Percutaneous coronary intervention

Findings Presented at ACC.24 Showed XARELTO® (rivaroxaban) Reduced the Risk of Clinically Significant Bleeding and Net Adverse Clinical Events or Rehospitalization

Retrieved on: 
Monday, April 8, 2024

NEW BRUNSWICK, N.J., April 8, 2024 /PRNewswire/ -- Johnson & Johnson announced today a new analysis of data from the PIONEER AF-PCI clinical trial demonstrating that XARELTO® (rivaroxaban) was associated with a reduced risk of clinically significant bleeding (CSB), and net adverse clinical events (NACE; a composite of clinically significant bleeding [CSB] or major adverse cardiovascular event [MACE]) or rehospitalization compared to warfarin among both elderly and non-elderly patients with nonvalvular atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI), a nonsurgical procedure designed to relieve narrowing or occlusion of the coronary artery.1,2 These data were featured in an oral presentation today at the American College of Cardiology 73rd Annual Scientific Session & Expo (ACC.24) in Atlanta, Georgia (Abstract #906-04).

Key Points: 
  • "Despite advances in cardiovascular care, patients with nonvalvular AF continue to be at risk of potentially life-threatening cardiovascular events, especially older patients considered difficult to treat due to multiple factors, including age and co-morbidities," said C. Michael Gibson*, M.D., CEO, of the nonprofit Baim Institute and professor of Medicine, Harvard Medical School.
  • "A significant challenge in managing nonvalvular AF in older individuals undergoing PCI is determining a treatment that balances the prevention of stroke with the risk for bleeding.
  • Results from the PIONEER AF-PCI trial reinforce the need to continue to research this complex and fragile elderly patient population."
  • "With this new exploratory analysis at ACC.24, we're pleased to bring the latest research to healthcare providers that adds to the growing body of clinical evidence in older adults."

Johnson & Johnson to Acquire Shockwave Medical

Retrieved on: 
Friday, April 5, 2024

Johnson & Johnson (NYSE: JNJ) and Shockwave Medical, Inc. (Nasdaq: SWAV) (“Shockwave”) today announced that they have entered into a definitive agreement under which Johnson & Johnson will acquire all outstanding shares of Shockwave for $335.00 per share in cash, corresponding to an enterprise value of approximately $13.1 billion including cash acquired.

Key Points: 
  • Johnson & Johnson (NYSE: JNJ) and Shockwave Medical, Inc. (Nasdaq: SWAV) (“Shockwave”) today announced that they have entered into a definitive agreement under which Johnson & Johnson will acquire all outstanding shares of Shockwave for $335.00 per share in cash, corresponding to an enterprise value of approximately $13.1 billion including cash acquired.
  • The transaction is expected to accelerate revenue growth for both Johnson & Johnson and Johnson & Johnson MedTech.
  • Delivers immediate operational accretion: The transaction will be accretive to operating margin for both Johnson & Johnson and Johnson & Johnson MedTech.
  • Under the terms of the agreement, Johnson & Johnson will acquire all outstanding shares of Shockwave for $335.00 per share in cash through a merger of Shockwave with a wholly owned Johnson & Johnson subsidiary.

Saghmos Therapeutics Announces Receipt of Notice of Allowance from Japanese Patent Office for Phase 3-Ready Cardiorenal Metabolic Modulator ST-62516

Retrieved on: 
Tuesday, March 12, 2024

Saghmos Therapeutics, Inc. (Saghmos), a privately held biopharmaceutical company, announced that it has received a Notice of Allowance from the Japanese Patent Office for a patent for its Phase 3-ready product, ST-62516 (trimetazidine), a cardiorenal metabolic modulator.

Key Points: 
  • Saghmos Therapeutics, Inc. (Saghmos), a privately held biopharmaceutical company, announced that it has received a Notice of Allowance from the Japanese Patent Office for a patent for its Phase 3-ready product, ST-62516 (trimetazidine), a cardiorenal metabolic modulator.
  • The patent will provide exclusivity through 2037, with broad claims for the reduction of acute kidney injury in patients with chronic kidney disease (CKD) undergoing procedures with contrast dyes.
  • "We are excited about the continued growth of Saghmos’ patent estate, with an issued US patent and Notices of Allowance for a second US patent and a Japanese patent,” commented Anna Kazanchyan, MD, Founder and CEO of Saghmos Therapeutics.
  • ST-62516 could benefit all PCI patients, not just those with comorbidities, to reduce the threat of AKI and MACKE after PCI.

Saranas Reveals Groundbreaking SAFE-MCS Study Results at CRT 2024

Retrieved on: 
Monday, March 11, 2024

“This study is the first of its kind to specifically evaluate bleeding complications in patients undergoing protected PCI, with independently adjudicated results.

Key Points: 
  • “This study is the first of its kind to specifically evaluate bleeding complications in patients undergoing protected PCI, with independently adjudicated results.
  • The Saranas Early Bird Bleed Monitoring System is the first and only FDA-approved device for real-time monitoring of endovascular bleed complications.
  • “We would like to thank the excellent team of physicians and coordinators who contributed to the success of this study,” commented Mike MacKinnon, CEO and President of Saranas.
  • Saranas is dedicated to establishing a new benchmark for bleed detection during and after endovascular procedures, with the goal of improving patient outcomes and decreasing healthcare expenses overall.”

OrbusNeich Achieves Record-High Revenue and Net Profit of US$154 Million and US$45.1 Million Respectively, Recommends Final Dividend Payment of HK10 cents per Share

Retrieved on: 
Thursday, March 7, 2024

-- Revenue hit record high at US$153.9 million, up 12.5% year-on-year

Key Points: 
  • -- Revenue hit record high at US$153.9 million, up 12.5% year-on-year
    -- Revenue from PCI balloons and PTA balloons grew by 12.1% and 29.0% year-on-year, respectively.
  • In particular, revenue from PCI balloons and PTA balloons grew by 12.1% and 29.0% year-on-year to US$115.4 million and US$14.7 million, respectively.
  • As at December 31, 2023, the Group was in a strong financial position with cash and bank balances amounting to US$255.8 million (2022: US$229.1 million).
  • Having considered future capital requirements, the Board has proposed a final dividend of HK10 cents per share in cash, as a token of appreciation for the continuous support of shareholders.

Saghmos Therapeutics Announces Appointment of FDA Veteran Stephen Grant, MD, as Chief Regulatory Officer

Retrieved on: 
Wednesday, February 21, 2024

Saghmos Therapeutics, Inc. (Saghmos), a privately held biopharmaceutical company, announced the appointment of Stephen Grant, MD, as Chief Regulatory Officer.

Key Points: 
  • Saghmos Therapeutics, Inc. (Saghmos), a privately held biopharmaceutical company, announced the appointment of Stephen Grant, MD, as Chief Regulatory Officer.
  • Dr. Grant was the former Deputy Director, Division of Cardiology and Nephrology at the FDA.
  • His guidance and his wealth of regulatory experience in the cardio-renal area at the FDA will tremendously benefit our mission to bring ST-62516 to patients,” said Anna Kazanchyan, MD, Founder and CEO of Saghmos.
  • ST-62516 could benefit all PCI patients, not just those with comorbidities, to reduce the threat of AKI and MACKE after PCI.

The University of Birmingham and Acticor Biotech announce the First Patient treated in LIBERATE, first clinical trial evaluating glenzocimab for heart attack

Retrieved on: 
Wednesday, February 7, 2024

February 7, 2024, the University of Birmingham and Acticor Biotech are proud to announce the first patient treated in the LIBERATE clinical study to evaluate glenzocimab efficacy in myocardial infarction.

Key Points: 
  • February 7, 2024, the University of Birmingham and Acticor Biotech are proud to announce the first patient treated in the LIBERATE clinical study to evaluate glenzocimab efficacy in myocardial infarction.
  • In 2022, the University of Birmingham and Acticor Biotech signed a partnership agreement to evaluate glenzocimab efficacy in myocardial infarction in a new clinical trial called LIBERATE.
  • This study is exploring the potential of glenzocimab in reducing the type of blood clotting responsible for heart damage during heart attacks.
  • Birmingham Health Partners is a strategic alliance between five organisations who collaborate to bring healthcare innovations through to clinical application:

Saghmos Therapeutics Announces Notice of Allowance for Second US Patent for Phase 3-Ready Cardiorenal Metabolic Modulator ST-62516

Retrieved on: 
Wednesday, February 7, 2024

Saghmos Therapeutics, Inc. (Saghmos), a privately held biopharmaceutical company, announced a Notice of Allowance for a second US patent for its Phase 3-ready product, ST-62516 (trimetazidine), a cardiorenal metabolic modulator.

Key Points: 
  • Saghmos Therapeutics, Inc. (Saghmos), a privately held biopharmaceutical company, announced a Notice of Allowance for a second US patent for its Phase 3-ready product, ST-62516 (trimetazidine), a cardiorenal metabolic modulator.
  • "We are very pleased to announce the Notice of Allowance for our second patent, which will enhance the long-term value of ST-62516.
  • Saghmos continues to build its intellectual property estate,” commented Anna Kazanchyan, MD, Founder and CEO of Saghmos Therapeutics.
  • ST-62516 could benefit all PCI patients, not just those with comorbidities, to reduce the threat of AKI and MACKE after PCI.

Avenacy Announces Launch of Bivalirudin for Injection in the U.S. Market

Retrieved on: 
Monday, January 29, 2024

Avenacy, a specialty pharmaceutical company focused on supplying critical injectable medications, today announced it has launched Bivalirudin for Injection in the United States as a therapeutic equivalent generic for Angiomax® for Injection (bivalirudin) approved by the U.S. Food and Drug Administration.

Key Points: 
  • Avenacy, a specialty pharmaceutical company focused on supplying critical injectable medications, today announced it has launched Bivalirudin for Injection in the United States as a therapeutic equivalent generic for Angiomax® for Injection (bivalirudin) approved by the U.S. Food and Drug Administration.
  • Bivalirudin for Injection is indicated for use as an anticoagulant for use in patients undergoing percutaneous coronary intervention (PCI) including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome.
  • Avenacy will begin shipping Bivalirudin for Injection to wholesale partners this week.
  • Bivalirudin for Injection had U.S. sales of approximately $25 million for the twelve months ending in June 2023.1
    Please see link for Full Prescribing Information.

Intravascular Ultrasound (IVUS) Global Strategic Analysis Report 2024 - ResearchAndMarkets.com

Retrieved on: 
Wednesday, January 10, 2024

The "Intravascular Ultrasound (IVUS) - Global Strategic Business Report" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Intravascular Ultrasound (IVUS) - Global Strategic Business Report" report has been added to ResearchAndMarkets.com's offering.
  • This report provides an overview of Medical Ultrasound, with a specific focus on Intravascular Ultrasound (IVUS) and its applications in the medical field.
  • It begins with a general introduction to medical ultrasound and highlights the advantages of ultrasound as compared to other imaging modalities.
  • The report discusses the indications and techniques of Intravascular Ultrasound, providing a comprehensive understanding of its use in medical procedures.