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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. “With the recent activation of a second clinical site, we now have two medical centers open for enrolling patients in our pivotal trial evaluating the safety and efficacy of our patented, first-in-class, cell-directed Selective Cytopheretic Device (SCD) extracorporeal therapy in critically ill adults with acute kidney injury (AKI) requiring continuous kidney replacement therapy (CKRT),” said Eric Schlorff, SeaStar Medical CEO. “We are working diligently to qualify additional medical centers to join this trial and expect the activation of several more sites in the coming weeks. We plan to provide periodic updates on site activation and patient enrollment as this important trial progresses. “There are considerable differences between our adult and our pediatric AKI programs,” he added. “Among them are the FDA pathways for approval and the proprietary characteristics between the pediatric SCD-PED and the adult SCD-ADULT devices. The two devices are completely different products and meant for different patient populations, although their mechanism of action is the same. The regulatory pathway, regulatory events and decisions between these two devices are independent of each other. Additionally, the addressable adult AKI patient population approximates 200,000 per year, which is about 50-times greater than the addressable pediatric population, which we estimate at around 4,000 patients annually. While the SCD-PED addresses a smaller commercial opportunity, we are deeply committed to bringing the potentially lifesaving benefits of this therapy to critically ill children. “Most pharmaceutical development programs begin in adult populations with plans for pediatric studies once safety and efficacy have been established. We elected to lead with the Humanitarian Device Exemption (HDE) regulatory pathway for the pediatric population based on the highly promising data from our SCD-PED study showing a 50% reduction in mortality and no dialysis required at Day 60,” said Mr. Schlorff. “Despite a challenging pediatric approval pathway, we are working collaboratively with the FDA. To our knowledge the SCD-PED would be among the first pediatric medical devices to be approved by the FDA’s Center for Biologics Evaluation and Research (CBER) through the HDE pathway, presenting a unique regulatory review situation. We believe the FDA has appropriately set a very high bar in its evaluation of the SCD-PED given the vulnerability of these critically ill children in the ICU. That said, we are confident that the SCD-PED device will meet or even exceed the high standards set by the FDA.” During the August 22 business update conference call, SeaStar Medical management will discuss progress with the adult AKI trial and review ongoing discussions with the FDA on the SCD-PED. Management will also review the Company’s value proposition, including the commercial opportunity. See below for details about participating in the conference call. SeaStar Medical provides the following updates on its clinical programs with its patented, first-in-class SCD, a cell-directed extracorporeal therapy for hospitalized patients with AKI requiring CKRT: Adult Acute Kidney Injury Two clinical sites have been activated in the pivotal NEUTRALIZE-AKI (NEUTRophil and Monocyte DeActivation via SeLective CytopheretIc Device - a RandomiZEd Clinical Trial in Acute Kidney Injury) clinical trial to evaluate the safety and effectiveness of the SCD-ADULT in critically ill adults with AKI in the intensive care unit (ICU) receiving CKRT. Approximately six million cases of adult AKI are diagnosed annually in the U.S., of which approximately 200,000 require CKRT. In 2022 the SCD-ADULT received FDA Breakthrough Device Designation for adult use. This designation is awarded to a therapy to treat a serious or life-threatening condition with preliminary clinical evidence indicating it may demonstrate substantial improvement over available therapies on clinically significant endpoints. Breakthrough therapies receive many benefits, including a commitment by the FDA to expedite development and review. The NEUTRALIZE-AKI trial is expected to enroll up to 200 patients at up to 30 U.S. medical centers. The trial’s primary endpoint is a composite of 90-day mortality or dialysis dependency of patients treated with SCD-ADULT in addition to CKRT as the standard of care, compared with the control group receiving only CKRT standard of care. Secondary endpoints include mortality at 28 days, ICU-free days in the first 28 days, major adverse kidney events at Day 90 and dialysis dependency at one year. The study will also include subgroup analyses to explore the effectiveness of SCD-ADULT therapy in AKI patients with sepsis and acute respiratory distress syndrome. The study design for NEUTRALIZE-AKI was recently accepted in the journal Nephron and a more complete description of the study can be found in the online version of the accepted manuscript here. SeaStar Medical anticipates approval for the SCD-ADULT in the first half of 2025 and commercial launch in the second half of 2025. Pediatric Acute Kidney Injury SeaStar Medical anticipates its first U.S. regulatory approval for the SCD-PED will be for pediatric patients with AKI being treated in the ICU with CKRT. Only about one-half of children in the ICU with AKI who require CKRT survive, with those surviving at risk of long-term life-threatening conditions such as chronic kidney disease. In June 2022 the Company submitted an HDE application to the FDA, having met the criteria with clinical results showing safety and probable clinical benefit to critically ill children with AKI who have few treatment options. A non-controlled pivotal study funded by the FDA Office of Orphan Products Development showed that those treated with the SCD-PED had no reported adverse events, a 50% reduction in mortality rate and no dialysis required at Day 60. The U.S. addressable population of about 4,000 pediatric patients is within the 8,000-patient HDE criteria. In May 2023 the Company received a letter from the FDA indicating that the application is not approvable in its current form and outlining specific guidance as to how the application may be amended and resubmitted. The Company continues to work diligently with FDA toward a resolution of this review process. The pediatric device SCD-PED is a smaller device than the SCD-ADULT with unique features, albeit the mechanism of action is still the same. The regulatory pathway, regulatory events and decisions between these two devices are independent of each other. With the license and distribution agreement with Nuwellis for the pediatric AKI indication in place, both teams have been preparing for commercialization with an initial focus on the top 50 U.S. hospitals that treat pediatric AKI patients. Nuwellis’ salesforce has established relationships with nephrologists and intensive care physicians who are trained in pediatric extracorporeal therapy. SeaStar Medical will continue to explore the application of its SCD technology across a broad range of indications involving dysregulated immune processes where proinflammatory activated neutrophils and monocytes may contribute to disease progression or severity, in both acute and chronic indications. Second Quarter Financial Results Research and development (R&D) expenses for the second quarter of 2023 were $2.0 million, compared with $0.6 million for the second quarter of 2022, with the increase primarily resulting from higher clinical trial and external services costs, and increases in payroll and personnel expenses. General and administrative (G&A) expenses for the second quarter of 2023 were $1.7 million, compared with $0.7 million for the second quarter of 2022, with the increase primarily due to increases in insurance expense, higher costs associated with SEC reporting, and increases in payroll, marketing and travel expenses. 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. The increased net loss primarily resulted from higher operating expenses, and changes in fair value of forward option-prepaid forward contracts and in fair value of convertible notes, partially offset by the change in fair value of notes payable during the 2022 quarter, and the gain on issuance of convertible notes and the change in fair value of warrants liability during the 2023 quarter. Six Month Financial Results R&D expenses for the first six months of 2023 were $3.8 million, compared with $1.0 million for the first six months of 2022. G&A expenses for the first half of 2023 were $4.5 million, versus $1.2 million for the first half of 2022. The net loss for the first half of 2023 was $8.9 million, or $0.64 per share, compared with a net loss of $1.9 million, or $0.26 per share, for the first half of 2022. The higher net loss primarily resulted from increases in operating and interest expenses, change in fair value of convertible notes, and a change in fair value of forward option-prepaid forward contracts, partially offset by the change in fair value of notes payable during the 2022 period, and the gain on issuance of convertible notes, change in fair value of warrants liability, and a gain on sale of recycled shares during the 2023 period. The Company reported cash of $13,000 as of June 30, 2023, compared with $47,000 as of December 31, 2022. At the closing of the merger agreement in October 2022, the Company entered into forward purchase agreements of shares and warrants with the potential to generate up to $10 million in proceeds, depending on the market price of shares. The Company also entered into a $100 million equity line of credit. In March 2023 the Company closed a $3.3 million first tranche of a $9.8 million private placement convertible debt offering, and in May 2023 closed on the second tranche of $2.2 million. In August 2023 the Company issued a convertible note for $543,000. Business Update Conference Call 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. Participants can pre-register for the conference call here. 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. Stockholders and other interested parties may also participate in the conference call by dialing 866-777-2509 from within the U.S. or 412-317-5413 from outside the U.S., and requesting the SeaStar Medical call. A live webcast of the call will be available here and will be archived for 90 days. A replay of the call will be available beginning two hours after the call ends through August 24, 2023 by dialing 877-344-7529 from within the U.S., 855-669-9658 from Canada or 412-317-0088 from outside the U.S. and Canada, and entering the conference identification number 8122409. About Hyperinflammation and the Selective Cytopheretic Device (SCD) SeaStar Medical has identified a clear, urgent, unmet clinical need for technology that addresses dysregulated immune responses, including hyperinflammation, which is the overproduction or overactivity of inflammatory cells that can lead to damage of vital organs. It occurs when the body overproduces inflammatory effector cells and other molecules that can be toxic or damaging to vital organs, and result in multi-organ failure and even death. This is known as the cytokine storm. Current treatment options have shown limited efficacy in managing a cytokine storm with many simply treating symptoms instead of stopping the inflammatory effector cells that cause the cytokine storm. The Selective Cytopheretic Device, or SCD, is a first-in-class, cell-directed extracorporeal therapy. Unlike pathogen removal and other blood-purification tools, the SCD selectively targets the most highly activated proinflammatory neutrophils and monocytes. The Company has observed that these most highly activated immune cells are turned off in a low calcium environment. The SCD is integrated into existing hemodialysis equipment that is widely available in ICUs across the U.S. It requires less than 15 minutes for physicians or hospital staff to attach. The SCD therapy mimics nature by creating a unique micro-environment, attracting these highly activated effector cells and neutralizing them in a low calcium setting, with these cells then returned into the body through the blood, and the body is signaled to focus on repair. Clinical Results with the SCD in AKI SCD therapy has produced favorable clinical results in critically ill adults and children with AKI in the ICU being treated with CKRT, today’s standard of care. The SCD has reduced mortality rates by up to 50% in four non-COVID clinical trials in which adult and pediatric AKI patients had on average three organ failures and with a significant number of patients also being septic. A similar reduction in mortality was observed in a study of 22 COVID-19 patients with AKI and/or acute respiratory distress syndrome. 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 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, the FDA letter and SeaStar’s intent to pursue appeal options and other actions in response to such letter; the ability of SeaStar to address deficiencies raised by the FDA; the ability of SCD to treat pediatric 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 risk that SeaStar may not be able to obtain regulatory approval of its SCD product candidates; (ii) the risk that SeaStar 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, (xiii) the risk that SeaStar Medical is unable to secure or protect its intellectual property, and (xi) 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. (iii) 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 Financial Tables to Follow SeaStar Medical holding Corporartion Condensed Consolidated Balance Sheets (Unaudited) June 30, December 31, 2023 2022 ASSETS Current assets Cash $ 13 $ 47 Other receivables — 12 Prepaid expenses 2,319 2,977 Total current assets 2,332 3,036 Forward option-prepaid forward contracts, net - 1,729 Other assets 2 2 Total assets $ 2,334 $ 4,767 LIABILITIES AND STOCKHOLDERS' DEFICIT Current liabilities Accounts payable $ 4,355 $ 1,927 Accrued expenses 1,095 2,245 Contingent upfront payment for license agreement 100 — Notes payable, net of deferred financing costs 5,907 1,178 Convertible notes 2,230 — Warrants liability 95 — Total current liabilities 13,782 5,350 Notes payable, net of deferred financing costs - 7,652 Total liabilities 13,782 13,002 Commitments and contingencies (see Note 10) Stockholders' deficit (1) Common stock - $0.0001 par value per share; 100,000,000 shares authorized; 18,121,238 and 12,699,668 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively 2 1 Additional paid-in capital 96,806 91,089 Accumulated deficit (108,256 ) (99,325 ) Total stockholders' deficit (11,448 ) (8,235 ) Total liabilities and stockholders' deficit $ 2,334 $ 4,767 SeaStar Medical Holding Corporation Condensed Consolidated Statements of Operations (Unaudited) Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 Operating expenses Research and development $ 2,007 $ 596 $ 3,791 $ 951 General and administrative 1,743 716 4,540 1,173 Total operating expenses 3,750 1,312 8,331 2,124 Loss from operations (3,750 ) (1,312 ) (8,331 ) (2,124 ) Other income (expense), net Interest expense (225 ) (191 ) (658 ) (360 ) Change in fair value of convertible notes (100 ) — — — Change in fair value of warrants liability 480 — 480 — Change in fair value of notes payable derivative liability — 601 — 578 Change in fair value of forward option-prepaid forward contracts (69 ) — (1,723 ) — Gain on sale of recycled shares — — 1,306 — Total other income (expense), net 86 410 (595 ) 218 Loss before provision for income taxes (3,664 ) (902 ) (8,926 ) (1,906 ) Provision for income taxes 5 — 5 — Net loss $ (3,669 ) $ (902 ) $ (8,931 ) $ (1,906 ) Net loss per share of common stock, basic and diluted $ (0.25 ) $ (0.12 ) $ (0.64 ) $ (0.26 ) Weighted-average shares outstanding, basic and diluted (1) 14,932,866 7,238,767 13,984,625 7,238,767 (1) Retroactively restated to give effect to the reverse recapitalization # # #

New York, Aug. 24, 2021 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Persistent Epithelial Defect - Market Insight, Epidemiology and Market Forecast - 2030" - The Persistent Epithelial Defect (PED) market report provides current treatment practices, emerging drugs, market share of the individual therapies, current and forecasted PED symptoms market size from 2018 to 2030 segmented by seven major markets. The report also covers current Persistent Epithelial Defect (PED) symptoms treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.Geographies Covered• The United States• EU5 (Germany, France, Italy, Spain, and the United Kingdom)• JapanStudy Period: 2018–2030Persistent Epithelial Defect (PED) Disease Understanding and Treatment AlgorithmPersistent Epithelial Defect (PED) OverviewPersistent corneal epithelial defects (PEDs or PCEDs) result from the failure of rapid re-epithelialization and closure within 10-14 days after a corneal injury, even with standard supportive treatment. In recent years, PED awareness has increased with increased research activities from various spectrum of ophthalmology research. However, the actual frequency of PED is not known as of now, but some of the studies have estimated the frequency based on the causative occurrence of the disease with underlying conditions.Some of the symptoms of PEDs are loss of corneal epithelial cells, delayed epithelialization post-injury, nonhealing epithelial defect, and others which can be commonly due to Epithelial/limbal, inflammatory disease, Neurotrophic, mechanical causes, and othersThe multi-layered corneal epithelium acts as a protective barrier to infectious agents via tight junctions between neighboring cells, and it maintains its smooth optical surface by constantly regenerating cells in the basal cell layer. Disruptions in this protective layer can render the eye susceptible to infection, stromal ulceration, perforation, scarring, and decreased visual acuity.Persistent Epithelial Defect (PED) Diagnosis and TreatmentIt covers the details of conventional and current medical therapies and diagnosis available in the Persistent Epithelial Defect (PED) market to treat the condition. It also provides country-wise treatment guidelines and algorithms across the United States, Europe, and Japan.The Persistent Epithelial Defect (PED) market report gives a thorough understanding of PED symptoms by including disease definition, symptoms, causes, pathophysiology, and diagnosis. It also provides PED symptoms of treatment algorithms and treatment guidelines for PED symptoms in the US, Europe, and Japan.Persistent Epithelial Defect (PED) EpidemiologyThe epidemiology division’s Persistent Epithelial Defect (PED) symptoms provide insights about the historical and current patient pool and the forecasted trend for every seven major countries. It helps recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of The report also provides the diagnosed patient pool and their trends along with assumptions undertaken.Key FindingsThe disease epidemiology covered in the report provides historical as well as forecasted Persistent Epithelial Defect (PED) epidemiology segmented as the Total Incident Cases of Persistent Epithelial Defect (PED), Gender-specific incidence of Persistent Epithelial Defect (PED), Etiology-specific incidence of Persistent Epithelial Defect (PED). The report includes the incident PED scenario in 7MM, covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan from 2018 to 2030.Country Wise- Persistent Epithelial Defect (PED) EpidemiologyThe epidemiology segment also provides the Persistent Epithelial Defect (PED) epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.The total 7MM incident cases of Persistent Epithelial Defect (PED) were 241,452 in 2020.Persistent Epithelial Defect (PED) Drug ChaptersThe drug chapter segment of the Persistent Epithelial Defect (PED) report encloses the detailed analysis of PED marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps understand the Persistent Epithelial Defect (PED) clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.The first step in the management of any epithelial abnormality is to determine the etiology of the disease. Treatment of the underlying processes is necessary for local therapy to be successful, standard treatments, such as bandage contact lenses (BCLs) and artificial tears (ATs), aim to provide barrier protection to the epithelial layer. Current treatments of PCED are for lubrication, bandage soft contact lenses, punctual plugs, debridement, and tarsorrhaphy.Products detail in the report…Persistent Epithelial Defect (PED) Emerging DrugsNexagon (OcuNexus Therapeutics, Eyevance Pharmaceuticals) is a first-in-class natural, antisense therapy that downregulates the cell membrane hemichannel forming protein, connexin43 (Cx43). Targeting the gap junctions may prevent immune system responses that may lead to inflammatory cascade and promote the microvasculature and regeneration of corneal epithelium. Currently, the drug is under Phase II studies for PED.Products detail in the report…Persistent Epithelial Defect (PED) Market OutlookThe Persistent Epithelial Defect (PED) market outlook of the report helps build a detailed comprehension of the historic, current, and forecasted Persistent Epithelial Defect (PED) market trends by analyzing the impact of current therapies on the market, unmet needs, drivers and barriers, and demand of better technology.This segment gives a thorough detail of Persistent Epithelial Defect (PED) market trend of each marketed drug and late-stage pipeline therapy by evaluating their impact based on an annual cost of therapy, inclusion and exclusion criteria’s, mechanism of action, compliance rate, growing need of the market, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, brand value, their impact on the market and view of the key opinion leaders. The calculated market data are presented with relevant tables and graphs to give a clear view of the market at first sight.According to the analyst, Persistent Epithelial Defect (PED) market in 7MM is expected to change in the study period 2018–2030.Key FindingsThis section includes a glimpse of the Persistent Epithelial Defect (PED) market in 7MM. The market size of PED in the seven major markets was found to be USD 165.3 million in 2020, and the market is estimated to increase for the study period (2018–2030).The United States Market OutlookThis section provides a total of Persistent Epithelial Defect (PED) market size and market size by therapies in the United States.The United States accounts for the highest PED market size compared to the EU5 (the United Kingdom, Germany, Italy, France, and Spain) and Japan.EU-5 Countries: Market OutlookThe total Persistent Epithelial Defect (PED) market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are provided in this section.Japan Market OutlookThe total Persistent Epithelial Defect (PED) market size and market size by therapies in Japan are also mentioned.Persistent Epithelial Defect (PED) Drugs UptakeThis section focuses on the rate of uptake of the potential drugs recently launched or expected to get launched in the market during the study period 2018–2030. The analysis covers Persistent Epithelial Defect (PED) market uptake by drugs, patient uptake by therapies, and drug sales.This helps understand the drugs with the most rapid uptake, reasons behind the maximal use of new drugs, and the comparison of the drugs based on market share and size, which will again be useful in investigating factors important in the market uptake in making financial and regulatory decisions.Persistent Epithelial Defect (PED) Pipeline Development ActivitiesThe report provides insights into different therapeutic candidates in Phase II and Phase III stage. It also analyses Persistent Epithelial Defect (PED) key players involved in developing targeted therapeutics.Major players include OcuNexus Therapeutics, Eyevance Pharmaceuticals, and Noveome Biotherapeutics are developing novel therapies to treat the underlying cause of the PED and others being assessed as potential therapies to be available in the market in the coming future.Pipeline Development ActivitiesThe report covers the detailed information of collaborations, acquisition, and merger, licensing, and patent details for Persistent Epithelial Defect (PED) emerging therapies.KOL ViewsTo keep up with current market trends, we take KOLs and SME’s opinion working Persistent Epithelial Defect (PED)domain through primary research to fill the data gaps and validate our secondary research. Their opinions help understand and validate current and emerging therapies treatment patterns or Persistent Epithelial Defect (PED) market trends. This will support the clients in potential upcoming novel treatment by identifying the market’s overall scenario and the unmet needs.Competitive Intelligence AnalysisWe perform a Competitive and Market Intelligence analysis of the Persistent Epithelial Defect (PED) Market by using various Competitive Intelligence tools: SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.Scope of the Report• The report covers the descriptive overview of Persistent Epithelial Defect (PED) explaining its causes, signs and symptoms, pathophysiology, and currently available therapies• Comprehensive insight has been provided into the Persistent Epithelial Defect (PED) epidemiology and treatment in the 7MM• Additionally, an all-inclusive account of both the current and emerging therapies for Persistent Epithelial Defect (PED) is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape• A detailed review of Persistent Epithelial Defect (PED) market; historical and forecasted is included in the report, covering drug outreach in the 7MM• The report provides an edge while developing business strategies by understanding trends shaping and driving the global Persistent Epithelial Defect (PED) marketReport Highlights• In the coming years, Persistent Epithelial Defect (PED) market is set to change due to the rising awareness of the disease and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market• The companies and academics are working to assess challenges and seek opportunities that could influence Persistent Epithelial Defect (PED) R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition• Major players are involved in developing therapies for PED. The launch of emerging therapies will significantly impact the Persistent Epithelial Defect (PED) market• A better understanding of disease pathogenesis will also contribute to the development of novel therapeutics for PED.• Our in-depth analysis of the pipeline assets across different stages of development (Phase III and Phase II), different emerging trends, and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activitiesPersistent Epithelial Defect (PED) Report Insights• Patient Population• Therapeutic Approaches• Persistent Epithelial Defect (PED) Pipeline Analysis• Persistent Epithelial Defect (PED) Market Size and Trends• Market Opportunities• Impact of upcoming TherapiesPersistent Epithelial Defect (PED) Report Key Strengths• 10 Years Forecast• 7MM Coverage• Persistent Epithelial Defect (PED) Epidemiology Segmentation• Key Cross Competition• Highly Analyzed Market• Drugs UptakePersistent Epithelial Defect (PED) Report Assessment• Current Treatment Practices• Unmet Needs• Pipeline Product Profiles• Market Attractiveness• Market Drivers and BarriersKey QuestionsMarket Insights:• What was the Persistent Epithelial Defect (PED) Market share (%) distribution in 2020, and how would it look in 2030?• What would be the Persistent Epithelial Defect (PED) total market Size as well as market Size by therapies across the 7MM during the forecast period (2021–2030)?• What are the market’s key findings across 7MM, and which country will have the largest Persistent Epithelial Defect (PED) market Size during the forecast period (2021–2030)?• At what CAGR, the Persistent Epithelial Defect (PED) market is expected to grow by 7MM during the forecast period (2021–2030)?• What would be the Persistent Epithelial Defect (PED) market outlook across the 7MM during the forecast period (2021–2030)?• What would be the Persistent Epithelial Defect (PED) market growth till 2030, and what will be the resultant market Size in the year 2030?• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?Epidemiology Insights:• What are the disease risk, burden, and unmet needs of Persistent Epithelial Defect (PED)?• What is the historical Persistent Epithelial Defect (PED) patient pool in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?• What would be the forecasted patient pool of Persistent Epithelial Defect (PED) in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?• What will be the growth opportunities in the 7MM concerning the patient population about Persistent Epithelial Defect (PED)?• Out of all 7MM countries, which country would have the highest incident Persistent Epithelial Defect (PED) population during the forecast period (2021–2030)?• At what CAGR is the population expected to grow by 7MM during the forecast period (2021–2030)?Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:• What are the current options for the treatment of Persistent Epithelial Defect (PED)?• What are the current treatment guidelines for treating Persistent Epithelial Defect (PED) in the USA, Europe, and Japan?• What are the Persistent Epithelial Defect (PED) marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, efficacy, etc.?• How many companies are developing therapies for the treatment of Persistent Epithelial Defect (PED)?• How many therapies are developed by each company for the treatment of Persistent Epithelial Defect (PED)?• How many emerging therapies are in the mid-stage and late development stages to treat Persistent Epithelial Defect (PED)?• What are the key collaborations (Industry–Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Persistent Epithelial Defect (PED) therapies?• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?• What are the clinical studies going on for Persistent Epithelial Defect (PED) and their status?• What are the key designations that have been granted for the emerging therapies for Persistent Epithelial Defect (PED)?• What are the global historical and forecasted markets of Persistent Epithelial Defect (PED)?Reasons to buy• The report will help in developing business strategies by understanding trends shaping and driving the Persistent Epithelial Defect (PED) market• To understand the future market competition in the Persistent Epithelial Defect (PED) market and Insightful review of the key market drivers and barriers• Organize sales and marketing efforts by identifying the best opportunities for Persistent Epithelial Defect (PED) in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom), and Japan• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors• Organize sales and marketing efforts by identifying the best opportunities for Persistent Epithelial Defect (PED) market• To understand the future market competition in the Persistent Epithelial Defect (PED) marketRead the full report: ReportlinkerReportLinker is an award-winning market research solution. 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June 7, 2021 13:30 UTC Preliminary results show intranasally delivered ST266 is safe PITTSBURGH--(BUSINESS WIRE)-- Noveome Biotherapeutics., a clinical-stage biopharmaceutical company focused on developing next-generation biologics for the promotion and restoration of cellular integrity of inflamed or damaged tissues, today announced preliminary results of a Phase 1 open label clinical trial to establish the safety of ST266 when delivered intranasally in Glaucoma Suspect patients. The trial was conducted at the University of Pennsylvania by Ahmara Ross, M.D., Ph.D. and Kenneth Shindler, M.D., Ph.D. of the University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA. ST266 is a novel “secretome”, a cell-free platform biologic containing hundreds of proteins and other growth factors involved in cellular healing and was administered as a targeted nasal spray using the SipNose, Ltd. Cribriform Targeted Device, for which Noveome recently announced a commercial license agreement ( .) The device is able to deliver ST266 to the cribriform plate at the back of the upper nasal cavity where is able to reach the optic nerve, eye and brain, bypassing the blood-brain barrier. Previously published preclinical efficacy and distribution studies laid the groundwork for the Phase 1 clinical trial reported here. The Phase 1 open label clinical trial was designed to assess the safety of intranasally delivered ST266 in Glaucoma Suspect patients diagnosed as having pre-glaucoma conditions that have not yet caused damage to the optic nerve. Dosing occurred in three cohorts. In the first cohort, subjects were intranasally administered ST266 at a dose of two hundred microliters (200 µL) daily for 14 days, in alternating single nostrils. In the second cohort, subjects were intranasally administered 200 µL to each nostril daily (400 µL total per day) for 14 days. In the third cohort, subjects were intranasally administered 200 µL to each nostril daily (400 µL total per day) for 28 days. No drug-related serious adverse events were reported. Preliminary safety assessments, reported here, were performed at baseline and at the end of drug treatment and included visual acuity, slit lamp exam, tonometry, retina exam and ERG, OCT for optic nerve fiber thickness layer, corneal pachymetry, gonioscopy, neuro-cognitive exam, MRI, lumbar puncture, chemistry panel, hematology, and nasopharyngeal exam. All results were normal. Three-, six- and twelve-month safety follow-up visits are planned for all subjects. More information about the study is available at under the identifier NCT03901781. “The preliminary safety results of this Phase 1 clinical trial of intranasally delivered ST266 is an important milestone for Noveome. Now that we have established safety of ST266 by this route of administration, we are actively planning efficacy trials in a variety of neurological and ophthalmological indications,” said Christopher Velis, CEO of Noveome. “We intend to pursue intranasal ST266 in our broad pipeline of indications such as concussion, glaucoma, optic neuritis, and retinal diseases.” About ST266 ST266 is a cell-free biologic containing hundreds of proteins and other factors involved in cellular healing, neuroprotection, and modulation of inflammation. ST266 is produced by collecting proteins and other factors secreted by a novel population of cells generated by a proprietary method of culturing amnion-derived epithelial cells collected from full term placentas which are normally discarded after birth. This secretome contains physiologic levels of multiple growth factors and cytokines and stimulates a variety of anti-inflammatory and neuroprotective responses in preclinical studies. The ST266 platform biologic enables the use of a scalable manufacturing process to produce quantities for all indications, A drug master been submitted with the FDA, supporting all ST266 investigational new drug (IND) applications. About Noveome Biotherapeutics, Inc. Based in Pittsburgh, Noveome Biotherapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing next-generation biologics for the promotion and restoration of cellular integrity of inflamed or damaged tissues. In addition to the Phase 1 trial reported above, Noveome has completed a Phase 2 open-label clinical trial that demonstrated the benefit ST266 had in healing persistent corneal epithelial defects (PEDs). The company has initiated a Phase 1 study evaluating the safety of intravenously administered ST266 in COVID-19 patients and is currently planning a Phase 2 clinical study to further characterize the efficacy and safety of ST266 for the treatment of PEDs. For more information, visit .