RCSI Bahrain continues to meet Global Healthcare Educational Standards and support the development of national healthcare programmes in the Gulf Countries

Bahrain, Manama, May 10, 2022 (GLOBE NEWSWIRE) — In line with the global standards of quality medical education, the Royal College of Surgeons in Ireland "" Medical University of Bahrain (RCSI Bahrain) received re–accreditation from the Medical Council of Ireland (IMC) for its undergraduate medicine programme in 2021, and revalidation from the Bahrain Education & Training Quality Authority (BQA) for its undergraduate nursing and MSc in nursing programmes in 2022. The undergraduate medicine programme has been accredited by the IMC since 2014 and the RCSI Bahrain School of Medicine is included in the World Directory of Medical Schools and listed on the International Association of Universities' "List of Universities of the World" by the UNESCO.

To perform the re–accreditation process, the IMC visiting team chaired by the Medical Council Member, Professor Mary O'Sullivan, Dean of the University of Limerick, Ireland, and comprising of Council and external members, met with the RCSI Bahrain Executive Management Team, School of Medicine staff, the University's Student Council, students from all year groups and RCSI Bahrain interns. This being to carry out the undergraduate medicine programme accreditation in alignment with the World Federation of Medical Education's (WFME) "Global Standards for Quality improvement in Medical Education' framework. The IMC issued a five–year renewal of the accreditation of the undergraduate medicine programme, which is valid until November 2026.

The BQA's review panel led by Professor Erika Sirsch, acting Dean of the nursing science faculty at the Philosophical–Theological University of Vallendar, Germany, comprised of three regional and international healthcare professionals, in addition to the BQA members. The review involved meetings with the RCSI Bahrain Executive Management Team, staff from both the School of Nursing and Midwifery and the School of Postgraduate Studies and Research, staff across the University's support units, as well as students and alumni. RCSI Bahrain received the decision of Full Confidence from the BQA and it continues to maintain its valid status as placed on National Qualifications Framework of Bahrain (NQF) for its Undergraduate Nursing and MSc in Nursing programmes.

Both visits from the IMC and BQA involved several meetings with RCSI Bahrain training leads and Clinical Lecturers and Tutors, programme Advisory Boards and employers from the Ministry of Health and the University's partner hospitals including King Hamad University Hospital, Bahrain Defence Force Hospital "" Royal Medical Services, Salmaniya Medical Complex, American Mission Hospital, multiple health centres across Bahrain and Cleveland Clinic in Abu Dhabi, UAE.

President of RCSI Bahrain, Professor Sameer Otoom commented, "With our accreditation standards and a world–renowned curriculum, RCSI Bahrain graduates attain a level of knowledge and clinical experience to compete for rewarding career opportunities worldwide, as well as supporting the development of national healthcare programmes in the Gulf Countries".

–Ends–

About RCSI Bahrain

RCSI Bahrain is a constituent university of RCSI, which was established in Dublin, Ireland, in 1784. RCSI Bahrain, an independent private university, opened its doors to a cohort of 28 medical students in 2004. It is a not–for–profit health sciences institution focused on education and research to drive positive change in all areas of human health worldwide. Today, the purpose–built campus is home to a student body of more than 1,300 across Schools of Medicine; Nursing and Midwifery and Postgraduate Studies and Research.

For more information, please visit www.rcsi.com/bahrain

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GLOBENEWSWIRE (Distribution ID 8539563)

Reuters Partners with The Globe and Mail’s Sophi.io Automation Platform

TORONTO, May 10, 2022 (GLOBE NEWSWIRE) — Sophi.io, an AI–powered automation, optimization and prediction platform developed by The Globe and Mail, is now working with Reuters – the news and media division of Thomson Reuters – as it continues to invest in the latest AI solutions for its newsroom. Sophi is helping to automate content curation on select sections on Reuters.com, which was relaunched in April 2021.

Sophi Site Automation is an AI system that autonomously curates digital content to find and promote an organization's most engaging content. Sophi looks at all content as it's published, and all traffic, to find the hidden gems that an organization's customers value the most.

In order to automate content curation, Sophi's algorithm has been learning from Reuters editors. The newsroom has been able to work with some of the latest AI solutions, which has resulted in giving time back to editors to focus on finding the next story and creating the journalism that makes Reuters such a trusted brand.

Josh London, Head of Reuters Professional and Chief Marketing Officer of Reuters, said: "Sophi's cutting–edge AI platform is one of the next steps in the evolution of our digital properties. Sophi will help us further our mission of bringing AI–based technology and tools to more corners of the workforce, whilst helping to bring our readers the stories they both want and need to know."

Michael Young, Chief Technology Officer for Reuters, said: "Our partnership with Sophi.io is another example of how a newsroom like ours can successfully deploy some of the latest AI solutions for effective content discovery. Our team worked closely with the Sophi team to ensure our Sophi Score reflected our business goals and we are pleased with the resulting site automation."

Mike O'Neill, Co–Founder and CEO of Sophi.io, added "We are delighted to have Reuters as a customer. They put their trust in Sophi and we are excited to automate curation across all of their article pages to start and expand the relationship to include more solutions down the road."

"It's wonderful to work with Reuters in this capacity," said Phillip Crawley, Publisher and CEO of The Globe and Mail. "They have a strong mission and Sophi.io is helping them continue to demonstrate how editorial integrity can be supported by AI."

About Reuters
Reuters is the world's leading provider of trusted news, insight and analysis, reaching billions of people worldwide every day. Founded in 1851, it brings together world–class journalism, industry expertise and cutting–edge technology with unparalleled speed, reliability and accuracy to enable people to make better decisions. Reuters is committed to the Trust Principles of independence, integrity and freedom from bias, and is the essential source of business, financial and world news delivered to financial professionals exclusively via Refinitiv services, and to the world's media organizations, industry events and directly to consumers.

About Sophi.io
Sophi.io (https://www.sophi.io) was developed by The Globe and Mail to help content publishers make important strategic and tactical decisions. It is a suite of AI and ML–powered automation, optimization and prediction solutions that include Sophi Site Automation, Sophi for Paywalls and Sophi for First Party Data. Sophi also powers one–click automated laydown of template–free print publishing. Sophi is designed to improve the metrics that matter most to your business, such as subscriber retention and acquisition, engagement, recency, frequency and volume.


GLOBENEWSWIRE (Distribution ID 8539467)

Taconic Biosciences Appoints Nomura Siam as Distributor in India for All Taconic Animal Models

RENSSELAER, N.Y., May 10, 2022 (GLOBE NEWSWIRE) — Taconic Biosciences, a global leader in providing drug discovery animal model solutions, has appointed Nomura Siam International Co., Ltd (NSI), an established distributor of laboratory animals and related products, as its preferred distributor in India.

India makes a significant contribution to global pharmaceutical and vaccine production, and its pharmaceutical and biotechnology research and development is expected to grow over the next decade. To support this growth, scientists in India need advanced mouse and rat models for pharmacology studies and toxicology and drug safety assessment. Research across all therapeutic areas requires genetically engineered models (GEMs). Additionally, mice with humanized immune systems are critical for immuno–oncology and other applications.

Taconic's portfolio comprises nearly 4,700 mouse and rat models, including widely used standard strains, immunodeficient models, and exclusive GEMs. Taconic is also a global leader in humanized immune system mouse generation. Taconic's industry–leading quality systems, genetic integrity, and globally harmonized animal health standards promote research reproducibility while its flexible approach to licensing reduces barriers to accessing valuable GEMs.

Based in Thailand, NSI is known for its focus on quality and customer service. The company's new agreement with Taconic significantly increases preclinical researchers' access to GEMs in India and allows NSI to offer this market a full spectrum of solutions.

"To date, rodent model selection and availability has been somewhat limited in India. We believe this partnership will provide India's growing pharmaceutical industry access to the most sophisticated and high–quality animal models available globally," said Dr. Michael Seiler, vice president of commercial products at Taconic. "We truly believe this partnership will support Taconic's desire to accelerate new life–saving therapeutics for the global community."

"Taconic's portfolio of sophisticated mouse models fills a major gap in the Indian market," said Taiichiro Kamiya, president of NSI. "By our frequent information sharing, and the improvement of logistic process, we will provide faster and easier access to GEMs for Indian users."

To learn more about Taconic's full line of animal model solutions, please call 1–888–TACONIC (888–822–6642) in the US, +45 70 23 04 05 in Europe, or email info@taconic.com.

About Taconic Biosciences, Inc.

Taconic Biosciences is a fully licensed, global leader in genetically engineered rodent models and services. Founded in 1952, Taconic provides the best animal solutions so that customers can acquire, custom–generate, breed, precondition, test, and distribute valuable research models worldwide. Specialists in genetically engineered mouse and rat models, microbiome, immuno–oncology mouse models, and integrated model design and breeding services, Taconic operates service laboratories and breeding facilities in the US and Europe, maintains distributor relationships in Asia, and has global shipping capabilities to provide animal models almost anywhere in the world.

About Nomura Siam International Co. Ltd. (NSI)

Nomura Siam International Co. Ltd., based in Bangkok, Thailand, was jointly established in 2012 by CLEA Japan, Inc. and Nomura Jimusho, Inc. as a comprehensive provider for the laboratory animal field. As a one–stop service supplier, NSI not only sells laboratory animals but also handles a wide range of related products, including equipment for breeding, conducting experiments, and environmental enrichment, as well as consulting services for preclinical research and laboratory animal facility design.

Media Contact:

Aidan Bouchelle
Associate Director, Marketing Operations
518–949–7598
Aidan.Bouchelle@taconic.com


GLOBENEWSWIRE (Distribution ID 8537399)

Dante Labs receives grant by Italian government to pilot revolutionary CE-IVD, clinical whole genome sequencing-based Citizen Test for a G7 country, starting a new era in clinical genomics

NEW YORK, May 10, 2022 (GLOBE NEWSWIRE) — Dante Labs, a global leader in genomics and precision medicine, is pleased to announce the Italian Ministry of Economic Development has selected Dante to develop and pilot the first fully–CE–IVD, clinically approved whole genome sequencing (WGS) test for the citizens of Italy to be named the Dante Citizen Test.

The goal of the project is to introduce clinical whole genome sequencing with clinical reports in the standard medical care of the country's hospitals and healthcare system and is the first step to introduce whole genome sequencing in the national healthcare system of a European and G7 country. The test will leverage Dante's proprietary Extensa software for reporting, interpretation and analysis of whole genome and medical data.

"Clinical whole genome sequencing will finally become a standard solution in public healthcare systems, not as a luxury for the few but as a right for every citizen, thanks to the Dante Citizen Test," said Andrea Riposati, CEO of Dante Labs. "The effective use of whole genome sequencing in standard clinical care requires mastery at sequencing, interpretation and integration of medical information, at scale. This is what we have been doing at Dante. Now, with partnerships with forward looking governments, like Italy's, we can impact millions of patients worldwide."

The groundbreaking project will be overseen by the Dante's newly appointed European Medical Genomics Board, which is made of national and multinational world leaders in genomics, including geneticists, molecular biochemists and clinical experts in pharmacogenomics, nutrigenomics and oncogenomics, prenatal, neonatal and pediatric rare diseases.

About Dante Labs

Dante Labs is a global genomic information company building and commercializing a new class of transformative health and longevity applications based on whole genome sequencing and AI. The Company uses its platform to deliver better patient outcomes from diagnostics to therapeutics with assets including one of the largest private genome databases with research consent, proprietary software designed to unleash the power of genomic data at scale and proprietary processes which enable an industrial approach to genomic sequencing.

Contact:

Laura D'Angelo
VP of Investor Relations
ir@dantelabs.com
+39 0862 191 0671
www.dantelabs.com


GLOBENEWSWIRE (Distribution ID 8538985)

Eurora Solutions is participating in the World Mail & Express EMEA conference

TALLINN, Estonia, May 10, 2022 (GLOBE NEWSWIRE) — Eurora Solutions, an Artificial Intelligence/Machine Learning–backed (AI/ML) cross–border e–commerce compliance platform, is pleased to announce that its management team will take part in the World Mail & Express EMEA conference between 10–12 May in Dubai, United Arab Emirates.

The Company's attendance follows Eurora's oversubscribed $40m Series A round, announced last month. Eurora plans to use the funds for global expansion, including in the Middle East, where rapid and high growth in the sector is expected – between 2016 and 2020 alone, the size of the e–commerce industry quadrupled in the region.

On Wednesday 11th of May, Eurora's COO, Egon Veerme, will present the company introduction titled “Reshaping Cross–Border Trade with AI–Based Solutions,” which will give an overview of Eurora's AI/ML–based e–commerce compliance platform that automates tax, compliance and customs services and can be used by online sellers, marketplaces, logistics and postal companies, and tax and customs authorities.

Eurora's COO, Egon Veerme, said: “I look forward to introducing Eurora at this leading e–commerce conference. Our platform is already used by hundreds of clients worldwide helping with tax and customs procedures. We view the Middle East as a priority market, and I'm confident that we'll be able to find new potential partners that could benefit from Eurora's platform and add value to our existing customers.”

Eurora's platform automatically processes 5,000 requests per second with up to 96% accuracy, the highest level of accuracy, speed, and automation available on the market. It operates at a fraction of the time and price of hybrid or manual code allocation solutions commonly used today. It assigns e–commerce products an appropriate HS code, calculates the applicable VAT and duty amounts, and automatically creates electronic declarations for duties and taxes via simple API integration.

Interested parties can learn more about Eurora's proprietary e–commerce compliance platform at Eurora's conference booth no 15 located at the InterContinental Dubai Festival City.

The following representatives of Eurora will be present at the WMX EMEA and available for meetings:

For more information:

Name Position
Anneli Aljas CFO pr@eurora.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/155b829d–c159–43eb–823a–8bb9d8e080e9


GLOBENEWSWIRE (Distribution ID 1000632343)

Capitec Bank Selects nCino to Drive Digital Business Banking Innovation

LONDON and STELLENBOSCH, South Africa, May 10, 2022 (GLOBE NEWSWIRE) — nCino, Inc. (NASDAQ: NCNO), a pioneer in cloud banking and digital transformation solutions for the global financial services industry, today announced that Capitec Bank (Capitec; JSE: CPI), South Africa's largest and fastest–growing digital bank has partnered with nCino. nCino is assisting with building the bank's Business Banking loan management system, optimising its simplicity and efficiency in line with Capitec's mission to help clients bank better to live better.

Karl Kumbier, Executive of Capitec Business, says he is very excited that Capitec has chosen nCino as a partner, saying that "Capitec is a brand that is associated with hard work, innovation, and disruption. It is the fastest–growing bank in the country and has over 70,000 business banking clients. We are looking forward to taking our ethos of simplicity even further, with the inclusion of this technology into our systems for a more seamless experience for the businesses we serve."

"We are extremely proud to be working with Capitec, an institution with an incredible reputation as South Africa's largest digital bank," said Pierre Naud, CEO at nCino. "With 17 million retail clients, Capitec has embraced an agile and innovative approach to growth. We're glad Capitec saw a partner in nCino and look forward to providing the Bank with industry–leading technology and a flexible platform that will help drive the sustainability and growth of its business banking operations."

Thomas Byrne, Head of Product, EMEA at nCino added, "As we continue to expand into new countries, we're developing additional depth and breadth to the nCino platform to solve the business, technical, and regulatory pain points that regularly trouble financial institutions on a global scale. We're looking forward to providing Capitec with a scalable platform that enables the bank to improve client and employee experiences by streamlining, digitising and automating complex processes for a faster, more efficient and transparent experience for business owners."

About Capitec
Capitec"Bank (JSE: CPI), the biggest digital bank in South Africa based on the number of clients, has gained over 18 million active clients' trust."Capitec"Bank offers simplified, affordable, and transparent banking with personalised service, using relevant innovative technology to drive down costs and increase security and accessibility. From a digital perspective,"Capitec"Bank is South Africa's largest digital bank with over 10 million digital clients.

The Group acquired Mercantile Bank, a business bank for small and medium enterprises, in 2019 and is committed to building a business bank that is disruptive in the market and scalable through digital technology.

About nCino
nCino (NASDAQ: NCNO) is the worldwide leader in cloud banking. The nCino Bank Operating System empowers financial institutions with scalable technology to help them achieve revenue growth, greater efficiency, cost savings and regulatory compliance. In a digital–first world, nCino's single cloud–based platform enhances the employee and client experience to enable financial institutions to more effectively onboard clients, make loans and manage the entire loan life cycle, and open deposit and other accounts across lines of business and channels. Transforming how financial institutions operate through innovation, reputation and speed, nCino is partnered with more than 1,750 financial institutions of all types and sizes on a global basis. For more information, visit www.ncino.com.

MEDIA CONTACTS
Jasmin Athwal, nCino Natalia Moose, nCino
+44 7881 374552 +44 7825 211135
jathwal@mww.com natalia.moose@ncino.com

This press release contains forward–looking statements within the safe harbour provisions of the Private Securities Litigation Reform Act of 1995. Forward–looking statements generally include actions, events, results, strategies and expectations and are often identifiable by use of the words "believes," "expects," "intends," "anticipates," "plans," "seeks," "estimates," "projects," "may," "will," "could," "might," or "continues" or similar expressions. Any forward–looking statements contained in this press release are based upon nCino's historical performance and its current plans, estimates, and expectations, and are not a representation that such plans, estimates, or expectations will be achieved. These forward–looking statements represent nCino's expectations as of the date of this press release. Subsequent events may cause these expectations to change and, except as may be required by law, nCino does not undertake any obligation to update or revise these forward–looking statements. These forward–looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially including, among others, risks and uncertainties relating to the market adoption of our solution, competition, international expansion, and privacy and data security matters. Additional risks and uncertainties that could affect nCino's business and financial results are included in reports filed by nCino with the U.S. Securities and Exchange Commission (available on our website at www.ncino.com or the SEC's website at www.sec.gov). Further information on potential risks that could affect actual results will be included in other filings nCino makes with the SEC from time to time.


GLOBENEWSWIRE (Distribution ID 8538684)

Hitachi Energy launches game-changing power semiconductor module globally for all types of electric vehicles

Zurich, Switzerland, May 10, 2022 (GLOBE NEWSWIRE) — Hitachi Energy, the global technology and market leader in power grids, today announced it will launch globally RoadPak, its pioneering power semiconductor module for electric vehicles at PCIM Europe, the world's leading power electronics trade fair in Nuremberg, Germany, May 10–12.

RoadPak sets a new benchmark in electric vehicle performance. This compact module uses state–of–the–art silicon carbide (SiC) technology to achieve exceptional levels of power density for faster charging, reliability over the vehicle's lifetime, and the lowest possible power losses for the longest possible driving range.

"RoadPak is the result of more than 100 years of Hitachi Energy innovation and market leadership in power electronics," said Niklas Persson, Managing Director of Hitachi Energy's Grid Integration business. "Along with our Grid–eMotion Flash and Fleet EV charging systems, it builds on our commitment to take e–mobility to the next level and advance a more sustainable energy future for all."

Tested by many EV manufacturers and with two seasons of flawless performance with the Mahindra Racing Formula E team, RoadPak is available in both the 750 volt and 1,200 volt ranges. This makes it ideal for all types of electric vehicle "" regular and luxury cars, commercial vehicles, buses, agricultural EVs, heavy–duty trucks and high–performance racing cars.

"We have had the privilege of piloting this advanced power module on our Mahindra M7Electro and M8Electro racing cars over the last two years, which has proven to significantly increase performance and reliability," said Dilbagh Gill, CEO and Team Principal of Mahindra Racing. "This high technology improvement allows us to develop next–generation state–of–the–art green automotive solutions and improve driving experience."

Power semiconductors are a critical component in electric vehicles. They are the heart of the inverter, which converts DC power from the vehicle's battery into the AC power that drives the motor. Reliability is key. RoadPak semiconductors are designed to operate faultlessly for more than four million start–stop cycles over the vehicle's lifetime.

The EV market is growing exponentially. Global sales of electric cars grew 40 percent in 2020 and almost doubled in 2021.1 In addition, all major car manufacturers have committed to phase out their petrol and diesel vehicles by 2030 or earlier.

Hitachi Energy has two separate manufacturing sources supporting security of supply worldwide for its SiC–based power semiconductor products, including RoadPak. The company makes its own SiC chips at its semiconductor factory in Switzerland and is supported by an independent SiC chip manufacturer in the United States, thereby securing supply in terms of both volumes and geographic availability.

Hitachi Energy's advanced semiconductor technology is a key component in its grid integration solutions that enable vast amounts of renewable energy to flow reliably through power grids and between nations. They are also key to the traction converter systems that drive high–speed electric trains and metros, and the electric vehicles that are making road transportation clean and sustainable.

Notes to the Editor:

1. According to the International Energy Agency and World Economic Forum respectively: https://www.iea.org/news/global–electric–car–sales–set–for–further–strong–growth–after–40–rise–in–2020 and https://www.weforum.org/agenda/2022/02/electric–cars–sales–evs/.

– End ""

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 38,000 people in 90 countries and generate business volumes of approximately $10 billion USD.

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 billions of yen (84,136 millions of U.S. dollars), 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


GLOBENEWSWIRE (Distribution ID 8538367)

Nyxoah Reports First Quarter 2022 Financial and Operating Results

REGULATED INFORMATION

Nyxoah Reports First Quarter 2022 Financial and Operating Results

Mont–Saint–Guibert, Belgium "" May 10, 2022, 08:50pm CET / 2:50pm 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 2022.

First Quarter 2022 Financial and Operating Highlights

  • Generated revenue of 660,000 from the commercialization of Genio in Europe, primarily in Germany, which represents year–over–year growth of more than three–and–and–half times and is more than double what was achieved in the fourth quarter of 2021
  • Exited the first quarter with 15 active implant sites in Germany, representing 25% growth over Q4 2021; Nyxoah expects to add an extra 10 sites by the end of the third quarter of 2022, bringing the total to 25 active implanting accounts and driving quarterly sales acceleration and market leadership in Germany by the end of 2022
  • Completed the first commercial Complete Concentric Collapse (CCC) patients in Germany
  • Accelerated monthly patient enrollment in the DREAM U.S. IDE study and continue to expect implants to be completed in the second quarter of 2022
  • The U.S. FDA approved Nyxoah's request to reduce the sample size in DREAM to 115 patients from the original 134, driven by new and favorable data from the BETTER SLEEP study; aside from the updated sample size, all other study parameters, including performance goals, statistical power, and significance level, remain identical to the original approved study
  • Nominated Raymond Cohen, Chief Executive Officer and board member of Axonics, Inc. and Virginia Kirby, Executive–in–Residence at the Discovery Launchpad at the University of Minnesota's Office of Technology Commercialization, for appointment to the Board of Directors, pending approval by the Annual Shareholders' Meeting on June 8, 2022; Don Deyo and Jan Janssen are stepping down, keeping the total number of board members at eight

"I am extremely pleased with our first quarter results and strong execution that resulted in an acceleration in sales and DREAM implants as we progress towards achieving all of our strategic priorities for 2022 and beyond," commented Olivier Taelman, Nyxoah's Chief Executive Officer. "On the commercial side, the 660,000 of revenue we booked in the first quarter was roughly equal to the revenue performance from the previous three quarters combined. We now have 15 active implant sites in Germany, and we will continue to add 10 more sites by the end of the third quarter. This growth validates our patient–centric, "Going Deep' strategy of developing Centers of Excellence as we increase therapy penetration at each of these sites. We were also thrilled to implant our first commercial CCC patients in Germany, and we expect continued acceleration in CCC implants following the positive response to our BETTER SLEEP data presentation at the World Sleep Congress in Rome, where we hosted 55 key opinion leaders during the pre–Congress symposium."

Mr. Taelman continued, "We are also happy with the acceleration in the pace of implants in our DREAM U.S. pivotal study, given recent weekly implant rates, which have increased meaningfully over the last month. We believe we have enough patients enrolled to complete the study by the end of the second quarter of 2022, particularly in light of the FDA's approval to reduce the sample size to 115 patients. We also continue our dialogue with FDA regarding our IDE submission for our ACCCESS trial for CCC patients in the U.S., and we expect to implant our first patient before the end of this year."

"Finally, I am thrilled to announce the nominations of Ray Cohen and Ginny Kirby for appointment to the Board of Directors. They will bring a wealth of knowledge that will benefit Nyxoah as we complete DREAM, prepare for our U.S. launch, and advance our pipeline. I look forward to working closely with both of them," concluded Mr. Taelman.

First Quarter 2022 Results

UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS AS AT AND FOR THE THREE MONTHS ENDED MARCH 31, 2022 "" INTERIM CONSOLIDATED STATEMENTS OF LOSS AND OTHER COMPREHENSIVE LOSS (IN THOUSANDS)

For the three months ended March 31
Notes 2022 2021
Revenue 660 185
Cost of goods sold ( 289) ( 52)
Gross profit 371 133
Research and Development Expense (3 595) (3 094)
Selling, General and Administrative Expense (4 193) (2 366)
Other income/(expense) 136 4
Operating loss for the period (7 281) (5 323)
Financial income 1 576 4
Financial expense ( 788) ( 325)
Loss for the period before taxes (6 493) (5 644)
Income taxes ( 208) ( 25)
Loss for the period (6 701) (5 669)
Loss attributable to equity holders (6 701) (5 669)
Other comprehensive loss
Items that may be subsequently reclassified to profit or loss (net of tax)
Currency translation differences ( 102) ( 70)
Total comprehensive loss for the year, net of tax (6 803) (5 739)
Loss attributable to equity holders (6 803) (5 739)
Basic Loss Per Share (in EUR) (0.260) (0.256)
Diluted Loss Per Share (in EUR) (0.260) (0.256)

The accompanying notes are an integral part of these condensed consolidated interim financial statements

UNAUDITED CONSOLIDATED BALANCESHEET (in thousands)

As at
March 31 2022 December 31 2021
ASSETS
Non–current assets
Property, plant and equipment 2 048 2 020
Intangible assets 28 526 25 322
Right of use assets 3 154 3 218
Deferred tax asset 529 46
Other long–term receivables 165 164
34 422 30 770
Current assets
Inventory 301 346
Trade receivables 619 226
Other receivables 1 607 2 286
Other current assets 1 197 1 693
Financial assets 45 041 '
Cash and cash equivalents 82 787 135 509
131 552 140 060
Total assets 165 974 170 830
EQUITY AND LIABILITIES
Capital and reserves
Capital 4 432 4 427
Share premium 228 158 228 033
Share based payment reserve 3 788 3 127
Other comprehensive income 100 202
Retained loss (93 864) (87 167)
Total equity attributable to shareholders 142 614 148 622
LIABILITIES
Non–current liabilities
Financial debt 7 952 7 802
Lease liability 2 664 2 737
Pension liability 80 80
Provisions 22 12
Deferred tax liability ' 5
10 718 10 636
Current liabilities
Financial debt 598 554
Lease liability 599 582
Trade payables 3 401 3 995
Current tax liability 3 588 2 808
Other payables 4 456 3 633
12 642 11 572
Total liabilities 23 360 22 208
Total equity and liabilities 165 974 170 830

UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS AS AT AND FOR THE THREE MONTHS ENDED MARCH 31, 2022 "" INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS (IN THOUSANDS)

For the three months ended March 31
2022 2021
CASH FLOWS FROM OPERATING ACTIVITIES
Loss before tax for the year (6 493) (5 644)
Adjustments for
Finance income (1 576) ( 4)
Finance expenses 788 325
Depreciation and impairment of property, plant and equipment and right–of–use assets 255 164
Amortization of intangible assets 208 211
Share–based payment transaction expense 665 '
Increase/(decrease) in provisions 10 '
Other non–cash items 180 3
Cash generated before changes in working capital (5 963) (4 945)
Changes in working capital
Decrease/(Increase) in inventory 45 ( 51)
(Increase)/decrease in trade and other receivables 884 (1 195)
Increase/(Decrease) in trade and other payables ( 392) 2 170
Cash generated from changes in operations (5 426) (4 021)
Interests received ' 1
Income tax paid (65) (34)
Net cash used in operating activities (5 491) (4 054)
CASH FLOWS FROM INVESTING ACTIVITIES
Purchases of property, plant and equipment ( 128) ( 169)
Capitalization of intangible assets (3 412) (1 606)
(Increase)/decrease in financial assets – current (44 032) '
Net cash used in investing activities (47 572) (1 775)
CASH FLOWS FROM FINANCING ACTIVITIES
Payment of principal portion of lease liabilities ( 146) ( 135)
Repayment of other loan ( 21) ( 21)
Interests paid ( 109) ( 105)
Proceeds from issuance of shares, net of transaction costs 130 52
Other financial costs (2) '
Net cash generated from financing activities ( 148) ( 209)
Movement in cash and cash equivalents (53 211) (6 038)
Effect of exchange rates on cash and cash equivalents 489 ( 55)
Cash and cash equivalents at January 1 135 509 92 300
Cash and cash equivalents at March 31 82 787 86 207

Revenue

Revenue was 660,000 for the first quarter ending March 31, 2022, compared to 185,000 for the first quarter ending March 31, 2021. The increase in revenue was attributable to the Company's commercialization of the Genio system, primarily in Germany.

Cost of Goods Sold

Cost of goods sold was 289,000 for the three months ending March 31, 2022, representing a gross profit of 371,000, or gross margin of 56.2%.

Research and Development Expenses

Research and Development expenses were 3.6 million for the three months ending March 31, 2022, versus 3.1 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 4.2 million for the first quarter of 2022, up from 2.4 million in the first 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 first quarter of 2022 was 7.3 million versus 5.3 million in the first quarter of 2021, driven by the acceleration in our R&D spending, as well as ongoing commercial and clinical activities. Nyxoah realized a net loss of 6.7 million for the quarter ended March 31, 2022, compared to a net loss of 5.7 million for the quarter ended March 31, 2021.

Cash Position
As of March 31, 2022, cash and financial assets totaled 127.8 million on March 31, 2022, compared to 135.5 million on December 31, 2021. Total cash burn was approximately 2.6 million per month during the first quarter of 2022. Nyxoah expects monthly cash burn to increase slightly as the year progresses to account for the commencement of the ACCCESS IDE trial in the U.S., and current cash position provides ample liquidity to get to U.S. commercialization in 2024.

First Quarter 2022 Report
Nyxoah's financial report for the first quarter of 2022, 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 tomorrow, May 10, 2022, at 2:00 p.m. CET / 8:00 a.m. ET, which will also be webcasted. To participate in the conference call, please dial one of the following numbers:

Conference ID: 8444917

USA: (844) 260–3718
Belgium: 0800 73264
International: (929) 517–0938

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, to be 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


GLOBENEWSWIRE (Distribution ID 1000632297)

LeddarTech Releases Its LeddarSteer Automotive-Grade, Solid-State Digital Beam Steering Technology for LiDAR Sensor Developers

QUEBEC, May 10, 2022 (GLOBE NEWSWIRE) — LeddarTech , a global leader in providing the most flexible, robust and accurate ADAS and AD sensing technology, is pleased to announce the official release of LeddarSteer, a digital beam steering solution designed for LiDAR smart sensor developers and Tier 1–2 automotive suppliers.

Digital beam steering refers to changing the direction of laser pulses in a LiDAR. Using a stack of alternating liquid crystal cells and polarization gratings enables to steer light at different angles at a specific wavelength in order to augment a LiDAR field of view while maximizing its performance, allowing digital beam steering for LiDAR to be achieved.

LeddarSteer digital beam steering offers a myriad of benefits to LiDAR smart sensor developers and Tier 1 and 2 customers, including:

  • Software–controlled on–the–fly adjustment
    • Frame–by–frame adjustment
    • Preset or customized configuration
    • Easy setup and interface
    • Voltage–controlled steering
  • Multiple LiDAR applications
    • Compatible with a wide range of LiDAR architectures
    • Enables one LiDAR to address multiple use cases
    • Field of view adjustable for various actions, including turns, exits, lane changes and slopes
    • Same LiDAR for highway and city driving
    • Reduces the number of sensors, generating cost savings
  • Automotive–grade solid–state technology, resulting in a significantly higher MTBF (mean time between failures)

LeddarSteer can be seamlessly integrated into an existing LiDAR to expand the field of view or integrated into new LiDAR development. The solution provides an enhanced signal–to–noise ratio by concentrating laser power on a small region of interest while reducing the size, cost and complexity of LiDAR components whilst maintaining or increasing the pixel count and resolution.

"For well over a decade, LeddarTech has been a leader in developing sensing solutions that enable our customers to deliver high–performance ADAS and AD sensors," stated Mr. Charles Boulanger, CEO of LeddarTech. "LeddarSteer is the only digital beam steering smart component designed for mass production with the flexibility, reliability, cost, size and performance required by the most demanding 3D sensing applications and supported by standard automotive manufacturing process," concluded Mr. Boulanger.

About LeddarTech

Founded in 2007, LeddarTech is a comprehensive end–to–end environmental sensing company that enables customers to solve critical sensing, fusion and perception challenges across the entire value chain. LeddarTech provides cost–effective perception solutions scalable from Level 2 ADAS to Level 5 full autonomy with LeddarVision, a raw–data sensor fusion and perception platform that generates a comprehensive 3D environmental model from a variety of sensor types and configurations. LeddarTech also supports LiDAR manufacturers and Tier 1–2 automotive suppliers with key technology building blocks such as LeddarSteer digital beam steering and the LeddarEngine, which is built on LeddarTech's Leddar technology employing patented signal acquisition and processing techniques to generate a richer and cleaner return signal at a lower cost. The LeddarEngine comprises a highly integrated, scalable LiDAR SoC and software combination that enables LiDAR developers and Tier 1–2 automotive suppliers to design their own LiDAR solutions. The company is responsible for several innovations in cutting–edge automotive and mobility remote–sensing applications, with over 120 patents granted or applied for, enhancing ADAS and autonomous driving capabilities.

Additional information about LeddarTech is accessible at www.leddartech.com and on LinkedIn, Twitter, Facebook and YouTube.

Contact:
Daniel Aitken, Vice–President, Global Marketing, Communications and Investor Relations, LeddarTech Inc.
Tel.: + 1–418–653–9000 ext. 232 daniel.aitken@leddartech.com

Investor relations contact: InvestorRelations@leddartech.com
https://investors.leddartech.com/

Leddar, LeddarTech, LeddarSteer, LeddarEngine, LeddarVision, LeddarSP, LeddarCore, LeddarEcho, VAYADrive, VayaVision, XLRator and related logos are trademarks or registered trademarks of LeddarTech Inc. and its subsidiaries. All other brands, product names and marks are or may be trademarks or registered trademarks used to identify products or services of their respective owners.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/75f154a6–27b8–4546–8614–00d3885feef0

A video accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/95010106–6e76–4996–ac0a–3c68c7c09d3d


GLOBENEWSWIRE (Distribution ID 8539022)