Humanitarian Device Exemption

SeaStar Medical Provides Updates on Enrollment of Adult Pivotal Clinical Study and Commercial Launch of Quelimmune, FDA-Approved in Pediatric Patients

Retrieved on: 
Tuesday, March 12, 2024
CKRT, Randomness, Sepsis, Survival rate, Neutrophil, Monocyte, AKI, Humanitarian Device Exemption, Patient, Hospital, Acute respiratory distress syndrome, Mortality, Acute kidney injury, Standard of care, MD, HDE, KRT, Safety, Dialysis, Chronic kidney disease, SCD, FDA, Food, Pharmaceutical industry

DENVER, March 12, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, provides updates on the acute kidney injury (AKI) programs it is developing with its patented, first-to-market, cell-directed Selective Cytopheretic Device (SCD) extracorporeal therapy in critically ill patients with AKI.

Key Points: 
  • “We now have 21 subjects enrolled across five clinical sites in our NEUTRALIZE-AKI pivotal clinical trial, which is intended to evaluate the safety and efficacy of our SCD in adult AKI patients.
  • Additional sites are progressing through the site activation and contract completion process,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical.
  • “We expect the pace of enrollment will accelerate as more medical centers come onboard.
  • With the Approval Order, SeaStar Medical can build Quelimmune Clinical Kits into inventory in parallel to the hospital approvals process.

Nuwellis’ Distribution Partner, SeaStar Medical, Receives FDA Humanitarian Device Exemption for Pediatric Selective Cytopheretic Device Quelimmune™

Retrieved on: 
Thursday, February 22, 2024
Sepsis, Humanitarian Device Exemption, Failure, Traction, Physician, FDA, Food, Dialysis, CKRT, Hospice and palliative medicine, Nephrology, Nursing care plan, SeaStar, HDE, Acute kidney injury, Patient, AKI, Mortality, Immune system

MINNEAPOLIS, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on transforming the lives of people with fluid overload, today announced its distribution partner, SeaStar Medical Holding Corporation (Nasdaq: ICU) (SeaStar Medical), has received Humanitarian Device Exemption (HDE) from the U.S. Food and Drug Administration (FDA) for Quelimmune™, its pediatric Selective Cytopheretic Device.

Key Points: 
  • MINNEAPOLIS, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on transforming the lives of people with fluid overload, today announced its distribution partner, SeaStar Medical Holding Corporation (Nasdaq: ICU) (SeaStar Medical), has received Humanitarian Device Exemption (HDE) from the U.S. Food and Drug Administration (FDA) for Quelimmune™, its pediatric Selective Cytopheretic Device.
  • Nuwellis has an exclusive U.S. license and distribution agreement with SeaStar Medical to distribute Quelimmune and will market and distribute the device to nephrologists and intensive care physicians who are trained in pediatric extracorporeal therapy.
  • “The pediatric segment of our business has gained significant traction since the 2020 FDA clearance of our Aquadex device for pediatric patients weighing 20kg or more – growing at a compound annual growth rate (CAGR) of over 30%.
  • Clinical studies have demonstrated Quelimmune’s potential to eliminate dialysis dependency, shorten intensive care unit time, and restore the lives of critically ill pediatric patients.

FDA Issues Approvable Letter for SeaStar Medical’s Selective Cytopheretic Device for Pediatric Patients

Retrieved on: 
Monday, October 30, 2023
FDA, Standard of care, Center for Biologics Evaluation and Research, HDE, Humanitarian Device Exemption, Food, SCD, Mortality, MD, Acute kidney injury, Inflammation, AKI, Hepatorenal syndrome, Dialysis, Cardiorenal syndrome, SeaStar, Intensive care medicine, CKRT, Letter, Neutrophil, Hospice and palliative medicine, Monocyte, Sepsis, Patient, Label, Infection, ICU, Pharmaceutical industry, Medical device, Research

As announced in early October 2023, SeaStar Medical expected the FDA to issue this approvable letter within a month of such announcement.

Key Points: 
  • As announced in early October 2023, SeaStar Medical expected the FDA to issue this approvable letter within a month of such announcement.
  • The issuance by the FDA of an Approvable Letter is a standard step in the approval process of a Humanitarian Device Exemption (HDE) application.
  • The Approvable Letter indicates that SeaStar Medical’s HDE application substantially meets the requirements for an Approval Order and outlines remaining administrative steps that must be finalized before the HDE can be active for commercialization.
  • The SCD-PED-01 (weight range ≥15 kg) and PED-02 (weight range ≥10 kg) studies demonstrated 75% and 83% reductions in mortality, respectively.

ZimVie Announces Over 2,000 Children Have Received The Tether™ VBT

Retrieved on: 
Tuesday, October 24, 2023
Tether, Icahn School of Medicine at Mount Sinai, VBT, FDA, Adolescence, Scoliosis, Minimally invasive procedure, Orthopedic surgery, Surgeon, Mount Sinai Hospital, Patient, Humanitarian Device Exemption, Pharmaceutical industry, Dentistry, Medicine

The Tether was approved as a Humanitarian Device by the FDA in 2019, based on over seven years of clinical data.

Key Points: 
  • The Tether was approved as a Humanitarian Device by the FDA in 2019, based on over seven years of clinical data.
  • Over fifty surgeons have performed VBT using the market-leading Tether system to treat patients diagnosed with adolescent idiopathic scoliosis.
  • “The Tether is an important and inspirational part of our motion preservation portfolio.
  • We remain dedicated to developing the market for vertebral body tethering and restoring daily life for this special group of patients.”

Nuwellis Provides Regulatory Update on SeaStar Medical’s Selective Cytopheretic Device Use in Pediatric Acute Kidney Injury Under a Humanitarian Device Exemption

Retrieved on: 
Tuesday, October 10, 2023
Humanitarian Device Exemption, Language, Food, SCD, Acute kidney injury, AKI, Sepsis, Risk, CKD, Center for Biologics Evaluation and Research, Mortality, Safety, FDA, SeaStar, Chronic kidney disease, CKRT, Marketing, Letter, ICU, Agency, HDE, Physician, Pharmaceutical industry, Nursing, Research

The correspondence indicates that an Approvable Letter is expected to be issued within a month.

Key Points: 
  • The correspondence indicates that an Approvable Letter is expected to be issued within a month.
  • In December of 2022, Nuwellis and SeaStar entered into a U.S. license and distribution agreement for SeaStar Medical’s SCD for pediatric AKI.
  • Under this agreement, Nuwellis will market and distribute the SCD through its direct salesforce to nephologists and intensive care physicians who are trained in pediatric extracorporeal therapy.
  • Children who survive an AKI episode are at risk for long-term conditions, including chronic kidney disease (CKD).1

SeaStar Medical Provides Regulatory Update Regarding Selective Cytopheretic Device Use in Pediatric Acute Kidney Injury Under a Humanitarian Device Exemption

Retrieved on: 
Tuesday, October 3, 2023
Letter, Chronic kidney disease, Neutrophil, Marketing, Infection, HDE, SCD, Center for Biologics Evaluation and Research, Language, AKI, Sepsis, Acute kidney injury, CKRT, Monocyte, Patient, Agency, Risk, Humanitarian Device Exemption, Mortality, ICU, Septic, FDA, Food, Safety, Pharmaceutical industry, Research

DENVER, Oct. 03, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of dysregulated immune responses including hyperinflammation on vital organs, announces receipt of a correspondence from the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) indicating that the Agency considers the Selective Cytopheretic Device (SCD) Pediatric (SCD-PED) to be approvable under a Humanitarian Device Exemption (HDE) for use in children weighing 10 kilograms or more with acute kidney injury (AKI) and sepsis or a septic condition requiring continuous kidney replacement therapy (CKRT) in the hospital intensive care unit (ICU).

Key Points: 
  • The correspondence further indicates that an Approvable Letter, which is a standard part of CBER’s approval process, is expected to be issued within a month.
  • The Approvable Letter will outline conditions, including language for safety, probable benefit and labeling for intended use, which will be required for formal marketing approval.
  • “The correspondence provides a clear path forward in making this much needed therapy accessible to critically ill children suffering with AKI and sepsis,” said Eric Schlorff, SeaStar Medical CEO.
  • The SCD-PED-01 (weight range ≥15 kg) and PED-02 (weight range ≥10 kg) studies demonstrated 75% and 83% reductions in mortality, respectively.

SeaStar Medical Reports Second Quarter 2023 Financial Results and Provides a Business Update

Retrieved on: 
Monday, August 14, 2023
Insurance, Shareholder, Neutrophil, Humanitarian Device Exemption, Chronic kidney disease, Marketing, HDE, SCD, Clinical trial, Center for Biologics Evaluation and Research, G&A, Sale, AKI, Dialysis, Sepsis, Acute kidney injury, CKRT, Hospital, Monocyte, PIN, Patient, Standard of care, Manuscript, Risk, Nephrology, Physician, HIV disease progression rates, Clinical study design, Nephron, Acute respiratory distress syndrome, Mortality, ICU, R, FDA, Letter, Safety, Pharmaceutical industry, Nursing, Life insurance, Research

DENVER, Aug. 14, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, reports financial results for the three and six months ended June 30, 2023 and provides a business update.

Key Points: 
  • Management to hold a business update conference call on August 22 beginning at 4:00 p.m. Eastern time
    DENVER, Aug. 14, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, reports financial results for the three and six months ended June 30, 2023 and provides a business update.
  • SeaStar Medical anticipates approval for the SCD-ADULT in the first half of 2025 and commercial launch in the second half of 2025.
  • The net loss for the second quarter of 2023 was $3.7 million, or $0.25 per share, compared with a net loss of $0.9 million, or $0.12 per share, for the second quarter of 2022.
  • SeaStar Medical management will host a business update conference call on Tuesday, August 22, 2023 beginning at 4:00 p.m. Eastern time (1:00 p.m. Pacific time) to provide a business update and answer questions.

EMulate Therapeutics Announces the Publication of Its Phase I/II Results in CNS Oncology: “An Expanded Safety/Feasibility Study of the EMulate Therapeutics Voyager™ System in Patients with Recurrent Glioblastoma”

Retrieved on: 
Wednesday, July 19, 2023
Oncology, Medical Devices, Health, Clinical Trials, Radiology, Biotechnology, Cancer Institute, GBM, Providence, Doctor of Philosophy, Glioblastoma, Humanitarian Device Exemption, Emulate, DIPG, Journal, MD, Patient, Diffuse intrinsic pontine glioma, FDA, Therapy, Pharmaceutical industry

EMulate Therapeutics, Inc. (EMulate) announced today the publication of its peer-reviewed clinical trial using EMulate’s technology for the treatment of glioblastoma in the Journal CNS Oncology https://www.futuremedicine.com/doi/10.2217/cns-2022-0016 .

Key Points: 
  • EMulate Therapeutics, Inc. (EMulate) announced today the publication of its peer-reviewed clinical trial using EMulate’s technology for the treatment of glioblastoma in the Journal CNS Oncology https://www.futuremedicine.com/doi/10.2217/cns-2022-0016 .
  • This marks an ongoing and developing pathway in the development of EMulate’s oncology treatment business.
  • “These results are pivotal for EMulate as we continue to develop, optimize and expand our technology’s use and value,” stated Chris Rivera, EMulate’s President and CEO.
  • We are also planning to initiate a pivotal Phase III study in these indications in early 2024.”

SeaStar Medical to Hold Business Update Conference Call on February 15, 2023

Retrieved on: 
Tuesday, February 14, 2023
FDA, PIN, Acute kidney injury, SCD, Humanitarian Device Exemption, Hospice and palliative medicine, AKI, HDE, Webcast, Pharmaceutical industry

Callers who pre-register will be given a conference passcode and unique PIN to gain immediate access to the call and bypass the live operator.

Key Points: 
  • Callers who pre-register will be given a conference passcode and unique PIN to gain immediate access to the call and bypass the live operator.
  • Participants may pre-register at any time, including up to and after the call start time.
  • Those who choose not to pre-register can access the live conference call by dialing the following and requesting the SeaStar Medical call:
    412-317-5413 from outside the U.S.
  • The live webcast of the conference call also will be available here .

Profound Medical to Present at the 2022 Jefferies London Healthcare Conference

Retrieved on: 
Tuesday, November 8, 2022
Investor, GLOBE, MRI, Prostate cancer, Food, Urethra, Technology, CE, Health Canada, Bone, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Webcast, NASDAQ, Humanitarian Device Exemption, Rectum, National Medical Products Administration, Company, Hyperthermia, Uterine fibroid, Conference, TSX, Hematuria, International Medical Corps, FDA, Pharmaceutical industry, Medical imaging

TORONTO, Nov. 08, 2022 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (Profound or the Company), a commercial-stage medical device company that develops and markets customizable, incision-free therapies for the ablation of diseased tissue, today announced that its CEO and Chairman, Arun Menawat, will present an update on the Companys business at the Jefferies London Healthcare Conference on Tuesday, November 15, 2022 at 12:20 p.m. GMT.

Key Points: 
  • TORONTO, Nov. 08, 2022 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (Profound or the Company), a commercial-stage medical device company that develops and markets customizable, incision-free therapies for the ablation of diseased tissue, today announced that its CEO and Chairman, Arun Menawat, will present an update on the Companys business at the Jefferies London Healthcare Conference on Tuesday, November 15, 2022 at 12:20 p.m. GMT.
  • The presentation will be broadcast live and archived on the Company's website at www.profoundmedical.com under "Webcasts" in the Investors section.
  • Profound is a commercial-stage medical device company that develops and markets customizable, incision-free therapies for the ablation of diseased tissue.
  • Profound is commercializing TULSA-PRO, a technology that combines real-time MRI, robotically-driven transurethral ultrasound and closed-loop temperature feedback control.