Month: December 2021

December 22, 2021

• Philips IVC Filter Removal Laser Sheath – CavaClear – is intended to safely ablate tissue to remove embedded IVC filters
• CavaClear is a first-in-class FDA-cleared solution for advanced IVC filter removal
• It is estimated that in the United States more than one million patients with IVC filters would benefit from filter removal to reduce the risk of long-term complications [1,2]
• Two independent and prospective clinical studies demonstrated that laser-assisted retrieval was 96-99.4% effective with a major adverse event rate of 0.7-2% [3,4]

Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology today announced the FDA has granted De Novo Clearance for Philips IVC Filter Removal Laser Sheath – CavaClear – to remove an IVC filter when previous methods of removal have failed. CavaClear is the first and only FDA-cleared solution for advanced IVC filter removal. Earlier in 2021, the FDA granted the device Breakthrough Device Designation. Laser has been clinically proven to provide a success rate over 99%, with low complication rates [3].

IVC filters are used to treat patients with venous thromboembolism, in which blood clots form in the deep veins of the leg and groin, and can travel through the circulatory system. They are placed in the inferior vena cava to capture blood clots from moving to the lungs. However, research has shown that IVC filters may have long-term complications [5]. The filters can fracture and travel through the bloodstream to other parts of the body. Other identified long-term risks associated with IVC filters include lower limb deep vein thrombosis and IVC occlusion. The FDA recommends that implanting physicians consider removing retrievable IVC filters as soon as they are no longer indicated [2].

Failure rates for IVC filter removal can be high and prior to CavaClear, limited options for removal existed if the filter became difficult to remove. Advanced retrieval tools and techniques are required if the IVC filter becomes embedded in the vasculature. Physicians previously had very few tools to remove the filter when complications occurred and until now there were no FDA-approved devices for this type of advanced removal.

“Today is a historic day. With the approval of CavaClear, physicians now have a device specifically geared remove chronically embedded IVC filters,” said Kush R. Desai MD, FSIR, Associate Professor of Radiology, Surgery, and Medicine, and Director of Deep Venous Interventions at Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA. “Backed by evidence, this technology can be applied to retrieve IVC filters that are no longer indicated, reducing potential clinical risk for patients and satisfying the FDA’s guidance to retrieve filters when they are no longer indicated.”

Clinical research supports laser-assisted removal
Two independent and prospective clinical studies demonstrated that laser-assisted retrieval was 96-99.4% effective with a major adverse event rate of 0.7-2% [3,4]. Philips CavaClear uses circumferential tissue ablation that can aid in capturing the filter within seconds of laser activation, which can help increase physician efficiency during removal, and may help lower costs by reducing the number of retrieval attempts needed to remove an embedded filter. In addition, the simple and safe design is easy for physicians to integrate into their workflow.

“With the FDA’s clearance of our IVC Filter Removal Laser Sheath – CavaClear – more than one million patients and their physicians now have access to a safe, effective and efficient option for advanced IVC filter removal,” said Chris Landon, Senior Vice President and General Manager Image Guided Therapy Devices at Philips. “This clearance demonstrates the commitment of Philips to innovating procedures with physician collaboration to meet unmet needs that can have a critical impact on the lives of patients and their families.”

[1] Philips internal market research data calculation.
[2] Health, C. for D. and R. Safety Communications – Removing Retrievable Inferior Vena Cava Filters: FDA Safety Communication. (2014).
[3] Kuo, W. et al. Laser‐Assisted Removal of Embedded Vena Cava Filters: A First‐In‐Human Escalation Trial in 500 Patients Refractory to High‐Force Retrieval. Journal of the American Heart Association 9:24, 1-9 (2020).
[4] Desai, K. et al. Excimer Laser Sheath-Assisted Retrieval of “Closed-Cell” Design Inferior Vena Cava Filters. J Am Heart Assoc; 9: e017240 (2020).
[5] Van Ha, T. G. Complications of inferior vena caval filters. Semin. Interv. Radiol. 23, 150–155 (2006).

For further information, please contact:

Joost Maltha
Philips Global Press Office
Tel: +31 6 10 55 8116
Email: joost.maltha@philips.com

Fabienne van der Feer
Philips Image Guided Therapy
Tel: + 31 622 698 001
E-mail: fabienne.van.der.feer@philips.com

About Royal Philips
Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people’s health and well-being, and enabling better outcomes across the health continuum – from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips generated 2020 sales of EUR 17.3 billion and employs approximately 78,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.

Attachments

• Philips IVC Filter Removal Laser Sheath – CavaClear 1
• Philips IVC Filter Removal Laser Sheath – CavaClear 2
• Philips IVC Filter Removal Laser Sheath – CavaClear 3

Corporate Communications

ADVERTISEMENT. This announcement is an advertisement for the purposes of Regulation (EU) 2017/1129, as amended (the “Prospectus Regulation”) relating to the intention of Iveco Group N.V. (the “Company”) to proceed with the proposed first admission to listing and trading of all of the common shares of the Company on the regulated market of Euronext Milan (the “Admission”). This announcement does not constitute or form part of a prospectus within the meaning of the Prospectus Regulation and has not been reviewed nor approved by any regulatory or supervisory authority in any jurisdiction, including any member state of the European Economic Area (each, an “EEA Member”), the United Kingdom and the United States. This announcement is for information purposes only and is not intended to constitute, and should not be construed as, an offer by or invitation by or on behalf of, the Company, CNH Industrial N.V (“CNH Industrial”), any of their advisors or any representative of the Company or CNH Industrial or any of their advisors, to purchase any securities or an offer to sell or issue, or the solicitation to buy securities by any person in any jurisdiction, including any EEA Member, the United Kingdom or the United States. The approval of the Prospectus (as defined below) by the Netherlands Authority for the Financial Markets (Autoriteit Financiële Markten, the “AFM”) should not be understood as an endorsement of the quality of the Shares (as defined below) and the Company. Potential investors should read the Prospectus before making an investment decision in order to fully understand the potential risks and rewards associated with the decision to invest in the Shares.

London, December 22, 2021

Iveco Group N.V. (the “Company”) today announces the publication of the supplement to the prospectus dated November 11, 2021 (the “Prospectus”) in connection with the intended admission to trading and listing of its common shares (“Common Shares”) on the regulated market of Euronext Milan (“Admission”) in the context of the intended separation of the relevant business segments from CNH Industrial N.V. (“CNH Industrial”) to the Company by way of a Dutch law statutory demerger (afsplitsing) (the “Demerger”). The supplement to the prospectus is dated December 22, 2021 (“Supplement“) and made available, inter alia, in connection with the publication of the Company’s 2021 interim condensed combined financial statements for the nine months ended September 30, 2021, as derived from the combined consolidated financial statements of CNH Industrial for the same period as published by CNH Industrial on November 4, 2021, and forward-looking statements and profit forecasts as presented at the Iveco Group Investor Day held on November 18, 2021.

Listing of and first trading on an ‘as-if-and-when-delivered’ basis in the Common Shares on Euronext Milan under symbol IVG is expected to commence on January 3, 2022 (the “First Trading Date”).

The Netherlands Authority for the Financial Markets (Stichting Autoriteit Financiële Markten, the “AFM”) has approved the Supplement. The Prospectus and the Supplement are available on the website of the Company (www.ivecogroup.com/investor_relations).

Risk Factors
Investing in the Company involves certain risks. A description of these risks, which include risks relating to the Company as well as risks relating to the Demerger and the Common Shares and special voting shares in the share capital of the Company (the “Special Voting Shares” and together with the Common Shares, the “Shares”) is included in the Prospectus and in the Supplement. Potential investors should read the Prospectus and the Supplement before making an investment decision in order to fully understand the potential risks and rewards associated with the decision to invest in the Shares.

Earlier announcements related to the Demerger and Admission
On December 17, 2021, CNH Industrial announced the publication of combined financial figures for both its ‘Off-Highway’ and ‘On-Highway’ businesses. On December 9, 2021, CNH Industrial and the Company announced the rating assigned to the Company by Fitch Ratings. On November 18, 2021, CNH Industrial and the Company presented the Company’s business, strategy and 2026 financial ambitions. On November 11, 2021, CNH Industrial and the Company announced the approval and publication of the Prospectus. On September 3, 2019, CNH Industrial announced the intention to separate the relevant business segments of the Company’s from CNH Industrial and to admit the Company’s shares to listing and trading on a regulated market. On June 11, 2021 and on July 5, 2021, CNH Industrial announced management changes for the Company in view of the Demerger and Admission. On October 18, 2021, CNH Industrial further announced that an Investor Day in respect of the Company, ahead of the Demerger and Admission, was to be held on November 18, 2021. These press releases are available on the corporate website of CNH Industrial (www.cnhindustrial.com/en-us/investor_relations) and/or on the corporate website of the Company (www.ivecogroup.com/investor_relations).

CNH Industrial N.V. (NYSE: CNHI / MI: CNHI) is a global leader in the capital goods sector with established industrial experience, a wide range of products and a worldwide presence. Each of the individual brands belonging to the Company is a major international force in its specific industrial sector: Case IH, New Holland Agriculture and Steyr for tractors and agricultural machinery; Case and New Holland Construction for earth moving equipment; Iveco for commercial vehicles; Iveco Bus and Heuliez Bus for buses and coaches; Iveco Astra for quarry and construction vehicles; Magirus for firefighting vehicles; Iveco Defence Vehicles for defence and civil protection; and FPT Industrial for engines and transmissions. More information can be found on the corporate website: www.cnhindustrial.com

Iveco Group N.V., after the completion of the Demerger as announced on November 11, 2021 (and expected to be effective on January 1, 2022), will be the parent company of the trucks and specialty vehicles, powertrain and related financial services businesses currently held by CNH Industrial. Iveco Group will therefore own and operate eight unique, yet unified commercial brands: IVECO, a pioneering champion that designs, manufactures and commercializes heavy, medium and light duty commercial vehicles; FPT Industrial, a global leader in providing its vast array of advanced powertrain technologies to customers in agriculture, construction, marine, power generation, and commercial vehicles alike; IVECO BUS and HEULIEZ, premium and mass-transit bus and coach brands; Iveco Defence Vehicles, for highly-specialized defence and civil protection equipment; ASTRA, a global expert in large scale heavy duty quarry and construction vehicles; Magirus, the industry-reputed firefighting vehicle and equipment manufacturer; and IVECO CAPITAL, the financing arm which supports them all, serving as the cornerstone of Iveco Group’s new business models. Further information about Iveco Group is available on the company’s website www.ivecogroup.com

Media contacts:
E-mail: mediarelations@cnhind.com
Francesco Polsinelli, Tel: +39 335 1776091
Laura Overall, Tel: +44 207 7660 386

Investor contacts
E-mail: investor.relations@cnhind.com
Federico Donati, Tel: +44 207 7660 386
Noah Weiss, Tel: +1 630 887 3745

www.cnhindustrial.com

DISCLAIMER
This announcement does not constitute a prospectus within the meaning of Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017 on the prospectus to be published when securities are offered to the public or admitted to trading on a regulated market, as amended (the “Prospectus Regulation”), and shares in Iveco Group N.V. will be allotted in circumstances that do not constitute “an offer to the public” within the meaning of the Prospectus Regulation. This announcement is not intended for distribution in jurisdictions that require prior regulatory review and authorization to distribute an announcement of this nature.

The release, publication or distribution of this announcement in certain jurisdictions may be restricted by law and therefore persons in such jurisdictions into which they are released, published or distributed, should inform themselves about, and observe, such restrictions.

This announcement is an advertisement and not a prospectus within the meaning of Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017 on the prospectus to be published when securities are offered to the public or admitted to trading on a regulated market, as amended (the “Prospectus Regulation”). With respect to the member States of the European Economic Area, no action has been undertaken or will be undertaken to make an offer to the public of the securities referred to herein requiring a publication of a prospectus in any relevant member State. As a result, the securities may not and will not be offered in any relevant member State except pursuant to a prospectus approved by the relevant market authorities in that member State or in accordance with the exemptions set forth in Article 3(2) of the Prospectus Regulation, if they have been implemented in that relevant member State, or under any other circumstances which do not require the publication of a prospectus pursuant to Article 3 of the Prospectus Regulation and/or to applicable regulations of that relevant member State. This announcement is not intended to constitute, and should not be construed as, an offer by or invitation by or on behalf of, the Company, CNH Industrial, any of its advisors or any representative of the Company or CNH Industrial or any of their advisors, to purchase any securities or an offer to sell or issue, or the solicitation to buy securities by any person in any jurisdiction, including any EEA Member, the United Kingdom or the United States.

The securities referred to herein may not be offered or sold in the United States of America absent registration or an applicable exemption from registration under the U.S. Securities Act of 1933, as amended. The Company and CNH Industrial do not intend to register all or any portion of the offering of the securities in the United States of America or to conduct a public offering of the securities in the United States of America.
This announcement does not constitute an offer of securities to the public in the United Kingdom. This announcement is being distributed to and is directed only at (i) persons who are outside the United Kingdom or (ii) persons who are investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”) and (iii) high net worth entities, and other persons to whom it may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as “Relevant Persons”). Any investment activity to which this announcement relates will only be available to and will only be engaged with, Relevant Persons. Any person who is not a Relevant Person should not act or rely on this document or any of its contents.

This announcement may include statements, including with respect to CNH Industrial’s and the Company’s financial condition, results of operations, business, strategy, plans and outlook, including the impact of certain transactions Not for release, publication or distribution in whole or in part, directly or indirectly, in or into any jurisdiction in violation of the relevant laws of such jurisdiction, and the payment of dividends and distributions, as well as share repurchases. These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “believes”, “estimates”, “anticipates”, “expects”, “intends”, “plans”, “targets”, “may”, “will” or “should” or, in each case, their negative or other variations or comparable terminology. These forward-looking statements are made as of the date of this announcement. Although CNH Industrial and the Company believe that such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance. By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. Such forward-looking statements are included for illustrative purposes only. Actual results may differ materially from the forward-looking statements as a result of a number of risks and uncertainties, many of which are outside CNH Industrial and the Company’s control. CNH Industrial and the Company expressly disclaim any intention or obligation to provide, update or revise any forward-looking statements in this announcement to reflect any change in expectations or any change in events, conditions or circumstances on which these forward-looking statements are based.

The price and value of securities may go up as well as down. Persons needing advice should contact a professional adviser. Information in this announcement or any of the documents relating to the Admission and the Demerger cannot be relied upon as a guide to future performance.
The Company may decide not to go ahead with the Admission and CNH Industrial may decide not to go ahead with the Demerger and there is therefore no guarantee that the Admission and the Demerger will occur. You should not base your financial decision on this announcement. Acquiring investments to which this announcement relates may expose an investor to a significant risk of losing all of the amount invested.

Attachment

• 20211222_PR_CNH_Industrial_Iveco_Group_supplement_prospectus

GiftChill adoption of Crypocurrency is increasing. There are many digital currencies that can be used to purchase popular brands of E-Gift Cards like Steam, iTunes, Amazon and many other through GiftChill platform.

TOKYO, Dec. 21, 2021 (GLOBE NEWSWIRE) — In November 2021, e-gift card leading platform, GiftChill, announced that it would add Shiba Inu as a payment method. Shiba Inu is a cryptocurrency that gives investors more cryptocurrency buying power. The announcement came in the wake of a similar action by Dogecoin, Shiba Inu’s rival. The token is compatible with Ethereum and has gained popularity this year after rising by about 777% within 30 days.

Why the Increase in Revenue After Adding Shiba Inu?

Shiba Inu is one of the tokens with a specific utility on the Ethereum blockchain. It’s also one of the notable currencies in the network built on the firm foundation of coveted assets built on canine-inspired meme coins. Since introducing the token, GiftChill has noted a significant rise in sales because of the flexibility the token provides. Its compatibility with Ethereum allows customers to use ShibaSwap, an app where they can trade tokens without an intermediary.

Other reasons for the increase in sales include:

•    Lower transaction costs: Shiba Inu attracts lower transaction costs because the payments happen on Ethereum. As the world anticipates a shift to Ethereum 2.0 soon, the costs will reduce further. It will motivate more shoppers to use Shiba Inu as payment for e-gift cards.
•    Borderless transactions: The integration of the token will enable international transfers. Most companies currently rely on bank transactions to do business, but this is time-consuming and involves paperwork. With Shiba Inu, shoppers can complete payments within minutes from any part of the world where the internet is available.

For GiftChill, Shiba Inu is the golden opportunity to ensure investors and holders continue to get discounted gifts from the platform. You can learn more about this at the retailer’s website www.giftchill.co.uk or contact them at Support@giftchill.co.uk

Related Images

Image 1: shiba army

shiba inu token are being used to buy gift cards

This content was issued through the press release distribution service at Newswire.com.

Attachment

• shiba army

DURHAM, N.C., Dec. 21, 2021 (GLOBE NEWSWIRE) — Data from the HIV Prevention Trials Network (HPTN) studies HPTN 083 and HPTN 084 helped provide important information for yesterday’s decision by the U.S. Food and Drug Administration (FDA) to approve ViiV Healthcare’s long-acting cabotegravir (CAB-LA) injections for the prevention of HIV. Sponsored and co-funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), these studies showed that CAB-LA injected once every eight weeks was superior to daily oral tenofovir/emtricitabine (TDF/FTC) for HIV prevention among cisgender men and transgender women who have sex with men (HPTN 083) and cisgender women (HPTN 084). Both studies also demonstrated that CAB-LA was well-tolerated, offering a new and important pre-exposure prophylaxis (PrEP) option for individuals at risk for HIV infection. ViiV Healthcare will market CAB-LA for PrEP under the brand name Apretude.

“This is a truly critical milestone for HIV pre-exposure prophylaxis providing a safe and effective alternative to daily pills,” said Dr. Myron Cohen, HPTN co-principal investigator, and director of the Institute for Global Health at the University of North Carolina in Chapel Hill. “Until we have a cure or vaccine, more prevention options that meet the needs of individuals at risk for HIV around the world are essential.”

HPTN 083 was co-funded by NIAID and ViiV Healthcare. HPTN 084 was co-funded by NIAID, the Bill & Melinda Gates Foundation, and ViiV Healthcare. Study product was provided by ViiV Healthcare and Gilead Sciences, Inc. Three other NIH institutes also collaborated on HPTN 083 and HPTN 084: the National Institute of Mental Health, the National Institute on Drug Abuse, and the Eunice Kennedy Shriver National Institute of Child Health and Human Development.

HPTN 083 enrolled 4,570 cisgender men and transgender women who have sex with men at research sites in Argentina, Brazil, Peru, South Africa, Thailand, the U.S., and Vietnam. In the study, 52 HIV infections occurred, with 12 new infections in the CAB arm and 39 new infections in the TDF/FTC arm. These findings translate to a 69 percent reduction in incident HIV infections in study participants given CAB-LA compared to TDF/FTC.

HPTN 084 enrolled 3,223 cisgender women at research sites in Botswana, Eswatini, Kenya, Malawi, South Africa, Uganda, and Zimbabwe. There were three new infections in the CAB arm and 36 new infections in the TDF/FTC arm, a 92 percent reduction in incident HIV infections in study participants given CAB-LA compared to TDF/FTC.

“HIV continues to disproportionately impact specific populations who need new HIV prevention options that are not only convenient but also highly effective,” said Dr. Wafaa El-Sadr, HPTN co-principal investigator, director of ICAP, and professor of epidemiology and medicine at Columbia University in New York. “CAB-LA is a long-awaited and welcomed addition to the HIV prevention toolkit, offering a potentially convenient option for so many around the world.”

About the HPTN

The HIV Prevention Trials Network (HPTN) is a worldwide collaborative clinical trials network that brings together investigators, ethicists, community members, and other partners to develop and test the safety and efficacy of interventions designed to prevent the acquisition and transmission of HIV. The U.S. National Institute of Allergy and Infectious Diseases, the U.S. National Institute of Mental Health, Office of The Director, the U.S. National Institute on Drug Abuse, and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, all part of the U.S. National Institutes of Health, co-fund the HPTN. The HPTN has collaborated with more than 85 clinical research sites in 19 countries to evaluate new HIV prevention interventions and strategies in populations with a disproportionate HIV burden. The HPTN research agenda – more than 50 trials ongoing or completed with over 161,000 participants enrolled and evaluated – is focused primarily on discovering new HIV prevention tools and evaluating integrated strategies, including biomedical interventions combined with behavioral risk reduction interventions and structural interventions. For more information, visit hptn.org.

Media inquiries: Eric Miller, +1.919.384.6465; emiller@fhi360.org