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KOLON TISSUEGENE COMPLETES PATIENT DOSING IN TWO PIVOTAL US PHASE III CLINICAL TRIALS FOR TG-C

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Completed patient dosing in US Phase 3 clinical trials.There will be a two-year follow-up period, followed by submission of the Biologics License Application (BLA) to permit marketing of TG-C once approved.

ROCKVILLE, Md., July 11, 2024 /PRNewswire/ — Kolon TissueGene, Inc. (‘the Company”) announced today that patient dosing has been completed on the US Phase 3 clinical trials for Knee Osteoarthritis. Since resuming patient recruitment in November 2021, the Company has completed 2 large clinical trials involving 1,066 patients in about 30 months.

Completion of patient dosing is a big milestone which enabled the Company to complete the pivotal Phase 3 clinical trials. The Company worked diligently with the US Food and Drug Administration (FDA) to get the clinical hold lifted in April 2020, which allowed resumption of the Phase 3 clinical trials in the US. The clinical hold was successfully lifted through extensive research based on scientific data on TG-C and an intensive regulatory review process.

Even though there were difficulties in the Phase 3 clinical trial process such as significant delays of the clinical studies in the US due to the global pandemic, the Company was able to complete patient dosing in the Phase 3 clinical trials with the determination and conviction to succeed in developing the world’s first and only cell and gene therapy for osteoarthritis of the knee.

During the patient recruitment process, approximately 6,700 patients signed up to participate in the Phase 3 clinical trials. Among them, more than 1,000 patients met eligibility criteria and were enrolled in the Phase 3 clinical trials.

In accordance with the protocol, the Company will continue a two-year follow-up on all dosed patients to assess the safety and efficacy after TG-C administration. The results of the Phase 3 clinical trials will be published at the end of the two-year follow-up period.

During the follow-up period, the Company will prepare the BLA submission package for the US FDA in order to obtain marketing authorization of TG-C in the US. The Company has already begun preparations related to commercial production (manufacturing) and is collaborating with Lonza, the world’s largest pharmaceutical CDMO.

“We expect the Phase 3 clinical trials to provide positive results, similar to the successfully completed Phase 2 clinical trial in the US” said Moon Jong Noh, PhD, CEO of the Company, adding, “When the Phase 3 clinical trials are successfully completed, we will start discussions with potential partners for commercial sales and marketing along with completion and submission of the BLA for product approval.” In addition, he said, “All executives and employees will do their best to repay all customers, shareholders, and others who have trusted and waited for the Company for a long time with meaningful results.”

About Kolon TissueGene, Inc. 
Kolon TissueGene, Inc., is an advanced cell therapies company that has developed a first-in-class cell and gene therapy targeting OA of the knee. The Company’s lead product, TG-C, is an allogeneic cell and gene therapy. The Company is conducting Phase 3 clinical trials in the US under a Special Protocol Assessment (SPA) agreement reached with the US FDA. Information about the trials can be found at the National Institutes of Health registry, www.clinicaltrials.gov.  For additional information about Kolon TissueGene, Inc., please visit www.tissuegene.com.

About TG-C
TG-C is a first-in-class cell and gene therapy targeting OA of the knee through a single intra-articular injection. Clinical trials held in the US and abroad have demonstrated pain relief and increased mobility, as well indicators towards decreased progression of OA and improvements in joint structure. The allogeneic (off-the-shelf) drug could provide an alternative to traditional treatment and surgery, or delay the progression of OA to minimize the need for multiple surgical interventions. In a concluded US Phase 2 clinical trial, Kolon TissueGene demonstrated a two-year improvement of pain and function. The Company seeks to continue to support these results through its Phase 3 clinical trials. In addition, the Company has designed the trials to seek a disease-modifying osteoarthritis drug (DMOAD) designation for TG-C from the US FDA—potentially making TG-C the first therapy to receive such a DMOAD label.

View original content:https://www.prnewswire.com/news-releases/kolon-tissuegene-completes-patient-dosing-in-two-pivotal-us-phase-iii-clinical-trials-for-tg-c-302195060.html

SOURCE Kolon TissueGene, Inc.

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“What If We Had This in 2020?” Data Viz 4 Good Bridges the Fortune 100 Data Gap for the Social Sector

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May 5, 2026

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SAN FRANCISCO, May 5, 2026 /PRNewswire/ — Data Viz 4 Good (DV4G) today announced the launch of its ImpactIQ platform, a breakthrough SaaS solution transforming how the social sector visualizes mission-critical data.

For founders Tyra Jean and Vanessa Francesca Ortega, both Ronald E. McNair Baccalaureate Scholars, the mission began with a pivotal question: “What if we had Data Viz 4 Good at Syracuse University back in 2020?”

CEO Tyra Jean—a former Public Policy & International Affairs Fellow at UC Berkeley and current D.S.W. candidate at the University of Southern California—developed the concept after bridging two vastly different worlds. “I worked as a data consultant for Fortune 100 companies and saw firsthand the massive gap in data infrastructure across the nonprofit sector,” said Jean. “We’re bringing enterprise-grade technology to the organizations that need it most.”

This vision, combined with the duo’s technical pedigree, has positioned them as emerging leaders in the next generation of AI-powered social infrastructure and frontrunners for Forbes’ 30 Under 30.

The platform’s technical moat is anchored by the COO Vanessa Francesca Ortega — Posse Alumni, SU Remembrance Scholar, and Newhouse’s Dean Branham Scholar. She is the founder & CEO of Civic Trust Systems, the core operating system powering municipal-scale AI platforms, including HellogovAI Inc.

“ImpactIQ is built on infrastructure originally designed to power secure, large-scale government service delivery,” said Ortega. “Through Civic Trust Systems, I developed the AI delivery model and user experience architecture that enables platforms like Hellogov. We are now applying that same level of security and privacy to the social sector.”

By leveraging Civic Trust Systems, DV4G delivers government-grade security, privacy-first data handing, and scalable AI intelligence— without the complexity of cost of traditional enterprise systems.

As a free resource for the sector, the founders co-host a DV4G Podcast on Instagram (@DataViz4GoodHQ). The next episode explores how ImpactIQ’s privacy-first architecture not only protects sensitive community data but also strengthens grant readiness and institutional trust.

DV4G is currently scaling ImpactIQ for global researchers, nonprofits, and mission-driven organizations seeking to modernize how they measure and communicate impact.

Unlock the full impact of your data at DataViz4Good.org.

Media inquiries: contact@dataviz4good.org

View original content:https://www.prnewswire.com/news-releases/what-if-we-had-this-in-2020-data-viz-4-good-bridges-the-fortune-100-data-gap-for-the-social-sector-302763285.html

SOURCE Data Viz 4 Good

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QuickLogic to Showcase EOS™ S3 and eFPGA Solutions at Sensors Converge

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May 5, 2026

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SAN JOSE, Calif., May 5, 2026 /PRNewswire/ — QuickLogic Corporation (NASDAQ: QUIK) will showcase its EOS™ S3 SoC and eFPGA solutions at Sensors Converge 2026, taking place at the Santa Clara Convention Center. Attendees can visit Booth 1039 to see how developers can build always-on, ultra-low power sensor and voice-enabled systems with greater flexibility and faster time-to-market.

At the booth, QuickLogic will highlight the EOS™ S3, a fully integrated platform designed for concurrent voice, motion, environmental, and biometric sensing. With its built-in low-power sound detection, Arm® Cortex®-M4F processor, and embedded FPGA, the EOS™ S3 enables developers to implement custom hardware acceleration while minimizing power consumption—ideal for battery-operated and always-on applications.

Date: May 6 and 7, 2026

Booth: 1039

Exhibit Hours:

Wednesday, May 6: 10:00 AM – 5:30 PMThursday, May 7: 10:00 AM – 4:00 PM

About QuickLogic
QuickLogic Corporation is a fabless semiconductor company specializing in eFPGA Hard IP, Strategic Radiation Hardened and Antifuse FPGAs and ruggedized programmable logic solutions. QuickLogic’s unique approach combines cutting-edge technology with open-source tools to deliver highly customizable, low-power solutions for aerospace and defense, industrial, computing, and consumer markets. For more information, visit www.quicklogic.com.

QuickLogic and logo are registered trademarks of QuickLogic. All other trademarks are the property of their respective holders and should be treated as such.

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SOURCE QuickLogic Corporation

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PIRELLI WILL START CYBER™ TYRE PRODUCTION IN GEORGIA UNDERLINING THE STRATEGIC IMPORTANCE OF THE U.S. MARKET

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May 5, 2026

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Pirelli further strengthens its commitment to the country. Investment and output expansion details will be communicated in the coming months following the finalization of the development plans

MILAN and WASHINGTON, May 5, 2026 /PRNewswire/ — Pirelli is reinforcing its long-term commitment to the United States with a key step in its product and industrial strategy. The Georgia plant, already dedicated to the most technologically advanced products for the U.S. market—both in the High-Value segment and in Motorsport—will be further enhanced by the production of connected tires featuring Cyber™ Tyre technology. This development highlights the strategic importance of the U.S. for Pirelli’s global growth roadmap, strengthening the company’s integrated industrial and technological presence in the country.

The announcement comes as Pirelli participates in the SelectUSA Investment Summit, the flagship event promoted by the U.S. Department of Commerce, where Cyber™ Tyre is being showcased as a core innovation shaping the future of smart mobility. 

Cyber™ Tyre is the world’s first hardware-and-software system capable of collecting data and information from sensors embedded in tires, processing them through Pirelli’s proprietary software and algorithms, and, by communicating in real time with the vehicle’s electronics, enabling new functionalities integrated with driving and control systems to enhance the driving experience and increase safety levels, as well as supporting connected infrastructure.

In a highly advanced market such as the United States, where digital and smart mobility solutions are rapidly expanding, Cyber™ Tyre represents a distinctive competitive advantage for Pirelli.

At SelectUSA, Cyber™ Tyre was showcased at the Georgia State booth, a particularly meaningful presence given Pirelli’s industrial footprint in the state, where it has been established for more than 20 years.

“The start of Cyber™ Tyre production in our Rome, Georgia plant is a significant milestone for Pirelli in this country,” said Claudio Zanardo, CEO of Pirelli North America. “It reflects our commitment to bringing advanced technologies like Cyber™ Tyre closer to the market, further strengthening our industrial footprint and innovation capabilities in the United States.”

To further enhance the role of Rome as a high-tech production site, Pirelli is finalizing the introduction of the latest version of the MIRS (Modular Integrated Robotized System) production process. It will be the most advanced manufacturing process for high-end, premium production within the entire Pirelli Group, and is exclusive to the Georgia factory. The process further enhances robotized production capabilities, increasing productivity, flexibility, and quality.

It is a highly digitalized system that enables a direct link between product design and its industrial application.

This development lays the groundwork for growth in Pirelli’s production capacity in Rome, an integral part of the Group’s industrial development plans, and will further strengthen Pirelli’s presence in the United States—one of its most important and strategic markets.

The Rome, Georgia, plant specializes in high-value tire production for the North American market. It also hosts a dedicated R&D center, further strengthening its role in technological development and product innovation.

The facility is recognized for its responsible sourcing practices, including the use of FSC® (Forest Stewardship Council®)-certified natural rubber, underscoring the company’s broader environmental commitment across its supply chain.

www.pirelli.com

View original content to download multimedia:https://www.prnewswire.com/news-releases/pirelli-will-start-cyber-tyre-production-in-georgia-underlining-the-strategic-importance-of-the-us-market-302763293.html

SOURCE Pirelli North America

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