FACS

EYLEA® HD (aflibercept) Injection 8 mg Pivotal Data in Wet Age-related Macular Degeneration (wAMD) and Diabetic Macular Edema (DME) Published in The Lancet

Retrieved on: 
Friday, March 8, 2024

TARRYTOWN, N.Y., March 08, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced The Lancet published one-year results from the pivotal PULSAR and PHOTON trials for EYLEA® HD (aflibercept) Injection 8 mg. Specifically, the publications detailed data demonstrating that EYLEA HD extended dosing regimens were non-inferior to EYLEA® (aflibercept) Injection 2 mg for both the treatment of wet age-related macular degeneration (wAMD) and diabetic macular edema (DME).

Key Points: 
  • Specifically, the publications detailed data demonstrating that EYLEA HD extended dosing regimens were non-inferior to EYLEA® (aflibercept) Injection 2 mg for both the treatment of wet age-related macular degeneration (wAMD) and diabetic macular edema (DME).
  • “Less than a year after its approval, EYLEA HD has already made an impact in the treatment of wet age-related macular degeneration and diabetic macular edema.
  • EYLEA HD has provided disease control for my tough-to-treat cases of diabetic eye disease and allowed both my diabetic and wet age-related macular degeneration patients to enjoy less frequent dosing with a similar safety profile to EYLEA.”
    PULSAR and PHOTON are two double-masked, active-controlled pivotal trials evaluating EYLEA HD compared to EYLEA.
  • In the U.S., Regeneron maintains exclusive rights to EYLEA and EYLEA HD.

Silk Road Medical Expands TCAR® Portfolio with Launch of Tapered ENROUTE® Transcarotid Stent System

Retrieved on: 
Tuesday, March 5, 2024

This launch expands upon the company’s prior ENROUTE Transcarotid Stent System, offering additional configurations to better tailor the Transcarotid Artery Revascularization (TCAR) procedure to patient anatomy.

Key Points: 
  • This launch expands upon the company’s prior ENROUTE Transcarotid Stent System, offering additional configurations to better tailor the Transcarotid Artery Revascularization (TCAR) procedure to patient anatomy.
  • “New tapered configurations for our ENROUTE Transcarotid Stent System build upon the robust portfolio of Silk Road’s carotid solutions.
  • The ENROUTE Transcarotid Stent System features an optimized cell design balancing lesion coverage and anatomical conformability for long-term plaque stabilization.
  • The stent system was purpose-built for TCAR with a short delivery system for ergonomic and precise stent delivery.

CG Oncology Announces First Patient Dosed in PIVOT-006 Phase 3 Clinical Trial of Cretostimogene in Intermediate-risk Non-Muscle Invasive Bladder Cancer

Retrieved on: 
Tuesday, February 27, 2024

IRVINE, Calif., Feb. 27, 2024 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients afflicted with bladder cancer, today announced the first patient has been dosed in the PIVOT-006 Phase 3 clinical trial of cretostimogene for the treatment of patients with intermediate-risk NMIBC following transurethral resection of the bladder tumor (TURBT).

Key Points: 
  • “The dosing of the first patient in our PIVOT-006 trial advances cretostimogene earlier in the treatment paradigm for NMIBC patients who face limited treatment options, frequent disease recurrence and repetitive surgery,” said Arthur Kuan, Chairman and Chief Executive Officer, CG Oncology.
  • The initial induction course is six weekly doses of cretostimogene containing 1x1012 VPs per milliliter.
  • The primary endpoint of this trial is overall RFS, with secondary endpoints including RFS at 12 and 24 months and PFS.
  • Cretostimogene is a novel therapy which has the potential to be a paradigm shift in how we might manage the ongoing burden of this highly recurrent aspect of bladder cancer.”

ARC Fertility Teams Up with Leapfrog for High-Value Family-Forming Benefits Webinar, Invites Self Insurance Stakeholders to Attend

Retrieved on: 
Tuesday, March 5, 2024

In collaboration with Leapfrog , this webinar is a testament to Leapfrog's dedication to fostering industry dialogue through its Partner Advisory Committee (PAC) where ARC Fertility is a proud member.

Key Points: 
  • In collaboration with Leapfrog , this webinar is a testament to Leapfrog's dedication to fostering industry dialogue through its Partner Advisory Committee (PAC) where ARC Fertility is a proud member.
  • David Adamson, MD, FRCSC, FACOG, FACS, Founder and CEO, ARC Fertility, and Eliza Chin, MD, MPH, Executive Director, American Medical Women's Association (AMWA), will lead the discussion.
  • ARC Fertility is set to guide CEOs, CFOs and corporate human resources (CHRs) through the intricate landscape of family-forming benefits.
  • Drawing from our experience, we will explore the challenges employers face and the benefits of a flexible and affordable family-forming benefits solution.

TriSalus Life Sciences Announces Real-World Data Demonstrating the Ability of TriNav® to Successfully Treat Patients with Higher Disease Burden and to Improve Delivery of Therapeutics to Liver Tumors

Retrieved on: 
Thursday, February 29, 2024

Key findings include that TriNav patients, despite a higher baseline disease burden and clinical complexity, showed overall clinical results comparable to patients with lower disease burden.

Key Points: 
  • Key findings include that TriNav patients, despite a higher baseline disease burden and clinical complexity, showed overall clinical results comparable to patients with lower disease burden.
  • In a matched cohort comparison, TriNav patients had fewer 30-day inpatient visits post-procedure than non-TriNav patients.
  • TriNav TARE patients with liver metastases had fewer clinical complications post-procedure vs. non-TriNav patients in a matched cohort comparison.
  • “This large sample size study underscores the particular benefits of the TriNav device compared to standard drug delivery systems.”

Ironwood Pharmaceuticals Announces Positive Topline Results from Global Phase III Trial of Once-Weekly Apraglutide in Adults with Short Bowel Syndrome with Intestinal Failure (SBS-IF)

Retrieved on: 
Thursday, February 29, 2024

Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company, today announced positive topline results from its pivotal Phase III STARS trial, which evaluated the efficacy and safety of once-weekly subcutaneous apraglutide in reducing parenteral support (PS) dependency in adult patients with short bowel syndrome with intestinal failure (SBS-IF).

Key Points: 
  • Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company, today announced positive topline results from its pivotal Phase III STARS trial, which evaluated the efficacy and safety of once-weekly subcutaneous apraglutide in reducing parenteral support (PS) dependency in adult patients with short bowel syndrome with intestinal failure (SBS-IF).
  • Based on these results, Ironwood plans to submit a new drug application (NDA) and other regulatory filings for apraglutide for use in adult patients with SBS who are dependent on PS.
  • The global, multicenter, double-blind, randomized, placebo-controlled trial evaluated the efficacy and safety of weekly subcutaneous injections of apraglutide in adult patients with SBS-IF.
  • Topline safety results were generally consistent with the safety profile demonstrated in apraglutide studies to date.

Medical Spa Show 2024 Presents Educational Opportunities Featuring an Array of Medical Aesthetics Superstars

Retrieved on: 
Thursday, March 7, 2024

CHICAGO, March 7, 2024 /PRNewswire-PRWeb/ -- The Medical Spa Show, presented by the American Med Spa Association (AmSpa), is the premier trade show for medical spas and non-invasive medical aesthetics, and it will take place from April 11 – 14, 2024, at Wynn Las Vegas. General registration for the event is open now through April 9, 2024—visit http://www.medicalspashow.com/register to register today.

Key Points: 
  • CHICAGO, March 7, 2024 /PRNewswire-PRWeb/ -- The Medical Spa Show, presented by the American Med Spa Association (AmSpa), is the premier trade show for medical spas and non-invasive medical aesthetics, and it will take place from April 11 – 14, 2024, at Wynn Las Vegas.
  • Some of the industry luminaries who will be appearing at Medical Spa Show 2024 include:
    Cary Deuber, CRNFA, CANS (Keynote Speaker): Cary Deuber, CRNFA, CANS, attended Baylor University, where she earned her BSN.
  • She went straight to work at Baylor University Medical Center in Dallas, where she initially settled into vascular and trauma surgery.
  • These medical aesthetics all-stars will also be appearing at MSS 2024:

Groundbreaking New Procedure for Azoospermic Men Involving Minimally Invasive Sperm Mapping Combined with Extended Sperm Search and Microfreeze Leads to First Pregnancy

Retrieved on: 
Thursday, March 7, 2024

NEW YORK, March 7, 2024 /PRNewswire-PRWeb/ --Maze Sexual & Reproductive Health has announced the first pregnancy worldwide as a result of a new, minimally invasive procedure. Specifically, sperm are collected via Sperm Mapping, and then searched for and, if found, frozen or used fresh using Extended Sperm Search and Microfreeze (ESSM). They can then be injected into a partner's egg. The combined procedure, called Grid Needle Sperm Extraction and MicroSearch (GN-SEM), will allow some men with no sperm in the ejaculate (azoospermia) the ability to initiate a pregnancy without surgically opening up the testicle.

Key Points: 
  • Specifically, sperm are collected via Sperm Mapping, and then searched for and, if found, frozen or used fresh using Extended Sperm Search and Microfreeze (ESSM).
  • I'm extremely proud of the fact that we have profoundly changed the way we treat azoospermic and cryptospermic men.
  • With men with cryptospermia (very very few sperm in the ejaculate) we have found and frozen sperm in almost 100% of men! ''
  • As of today, Maze has 30 babies born from sperm collected through ESSM, and 97 men whose sperm are stored.

Dr. John Mulhall Joins FirmTech's Scientific Advisory Board to Promote Innovation in Men's Sexual Health

Retrieved on: 
Wednesday, March 6, 2024

BOZEMAN, Mont., March 6, 2024 /PRNewswire/ -- FirmTech, the revolutionary sexual technology wellness company, today announced that John P. Mulhall, MD, MSc, FECSM, FACS, FRCSI, has joined its Scientific Advisory Board. Dr. Mulhall brings decades of experience and leadership in men's sexual health care to FirmTech, and a personal commitment to drive innovation that will improve men's lives. He will partner with renowned colleagues to provide independent guidance, analysis of sextech data, and evaluation of FirmTech product offerings to ensure they are science-backed and effective for men and women who want to improve their sexual performance and health.

Key Points: 
  • A world-renowned leader in men's sexual health, Mulhall joins esteemed colleagues dedicated to providing science-backed research that advances the field of sexual wellness
    BOZEMAN, Mont., March 6, 2024 /PRNewswire/ -- FirmTech , the revolutionary sexual technology wellness company, today announced that John P. Mulhall, MD, MSc, FECSM, FACS, FRCSI, has joined its Scientific Advisory Board.
  • Dr. Mulhall brings decades of experience and leadership in men's sexual health care to FirmTech, and a personal commitment to drive innovation that will improve men's lives.
  • "Wearable technology is the wave of the future for sexual wellness, and I'm excited to join FirmTech's independent scientific advisory board to help drive science-backed innovation," said Dr. Mulhall.
  • Dr. Mulhall is the Director of the Male Sexual and Reproductive Medicine Program at Memorial Sloan Kettering Cancer Center in New York City.

Rutgers Cancer Institute of New Jersey and RWJBarnabas Health Retains its Position as New Jersey's Only National Cancer Institute-Designated Comprehensive Cancer Center

Retrieved on: 
Tuesday, March 5, 2024

NEW BRUNSWICK, N.J., March 5, 2024 /PRNewswire/ -- Rutgers Cancer Institute of New Jersey, together with RWJBarnabas Health, the state's leading cancer center and only Comprehensive Cancer Center as recognized by the National Cancer Institute (NCI), has scored in the "exceptional" range and was redesignated by the National Cancer Institute, placing it among the top cancer centers reviewed in 2023.

Key Points: 
  • NEW BRUNSWICK, N.J., March 5, 2024 /PRNewswire/ -- Rutgers Cancer Institute of New Jersey, together with RWJBarnabas Health, the state's leading cancer center and only Comprehensive Cancer Center as recognized by the National Cancer Institute (NCI), has scored in the "exceptional" range and was redesignated by the National Cancer Institute, placing it among the top cancer centers reviewed in 2023.
  • This redesignation ensures that Rutgers Cancer Institute maintains its "Comprehensive Cancer Center" status to support the continuation of outstanding world class research and comprehensive care.
  • "For decades, Rutgers Cancer Institute has been a lifeline for those battling the cruel and relentless disease of cancer.
  • As the only NCI-Designated Comprehensive Cancer Center, Rutgers Cancer Institute is essential to the health of the people of our state and the advancement of cancer research nationally," says Congressman Frank Pallone.