PMA

Evolus Reports First Quarter 2024 Results and Provides Business Update

Retrieved on: 
Dienstag, Mai 7, 2024
Cosmetics, Lifestyle, Retail, Health, Consumer, Pharmaceutical, FDA, Depreciation, Patient, PMA, Growth, Pharmaceutical industry

Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a focus on building an aesthetic portfolio of consumer brands, today reported financial results for the first quarter ended March 31, 2024, and provided a business update.

Key Points: 
  • Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a focus on building an aesthetic portfolio of consumer brands, today reported financial results for the first quarter ended March 31, 2024, and provided a business update.
  • Operating expenses for the first quarter of 2024 were $68.3 million, compared to $69.6 million in the fourth quarter of 2023.
  • Non-GAAP operating expenses for the first quarter of 2024 were $42.1 million, compared to $45.5 million in the fourth quarter of 2023.
  • Loss from operations for the first quarter of 2024 was $8.9 million, compared to $8.6 million in the fourth quarter of 2023.

Injectsense First-in-Human Glaucoma Device Study Approved by Ethics Committee at Centro de la Vision Clinic

Retrieved on: 
Montag, Mai 6, 2024
FDA, University, Ecosystem, Safety, NIH, IDE, IOP, Research, Pressure, Patient, Eye, Physician, Cataract, SBIR, Glaucoma, PMA, Pharmaceutical industry

IOP is a key physiological marker that helps determine glaucoma risk and chances for disease progression. Injectsense's iOP-Connect™ implantable sensor offers doctors the unprecedented ability to see a patient's continuous diurnal IOP activity over decades -- without patient intervention. The measurements enable physicians to determine whether there have been pressure excursions outside of the patient's normal baseline and whether the patients are in an unstable or progressing state of glaucoma. These insights will make it possible to manage therapy effectiveness. 

Key Points: 
  • EMERYVILLE, Calif., May 6, 2024 /PRNewswire/ -- Injectsense Inc ., a sensor-enabled digital health company, announced that the ethics committee at the Centro de la Vision Clinic in Santiago, Chile, has approved a 20-patient study that will confirm safety and effectiveness of the company's ultra-miniature wireless pressure sensor, designed to continuously measure intra-ocular pressure (IOP) for glaucoma.
  • The study will be led by Dr. Juan Jose Mura , a glaucoma specialist at the clinic and an ophthalmologist at the University of Chile.
  • His research interests include surgical reconstruction of the anterior segment of the eye as well as cataract and glaucoma procedures.
  • Following the human study, Injectsense will continue its cooperation with key medical institutions and medical advisors to prepare post-IDE data development plans with a view towards patient enrollment.

Implantable Tibial Nerve Stimulation added as Treatment Option within AUA/SUFU 2024 OAB Guideline

Retrieved on: 
Donnerstag, Mai 2, 2024
Leg, FDA, Physician, Society, Patient, Diagnosis, Urinary incontinence, American Urological Association, Health, OAB, Treatment, AUA, Fascia, SUFU, Guideline, Quality of life, PMA, Female, Nursing

The eCoin® ITNS device is the only fully implantable FDA PMA approved device for treating urge urinary incontinence (UUI), the primary symptom of OAB.

Key Points: 
  • The eCoin® ITNS device is the only fully implantable FDA PMA approved device for treating urge urinary incontinence (UUI), the primary symptom of OAB.
  • This highlights the significant need for evolutionary treatment options to address the growing burden of a largely underserved OAB population.
  • "Valencia Technologies is humbled and honored to have the opportunity to take a lead role in the implantable tibial nerve stimulation space."
  • The eCoin® device contains a primary-cell battery that once activated, automatically delivers intermittent stimulation to the tibial nerve to reduce UUI symptoms.

Mission Systems Integration Specialist D&J Aviation Joins SmartSky® Installation Network

Retrieved on: 
Dienstag, April 30, 2024
ATG, D&J, Citation, Pilatus, Aviation, Engineering, D & J, Supplemental type certificate, MRO, Beechcraft King Air, Government, SDVOSB, PMA, STC, Airline

RESEARCH TRIANGLE, N.C., April 30, 2024 /PRNewswire/ -- SmartSky, provider of the most advanced inflight air-to-ground (ATG) connectivity for business aviation, today announced D&J Aviation as a new sales and installation partner. D&J recently completed a first-article installation of the award-winning SmartSky LITE™ on a King Air C90, with a Supplemental Type Certificate (STC) expected in the coming months. They are now commencing a SmartSky LITE first-of-type installation on a Citation Encore 560.

Key Points: 
  • They are now commencing a SmartSky LITE first-of-type installation on a Citation Encore 560.
  • D & J recently completed a first-article installation of the award-winning SmartSky LITE™ on a King Air C90.
  • Headquartered in Colorado Springs, D&J is a certified Service-Disabled Veteran-Owned Small Business (SDVOSB) Maintenance, Repair and Overhaul (MRO) with over 40 years of aviation integration and installation experience for both commercial and government aviation customers.
  • Their capabilities include a Part 145 FAA certified repair station, engineering and design, mission systems integration, PMA contract manufacturing, as well as expertise in small unmanned aircraft systems.

Harmonic Extends cOS Broadband Platform with Breakthrough Intelligent Speed Maximizer

Retrieved on: 
Montag, April 29, 2024
Quality of experience, Cos, Harmonic, Machine learning, Artificial intelligence, ISM, PMA

SAN JOSE, Calif., April 29, 2024 /PRNewswire/ -- Harmonic (NASDAQ: HLIT) today announced the new Beacon intelligent speed maximizer (ISM) application integrated on the cOS™ virtualized broadband platform alongside its market-leading vCMTS and fiber applications. The Beacon ISM provides greater spectrum efficiency to maximize upstream and downstream speeds on a per-subscriber basis, enhancing quality of experience (QoE) and contributing to subscriber revenue growth and retention.

Key Points: 
  • New Beacon Application Maximizes Broadband Speeds, Improves Reliability, Enhances Quality of Experience and Lowers OPEX
    SAN JOSE, Calif., April 29, 2024 /PRNewswire/ -- Harmonic (NASDAQ: HLIT) today announced the new Beacon intelligent speed maximizer (ISM) application integrated on the cOS™ virtualized broadband platform alongside its market-leading vCMTS and fiber applications.
  • The Beacon ISM is a breakthrough edge compute application on the cOS platform offering increased scalability, security and network reliability compared to traditional profile management applications (PMA) and enabling operators to gain maximum value from their DOCSIS 3.1 networks.
  • Leveraging the cOS platform's field-proven, horizontally scalable software architecture, Beacon takes cOS further with advanced artificial intelligence and machine learning technologies.
  • Further information about Harmonic's market-leading cOS broadband platform and versatile portfolio of network edge devices, visit www.harmonicinc.com/broadband .

EQS-News: Mainz Biomed Reports Positive Topline Results from Pooled Study Evaluating Novel mRNA Biomarkers and Proprietary AI Algorithm for Integration into Pivotal FDA PMA Clinical Trial for Next-Gen CRC Test

Retrieved on: 
Freitag, Mai 3, 2024
FDA, Cancer, CDC, Colorectal cancer, CRC, Trial of the century, Polyp, Patient, Colonoscopy, FIT, Gene expression, Messenger, Biomarker, PMA, Medical imaging

“We conducted this pooled study to fine-tune the minimal biomarker set to be used to optimize sensitivity and specificity of the results in Mainz Biomed’s next generation CRC screening tool.

Key Points: 
  • “We conducted this pooled study to fine-tune the minimal biomarker set to be used to optimize sensitivity and specificity of the results in Mainz Biomed’s next generation CRC screening tool.
  • Hence these results represent a critical milestone on our path to launching our FDA PMA pivotal study ReconAAsense, which is planned to recruit up to 15,000 patients.
  • Each subject outcome was compared to the results from the next generation test incorporating the novel mRNA biomarkers and FIT.
  • The Company plans to publish results of this study at a major medical conference during the second quarter of 2024.

Integer Holdings Corporation Reports First Quarter 2024 Results

Retrieved on: 
Donnerstag, April 25, 2024
Neuromodulation, Arrhythmia, Growth, Acquisition, EPS, PMA, GAAP, Electrophysiology, Electrochemistry

PLANO, Texas, April 25, 2024 (GLOBE NEWSWIRE) -- Integer Holdings Corporation (NYSE:ITGR) today announced results for the three months ended March 29, 2024.

Key Points: 
  • PLANO, Texas, April 25, 2024 (GLOBE NEWSWIRE) -- Integer Holdings Corporation (NYSE:ITGR) today announced results for the three months ended March 29, 2024.
  • First Quarter 2024 Highlights (compared to First Quarter 2023, except as noted)
    Sales increased 10% to $415 million, with organic growth of 6%.
  • Cardiac Rhythm Management & Neuromodulation sales increased 8% in the first quarter 2024 compared to the first quarter 2023, with strong growth in emerging Neuromodulation customers with PMA (pre-market approval) products and strong demand in Cardiac Rhythm Management.
  • Electrochem sales decreased in the first quarter 2024 compared to the first quarter 2023, returning to a normalized run-rate after previously higher sales from the supply chain recovery.

Mainz Biomed Reports Positive Topline Results from Pooled Study Evaluating Novel mRNA Biomarkers and Proprietary AI Algorithm for Integration into Pivotal FDA PMA Clinical Trial for Next Generation Colorectal Cancer Diagnostic

Retrieved on: 
Donnerstag, April 25, 2024
FDA, Cancer, CDC, Colorectal cancer, CRC, Trial of the century, Polyp, Patient, Colonoscopy, FIT, Gene expression, Messenger, Biomarker, PMA, Medical imaging

“We conducted this pooled study to fine-tune the minimal biomarker set to be used to optimize sensitivity and specificity of the results in Mainz Biomed’s next generation CRC screening tool.

Key Points: 
  • “We conducted this pooled study to fine-tune the minimal biomarker set to be used to optimize sensitivity and specificity of the results in Mainz Biomed’s next generation CRC screening tool.
  • Following colonoscopy and any applicable histopathology, subjects were classified into groups: CRC, advanced adenoma, non-advanced adenoma, no findings, or non-colorectal cancer.
  • Each subject outcome was compared to the results from the next generation test incorporating the novel mRNA biomarkers and FIT.
  • The Company plans to publish results of this study at a major medical conference during the second quarter of 2024.

ABB pioneers advanced cable protection solution crafted from discarded ocean fishing nets

Retrieved on: 
Montag, April 22, 2024
Risk, LCA, REACH, OBP, Water, IP66, Carbon, Dust, Environment, Summative assessment, ALDFG, European, Telecommunications, Carbon accounting, Renewable energy, PMA, ABB, Electrical wiring

To help address dangerous marine pollution, ABB Installation Products pioneered industry-leading cable protection crafted from 50% recycle-based polyamide using primarily recovered fishing nets.

Key Points: 
  • To help address dangerous marine pollution, ABB Installation Products pioneered industry-leading cable protection crafted from 50% recycle-based polyamide using primarily recovered fishing nets.
  • High-performance wire and cable protection is essential to powering electrical systems and production environments safely and reliably.
  • ABB leveraged its nearly 50 years of cable and conduit technology and dedicated circularity approach with Envalior’s deep materials expertise.
  • ABB’s PMA EcoGuard cable protection products include Envalior’s Akulon® RePurposed, a 100% recycled-based polyamide made of fishing nets recovered from coastlines.

Novocure Reports First Quarter 2024 Financial Results

Retrieved on: 
Donnerstag, Mai 2, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, METIS, Congress, Cancer, Paclitaxel, EDT, Investment, Temozolomide, Food, Survival, Gynaecology, Immunotherapy, Lung cancer, Partnership, GBM, Webcast, Glioblastoma, Disclosure, IND, Prescription, ASCO, Regulation Fair Disclosure, Patient, Brain, Society, Loss, Regulation, PLD, Marketing, Clinical trial, NSCLC, PMA, Investigational New Drug, Pharmaceutical industry

Novocure (NASDAQ: NVCR) today reported financial results for the quarter ended March 31, 2024.

Key Points: 
  • Novocure (NASDAQ: NVCR) today reported financial results for the quarter ended March 31, 2024.
  • Research, development, and clinical studies expenses for the quarter were $51.6 million, a decrease of 14% from the same period in 2023.
  • Sales and marketing expenses for the quarter were $55.2 million, an increase of 8% compared to the same period in 2023.
  • Novocure will host a conference call and webcast to discuss first quarter 2024 financial results at 8:00 a.m. EDT today, Thursday, May 2, 2024.