BDD

ONWARD® Medical Reports Full Year 2023 Financial and Operating Results and Shares 2024 Highlights Year-to-Date

Retrieved on: 
목요일, 4월 25, 2024
FDA, De novo, Partnership, EUR, TAP, Spinal cord, Lead, BDD, Defense, American Academy, Class, MJFF, Equity, Safety, ARC, BCI, Euronext, Research, University, Hemiunu, Global marketing, Government, SCI, Nature Medicine, Paralysis, Movement, SDVOSB, Pharmaceutical industry

The Company is developing a portfolio of ARC-IM Leads, each optimized for placement on a different area of the spinal cord.

Key Points: 
  • The Company is developing a portfolio of ARC-IM Leads, each optimized for placement on a different area of the spinal cord.
  • Also in November, ONWARD Medical research partner .NeuroRestore was awarded a $1 million grant from The Michael J.
  • In Q2, Bryan, Garnier & Co reinitiated research coverage of ONWARD Medical following the appointment of a new equity research analyst.
  • For 2023, the Company reported an operating loss of EUR 35.5M compared to EUR 32.0M in 2022.

Predicine Announces Collaboration with Apollomics to Develop PredicineCARE™ as a Companion Diagnostic Assay in Lung Cancer

Retrieved on: 
금요일, 4월 5, 2024
Lung cancer, Liquid biopsy, Nucleic acid thermodynamics, Patient, NGS, Deletion, Blood, DNA, Urine, BDD, NSCLC, Food

HAYWARD, Calif., April 05, 2024 (GLOBE NEWSWIRE) -- Predicine, Inc., a leading molecular insights company, today announced a collaboration with Apollomics, Inc.

Key Points: 
  • HAYWARD, Calif., April 05, 2024 (GLOBE NEWSWIRE) -- Predicine, Inc., a leading molecular insights company, today announced a collaboration with Apollomics, Inc.
  • This collaboration aims to advance the development of PredicineCARE™, a blood cell-free DNA (cfDNA) next-generation sequencing (NGS) assay, to identify non-small cell lung cancer (NSCLC) patients who may benefit from targeted therapy.
  • PredicineCARE™ was granted Breakthrough Device Designation (BDD) from the U.S. Food and Drug Administration on August 23, 2022.
  • PredicineCARE™ is a comprehensive, state-of-the-art NGS assay that interrogates point mutations/indels, fusions, amplifications, and deletions in key cancer-associated genes using cfDNA from liquid biopsy samples such as blood and urine.

Predicine Introduces PredicineCARE™ NGS Kit for Global Clinical Trials, CDx Development and Patient Testing

Retrieved on: 
금요일, 4월 12, 2024
CDX, Nucleic acid thermodynamics, Tissue, NGS, DNA, RUO, Laboratory, Urine, BDD, Cancer, Liquid biopsy, Deletion, Blood, FDA, Food

HAYWARD, Calif., April 05, 2024 (GLOBE NEWSWIRE) -- Predicine, Inc., a leading molecular insights company, announced the release of its innovative PredicineCARE™ NGS Kit. This offering presents a research-use-only (RUO) next-generation sequencing (NGS) kit packaged for genomic profiling across various cancers, facilitating global applications in clinical trials, companion diagnostics (CDx) development, and patient testing.

Key Points: 
  • HAYWARD, Calif., April 05, 2024 (GLOBE NEWSWIRE) -- Predicine, Inc., a leading molecular insights company, announced the release of its innovative PredicineCARE™ NGS Kit.
  • This offering presents a research-use-only (RUO) next-generation sequencing (NGS) kit packaged for genomic profiling across various cancers, facilitating global applications in clinical trials, companion diagnostics (CDx) development, and patient testing.
  • This newly introduced PredicineCARE™ NGS kit integrates a comprehensive, state-of-the-art NGS assay capable of detecting point mutations, indels, fusions, amplifications, and deletions in key cancer-associated genes.
  • “Predicine’s centralized global lab network coupled with the decentralized kitted offering provides a standardized approach to support clinical trials, CDx development and patient testing on a global scale.”

ONWARD® Medical Submits De Novo Application to FDA for its ARC-EX® System

Retrieved on: 
화요일, 4월 2, 2024
De novo, DPT, BCI, Arm, Paralysis, Evaluation, Doctor of Philosophy, Quality of life, Euronext, BDD, Annual report, Craig Hospital, Spinal cord, Safety, ARC, Food, Marketing, FDA, SCI, NCS, Movement, Hand, Medical device

EINDHOVEN, the Netherlands, April 02, 2024 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative spinal cord stimulation therapies to improve or restore movement, function, and independence in people with spinal cord injury (SCI), today announces it has submitted its De Novo application to the US Food and Drug Administration (FDA) to allow marketing of its breakthrough ARC-EX System to restore function of the upper extremities after SCI.

Key Points: 
  • The submission marks an historic milestone for the Company in its mission to restore mobility and function for people with SCI.
  • Once cleared by the FDA, ARC-EX will be the first-ever spinal cord stimulation therapy to restore hand and arm function after SCI and the first commercial product for ONWARD Medical.
  • “We are delighted to be one step closer to bringing our breakthrough ARC-EX System to people living with SCI after submitting this De Novo application for regulatory clearance in the United States,” said ONWARD Medical CEO Dave Marver.
  • The ARC-EX System was previously awarded FDA Breakthrough Device Designation (BDD) for upper limb function, which provided prioritized FDA review, the opportunity to interact with FDA experts, and the potential for additional reimbursement.

Bayer AG and Lavie Bio Continue for Second Year of Biofungicides Validation Following Successful Lab and Greenhouse Testing

Retrieved on: 
화요일, 3월 19, 2024
AG, Farmer, Vegetable, Partnership, Bayer, BDD, Oomycete

The tests have demonstrated the efficacy of Lavie Bio's biofungicides in addressing devastating diseases that affect fruits and vegetables worldwide.

Key Points: 
  • The tests have demonstrated the efficacy of Lavie Bio's biofungicides in addressing devastating diseases that affect fruits and vegetables worldwide.
  • Building on these positive outcomes, the companies are progressing to a second year of validation trials in field experiments.
  • "Biofungicides are a real opportunity for innovation, and we are looking forward to the new solutions this partnership with Lavie Bio helps us deliver together."
  • Lavie Bio's commitment to refining its promising bio fungicides through joint validation trials with Bayer AG serves as a powerful testament to the company's development capabilities, leveraging its innovative BDD platform powered by Evogene's MicroBoost AI tech-engine.

Dermatology Imaging Devices Market Sees Strong 13% CAGR (2024-2030), Propelled by Rising Skin Cancer Cases

Retrieved on: 
수요일, 3월 13, 2024
Research, Diagnosis, OCT, Prevalence, Application, Partnership, Chapter Three, Hospital, Dermatology, AI, Skin, BDD, International, Google Images, FDA, USD, Health, Moles, Food

The global dermatology imaging devices market size is anticipated to reach USD 5.60 billion by 2030 and it is projected to grow at a CAGR of 13.09% from 2024 to 2030.

Key Points: 
  • The global dermatology imaging devices market size is anticipated to reach USD 5.60 billion by 2030 and it is projected to grow at a CAGR of 13.09% from 2024 to 2030.
  • The growing prevalence of skin disorders such as cancer, and inflammatory dermatoses, among others are the major contributing factors for market growth.
  • Dermatology imaging devices are efficient as they provide non-invasive, high-resolution visualization of skin lesions and other related conditions.
  • Technological advancements in dermatology imaging devices such as high-resolution images, integration with AI, 3D imaging are further expected to contribute to the market growth.

ONWARD® Medical Accepted to New US FDA TAP Program for Development of its ARC-BCI™ System

Retrieved on: 
월요일, 3월 11, 2024
SCI, Paralysis, BCI, FDA, ARC, BDD, Euronext, Risk, TAP, History, Patient, Movement, Medical device

This acceptance follows ONWARD Medical’s announcement last week that its investigational ARC-BCI System was awarded FDA Breakthrough Device Designation (BDD), a requirement for TAP consideration.

Key Points: 
  • This acceptance follows ONWARD Medical’s announcement last week that its investigational ARC-BCI System was awarded FDA Breakthrough Device Designation (BDD), a requirement for TAP consideration.
  • ONWARD Medical is only the second BCI company to be accepted into the program.
  • TAP provides ONWARD Medical with early and frequent strategic engagement from the FDA, patients, providers, and payers to facilitate more rapid development and widespread patient access to safe, effective, high-quality medical devices of public health importance.
  • “We are honored to be one of the first BCI companies included in this important program, which allows for the fastest FDA review times of new medical technology,” said ONWARD Medical CEO Dave Marver.

ONWARD® Medical Awarded 10th Breakthrough Device Designation for Brain-Computer Interface (BCI) from US FDA

Retrieved on: 
목요일, 2월 29, 2024
Nature, SCI, Artificial intelligence, Paralysis, BCI, FDA, ARC, Food, Euronext, BDD, Learning, Communication, History, Walking, Spinal cord, Movement, Area studies, Brain, Medical device

This is the tenth FDA BDD awarded to ONWARD Medical.

Key Points: 
  • This is the tenth FDA BDD awarded to ONWARD Medical.
  • The designation is reserved for novel, cutting-edge therapies addressing an unmet need and provides many potential regulatory and reimbursement advantages.
  • This latest award gives ONWARD Medical priority FDA review, the opportunity to interact with FDA experts throughout the pre-market regulatory review phase, and the potential to seek additional reimbursement for its ARC-BCI System.
  • “Brain-computer interface technology unlocks the transformative potential to enhance ARC-IM with thought-driven control of movement after paralysis,” said ONWARD Medical CEO Dave Marver.

THE CHRISTOPHER & DANA REEVE FOUNDATION ANNOUNCES $3.1M SPINAL CORD INJURY RESEARCH GRANTS

Retrieved on: 
수요일, 3월 6, 2024
Therapy, Blood pressure, SCI, Medicine, Psychology, Arm, Paralysis, BCI, FDA, ARC, Quality of life, Food, Neuroprosthetics, BSI, BDD, Safety, Tetraplegia, CNS, Science, Movement, Research, Medical device

SHORT HILLS, N.J., March 6, 2024 /PRNewswire/ -- The Christopher & Dana Reeve Foundation, a leading nonprofit organization dedicated to curing spinal cord injury by funding innovative research and improving the quality of life for individuals and families impacted by paralysis, announced today three new spinal cord injury (SCI) research grants totaling $3.1 million. The grants support clinical trials and research tools aimed at accelerating the therapeutic development of SCI treatments.

Key Points: 
  • SHORT HILLS, N.J., March 6, 2024 /PRNewswire/ -- The Christopher & Dana Reeve Foundation , a leading nonprofit organization dedicated to curing spinal cord injury by funding innovative research and improving the quality of life for individuals and families impacted by paralysis, announced today three new spinal cord injury (SCI) research grants totaling $3.1 million.
  • The Reeve Foundation is dedicated to developing real-world treatments for people living with spinal cord injury (SCI) and paralysis.
  • Today, as 21st-century technology and cumulative scientific gains converge, we are on the cusp of a new era in spinal cord injury research.
  • "These grants represent a fresh approach to spurring the SCI scientific arena forward through our support of high-risk-high-reward endeavors that address unmet needs of individuals living with spinal cord injury," said Marco Baptista, Ph.D., Chief Scientific Officer of the Reeve Foundation.

Lavie Bio Successfully Secures Second Half Advance Payment of $2.5M after Meeting Corteva's Licensing Agreement Requirements

Retrieved on: 
수요일, 2월 28, 2024
AG, Farmer, BDD, Environment, Fruit, Video game

REHOVOT, Israel, Feb. 28, 2024 /PRNewswire/ -- Lavie Bio Ltd., a leading ag-biologicals company that develops microbiome-based, computational-driven bio-stimulant and bio-pesticide novel products, and a subsidiary of Evogene Ltd. (Nasdaq: EVGN) (TASE: EVGN), announced that it has successfully secured the second-half advance payment of $2.5 million after meeting Corteva's (NYSE: CTVA) licensing agreement requirements. This payment signifies the completion of a $5 million advance payment outlined in the licensing agreement signed in July 2023. Following the initial $2.5 million installment received in September 2023, Lavie Bio has now fulfilled the requirements set by Corteva and secured the remaining portion of the advance payment.

Key Points: 
  • This payment signifies the completion of a $5 million advance payment outlined in the licensing agreement signed in July 2023.
  • Following the initial $2.5 million installment received in September 2023, Lavie Bio has now fulfilled the requirements set by Corteva and secured the remaining portion of the advance payment.
  • Lavie Bio will also be eligible for additional future milestone payments and royalties from Corteva's expected future sales of these products.
  • "We're pleased to achieve this milestone in our collaboration with Corteva," said Amit Noam, CEO of Lavie Bio.