Zoom Becomes the First Video Communications Client to Attain Common Criteria Certification

SAN JOSE, Calif., Jan. 10, 2022 (GLOBE NEWSWIRE) — Zoom Video Communications, Inc. (NASDAQ: ZM) today announced that Zoom Meeting Client version 5.6.6 has become the first video communications client to attain certification for Common Criteria Evaluation Assurance Level 2 (v3.1 rev. 5), issued by the German Federal Office for Information Security (BSI).

Common Criteria is an international standard for objectively evaluating that an IT product satisfies a defined set of security requirements. The evaluation involves analyzing a specific set of security targets, including guidance documentation, architectural design, life cycle aspects, testing and vulnerability assessment. The Zoom Meeting Client v5.6.6 has been evaluated by the BSI against the Common Criteria standard and found to exhibit a clear chain of evidence that the process of specification, implementation, and evaluation has been conducted in a rigorous and standard manner.

Mutually recognized in more than 25 countries including the UK, US, Canada, and Germany, Common Criteria is regarded as a leading benchmark for IT product security certification. A growing number of users expect IT vendors to produce trusted and reliable evidence for the cybersecurity capabilities of their products.

"This Common Criteria certification represents a major milestone for Zoom," said Jason Lee, Chief Information Security Officer at Zoom. "We're the first video communications client to receive this important certification, reinforcing our commitment to our customers. Security and privacy are the cornerstones of everything we do, and we are continually innovating secure solutions for all users of our platform."

At present, the BSI has certified Zoom version 5.6.6 for Windows, macOS, iOS, and Android. While version 5.6.6 was the version of Zoom client available at the time of the certification, we always recommend customers utilize the newest version of the client to take advantage of Zoom's latest security updates and features.

"The Common Criteria certification is a global benchmark in cybersecurity," said Sandro Amendola, Head of Standardization/Certification/Telecommunications Networks Security Department, BSI. "The Zoom client demonstrated a high security standard across its product, successfully completing one of the most demanding evaluation procedures a company can undertake."

To learn more about Zoom's Common Criteria certification, please visit the BSI website and the Zoom Trust Center.

About Zoom
Zoom is for you. We help you express ideas, connect to others, and build toward a future limited only by your imagination. Our frictionless communications platform is the only one that started with video as its foundation, and we have set the standard for innovation ever since. That is why we are an intuitive, scalable, and secure choice for individuals, small businesses, and large enterprises alike. Founded in 2011, Zoom is publicly traded (NASDAQ: ZM) and headquartered in San Jose, California. Visit zoom.com and follow @zoom.

Zoom Public Relations
Matt Nagel

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General Fusion achieves critical technology milestone for practical fusion power

VANCOUVER, British Columbia, Jan. 10, 2022 (GLOBE NEWSWIRE) — General Fusion announced today it has successfully achieved several aggressive performance goals of a prototype system for its Fusion Demonstration Plant (FDP). The company's plasma compression prototype, located at its Vancouver, Canada laboratory, is being used to demonstrate a critical element of its proprietary Magnetized Target Fusion (MTF) technology. This important milestone marks another significant step toward General Fusion's goal of creating practical and commercially viable fusion power.

Commissioned in early 2021, the prototype machine drives a forceful, but precisely shaped, symmetric collapse of a large liquid vortex cavity in tens of milliseconds. The forces involved in the full–scale FDP compression system will be immense, pushing the limits of material science, fluid dynamics, and mechanical design. Achieving this milestone with the prototype significantly reduces engineering and technical risks for General Fusion's FDP. It will use a collapsing liquid metal cavity to heat and compress plasma fuel to fusion conditions at 100 million degrees Celsius.

The idea of using a collapsing liquid metal cavity to create fusion has been around for decades, but General Fusion has been able to bring new enabling technologies such as high–speed digital control systems, additive manufacturing, and advanced composite materials to make this concept viable and to de–risk its implementation in the FDP. Driving a rapid, smooth, and spherically shaped collapse of a cavity created inside a rotating liquid has been a difficult engineering challenge that General Fusion has now demonstrated in this prototype machine. It is the pathfinder for a larger prototype being built in 2022 to validate further refinements to various engineering aspects of this technology.

"Net energy production is essential, but not really the ultimate goal of commercializing fusion energy, which is building economical, carbon–free fusion power plants," said Christofer Mowry, CEO, General Fusion. "Our unique technology, two decades in the making, solves the long–standing challenges of building practical fusion power plants for the world's energy markets struggling to move away from fossil fuels. The successful performance of this important prototype validates we are on the path to success."

General Fusion's unique MTF technology overcomes several key challenges of creating practical fusion energy. MTF will economically create fusion conditions, efficiently convert fusion energy into carbon–free electricity, protect the fusion machine from burning fusion plasma, and produce enough fusion fuel for its own use. General Fusion's prototype compression system validates one of the most critical parts of its MTF technology because a mechanically collapsed liquid cavity is a cornerstone for MTF overcoming all these challenges.

About General Fusion
General Fusion is pursuing the fastest and most practical path to commercial fusion energy and is based in Vancouver, Canada, with locations in London, U.K., and Oak Ridge, Tennessee, U.S.A. The company was established in 2002 and is funded by a global syndicate of leading energy venture capital firms, industry leaders, and technology pioneers. Learn more at www.generalfusion.com.

General Fusion Media Relations

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A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/a8d18aac–c6fb–4486–ad73–6d0c0ea1cb81

GLOBENEWSWIRE (Distribution ID 8423590)

MeMed raises $93M to accelerate commercialization of its host immune-response product portfolio

MeMed raises $93M to accelerate commercialization of its
host immune–response product portfolio

MeMed BV test recently cleared for use by US FDA to aid in distinguishing between bacterial and viral infection on the point–of–need platform MeMed Key

HAIFA, Israel; BOSTON, MA; January 10th, 2022 "" MeMed, a leader in host response technologies, today announces a $93 million private financing round, bringing total funding in the Company to over $200 million, including support from the U.S. Department of Defense and EU Commission. Funds will be used to scale up manufacturing, accelerate commercialization and expand MeMed's pioneering host immune response product portfolio.

MeMed's technology suite decodes the body's immune response within minutes, providing physicians with important patient management solutions that tackle key clinical dilemmas. The U.S. Food and Drug Administration (FDA) recently granted a landmark clearance for the use of the MeMed BV test on the point–of–need platform MeMed Key , to help healthcare providers distinguish between bacterial and viral infections in both children and adults. MeMed has also developed the MeMed COVID–19 Severity test for predicting severe outcomes in COVID–19 patients, which has been cleared for use in Europe.

The latest financing brings together new and existing investors including Horizons Ventures, Shavit Capital, Social Capital, La Maison Partners, Touchwood Capital, Caesara Medical Holdings, Union Tech Ventures, ClaI Insurance, Phoenix Insurance, Poalim Equity and Western Technology Investment.

Eran Eden, MeMed's co–founder and CEO, said: "This new investment will enable MeMed to expand operations with a focus on the U.S. We are grateful to our investors for their support and will leverage the funds, the recent FDA clearance, and our growing network of partnerships to provide broad patient access to our technology, as well as expand our product portfolio of pioneering host response solutions."

Patrick Zhang, Horizons Ventures, said: "We strongly believe that MeMed's strategy of using host immune response technologies is a significant advance in the improvement of two major issues in healthcare today: the rise of antimicrobial resistance due to unnecessary prescription of antibiotics and effectively triaging patients infected with COVID–19. We look forward to playing a role in how MeMed, a category leader in this area, is transforming the way diseases are diagnosed and treated to improve patient healthcare across the globe."


About MeMed
Our mission is to translate the immune system's complex signals into simple insights that transform the way diseases are diagnosed and treated, profoundly benefiting patients and society. For additional information on MeMed, please visit http://www.me–med.com.

MeMed Contacts:
Media: Will Harris, VP Marketing, MeMed

IR: Kfir Emmer, CFO, MeMed

Media Contacts:
Consilium Strategic Communications


GLOBENEWSWIRE (Distribution ID 1000588096)

Nyxoah Provides General Corporate Update

Nyxoah Provides General Corporate Update

Transformational 2021 positions Nyxoah for further clinical, regulatory, and commercial milestones in 2022

Mont–Saint–Guibert, Belgium "" January 10, 2022, 7:00am CET / 1:00am 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 provided a general corporate update.

2021 Highlights

  • Implanted first U.S. patient in the DREAM IDE pivotal study in December 2020; there are currently 15 active and enrolling patient sites in the U.S., with implants expected to be completed in Q1 2022
  • Secured CE Mark MR conditional labeling for the Genio system in January, ensuring that implanted patients can undergo full–body 1.5T and 3T MRI diagnostic scans
  • Raised $97.8 million in a Nasdaq initial public offering in July, successfully completing Nyxoah's second IPO after previously raising $100 million in the September 2020 Euronext Brussels IPO
  • Granted U.S. FDA Breakthrough Device Designation for the treatment of adult patients with moderate to severe OSA and Complete Concentric Collapse (CCC) of the soft palate in September; engaged in sprint discussions with FDA regarding the IDE study for CCC patients in the U.S., which Nyxoah hopes to commence in the second half of 2022
  • Received expanded CE Mark indication to treat CCC patients in October, thus increasing Nyxoah's total addressable market by at least 30% and thereby enabling patients not to have to undergo a Drug–Induced Sleep Endoscopy (DISE) procedure prior to Genio implantation
  • Made strong commercial progress in Germany after obtaining a dedicated DRG code in January
  • Obtained DRG coding in Switzerland in March and secured first revenue in Spain; submitted reimbursement files in other key European markets
  • Entered exclusive licensing agreement with Vanderbilt University in February to develop next generation neurostimulation technologies, specifically a stimulator focused on the Ansa Cervicalis, which innervates the palatoglossus and/or the palatopharyngeus muscle; this collaboration has thus far resulted in initial prototyping discussions, and Nyxoah expects to make further progress on this project in 2022
  • Appointed Loic Moreau as Chief Financial Officer effective January 1, 2022, replacing Fabian Suarez, who is pursuing a new opportunity as CEO of a startup MedTech company
  • Announced the appointment of Rita Johnson–Mills to the Board of Directors in August

"2021 was a transformational year for Nyxoah as we achieved several important clinical, regulatory, commercial, and financial accomplishments and set ourselves up for continued progress in 2022 and beyond," said Olivier Taelman, CEO of Nyxoah. "On the clinical front, we announced that our BETTER SLEEP clinical trial achieved a statistically significant mean reduction in the Apnea Hypopnea Index (AHI) from baseline to six months post implantation for the entire cohort as well as for the subgroup of patients with Complete Concentric Collapse (CCC) of the soft palate. We will be submitting the full data set for journal publication and look forward to discussing more fully once the data are published, hopefully in the first half of 2022. We are extremely encouraged by the data generated by BETTER SLEEP, which were used by our notified body DEKRA to expand our CE Mark indication to include CCC patients as well as by FDA in granting us Breakthrough Device Designation for the treatment of CCC patients in the U.S. We are also excited to partner with Dr. David Kent and his team at Vanderbilt University on the development of a next generation device that stimulates the Ansa Cervicalis, which Dr. Kent's research suggests could be another effective way to treat OSA patients, and we look forward to advancing our work in creating a stimulator that leverages this novel approach."

Mr. Taelman continued, "As we begin 2022, our primary clinical focus is on our DREAM U.S. IDE pivotal study in which patient enrollment and implants are well underway, and we still expect to complete our target of 134 implants by the end of Q1 2022. We continue to generate great enthusiasm from physicians and patients as we activate more sites and enroll more patients, and we are seeing implant rates accelerating as we move into the new year. We have also been encouraged by our sprint discussions with FDA regarding our IDE trial for CCC patients in the U.S., which we hope to commence in the second half of 2022. From a commercial standpoint, we have made tremendous progress in our key geographic markets, securing DRG codes in Germany and Switzerland, obtaining hospital reimbursement in Spain and awaiting reimbursement decisions in Belgium, the Netherlands, and the Nordic countries. Our commercial strategy centers on the concept of going deep as opposed to going wide; in other words, we want to focus our strategy on key Centers of Excellence with high levels of clinical expertise and patient care, large patient pools, and well–coordinated clinical and administrative infrastructures. This strategy, combined with our ability to treat CCC patients, has enabled us to gain meaningful market share in Germany, and we expect to exit 2022 as the market leader in that important country."

Mr. Taelman concluded, "As proud and excited as we are of our significant accomplishments in 2021, we have our sights set much higher for 2022. Aiding our efforts is a strong balance sheet that we bolstered in July with close to $100 million raised in our Nasdaq IPO, less than one year after raising close to $100 million in our Euronext IPO in September 2020. This liquidity gives us ample flexibility to complete the DREAM study, conduct the ACCCESS study, invest further in our existing commercial operations, and begin to build out a U.S. commercial operation in anticipation of launch following FDA approval. We are extremely well positioned to execute on our clinical, regulatory, and commercial initiatives, and we look forward to providing further updates on our progress as the year unfolds."

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.

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; 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. 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.

Loic Moreau, Chief Financial Officer
+32 473 33 19 80

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

Gilmartin Group
Vivian Cervantes


GLOBENEWSWIRE (Distribution ID 1000588091)