Nyxoah raises €25 million in private funding round

Nyxoah raises 25 million in private funding round

Mont–Saint–Guibert, Belgium "" 12 February 2020, Nyxoah S.A., a healthtech company developing neuromodulation–based therapeutic solutions for sleep disordered breathing conditions, today announced that it has raised 25 million in a private financing round. Completion of the financing round is subject to customary closing conditions and is expected to occur later this month.

ResMed Inc. (NYSE:RMD) (ASX:RMD), a world–leading digital health company in the fields of sleep apnea, COPD, and other chronic diseases, joined as a new shareholder.

Under the lead of Mr. Robert Taub, Nyxoah executive chairman, Cochlear Limited (ASX:COH) and several historical shareholders completed the 25 million financing round.

The proceeds will enable Nyxoah to further advance in developing long–term clinical evidence on the Genio system, prepare for the IDE pivotal trial in the United States and accelerate the ongoing market access and commercialisation activities in Europe, Australia and New Zealand.

Olivier Taelman, CEO of Nyxoah, commented: "We have an innovative approach to treating OSA. Having ResMed, the global leader in sleep apnea, support this significant funding round along with our existing shareholders will help Nyxoah to further accelerate its development."

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About Obstructive Sleep Apnea (OSA) and the Genio system
OSA is the world's most common sleep disorder, affecting almost one billion people globally1.
OSA makes a person stop breathing during sleep, while the airway repeatedly becomes partially (hypopnea) or totally (apnea) blocked, limiting the amount of air that reaches the lungs. OSA is a chronic condition that is associated with increased mortality risk and comorbidities, including cardiovascular diseases, type 2 diabetes, obesity, depression and stroke. The current standard of care consists of Positive Airway Pressure (PAP) therapy, a treatment whereby air is pushed into the upper airway to keep it open.

The Genio system is the world's first and only, battery–free, leadless and minimally invasive implanted neurostimulator designed to keep the upper airway open during sleep for certain people with OSA by bilateral stimulation of the hypoglossal nerve.

About Nyxoah
Nyxoah is a healthtech company focused on the development and commercialisation of innovative solutions and services for sleep disordered breathing conditions. Nyxoah's lead solution platform is based on the Genio system, a validated, user–centered, next generation hypoglossal neurostimulation therapy for OSA, the world's most common sleep disordered breathing condition that is associated with increased mortality risk and comorbidities including cardiovascular diseases, depression and stroke.

Following successful completion of the BLAST OSA study in patients with moderate to severe OSA, the Genio system received its European CE Mark in March 2019. The Company is currently conducting the BETTER SLEEP study in Australia and New Zealand for therapy indication expansion, and a post–marketing EliSA study in Europe to confirm the long–term safety and efficacy of the Genio system. The IDE pivotal study to prepare for US market entrance is currently in discussion with the FDA.

For more information, please visit www.nyxoah.com.
Caution "" CE marked since 2019. Investigational device in the United States. Limited by federal law to investigational use.


1 Benjafield, Adam V et al. Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature–based analysis. Lancet Respir Med 2019 Published Online July 9, 2019 http://dx.doi.org/10.1016/S2213–2600(19)30198–5

Intuitive Acquires Orpheus Medical to Expand Informatics Platform for Hospitals

SUNNYVALE, Calif., Feb. 10, 2020 (GLOBE NEWSWIRE) — Intuitive (Nasdaq: ISRG), a global technology leader in minimally invasive care and the pioneer of robotic–assisted surgery, announced it has acquired privately held Orpheus Medical to deepen and expand its integrated informatics platform.

Orpheus Medical provides hospitals with information technology connectivity, as well as expertise in processing and archiving surgical video.

"The addition of Orpheus will provide customers ""including surgeons, patient care teams and hospitals""with ready access to and a deeper understanding of their data, which we believe may help our customers improve patient outcomes and lower total treatment costs," said Julian Nikolchev, Intuitive's senior vice president of corporate development and strategy.

Orpheus develops and distributes its clinical video management and analytics platform, which hospitals use across surgical disciplines. The platform offers the ability to capture and share clinical video and imaging from many sources, which may help improve physician and OR care team workflow and enable analysis of their interventions.

"Combining both companies' innovative technologies with Intuitive's global reach and resources will enable current and future customers easier and faster access to their data," said Gaddi Menahem, CEO of Orpheus Medical.

Orpheus will be a wholly owned subsidiary of Intuitive. Terms of the acquisition were not disclosed.

About Intuitive
Intuitive (Nasdaq: ISRG), headquartered in Sunnyvale, Calif., is a global technology leader in minimally invasive care and the pioneer of robotic–assisted surgery. At Intuitive, we believe that minimally invasive care is life–enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.

Intuitive brings more than two decades of leadership in robotic–assisted surgical technology and solutions to its offerings, and develops, manufactures and markets the da Vinci surgical system and the Ion endoluminal system.

About the da Vinci Surgical System
There are several models of the da Vinci surgical system. The da Vinci surgical systems are designed to help surgeons perform minimally invasive surgery. Da Vinci systems offer surgeons high–definition 3D vision, a magnified view, and robotic and computer assistance. They use specialized instrumentation, including a miniaturized surgical camera and wristed instruments (i.e., scissors, scalpels and forceps) that are designed to help with precise dissection and reconstruction deep inside the body.

For more information, please visit the company's website at www.intuitive.com.

Forward–Looking Statement

This press release contains forward–looking statements, including statements regarding the company's acquisition of Orpheus Medical. These forward–looking statements are necessarily estimates reflecting the best judgment of the company's management and involve a number of risks and uncertainties that could cause actual results to differ materially from those suggested by the forward–looking statements. These forward–looking statements should, therefore, be considered in light of various important factors, including, but not limited to, the following: the risk that Orpheus Medical cannot successfully expand its customer base or grow revenue after closing, risks associated with integrating a newly acquired business outside of the United States, diversion of management and other resources in supporting the newly acquired business, and other risk factors under the heading "Risk Factors" in the Company's report on Form 10–K for the year ended December 31, 2018, as updated by the Company's other filings with the Securities and Exchange Commission. Statements using words such as "estimates," "projects," "believes," "anticipates," "plans," "expects," "intends," "may," "will," "could," "should," "would," "targeted," and similar words and expressions are intended to identify forward–looking statements. You are cautioned not to place undue reliance on these forward–looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update or release any revisions to these forward–looking statements, except as required by law.

Contact
Global Public Affairs
Intuitive Surgical
corp.comm@intusurg.com
+1–408–523–7337

Source: Intuitive Surgical, Inc.

PN# 1069571–RevA–US–February2020