Category: Asean

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Fortrea Establishes Industry Partnership with Veeva and Advarra to Streamline Patient and Site Clinical Trial Experience

Companies partner to provide patients and sites with easy access to study information in one integrated solution

DURHAM, N.C., Jan. 09, 2024 (GLOBE NEWSWIRE) — Fortrea (Nasdaq: FTRE) (the “Company”), a leading global contract research organization (CRO), today announced an industry partnership with founding members Veeva Systems Inc., a leading provider of industry cloud solutions for the global life sciences industry, and Advarra, a leading provider of clinical research technology for clinical research investigator sites and sponsors, to deliver an integrated patient- and site-centric solution that streamlines the clinical trial experience.

In an industry faced with complex challenges to clinical trial execution, Fortrea is establishing an alliance of industry partners—beginning with founding members, Veeva and Advarra—to tackle some of these challenges head-on. Many sites are burdened by administrative operations that have multiple, complex technologies with limited interoperability. This impacts their ability to focus on what matters most—the patients—and improving their recruitment and experience participating in clinical studies.

Fortrea, Veeva and Advarra are partnering to offer a seamless, unified technology solution that integrates best-in-class technologies and leverages Fortrea’s process expertise. This will help ease the administrative burden for patients and sites and increase the accessibility of clinical trials for the public.

“We heard from our Site Advisory Board that the multitude of technologies used on a study is one of their greatest challenges,” said Fortrea Chief Operating Officer and President of Clinical Services Mark Morais. “Working with industry-leading partners and founding members, Veeva and Advarra, we’re taking action to remove complexities so we can address the pain points of sites and patients and make a difference. We are leveraging our unique vantage point in the industry that enables us to layer our expertise over the tech and data ecosystems from best-in-class partners—adding to our alliance as we go—to dramatically simplify the experience for patients, sites and sponsors.”

For sites, the partnership is set to deliver:

  • a cloud-based, simplified sign-on experience for Fortrea-run studies
  • access to study technologies through a single dashboard
  • a unified environment with a single repository for study documents and records

For patients, the solution is being designed to offer:

  • easy-to-access, step-by-step, visit-by-visit support and education throughout a patient’s trial journey
  • a simplified user experience through a single platform
  • self-referral functionality to search and find studies in their disease area of interest
  • ongoing patient support and education via an online portal or mobile app
  • a simplified mobile and web application for consenting and responding to outcome surveys

“Veeva is helping to advance clinical trials with connected applications that reduce the burden of participating for patients, streamline execution for research sites and increase transparency for sponsors,” said Jim Reilly, vice president, Veeva Development Cloud Strategy. “Extending our partnership with Fortrea to deliver Veeva Clinical Platform applications will meet the unique needs of patients, sites and sponsors while significantly improving study data quality and collaboration with sites.”

“Advarra’s mission is to break the silos that impede clinical research, so we are excited to provide our Longboat solution and IRB services as part of this innovative and collaborative partnership aimed at reducing site and patient burden,” said Elisa Cascade, chief product officer at Advarra.  “By leveraging our Longboat solution, Fortrea will deliver a reimagined clinical research experience that will improve both protocol compliance and site and patient engagement throughout the clinical trial process.”

Learn more about how Fortrea is driving healthcare innovation throughout the world at Fortrea.com. For more information on the technology platforms, visit Veeva Clinical Platform and Advarra Longboat.

About Fortrea

Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology-enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team of about 19,000 people working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com and follow us on LinkedIn and X (formerly Twitter) @Fortrea.

Fortrea Contacts:
Fortrea Media: Galen Wilson – 703-298-0802, media@fortrea.com
Fortrea Media: Kate Dillon – 646-818-9115, kdillon@prosek.com

GlobeNewswire Distribution ID 9015283

Posted on

Fortrea Establishes Industry Partnership with Veeva and Advarra to Streamline Patient and Site Clinical Trial Experience

Companies partner to provide patients and sites with easy access to study information in one integrated solution

DURHAM, N.C., Jan. 09, 2024 (GLOBE NEWSWIRE) — Fortrea (Nasdaq: FTRE) (the “Company”), a leading global contract research organization (CRO), today announced an industry partnership with founding members Veeva Systems Inc., a leading provider of industry cloud solutions for the global life sciences industry, and Advarra, a leading provider of clinical research technology for clinical research investigator sites and sponsors, to deliver an integrated patient- and site-centric solution that streamlines the clinical trial experience.

In an industry faced with complex challenges to clinical trial execution, Fortrea is establishing an alliance of industry partners—beginning with founding members, Veeva and Advarra—to tackle some of these challenges head-on. Many sites are burdened by administrative operations that have multiple, complex technologies with limited interoperability. This impacts their ability to focus on what matters most—the patients—and improving their recruitment and experience participating in clinical studies.

Fortrea, Veeva and Advarra are partnering to offer a seamless, unified technology solution that integrates best-in-class technologies and leverages Fortrea’s process expertise. This will help ease the administrative burden for patients and sites and increase the accessibility of clinical trials for the public.

“We heard from our Site Advisory Board that the multitude of technologies used on a study is one of their greatest challenges,” said Fortrea Chief Operating Officer and President of Clinical Services Mark Morais. “Working with industry-leading partners and founding members, Veeva and Advarra, we’re taking action to remove complexities so we can address the pain points of sites and patients and make a difference. We are leveraging our unique vantage point in the industry that enables us to layer our expertise over the tech and data ecosystems from best-in-class partners—adding to our alliance as we go—to dramatically simplify the experience for patients, sites and sponsors.”

For sites, the partnership is set to deliver:

  • a cloud-based, simplified sign-on experience for Fortrea-run studies
  • access to study technologies through a single dashboard
  • a unified environment with a single repository for study documents and records

For patients, the solution is being designed to offer:

  • easy-to-access, step-by-step, visit-by-visit support and education throughout a patient’s trial journey
  • a simplified user experience through a single platform
  • self-referral functionality to search and find studies in their disease area of interest
  • ongoing patient support and education via an online portal or mobile app
  • a simplified mobile and web application for consenting and responding to outcome surveys

“Veeva is helping to advance clinical trials with connected applications that reduce the burden of participating for patients, streamline execution for research sites and increase transparency for sponsors,” said Jim Reilly, vice president, Veeva Development Cloud Strategy. “Extending our partnership with Fortrea to deliver Veeva Clinical Platform applications will meet the unique needs of patients, sites and sponsors while significantly improving study data quality and collaboration with sites.”

“Advarra’s mission is to break the silos that impede clinical research, so we are excited to provide our Longboat solution and IRB services as part of this innovative and collaborative partnership aimed at reducing site and patient burden,” said Elisa Cascade, chief product officer at Advarra.  “By leveraging our Longboat solution, Fortrea will deliver a reimagined clinical research experience that will improve both protocol compliance and site and patient engagement throughout the clinical trial process.”

Learn more about how Fortrea is driving healthcare innovation throughout the world at Fortrea.com. For more information on the technology platforms, visit Veeva Clinical Platform and Advarra Longboat.

About Fortrea

Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology-enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team of about 19,000 people working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com and follow us on LinkedIn and X (formerly Twitter) @Fortrea.

Fortrea Contacts:
Fortrea Media: Galen Wilson – 703-298-0802, media@fortrea.com
Fortrea Media: Kate Dillon – 646-818-9115, kdillon@prosek.com

GlobeNewswire Distribution ID 9015283

Posted on

Fortrea Establishes Industry Partnership with Veeva and Advarra to Streamline Patient and Site Clinical Trial Experience

Companies partner to provide patients and sites with easy access to study information in one integrated solution

DURHAM, N.C., Jan. 09, 2024 (GLOBE NEWSWIRE) — Fortrea (Nasdaq: FTRE) (the “Company”), a leading global contract research organization (CRO), today announced an industry partnership with founding members Veeva Systems Inc., a leading provider of industry cloud solutions for the global life sciences industry, and Advarra, a leading provider of clinical research technology for clinical research investigator sites and sponsors, to deliver an integrated patient- and site-centric solution that streamlines the clinical trial experience.

In an industry faced with complex challenges to clinical trial execution, Fortrea is establishing an alliance of industry partners—beginning with founding members, Veeva and Advarra—to tackle some of these challenges head-on. Many sites are burdened by administrative operations that have multiple, complex technologies with limited interoperability. This impacts their ability to focus on what matters most—the patients—and improving their recruitment and experience participating in clinical studies.

Fortrea, Veeva and Advarra are partnering to offer a seamless, unified technology solution that integrates best-in-class technologies and leverages Fortrea’s process expertise. This will help ease the administrative burden for patients and sites and increase the accessibility of clinical trials for the public.

“We heard from our Site Advisory Board that the multitude of technologies used on a study is one of their greatest challenges,” said Fortrea Chief Operating Officer and President of Clinical Services Mark Morais. “Working with industry-leading partners and founding members, Veeva and Advarra, we’re taking action to remove complexities so we can address the pain points of sites and patients and make a difference. We are leveraging our unique vantage point in the industry that enables us to layer our expertise over the tech and data ecosystems from best-in-class partners—adding to our alliance as we go—to dramatically simplify the experience for patients, sites and sponsors.”

For sites, the partnership is set to deliver:

  • a cloud-based, simplified sign-on experience for Fortrea-run studies
  • access to study technologies through a single dashboard
  • a unified environment with a single repository for study documents and records

For patients, the solution is being designed to offer:

  • easy-to-access, step-by-step, visit-by-visit support and education throughout a patient’s trial journey
  • a simplified user experience through a single platform
  • self-referral functionality to search and find studies in their disease area of interest
  • ongoing patient support and education via an online portal or mobile app
  • a simplified mobile and web application for consenting and responding to outcome surveys

“Veeva is helping to advance clinical trials with connected applications that reduce the burden of participating for patients, streamline execution for research sites and increase transparency for sponsors,” said Jim Reilly, vice president, Veeva Development Cloud Strategy. “Extending our partnership with Fortrea to deliver Veeva Clinical Platform applications will meet the unique needs of patients, sites and sponsors while significantly improving study data quality and collaboration with sites.”

“Advarra’s mission is to break the silos that impede clinical research, so we are excited to provide our Longboat solution and IRB services as part of this innovative and collaborative partnership aimed at reducing site and patient burden,” said Elisa Cascade, chief product officer at Advarra.  “By leveraging our Longboat solution, Fortrea will deliver a reimagined clinical research experience that will improve both protocol compliance and site and patient engagement throughout the clinical trial process.”

Learn more about how Fortrea is driving healthcare innovation throughout the world at Fortrea.com. For more information on the technology platforms, visit Veeva Clinical Platform and Advarra Longboat.

About Fortrea

Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology-enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team of about 19,000 people working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com and follow us on LinkedIn and X (formerly Twitter) @Fortrea.

Fortrea Contacts:
Fortrea Media: Galen Wilson – 703-298-0802, media@fortrea.com
Fortrea Media: Kate Dillon – 646-818-9115, kdillon@prosek.com

GlobeNewswire Distribution ID 9015283

Posted on

Nyxoah Announces Preliminary Results for the Fourth Quarter and Full Year 2023

Nyxoah Announces Preliminary Results for the Fourth Quarter and Full Year 2023

Mont-Saint-Guibert, Belgium – January 9, 2024, 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 announced certain preliminary, unaudited results for the fourth quarter and full year ended December 31, 2023.

Preliminary, Unaudited Fourth Quarter and Full Year 2023 Results

  • Revenue for the fourth quarter of 2023 is anticipated to be approximately €1.8 million, a 40% increase over the fourth quarter of 2022 and an 87% increase over the third quarter of 2023.
  • Revenue for the full year 2023 is anticipated to be approximately €4.3 million, a 41% increase over the full year 2022.
  • Ended the year with 48 active German accounts.

“We are excited with the strong preliminary fourth quarter sales, which are anticipated to be nearly double from last quarter. This anticipated growth reflects both strong underlying demand for Genio and focus on streamlining the patient referral pathway through initiatives such as our direct-to-consumer online campaigns launched in March,” commented Olivier Taelman, Chief Executive Officer. “This performance throughout 2023 sets the stage for an exciting 2024, as in a few months we expect to report data from our DREAM US pivotal trial, file for FDA approval, begin preparations to enter the US market, and begin to see contribution from the ResMed commercial partnership in Germany.”

The preliminary, unaudited revenue results described in this press release are estimates only and are subject to revision until Nyxoah reports its full financial results for 2023 in its Annual Report on Form 20-F.

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 U.S. 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; reporting data from Nyxoah’s DREAM US pivotal trial; filing for FDA approval; entrance to the US market, contributions from the ResMed commercial partnership in Germany; 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, 2022, filed with the Securities and Exchange Commission (“SEC”) on March 22, 2023, 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

Attachment

GlobeNewswire Distribution ID 1000908020

Posted on

Nyxoah Announces Preliminary Results for the Fourth Quarter and Full Year 2023

Nyxoah Announces Preliminary Results for the Fourth Quarter and Full Year 2023

Mont-Saint-Guibert, Belgium – January 9, 2024, 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 announced certain preliminary, unaudited results for the fourth quarter and full year ended December 31, 2023.

Preliminary, Unaudited Fourth Quarter and Full Year 2023 Results

  • Revenue for the fourth quarter of 2023 is anticipated to be approximately €1.8 million, a 40% increase over the fourth quarter of 2022 and an 87% increase over the third quarter of 2023.
  • Revenue for the full year 2023 is anticipated to be approximately €4.3 million, a 41% increase over the full year 2022.
  • Ended the year with 48 active German accounts.

“We are excited with the strong preliminary fourth quarter sales, which are anticipated to be nearly double from last quarter. This anticipated growth reflects both strong underlying demand for Genio and focus on streamlining the patient referral pathway through initiatives such as our direct-to-consumer online campaigns launched in March,” commented Olivier Taelman, Chief Executive Officer. “This performance throughout 2023 sets the stage for an exciting 2024, as in a few months we expect to report data from our DREAM US pivotal trial, file for FDA approval, begin preparations to enter the US market, and begin to see contribution from the ResMed commercial partnership in Germany.”

The preliminary, unaudited revenue results described in this press release are estimates only and are subject to revision until Nyxoah reports its full financial results for 2023 in its Annual Report on Form 20-F.

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 U.S. 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; reporting data from Nyxoah’s DREAM US pivotal trial; filing for FDA approval; entrance to the US market, contributions from the ResMed commercial partnership in Germany; 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, 2022, filed with the Securities and Exchange Commission (“SEC”) on March 22, 2023, 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

Attachment

GlobeNewswire Distribution ID 1000908020

Posted on

Nyxoah Announces Preliminary Results for the Fourth Quarter and Full Year 2023

Nyxoah Announces Preliminary Results for the Fourth Quarter and Full Year 2023

Mont-Saint-Guibert, Belgium – January 9, 2024, 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 announced certain preliminary, unaudited results for the fourth quarter and full year ended December 31, 2023.

Preliminary, Unaudited Fourth Quarter and Full Year 2023 Results

  • Revenue for the fourth quarter of 2023 is anticipated to be approximately €1.8 million, a 40% increase over the fourth quarter of 2022 and an 87% increase over the third quarter of 2023.
  • Revenue for the full year 2023 is anticipated to be approximately €4.3 million, a 41% increase over the full year 2022.
  • Ended the year with 48 active German accounts.

“We are excited with the strong preliminary fourth quarter sales, which are anticipated to be nearly double from last quarter. This anticipated growth reflects both strong underlying demand for Genio and focus on streamlining the patient referral pathway through initiatives such as our direct-to-consumer online campaigns launched in March,” commented Olivier Taelman, Chief Executive Officer. “This performance throughout 2023 sets the stage for an exciting 2024, as in a few months we expect to report data from our DREAM US pivotal trial, file for FDA approval, begin preparations to enter the US market, and begin to see contribution from the ResMed commercial partnership in Germany.”

The preliminary, unaudited revenue results described in this press release are estimates only and are subject to revision until Nyxoah reports its full financial results for 2023 in its Annual Report on Form 20-F.

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 U.S. 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; reporting data from Nyxoah’s DREAM US pivotal trial; filing for FDA approval; entrance to the US market, contributions from the ResMed commercial partnership in Germany; 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, 2022, filed with the Securities and Exchange Commission (“SEC”) on March 22, 2023, 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

Attachment

GlobeNewswire Distribution ID 1000908020

Posted on

Institutional Investors’ Enthusiasm Grows for Innovative Private Equity Fund

Investors with deep pockets seek refuge in GDP Capital’s PE-BOND Fund amidst turbulent markets

Key Investment Sectors

Private Equity and other investment sectors are operatingin challenging and unpredictable environments today

KUALA LUMPUR, Malaysia, Jan. 09, 2024 (GLOBE NEWSWIRE) — The COVID-19 pandemic has unleashed unprecedented economic turmoil, resulting in contracting markets and dwindling returns worldwide.

Private Equity and other investment sectors find themselves navigating an exceptionally challenging and unpredictable landscape. In an environment with limited profitable opportunities, preserving dry powder appears to be a prudent choice. An alternative, however, has emerged—a haven for investors with substantial resources.

Private Equity and other investment sectors are operatingin challenging and unpredictable environments today

Private Equity and other investment sectors are operating
in challenging and unpredictable environments today

Introducing GDP Capital’s PE-BOND Fund LP, one of Private Equity’s latest offerings poised to make waves on the international stage. In today’s dismal or negative return environment, this fund has the potential to significantly enhance your return on investment while offering a sense of security.

GDP Capital’s investment structure is nothing short of unique, possibly the first of its kind. Here’s why it stands out:

  • A Private Equity structure fortified with the security of a bond.
  • Investments are channelled into government-approved projects.
  • Capital invested is backed by government guarantees and repaid within a 10-year horizon.
  • GDP Capital secures equity in the involved companies and their respective projects, each contributing dividend.

The Fund mandates a minimum commitment above US$25 million, making it ideally suited for Sovereign Wealth Funds, Retirement Funds, Institutional Investors, Endowments, Insurance Companies, Banks, Family Offices, and major investment firms.

A Balance of High Returns and Capital Safety:

“While structuring the fund, we overcame numerous hurdles to satisfy governmental, legal, regulatory, and investor requirements. After two years of meticulous development, potential investors are displaying keen interest,” commented Gurmit S. Sidhu, the founder and Managing Director of GDP Capital Limited, on the fund and its offerings.

With an adept team comprising tax and legal advisors, investment bankers, and political analysts, GDP Capital Limited stands ready to support top-tier investors in surpassing their investment objectives.

This unique investment Fund, set to launch in January 2024, is spearheaded by GDP Capital Limited, a Private Equity Fund Manager incorporated in the British Virgin Islands (BVI) and regulated by the BVI Financial Services Commission (BVI FSC).

GDP PE-BOND Fund LP represents an extraordinary opportunity for investors seeking capital safety and accelerated returns.

Explore the Merits Further:

Astute investors who recognize the benefits offered by GDP Capital may wish to delve deeper into its merits. For additional details, please visit: www.gdpcapitalltd.com

About GDP Capital Limited:

GDP Capital Limited is a Private Equity Fund Manager incorporated in the British Virgin Islands (BVI) and regulated by the BVI Financial Services Commission (BVI FSC). The firm collaborates with stable and investor-friendly governments seeking funding for priority projects to expedite economic development and achieve real GDP growth.

Funding is extended for viable and strategically significant government projects contributing to sustainable economic growth. While initially focusing on Asia, the company has expansion plans for other global regions. Given the substantial funding requirements of governments, GDP Capital provides institutional investors with the assurance of government guarantees, facilitating investments ranging from US$100 million to US$1 billion.

Media Contact:
Investor Relations
pr@gdpcapitalltd.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/2a9a601f-7cd5-459c-b4f7-f42d96113ccd

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Recursion Adds New Chemical Entity Targeting Fibrotic Diseases to Late Discovery Pipeline

Potential First-in-Class Novel Molecule with Novel Target In-Licensed from Collaboration with Bayer

SALT LAKE CITY, Jan. 04, 2024 (GLOBE NEWSWIRE) — Recursion (NASDAQ: RXRX), a leading clinical stage TechBio company decoding biology to industrialize drug discovery, today announced it has signed an agreement with Bayer AG to in-license a new chemical entity that emerged from the companies’ fibrosis research collaboration. The compound represents a novel approach to treating fibrotic diseases with compelling early data suggesting the potential to reverse disease-related fibrotic processes, including immuno-mesenchymal dysfunction.

“Since initiating our research collaboration with Bayer in 2020, we have worked diligently to apply the power of the Recursion OS to identify and advance potential candidates in challenging areas of disease biology,” said Chris Gibson, Ph.D., Co-founder and CEO of Recursion. “We are excited to bring this asset into our internal pipeline and accelerate the compelling science behind this program while our research collaboration with Bayer focuses on precision oncology.”

Recursion applied phenotypic screening of human cells to identify small molecules that reverse the phenotypic features of disease-state fibrocyte cells into those of healthy-state cells. Leveraging the power of Recursion’s Maps of Biology and Chemistry revealed a relationship between small molecule hits and a novel target that could impact fibrotic diseases. The most promising small molecule hits were confirmed as potent inhibitors of this novel target in validation experiments, and lead optimization studies are currently ongoing.

Fibrotic diseases are a significant cause of morbidity and mortality worldwide with high unmet need for patients. One of the biggest challenges in the treatment of fibrotic diseases is the underlying complex biology and the associated difficulty in discovering disease-modifying drug targets. Recursion’s technology is uniquely suited to accelerate discoveries in these and other complex areas of disease biology.

About Recursion
Recursion (NASDAQ: RXRX) is a clinical stage TechBio company leading the space by decoding biology to industrialize drug discovery. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously expands one of the world’s largest proprietary biological and chemical datasets. Recursion leverages sophisticated machine-learning algorithms to distill from its dataset a collection of trillions of searchable relationships across biology and chemistry unconstrained by human bias. By commanding massive experimental scale — up to millions of wet lab experiments weekly — and massive computational scale — owning and operating one of the most powerful supercomputers in the world, Recursion is uniting technology, biology, and chemistry to advance the future of medicine.

Recursion is headquartered in Salt Lake City, where it is a founding member of BioHive, the Utah life sciences industry collective. Recursion also has offices in Toronto, Montréal and the San Francisco Bay Area. Learn more at www.Recursion.com, or connect on Twitter and LinkedIn.

Media Contact
Media@Recursion.com

Investor Contact
Investor@Recursion.com

Forward-Looking Statements
This document contains information that includes or is based upon “forward-looking statements” within the meaning of the Securities Litigation Reform Act of 1995, including, without limitation, those regarding early and late stage discovery, preclinical, and clinical programs; licenses and collaborations; prospective products and their potential future indications and market opportunities; Recursion OS and other technologies; business and financial plans and performance; and all other statements that are not historical facts. Forward-looking statements may or may not include identifying words such as “plan,” “will,” “expect,” “anticipate,” “intend,” “believe,” “potential,” “continue,” and similar terms. These statements are subject to known or unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements, including but not limited to: challenges inherent in pharmaceutical research and development, including the timing and results of preclinical and clinical programs, where the risk of failure is high and failure can occur at any stage prior to or after regulatory approval due to lack of sufficient efficacy, safety considerations, or other factors; our ability to leverage and enhance our drug discovery platform; our ability to obtain financing for development activities and other corporate purposes; the success of our collaboration activities; our ability to obtain regulatory approval of, and ultimately commercialize, drug candidates; our ability to obtain, maintain, and enforce intellectual property protections; cyberattacks or other disruptions to our technology systems; our ability to attract, motivate, and retain key employees and manage our growth; inflation and other macroeconomic issues; and other risks and uncertainties such as those described under the heading “Risk Factors” in our filings with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10-K. All forward-looking statements are based on management’s current estimates, projections, and assumptions, and Recursion undertakes no obligation to correct or update any such statements, whether as a result of new information, future developments, or otherwise, except to the extent required by applicable law.

GlobeNewswire Distribution ID 9012419

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Recursion Adds New Chemical Entity Targeting Fibrotic Diseases to Late Discovery Pipeline

Potential First-in-Class Novel Molecule with Novel Target In-Licensed from Collaboration with Bayer

SALT LAKE CITY, Jan. 04, 2024 (GLOBE NEWSWIRE) — Recursion (NASDAQ: RXRX), a leading clinical stage TechBio company decoding biology to industrialize drug discovery, today announced it has signed an agreement with Bayer AG to in-license a new chemical entity that emerged from the companies’ fibrosis research collaboration. The compound represents a novel approach to treating fibrotic diseases with compelling early data suggesting the potential to reverse disease-related fibrotic processes, including immuno-mesenchymal dysfunction.

“Since initiating our research collaboration with Bayer in 2020, we have worked diligently to apply the power of the Recursion OS to identify and advance potential candidates in challenging areas of disease biology,” said Chris Gibson, Ph.D., Co-founder and CEO of Recursion. “We are excited to bring this asset into our internal pipeline and accelerate the compelling science behind this program while our research collaboration with Bayer focuses on precision oncology.”

Recursion applied phenotypic screening of human cells to identify small molecules that reverse the phenotypic features of disease-state fibrocyte cells into those of healthy-state cells. Leveraging the power of Recursion’s Maps of Biology and Chemistry revealed a relationship between small molecule hits and a novel target that could impact fibrotic diseases. The most promising small molecule hits were confirmed as potent inhibitors of this novel target in validation experiments, and lead optimization studies are currently ongoing.

Fibrotic diseases are a significant cause of morbidity and mortality worldwide with high unmet need for patients. One of the biggest challenges in the treatment of fibrotic diseases is the underlying complex biology and the associated difficulty in discovering disease-modifying drug targets. Recursion’s technology is uniquely suited to accelerate discoveries in these and other complex areas of disease biology.

About Recursion
Recursion (NASDAQ: RXRX) is a clinical stage TechBio company leading the space by decoding biology to industrialize drug discovery. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously expands one of the world’s largest proprietary biological and chemical datasets. Recursion leverages sophisticated machine-learning algorithms to distill from its dataset a collection of trillions of searchable relationships across biology and chemistry unconstrained by human bias. By commanding massive experimental scale — up to millions of wet lab experiments weekly — and massive computational scale — owning and operating one of the most powerful supercomputers in the world, Recursion is uniting technology, biology, and chemistry to advance the future of medicine.

Recursion is headquartered in Salt Lake City, where it is a founding member of BioHive, the Utah life sciences industry collective. Recursion also has offices in Toronto, Montréal and the San Francisco Bay Area. Learn more at www.Recursion.com, or connect on Twitter and LinkedIn.

Media Contact
Media@Recursion.com

Investor Contact
Investor@Recursion.com

Forward-Looking Statements
This document contains information that includes or is based upon “forward-looking statements” within the meaning of the Securities Litigation Reform Act of 1995, including, without limitation, those regarding early and late stage discovery, preclinical, and clinical programs; licenses and collaborations; prospective products and their potential future indications and market opportunities; Recursion OS and other technologies; business and financial plans and performance; and all other statements that are not historical facts. Forward-looking statements may or may not include identifying words such as “plan,” “will,” “expect,” “anticipate,” “intend,” “believe,” “potential,” “continue,” and similar terms. These statements are subject to known or unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements, including but not limited to: challenges inherent in pharmaceutical research and development, including the timing and results of preclinical and clinical programs, where the risk of failure is high and failure can occur at any stage prior to or after regulatory approval due to lack of sufficient efficacy, safety considerations, or other factors; our ability to leverage and enhance our drug discovery platform; our ability to obtain financing for development activities and other corporate purposes; the success of our collaboration activities; our ability to obtain regulatory approval of, and ultimately commercialize, drug candidates; our ability to obtain, maintain, and enforce intellectual property protections; cyberattacks or other disruptions to our technology systems; our ability to attract, motivate, and retain key employees and manage our growth; inflation and other macroeconomic issues; and other risks and uncertainties such as those described under the heading “Risk Factors” in our filings with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10-K. All forward-looking statements are based on management’s current estimates, projections, and assumptions, and Recursion undertakes no obligation to correct or update any such statements, whether as a result of new information, future developments, or otherwise, except to the extent required by applicable law.

GlobeNewswire Distribution ID 9012419

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New research harnesses AI and satellite imagery to reveal the expanding footprint of human activity at sea

Study reveals 75 percent of the world’s industrial fishing vessels are hidden from public view

WASHINGTON, D.C., Jan. 03, 2024 (GLOBE NEWSWIRE) — A new study published today in the journal Nature offers an unprecedented view of previously unmapped industrial use of the ocean and how it is changing.

The groundbreaking study, led by Global Fishing Watch, uses machine learning and satellite imagery to create the first global map of large vessel traffic and offshore infrastructure, finding a remarkable amount of activity that was previously “dark” to public monitoring systems.

The analysis reveals that about 75 percent of the world’s industrial fishing vessels are not publicly tracked, with much of that fishing taking place around Africa and south Asia. More than 25 percent of transport and energy vessel activity are also missing from public tracking systems.

“A new industrial revolution has been emerging in our seas undetected—until now,” said David Kroodsma, director of research and innovation at Global Fishing Watch and co-lead author of the study. “On land, we have detailed maps of almost every road and building on the planet. In contrast, growth in our ocean has been largely hidden from public view. This study helps eliminate the blind spots and shed light on the breadth and intensity of human activity at sea.”

Researchers from Global Fishing Watch, the University of Wisconsin-Madison, Duke University, UC Santa Barbara and SkyTruth analyzed 2 million gigabytes of satellite imagery spanning 2017-2021 to detect vessels and offshore infrastructure in coastal waters across six continents where more than three-quarters of industrial activity is concentrated.

By synthesizing GPS data with five years of radar and optical imagery, the researchers were able to identify vessels that failed to broadcast their positions. Using machine learning, they then concluded which of those vessels were likely engaged in fishing activity.

“Historically, vessel activity has been poorly documented, limiting our understanding of how the world’s largest public resource—the ocean—is being used,” said co-lead author Fernando Paolo, senior machine learning engineer at Global Fishing Watch. “By combining space technology with state-of-the-art machine learning, we mapped undisclosed industrial activity at sea on a scale never done before.”

While not all boats are legally required to broadcast their position, vessels absent from public monitoring systems, often termed “dark fleets,” pose major challenges for protecting and managing natural resources. Researchers found numerous dark fishing vessels inside many marine protected areas, and a high concentration of vessels in many countries’ waters that previously showed little-to-no vessel activity by public monitoring systems.

“Publicly available data wrongly suggests that Asia and Europe have similar amounts of fishing within their borders, but our mapping reveals that Asia dominates—for every 10 fishing vessels we found on the water, seven were in Asia while only one was in Europe,” said co-author Jennifer Raynor, assistant professor of natural resource economics at the University of Wisconsin-Madison. “By revealing dark vessels, we have created the most comprehensive public picture of global industrial fishing available.”

The study also shows how human activity in the ocean is changing. Coinciding with the COVID-19 pandemic, fishing activity dropped globally by about 12 percent, with an 8 percent decline in China and a 14 percent drop elsewhere. In contrast, transport and energy vessel activity remained stable.

Offshore energy development surged during the study period. Oil structures increased by 16 percent, while wind turbines more than doubled. By 2021, turbines outnumbered oil platforms. China’s offshore wind energy had the most striking growth, increasing ninefold from 2017 to 2021.

“The footprint of the Anthropocene is no longer limited to terra firma,” said co-author Patrick Halpin, professor of marine geospatial ecology at Duke University. “Having a more complete view of ocean industrialization allows us to see new growth in offshore wind, aquaculture and mining that is rapidly being added to established industrial fishing, shipping and oil and gas activities. Our work reveals that the global ocean is a busy, crowded and complex industrial workspace of the growing blue economy.”

The study highlights the potential of this new technology to tackle climate change. Mapping all vessel traffic will improve estimates of greenhouse gas emissions at sea, while maps of infrastructure can inform wind development or aid in tracking marine degradation caused by oil exploration.

“Identifying offshore infrastructure is critical for understanding offshore energy development impacts and trends, and is crucial data for our work to detect marine pollution events and hold responsible parties to account,” said co-author Christian Thomas, a geospatial engineer at SkyTruth.  

The open data and technology used in the study can help governments, researchers and civil society to identify hotspots of potentially illegal activity, determine where industrial fishing vessels may be encroaching on artisanal fishing grounds, or simply better understand vessel traffic in their waters.

“Previously, this type of satellite monitoring was only available to those who could pay for it. Now it is freely available to all nations,” concluded Kroodsma. “This study marks the beginning of a new era in ocean management and transparency.”

The study was made possible thanks to the generous support of Bloomberg Philanthropies, National Geographic Pristine Seas and Oceankind, and our technology partner, Google. As an awardee of The Audacious Project, a collaborative funding initiative that is catalyzing social impact on a grand scale, Global Fishing Watch is able to further the application of this innovative work.

Notes to the editor:

  • Download supporting data visualizations and figures from the paper here: Media kit
  • Download the data at: https://globalfishingwatch.org/datasets-and-code
  • Data providers: The co-authors of the study wish to acknowledge the contribution from the following technology and data providers; AIS: Spire, ORBCOMM; Radar and optical imagery: European Space Agency (ESA); and Computing resources: Google / Earth Engine.

Global Fishing Watch is an international nonprofit organization dedicated to advancing ocean governance through increased transparency of human activity at sea. By creating and publicly sharing map visualizations, data and analysis tools, we aim to enable scientific research and transform the way our ocean is managed. We believe human activity at sea should be public knowledge in order to safeguard the global ocean for the common good of all.

Attachments

Sarah Bladen
Global Fishing Watch
+44 79 20333832
sarah.bladen@globalfishingwatch.org

Lisa Tossey
Global Fishing Watch
+1 302 4486638
lisa.tossey@globalfishingwatch.org

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