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

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 


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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

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