trial treatment duration requested to continue PrimeC, which is provided to them in an Investigator Initiated Trial, not limited to time. The PARADIGM clinical study observed a statistically significant slowing of disease progression in patients who used PrimeC versus placebo, based on the ALS Functional Rating Scale-Revised (ALSFRS-R). The Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS) is the gold standard instrument for evaluating the functional status of patients with ALS. It is used to monitor functional change in a patient over time. NeuroSense reports that most patients enrolled in both the active and placebo arms of the trial were concurrently treated with Riluzole, the ALS standard of care medication, indicating PrimeC slowed disease progression well beyond the level afforded by the FDA-approved ALS drug. The FDA and the European Medicines Agency have granted PrimeC Orphan Drug Designation. Commercialization Of PrimeC In Canada And Worldwide Health Canada’s Notice of Compliance with Conditions (NOC/c) is authorization to market a drug, with the condition that the sponsor undertake additional studies to verify the clinical benefit. As such, this speeds up the time to market for the drug, enabling earlier commercialization. In advancing PrimeC's commercialization potential, NeuroSense plans to submit its regulatory dossier to Health Canada in Q2 2025, with a regulatory decision anticipated by Q1 2026, and NeuroSense estimates the market opportunity for PrimeC in Canada alone to be approximately $100 million to $150 million in annual revenue, reflecting the unmet need for effective ALS treatments. Beyond Canada, NeuroSense plans to pursue regulatory approval in additional global markets as part of its broader strategy to make PrimeC accessible to ALS patients worldwide. Alon Ben-Noon, CEO of NeuroSense, stated, “The Canadian market presents a significant near-term opportunity, with the addressable market for PrimeC valued above $100 million in annual revenue. Securing early commercialization approval in Canada would represent an important milestone, not only to address the unmet need for ALS treatments but also as part of our strategy to drive sustainable growth. With additional markets on our radar, this marks the beginning of what we anticipate will be a long-term revenue-generating opportunity." Looking Forward NeuroSense’s PrimeC has the potential to reshape the landscape for ALS treatment, enhancing the quality of life for individuals around the globe afflicted by this debilitating disease. The promising results from the PARADIGM clinical trial and NeuroSense's commercial advancement plans for the drug indicate that PrimeC may soon be able to benefit ALS patients around the world and potentially position the company to be a leader in treating the disease. Featured photo courtesy of NeuroSense Therapeutics. 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

October 17, 2024 02:00 PM Eastern Daylight Time

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Minerva Surgical Signs Agreement with Blackmaple Group (BMG) and WHAAPA

Minerva Surgical, Inc.

Minerva Surgical, a manufacturer and distributor of minimally invasive gynecologic technologies, today announced a new strategic partnership with Blackmaple Group, designed to provide access to office-based solutions for its Women’s Health Administrative and Purchasing Alliance (WHAAPA) physician members for the detection and treatment of uterine conditions. The Medical Endoscopy Image Processing System and the Minerva ES Ablation System – both of which will be available to BMG WHAAPA members under this new agreement – are designed to quickly and effectively address causes of Abnormal Uterine Bleeding (AUB) a set of debilitating conditions affecting one in three women. Left untreated, AUB may drive women to withdraw or become absent from family, social, and work activities. Some of these conditions can be life threatening, if not detected early. According to Darin Hammers, CEO of Minerva Surgical, “Integrating hysteroscopy into the office setting enables gynecologists to detect uterine cavity disease earlier and more accurately than using other, less sensitive methods. The Minerva ES endometrial ablation can be performed in the comfort of the office setting, while reducing the cost to the patient. Effectiveness of the Minerva ES has been proven in clinical trials demonstrating procedure safety and long-term avoidance of hysterectomy in over 99% of the patients.” Additionally, Minerva ES is a one-time, non-hormonal, incisionless treatment with the recovery time of 1-2 days. “The agreement with Minerva Surgical is important to Blackmaple Group because it provides WHAAPA members with more options to safely and effectively treat patients in the office setting”, said Dr. Jeff Gold, CEO of BMG. About Minerva Surgical: Minerva Surgical is a Women’s Health company committed to improving women's health and quality of life by providing access to minimally invasive, technologically advanced, and innovative solutions for early detection, treatment, and management of uterine conditions. About Blackmaple Group: founded in 2008 as a consulting firm focused on bringing business rigor to provider group management, the Blackmaple Group (BMG) has grown to become an industry leader in procurement, medical group management and healthcare economics. Under the leadership of its founder Dr. Jeff Gold and COO Marc Cooper, BMG has grown to over 16,000 physician members across the United States and continues to add new clients every day. Contact Details Kevin Tracey +1 855-646-7874 info@minervasurgical.com Company Website https://minervasurgical.com/

October 17, 2024 10:00 AM Eastern Daylight Time

AGC Biologics Seattle Achieves Approval for all 2024 Biologics License Applications from U.S. Food and Drug Administration, Concluding Pre-License Inspection

AGC Biologics

AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), announced the U.S. Food and Drug Administration (FDA)’s approval of a third Biologics License Applications (BLA) from the March 2024 inspection of the company’s Seattle facility. The closure of this inspection and final BLA approval resulted in each of the three commercial products evaluated being approved for commercial production – a regulatory compliance and quality milestone for the site. The Seattle CDMO facility welcomed the FDA in March 2024 for an intensive week of three product inspections. The approved products include two FC-fusion proteins and a monoclonal antibody (mAb). One of the FC-fusion proteins is focused on treating non-muscle invasive bladder cancer; the other is designed to treat age-related neovascular Macular Degeneration (nAMD) and other serious retinal diseases. The mAb product targets chronic-versus-host disease (GVHD). The series of 2024 BLA approvals continues a trend of successful regulatory milestones for the AGC Biologics Seattle site. The FDA has approved four biologics products manufactured at this facility in the last two years. AGC Biologics received commercial approval at the end of 2022 for a mAb product targeting type 1 diabetes (T1D), the first and only treatment of its type at the time of approval. “Performing an agency inspection for three products simultaneously is not easy and I am extremely proud of this result. We took on the challenge and helped ensure every product evaluated achieved commercial approval this year,” said Jose Gonzalez, General Manager, AGC Biologics Seattle. “This is a tremendous achievement for our site. For our partners bringing lifesaving treatments to patients, it is pivotal for their manufacturing partner to maintain regulatory compliance and a high level of product quality to help them reach commercial success. This is a shining example of AGC Biologics’ Seattle ability to do that.” AGC Biologics operates multiple mammalian cGMP manufacturing lines of various scales at its Seattle site, which serves as a center of excellence for formulation and employs the latest fed-batch and perfusion manufacturing processes. In the past year, AGC Biologics Seattle has also expanded to include a new microbial-based manufacturing line system and a state-of-the-art 67,000 sq. ft. GMP-compliant warehouse to further enhance the quality, efficiency and operational excellence of the site. To learn more about AGC Biologics’ protein biologics manufacturing site in Seattle, visit www.agcbio.com/facilities/seattle. For more information on the company’s end-to-end global CDMO services in the U.S., Europe and Japan visit www.agcbio.com. About AGC Biologics: AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 Team Members worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is a part of AGC Inc.’s Life Science Company. The Life Science company runs more than 10 global facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit www.agcbio.com. Contact Details AGC Biologics Nick McDonald +1 425-419-3555 nmcdonald@agcbio.com Company Website https://www.agcbio.com/

October 17, 2024 05:57 AM Eastern Daylight Time

Symphion® Technology to Help Gynecologists Mitigate Nationwide Saline Shortage

Minerva Surgical, Inc.

As the nationwide saline shortage impacts healthcare facilities across the country and the number of elective procedures is being reduced or halted, The Symphion technology from Minerva Surgical offers a solution to help gynecologists mitigate the rationing of saline for operative hysteroscopy procedures. A key feature of the Symphion Operative Hysteroscopy System is the fluid recirculation system. Unlike many uterine tissue removal products that use multiple bags of saline for operative hysteroscopy procedures, Symphion is designed to use one bag of saline during the uterine polyp or uterine fibroid removal. Symphion is the only operative hysteroscopy system with the capability to filter and recirculate saline for continuous use during each procedure. In addition to conserving saline with the fluid recirculation feature, Symphion may improve procedural efficiency by eliminating a workflow disruption or stoppage to replace a depleted bag of saline. This is a common occurrence with open-loop, weight-based fluid management systems. Other features of the Symphion Operative Hysteroscopy System include. • Volumetrically limit patient exposure to saline fluid absorption below the maximum AAGL guidelines of 2500mL • One bipolar RF tissue resecting device to remove uterine polyps and fibroids • Control persistent bleeding with optional coagulation function, which ACOG recognized as an advantage for a tissue removal device • Maintain visibility with independent on-demand aspiration to flush the uterine cavity • Optional digital fluid deficit readout device Darin Hammers, Minerva Surgical Chief Executive Officer said, “Symphion was engineered to address the needs of operative hysteroscopy. We are proud to support our physician and health system partners with a solution to help navigate this critical saline supply shortage and help them continue to provide relief to patients that suffer from Abnormal Uterine Bleeding (AUB).” About Minerva Surgical: Minerva Surgical is a Women’s Health company committed to improving women’s health and quality of life by providing access to minimally invasive, technologically advanced, and innovative solutions for early detection, treatment, and management of uterine conditions. Contact Details Kevin Tracey +1 855-646-7874 info@minervasurgical.com Company Website https://minervasurgical.com/

October 16, 2024 11:00 AM Eastern Daylight Time

RedHill Biopharma Secures U.S. Government Funding Through BARDA To Advance Opaganib For Ebola Treatment

Benzinga

By Meg Flippin, Benzinga A decade after a deadly ebola outbreak that left more than 11,000 people dead and only six years after another outbreak killed over 2,000, more needs to be done to find an effective treatment for this infectious disease. That’s what RedHill Biopharma Ltd. (NASDAQ: RDHL), a specialty biopharmaceutical company, is seeking to do with its novel, potentially broad-acting, host-directed therapy, opaganib, a first-in-class new chemical entity with anti-inflammatory, anti-cancer and antiviral activity. The U.S. government’s Biomedical Advanced Research and Development Authority (BARDA), a center of the Department of Health and Human Services’ (HHS) Administration for Strategic Preparedness and Response (ASPR), just selected opaganib for further development to treat exposure to Ebola virus disease (EBOV). To date, RedHill Biopharma said opaganib has made positive progress on the expected Animal Rule pathway towards potential approval as a treatment for EBOV. The Animal Rule allows for the use of pivotal animal model efficacy studies to support the U.S. Food and Drug Administration’s (FDA) approval of new drugs when human clinical trials are not ethical or feasible. New Treatments Needed Ebola is a rare and often deadly virus caused by infection by one of a group of four viruses known as ebolaviruses. Transmission of the disease is mostly through contact with an infected animal (bat or nonhuman primate) or a sick or dead person infected with an ebolavirus. Currently, only Inmazeb, a combination of three monoclonal antibodies and Ebanga, a single monoclonal antibody, are FDA-approved to treat EBOV. Both are intravenously administered. According to RedHill Biopharma, there is an urgent need for host-directed small molecule therapies that may be effective against multiple strains of ebolavirus, are less likely to be impacted by viral mutation and are easy to store, distribute and administer, especially in areas where healthcare services and infrastructures may be sub-optimal. With ebola cases predicted to grow in the years to come, driven by a lack of effective treatment, so is the market size for vaccines and treatments. According to one forecast, the ebola drug and vaccine market is poised to reach $223.7 million by 2027, growing at a CAGR of 12.8% from 2022 to 2027. Opaganib, which is orally administered, is thought to work through the inhibition of multiple pathways, the induction of autophagy and apoptosis and the disruption of viral replication, through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SPHK2, DES1 and GCS). BARDA To Provide Funding Under the cost-sharing agreement with BARDA, BARDA will provide funding to further advance opaganib to mitigate infections and contain EBOV outbreaks. In an in vivo EBOV study with the United States Army Medical Research Institute of Infectious Diseases, RedHill Biopharma said opaganib delivered a statistically significant increase in survival time when given at 150 mg/kg twice a day. RedHill Biopharma said it’s the first host-directed molecule to show activity in EBOV. What’s more, RedHill said opaganib also recently demonstrated a distinct synergistic effect when combined individually with the COVID-19 antiviral treatment remdesivir, significantly improving potency while maintaining cell viability. “EBOV is deadly, killing, on average, half of all those who contract it. This year marks ten years since the West Africa Ebola epidemic in which 11,000 people died, and yet there are still no host-directed, small molecule therapies approved to provide effective and usable treatment strategies,” said Guy Goldberg, RedHill’s Chief Business Officer. “There are also enormous geopolitical and logistical challenges to overcome in managing outbreaks such as EBOV, and others like Mpox, and so new host-directed, small-molecule therapeutic options for biodefense and global health preparedness could prove to be major life-saving advances – this is especially true if they are capable of viral mutation-resistance, have extended shelf-lives for long-term storage, are relatively straightforward to transport to hard-to-reach territories and are easy to administer without the need for cold-storage or injections.” Fighting More Than EBOV In addition to EBOV, RedHill said opaganib has demonstrated antiviral activity against SARS-CoV-2, multiple variants and several other viruses, including Influenza A. Opaganib is currently also in development for multiple oncology, viral, inflammatory and diabetes and obesity-related indications, including COVID-19, acute respiratory distress syndrome (ARDS) and radiological and chemical protection or mitigation. RedHill Biopharma’s novel drug has also been selected for evaluation by other NIH-funded U.S. government countermeasure programs including the Radiation and Nuclear Countermeasures Program (RNCP) for development as a potential treatment for Acute Radiation Syndrome (ARS) and by the BARDA Chemical Medical Countermeasures (Chem MCM) Program and the NIH/NIAID Chemical Countermeasures Research Program (CCRP), in addition to several other U.S. government and non-government collaborations. Ebola is a fast-spreading and often deadly disease that needs better solutions. RedHill Biopharma and BARDA are betting on opaganib to potentially provide another easier-to-mobilize option to fight outbreaks. To learn more about RedHill Biopharma’s novel drug, click here. Featured photo by CDC 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

October 15, 2024 09:00 AM Eastern Daylight Time

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AmeriLife's MCC Brokerage Strengthens Market Position with Diversity Insurance Agency Partnership

AmeriLife

MCC Brokerage, an innovative field marketing organization in the life and health insurance industry and affiliate partner of AmeriLife Group, LLC, today announced that it has partnered with Diversity Insurance Agency, a Medicare Advantage brokerage company with more than 900 contracted agents licensed in nearly all 50 U.S. states. Per the agreement, terms of the deal were not disclosed. “We are excited to welcome Tim Barlow and his team to our growing Health Distribution network,” said Darren Houck, President of MCC Brokerage. “Diversity Insurance has set itself apart from other agencies through its hands-on approach to training, lead programs, and expert support staff, and we are confident in its continued success.” By meeting people where they are, investing in them, and nurturing their growth, Diversity Insurance Agency provides its agents with the tools and training needed to succeed. Powered by a grassroots approach, a mature outreach program of specialized community events, and a traditional door-to-door educational initiative, licensed agents guide their clients through coverage that meets their personal health and financial needs. “Securing the proper Medicare coverage can be a complex, overwhelming task for many beneficiaries,” said Tim Barlow, President of Diversity Insurance Agency. “Our personalized approach and training protocols ensure that agents are well-versed in plan offerings available in each community we serve and are trained to help consumers balance the costs and benefits to meet their needs. We are thrilled to continue this level of service with the MCC Brokerage team and AmeriLife’s distribution and partnership platform.” With MCC Brokerage and AmeriLife, DIA will enjoy expanded access to tools and resources to boost its reach, productivity, and profitability. "Tim and his team have taken traditional, person-to-person relationship-building to the next level," said Scotty Elliott, Chief Distribution Officer of Health for AmeriLife. "This approach is vital to building trust with our customers, validates the importance of health insurance agents' role in the insurance process, and reflects an important segment of AmeriLife’s core, value-based belief in how we conduct our business." ### About Diversity Insurance Agency With headquarters in Saline, Michigan, Diversity Insurance Agency takes pride in its extensive agent training program, creating expert consumer journeys when seeking comprehensive consultation and personalized health insurance recommendations. Our agents live in the communities they serve. They are well-versed in all plan offerings they provide and are trained to assist with presenting all available options and customizations based on the individual's particular life journey. For more information, visit www.diversityins.com. About MCC Brokerage As an award-winning, innovative, and passionate field marketing organization in the life and health insurance industry, MCC Brokerage embodies a collaboration versus competition mindset, empowering agents to grow their businesses. We aim to assist agents in creating their most robust business possible, utilizing over 50 collective years of expertise. We strive to support our agents’ endeavors through building lasting relationships and unmatched customer service. For more information, visit www.mccbrokerage.com. About AmeriLife AmeriLife’s strength is its mission: to provide insurance and retirement solutions to help people live longer, healthier lives. In doing so, AmeriLife has become recognized as the leader in developing, marketing, and distributing life and health insurance, annuities, and retirement planning solutions to enhance the lives of pre-retirees and retirees across the United States. For over 50 years, AmeriLife has partnered with top insurance carriers to provide value and quality to customers through a distribution network of over 300,000 insurance agents, financial professionals, and over 100 marketing organizations and insurance agency locations nationwide. For more information, visit AmeriLife.com and follow AmeriLife on Facebook and LinkedIn. Contact Details Jeff Maldonado media@amerilife.com Partnership Inquiries Alex Hyer corporatedevelopment@amerilife.com Company Website https://amerilife.com/

October 15, 2024 09:00 AM Eastern Daylight Time

This Company Is Saving Lives With Personal Emergency Response Systems

Benzinga

By Johnny Rice, Benzinga Chia-Lin Simmons, CEO of LogicMark (NASDAQ: LGMK), was recently interviewed by Benzinga. LogicMark is a cutting-edge provider of personal emergency response systems (PERS), health communications devices and IoT technologies. CEO Chia-Lin Simmons spoke about the company and its growth strategies aimed at increasing shareholder value. She discussed her efforts to turn the company around, shifting from a one-time purchase hardware model to a SAAS and recurring revenue model. Additionally, she talked about LogicMark’s expansion into personal safety, not just for aging adults but for all. Watch the full interview here: Featured photo by Piotr Chrobot 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

October 14, 2024 09:15 AM Eastern Daylight Time

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News Release

Kairos Pharma (NYSEAmerican: KAPA): Advancing New Strategies to Overcome Cancer Treatment Challenges

KAPA

The global oncology landscape is on the brink of transformation, with cancer cases expected to rise sharply, particularly in lower-income countries, where the number of new cases could soar to 32 million annually by 2050. This growing demand for cancer treatments has driven global spending on oncology medicines to $223 billion in 2023, with a projected increase to $409 billion by 2028. The launch of 25 novel oncology drugs in 2023, along with over 2,000 new clinical trials, highlights a dynamic period of innovation in the sector. Breakthrough therapies, including cell and gene therapies, antibody-drug conjugates, and radioligand treatments, show significant promise but remain unevenly accessible. As oncology treatments continue to evolve at a rapid pace, this environment presents a unique window of opportunity for investors to explore emerging biopharma companies, which are positioned to lead the charge in addressing unmet medical needs in cancer care. Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company based in Los Angeles, is steadily building a presence in the oncology space. Focusing on therapies aimed at overcoming cancer drug resistance and immune suppression, Kairos has developed a promising pipeline that could attract attention. Among its most notable candidates is ENV105, a therapy designed to target the mechanisms that allow tumors to evade treatment. With ongoing clinical trials and a recent IPO, Kairos Pharma (KAPA) shows potential as an emerging player in biotechnology, particularly as it continues to develop personalized cancer treatments. Exploring New Avenues in Cancer Treatment with ENV105 At the forefront of Kairos Pharma's mission is ENV105, a groundbreaking therapy aimed at reversing drug resistance in cancer patients. This drug distinguishes itself from traditional treatments by targeting the mechanisms that allow tumors to evade existing therapies. Mechanism of Action: ENV105 works by inhibiting the CD105 protein, which plays a critical role in the Bone Morphogenetic Protein (BMP) pathway. Unlike many cancer treatments that focus on blocking Tumor Necrosis Factor (TNF), ENV105 addresses the BMP pathway, which can contribute to increased tumor resistance. By disrupting this pathway, ENV105 enhances the effectiveness of existing cancer treatments. Biomarker Advantage: A significant aspect of ENV105 is its associated biomarker, which can predict patient responses before treatment begins. This capability allows for a more personalized approach, ensuring that patients who are most likely to benefit from the therapy are identified upfront, potentially increasing treatment success rates. Clinical Trial Successes The results from recent clinical trials are promising. In studies involving ENV105, 62% of patients experienced disease stabilization or regression after just two months of treatment—a remarkable outcome compared to the typical response rates seen in similar populations. Additionally, ENV105 has shown efficacy in enhancing the effects of existing therapies for both prostate and lung cancers, two of the most prevalent cancer types. Recent Developments and Partnerships Kairos Pharma is making significant strides in its clinical trials. The company recently dosed its first patients in a Phase 1 trial combining ENV105 with osimertinib for non-small cell lung cancer. This trial aims to evaluate the safety and tolerability of the combination, while a concurrent Phase 2 trial tests ENV105 alongside apalutamide for treating castrate-resistant prostate cancer. John Yu, CEO of Kairos Pharma, emphasizes the company’s commitment to addressing urgent medical needs: “The initiation of these trials speaks to the dedication of the Kairos team to develop therapies for today’s unmet medical needs.” Further enhancing its prospects, Kairos Pharma has partnered with PreCheck Health Services to develop companion biomarkers that will identify which patients are most likely to benefit from ENV105. This collaboration aims to incorporate advanced molecular diagnostics into clinical practice, allowing for better patient selection and monitoring. On September 16, 2024, Kairos Pharma made its debut on the NYSE American under the ticker symbol “KAPA,” successfully raising $6.2 million through its initial public offering. The proceeds will be vital for funding ongoing clinical trials and advancing its diverse pipeline, which includes ENV105 and other innovative candidates like KROS 101. Conclusion With its focus on reversing cancer drug resistance and improving immune response, KAPA is poised to make an impact in oncology. As Kairos Pharma continues to advance its trials and develop personalized cancer therapies, it stands on the brink of potentially revolutionizing cancer treatment. For those looking to invest in a company with a bright future in biotechnology, Kairos Pharma is one for the watchlist. Disclaimers: RazorPitch Inc. "RazorPitch" is not operated by a licensed broker, a dealer, or a registered investment adviser. This content is for informational purposes only and is not intended to be investment advice. The Private Securities Litigation Reform Act of 1995 provides investors a safe harbor in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions, or future events or performance are not statements of historical fact may be forward looking statements. Forward looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties which could cause actual results or events to differ materially from those presently anticipated. Forward looking statements in this action may be identified through use of words such as projects, foresee, expects, will, anticipates, estimates, believes, understands, or that by statements indicating certain actions & 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 investors 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

October 14, 2024 06:00 AM Eastern Daylight Time

MedCognetics Introduces the First Embedded AI Cancer Detection System for Mammography Imaging

MedCognetics

MedCognetics, Inc., a company focusing on medical imaging AI, today announced the successful testing and implementation of the first embedded AI image processing and cancer detection system for mammography. The system utilizes the NVIDIA IGX Orin TM medical-grade edge AI platform alongside MedCognetics’ advanced AI-enabled software, CogNet AI-MT, which was developed in collaboration with clinical leaders worldwide. CogNet AI-MT has been trained on a diverse global dataset to enhance the performance of radiologists and help improve patient outcomes worldwide. Incorporating MedCognetics’ new system would allow for AI-driven image enhancement and cancer detection to occur in real-time within the mammography device itself. The embedded solution eliminates latency, delivering immediate, high-quality image analysis, a significant improvement over traditional setups that require external workstations or cloud-based processing. This approach is poised to improve patient outcomes through faster results, enhanced image quality and reduced hardware costs. “Embedding our CogNet AI-MT software directly into mammography imaging equipment means we can enhance image quality and provide immediate cancer detection without the need for costly hardware upgrades,” said Debasish “Ron” Nag, CEO of MedCognetics. “Using the NVIDIA IGX platform, we’re advancing medical imaging technology, making high-quality diagnostic tools more accessible to radiologists and imaging centers around the world.” The NVIDIA IGX Orin platform combines enterprise-level hardware, software, and support. It is purpose-built for industrial and medical edge computing. The platform delivers the performance, durability, security, and safety required for advanced AI applications and features programmable safety extensions, commercial OS support, and powerful AI software. These capabilities, equip organizations to confidently deploy AI safely and securely for enhanced human and machine collaboration. The embedded AI system developed by MedCognetics offers several key benefits: On-Premises Device: Rapid, complete analysis right in the radiology workflow. Enhanced Image Quality: AI-driven enhancements improve the clarity and detail of images without requiring high-end, expensive hardware. Immediate Results: Processing occurs within the device, providing instant analysis and reducing the wait time for results. Cost Efficiency: Medical device manufacturers can achieve high-end image quality at a fraction of the cost by utilizing AI rather than upgrading hardware. Workflow Optimization: Enables worklist prioritization and clinic-determined workflow optimization, enhancing the accuracy and efficiency of radiologists and imaging centers. Easy Upgrades and Maintenance: Software-based solutions are easier to update and maintain, helping to ensure that medical imaging equipment remains cutting-edge without frequent hardware replacements. Earlier this year, MedCognetics was awarded a groundbreaking patent by the United States Patent and Trademark Office (USPTO) for its inclusive, unbiased medical imaging AI technology in mammography. Its expertise in embedded engineering, combined with the NVIDIA IGX platform, is poised to significantly advance medical imaging technology. This work underscores the importance of integrating AI into medical devices to enhance diagnostic capabilities and patient care. For more information about this new embedded AI cancer detection system, visit here. About CogNet AI-MT® CogNet AI-MT is part of MedCognetics' comprehensive CogNet AI™ platform, designed to enhance radiologists' capabilities by expanding insights and awareness in medical imaging. This unbiased platform, trained on a diverse global dataset, advances the performance of radiologists and imaging centers, delivering accurate care for patients worldwide. CogNet AI-MT employs advanced AI and Machine Learning (ML) to detect early signs of cancer across all ethnicities and can be deployed on customer premises, in the cloud, or via the web. The platform is FDA 510(k) cleared for triage of mammogram images. Useful Links: Learn More: www.medcognetics.com Follow us: X | LinkedIn Sales and Partnership Inquiries: Please contact MedCognetics, Inc. at: media@medcognetics.com About MedCognetics, Inc. MedCognetics provides an advanced AI software platform that integrates into radiology workflow. In addition, the AI algorithm is trained on a diverse global patient dataset to mitigate data biasing. The future of AI in healthcare is unbiased services and MedCognetics is at the forefront of creating a more predictable medical outcome and ultimately saving lives. Founded in 2020, the company is based in Dallas, Texas. For more information, please visit our website at www.medcognetics.com. # # # Contact Details ANW Networks Alicia Nieva-Woodgate +1 415-515-0866 alicia@anwnetworks.com Company Website https://www.medcognetics.com

October 10, 2024 11:15 AM Eastern Daylight Time

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