Latest news with #Lecanemab
5 days ago
- Health
Japan OKs Price Cut for Alzheimer's Drug Lecanemab
News from Japan Aug 6, 2025 20:15 (JST) Tokyo, Aug. 6 (Jiji Press)--A Japanese health ministry panel Wednesday approved a plan to cut the price of Lecanemab, an Alzheimer's drug codeveloped by Japanese drugmaker Eisai Co. and U.S. industry peer Biogen Inc., by 15 pct in Japan starting Nov. 1. The decision is based on an assessment by the Central Social Insurance Medical Council that cited the low cost-effectiveness of the drug used to treat dementia caused by Alzheimer's disease. The price of the drug will be lowered to 97,277 yen for a 500-milligram bottle. Dosages are based on weight. For example, a patient weighing 50 kilograms would see an annual cost reduction from about 2.98 million yen to about 2.53 million yen. Lecanemab is said to be innovative because it removes abnormal proteins that accumulate in patients' brains, and is expected to slow the progression of the disease. The medication was subject to a system that adjusts drug prices based on cost-effectiveness for high-priced or large-market drugs. [Copyright The Jiji Press, Ltd.] Jiji Press
The Independent
01-08-2025
- Health
- The Independent
Alzheimer's ‘wonder drug' slows progression of disease by four years - and could even reverse it
An Alzheimer's 'wonder drug' can delay the progression of the disease by four years, according to a new study. Researchers found that patients who were given the drug lecanemab in the earliest days of their disease reported an improvement, or no decline at all, in cognitive function. The trial of 478 patients who stayed on the drug for four years saw their dementia score rise by an average of 1.75 over the whole period - a score significantly lower than the average rise of one or two points over one year. Almost one million people in the UK suffer from dementia, with Alzheimer's the most common form of the disease. Urgent demand for new treatments is increasing as the number is expected to rise to 1.4 million by 2040. The new data presented at the Alzheimer's Association International Conference in Toronto suggested the drug was most promising for those with low levels of tau, the protein that grows as Alzheimer's progresses. In a subgroup of patients with low levels of tau, promising results showed 69 per cent of the group had no decline at all over four years, and 56 per cent saw an improvement in their cognitive scores. Speaking to The Telegraph, Professor Christopher Van Dyck, the director of the Alzheimer's Research unit at the Yale school of medicine and the study leader, said: 'The thing I really focus on is the time saved. You will get worse over time, but it will take longer to get there.' Lecanemab was approved for use in the UK last year after trials showed its effectiveness in slowing the progression of the disease. It is a disease-modifying drug, which means that it was developed to tackle the causes of Alzheimer's disease rather than only relieving the symptoms. It works by targeting the protein amyloid, which is thought to build up in the brain and become toxic to brain cells, causing Alzheimer's symptoms. Other similar drugs, like donanemab, have also been shown to slow the rate at which memory and thinking get worse by more than 20 per cent. Both drugs are approved by the Medicines and Healthcare products Regulatory Agency (MHRA) but were rejected for use by the NHS because the benefits were deemed to be 'too small' to justify the cost. Dr Sheona Scales, the director of research at Alzheimer's Research UK, told The Telegraph: 'These latest findings offer renewed hope that Alzheimer's treatments can meaningfully change the course of the disease, not just slow decline in the short term. 'New long-term data show that the benefits of donanemab may continue even after treatment ends, and people on lecanemab for up to four years maintained cognitive gains, with some even improving. Among those treated early with lecanemab and with low levels of tau, over half showed no decline after four years. 'This is the first wave of disease-modifying treatments for Alzheimer's and, while the progress is encouraging, there are still many pieces of the puzzle we don't yet have.'
Yahoo
30-07-2025
- Health
- Yahoo
New Data Presented at AAIC Demonstrates Investigational LEQEMBI® (lecanemab-irmb) 360 mg Subcutaneous Maintenance Dosing Could Offer a New Option for Ongoing Treatment of Early Alzheimer's Disease
Lecanemab subcutaneous autoinjector has the potential to become a new expanded treatment option for patients with early Alzheimer's disease, their care partners and healthcare professionals, with results showing a comparable efficacy and safety profile to the intravenous formulation TOKYO and CAMBRIDGE, Mass., July 30, 2025 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that results on investigational maintenance therapy with subcutaneous autoinjector (SC-AI) of lecanemab-irmb (U.S. brand name: LEQEMBI®), an anti-amyloid beta (Aβ) protofibril* antibody for the treatment of early Alzheimer's disease (AD), were presented at the Alzheimer's Association International Conference (AAIC) 2025, held in Toronto, and virtually. Only lecanemab fights AD in two ways— targeting both protofibrils and plaque, which can impact tau accumulation downstream. Importance of Ongoing Treatment and SC Development Program Due to the reaccumulation of AD biomarkers and return to placebo rate of decline after therapy is stopped1, Eisai is investigating a new lecanemab SC maintenance treatment option following 18 months of IV therapy so patients can continue to fight this progressive, relentless disease. Clinical trials of lecanemab SC were conducted as a sub-study of the open-label extension (OLE) following the core Phase 3 Clarity AD study in individuals with early AD, to evaluate a range of doses administered by SC vial or autoinjector. Eisai has developed a SC-AI for maintenance therapy at a dose of 360 mg weekly and a 500 mg SC-AI is being developed for initiation dosing. Similar Impact on Clinical Outcomes and Biomarkers with IV and SC Dosing The pharmacology (PK/PD), clinical (efficacy endpoints such as CDR-SB) and biomarker (amyloid PET and blood biomarkers) relationships established with extensive clinical data supported the FDA approval of IV maintenance therapy after the initial 18 months of treatment and support the investigational SC maintenance dose option. Data supports that transitioning to a weekly 360 mg SC AI dose of lecanemab after 18 months of initiation dose (10 mg/kg IV biweekly) maintains clinical and biomarker benefits comparable to continued biweekly IV dosing. Clinical and biomarker responses at 48 months with monthly IV maintenance dosing are similar to the responses with ongoing biweekly dosing whether patients are amyloid positive (>30 CL) or negative (<30 CL) at 18 months. Data shows the 500 mg SC AI has equivalent exposure as the initial treatment regimen of 10 mg/kg IV biweekly up to 18 months for amyloid removal, efficacy, and ARIA-E. Safety MattersThe safety profile of 360 mg weekly SC maintenance dosing was shown to be consistent with that of IV maintenance therapy, with <1% systemic injection/infusion reactions. Across all SC doses, the rate of systemic injection/infusion reactions is 1% compared to 26% with IV. The 360 mg SC maintenance dose was initiated after 18 months of IV treatment, beyond the high-risk period for ARIA. There were 0 cases of ARIA-E observed out of 49 treated with 360 mg SC weekly maintenance for a mean of 6 months. Study Participants Successfully Administered SC-AI and Found it Easy to UseTo optimize the safe and effective use of SC autoinjector (SC-AI), additional studies were conducted, including a human factors (HF) study and a tolerability assessment of the device. The HF Study involved 110 participants (63 early AD patients, 32 care partners, and 15 healthcare professionals: HCPs) to assess the appropriate administration of lecanemab SC-AI. Overall, 95% (104/110) of participants successfully administered the maintenance dose. The Autoinjector Device Acceptability Study involved 126 participants (25 early AD patients, 50 care partners, and 51 HCPs), to evaluate the device's ease of use, convenience and feasibility of administration. As an interim outcome, over 95% of participants reported that the SC-AI is easy to administer. They were highly satisfied with it and had no concerns about administration, even at home. Furthermore, all patients responded that they welcomed the introduction of SC-AI. These studies and evaluations of lecanemab SC-AI have demonstrated that the investigational SC-AI offers efficacy and safety comparable to IV administration with the potential to reduce the incidence of infusion site adverse events. From the perspective of patients and care partners, benefits included the ability to use the device at home, shortening treatment time, and to continue treatment without having to worry about visiting an infusion center. From the perspective of HCPs, they reported that the device has the potential to provide a new option for patients who are benefiting from lecanemab to continue the treatment. The SC formulation has the potential to reduce medical preparation and administration time related to IV therapy. These factors suggest that the SC AI may play an important role in continuing treatment for early AD. This release is based on the content of the presentations given at AAIC, "Featured Research Session #4-13-FRS-C: Lecanemab Subcutaneous Formulation for Maintenance Dosing: The Potential of a New and Convenient Option for Ongoing Treatment in Early Alzheimer's Disease," held at 9:00 AM on Wednesday, July 30, and also includes some content from the Developing Topics session held at 8:00 AM on Sunday, July 27, entitled "Patient, Care Partner, and Health Care Professional Opinion of the Lecanemab Autoinjector for Subcutaneous Delivery in Early Alzheimer's Disease Patients." Eisai serves as the lead for lecanemab's development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority. * Protofibrils are thought to be the most toxic Aβ species that contribute to brain damage in AD and play a major role in the cognitive decline of this progressive and devastating disease. Protofibrils can cause neuronal and synaptic damage in the brain, which can subsequently adversely affect cognitive function through multiple mechanisms.1 The mechanism by which this occurs has been reported not only by increasing the formation of insoluble Aβ plaques, but also by directly damaging signaling between neurons and other cells. It is believed that reducing protofibrils may reduce neuronal damage and cognitive impairment, potentially preventing the progression of AD. 2 MEDIA CONTACTSEisai Co., Ltd. Public Relations Department TEL: +81 (0)3-3817-5120 Eisai Europe, Ltd. EMEA Communications Department +44 (0) 797 487 9419 Emea-comms@ Eisai Inc. (U.S.) Libby Holman +1-201-753-1945 Libby_Holman@ Biogen Inc. Madeleine Shin +1-781-464-3260 INVESTOR CONTACTSEisai Co., Ltd. Investor Relations Department TEL: +81 (0) 3-3817-5122 Biogen Inc. Tim Power + 1-781-464-2442 IR@ Notes to Editors 1. About lecanemab (generic name, brand name: LEQEMBI®)Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). Protofibrils are believed to contribute to the brain injury that occurs with AD and are considered to be the most toxic form of Aβ, having a primary role in the cognitive decline associated with this progressive, debilitating condition.1 Protofibrils cause injury to neurons in the brain, which in turn, can negatively impact cognitive function via multiple mechanisms, not only increasing the development of insoluble Aβ plaques but also increasing direct damage to brain cell membranes and the connections that transmit signals between nerve cells or nerve cells and other cells.2 It is believed the reduction of protofibrils may prevent the progression of AD by reducing damage to neurons in the brain and cognitive dysfunction. Lecanemab has been approved in 46 countries and is under regulatory review in 11 countries. In January 2025, the supplemental Biologics License Application (sBLA) for intravenous (IV) maintenance dosing of the treatment was approved in the U.S. After an 18 months initiation phase with once every two weeks of dosing, a transition to the maintenance dosing regimen of 10 mg/kg once every four weeks or continuing 10 mg/kg once every two weeks may be considered. Additionally, the U.S. Food and Drug Administration (FDA) accepted Eisai's Biologics License Application (BLA) for the LEQEMBI subcutaneous autoinjector for weekly maintenance dosing in January 2025 and set a PDUFA action date for August 31, 2025. Since July 2020 the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy. 2. About the Collaboration between Eisai and Biogen for ADEisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority. 3. About the Collaboration between Eisai and BioArctic for ADSince 2005, Eisai and BioArctic have had a long-term collaboration regarding the development and commercialization of AD treatments. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement with BioArctic in December 2007. The development and commercialization agreement on the antibody lecanemab back-up was signed in May 2015. 4. About Eisai Co., Corporate Concept is "to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides." Under this Concept (also known as human health care (hhc) Concept), we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology. In addition, we demonstrate our commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), by working on various activities together with global partners. For more information about Eisai, please visit (for global headquarters: Eisai Co., Ltd.), and connect with us on X, LinkedIn and Facebook. The website and social media channels are intended for audiences outside of the UK and Europe. For audiences based in the UK and Europe, please visit and Eisai EMEA LinkedIn. 5. About Biogen Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patient's lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. The company routinely posts information that may be important to investors on its website at Follow Biogen on social media – Facebook, LinkedIn, X, YouTube. Biogen Safe HarborThis news release contains forward-looking statements, including about the potential clinical effects of lecanemab; the potential benefits, safety and efficacy of lecanemab; potential regulatory discussions, submissions and approvals and the timing thereof; the treatment of Alzheimer's disease; the anticipated benefits and potential of Biogen's collaboration arrangements with Eisai; the potential of Biogen's commercial business and pipeline programs, including lecanemab; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by such words as "aim," "anticipate," "assume," "believe," "contemplate," "continue," "could," "estimate," "expect," "forecast," "goal," "guidance," "hope," "intend," "may," "objective," "plan," "possible," "potential," "predict," "project," "prospect," "should," "target," "will," "would," and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements. These forward-looking statements are based on management's current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. We caution that these statements are subject to risks and uncertainties, many of which are outside of our control and could cause future events or results to be materially different from those stated or implied in this document, including, among others, uncertainty of long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; expectations, plans and prospects relating to product approvals, approvals of additional indications for our existing products, sales, pricing, growth, reimbursement and launch of our marketed and pipeline products; our ability to effectively implement our corporate strategy; the successful execution of our strategic and growth initiatives, including acquisitions; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission. These statements speak only as of the date of this press release and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in our subsequent reports on Form 10-Q and Form 10-K, in each case including in the sections thereof captioned "Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in our subsequent reports on Form 8-K. Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise. References Amin L, Harris DA. Aβ receptors specifically recognize molecular features displayed by fibril ends and neurotoxic oligomers. Nat Commun. 2021;12:3451. doi:10.1038/s41467-021-23507-z Ono K, Tsuji M. Protofibrils of Amyloid-β are Important Targets of a Disease-Modifying Approach for Alzheimer's Disease. Int J Mol Sci. 2020;21(3):952. doi: 10.3390/ijms21030952. PMID: 32023927; PMCID: PMC7037706. View original content to download multimedia: SOURCE Eisai Inc.
See - Sada Elbalad
30-07-2025
- Health
- See - Sada Elbalad
Saudi Arabia Approves First Alzheimer's Treatment
Israa Farhan Saudi Arabia has approved its first-ever treatment for Alzheimer's disease, marking a major step forward in the kingdom's efforts to expand cutting-edge healthcare. The Saudi Food and Drug Authority (SFDA) announced on Tuesday the registration of the drug Leqembi (Lecanemab), a pioneering biologic therapy administered via intravenous infusion every two weeks. The medication is designed for patients in the early stages of Alzheimer's, including those with mild cognitive impairment or early dementia. It specifically targets individuals who carry no more than one copy of the ApoE4 gene variant, which is associated with increased Alzheimer's risk. According to the SFDA, Leqembi belongs to a new class of innovative biologic drugs developed using monoclonal antibody technology. The treatment works by targeting beta-amyloid proteins that build up in the brain, helping to slow the formation of plaques known to be linked to cognitive decline in Alzheimer's patients. The approval followed a thorough evaluation of the drug's efficacy, safety, and quality. Clinical trials have shown promising results, indicating that the treatment can slow disease progression compared to a placebo, based on standard clinical measures used to assess Alzheimer's treatments. Common side effects reported include headaches, infusion-related symptoms, and changes detectable by MRI scans known as Amyloid-Related Imaging Abnormalities (ARIA), which may involve brain swelling or microbleeds. These effects are associated with the drug's mechanism and are closely monitored during treatment. The SFDA stressed the importance of regular monitoring throughout the treatment period, especially to track potential side effects. It also highlighted the need for genetic screening before starting the therapy to reduce the risk of adverse reactions. As part of the approval conditions, the pharmaceutical company is required to submit ongoing safety and efficacy reports and implement a robust risk management plan to ensure safe and effective use of the drug. read more Gold prices rise, 21 Karat at EGP 3685 NATO's Role in Israeli-Palestinian Conflict US Expresses 'Strong Opposition' to New Turkish Military Operation in Syria Shoukry Meets Director-General of FAO Lavrov: confrontation bet. nuclear powers must be avoided News Iran Summons French Ambassador over Foreign Minister Remarks News Aboul Gheit Condemns Israeli Escalation in West Bank News Greek PM: Athens Plays Key Role in Improving Energy Security in Region News One Person Injured in Explosion at Ukrainian Embassy in Madrid News Israeli-Linked Hadassah Clinic in Moscow Treats Wounded Iranian IRGC Fighters Arts & Culture "Jurassic World Rebirth" Gets Streaming Date News China Launches Largest Ever Aircraft Carrier News Ayat Khaddoura's Final Video Captures Bombardment of Beit Lahia Videos & Features Tragedy Overshadows MC Alger Championship Celebration: One Fan Dead, 11 Injured After Stadium Fall Business Egyptian Pound Undervalued by 30%, Says Goldman Sachs Lifestyle Get to Know 2025 Eid Al Adha Prayer Times in Egypt Arts & Culture South Korean Actress Kang Seo-ha Dies at 31 after Cancer Battle Arts & Culture Lebanese Media: Fayrouz Collapses after Death of Ziad Rahbani Sports Get to Know 2025 WWE Evolution Results
Business Wire
28-07-2025
- Health
- Business Wire
Hyperfine Swoop ® AI-Powered Portable MRI System Demonstrates 100% Sensitivity for ARIA-E Detection in New Data Presented at the 2025 Alzheimer's Association International Conference
TORONTO--(BUSINESS WIRE)-- Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared AI-powered portable MRI system for the brain—the Swoop ® system—announced promising early results from the CARE PMR (Capturing ARIA Risk Equitably with Portable MR) study presented at the 2025 Alzheimer's Association International Conference in Toronto, Canada. The Swoop® system achieved 100% sensitivity in detecting mild to moderate ARIA-E, a condition marked by cerebral edema. Share Researchers from the Benzinger Lab at Washington University School of Medicine in St. Louis reported interim results from 31 Alzheimer's patients undergoing Lecanemab therapy. Participants were scanned using the Swoop ® system within one week of their clinical high-field MRI scans, as part of the safety monitoring protocol required by the FDA when it approved Lecanemab. The Swoop ® system achieved 100% sensitivity in detecting mild to moderate ARIA-E, a condition marked by cerebral edema. Researchers note that while ultra-low-field MRI is promising as a triage tool to screen for ARIA-E, high-field MRI may remain necessary for comprehensive evaluation in some cases. Appropriate use guidelines for amyloid-targeting therapies, including Lecanemab and Donanemab, require MRI safety monitoring at multiple, specific intervals throughout the course of therapy. However, regular screening with conventional MRI systems is often hindered by high costs, scheduling delays, and logistical challenges for both patients and caregivers. The Swoop ® system addresses these barriers by offering an affordable, portable imaging solution that is readily available to patients at the point of care, such as neurology offices and infusion clinics. Dr. Tammie Benzinger, principal investigator of the study, noted, 'This research could help alleviate the burden on families and facilities and improve overall access to care. We are hoping to expand the project to Washington University's Medical Campus to include community sites offering infusion therapy for early Alzheimer's disease.' These findings from the CARE PMR study underscore the potential of portable MRI to transform ARIA-E monitoring and expand access to care. The Swoop ® system enables clinicians to confidently detect ARIA-E, while offering patients and caregivers the convenience of point-of-care screening, eliminating the need for separate imaging appointments. 'We are proud to collaborate with leading clinicians and researchers who share our vision of advancing Alzheimer's care through accessible innovation,' said Edmond Knopp, MD, Chief Medical Officer at Hyperfine. The CARE PMR study is a collection of data from multiple sites assessing the clinical utility and workflow benefits of using Swoop ® system images to detect amyloid-related imaging abnormalities (ARIA) in Alzheimer's patients receiving amyloid-targeting therapy. It is funded by the Alzheimer's Association and the American Society of Neuroradiology. For more information about the Swoop ® system, please visit About the Swoop ® Portable MRI Systems The Swoop ® Portable MR Imaging ® Systems are U.S. Food and Drug Administration (FDA) cleared for brain imaging of patients of all ages. They are portable, ultra-low-field magnetic resonance imaging devices for producing images that display the internal structure of the head where full diagnostic examination is not clinically practical. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. About Hyperfine, Inc. Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop ® system—the first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of providing imaging at multiple points of professional care. The mission of Hyperfine, Inc. is to revolutionize patient care globally through transformational, accessible, clinically relevant diagnostic imaging. Founded by Dr. Jonathan Rothberg in a technology-based incubator called 4Catalyzer, Hyperfine, Inc. scientists, engineers, and physicists developed the Swoop ® system out of a passion for redefining brain imaging methodology and how clinicians can apply accessible diagnostic imaging to patient care. For more information, visit The Hyperfine logo, Swoop, and Portable MR Imaging are registered trademarks of Hyperfine, Inc. The Swoop logo, Optive AI logo, and Optive AI are trademarks of Hyperfine, Inc. Forward-Looking Statements This press release includes 'forward-looking statements' within the meaning of the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995. Actual results of Hyperfine, Inc. (the 'Company') may differ from its expectations, estimates and projections and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as 'expect,' 'estimate,' 'project,' 'budget,' 'forecast,' 'anticipate,' 'intend,' 'plan,' 'may,' 'will,' 'could,' 'should,' 'believes,' 'predicts,' 'potential,' 'continue,' and similar expressions (or the negative versions of such words or expressions) are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, the Company's goals and commercial plans, the benefits of the Company's products and services, and the Company's future performance and its ability to implement its strategy. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside of the Company's control and are difficult to predict. Factors that may cause such differences include, but are not limited to: the success, cost and timing of the Company's product development and commercialization activities, including the degree that the Swoop ® system is accepted and used by healthcare professionals; the impact of COVID-19 on the Company's business; the inability to maintain the listing of the Company's Class A common stock on the Nasdaq; the Company's inability to grow and manage growth profitably and retain its key employees; changes in applicable laws or regulations; the inability of the Company to raise financing in the future; the inability of the Company to obtain and maintain regulatory clearance or approval for its products, and any related restrictions and limitations of any cleared or approved product; the inability of the Company to identify, in-license or acquire additional technology; the inability of the Company to maintain its existing or future license, manufacturing, supply and distribution agreements and to obtain adequate supply of its products; the inability of the Company to compete with other companies currently marketing or engaged in the development of products and services that the Company is currently marketing or developing; the size and growth potential of the markets for the Company's products and services, and its ability to serve those markets, either alone or in partnership with others; the pricing of the Company's products and services and reimbursement for medical procedures conducted using the Company's products and services; the Company's estimates regarding expenses, revenue, capital requirements and needs for additional financing; the Company's financial performance; and other risks and uncertainties indicated from time to time in Company's filings with the Securities and Exchange Commission, including those under 'Risk Factors' therein. The Company cautions readers that the foregoing list of factors is not exclusive and that readers should not place undue reliance upon any forward-looking statements, which speak only as of the date made. The Company does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based.
