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Theriva Biologics Hits Several Milestones In 2023, Positioning Itself For Growth As The Firm Targets Difficult-To-Treat Cancers

Benzinga

By Meg Flippin, Benzinga Theriva™ Biologics (AMEX: TOVX), the clinical-stage immuno-oncology company developing therapies for difficult-to-treat cancers, hit several milestones during 2023, potentially positioning it for a strong year ahead. That could be good news for patients with pancreatic, retinoblastoma, head and neck, brain or ovarian cancers. If Theriva is right, its oncolytic viruses can overcome the protective barrier surrounding solid tumors and selectively kill tumor cells. Its developmental therapies are designed to enable systemic delivery – which means they can target the tumor and distant metastases and have the potential to enhance current standard-of-care therapies, the company says. Theriva’s oncolytic viruses can be administered intravenously or as a direct injection into the tumor or tumor compartment. Trials Underway Announcing its financial results for the full year 2023, Theriva reported ending the year in a good position with VCN-01, its lead therapy candidate. VCN-01 is currently in a phase 2b trial for the treatment of patients with pancreatic ductal adenocarcinoma (PDAC) and in investigator-sponsored studies in a number of indications. As of late March, dosing was underway and enrollment continues to progress for VIRAGE, the randomized, controlled, multicenter open-label phase 2b trial of VCN-01 in combination with standard-of-care chemotherapy as a first-line therapy in newly diagnosed metastatic PDAC patients. The trial is targeting enrollment of 92 evaluable patients and the company reports it's on track to complete enrollment in the first half of this year. Patients are being enrolled in six sites in the U.S. and nine in Spain and will continue without any changes to the protocol after an evaluation by the Independent Data Monitoring Committee (IDMC) found no safety concerns. Intravenous VCN-01 has been well tolerated and demonstrated a safety profile consistent with prior clinical trials, Theriva reports. Importantly, it said no additional toxicities were observed in patients receiving a second dose of VCN-01. That means repeated systemic dosing of VCN-01 is feasible from a safety perspective, paving the way for Theriva to focus on whether the repeated dose VCN-01 regimen may lead to improved clinical outcomes for patients. “We believe VCN-01’s differentiated mechanism of action has the potential to address the urgent need for new treatment options for patients with PDAC by degrading the tumor matrix and increasing tumor access by VCN-01 and co-administered cancer therapies,” said Theriva CEO Steven Shallcross during a conference call to discuss full year 2023 earnings. To date, more than 100 patients have been dosed with VCN-01 in clinical trials in patients with a broad range of cancers, including PDAC, retinoblastoma, colorectal cancer and head and neck squamous cell carcinoma (HNSCC). Additional investigator-sponsored studies have been initiated in patients with brain cancers and ovarian cancers. Beyond Pancreatic Cancer Treating pancreatic cancer with VCN-01 isn’t the only area Theriva focused on during the year. The company is also engaged in a phase 1 trial evaluating the safety and activity of intravitreal VCN-01 in pediatric patients with refractory retinoblastoma. That trial is making progress, with the company completing patient treatment. The trial is designed to evaluate escalating doses of VCN-01 administered by two intravitreal injections separated by 14 days. The investigator-sponsored phase 1 trial will complete patient follow-up in the first half of 2024, and the results will help inform the planned phase 2 trial design, Theriva says. Additionally, the University of Pennsylvania continues to enroll and treat patients in their phase 1 investigator-sponsored trial administering VCN-01 with huCART-meso cells to patients with ovarian or pancreatic cancers. VCN-01 is designed to increase tumor immunogenicity and improve access by additional therapies such as huCART-meso cells. Dosing is also underway for the ongoing phase 1b/2a randomized, double-blinded, placebo-controlled clinical trial of SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant (HCT) recipients for the prevention of acute graft-versus-host-disease (aGVHD). Theriva said SYN-004 appears to be well tolerated. Collaborating And Expanding Partnerships Not one to rest, Theriva was also busy during the year expanding collaborations and identifying new areas that may benefit from VCN-01. Late last year it signed an exclusive option to license intellectual property from Sant Joan de Déu-Barcelona Children’s Hospital (SJD) to explore the therapeutic potential of VCN-01 in combination with topoisomerase I inhibitors. This strengthens a long-term research collaboration with SJD and builds on an ongoing trial evaluating VCN-01 in pediatric cancers. The company is also pursuing licensing discussions for its SYN-020 intestinal alkaline phosphatase asset. SYN-020 is a recombinant bovine intestinal alkaline phosphatase (IAP) formulated for oral delivery to the small intestine and designed to diminish fat absorption and intestinal inflammation, tighten the gut barrier to mitigate “leaky gut” and promote a healthy microbiome. It has the potential to become a multi-indication therapeutic capable of addressing disorders stemming from gastrointestinal (GI) inflammation. Theriva is doing all this and keeping costs down. For the year ended December 31, 2023, general and administrative expenses decreased 28% to $7.1 million from $9.9 million in the year-earlier period. Meanwhile, the company increased spending on research and development by 22%, with an eye on the future based on an observed uptick in demand for its compounds. “In 2023, we continue to make steady progress to drive forward our oncology-focused portfolio designed to address unmet needs for difficult-to-treat cancers,” said Shallcross on the earnings call. “Our primary efforts and resources are focused on pursuing multiple therapeutic opportunities for our lead clinical candidate VCN-01. We'll continue to look for ways to drive additional value for our shareholders and for the long-term success of what we're trying to do, namely delivering promising treatments for very, very difficult-to-treat cancers.” 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

April 17, 2024 08:30 AM Eastern Daylight Time

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Japan’s Premier Clinical CRO A2 Healthcare, an ITOCHU Subsidiary, Launches US Expansion

A2 Healthcare

A2 Healthcare, ITOCHU Corporation’s (ITOCY) leading subsidiary in healthcare headquartered in Tokyo, Japan, announced its US expansion. Leveraging regulatory strategy and clinical development expertise in Japan and Taiwan on a global scale, A2 Healthcare aims to transform the Japanese drug market, the third largest in the world. The company will support new drug development in Japan by expanding its partnerships with biotech and pharmaceutical companies based in the United States, the world leader in biopharmaceutical R&D. The United States accounts for around a third of the global market, according to the Pharmaceutical Research and Manufacturers Association (PhRMA). A2 Healthcare President and CEO Hitoshi Kamiya is confident that the Boston branch will help US companies navigate the Japanese market. “Pharmaceutical companies shy away from the Japanese market due to Japan’s strict pharmaceutical regulations, complex clinical trial-related procedures, and drug pricing system that differs from Europe and the United States. Hence, fewer new drugs enter the Japanese market, creating ‘drug loss.’ In 2020, 72 percent of drugs approved in Europe and the United States were not approved in Japan,” said Kamiya. “Unfortunately, this rate is on the rise. More than half of the domestically unapproved drugs in Japan are developed by biotech companies overseas. With the launch of the US office in Boston, A2 Healthcare is optimally positioned to change this narrative. We are offering a new mechanism to eliminate drug loss by encouraging companies to develop drugs in Japan at ease.” As a top CRO in Japan, A2 Healthcare has successfully supported new drug development, including a large number of sponsor-initiated clinical trials and investigator-initiated studies in various fields and diseases. A2 Healthcare’s advanced use of IT in its innovative clinical trials and high patient enrollment results in Japan were recognized with the “Best CRO/CDMO” prize from the Citeline Pharma Intelligence Awards Japan in October 2023. The Boston metropolitan area is an ideal networking environment as part of the world's largest biotech cluster with more than 1,000 biotech companies working on new drug development pipelines. A2 Healthcare will also offer its Pipeline Accelerator Program, a financing program for these companies. Hiroki Matsushima, head of A2 Healthcare’s Global Business Expansion in charge of the US Boston Office, stated, “Boston is the perfect location for launching global CRO services for new drug development in Japan, especially in supporting the development of drugs highly sought after by Japanese patients.” He added, “Japan is a country with a population of over 120 million people and an average lifespan of 84 years. In clinical trials, patient compliance is very high, while the drop-out rate is low. Sustained by a large patient pool for most target indications, Japan remains one of the most attractive and cost-effective places to implement global drug development plans. Additionally, Japan's low inflation over the past decades has helped keep costs down, unlike in most other countries.” A trusted partner for the global life science, medical and pharmaceutical industries, A2 Healthcare offers the most efficient regulatory pathway in Japan for new drug development and regulatory submissions to gain approval. Combining extensive clinical experience and 84 million patient data from 97,000 Japanese sites in the company’s own database, A2 Healthcare has recently achieved a 96 percent enrollment compliance rate within the agreed schedule, setting an impressive standard in the CRO industry. For more information about A2 Healthcare’s services and to request business meetings, contact the Boston Office at matsushima-h@a2healthcare.com or +1(857) 265-0605. ### About A2 Healthcare Corporation A2 Healthcare Corporation, an ITOCHU company, is a premier clinical contract research organization (CRO) founded in 2003 to enhance the quality of lives. Specializing in global clinical trial and research services, we support the development of new drug treatments across wide-ranging therapeutic areas and modalities. A2 Healthcare operates in the United States, Japan and Taiwan, leading the industry by providing best-in-class quality and deliverables through its clinical operations. For more information, visit www.a2healthcare.com/en. Media Contact: A2 Healthcare US Boston Office Hiroki MATSUSHIMA matsushima-h@a2healthcare.com +1(857) 265-0605 A2 Healthcare Japan PR: marke@a2healthcare.com Investor Relations: watanabe-se@a2healthcare.com Contact Details A2 Healthcare US Boston Office Hiroki MATSUSHIMA +1 857-265-0605 matsushima-h@a2healthcare.com

April 17, 2024 08:04 AM Eastern Daylight Time

Clarified Precision Medicine Raises $1.2 Million in Seed Funding and Appoints Health Tech Leader Rajni Natesan, MD, MBA as CEO

Clarified Precision Medicine

Clarified Precision Medicine, the only company that provides oncologists with prioritized therapy options via a combination of algorithmic testing and physician oversight, announced that it closed on its seed round of $1.2 million led by Avestria Ventures, with participation from Joyance Partners, both early-stage funds focused on improving health. The company also named Rajni Natesan, MD, MBA as its Chief Executive Officer. Dr. Natesan is an experienced executive and medical doctor with an extensive background scaling startups at the intersection of healthcare and technology, with a focus on artificial intelligence and machine learning. “Clarified Precision Medicine is offering the right technology at the right time,” Dr. Natesan said. “I’m excited to guide Clarified through this period of commercialization and growth as we follow through on our mission to provide any patient, anywhere, with cutting-edge, guidelines-based access to precision medicine.” Founded in 2021 by Dr. Lincoln Nadauld, MD, PhD, Lisa Alderson, MBA, Howard McLeod, PharmD, and Jody Simon, PharmD, Clarified Precision Medicine uses an algorithm to analyze NGS lab results and then works with oncologists to interpret genomic test results to recommend the best targeted treatment. I n the United States, there are 18 million patients with a history of cancer and 1.9 million new cancer diagnoses each year. Patients who receive precision therapies have survival rates that are three times greater than those who do not. However, 75 percent of doctors say they need help interpreting genomic tests—which leads to more effective utilization of these powerful 21-century tools. Clarified’s combination of advanced technology and physician oversight provides oncologists at community cancer centers with the precision treatment knowledge and expertise usually reserved for leading research institutions. “Dr. Natesan is the perfect leader to help us scale Clarified Precision Medicine to ensure that oncology practices across the country have access to expert guidance to deliver improved outcomes,” said Clarified Precision Medicine Co-founder Lisa Alderson. “She has the right combination of business acumen and clinical expertise to drive adoption and engage with key stakeholders to make world-class precision medicine expertise accessible to every cancer patient and every oncology practice. We’re excited to support Dr. Natesan as she leads us into the next chapter of growth.” With deep C-suite expertise in finance, strategy, operations and clinical functions across medical devices and health tech, Dr. Natesan has led companies across all phases of their product and organizational life cycles, from conceptual design to FDA trials, commercialization, IP and M&A preparation. Dr. Natesan began her career as one of the first physicians on Wall Street, leading health care mergers, acquisitions and financing deals for pharma, biotech and med device clients as an investment banker in Lehman Brothers’ health care group and as a health care strategy consultant in a boutique practice. Most recently, Dr. Natesan served as Chief Strategy and Medical Officer at Braid Health, a venture-backed, disruptive digital health infrastructure company. Clarified Precision Medicine is already supporting numerous U.S. oncology practices and testing labs and offers flexible payment options, including direct insurance billing in some cases. More information on Clarified Precision Medicine solutions is available from the Clarified Precision Medicine Business Development team. About Clarified Precision Medicine Clarified Precision Medicine is the first scalable molecular tumor board with a combination of ML-based platform plus medical group, offering expert clinical somatic and pharmacogenomics consultations through its ClarifiedSelect™ and OncoGuardian™ solutions. Clarified accelerates the delivery of guidelines-based genomic insights to patients and providers by bringing together nationally recognized experts in medical oncology, oncology pharmacy, data integration, and molecular pathology who have over 100 years of collective experience in the application of precision oncology. For more information, visit: www.clarifiedprecisionmedicine.com Contact Details For Clarified Precision Medicine info@clarifiedmedicine.com Company Website https://clarifiedprecisionmedicine.com/

April 16, 2024 10:09 AM Eastern Daylight Time

PathAI Partners with Google Cloud to Transform Drug Discovery and Precision Medicine Through AI-Powered Pathology

PathAI

PathAI, a global leader in AI-powered pathology, today announced a strategic partnership with Google Cloud at Bio-IT World Conference & Expo to help biopharma companies and anatomic pathology (AP) labs accelerate the adoption of AI and digital pathology. PathAI’s AISight 1 Intelligent Image Management System (IMS) is an AI-native IMS that seamlessly blends PathAI and third-party algorithms into a single laboratory workflow and image analysis platform, providing researchers and pathologists direct access to powerful biomarker quantification tools that have the potential to increase lab operational efficiency and aid in disease staging and scoring. PathAI will leverage Google Cloud’s infrastructure to bring AISight to more biopharma companies and AP labs worldwide, enabling faster deployments of novel AI models for a variety of clinical and research needs. "Bio-IT World is where pioneers convene to address the industry's most significant challenges, including how to leverage massive scale data from biological and clinical studies to accelerate the discovery and development of transformative new therapies for patients. PathAI partners across the drug development paradigm, firstly with biopharma by enabling the development of new insights and diagnostics and supporting global clinical trials through PathAI’s AISight Clinical Trials platform, trial-ready algorithms, and Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) compliant laboratory; and also with AP labs ensuring scaled access to algorithms through AISight," said Dr. Andy Beck, CEO and co-founder of PathAI. "Our partnership with Google Cloud helps us transform our capabilities to accelerate adoption of these powerful tools and ultimately reshape how disease is understood and treated.” The partnership will involve the integration of PathAI’s AISight solution with Google Cloud's infrastructure and AI capabilities, providing: Accelerated adoption of precision medicine solutions: Google Cloud's infrastructure enables rapid scaling of AISight's digital pathology IMS and algorithmic capabilities globally, aiding digital pathology laboratory operations and researchers in processing petabytes worth of data for large-scale biomarker discovery and clinical studies, ultimately bringing advancements to patients more quickly. Customized solutions and tailored AI models: The latest Google Cloud AI tools within the AISight platform provide the ability to quickly develop customized solutions and deploy novel AI models tailored to specific research needs. "We understand the urgent need within the biopharmaceutical industry for secure, scalable solutions in AI-driven drug discovery, laboratory operations, and biomarker quantification,” said Ryan Terry, managing director, Healthcare and Life Sciences, Google Cloud. "We're incredibly excited to partner with PathAI to create a new wave of solutions that leverage precision medicine to help solve the industry’s most significant challenges." 1 AISight is For Research Use Only. Not for use in diagnostic procedures. About PathAI PathAI is dedicated to improving patient outcomes through its groundbreaking AI-powered pathology platform. Our solutions provide invaluable insights for biopharmaceutical companies, researchers, and laboratories, ultimately enabling precision pathology and the vision of more effective treatments. Learn more at www.pathai.com. Contact Details SVM Public Relations and Marketing Communications Maggie Naples +1 401-490-9700 pathai@svmpr.com Company Website https://www.pathai.com/

April 16, 2024 09:00 AM Eastern Daylight Time

Isospec Analytics raises $1.9m as it introduces breakthrough technology to rapidly identify unknown molecules at scale

Isospec Analytics

When developing new drugs, nutitional products, or pesticides, it’s critical that unknown molecules are identified correctly. But accurate identification is a lengthy process and all too often unsuccessful, leading to failed regulatory processes, or worse, consumer health being put in danger. Today, Isospec Analytics has raised $1.9M to commercialize new technologies for molecular analysis that rapidly identify unknown molecules in minutes, helping pharmaceuticals, nutrition and agritech companies develop safer products and enabling researchers to discover new biomarkers. Isospec’s $1.9M pre-seed round is led by Founderful (formerly Wingman Ventures), with additional participation from specialized investors Tiny.vc, another.vc and Venture Kick. Isospec was founded in 2022 by Ahmed Ben Faleh, Stephan Warnke, and Thomas Rizzo, who partnered together to explore how they could redefine the process of molecular analysis to access new biological information and enable breakthroughs in diagnostics, therapeutics, and nutrition. Based on over 20 years of research, the founders combined technologies from multiple disciplines – analytical chemistry, photonics, and cryogenic materials initially designed for space applications – to build a tool that can generate a new data dimension about molecular structures. This allows for the identification of molecules which were, until now, unknown. Today, identifying an unknown molecule is primarily based on mass analysis, which does not provide sufficient information. Identifying a by-product or an impurity requires the combination of high sensitivity to detect trace amounts in a sample, coupled with the ability to generate data that can definitively identify the structure of a molecule. Existing tools lack either one or both of these capabilities. “Unfortunately, mass alone does not uniquely determine the structure of a molecule. Several different molecules can have exactly the same mass, called isomers, but totally different properties. For example, one isomer might be toxic, while another may be a life-saving therapeutic,” said Thomas Rizzo, Professor of Chemistry at EPFL. Definitive molecular identification currently requires the combination of several techniques and a lengthy process including purification and multiple syntheses. Companies developing new products are thus faced with a dilemma: either spend months identifying unknowns and delay their go-to-market, or move forward based on guesses and risk failing regulatory requirements and endanger consumer health. In comparison, Isospec’s technology generates unique, information-rich metrics that allow for the rapid identification of unknown molecules in minutes instead of months, bringing unprecedented scalability to molecular identification. “By adding infrared analysis directly inside a mass spectrometer, we have a valuable new dimension by which to identify molecules,” adds Professor Thomas Rizzo. Originating from the Laboratory of Molecular Physical Chemistry (LCPM) at EPFL, Isospec’s breakthrough technology is already being used in the analysis of sugars and metabolites within the food and agritech industry to carry out quality control and support product R&D. However, the team believes the real potential of their technology is in the discovery of new biomarkers for therapeutics development and diagnostics. “In a human blood sample, there are 15,000 small biological molecules that can give precise information about a person’s health at any given time. However, less than 5% of these molecules can be identified. The ability to rapidly identify new molecules means we can now leverage the 95% unknown molecular space to develop treatments to the deadliest diseases,” said co-founder and CEO Dr. Ahmed Ben Faleh. These combined use cases were compelling for Isospec’s investors. “Isospec’s value proposition, which offers early access to its cutting-edge research in biomolecular analysis as a service, convinced us of the potential of the technology and the team,” explains Alex Stöckl, partner at Founderful and board member of Isospec. “Isospec is one of the first 8 companies in which we have invested with our second fund, which aims to reach $120M.” The team is currently working on the scalability of their platform, introducing automation at every step and implementing machine learning tools for data analysis and insight generation. “This round allows us to build a software team composed of experts in data engineering,” said Dr Ahmed Ben Faleh. Against the highly competitive backdrop of the sugar and metabolite analytical markets, Isospec is setting its sights on becoming the leading provider of molecular analysis solutions and biomarker discovery technology. About Isospec Isospec Analytics is an EPFL spin-off based in Lausanne – Switzerland, whose mission is to implement technology to discover new disease biomarkers, accelerate the development of therapeutics and transform the future of clinical nutrition. For more information please visit IsoSpec Analytics About Founderful Founderful is Switzerland’s leading pre-seed fund. We give every founder our deepest understanding and highest levels of support, and together, we’re building the future of the Swiss startup ecosystem. Contact Details isospec Bilal Mahmood +44 7714 007257 b.mahmood@stockwoodstrategy.com Company Website https://www.isospecanalytics.com/

April 16, 2024 08:00 AM Eastern Daylight Time

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News Release

NuggMD to Again Offer Cannabis Support Line, the Too-High Hotline, on 4/20

NuggMD

NuggMD, the nation's leading medical marijuana telemedicine platform, is once again helping accidental cannabis over-indulgers find support this 4/20 with its Too-High Hotline. The hotline (323-518-2728), first established last April, is a resource for consumers who, for whatever reason—cough, cough—want a friendly voice who will converse with them, calm them down, or just listen. States have seen an explosion in much-needed harm- and anxiety-reduction measures, thanks to the reduced stigma around cannabis use. Still, many Americans resist seeking help for highly emotional psychedelic experiences because cannabis is still illegal at the federal level. This results in unguided use by consumers who are unprepared to handle unusual mental effects. It is why emergency-room visits for the overconsumption of cannabis usually spike on April 20. “To be clear: Yes, this is a real service. Anyone who consumes, or consumes too much, this April 20 can call us and talk to us about whatever they want to. No judgments,” said Alex Milligan, co-founder and CMO of NuggMD. He continued: “There is also a serious side to the 4/20 holiday that I hope gets more attention this year. The cannabis movement acknowledges the need for harm-reduction measures as the substance continues to gain mainstream acceptance. Use of the plant affects different people in different ways, and the truth is that some of those effects are negative or unpleasant. So, beyond setting up the Too-High Hotline every April, we are committed to consumer empowerment and education every day throughout the year.” NuggMD’s Too-High Hotline is available to everyone in the United States this 4/20 to offer support during or after their cannabis experience. NuggMD is also educating patients about harm reduction and support options through a dedicated landing page, nationwide email notifications to its network of more than a million patients, and additional ongoing campaigns focused on harm reduction and safe consumption. To learn more about NuggMD’s Too High Hotline, please visit https://www.nuggmd.com/support. 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 1,300,000 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 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

April 15, 2024 04:41 PM Eastern Daylight Time

Comtex Launches Omnia: A Cutting-Edge News API Platform leveraging NLP and AI

Comtex

Comtex News Network, Inc (Comtex), a leading provider of news aggregation and distribution services to top firms in financial services, news publishing, syndication, and analytics, proudly announces the launch of its innovative API platform, Omnia. Omnia is a state-of-the-art API platform designed to revolutionize the way businesses access and utilize news content. Omnia empowers users with instant access to real-time streaming news, AI-generated article summaries, enhanced tagging and categorization based on NLP, advanced filtering, and access to an extensive catalog of curated news sources. Key Features of Omnia Include: Real-time Streaming News: Omnia provides real-time streaming news via websockets push and REST API for seamless integration into existing systems. Enhanced Tagging and Categorization: Leveraging AI and proprietary NLP-based algorithms, Omnia offers enhanced tagging and categorization of content, including press releases, earnings releases, product categories, and more. AI-Generated Article Summaries: Omnia utilizes AI to generate concise and searchable article summaries, enabling users to quickly grasp an article before reading it. Advanced Filtering: Omnia's advanced filtering capabilities allow users to customize their news feeds based on specific criteria, ensuring they receive only the most relevant content. Access to an extensive collection of curated, high-quality sources used by top companies in financial services, analytics, research and a broad range of industries. Omnia is designed for rapid integration and serves a variety of use cases, including training of LLMs, financial platforms, asset management, trading, academic research, legal research, market research, and much more. Commenting on the launch, Comtex CEO Kan Devnani said, "We are pleased to bring a flexible, state-of-the-art news platform with access to curated, premium news sources to market. Omnia is an extendable platform, combining AI with our rich experience applying NLP to news content. This will allow clients to derive more intelligence and insights from the news content we offer and help clients curate and identify the content most relevant to them. Comtex will use Omnia to deliver evolving analytics and insight to its users." Access to Omnia can be trialed by visiting https://www.comtex.com/api. Comtex encourages users to explore its features and capabilities. To learn more about Omnia and request a demo, please contact sales@comtex.com or visit https://www.comtex.com/api. About Comtex News Network, Inc (Comtex): Comtex News Network Inc (Comtex) is a leading provider of news aggregation services to top firms in financial services, news publishing, syndication, and analytics. With a wealth of experience and expertise, Comtex delivers comprehensive news solutions that empower businesses to make informed decisions and stay ahead of the competition. Comtex also offers syndication services to content providers and platforms to generate traffic to online content. Contact Details Comtex News Network Media Relations sales@comtex.com

April 12, 2024 02:01 PM Eastern Daylight Time

Game-Changing Tumor Freezing Technology Has The Potential To Offer Women First-Ever Minimally Invasive Alternative To Breast Lumpectomy Surgery

Benzinga

By Meg Flippin, Benzinga IceCure Medical Ltd. (NASDAQ: ICCM), which is set to submit results from the largest cryoablation study of its kind to the FDA, may set a new standard of care for early-stage breast cancer in women who elect not to have surgery. This could be a game-changer for the medical community and IceCure alike. When it comes to the early onset of breast cancer, the typical treatment protocol is for women to undergo a lumpectomy followed by chemotherapy, hormone or radiation therapy. The lumpectomy involves removing the tumor and some healthy tissue around it surgically in a hospital operating room. It requires heavy sedation, is often painful and has a long recovery time. While tens of thousands of lumpectomies are performed annually in the U.S., it is not a perfect solution. In about 20% of cases, a second surgical procedure known as a re-excision is required to get rid of lingering cancer cells. Some tumors are difficult to spot or feel which makes them hard to locate during the surgery and thus follow-up surgeries are often required. Re-excision can not only be costly, it adds to the recovery time and weighs on the patient’s mental health. Some women, concerned about their future, opt at that point for a mastectomy. Freezing Tumors May Be The Answer With about 280,000 women diagnosed with invasive breast cancer each year, and around 340,000 total cases, finding better alternatives is front and center for many healthcare providers, drug companies and biotechs including IceCure Medical Ltd. (NASDAQ: ICCM). IceCure is expanding the use of ProSense®, an advanced liquid-nitrogen-based cryoablation therapy for the treatment of tumors (benign and cancerous) by freezing, with the primary focus areas being breast, kidney, bone and lung cancer. Cryoablation is a potentially attractive option for treating tumors because it is minimally invasive and has little pain associated with it. Tumors can be seen clearly by using imaging modalities like ultrasound or computerized tomography (CT), accurately destroying diseased tissue within the tumor zone. Cryoablation reduces surgery-related complications, downtime for the patient and economic burden to the insurer and the medical provider, as well as reducing the need for secondary lumpectomy in breast cancer. IceCure likens its ProSense procedure for breast tumors to that of going to the dentist, with no scarring or general anesthesia required. Rather, IceCure relies on lidocaine used locally so there is no need to go to a hospital or stay overnight to recover, all of which reduces costs and speeds up recovery. Unlike lumpectomies, cryoablation does not involve the excision of breast tissue, thereby eliminating many of the adverse cosmetic effects of tumor excision as well. Some researchers have even called cryoablation the “ultimate esthetic solution for breast cancer” because it reduces the need for pre-emptive or corrective surgical procedures to maintain or restore breast volume, contour and symmetry. For all of those reasons, breast cancer cryoablation has emerged as a possible alternative to lumpectomy for early-stage breast cancer over the past decade. Promising Topline Results IceCure recently announced positive topline results from its ICE3 study, which it says is the largest controlled multicenter clinical trial ever performed in the U.S. for liquid nitrogen (LN2) based cryoablation of low-risk, early-stage malignant breast tumors, following the five-year follow-up evaluation of the ICE3 study's last patient. In the ICE3 study, 96.39% of patients (187 out of 194 patients) were local recurrence-free with no significant device-related adverse events or complications reported. Based on those topline results, the company said ProSense has the potential to be a safe and effective alternative to lumpectomy for early-stage breast cancer. The company says it is on track to submit the full data set and results to the U.S. Food and Drug Administration (FDA) for marketing clearance any day now, and Prosense is already approved for breast cancer in other territories like Europe. The breast cancer market size is significant, and was valued at $31.89 billion in 2022 and is forecast to hit $70.53 billion by 2030, growing at a CAGR of 10.43% over 2023-2030. The tumor ablation market is expected to reach $2.4 billion by 2028, growing at a CAGR of 13.2% from now until then. "We are very pleased with this topline outcome and believe these results demonstrate a highly favorable safety and efficacy profile that positions ProSense® as a desirable alternative to lumpectomy for early-stage breast cancer," said Eyal Shamir, Chief Executive Officer of IceCure. "While the FDA evaluates the data, we are optimistic its upcoming decision will give women in the U.S. the same access as those who are already benefiting from ProSense® in other countries,” he said. ProSense has regulatory approval in 15 countries for a broad range of indications including in Europe, Brazil, Canada and China. Incidents of breast cancer are increasing around the world, with many people facing invasive and time-consuming procedures. While lumpectomies will continue to be necessary sometimes, companies like IceCure may be giving patients an alternative way to fight this disease. With full data being submitted to the FDA any day now, if approved it could prove to be game-changing for IceCure and women across America diagnosed with early-stage breast cancer. 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

April 12, 2024 01:35 PM Eastern Daylight Time

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Cardio Diagnostics Inks Groundbreaking Telehealth Agreement With Navierre And Expands Access To Cardiovascular Tests

Cardio Diagnostics Holdings, Inc

By Jeremy Golden, Benzinga Cardio Diagnostics Holdings, Inc. (NASDAQ: CDIO), an artificial intelligence-powered precision cardiovascular medicine company that makes cardiovascular disease prevention and early detection more precise, has inked a new deal with an innovative digital health technology platform. Cardio Diagnostics’ strategic partnership with Navierre — which revolutionizes how patients access healthcare by acting as a true health companion for every stage of life — aims to significantly expand access to Cardio Diagnostics' industry-leading, AI-enabled precision cardiovascular diagnostic tests. On April 1, Cardio Diagnostics’ precision heart health solutions, including its flagship AI-powered epigenetic-genetic cardiovascular risk, detection and management tests, became available to thousands of patients and clinicians on Navierre’s platform. Now, Navierre-partnered clinicians across the United States can seamlessly order these tests for their patients. Consumers can easily register for a profile on the platform by filling out a health questionnaire and requesting a test. Those clinical tests, Epi+Gen CHD and PrecisionCHD, only require a blood sample that can be collected in provider settings, at home or via mobile phlebotomy. This ease of collection will enable Cardio Diagnostics’ partnership with Navierre to leverage the growing telehealth market and revolutionize the patient cardiovascular care journey through earlier detection, accessible specialty care and personalized prevention. “We are thrilled to partner with Navierre to make our industry-leading cardiovascular clinical tests more widely available to patients and clinicians nationwide,” said Meesha Dogan, Ph.D., CEO and Co-Founder of Cardio Diagnostics. “Navierre’s innovative platform aligns with our mission to transform cardiovascular care through AI-driven precision diagnostics and personalized prevention strategies.” Cardiovascular Market Growth Nearly 50% of Americans live with diabetes, obesity, hypertension or another major cardiovascular risk, according to the Centers for Disease Control and Prevention (CDC). Cardiovascular disease is the leading cause of death worldwide, accounting for nearly 19 million deaths annually. This impact on a growing number of people across the world means the demand for cardiovascular diagnostics has never been higher. Companies in the field are in a position to achieve robust growth as they strive to meet the demand. Projections indicate a Compound Annual Growth Rate (CAGR) of 5.1% in the cardiovascular diagnostics market, whose market valuation is expected to reach $9.7 billion by 2033. This surge can be attributed to the escalating demand for sophisticated and accessible diagnostic technologies in the fight against cardiovascular diseases. Following this upward trend, the digital health and telehealth markets are poised for growth that has been fueled by the rapid adoption of telehealth services and the integration of AI technologies. The AI healthcare market, which is also poised for significant growth, had an estimated size of $22.45 billion in 2023, a number that’s expected to accelerate at a CAGR of 36.4%. Finally, the telehealth market, with a valuation of $128.12 billion in 2022, is forecasted to quadruple by 2030 to $504.24 billion. These developments have changed the healthcare landscape and underscore the Cardio Diagnostics-Navierre partnership’s positioning to capitalize on these market shifts. Navierre provides a digital health platform that can integrate Cardio Diagnostics’ tests into a broader telehealth ecosystem, expanding access and facilitating earlier cardiovascular risk detection. That means the flexibility of Cardio Diagnostics’ tests will pave the way for rapid nationwide scaling with minimal infrastructure barriers. Thus, the partnership could make specialty cardiology care more readily available for all communities, including those that are often underserved. By expanding the sites of care to telehealth and remote-enabled provider organizations, this partnership addresses the critical issue of increasing wait times for specialty care while democratizing access to top-tier heart disease services. This collaboration directly responds to current diagnostic methods' limitations, offering a scalable solution that extends to remote zip codes in the U.S. Advances In The Fight Against The Top Cause Of Death The COVID-19 pandemic has accelerated the adoption of digital health solutions, with the CDC reporting that 36% of adults used telehealth services in 2021. McKinsey & Company estimates that up to $250 billion of U.S. healthcare spending could be virtualized, representing about 20% of all Medicare, Medicaid and commercial outpatient, office and home health expenditures. This shift to digital health and AI-driven diagnostics could have a broad impact on the cardiovascular detection, care and management industry. Across the country, there is a need for more accessible and systemic healthcare solutions. This new partnership offers an important response to the goal of combating cardiovascular diseases globally while committing to health equity and access. “Cardio Diagnostics’ groundbreaking testing solutions are an exciting addition to our curated list of products and services we offer to our users,” said Mustafa Dinani, CEO and co-founder of Navierre. “By combining our innovative platform with their AI-driven precision diagnostics, we empower patients and clinicians with the tools they need to identify cardiovascular risk early when it can be most effectively addressed. Together, we are making significant strides in the fight against the world’s leading cause of death,” he said. Featured photo by Ali Hajiluyi on Unsplash Cardio Diagnostics is an artificial intelligence-powered precision cardiovascular medicine company that makes cardiovascular disease prevention, detection, and management more accessible, personalized, and precise. The Company was formed to further develop and commercialize clinical tests by leveraging a proprietary Artificial Intelligence (AI)-driven Integrated Genetic-Epigenetic Engine (“Core Technology”) for cardiovascular disease to become one of the leading medical technology companies for improving prevention, detection, and treatment of cardiovascular disease. For more information, please visit www.cardiodiagnosticsinc.com. Certain statements and information included in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Act of 1995. When used in this press release, the words or phrases “will”, "will likely result," "expected to," "will continue," "anticipated," "estimate," "projected," "intend," “goal,” or similar expressions are intended to identify "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to certain risks, known and unknown, and uncertainties, many of which are beyond the control of the Company. Such uncertainties and risks include but are not limited to, our ability to successfully execute our growth strategy, changes in laws or regulations, economic conditions, dependence on management, dilution to stockholders, lack of capital, the effects of rapid growth upon the Company and the ability of management to effectively respond to the growth and demand for products and services of the Company, newly developing technologies, the Company’s ability to compete, regulatory matters, protection of technology, the effects of competition and the ability of the Company to obtain future financing. An extensive list of factors that can affect future results are discussed in the Current Report on Form 10-K for the period ended December 31, 2022 and Form 10-Q for the period ended March 31, 2023, under the heading “Risk Factors” in Part I, Item IA thereof, and other documents filed from time to time with the Securities and Exchange Commission. Such factors could materially adversely affect the Company's financial performance and could cause the Company's actual results for future periods to differ materially from any opinions or statements expressed within this press release. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Gene Mannheimer - Investor Relations +1 855-226-9991 investors@cardiodiagnosticsinc.com Company Website https://cardiodiagnosticsinc.com/

April 12, 2024 08:45 AM Eastern Daylight Time

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