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Daily Archives: January 26, 2021

Nyxoah announces full-body 1.5T and 3T MRI compatibility for the Genio® system to treat Obstructive Sleep Apnea (OSA)

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Mont-Saint-Guibert, Belgium – 26th January, 2021 – Nyxoah SA (Euronext: NYXH) (“Nyxoah” or the “Company”), a health-technology company focused on the development and commercialization of innovative solutions and services to treat Obstructive Sleep Apnea (OSA), today announces the Company has received CE Mark Magnetic Resonance Imaging (MRI) conditional labeling for the current Genio® neurostimulation-based OSA therapy to treat Obstructive Sleep Apnea.

This revised labeling ensures that patients who receive the Genio® system and those already implanted can now undergo full-body 1.5T and 3T MRI diagnostic scans within approved parameters and access the benefits of Genio® unique bilateral stimulation therapy.

Olivier Taelman, Chief Executive Officer of Nyxoah, commented: “We are delighted to announce full-body 1.5T and 3T MR conditional CE mark approval for the Genio® system, resulting from the unique and unparalleled design of our technology. Such an extensive labeling is unique to Nyxoah in the field of neurostimulation-based OSA therapies. Currently other therapies cannot fully  address this need due to limitations to 1.5T MRI scans and body areas exclusion. As a company, Nyxoah always puts the patient first and seeks to ensure minimal disruption of their daily life and optimal Quality of Life (QOL).”

Prof. Dr. Clemens Heiser, MD, MHBA, PhD, ENT surgeon from Klinikum Rechts der Isar – Munich added: “Prevalence of MRI scans as diagnostic modality is growing, especially for OSA patients, as this condition is being associated with increased risk of comorbidities, such as cardiovascular diseases. The addition of 1.5T and 3T full-body MR conditional labeling for the Genio® system will be another critical benefit for my patients and will help me ensure those who may need an MRI can benefit from Nyxoah’s innovations with no fear for themselves and their implant during the exam”.

For further information, please contact:

Nyxoah
Milena Venkova, Corporate Communications Manager
milena.venkova@nyxoah.com
+32 490 11 93 57

About Nyxoah

Nyxoah is a healthtech company focused on the development and commercialization of innovative solutions and services to treat Obstructive Sleep Apnea (OSA). Nyxoah’s lead solution is the Genio® system, a CE-validated, patient-centered, next generation hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk1 and comorbidities including cardiovascular diseases, depression and stroke.
Following the successful completion of the BLAST OSA study in patients with moderate to severe OSA, the Genio® system received its European CE Mark in 2019. The Company is currently conducting the BETTER SLEEP study in Australia and New Zealand for therapy indication expansion, the DREAM IDE pivotal study for FDA approval and a post-marketing EliSA study in Europe to confirm the long-term safety and efficacy of the Genio® system.
For more information, please visit www.nyxoah.com.

Caution – Genio® is CE marked since 2019. Investigational device in the United States. Limited by U.S. federal law to investigational use in the United States.


1 Young T. et al: Sleep Disordered Breathing and Mortality: Eighteen-Year Follow-up of the Wisconsin Sleep Cohort, Sleep. 2008 Aug 1; 31(8): 1071–1078.

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Nyxoah announces full-body 1.5T and 3T MRI compatibility for the Genio® system to treat Obstructive Sleep Apnea (OSA)

A picture containing clock, light, drawing Description automatically generated

Mont-Saint-Guibert, Belgium – 26th January, 2021 – Nyxoah SA (Euronext: NYXH) (“Nyxoah” or the “Company”), a health-technology company focused on the development and commercialization of innovative solutions and services to treat Obstructive Sleep Apnea (OSA), today announces the Company has received CE Mark Magnetic Resonance Imaging (MRI) conditional labeling for the current Genio® neurostimulation-based OSA therapy to treat Obstructive Sleep Apnea.

This revised labeling ensures that patients who receive the Genio® system and those already implanted can now undergo full-body 1.5T and 3T MRI diagnostic scans within approved parameters and access the benefits of Genio® unique bilateral stimulation therapy.

Olivier Taelman, Chief Executive Officer of Nyxoah, commented: “We are delighted to announce full-body 1.5T and 3T MR conditional CE mark approval for the Genio® system, resulting from the unique and unparalleled design of our technology. Such an extensive labeling is unique to Nyxoah in the field of neurostimulation-based OSA therapies. Currently other therapies cannot fully  address this need due to limitations to 1.5T MRI scans and body areas exclusion. As a company, Nyxoah always puts the patient first and seeks to ensure minimal disruption of their daily life and optimal Quality of Life (QOL).”

Prof. Dr. Clemens Heiser, MD, MHBA, PhD, ENT surgeon from Klinikum Rechts der Isar – Munich added: “Prevalence of MRI scans as diagnostic modality is growing, especially for OSA patients, as this condition is being associated with increased risk of comorbidities, such as cardiovascular diseases. The addition of 1.5T and 3T full-body MR conditional labeling for the Genio® system will be another critical benefit for my patients and will help me ensure those who may need an MRI can benefit from Nyxoah’s innovations with no fear for themselves and their implant during the exam”.

For further information, please contact:

Nyxoah
Milena Venkova, Corporate Communications Manager
milena.venkova@nyxoah.com
+32 490 11 93 57

About Nyxoah

Nyxoah is a healthtech company focused on the development and commercialization of innovative solutions and services to treat Obstructive Sleep Apnea (OSA). Nyxoah’s lead solution is the Genio® system, a CE-validated, patient-centered, next generation hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk1 and comorbidities including cardiovascular diseases, depression and stroke.
Following the successful completion of the BLAST OSA study in patients with moderate to severe OSA, the Genio® system received its European CE Mark in 2019. The Company is currently conducting the BETTER SLEEP study in Australia and New Zealand for therapy indication expansion, the DREAM IDE pivotal study for FDA approval and a post-marketing EliSA study in Europe to confirm the long-term safety and efficacy of the Genio® system.
For more information, please visit www.nyxoah.com.

Caution – Genio® is CE marked since 2019. Investigational device in the United States. Limited by U.S. federal law to investigational use in the United States.


1 Young T. et al: Sleep Disordered Breathing and Mortality: Eighteen-Year Follow-up of the Wisconsin Sleep Cohort, Sleep. 2008 Aug 1; 31(8): 1071–1078.

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UCSF QBI and Icahn School of Medicine at Mount Sinai Scientists Report New Preclinical Data Published in Science on Potential Best-in-Class COVID-19 Anti-Viral Treatment: Plitidepsin

Aplidium albicans

Aplidin was extracted from Aplidium albicans, a sea squirt found off the coast of Spain

First studies reported on antiviral drug effects against new variant mutant “U.K.” strain of SARS-CoV-2

Plitidepsin shows potent anti-viral effect in preclinical models of original SARS-CoV-2 as well as the new mutant U.K. strain, and by inhibiting a key host protein, has the potential to have antiviral activity against other future mutations and viruses

Drug targets the biologic pathway prospectively identified and published in Nature months ago from QBI research on SARS CoV-2 which elucidated host proteins and pathways that fuel the survival and virulence of the virus

SAN FRANCISCO, Jan. 25, 2021 (GLOBE NEWSWIRE) —  In a study published online in Science today, scientists at UCSF QBI and the Department of Microbiology at Icahn School of Medicine at Mount Sinai (ISMMS) reported data showing the promise and potential of Aplidin® (plitidepsin), a drug approved by the Australian Regulatory Agency for the treatment of multiple myeloma, against SARS-CoV-2, the virus that causes COVID-19. Specifically, plitidepsin demonstrated antiviral activity that was 27.5-fold more potent against SARS-CoV-2 in vitro than remdesivir, a drug that received FDA emergency use authorization in 2020 for the treatment of COVID-19. In addition, in two preclinical models of COVID-19, plitidepsin showed a 100-fold reduction in viral replication in the lungs and demonstrated an ability to reduce lung inflammation. Furthermore, in a separate publication in bioRxiv, the researchers, in collaboration with Greg Towers and Clare Jolly at University College London in London, England, shared additional in vitro data demonstrating comparable anti-viral activity of plitidepsin in the newly identified b.1.1.7 variant mutant strain of SARS-CoV-2 when compared to the original SARS-CoV-2 strain. Additionally, they found plitidepsin to be ~100 times more potent than remdesivir in human epithelial cells.

The studies were led by the laboratories of Nevan Krogan, Ph.D., Director of the Quantitative Biosciences Institute (QBI) at the School of Pharmacy at UC San Francisco, Senior Investigator at Gladstone Institutes, and Adolfo García-Sastre, Ph.D., Professor in the Department of Microbiology and Director of the Global Health and Emerging Pathogens Institute of ISMMS in New York, among others.

“From the start, our scientific investigation at QBI’s Coronavirus Research Group (QCRG) was to research where and how the SARS-CoV-2 virus was co-opting its human host to thrive, survive and become deadly,” said Dr. Krogan. “That research led us to a biologic pathway, eukaryotic translation machinery, where inhibition of this pathway showed significant antiviral activity in cell culture. One of the promising agents that arose from our screen of drugs that inhibit this pathway was plitidepsin. The preclinical data published today showing increased potency compared to remdesivir, and in conjunction with recent early clinical data showing promise in COVID-19 patients as reported by the drug’s manufacturer, highlight plitidepsin should be further evaluated as a COVID-19 therapy. Additionally, this further validates our prospective and novel approach of looking first at host mechanisms that permit the virus to wreak havoc. By targeting host factors that enable or facilitate disease, we have the potential to have a more far-reaching impact in drug development. In this case, SARS-CoV-2 and its mutant strains, and possibly other viruses that leverage the same pathway may also be susceptible to the same therapeutic agents that inhibit this virus-host interaction.”

The research studies showed that the anti-SARS-CoV-2 activity of plitidepsin was potent in human cells, with an IC90 of 0.88 nM, which was a 27.5-fold more potent antiviral than remdesivir tested in the same cell line. In addition, the antiviral effect of plitidepsin was tested in an established model of human lung cells, which showed that treatment with plitidepsin inhibited SARS-CoV-2 replication with an IC90 of 3.14 nM and a selectivity index of 40.4, suggesting that plitidepsin has potent antiviral activity in primary human lung cells. The researchers also tested the synergy between plitidepsin and remdesivir, given remdesivir’s use as part of the current standard of care for the treatment of COVID-19. In vitro data suggests that plitidepsin has an additive effect with remdesivir and would be a potential candidate to be considered in a combined therapy.

Dr. García-Sastre added, “The ongoing SARS-CoV-2 pandemic has created the immediate need for antiviral therapeutics that can be moved into the clinic urgently. This led us to screen clinically approved drugs with established bioavailability, pharmacokinetics and safety profiles. Our previous study of the SARS-CoV-2 interactome led us to the eEF1A eukaryotic translation pathway as a druggable target with the potential for potent inhibition of SARS-CoV-2. Furthermore, this pathway has been previously described to be an important host factor for the replication of many viral pathogens, including influenza virus and RSV suggesting its pan-antiviral targeting potential. These studies have only been possible by the combined efforts and expertise of the multiple academic research groups that are co-authors in the published study. We have also been doing these studies in close collaboration with PharmaMar, the company that first isolated the potent eEF1A inhibitor plitidepsin/ Aplidin® from a sea organism.”

“Plitidepsin is an extremely potent inhibitor of SARS-CoV-2, but its most important strength is that it targets a host protein rather than a viral protein,” said Kris White, Ph.D., Assistant Professor in the Department of Microbiology of Icahn School of Medicine at Mount Sinai (ISMMS), who was a corresponding author on the Science paper. “This means that if plitidepsin is successful in the treatment of COVID-19, the SARS-CoV-2 virus will be unable to gain resistance against it through mutation, which is a major concern with the spread of the new U.K. and South African variants.”

Aplidium albicans

Aplidin was extracted from Aplidium albicans, a sea squirt found off the coast of Spain

About QBI: The Quantitative Biosciences Institute (QBI) is a University of California organized research unit reporting through the UCSF School of Pharmacy. QBI fosters collaborations across the biomedical and the physical sciences, seeking quantitative methods to address pressing problems in biology and biomedicine. Motivated by problems of human disease, QBI is committed to investigating fundamental biological mechanisms, because ultimately solutions to many diseases have been revealed by unexpected discoveries in the basic sciences. Learn more at qbi.ucsf.edu.

About UCSF: The University of California, San Francisco (UCSF) is exclusively focused on the health sciences and is dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. UCSF Health, which serves as UCSF’s primary academic medical center, includes top-ranked specialty hospitals and other clinical programs, and has affiliations throughout the Bay Area. Learn more at ucsf.edu or see our Fact Sheet.

Coronavirus Spike Protein

Structure of the coronavirus Spike protein (light blue, dark blue, and grey), which is essential for viral entry into human cells, adorned with the mutations (red, 8 in Spike) in the United Kingdom coronavirus variant.

About the Mount Sinai Health System: The Mount Sinai Health System is New York City’s largest academic medical system, encompassing eight hospitals, a leading medical school the Icahn School of Medicine, and a vast network of ambulatory practices throughout the greater New York region. Mount Sinai is a national and international source of unrivaled education, translational research and discovery, and collaborative clinical leadership ensuring that we deliver the highest quality care—from prevention to treatment of the most serious and complex human diseases. Learn more at mountsinai.org.

About Gladstone Institutes: To ensure our work does the greatest good, Gladstone Institutes focuses on conditions with profound medical, economic, and social impact—unsolved diseases. Gladstone is an independent, nonprofit life science research organization that uses visionary science and technology to overcome disease. It has an academic affiliation with UC San Francisco. Learn more at gladstone.org.

Coronavirus Spike Protein

Structure of the coronavirus Spike protein (light blue, dark blue, and grey), which is essential for viral entry into human cells, adorned with the mutations (red, 8 in Spike) in the United Kingdom coronavirus variant.

Authorship and funding: This work was funded by grants from the National Institute of Mental Health and the National Institute of Allergy and Infectious Diseases, both part of the National Institutes of Health; the Defense Advanced Research Projects Agency; the Center for Research for Influenza Pathogenesis; the Centers of Excellence for Influenza Research and Surveillance of the National Institute of Allergy and Infectious Diseases; the Centers of Excellence for Integrative Biology of Emerging Infectious Diseases of the Agence Nationale de la Recherche (France); F. Hoffmann-LaRoche AG; Vir Biotechnology, Centre for Integrative Biological Signalling Studies (CIBSS), European Research Council (ERC) and QCRG philanthropic donors. Shokat is a Howard Hughes Medical Institute investigator. A complete list of authors and full funding information is available in the Science paper.

Media Contacts

UCSF QBI UCSF
Sylvia Wheeler, Wheelhouse LSA Pete Farley, UCSF Office of Communications
swheeler@wheelhouselsa.com peter.farley@ucsf.edu
415-317-3781
Aljanae Reynolds, Wheelhouse LSA Mount Sinai Health System
areynolds@wheelhouselsa.com Lucia Lee, Mount Sinai Communications
lucia.lee@mountsinai.org
917-837-8914
Gladstone Institutes Icahn School of Medicine at Mount Sinai
Julie Langelier, Gladstone Communications Marlene Espinoza-Moraga, PhD
Julie.langelier@gladstone.ucsf.edu marlene.espinozamoraga@mssm.edu
415-734-5000 212-241-9812

Photos accompanying this announcement are available at

https://www.globenewswire.com/NewsRoom/AttachmentNg/f42dab31-fb28-4b44-a755-9578899e1c37

https://www.globenewswire.com/NewsRoom/AttachmentNg/ea32d7c0-2aed-4541-a530-764bb2cb74dd

https://www.globenewswire.com/NewsRoom/AttachmentNg/35a69fe5-e473-4fcc-bada-7512ce436896

https://www.globenewswire.com/NewsRoom/AttachmentNg/6638f44e-4df0-4043-8b29-e013b2519c0e

A video accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/97334c89-f27f-4029-be38-63a1d75bb46a

Govt facilities can be turned into swab test centres during emergency – KSN

The use of government buildings and facilities as swab test and temporary deployment centres of civil servants to services in need of additional health and safety support is among measures to be taken by the authorities in the implementation and management of emergency.

Chief Secretary to the Government Tan Sri Mohd Zuki Ali said it was also among the proposals discussed by the The Emergency Management Technical Committee and was agreed upon by the National Security Council Emergency Session.

The proposals were among the committee’s focuses on the mobilisation of the Federal and State Public Services’ resources, he said in a statement today.

The committee was set up to ensure the smooth implementation of the Emergency (Essential Powers) Ordinance 2021.

Mohd Zuki said the committee, which has to date, convened four times also focuses on the integration of public and private hospital services capabilities during the emergency, to ensure complete and integrated health access for COVID-19 and non-COVID-19 patients are guaranteed.

The integration is also aimed at optimising existing health resources and expertise to provide treatment to patients during the COVID-19 pandemic, he added.

Mohd Zuki said the integration would also see public hospitals, including university hospitals, Armed Forces hospitals, and private hospitals operating on a hybrid basis, based on the concept of cluster hospitals under the COVID-19 Integrated Control Centre.

He said the capacity of existing laboratories, especially at government departments and public universities, would be optimised to conduct mass COVID-19 detection.

“The mechanism to cover the treatment costs for COVID-19 patients at private hospitals by insurance companies is being studied by the Finance Ministry, Health Ministry, Bank Negara Malaysia and the insurance industry,” he said.

Mohd Zuki said the role of the private sector would be strengthen to treat COVID-19 patients who can afford their own medical and treatment costs.

He said, another focus discussed was the use of National Service Training Programme (PLKN) camps, Kem Bina Negara and other suitable facilities as temporary detention depots for the use of the Prisons Department, Immigration departments, Royal Malaysian Police on rental basis, to ensure physical distancing is maintained.

Sixteen PLKN camps nationwide, have been identified for that purpose, he added.

Mohd Zuki said the Communications and Multimedia Ministry (KKMM) would collect views and feedback from the people on the emergency.

“KKMM will also establish a special channel to ensure accurate information related to the implementation and management of emergency is channelled to the people,” he said.

Mohd Zuki said the committee would continue to monitor matters arising from the emergency proclamation so that the best recommendations can be put forward for consideration of the National Security Council Emergency Session.

He stressed that the public services administration would not be disrupted and would run as usual during the emergency period, to ensure smooth government delivery services with full adherence to the standard operating procedures set.

Mohd Zuki also reminded all Malaysians to always verify the authenticity of any information they received as the spread of unverified information would affect the government’s efforts to fight the COVID-19 pandemic.

“Let us all continue to pray that the COVID-19 pandemic can be fully overcome to protect the prosperity, economic stability and public order,” he said.

Source: BERNAMA News Agency

Reshuffle in Johor Civil Service due to retirements, promotions

A total of 58 state administrative officers are involved in a reshuffle exercise to fill vacancies due to the mandatory retirement and promotion of several senior officers in the Johor Civil Service (JSC).

Leading the list effective Feb 1 is former Iskandar Puteri City Council (MBIP) Mayor Datuk Salehuddin Hasan, who was sworn in as Johor State Financial Officer yesterday.

In a statement issued today, State Secretary Datuk Azmi Rohani said Salehuddin replaced Datuk A. Rahim Nin who went on compulsory retirement this month.

Taking over as MBIP Mayor is Datuk Mohd Haffiz Ahmad, the former Muar district officer while he will succeded by current Muar Municipal Council president Mustaffa Kamal Shamsudin.

“Zulkifly Mohd Tahir, who prior to this was Pontian district officer has been appointed Johor Islamic Religious Council chief executive officer while Batu Pahat district officer has been transferred to Johor Special Water (JSW) as its Executive Director,” Azmi said.

Also involved in the reshuffle is Kota Tinggi district officer Farizal Ismail, who will now helm Institut Dato’ Onn as its director, while former Kluang district officer Ismail Abu has been appointed Batu Pahat district officer.

His position in Kluang will be taken over by Jamaludin A. Hamid while Mohd Rafi Abdullah has been appointed the new Pontian district officer.

The reshuffle this time around also involves a number of women, with six holding key positions.

They include Shubanah Yusuf who has been appointed Deputy State Secretary (Monitoring and People’s Wellbeing) and Nor Azleena Abdul Rahman, who replaces her as State Legislative Assembly secretary, Azmi said.

The reshuffle exercise will also, for the second time in JSC’s history, see a woman, Hazlina Jalil, being appointed as a district officer.

Hazlina was Pengerang Municipal Council president prior to her new appointment.

Source: BERNAMA News Agency

MCO: Armed forces to help monitor Sibu longhouse residents

The Sarawak Disaster Management Committee (JPBN) will discuss with the police and the armed forces on more effective measures to address the issue of longhouse residents using forest trails to escape the lockdown imposed due to the spread of COVID-19 infection in Sibu.

Its chairman Datuk Amar Douglas Uggah Embas said he had instructed Sarawak police commissioner Datuk Aidi Ismail and the armed forces to present a more effective empowerment programme at the committee’s daily meeting tomorrow in order to prevent this act from continuing.

“We close the area to make sure no one slips out of the areas but there were also residents of longhouses who are still stubborn and sneak out. It is an irresponsible act,” he said at the COVID-19 daily press conference here today.

Uggah, who is also Sarawak deputy chief minister, said community leaders in areas under movement restrictions could also help ensure that every household complied with the guidelines set during the enforcement of the Movement Control Order (MCO) in the longhouses involved.

Yesterday, Sibu district police chief ACP Stanley Jonathan Ringgit was reported to have said he did not deny that there were residents in longhouses, under the MCO, who moved in and out of their homes but police action is hampered due to the vastness of the area to be monitored.

Meanwhile, Uggah said today that there were three new deaths involving COVID-19 infections in Sibu bringing the total number of fatalities in Sarawak to 33.

He added that the total number of positive COVID-19 cases in the state is at 3,704 cases.

Source: BERNAMA News Agency

Wait for official announcement on closure of 5-star hotel – MAH Penang

The Malaysian Association of Hotels (MAH) has urged the public to wait for an official announcement on the closure of a 662-room five-star hotel here by its management.

MAH Penang branch chairman Raj Kumar told Bernama that he was aware of the internal memo, mentioning the closure of the Equatorial Hotel Penang, which went viral on social media.

The internal memo stated that the last day of the Equatorial Hotel Penang’s operation would be decided sometime before March 31 this year, due to the adverse effects caused by the COVID-19 pandemic.

He said that he had tried contacting the hotel general manager Alan Ong to verify the statement, but no progress has been made thus far.

“We can only wait until the hotel management team to make the official announcement. However, if this were to be true, then it would truly be a sad day for us all,” he said.

Located in the hillock of Bukit Jambul near the Penang International Airport, the Equatorial Hotel Penang has been operating since the late 1980s.

Source: BERNAMA News Agency