Cochlear Limited

Sensorion Announces it Has Met Primary Endpoint for SENS-401 Phase 2a Clinical Study for Residual Hearing Preservation

Retrieved on: 
Monday, March 11, 2024
Science, Biotechnology, Research, Pharmaceutical, Health, Medical Devices, Genetics, Clinical Trials, Cochlear Limited, Cochlear, Patient, Cochlea, POC, Perilymph, Huber loss, Data, Hearing, Physician, Medical device

Sensorion (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent hearing loss disorders, today announces it has met the primary endpoint for its Proof of Concept (POC) Phase 2a clinical trial of SENS-401 for residual hearing preservation following cochlear implantation.

Key Points: 
  • Sensorion (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent hearing loss disorders, today announces it has met the primary endpoint for its Proof of Concept (POC) Phase 2a clinical trial of SENS-401 for residual hearing preservation following cochlear implantation.
  • The study has been developed in collaboration with Cochlear Limited (Cochlear), the global leader in implantable hearing devices.
  • On February 1, 2024, Sensorion announced the completion of patient inclusion in the Phase 2a clinical trial of SENS-401 for the residual hearing preservation after cochlear implantation.
  • Nawal Ouzren, Chief Executive Officer of Sensorion, said: "We are delighted to announce we met the primary endpoint for the Phase 2a clinical trial of SENS-401 for residual hearing preservation.

Sensorion Announces the Completion of Patient Inclusion in Phase 2a Clinical Trial of SENS-401 for Residual Hearing Preservation After Cochlear Implantation

Retrieved on: 
Thursday, February 1, 2024
Biotechnology, Medical Devices, Health, Pharmaceutical, Clinical Trials, Perilymph, Clinical trial, Cochlear Limited, Trust, Patient, Cochlea, Physician, Safety, Huber loss, Medical device

Sensorion (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders, today announces the recruitment of the last patient in its Phase 2a clinical trial of SENS-401 for residual hearing preservation in adult patients following cochlear implantation.

Key Points: 
  • Sensorion (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders, today announces the recruitment of the last patient in its Phase 2a clinical trial of SENS-401 for residual hearing preservation in adult patients following cochlear implantation.
  • Patients start treatment with SENS-401 7 days before implantation and continue to receive SENS-401 for a further 42 days.
  • The study has been developed with Sensorion’s partner, Cochlear Limited, the global leader in implantable hearing devices.
  • The first preliminary efficacy data from this clinical trial were very promising and reinforce our confidence in the potential of SENS-401 in hearing loss prevention."

Cochlear and TechSee Win Silver in the 13th Annual Best in Biz Awards 2023

Retrieved on: 
Wednesday, January 24, 2024
ASX, Silver, Cochlear Limited, Marketing, Augmented reality, Publication, Huber loss, Smartphone, Customer service, Video game

NEW YORK, Jan. 24, 2024 /PRNewswire/ -- TechSee is excited to announce their customer, Cochlear Limited (ASX: COH), the global leader in implantable hearing solutions, has been named a silver winner in the Most Innovative Product of the Year - Healthcare category in Best in Biz Awards, the only independent business awards program judged each year by prominent editors and reporters from top-tier publications in North America for use of TechSee's technology.

Key Points: 
  • Cochlear, together with TechSee, a renowned leader in computer vision technology, has changed customer support for the hearing impaired by introducing interactive live video support sessions to offer easy and accessible remote service.
  • This revolutionary solution empowers Cochlear Device Support Specialists to "see what customers see," enabling them to guide users more efficiently in setting up or troubleshooting their devices.
  • "Partnering with TechSee has allowed us to take Cochlear customer support and experience to the next level using visual customer assistance.
  • For a full list of winners in Best in Biz Awards 2023, visit http://www.bestinbizawards.com/2023-winners .

Industry Veteran Abbas Hussain Appointed as Chair of Asceneuron

Retrieved on: 
Monday, December 18, 2023
SAN, Chair, Teva Pharmaceuticals, Abingworth (company), Patient, Adviser, Sofinnova, Spondyloarthropathy, Medicinal chemistry, Capital, CSL Limited, Stanford University, Eli Lilly, Pamlab, Conference, CSL Vifor, Non-executive director, Growth, GSK plc, OGA, Cochlear Limited, Pharmaceutical industry, Science, Immunocore

Abbas Hussain has over 35 years of experience in the healthcare industry, building and growing businesses across the globe.

Key Points: 
  • Abbas Hussain has over 35 years of experience in the healthcare industry, building and growing businesses across the globe.
  • Abbas Hussain, Chair of the Board of Directors of Asceneuron, remarked: "There have been tremendous advances in the treatment of neurodegenerative disorders which impact millions of people globally every year.
  • Abbas currently holds various Non-Executive Director and Advisor roles at Alfasigma SpA, 4Bio Capital, C-Bridge Capital and GLG Institute.
  • In addition, Abbas also provides expert advisory services to private equity and venture capital firms focused on the healthcare sector.

Industry Veteran Abbas Hussain Appointed as Chair of Asceneuron

Retrieved on: 
Monday, December 18, 2023
SAN, Chair, Teva Pharmaceuticals, Abingworth (company), Patient, Adviser, Sofinnova, Spondyloarthropathy, Medicinal chemistry, Capital, CSL Limited, Stanford University, Eli Lilly, Pamlab, Conference, CSL Vifor, Non-executive director, Growth, GSK plc, OGA, Cochlear Limited, Pharmaceutical industry, Science, Immunocore

Abbas Hussain has over 35 years of experience in the healthcare industry, building and growing businesses across the globe.

Key Points: 
  • Abbas Hussain has over 35 years of experience in the healthcare industry, building and growing businesses across the globe.
  • Abbas Hussain, Chair of the Board of Directors of Asceneuron, remarked: "There have been tremendous advances in the treatment of neurodegenerative disorders which impact millions of people globally every year.
  • Abbas currently holds various Non-Executive Director and Advisor roles at Alfasigma SpA, 4Bio Capital, C-Bridge Capital and GLG Institute.
  • In addition, Abbas also provides expert advisory services to private equity and venture capital firms focused on the healthcare sector.

Sensorion Reports 2023 First Half Results

Retrieved on: 
Wednesday, September 20, 2023
Biotechnology, Pharmaceutical, General Health, Health, Medical Devices, Genetics, Clinical Trials, Other Health, GMP, US Foods, Ear, PTA, European Medicines Agency, Huber loss, G&A, Malignancy, Patient, Institut Pasteur Korea, R, Cisplatin, POC, Pasteur Institute, Good manufacturing practice, Hearing loss, Congenital hearing loss, Cochlear Limited, IHC, Bioreactor, Perilymph, EMA, Platinum, Ototoxicity, HIV disease progression rates, Hearing, CIO, FDA, IND, Health care, Cochlea, Cell, AAV, GJB2, Presbycusis, Audiogram, Hertz, ANSM, KOL, Partnership, Neoplasm, Concept, Clinical trial, Quality of life, CTA, Medication, CDMO, Orphan, Pharmaceutical industry, Dentistry, Vaccine, Medical device, Cryptocurrency, Rare-earth element

In the first half of 2023, Sensorion achieved a major development milestone by completing the preclinical package, and successfully producing the GMP dual AAV OTOF-GT batches at 200L clinical scale.

Key Points: 
  • In the first half of 2023, Sensorion achieved a major development milestone by completing the preclinical package, and successfully producing the GMP dual AAV OTOF-GT batches at 200L clinical scale.
  • In April 2023, Sensorion announced the candidate selection for GJB2-GT during its R&D Day focusing on gene therapy.
  • The first patient was enrolled in December 2022 and Sensorion anticipates the publication of the preliminary results in H2 2023.
  • The annual accounts on June 30, 2023, drawn up according to IFRS standards and approved by the Board of Directors on September 18, 2023.

Sensorion Reports Positive Efficacy Data from SENS-401 Phase 2a Clinical Study

Retrieved on: 
Wednesday, July 5, 2023
Biotechnology, Health, Genetics, Pharmaceutical, Clinical Trials, KOL, Q&A, PTA, Hearing loss, Speech, Huber loss, Cochlea, Sorbonne, Cochlear Limited, Perilymph, AP-HP, Dental implant, Patient, Hearing, Hospital, POC, Robotics, News, Pharmaceutical industry, Medical device, Dentistry

Analysis of the preliminary data will be presented at the Company’s KOL webinar taking place today, Wednesday, July 5, 2023 (event details below).

Key Points: 
  • Analysis of the preliminary data will be presented at the Company’s KOL webinar taking place today, Wednesday, July 5, 2023 (event details below).
  • On June 19th, 2023, Sensorion announced that in preliminary data from the Phase 2a study, SENS-401 was detected in the perilymph of all 5 adult patients treated with the product.
  • Levels of SENS-401 were considered consistent with potential therapeutic effects after seven days of repeated oral treatment.
  • Nawal Ouzren, Chief Executive Officer of Sensorion, stated: “We are very excited to see such promising new preliminary data for our ongoing Phase 2a clinical study of SENS-401.

Nyxoah Raises $3 Million from an At-the-Market Equity Offering

Retrieved on: 
Monday, March 27, 2023
Mont-Saint-Guibert, CET, Obstructive sleep apnea, Enterprise file synchronization and sharing, OSA, Cochlear Limited, Sale, Prospectus, Euronext, Form, Security (finance), Cryptocurrency

Mont-Saint-Guibert, Belgium – March 27, 2023, 10:05pm CET / 4:05pm 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 Company raised $2.8 million in gross proceeds pursuant to the Company’s $50 million at-the-market ("ATM") program established on December 22, 2022 at an issue price equal to the market price on the Nasdaq Global Market at the time of the sale.

Key Points: 
  • Mont-Saint-Guibert, Belgium – March 27, 2023, 10:05pm CET / 4:05pm 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 Company raised $2.8 million in gross proceeds pursuant to the Company’s $50 million at-the-market ("ATM") program established on December 22, 2022 at an issue price equal to the market price on the Nasdaq Global Market at the time of the sale.
  • The shares were purchased by historical Nyxoah shareholder Cochlear Limited, and the proceeds will be used for general corporate purposes.
  • The ordinary shares described above were sold pursuant to the Company’s shelf registration statement on Form F-3 (File No.
  • 333-268955), previously filed with the Securities and Exchange Commission (“SEC”) on December 22, 2022, which became effective on January 6, 2023, and a prospectus supplement dated January 6, 2023 and the accompanying prospectus the Company filed with the SEC in connection with the offer and sale of the Company’s common stock pursuant to the Controlled Equity OfferingSM Sales Agreement, dated as of December 22, 2022 with Cantor Fizgerald & Co., as sales agent ( [email protected] ).

Sensorion Announces Its Attendance at the 41st Annual J.P. Morgan Healthcare Meeting in San Francisco

Retrieved on: 
Monday, December 5, 2022
Research, People with Disabilities, Genetics, Clinical Trials, Other Health, Biotechnology, Pharmaceutical, Consumer, Health, Science, Pasteur Institute, CIO, Diagnosis, Genetics, Biomarker, Patient, Hearing loss, Trial of the century, Cochlear Limited, Deafness, Hearing, Mutation, Vaccine, Dentistry, GJB2

If you wish to book a meeting with Sensorions management team, please contact us by email at [email protected] .

Key Points: 
  • If you wish to book a meeting with Sensorions management team, please contact us by email at [email protected] .
  • A Phase 2 study of SENS-401 was also completed in Sudden Sensorineural Hearing Loss (SSNHL) in January 2022.
  • Sensorion pursues its broad strategic collaboration with Institut Pasteur focused on the genetics of hearing.
  • The Company is also working on the identification of biomarkers to improve diagnosis of these underserved illnesses.

Sensorion receives Orphan Drug Designation for OTOF-GT for the treatment of otoferlin gene-mediated hearing loss from the US Food and Drug Administration

Retrieved on: 
Wednesday, November 30, 2022
Biotechnology, FDA, Health, Clinical Trials, Marketing, US Foods, Patient, Deafness, European Medicines Agency, Diagnosis, European Commission, Genetics, Clinical trial, Degenerative disease, Pasteur Institute, Food, ODD, Mutation, EMA, CIO, Biomarker, Hearing loss, Cochlear Limited, CTA, Hearing, AAV, Trial of the century, Congenital hearing loss, FDA, Pharmaceutical industry, Europe 1

Sensorions OTOF-GT dual vector AAV gene therapy development program aims to restore hearing in people living with otoferlin deficiency.

Key Points: 
  • Sensorions OTOF-GT dual vector AAV gene therapy development program aims to restore hearing in people living with otoferlin deficiency.
  • Patients with mutations in OTOF suffer from severe to profound sensorineural prelingual non syndromic hearing loss.
  • Otoferlin deficiency is responsible for up to 8% of all cases of congenital hearing loss, with around 20,000 people affected in the US and Europe1.
  • In September 2022, the Company received a positive opinion on an application for Orphan Drug Designation (ODD) from the European Medicines Agency (EMA).