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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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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.


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