SeaStar Medical Bolsters Operational Expertise with Appointment of Thomas R. Mullen as Vice President of Operations and Product Development
SeaStar Medical (Nasdaq:ICU) has appointed Thomas R. Mullen as Vice President of Operations and Product Development. With over 30 years in the medical device field, Mullen aims to drive the growth and commercialization of SeaStar's innovative therapies targeting hyperinflammation in vital organs. He previously served as a consultant to the company since 2020 and brings extensive experience in operations and regulatory compliance. The company’s Selective Cytopheretic Device is currently under FDA evaluation for a Humanitarian Device Exemption for treating acute kidney injury, with potential commercialization expected in mid-2023.
- Appointment of Thomas R. Mullen as VP of Operations expected to enhance product development and operations.
- Mullen's extensive experience in medical devices may support the company's growth trajectory.
- Selective Cytopheretic Device (SCD) is under FDA review, with commercialization anticipated in Q2 2023.
- Dependence on FDA approval for SCD poses risks to expected commercialization timeline.
- Potential challenges in achieving commercial success and profitability.
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. As we continue our preparations for success in treating both acute and chronic illnesses through advanced product offerings, we believe Tom’s extensive experience and expertise will be invaluable. We have had the pleasure of working with Tom since 2020 and during that time he has, among other things, ensured that our business objectives and agency regulations were met. As we continue to progress, we are pleased to welcome him as VP, Operations and Product Development, and look forward to continuing to leverage the leadership and skills he has amassed over the course of his career,” commented Eric Schlorff, Chief Executive Officer of SeaStar Medical.
Since 1993, Mr. Mullen has led Mullen Business Development, a manufacturing, engineering and operations consulting firm. Since its founding, he has served as a consultant to several medical device organizations from startup to Fortune 500 to establish and execute strategies, budgets and plans, as well as develop products, processes and operational systems. Mr. Mullen has served as a consultant to SeaStar Medical since 2020, during which time he oversaw contract manufacturing activities, assisted with agency submissions and provided remediation of compliance documentation. During his consulting career, Mr. Mullen has managed the relocation of multiple manufacturing lines from the U.S. to Mexico, completed successful external ISO and FDA audits, and has written and sourced compliance documentation for product development and design control. Prior to his consultancy with SeaStar Medical, he oversaw the manufacturing, engineering, and project management for an implantable tissue heart patch, qualification of aseptic processing, biocompatibility analyses, and sterilization validation for new products.
Additional career highlights include Managing Partner at 2MB2 Ventures, Director of Operations at WalkMed Infusion, Director of Manufacturing Engineering at Colorado MedTech, Principal Engineer/Project Manager at Medtronic Perfusion Systems, Business Development and Finance Acquisition at Standard Infusion, and several positions held at COBE Cardiovascular including District Sales Manager, Senior Production Manager and Senior Manufacturing Engineer.
Mr. Mullen added, “This is an exciting time for SeaStar Medical. Having worked with the team over the past few years, I believe SeaStar Medical has a proprietary solution with a potential life-saving therapy for critically and chronically ill patients. I am proud to be a part of the efforts to reduce the consequences of hyperinflammation on vital organs and look forward to working more closely with the team and positioning the Company for potential commercialization.”
As VP, Operations and Product Development, Mr. Mullen will oversee the development and advancement of the Company’s Selective Cytopheretic Device (SCD), a patented cell-directed extracorporeal therapy that works with continuous kidney replacement therapy (CKRT) systems to selectively target and reduce the inflammatory effects of activated neutrophils while transitioning pro-inflammatory monocytes to promote reparative processes. The SCD is currently being evaluated by the FDA for a Humanitarian Device Exemption (HDE) marketing approval for use in children (>20 kgs) with acute kidney injury (AKI). The Company expects the FDA to complete a substantive review of its HDE application during the first quarter of 2023, with a potential commercial launch expected in the second quarter of 2023.
About SeaStar Medical Holding Corporation
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’s novel technologies rely on science and innovation to provide life-saving solutions to critically ill patients. It is developing and commercializing extracorporeal therapies that target the effector cells that drive systemic inflammation, causing direct tissue damage and secreting a range of pro-inflammatory cytokines that initiate and propagate imbalanced immune responses. For more information visit www.seastarmedical.com or visit us on LinkedIn or Twitter.
Forward Looking Statements
This press release contains certain forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1955. These forward-looking statements include, without limitation, SeaStar Medical’s expectations with respect to the timing of regulatory approval of its products and other corporate milestones, the ability of SCD to treat patients with AKI, and the potential benefits of SCD to treat other diseases. Words such as “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside SeaStar Medical’s control and are difficult to predict. Factors that may cause actual future events to differ materially from the expected results, include, but are not limited to: (i) the inability to recognize the anticipated benefits of the business combination with LMAO, which may be affected by, among other things, competition and the ability of the post-combination company to grow and manage growth profitability and retain its key employees, (ii) costs related to the business combination, (iii) the outcome of any legal proceedings that may be instituted against SeaStar Medical following the business combination, (x) the ability to maintain the listing of its securities on NASDAQ, (iv) the ability to implement business plans, forecasts, and other expectations after the completion of the proposed business combination, and identify and realize additional opportunities, (v) the risk of downturns and the possibility of rapid change in the highly competitive industry in which SeaStar Medical operates, (vi) the risk that SeaStar Medical and its current and future collaborators are unable to successfully develop and commercialize its products or services, or experience significant delays in doing so, including failure to achieve approval of its products by applicable federal and state regulators, (vii) the risk that SeaStar Medical may never achieve or sustain profitability; (viii) the risk that SeaStar Medical may need to raise additional capital to execute its business plan, which many not be available on acceptable terms or at all; (ix) the risk that third-parties suppliers and manufacturers are not able to fully and timely meet their obligations, (x) the risk of product liability or regulatory lawsuits or proceedings relating to SeaStar Medical’s products and services, (xi) the risk that SeaStar Medical is unable to secure or protect its intellectual property, and (xiii) other risks and uncertainties indicated from time to time in SeaStar Medical’s registration statement on Form S-4, as amended (File No. 333-264993), including those under the “Risk Factors” section therein and in SeaStar Medical’s other filings with the SEC. The foregoing list of factors is not exhaustive. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and SeaStar Medical assume no obligation and do not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise.
Media Contact:
PSC Consulting
Patty Caballero
(973) 348-5055
patty@pscconsulting.net
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