DDD

Aurora Spine Corporation Celebrates Second Anniversary of Initial Implantation of the World’s First Bone Density Matched DEXA-C Cervical Interbody Fusion Device

Retrieved on: 
Wednesday, March 20, 2024

The DEXA-C implants, a line of cervical cages for anterior cervical discectomy with fusion (ACDF) procedures, are the first of its kind in the world offering an implant based upon a patient's bone density.

Key Points: 
  • The DEXA-C implants, a line of cervical cages for anterior cervical discectomy with fusion (ACDF) procedures, are the first of its kind in the world offering an implant based upon a patient's bone density.
  • I am able to confidently offer multilevel anterior fusions to patients who likely could not have benefitted from other existing implants because of their bone density.
  • In June 2023, Aurora announced that the first patient has been enrolled for its multicenter study of DEXA-CTM Cervical Interbody System.
  • Preliminarily, we have seen both in radiographs and surgical exploration that patients have incipient bone fusion by 90 days after surgery.

Best-selling Built-in Bra Plus Size Dress Gets an Upgrade: RCA Public Label to release The Game Changer 2.0

Retrieved on: 
Wednesday, March 13, 2024

Renee Cafaro's patented built-in bra invention was integrated into a versatile travel dress and released to much fanfare in 2021.

Key Points: 
  • Renee Cafaro's patented built-in bra invention was integrated into a versatile travel dress and released to much fanfare in 2021.
  • The Game Changer has sold out several times since its release and using feedback from customers, Public Label will release Game Changer 2.0 with a few new upgrades this Spring.
  • RCA Public Label's patented Plus Size Game Changer Travel Dress does it all and it's getting an upgrade this spring!
  • The Game Changer dress will still have the same all-in-one capability consumers love but with added accessibility, sizes and styling options.

Orchestra BioMed Announces Presentation of Results from Clinical Study Demonstrating Favorable Hemodynamic Effects of AVIM Therapy In Hypertensive Pacemaker Patients

Retrieved on: 
Wednesday, March 6, 2024

These data demonstrate the favorable impact of AVIM therapy compared to standard right ventricular (RV) pacing on systolic blood pressure and overall cardiac function when delivered using both conduction system andstandard pacing lead locations.

Key Points: 
  • These data demonstrate the favorable impact of AVIM therapy compared to standard right ventricular (RV) pacing on systolic blood pressure and overall cardiac function when delivered using both conduction system andstandard pacing lead locations.
  • The PV loop study was conducted at Na Homolce Hospital in Prague by Prof. Petr Neužil, M.D.
  • AVIM therapy is an investigational patented bioelectronic therapy, administered using a standard dual-chamber pacemaker, designed to immediately, substantially and persistently reduce blood pressure.
  • “Well-conducted invasive PV loop studies are a robust way to evaluate the impact of a novel therapy like AVIM on hemodymanics and overall cardiac function.

Mesoblast Reports Financial Results and Operational Update for Half-Year Ended December 31, 2023

Retrieved on: 
Wednesday, February 28, 2024

NEW YORK, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an operational update and reported financial results for the period ended December 31, 2023.

Key Points: 
  • NEW YORK, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an operational update and reported financial results for the period ended December 31, 2023.
  • Reduction in net cash usage for operating activities:
    For the three months ended December 31, 2023, net cash usage was US$12.3 million, a 25% reduction versus the comparative quarter in FY2023.
  • For the six months ended December 31, 2023, net cash usage was US$26.6 million, a 14% reduction versus the comparative period in FY2023.
  • Manufacturing reduced by 47% for the six months ended December 31, 2023, from US$12.8 million to US$6.7 million.

Bone Biologics Reports Progress With NB1 Clinical Program

Retrieved on: 
Friday, March 1, 2024

Bone Biologics Corporation (NASDAQ: BBLG), a developer of orthobiologic products for spine fusion markets, reports progress with advancing its product candidate NB1 into human clinical testing for spinal fusion.

Key Points: 
  • Bone Biologics Corporation (NASDAQ: BBLG), a developer of orthobiologic products for spine fusion markets, reports progress with advancing its product candidate NB1 into human clinical testing for spinal fusion.
  • Following Human Research Ethics Committee (HREC) approval last year in Australia for the multicenter, prospective, randomized pilot clinical trial, the Company reports that three hospital sites have been engaged to participate in the pilot clinical trial.
  • This pilot clinical trial will evaluate the safety and effectiveness of NB1 in 30 adult subjects who undergo transforaminal lumbar interbody fusion (TLIF) to treat degenerative disc disease (DDD).
  • The study design was previously reviewed and agreed upon by the Division of Orthopedic Devices in a Pre-submission to support progression to a pivotal clinical trial in the United States.

Providence Medical Technology Announces FDA Clearance of CAVUX® FFS-LX Lumbar Facet Fixation System for 1- and 2-Level Lumbar Spinal Fusion

Retrieved on: 
Wednesday, January 10, 2024

PLEASANTON, Calif., Jan. 10, 2024 /PRNewswire/ -- Providence Medical Technology, Inc. (PMT), a medical device innovator focused on improving surgical outcomes for high-risk spine surgery patients, announced that the U.S. Food and Drug Administration (FDA) has cleared its CAVUX® FFS-LX: Lumbar Facet Fixation System for use in lumbar spinal fusion surgery. 

Key Points: 
  • CAVUX® FFS-LX is a novel integrated cage and screw system that is implanted bilaterally in the facet joints to treat lumbar degenerative disc disease (DDD).
  • The implant spans the facet interspace with points of fixation at each end of the construct to offer additional stabilization for 1- or 2-level lumbar interbody fusion.
  • CAVUX® FFS-LX may be used with or without pedicle screws and rods and is implanted using the company's CORUS™ Spinal System-LX tissue-sparing access and spinal fusion system.
  • Patients who fail to fuse after a lumbar spine fusion surgery face a substantial risk of added complications, suffering, and costly revision procedures.

Vy Spine Announces FDA Clearance for its ClariVy OsteoVy PEKK Cervical IBF

Retrieved on: 
Tuesday, November 14, 2023

Vy Spine , a spine innovation leader using differentiated materials and designs, announced today that it has received U.S. Food and Drug Administration (FDA) clearance for its ClariVy OsteoVy PEKK Cervical IBF, indicated for intervertebral body fusion for use at one level in the cervical spine, from C3 to T1, for the treatment of degenerative disc disease (DDD).

Key Points: 
  • Vy Spine , a spine innovation leader using differentiated materials and designs, announced today that it has received U.S. Food and Drug Administration (FDA) clearance for its ClariVy OsteoVy PEKK Cervical IBF, indicated for intervertebral body fusion for use at one level in the cervical spine, from C3 to T1, for the treatment of degenerative disc disease (DDD).
  • The novel ClariVy OsteoVy PEKK Cervical IBF device combines the osseointegration properties of the OXPEKK material and the OsteoVy lattice structure unique to Vy Spine.
  • Vy Spine’s proprietary OsteoVy lattice structure aids in bony integration as well as wicking, PEKK being a hydrophilic material, to provide even greater benefit as an interbody implant.
  • “The ClariVy OsteoVy PEKK clearance is the first in a long line of Vy Spine implants which will utilize the unique qualities of our proprietary OsteoVy PEKK designs,” said Bret Berry, President of Product Development for Vy Spine.

The Donerail Group Reiterates Intent to Vote Against Stratasys’ Proposed Acquisition of Desktop Metal and Highlights Board’s Complete Failure as Fiduciaries

Retrieved on: 
Thursday, September 21, 2023

LOS ANGELES, Sept. 21, 2023 (GLOBE NEWSWIRE) --

Key Points: 
  • In conjunction with our skepticism regarding a DM acquisition, we have extensively detailed our concerns regarding historical actions undertaken by the Board.
  • Notwithstanding the DM acquisition – a transaction that we intend to vote AGAINST given the multitude of clear value-creating options that do exist – our concern regarding the Board’s ability to be appropriate fiduciaries for shareholders has risen to alarming levels.
  • In 11 of those 12 unsolicited acquisition proposals, Stratasys rejected the unsolicited proposal without engagement.
  • For these reasons we intend to vote AGAINST the proposed Desktop Metal acquisition.

Grundfos to Debut New Water Quality Technology at WEFTEC 2023; New Head of Solutions, CMO to Speak

Retrieved on: 
Monday, September 18, 2023

Ralph Exton, Grundfos’ new Head of Solutions and Chief Marketing Officer, will participate in a Lightning Debate titled “Powering Water's Future Innovation Ecosystem: Technological Genius vs.

Key Points: 
  • Ralph Exton, Grundfos’ new Head of Solutions and Chief Marketing Officer, will participate in a Lightning Debate titled “Powering Water's Future Innovation Ecosystem: Technological Genius vs.
  • With offerings like our Demand Driven Distribution and Grundfos Connect, we reinforce existing infrastructures to ensure they operate seamlessly.
  • Grundfos Connect Product Manager Steve Frangione will conduct live demos of Grundfos Connect at the Grundfos booth #1021 and at the WEFTEC Launchpad event on Oct. 2, 2023.
  • Stop by the Grundfos booth at WEFTEC to learn more about the Seal Pump Challenge and the Grundfos water quality technology .

Zeitview Reveals 51% of Large-Scale U.S. Solar Plants are in 'Excellent' or 'Good' Condition

Retrieved on: 
Thursday, September 7, 2023

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20230907696936/en/
    Using crewed aircraft to capture aerial imagery and thermal scans, Zeitview successfully recorded data on 95 GW of the United States fleet of solar power plants during the 2023 North American Solar Scan.
  • On average, larger plants tend to be healthy, with more than 50% of the 100 MW and larger fleets in excellent or good condition.
  • Using crewed aircraft to capture aerial imagery and thermal scans, Zeitview successfully recorded asset condition data on 95 GW of the United States fleet of solar power plants during the 2023 North American Solar Scan.
  • Zeitview applies a three-letter asset rating system from AAA to DDD upon scan completion to reflect a site's condition.