FFR

Cleerly® ISCHEMIA™ Software Device Billable With AMA Category I CPT® Code for Noninvasive Estimates of Fractional Flow Reserve

Retrieved on: 
Thursday, February 22, 2024

The American Medical Association (AMA) defines this service as a complementary augmented intelligence tool for noninvasive estimates of fractional flow reserve (FFR) to assist healthcare professionals in clinical diagnosis and decision making.

Key Points: 
  • The American Medical Association (AMA) defines this service as a complementary augmented intelligence tool for noninvasive estimates of fractional flow reserve (FFR) to assist healthcare professionals in clinical diagnosis and decision making.
  • The Category I CPT® code is an addition to the Category III CPT® codes (CPT® 0623T, 0624T, 0625T, 0626T) used for reporting Cleerly’s advanced coronary atherosclerosis analysis.
  • “The Cleerly ISCHEMIA software provides noninvasive estimates of FFR values that help healthcare professionals make critical decisions in the management of patients with suspected coronary artery disease,” said James P. Earls, MD, Chief Medical Officer of Cleerly.
  • The application of Cleerly ISCHEMIA supports improvements in physician certainty, guides medical therapy decision making, and reduces unnecessary invasive and non-invasive testing2-6.

Sirnaomics to Present Latest Developments of STP705 for Focal Fat Reduction at IMCAS World Congress 2024

Retrieved on: 
Monday, February 5, 2024

and SUZHOU, China, Feb. 5, 2024 /PRNewswire/ -- Sirnaomics Ltd. (the "Company", Stock Code: 2257, together with its subsidiaries, the "Group" or "Sirnaomics"), a leading biopharmaceutical company engaging in discovery and development of advanced RNAi therapeutics, presented the latest developments on Polypeptide Nanoparticle (PNP) platform, and its pipeline program STP705 for Focal Fat Reduction's positive clinical data, at IMCAS World Congress 2024, which is taking place in Paris from February 1st - 3rd, 2024.

Key Points: 
  • and SUZHOU, China, Feb. 5, 2024 /PRNewswire/ -- Sirnaomics Ltd. (the "Company", Stock Code: 2257, together with its subsidiaries, the "Group" or "Sirnaomics"), a leading biopharmaceutical company engaging in discovery and development of advanced RNAi therapeutics, presented the latest developments on Polypeptide Nanoparticle (PNP) platform, and its pipeline program STP705 for Focal Fat Reduction's positive clinical data, at IMCAS World Congress 2024, which is taking place in Paris from February 1st - 3rd, 2024.
  • Previously, Sirnaomics had reported that a poster with positive clinical data of STP705 for focal fat reduction (FFR) was presented at the 2023 Fall Clinical Dermatology Conference.
  • The safety and efficacy results of this Phase I study support further investigation of STP705 as a potential alternative to other injectables for FFR.
  • The positive data from the Phase I clinical study has led to the Group advancing the program to the Phase II clinical study stage.

EPV Expands Utilisation of Hansen’s Trading Solution

Retrieved on: 
Wednesday, January 24, 2024

As part of the agreement, EPV will leverage the modular capabilities of Hansen Trade by expanding its utilisation of the trading solution to encompass aFRR and FCR market trading.

Key Points: 
  • As part of the agreement, EPV will leverage the modular capabilities of Hansen Trade by expanding its utilisation of the trading solution to encompass aFRR and FCR market trading.
  • This expansion builds upon EPV’s current deployment of Hansen Trade Intraday Trading, Day-Ahead Trading and Regulating Power Market (mFRR) operations.
  • With Hansen Trade, EPV will be able to operate in all physical trading marketplaces, including Nord Pool’s Intraday and Day-Ahead markets, as well as the mFRR, aFRR, FCR and FFR markets.
  • Mika Luoto, Head of Operations at EPV, commented: “Over the years, Hansen’s unwavering commitment to product development has consistently surpassed our expectations.

Haemonetics Corporation Completes Acquisition of OpSens Inc.

Retrieved on: 
Tuesday, December 12, 2023

"Expanding our Hospital portfolio with OpSens' products creates exciting growth and diversification opportunities, while providing immediately accretive financial benefits," said Chris Simon, Haemonetics' President and Chief Executive Officer.

Key Points: 
  • "Expanding our Hospital portfolio with OpSens' products creates exciting growth and diversification opportunities, while providing immediately accretive financial benefits," said Chris Simon, Haemonetics' President and Chief Executive Officer.
  • "We are pleased to officially welcome OpSens to Haemonetics and look forward to driving greater access to OpSens' essential solutions and benefits for physicians and patients throughout the world."
  • Haemonetics financed the acquisition through a combination of cash-on-hand and a $110 million draw under its revolving credit facility.
  • Following this acquisition, Haemonetics estimates that its net debt to EBITDA ratio, as defined in Haemonetics' existing credit agreement, will be approximately 2.3x.

iFR and FFR are equally safe to diagnose and treat heart disease according to largest-ever analysis of new real-world, long-term data

Retrieved on: 
Thursday, October 26, 2023

iFR is an innovative pressure-derived index only offered by Philips that is used to assess coronary blockages during interventional procedures.

Key Points: 
  • iFR is an innovative pressure-derived index only offered by Philips that is used to assess coronary blockages during interventional procedures.
  • The analysis, “Long-term Safety of Revascularization Deferral Based on Instantaneous Wave-Free Ratio or Fractional Reserve,” compares patient outcomes using iFR and FFR in the diagnosis and treatment of heart disease.
  • The cumulative MACE risks for each group differentiated by 1.6% (iFR: 21.5%, FFR: 19.9%, HR 1.09 (95% CI: 0.90-1.33 at 5 years).
  • iFR is considered the Gold Standard for hyperemia-free physiologic assessment for measuring pressure in diagnostic and interventional procedures [1,4].

Haemonetics Corporation Announces Definitive Agreement to Acquire OpSens, Inc.

Retrieved on: 
Tuesday, October 10, 2023

BOSTON, Oct. 10, 2023 /PRNewswire/ -- Haemonetics Corporation (NYSE: HAE), a global medical technology company focused on delivering innovative medical solutions to drive better patient outcomes, and OpSens, Inc. (TSX:OPS) (OTCQX:OPSSF), a medical device cardiology-focused company delivering innovative solutions based on its proprietary optical technology, today announced that they have entered into a definitive agreement under which Haemonetics will acquire all outstanding shares of OpSens for CAD $2.90 per share in an all-cash transaction representing a fully diluted equity value of approximately USD $253 million at current exchange rate.

Key Points: 
  • OpSens also manufactures a range of fiber optic sensor solutions used in medical devices and other critical industrial applications.
  • Stewart Strong, President, Global Hospital at Haemonetics, said, "With the acquisition of OpSens, we expand our leadership in interventional cardiology and strengthen our foundation for additional growth and diversification.
  • Following this acquisition, Haemonetics' net debt to EBITDA ratio, per the terms set forth in the Company's existing Credit Agreement, is expected to be approximately 2.1x.
  • Haemonetics posted supplemental slides with additional information about this transaction to Haemonetics' investor relations website.

New Data from Clinical Studies Further Validate HeartFlow’s All-in-One Portfolio of Precision Coronary Care Solutions

Retrieved on: 
Friday, July 28, 2023

MOUNTAIN VIEW, Calif., July 28, 2023 (GLOBE NEWSWIRE) -- Respective results from the REVEALPLAQUE, DECODE, and SMART-CT clinical studies demonstrate the accuracy, utility, and efficiency of HeartFlow’s portfolio of coronary computed tomography angiography (CCTA)-based precision coronary care technologies.

Key Points: 
  • MOUNTAIN VIEW, Calif., July 28, 2023 (GLOBE NEWSWIRE) -- Respective results from the REVEALPLAQUE, DECODE, and SMART-CT clinical studies demonstrate the accuracy, utility, and efficiency of HeartFlow’s portfolio of coronary computed tomography angiography (CCTA)-based precision coronary care technologies.
  • HeartFlow is the first company to offer a suite of technologies to help clinicians non-invasively identify stenoses in the coronary arteries ( RoadMap™Analysis ), assess coronary blood flow ( FFR C T Analysis ), and characterize and quantify coronary atherosclerosis ( Plaque Analysis ).
  • Together, this comprehensive solution offers valuable data not currently available with traditional non-invasive diagnostics tools, allowing clinicians to see the full picture of their patients’ coronary artery disease (CAD).
  • "Until now, clinicians have not had access to a complete view of a patient’s heart health with accurate data on coronary anatomy, physiology, and plaque.

Pulse Medical receives FDA Breakthrough Device Designation for its μFR® system

Retrieved on: 
Friday, May 26, 2023

SHANGHAI, May 26, 2023 /PRNewswire/ -- Pulse Medical Technology, Inc. (Pulse Medical) 4th generation μFR® system has received an FDA Breakthrough Device designation.

Key Points: 
  • SHANGHAI, May 26, 2023 /PRNewswire/ -- Pulse Medical Technology, Inc. (Pulse Medical) 4th generation μFR® system has received an FDA Breakthrough Device designation.
  • Pulse Medical, founded in 2015, located in Shanghai, China, is dedicated to developing innovative technology for precise diagnosis and optimal treatment of patients with pan-vascular disease.
  • Pulse Medical has been pioneering and invented the key algorithm of μFR®, the fast computation methodology of fractional flow reserve (FFR) from multiple imaging data.
  • The classification enables a coordinated and expedited review process with FDA, accelerating the commercialization of Pulse Medical.

Pulse Medical receives FDA Breakthrough Device Designation for its μFR® system

Retrieved on: 
Friday, May 26, 2023

SHANGHAI, May 26, 2023 /PRNewswire/ -- Pulse Medical Technology, Inc. (Pulse Medical) 4th generation μFR® system has received an FDA Breakthrough Device designation.

Key Points: 
  • SHANGHAI, May 26, 2023 /PRNewswire/ -- Pulse Medical Technology, Inc. (Pulse Medical) 4th generation μFR® system has received an FDA Breakthrough Device designation.
  • Pulse Medical, founded in 2015, located in Shanghai, China, is dedicated to developing innovative technology for precise diagnosis and optimal treatment of patients with pan-vascular disease.
  • Pulse Medical has been pioneering and invented the key algorithm of μFR®, the fast computation methodology of fractional flow reserve (FFR) from multiple imaging data.
  • The classification enables a coordinated and expedited review process with FDA, accelerating the commercialization of Pulse Medical.

Philips showcases its latest portfolio of cardiology innovations that deliver clinical confidence and efficiency in treating cardiac disease at EuroPCR 2023

Retrieved on: 
Thursday, May 11, 2023

The Philips cardiology portfolio addresses the need for integrating imaging, devices, software, informatics, and services at each point in the cardiac patient journey.

Key Points: 
  • The Philips cardiology portfolio addresses the need for integrating imaging, devices, software, informatics, and services at each point in the cardiac patient journey.
  • Philips’ proven physiology technologies can enable interventionalists to perform ultra-low contrast percutaneous coronary intervention (ULC-PCI) procedures with greater confidence.
  • In line with the company’s commitment to supporting its innovations with clinical evidence, Philips’ clinical partners will present new data during late-breaking sessions at EuroPCR that could help inform treatment for PCI patients.
  • For a full calendar of Philips events, session registration and to learn more about cardiology solutions being showcased in Philips Booth #F20 at EuroPCR 2023, please visit our website .