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Lindus Health Launches Bespoke “All-in-One Medical Device CRO” Offering for Medical Device Clinical Trials

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NEW YORK, June 27, 2024 /PRNewswire/ — Lindus Health, the “anti-CRO” running radically faster, more reliable clinical trials for life science pioneers, has unveiled their all-encompassing contract research organization (CRO) and technology solution customized for the execution of medical device clinical trials.

Lindus Health has enrolled over 11,000 medical device trial participants to date in the US, UK, and Europe, and has demonstrated consistent success in executing device studies across virtually all therapeutic areas, including neurology, ophthalmology, cardiovascular, respiratory, and more. This covers many device types including Class I (low-risk) and Class II (moderate-risk) devices, diagnostics and others, as well as regulatory pathways such as premarket approval (PMA) and Conformité Européenne (CE) marking. With the introduction of their “All-in-One Medical Device CRO,” Lindus will accelerate and enhance clinical trials for medical devices, pulling from their robust resume in device development.

Lindus Health’s new offering integrates traditional CRO services and comprehensive experience in medical device clinical trials. Additionally, they have unique recruitment capabilities by utilizing their database of over 30 million electronic health records (EHRs) and or in-house digital marketing. This offering also includes their home-grown eClinical technology, Citrus™. Lindus offers extensive in-house site capabilities including their own virtual/hybrid site and physical community site networks. This all-inclusive package equips medical device sponsors with all the necessary tools to run their studies under one roof.

Medical device clinical trials follow distinct regulatory pathways and often require extensive post-market surveillance and reporting. Lindus Health’s offering leverages their expertise in FDA 510(k) and De Novo submissions and participant monitoring in device trials alongside their virtual and traditional site capabilities, multi-channel recruitment approaches, and more. Their tech-driven approaches to nearly all facets of medical device trial execution enable them to achieve study milestones quicker and enroll participants twice as fast as traditional CROs.

“Device trials are highly unique in the endpoints they measure, the level of support that may be needed to educate participants on the investigational device, shipping and storage considerations, and much more,” said Anthony Brogno, Director of Clinical Operations at Lindus Health. “Whether it’s a decentralized or site-based study, our ‘All-in-One Medical Device CRO’ allows us to help sponsors navigate the specialized demands of these trials at every stage while prioritizing patient experience.”

The “All-in-One Medical Device CRO” offering provides medical device companies with an exhaustive suite of features:

End-to-end CRO and study management: From startup through close-out, Lindus Health’s clinical operations team handles all project-related and administrative medical device study activities.Innovative recruitment tactics: Lindus’ multifaceted approach to recruitment involving primary care collaboration, screening from a network of over 30 million EHRs, digital marketing capabilities and more help medical device sponsors quickly meet enrollment timelines.Study-specific eClinical software: Citrus™, Lindus Health’s proprietary trial execution technology, houses all the necessary tools needed to run medical device research in one place, including the Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), patient scheduling, eConsent, IRT/randomization, and more, tailored to each individual study.Medical device and regulatory expertise: The Lindus Health team, including its advisors, offer expert insights in medical device trial operations including deep knowledge of regulatory frameworks and staying current with industry trends.Dedicated site services: Lindus’ site operations team maintains strong rapport with principal investigators (PIs) and research staff to effectively manage clinical trials of various models, including single-site or multi-site and virtual/hybrid or traditional.

“Working with the Lindus Health team has been a game changer,” said Akash Bijalani, Director of Global Market Access at Aptar, a global leader in medical technologies. “They have a can-do attitude and make things happen, going above and beyond the call of duty.”

Lindus Health’s “All-in-One Medical Device CRO” is bolstered by the support of their advisory board, including Robert Langer, co-founder of Moderna, and other medical device industry experts such as Acacia Parks, Chris Butler, Peter Polos, Jason Bain, and David Stempel.

Lindus Health is passionate about helping sponsors bring innovative medical devices to market by streamlining all variables of the clinical research process while ensuring stellar trial experiences for both sponsors and participants.

To learn more about Lindus Health’s “All-in-One Medical Device CRO,” click here.

About Lindus Health
Lindus Health is an anti-CRO running radically faster and more reliable trials for life science pioneers – bringing ground-breaking treatments to patients more quickly. This is achieved through a commercial model that aligns incentives (fixed-priced quotes per study, with milestone-based payments), a world-class clinical operations team with its unique software platform, and access to over 30 million Electronic Health Records.

Clinical trials are the biggest bottleneck to advances in healthcare. Lindus Health removes this constraint by handling the end-to-end execution of clinical studies, including design, patient recruitment, clinical data capture, monitoring and project management.

To date, Lindus Health has delivered more than 90 trials across the US, UK, and Europe to tackle a range of conditions, including diabetes, asthma, acne, social anxiety, major depressive disorder, hypertension, chronic fatigue syndrome and insomnia. The company has raised over $24M from investors including Peter Thiel, CREANDUM, Firstminute Capital, Presight Capital, Seedcamp, Hambro Perks, Amino Collective and Calm/Storm.

Lindus Health Media Contact:
Jodi Perkins
Amendola for Lindus Health
jperkins@acmarketingpr.com 

 

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SOURCE Lindus Health

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HKBN Signs HK$5.25bn Sustainability-Linked Loan

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HONG KONG, Dec. 24, 2024 /PRNewswire/ — HKBN Ltd. (“HKBN” or the “Company”; SEHK stock code: 1310) is delighted to announce the signing of its inaugural HK$5.25 billion syndicated Sustainability-Linked Loan (the “SLL Facility”) under the HKBN Ltd. Sustainability-Linked Financing Framework (“Framework”), with 11 leading international, regional and local banks. The facility includes enhanced terms and a greenshoe mechanism that allows HKBN to upsize the loan in the future. Proceeds from the SLL Facility will be used to refinance the Company’s outstanding loans.

The overwhelming response from the market is a vote of confidence in HKBN’s business plan. This landmark SLL Facility reaffirms HKBN’s long-term commitment to sustainability and responsible business practices while driving business growth. It also includes an interest rate adjustment mechanism that is linked to predetermined sustainability performance targets (SPTs). This will allow HKBN to benefit from savings in borrowing costs upon the successful attainment of the specified key performance indicators (KPIs).

The specified KPIs and SPTs are tailored to address climate change mitigation and cybersecurity within HKBN. The first KPI focuses on Scopes 1 and 2 emissions. The second KPI involves the average failure rate of phishing assessments for HKBN’s Talents. The third and final KPI comprises Scope 3 emissions. Emissions reduction targets were set in line with HKBN’s near-term GHG emissions reduction targets recently validated by the Science-Based Targets initiative (“SBTi”); while those for KPI 2 were set based on the performance results from impromptu simulated email assessments, which the company will conduct to evaluate its Talents’ susceptibility to phishing attacks – a vital and necessary exercise for measuring cybersecurity risk.

HKBN has appointed Sustainable Fitch to provide a Second Party Opinion (“SPO”) on the Framework with an overall rating of “Good”. The SPO affirms that the Framework aligns with the Sustainability-Linked Loan Principles set forth by the Loan Market Association, the Loan Syndications and Trading Association, and the Asia Pacific Loan Market Association.

The SLL Facility is led by Bank of China (Hong Kong) Limited, BNP Paribas, Cathay United Bank Company, Limited, Hong Kong Branch, Crédit Agricole Corporate and Investment Bank, Hong Kong Branch, DBS Bank Ltd., ING Bank N.V., Hong Kong Branch and The Bank of East Asia, Limited as the Mandated Lead Arrangers, Bookrunners and Underwriters and participated by Fubon Bank (Hong Kong) Limited, Natixis, Hong Kong Branch, Shanghai Pudong Development Bank Co., Ltd., Hong Kong Branch and Taipei Fubon Commercial Bank Co., Ltd. as the Mandated Lead Arrangers and Bookrunners. Crédit Agricole Corporate and Investment Bank, Hong Kong Branch and ING Bank N.V., Hong Kong Branch are the Joint Sustainability Coordinators. Rothschild & Co is the financial adviser for HKBN.

Derek Yue, HKBN Co-Owner & Chief Financial Officer said, “Through this refinancing deal, HKBN is not just reshaping our financial well-being with better loan terms, but setting a new standard for corporate accountability and sustainability. Our focus on achieving key performance indicators in climate change mitigation and cybersecurity reflects our dedication to a more sustainable future and a secure digital environment. We believe that by aligning our financing initiatives with these crucial objectives, we are not only strengthening our business but also contributing to a better world for all.”

Nancy Cheng, Managing Director, Head of Tech Coverage APAC, at Crédit Agricole Corporate and Investment Bank, commented, “Being a long-standing banking partner of HKBN, we are delighted to play a key part in HKBN’s inaugural SLL transaction, which is the very first in Hong Kong for the telecommunications market. It establishes a new benchmark for the sector, akin to how HKBN has continually set and raised the bar for broadband speeds in Hong Kong. We are dedicated to continuing our role in supporting HKBN’s financing and sustainability journey in the future.”

Shalini Sujanani, Managing Director, TMT & Healthcare for ING in Asia Pacific, commented, “We are pleased to support HKBN’s sustainability journey as Joint Sustainability Coordinator for this landmark facility. By embedding ambitious KPIs into their financing, HKBN demonstrates that sustainability and business performance can go hand in hand. This SLL Facility reflects the growing importance of aligning financial strategies with environmental and social objectives, and we are excited to help HKBN drive meaningful impact through this partnership.”

About HKBN Ltd.

HKBN Ltd. (SEHK Stock Code: 1310, together with its subsidiaries, “HKBN” or the “Group”) is an investment holding company.  Headquartered in Hong Kong with operations spanning across Hong Kong, Macau and mainland China, the Group is a leading integrated telecommunications and technology services provider. The Group provides a full range of one-stop, high-quality information and communication technology (ICT) solutions and an unlimited services portfolio. HKBN’s extensive tri-carrier fibre infrastructure covers around 2.6 million residential homes and 8,200 commercial buildings and facilities across Hong Kong. Committed to creating a lasting positive impact to wherever it operates, HKBN embraces a core purpose to “Make our Home a Better Place to Live” and has received a highest possible rating of AAA in MSCI’s 2024 ESG Ratings assessment in environment, society and governance. The Group is managed by hundreds of Co-Owners (supervisory and management level Talents in the Group) who invested their savings to buy shares of HKBN Ltd.. For more information about HKBN, please visit https://www.hkbn.net/group/en.

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SOURCE HKBN Ltd.

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Genifi Announces Transfer of Customer Contracts for tunl.chat Business

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TORONTO, Dec. 23, 2024 /CNW/ – Genifi inc. (TSXV: GNFI) (“genifi” or the “Company”) announced today that it has reached an agreement with Ada Support Inc. (“Ada”) to transfer the Company’s tunl.chat customers to Ada. tunl.chat has been a white label of Ada’s platform offered by the Company and given that the Company has now reduced its employee headcount and services business significantly it no longer made commercial sense to continue to offer this product.  Ada has agreed to pay $20,000 to the Company in connection with the transfer of the customers.  Completion of the transfer remains subject to the satisfaction of certain conditions. The transfer of customers is expected to be made effective in early January 2025. 

The Company also announced today that it has terminated the employment agreements with Tom Beckerman (CEO) and Andrew Hilton (CFO). Both Mr. Beckerman and Mr. Hilton will be retained as contractors to serve in the roles of CEO and CFO, respectively. Mr. Beckerman’s compensation will be reduced by 50% as part of this change and Mr. Hilton’s compensation will remain unchanged. The change in the nature of the retention of Mr. Beckerman and Mr. Hilton was made as a result of the fact that the Company has largely ceased active operations. The terminations also stop the accrual of potential future severance owing to Mr. Beckerman and Mr. Hilton. The Company’s independent directors have approved a severance payment to Mr. Beckerman equal to two years of salary and a severance payment to Mr. Hilton equal to six months of salary.

The Company will continue to review strategic alternatives and will provide updates in future press releases.

About genifi inc.:

Further information on the Company can be found at www.genifi.com.

Forward-Looking and Cautionary Statements

Certain information set out in this news release constitutes forward-looking information. Forward looking statements are often, but not always, identified by the use of words such as “seek”, “anticipate”, “plan”, “continue”, “estimate”, “expect”, “may”, “will”, “intend”, “could”, “might”, “should”, “believe” and similar expressions. Specifically, and without limitation, this press release contains forward-looking statements and information relating to the closing of the transaction with Ada and the timing thereof. Although genifi believes that the expectations reflected in such forward-looking statements are based upon reasonable assumptions, and that information obtained from third party sources is reliable, they can give no assurance that those expectations will prove to have been correct.

Readers are cautioned not to place undue reliance on forward-looking statements included in this document, as there can be no assurance that the plans, intentions or expectations upon which the forward-looking statements are based will occur. By their nature, forward-looking statements involve numerous assumptions, known and unknown risks and uncertainties that contribute to the possibility that the predictions, forecasts, projections and other forward-looking statements will not occur, which may cause actual results in future periods to differ materially from any estimates or projections of future performance or results expressed or implied by such forward-looking statements. These risks and uncertainties include, among other things, the ability to satisfy the conditions to the completion of the transaction with Ada, risk factors set forth in genifi’s Management’s Discussion and Analysis for the period ended September 30, 2024, a copy of which is filed on SEDAR+ at www.sedarplus.ca. Readers are cautioned that this list of risk factors should not be construed as exhaustive. These statements are made as at the date hereof and unless otherwise required by law, genifi does not intend, or assume any obligation, to update these forward-looking statements.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

SOURCE genifi inc.

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TPIsoftware Partners with Vietnam’s Key Leaders to Realize ESG Strategies Through MOU Signing and Cross-National Collaboration

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TAIPEI, Dec. 24, 2024 /PRNewswire/ — Taiwan’s software company TPIsoftware (TWSE: 7781) and its partners are to sign a multilateral Memorandum of Understanding (MOU) to formalize the cross-border collaboration on facilitating greenhouse gases (GHGs) inventory with tech-driven solutions. The MOU signing will take place on December 26 in Hanoi, Vietnam, along with the product launch of GreenSwift—an AI-driven carbon management platform by TPIsoftware.

Earlier, TPIsoftware and Nam Cau Kien Eco-Industrial Park in Vietnam announced a pilot project to implement GreenSwift in the park. The project aims to strengthen the ESG initiative across the area by optimizing the efficiency of carbon management. Details of the project will be unveiled during the GreenSwift launch event.

The MOU sets forth a framework to strengthen the parties’ Environmental, Social and Governance (ESG) commitment with enhanced regulatory compliance and transparency, enabling enterprise carbon disclosure for a decarbonized, sustainable future. Led by TPIsoftware and Global Green Innovation Technology (GGI., Technology), the MOU signing brings together government officials, the private sector and ESG experts in Vietnam and will be witnessed by Dr. Nguyen Kim Anh, ESG Advisory Expert and Senior Scientist at Institute of Geography, Vietnam Academy of Science and Technology, Tony Kuo, Founder and CEO of Katina Capital Partners, Mai Hoai An, Chairman of ITD Group, Phan Quoc Dzung, Vice Chairman cum General Director of Bao Long Insurance, and Thomas Cheng, General Manager of ThinkTron Ltd.

Following the MOU signing, the GreenSwift product launch focuses on a comprehensive, practical approach to achieving net zero through carbon management and inventory enabled by advanced AI technology. Keynote speakers feature representatives from Vietnam’s Ministry of Transportation and Ministry of Science and Technology, who will delve into the opportunities and ongoing challenges of climate action and environmental sustainability in the country. Additionally, Dr. Nguyen Kim Anh will share an in-depth analysis of how ESG standards can be effectively implemented across industries in Vietnam. The event will be followed by a product demonstration presented by Do Vuong Phong, General Manager of TPIsoftware Vietnam, to showcase GreenSwift’s key features. The carbon management platform adopts Generative AI to enable efficient GHG inventory, streamline reporting and ensure compliance with international standards.

Yilan Yeh, General Manager of TPIsoftware, said, “GreenSwift is a SaaS-based carbon management platform designed to measure carbon reduction and maximize ESG efforts for enterprises. Together with ElectriSwift, TPIsoftware’s AI Building Energy Conservation System, enterprises are able to reinforce their ESG strategies through streamlining GHG accounting and energy saving, making their sustainability initiatives visible and impactful. We look to build a long-lasting cooperation with the local government, private sector and residents to realize their commitment to ESG goals.”

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SOURCE TPIsoftware

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