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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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Desay SV Collaborates with Qualcomm to Deliver New Intelligent AI Cabin Platform Powered by Snapdragon Elite Automotive Platforms

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Highlights:

New Desay SV G10PH is designed to support superior computing, graphics, and advanced AI-enabled cabin products for automotive OEMs, ensuring cutting-edge performance and functionality.The G10PH is engineered for real-time decision-making, adaptive responses, and proactive assistance to create tailored and intuitive driving experiences.Collaboration is built on a strong and long-term working relationship, marked by the successful development of innovative cabin platforms for global automakers.

LAS VEGAS, Jan. 10, 2025 /PRNewswire/ — Desay SV and Qualcomm Technologies, Inc. held a joint signing ceremony at CES today to commemorate the companies’ co-innovation to deliver Desay SV’s next-generation intelligent cabin platform, the G10PH. Desay SV and Qualcomm Technologies have a strong long-term relationship focused on developing innovative cabin solutions, which are now integrated into millions of vehicles across the globe. Building on this, the companies will collaborate on the G10PH intelligent cabin platform powered by Qualcomm Technologies’ Snapdragon® Cockpit Elite platform. 

The G10PH harnesses the advanced artificial intelligence (AI) capabilities, superior computing and high-definition graphics of the Snapdragon Cockpit Elite platform to push the boundaries of automotive technology. With the Snapdragon Cockpit Elite’s state-of-the-art Qualcomm Oryon™ CPU, Qualcomm® Hexagon™ NPU for accelerated AI performance and improved Qualcomm® Adreno™ GPU, this cutting-edge system provides automakers with the tools to deliver a smart, intuitive, and personalized experience for drivers and passengers*. Additionally, the G10PH enables real-time decision-making, adaptive responses, and proactive assistance, creating an exclusive intelligent cabin assistant that is finely tuned to users’ habits. Every vehicle utilizing the G10PH will feature seamless user interface and support personalized features designed to enhance comfort and convenience befitting a premium user-centric driving experience. 

“At the new inflection point of ‘Software-Defined Vehicle’ and ‘AI-Defined Vehicle,’ Desay SV, together with Qualcomm Technologies, launched the premium AI intelligent cabin platform G10PH, which marks another technological revolution in the process of intelligent cabin and is an important example of Desay SV leading the development of cabin intelligence upgrade,” said Jian Xu, CEO of Desay SV. “We hope that this platform will give a strong impetus to the intelligent transformation of global automotive manufacturers, reshape the new ecosystem of future mobility, and accelerate the realization of the era of intelligent mobility.”

“The automotive industry is on the brink of a new era of intelligent transformation, driven by software and AI. Qualcomm Technologies and Desay SV have built a robust foundation of collaboration, and with our combined expertise in intelligent cockpits and we are excited about the new products featuring Snapdragon Cockpit Elite,” said Nakul Duggal, group general manager, automotive, industrial, and cloud, Qualcomm Technologies, Inc. “These innovations will enable automakers to deliver more advanced AI features and experiences to consumers, setting a new standard in the industry.”

Intelligent cockpit is the carrier of various sensing and interaction technologies, and it reflects the state of development in intelligent vehicle technology. According to KPMG’s analysis, China’s intelligent cabin market will reach RMB212.7 billion in 2026, with a compound annual growth rate of about 17% from 2022 to 2026, and the penetration rate is expected to increase from 59% to 82%. According to the “Smart Cockpit Assembly Data List for January-September 2024” by Gasgoo Automotive Research Institute, Desay SV holds the leading position in the market with an assembly volume of 630,492 units, accounting for 15.5% of the market share.

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About Desay SV

Desay SV (002920.SZ) is a leading mobility technology company with R&D and service branches in Germany, Japan, Singapore, Spain, USA, etc. The company focuses on efficiently integrating smart cabin, smart drive, and smart service. Relying on 39 years of accumulation, Desay SV has excelled in R&D, design, quality management, and intelligent manufacturing. Desay SV’s continuous innovation and comprehensive capabilities earn the long-term trust of global customers, including Chery, Geely, SAIC, Toyota, Volkswagen, Volvo, etc., and have helped it rank 74th in the Automotive News 2024 top 100 global auto parts suppliers. For more information, please visit Desay SV online at www.desaysv.com or follow us on: https://www.linkedin.com/company/13690363

About Qualcomm

Qualcomm relentlessly innovates to deliver intelligent computing everywhere, helping the world tackle some of its most important challenges. Our proven solutions drive transformation across major industries, and our Snapdragon® branded platforms power extraordinary consumer experiences. Building on our nearly 40-year leadership in setting industry standards and creating era-defining technology breakthroughs, we deliver leading edge AI, high-performance, low-power computing, and unrivaled connectivity. Together with our ecosystem collaborators, we enable next-generation digital transformation to enrich lives, improve businesses, and advance societies. At Qualcomm, we are engineering human progress. 

Qualcomm Incorporated includes our licensing business, QTL, and the vast majority of our patent portfolio. Qualcomm Technologies, Inc., a subsidiary of Qualcomm Incorporated, operates, along with its subsidiaries, substantially all of our engineering and research and development functions and substantially all of our products and services businesses, including our QCT semiconductor business. Snapdragon and Qualcomm branded products are products of Qualcomm Technologies, Inc. and/or its subsidiaries. Qualcomm patents are licensed by Qualcomm Incorporated.

Qualcomm, Snapdragon, Qualcomm Oryon, Hexagon and Adreno are trademarks or registered trademarks of Qualcomm Incorporated.

*All performance targets are compared to previous generation, based on preliminary internal testing, and subject to change upon final validation. 

View original content to download multimedia:https://www.prnewswire.com/news-releases/desay-sv-collaborates-with-qualcomm-to-deliver-new-intelligent-ai-cabin-platform-powered-by-snapdragon-elite-automotive-platforms-302347873.html

SOURCE Desay SV

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VerifiedX Releases VFX SwitchBlade Wallet Featuring First-Mover Bitcoin Utility at BitMart

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TORONTO, Jan. 10, 2025 /PRNewswire/ — The VerifiedX (VFX) Network, VerifiedX.io, has launched its mainnet non-custodial wallet VFX SwitchBlade, which enables full native Bitcoin functionality. The VFX SwitchBlade also supports a ‘first-mover’ fully decentralized and self custodial Bitcoin Tokenization (Verified Bitcoin) with on-chain native features, enabling real day-to-day utility, while solving current frictions for all Bitcoiners globally today. 

 

Verified Bitcoin (vBTC) enables anyone the ability to save, spend, withdraw, borrow, lend, mint & transfer media / documents, and vault actual Bitcoin with on-chain recovery features eliminating the need for third-parties or hardware wallets, through a feature rich simple text smart contract. This incredibly unique Bitcoin token provides for enhanced privacy with near-instant transaction finality, all with near-zero fees. Verified Bitcoin tokens are transferable in any denomination completely peer-to-peer, so long as they have a native Bitcoin balance and always maintain a fully decentralized and non-custodial evergreen 1:1 peg. This means that 1 vBTC will always equal 1 BTC and token owners may withdraw their underlying Bitcoin anytime with a ‘one-click’ multisig action or off-ramp the token itself, in whole or in part, at any participatory liquidity provider.

This empowering development will inevitably help provide congestion relief for the Bitcoin network, dramatically reduce Bitcoin holders cost of ownership and transfers, enable media embedding, and increase self-custodial security exponentially, adding immediate utility to holders of the largest digital asset class. It is anticipated that Verified Bitcoin may also help facilitate additional native scarcity with Total Value Vaulted (TVV) over time on VerifiedX Vaults.

VerifiedX – VFX (VerifiedX.IO) is the first open-source decentralized network that is both a universal layer 1 and a Bitcoin specific sidechain for the purpose of tokenized self-custody, on-chain storage, and peer-to-peer commerce of both digital & physical assets.

For Further Inquiries:
Website: https://verifiedx.io/
Discord: https://discord.gg/7cd5ebDQCj
Twitter (X)): https://twitter.com/vfxblockchain
Github: https://github.com/verifiedxblockchain

View original content to download multimedia:https://www.prnewswire.com/news-releases/verifiedx-releases-vfx-switchblade-wallet-featuring-first-mover-bitcoin-utility-at-bitmart-302348083.html

SOURCE VerifiedX.io

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Ratehub Inc. launches a new personal loans marketplace powered by its LoanFinder tool

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Canadian financial technology company launches a personal loans marketplace, simplifying borrowing for Canadians and helping members manage debt better

TORONTO, Jan. 10, 2025 /CNW/ – Ratehub Inc., a leading Canadian financial technology company, has launched a new personal loans marketplace as part of its mission to empower Canadians with the tools and resources to make confident financial decisions.

This launch brings Ratehub closer to its vision of becoming Canada’s go-to source and one-stop shop for all personal finance products. With LoanFinder, Ratehub’s custom-built tool, members can easily explore and compare a range of loan options tailored to their unique needs. Members can quickly secure pre-approval for the best rates, saving both time and money—all within one easy-to-use platform.

“Our launch into personal loans is an important milestone towards achieving our vision of being the one-stop shop for all consumers’ financial needs – spend, save, borrow, invest, and protect,” said Naga Parvatharajan, CEO of Ratehub Inc. “LoanFinder, is a game-changer for Ratehub members. It uses our own data and credit bureau information to pre-approve you for the best loan offers, all without impacting your credit score. We’re thrilled to be working with Fig Financial and Spring Financial as our first partners to bring Canadians simpler borrowing options and help them manage debt better.”

Ratehub members will benefit from:

Comprehensive loan marketplace: Best pre-approved offers through LoanFinder matched to the lender, maximizing members’ approval odds without impacting their credit scoresSeamless digital experience: A fast, fully digital loan application process from the convenience of members’ homesFinancial education: Access to expert articles and resources to guide members on what to look for when selecting loansTransparency: Clear and unbiased information to help members make informed decisionsValue: Save money by refinancing credit card debt, reducing monthly payments, funding home improvement projects, or other needs

“In today’s challenging financial environment, it’s more important than ever to provide the tools and resources that help Canadians make confident decisions,” said Natasha Macmillan, Director of Everyday Banking at Ratehub.ca. “Our goal is to support every Ratehub member based on their financial needs and journey. Our launch of personal loans will allow members to navigate these products and empower them to make well-informed decisions.”

Currently offering comparisons for personal loans, Ratehub’s ultimate goal is to provide a complete range of loan types, with personalized recommendations that help members find the perfect match for their eligibility and financial situation. Ratehub is committed to helping Canadians find their best borrowing option based on their unique financial needs, and ultimately empowering them to manage debt better and take control of their financial future.

About Ratehub Inc.
Ratehub Inc. is the one-stop shop for all consumer finance needs – Save, Spend, Borrow, Invest and Protect. We connect Canadians to the best financial tools, advice, and products on the market through our financial product comparison site and mortgage brokerage, Ratehub.ca, mortgage lender, CanWise, insurance brokerage, RH Insurance, and personal finance website, MoneySense. Millions of Canadians visit Ratehub.ca and MoneySense every year to get personalized recommendations on the best mortgage rates, credit cards, savings accounts, GICs, and insurance products. To learn more, visit www.ratehub.ca or www.canwise.com or www.rhinsurance.ca or www.moneysense.ca.

SOURCE Ratehub Inc.

SOURCE Ratehub Inc.

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