LVAD

Cadrenal Therapeutics Receives FDA Orphan Drug Designation for Tecarfarin for Prevention of Thromboembolism and Thrombosis in Patients with LVADs, RVADs, Biventricular Assist Devices, and Total Artificial Hearts

Retrieved on: 
Tuesday, April 9, 2024
ODD, Warfarin, Thrombosis, VADS, Risk, Vitamin K antagonist, New Drug Application, Patient, Apixaban, Stroke, Anticoagulant, Splenic infarction, Death, Therapy, Bleeding, LVAD, FDA, VKA, Pharmaceutical industry

PONTE VEDRA, Fla., April 9, 2024 /PRNewswire/ -- Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing tecarfarin, a late-stage novel oral and reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients with rare cardiovascular conditions, announced today that the United States Food and Drug Administration (FDA) has granted tecarfarin Orphan Drug Designation (ODD) for the prevention of thromboembolism and thrombosis in patients with an implanted mechanical circulatory support device (left ventricular assist device (LVAD), right ventricular assist device (RVAD), collectively known as ventricular assist devices (VADs), biventricular assist device, and total artificial heart).

Key Points: 
  • "This second orphan drug designation highlights the expanded need for tecarfarin where existing anticoagulation therapies are inadequate," said Quang Pham, Founder, Chairman and Chief Executive Officer of Cadrenal Therapeutics.
  • "We are dedicated to advancing tecarfarin through clinical development options as swiftly as possible."
  • Since its adoption in 1983, the Orphan Drug Act has helped countless individuals living with these conditions gain access to life-enhancing and life-saving therapies.
  • The designation is made to promote safe and efficacious products for the treatment of rare conditions.

Daxor Corporation CEO and President Michael Feldschuh Provides Corporate Update in Letter to Shareholders

Retrieved on: 
Monday, March 18, 2024
Department of Defence, Food and Drug Administration, Burn, Learning, Patient, BVA, Sale, Nature, Statistics, Investment, Note, LVAD, ICU, Duke, Form, Blood volume, NIH, Heart failure, Length of stay, American College, Operation, Hand, Health, Food, Sepsis, Acceleration, Letter, Proxy, Knowledge, Research, Hospital, Acquisition, CLIA, Clinical study design, Family, FDA, Consultant, Annual general meeting, Diagnosis, RCT, Financial statement, Growth, Syncope, Mortality, National Institutes of Health, Nursing care plan, Bangladesh Technical Education Board, Net, Government, Physician, Medicine, Pharmaceutical industry

We have never been more focused on our mission and goals. Every team member at Daxor sees both the remarkable strides the company has made over the past year solidifying its position as the global leader in blood volume measurement technology and the promise of what our rapid expansion means for both the company and the tens of millions of patients whose care we are eager to significantly improve. In every area 2023 and the strong start of 2024 has shown substantial progress for the company -- in revenue growth, new customer acquisitions, increasing utilization of our products by existing customers, next generation systems completed and under Food and Drug Administration (FDA) review, positive clinical studies, new patents granted and pending, successful National Institutes of Health (NIH) grant awards, Department of Defense (DoD) contracts awarded, and further research and development for groundbreaking products set to launch in subsequent fiscal years. I will detail below more in these areas but first wish to review why our company’s mission to commercialize the products that enable optimal patient care is so vital.

Key Points: 
  • Oak Ridge, TN, March 18, 2024 (GLOBE NEWSWIRE) -- Daxor Corporation (Nasdaq: DXR), the global leader in blood volume measurement technology today issued a corporate update in a Letter to Shareholders filed in its certified shareholder report on Form N-CSR on March 15, 2023 from CEO & President, Michael Feldschuh.
  • Many of these markers are costly, some are invasive, and none are accurate – in contrast to Daxor’s proven 98% accurate system.
  • Care teams cannot effectively treat what they do not correctly diagnose, so our rapid accurate diagnostic test is a game-changer.
  • Daxor has been reporting as an investment company under the Investment Company Act of 1940 since January 1, 2012.

Mesoblast Successfully Completes Placement and Accelerated Entitlement Offer

Retrieved on: 
Wednesday, March 13, 2024
Principal, LVAD, MESO, Patient, Heart failure, MSB, FDA, Entitlement, Inflammation

NEW YORK, March 13, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced it has received firm commitments to complete its pro-rata accelerated non-renounceable entitlement offer that was launched on 4 December, 2023 (Entitlement Offer).

Key Points: 
  • NEW YORK, March 13, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced it has received firm commitments to complete its pro-rata accelerated non-renounceable entitlement offer that was launched on 4 December, 2023 (Entitlement Offer).
  • Together the entitlement offer and institutional placement raised gross proceeds of A$97 million, including A$36.7 million committed today on the same terms as the Entitlement Offer, primarily from Mesoblast’s existing major shareholders.
  • Dr. Eric Rose, the Company’s Chief Medical Officer and a director of Mesoblast, subscribed for additional shares of A$1.5 million, subject to shareholder approval.
  • Dr. Rose is a world-renowned heart surgeon who performed the world’s first successful heart transplant in children and was for many years Chairman of Columbia University’s Department of Surgery.

BioCardia Announces CMS Approval of Coverage for CardiAMP Cell Therapy Confirmatory Phase III Heart Failure Study

Retrieved on: 
Tuesday, March 12, 2024
BCDA, Patient, Mortality, Quality of life, Therapy, LVAD, Medicare, FDA, CMS, Arrest, Heart failure, Pharmaceutical industry

CMS has reviewed the CardiAMP Heart Failure II Trial and approved the investigational product, related and routine items and services for purposes of Medicare coverage.

Key Points: 
  • CMS has reviewed the CardiAMP Heart Failure II Trial and approved the investigational product, related and routine items and services for purposes of Medicare coverage.
  • The CardiAMP Heart Failure II Trial is FDA approved to enroll up to 250 patients at up to 40 clinical centers.
  • “We are pleased that CMS has provided coverage support for the confirmatory CardiAMP Heart Failure II study.” said Peter Altman, PhD., BioCardia’s President and Chief Executive Officer.
  • “To my knowledge, no therapy has been proven to reduce mortality in these patients, and CardiAMP Heart Failure II has great potential to achieve this outcome by confirming our CardiAMP Heart Failure Trial results.”

United States Food & Drug Administration (FDA) Supports Accelerated Approval Pathway for Rexlemestrocel-L in End-Stage Heart Failure Patients with a Left Ventricular Assist Device (LVAD)

Retrieved on: 
Sunday, March 10, 2024
Heart, Licensure, MPC, Incidence, Regenerative Medicine Advanced Therapy, MSB, Inflammation, IL-6, FDA, U.S. FDA, BLA, MESO, Patient, Type, LVAD, Mortality, Pharmaceutical industry

“We are very pleased with FDA’s feedback that the presented results from our pivotal study of rexlemestrocel-L in end-stage HFrEF patients with LVADs may support an accelerated approval,” said Mesoblast CEO Dr. Silviu Itescu.

Key Points: 
  • “We are very pleased with FDA’s feedback that the presented results from our pivotal study of rexlemestrocel-L in end-stage HFrEF patients with LVADs may support an accelerated approval,” said Mesoblast CEO Dr. Silviu Itescu.
  • “We intend to request a pre-Biologics License Application (BLA) meeting to discuss data presentation, timing and FDA expectations for an accelerated approval filing.”
    Every year in the United States over 100,000 patients progress to end-stage HFrEF.
  • In contrast, in ischemic patients treated with rexlemestrocel-L, IL-6 levels returned to normal by 2 months and remained low through 12 months.
  • Mesoblast intends to request a pre-BLA meeting with FDA to discuss data presentation, timing and FDA expectations for an accelerated approval filing in end-stage ischemic HFrEF patients with LVAD implantation.

Mesoblast Reports Financial Results and Operational Update for Half-Year Ended December 31, 2023

Retrieved on: 
Wednesday, February 28, 2024
DREAM, RPD, Growth, PLI, SIX, BMT, FIRST, Diagnosis, Mortality, Bangladesh Technical Education Board, Blood, HLHS, MSB, Degenerative disc disease, NIH, Marketing, Pain, MACE, BLA, Survival, Heart failure, Hypoplastic left heart syndrome, LVAD, Randomized controlled trial, FINANCIAL, Inflammation, Biopharmaceutical, ODD, Heart, Mesoblast, Regenerative Medicine Advanced Therapy, FDA, Priority review, MESO, Risk, Administration, Death, Patient, PRV, DDD, Pharmaceutical industry

NEW YORK, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an operational update and reported financial results for the period ended December 31, 2023.

Key Points: 
  • NEW YORK, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an operational update and reported financial results for the period ended December 31, 2023.
  • Reduction in net cash usage for operating activities:
    For the three months ended December 31, 2023, net cash usage was US$12.3 million, a 25% reduction versus the comparative quarter in FY2023.
  • For the six months ended December 31, 2023, net cash usage was US$26.6 million, a 14% reduction versus the comparative period in FY2023.
  • Manufacturing reduced by 47% for the six months ended December 31, 2023, from US$12.8 million to US$6.7 million.

Manuscript Discussing the Benefit of SeaStar Medical’s Selective Cytopheretic Device in Patients with Heart Failure and Hyperinflammation Published in European Journal of Heart Failure

Retrieved on: 
Tuesday, February 27, 2024
Cardiorenal syndrome, Division, Inflammation, FDA, Food, SCD, Emeritus, Manuscript, Hospital, Heart failure, European Journal, University, SeaStar, Internal medicine, Glucocorticoid, Acute kidney injury, Michigan Medicine, Drug, Monocyte, FACC, Acute respiratory distress syndrome, LVAD, Mortality, Heart, Pharmaceutical industry

DENVER, Feb. 27, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces publication of a manuscript discussing the role of chronic dysregulated systemic inflammation in heart failure and the potential application of the adult Selective Cytopheretic Device, part of the Quelimmune™ product family, in enabling previously ineligible patients with severe disease to receive a left ventricular assist device (LVAD) or heart transplant in the peer-reviewed European Journal of Heart Failure February 2024, Pitt, B., Iyer, S.P.N. and Humes, H.D. (2024), Eur J Heart Fail. https://doi.org/10.1002/ejhf.3177.

Key Points: 
  • The manuscript, titled “New Opportunity for Targeting Systemic Inflammation in Patients with Heart Failure through Leukocyte Immunomodulation” cites increasing evidence of the role of chronic systemic inflammation in patients with heart failure and discusses the Adult SCD’s potential to improve hypertensive heart failure and mortality following hospitalization for acute or worsening heart failure.
  • Following treatment with the Adult SCD, this patient was effectively bridged to LVAD three days after discontinuing treatment and was subsequently discharged without further complications.
  • “Prior attempts targeting singular proinflammatory factors as well as systemic immunosuppression with glucocorticoids in patients with acute heart failure have yielded unclear results, raising the need to identify new strategies.
  • “While our manuscript discusses a positive outcome in one patient following treatment for six hours daily over six consecutive days, the results suggest that more study with Adult SCD is warranted for patients with heart failure and hyperinflammation.”

National Top Teaching Hospital Award earned by Deborah Heart and Lung Center

Retrieved on: 
Thursday, December 7, 2023
Lung, TAVR, Health, MSN, COPD, Patient safety organization, Research, Safety, Patient safety, Society of Thoracic Surgeons, Patient satisfaction, RN, LVAD, Patient, Multimedia, Hospitality Awarding Body, Leapfrog, Heart failure, Heart, CMS, News, Diagnosis, Health information management, Medicare, Hospital, Nursing, MD

BROWNS MILLS, N.J., Dec. 7, 2023 /PRNewswire/ -- Deborah Heart and Lung Center was named a 2023 Top Teaching Hospital by The Leapfrog Group. The national Award recognizes outstanding patient safety and quality.

Key Points: 
  • BROWNS MILLS, N.J., Dec. 7, 2023 /PRNewswire/ -- Deborah Heart and Lung Center was named a 2023 Top Teaching Hospital by The Leapfrog Group.
  • Deborah President and CEO Joseph Chirichella said, "Leapfrog's Top Teaching Hospital Award demonstrates the importance we put on patient safety and quality in our health system every day.
  • Deborah Heart and Lung Center Deborah Heart and Lung Center in Browns Mills, New Jersey is a teaching hospital in the prevention, diagnosis, research and treatment of heart, lung and vascular diseases.
  • Deborah Heart and Lung Center was recognized as a Top Teaching Hospital by the Leapfrog Group.

BioCardia Reports Third Quarter 2023 Business Highlights and Financial Results

Retrieved on: 
Wednesday, November 8, 2023
FDA, Research, Security (finance), N-terminal prohormone of brain natriuretic peptide, Heart failure, Arrest, Heart, Therapy, Facial muscles, Medicare, Microsoft Exchange Server, Mortality, Data, BCDA, Pharmaceuticals and Medical Devices Agency, Maintenance, Ischemia, Phase, Quality of life, Data monitoring committee, PMDA, LVAD, Clinical trial, Risk, Marketing, III, Safety, Trial of the century, Patient, DSMB, Pharmaceutical industry, Medical device, Cryptocurrency, Helix

The Company will also hold a conference call at 4:30 PM ET today in which it will discuss business highlights.

Key Points: 
  • The Company will also hold a conference call at 4:30 PM ET today in which it will discuss business highlights.
  • During the third quarter of 2023, BioCardia worked with the DSMB to unblind a small committee within the Company to review the closed session DSMB report of interim study results to better understand the rationale behind their recommendation.
  • The Company expects to complete the roll-in cohort of patients in the fourth quarter of 2023 and begin the randomized phase of the trial.
  • Third Quarter 2023 Financial Results:
    Revenues were approximately $357,000 for the three months ended September 2023, compared to approximately $212,000 for the three months ended September 2022.

Tampa General Hospital Welcomes New Members and Leadership to its Board of Directors; Celebrates Countless Contributions of Longtime Board Members

Retrieved on: 
Wednesday, October 18, 2023
Intelligence, TGH, Tampa General Hospital, Education, Modern Healthcare, Dingle, TECO Energy, Business development, Committee on Finance, City of London Finance Committee, USF Health Byrd Alzheimer's Institute, Health, Volunteering, BC Children's Hospital Foundation, Software, Cardiology, University of Florida Health Science Center, Lieutenant colonel, Growth, United States Department of the Army, LVAD, Partnership, Gillette, MacDill Air Force Base, Council for Excellence in Government, Public, Patient, Hospital, Heart failure, Nursing, Management, Airline

He first joined the board in 2017 in his role as chair of the Tampa General Hospital Foundation.

Key Points: 
  • He first joined the board in 2017 in his role as chair of the Tampa General Hospital Foundation.
  • The FHSC board, which is comprised of volunteers, serves as the governing body for Tampa General Hospital and its affiliates.
  • New board members are nominated by a committee and approved by the full board.
  • Leadership and board members are eligible to serve three three-year terms, and the chair of the Tampa General Hospital Foundation serves a two-year ex-officio term on the FHSC board.