SeaStar Medical to Present at the Dawson James Small Cap Growth Conference on October 12, 2023
- SeaStar Medical announces two recent regulatory developments at conference: Expecting Approvable Letter for Selective Cytopheretic Device (SCD) Pediatric and received Breakthrough Device Designation for SCD in cardiorenal syndrome
- None.
DENVER, Oct. 05, 2023 (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 that Eric Schlorff, CEO, will present a company overview at the 8th Annual Dawson James Small Cap Growth Conference on Thursday, October 12 at 2:30 p.m. Eastern time (11:30 a.m. Pacific time). The conference is being held at the Wyndham Grand Harborside Hotel in Jupiter, Fla.
“We are excited to share two very recent transformational regulatory development at this conference,” said Eric Schlorff, SeaStar Medical CEO. “The FDA has informed us to expect an Approvable Letter within a month for use of our Selective Cytopheretic Device (SCD) Pediatric in critically ill children with acute kidney injury and sepsis or septic conditions, providing us with clear path toward the first market approval for our patented cell-directed extracorporeal therapy. We also received Breakthrough Device Designation for the SCD in cardiorenal syndrome, which is among the additional indications in which we believe dysregulating the immune processes could provide significant benefit.”
A live webcast of the conference presentation will be available on the Events & Presentations page of the Company's website. A replay of the webcast will be available for 90 days.
About SeaStar Medical
SeaStar Medical is a medical technology company that is 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. The Company is developing and commercializing cell-directed 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 https://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 regulatory approval process for HDE; the anticipated timing for commercialization of SCD; and the benefits of SCD to treat acute kidney injury (AKI) and 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 risk that SeaStar Medical may not be able to obtain regulatory approval of its SCD product candidates; (ii) the risk that SeaStar Medical may not be able to raise sufficient capital to fund its operations, including clinical trials; (iii) 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, (iv) the risk that SeaStar Medical may never achieve or sustain profitability; (v) the risk that SeaStar Medical may not be able to access funding under existing agreements, including the equity line of credit and forward purchase agreements; (vi) the risk that third-parties suppliers and manufacturers are not able to fully and timely meet their obligations, (vii) the risk of product liability or regulatory lawsuits or proceedings relating to SeaStar Medical’s products and services, (viii) the risk that SeaStar Medical is unable to secure or protect its intellectual property, and (ix) other risks and uncertainties indicated from time to time in SeaStar Medical’s Annual Report on Form 10-K, 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.
Contact:
LHA Investor Relations
Jody Cain
(310) 691-7100
Jcain@lhai.com
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