Design history file

SeaStar Medical Bolsters Operational Expertise with Appointment of Thomas R. Mullen as Vice President of Operations and Product Development

Retrieved on: 
Friday, December 2, 2022
Monocyte, Business development, Form, LMAO, Inflammation, SeaStar, Fortune 500, Medicine, CKRT, Neutrophil, ISO, Sterilization, Design history file, SCD, Growth, Acute kidney injury, Partner (business rank), FDA, COBE, Senior, Engineering, Patient, AKI, Science, Cytokine, Risk, HDE, Failure, Pleasure, Risk management, Pharmaceutical industry

DENVER, COLORADO, Dec. 02, 2022 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq:ICU), (SeaStar Medical or the Company), a medical technology company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, today announced the appointment of Thomas R. Mullen as Vice President of Operations and Product Development.

Key Points: 
  • DENVER, COLORADO, Dec. 02, 2022 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq:ICU), (SeaStar Medical or the Company), a medical technology company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, today announced the appointment of Thomas R. Mullen as Vice President of Operations and Product Development.
  • Mr. Mullen is a proven medical device professional with 30 years of experience leading business operations, manufacturing, engineering, product development and regulatory remediation.
  • SeaStar Medical has continued to evolve and remains on a trajectory of growth including near-term potential for commercialization.
  • Since 1993, Mr. Mullen has led Mullen Business Development, a manufacturing, engineering and operations consulting firm.

SeaStar Medical’s Lead Product Candidate, the Selective Cytopheretic Device (SCD), Included in Consensus Statement for Pediatric Acute Kidney Injury in First Pediatric Acute Disease Quality Initiative (ADQI) Meeting

Retrieved on: 
Monday, November 7, 2022
Consensus, GLOBE, NASDAQ, Critical care, Pharmacology, Monocyte, Industry, SCD, Design history file, FDA, Patient, SEC, Form, Company, Dialysis, CRRT, Private Securities Litigation Reform Act, Mortality, Acute kidney injury, ICU, Delphi, Consensus decision-making, Chronic kidney disease, LMAO, Renal replacement therapy, Forward-looking statement, IL-6, Inflammation, Gaps, HDE, Humanitarian Device Exemption, Education, Nephrology, Epidemiology, Hemofiltration, Contraindication, Disease, CKD, Science, Biology, Solution, CKRT, Research, Neutrophil, AKI, Adult, Risk, SeaStar, Cytokine, Failure, Medicine, Pharmaceutical industry

DENVER, COLORADO, Nov. 07, 2022 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq:ICU), (“SeaStar Medical” or the “Company”), a medical technology company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, today announced its Selective Cytopheretic Device (SCD) has been included in the Consensus Statement for pediatric acute kidney injury (AKI) as part of the first Pediatric Acute Disease Quality Initiative (pADQI) meeting. The outcome of the meeting, titled “Consensus-Based Recommendations on Priority Activities to Address Acute Kidney Injury in Children,” has been published in JAMA Network Open1.

Key Points: 
  • The outcome of the meeting, titled Consensus-Based Recommendations on Priority Activities to Address Acute Kidney Injury in Children , has been published in JAMA Network Open1.
  • The first pediatric ADQI convened in November 2021 to develop expert-driven pediatric specific recommendations on AKI.
  • Its primary aim was to identify the work priorities across the pediatric AKI landscape of care, education, research and advocacy.
  • We are extremely pleased to have SeaStar Medicals SCD included in the Consensus Statement of ADQI, which builds upon the existing support within the pediatric community for this important therapy.

SeaStar Medical (NASDAQ: ICU) Commences Trading on Nasdaq Capital Market and Outlines Corporate Strategy and Near-Term Catalysts

Retrieved on: 
Monday, October 31, 2022
Manifest and latent functions and dysfunctions, Safety, Death, Inflammation, AKI, Nasdaq, Design history file, Failure, Forward-looking statement, Industry, Regulation of tobacco by the U.S. Food and Drug Administration, Risk, Private Securities Litigation Reform Act, Acquisition, NASDAQ, Monocyte, Environment, Science, University, Cytokine, Medicine, Patient, Disease, GLOBE, Population, Acute respiratory distress syndrome, CKD, Humanitarian Device Exemption, Solution, LMAO, SEC, Form, Homeostasis, Neutrophil, Mortality, SCD, FDA, Therapy, COVID-19, Trial of the century, Food, HDE, Physician, CKRT, SeaStar, Adult, Company, Growth, Acute kidney injury, Microdeletion syndrome, Jean-Louis Vincent, Chronic kidney disease, Pharmaceutical industry

Denver, Colorado, Oct. 31, 2022 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a medical technology company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, today announced the commencement of trading on the Nasdaq Capital Market under the ticker symbol “ICU” having successfully completed its previously announced definitive agreement for a business combination transaction with LMF Acquisition Opportunities, Inc. (NASDAQ: LMAO) (LMAO), a special purpose acquisition company. The Company also provided a business outlook and outlined key upcoming milestones.

Key Points: 
  • SeaStar Medical has continued to deliver on its promises with operational excellence.
  • In addition to the progress weve made on the corporate front, we continue to advance our innovative SCD therapy platform.
  • I am excited for what is to come and look forward to providing updates as we execute on the milestones ahead.
  • Denver-based SeaStar Medical (Nasdaq: ICU) is a medical technology company that is focusing on redefining how extracorporeal therapies may reduce the consequences of excessive inflammation on vital organs.

SeaStar Medical Completes Business Combination with LMF Acquisition Opportunities

Retrieved on: 
Friday, October 28, 2022
Bitcoin, LM, SEC, Company, Form, Acquisition, LinkedIn, Board of directors, Regulation of tobacco by the U.S. Food and Drug Administration, Cytokine, NASDAQ, Private Securities Litigation Reform Act, Forward-looking statement, CEO, Risk, LMAO, Design history file, Association, Food, Inflammation, Foley & Lardner, Patient, AKI, HDE, Industry, SCD, GLOBE, Twitter, FDA, Acute kidney injury, Vii, Failure, CFO, Science, SeaStar, LLP, Solution, Humanitarian Device Exemption, Risk management, Pharmaceutical industry, Nasdaq

DENVER and TAMPA, Fla., Oct. 28, 2022 (GLOBE NEWSWIRE) -- SeaStar Medical, Inc., a medical technology company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, today announced that it has completed its previously announced business combination with LMF Acquisition Opportunities, Inc. (NASDAQ:LMAO) (LMAO), a special purpose acquisition company sponsored by LM Funding America, Inc. (NASDAQ: LMFA). The business combination closed on October 28, 2022.

Key Points: 
  • DENVER and TAMPA, Fla., Oct. 28, 2022 (GLOBE NEWSWIRE) -- SeaStar Medical, Inc., a medical technology company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, today announced that it has completed its previously announced business combination with LMF Acquisition Opportunities, Inc. (NASDAQ:LMAO) (LMAO), a special purpose acquisition company sponsored by LM Funding America, Inc. (NASDAQ: LMFA).
  • Following the closing of the business combination, LMF Acquisition Opportunities, Inc. was renamed SeaStar Medical Holding Corporation and will operate under the same management team as SeaStar Medical, which is led by Eric Schlorff, CEO.
  • Maxim Group LLC served as sole financial advisor and Morgan Lewis & Bockius LLP served as legal counsel to SeaStar Medical in connection with the business combination.
  • These forward-looking statements include, without limitation, SeaStar Medical Holding Corporations, LMAOs and SeaStar Medicals expectations with respect to the proposed business combination between LMAO and SeaStar Medical, including statements regarding the benefits of the transaction, the ability of SeaStar Medical Holding Corporation to achieve value for its stakeholders, the implied valuation of SeaStar Medical, the products offered by SeaStar Medical Holding Corporation and the markets in which it operates, and the expected timing of regulatory approval of SeaStar Medical Holding Corporations products.

MEDICAL MARIJUANA ACCESS AND PATIENT SAFETY, INC. ISSUES STATEMENT ON PENNSYLVANIA DEPARTMENT OF HEALTH'S WITHDRAWAL OF ITS APPEAL TO RECALL CERTAIN VAPORIZED MEDICAL MARIJUANA PRODUCTS

Retrieved on: 
Monday, August 22, 2022
Complaint, Caregiver, DOH, Commonwealth, Court, Terpene, Patient safety, Pennsylvania Department of Health, Timeline of cannabis laws in the United States, Confusion, Pennsylvania Department of Drug and Alcohol Programs, Design history file, Patient, Medical device

HARRISBURG, Pa., Aug. 22, 2022 /PRNewswire/ -- Medical Marijuana Access and Patient Safety, Inc. issued the following statement on the Pennsylvania Department of Health's withdrawal of its appeal to recall certain vaporized medical marijuana products:

Key Points: 
  • HARRISBURG, Pa., Aug. 22, 2022 /PRNewswire/ -- Medical Marijuana Access and Patient Safety, Inc. issued the following statement on the Pennsylvania Department of Health's withdrawal of its appeal to recall certain vaporized medical marijuana products:
    On August 17, 2022, the Pennsylvania Department of Health ("DOH") voluntarily withdrew its appeal of the preliminary injunction granted to Medical Marijuana Access and Patient Safety, Inc.'s ("MMAPS") to recall certain vaporized medical marijuana products (the "June 2 Order").
  • All products impacted by the June 2 Order can continue to be produced and sold through licensed dispensaries across the Commonwealth.
  • The ruling follows an order granting MMAPS's application to Vacate Automatic Supersedeas (the "June 15 Order"), which reinstated the Court's June 2, 2022 preliminary injunction against the DOH's recall.
  • In light of these facts, MMAPS believes the DOH should drop the remaining litigation to prevent further confusion and increased costs for patients.

Samsara Vision Announces First U.S. Surgeries of the SING IMT™ (Smaller-Incision New-Generation Implantable Miniature Telescope), for Age-Related Macular Degeneration as part of the CONCERTO Study

Retrieved on: 
Monday, July 11, 2022
Other Consumer, Manufacturing, Seniors, Other Science, Other Technology, Research, Optical, Medical Devices, Consumer, Science, Technology, Clinical Trials, FDA, Biotechnology, Surgery, Other Manufacturing, Health, Engineering, Food and Drug Administration, Trial of the century, Safety, Severe cognitive impairment, Person, Quality of life, FDA, Macular degeneration, Visual acuity, United, Unitary state, CONCERTO, Method, Disease, Design history file, Risk, Doctor of Philosophy, AMD, Intellectual property, Marketing, Food, Intraocular pressure, Knowledge, Ageing, Legislation, Vision, SING, Ownership, Register, Forward-looking statement, Multimedia, Pressure, U.S. Securities and Exchange Commission, Technology, Patient, Research, MD, Eye, Form, MBA, Dentistry, Health insurance, Pharmaceutical industry

In addition, candidates cannot have had previous cataract surgery in the study eye and must agree to post-operative comprehensive visual rehabilitation and training.

Key Points: 
  • In addition, candidates cannot have had previous cataract surgery in the study eye and must agree to post-operative comprehensive visual rehabilitation and training.
  • Im pleased that the SING IMT telescopic micro-optical device allows for ease of insertion and centration.
  • We look forward to working with the eye health community across the country during the CONCERTO study.
  • The SING IMT is a Galilean-style telescope implant designed to improve visual acuity and quality of life for patients with late-stage AMD.

Samsara Vision and Lansheng Medical “MyVision” Announce Collaboration to Commercialize the SING IMT™ in China

Retrieved on: 
Wednesday, June 8, 2022
Medical Devices, Health, Consumer, Surgery, Seniors, Optical, Severe cognitive impairment, Human, Intellectual property, Ophthalmology, Research, Marketing, Knowledge, Ownership, Form, Pressure, Legislation, Register, CEO, Design history file, Unitary state, Forward-looking statement, SING, Disease, AMD, U.S. Securities and Exchange Commission, Vision, Method, Patient, Technology, Risk, Quality of life, Prevalence, Population, Ageing, Person, Pharmaceutical industry, Medical device, Cryptocurrency

MyVision will execute the clinical program necessary for regulatory approval, commercialize the SING IMT, coordinate reimbursement, and drive sales, marketing, and customer relationships.

Key Points: 
  • MyVision will execute the clinical program necessary for regulatory approval, commercialize the SING IMT, coordinate reimbursement, and drive sales, marketing, and customer relationships.
  • MyVision will be responsible for securing market approvals for the SING IMT in mainland China, Macau, and the Hainan Province.
  • With this collaboration with Samsara Vision, MyVision will leverage its successful experiences and deep understanding of the Chinese market for the potential commercialization of SING IMT in mainland China, Macau, the Hanain Province, and Hong Kong, said Jack Zhang, CEO of MyVision.
  • By collaborating to bring SING IMT to China while simultaneously advancing the U.S. Clinical program and European commercial launch, Samsara Vision continues to progress on that promise.

Fintech Unicorn Neon Appoints Bay Area Tech Veteran to Role of Chief Design Officer

Retrieved on: 
Monday, April 11, 2022
LinkedIn, MEI, Federal University of Minas Gerais, CIID, Copenhagen Institute of Interaction Design, Webby Awards, UFMG, Google, Interaction, BBVA, NASA RealWorld-InWorld Engineering Design Challenge, Google Spaces, BFA, SCFI, MIT Media Lab, Harvard University, Love, Copenhagen Institute, Technology, Twitter, MS, Mobile World Congress, GLOBE, Design history file, Attention, Education, Neon, National university, Acquisition, MIT, Bank, Video game, B3 (stock exchange), San Francisco Bay Area

Neon, which recently achieved unicorn status with its latest round of funding, believes that everyone deserves a bright future. The company was founded with the specific mission to decrease inequality and promote change -- in the lives of its customers and in the country of Brazil.

Key Points: 
  • Pereira, who previously held the position of senior product design manager at Twitter will now lead Neons fintech product design.
  • Neon, which recently achieved unicorn status with its latest round of funding, believes that everyone deserves a bright future.
  • My main focus at Neon will be to use my inclusive design experience to ensure we build accessible products that work for everyone.
  • This initiative will make it easy for the new Chief Design Officer to lead his department from the San Francisco Bay Area in the United States, where he currently resides.

Joby Completes Initial FAA Systems, Compliance Reviews for Aircraft Certification

Retrieved on: 
Friday, March 18, 2022
Air, Environment, Transport, Transportation, Alternative Energy, Energy, Travel, Private Securities Litigation Reform Act, Company, Joby Aviation, Aircraft, Form, Federal Aviation Administration, Growth, Multimedia, NYSE, The Public-Access Computer Systems Review, Certification, Environment, U.S. Securities and Exchange Commission, Review, Joby, Safety, Goal, CA, Design history file, FAA, Aviation, Engineering, EVTOL, Security (finance), Airline, 3D printing, Risk management, Audit

(Photo: Business Wire)

Key Points: 
  • (Photo: Business Wire)
    These reviews, completed at the end of last year, were recently granted approval by the FAA, providing the Company with confidence in its development approach, preliminary production design, and defined path toward certification.
  • The Compliance Review evaluated Jobys approach to the development and verification of aerospace-grade software and airborne electronic hardware.
  • Earlier this month, Joby announced it had completed its first series of FAA conformity tests to confirm the material strength of the composite material comprising the aerostructure of the aircraft.
  • In 2020, Joby became the first and only eVTOL company to sign a G-1 (stage 4) certification basis with the FAA, having received an initial (stage 2) signed G-1 from the FAA in 2019.

Joby Begins First Conformity Testing, Enters Next Phase of Certification Process

Retrieved on: 
Thursday, February 10, 2022
Automotive, Air, Transport, Alternative Energy, Energy, Alternative Vehicles, Fuels, Fleet Management, Toray Advanced Composites, Private Securities Litigation Reform Act, Federal Aviation Administration, Growth, Form, U.S. Securities and Exchange Commission, DER, Multimedia, Design history file, Company, EVTOL, Aviation, CA, Safety, Security (finance), Compliance, NYSE, CEO, Goal, Joby Aviation, Environment, FAA, Aircraft, Certification, Airline, 3D printing, Medical device, Joby

(Photo: Business Wire)

Key Points: 
  • (Photo: Business Wire)
    The start of conformity testing is a significant moment for Joby as the Companys aircraft type certification program enters the implementation phase for the first time.
  • The resulting compliance data will form the foundation for future testing of structural components of the aircraft as Joby progresses through the type certification process.
  • Each system and structure of the Joby aircraft will enter the implementation phase and begin conformity testing following completion and approval of requirements definition and compliance planning.
  • After years of development and company testing, were excited to formally begin the process of conformity testing, said JoeBen Bevirt, founder and CEO of Joby.