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Abbott said its 15-minute, hand-held blood test could help rule out the need for imaging scans to check for tissue damage in the 24 hours following a possible concussion or traumatic brain injury. Abbott has obtained a new clearance from the FDA for its rapid blood test to check out patients suspected of having a concussion or a mild traumatic brain injury. With a 15-minute result given by a hand-held cartridge reader, the company said its test can be used at an adult’s bedside in an emergency room as well as within urgent care clinics or other healthcare settings to help rule out the need for a CT scan. It is designed to be used within the first 24 hours after a head injury. But you won’t see Abbott’s i-STAT Alinity diagnostic device on the sidelines of sporting events just yet—the FDA’s green light still limits its use to locations with certified laboratory testing privileges. The latest clearance, however, is a step in that direction, as it now allows the hand-held test to use whole, untreated blood samples. Its first FDA nod, from early 2021, had required that blood samples first be spun in a lab centrifuge to separate out the necessary plasma. The test also picked up a separate green light last year for its use on Abbott’s larger Alinity lab hardware. “Clinicians have needed an objective way to assess patients with concussions,” Beth McQuiston, M.D., medical director in Abbott's diagnostics business, said in a statement. The company estimates that nearly 5 million people in the U.S. visit emergency rooms for a TBI each year, while more than half of people who may have a concussion never get checked. “When you look at all the other diseases, or other organs in the body, they all have blood tests to help assess what's happening,” McQuiston said. “Now, we have a whole blood test that can help assess the brain right at the patient's bedside—expanding access to more health providers and therefore patients.” The cartridge-based test searches the blood for two compounds released by the brain following tissue damage, known as ubiquitin C-terminal hydrolase L1 and glial fibrillary acidic protein.  A previous clinical study showed that an early analysis of these biomarkers could also help predict how well a patient will recover from a TBI in the weeks that follow as well as the chances of long-term complications such as comas, disability or death. Abbott said it is currently developing its i-STAT test into one that can be used nearly anywhere as well as with teenagers and children.

The test, run on Abbott's portable i-STAT® Alinity® instrument, uses whole blood to help evaluate patients with a suspected mild traumatic brain injury (mTBI), or concussion The test produces lab-quality results in 15 minutes Clinicians are now able to get a result at the patient's bedside, making the test accessible at urgent care clinics and other healthcare settings outside the hospital emergency room The test can be used to help evaluate patients up to 24 hours after injury ABBOTT PARK, Ill., April 1, 2024 /PRNewswire/ -- Abbott's i-STAT TBI cartridge has received clearance from the U.S. Food and Drug Administration (FDA) to be used with whole blood, allowing doctors to help assess patients with suspected concussion at the patient's bedside and obtain lab-quality results in 15 minutes. Previously, the tests to help with the assessment of TBI were only cleared for use with plasma or serum, requiring samples to be sent to a lab for processing and testing. This new clearance will enable testing to be performed in an array of new healthcare settings beyond hospital emergency departments including urgent care clinics with a certificate to perform moderate complexity tests. This is an important step toward a future where testing could be done outside traditional healthcare settings, such as on the sidelines of sporting events. The whole blood test on a portable instrument helps clinicians evaluate patients 18 years of age and older who present with suspected mild traumatic brain injury or mTBI, commonly known as concussion. Test results can help rule out the need for a CT scan of the head and assist in determining the best next steps for patient care. The ability to perform the test with a whole blood sample means testing can take place at healthcare settings without a lab which helps to accelerate the evaluation of head traumas. With this clearance, the i-STAT TBI test can be used to help evaluate patients up to 24 hours after injury, an important advancement since those injured often wait before seeking care. Nearly 5 million people go to the emergency department for a TBI in the U.S. each year, but more than half of people who suspect they have a concussion never get it checked. For decades, standard TBI assessment has remained the same, with doctors leveraging the Glasgow Coma Scale, a subjective doctor assessment, and CT scans to detect brain tissue damage or lesions. "Emergency departments can be a busy place. It's important to be able to triage patients quickly," said Geoffrey Manley, M.D., PhD, Chief of Neurosurgery at Zuckerberg San Francisco General Hospital, Professor of Neurosurgery at the University of California San Francisco and contact principal investigator for the TRACK-TBI Network. "Historically, that process for suspected concussions was largely subjective. With the help of this whole blood test, we can quickly and objectively determine whether or not a patient needs a CT scan or additional evaluation, right at the point of care. It's an incredibly helpful tool that advances the treatment of traumatic brain injury." How the test works The i-STAT TBI cartridge with the i-STAT Alinity System requires a small venous blood sample, which is applied to the test cartridge. The cartridge is then inserted into the portable i-STAT Alinity instrument. The test measures two biomarkers from the brain that may be released into the bloodstream, indicating a possible brain injury. Testing for these two biomarkers – ubiquitin C-terminal hydrolase L1 (UCH-L1) and glial fibrillary acidic protein (GFAP) – in the aftermath of an injury can provide clinicians with essential information about a patient's condition and can help healthcare providers decide an appropriate treatment plan. "Clinicians have needed an objective way to assess patients with concussions," said Beth McQuiston, M.D., medical director in Abbott's diagnostics business. "When you look at all the other diseases, or other organs in the body, they all have blood tests to help assess what's happening. Now, we have a whole blood test that can help assess the brain right at the patient's bedside – expanding access to more health providers and therefore patients." The newly cleared test expands Abbott's TBI test offerings, which includes the i-STAT TBI Plasma test and the ARCHITECT® and Alinity i lab test (serum and plasma), which were all cleared previously. The ability to use whole blood to help assess TBI is an important step in Abbott's vision to make its tests available in all settings where people seek care for head injuries. Abbott is engaged in ongoing research and planning that may, in the future, allow the test to be used in non-healthcare settings and with a broader population including teens and pediatrics. About Abbott: Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Connect with us at and on LinkedIn, Facebook, Instagram, X and Youtube. The i-STAT TBI blood test was developed in collaboration with the U.S. Department of Defense U.S. Army Medical Research and Development Command's (USAMRDC) U.S. Army Medical Materiel Development Activity (USAMMDA). The USAMRDC has been dedicated to developing a solution for the objective detection and evaluation of TBI for more than two decades and has played a critical role in developing the TBI test on Abbott's i-STAT Alinity platform. The Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) research team was the first to demonstrate how this TBI blood test can be used for the benefit of TBI patients in clinical care. SOURCE Abbott

- Announced private placement of up to $149.4 million led by RA Capital Management with participation from Armistice Capital, Special Situations Funds and Soleus Capital; pro forma cash and cash equivalents from upfront proceeds expected to provide runway through the end of 2025 - CervoMed on track to complete enrollment in 2Q 2024 in its RewinD-LB Phase 2b clinical trial evaluating neflamapimod in patients with dementia with Lewy bodies (DLB); topline data expected in 4Q 2024 - Integrated summary of results from AscenD-LB Phase 2a trial published in peer-reviewed journal and presentations at a major scientific conference further inform on the potential of neflamapimod in DLB and probability of success in RewinD-LB - Appointed Joshua Boger, Ph.D., as Chair of the Board of Directors; Dr. Boger is the founder and former CEO of Vertex Pharmaceuticals BOSTON, April 01, 2024 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical stage company focused on developing treatments for age-related neurologic disorders, today reported its financial results for the fourth quarter and full year ended December 31, 2023. “In 2023, we made transformative advancements to build our business, including successfully listing on NASDAQ and have begun 2024 by strengthening our leadership with the appointment of industry veteran, Joshua Boger, Ph.D., as non-executive Chair of the Board,” said John Alam, MD, Chief Executive Officer of CervoMed. “With this momentum, we look forward to building on recent publications that position our lead clinical program, neflamapimod, as a highly differentiated, first-to-market treatment option for patients with DLB. Our RewinD-LB Phase 2b trial is well powered, designed to include patients most likely to benefit from neflamapimod, and is expected to provide a path to market in this high value indication. We remain on track to fully enroll the RewinD-LB trial within the second quarter of this year, followed by availability of topline efficacy results in the fourth quarter of 2024.” Recent Highlights and Anticipated Milestones Enrollment in the randomized, controlled Phase 2b RewinD-LB trial evaluating oral neflamapimod in patients with DLB continues to progress and the Company remains on track to complete enrollment in the second quarter of 2024.At the International Conference on Alzheimer’s & Parkinson’s Diseases (AD/PD) in March 2024, the Company presented data from the AscenD-LB Phase 2a trial in a poster demonstrating that, neflamapimod treatment led to significant improvement compared to placebo in the change in plasma levels of glial fibrillary acidic protein (GFAP) in patients with pure DLB. Moreover, the neflamapimod treatment effects on GFAP were correlated to clinical outcomes, assessed by the CDR-SB. In a separate presentation at AD/PD, scientific collaborators from University College London presented data demonstrating neflamapimod improves axonal transport in a transgenic mouse model of frontotemporal dementia.CervoMed’s CEO, John Alam, MD, participated in a panel discussion at AD/PD titled, “New Insights in the Development of Biomarkers, Imaging, and Therapy of Alpha-synuclein, LRKK2, and GBA Pathologies.” Integrated summary of results from the AscenD-LB Phase 2a trial evaluating treatment with neflamapimod in patients with DLB were published in the Journal of Prevention of Alzheimer’s Disease (JPAD) in February 2024. The manuscript is available online and along with the integrated summary, includes the first peer reviewed publication of positive electroencephalogram and MRI data with neflamapimod treatment. The ongoing RewinD-LB study was designed based on key learnings from the Phase 2a AscenD-LB trial of neflamapimod, including the use of a single dose regimen of neflamapimod 40mg three-times-a-day (TID), enrolling patients with pure DLB (with pre-treatment plasma ptau181 below cutoff) and selecting the Clinical Dementia Rating Sum of Boxes (CDR-SB) scale as the primary endpoint. The RewinD-LB trial also includes the use of structural and functional MRI in a 40-patient subgroup to assess treatment effects on atrophy of the basal forebrain, as well its functional connectivity. Corporate Update On March 28, 2024, the Company announced entry into a securities purchase agreement pursuant to which it agreed to sell an aggregate of 2,532,285 units (the “Units”), each Unit comprised of (i) (A) one share of its common stock or (B) one pre-funded warrant to purchase one share of common stock, and, in each case, (ii) one Series A warrant to purchase one share of common stock to a select group of institutional and accredited healthcare specialist investors led by RA Capital Management in a private placement. Each Unit will have a purchase price of $19.745 (or $19.744 in the case of Units that include a pre-funded warrant in lieu of common stock). The Company anticipates the aggregate upfront gross proceeds from the private placement will be approximately $50 million, before deducting any offering-related fees and expenses, and up to approximately $99.4 million in additional aggregate gross proceeds if the Series A warrants are fully exercised for cash. The Series A warrants have an initial exercise price of $39.24 per share, representing a 100% premium to the last sale on March 27, 2024, will be immediately exercisable, and will expire at the earlier of (i) April 1, 2027 or (ii) 180 days after the date that the Company makes a public announcement of positive top-line data from the Company’s Phase 2b RewinD-LB clinical trial evaluating neflamapimod for treatment of patients with dementia with Lewy bodies (“DLB”). The private placement is expected to close on or about April 1, 2024, subject to customary closing conditions.Appointed industry leader Joshua Boger, Ph.D., as non-executive Chair of the Board. Dr. Boger is an industry veteran who has served in multiple scientific and business leadership roles in his 40+ year career. Notably, he is the founder and former CEO of Vertex Pharmaceuticals. Full Year 2023 Financial Results Cash Position: As of December 31, 2023, CervoMed had $7.8 million in cash and cash equivalents as compared to $4.1 million as of December 31, 2022. The Company currently expects its cash position as of December 31, 2023, along with the remaining funds to be received from the NIA grant received and the upfront private placement funding of $50.0 million announced March 28, 2024, and expected to be received by the Company on April 1, 2024, will enable it to fund its operating expenses and capital expenditures through the end of 2025. Grant Revenue: Grant revenue was $7.1 million for the year ended December 31, 2023, compared to no revenue for the same period in 2022. Research and Development (R&D) Expenses: R&D expenses for the year ended December 31, 2023, were $8.4 million, compared to $1.3 million for the year ended December 31, 2022. This increase was attributed to the RewinD-LB Phase 2b clinical study in DLB which began in the first quarter of 2023. General and Administrative (G&A) Expenses: G&A expenses were $6.5 million for the year ended December 31, 2023, versus $2.1 million for the year ended December 31, 2022. This increase was attributable to the additional costs related to the reverse merger, which closed in August 2023, compensation for additional headcount, and professional service fees. Operating Loss: Operating loss was $7.8 million for the year ended December 31, 2023, compared to $3.4 million for the year ended December 31, 2022. Net Loss: Net Loss was $2.2 million for the year ended December 31, 2023, compared to a net loss of $5.8 million for year ended December 31, 2022. The lower net loss in 2023 versus 2022 was driven by a noncash gain recognized for the conversion of the convertible notes upon the closing of the reverse merger, which was based on the stock price on the date of the transaction. About the RewinD-LB Phase 2b Study in Dementia with Lewy BodiesCervoMed’s ongoing Phase 2b study, RewinD-LB, is a randomized, 16-week, double-blind, placebo-controlled clinical trial evaluating oral neflamapimod (40mg TID) in up to 160 patients with very mild or mild dementia due to DLB. Patients completing the 16-week placebo-controlled study period will be able to continue in the study while receiving open label neflamapimod treatment for an additional 32 weeks. Patients with AD-related co-pathology, assessed by a blood biomarker (plasma ptau181), will be excluded. The primary endpoint in the study is change in CDR-SB, and secondary endpoints include the Timed Up and Go test, a cognitive test battery, and the Clinician’s Global Impression of Change. The RewinD-LB study is funded by a $21 million grant from the National Institutes of Health’s National Institute on Aging, which will be disbursed over the course of the study as costs are incurred. The study includes 41 sites (30 in the United States, 8 in the United Kingdom, and 3 in the Netherlands), all of which have been initiated. More information on the RewinD-LB study, including contact information on active clinical trial sites, is available at clinicaltrials.gov. About CervoMedCervoMed Inc. is a clinical-stage company focused on developing treatments for age-related neurologic disorders. The Company is currently developing neflamapimod, an investigational, orally administered small molecule brain penetrant that inhibits p38MAP kinase alpha. Neflamapimod has the potential to treat synaptic dysfunction, the reversible aspect of the underlying neurodegenerative processes that causes disease in DLB and certain other major neurological disorders. Neflamapimod is currently being evaluated in a Phase 2b study in patients with DLB. Forward-Looking StatementsThis press release includes express and implied forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, regarding the intentions, plans, beliefs, expectations or forecasts for the future of the Company, including, but not limited to, the therapeutic potential of neflamapimod, the anticipated timing and achievement of clinical and development milestones, including the completion and achievement of primary endpoints of the Company’s Phase 2b clinical trial, the anticipated timing, size, closing and receipt of proceeds from the pending private placement transaction, expectations regarding market conditions, the satisfaction of customary closing conditions related to the private placement and the anticipated use of proceeds therefrom, and projected cash runway. Terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately,” “potential” or other words that convey uncertainty of future events or outcomes may identify these forward-looking statements. Although there is believed to be reasonable basis for each forward-looking statement contained herein, forward-looking statements by their nature involve risks and uncertainties, known and unknown, many of which are beyond the Company’s control and, as a result, actual results could differ materially from those expressed or implied in any forward-looking statement. Particular risks and uncertainties include, among other things, those related to: the Company’s available cash resources and the availability of additional funds on acceptable terms; the results of the Company’s clinical trials; the likelihood and timing of any regulatory approval of neflamapimod or the nature of any feedback the Company may receive from the U.S. Food and Drug Administration; the ability to implement business plans, forecasts, and other expectations in the future; general economic, political, business, industry, and market conditions, inflationary pressures, and geopolitical conflicts; and the other factors discussed under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 filed with the U.S. Securities and Exchange Commission (SEC) on March 29, 2024, and other filings that the Company may file from time to time with the SEC. Any forward-looking statements in this press release speak only as of the date hereof (or such earlier date as may be identified). The Company does not undertake any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except to the extent required by law. This press release shall not constitute an offer to sell or the solicitation of an offer to buy Company securities, nor shall there be any offer, solicitation or sale of Company securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. Investor Contact: PJ KelleherLifeSci AdvisorsInvestors@cervomed.com617-430-7579 CervoMed Inc. Consolidated Balance Sheets December 31, 2023 2022 Assets Current assets: Cash and cash equivalents $7,792,846 $4,093,579 Prepaid expenses 1,256,501 64,127 Grant receivable 915,404 - Total current assets 9,964,751 4,157,706 Other assets 7,770 - Total assets $9,972,521 $4,157,706 Liabilities, Convertible Preferred Stock and Stockholders’ Equity (Deficit) Current liabilities: Accounts payable $662,471 $97,302 Accrued expenses and other current liabilities 1,933,276 644,252 Convertible notes - 12,414,000 Total liabilities 2,595,747 13,155,554 Commitments and Contingencies (Note 10) Convertible preferred stock: Series A preferred stock $0.001 par value; 30,000,000 and 0 shares authorized at December 31, 2023 and 2022, respectively, 0 shares issued and outstanding at December 31, 2023 and December 31, 2022 - - Series A-1 preferred stock, $0.001 par value; 0 and 1,960,600 shares authorized at December 31, 2023 and 2022, respectively; 0 and 1,960,600 shares issued and outstanding at December 31, 2023 and December 31, 2022, respectively - 246,849 Series A-2 preferred stock, $0.001 par value; 0 and 335,711 shares authorized at December 31, 2023 and 2022, respectively; 0 and 335,711 shares issued and outstanding at December 31, 2023 and December 31, 2022, respectively - 4,173,267 Series B preferred stock, $0.001 par value; 0 and 1,034,890 shares authorized at December 31, 2023 and 2022, respectively; 0 and 1,034,890 shares issued and outstanding at December 31, 2023 and December 31, 2022, respectively - 19,867,095 Total convertible preferred stock - 24,287,211 Stockholders’ Equity (Deficit): Common stock, $0.001 par value: 1,000,000,000 and 4,163,600 shares authorized as of December 31, 2023 and 2022, respectively, 5,674,520 and 518,140 shares issued and outstanding at December 31, 2023 and December 31, 2022, respectively 5,674 518 Additional paid-in capital 61,811,889 18,983,339 Accumulated deficit (54,440,789) (52,268,916)Total stockholders' equity (deficit) $7,376,774 (33,285,059)Total liabilities, convertible preferred stock and stockholders' equity (deficit) $9,972,521 $4,157,706 CervoMed Inc. Consolidated Statements of Operations Years Ended December 31, 2023 2022 Grant revenue $7,144,872 $- Operating expenses: Research and development 8,438,499 1,336,469 General and administrative 6,519,268 2,139,065 Total operating expenses 14,957,767 3,475,534 Loss from operations (7,812,895) (3,475,534)Other income (expense): Other income (expense) 5,421,592 (2,389,152)Interest income 219,430 62,226 Interest expense - (587)Total other income (expense) 5,641,022 (2,327,513)Net loss $(2,171,873)$(5,803,047)Per share information: Net loss per share of common stock - basic and diluted $(0.82)$(11.20)Weighted average shares outstanding - basic and diluted 2,661,416 518,140