ODI

Nyxoah Announces DREAM U.S. Pivotal Study Meets Primary Endpoints

Retrieved on: 
Tuesday, March 19, 2024
DREAM, OSA, Annual report, ODI, Patient, PSG, Mont-Saint-Guibert, IDE, AHI, Euronext, ITT, Oxygen, Obstructive sleep apnea, Pharmaceutical industry

The DREAM study is a pivotal trial, being conducted under an investigational device exemption (IDE) and is designed to support the marketing authorization of the Genio® hypoglossal nerve stimulation system (HGNS) in the United States.

Key Points: 
  • The DREAM study is a pivotal trial, being conducted under an investigational device exemption (IDE) and is designed to support the marketing authorization of the Genio® hypoglossal nerve stimulation system (HGNS) in the United States.
  • Study participants entered the DREAM study with a mean AHI of 28.0, mean ODI of 27.0 and mean body mass index of 28.5.
  • “DREAM is a pivotal, multicenter, international study of Genio, a next generation HGNS technology offering patients bi-lateral stimulation with a non-implanted battery solution powered and controlled by a wearable.
  • A webcast of the call will be accessible via the Investor Relations page of the Nyxoah website or through this link: DREAM Results Webcast .

Outcomes of a Posterior Approach to SI Joint Fusion with LinQ™ Reflect Clinical Efficacy and Durability at 12 Months

Retrieved on: 
Wednesday, March 20, 2024
Depression, Disability, ODI, Patient, Anxiety, Sleep, LinQ, Clinical trial, Trial of the century, Pain, Fatigue, Physician, Medicine

TAMPA, Fla., March 20, 2024 /PRNewswire/ -- Final data from a landmark study on PainTEQ's posterior approach SI joint fusion with the LinQ™ implant revealed improved pain and function scores and an excellent safety profile at 12 months post-operation.

Key Points: 
  • TAMPA, Fla., March 20, 2024 /PRNewswire/ -- Final data from a landmark study on PainTEQ's posterior approach SI joint fusion with the LinQ™ implant revealed improved pain and function scores and an excellent safety profile at 12 months post-operation.
  • The Single Arm, Multicenter, Prospective, Clinical Study on a Minimally Invasive Posterior Sacroiliac Fusion Allograft Implant ( SECURE ) study represents the largest and first-of-its-kind clinical trial for any posterior approach, and addresses the paucity of data for 12-month prospective outcomes.
  • The study's data on 83 patients revealed a statistically significant mean improvement in VAS scores (0-100) of 43.3 at 12 months versus baseline.
  • There was also a strong safety profile with only five total adverse events and no implant-related significant adverse events were observed.

What to Watch this February on Willow

Retrieved on: 
Friday, February 9, 2024
TV and Radio, Entertainment, Sports, Cricket, Visakhapatnam, T20I, Gabba, ODI, Multimedia, Odis, WILLOW

View the full release here: https://www.businesswire.com/news/home/20240209095475/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20240209095475/en/
    In the gripping Australia vs West Indies series, available exclusively on Willow , the Test series concluded in a 1-1 draw, while Australia dominated the ODIs, winning 3-0.
  • Highlights include Xavier Bartlett's standout performance, becoming the first Australian with four-wicket hauls in his first two ODIs.
  • The third ODI in Canberra marked the shortest completed men's ODI in Australia, with Australia securing a record win by 259 balls remaining.
  • West Indies vs. Australia, 2nd Test : Tense moments and skillful play, catch the details of Day 1's play at the Gabba.

ProSomnus Severe Indication 510(k) Submission Accepted for Review by the FDA

Retrieved on: 
Tuesday, January 30, 2024
AHI, Calendar, MD, Obstructive sleep apnea, Patient, Safety, FDA, OSA, CPAP, Sleep apnea, ODI, Pharmaceutical industry

The clinical data submitted by the Company in support of its 510(k) submission included data on 92 patients with severe OSA from two prospective clinical studies.

Key Points: 
  • The clinical data submitted by the Company in support of its 510(k) submission included data on 92 patients with severe OSA from two prospective clinical studies.
  • “We believe the clinical data from treating patients with severe Obstructive Sleep Apnea combined with an excellent safety profile derived from hundreds of thousands of real-world cases, positions us well for obtaining severe indication clearance from the FDA,” noted Dr. John Remmers, MD, ProSomnus Chief Scientist.
  • FDA guidance indicates that the FDA seeks to complete its review of 510(k) submissions within 90 calendar days of date of receipt, excluding time required by the Company to respond to additional information requests.
  • The time required to respond to any such requests will depend on the nature of the request.

Nyxoah Announces 2024 Strategic Priorities

Retrieved on: 
Wednesday, January 17, 2024
DREAM, ResMed, Patient, Euronext, CCC, Partnership, Mont-Saint-Guibert, AHI, Obstructive sleep apnea, ODI, DTC, Investment, CPAP, OSA, Safety, PMA, Growth, Pharmaceutical industry

Mont-Saint-Guibert, Belgium – January 17, 2024, 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, in anticipation of upcoming investor meetings, its strategic priorities for 2024.

Key Points: 
  • Mont-Saint-Guibert, Belgium – January 17, 2024, 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, in anticipation of upcoming investor meetings, its strategic priorities for 2024.
  • Complete patient follow up in the DREAM U.S. pivotal study and report efficacy and safety data by early April.
  • Accelerate investments in the U.S. commercial organization in preparation for a late 2024 launch.
  • For 2024, we expect continued sales growth driven by an increasing benefit from direct-to-consumer (DTC) initiatives, initial contribution from the ResMed commercial partnership in Germany and geographic expansion.

Fisker Provides Update on Recent Business Activities

Retrieved on: 
Tuesday, January 23, 2024
Vehicle Technology, EV, Electric Vehicles, Mobile, Wireless, IOT (Internet of Things), Alternative Vehicles, Fuels, Apps, Applications, Technology, Automotive, Environment, Green Technology, Automotive Manufacturing, Manufacturing, NHTSA, Head, National Automobile Dealers Association, OEM, Accounting, Multimedia, Inc., Sale, ODI, NADA, Control, Fisker Inc., Marketing, EVP, Car dealership

Fisker Inc. (NYSE: FSR) (“Fisker”), driven by a mission to create the world’s most emotional and sustainable electric vehicles, today is providing an update on recent business activities.

Key Points: 
  • Fisker Inc. (NYSE: FSR) (“Fisker”), driven by a mission to create the world’s most emotional and sustainable electric vehicles, today is providing an update on recent business activities.
  • View the full release here: https://www.businesswire.com/news/home/20240123692325/en/
    Fisker Inc. provided an update on recent business activities.
  • Since this announcement, Fisker has seen substantial interest from potential partner dealers across the United States, Canada, and Europe.
  • Fisker is scheduled to host dealers at its headquarters in Manhattan Beach during the week of January 29.

Fisker Issues Statement on NHTSA Preliminary Evaluation

Retrieved on: 
Friday, January 19, 2024
Automotive, General Automotive, Automotive Manufacturing, EV, Electric Vehicles, Manufacturing, Alternative Vehicles, Fuels, Inc., Fisker Inc., ODI, NHTSA, Fisker

Fisker Inc. (NYSE: FSR) (“Fisker”) has issued the following statement on the National Highway Traffic Safety Administration (NHTSA) Office of Defects Investigation’s (ODI) Preliminary Evaluation of reported braking issues with the 2023 Fisker Ocean:

Key Points: 
  • Fisker Inc. (NYSE: FSR) (“Fisker”) has issued the following statement on the National Highway Traffic Safety Administration (NHTSA) Office of Defects Investigation’s (ODI) Preliminary Evaluation of reported braking issues with the 2023 Fisker Ocean:
    The Fisker Ocean brake system uses both friction braking and regenerative braking.
  • In December 2023, Fisker responded to customer feedback and issued an Over-the-Air update (Version 1.10) to the regenerative system that improved the customer experience when traveling over bumps and uneven surfaces, resolving the issue.
  • The Fisker Ocean brake system meets or exceeds all US and international performance requirements.

Accelus Announces Renewed Focus on Pioneering Minimally Invasive Outpatient Procedures with Its Advanced Adaptive Geometry Technology

Retrieved on: 
Thursday, December 7, 2023
Subsidence, Pain, PALM, ODI, BEACH, ASC, Surgeon, Visual analogue scale, Lordosis, Innovation, Geometry, Abdominal ultrasonography, Spine, Human, Patient, Oswestry Disability Index, Hospital

"We’re excited about the ongoing shift toward minimally invasive, awake and outpatient spinal fusion surgeries, as it allows a broader spectrum of patients to experience the benefits of these less invasive, more patient-centric procedures,” said Kevin McGann, President & CEO of Accelus.

Key Points: 
  • "We’re excited about the ongoing shift toward minimally invasive, awake and outpatient spinal fusion surgeries, as it allows a broader spectrum of patients to experience the benefits of these less invasive, more patient-centric procedures,” said Kevin McGann, President & CEO of Accelus.
  • This controlled, in-situ, multiplanar expansion is designed to restore foraminal height, reestablish sagittal balance and reduce subsidence, a common concern in spinal fusion procedures.
  • The recent article, " Backbones of Innovation Signal What's Next in Spine Care ," published in BoneZone, highlights Accelus's role in this transformation.
  • No implant-related complications, cage subsidence, cage migration or need for revision surgery were reported at the one-year mark for this study.

Aurora Spine Corporation Announces Newly Published Paper on First 6-month Clinical Evaluation of its ZIP™ Fusion Implant

Retrieved on: 
Monday, December 4, 2023
ASG, Walking, Principal investigator, Neurosurgery, Physician, ODI, Buttocks, FDA, Pain, Decompression, Chronic pain, Spinal cord, Visual analogue scale, IRB, Low back pain, Trial of the century, Groin, PROMIS, PGIC, Institutional review board, Back pain, ZIP, Human, Patient, Safety, Journal, Leg, Spinal stenosis, Degenerative disc disease, Oswestry Disability Index, Birth control

This 6-month interim analysis at 42% enrollment of patients was conducted to determine prolonged safety and efficacy of the ZIP interspinous fusion device.

Key Points: 
  • This 6-month interim analysis at 42% enrollment of patients was conducted to determine prolonged safety and efficacy of the ZIP interspinous fusion device.
  • Dr. Sebastian Koga, a neurosurgeon from Covington, LA emphasized, “Our study demonstrates that the ZIP device provides a stable platform for posterior fusion.
  • I am happy to contribute objective clinical evidence to this area of spine surgery.
  • A previously published retrospective study has also demonstrated the ZIP device’s safety and effectiveness in the hands of interventional pain physicians.

C4 Therapeutics Reports Third Quarter 2023 Financial Results and Recent Business Highlights

Retrieved on: 
Wednesday, November 1, 2023
Neoplasm, Controlled Impact Demonstration, Research, NSCLC, Public expenditure, National Medical Products Administration, Dexamethasone, Disease, CRC, Annual general meeting, Security (finance), Melanoma, BRAF, Wind, Caregiver, Roche, NHL, Safety, Therapy, Patient, Administration, BRAF V600, Research and development, Plasma, CCCC, Xerostomia, G&A, Conference, CTA, Synovial sarcoma, TPD, Clinical trial, ODI, Anemia, BRD9, Finance, Fatigue, Half-life, NMPA, Aes, Strategic planning, Colorectal cancer, R, High-level radioactive waste management, RECIST, Lung cancer, Combination therapy, Neutropenia, Pharmaceutical industry, Cryptocurrency, Fine chemical, Vaccine, Video game, Dysgeusia, Biogen

WATERTOWN, Mass., Nov. 01, 2023 (GLOBE NEWSWIRE) -- C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science to develop a new generation of small-molecule medicines and transform how disease is treated, today reported financial results for the third quarter ended September 30, 2023, as well as recent business highlights.

Key Points: 
  • Revenue: Total revenue for the third quarter of 2023 was $11.1 million, compared to $6.8 million for the third quarter of 2022.
  • Research and Development (R&D) Expense: R&D expense for the third quarter of 2023 was $28.3 million, compared to $29.7 million for the third quarter of 2022.
  • Net Loss and Net Loss per Share: Net loss for the third quarter of 2023 was $27.0 million, compared to $32.0 million for the third quarter of 2022.
  • Net loss per share for the third quarter of 2023 was $0.55 compared to $0.65 for the third quarter of 2022.