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FDA Approves Genio® 2.1 For Use in DREAM U.S. IDE Pivotal Study

FDA Approves Genio 2.1 For Use in DREAM U.S. IDE Pivotal Study

New smartphone application, upgraded activation chip, improved user interface, and stimulation amplitude trimming enhance patient experience and comfort

Mont–Saint–Guibert, Belgium "" June 1, 2022, 10:30pm CET / 4:30pm 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 that the U.S. Food and Drug Administration (FDA) has approved the use of Nyxoah's next generation Genio 2.1 system for use in the Company's DREAM U.S. IDE pivotal study. Genio 2.1's upgrades are entirely related to the external components of the Genio system, as the implantable stimulator remains unchanged.

Genio 2.1 further demonstrates Nyxoah's patient–centric approach to addressing the needs of those suffering from moderate–to–severe OSA. The system features updates to the Genio activation chip and a new smartphone application to enable daily reporting of therapy usage, which will support therapy acclimation and long–term compliance. Additional features of Genio 2.1 include an improved user interface and the ability for clinicians to make more incremental stimulation adjustments. This is particularly meaningful for patients who are more sensitive to neurostimulation, as with Genio 2.1 physicians can fine–tune stimulation amplitude to determine the optimal level of comfort for patients without compromising therapy efficacy.

"Genio 2.1's features, along with existing full–body 3.0T MRI compatibility, illustrate Nyxoah's patient–first mission in OSA product development," commented Olivier Taelman, Nyxoah's Chief Executive Officer. "The updated activation chip and new smartphone app, combined with our upgraded user interface and increased stimulation resolution, represent key next steps in optimizing patient outcomes. We are excited to make these important new features available to patients in our DREAM trial."

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.

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

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GLOBENEWSWIRE (Distribution ID 1000656900)

Madison Realty Capital Receives Strategic Minority Investment from ICONIQ

NEW YORK, June 01, 2022 (GLOBE NEWSWIRE) — Madison Realty Capital, a vertically integrated real estate private equity firm focused on debt and equity investment strategies, today announced that ICONIQ Investment Management ("ICONIQ") has made a strategic minority investment in the firm that will advance its long–term growth and success. Terms of the investment were not disclosed.

Madison Realty Capital will leverage ICONIQ's financial and strategic support to grow its global network of institutional relationships, expand upon its products and augment its team with top talent, while continuing to execute on its core competencies within private real estate debt and equity investing. Madison Realty Capital's investment process, management, and day–to–day operations will remain unchanged.

Josh Zegen and Brian Shatz, Managing Principals and Co–Founders of Madison Realty Capital, said "We are pleased to establish this strategic partnership, and further our existing relationship with ICONIQ. This investment is a testament to the trust that we foster with our partners and investors. ICONIQ's investing expertise and network are complementary to our own, and we look forward to expanding our footprint across the U.S., developing new relationships with top–tier borrowers, lenders, and developers, and accelerating the growth of our business to the benefit of our global, institutional investor base."

Sam Kurtzman, Portfolio Manager at ICONIQ, stated, "Madison Realty Capital has developed an accomplished institutional platform with nearly two decades of experience investing across market cycles. The firm is one of the most active private real estate lenders in the U.S. and we believe continues to differentiate itself as a lender of choice for borrowers seeking flexible financing solutions with certainty of execution."

Nugi Jakobishvili, Chief Investment Officer at ICONIQ, added, "The firm's principals "" Brian Shatz, Josh Zegen, and Adam Tantleff "" have cultivated a strong culture and highly experienced team, and we look forward to working together to expand an already successful relationship to further the growth of Madison Realty Capital's platform for years to come."

ICONIQ's investment follows a record year for Madison Realty Capital, which last year completed $6.4 billion in transaction volume across 72 deals and raised $2.08 billion for Madison Realty Capital Debt Fund V LP, the firm's largest debt fund to date.

About Madison Realty Capital

Madison Realty Capital is a vertically integrated real estate private equity firm that, as of March 31, 2022, manages approximately $8.5 billion in total assets on behalf of a global institutional investor base. Since 2004, Madison Realty Capital has completed approximately $20 billion in transactions providing borrowers with flexible and highly customized financing solutions, strong underwriting capabilities, and certainty of execution. Headquartered in New York City, with an office in Los Angeles, the firm has approximately 70 employees across all real estate investment, development, and property management disciplines. Madison Realty Capital has been frequently named to the Commercial Observer's prestigious "Power 100" list of New York City real estate players and is consistently cited as a top construction lender, among other industry recognitions. To learn more, follow us on LinkedIn and visit www.madisonrealtycapital.com.


GLOBENEWSWIRE (Distribution ID 8563336)

D’Addario Designates June 6, 2022, as #WorldStringChangeDay

FARMINGDALE, N.Y., June 01, 2022 (GLOBE NEWSWIRE) — D'Addario, the world's premier guitar string maker, is proud to announce the inaugural celebration of #WorldStringChangeDay on Monday, June 6, 2022.

As the world leader in guitar string innovation and quality, D'Addario is inviting musicians around the globe to celebrate the ritual and reward of caring for their instrument with a fresh set of strings.

"There's nothing better than the feel and tone of fresh strings," says acclaimed Brazilian Guitarist and Technician Lari Basilio. "It makes the playability smoother, the tone more vibrant, and inspires you again!"

Players on social media will be encouraged to show off how their instrument looks, plays, and sounds with fresh strings and dive into their own preferences and string–changing techniques.

Throughout the week leading up to #WorldStringChangeDay, Guitarists, Bassists, Ukulele, and Mandolin players across D'Addario's worldwide artist roster, like Herman Li, Evan Taucher, Lari Basilio, JB Brubaker, Casper Esman, Mark Tremonti, and more will be sharing content around the importance of changing strings and maintaining your instrument.

“D'Addario strings have always been my go–to,” says Grammy–Nominated guitarist Michael Kiwanuka. “There's just something about them that makes my guitar sound and feel the way it should. They're the first step to achieving a great tone. With a fresh set of strings, I'm always inspired to pick up my guitar and play.”

As part of the new holiday, D'Addario will be hosting a giveaway via social media where players can post a story of them changing their strings for a chance to win a set of strings of their choice.

Musicians are encouraged to post on their social media pages using #WorldStringChangeDay to be a part of the conversation and have a chance to have their posts shared by D'Addario & Co.

D'Addario's history of manufacturing guitar strings dates back to the 1600s in Salle, Italy. As part of their commitment to vertical integration, D'Addario manufactures more than 700,000 strings a day in Farmingdale, New York, made possible by their own in–house wire mill.

To learn more about how you can get involved, please visit: https://ddar.io/WSCD.PR

D'Addario & Company, Inc.

D'Addario is the world's largest manufacturer of musical instrument accessories, marketed under several product brands: D'Addario Fretted, D'Addario Orchestral, D'Addario Woodwinds, Promark Drumsticks, Evans Drumheads, and Puresound Snare Wires. A family–owned and operated business with roots dating back to the 17th century, D'Addario now has over 1,100 employees worldwide, and manufactures 95% of its products in the U.S. while utilizing Toyota's Lean manufacturing principles. D'Addario musical accessories are distributed in 120 countries, serve more than 3,300 U.S. retailers, all major e–commerce sites, and are the preferred choice of musicians worldwide such as, Keith Urban, Zac Brown, Brandi Carlile, Dave Matthews, Gary Clark Jr., Chris Thile, Ry Cooder, Joe Satriani, Julia Fischer, Anderson .Paak, Kacey Musgraves and more.

The D'Addario Foundation believes in the power of music to unlock creativity, boost self–confidence, and enhance academics. D'Addario also reinforces its role as a social and environmental leader with initiatives such as Playback and PlayPlantPreserve.

Media Contact – D'Addario & Co, Inc.
Natalie Morrison (natalie.morrison@daddario.com)
https://www.daddario.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/94e60972–3b85–46fd–aa13–11bf42c8927d


GLOBENEWSWIRE (Distribution ID 8561452)

First CE-IVD marked AI solution for prognostic risk stratification of breast cancer patients.

Stockholm, Sweden, June 01, 2022 (GLOBE NEWSWIRE) — Stratipath, a global leader in AI–based precision diagnostic solutions, today announced that its AI software for prognostic risk stratification of breast cancers, Stratipath Breast, is now CE–IVD marked. This paves the way for clinical implementation in the European Union. Based on the analysis of digital histopathology whole slide images, stained with haematoxylin and eosin (H&E) the software provides novel decision support to clinicians and enables precision medicine for more patients.

Stratipath Breast is the first EU regulatory compliant solution for risk stratification of breast cancer using AI–based precision diagnostics to analyse cancer tissue, and enabling identification of patients with increased risk of disease progression.

In contrast to traditional molecular tests, AI–based risk stratification enables faster turnaround times for results, provides new information at the point of diagnosis and reduces the need for expensive molecular testing, allowing for wider use and benefit to more patients.

“Stratipath Breast offers a faster and cheaper alternative to molecular assays, allowing more patients to have access to precision diagnostics. By using Stratipath Breast, clinicians can diagnose with support from prognostic information, while reducing laboratory time and costs," says Johan Hartman, professor in pathology at Karolinska Institutet, Stockholm, and co–founder of Stratipath.

Histological tumour grade is a strong prognostic indicator of breast cancer. Grading of invasive breast cancer is performed on all invasive breast cancers based on morphological assessment, according to the Nottingham Histologic Grade (NHG), resulting in the low– to high–risk categories NHG 1, 2 or 3. But currently, more than 50% of all breast cancer patients are categorised as of intermediate risk (i.e NHG 2), which provides little clinical utility for treatment decision–making. The consequential over– and undertreatment of patients with early breast cancer has become one of the main challenges for treating physicians, and the clinical decisions are often dependent on expensive molecular assays that are not accessible to the majority of patients.

Using deep learning, Stratipath Breast enables cancer detection and classification of intermediate risk tumours into low– and high–risk groups, based on grade–related tumour morphology. The stratification comes from a rigorous scientific development process and validation using multi–source real–world datasets, comprising histopathology images and associated clinical outcome data.

The system measures risk–associated morphological patterns locally in the image and aggregates this information across the analysed tissue area to establish whether the tumour belongs to the high– or low–risk group. Results from Stratipath Breast provide prognostic information and are intended to be used as a decision support tool, together with other clinical and pathological information.

Stratipath Breast provides an optimal workflow through integration with leading digital pathology solutions. It can also be used on its own, via the Stratipath customer web portal. Access to Stratipath Breast will be provided as a Software as a Service solution, by a subscription or pay as you use model. Not marketed in the USA.

About Stratipath
Stratipath is a spin–out from Karolinska Institutet in Stockholm, Sweden, bringing pioneering research in AI and precision medicine into clinical use. The company was founded in 2019 by Johan Hartman, M.D., PhD, Mattias Rantalainen, PhD and Fredrik Wetterhall with a mission to radically improve cancer treatment decisions and patient outcomes. Stratipath offers an AI precision diagnostic solution for healthcare and can offer an accelerated path for pharma and biotech companies to identify patients most likely to benefit from novel therapies.

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GLOBENEWSWIRE (Distribution ID 8563634)