Bombardier Achieves Important Milestones on EcoJet Research Project, Continues Industry-Defining Work Toward Sustainable Aviation

Bombardier’s EcoJet Research Project

Bombardier’s EcoJet research project aims to develop and mature technologies to support a sustainable future for business aviation.

  • Bombardier successfully completes initial flight testing phase on the EcoJet research project, using a model of a blended-wing-body aircraft.
  • The subsequent phase of testing, focusing on flying a larger scaled model, is well underway.
  • The EcoJet research project aims to develop and mature technologies to support a sustainable future for business aviation.

GENEVA, May 22, 2023 (GLOBE NEWSWIRE) — Bombardier presented the progress made on its EcoJet research project, a research platform that aims to develop technologies with the goal of reducing aircraft emissions through a combination of advanced aerodynamics and propulsion enhancements. After several years of research, the organization successfully completed its first phase of testing with a small-scale model of a blended-wing-body aircraft, representing approximately 7% of a large business jet. Bombardier is now building on the significant knowledge acquired to engage in a second phase of testing with a model twice as large, and which completed its first flight last year to pave the way for this next test campaign.

“Bombardier has taken a leadership position in the industry’s efforts to reduce its environmental footprint, and the EcoJet research project is paramount to developing the technologies that will bring us toward the goal of net zero emissions by 2050,” said Stephen McCullough, Senior Vice President of Engineering and Product Development. “We are very pleased to see the highly engaging results yielded so far and to continue our trailblazing work as we kick off the next phase of this game-changing research project. The EcoJet research project has garnered a high level of interest across the industry, and we are looking forward to mobilizing partners as we continue to define the future of business aviation.”

Bombardier’s team noted highly positive results during the design optimization loops and initial flight test campaign. Those include the deployment of a next-generation Product Lifecycle Management (PLM) platform, the confirmation of a sixth-generation transonic wing modeling capability, and the demonstration of a new aircraft control architecture.

This research and technology project aims to reduce aircraft emissions by up to 50% through a combination of aerodynamic and propulsion enhancements. Renowned for its leading expertise and ingenuity, Bombardier created the EcoJet research project to develop and mature powerful technologies to leverage in future projects, as part of its firm commitment to a sustainable future for business aviation.

On top of its comprehensive EcoJet research project, Bombardier has taken several actions as part of its roadmap toward sustainable aviation. In the last three years, Bombardier published Environmental Product Declarations (EPD) for its Challenger 3500, Global 5500, Global 6500 and Global 7500 aircraft. These extensive declarations are the result of years of scientific efforts and are meant to act as tools for the aviation industry to drive sustainable innovations across its activities spectrum. Bombardier is also using Sustainable Aviation Fuel (SAF), at a 30% blend, to cover the totality of its flight operations, utilizing the Book-and-Claim system. The initiative will create a significant gain by reducing the annual greenhouse gas emissions associated with fuel used in Bombardier’s flight operations by approximately 25%.

About Bombardier

Bombardier (BBD-B.TO) is a global leader in aviation, focused on designing, manufacturing, and servicing the world’s most exceptional business jets. Bombardier’s Challenger and Global aircraft families are renowned for their cutting-edge innovation, cabin design, performance, and reliability. Bombardier has a worldwide fleet of approximately 5,000 aircraft in service with a wide variety of multinational corporations, charter and fractional ownership providers, governments, and private individuals. Bombardier aircraft are also trusted around the world in government and military special-mission roles leveraging Bombardier Defense’s proven expertise.

Headquartered in Greater Montréal, Québec, Bombardier operates aerostructure, assembly and completion facilities in Canada, the United States and Mexico. The company’s robust customer support network services the Learjet, Challenger and Global families of aircraft, and includes facilities in strategic locations in the United States and Canada, as well as in the United Kingdom, Germany, France, Switzerland, Italy, Austria, the UAE, Singapore, China and Australia.

For corporate news and information, including Bombardier’s Environmental, Social and Governance report, as well as the company’s plans to cover all its flight operations with Sustainable Aviation Fuel (SAF) utilizing the Book and Claim system visit bombardier.com. Learn more about Bombardier’s industry-leading products and customer service network at businessaircraft.bombardier.com. Follow us on Twitter @Bombardier.

Bombardier, Learjet, Challenger 3500, Global 5500, Global 6500 and Global 7500 are registered or unregistered trademarks of Bombardier Inc. or its subsidiaries.

Visuals related to Bombardier’s announcements at EBACE are available here.

For Information

Christina Lemyre McCraw
Manager, Public Relations and Communications
Bombardier
+1 514 497 4928
christina.lemyremccraw@aero.bombardier.com

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GlobeNewswire Distribution ID 8843576

Bombardier’s Certified Pre-Owned Aircraft Program Continues to Flourish, Showcases Pristine Challenger 605 Aircraft at EBACE 2023

Bombardier’s Certified Pre-Owned Challenger 605 aircraft

Bombardier’s Certified Pre-Owned Challenger 605 aircraft on display at EBACE

  • Bombardier’s CPO program has established a dynamic premium category for customers in the pre-owned business jet market
  • Customer interest has been overwhelmingly positive with several aircraft in service worldwide
  • CPO aircraft carry an exclusive one-year OEM warranty* and are selected by the team, inspected and updated with refurbished interiors, latest avionics and connectivity enhancements, and freshly completed maintenance

GENEVA, May 22, 2023 (GLOBE NEWSWIRE) — Bombardier today presented for the first time its turn-key Certified Pre-Owned aircraft program (CPO) by showcasing a pristine Challenger 605 aircraft at the European Business Aviation Convention & Exhibition (EBACE). Launched in mid-2021, Bombardier is the first OEM to introduce a refurbishment and upgrade offering for business jets – a premium class of pre-owned Learjet, Challenger and Global aircraft, that are selected, inspected and updated featuring refurbished interiors, fresh paint, upgraded avionics and connectivity systems, all specifically adhering to Bombardier’s highest quality and safety standards.

The stunning Challenger 605 jet featured at EBACE aptly illustrates the attributes of the CPO program, with its immaculate new interior and paint; brand-new Collins Pro Line 21 advanced avionics in the cockpit; industry-defining cost-per-flight-hour Smart Parts Preferred and Smart Link Plus connected aircraft programs enrolled ready; and Ka-Band cabin connectivity. Customer interest in Bombardier’s CPO program is gaining momentum – and with an annual average of 460 used Bombardier aircraft transacting over the past five years, there’s a healthy pool of aircraft to bring into the program.

“Bombardier customers wanted a certified option beyond the traditional pre-owned aircraft offering and our new CPO program certainly delivers on this premise,” said Paul Sislian, Executive Vice President, Bombardier Aftermarket Services and Strategy. “As the OEM, we are uniquely positioned to provide them with a best-in-class, turn-key certified aircraft solution – a new and exciting category in the industry.”

Bombardier’s Certified Pre-Owned aircraft are fully mission-capable upon delivery: they have airframe, engine and APU program coverage, an exclusive one-year OEM warranty*, and all applicable maintenance completed. All CPO products come with a Level 3 pre-buy inspection and are completed at Bombardier facilities around the world. And under Bombardier’s Smart Services coverage programs, customers receive turnkey solutions consistent with the program available for new aircraft buyers. Smart Services coverage programs are offered for Learjet, Challenger and Global aircraft.**

To ensure interested CPO customers have the latest pre-owned information at their fingertips, Bombardier has also created a dedicated pre-owned inventory web page with well-documented spec sheets describing in detail all the modifications, upgrades and maintenance completed on its CPO aircraft. It also produces a comprehensive Bombardier Pre-owned Market Report, highlighting the latest transaction trends, pre-owned inventory saturation levels and market commentaries for all pre-owned Bombardier aircraft.

Confirming Bombardier’s Certified Pre-Owned aircraft program is gaining traction, it is now fully recognized by appraisal authorities such as Aircraft Bluebook, Vref, and AircraftPost, who now report CPO aircraft in a distinct category from other pre-owned aircraft.

*One-year warranty on the airframe. Certain conditions apply.
** May not apply to all aircraft; certain conditions apply.

About Bombardier

Bombardier (BBD-B.TO) is a global leader in aviation, focused on designing, manufacturing, and servicing the world’s most exceptional business jets. Bombardier’s Challenger and Global aircraft families are renowned for their cutting-edge innovation, cabin design, performance, and reliability. Bombardier has a worldwide fleet of approximately 5,000 aircraft in service with a wide variety of multinational corporations, charter and fractional ownership providers, governments, and private individuals. Bombardier aircraft are also trusted around the world in government and military special-mission roles leveraging Bombardier Defense’s proven expertise.

Headquartered in Greater Montréal, Québec, Bombardier operates aerostructure, assembly and completion facilities in Canada, the United States and Mexico. The company’s robust customer support network services the Learjet, Challenger and Global families of aircraft, and includes facilities in strategic locations in the United States and Canada, as well as in the United Kingdom, Germany, France, Switzerland, Italy, Austria, the UAE, Singapore, China and Australia.

For corporate news and information, including Bombardier’s Environmental, Social and Governance report, as well as the company’s plans to cover all its flight operations with Sustainable Aviation Fuel (SAF) utilizing the Book and Claim system visit bombardier.com. Learn more about Bombardier’s industry-leading products and customer service network at businessaircraft.bombardier.com. Follow us on Twitter @Bombardier.

Bombardier, Certified Pre-Owned, Smart Parts Preferred, Smart Link Plus, Smart Services, Learjet, Challenger, Challenger 605 and Global are registered or unregistered trademarks of Bombardier Inc. or its subsidiaries.  Pro Line 21 is a trademark of Collins Aerospace.

Visuals related to Bombardier’s announcement at EBACE are available here.

For information

Matthew Nicholls
Sr. Public Affairs and Communications Advisor
Bombardier
+1 514-243-8214
Matthew.Nicholls@aero.bombardier.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/271da6d5-cbe3-405c-ac72-1f0f7aec38d6

GlobeNewswire Distribution ID 8843585

Impulse Dynamics Announces First Implant for CCM-D™ Clinical Trial

World’s First Device Combining CCM Therapy With an ICD in a Single Rechargeable Implant That Treats Both Heart Failure Symptoms and Sudden Cardiac Death

MARLTON, N.J., May 18, 2023 (GLOBE NEWSWIRE) — Impulse Dynamics plc, a global medical device company dedicated to improving the lives of people with heart failure, announced the completion of the first implantation for the INTEGRA-D clinical trial, designed to evaluate the safety and efficacy of two proven cardiac therapies combined — CCM® and an implantable cardioverter defibrillator (ICD) — in a single device (CCM-D). The Optimizer® IntegraTM CCM-D System delivers CCM therapy to improve quality of life and reduce heart failure symptoms, and ICD therapy to treat life-threatening arrhythmias that may cause sudden cardiac death. The investigational technology is rechargeable with long battery life, potentially reducing the need for replacement procedures.

The journey of a heart failure patient often involves debilitating symptoms and declining quality of life.

CCM therapy delivered by the Optimizer System improves quality of life and helps patients feel better. Patients indicated for CCM therapy may also be at a higher risk for arrythmias and sudden cardiac arrest and are therefore often offered an ICD to treat their heart for life-threatening arrythmias, should they occur. The INTEGRA-D trial is the first to evaluate the Optimizer Integra CCM-D System that combines both therapies into a single device, designed to last for many years.

“The first-in-the-world implant of this novel technology has potential to advance treatments for patients living with heart failure,” said Niraj Varma, M.D., Ph.D., electrophysiologist at Cleveland Clinic and National Primary Investigator of the INTEGRA-D clinical trial. “The trial aims to study whether this device can protect heart failure patients from the risk of sudden cardiac death while also treating heart failure symptoms.”

“We hope combining cardiac contractility modulation therapy and ICD therapy with prolonged battery life will reduce the number of leads and the number of procedures a patient may have to endure,” said Bruce Wilkoff, M.D., Director of Cardiac Pacing and Tachyarrhythmia Devices at Cleveland Clinic and Principal Investigator of the INTEGRA-D trial. “The first implant went well, and we look forward to further studying this device.”

The INTEGRA-D trial is a multicenter study of 300 subjects from 75 centers that will evaluate the combination of CCM and ICD therapy in a single device via the Optimizer Integra CCM-D System. The study will assess the performance of the CCM-D device in effectively treating episodes of ventricular tachycardia and/or ventricular fibrillation while also providing CCM treatment for heart failure. Patients enrolled in the study will receive the Optimizer Integra CCM-D System, and will be followed for at least two years.

“This clinical study is important in proving the potential benefit of combining CCM therapy, which improves quality of life in patients with heart failure, with gold-standard ICD technology that delivers lifesaving therapy for sudden cardiac death,” said Nir Uriel, M.D., Director of Advanced Heart Failure and Cardiac Transplantation at New York-Presbyterian and National Co-Principal Investigator for the INTEGRA-D trial. Dr. Uriel is also a professor of cardiology at Columbia University Vagelos College of Physicians and Surgeons and an Adjunct Professor of Medicine in the Greenberg Division of Cardiology at Weill Cornell Medicine.

“Today’s announcement is another example of our commitment to a continuous pace of innovation to build a comprehensive platform in interventional heart failure and help improve the lives of many patients that suffer from this debilitating disease,” said Simos Kedikoglou, M.D., Chief Executive Officer of Impulse Dynamics. “We are proud to partner with physicians at leading centers around the world to conduct important research on this first-of-its-kind rechargeable combination device designed to address a major unmet need of a large patient group.”

About the Optimizer Integra CCM-D System and CCM Therapy

The Optimizer Integra CCM-D System is an investigational device that combines CCM therapy and ICD therapy into one device. “Investigational” means that the study device is currently being tested. It is not approved by the U.S. Food and Drug Administration (FDA).

Impulse Dynamics currently offers the Optimizer system that is FDA-approved and CE-marked. The Optimizer system delivers CCM therapy — the company’s proprietary technology — to the heart. CCM therapy has been designed by Impulse Dynamics to significantly improve the heart’s contraction, allowing more oxygen-rich blood to be pushed out through the body. CCM therapy is indicated to improve the 6-minute hall walk, quality of life, and functional status of NYHA Class III heart failure patients who remain symptomatic despite guideline-directed medical therapy, are not indicated for CRT, and have a left ventricular ejection fraction ranging from 25 to 45 percent.

CCM is the brand name for cardiac contractility modulation — a therapy that delivers non-excitatory electrical pulses from the implantable Optimizer device to improve heart contraction. CCM therapy sends unique electrical pulses to the heart cells during the absolute refractory period. In doing so, CCM helps the heart contract more forcibly. Impulse Dynamics has completed numerous clinical studies, including several randomized controlled trials, and CCM therapy has been published in more than 120 peer-reviewed journal articles.

About Impulse Dynamics

Impulse Dynamics is dedicated to advancing the treatment of heart failure for patients and the healthcare providers who care for them. The company pioneered its proprietary CCM therapy, which uses the Optimizer technology platform to improve quality of life in heart failure patients. CCM therapy is delivered through the Optimizer system, which includes an IPG implanted in a minimally invasive procedure and approved for commercial use in the United States and 44 countries worldwide. More than 9,000 patients have received the therapy as part of clinical trials and real-world use, where it is proven to be safe and effective for heart failure patients with debilitating symptoms who otherwise have few effective options available to them. To learn more, visit www.ImpulseDynamics.com, or follow the company on LinkedInTwitter, and Facebook.

Forward-looking Statements

This press release contains forward-looking statements. All statements other than statements of historical facts contained in this press release are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as ‘‘may,’’ ‘‘will,’’ ‘‘should,’’ ‘‘expect,’’ ‘‘plan,’’ ‘‘anticipate,’’ ‘‘could,’’ ‘‘intend,’’ ‘‘target,’’ ‘‘project,’’ ‘‘contemplate,’’ ‘‘believe,’’ ‘‘estimate,’’ ‘‘predict,’’ ‘‘potential’’ or ‘‘continue’’ or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements include, but are not limited to, statements concerning potential benefits of CCM therapy, and CCM therapy combined with an ICD delivered via a single device (CCM-D), and the absence of risks associated therewith; the ability for CCM therapy and our products to fill a significant unmet medical need for patients with heart failure; and the short-term and long-term benefits of the Optimizer Integra CCM-D System and CCM therapy in patients with heart failure, as well as to the physicians treating those patients. These forward-looking statements are based on management’s current expectations and involve known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Other important factors that could cause actual results, performance or achievements to differ materially from those contemplated in this press release include, without limitation: the company’s future research and development costs, capital requirements and the company’s needs for additional financing; commercial success and market acceptance of CCM therapy; the company’s ability to achieve and maintain adequate levels of coverage or reimbursement for Optimizer systems or any future products the company may seek to commercialize; competitive companies and technologies in the industry; the company’s ability to expand its indications and develop and commercialize additional products and enhancements to its current products; the company’s business model and strategic plans for its products, technologies and business, including its implementation thereof; the company’s ability to expand, manage and maintain its direct sales and marketing organization; the company’s ability to commercialize or obtain regulatory approvals for CCM therapy and its products, or the effect of delays in commercializing or obtaining regulatory approvals; FDA or other U.S. or foreign regulatory actions affecting us or the healthcare industry generally, including healthcare reform measures in the United States and international markets; the timing or likelihood of regulatory filings and approvals; and the company’s ability to establish and maintain intellectual property protection for CCM therapy and products or avoid claims of infringement. The company does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein. These forward-looking statements should not be relied upon as representing the company’s views as of any date subsequent to the date of this press release.

Rohan More, Global Vice President of Marketing
Impulse Dynamics
856-642-9933
rmore@impulsedynamics.com

Harriss Currie, Chief Financial Officer
Impulse Dynamics
856-642-9933
hcurrie@impulsedynamics.com

GlobeNewswire Distribution ID 8841961

Architects Lina Ghotmeh and Asif Khan appointed for two major museums in AlUla, Saudi Arabia

Lina Ghotmeh and Asif Khan, courtesy Royal Commission for AlUla, photo by Luke Walker

Architects Lina Ghotmeh and Asif Khan appointed for two major museums in AlUla, Saudi Arabia

ALULA, Saudi Arabia, May 18, 2023 (GLOBE NEWSWIRE) — The Royal Commission for AlUla (RCU) announces Lina Ghotmeh and Asif Khan as architects for two upcoming museums in its constellation of cultural assets. Ghotmeh will design the contemporary art museum and Khan will design the museum of the Incense Road. Both museums are situated in AlUla, a destination in northwest Arabia with 7,000 years of continuous human history.

Khan, who was awarded a MBE for his services to architecture and is currently working on the renewal of the Barbican Centre and the new London Museum, is known for his radical approach to architecture, which merges history with the future, grounding projects in material experimentation and social context.

Award winning Ghotmeh, who is designing the 2023 Serpentine Pavilion, creates work that sits at the intersection of art, architecture and design. Her practice is developed through a process of thorough historical research, emerging in complete symbiosis with nature as exquisite interventions that enliven memories and the senses.

The architects were chosen through an international competition. The jury comprised of key stakeholders and specialists in architecture, landscape and museology, supported by a technical panel, and was chaired by Dr Khaled Azzam, the architect of AlUla’s Journey Through Time Masterplan.

We are excited to announce the appointed architects to these two significant museums – the first of 15 cultural assets being developed as part of AlUla’s Journey Through Time Masterplan. AlUla is a spectacular landscape of discovery, where heritage, works of nature and humankind combine to reveal a long and intimate relationship between people and their environment. This Masterplan will guide the reinvigoration of AlUla establishing a new cultural legacy including the implementation of a circular economy expected to create 38,000 new jobs.

Dr Khaled Azzam – Architect, Journey Through Time Masterplan, Royal Commission for AlUla

The architecture of the contemporary art museum in AlUla immerses visitors in a creative journey from the desert expanse to the lush cultural oasis of AlUla, interweaving the natural environment, agriculture and art to reveal the heart of contemporary culture. Through a series of garden pavilions, the museum presents a constant interplay between art and nature, capturing the essence of this unique place. The galleries offer surprising and anchored perspectives on the many facets of AlUla, from the microclimates of the oasis to the expanse of the desert, evoking a deep sense of attachment to the land and its heritage.

Lina Ghotmeh, architect, contemporary art museum in AlUla

AlUla resonated with me deeply as did the local community members I met. The design takes the form of a public space, not a museum within walls, situated in AlJadidah village with galleries and spaces for sensory experiences and learning. The mountains are a constant background, whose sand dunes reach down to greet the edges of the museum, while stepped terraces of gardens act as a new interface between the village and the oasis. 

I am excited about how the museum of the Incense Road can be brought into the collective memory of the world, and become a transformative asset for the local community.

Asif Khan, architect, museum of the Incense Road

The contemporary art museum in AlUla is a museum of regional and global contemporary art with Arabia at its heart. Offering a core collection of works by artists from regions adjoining the Red Sea, the Arabian Sea and the Eastern Mediterranean in dialogue with their contemporaries from across the world, the collection aims to evolve in partnership with these artists, including a robust programme of commissioned works. As the primary art museum in AlUla, it contributes to the region’s legacy as a cultural beacon, generating opportunities for artists, designers, creatives and curators.

An adjoining series of artist-designed gardens will ensure the experience is connected to the landscape in which it sits. Integrated into the distinctive AlUla oasis, set amongst vegetable gardens, palm groves, mountain ranges and an ancient settlement, the museum will explore sensitive environmental design and function as a catalyst for environmental renewal and regeneration of the oasis. It will be structured as an archipelago of pavilion galleries interspersed with a mosaic of artist gardens. Its balance of interior and exterior galleries and gardens will allow visitors to define their own encounters both with art and the natural landscape.

The museum of the Incense Road will be the world’s first museum dedicated to this epic and millennia-old network of major land and sea trading routes, celebrating AlUla’s cultural legacy as a place of exchange at the confluence of civilisations. Bringing to life global histories, through which ideas, goods and culture were exchanged, it shines a light on north-west Arabia as a cultural epicentre. Living and dynamic narratives will include spotlighting the discoveries of ongoing excavations, highlighting the active nature of AlUla’s archaeological sites and the cultural importance of the Incense Road. At the forefront of innovative museum practice, it will enable visitors to engage through layered, multidisciplinary interpretation anchored by carefully curated collections.

The museum of the Incense Road is being developed in dialogue with AlUla’s ancient heritage – including Hegra, Saudi Arabia’s first UNESCO World Heritage Site – and its host village, AlJadidah. It will be an extension of the urban fabric that sits towards the oasis edge, looking out on a vista where Dadan and Hegra – once vibrant cities that thrived as a result of the Incense Road – are located. Guided by subject experts and the local community, the museum of the Incense Road will continue to be developed through extensive local and international collaboration with specialists across fields including academia and museology.

Both museums offer a unique entry point into AlUla’s rich and extensive cultural offering and will be developed with a socially responsible approach to the preservation, interpretation, meaningful community engagement and presentation of AlUla’s cultural inheritance. They will consider how to reduce environmental impact while building meaningful spaces, particularly regarding conservation, controlled temperature, humidity and lighting, and will work with a network of cultural leaders at an institutional, thematic and discipline level in the spirit of reciprocal exchange.

Notes to editors

About AlUla:

Located 1,100 km from Riyadh, in north-west Saudi Arabia, AlUla is a place of extraordinary natural and human heritage. The vast area, covering 22,561km², includes a lush oasis valley, towering sandstone mountains and ancient cultural heritage sites dating back thousands of years to when the Lihyan and Nabataean kingdoms reigned.

The most well-known and recognised site in AlUla is Hegra, Saudi Arabia’s first UNESCO World Heritage Site. A 52-hectare ancient city, Hegra was the principal southern city of the Nabataean Kingdom and comprises more than 100 well-preserved tombs with elaborate facades cut out of the sandstone outcrops surrounding the walled urban settlement. Current research also suggests Hegra was the most southern outpost of the Roman Empire after the Nabataeans were conquered in 106 CE.

In addition to Hegra, AlUla is home to fascinating historical and archaeological sites such as Ancient Dadan, the capital of the Dadan and Lihyan Kingdoms, which is considered one of the most developed 1st-millennium BCE cities of the Arabian Peninsula; thousands of ancient rock art sites and inscriptions at Jabal Ikmah; and AlUla Old Town, a labyrinth of more than 900 mudbrick homes developed from at least the 12th century.

About The Royal Commission for AlUla:

The Royal Commission for AlUla (RCU) was established by royal decree in July 2017 to protect and safeguard AlUla, a region of outstanding natural and cultural significance in north-west Saudi Arabia. RCU is embarking on a long-term plan to develop and deliver a sensitive, sustainable transformation of the region, reaffirming it as one of the country’s most important archaeological and cultural destinations and preparing it to welcome visitors from around the world. RCU’s development work in AlUla encompasses a broad range of initiatives across archaeology, tourism, culture, education and the arts, reflecting the ambitious commitment to cultivate tourism and leisure in Saudi Arabia, outlined in Vision 2030.

Lina Ghotmeh works and lives in Paris, where she leads her multidisciplinary practice Lina Ghotmeh — Architecture. Her visionary and materially sensitive works emerge in complete symbiosis with their environment while soliciting memory and senses.

Lina Ghotmeh is the nominated Architect for this year’s 22nd Serpentine Pavilion and her projects include Ateliers Hermès (first low carbon, energy positive building in France) delivered this April 2023, Stone Garden crafted tower and gallery spaces in Beirut (Dezeen Architecture of the year 2021 Prize), the Estonian National Museum (Grand Prix Afex 2016, project she designed in partnership with Dorell.Ghotmeh.Tane), Wonderlab Master crafts exhibition in Tokyo and Beijing & award winning Les Grands Verres restaurants for the Palais de Tokyo, Paris, France.

She is the recipient of multiple awards including the 2020 Schelling Prize, the 2020 Tamayouz “Woman of Outstanding Achievement”, the French Fine Arts Academy Cardin Award 2019, the Architecture Academy Dejean 2016 and the French Ministry AJAP Prize in 2008. Her works have been exhibited at the 17th Architecture Biennale in Venice, at the MAXXI in Rome, and currently at the Cooper Hewitt in New York.  She is active in Academic life and was Louis I Khan professor at Yale and Gehry Chair at the University of Toronto.

Asif Khan founded his London-based practice in 2007, which designs buildings, landscapes, installations, exhibitions and objects. His work is concerned with sensory experience, craftsmanship, cultural exchange and the merging of history with future worlds.

Asif Khan is currently working on the Barbican Art Centre Renewal, the new London Museum, opening 2026, itself the largest cultural project in Europe, and Liverpool Canning Dock waterfront transformation, a site at the centre of the Transatlantic Slave Trade. In 2020 he completed 6.5km of public realm design of Dubai Expo 2020, where his carbon-fibre Entry Portals received the Dezeen public award 2021 and nomination for the Aga Khan award for Architecture. He received the Grand Prix for Innovation (Cannes 2014) and Architect of the Year (German Design Council 2017).

His works have been exhibited at the Royal Academy of Arts, V&A, Milan Salone, Milan Triennale, Gwangju Design Biennale, the Design Museum, London, London Design Week, Tokyo Design Week, and currently at MAAT Lisbon. He has taught at the Royal College of Art and at Musashino Art University, Tokyo. Khan was awarded an MBE for Services to Architecture in 2017 and currently serves as Vice Chairman of the Design Museum in London.

Press contacts:

Vicky Newark
Pelham Communications
vicky@pelhamcommunications.com

Sherif Elhalafawy
Royal Commission for AlUla
s.elhalafawy@rcu.gov.sa

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Chairman of Avia Solutions Group Gediminas Ziemelis: 10 big challenges for passenger aviation sustainability for the next 3 years

DUBLIN, Ireland, May 17, 2023 (GLOBE NEWSWIRE) — Ensuring sustainable operations has become a primary driver for aviation businesses in recent years. Nonetheless, this dynamic industry faces a multitude of challenges that can impede companies’ efforts to enhance profitability. While several factors contribute to the aviation industry’s struggles, certain key issues merit highlighting as primary culprits.

High market $ interest rates for heavily leveraged and drowning-in-debt airlines will be even higher

In recent years, the aviation industry has experienced a significant drop in demand for air travel, resulting in many airlines facing financial losses. To stay afloat during this time, airlines have taken on additional debt. However, this increased debt has resulted in higher risk for lenders, leading to higher market interest rates for the airlines.

In addition to the impact of the pandemic on the industry, other factors such as rising fuel costs and increased competition have also contributed to the financial struggles of many airlines. These factors have made it increasingly challenging for heavily leveraged airlines to generate profits and pay off their debt, leading to concerns about the sustainability of their business models.

The combination of these factors has led to a situation where heavily indebted airlines are now facing even higher market interest rates, which can exacerbate their financial difficulties.

Much higher insurance costs — worsening war risks could push insurance premiums higher

The aviation industry is grappling with rising insurance costs due to worsening geopolitical risks. This is highly influenced by the fact that, as stated by leading insurance companies, around 500 aircraft leased to Russian operators remain trapped in Russia. Insurers are facing potential liability issues due to the uncertain situation created by the Russian government’s refusal to release the aircraft.

As a result, insurers are struggling to assess the level of risk involved, leading to a wide range of potential losses estimated to be up to $30 billion, according to industry sources. This uncertainty is likely to drive up insurance premiums for airlines, impacting the industry as a whole.

Passengers will remember compensations for flight delays, and it will impact airlines’ unplanned costs

The EU regulation 261/2004 provides compensation for passengers who experience delays, cancellations, overbooking, or denied boarding. Depending on the specific circumstances and subject to certain conditions, affected passengers may be eligible for a compensation claim ranging from €250 to €600 per person. Before the COVID-19 pandemic, the rate of flight delays in the EU that fell under compensation was 1.5% of all flights, with an average compensation amount of €375 per delayed flight.

In 2019, EU airlines carried a total of 1.12 billion passengers, with 1.7 million flights experiencing delays and resulting in a total compensation pay-out of €6.3 billion. Only 10% of affected passengers currently file complaints directly with the airlines or via specialised service companies, such as Skycop or Airhelp.

However, this number is expected to increase significantly, as after COVID-19 the industry faces capacity shortages and other challenges. As a result, the number of claimable flights that experience delays could increase from 1.5% to 5%, potentially leading to a total compensation pay-out of €20 billion.

LEAP engines challenges will impact more aircraft on the ground and shortage of capacity;

According to our internal research, presently, the aviation industry operates a fleet of 1397 A320neo aircraft with LEAP-1A engines, totalling 3080 engines with an average of 2.2 engines per aircraft, and 1043 Boeing 737 MAX aircraft with LEAP-1B engines, totalling 2338 engines with an average of 2.2 engines per aircraft. To maintain these engines, there are 21 locations globally for LEAP-1A overhaul and maintenance and 22 locations for LEAP-1B engines.

However, the grounding of 16,000 aircraft (equivalent to 60% of the total fleet) in 2020-2021 has led to a staggering 60% postponement of LEAP engine maintenance. Consequently, there is now a significant maintenance gap across 43 locations, resulting in wait times of 9-10 months for engine maintenance, which could potentially disrupt airline operations.

OEM production and supply chain disrupted during 2023-2025 will cause a shortage of aircraft capacity;

The COVID-19 pandemic has had a profound impact on the aerospace industry. Original Equipment Manufacturers (OEMs) such as Boeing and Airbus have experienced significant disruptions in their production and supply chains. In response to the global economic slowdown and reduced demand for air travel, OEMs have cut their production levels by around half compared to pre-COVID levels. However, this has led to a shortage of aircraft capacity, which is hindering the industry’s recovery efforts.

The production cuts have affected over 5,000 suppliers in the supply chain, all of whom have had to reduce their volumes during the pandemic. Consequently, the recovery of the aerospace industry is projected to take 2.5-4 years to return to pre-COVID production levels. This prolonged period of disruption is likely to have significant consequences for the industry and its stakeholders.

In 2020-2021, the cancellation of pilot cadet programs and planned retirements caused a pilot shortage in 2023-2024 and a rapid increase in costs for airlines;

The aviation industry faces a constant demand for new pilots, as approximately 3% of pilots retire annually. However, the COVID-19 pandemic has caused a major setback in the industry, with all cadet programs being either postponed or cancelled.

Hence, there is now a significant pilot shortage issue, leading to rapid cost increases. It is estimated that industry will experience a shortage of 300,000 pilots within a decade. This shortage is expected to create significant challenges, particularly in India, which is anticipated to have the largest pilot shortage.

Challenges to book MRO slots after COVID-19, because scheduled maintenance events were postponed

Another issue caused by the COVID-19 pandemic is a significant accumulation of MRO services for aircraft worldwide. As a result of the unprecedented reduction in air travel and the grounding of many aircraft, scheduled maintenance was delayed or deferred.

Nonetheless, as air travel demand begins to recover and airlines return to full operations, the challenge of booking MRO slots to perform necessary maintenance on these aircraft has emerged. Many airlines are finding that MRO facilities are already operating at full capacity, resulting in long wait times and potential disruptions to airline operations. This accumulation of maintenance is expected to persist for some time, creating obstacles to the aviation industry’s recovery efforts.

Challenge to find engines maintenance slots for V2500, and RR engines due to deferred maintenance

Airlines that operate aircraft with V2500 and RR engines are also encountering difficulties in scheduling maintenance for their engines due to high demand and limited availability. This has created a challenging situation, particularly for airlines with large fleets of such aircraft.

The lack of available maintenance slots has forced airlines to ground some of their aircraft, leading to operational disruptions and revenue losses. In addition to the financial impact, the situation also poses safety concerns as delayed maintenance can compromise the safety and reliability of the engines, potentially leading to more significant problems in the future.

ESG requirements for greener aviation didn’t disappear in the medium term

The International Civil Aviation Organisation’s (ICAO) 41st Assembly, held in Montreal in October 2022, marked a significant milestone for the aviation industry’s commitment to sustainability. The assembly committed to a Long Term Aspirational Goal (LTAG) to achieve net zero CO2 emissions by 2050, which has brought Environment, Society, and Governance (ESG) issues to the forefront of the sustainable aviation conversation.

The LTAG’s ambitious target is challenging, but it has the potential to encourage airlines to accelerate the development and adoption of greener jet fuels and other technical improvements to decarbonise flying. This will require a significant shift in industry-wide mindset, investment in research and development, and collaboration between airlines, manufacturers, and governments to achieve the long-term goal.

After COVID-19, debts for spare parts, MRO services, and aircraft leasing will impact that some aircraft will still be grounded, which will cause capacity demand

The challenging situation in the industry has pushed airlines to take on additional debt to finance various aspects of their operations, such as spare parts, MRO services, and aircraft leasing. However, the increase in outstanding debt for the industry could have significant implications, with some airlines potentially struggling to pay off their debts, which could result in a reduction in capacity as airlines are forced to ground some of their aircraft or cut routes to minimise costs.

Insider data shows that the industry’s outstanding debt has jumped over 20% since 2020, reaching more than $300 billion. To raise capital, global air carriers have sold $63 billion in bonds and loans so far this year.

Media contact:
Silvija Jakiene
Chief Communications Officer
Avia Solutions Group
silvija.jakiene@aviasg.com
+370 671 22697

GlobeNewswire Distribution ID 1000810732

Sweegen’s Rebaudioside M receives full authorization for use in the United Kingdom

Bestevia Reb M expands sugar reduction solutions in the U.K.and is now available to food and beverage producers.

Rancho Santa Margarita, Calif., May 17, 2023 (GLOBE NEWSWIRE) — Global sweetness and flavor innovator, Sweegen has announced that its Bestevia® Rebaudioside M (Reb M) has been fully authorized for use in the United Kingdom (U.K.) This regulatory approval marks a significant milestone for Sweegen, as it becomes the first and only company to receive authorization for any steviol glycosides produced using alternative technologies in the U.K.

Reb M, a high-purity steviol glycoside derived from the stevia plant, is renowned for its clean and sugar-like taste profile. It offers a natural, zero-calorie sweetness solution, making it an ideal choice for food and beverage manufacturers seeking to reduce sugar content and provide healthier options to consumers. Sweegen’s nature-based sweeteners, including its Reb M, offer a scalable and cost-effective alternative to traditional sugar.

Brands in the U.K. have eagerly anticipated the authorization of Sweegen’s Bestevia Reb M during the initial formulation phase and tastings. They are actively collaborating with Sweegen’s food and beverage applications experts based at its EMEA U.K. Innovation Studio in Reading, England, to integrate this highly sought-after stevia ingredient, along with Sweegen’s outstanding taste modulation and unique sweeteners, into their formulations.

Damian Bellusci, Vice President of Sales EMEA/APAC at Sweegen, expressed his excitement about the authorization, stating, “We are extremely proud to be the pioneers in securing full authorization for Bestevia Reb M in the U.K. This milestone reaffirms Sweegen’s commitment to providing innovative, nature-based, and sustainable sweetening solutions to the industry. Reb M offers food and beverage manufacturers an exceptional tool to meet consumer demands for healthier products without compromising taste.”

The decision to authorize the bioconversion manufacturing method for steviol glycosides, including Reb M, was made by the Minister for Primary Care and Public Health in relation to England, the Welsh Ministers in relation to Wales, and the Minister for Public Health, Women’s Health and Sport in relation to Scotland. The authorization is per Article 10(1) of retained Regulation 1333/2008, fulfilling the requirements.

The authorized manufacturing method allows for using steviol glycosides, including Reb M, in the Great Britain (GB) market. The Regulations provide updated terms of authorization for using this method in GB, with the terms being similar to those in the European Union (EU) and Northern Ireland. For the latest information, referring to the relevant EU Regulations on the EUR-Lex website is recommended.

Casey McCormick, Vice President of Global Innovation at Sweegen, emphasized the significance of Reb M in driving product innovation. “The approval of Bestevia Reb M in the UK represents a very positive step forward for brands looking to improve the nutrition profile of their products. The clean, sweet taste of our Bestevia Reb M enables new approaches to reduce and eliminate sugar in a way that exceeds consumers’ expectations  and supports public health objectives to reduce sugar consumption.”

Hadi Omrani, Vice President of Technical and Regulatory Affairs at Sweegen, highlighted the rigorous safety and compliance standards behind Bestevia Reb M’s authorization. Omrani stated, “At Sweegen, we prioritize safety, quality, and regulatory compliance. Obtaining full authorization for Bestevia Reb M in the U.K. required thorough scientific evaluations and stringent assessments to ensure its safety for consumption. This achievement reflects our commitment to delivering superior products that meet the highest industry standards.”

Sweegen is dedicated to revolutionizing the sweetener market with innovative solutions that promote healthier choices without compromising taste. The full authorization of Bestevia Reb M in the U.K. reinforces Sweegen’s leadership in the nature-based sweetener space and positions the company as a trusted partner for food and beverage manufacturers worldwide.

Sweegen recently attained FEMA GRAS status for sweet proteins brazzein and thaumatin II, complementing steviol glycosides in food and beverage production. With the addition of brazzein and thaumatin II, Sweegen continues to expand its portfolio of safe and effective taste-modulating flavors that can help food and beverage manufacturers meet the demand for healthier and delicious products to align with consumers’ holistic approaches to wellness. Brazzein is the star ingredient in Sweegen’s newly launched Sweetensify flavors for taste modulation, an ideal flavors tool for brands seeking to create sugar-like tastes in food and beverages.

About Sweegen

Sweegen provides sweet-taste solutions for food and beverage manufacturers around the world.
We are on a mission to reduce sugar and artificial sweeteners in the global diet. Partnering with customers, we create delicious zero-sugar products that consumers love. With the best modern sweeteners in our portfolio, such as Bestevia® Rebs B, D, E, I, M, and N, and sweet proteins brazzein and thaumatin, along with our deep knowledge of flavor modulators and texturants, Sweegen delivers market-leading solutions that customers want, and consumers prefer. Well. Into the Future.

Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1996. Sweegen’s actual results may differ from the estimates, assumptions, and other illustrative material contained herein, and consequently, a reader should not rely on these forward-looking statements as predictions of future events. These forward-looking statements include, without limitation, illustrative information regarding Sweegen’s bottom-up assumed market potential, assumed hit rate, and the resulting revenue based on these model inputs. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results.

Industry, Market, and Other Data
In this press release, we rely on and refer to information and statistics regarding market participants in the sectors in which Sweegen competes and other data. We obtained this information and statistics from our own internal estimates and third-party sources, including reports by market research firms and company filings. We do not expressly refer to these sources. All of this information involves a number of assumptions and limitations, and the sources of such information cannot guarantee the accuracy or completeness of such information. The industry in which Sweegen operates is subject to a high degree of uncertainty and risk due to a variety of important factors, any of which could cause results to differ materially from those expressed in the estimates made by Sweegen or third parties.

Cautionary Statement Concerning Forward-Looking Statements
This press release contains forward-looking statements, including, among other statements, statements regarding the future prospects for Reb M stevia leaf sweetener, brazzein, and thaumatin. These statements are based on current expectations but are subject to certain risks and uncertainties, many of which are difficult to predict and beyond Sweegen’s control.

Relevant risks and uncertainties could cause actual results to differ materially from those expressed in or implied by the forward-looking statements and, therefore, should be carefully considered. Sweegen assumes no obligation to update any forward-looking statements as a result of new information or future events or developments.

Attachments

Ana Arakelian
Sweegen
+1.949.709.0583
ana.arakelian@sweegen.com

GlobeNewswire Distribution ID 8841398

Nyxoah Reports First Quarter 2023 Financial and Operating Results

REGULATED INFORMATION

Nyxoah Reports First Quarter 2023 Financial and Operating Results

Mont-Saint-Guibert, Belgium – May 16, 2023 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 first quarter of 2023.

Recent Financial and Operating Highlights

  •  Completed all 115 implants in the DREAM U.S. pivotal trial, with 12-month data expected in the first quarter of 2024.
  •  Initiated the modular PMA submission with the filing of the first module.
  •  Submitted 12-month data1 on the first 34 DREAM patients as a late-breaking abstract to SLEEP 2023 demonstrating a 65% AHI responder rate, a 76% ODI responder rate and safety in-line with expectations. The abstract will be presented in a late-breaking poster session on June 6th. These data are preliminary and not conclusive of final DREAM success.
  •  Implanted the first patients in the ACCCESS U.S. IDE pivotal study to treat complete concentric collapse (CCC). Implant completion expected in 2024.
  •  Hired Christoph Eigenmann as Chief Commercial Officer.
  •  Raised €19 million from new and historical shareholders including ResMed, Cochlear and Robert Taub, Nyxoah’s Chairman and Founder.
  •  Ended the quarter with 40 active German accounts and quarterly sales of €441 thousand.
  •  Expanded European market access with first implants in Austria.
  •  Strengthened the supply chain with the Belgium manufacturing facility receiving clearance from the EU notified body.

“In 2023, our focus is in the U.S. on DREAM patient follow up resulting in reaching the primary endpoints. I am excited by the data on the first 34 patients and look forward to sharing the full abstract results at SLEEP 2023 next month. Our increasing conviction in DREAM outcomes is accelerating investment in our commercial organization, starting with the addition of Christoph as Chief Commercial Officer,” commented Olivier Taelman, Nyxoah’s Chief Executive Officer. “Christoph’s hire, along with the €19 million raised from key investors, puts us in a strong position as we embark on our next stage of growth.”

First Quarter 2023 Results

UNAUDITED CONDENSED CONSOLIDATED FINANCIAL INFORMATION – CONSOLIDATED STATEMENTS OF LOSS AND OTHER COMPREHENSIVE LOSS FOR THE THREE MONTHS ENDED MARCH 31, 2023  (in thousands)

        For the three months ended March 31
2023   2022
Revenue €441 €660
Cost of goods sold   (175) (289)
Gross profit €266 €371
Research and Development Expense   (6,157) (3,595)
Selling, General and Administrative Expense (5,551) (4,193)
Other income/(expense) 46 136
Operating loss for the period   €(11,396) €(7,281)
Financial income 625 1,576
Financial expense   (958) (788)
Loss for the period before taxes €(11,729) €(6,493)
Income taxes   (182) (208)
Loss for the period €(11,911) €(6,701)
     
Loss attributable to equity holders €(11,911) €(6,701)
Other comprehensive loss  
Items that may be subsequently reclassified to profit or
loss (net of tax)
Currency translation differences   (28) ( 102)
Total comprehensive loss for the year, net of tax €(11,939) €(6,803)
Loss attributable to equity holders   €(11,939) €(6,803)
Basic Loss Per Share (in EUR) €(0.460) €(0.260)
Diluted Loss Per Share (in EUR) €(0.460) €(0.260)

 UNAUDITED CONDENSED CONSOLIDATED FINANCIAL INFORMATION – CONSOLIDATED STATEMENT OF FINANCIAL POSITION AS OF MARCH 31, 2023 (in thousands)

    As at
March 31
2023
  December 31 2022
ASSETS
Non-current assets      
Property, plant and equipment €2,721 €2,460
Intangible assets 42,447   39,972
Right of use assets 3,669 3,159
Deferred tax asset     50   47
Other long-term receivables 169 173
    €49,056   €45,811
Current assets      
Inventory     1,249   882
Trade receivables 1,499 1,463
Other receivables     1,419   1,775
Other current assets 1,663 1,284
Financial assets 62,403 76,968
Cash and cash equivalents 33,664 17,888
  €101,897 €100,260
Total assets €150,953 €146,071
   
EQUITY AND LIABILITIES
Capital and reserves    
Capital 4,859 4,440
Share premium 243,488   228,275
Share based payment reserve   6,582 5,645
Other comprehensive income 148   176
Retained loss   (130,051) (118,212)
Total equity attributable to shareholders €125,026 €120,324
     
LIABILITIES
Non-current liabilities    
Financial debt 8,381   8,189
Lease liability   3,112 2,586
Pension liability 25  
Provisions   74 59
Deferred tax liability  
€11,592 €10,834
Current liabilities    
Financial debt 390   388
Lease liability   711 719
Trade payables 5,012   4,985
Current tax liability 3,619   3,654
Other payables 4,603   5,167
  €14,335 €14,913
Total liabilities €25,927 €25,747
Total equity and liabilities €150,953 €146,071

Revenue

Revenue was €441,000 for the first quarter ending March 31, 2023, compared to €660,000 for first quarter ending March 31, 2022.

Cost of Goods Sold

Cost of goods sold was €175,000 for the three months ending March 31, 2023, representing a gross profit of €266,000, or gross margin of 60.3%. This compares to total cost of goods sold of €289,000 in the first quarter ending March 31, 2022, for a gross profit of €371,000, or gross margin of 56.2%.

Research and Development Expenses

Research and development expenses were €6.2 million for the three months ending March 31, 2023, versus €3.6 million for the prior year period, driven by an acceleration in clinical activities, notable the start of the ACCCESS study.

Selling, General and Administrative Expenses

Selling, general and administrative expenses rose to €5.6 million for the first quarter of 2023, up from €4.2 million in the first quarter of 2022. 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 the U.S. commercial launch.

Operating Loss

Total operating loss for the first quarter 2023 was €11.4 million versus €7.3 million in the first quarter of 2022. This was driven by the acceleration in the Company’s R&D spending, as well as ongoing commercial and clinical activities.

Cash Position
As of March 31, 2023, cash and financial assets totaled €96.1 million, compared to €94.9 million on December 31, 2022.  Total cash burn was approximately €4.9 million per month during the first quarter of 2023.

First Quarter 2023 Report
Nyxoah’s financial report for the first quarter of 2023, including details of the 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 open to the public today at 10:30pm CET / 4:30pm 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://edge.media-server.com/mmc/p/imeku8f7

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; 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
David DeMartino, Chief Strategy Officer
david.demartino@nyxoah.com
+1 310 310 1313


1 For the trial to be successful, of the 115 patients, at least 63% of patients need to be AHI and ODI responders at the 12-month follow-up.

Attachment

GlobeNewswire Distribution ID 1000810492