Nyxoah Announces CE-Mark Indication Approval to Treat Complete Concentric Collapse (CCC) Patients


Nyxoah Announces CE–Mark Indication Approval to Treat Complete Concentric Collapse (CCC) Patients

Notified Body DEKRA approves IFU changes to remove warning regarding CCC patients

Mont–Saint–Guibert, Belgium "" October 4, 2021, 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 DEKRA Notified Body has approved the Company's proposed indication for the Genio system to treat patients with a Complete Concentric Collapse ("CCC"). DEKRA attributed the updated Genio therapeutic indication to the BETTER SLEEP study data presented by the Company, concluding that "the effectiveness results and safety profile for both CCC and non–CCC patients are comparable". Patients, therefore, do not have to undergo a Drug–Induced Sleep Endoscopy (DISE) procedure to determine if they have CCC at the soft palate level prior to Genio implantation.

"We are thrilled that the Notified Body has approved the Genio system as a treatment option for the large population of CCC patients. This will expand our total addressable market by at least 30%.", said Olivier Taelman, CEO of Nyxoah. "Combined with the Breakthrough Device Designation granted by the U.S. FDA last month, the DEKRA approval provides further validation that our bilateral approach is well suited for both non–CCC and CCC patients. This broader indication will help accelerate our commercial activities in key European markets while we continue to pursue a clinical and regulatory pathway to make Genio available to both non–CCC and CCC patients in the U.S."

Prof. Dr. med. Clemens Heiser, MD, PhD "" Head of ENT Sleep Laboratory at Klinikum Rechts der Isar ""Technical University of Munich and worldwide recognized Key Opinion Leader in sleep surgery commented: "Until now, Obstructive Sleep Apnea (OSA) patients presenting a CCC were not suitable for marketed unilateral hypoglossal nerve stimulation systems and had to be excluded from this technique. With previous research from my group, bilateral stimulation seems to open the soft palate even with CCC. Bilateral neurostimulation solution is a new hope for these patients in need for a safe and efficient therapy. A full–body 1.5T and 3T MRI compatibility combined with CCC indication for the Genio bilateral stimulation solution will change a lot in the future for hypoglossal nerve stimulation therapy."

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 in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE–Mark indication approval to treat 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.

Jeremy Feffer, VP IR and Corporate Communications
+1 917 749 1494

Gilmartin Group
Vivian Cervantes


GLOBENEWSWIRE (Distribution ID 1000550763)

Sweegen Expands Sugar Reduction Portfolio With High-Intensity Sweetener Brazzein

Rancho Santa Margarita, Calif., Oct. 04, 2021 (GLOBE NEWSWIRE) — Sweegen is expanding its extensive sweetener portfolio in early 2022 with the zero–calorie, high–intensity sweetener brazzein. The product was developed in collaboration with long–term innovation partner Conagen, which has scaled it to commercial production. Brazzein is a small, heat–stable protein, 500 to 2,000 times sweeter than regular sugar, making it very attractive to food and beverage manufacturers seeking excellent value in a sweetener.

As a sweetener, brazzein promises little to no bitter aftertaste and helps to reduce sweet linger, reducing taste modulation challenges in the natural sweetener space. Brazzein is stable in a wide range of pH and retains its qualities after pasteurization. It is also readily soluble, making it ideal for sugar reduction across a spectrum of food and beverage applications.

"Introducing a high–purity brazzein to Sweegen's portfolio of natural sweeteners is one more creative solution for helping brands make low–calorie better–for–you products," said Sweegen's SVP, Head of Global Innovation, Shari Mahon. "Brands can look forward to exploring the synergistic benefits of combining brazzein and stevia for reducing sugar in food and beverages in a cost–effective way."

As a sweet protein, brazzein has great promise to fit into consumer diets, such as Keto, diabetes, or low–to–no carbohydrate lifestyles. Health–conscious consumers are also turning away from artificial sweeteners and accepting nature–based sweeteners, such as stevia and allulose.

Brazzein's extraordinary qualities stand out among high–intensity sweeteners, but the quest to scale and commercialize it has proven difficult until now. Found sparingly in nature, brazzein derives from the West African climbing plant's fruit, oubli. To scale brazzein sustainably, Conagen produces it by a proprietary precision fermentation process, a technology producing clean, nature–based ingredients.

"Brazzein is the first product generated from our new peptide platform, which fits well into our existing world–scale, precision fermentation infrastructure," said Conagen's Vice President of Innovation, Casey Lippmeier, Ph.D. "Peptides and small proteins like brazzein can be very difficult to make economically. However, now that we have successfully scaled this peptide, we expect more sustainable, novel peptide ingredients will rapidly follow."


About Sweegen

Sweegen provides sweet taste solutions for food and beverage manufacturers around the world.

We are on a mission to reduce the sugar and artificial sweeteners in our global diet. Partnering with customers, we create delicious zero–sugar products that consumers love. With the best next–generation stevia sweeteners in our portfolio, such as Signature Bestevia Rebs B, D, E, I, M, and N, along with our deep knowledge of flavor modulators and texturants, Sweegen delivers market–leading solutions that customers want, and consumers prefer. Be well. Choose well.

For more information, please contact info@sweegen.com and visit Sweegen's website, www.sweegen.com.

Cautionary Statement Concerning Forward–Looking Statements

This press release contains forward–looking statements, including, among other statements, statements regarding the future prospects for Reb M stevia leaf sweetener. These statements are based on current expectations but are subject to certain risks and uncertainties, many of which are difficult to predict and are beyond the control of Sweegen, Inc.

Relevant risks and uncertainties include those referenced in the historic filings of Sweegen, Inc. with the Securities and Exchange Commission. These risks and uncertainties could cause actual results to differ materially from those expressed in or implied by the forward–looking statements, and therefore should be carefully considered. Sweegen, Inc. assumes no obligation to update any forward–looking statements due to new information or future events or developments.


GLOBENEWSWIRE (Distribution ID 8366893)