FRANZCR

PreludeDx to Present New Data on the Clinical Utility of DCISionRT in Australian Patients with DCIS at the 2023 San Antonio Breast Cancer Symposium

Retrieved on: 
Tuesday, December 5, 2023
Patient, GenesisCare, Medicine, Ductal carcinoma, CP, RT, MBBS, DCIS, FRANZCR, Pharmaceutical industry

LAGUNA HILLS, Calif., Dec. 05, 2023 (GLOBE NEWSWIRE) -- Prelude Corporation (PreludeDx), a leader in molecular diagnostics and precision medicine for early-stage breast cancer, today announced it will present data demonstrating the decision impact on physician recommendations for radiation therapy (RT) in ductal carcinoma in situ (DCIS) patients in Australia.

Key Points: 
  • LAGUNA HILLS, Calif., Dec. 05, 2023 (GLOBE NEWSWIRE) -- Prelude Corporation (PreludeDx), a leader in molecular diagnostics and precision medicine for early-stage breast cancer, today announced it will present data demonstrating the decision impact on physician recommendations for radiation therapy (RT) in ductal carcinoma in situ (DCIS) patients in Australia.
  • The data will be presented at the 2023 San Antonio Breast Cancer Symposium (SABCS), held on December 5 - 9, 2023 at the Henry B. Gonzalez Convention Center, San Antonio, Texas.
  • Specifically, in the interim analysis of 483-patients treated with breast conserving surgery in Australia, the use of the test resulted in a 41% change in RT recommendations and a 9% change in hormone therapy (HT) recommendations.
  • “The integration of DCISionRT into the clinical decision-making processes has a substantial impact on recommendations to personalize care and prevent over- and under-treatment,” said Dr. Yvonne Zissiadis, MBBS, FRANZCR, radiation oncologist, GenesisCare and principal investigator.

Surmodics Announces 24-Month Data from the SWING Trial Presented at VEITHsymposium

Retrieved on: 
Thursday, November 16, 2023
Health, Clinical Trials, Medical Devices, Safety, Peripheral artery disease, FRANZCR, DCB, Aortoiliac occlusive disease, Auckland City Hospital, Ambient occlusion, PP, CLTI, Freedom, HIV disease progression rates, Classification, ONZM, Pharmaceutical industry, Medical imaging

The SWING Trial is a 35-subject prospective, multi-center, single-arm, feasibility study to evaluate the safety and performance of the Sundance Sirolimus DCB when used to treat occlusive disease of the infrapopliteal arteries.

Key Points: 
  • The SWING Trial is a 35-subject prospective, multi-center, single-arm, feasibility study to evaluate the safety and performance of the Sundance Sirolimus DCB when used to treat occlusive disease of the infrapopliteal arteries.
  • Both primary endpoints of the SWING Trial were achieved.
  • Primary safety endpoint data showed no perioperative deaths or major amputations at 30 days, and just one major re-intervention was reported among the 35 trial subjects.
  • “These results are promising and will inform future trials, which we hope will continue to advance improved treatments for our patients.”

Surmodics Announces SWING Trial 12-Month Data to be Presented at ISET Conference on January 18

Retrieved on: 
Monday, January 16, 2023
Medical Supplies, Health, Medical Devices, Surgery, Clinical Trials, Pharmaceutical, Cardiology, FRANZCR, Cell, MS, Auckland City Hospital, Aortoiliac occlusive disease, Safety, SCB Park Plaza, ISET, PHD, ONZM, Master of Medicine, Sale, DCB, Restenosis, International Symposium on Endovascular Therapy, Pharmaceutical industry, FRACS, Bachelor of Medicine, Bachelor of Surgery, MBBS, Anesthetic

The session will be held on Wednesday, January 18, at the 35th annual International Symposium on Endovascular Therapy (ISET) conference in Miami, Florida.

Key Points: 
  • The session will be held on Wednesday, January 18, at the 35th annual International Symposium on Endovascular Therapy (ISET) conference in Miami, Florida.
  • Professor Varcoe will also discuss the differentiated capabilities of the Surmodics crystalline drug release platform for sirolimus-coated balloons (SCBs) in connection with 12-month data from the SWING trial.
  • Professor Varcoe recently presented SWING Trial 12-month data on Nov. 16 at the 49th Annual Symposium on Vascular and Endovascular Issues (VEITHsymposium).
  • The Sundance Sirolimus Drug-Coated Balloon is not available for sale anywhere in the world, and currently is for investigational use only.

Surmodics Announces 12-Month Data from the SWING Trial Presented at VEITHsymposium

Retrieved on: 
Thursday, November 17, 2022
Medical Supplies, Health, Medical Devices, Surgery, Clinical Trials, Pharmaceutical, Cardiology, MALE, Restenosis, Sale, Ambient occlusion, Peripheral artery disease, Cell, DCB, Freedom, PHD, PP, FRANZCR, MS, Safety, HIV disease progression rates, IVD, Disease, Master of Medicine, Annual report, ONZM, Growth, Classification, MD, Aortoiliac occlusive disease, Pharmaceutical industry, Medical imaging, FRACS, MBBS, Bachelor of Medicine, Bachelor of Surgery

The primary efficacy endpoint is the rate of late lumen loss at 6 months, as assessed by quantitative vascular angiography.

Key Points: 
  • The primary efficacy endpoint is the rate of late lumen loss at 6 months, as assessed by quantitative vascular angiography.
  • Both primary endpoints of the SWING Trial were achieved.
  • Primary safety endpoint data showed no perioperative deaths or major amputations at 30 days, and just one major re-intervention was reported among the 35 trial subjects.
  • The SWING Trial demonstrates that the Sundance Sirolimus DCB has tremendous promise and warrants evaluation in a large-scale pivotal trial.

Surmodics Announces SWING Trial 12-Month Data to be Presented at VEITHsymposium on November 16

Retrieved on: 
Friday, November 11, 2022
Medical Devices, Health, Surgery, Clinical Trials, General Health, Pharmaceutical, Aortoiliac occlusive disease, Sale, Company, Annual report, NASDAQ, Disease, Auckland City Hospital, Technology, Cell, DCB, SEC, Safety, Investor, 3rd Floor, Forward-looking statement, MS, Restenosis, Master of Medicine, FRANZCR, AMP, Growth, Amputation, PHD, ONZM, Pharmaceutical industry, Bachelor of Medicine, Bachelor of Surgery, FRACS, Anesthetic, MBBS

The session will be held on Wednesday, November 16, at the 49th Annual Symposium on Vascular and Endovascular Issues (VEITHsymposium) in New York City.

Key Points: 
  • The session will be held on Wednesday, November 16, at the 49th Annual Symposium on Vascular and Endovascular Issues (VEITHsymposium) in New York City.
  • Professor Andrew Holden, MBChB, FRANZCR, EBIR, ONZM, Director of Northern Region Interventional Radiology Service at Auckland City Hospital in Auckland, New Zealand, is also a co-lead investigator for the SWING Trial.
  • Professor Varcoe recently presented SWING Trial 6-month data on October 11 as part of the Amputation Prevention Symposium (AMP) in Lugano, Switzerland.
  • Surmodics is a leading provider of surface modification technologies for intravascular medical devices and chemical components for in vitro diagnostic immunoassay tests and microarrays.

6-Month Data from the Surmodics SWING BTK First-in-Human Trial Presented at AMP Europe

Retrieved on: 
Tuesday, October 11, 2022
Health, Medical Devices, Surgery, General Health, Clinical Trials, Pharmaceutical, Cardiology, Disease, Sale, SEC, LLL, MS, Population, CLI, Growth, Investor, FIH, PHD, Annual report, NASDAQ, DCB, Cell, Amputation, Restenosis, Technology, ONZM, Company, IVD, MD, RVD, Safety, Diabetes, AMP, FRANZCR, Master of Medicine, Forward-looking statement, Aortoiliac occlusive disease, Medical device, Pharmaceutical industry, FRACS, MBBS, Bachelor of Medicine, Bachelor of Surgery

The studys primary safety endpoint data showed no perioperative deaths or major amputations at 30 days and just one major re-intervention was reported among the 35 trial subjects.

Key Points: 
  • The studys primary safety endpoint data showed no perioperative deaths or major amputations at 30 days and just one major re-intervention was reported among the 35 trial subjects.
  • The Sundance Sirolimus Drug-Coated Balloon is not available for sale anywhere in the world, and currently is for investigational use only.
  • Surmodics is pursuing highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements.
  • The content of Surmodics website is not part of this press release or part of any filings that the company makes with the SEC.

6-Month Data from the Surmodics SWING First-in-Human Study to be Presented at AMP Europe

Retrieved on: 
Friday, October 7, 2022
Biotechnology, Pharmaceutical, Surgery, General Health, Health, Medical Devices, Clinical Trials, Other Health, Quality of life, Disease, Risk, SEC, Sale, MS, Growth, Investor, PHD, Annual report, NASDAQ, Patient, Cell, Amputation, Restenosis, Technology, ONZM, Company, Auckland City Hospital, Safety, AMP, FRANZCR, Master of Medicine, Forward-looking statement, Aortoiliac occlusive disease, Pharmaceutical industry, FRACS, MBBS, Bachelor of Medicine, Bachelor of Surgery, Anesthetic

The session will be held on Tuesday, October 11, at the Amputation Prevention Symposium (AMP) in Lugano, Switzerland.

Key Points: 
  • The session will be held on Tuesday, October 11, at the Amputation Prevention Symposium (AMP) in Lugano, Switzerland.
  • He will review safety and efficacy data collected through 6-months of follow-up for 35 patients with occlusive disease of the infra-popliteal arteries who were treated at study sites in Australia, New Zealand, or locations in Europe.
  • Study subjects will be followed for 36 months after the index procedure.
  • I am excited to present the 6-month SWING data to an audience of my peers at AMP Europe.

New Liquid Embolic Multi-Center Trial Successfully Enrolls Final Patient

Retrieved on: 
Thursday, September 1, 2022
FRANZCR, Neoplasm, ONZM, Interventional radiology, Technology, GPX, Embolus, SIR, Birth, SALT, DMSO, LINC, Aneurysm, Multimedia, Bleeding, Polymerization, Society of Interventional Radiology, Society, Pharmaceutical industry, Medical imaging, Bachelor of Medicine, Bachelor of Surgery, Auckland City Hospital

SALT LAKE CITY, Sept. 1, 2022 /PRNewswire/ -- Fluidx Medical announces completion of trial enrollment for its novel embolic device, GPX. In this multi-center trial, GPX was used to treat a variety of primary and metastatic tumors, renal adenoma tumors, and a range of other arterial and venous applications.

Key Points: 
  • SALT LAKE CITY, Sept. 1, 2022 /PRNewswire/ -- Fluidx Medical announces completion of trial enrollment for its novel embolic device, GPX.
  • In this multi-center trial, GPX was used to treat a variety of primary and metastatic tumors, renal adenoma tumors, and a range of other arterial and venous applications.
  • "In the trial, GPX showed significant potential to advance liquid embolics, penetrating very distally, providing profound embolization, and demonstrating excellent radiopacity which helped to avoid non-target embolization and preserve healthy adjacent tissue."
  • The GPX Embolic Device is under development and does not have marketing clearance or approval in any market at this time.

Fluidx Medical Technology Announces Series A Led by Multinational Strategic Investor

Retrieved on: 
Wednesday, December 1, 2021
DMSO, CEO, Bed, Polymerization, Technology, Time, Blood, SALT, Health, ONZM, Embolus, GPX, Series, Interventional radiology, FRANZCR, Embolism, Pharmaceutical industry, Medical imaging, Medical device

"The material is very radiopaque during delivery and has demonstrated excellent distal penetration, particularly important in our tumor embolization cases."

Key Points: 
  • "The material is very radiopaque during delivery and has demonstrated excellent distal penetration, particularly important in our tumor embolization cases."
  • *
    "The GPX team achieved a great deal with seed funding including first patient use of the device.We have been very pleased with the overwhelming investor support for our Series A raise," said Libble Ginster, CEO of Fluidx Medical Technology.
  • "Our company's mission is to elevate patient care through innovation, and we look forward to bringing the GPX technology to the clinical community."
  • *Fluidx Medical Technology data on file.