Turnkey Suite of Services Give Small and Medium Businesses the Data, People, and Content Needed to Drive Interest in their Brand
CHELMSFORD, MA / ACCESSWIRE / June 19, 2024 / Harte Hanks, Inc. (NASDAQ:HHS), the 101-year-old Massachusetts-based global leader in customer experience solutions, has unveiled its newest innovation – Demand Generation In a Box. It’s an all-in-one offering that combines data, sales, and marketing services for business-to-business lead generation and opportunity creation. Specifically geared toward small and medium businesses, Demand Generation In a Box includes comprehensive data to help companies identify high-potential leads. It can also include outsourced sales development representatives to streamline lead qualification and outbound sales efforts, and media, content, and digital marketing offerings.
“We’ve seen tremendous market demand for a turnkey solution with rapid deployment that will help companies generate more high-quality leads and close more business,” said Kelly Waller, SVP of Sales and Marketing for Harte Hanks.
“We know that scaling businesses worldwide are facing strong revenue headwinds. Everything from resource constraints and limited expertise to rapid content creation and data management demands. Moving forward, every dollar spent will need to work harder to grow at the same pace, and that’s why we are rolling out Demand Generation In a Box.”
Demand Generation in a Box services scale depending on the needs of the business. An Essentials package, which includes a foundational data package, weekly reporting, campaign strategy, sales playbook, and digital prospecting through email, display, and social media, starts at $10,000.
“Unveiling this new product is just one of the many bold initiatives we’ve launched this year under Elevate, our transformative program designed to expand our customer base, diversify our product lineup, and boost our efficiency. We’re also thrilled to kick off our first-ever global Enable360 event in London next week,” said Kirk Davis, Chief Executive Officer of Harte Hanks.
Demand Generation in a Box requires no new software or hardware and integrates seamlessly with existing business processes. Campaigns can be up and running in just six weeks to help drive high-quality leads and conversions.
Harte Hanks (NASDAQ:HHS) is a leading global customer experience company whose mission is to partner with clients to provide them with CX strategy, data-driven analytics and actionable insights combined with seamless program execution to better understand, attract and engage their customers.
Using its unparalleled resources and award-winning talent in the areas of Customer Care, Fulfillment and Logistics, and Marketing Services, Harte Hanks has a proven track record of driving results for some of the world’s premier brands, including Bank of America, GlaxoSmithKline, Unilever, Pfizer, HBOMax, Volvo, Ford, FedEx, Midea, Sony and IBM among others. Headquartered in Chelmsford, Massachusetts, Harte Hanks has over 2,500 employees in offices across the Americas, Europe, and Asia Pacific.
As used herein, “Harte Hanks” or “the Company” refers to Harte Hanks, Inc. and/or its applicable operating subsidiaries, as the context may require. Harte Hanks’ logo and name are trademarks of Harte Hanks.
Certain statements discussed in this release as well as in other reports, materials and oral statements that the Company releases from time to time to the public may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Generally, words such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “believe,” “plan,” “target,” “forecast” and similar expressions are intended to identify forward- looking statements. Such forward-looking statements concern management’s expectations, strategic objectives, business prospects, anticipated economic performance and financial condition and other similar matters. Forward-looking statements are inherently uncertain and subject to a variety of assumptions, risks and uncertainties that could cause actual results to differ materially from those anticipated or expected by the management of the Company. These statements are not guarantees of future performance and actual events or results may differ significantly from these statements. Given these risk factors, investors and analysts should not place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date of the document in which they are made. The Company disclaims any obligation or undertaking to provide any updates or revisions to any forward-looking statement to reflect any change in the Company’s expectations or any change in events, conditions or circumstances on which the forward-looking statement is based, except as required by law. It is advisable, however, to consult any further disclosures the Company makes in its filings with the Securities and Exchange Commission, including Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K (if any). These statements constitute the Company’s cautionary statements under the Private Securities Litigation Reform Act of 1995.
Comstock (NYSE: LODE) innovates technologies that contribute to global decarbonization and circularity by efficiently converting under-utilized natural resources into renewable fuels and electrification products that contribute to balancing global uses and emissions of carbon. The Company intends to achieve exponential growth and extraordinary financial, natural, and social gains by building, owning, and operating a fleet of advanced carbon neutral extraction and refining facilities, by selling an array of complimentary process solutions and related services, and by licensing selected technologies to qualified strategic partners. To learn more, please visit www.comstock.inc.
Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Shareholder update. In a letter to shareholders, Comstock provided additional details regarding how the company expects to finance its growth initiatives across its business segments. Comstock intends to minimize the issuance of equity by using alternative sources of funding at the subsidiary level. Additionally, Comstock expects to commence sales of its real estate holdings in Silver Springs, Nevada and its interest in the Sierra Springs Opportunity Fund in the coming months. Proceeds from the asset sales will fund, among other things, advancing mine development plans for the company’s Dayton-Spring Valley resource areas.
Comstock Metals. Comstock intends to secure debt and equity capital at the subsidiary level to fund the construction of Comstock Metals’ first two industry-scale facilities. Discussions are ongoing with multiple counterparties interested in participating in primarily debt financing with agreements expected in the third quarter of 2024. Comstock Metals recently commissioned its first demonstration-scale photovoltaic recycling facility in Silver Springs, Nevada, secured revenue generating contracts, and began receiving end-of-life solar panels.
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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Comtech Telecommunications Corp. engages in the design, development, production, and marketing of products, systems, and services for advanced communications solutions in the United States and internationally. It operates in three segments: Telecommunications Transmission, Mobile Data Communications, and RF Microwave Amplifiers. The Telecommunications Transmission segment provides satellite earth station equipment and systems, over-the-horizon microwave systems, and forward error correction technology, which are used in various commercial and government applications, including backhaul of wireless and cellular traffic, broadcasting (including HDTV), IP-based communications traffic, long distance telephony, and secure defense applications. The Mobile Data Communications segment provides mobile satellite transceivers, and computers and satellite earth station network gateways and associated installation, training, and maintenance services; supplies and operates satellite packet data networks, including arranging and providing satellite capacity; and offers microsatellites and related components. The RF Microwave Amplifiers segment designs, develops, manufactures, and markets satellite earth station traveling wave tube amplifiers (TWTA) and broadband amplifiers. Its amplifiers are used in broadcast and broadband satellite communication; defense applications, such as telecommunications systems and electronic warfare systems; and commercial applications comprising oncology treatment systems, as well as to amplify signals carrying voice, video, or data for air-to-satellite-to-ground communications. The company serves satellite systems integrators, wireless and other communication service providers, broadcasters, defense contractors, military, governments, and oil companies. Comtech markets its products through independent representatives and value-added resellers. The company was founded in 1967 and is headquartered in Melville, New York.
Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.
Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
A Refinancing. Comtech announced a new $222 million credit facility, replacing the previous facility which was due this October. The refi removes a significant uncertainty, in our view, and will enable a return to a normal operating environment over time. The interest rate is a blended 14%, up from the 10% under the previous facility.
3Q Results. Supplier and customer worry about Comtech’s financial status resulted in a push to the right for sales, negatively impacting 3Q24 results. Revenue was $128.1 million, down from $136.3 million last year and below our $139 million projection. Adjusted EBITDA totaled $11.9 million, or a 9.3% margin, compared to $12.5 million and a 9.2% margin in 3Q23. Comtech reported a net loss of $1.0 million, or a loss of $0.04/sh, compared to a loss of $9.2 million, or $0.33/sh last year.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Kelly (Nasdaq: KELYA, KELYB) connects talented people to companies in need of their skills in areas including Science, Engineering, Education, Office, Contact Center, Light Industrial, and more. We’re always thinking about what’s next in the evolving world of work, and we help people ditch the script on old ways of thinking and embrace the value of all workstyles in the workplace. We directly employ nearly 350,000 people around the world and connect thousands more with work through our global network of talent suppliers and partners in our outsourcing and consulting practice. Revenue in 2021 was $4.9 billion. Visit kellyservices.com and let us help with what’s next for you.
Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.
Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
MRP Call. On Tuesday, Kelly management held a conference call to discuss the completion of the Motion Recruitment Partners (MRP) deal. Management provided additional details regarding the financial profile of MRP and how it will integrate into Kelly, valuation details regarding the deal, and the Company’s goal of reducing debt as a result of the acquisition.
Improved Financial Profile. Kelly improves on both its gross and adjusted EBITDA margins with the deal. MRP had a 30% gross margin and 7% adj. EBITDA margin for fiscal year 2023 compared to Kelly’s 20% and 2.3%, respectively. Like the rest of the staffing industry, MRP’s fiscal 2023 was impacted by the macro environment as margins decreased from 33% gross and 9% adj. EBITDA for the 2022 fiscal year. We believe that MRP’s financial performance will be beneficial in the short-term for Kelly, but more so in the future when the environment starts to normalize.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
In a monumental shift in the tech landscape, Nvidia (NVDA) has overtaken Microsoft (MSFT) to become the world’s most valuable publicly traded company. This remarkable feat, fueled by Nvidia’s dominance in the artificial intelligence (AI) chip market, has sent shockwaves through the industry and underscores the transformative power of generative AI technology.
On Tuesday, June 18, 2024, Nvidia’s stock price surged nearly 4%, propelling its market capitalization to an astounding $3.35 trillion, surpassing Microsoft’s market cap of $3.32 trillion. This milestone solidifies Nvidia’s position as the tech industry’s undisputed leader in AI chips and integrated software, a pivotal role that has driven its meteoric rise in recent years.
Nvidia’s Explosive Growth and the AI Revolution
Nvidia’s stock has skyrocketed over the past year, gaining a staggering 215%, and a remarkable 3,400% over the last five years. This unprecedented growth can be directly attributed to the generative AI explosion that began with the debut of OpenAI’s ChatGPT platform in late 2022.
As the go-to supplier for AI chips and software, Nvidia’s products have become indispensable for tech giants like Amazon, Google, Meta, Microsoft, and Tesla, powering everything from cloud-based AI offerings to their own AI models and services. This strategic advantage has propelled Nvidia to the forefront of the AI revolution, outpacing rivals AMD and Intel, who are now racing to catch up.
Nvidia’s Dominance in the AI Chip Market
Nvidia’s Data Center segment, which encompasses its AI chip business, saw a staggering 427% year-over-year revenue increase in the first quarter of 2024, accounting for a remarkable 86% of the company’s total revenue. This meteoric growth highlights the insatiable demand for Nvidia’s AI chips and software, cementing its position as the cornerstone of the AI revolution.
With the recent announcement of its upcoming Blackwell Ultra and Rubin AI chip platforms, Nvidia is doubling down on its AI supremacy, aiming to maintain its lead over competitors like AMD and Intel, who are aggressively developing their own AI chips.
Challenges and Competition Ahead
Despite its current dominance, Nvidia faces mounting competition from its own customers, as tech giants like Amazon, Google, and Microsoft seek to reduce their reliance on Nvidia’s chips and cut costs. These companies are investing billions in developing their own AI chips, aiming to gain greater control over their AI capabilities and reduce their dependence on Nvidia.
Additionally, rivals like AMD and Intel are making significant strides in the AI chip market, with AMD’s MI325X and MI350 chips slated for release in 2024 and 2025, and Intel’s Gaudi 2 and Gaudi 3 accelerators promising to undercut Nvidia on price.
Riding the AI Wave
Nvidia’s ascent to become the world’s most valuable company is a testament to its visionary leadership and its ability to capitalize on the AI revolution. As the demand for AI chips and software continues to soar, Nvidia’s position at the forefront of this transformative technology has propelled its growth to unprecedented heights.
However, with intense competition on the horizon, Nvidia faces the challenge of maintaining its innovative edge and fending off rivals eager to chip away at its dominance. As the AI arms race intensifies, Nvidia’s ability to navigate this rapidly evolving landscape will be critical to sustaining its newfound status as the world’s most valuable company.
10,000-participant randomized Phase 2b study will evaluate and compare GeoVax’s multi-antigen, vaccine candidate (GEO-CM04S1) to an approved vaccine against COVID-19 under BARDA’s Clinical Studies Network
Project NextGen is a $5 billion initiative by the U.S. Department of Health and Human Services to develop innovative vaccines and therapeutics providing broader and more durable protection against current and future COVID-19 viral strains
Atlanta, GA, June 18, 2024 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that it received an award through the Rapid Response Partnership Vehicle (RRPV) to advance development of GEO-CM04S1, GeoVax’s dual-antigen next-generation COVID-19 vaccine, in a Phase 2b clinical trial. The RRPV is a Consortium funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS).
Under the agreement, GeoVax will sponsor a 10,000-participant, randomized, Phase 2b double-blinded study to compare the efficacy, safety, and immunogenicity of GEO-CM04S1 with a U.S. Food and Drug Administration (FDA)-approved mRNA COVID-19 vaccine. Preparations for the study are underway, and execution of the study will be fully funded by BARDA under its Clinical Studies Network.
The direct award to GeoVax of approximately $24.3 million, which may increase to as much as $45 million, will fund the manufacturing of clinical materials and support for the Phase 2b clinical trial, including regulatory activities. BARDA has made separate awards through its Clinical Studies Network to support execution of the study. That funding will represent approximately $343M from the Project NextGen program for a CRO to execute the clinical trial using GeoVax’s vaccine.
“We are honored and proud to receive this award from BARDA to advance our next-generation vaccine against COVID-19. This contract not only provides the vital resources for advancing the development of GEO-CM04S1, but it also advances our MVA platform in infectious diseases,” said David Dodd, Chairman & CEO of GeoVax.
Mr. Dodd continued, “First-generation COVID-19 vaccines were beneficial during the peak of the pandemic but are limited in breadth and durability of clinical protection, requiring frequent updates. Now that COVID-19 is in an endemic stage, many people continue to have their everyday lives impacted in meaningful ways. Furthermore, there are an estimated 23 million adults in the U.S. with immunocompromised conditions who are less likely to have an adequate response to current vaccines and are more likely to potentially experience severe COVID-19 symptoms, hospitalization and the risk of death, even after vaccination. GEO-CM04S1 was designed to address these limitations by inducing durable neutralizing antibody and T-cell-based immunity against current and future SARS-CoV-2 variants. Our vaccine has continued to demonstrate induction of potent immune responses with potential to drive broad and durable clinical protection, and we eagerly anticipate commencing the Phase 2b study to further demonstrate the value and advantages of our technology.”
Funding for this award is provided under Project NextGen, a $5 billion initiative by HHS to advance a pipeline of new, innovative vaccines and therapeutics providing broader and more durable protection for COVID-19 than the first generation COVID vaccines and medicines. BARDA is supporting the development of new vaccines and therapeutics to better address the waning immunity and resistance to current and future SARS-CoV2 viral strains. GeoVax’s vaccine candidate provides many of the features identified by BARDA including broader protection among variants of concern (VOC) and a longer duration of protection.
This project is being funded with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under Other Transaction (OT) number: 75A50123D00005.
About GEO-CM04S1
GEO-CM04S1 is based on GeoVax’s MVA viral vector platform, which supports the presentation of multiple vaccine antigens to the immune system in a single dose. GEO-CM04S1 encodes for both the spike (S) and nucleocapsid (N) antigens of SARS-CoV-2 and is specifically designed to induce both antibody and T-cell responses to those parts of the virus less likely to mutate over time. The more broadly functional engagement of the immune system is designed to protect against severe disease caused by continually emerging variants of COVID-19. Vaccines of this format should not require frequent and repeated modification or updating.
GEO-CM04S1 is currently being evaluated in three ongoing Phase 2 clinical trials:
As a primary vaccine in immunocompromised patients (with hematologic cancers receiving cell transplants or CAR-T therapy). ClinicalTrials.gov Identifier: NCT04977024. A recent presentation of unpublished data from the open-label portion of the trial indicates that GEO-CM04S1 is highly immunogenic in these patients, inducing both antibody responses, including neutralizing antibodies, and T-cell responses.
As a booster vaccine in immunocompromised patients with chronic lymphocytic leukemia (CLL), a recognized high-risk group for whom current mRNA vaccines and monoclonal antibody (MAb) therapies appear inadequate relative to providing protective immunity. ClinicalTrials.gov Identifier: NCT05672355.
As a booster vaccine for healthy adults who have previously received the Pfizer or Moderna mRNA vaccine. gov Identifier: NCT04639466.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, which recently completed enrollment in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com.
Forward-Looking Statements
This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.
Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
Mexico City, Mexico, June 18, 2024 – (GLOBE NEWSWIRE) Codere Online (Nasdaq: CDRO / CDROW, the “Company”), a leading online gaming operator in Spain and Latin America, is pleased to announce its groundbreaking collaboration with Blip, an AI-first conversational platform, to introduce an unparalleled gaming experience to its Mexican customers. This strategic alliance marks a significant milestone both in the global online gaming sector as well as in Mexico.
As the largest market by revenue for Codere Online, Mexico has been a focal point of growth and investment over the past several years. With a clear commitment to enhancing the gaming experience for its customers, Codere Online has consistently strived to introduce innovative solutions that cater to the evolving needs and preferences of its customers.
The latest venture with Blip underscores Codere Online’s dedication to pioneering advancements within the industry. The introduction of a conversational chatbot based on a leading communications platform, developed by Blip, will offer players new features and functionalities that will take their gaming experience to new heights.
This chatbot will enable Codere Online to launch exciting promotions and seamlessly service customers through an AI-powered, fully automated conversational chatbot integrated into one of the most widely used communications platforms. This cutting-edge technology, developed by Blip, will revolutionize the way players engage with Codere Online’s gaming platform, ensuring swift and personalized interactions.
Commenting on this transformative collaboration, Debbie Guivisdalsky, Codere Online’s Chief Operating Officer, stated: “we are thrilled to join forces with Blip to introduce this chatbot to the Mexican market. This strategic alliance exemplifies our commitment to innovation and customer satisfaction and will be a great tool to connect with our customers in an efficient way.
Mrs. Guivisdalsky further added: “the introduction of this state of the art chatbot represents another milestone in our path to delivering exceptional experiences to our players. Through this collaboration, we expect to provide superior experiences for our customers in Mexico while improving our ability to deploy highly targeted promotional campaigns”.
Jaime Navarro, Executive Director for EMEA & Latin America at Blip, asserted “Codere Online and Blip share a strong entrepreneurial spirit and are all about innovation and business transformation, which is why we could not think of a better fit. We are excited to work together to bring forward a cutting-edge conversational experience to the online gaming community in Mexico”.
About Codere Online Codere Online refers, collectively, to Codere Online Luxembourg, S.A. and its subsidiaries. Codere Online launched in 2014 as part of the renowned casino operator Codere Group. Codere Online offers online sports betting and online casino through its state-of-the art website and mobile applications. Codere currently operates in its core markets of Spain, Mexico, Colombia, Panama and the City of Buenos Aires (Argentina). Codere Online’s online business is complemented by Codere Group’s physical presence in Spain and throughout Latin America, forming the foundation of the leading omnichannel gaming and casino presence.
About Blip Blip is an AI-first platform that offers the best conversational intelligence solutions to help businesses connect with their customers through digital channels and leading messaging apps, such as WhatsApp, Messenger, RCS, Apple and Telegram.
Blip is present in more than 32 countries and has offices in Belo Horizonte and São Paulo in Brazil, Mexico City in Mexico, and Madrid in Spain. The brand has helped around 4,000 companies such as Dell, GM, Coca-Cola, Stellantis, Claro, and others to sell, engage and relate to consumers on digital channels.
About Codere Group Codere Group is a multinational group devoted to entertainment and leisure. It is a leading player in the private gaming industry, with four decades of experience and with presence in seven countries in Europe (Spain and Italy) and Latin America (Argentina, Colombia, Mexico, Panama, and Uruguay).
Contacts:
Investors and Media Guillermo Lancha Director, Investor Relations and Communications Guillermo.Lancha@codere.com (+34)-628-928-152
Gap in non-oral prescriptions relative to AHS guidelines represents an opportunity to increase awareness of Tonix’s two FDA-approved non-oral treatments for acute migraine
Zembrace® SymTouch® (sumatriptan injection) and Tosymra® (sumatriptan nasal spray) are indicated for the treatment of acute migraine in adults
CHATHAM, N.J., June 18, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, presented data from a poster presentation at the 66th Annual Scientific Meeting of the American Headache Society (AHS), held June 13-16, 2024. A copy of the Company’s poster presentation is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com.
In the poster presentation titled, “American Headache Society Consensus Statement and Other Recommendations: How Many Practitioners Comply With the Recommendations?,” a retrospective review of real-world data compares real world usage of non-oral migraine products with the most recent AHS consensus statement. The data reaffirms several past recommendations from the AHS and stresses the need for customizing treatment of migraine headaches to the needs of patients, as well as using the most appropriate route of administration for any given acute attack based on the clinical presentation. So far, real world data show that compliance with the guidelines and the consensus statement have yet to be achieved but has the potential to be increased. Specifically, the data show the use of non-oral drugs for treating an acute migraine attack was only 7% in 2012 and has decreased to below 4% in 2023, when the potential need for such drugs is anticipated to be a significant percentage of patients based on epidemiological data.
“We believe personalizing therapy for migraine is the future and it is hoped that non-oral medicines will address some of the persistent dissatisfaction patients experience with their migraine treatments,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “We hope that educating prescribers about the importance of customized treatments will lead to enhanced satisfaction and improve the quality of life of migraine patients. This represents an opportunity for growth in non-oral first-line therapeutics such Tonix’s Zembrace SymTouch and Tosymra.”
“Inconsistent and incomplete response to traditional or emerging oral acute migraine medications continue to be a burden for individuals living with migraines. We believe that both Zembrace SymTouch and Tosymra, due to their rapid-onset and route of administration are well suited to address this unmet need,” said James Hunter, Executive Vice President of Commercial Operations at Tonix Pharmaceuticals and President of Tonix Medicines.
Zembrace SymTouch is the only actively promoted brand of sumatriptan autoinjector in the U.S. (other sumatriptan autoinjector products on the market are Imitrex® and generics to Imitrex®). It has a unique low dose and has demonstrated onset of migraine pain relief in as few as 10 minutes (17% of patients vs. 5% for placebo)1. Zembrace SymTouch also demonstrated migraine pain freedom for 46% of patients (vs 27% for placebo) at 2 hours in a single-attack, double-blind study (N=230)2. Tosymra employs Intravail® permeation enhancer technology and is pharmacokinetically equivalent to 4 mg subcutaneous sumatriptan.3,4, Tosymra delivers migraine pain relief in as little as 10 minutes with just one spray for some patients (13% vs. 5% for placebo).1,4,5
About Migraine
Nearly 40 million people in the United States suffer from migraine6 and it has been recognized as the second leading cause of disability in the world7. Migraine is characterized by debilitating attacks lasting four to 72 hours with multiple symptoms, including pulsating headaches of moderate to severe pain intensity often associated with nausea or vomiting, and/or sensitivity to sound (phonophobia) and sensitivity to light (photophobia)8.
1Mathew NT, et al. Dose ranging efficacy and safety of subcutaneous sumatriptan in the acute treatment of migraine. US Sumatriptan Research Group. Arch Neurol. 1992;49(12):1271-1276.
2Landy, S. et al. Efficacy and safety of DFN-11 (sumatriptan injection, 3 mg) in adults with episodic migraine: a multicenter, randomized, double-blind, placebo-controlled study. J Headache Pain. 19, 69 (2018).
3Brand-Schieber E, Munjal S, Kumar R, et al. Human factors validation study of 3 mg sumatriptan autoinjector, for migraine patients. Med Devices (Auckl). 2016;9:131-137.
4Tosymra [package insert]. Maple Grove, MN: Upsher-Smith Laboratories, LLC: Feb 2021.
5Wendt J, et al. A randomized, double-blind, placebo-controlled trial of the efficacy and tolerability of a 4-mg dose of subcutaneous sumatriptan for the treatment of acute migraine attacks in adults. Clinical Therapeutics. 2006;28(4):517-526.
6IQVIA 2022 retail sales from the National Sales Perspectives (NSP) audit within the SMART database estimates Zembrace sales of ~$19.6 M and Tosymra sales of ~$3.5 M
7GBD 2016 Headache Collaborators. Global, regional, and national burden of migraine and tension-type headache, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol 2018;17(11):954-976.
8Headache Classification Committee of the International Headache Society (IHS). The international classification of headache disorders, 3rd edition. Cephalalgia. 2018;38(1):1–211.
Tonix Pharmaceuticals Holding Corp.*
Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya1, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation and is in Phase 2 development supported by a grant from the National institute of Drug Abuse. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.
*Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication.
1Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.
This press release and further information about Tonix can be found at www.tonixpharma.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
Zembrace® SymTouch® (sumatriptan Injection): IMPORTANT SAFETY INFORMATION
Zembrace SymTouch (Zembrace) can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:
discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
pain or discomfort in your arms, back, neck, jaw or stomach
shortness of breath with or without chest discomfort
breaking out in a cold sweat
nausea or vomiting
feeling lightheaded
Zembrace is not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.
Do not use Zembrace if you have:
history of heart problems
narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
uncontrolled high blood pressure
hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
severe liver problems
taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, dihydroergotamine.
are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
an allergy to sumatriptan or any of the components of Zembrace
Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.
Zembrace can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.
Zembrace may cause serious side effects including:
changes in color or sensation in your fingers and toes
sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
serotonin syndrome, a rare but serious problem that can happen in people using Zembrace, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
hives (itchy bumps); swelling of your tongue, mouth, or throat
seizures even in people who have never had seizures before
The most common side effects of Zembrace include: pain and redness at injection site; tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired.
Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace. For more information, ask your provider.
This is the most important information to know about Zembrace but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit www.tonixpharma.com or call 1-888-650-3789.
You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
INDICATION AND USAGE
Zembrace is a prescription medicine used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.
Zembrace is not used to prevent migraines. It is not known if it is safe and effective in children under 18 years of age.
Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop Tosymra and get emergency medical help if you have any signs of heart attack:
discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
pain or discomfort in your arms, back, neck, jaw, or stomach
shortness of breath with or without chest discomfort
breaking out in a cold sweat
nausea or vomiting
feeling lightheaded
Tosymra is not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam is done and shows no problem.
Do not use Tosymra if you have:
history of heart problems
narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
uncontrolled high blood pressure
severe liver problems
hemiplegic or basilar migraines. If you are not sure if you have these, ask your healthcare provider.
had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider if you are not sure if your medicine is listed above.
are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
an allergy to sumatriptan or any ingredient in Tosymra
Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.
Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.
Tosymra may cause serious side effects including:
changes in color or sensation in your fingers and toes
sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
cramping and pain in your legs or hips, feeling of heaviness or tightness in your leg muscles, burning or aching pain in your feet or toes while resting, numbness, tingling, or weakness in your legs, cold feeling or color changes in one or both legs or feet
increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
serotonin syndrome, a rare but serious problem that can happen in people using Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
hives (itchy bumps); swelling of your tongue, mouth, or throat
seizures even in people who have never had seizures before
The most common side effects of Tosymra include: tingling, dizziness, feeling warm or hot, burning feeling, feeling of heaviness, feeling of pressure, flushing, feeling of tightness, numbness, application site (nasal) reactions, abnormal taste, and throat irritation.
Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Tosymra. For more information, ask your provider.
This is the most important information to know about Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit www.tonixpharma.com or call 1-888-650-3789.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
INDICATION AND USAGE Tosymra is a prescription medicine used to treat acute migraine headaches with or without aura in adults.
Tosymra is not used to treat other types of headaches such as hemiplegic or basilar migraines or cluster headaches.
Tosymra is not used to prevent migraines. It is not known if Tosymra is safe and effective in children under 18 years of age.
CHICAGO, June 18, 2024 (GLOBE NEWSWIRE) — GoHealth, Inc. (GoHealth) (NASDAQ: GOCO), a leading health insurance marketplace and Medicare-focused digital health company, announced the company will present at the Noble Capital Markets Consumer, Communications, Media, and Technology Emerging Growth Virtual Equity Conference on Wednesday, June 26, 2024, at 2:00 p.m. Eastern Time.
A live webcast of the presentation may be accessed through a link that will be posted on GoHealth’s Investor Relations website, https://investors.gohealth.com/. A replay will be available through the same link following the conference.
About GoHealth, Inc.
GoHealth is a leading health insurance marketplace and Medicare-focused digital health company whose purpose is to compassionately ensure consumers’ peace of mind when making healthcare decisions so they can focus on living life. For many of these consumers, enrolling in a health insurance plan is confusing and difficult, and seemingly small differences between health plans may lead to significant out-of-pocket costs or lack of access to critical providers and medicines. GoHealth’s proprietary technology platform leverages modern machine-learning algorithms, powered by over two decades of insurance purchasing behavior, to reimagine the process of matching a health plan to a consumer’s specific needs. Its unbiased, technology-driven marketplace coupled with highly skilled licensed agents has facilitated the enrollment of millions of consumers in Medicare plans since GoHealth’s inception. For more information, visit https://www.gohealth.com.
CHANDLER, Ariz. – June 18, 2024 — Comtech (NASDAQ: CMTL) (“the Company”) today announced its third quarter fiscal 2024 financial results in a letter to shareholders which is now posted to the Investor Relations section of Comtech’s website. Investors are invited to access the third quarter fiscal 2024 shareholder letter at comtech.com/investors/. A copy of the letter will also be filed with the Securities and Exchange Commission in a Form 8-K.
Comtech also announced that on June 17, 2024, the Company entered into a $222.0 million credit facility with a new syndicate of lenders which is expected to be funded on or around June 18, 2024. The New Credit Facility matures on July 31, 2028, consists of a committed $162.0 million term loan facility and $60.0 million revolver loan facility and is expected to have outstanding borrowings at close of approximately $187.0 million, reflecting $25.0 million drawn on the revolver. A copy of the credit agreement will be filed with the Securities and Exchange Commission in a Form 8-K.
Comtech also intends to host an earnings conference call at 8:30AM ET today, Tuesday, June 18, 2024. Individuals can access the conference call by dialing (800) 267-6316 (domestic) or (203) 518-9783 (international) and using the conference I.D. of “Comtech.” A replay of the conference call will be available for two weeks by dialing (888) 566-0152 or (402) 220-9186. A live webcast of the call is also available at comtech.com/investors/.
About Comtech
Comtech Telecommunications Corp. is a leading global technology company providing terrestrial and wireless network solutions, next-generation 9-1-1 emergency services, satellite and space communications technologies, and cloud native capabilities to commercial and government customers around the world. Our unique culture of innovation and employee empowerment unleashes a relentless passion for customer success. With multiple facilities located in technology corridors throughout the United States and around the world, Comtech leverages our global presence, technology leadership, and decades of experience to create the world’s most innovative communications solutions.For more information, please visit www.comtech.com.
Forward-Looking Statements
Certain information in this press release contains statements that are forward-looking in nature and involve certain significant risks and uncertainties. Actual results could differ materially from such forward-looking information. The Company’s Securities and Exchange Commission filings identify many such risks and uncertainties. Any forward-looking information in this press release is qualified in its entirety by the risks and uncertainties described in such Securities and Exchange Commission filings.
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Grant Provides Up To $367 Million Funding For The Phase 2b Trial. GeoVax announced that it has been selected to receive a Project NexGen grant to test CM04S1 in a Phase 2b study for prevention of COVID-19. The study will test CM04S1 against an approved vaccine in a randomized trial enrolling 10,000 volunteers. GeoVax will receive about $24.3 million for manufacturing, materials, and trial preparations, which can be increased to $45 million. About $343 million will be awarded to a CRO to conduct the trial.
Phase 2b Trial Will Have A Large Enrollment. The trial is designed as a Phase 2b double-blind study comparing GeoVax CM-04S1 to an approved mRNA COVID-19 vaccine. Enrollment will have an estimated 10,000 healthy volunteers to determine efficacy, safety, and immunogenicity of the vaccines. Previous trials with CM04S1 have shown both humoral and cellular immunity to multiple strains of the SARS-CoV-2 virus, with rapid and durable protection.
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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Boston Scientific Corporation has taken a major strategic step to strengthen its position in the vascular medical technology space by announcing a definitive agreement to acquire Silk Road Medical, Inc. for approximately $1.16 billion. This acquisition adds an innovative and clinically differentiated technology for stroke prevention to Boston Scientific’s already impressive portfolio of vascular solutions.
The target company, Silk Road Medical, is a pioneering medical device firm that has developed a revolutionary platform called TCAR (transcarotid artery revascularization) to treat carotid artery disease, a major cause of strokes. Carotid artery disease is responsible for one-third of all strokes and occurs when the carotid arteries in the neck become narrowed or blocked due to plaque buildup. Traditional treatment options include medical therapy management, stenting, or open surgery, all of which carry risks.
Silk Road’s TCAR procedure takes a minimally invasive approach by accessing the carotid artery through a small incision in the neck and temporarily reversing blood flow away from the brain during stenting. This prevents plaque from dislodging and causing a stroke, while a stent is placed to stabilize the blockage and prevent future strokes. Cat Jennings, President of Vascular Peripheral Interventions at Boston Scientific, praised the TCAR platform as “a notable advancement in the field of vascular medicine” that has “revolutionized stroke prevention and the treatment of carotid artery disease.”
The TCAR system gained U.S. Food and Drug Administration approval in 2015 and is supported by several clinical studies demonstrating a reduced risk of stroke and other complications associated with traditional open surgery. Notably, Silk Road Medical’s products are the only devices commercially available for use during the TCAR procedure, positioning the company as a leader in this fast-growing market segment.
Under the terms of the agreement, Boston Scientific will acquire all outstanding shares of Silk Road Medical for $27.50 per share in cash. Silk Road Medical is expected to generate net revenue of $194-198 million in 2024, reflecting 10-12% growth over the prior fiscal year. Boston Scientific anticipates the acquisition will be immaterial to its adjusted earnings per share in 2024 and 2025, and accretive thereafter.
For Boston Scientific, this strategic acquisition aligns perfectly with its core vascular business and strengthens its stroke solutions capabilities. By acquiring Silk Road Medical, Boston Scientific gains access to the innovative TCAR technology and can leverage its global commercial footprint and extensive physician relationships to drive further adoption of the platform. The combined entity can also explore potential synergies and opportunities to expand the applications of the TCAR technology beyond carotid artery disease.
The transaction is subject to customary closing conditions, including regulatory approvals, and Boston Scientific expects to complete the acquisition in the second half of 2024. While integrating Silk Road Medical’s operations, Boston Scientific plans to reinforce its commitment to providing meaningful innovation for physicians who treat patients with peripheral vascular disease.
This acquisition represents a strategic move by Boston Scientific to bolster its vascular offerings with a clinically differentiated and commercially successful stroke prevention technology. By integrating Silk Road Medical’s cutting-edge TCAR platform, Boston Scientific further solidifies its position as a leader in the vascular medical technology space and demonstrates its dedication to advancing solutions that improve patient outcomes and reduce the cost of healthcare.
