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This Healthcare Tech Company Has Become The First To Receive FDA De Novo Authorization For An OTC COVID-19 Test

Benzinga

By Rachael Green, Benzinga The healthcare technology company Cue Health Inc. (NASDAQ: HLTH) has become the first company to get De Novo authorization from the U.S. Food and Drug Administration (FDA) for an over-the-counter COVID-19 test — as well as being the first FDA De Novo authorization for any over-the-counter molecular test for a respiratory disease. The Cue COVID-19 Molecular Test is designed for both at-home and point-of-care use. Cue Health was also previously the first company to receive an Emergency Use Authorization (EUA) from the FDA for an at-home molecular diagnostic test available without a prescription, which helped the company rake in over $1 billion in revenue over two years from both public (government entities) and private (point-of-care, enterprise, and direct-to-consumer) customers because it is highly accurate and has an easy-to-use design. There are still an average of over 2,000 patients with COVID-19 admitted to hospitals every day in the United States. For both the flu and COVID-19, early diagnosis and treatment are critical to preventing serious illness and even death. In March, the FDA recommended to manufacturers that had received EUAs for their COVID-19 tests to submit new applications and meet the requirements for full clearance in order to keep selling their products. Cue has already achieved that new FDA authorization for its COVID-19 test., and it also has an EUA under FDA review for its Flu A/B + COVID-19 multiplex test, plus additional requests for De Novo classification under review including for its standalone flu test and its respiratory syncytial virus (RSV) test. The company already has an EUA for its molecular test to detect the monkeypox virus. The at-home and point-of-care COVID-19 tests deliver lab-quality results to connected mobile smart devices in about 20 minutes. The test integrates into Cue Care, the company's state-of-the-art test-to-treatment service where patients can connect with a healthcare provider through the Cue Health App to discuss their results, form a treatment plan and have prescribed medications delivered straight to their door. COVID-19 Diagnostics Market Remains As The Disease Becomes Endemic Cue’s De Novo authorization comes as public health officials and epidemiologists have been continuously reporting that COVID-19 has transitioned from pandemic to endemic. Similar to the flu, COVID-19 cases will likely continue to cycle between highs and lows, but in a relatively more predictable manner. Movement into endemic status only means that testing will be even more important and needed over a much longer period of time. Early diagnosis of a respiratory illness can potentially lead to a milder infection and a decreased likelihood of hospitalization. Maintaining vigilance in preventing infection and opting for early detection and treatment at the first sign of symptoms (especially in households with children, senior citizens, family members with disabilities, or other at-risk individuals) can be crucial, especially for COVID-19. Cue Health’s diagnostic platform is able to help both patients and care providers stay ahead of COVID-19 over the long term, as the disease enters its endemic stage. By providing fast and accurate results, the platform could help minimize the spread of the disease and the risk of hospitalizations. Cue’s Molecular Diagnostic Platform — A Game Changer For Testing Cue’s test is a NAAT (Nucleic Acid Amplification Test) that amplifies and detects the virus’s RNA. Because it can amplify the genetic material, Cue’s test is much more sensitive than an antigen test. In clinical studies, the Cue COVID-19 Molecular Test matched three FDA-authorized, lab-based PCR tests with 98% accuracy. The company’s innovative technology turned the complex test into a user-friendly kit that requires no advanced training. Cue’s molecular test is proven to deliver accurate results even in the early days after exposure whereas antigen results are not nearly as reliable. This is important as, according to the CDC, treatment must be started within days after you first develop symptoms to be effective. Cue's molecular test, which delivers results in 20 minutes, is also much faster than a PCR test, which can take anywhere from 12 hours to five days. The test can be used on adults or children with or without signs or symptoms of COVID-19 and it is self-contained, meaning it doesn’t involve mixing fluids or running an involved testing procedure. Users simply insert the cartridge into their Cue Reader, collect a nasal sample with a Cue Sample Wand, and insert the Wand into the cartridge. About 20 minutes later, results are sent to the Cue Health App on the user’s phone. With its head start in the transition from EUA to permanent market authorization for its at-home COVID-19 molecular test and a slate of additional at-home tests compatible with the same Cue Reader device, analysts have expressed optimism about the healthcare tech company’s future earnings potential. This document may depict certain future planned care offerings which are subject to completion of development and/or may require regulatory authorization, clearance, or approval before they can be commercialized. This post contains sponsored content. This content is for informational purposes only and not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

August 18, 2023 09:00 AM Eastern Daylight Time

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Cepton announces record LiDAR shipments as company unveils 2Q earnings

Cepton Inc

Cepton Inc. vice president of Product Brunno Moretti joined Steve Darling from Proactive to discuss the company's second-quarter performance and strategic developments. Cepton has achieved a new company record for shipments of LiDAR technology across the automotive and smart infrastructure markets, showcasing the company's strong momentum. Moretti highlighted that Cepton is anticipating a significant increase in shipment volume for each subsequent quarter throughout the remainder of the year. The company is also actively fulfilling a multi-million dollar tolling contract, a significant achievement within its portfolio. In addition, Moretti mentioned the company's strategic expansion, particularly in Detroit, where Cepton has bolstered its team with industry expert Luis Gonçalves, formerly associated with General Motors (GM) and the American automotive sector. This move is expected to support Cepton's volume production operations and enhance its market presence. Cepton's strong 2Q performance, strategic partnerships, and expansion efforts underscore its commitment to advancing lidar technology and its applications in the automotive and smart infrastructure sectors. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

August 17, 2023 12:56 PM Eastern Daylight Time

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Spectral MD takes steps toward Rosecliff Acquisition Corp merger

Spectral MD Holdings Ltd

Spectral MD Holdings' general counsel Vince Capone joins Steve Darling on Proactive to provide insights into the latest developments at the company. Capone highlighted the significance of Rosecliff Acquisition Corp's filing of Form 424, a crucial step in Spectral MD's ongoing journey. This filing is triggered by the effectiveness of the RS-4 with Rosecliff, signifying an upcoming shareholder meeting to approve the transaction. The merger aims to reshape Spectral MD into a holding company under Rosecliff, adopting the new name "Spectral AI." This transformation also involves a NASDAQ ticker change from "CLF" to "MD AI." Capone underlined a significant milestone – the successful clearance of the SEC examiner's review, which is pivotal for the transaction. He noted the accelerated timeline for this process compared to the typical three to four months, indicating the company's agile approach. The timeline for further progress is set for September 8, targeting the NASDAQ listing, and the company's exit from other markets. With shareholder meetings for both Spectral MD and Rosecliff scheduled for August 31 and September 6 respectively, the rapid pace of developments is evident. Capone expressed his enthusiasm for the exciting journey ahead, recognizing the dedicated efforts of the team. The transformation promises to be a substantial stride for Spectral MD, and the interview concluded with anticipations for the upcoming listing and more updates. Contact Details Proactive USA +1 604-688-8158 na-editorial@proactiveinvestors.com

August 17, 2023 12:51 PM Eastern Daylight Time

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Gamelancer Media beats its own forecasts with 2Q financial results

Gamelancer Media Corp

Gamelancer Media Corp CEO Jon Dwyer joined Steve Darling from Proactive to announce the company's financial achievements for the second quarter of 2023. The reported results surpassed management's expectations, showcasing an impressive 171% growth in revenue to C$1.42 million for the quarter ended June 30, 2023, compared to the same period in 2022. Dwyer emphasized to Proactive that the 2Q 2023 financial report not only highlights Gamelancer's exceptional revenue growth but also underscores the company's capacity to foster sustainable growth both in terms of revenue and network expansion. He emphasized that Gamelancer's unique value proposition, which combines owned and operated channels with its creative studio JoyBox, sets the stage for a distinctive media offering to brands. Dwyer also shared the company's ongoing efforts to optimize operational costs, a strategy that aligns with its goal of achieving positive underlying earnings (EBITDA) results by the fourth quarter of 2023. This commitment to financial efficiency and strategic growth positions Gamelancer for continued success in the competitive media landscape. Contact Details Proactive Investors Canada +1 604-688-8158 na-editorial@proactiveinvestors.com

August 17, 2023 12:44 PM Eastern Daylight Time

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Family Tech for School and Home

News Media Group, Inc.

Contact Details News Media Group, Inc. Karl Wayne +1 334-440-6397 karl@newsmg.com Company Website https://newsmg.com/

August 17, 2023 12:01 PM Eastern Daylight Time

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Harvest Thermal Earns Inclusion in CEC Title 24 Compliance Software

Harvest Thermal

The electronic rulebook of Title 24 compliance for energy now includes Harvest Thermal’s smart thermal battery solution as an efficiency option. The California energy code for new construction and major remodels is becoming increasingly challenging to meet. Architects, homebuilders and remodelers need more cost-effective solutions to include in their projects. Harvest Thermal offers project developers a climate-friendly and cost-effective tool to meet code requirements. Its unique thermal battery solution uses a single heat pump for both heating and hot water. The smart Harvest Pod leverages cheap, clean electricity to store heat at midday while releasing it to the home whenever needed. Smart controls optimize for homeowner comfort while delivering up to 45% lower energy costs and 90% carbon reductions compared to gas. “Harvest Thermal’s inclusion in the CEC Title 24 database is very significant for architects, homebuilders and remodelers,” said Pierre Delforge, Head of Product and Operations at Harvest Thermal. “They will see outsized benefits with significantly lower EDR scores, lowering their costs and improving the performance of their buildings.” Building plans submitted for permitting must achieve scores at or below the Energy Design Rating (EDR) compliance threshold as calculated by the CBECC-Res compliance software. Plans that include Harvest Thermal get extra credit, lowering both Efficiency and Total EDR scores, and helping to avoid other more costly measures. Harvest Thermal also qualifies for the new California Electric Homes Program (CalEHP) for all-electric new construction, bringing more value to homebuilders’ projects. The technology fits into recognizable floorplans, enabling developers to seamlessly integrate Harvest into their designs. For more information on how to incorporate Harvest Thermal into the CBECC-Res database as a combined heat and hot water system see the instructions in this presentation. Harvest Thermal is redesigning home heating, cooling and hot water for the planet. Its market-leading thermal battery system cuts carbon emissions by 90% from home heating and hot water compared to gas and 50% compared to heat pumps without storage. The cloud-connected Harvest Pod leverages machine learning software, sensors, and controls to reduce carbon emissions and save on monthly heating bills. It also supports a cleaner, cheaper, and more resilient grid. Founded in 2019, Harvest Thermal has received support from the National Science Foundation, the California Energy Commission, Peninsula Clean Energy, and leading private investors. In 2023, Harvest Thermal was named to Fast Company’s Most Innovative Companies list; awarded NREL Industry Growth Forum’s People’s Choice Award; and won a Silver Edison Award for Sustainable Design in the category of Consumer Solutions. Contact Details Harvest Thermal David Tuft +1 202-494-0813 david@harvest-thermal.com Company Website https://www.harvest-thermal.com/

August 17, 2023 08:00 AM Pacific Daylight Time

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Portfolio Trading Insights on H1 2023: Volumes and Execution Quality Take Center Stage

Tradeweb

The first half of 2023 offered a volatile macro backdrop for U.S. credit markets, as elevated inflation, rates uncertainty and an ongoing banking crisis continued to weigh on our markets. Despite these hurdles, one constant theme in credit markets has been the use of portfolio trading to move large baskets of risk. Tradeweb has been the market leader in electronifying this protocol and our growth has continued through 2023, with combined U.S. Investment Grade (IG) and U.S. High Yield (HY) volumes in portfolio trading up 22% in the first half of 2023 compared with prior year period. This momentum continued into July; we estimate portfolio trading made up 6% [1] share of total TRACE in July 2023, which is the highest we’ve seen since November 2021. In this piece we highlight some of the trends we’ve seen in portfolio trading over the first six months of 2023 – and what this could mean for the next wave of portfolio trading innovation. For example, in response to growing client engagement and interest in using the protocol in different ways, we recently introduced ‘Bulk Crossing’ functionality within portfolio trading to allow clients and dealers to trade more efficiently by trading hundreds (or thousands) of corporate bonds with Treasury hedges, while consolidating the numerous Treasury trades into one ticket per benchmark. This feature allows both clients and dealers to trade more efficiently by reducing their number of tickets, and has grown in popularity for both Net Proceeds and Trade-at-Close (or Ref+) portfolio trades. Measuring the Size of the U.S. Portfolio Trading Market – An Update On May 15, 2023, the FINRA TRACE reporting rules took effect which require dealers to start reporting their portfolio trade transactions to TRACE. This change signifies how far portfolio trading has come over the past five years; it is a testament to the increased electronification of this protocol and of credit markets more broadly. The new requirements allow market participants to achieve a better understanding of the size of the market and therefore adjust their pricing models to consume these trades in a more informed way. This new reporting metric has also allowed us to validate our model for estimating portfolio trading market size on TRACE (discussed in more detail here ). We will continue to monitor the performance of our portfolio trading estimation model as more portfolio trades are tagged on TRACE over the coming months. [1] Based on TRACE Portfolio Trading Execution Volumes Vary Throughout the Month Portfolio trading is utilized by clients for a multitude of reasons. This can range from very specific sector level views to huge monthly or quarterly rebalances. Month-end tends to be a popular time for portfolio trades for a variety of reasons. Below we illustrate the average day’s volume given its position in the month during the first half of 2023 vs the first half of 2022. Looking at the chart below, the final week of the month averaged 42% more volume as compared to the previous weeks during the month. This trend helped drive the overall increase in portfolio trading over the last year. One reason that month-end is a popular time for portfolio trades is that the protocol provides an easy way for clients to rebalance their portfolio to maintain their monthly mandates and exposures. These types of rebalancing trades are typically slightly larger in size and have more line items than other portfolio trades. We can see this activity in the data: in H1 2023, portfolio trade baskets traded on Tradeweb during the last three days of the month averaged 17% more volume and 47% more line items as compared to portfolios traded during the previous days of the month. Portfolio trades near month-end also tend to include more distinct sectors in their make up as compared to portfolio trades happening at other times of the month. Although this is not a direct measure of diversity in bond portfolios, this larger sector range is also indicative of these rebalancing type trades. Portfolio Trading Execution Quality As discussed in earlier blog posts, there are several ways of measuring execution quality for trading in credit markets. One metric we use in our transaction cost analyses is the percentage bid/offer spread captured (%BOS). This is simply the percentage of Tradeweb Ai-Price bid/offer spread that the traded level captured. In H1 2023, we saw improvements in portfolio trade execution quality compared to H1 2022. The median %BOS captured is now very close to mid and has almost returned back to 2021 levels. HY portfolio trade execution quality has also significantly improved since the beginning of the year, despite HY TRACE having fallen around 4% from H1 2022 to H1 2023. We also previously discussed the factors that drive portfolio execution quality at the portfolio level. One interesting trend we wanted to explore further was execution quality at the line level in a portfolio trade and how it varies by size. Intuitively, we would expect higher execution costs on chunkier lines in the portfolio due to a size premium, but also potentially higher costs on those with very small size. This is because a client may be willing to incur slightly higher costs on small trades in order to obtain the certainty of execution on these items. Using H1 2023 Tradeweb portfolio trading data, we looked at how the %BOS captured varied by line size. We can clearly see both in IG and HY that execution quality falls as line size increases, which is expected due to the extra cost associated with trading large sizes. The chart also implies that the optimal size for execution quality is around 50k-500k for IG and 50k-100k in HY, which corresponds with what we tend to see on average for portfolio trades on our platform. The inverted U shape is also indicative of the ‘small trade’ effect where trade costs may be slightly higher for very small line sizes. This implies that clients are willing to accept comparatively worse levels on those bonds since they know they are able to trade them with certainty as part of the broader basket. This effect, however, seems to be much smaller than the higher costs associated with larger line sizes and is still well inside the bid/offer. Looking Forward Even as TRACE volumes declined in Q2 2023 as compared with strong comps in Q1 2023, we’ve seen portfolio trading continue to maintain its significant share of the overall market, and we believe it is here to stay. As the protocol evolves, such as we have seen with the use of Bulk Crossing, we are confident that clients will continue to leverage portfolio trading in innovative ways, and in every market condition. About Tradeweb Markets Tradeweb Markets Inc. (Nasdaq: TW) is a leading, global operator of electronic marketplaces for rates, credit, equities and money markets. Founded in 1996, Tradeweb provides access to markets, data and analytics, electronic trading, straight-through-processing and reporting for more than 40 products to clients in the institutional, wholesale and retail markets. Advanced technologies developed by Tradeweb enhance price discovery, order execution and trade workflows while allowing for greater scale and helping to reduce risks in client trading operations. Tradeweb serves approximately 2,500 clients in more than 65 countries. On average, Tradeweb facilitated more than $1.2 trillion in notional value traded per day over the past four quarters. For more information, please go to www.tradeweb.com. Forward-Looking Statements This release contains forward-looking statements within the meaning of the federal securities laws. Statements related to, among other things, our outlook and future performance, the industry and markets in which we operate, our expectations, beliefs, plans, strategies, objectives, prospects and assumptions and future events are forward-looking statements. We have based these forward-looking statements on our current expectations, assumptions, estimates and projections. While we believe these expectations, assumptions, estimates and projections are reasonable, such forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond our control. These and other important factors, including those discussed under the heading “Risk Factors” in documents of Tradeweb Markets Inc. on file with or furnished to the SEC, may cause our actual results, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. Given these risks and uncertainties, you are cautioned not to place undue reliance on such forward-looking statements. The forward-looking statements contained in this release are not guarantees of future performance and our actual results of operations, financial condition or liquidity, and the development of the industry and markets in which we operate, may differ materially from the forward-looking statements contained in this release. In addition, even if our results of operations, financial condition or liquidity, and events in the industry and markets in which we operate, are consistent with the forward-looking statements contained in this release, they may not be predictive of results or developments in future periods. Any forward-looking statement that we make in this release speaks only as of the date of such statement. Except as required by law, we do not undertake any obligation to update or revise, or to publicly announce any update or revision to, any of the forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this release. Contact Details Tradeweb Media Contact Daniel Noonan +1 646-767-4677 Daniel.Noonan@Tradeweb.com Company Website http://www.tradeweb.com

August 17, 2023 10:47 AM Eastern Daylight Time

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PathAI Announces Commercial Availability of AISight™ Digital Pathology Image Management System to Power the Next Generation of Pathology Labs

PathAI

PathAI, a global leader in AI-powered pathology, today announced the commercial launch of its AISight TM digital pathology image management system (IMS) for anatomic pathology laboratories. 1 The launch comes at a time when the pathology space is increasingly transitioning to digitally-enabled reads and recognizing the utility of AI and machine learning to enhance quality control, standardize diagnoses, and quantitate biomarkers. AISight is a cloud-based platform that enables efficient, end-to-end digital pathology workflows. AISight provides best-in-class image and case management, ingestion, and viewing while seamlessly enabling access and deployment of AI applications. AISight can also be integrated bidirectionally with laboratory information systems for streamlined workflow adoption. Anatomic pathology laboratories of all sizes and specialties – including health systems, reference laboratories, independent pathology labs, and academic medical centers – may utilize AISight. 1 “We are thrilled to make the AISight Image Management System available to labs globally. We’ve been honing this platform with input from hundreds of pathologists from dozens of institutions, and this launch underpins all of the work PathAI does to support pathologists, biopharma partners, and the academic research community,” said Dr. Andy Beck, M.D. Ph.D., chief executive officer and co-founder of PathAI. “Expanding the feature set to support pathology workflows as an IMS for anatomic pathologist laboratories is a natural progression for PathAI as we strive to meet our mission of improving patient outcomes with AI-powered pathology.” This announcement builds on prior progress as PathAI’s solutions increasingly support digital pathology workflows. In March of this year, PathAI announced the Early Access Program for AISight, and the 12 leading anatomic pathology laboratories that began trialing the platform. Subsequently, PathAI announced the availability of its first 5 algorithm products through the platform including AIM-PD-L1 algorithms across 4 indications, and the AIM-HER2 Breast Cancer algorithm. 2 In addition to AISight for research use, PathAI also has a regulated platform, AISight™ Dx, that has 510(k) clearance for primary digital diagnosis in the US and is CE-marked in the EU. “We have been overwhelmed with the positive feedback from pathologists, lab directors, operators, and administrators who have trialed AISight and we’re excited to make it available at scale,” said Eric Walk, M.D., F.C.A.P., chief medical officer at PathAI. “AISight provides a one-stop shop for digital pathology case management that is flexible for multiple use cases given its interoperability and configurability. We will continue iterating on new and improved features as we listen to our users and release updates as they become available.” To learn more about AISight IMS, register for our upcoming webinar, visit our website, or meet with our team at upcoming conferences including ECP, CAP, and PathVisions. 1 AISight™ is for research use only. Not for clinical use in diagnostic procedures. 2 AIM-PD-L1™ and AIM-HER2™are research use only. Not for clinical use in diagnostic procedures. About PathAI PathAI is the only AI-focused technology company to provide comprehensive precision pathology solutions from wet lab services to algorithm deployment for clinical trials and diagnostic use. Rigorously trained and validated with data from more than 15 million annotations, its AI-powered models can be leveraged to optimize the analysis of patient samples to improve efficiency and accuracy of pathology interpretation, as well as to better gauge therapeutic efficacy and accelerate drug development for complex diseases. PathAI, which is headquartered in Boston, MA, and operates a CAP/CLIA-certified laboratory in Memphis, TN, is proud to have a team of 600+ innovative thinkers from around the globe. 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/

August 17, 2023 10:00 AM Eastern Daylight Time

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Agora Data Successfully Secures $160 Million in Fourth Private Term Financing

Agora Data, Inc.

Agora Data, Inc., a fintech company transforming automotive financing for U.S. car dealerships by offering abundant, low-cost capital with precision loan performance data and analytics, closed a $160 million private term financing on August 11, 2023. This latest transaction represents the fourth privately placed term financing for Agora. Each of the company’s first three term financings performed better than projected. “To close a term financing transaction in today’s challenging market conditions is proof-positive of the strength of the Agora team and how accurately we manage and predict portfolio performance,” said Steve Burke, CEO, Agora Data. “Fueling Agora’s mission to enable any car dealer to be a finance company, this $160 million private term financing provides additional funding capacity and reiterates our commitment to our customers’ future growth.” The $160 million private term financing marks a significant milestone in Agora Data’s growth trajectory. The company closed the first-ever crowdsourced auto securitization in late 2020, introducing a new way for car dealerships to access capital markets financing by aggregating loan portfolios of varying sizes. The company’s diversified financing strategy has resulted in multiple successful crowdsourced securitizations and private term transactions, all powered by its proprietary artificial intelligence (AI) and machine learning algorithms. With its patent pending modeling that delivers unparalleled accuracy, Agora leverages over $350 billion of loan data for car dealerships to optimize their non-prime portfolios. As a result, more favorable financing terms and highly competitive loan interest rates are available, reshaping the landscape of lending possibilities for dealers and finance companies to finance more non-prime customers, sell more cars, and make more money. Access to abundant capital has been a longstanding challenge for U.S. car dealers who offer or who want to offer financing to non-prime customers. Agora proactively addresses these challenges and presents a transformative fintech approach for dealers to keep their customers and make a gross profit on cars and financing profit on loans. # # # About Agora Data, Inc. Agora Data, Inc. is an automotive industry fintech revolutionizing financing for car dealers and finance companies. Car dealerships can secure affordable capital to build their own non-prime captive finance company, obtain actionable loan performance data to improve their lending portfolios, and use a wide range of solutions to grow their business safely. Powered by patent pending artificial intelligence (AI) and machine learning technology, car dealers can access real-time data analytics and planning resources to help optimize the performance of their portfolios. Agora Data made history by closing the first-ever crowdsourced non-prime auto securitization in 2020 and continually brings groundbreaking financing solutions to an underserved market. For more information, visit www.agoradata.com or contact us at 1-877-592-4672. Contact Details Eric Nemeth nemeth@ericpr.com Company Website https://agoradata.com/

August 17, 2023 09:06 AM Eastern Daylight Time

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