Anticoagulant

Foldax Completes Enrollment in India Clinical Trial Evaluating TRIA™ Polymer Surgical Mitral Heart Valve

Retrieved on: 
Monday, November 27, 2023

Foldax® , Inc., a leader in the development of innovative, polymer heart valves, today announced completion of enrollment in the Indian clinical trial of the TRIA™ polymer surgical mitral heart valve.

Key Points: 
  • Foldax® , Inc., a leader in the development of innovative, polymer heart valves, today announced completion of enrollment in the Indian clinical trial of the TRIA™ polymer surgical mitral heart valve.
  • The TRIA mitral valve is designed specifically for the anatomy and pressures of the mitral position.
  • “We are excited to see early promising results from the TRIA polymer mitral valve,” said Kaushal Pandey, MD, with P.D.
  • “The blood flow dynamics are excellent, and the polymer material properties are formulated to resist calcification, one of the main causes of tissue valve failure.”
    The Indian TRIA surgical mitral valve study is a prospective multicenter clinical trial.

Newly Published Study Demonstrates Safety and Efficacy of Calyxo’s CVAC Aspiration System for Patients with Large Kidney Stones

Retrieved on: 
Tuesday, November 14, 2023

“This study confirms that SURE with CVAC is an excellent option for patients with large stone burdens, especially patients who are high-risk to undergo PCNL or patients who prefer a more minimally invasive alternative to PCNL,” said Dr. Stern.

Key Points: 
  • “This study confirms that SURE with CVAC is an excellent option for patients with large stone burdens, especially patients who are high-risk to undergo PCNL or patients who prefer a more minimally invasive alternative to PCNL,” said Dr. Stern.
  • This study builds on a previous safety and feasibility study published in the Journal of Endourology in 2022, which demonstrated that the CVAC Aspiration System could safely navigate throughout the kidney, remove significantly more kidney stone volume, and clear a higher proportion of it compared to traditional basket techniques.
  • This new large-stone study is especially encouraging because it indicates patients may also be spared secondary procedures often required in kidney stone care.
  • The CVAC Aspiration System is a novel technology that uses irrigation and aspiration to remove kidney stones after laser lithotripsy with the goal of a surgically stone-free outcome.

Anthos Therapeutics' Novel Dual-Acting Factor XI/XIa Inhibitor, Abelacimab 150 mg, Demonstrated a 67% Reduction in the Primary Endpoint of Major or Clinically Relevant Non-Major Bleeding Compared with Rivaroxaban in Patients with Atrial Fibrillation

Retrieved on: 
Sunday, November 12, 2023

Anthos Therapeutics has initiated an extension study to enable patients to transition from rivaroxaban to abelacimab to benefit from the improved bleeding profile.

Key Points: 
  • Anthos Therapeutics has initiated an extension study to enable patients to transition from rivaroxaban to abelacimab to benefit from the improved bleeding profile.
  • Although currently available anticoagulants are effective in preventing strokes in patients with atrial fibrillation, the risk of bleeding remains an issue.
  • “Based on the evidence to date, we are highly confident that abelacimab will offer a potential game-changing treatment approach for patients with atrial fibrillation."
  • Abelacimab is an investigational agent and is not approved for any indication in any country.

Conformal Medical Selected as Powerhouse MedTech Company of the Year by New England Venture Capital Association's 2023 NEVY Awards

Retrieved on: 
Tuesday, December 12, 2023

NASHUA, N.H., Dec. 12, 2023 /PRNewswire/ -- Conformal Medical, Inc. announced today that the company was selected as the Powerhouse MedTech Company of the Year at the 11th Annual NEVY Awards .

Key Points: 
  • NASHUA, N.H., Dec. 12, 2023 /PRNewswire/ -- Conformal Medical, Inc. announced today that the company was selected as the Powerhouse MedTech Company of the Year at the 11th Annual NEVY Awards .
  • Hosted by the New England Venture Capital Association, the event celebrates the region's startup, venture backed companies, recognizing top innovators and companies in New England.
  • This year's Peace, Love, NEVY's awards were presented during the December 7th live event at the House of Blues in Boston.
  • "Conformal is honored to be selected for this prestigious award and we appreciate the New England Venture Capital Association for its continued support of companies and investors driving innovation in New England," said James Reinstein, President and CEO of Conformal Medical.

InsightRX Brings Groundbreaking Advancements in Model-Informed Precision Dosing to the ASHP Midyear Conference

Retrieved on: 
Tuesday, November 28, 2023

SAN FRANCISCO, Nov. 28, 2023 /PRNewswire/ -- InsightRX – which provides cloud-based precision medicine software to optimize treatment decisions – today announced three major enhancements to current precision dosing solutions based on recent scientific and technological breakthroughs, as well as expansion into new therapeutic areas.

Key Points: 
  • InsightRX executives will be at Booth 566 of the American Society of Healthcare Pharmacists (ASHP) Midyear 2023 conference in Anaheim, Calif., from Dec. 3-7, to discuss these product enhancements and the science behind them.
  • InsightRX's Nova precision dosing software platform offers multiple pharmacokinetic (PK) models for dosing of vancomycin, which is used to treat and prevent bacterial infections.
  • When using model-informed precision dosing (MIPD), a measured level sometimes does not fit well with a model's predictions.
  • Come by the InsightRX booth 566 to discuss how precision dosing solutions can help advance clinical practice for your organization.

AcelRx to Host KOL Panel Discussion on Current Anticoagulant Use in Dialysis and the Upcoming Niyad™ Clinical Study

Retrieved on: 
Tuesday, November 7, 2023

SAN MATEO, Calif., Nov. 7, 2023 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced that it will host a virtual Key Opinion Leader (KOL) panel discussion on its lead candidate Niyad™ (nafamostat) for use as an anticoagulant in dialysis circuits. The panel will feature two thought-leaders in the nephrology and critical care fields who are also co-authors on a recent market research manuscript reporting current issues with anticoagulants in the dialysis circuit. The panel will also discuss the NEPHRO CRRT (Nafamostat Efficacy in Phase 3 Registrational Continuous Renal Replacement Therapy) Study, a registrational study comparing Niyad with placebo for dialysis circuit anticoagulation, which is planned to start in the fourth quarter. Both panel members are principal investigators in the trial.

Key Points: 
  • The panel will feature two thought-leaders in the nephrology and critical care fields who are also co-authors on a recent market research manuscript reporting current issues with anticoagulants in the dialysis circuit.
  • The panel will also discuss the NEPHRO CRRT (Nafamostat Efficacy in Phase 3 Registrational Continuous Renal Replacement Therapy) Study, a registrational study comparing Niyad with placebo for dialysis circuit anticoagulation, which is planned to start in the fourth quarter.
  • The webcasted event will take place on Wednesday, December 6, 2023 at 11:00 a.m.
  • A live question and answer will follow the discussion.

A new anticoagulant in Pharmascience Canada's portfolio this fall!

Retrieved on: 
Thursday, November 2, 2023

MONTREAL, Nov. 2, 2023 /CNW/ - Pharmascience Canada launches the generic drug Prpms-RIVAROXABAN, a product fully manufactured in Canada.

Key Points: 
  • MONTREAL, Nov. 2, 2023 /CNW/ - Pharmascience Canada launches the generic drug Prpms-RIVAROXABAN, a product fully manufactured in Canada.
  • It helps prevent blood clots from forming by directly blocking the activity of a clotting factor called Factor-Xa.
  • "Pharmascience is proud and committed to serving Canadian patients through the local production of our medications!
  • mentioned Mike Dutton, Vice President, and General Manager of Pharmascience Canada.

Conformal Medical Announces Compelling One-Year Data from its Left Atrial Appendage Occlusion (LAAO) Early Feasibility Study

Retrieved on: 
Tuesday, October 24, 2023

CLAAS® System live case presentation by Dr. Shephal Doshi on Thursday, October 26th

Key Points: 
  • CLAAS® System live case presentation by Dr. Shephal Doshi on Thursday, October 26th
    NASHUA, N.H., Oct. 24, 2023 /PRNewswire/ -- Conformal Medical, Inc. announced today the positive one-year results from the company's CONFORMAL Early Feasibility Study (EFS).
  • "These results are clinically compelling and support the feasibility of the CLAAS System to safely and effectively provide durable closure for LAAO indicated patients."
  • The multi-center, single-arm, prospective study enrolled patients indicated for LAAO at 10 U.S. clinical sites.
  • Wednesday, October 25th - Conformal Medical to host a breakfast symposium, "CLAAS Act: Conformal Medical Overview and CONFORM Trial Update" at 6:30am PT in Presentation Theater 1.

Lecanemab named one of the world's best inventions in 2023 by TIME

Retrieved on: 
Tuesday, October 24, 2023

"It is a great honor and tremendous recognition that lecanemab is included in TIME's list of the world's best inventions this year.

Key Points: 
  • "It is a great honor and tremendous recognition that lecanemab is included in TIME's list of the world's best inventions this year.
  • TIME's annual list of the best inventions includes "200 extraordinary innovations changing lives."
  • The information was released for public disclosure, through the agency of the contact persons below, on October 24, 2023, at 4.50 p.m. CET.
  • ARIA usually occurs early in treatment and is usually asymptomatic, although serious and life-threatening events rarely can occur.

Conformal Medical to Present One-Year Data from its Left Atrial Appendage Occlusion (LAAO) Early Feasibility Study at TCT 2023

Retrieved on: 
Thursday, October 19, 2023

NASHUA, N.H., Oct. 19, 2023 /PRNewswire/ -- Conformal Medical, Inc. announced today the one-year results from the company's CONFORMAL Early Feasibility Study (EFS) will be presented during the 2023 Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco, CA. Dr. William Gray, System Chief, Cardiovascular Diseases at Main Line Health and professor at Lankenau Institute for Medical Research will present, "Conformal CLAAS LAAO Device EFS 1-Year TEE Follow Up" during a moderated abstract session.

Key Points: 
  • "I look forward to presenting the much anticipated one-year TEE follow up data from our initial clinical experience," stated Dr. Gray.
  • "We are extremely pleased to have the one-year Conformal EFS data presented at this year's TCT conference," commented James Reinstein, CEO of Conformal Medical.
  • Conformal Medical is currently enrolling patients in its CONFORM Pivotal Trial to support U.S. commercialization.
  • Wednesday, October 25th - Conformal Medical to host a breakfast symposium, "CLAAS Act: Conformal Medical Overview and CONFORM Trial Update" at 6:30am PT in Presentation Theater 1.