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Candel Therapeutics Sets Stage For Success With Cancer-Fighting Immunotherapies

Candel Therapeutics

By Jeremy Golden, Benzinga A clinical-stage biopharmaceutical company looks forward to the year ahead with several promising developments in motion. Focused on the development of multimodal biological immunotherapies to help patients fight cancer, Candel Therapeutics, Inc. (NASDAQ: CADL) is innovating a new frontier in the field of immunotherapy. By leveraging a data-driven approach, the company seems poised to advance next-generation immunotherapies in its pipeline as well as create new product candidates. Following up on promising initial clinical and biomarker data in hard-to-treat cancers, Candel is moving forward with a focus on strategic key value drivers and catalysts. Lead Candidates Based in Needham, Massachusetts, Candel is developing two off-the-shelf clinical-stage investigational viral immunotherapies. Designed to elicit an individualized anti-cancer response, they are based on novel, genetically modified adenovirus and herpes simplex virus (HSV) gene constructs, respectively. CAN-2409 is the lead product candidate from the adenovirus platform. It’s in the midst of ongoing late-stage clinical trials in non-small cell lung cancer (NSCLC) (phase 2), borderline resectable pancreatic cancer (phase 2) and localized, non-metastatic prostate cancer (phase 2 and 3). CAN-3110 is the lead product candidate from the HSV platform. A phase 1 clinical trial in recurrent high-grade glioma (HGG) is currently ongoing. Candel’s enLIGHTEN™ Discovery Platform is a systematic, iterative HSV-based discovery platform that leverages human biology and advanced analytics to create new viral immunotherapies for solid tumors. The year 2023 was a productive one for Candel. The company received Fast Track Designation from the FDA based on encouraging clinical activity and biomarker data from the phase 2 clinical trial of CAN-2409 in NSCLC, was also granted Fast Track Designation based on the positive interim data from the ongoing randomized phase 2 clinical trial in borderline resectable pancreatic cancer, published the activity of CAN-3110 in recurrent high-grade glioma in Nature and presented data on the first molecule that was discovered based on the enLIGHTEN TM Discovery Platform at the Annual Meeting of the Society for Immunotherapy of Cancer (SITC). In NSCLC, the phase 2 clinical trial showed that experimental therapy with CAN-2409 achieved disease control in most of the patients who had an inadequate response to immune checkpoint inhibitor treatment. Importantly, there was an abscopal effect (improvement of uninjected lesions) in most patients with metastatic disease. There was an increase in effector/cytotoxic T cells and natural killer cells in peripheral blood after the second CAN-2409 administration (the booster), which was linked with subsequent improved survival. Candel reports that it has observed an encouraging number of long survivors, which the company believes demonstrates that CAN-2409 may induce a new state of functional immunosurveillance and durable disease control. The gold standard endpoint in this population is overall survival. Based on the currently available treatments, median overall survival ≥ 14 months will be considered a significant improvement compared to standard of care. Candel also reported positive interim data from a randomized, controlled clinical trial that revealed a notable increase in survival in patients with borderline resectable pancreatic ductal adenocarcinoma (PDAC) after experimental treatment with CAN-2409 plus standard-of-care treatment compared to standard-of-care control treatment alone. The estimated overall survival rate was 71.4% at 24 months in CAN-2409 treated patients versus 16.7% in the control arm after chemoradiation. In patients with progressive disease, there was both a CA19-9 (tumor biomarker) and a survival response to salvage chemotherapy in the CAN-2409 arm but not in the control arm. Dense aggregates of immune cells were observed in PDAC tissue after CAN-2409 treatment, confirming the activation of a robust antitumoral immune response in this immunosuppressive form of cancer. “In 2023, we received Fast Track Designation for both NSCLC and pancreatic cancer, a validation from the FDA on the potential of CAN-2409, our most advanced product candidate,to address these unmet medical need cancers,” said Paul Peter Tak, MD PhD FMedSci, President and CEO of Candel. “Clinical data from the ongoing phase 1 clinical trial of CAN-3110 in patients with recurrent high-grade glioma have recently been published in Nature, serving as further recognition of the scientific and clinical excellence of Candel’s programs.” Candel and collaborators at the Brigham and Women’s Hospital published in the high-impact journal Nature that CAN-3110 was well tolerated with no dose-limiting toxicity reported. The investigators observed a nearly doubling of the expected median overall survival after just a single injection of CAN-3110 when compared to expected survival in patients treated with current chemotherapeutic standards of care. Positive HSV-1 serology was a predictor of response and was associated with improved survival. Furthermore, increased infiltrating immune cells in the tumor microenvironment and expansion of the T cell repertoire after treatment were associated with improved survival. Importantly, these results were seen after a single injection of CAN-3110; Candel and its collaborators are currently evaluating a multiple-injection regimen, supported by the Break Through Cancer foundation. “The data generated with CAN-3110 in recurrent high-grade glioma represents a significant step forward in the development of groundbreaking therapeutic candidates for this difficult-to-treat disease,” said Francesca Barone, M.D. PhD, CSO, at Candel Therapeutics. “At the same time, they provide proof of concept for the expansion of CAN-3110 in other Nestin positive tumors, which include a diverse spectrum from triple negative breast cancer to melanoma to soft tissue sarcoma.” What’s To Come Backed by promising clinical and biomarker data in hard-to-treat indications, the company expects six data readouts across three platforms this year, including overall survival data in NSCLC and topline data of the potentially registrational phase 3 clinical trial in prostate cancer. Those data readouts include: Topline overall survival (OS) data for CAN-2409 in a phase 2 topline trial for NSCLC in Q2 2024 Updated overall survival data for CAN-2409 in a phase 2 trial for borderline resectable pancreatic cancer in Q2 2024 New data on the second drug candidate from the enLIGHTEN Discovery Platform by Q3 2024 Phase 1 data for CAN-3110 in recurrent high-grade glioma in 2H 2024 for the multiple injection cohort Phase 2 topline data for CAN-2409 in low-to-intermediate-risk, localized, non-metastatic prostate cancer in Q4 2024 Phase 3 topline data for CAN-2409 in localized intermediate/high-risk prostate cancer in Q4 2024 During the SITC Annual Meeting and the International Oncolytic Virus Conference (both in 2023), Candel presented the first experimental candidate from enLIGHTEN Discovery Platform Alpha 201-macro-1, an investigational, locally-delivered biological oncolytic therapeutic designed to interfere with the CD47/SIRP1a pathway which demonstrated better inhibition of tumor growth when compared to systemic anti-CD47 antibody therapy in a mouse model of breast cancer. Francesca Barone, M.D. PhD, said “With the enLIGHTEN Discovery Platform, we are leveraging our internal capabilities in advanced analytics, cancer biology and vectorology to design a new class of multimodal therapeutics that can overcome mechanisms of resistance present in the tumor microenvironment.s “This platform is open for collaborations with external partners as illustrated by our collaboration with U Penn aimed at designing a viral gene construct able to support the therapeutic efficacy of CAR-T therapy in pancreatic cancer.” Candel is a clinical stage biopharmaceutical company focused on developing off-the-shelf multimodal biological immunotherapies that elicit an individualized, systemic anti-tumor immune response to help patients fight cancer. Candel has established two clinical stage multimodal biological immunotherapy platforms based on novel, genetically modified adenovirus and herpes simplex virus (HSV) gene constructs, respectively. CAN-2409 is the lead product candidate from the adenovirus platform and is currently in ongoing clinical trials in non-small cell lung cancer (NSCLC) (phase 2), borderline resectable pancreatic cancer (phase 2), and localized, non-metastatic prostate cancer (phase 2 and phase 3). CAN-3110 is the lead product candidate from the HSV platform and is currently in an ongoing investigator-sponsored phase 1 clinical trial in recurrent high-grade glioma (HGG). Finally, Candel’s enLIGHTEN™ Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new viral immunotherapies for solid tumors. This article includes certain disclosures that contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the timing and advancement of development programs, including the timing and availability of additional data, key data readout milestones, including CAN-3110 in HGG; expectations regarding the potential benefits conferred by Fast Track Designation; expectations regarding the therapeutic benefit of its programs, including the potential for its programs to extend patient survival; and expectations regarding cash runway and expenditures. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the timing and advancement of development programs; expectations regarding the therapeutic benefit of the Company’s programs; that final data from our pre-clinical studies and completed clinical trials may differ materially from reported interim data from ongoing studies and trials; the Company’s ability to efficiently discover and develop product candidates; the Company’s ability to obtain and maintain regulatory approval of product candidates; the Company’s ability to maintain its intellectual property; the implementation of the Company’s business model, and strategic plans for the Company’s business and product candidates, and other risks identified in the Company’s SEC filings, including the Company’s most recent Quarterly Report on Form 10-Q filed with the SEC, and subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the Company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Aljanae Reynolds +1 617-916-5445 areynolds@wheelhouselsa.com Company Website https://www.candeltx.com/

February 15, 2024 08:25 AM Eastern Standard Time

Cardio Diagnostics (NASDAQ: CDIO) Expands Partnership With Family Medicine Specialists To Bring Specialty Cardiology Tests To Select Walmart Supercenters

Cardio Diagnostics Holdings, Inc

By Jeremy Golden, Benzinga A precision cardiovascular medicine company’s innovative AI-driven epigenetic-genetic blood tests will soon be available in one of the nation’s largest retailers. Beginning Q2 2024, Cardio Diagnostics (NASDAQ: CDIO) will bring its advanced blood-based epigenetic-genetic tests, Epi+Gen CHD and PrecisionCHD, to the Walmart Supercenter in Round Lake Beach, Illinois. The northern suburb of Chicago has been chosen as the strategic starting point for a new retail healthcare initiative, the company said. The initiative is an expansion of the ongoing Heart Attack Prevention Initiative, a partnership with Family Medicine Specialists (FMS). With the launch of the Heart Attack Prevention Initiative, FMS started deploying Epi+Gen CHD in at least 1,200 patients with coronary heart disease (CHD) risk factors across its BlueCross BlueShield Medicare, Medicaid, HMO and PPO health plans. According to the company, this partnership benefits both patients and providers through early heart attack risk prevention, in addition to offering significant value to health plans. By leveraging Cardio Diagnostics’ technology, FMS is increasing the accessibility of clinical cardiovascular diagnostic solutions, moving them beyond traditional provider settings and into the more accessible realm of retail healthcare for hundreds of additional patients in Lake County, Illinois. “Our partnership with FMS to bring our tests to their Walmart locations is a game-changer in the field of cardiovascular health management,” said Meesha Dogan, Ph.D., Co-Founder and CEO of Cardio Diagnostics. “By integrating Cardio Diagnostics’ state-of-the-art clinical tests within FMS’s expansive retail network, we are shifting the paradigm from a model that relies on specialty care infrastructure to one that meets American communities in their backyard. This strategic alliance not only democratizes access to top-tier heart disease services but also propels Cardio Diagnostics as a leader in cardiovascular retail healthcare innovation. Our ultimate goal is to meet patients where they are, weaving advanced medical services seamlessly into the fabric of their everyday lives.” Accessibility The retail healthcare footprint and market share continue to grow as more Americans embrace the convenience and accessibility of high-quality healthcare services. In their most recent report, AMN Healthcare reported that 30.3% (79.6 million) Americans received care at a retail clinic. About 32.8% of Americans are forecasted to do so in 2024. At the Round Lake Beach Walmart location of FMS, walk-ins will have access to both of Cardio Diagnostics’ clinical blood tests. The company’s epigenetic-genetic cardiovascular clinical blood tests, Epi+Gen CHD and PrecisionCHD detect heart attack risk and coronary heart disease status, respectively. These tests are easy to administer in the retail healthcare setting because they only require a simple blood draw, bringing this vital service closer to patients. “At Family Medicine Specialists, we have multiple retail healthcare partnerships and are particularly excited about our unique and innovative partnership with Cardio Diagnostics, a leader in clinical cardiovascular diagnostic solutions. This collaboration will enable us to bring advanced cardiac diagnostic tools directly into our retail healthcare clinic locations, enhancing our ability to provide more advanced patient care without the need for additional infrastructure,” Jason Bellucci, MBA, President of Family Medicine Specialists, said. “We believe that this partnership will empower our clinicians with additional resources to better serve our patients’ needs.” Bringing Precision Cardiovascular Testing To Each Neighborhood Heart attacks and coronary heart disease pose significant health risks, and earlier detection and intervention remain crucial for prevention. In the current healthcare paradigm, accessing specialized tests for assessing heart attack risk or diagnosing coronary heart disease means having to navigate complex schedules and significant wait times. While primary care and family medicine practices have managed to maintain relatively shorter waits, specialty areas like cardiology have seen a significant rise, with the average wait time now extending to about 26.6 days. This delay particularly impacts cardiology patients, where timely intervention can be crucial. With 45% of Americans projected to have some form of cardiovascular disease by 2035, the key question is: how can Americans and their providers quickly gain clarity about a patient’s heart disease without weeks of waiting for a specialist appointment? One answer is that cardiology specialty tests must be routinely and readily available in community settings, such as retail healthcare stores. With the deployment of Cardio Diagnostics’ advanced blood tests across select Walmart locations, the company strives to alleviate the critical issue of increasing wait times for specialty care. Beginning with the Round Lake Beach location, expansion to other Walmarts is a key opportunity to reduce wait times for cardiac assessments and care, furthering community-based access to heart disease solutions. The company intends to continue its pursuit of providing organizations with a strong retail healthcare presence and desire to enhance their existing heart disease-related services with precision cardiovascular diagnostic and risk assessment technologies. 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/

February 15, 2024 08:20 AM Eastern Standard Time

Syra Health (NASDAQ: SYRA) Becomes A Subcontractor For The $75 Billion Federal Contract Awarded To Caduceus Healthcare

Syra Health

By Jeremy Golden, Benzinga Syra Health Corp. (NASDAQ: SYRA), a healthcare technology company has been selected as a subcontractor for a contract awarded to Caduceus Healthcare, Inc. The federal Department of Health and Human Services (HHS), Administration for Families and Children (ACR) and Office of Refugee Resettlement (ORR) Medical Staffing and Support issued the contract with a ceiling value of $75 billion. Based in Carmel, Indiana, Syra Health will provide multiple services to Georgia-based Caduceus Healthcare, Inc., which is the prime contractor in support of this multi-billion-dollar Federal Influx Care Facilities contract. The indefinite-delivery, indefinite-quantity (IQID) contract is set to provide temporary shelter, care facilities, direct care services, medical care, case management, education, and transportation for HHS's Influx Care Facilities. Periodic IDIQ task orders will define the scope of work for Syra Health. “Syra is honored to be part of this important federal contract to help ensure the welfare, health, and safety of children through this important program,” said Sandeep Allam, Executive Chairman and President, Syra Health. “We look forward to a long-standing partnership with Caduceus Healthcare in fulfillment of this multi-year contract.” Syra Health aims to address some of healthcare's most significant challenges in areas such as behavioral and mental health, digital health, and population health by providing innovative services and technology solutions. The company’s products and services are centered around prevention, improved access, and affordable care, supplying solutions to payers, providers, life sciences organizations, academic institutions, and the government. The partnership with Caduceus Healthcare comes after Syra Health announced the launch of its federal government solutions business unit in December 2023 to build upon its years of service in the state and local government sector. “We are thrilled about the rapid success of our federal government solutions through this partnership that has awarded us our first federal-based contract,” said Dr. Deepika Vuppalanchi, CEO of Syra Health. “Our ability to service local, state, and now federal agency agreements, provides us with broadened capabilities and experience that will serve us well as we continue to bid on additional federal contracts.” Syra Health is a healthcare technology company addressing some of healthcare's most significant challenges in areas such as behavioral and mental health, digital health, and population health, by providing innovative services and technology solutions. Syra Health’s products and services are centered on prevention, improved access, and affordable care. Syra Health supplies its solutions to payers, providers, life sciences organizations, academic institutions, and government. For more information, please visit www.syrahealth.com. Statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements." These statements include, but are not limited to, statements relating to the expected use of proceeds, the Company’s operations and business strategy and the Company’s expected financial results. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The forward-looking statements contained in this press release are based on management's current expectations and are subject to substantial risks, uncertainty and changes in circumstances. Investors should read the risk factors set forth in our registration statement on Form S-1 and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Syra Health Corp. Christine Drury +1 463-345-8950 Christined@syrahealth.com Company Website https://www.syrahealth.com/

February 14, 2024 08:25 AM Eastern Standard Time

PathAI Announces Exclusive Collaboration with Roche Tissue Diagnostics to Advance AI-enabled Interpretation for Companion Diagnostics

PathAI

PathAI, Inc., a leading AI-powered precision pathology company, today announced an expanded and exclusive relationship with Roche Tissue Diagnostics (RTD) that will bring AI-enabled interpretation to companion diagnostics. Building upon the success of their initial partnership announced in October of 2021, this expanded collaboration will provide an integrated and streamlined solution for biopharma sponsors looking to develop AI-enabled companion diagnostics. Under this agreement, PathAI will exclusively work with Roche Tissue Diagnostics (RTD) to develop AI-enabled digital pathology algorithms in the companion diagnostics space. RTD will work exclusively with PathAI for a pre-specified term as the sole external algorithm development company for AI-powered companion diagnostics, while retaining the ability to continue to develop its own algorithms for companion diagnostics. PathAI will retain the ability to freely develop algorithms outside of companion diagnostics. RTD and PathAI will create an integrated CDx assay, plus algorithm development process, to provide biopharma sponsors a seamless solution for AI-enabled companion diagnostics. With the increasing investment in immuno-oncology (IO) and now antibody drug conjugates (ADCs), the need for diagnostic tools that are optimized for patient selection will be critical for development, regulatory, and commercial success. "This collaboration with Roche is a testament to our shared commitment to advancing the field of digital pathology and AI-enabled diagnostics for both drug development and clinical care,” said Dr. Andy Beck, CEO and Co-Founder of PathAI. “High medical value diagnostic products with seamless integration into the laboratory workflow will accelerate the transition to digital pathology as the standard to aid clinicians in diagnosis and biomarker characterization." These co-developed, AI-enabled assays will be commercialized globally through Roche’s navify® Digital Pathology platform. PathAI will continue to distribute its AISight ® Image Management System (IMS), and its broad portfolio of algorithmic products. “As the market leader in companion diagnostics, we strive to continuously bring new innovations in personalized healthcare,” said Jill German, Head of Roche Tissue Diagnostics. “This collaboration with PathAI will allow us to accelerate our ability to meet the demand from biopharma companies looking to develop AI-enabled companion diagnostics, and provide them with a powerful end-to-end solution in the pursuit of precision therapeutics.” To learn more about this partnership, contact PathAI ( BD@PathAI.com ) to organize a meeting. About PathAI, Inc.: PathAI is a recognized leader in the biopharma partnering space, uniquely combining AI-powered pathology solutions with end-to-end central pathology and histology services. The company supports biopharma partners in executing clinical trials where pathology-based endpoints, biomarker classification, and/or superior histology quality are critical to successfully gauging therapeutic efficacy, accelerating drug development for complex diseases. PathAI has already supported multiple Phase 2 clinical trials in NASH, IBD, and breast cancer, as well as oncology neoadjuvant trials, and is now expanding into larger scale global Phase 3 studies, as well as additional indications. PathAI provides a fully integrated approach to clinical trials, enabling pharma partners to leverage the power of AI without the heavy lift of implementation. This helps reduce the impact of challenges associated with clinical trials, including unreliable turnaround times, variable histology, stain or scan/digitization quality, and challenging assessment of histological endpoints. The lab offers all major immunohistochemistry staining platforms, with flexible workflows across different scanners, stains, and biopsy types, which improves the quality of clinical trials. Services include access to PathAI’s extensive network of over 500 US Board Certified pathologists to perform high quality reading with rapid turnaround time in a cost-effective manner, plus seamless integration of PathAI's advanced AI-solutions to ensure high-quality, reproducible results with every scan. PathAI is headquartered in Boston, MA, and manages a CAP/CLIA-certified diagnostics clinical laboratory (formerly known as Poplar Healthcare) – one of the country’s largest anatomic pathology labs – in Memphis, TN. For more information, please visit 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/

February 13, 2024 10:00 AM Eastern Standard Time

Creo Medical Group expands reach of Speedboat UltraSlim; announces tie-up with Abu Dhabi university

Creo Medical Group PLC

Creo Medical Group CEO Craig Gulliford joined Proactive's Stephen Gunnion following the deployment of the Speedboat UltraSlim device in the Asia Pacific region, marking a significant milestone for the company. The Speedboat UltraSlim, a culmination of years of development, miniaturizes laparoscopic advanced energy capabilities into a compact device enhancing endoscopic surgery. This innovation enables precise surgical procedures with minimal invasiveness, targeting precancerous and cancerous lesions in the gastrointestinal tract. Gulliford highlighted the device's successful clinical applications in various regions, including the US, South America, Europe, and recently at the Prince of Wales Hospital in Hong Kong, focusing on stomach and colon lesions. The technology aims to reduce the need for conventional surgery, offering a safer alternative with lower complication rates. Additionally, Creo announced a strategic collaboration with Khalifa University of Science and Technology in Abu Dhabi to develop intellectual property and expand its technological reach into the Middle East. This partnership aims to foster innovation and enhance medical outcomes, reinforcing Creo Medical's commitment to advancing medical technology and improving patient care globally. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

February 12, 2024 10:00 AM Eastern Standard Time

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Vivos Therapeutics CEO Kirk Huntsman Discusses FDA Approval and Market Disruptions

Vivos Therapeutics

Vivos Therapeutics CEO Kirk Huntsman joined Steve Darling from Proactive to highlight certain significant favorable market developments creating new opportunities to widen its funnel of potential users of Vivos’ oral appliance therapies. This comes after the U.S. FDA granted, for the first time ever, a clearance to the Vivos CARE appliances to treat moderate and severe OSA in adults, (18 years of age and older) with positive airway pressure and/or myofunctional therapy, as needed. Huntsman highlighted several other factors contributing to the positive market conditions for Vivos. The recent discontinuation of many devices by Philips Respironics is expected to disrupt the supply chain, potentially affecting patient care. Additionally, the recalls of continuous positive airway pressure (CPAP) devices have left millions of OSA sufferers searching for alternative treatments. United Healthcare's recognition of oral appliance therapy as a prerequisite for surgical treatment in adult patients with moderate to severe OSA is another important development. These factors are collectively creating a significant opportunity for Vivos to expand its user base and offer effective treatment options to those in need. Contact Details Proactive Investors +1 347-449-0879 na-editorial@proactiveinvestors.com

February 12, 2024 09:24 AM Eastern Standard Time

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Roberts & Ryan Inc., America's first Service-Disabled Veteran-Owned (SDVO) broker-dealer, is pleased to welcome Andrew Reynolds as its newest Managing Director.

Roberts & Ryan, Inc.

Andrew Reynolds joins Roberts & Ryan as Managing Director and has more than 30 years of experience in equity trading, capital markets, portfolio management, options & derivatives, sales & business development, investor relations, and corporate compliance. Prior to joining Roberts & Ryan, Mr. Reynolds was Head of Equity Trading and a Registered Principal at Tullett Prebon and KCCI Ltd. Before that, he was Head Trader and Floor Broker at Tradition North America and R.J. Murphy & Associates. Prior to that, he was Head Trader at Preferred Technology. Mr. Reynolds began his career as an Options Clerk at Pershing, LLC. “Andrew brings extensive experience in equity trading and represents Roberts & Ryan’s commitment to providing best in class service and execution,” said James McDevitt, Roberts & Ryan’s Senior Director of Equity Sales and Trading, Capital Markets. “He will be a tremendous advocate for our social mission of supporting veterans and their families. I’m very excited to have him join our team.” Mr. Reynolds is a member of the Securities Traders Association (STA), the Securities Traders Association of New York (STANY), Philadelphia Traders (ITAP), and the National Investor Relations Institute (NIRI). He holds SIE and FINRA Series 7, 24, 25, 55, 57 & 63 licenses. Mr. Reynolds served as a Technical Warfare Specialist, Team Leader, and Group Leader in the 25 th Infantry Division of the United States Army and is a graduate of Archbishop Ryan in Philadelphia. About Roberts and Ryan, Inc. Roberts & Ryan, Inc. is a Service-Disabled Veteran Owned (SDVO) broker-dealer with execution capabilities in the capital markets, equities, and fixed-income trading. The firm was founded in 1987 by a United States Marine Corps Vietnam combat veteran and Purple Heart recipient. With over $1.8 million in committed donations, Roberts & Ryan is active in donating to charitable foundations that make significant positive impacts in the lives of Veterans and their families, focusing primarily on general wellness, mental health, and career transition. To learn more about Roberts & Ryan, please visit www.roberts-ryan.com. Contact Details Michael C. Del Priore +1 646-859-4061 mdelpriore@roberts-ryan.com Company Website https://www.roberts-ryan.com

February 12, 2024 09:00 AM Eastern Standard Time

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Poolbeg Pharma says research confirms $10B plus opportunity for POLB 001 in cancer immunotherapies

Poolbeg Pharma PLC

Poolbeg Pharma Plc chief business officer David Allmond joined Proactive's Stephen Gunnion with details of independent research that confirms the massive market potential for Poolbeg's POLP 001 in cancer immunotherapies. This asset is being explored for its ability to potentially prevent or treat cytokine release syndrome (CRS), a significant side effect of cancer immunotherapies. With the cancer immunotherapy market expected to reach $140 billion by 2030, POLB 001 presents an over $10 billion opportunity if successful. Additionally, Allmond elaborated on Poolbeg's increasing emphasis on rare and orphan diseases, leveraging its ongoing programs in influenza with POLB 001, obesity, metabolic conditions, and AI-driven discovery for novel targets. The company is actively considering strategies to acquire near-stage commercial or in-market products in this high unmet need, limited competition sector. This approach aligns with Poolbeg's evolution towards a commercial-stage organization, aiming to generate revenue and continue its growth trajectory. Furthermore, Allmond explained how POLB 001 fits into the rare orphan disease space, given its potential applications in orphan cancers where immunotherapies have shown success. Poolbeg's strategic pivot towards rare and orphan diseases complements its existing portfolio, aiming for a dual-track growth strategy focusing on both its current programs and commercial opportunities in the rare and orphan disease market. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

February 12, 2024 08:03 AM Eastern Standard Time

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Creo Medical ends "pivotal" 2023 year with clear path to cashflow breakeven

Creo Medical Group PLC

Creo Medical Group CEO Craig Gulliford tells Proactive's Stephen Gunnion that 2023 was a pivotal year for the company. Amid challenging market conditions, Creo successfully secured crucial funding, setting a foundation for enhanced operational focus rather than fundraising efforts. Key milestones included the launch of the Speedboat UltraSlim, a significant advancement in minimising medical device size, which led to the company's largest quarter in orders and technology uptake. This innovation, alongside the early market release of selected products, received positive feedback and significant regulatory clearances in the US and Europe, propelling Creo towards a robust setup for 2024. Furthermore, Creo announced progress with its SpydrBlade and MicroBlate programs, showcasing advancements in surgical technology and partnerships with leading robotic surgery firms. Financially, Creo reported a 13% revenue increase to £30.8 million and a 10% reduction in operating costs, reflecting strategic shifts towards more cost-effective and revenue-generating operations. These developments signal Creo's transition into a fully commercial business, with a clear path to cash flow breakeven by 2025. Contact Details Proactive UK Ltd Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

February 12, 2024 07:43 AM Eastern Standard Time

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