EFS

"Striving for Greatness" with Olympic Gold Medalist Allyson Felix and Dallas-based Nonprofit Educational First Steps

Retrieved on: 
Mittwoch, September 20, 2023
Steps, Pregnancy, Four-step impact assessment, Olympic Games, World championship, United States Swimming National Championships, History, Athlete, Education, Olympic, EFS, The Ritz-Carlton Hotel Company, Greatness, Female, Toy

Through their early childhood education program, the Four Steps to Excellence, Educational First Steps transforms existing childcare centers into nationally accredited preschools.

Key Points: 
  • Through their early childhood education program, the Four Steps to Excellence, Educational First Steps transforms existing childcare centers into nationally accredited preschools.
  • This fall, Educational First Steps and event co-chairs Angela Hosseini and Lupe Mora proudly announce "Striving for Greatness with Allyson Felix," a benefit scheduled for 6:30 PM CST on Tuesday, February 20th, 2024 at The Ritz-Carlton Dallas.
  • Allyson Felix is the most decorated Track and Field Olympian in history, as an eleven-time Olympic medalist, seven-time Olympic Champion, and World Record Holder.
  • Furthering her efforts, Felix helped ensure that complimentary childcare would be offered at the National Championships for competing athletes.

Implantica announces two independent scientific presentations on RefluxStop™ from the 2023 Annual ISDE conference

Retrieved on: 
Dienstag, September 19, 2023
Certification, Surgeon, Disease, University, Safety, ISDE, NCI-designated Cancer Center, Research, University of Veterinary Medicine Vienna, Patient, General Hospital, CEST, EFS, General surgery, International Society, Medical device, Dentistry, Esophagus

), a medtech company at the forefront of bringing advanced technology into the body, was honored to see multiple independent scientific podium presentations on RefluxStop™, an innovative procedure for the treatment of acid reflux, showcased at the 2023 International Society for Diseases of the Esophagus (ISDE) meeting in Toronto, Canada.

Key Points: 
  • ), a medtech company at the forefront of bringing advanced technology into the body, was honored to see multiple independent scientific podium presentations on RefluxStop™, an innovative procedure for the treatment of acid reflux, showcased at the 2023 International Society for Diseases of the Esophagus (ISDE) meeting in Toronto, Canada.
  • The presentations covering RefluxStop™ safety and efficacy real-world data on 85 patients and an overview of the RefluxStop™ procedure were featured as part of this year's ISDE scientific program, on September 8th, 2023.
  • Once again, we congratulate Prof. Schoppmann and Dr. Lehmann for their distinguished leadership in the field of acid reflux," said Dr. Peter Forsell, CEO of Implantica.
  • The company's Certified Adviser is FNCA Sweden AB, [email protected]
    The information was sent for publication, through the agency of the contact person set out above, on September 19, 2023, at 08:00 a.m. (CEST).

PathMaker Neurosystems Announces Initiation of First-in-Human Trial in ALS for Non-Invasive Neuromodulation Device

Retrieved on: 
Donnerstag, September 14, 2023
Spaulding Rehabilitation Hospital, Muscular Dystrophy Association, Physical medicine and rehabilitation, CERF, Clinical trial, DSM-IV codes, Associate, Bangladesh Technical Education Board, Rehabilitation, Faculty, EFS, Healey, Entrepreneurship, Hospital, MDA, Massachusetts General Hospital, MPH, ALS, Muscular dystrophy, NIH, Safety, Pharmaceutical industry

BOSTON and PARIS, Sept. 14, 2023 (GLOBE NEWSWIRE) -- PathMaker Neurosystems Inc. (“PathMaker”), a near-commercial stage neuromodulation company developing breakthrough non-invasive systems for the treatment of serious neurological disorders, announced today the initiation of a first-in-human clinical trial evaluating its MyoRegulator® device for the treatment of amyotrophic lateral sclerosis (ALS).

Key Points: 
  • BOSTON and PARIS, Sept. 14, 2023 (GLOBE NEWSWIRE) -- PathMaker Neurosystems Inc. (“PathMaker”), a near-commercial stage neuromodulation company developing breakthrough non-invasive systems for the treatment of serious neurological disorders, announced today the initiation of a first-in-human clinical trial evaluating its MyoRegulator® device for the treatment of amyotrophic lateral sclerosis (ALS).
  • This single-center, single-arm, open-label Early Feasibility Study (EFS) is designed to assess the safety and feasibility of the MyoRegulator® device in treating people with ALS, and is being carried out in conjunction with Spaulding Rehabilitation Hospital (Charlestown, MA).
  • “We are tremendously excited to launch this first-in-human trial of MyoRegulator® in ALS,” said Nader Yaghoubi, M.D., Ph.D., Co-Founder and CEO of PathMaker.
  • The MyoRegulator® device based on this technology has been used successfully and safely in two completed clinical trials for post-stroke spasticity.

Anteris Announces Participation at the Cantor Healthcare Conference on Sept 26th 2023

Retrieved on: 
Dienstag, September 12, 2023
Medical Devices, Health, Health Technology, Clinical Trials, Cardiology, Biotechnology, MeasureNet Technology Ltd., Cantor, Clinical trial, ASX, Aortic stenosis, Patient, TAVR, EFS, Conference, Pharmaceutical industry

Mr. Paterson will present the latest clinical data for DurAVR™, the Company’s lead technology and a best-in-class TAVR for the treatment of aortic stenosis.

Key Points: 
  • Mr. Paterson will present the latest clinical data for DurAVR™, the Company’s lead technology and a best-in-class TAVR for the treatment of aortic stenosis.
  • This will be followed with a fireside chat with Cantor’s medtech analyst, Ross Osborn.
  • One-year data from European EFS of DurAVR™ was presented at the TVT Structural Heart Conference on June 9th 2023 and available on the investor portal of the Company’s website.
  • Thirty (30) day data results from the ongoing U.S. EFS of DurAVR™ is targeted for 4Q2023.

Surgical Outcomes of Perioperative Durvalumab in AEGEAN Study to be Presented at IASLC 2023 World Conference on Lung Cancer

Retrieved on: 
Dienstag, September 12, 2023
CT, MPR, Arm, International Association, Lung cancer, Pneumonectomy, Research, NSCLC, Lung, PCR, AstraZeneca, Cardiothoracic surgery, HIV disease progression rates, MD, Patient, Physician, ECOG, Division, EGFR, AJCC, EFS, AEGEAN, Conference, Birth control, Medical imaging, Dentistry

SINGAPORE, Sept. 12, 2023 /PRNewswire-PRWeb/ -- Adding perioperative durvalumab to neoadjuvant chemotherapy did not adversely impact surgery in patients with resectable NSCLC and was associated with a tolerable surgical safety profile, according to research presented today from the phase 3 AEGEAN trial at the International Association for the Study of Lung Cancer 2023 World Conference on Lung Cancer in Singapore.

Key Points: 
  • Adding perioperative durvalumab to neoadjuvant chemotherapy did not adversely impact surgery in patients with resectable NSCLC and was associated with a tolerable surgical safety profile, according to research presented today from the phase 3 AEGEAN trial at the International Association for the Study of Lung Cancer 2023 World Conference on Lung Cancer in Singapore.
  • SINGAPORE, Sept. 12, 2023 /PRNewswire-PRWeb/ -- Adding perioperative durvalumab to neoadjuvant chemotherapy did not adversely impact surgery in patients with resectable NSCLC and was associated with a tolerable surgical safety profile, according to research presented today from the phase 3 AEGEAN trial at the International Association for the Study of Lung Cancer 2023 World Conference on Lung Cancer in Singapore.
  • The AEGEAN trial is a double-blind, placebo-controlled phase 3 study that evaluated the use of perioperative durvalumab in combination with neoadjuvant chemotherapy compared to neoadjuvant chemotherapy alone.
  • AEGEAN data from outcomes for patients with documented EGFR mutations are also being presented at IASLC 2023 World Conference on Lung Cancer.

Autolus Therapeutics announces data from AUTO1/22 trial in pediatric Acute Lymphoblastic Leukemia published in the journal Blood

Retrieved on: 
Dienstag, September 5, 2023
Antigen, B-cell lymphoma, CD19, Blood, CD22, MRD, CAR, Cytokine release syndrome, Patient, B-ALL, EFS, European Society for Medical Oncology, Therapy, Blinatumomab, Disease, Pharmaceutical industry, Vaccine

CD19 negative relapse is a major cause of treatment failure after CD19 CAR T cell therapy for pediatric B-ALL.

Key Points: 
  • CD19 negative relapse is a major cause of treatment failure after CD19 CAR T cell therapy for pediatric B-ALL.
  • AUTO1/22 maintained the safety profile of obe-cel alone, with no cases of severe cytokine release syndrome.
  • This includes 2 (of 3) patients who had CD19 negative disease, demonstrating the efficacy of the CD22 CAR.
  • “CAR T-cell therapies which co-target CD19 and CD22 are needed to prevent antigen-negative escape in pediatric B-ALL.

Vivani Medical Subsidiary Cortigent to Present Orion Clinical Study Results at The Eye and The Chip World Research Congress on Artificial Vision October 8-10

Retrieved on: 
Dienstag, September 5, 2023
Neurology, Biotechnology, Pharmaceutical, Optical, Health, Medical Devices, Health Technology, Clinical Trials, Medicine, Orion (system-on-a-chip), Orion, Food and Drug Administration, Research, Brain, Eye, Bangladesh Technical Education Board, Congress, Visual cortex, Clinical trial, Neuroscience, EFS, Knowledge, Visual perception, Principal, FDA, Food, Safety, Pharmaceutical industry

Vivani Medical, Inc. (NASDAQ: VANI), an innovative, preclinical-stage biopharmaceutical company developing novel, long-term drug implants, announced today that its wholly-owned subsidiary Cortigent, Inc., a company pioneering targeted neurostimulation technology to recover critical body functions, will present the Early Feasibility Study (EFS) results for the Orion® Visual Cortical Prosthesis System at The Eye & The Chip: 13th World Research Congress on Artificial Vision in Southfield, Michigan on October 8-10, 2023.

Key Points: 
  • Vivani Medical, Inc. (NASDAQ: VANI), an innovative, preclinical-stage biopharmaceutical company developing novel, long-term drug implants, announced today that its wholly-owned subsidiary Cortigent, Inc., a company pioneering targeted neurostimulation technology to recover critical body functions, will present the Early Feasibility Study (EFS) results for the Orion® Visual Cortical Prosthesis System at The Eye & The Chip: 13th World Research Congress on Artificial Vision in Southfield, Michigan on October 8-10, 2023.
  • Cortigent’s Principal Investigator for the National Institutes of Health - funded Orion EFS (UH3NS103442), Uday Patel Ph.D., will give a talk covering the abstract “Orion Visual Cortical Prosthesis System: 5-year Clinical Trial Results” that has been accepted by this preeminent research congress focused on recent advances in nanoelectronics and neurobiology to provide artificial vision.
  • The Orion EFS has been extended to a six-year study to assess the long-term safety, reliability, and visual function provided by this novel medical device, and to allow exploration of novel techniques to further improve efficacy.
  • The Orion System is an investigational device that will require successful completion of one or more pivotal clinical trial(s) and subsequent U.S. Food and Drug Administration (FDA) approval for commercialization.

BriaCell Accepts Letter of Intent from Weill Cornell Medicine Outlining Plans to Initiate a Clinical Trial of Bria-IMT™ in High-Risk Early-Stage Triple Negative Breast Cancer

Retrieved on: 
Donnerstag, August 31, 2023
TNBC, CPI, Survival, Clinical trial, Personalized medicine, Quality of life, CMO, Sandra, Immunotherapy, PCR, Associate, Trial of the century, NEJM, Patient, Keynote, Weill Cornell Medicine, TSX, EFS, Letter, Therapy, BCT, Neoadjuvant therapy, Safety, Pharmaceutical industry

“We are beyond excited to work with a world class research team at Weill Cornell Medicine led by Dr. Cristofanilli,” stated Dr. Williams, BriaCell’s President & CEO.

Key Points: 
  • “We are beyond excited to work with a world class research team at Weill Cornell Medicine led by Dr. Cristofanilli,” stated Dr. Williams, BriaCell’s President & CEO.
  • “We are grateful for this collaboration on Bria-IMT™ as a much-needed oncology treatment solution for early stage TNBC patients and will gladly support the Phase 2 clinical study by providing Bria-IMT™ and expertise.”
    “Bria-IMT™ combination regimen’s recently reported clinical data shows a favorable safety and efficacy profile in heavily pre-treated advanced metastatic breast cancer patients,” Dr. Cristofanilli said.
  • The clinical trial is designed to evaluate the safety, and efficacy of the Bria-IMT™ combination regimen with CPI in early TNBC patients who completed neoadjuvant therapy and did not achieve pathological complete remission (pCR).
  • The primary endpoint of event-free survival (EFS) will be compared to the EFS of 55% in the historical control from Keynote 522 (Schmid et al, NEJM 2022; 386:556-567).

Trisol announces successful implants of its Transcatheter Tricuspid Valve in the US

Retrieved on: 
Mittwoch, August 23, 2023
University of Virginia Health System, University, TR, Food and Drug Administration, Cardiopulmonary bypass, Risk, Valvular heart disease, EFS, Principal, Food, Medical device, Trisol, MD

YOKNEAM, Israel, Aug. 23, 2023 /PRNewswire/ -- The heart teams at the Piedmont Heart Institute in Atlanta, Georgia, USA and the University of Virginia Health System in Charlottesville, VA, USA, successfully performed the first two implantations in the US of the Trisol Transcatheter Tricuspid Valve Replacement as part of a U.S. Food and Drug Administration approved Early Feasibility Study (EFS), led by Principal Investigator Isaac George, MD.

Key Points: 
  • We were able to abolish the patient's valvular heart disease via a minimally invasive procedure without the need for cardiopulmonary bypass.
  • Trisol patented valve features a distinctive design, that sets it apart from other tricuspid valves technologies.
  • Trisol valve is comprised of a single leaflet, the leaflet is affixed by 2 commissures enabling it to function as a bi-leaflet valve.
  • Five of these implants were performed as part of the Israeli Pilot Study, led by Principal Investigator Ran Kornowski, MD.

Trisol announces successful implants of its Transcatheter Tricuspid Valve in the US

Retrieved on: 
Mittwoch, August 23, 2023
University of Virginia Health System, University, TR, Food and Drug Administration, Cardiopulmonary bypass, Risk, Valvular heart disease, EFS, Principal, Food, Medical device, Trisol, MD

YOKNEAM, Israel, Aug. 23, 2023 /PRNewswire/ -- The heart teams at the Piedmont Heart Institute in Atlanta, Georgia, USA and the University of Virginia Health System in Charlottesville, VA, USA, successfully performed the first two implantations in the US of the Trisol Transcatheter Tricuspid Valve Replacement as part of a U.S. Food and Drug Administration approved Early Feasibility Study (EFS), led by Principal Investigator Isaac George, MD.

Key Points: 
  • We were able to abolish the patient's valvular heart disease via a minimally invasive procedure without the need for cardiopulmonary bypass.
  • Trisol patented valve features a distinctive design, that sets it apart from other tricuspid valves technologies.
  • Trisol valve is comprised of a single leaflet, the leaflet is affixed by 2 commissures enabling it to function as a bi-leaflet valve.
  • Five of these implants were performed as part of the Israeli Pilot Study, led by Principal Investigator Ran Kornowski, MD.