Technology

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

Published

2 years ago

July 11, 2024

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.

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SOURCE Kolon TissueGene, Inc.

Technology

RIVANNA nominated for MedTech Scale-Up of the Year at MedTech World Awards 2026 | North America

Published

46 minutes ago

May 5, 2026

Nomination places the Charlottesville-based company among growth-stage medtech leaders recognized for commercial momentum in AI-powered clinical decision support; public voting is open through May 8

CHARLOTTESVILLE, Va., May 5, 2026 /PRNewswire/ — RIVANNA®, developer of AI-powered clinical decision-support solutions, today announced that it has been nominated for MedTech Scale-Up of the Year at the MedTech World Awards 2026 | North America. Public voting is open through Friday, May 8, 2026, with category winners to be announced at the inaugural North American Awards Gala on May 11, 2026, at the Hilton West Palm Beach in Florida.

The MedTech Scale-Up of the Year category honors a growth-stage company successfully scaling revenues, partnerships, and adoption across the global medical technology ecosystem. Nominees across the program’s 22 categories were selected through a structured process led by the MedTech World Steering Committee, with category winners determined by a combination of expert evaluation and public voting from the global MedTech community.

“We have built RIVANNA on validation earned from the most rigorous technical buyers in healthcare: competitive federal awards translated into FDA-cleared products, each paired with a commercial program that meets clinicians where they work,” said Will Mauldin, PhD, Co-founder and CEO of RIVANNA. “Being nominated for MedTech Scale-Up of the Year is a meaningful affirmation of that approach and the team executing it.”

Public voting closes Friday, May 8, 2026. Members of the MedTech community are invited to support RIVANNA’s nomination at the official voting page: vote here.

The award nomination follows a year of measurable scaling for RIVANNA:

In October 2025, RIVANNA reported on being named a finalist in MedTech Innovator’s 2025 Early-Stage Grand Prize competition, selected from nearly 1,500 global applicants to represent the top 4% of medtech innovations worldwide.In December 2025, RIVANNA reported on the U.S. Food and Drug Administration’s 510(k) clearance of its Accuro® 3S Needle Guide Kit consumables, building on existing Accuro 3S device clearance.In April 2026, RIVANNA reported on peer-reviewed findings, published in 2025 in the Journal of Emergency Medicine (DOI: 10.1016/j.jemermed.2025.11.011), showing that the Accuro® XV musculoskeletal imaging system enables non-physician operators to acquire diagnostic-quality scans after just one hour of hands-on training.In May 2026, RIVANNA reported on the U.S. Food and Drug Administration’s 510(k) clearance of the Accuro® XV Diagnostic Ultrasound System for musculoskeletal imaging, authorizing commercial use across hospital and clinic settings.The company’s clinical program now spans eight sites nationwide with more than 1,500 patients enrolled.

The 2026 MedTech World Awards | North America, powered by Blue Goat Cyber, will be presented Monday, May 11, 2026, at the inaugural North American Awards Gala at the Hilton West Palm Beach, marking the first time the MedTech World Awards have been hosted in the United States.

About the MedTech Scale-Up of the Year Award
Presented by MedTech World, the MedTech Scale-Up of the Year category recognizes growth-stage medical technology companies demonstrating strong commercial momentum, expanding partnerships, and accelerating real-world adoption. The award is one of 22 categories spanning innovation, clinical excellence, regulatory strategy, investment, and leadership across the global MedTech ecosystem.

About RIVANNA
RIVANNA® is a medical technology company developing clinical decision-support solutions powered by proprietary clinical datasets, AI models, and purpose-built imaging hardware. The company’s platform automates complex anatomical analysis at the point of care, enabling faster, more confident clinical decisions while reducing variability and expanding access to advanced capabilities. The first applications target significant market opportunities in regional anesthesia and fracture care. RIVANNA has built a proven FDA regulatory track record across its Accuro® platform, with device clearances for Accuro® 3S (spinal needle guidance) and Accuro® XV (musculoskeletal imaging), a portfolio of supporting cleared consumables, and AI software modules advancing through regulatory review. The company is backed by 100+ patents and validated through clinical partnerships with leading academic medical centers. RIVANNA is headquartered in Charlottesville, Virginia, and operates an FDA-registered, ISO 13485:2016-certified manufacturing facility. Learn more at rivannamedical.com.

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SOURCE RIVANNA

Technology

D2L Launch Week Highlights Latest Product Releases

Published

46 minutes ago

May 5, 2026

Latest innovations are designed to save time, simplify workflows, and help drive better learning outcomes

TORONTO, May 5, 2026 /PRNewswire/ – D2L, a global leader in learning innovation, hosted its first-ever D2L Launch Week, a four-day virtual webinar series spotlighting the company’s latest product innovations across D2L Brightspace in 2026.

Throughout the week, D2L showcased a range of product releases through live demos and practical customer use cases, highlighting how institutions, school districts and organizations can help to drive engagement and improve learning outcomes. The featured updates include enhancements to D2L Lumi for idea generation, intervention suggestions, quiz creation and summarization; tools to strengthen parent and guardian outreach; and administrative capabilities designed to help large organizations delegate course and configuration management more effectively.

“We’re proud to showcase the ways D2L continues to innovate to help make learning more personalized, efficient, and scalable,” said Christian Pantel, Chief Product Officer at D2L. “From new D2L Lumi features to enhanced communication tools and more flexible distributed administration capabilities, these updates are designed to help our customers save time, improve usability, and deliver better learning experiences at scale.”

Enhancements to D2L Lumi

Among the new capabilities were several updates to D2L’s AI-native tool, D2L Lumi, designed to improve usability, transparency, and alignment across workflows, including:

D2L Lumi Ideas: Generates assignment and discussion ideas directly within Brightspace, making it easier to generate high quality content aligned to learning outcomes.D2L Lumi Insights: Gives educators access to learning intervention suggestions, designed to provide recommended next steps based on learner data.D2L Lumi Quiz: Helps educators generate questions from multiple course content topics and includes a more streamlined question-generation workflow.D2L Lumi Summary: Supports summarization from more content sources, including nested submodules, and can give educators the ability to preview and adjust source text before summarization.

Updates to Parent and Guardian Communications

D2L also introduced new parent and guardian communication enhancements to help K-12 educators strengthen engagement beyond the classroom. Teachers can now send bulk emails to all parents and guardians associated with students in their class. For individual student outreach, teachers can also email parents and guardians of a specific learner, making it easier to share timely updates on student progress and classroom activity.

Manage Distributed Administration at Scale

Distributed Administration gives organizations more flexibility to delegate administrative responsibilities across organization levels. With Distributed Administration, administrators can manage specific areas, enabling them to oversee courses while helping to reduce bottlenecks and free up time.

Learn more about the latest product releases showcased at D2L Launch Week.

About D2L
D2L is transforming the way the world learns, helping learners achieve more than they dreamed possible. Working closely with customers all over the world, D2L is on a mission to make learning more inspiring, engaging and human. Find out how D2L helps transform lives and delivers outstanding learning outcomes in K-12, higher education and businesses.

D2L Media Contact
PR@D2L.com
X: @D2L
© 2026 D2L Corporation.

The D2L family of companies includes D2L Inc., D2L Corporation, D2L Ltd, D2L Australia Pty Ltd, D2L Europe Ltd, D2L Asia Pte Ltd, D2L India Pvt Ltd, D2L Brasil Soluções de Tecnologia para Educação Ltda and D2L Sistemas de Aprendizaje Innovadores, S. D2 R.L de C.V., and H5P Group AS.

All D2L and H5P marks are owned by the D2L group of companies. Please visit D2L.com/trademarks for a list of D2L marks. All other trademarks are the property of their respective owners.

View original content to download multimedia:https://www.prnewswire.com/news-releases/d2l-launch-week-highlights-latest-product-releases-302763345.html

SOURCE D2L

Technology

Ultima Markets Celebrates 10th Anniversary

Published

46 minutes ago

May 5, 2026

10 Years of Trust. Focused on Tomorrow.

EBENE CYBERCITY, Mauritius, May 5, 2026 /PRNewswire/ — Ultima Markets Ltd (“UM”), authorised and regulated by the Financial Services Commission of Mauritius, marks its 10th anniversary under the theme, “10 Years of Trust. Focused on Tomorrow.” Since 2016, UM has transformed into a leading global brokerage.

Milestones

UM built a world-class trading space through ultra-fast tech and strict compliance, launching the UM Terminal, AI-driven MT5, and Mobile App. Key milestones include FSC Mauritius Authorisation (2023), a Willis Towers Watson partnership providing $1M fund protection, joining the UN Global Compact (2024), and securing 50+ awards by 2026.

Celebrating Lasting Partnerships

Exclusive initiatives include:

Ultimate Trader Cup: An epic trading competition to prove your edge.Ultima Loyalty Programme: A tiered system turning loyalty into long-term rewards.Ultima Partnership Programme: Leverage 10 years of market trust into lasting revenue.Inter Partnership Perks: VIP events and match access via its Inter partnership.

The Five ‘U’s

Core values guiding UM’s next decade:

User: Designing around trader needs and removing friction.United: Fostering community growth through learning.Upright: Acting transparently and ethically.Upward: Pursuing continuous product and performance growth.Upgrade: Elevating trader skills, tools, and outcomes.

Focused on Tomorrow

Guided by The Five ‘U’s, UM remains focused on tomorrow, investing in innovation, transparency, and global expansion. Building on recent advancements like Copy Trading Pro and UM Academy, its commitment is providing the ultimate trading edge and elite support worldwide.

About Ultima Markets

Ultima Markets Ltd is authorised and regulated by the Financial Services Commission of Mauritius, offering a secure, regulated CFD trading experience. As the Official Regional Partner of FC Internazionale Milano, UM unites football passion with trading knowledge. Serving 170+ countries with 1,000+ instruments, the broker is a 50+ award winner and proud UN Global Compact supporter, aligning with Sustainable Development Goals for responsible growth. The products, services and initiatives described in this press release are offered exclusively by Ultima Markets Ltd. This communication is not directed at, nor are the products and services described herein available to, residents of the United Kingdom.

Ultima Markets (UK) Limited (“UM UK”) is a distinct legal entity authorised and regulated by the Financial Conduct Authority (“FCA”) in the United Kingdom. UM UK secured its FCA authorisation in 2025. UM UK is not the subject of this press release.

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