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

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6 months ago

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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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StoneAge Named a 2025 Real Leaders® Top Impact Company Recognized for Producing Ownership Mindset and Purpose-Driven Leadership

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January 10, 2025

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StoneAge, a global leader in industrial waterblast equipment, is proud to announce its inclusion in the Real Leaders® Top Impact Companies 2025 list, ranking 35th in the top 50 companies recognized. In addition to this prestigious award, StoneAge is also a finalist for the Top People award, which will be announced the first week in February. This recognition highlights the company’s dedication to fostering an ownership culture and driving positive change through its innovative Employee Stock Ownership Plan (ESOP).

DURANGO, Colo., Jan. 10, 2025 /PRNewswire-PRWeb/ — StoneAge, a global leader in industrial waterblast equipment, is proud to announce its inclusion in the Real Leaders® Top Impact Companies 2025 list, ranking 35th in the top 50 companies recognized. In addition to this prestigious award, StoneAge is also a finalist for the Top People award, which will be announced the first week in February. This recognition highlights the company’s dedication to fostering an ownership culture and driving positive change through its innovative Employee Stock Ownership Plan (ESOP).

“We are thrilled to be recognized as a 2025 Top Impact Company by Real Leaders®,” said Kerry Siggins, President and CEO of StoneAge. “Our ongoing focus on building an ownership culture and creating a workplace where everyone thrives is a significant driver in our achievement of this award.”

The Real Leaders® Impact Awards celebrate companies committed to putting a dynamic spin on capitalism to solve the world’s greatest challenges. StoneAge’s commitment to building a better, more sustainable future is rooted in its unique ownership model and core values of teamwork, self-leadership, and delivering on the StoneAge Assurance Promise.

“We are thrilled to be recognized as a 2025 Top Impact Company by Real Leaders®,” said Kerry Siggins, President and CEO of StoneAge. “Our ongoing focus on building an ownership culture and creating a workplace where everyone thrives is a significant driver in our achievement of this award. We are proud to be an employee-owned company where everyone shares in the success of the company. Our “Own It” culture and employee ownership plan are changing peoples’ lives.”

As a 100% employee-owned company, StoneAge continues to set the standard in its industry, proving that purpose-driven leadership and economic success go hand in hand. This recognition by Real Leaders® reinforces StoneAge’s commitment to making a lasting, positive impact on its employees, customers, and the world at large.

About StoneAge

StoneAge, based in Durango, CO, is a leading manufacturer of industrial waterblast equipment. The company is 100% employee-owned, fostering an “Own It” culture that empowers its team to excel personally and professionally.

About Real Leaders®

Real Leaders® is the premier platform for purpose-driven leaders dedicated to creating a better world. Its annual Top Impact Companies list recognizes businesses leading the way in positive global impact.

Media Contact
Brittany Harris, StoneAge Inc, 1 9702592869, brittany.harris@stoneagetools.com, www.stoneagetools.com

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SOURCE StoneAge Inc

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Cognizant CEO Ravi Kumar S Honored with Prestigious Pravasi Bharatiya Samman Award

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January 10, 2025

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BHUBANESWAR, India, Jan. 10, 2025 /PRNewswire/ — Ravi Kumar S, CEO of Cognizant, a leading global technology company, has been honored with the prestigious Pravasi Bharatiya Samman Award, the highest accolade awarded by the Government of India for overseas Indians. The honor was conferred by Smt. Droupadi Murmu, President of India at the Pravasi Bharatiya Divas Convention in Bhubaneswar, Odisha. The award acknowledges the outstanding contributions of the Indian diaspora for creating a better understanding of India abroad, supporting India’s causes and working for the welfare of the Indian community.

“I am deeply honored to receive the Pravasi Bharatiya Samman Award,” said Ravi Kumar S, CEO, Cognizant. “This recognition is a reflection of Cognizant’s steadfast commitment to India’s growth story. With nearly 70% of our 340,000-strong global workforce based in India, we are focused on advancing AI-first capabilities, driving innovation, and reinforcing India’s position as a global leader in digital talent.”

Ravi began his distinguished career as a nuclear scientist at the Bhabha Atomic Research Center of India. His dedication to empowering both current and future talent for the jobs of tomorrow through comprehensive skilling has been a cornerstone of his career. He is also a strong advocate for social and economic mobility, championing programs that elevate education, upskilling, and the empowerment of women, especially through public-private partnerships.

Under Ravi’s leadership, Cognizant launched the groundbreaking Synapse initiative in 2024, aiming to train one million people globally in emerging technologies by 2026, with a special emphasis on AI and a focus on India. The initiative has already reached over 275,000 individuals. Synapse builds on Cognizant’s longstanding commitment to economic mobility, supported by over $70 million in philanthropic funds through 117 grants to 77 organizations globally.

For the past three decades, Cognizant has been integral to India’s growth story and is the second-largest multinational employer in the Indian technology sector. Additionally, the company, through its Foundation in India and employee-volunteering program – Cognizant Outreach, has been dedicated to uplifting underserved communities and improving everyday lives.

Ravi was named CEO of Cognizant in January 2023 and joined the board of directors for the US-India Strategic Partnership Forum in 2024. He is a member of the board of directors of TransUnion. He is also on the board of governors of New York Academy of Sciences and the board of directors for the U.S. Chamber of Commerce. His full biography can be viewed here.

For the last 30 years, Cognizant has helped companies modernize technology, reimagine processes and transform experiences so they stay ahead in an ever-changing world. By leveraging cutting-edge digital technologies like AI, cloud, and process automation, Cognizant delivers industry-specific solutions through the expertise of its global workforce, helping clients engineer intuition into their businesses. With headquarters in the US, Cognizant footprint extends from India to Europe, North America, South America and the Middle East. In India, the company has a strong presence in Bengaluru, Bhubaneswar, Chennai, Coimbatore, Delhi-NCR, Hyderabad, Indore, Kochi, Kolkata, Mangaluru, Mumbai, and Pune.

About Cognizant 
Cognizant (Nasdaq: CTSH) engineers modern businesses. We help our clients modernize technology, reimagine processes, and transform experiences to stay ahead in our fast-changing world. Together, we’re improving everyday life. See how at www.cognizant.com or @cognizant.

For more information, contact:

U.S.

Name Bill Abelson

Email william.abelson@cognizant.com

Europe / APAC

Name Christina Schneider

Email christina.schneider@cognizant.com

India

Name Rashmi Vasisht

Email rashmi.vasisht@cognizant.com

 

View original content to download multimedia:https://www.prnewswire.com/news-releases/cognizant-ceo-ravi-kumar-s-honored-with-prestigious-pravasi-bharatiya-samman-award-302348142.html

SOURCE Cognizant Technology Solutions Corporation

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“Transform IT. Transform Everything:” Info-Tech LIVE 2025 Registration Opens for June 2025 IT Conference in Las Vegas

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January 10, 2025

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Info-Tech Research Group has opened registration for its flagship event, Info-Tech LIVE 2025, taking place June 10–12 at The Bellagio, Las Vegas. The conference will bring together more than 3,000 IT leaders and experts to explore actionable strategies and insights under the theme “Transform IT. Transform Everything.”

TORONTO, Jan. 10, 2025 /PRNewswire/ – Info-Tech Research Group, a global leader in IT research and advisory, has announced that registration is now open for Info-Tech LIVE 2025, the premier event for IT leaders, set to take place June 10–12 at The Bellagio in Las Vegas. With this year’s theme, “Transform IT. Transform Everything.”, the conference is set to deliver actionable insights, hands-on sessions, and unparalleled networking opportunities designed to equip attendees with the tools and strategies to navigate today’s rapidly evolving IT landscape.

Building on the massive success of last year’s event, Info-Tech LIVE will bring together over 3,000 IT executives, offering a platform for learning, collaboration, and inspiration. Attendees can look forward to 50+ keynote sessions, 60+ industry roundtables and panels, 60+ breakout and workshop sessions, and more than 700 opportunities for one-on-one analyst discussions. LIVE 2025 also provides extensive opportunities for peer-to-peer networking, fostering meaningful connections and collaborative discussions within the IT space.

“LIVE 2025 is designed to empower IT leaders to drive meaningful change within their organizations by equipping them with actionable strategies to tackle today’s challenges and seize tomorrow’s opportunities,” says Info-Tech Research Group’s Chief Research Officer, Gord Harrison. “While our theme for LIVE 2025 is ‘Transform IT. Transform Everything.,’ we are also emphasizing our subtheme, ‘Research for Everyone.’ This approach highlights the importance of empowering entire teams, not just individual leaders. True IT transformation happens when CIOs invest in upskilling their teams, fostering collaboration, and enabling everyone to contribute to innovation that reshapes organizations as a whole.”

Info-Tech LIVE 2025 Preliminary Agenda Highlights

LIVE 2025 will feature sessions tailored to IT leaders that focus on pressing topics and address real-world challenges, ensuring attendees leave equipped with solutions that translate theory into action. Some of the main sessions will highlight:

Emerging Technology Trends: An exploration of advancements shaping the IT landscape, with a focus on their implications for organizational strategy and innovation.AI and Analytics Strategies: Practical insights into implementing AI solutions and leveraging analytics to improve decision-making and drive business innovation.Cybersecurity Challenges and Resilience: Frameworks and approaches for managing risk and enhancing resilience in an increasingly complex cybersecurity environment.Leadership Development and Talent Strategies: Strategies for building and sustaining high-performing IT teams while addressing workforce challenges and future talent needs.Operational Efficiency and IT Transformation: Guidance on optimizing IT processes to align with broader organizational goals and achieve operational excellence.

What Info-Tech LIVE 2025 Offers the IT Industry

Expert-Led Keynotes and Panels: Sessions led by industry experts and thought leaders, offering insights into critical trends and strategies shaping the future of IT.Hands-On Workshops: Interactive sessions designed to equip participants with practical strategies and tools to address organizational challenges effectively.Peer Networking: Opportunities to connect with IT professionals and executives from a wide range of industries, fostering collaboration and knowledge sharing.One-on-One Analyst Discussions: Personalized sessions with Info-Tech’s renowned analysts, providing tailored guidance and actionable insights to support strategic initiatives.

Media Pass Applications

Media professionals, including journalists, podcasters, and influencers, are invited to attend Info-Tech LIVE 2025 to gain exclusive access to research, content, and interviews with industry leaders. For those unable to attend in person, Info-Tech offers a digital pass option, providing access to live-streamed keynotes, select sessions, and exclusive virtual interviews with speakers and analysts.

Media professionals looking to apply for in-person or digital passes can contact pr@infotech.com to secure their spot and cover the latest advancements in IT directly from the event or remotely.

Exhibitor Opportunities

Exhibitors are also invited to be part of Info-Tech LIVE and showcase their products and services to a highly engaged audience of IT decision-makers. For more information about becoming an Info-Tech LIVE exhibitor, please contact events@infotech.com.

Further details on keynote speakers and agenda will be announced in the coming weeks and months. Follow Info-Tech Research Group on LinkedIn and X for updates.

About Info-Tech Research Group

Info-Tech Research Group is one of the world’s leading research and advisory firms, proudly serving over 30,000 IT and HR professionals. The company produces unbiased, highly relevant research and provides advisory services to help leaders make strategic, timely, and well-informed decisions. For nearly 30 years, Info-Tech has partnered closely with teams to provide them with everything they need, from actionable tools to analyst guidance, ensuring they deliver measurable results for their organizations.

To learn more about Info-Tech’s divisions, visit McLean & Company for HR research and advisory services and SoftwareReviews for software-buying insights. 

Media professionals can register for unrestricted access to research across IT, HR, and software and hundreds of industry analysts through the firm’s Media Insiders program. To gain access, contact pr@infotech.com.

View original content to download multimedia:https://www.prnewswire.com/news-releases/transform-it-transform-everything-info-tech-live-2025-registration-opens-for-june-2025-it-conference-in-las-vegas-302348149.html

SOURCE Info-Tech Research Group

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