BDD

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

Retrieved on: 
Monday, March 11, 2024

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: 
Thursday, February 29, 2024

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: 
Wednesday, March 6, 2024

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: 
Wednesday, February 28, 2024

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.

SI-BONE, Inc. Receives FDA 510(k) Clearance for a Smaller Diameter iFuse Bedrock Granite Implant with an Expanded Indication and Application

Retrieved on: 
Tuesday, January 30, 2024

SANTA CLARA, Calif., Jan. 30, 2024 (GLOBE NEWSWIRE) -- SI-BONE, Inc., (Nasdaq: SIBN), a Silicon Valley-based medical device company dedicated to solving musculoskeletal disorders of the sacropelvic anatomy, announces FDA 510(k) premarket clearance of the iFuse Bedrock Granite® Implant System (Granite) in a smaller (9.5 mm) diameter with both an expanded indication in pediatric patients and an expanded application that includes use in the S1 trajectory. When placed across the SI joint, the Granite implant provides sacroiliac fusion and sacropelvic fixation as a foundational element for multi-segment spinal fusion.

Key Points: 
  • When placed across the SI joint, the Granite implant provides sacroiliac fusion and sacropelvic fixation as a foundational element for multi-segment spinal fusion.
  • This 510(k) clearance follows the initial clearance of the iFuse Bedrock Granite System in May 2022 that included implants of 10.5 mm and 11.5 mm in diameter.
  • The iFuse Bedrock Granite System was also awarded a Breakthrough Device Designation (BDD) by the Food & Drug Administration (FDA) and a New Technology Add-on Payment (NTAP) by the Centers for Medicare and Medicaid Services (CMS).
  • The addition of a 9.5 mm diameter to the Granite product line now offers surgeons one of the more commonly used sizes to treat these patients.”

Predicine Announces Collaboration with Janssen to Develop PredicineCARE™ as a Companion Diagnostic Assay in Localized Bladder Cancer

Retrieved on: 
Monday, January 8, 2024

HAYWARD, Calif., Jan. 08, 2024 (GLOBE NEWSWIRE) -- Predicine, Inc., a leading molecular insights company, today announced a collaboration with Janssen Pharmaceutica NV (Janssen), a Johnson & Johnson company.

Key Points: 
  • HAYWARD, Calif., Jan. 08, 2024 (GLOBE NEWSWIRE) -- Predicine, Inc., a leading molecular insights company, today announced a collaboration with Janssen Pharmaceutica NV (Janssen), a Johnson & Johnson company.
  • This collaboration focuses on the development of the PredicineCARE™ urine cell-free DNA (cfDNA) next-generation sequencing (NGS) assay as a companion diagnostic to identify patients who may benefit from targeted therapy.
  • PredicineCARE™ received 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 gene deletions in key cancer-associated genes using cfDNA in urine.

SpineX Announces Successful in-Human Results to Treat Adults with Cerebral Palsy

Retrieved on: 
Wednesday, January 3, 2024

SpineX Inc. today announced groundbreaking results in its first in-human study treating an adult with Cerebral Palsy (CP).

Key Points: 
  • SpineX Inc. today announced groundbreaking results in its first in-human study treating an adult with Cerebral Palsy (CP).
  • View the full release here: https://www.businesswire.com/news/home/20240103634112/en/
    CP patient walking down stairs before vs after SCiP therapy.
  • Note the minimal hand support needed and the more confident steps taken by her after eight weeks of SCiP therapy.
  • “I am excited by the potential impact that SCiP could have on the CP population for both adults and children.”

CGBio's 'NOVOSIS PUTTY' Receives FDA 'Breakthrough Device Designation,' Accelerate Entry into the US Market

Retrieved on: 
Tuesday, January 2, 2024

On September 15, 2023, FDA published an update to the guidance document – "Breakthrough Devices Program, Guidance for Industry and Food and Drug Administration Staff.

Key Points: 
  • On September 15, 2023, FDA published an update to the guidance document – "Breakthrough Devices Program, Guidance for Industry and Food and Drug Administration Staff.
  • The FDA considers all of these factors to determine whether a device is 'reasonably expected to provide more effective treatment or diagnosis,'" according to the guidance.
  • Devices with 'Breakthrough Device Designation' benefit from prioritized FDA support during the approval process.
  • This streamlined approach speeds up FDA approval, allowing for quicker entry into the U.S. market compared to other devices.

Appvance unleashes AIQ 5.0, featuring Generative AI V3

Retrieved on: 
Tuesday, December 19, 2023

SANTA CLARA, Calif., Dec. 19, 2023 /PRNewswire/ -- Appvance, the leader in generative AI for software quality, is excited to announce the launch of Appvance IQ (AIQ) 5.0, a groundbreaking update that marks a significant leap forward in the world of AI-native automated testing.

Key Points: 
  • SANTA CLARA, Calif., Dec. 19, 2023 /PRNewswire/ -- Appvance, the leader in generative AI for software quality, is excited to announce the launch of Appvance IQ (AIQ) 5.0, a groundbreaking update that marks a significant leap forward in the world of AI-native automated testing.
  • This release features the game-changing Generative AI V3, a comprehensive update that enhances performance, reporting, visual object recognition, and bug-finding accuracy.
  • Generative AI V3 is the result of a decade of research and continued advancements since the launch of AI-native script generation in 2018.
  • "AIQ 5.0 advances Autonomous Testing by taking a revolutionary approach to generative AI that delivers unparalleled levels of productivity, coverage, and defect detection," said Appvance CEO, Andre Liao.

Lavie Bio Announces Expansion of its Bio-Inoculant Product for Spring Wheat, Yalos™, to Durum and Barley

Retrieved on: 
Tuesday, November 28, 2023

REHOVOT, Israel, Nov. 28, 2023 /PRNewswire/ -- Lavie Bio Ltd., a subsidiary of Evogene Ltd. (Nasdaq: EVGN) (TASE: EVGN), a leading ag-biological company committed to elevating food quality, sustainability, and agricultural productivity through microbiome-based innovations, is pleased to announce the expansion of its microbiome-based product for spring wheat, now rebranded as Yalos™ (formerly Thrivus™), to include durum and barley, significantly broadening its potential market reach. This expansion follows very successful field trials conducted in the US in 2023 in durum and barley, which generated on average over 7% of yield increase. Yalos™ is a seed treatment that enhances production by improving soil nutrients, reducing environmental stress, and increasing yields. It aims to boost yield in all small grains, starting with spring wheat, durum, and barley.

Key Points: 
  • This expansion follows very successful field trials conducted in the US in 2023 in durum and barley, which generated on average over 7% of yield increase.
  • It aims to boost yield in all small grains, starting with spring wheat, durum, and barley.
  • "We are very satisfied with these results from our 2023 field trials enabling us to offer our product to durum & barley growers in 2024."
  • Lavie Bio continues to lead the agricultural innovation frontier, championing sustainable practices and enhancing crop yields.