Day: November 9, 2022

Contributing to TenneT’s carbon neutrality goals to build a sustainable and resilient grid in Germany

Zurich, Switzerland, Nov. 09, 2022 (GLOBE NEWSWIRE) — Hitachi Energy announced today it will provide the world’s first sulfur hexafluoride (SF₆) free 420-kilovolt (kV) gas-insulated switchgear (GIS) technology and a state-of-the-art modular prefabricated grid connection solution at a key node at TenneT’s power grid in Germany, supporting the leading European grid operator to achieve its carbon neutrality goals.

This project covers a major grid connection upgrade which significantly extends the operating life of existing power assets to ensure the longevity and continued efficiency of the existing power infrastructure. The global technology leader will deliver innovative EconiQ 420 kV GIS that uses a game-changing technology that eliminates SF₆ with reliable and scalable solutions for the lowest carbon footprint.

TenneT is a major transmission system operator in the Netherlands and Germany, supplying power to some 42 million homes and businesses in both countries. The company aims to be a driving force behind the energy transition by investing in eco-efficient technologies to reduce greenhouse gas emissions. As a transmission system operator, TenneT is a key player on the historic path to a safe, reliable and carbon-free energy system.

To support TenneT on its transition to SF₆-free solutions, Hitachi Energy will contribute pioneering technologies, unique system integration capabilities, engineering expertise and extensive experience with local grid code requirements to strengthen the grid connection at the 220-megawatt (MW) Erzhausen pumped storage power plant near Hanover. This project uses Building Information Modeling, a consolidated and collaborative digital working method that allows decision-based 3D modeling and improves facility management via a digital twin for the life cycle of the power asset. The entire project will be completed in 2026.

In this project, Hitachi Energy will install three bays of EconiQ 420 kV GIS to enable the transmission of large amounts of electricity over long distances while eliminating significant volumes of SF₆. This eco-efficient innovation remains similar in size while being 100 percent as reliable as the conventional GIS solution based on SF₆. This installation will effectively avoid the addition of nearly 2,300 kg of SF₆, equivalent to removing the CO₂ emissions of around 1,150¹ passenger vehicles per year.

“We are proud to collaborate with TenneT in their efforts to accelerate the energy transition and strengthen the power infrastructure in Germany,” said Claudio Facchin, Chief Executive Officer of Hitachi Energy. “At Hitachi Energy, we are championing the urgency of the energy transition through innovation and collaboration. Through our modular prefabricated grid connections and EconiQ high-voltage switchgear technology, we are supporting our customers to reduce their carbon footprint and enabling a more sustainable, flexible and secure energy system.”

EconiQ is Hitachi Energy’s eco-efficient portfolio for sustainability, where products, services and solutions are proven to deliver exceptional environmental performance. Hitachi Energy has placed sustainability at the heart of its Purpose and is advancing a sustainable energy future for all.

¹ Based on the assumption that a passenger vehicle emits 19 kg CO₂ equivalent per 100 km and drives 10,000 km per year.

About Hitachi Energy Ltd.

Hitachi Energy is a global technology leader that is advancing a sustainable energy future for all. We serve customers in the utility, industry and infrastructure sectors with innovative solutions and services across the value chain. Together with customers and partners, we pioneer technologies and enable the digital transformation required to accelerate the energy transition towards a carbon-neutral future. We are advancing the world’s energy system to become more sustainable, flexible and secure whilst balancing social, environmental and economic value. Hitachi Energy has a proven track record and unparalleled installed base in more than 140 countries. Headquartered in Switzerland, we employ around 40,000 people in 90 countries and generate business volumes of approximately $10 billion USD.

https://www.hitachienergy.com

https://www.linkedin.com/company/hitachienergy

https://twitter.com/HitachiEnergy

About Hitachi, Ltd.

Hitachi drives Social Innovation Business, creating a sustainable society with data and technology. We will solve customers’ and society’s challenges with Lumada solutions leveraging IT, OT (Operational Technology) and products, under the business structure of Digital Systems & Services, Green Energy & Mobility, Connective Industries and Automotive Systems. Driven by green, digital, and innovation, we aim for growth through collaboration with our customers. The company’s consolidated revenues for fiscal year 2021 (ended March 31, 2022) totaled 10,264.6 billion yen ($84,136 million USD), with 853 consolidated subsidiaries and approximately 370,000 employees worldwide. For more information on Hitachi, please visit the company’s website at https://www.hitachi.com.

Attachments

• Hitachi Energy executives signing a deal to provide world’s first SF6-free 420 kV gas-insulated switchgear technology at TenneT’s grid connection in Germany
• EconiQ

Jocelyn Chang
Hitachi Energy Ltd.
+41793847775
jocelyn.chang@hitachienergy.com

GlobeNewswire Distribution ID 8692688

Leading Vietnam bank will use Temenos to power digital banking for over 15 million retail and business customers

GENEVA, Nov. 09, 2022 (GLOBE NEWSWIRE) —  Temenos (SIX: TEMN), today announced that Sacombank, one of the largest banks in Vietnam with over 15 million customers, has selected Temenos Infinity to elevate its digital banking and deliver a seamless omnichannel experience to retail and business customers.

Since Kony’s acquisition in 2019, Temenos Infinity has been selected by over 200 new customers and the product’s leadership has been cemented with multiple analyst accolades. Temenos has been named a leader in the Forrester Waves: Digital Banking Engagement Platforms and Digital Banking Engagement Hubs evaluations in 2021. Temenos was also the only vendor rated best-in-class in Aite Matrix Evaluation of US digital banking solutions.

Sacombank has a customer-centric business strategy focused on providing high-quality financial products and services to individual and corporate customers, especially small and medium-sized enterprises. Temenos Infinity will enable the bank to reimagine the way it interacts with customers and meet the growing customer demand for digital products and services and fast, frictionless customer experiences.

Vietnam is leading the way in digital banking in Southeast Asia. It has a large younger demographic of digitally savvy consumers and a vibrant local fintech and ecommerce industry. Vietnamese enjoy quick and easy digital experiences for a wide variety of services and expect the same from their banking.

Temenos Infinity is a true omnichannel, multi experience platform-based product that enables a comprehensive 360-degree customer view, helping Sacombank to acquire, service, retain and cross-sell to customers, on multiple channels and devices using native features. Offering pre-composable banking services – built on microservices and accessible via APIs – the platform enables Sacombank to develop innovative products quickly and that bring real benefits to consumers and businesses.

The bank plans to introduce fully digital customer onboarding and origination as well as enhance the service experience for existing customers through digital channels. Additionally, Temenos’ open and composable platform will help Sacombank connect with e-commerce providers, social networks and other online services to accelerate a cashless ecosystem, a priority for the Government of Vietnam.

In selecting a new digital banking platform, Sacombank looked at various leading solutions in the market and after a thorough evaluation decided on Temenos Infinity. Sacombank is a longstanding Temenos customer and will run Temenos Infinity on top of its existing Temenos Transact core, providing complete front-to-back banking capabilities on a single platform.

Temenos Infinity is the world’s best-selling digital banking platform used by over 850 financial institutions, from global tier one banks to digital challengers. It can connect to any core banking system as a standalone solution for larger banks or to Temenos Transact. Temenos Infinity can run on any cloud or as SaaS on the Temenos Banking Cloud.

Bui Van Dung (Mr.), Deputy CEO, Sacombank said: “The omnichannel platform project is an unavoidable step to make a breakthrough in digital business of Sacombank. Sacombank believes that Temenos has the best reputation, capacity, and technology in omnichannel, along with a consultant team experienced in implementing similar projects at the leading banks, financial institutions in area and world-wide, hence, Temenos is able to support Sacombank in implementing its digital business strategy to comprehensively innovate in quality.”

Craig Bennett, Managing Director – APAC, Temenos, said: “Vietnam is a strategic market for Temenos. More than 20 Vietnamese banks run on our core banking technology, and we see growing adoption and interest for our Temenos Infinity digital banking platform. As one of the biggest banks in Vietnam and the Southeast Asia region, we are hugely proud to extend our relationship with Sacombank. Adding Temenos Infinity to the bank’s technology stack will propel the bank forward, opening new opportunities and delivering outstanding customer experiences.”

About Temenos
Temenos (SIX: TEMN) is the world’s leading open platform for composable banking, creating opportunities for over 1.2 billion people around the world every day. We serve over 3000 banks from the largest to challengers and community banks in 150+ countries by helping them build new banking services and state-of-the-art customer experiences. The Temenos open platform helps our top-performing clients achieve return on equity three times the industry average and cost-to-income ratios half the industry average.

For more information, please visit www.temenos.com.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/54af5e1a-1e98-4441-897e-7d90b91e8ad4

Media Contacts

 
Jessica Wolfe & Scott Rowe
Temenos Global Public Relations
Tel: +1 610 232 2793 & +44 20 7423 3857
Email: press@temenos.com

Alistair Kellie
Newgate Communications on behalf of Temenos
Tel: +44 20 7680 6550
Email: allnewgatetemenos@newgatecomms.com

GlobeNewswire Distribution ID 8692708

STOCKHOLM & NEW YORK, Nov. 09, 2022 (GLOBE NEWSWIRE) — Today, the Tällberg Foundation announced the winners of this year’s Tällberg-SNF-Eliasson Global Leadership Prizes, awarded annually to well-established leaders working in any field and any country, whose leadership is courageous, innovative, rooted in universal values and global in application or in aspiration.

The 2022 laureates:

Yevgenia Albats, Russia, for her passionate commitment to reporting truth in the face of repression and corruption, and for forcefully asserting her—and every Russian’s—personal responsibility to work for a democratic future in their country.

Sam Muller, Netherlands, for his innovative work in creating and implementing new, concrete concepts and ways of working for law practitioners that focus on solving people’s real needs and thereby reinforce their commitment to democracy.

Gladys Kalema-Zikusoka, Uganda, for her persistent, innovative leadership in developing new approaches to human/wildlife interaction at a time when the danger of zoonotic diseases is rising worldwide.

“Converging crises are challenging all our societies. If we ever needed great leadership it is now,” said Alan Stoga, the Tällberg Foundation’s chairman. “What these three extraordinary individuals—working in dramatically different contexts on different kinds of problems—demonstrate is the power of courageous, creative, persistent leadership.”

The Prizes are made possible by the financial and moral support of the Stavros Niarchos Foundation (SNF). SNF Co-President Andreas Dracopoulos said, “What each of the most serious challenges humanity faces—such as climate change, the erosion of democracy, unmet mental health needs, the risk of future pandemics—requires is sound, selfless leadership. SNF is proud to support the Prizes in recognizing leaders whose practical optimism unlocks human potential to meet these critical challenges.

“We are deeply committed to the idea that great leadership comes in many different flavors. The leaders selected by the jury this year prove the point. What do a journalist, a jurist and a veterinarian have in common? Great leadership skills and the fundamental optimism to challenge the status quo with innovation and energy. The world needs as much of that as we can find, which is why SNF supports this initiative.”

The winners receive a $50,000 cash award and the opportunity to participate in the Tällberg Foundation’s global leaders’ network. They will be honored in a virtual celebration on Dec. 13. To register to participate, go to tallberg-snf-eliasson-prize.org.

The Tällberg Foundation separately recognizes and honors emerging leaders whose work has less track record and more potential. This year’s emerging leader laureates will be announced on Nov. 16.

Prize winners are nominated through an online process open to anyone anywhere and are ultimately selected by a global jury. The Tällberg-SNF-Eliasson Global Leadership Prize was established in 2015 and has honored 27 global leaders.

Learn more at tallberg-snf-eliasson-prize.org.

Contact Information:
Cecilia Nordström
office@tallbergfoundation.org
+46 70 618 3587

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

GlobeNewswire Distribution ID 8692267

The following is an extract from the “Iveco Group 2022 Third Quarter Results” press release. The complete press release can be accessed by visiting the media section of the Iveco Group corporate website: https://www.ivecogroup.com/media/corporate_press_releases or consulting the accompanying PDF:

Iveco Group consolidated revenues of €3.5 billion (up 19% year on year).
Adjusted EBIT of €101 million and adjusted net income of €30 million.
Net cash of Industrial Activities at €561 million.

Consolidated revenues of €3,520 million, up 19.0%. Net revenues of Industrial Activities of €3,471 million, up 18.6%, mainly due to higher volumes and positive price realization.

Adjusted EBIT of €101 million (€44 million increase compared to Q3 2021), with a 2.9% margin (up 100 bps compared to Q3 2021). Adjusted EBIT of Industrial Activities of €64 million (€33 million in Q3 2021), with positive price realization, higher volumes and better mix more than offsetting higher raw material and energy costs.

Adjusted net income of €30 million (€15 million increase compared to Q3 2021), which primarily excludes the gain on the final step of Chinese joint ventures’ restructuring. Adjusted diluted earnings per share of €0.10 (up €0.06 compared to Q3 2021).

Financial expenses of €65 million (€31 million in Q3 2021), increasing mainly due to hyperinflation impacts in Argentina and Turkey, and higher interest rates.

Reported income tax expense of €14 million, with adjusted effective tax rate (adjusted ETR) of 17% and 32% for the three and nine months, respectively. The year-to-date adjusted ETR is in line with the current full year expectation and reflects different tax rates applied in the jurisdictions where the Group operates and some other discrete items.

Net cash of Industrial Activities at €561 million (€1,063 million at 31^st December 2021 or €625 million at 30^th June 2022). Free cash flow of Industrial Activities was negative €232 million, a €316 million improvement compared to Q3 2021 primarily due to lower working capital absorption mainly driven by higher production and sales.

Available liquidity at €3,554 million as of 30^th September 2022, up €59 million from 30^th June 2022, including €2,000 million of undrawn committed facilities.

 

Attachment

• 20221109_PR_IVG_Q3_2022

GlobeNewswire Distribution ID 1000755806

REGULATED INFORMATION

Nyxoah Reports Third Quarter 2022 Financial and Operating Results

DREAM US pivotal 12-month clinical data expected in fall of 2023

Mont-Saint-Guibert, Belgium – November 8, 2022, 10:05pm CET / 4:05pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today reported financial and operating results for the quarter ended September 30, 2022.

Third Quarter 2022 Financial and Operating Highlights

• Completed 110 of 115 implants in the DREAM U.S. pivotal trial to date, with 12-month clinical data expected in the fall of 2023 and regulatory approval in the second quarter of 2024
• Activated the first clinical sites in the ACCCESS U.S. pivotal trial to treat complete concentric collapse (CCC) patients in the U.S., with first implants expected in the fourth quarter of 2022
• Reported revenue of €182,000 from the commercialization of Genio®; sales during the third quarter were impacted by a temporary inventory shortage in Germany due to a disruption at a component supplier, resulting in unfulfilled third quarter orders of approximately €700,000 in Germany; this supply disruption has subsequently been remedied and the vast majority of the open orders have since been filled
• Ended the third quarter with 32 active sites in Germany, up from 26 sites at the end of the second quarter 2022; expects to have up to 40 active sites by the end of 2022
• Launched the “Care4” program, using the AcuPebble home sleep test at selected centers of excellence in Germany to accelerate the time from CPAP failure to our Genio solution
• Received CE Mark for the next-generation Genio system, Genio 2.1

“With 110 implants in the DREAM trial, we believe we are within weeks of completion of the implants, keeping us on track for 12-month data next fall,” commented Olivier Taelman, Nyxoah’s Chief Executive Officer. “Additionally, ACCCESS, our second US pivotal trial is launched, and first patients are expected to be implanted before year end. This trial is focused on addressing the unmet need of approximately 30% of OSA patients contra-indicated in the U.S. to hypoglossal nerve stimulation due to their complete concentric collapse.”

Mr. Taelman continued, “Commercially in Germany, where we have both CCC and non-CCC indications already, we continue to build on our momentum, as patients and clinicians increasingly recognize the unique benefits of the Genio solution. While third quarter sales reflected a temporary supply disruption, the fourth quarter is off to a strong start, as we are filling both open orders from the third quarter and new ones. This gives us confidence that we can be the German market leader exiting 2022.”

Third Quarter 2022 Results

UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL INFORMATION – INTERIM CONSOLIDATED STATEMENTS OF LOSS AND OTHER COMPREHENSIVE LOSS FOR THE THREE MONTHS AND NINE MONTHS ENDED SEPTEMBER 30, 2022 (in thousands)

			For the three months ended September 30				For the nine months ended September 30
			2022		2021		2022		2021
Revenue			€ 182		€ 203		€ 1 777		€ 557
Cost of goods sold			( 63)		( 82)		( 685)		( 198)
Gross profit			€ 119		€ 121		€ 1 092		€ 359
Research and Development Expense			(4 221)		(3 517)		(11 286)		(9 009)
Selling, General and Administrative Expense			(4 763)		(4 496)		(13 492)		(10 775)
Other income/(expense)			87		( 178)		237		( 274)
Operating loss for the period			€ (8 778)		€ (8 070)		€ (23 449)		€ (19 699)
Financial income			5 127		29		11 372		72
Financial expense			(2 524)		( 585)		(5 473)		(1 484)
Loss for the period before taxes			€ (6 175)		€ (8 626)		€ (17 550)		€ (21 111)
Income taxes			( 65)		( 136)		( 379)		( 260)
Loss for the period			€ (6 240)		€ (8 762)		€ (17 929)		€ (21 371)
Loss attributable to equity holders			€ (6 240)		€ (8 762)		€ (17 929)		€ (21 371)
Other comprehensive loss
Items that may be subsequently reclassified to profit or loss (net of tax)
Currency translation differences			100		( 54)		( 14)		138
Total comprehensive loss for the year, net of tax			€ (6 140)		€ (8 816)		€ (17 943)		€ (21 233)
Loss attributable to equity holders			€ (6 140)		€ (8 816)		€ (17 943)		€ (21 233)
Basic Loss Per Share (in EUR)			€ (0.242)		€ (0.348)		€ (0.695)		€ (0.923)
Diluted Loss Per Share (in EUR)			€ (0.242)		€ (0.348)		€ (0.695)		€ (0.923)

UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL INFORMATION – INTERIM CONSOLIDATED STATEMENT OF FINANCIAL POSITION AS AT SEPTEMBER 30, 2022 (in thousands)

				As at
				September 30, 2022		December 31, 2021
ASSETS
Non-current assets
Property, plant and equipment				€ 2 216		€ 2 020
Intangible assets				36 488		25 322
Right of use assets				3 413		3 218
Deferred tax asset				2 423		46
Other long-term receivables				188		164
				€ 44 728		€ 30 770
Current assets
Inventory				594		346
Trade receivables				757		226
Other receivables				2 022		2 286
Other current assets				587		1 693
Financial assets				25 505		−
Cash and cash equivalents				89 877		135 509
				€ 119 342		€ 140 060
Total assets				€ 164 070		€ 170 830

EQUITY AND LIABILITIES
Capital and reserves
Capital			4 440		4 427
Share premium			228 275		228 033
Share based payment reserve			5 225		3 127
Other comprehensive income			188		202
Retained loss			(105 058)		(87 167)
Total equity attributable to shareholders			€ 133 070		€ 148 622
LIABILITIES
Non-current liabilities
Financial debt			8 035		7 802
Lease liability			2 831		2 737
Pension liability			80		80
Provisions			47		12
Deferred tax liability			−		5
			€ 10 993		€ 10 636
Current liabilities
Financial debt			656		554
Lease liability			722		582
Trade payables			5 346		3 995
Current tax liability			5 391		2 808
Other payables			7 892		3 633
			€ 20 007		€ 11 572
Total liabilities			€ 31 000		€ 22 208
Total equity and liabilities			€ 164 070		€ 170 830

UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL INFORMATION – INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS AS AT SEPTEMBER 30, 2022 (in thousands)

			For the nine months ended September 30
			2022		2021
CASH FLOWS FROM OPERATING ACTIVITIES
Loss before tax for the year			€ (17 550)		€ (21 111)
Adjustments for
Finance income			(11 372)		( 72)
Finance expenses			5 473		1 484
Depreciation and impairment of property, plant and equipment and right-of-use assets			832		558
Amortization of intangible assets			607		653
Share-based payment transaction expense			2 136		784
Increase/(Decrease) in provisions			36		4
Other non-cash items			( 353)		247
Cash generated before changes in working capital			€ (20 191)		€ (17 453)
Changes in working capital
Decrease/(Increase) in inventory			( 248)		( 33)
(Increase)/Decrease in trade and other receivables			1 100		(2 876)
Increase/(Decrease) in trade and other payables			1 265		2 563
Cash generated from changes in operations			€ (18 074)		€ (17 799)
Income tax paid			( 314)		( 205)
Net cash used in operating activities			€ (18 388)		€ (18 004)

CASH FLOWS FROM INVESTING ACTIVITIES
Purchases of property, plant and equipment			( 484)		(1 257)
Capitalization of intangible assets			(11 774)		(7 219)
Purchase of financial assets – current			(44 032)		−
Proceeds from sale of financial assets – current			24 582		−
Interest income on financial assets			63		−
Net cash used in investing activities			€ (31 645)		€ (8 476)
CASH FLOWS FROM FINANCING ACTIVITIES
Payment of principal portion of lease liabilities			( 497)		( 358)
Repayment of other loan			( 62)		( 63)
Interests paid			( 185)		( 324)
Repayment of recoverable cash advance			( 220)		( 280)
Proceeds from issuance of shares, net of transaction costs			255		76 070
Other financial costs			( 55)		( 7)
Net cash used in financing activities			€ ( 764)		€ 75 038
Movement in cash and cash equivalents			€ (50 797)		€ 48 558
Effect of exchange rates on cash and cash equivalents			5 165		56
Cash and cash equivalents at January 1			€ 135 509		€ 92 300
Cash and cash equivalents at September 30			€ 89 877		€ 140 914

Revenue

Revenue was €182,000 for the third quarter of 2022, compared to €203,000 for the prior year period. The decrease in revenue was attributable to the temporary supply disruption that caused a delay in order fulfillment.

Cost of Goods Sold

Cost of goods sold was €63,000 for the three months ending September 30, 2022, representing a gross profit of €119,000, or gross margin of 65.3%. This compares to total costs of goods sold of €82,000 in the third quarter of 2021, for a gross profit of €121,000, or gross margin of 59.6%.

Research and Development Expenses

Research and development expenses were €4.2 million for the three months ending September 30, 2022, versus €3.5 million for the prior year period, reflecting the Company’s investments in the development of next generation versions of the Genio system as well as ongoing clinical studies, most notably DREAM in the U.S.

Selling, General and Administrative Expenses

General and administrative expenses rose to €4.8 million for the third quarter of 2022, up from €4.5 million in the third quarter of 2021. This was due primarily to increased commercial efforts in Germany and other European markets, as well as investments in Nyxoah’s corporate infrastructure. The Company expects to continue adding headcount across the organization ahead of U.S. commercial launch.

Operating Loss

Total operating loss for the third quarter of 2022 was €8.8 million versus €8.1 million in the third quarter of 2021. This was driven by the delay of third quarter revenue due to the temporary supply disruption, the acceleration in the Company’s R&D spending, and ongoing commercial and clinical activities. Nyxoah realized a net loss of €6.2 million for the third quarter of 2022, compared to a net loss of €8.8 million for the third quarter.

Cash Position

As of September 30, 2022, cash and financial assets totaled €115.4 million, compared to €135.5 million on December 31, 2021.   Total cash burn was approximately €3.0 million per month during the third quarter of 2022, and is expected to increase going forward to account for the ACCCESS IDE trial in the U.S.

Third Quarter 2022 Report

Nyxoah’s financial report for the third quarter of 2022, including details of the unaudited consolidated results, are available on the investor page of Nyxoah’s website (https://investors.nyxoah.com/financials).

Conference call and webcast presentation
Nyxoah will conduct a conference call to open to the public today at 10:30 p.m. CET / 4:30 p.m. ET, which will also be webcast. To participate in the conference call, please access the following link to register for a dial-in number:

https://register.vevent.com/register/BI0d7e0daed6e34e548b85e51146400c1a

A question-and-answer session will follow the presentation of the results. To access the live webcast, go to https://investors.nyxoah.com/events. The archived webcast will be available for replay shortly after the close of the call.

About Nyxoah
Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA). Nyxoah’s lead solution is the Genio® system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest.

Following the successful completion of the BLAST OSA study, the Genio® system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company is currently conducting the DREAM IDE pivotal study for FDA and US commercialization approval.

For more information, please visit http://www.nyxoah.com/.

Caution – CE marked since 2019. Investigational device in the United States. Limited by U.S. federal law to investigational use in the United States.

Forward-looking statements
Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company’s or, as appropriate, the Company directors’ or managements’ current expectations regarding the Genio® system; future financial performance and market position; planned and ongoing clinical studies of the Genio® system; the potential advantages of the Genio® system; Nyxoah’s goals with respect to the development, regulatory pathway and potential use of the Genio® system; the utility of clinical data in potentially obtaining FDA approval of the Genio® system; and the Company’s results of operations, financial condition, liquidity, performance, prospects, growth and strategies. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. Additionally, these risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the “Risk Factors” section of the Company’s Annual Report on Form 20-F for the year ended December 31, 2021, filed with the Securities and Exchange Commission (“SEC”) on March 24, 2022, and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

Contacts:
Nyxoah
Loic Moreau, Chief Financial Officer
corporate@nyxoah.com
+32 473 33 19 80

Jeremy Feffer, VP IR and Corporate Communications
jeremy.feffer@nyxoah.com
+1 917 749 1494

 

Attachment

• ENGLISH Q3 2022 Earnings PR – FINAL

GlobeNewswire Distribution ID 1000755751