联合 国

证券 交易委员会

华盛顿， 特区20549

形式 10-K/A

（修正案 号1）

（马克 一）

☒ 根据1934年《证券交易所法》第13或15（d）条提交的年度报告

截至本财政年度止12月31日, 2023

或

☐ 根据1934年《证券交易所法》第13或15（d）条提交的过渡报告

为 从_到_的过渡期

委员会 文件号： 001-40386

ONEMEDNET 公司

（确切的 章程中规定的注册人名称）

注册者的 电话号码，包括地区代码： (800) 918-7189

证券 根据该法案第12（b）条登记的：

证券 根据该法案第12（g）条登记：无

指示 如果注册人是《证券法》第405条规定的知名经验丰富的发行人，则勾选标记。是的 不是 ☒

指示 如果注册人无需根据该法案第13条或第15（d）条提交报告，则勾选标记。是的 不是 ☒

指示 勾选注册人（1）是否已提交证券交易所第13或15（d）条要求提交的所有报告 过去12个月内的1934年法案（或要求登记人提交此类报告的较短期限内），和（2） 在过去90天内一直遵守此类提交要求。是的 不是 ☒

指示 检查注册人是否已以电子方式提交了根据规则需要提交的所有交互数据文件 S-t法规第405条（本章第232.405条）在过去12个月内（或注册人 被要求提交此类文件）。 是 没有

指示 通过勾选注册人是否是大型加速文件夹、加速文件夹、非加速文件夹、小型报告夹 公司，或新兴成长型公司。请参阅“大型加速文件夹”、“加速文件夹”的定义 《交易法》第120亿.2条中的“小型报告公司”和“新兴成长公司”。

如果 新兴成长型公司，如果注册人选择不使用延长的过渡期来遵守规定，请通过勾选标记表示 根据《交易法》第13（a）条规定的任何新的或修订的财务会计准则。 ☐

指示 检查注册人是否已提交其管理层对其有效性评估的报告和证明 根据《萨班斯-奥克斯利法案》（15 USC）第404（b）条对其财务报告的内部控制7262（b））由注册人 编制或出具审计报告的公共会计师事务所。 ☐

如果 证券是根据该法案第12（b）条登记的，通过复选标记表明登记人的财务报表是否 文件中包含的内容反映了对之前发布的财务报表错误的更正。 ☒

指示 勾选这些错误更正是否是需要对基于激励的薪酬进行恢复分析的重述 根据§240.10D-1（b），注册人的任何执行官员在相关恢复期内收到。 ☐

指示 通过勾选注册人是否是空壳公司（定义见该法案第120亿.2条规则）。是的否 ☒

作为 截至2024年6月28日，非关联公司持有的注册人普通股总市值为美元9.7 百万（基于 2024年6月28日普通股收盘价0.98美元）。

作为 2024年10月31日，有 28,175,172 普通股，面值美元0.0001 每股已发行和发行，以及 注册人已发行和发行的0股优先股，每股面值0.0001美元。

解释性 注意

OneMedNet 特拉华州的公司(f/k/a data Knight Acquisition Corp.)正在提交本修正案第1号(This 对截至2023年12月31日的年度报告Form 10-K/A的“修订”(经如此修订，“经修订 表10-K/A“)，已于2024年4月9日提交给美国证券交易委员会(”美国证券交易委员会“)(以下简称”该委员会“) “原始表格10-K”)，以重申原始表格10-K的全部内容，包括重新陈述其合并的 原表格所载的2023年、2023年和2022年12月31日终了年度财务报表，包括附注 10-k，并取代由BF BorgersCPA PC(BF)编写的独立注册会计师事务所报告 Borgers“)与独立注册会计师事务所的报告一起包含在原始的10-k表格中 Withum Smith+Brown，PC(“Withum”)包括在本修正案中。这项修正案是由于以下命令而提交的 2024年5月3日，暂停BF Borgers在美国证券交易委员会前出庭和执业，并纠正 原始表格10-K，Withum受聘取代BF Borgers成为其独立注册会计师事务所。

这 表格10-k重申了2023年原始表格10-k以及因可转换票据、认购证、 基于股票的薪酬费用以及去SPAC交易，包括相关负债和资本重组，以及相关的 重新审计公司2023财年和2022财年财务报表。

作为 除非另有说明或上下文另有要求，否则在本修订后的表格10-k中使用的“我们”、“我们”、 “我们的”、“ONMD”、“OneMedNet”和“公司”指OneMedNet Corporation（f/k/a Data 骑士收购公司），一家特拉华州公司及其合并后的子公司在业务合并生效后 Data Knights Acquisition Corp.（“Data Knights”）和OneMedNet Corporation（“Legacy ONMD”）（“业务 合并”）根据日期为2022年4月25日的合并协议和计划（“合并协议”），由以下各方 Data Knights，Data Knights Merger Sub，Inc.，一家特拉华州公司，也是Data Knights的全资子公司（“合并子公司”）， Legacy ONMD，Data Knights，LLC，特拉华州一家有限责任公司（“赞助商”或“买家代表”） 以及保罗·凯西（Paul Casey）以卖方代表的身份于2023年11月7日结束。

ONEMEDNET 公司

年度 截至2023年12月31日的年度Form 10-K/A报告

索引

警示 关于前瞻性陈述的注释

一定的 我们不时作出的声明，包括这份经修订的表格10-k所载的声明，均为“前瞻性声明”。 1995年《私人证券诉讼改革法》和《证券法》第27A条所指的声明 经修订的1933年《证券法》(以下简称《证券法》)和经修订的《1934年证券交易法》(简称《证券交易法》)第21E条 行动“)。本修正后的表格10-k中除有关历史事实的陈述外，其他所有陈述均为前瞻性陈述。 这份经修订的表格10-k中的前瞻性陈述仅为预测。我们的这些前瞻性陈述在很大程度上是基于 根据我们目前对未来事件和财务趋势的预期和预测，我们认为这些事件和财务趋势可能会影响我们的业务、财务 条件和操作结果。在某些情况下，您可以通过“预期”等术语来识别这些前瞻性陈述。 “相信”、“继续”、“可能”、“取决于”、“估计”、“期望” “打算”、“可能”、“正在进行”、“计划”、“潜在”、“预测”、“项目” “应该”、“将会”、“将会”或这些术语的否定或其他类似的表达，尽管不是 所有前瞻性声明都包含这些话。我们的这些前瞻性陈述是基于我们目前的预期和预测 关于我们认为可能会影响我们的财务状况、运营结果、战略、短期和长期的未来事件和趋势 业务运营和目标，以及财务需求。

我们 运营涉及风险和不确定性，其中许多超出了我们的控制范围，其中任何一项或其组合都可能 对我们的经营业绩以及前瞻性陈述最终是否被证明正确产生重大影响。我们已经根据 这些前瞻性陈述主要基于我们当前对未来事件和趋势的预期和预测，我们认为这些事件和趋势可能会 影响我们的财务状况、运营结果、业务战略、短期和长期业务运营和目标， 和财务需求。本修订后的表格10-k中的前瞻性陈述包括但不限于反映管理层的陈述 对未来财务业绩和运营支出的预期（包括我们继续作为持续经营企业的能力、提高 额外资本以及在未来的运营中取得成功）、预期增长、盈利能力和业务前景以及运营费用。

前瞻性 陈述只是当前的预测，并且受到已知和未知的风险、不确定性和其他可能导致我们的风险的因素的影响。 实际结果、活动水平、绩效或成就与此类陈述的预期存在重大差异。 这些因素包括，我们认为可能导致实际结果与其他因素不同的未知风险和不确定性 这些前瞻性陈述在“风险因素”标题和本修订后的表格10-k中的其他地方列出。 新的风险和不确定性时有发生，我们不可能预测所有的风险和不确定性 可能对前瞻性陈述产生影响，包括但不限于与以下方面相关的风险和不确定性：

这些 前瞻性陈述受到许多风险、不确定性和假设的影响，包括“风险”中描述的风险、不确定性和假设 因素。”此外，我们在竞争激烈且瞬息万变的环境中运营。新的风险不时出现。是 我们的管理层无法预测所有风险，也无法评估所有因素对我们业务的影响或影响程度 任何因素或因素组合可能导致实际结果与任何前瞻性陈述中包含的结果存在重大差异 我们可能会做出。鉴于这些风险、不确定性和假设，本修订本中讨论的前瞻性事件和情况 表格10-k可能不会发生，实际结果可能与前瞻性报告中预期或暗示的结果存在重大不利差异 报表

你 不应依赖前瞻性陈述作为对未来事件的预测。尽管我们相信期望反映了 前瞻性陈述是合理的，我们不能保证未来的结果、活动水平、绩效或事件 以及前瞻性陈述中反映的情况将实现或发生。此外，除法律要求外，均不 我们或任何其他人对前瞻性陈述的准确性和完整性承担责任。我们没有义务 在本修订后的表格10-k日期后以任何原因公开更新任何前瞻性陈述，以符合这些陈述 实际结果或我们期望的变化。

你 应阅读本修订后的表格10-k以及我们通过引用纳入本修订后的表格10-k中的文件，并理解 我们的实际未来结果、活动水平、表现以及事件和情况可能与我们的情况存在重大差异 期望。由于许多已知和未知的风险和不确定性，我们的实际结果或绩效可能会存在重大差异 这些前瞻性陈述所表达或暗示的内容，包括“风险因素”部分所描述的内容 从第18页开始以及本修订表格10-k的其他地方。

部分 我

项目 1.业务

公司 概述

OneMedNet 是全球临床成像创新提供商和监管级成像真实世界数据（“iRWD”）的策展人^TM”) OneMedNet的创新解决方案将医疗保健提供者和患者联系起来，满足生命科学领域的关键需求 提供直接访问临床图像和相关的上下文患者记录。OneMedNet的创新技术得到证实 对新兴市场真实世界数据（定义如下）成像的商业和监管可行性，并提供监管级 以图像为中心的iRWD^TM 这完全符合OneMedNet的生命科学合作伙伴病例选择协议并铺平了道路 对于真实世界证据（定义如下）。

OneMedNet 成立是为了解决医疗保健提供者之间共享临床图像的缺陷。这导致了ONN的初始 产品束^TM 图像交换使与ONN最大的十多年来成功共享图像 客户是爱尔兰共和国。

OneMedNet 通过响应对真实世界数据（定义如下）（“RWD”）和真实数据的需求和利用来继续创新 世界证据（RWE），特别是专注于临床图像及其相关背景临床记录的数据。我们能够 利用内部技术能力以及OneMedNet从第一年起就强大的医疗保健提供商安装基础 带有BEAM的产品^TM 推出iRWD，成为生命科学公司首个RWD解决方案^TM2019年。

OneMedNet 提供创新解决方案，释放临床图像档案中包含的重要价值。随着不断发展的联邦网络 OneMedNet在95多个医疗保健机构中拥有快速搜索和广泛管理来自联邦机构的多层数据的能力 一群医疗保健机构。“医疗机构”一词专门指医院、综合交付 为OneMedNet提供成像的网络（“IDT”）和成像中心，OneMedNet代表了我们数据的核心来源。在 目前，OneMedNet与超过95个向我们提供监管级成像的机构合作。OneMedNet可以访问更多内容 超过95个设施，因为这些签约设施有200多个地点，包括办公室和诊所， Total可从200多个客户生成监管级图像。这些客户中，都是数据提供者，也有一些是数据 购买者。

最初， 这一切都是为了解决患者护理提供者的多样化访问需求。这一重点系统性地演变为快速解决 图像分析和研究人员、临床医生、监管机构、科学家等的需求不断增长。联邦网络允许OneMedNet 访问以下数据以作为RWD提供给研究。

房 世界数据是在常规护理提供背景下收集的任何数据，与临床期间收集的数据形成鲜明对比 研究设计以不代表现实世界护理和结果的方式控制变异性的试验。

一 推动其使命的关键要素是OneMedNet相信我们有一个独特的机会来对 改善数千万人的生活，同时提高客户的业务生产力。首先，OneMedNet的 iRWD^TM 产品在使生命科学公司提供更安全、更有效的患者护理方面发挥着重要作用 尽早上市。在iRWD中使用我们精心策划的去识别临床数据^TM 提供生命科学产品开发， 生命科学公司通过验证和监管审批流程，以更有意义的方式为患者护理进步做出贡献。 此外，生命科学改进了生命科学公司的产品开发和验证流程，这使各方受益。

显著 现有文件表明，真实世界数据可以为更广泛、更有代表性的患者群体提供更广泛的见解。 因此，美国食品和药物管理局（“FDA”）制定了监管批准的真实世界数据指南。 利用高度可靠和优质的真实世界数据，严格遵守所有非常具体的数据分层要求 可以补充或取代临床试验。

OneMedNet 涵盖真实世界数据成像的完整价值链;它始于我们10多年的联合提供商网络，并得到支持 由专家内部临床团队管理的多方面数据策展流程进行。此外，我们还与生活携手共进 科学合作伙伴制定病例选择方案，并在需要时制作病例报告表以供监管机构批准。我们 专注于通过OneMedNet的iRWD支持生命科学进步来创造价值^TM 它拥有解锁的钥匙 无限的患者护理进步。我们相信我们释放了以研究级图像为中心的iRWD的力量^TM 策划的是 满足每个队列要求并经得起前瞻性临床试验的严格要求。

今天， 生命科学公司，包括制药公司、人工智能（“AI”）开发人员、医疗器械企业、 和临床研究组织在获取丰富、高质量的患者数据方面面临着同样广泛的挑战，这些数据明确 符合他们精确的队列规格。患者诊断的很大一部分涉及临床成像，大约 按大小计算，90%的医疗保健数据与成像相关。从历史上看，大部分成像价值都来自于其最初的审查， 图像档案的进一步收益非常有限。

我们 帮助提供商“充分发挥成像档案的价值”。^TM 通过利用OneMedNet的iRWD^TM 提供， 提供商可以通过简化的数据访问来极大地改善他们的研究工作。医疗保健提供者，例如医院、诊所 成像中心还可以通过在明确定义和去识别数据中共享去识别数据来加速生命科学患者护理创新 和安全的方式。作为回报，收入就会产生并应用于关键且可能没有资金的提供商项目。

的 OneMedNet差异

我们 相信OneMedNet十多年来一直是提取、保护和传输医疗数据业务的领导者。这样做需要 专业知识：

实现 所有基本要素的内部专业知识是一项挑战，我们相信这会阻止许多组织尝试此类冒险。 我们为这一雄心勃勃的成就感到自豪，同时不断努力保持最先进的专业知识。OneMedNet严格遵守 在所有互动和活动中遵守最高水平的专业和道德标准以及适用法规。

我们 相信OneMedNet是监管级成像RWD策展人领域的领导者。这样做需要AI/ML方面的专业知识 技术、数据隐私/安全以及临床患者状况和医疗保健记录保存方面的专业知识。拥有或实现， 所有基本学科的专业知识是一项具有挑战性的成就。OneMedNet在我们的临床图像交换方面取得了重大领先 该解决方案在十多年前帮助该公司成立。所有数据在联邦OneMedNet iRWD中保持“本地”^TM 提供商网络-这意味着所有数据都保留在本地，直到特定的去识别数据获得特定生命的许可 科学研究机会。

OneMedNet的 竞争优势

我们 相信OneMedNet iRWD^TM 提供最好的先进技术、临床专家策展和服务。医学成像 并使用最先进的AI/ML技术在每个网络站点对相关临床数据进行索引。这通常包括电子产品 健康记录（“EHR”）、放射学、心脏病学、实验室、病理学等。我们的内部临床团队进行密集的策展 数据，以便结果满足生命科学数据收集协议（“DPP”）的规范和要求-无论 复杂性的。

我们 相信OneMedNet通过以下三种主要方式释放成像和EHR数据的价值：

OneMedNet的 使用多步骤质量控制流程对数据进行完全去识别，并且超出了受保护的健康信息（“PHI”） 包括个人可识别信息（“PRI”）、网站可识别信息等。重要的是，生命科学 用户以他们所需的确切格式接收数据。不需要数据筛选或操纵。数据已经准备好了 使用.此外，OneMedNet具有独特的知识、工具和经验组合，可以：

最后， OneMedNet拥有一支由经验丰富、训练有素的数据策展人组成的团队。这个团队意识到它的复杂性和关键性 临床数据，并且可以与提供商和生命科学专家有效沟通。

行业 背景

一 由塔夫茨药物开发研究中心撰写的2016年分析发表在《健康经济学杂志》上， 将药物推向市场的成本（包括批准后的研究和开发）高达惊人的28.7亿美元。与此同时一个 塔夫茨药物开发研究中心2018年的研究指出，新药开发的时间轴从12.8 平均药物的寿命为17.2年，而仅影响数百名患者的超孤儿药物则为17.2年。这就给了生活的责任 科学组织将找到更快地为患者提供治疗的方法，尤其是那些无法等待17年的患者 进行可能挽救生命的治疗。了解患者如何实际使用药品可以帮助整个行业的利益相关者 医疗保健生态系统做出重要且可能挽救生命的实时决策。

真实 世界数据是观察性数据，通常在批准的医疗产品上市时收集，并由“REAL”使用 真实生活中的患者，而不是临床试验或真实患者的真实世界图像。FDA引用了几个潜在的来源 真实世界数据，包括电子病历、索赔、疾病和产品登记。有多种类型的数据，包括结构化的 以及非结构化数据、临床和账单数据、交易数据和索赔数据、患者生成的数据以及从其他 可以阐明患者健康状况的来源以及更多。随着对医疗数据的依赖呈指数级增长，OneMedNet 注意到对信息的依赖增加了，这些信息来自多个额外来源，包括电子病历、索赔、登记处、 临床试验、患者和提供商调查、可穿戴设备等。这些额外的来源包括物联网(IoT)、 社交媒体论坛和博客。真实世界数据有可能打破效率低下的问题，填补以下信息孤岛中的空白 医疗保健生态系统中的所有利益相关者，包括提供者、付款人、制造商、政府实体和患者。此信息 反过来，分享使各方能够获得新的见解，支持基于价值的护理，并提供更好的健康结果。

商业化 一种药物需要其开发商利用各种真实世界数据来源来识别患者群体并完善销售和营销 针对这些人群的战略以及许多其他事业。从历史上看，这种做法涉及购买大量数据 来自数据聚合器或数据平台，即使不是直接来自源本身，有时对质量没有太多了解 数据。准备这些数据进行分析既昂贵又耗时;因此，许多组织会将该过程外包 提供给顾问或第三方供应商。此外，准备这些数据供未经培训的顾问分析的过程可能会产生一个 静态分析，难以针对后续问题或潜在差异进行修改或初始化。

Definitions of Real World Data and Real World Evidence

Real World Data has become a powerful tool in the life sciences industry. After decades of relying on clinical data as the gold standard for decision making, industry leaders now recognize how data collected in the real world adds valuable context and insight to their efforts. From identifying unmet medical needs and defining the patient journey, to supporting regulatory submissions, proving value to payers, and shaping market strategies, Real World Data adds value at every stage of the drug development lifecycle. Real World Data also sets the foundation for Real World Evidence, and while the terms are often used interchangeably, they are distinct, and they are changing health care. Here’s how it happens:

的 数字图像的发展促进了OneMedNet提供的真实世界数据中医学成像的可用性 分析以提高诊断的准确性并使用人工智能算法对大型医学图像数据库进行被动筛查 例如OneMedNet应用的那些。算法还可以帮助从具有病理学的医学图像中识别其他有价值的诊断测试。

房 世界证据是通过分析得出的有关医疗产品的使用和潜在受益或风险的临床证据 根据FDA的定义，真实世界数据。真实世界证据可以通过不同的研究设计或分析生成，包括但 不限于随机试验，包括大型简单试验、务实试验和观察性研究（前瞻性和/或回顾性）。 真实世界证据和真实世界数据的差异集中在最终用例上。真实世界数据可以采取索赔、EHR、 实验室、数据等。这种见解通常用于更好地了解患者的旅程或疾病的自然史（如何 如果不及时治疗，疾病就会进展。）

房 相比之下，World Evidence建立在许多这些数据集的基础上，并为提交做好准备，作为监管审查的一部分，例如 例如，向FDA或欧洲药品管理局（“EMA”）提供支持，以支持客户的临床试验申请。 当数据（特别是成像数据）提交给FDA时，该机构要求以下内容：

一 现实世界证据一直被严重依赖的领域与肿瘤学批准有关。FDA肿瘤学卓越中心 在2021年的美国临床肿瘤学会上提交了一份对此的分析报告，研究了包含Real 世界数据和真实世界证据。该分析研究了2011-2020年间提交的94份申请，结果显示 在此期间，纳入真实世界数据以支持监管决策的情况大幅增加。仅在2020年，就有 有28份关于肿瘤学产品的提交包含真实世界的数据。在肿瘤学背景之外，可能是最值得注意的 最近一个依赖真实世界证据的批准例子是FDA 2021年7月批准了Astella Pharma的一个新适应症 S公司推出的预防肺移植患者器官排斥反应的药物计划(或他克莫司)。那里的批准 是基于一项非干预性研究，提供了有效的真实世界证据。FDA的新闻稿宣布了这一批准 他指出，批准具有重要意义，因为它反映了一项设计良好的非干预性研究如何依赖于符合目的的研究 与适当的对照相比，真实世界的数据可以被认为是足够的，并且根据FDA的规定得到很好的控制。“

一个 最近值得注意的另一项批准是FDA于2021年12月批准了补充BLA（生物许可申请） Orencia®预防移植物抗宿主病。该应用程序包括来自随机临床试验的数据，以及其他 使用国际中心的真实世界数据进行的一项基于登记的临床研究提供了有效性证据 血液和骨髓移植研究。该登记研究分析了54名接受Orencia®预防治疗的患者的结果 移植物抗宿主病与标准免疫抑制药物联合治疗的162名患者 单独使用药物，并在该适应症中显示出疗效。

AI is employed in Real World Data to enhance data anomaly detection, standardization, and quality checking at the pre-processing stage. AI is expected to offer pharma and biotech companies the ability to increase meaningful Real World Evidence output, decrease time to insights, and make the most of the available vast data sources. A Real World Evidence technology platform that delivers smart data processing, analysis, and outcomes offers an unparalleled opportunity to capitalize on these computing advancements.

When used as part of an overall comprehensive Real World Evidence strategy, AI innovations can enhance drug development, improve patient treatment and access, and drive valuable new business opportunities.

In post-marketing studies, adverse events reporting is an area where AI is used, creating greater automation and efficiency in historical data sets. Techniques like natural language processing (“NLP”) enable AI to scan tens of thousands of records and quickly find adverse event details. AI-integrated analytics and automation provide access to crucial insights from historical clinical trial Real World Data and Real World Evidence, expanding end-to-end clinical trial capabilities:

AI 正在推动蛋白质结构识别的突破性飞跃，法规的进步正在为医疗保健研究组织提供 访问真实世界数据以加速临床试验流程。我们相信人工智能技术具有无与伦比的潜力 提供创新的试验设计和收集、组织和分析临床试验产生的越来越多的数据。 人工智能在临床试验中有许多应用，无论是短期还是长期。人工智能技术使对转型至关重要的创新成为可能 临床试验，例如无缝结合I期和II期、开发新型以患者为中心的终点以及收集和分析 真实世界数据。

OneMedNet 相信人工智能工具还能为医院和卫生系统带来更广泛的好处。加拿大滑铁卢大学Alexander Wong教授 人工智能和医学成像研究主席指出，人工智能的好处包括减轻放射科负担的潜力 在评估扫描和预测未来对综合医院和重症监护病床的需求以及对设备的需求方面， 作为呼吸机和呼吸机、药品、口罩和呼吸机喉舌，以及协助劳动力规划。

跨 一组多样化的成像模式、数字图像通常包括元数据和/或注释，其中可能包括受保护的健康信息 (例如， 患者姓名、出生日期）。尽管诊断图像通常不需要像 基因组数据，研究人员还必须删除面部特征或其他可以识别患者的特征。

数字 图像分析可通过分析大量组织样本或其他医学图像来支持研究和开发 通过将患者肿瘤的一部分移植到人源化中来运行分子筛选，对生物标志物和治疗反应进行建模 小鼠或源自类似微型器官的干细胞的3D组织培养物。这些模型使研究人员能够进行受控 实验室实验可以为治疗方法提供信息，并通过将预测的治疗反应与实际临床结果联系起来 该数据传输到EHR、索赔和其他真实世界数据来源。同样，临床前研究可以通过安全性评估来了解 在动物模型或动物分子生物标志物或解剖异常研究中进行，以最大限度地减少人类研究的负担 参与者研究结果还可以通过根据预测的反应对参与者进行分层并确定来为临床试验优化提供信息 适当的资格标准。

评价 监管决策背景下的真实世界证据不仅取决于对用于生成的方法的评估 证据还包括基础现实世界数据的可靠性和相关性;这些结构可能会提出不同的类型 的考虑。真实世界证据是指从真实世界分析中得出的有关产品风险和收益的证据 世界数据。例如，FDA使用了来自其最大的多站点Sentinel系统的真实世界数据和真实世界证据 致力于医疗产品安全的全球分布式数据库，用于监测受监管产品的安全性，而不是上市后 问题研究它已经针对涉及五种产品的九个潜在安全问题进行了此类处理。

房 世界证据是通过分析得出的有关医疗产品的使用和潜在受益或风险的临床证据 真实世界数据。真实世界证据可以通过不同的研究设计或分析生成，包括但不限于随机化 试验，包括大型简单试验、务实试验和观察性研究（前瞻性和/或回顾性）。

不像 传统临床试验，可以策划必要的数据元素并强制收集，创建真实世界证据 需要评估、验证和汇总通过常规临床实践获得的各种（通常是不同的）数据来源。 不同的利益相关者以多种不同的方式使用真实世界证据。

从 真实世界数据到真实世界证据

的 创建真实世界证据需要结合强大的分析、经过验证的方法和丰富的可用知识 真实世界数据源（例如， 现有质量注册中心中捕获哪些数据，可以通过EHR捕获哪些数据 和病例报告表或声明，以及哪些患者组织捕获相关患者队列的数据）。该过程包括几个 步骤，总结如下：

Real World Evidence has been proven to fill a gap between research (what we learn) and everyday practice (what we do) in healthcare, and it creates a difference between what is expected to happen and what really happens. Driving measurable improvements in healthcare requires us all to be rooted in the reality of what actually happens before, during, and after clinical procedures, interventions, and office visits. Real World Evidence fills those gaps and documents the truth by establishing definitively what really happens when doctors treat a wide range of patients that do not look like the homogeneous patient groups in a clinical trial. Because of this, Real World Evidence serves many uses and provides many benefits across the healthcare ecosystem.

As more countries battle to contain healthcare costs, and as the population ages and the number of patients with chronic diseases increases, the need to remove inefficiencies and upgrade the delivery of coordinated care that improves outcomes is more pressing. At the same time, life sciences companies are facing tumultuous times. Industry globalization, the end of the blockbuster era, and an increasingly complex regulatory environment all add to the difficulty of bringing products to market. And across the board, companies are moving toward a patient-centric and outcome-focused model. In this environment, Real World Evidence can be transformative for the industry when Real World Data is combined with the right technology framework and the regulatory intelligence to make sense of it. As data is consumed across life sciences in different ways and by different stakeholders, it can provide valuable insights and “evidence” across the product life cycle. In addition, stakeholders across the healthcare ecosystem use this new knowledge to support decision-making and improve safety and effectiveness, and ultimately, patient outcomes.

Uses of Real World Evidence in Life Sciences, Among Regulators, Clinicians, Researchers and Healthcare Systems

According to repeated studies by Deloitte, the importance of Real World Evidence continues to rise as it promises to accelerate regulatory decision-making and support the approval of new indications for drugs already on the market. Life sciences, pharmaceutical and medical device companies are significant consumers of Real World Evidence because it can provide value across the entire product lifecycle from pre-trial design to clinical studies and trials to post-market surveillance. Medical product developers are using Real World Evidence to support clinical trial designs (e.g., large simple trials, pragmatic clinical trials) and observational studies to generate innovative, new treatment approaches.

Real World Evidence can be used to make clinical trials more effective and efficient, for example in patient recruitment or label extension, Real World Evidence gathered from other studies or from currently marketed products in a similar category, for example, can have a positive effect on the product portfolio by exposing positive side effects as new potential indications. The most famous example is Viagra, which was initially studied as a drug to lower blood pressure, but an unexpected side effect led to the drug ultimately being approved for erectile dysfunction.

The benefits of Real World Evidence derived from Real World Data are increasingly being recognized by regulatory authorities. The FDA released a framework for using Real World Evidence to support the process of drug regulation and submission. This is a major step toward recognizing that clinical trials, while still relevant, are not the only way to assess the efficacy and safety of a product. Indeed, the FDA is soon expected to conduct its first full post-market safety approval using only Real World Evidence.

Real World Evidence is now accepted as a reliable source of information for regulatory decision making in certain circumstances. A primary rationale for the FDA to use Real World Evidence is to help support the approval of a new or extended use for a drug approved under the FD&C Act and to help support or satisfy post-approval study requirements always with the condition that the data quality is up to the standard required. In a recent statement, the FDA even noted how new tools for capturing data in the post-market period, including more sophisticated use of Real World Data and Real World Evidence are providing new approaches to address important questions about the safety and benefits of new drugs in real world settings and that these approaches have the potential to do to so more rapidly and with greater efficiency than traditional methods.

Why Do We Need Real World Evidence?

There is a gap between research (what we learn) and everyday practice (what we do) in healthcare, and it creates a difference between what is expected to happen and what really happens. But it is what really happens that matters. Driving measurable improvements in healthcare requires us all to be rooted in the reality of what actually happens before, during, and after clinical procedures, interventions, and office visits. Real World Evidence is here to fill those gaps and root us in truth. It tells us what really happens when doctors treat a wide range of patients that don’t look like the homogeneous patient groups in a clinical trial. Because of this, Real World Evidence serves many uses and provides many benefits across the healthcare ecosystem.

Uses of Real World Evidence in Pharmaceutical and Device Companies

Pharmaceutical and medical device companies are major consumers of Real World Evidence, as it can provide value across the entire product lifecycle. Real World Evidence plays an important role for research across the product lifecycle for both pharmaceutical and device companies. It can inform pre-trial study design by helping researchers identify potential patients and create proper inclusion criteria for clinical trials. Much of medical innovation is driven by traditional clinical trials, where new pharmaceuticals and devices are rigorously studied and tracked before they can be sold and widely distributed.

Although clinical trials are incredibly important to determine the safety and efficacy of new technologies, when compared to Real World Evidence, they do have some limitations. For example, a traditional clinical trial can have strict inclusion criteria that makes it challenging for providers to accurately extrapolate the results of a clinical trial to a broader population. Clinical trial participation is often limited by who the study administrators are able to recruit, and various demographics are often not able to participate. This again challenges the generalizability of clinical trial results across patient populations. Real World Evidence can help overcome the limitations of clinical trials by providing information about a broader cross-section of society. This can help clinicians, researchers, and industry partners better understand their products and how they work.

Once a product is approved and marketed, Real World Evidence assists pharmaceutical or medical device companies understand their products’ relative safety, effectiveness, value, off-label use and more. This post-market surveillance, or post-marketing surveillance, is valuable to stakeholders across the healthcare industry.

The AI-enabled patient enrichment and recruitment process can improve suitable cohorts and increase clinical trial effectiveness, data management, analysis, and interpretation of multiple Real World Data sources, including EHR and medical imaging data. This presents a unique opportunity for NLP to perform the sophisticated analysis necessary to combine genomic data with electronic medical records (“EMR”) and other patient data, present in various locations, owners, and formats - from handwritten paper copies to digital medical images - to surface biomarkers that lead to endpoints that can be more efficiently measured, and thereby identify and characterize appropriate patient subpopulations. AI-enabled systems can help to improve patient cohort composition and aid with patient recruitment.

AI technologies can help biopharma companies identify target locations, qualified investigators, and priority candidates and collect and collate evidence to satisfy regulators that the trial process complies with good clinical practice requirements. One of the most important elements of a clinical trial is a selection of high-functioning investigator sites. Site qualities such as resource availability, administrative procedures, and experienced clinicians with in-depth knowledge and understanding of the disease can shape study timelines and data quality, accuracy, completeness, and consistency.

AI integrated clinical trial programs can help monitor and manage patients by automating Real World Data capture, sharing data across systems, and digitalizing standard clinical assessments. AI technologies and wearable technologies can help enable continuous patient monitoring and generate real-time insights into the safety and effectiveness of treatment while predicting the possible risk of dropouts, thereby enhancing patient engagement and retention. To comply with trial adherence criteria, patients must keep detailed records of their medication intake and other data points related to their bodily functions, response to medication, and daily protocols. This can be an overwhelming and tedious task, leading to 40% of patients becoming non-adherent after 150 days into a clinical trial. Wearable devices/sensors and video monitoring are used to collect patient data automatically and continuously, thereby relieving the patient of this task. In combination with wearable technology, AI techniques offer new approaches to developing real-time, power-efficient, mobile, and personalized patient monitoring systems.

Among regulators, clinicians, academic researchers and healthcare systems, the reliance on curated Real World Evidence has grown significantly because of the value it can provide, which is unique relative to each parties’ objectives and mandates. It also helps that the FDA has also sharpened its focus on Real World Data and Real World Evidence. For example, in late 2022, the FDA published proposed guidance related to data standards for product submissions with Real World Data and also weighed in on the use of Real World Data and Real World Evidence to support regulatory decision-making for drugs and biological products with specific advice for data from EHR and medical claims. In addition, the FDA uses Real World Data and Real World Evidence to monitor post-market safety and adverse events and to make regulatory decisions. The health care community is using these data to support coverage decisions and to develop guidelines and decision support tools for use in clinical practice.

AI with deep-learning capability is also helpful in organizing and translating a vast amount of structured and unstructured data to Real World Evidence. The human mind can possibly manage 4-5 variables; therefore, AI-enabled data mapping and integration and their normalization into a common data model according to disease pathway and workflow will likely be useful for both quality management in clinical trials and generating meaningful insight for human disease by providing a broader perspective based on Real World data.

Market Size

The global Real World Evidence solutions market size was estimated at USD $2.6 billion in 2023 and is expected to grow at a compound annual growth rate (CAGR) of 8.4% from 2024 to 2030. The market growth is driven by rising demand for enhanced Real World Evidence capabilities within the life science industry, reflecting an increasing market shift from volume to value-based care. Advancements in data analytics and Real World Evidence contribute to supporting regulatory compliance, research, and solution development efforts in medical device and life sciences organizations. For instance, the increased demand for Real World Evidence solutions is prompting players to introduce new products, fostering market growth. In October 2023, Maxis Clinical Sciences launched Real World Evidence Solutions, providing diverse Real World Data capture and analysis to improve clinical research and care.

Government initiatives supporting Real World Evidence programs, evolving regulations, and actionable Real World Data enable organizations to conduct outcomes-based analyses, contributing to the overall market expansion. For instance, in December 2022, the FDA launched the Real World Evidence Program. This program aims to raise awareness that Real World Evidence can support regulatory decisions, identify approaches for generating Real World Evidence to meet post-approval study requirements or effectiveness labeling and develop agency processes that foster consistent decision-making and shared learning regarding Real World Evidence.

The COVID-19 pandemic further accelerated the adoption of Real World Evidence solutions, with governments collaborating with market players to implement these solutions. For instance, in June 2021, ConcertAI and the FDA initiated a five-year collaborative research program, Evaluation of Real World Outcomes and Safety in the Treatment of Cancer. The partnership leverages ConcertAI’s oncology Real World Data and advanced AI technology solutions to generate Real World Evidence for various clinical and regulatory use cases.

. Real World Evidence solutions services allow pharmaceutical companies and healthcare providers as well as payers by providing efficient management of operations and accelerating the process of drug development and its approval, which fuels market growth. Support from regulatory bodies for using Real World Evidence solutions and an increase in research and development spending are anticipated to boost the market growth.

The Real World Evidence solution providers are increasingly forming strategic partnerships with AI solution providers to offer integrated solutions. For instance, in April 2023, ConcertAI, a player in AI SaaS technology and Real World Evidence solutions for healthcare and life sciences, partnered with PathAI, an AI-powered pathology provider, to introduce a first-in-class quantitative histopathology and curated clinical Real World Data solution. This collaboration integrates ConcertAI’s Patient360 and RWD360 products with PathAI’s PathExplore tumor microenvironment panel. Based on end user, the global Real World Evidence solutions market is segmented into pharmaceutical, biotechnology, and medical device companies; healthcare payers; healthcare providers; and other end-users (academic research institutions, patient advocacy groups, regulators, and health technology assessment agencies). The large share of this segment is primarily attributed to the increasing importance of Real World Evidence studies in drug development and approvals and the growing need to avoid costly drug recalls and assess drug performance in Real World settings.

With the growing need for evidence generated from Real World Data, the increasing importance of epidemiological data in decision making, and a shift from volume to value-based care, there has been an increased focus on patient registries, a rise in the adoption of EMR in hospitals, and exponential growth in mobile health data and social media, which have resulted in the generation of huge amounts of medical data. In 2021, the Real World datasets segment is estimated to account for the larger share of 51.2% of the global Real World evidence solutions market. According to Coherent Market Insights, the global Real World Data market is estimated to be valued at $1.59 billion in 2023 and is expected to exhibit a CAGR of 14.4% during the forecast period (2023-2030).

Our Long-Term Growth Strategies

Our long-term growth strategy is anchored on the following key pillars:

Corporate Information

Data Knights was originally incorporated in Delaware on February 8, 2021 under the name “Data Knights Acquisition Corp” as a special purpose acquisition company, formed for the purpose of effecting a merger, capital stock exchange, asset acquisition, stock purchase, reorganization or similar business combination with one or more businesses. On November 7, 2023, we held the closing of the Business Combination (the “Closing”) whereby Merger Sub merged with and into Legacy ONMD, with Legacy ONMD continuing as the surviving entity, which resulted in all of the issued and outstanding capital stock of Legacy ONMD being exchanged for shares of the Company’s Class A Common Stock, $0.0001 par value per share (“Common Stock”), upon the terms set forth in the Merger Agreement.

The Business Combination that closed on November 7, 2023, pursuant to the Merger Agreement, led to Data Knights changing its name to “OneMedNet Corporation” and the business of Data Knights became the business of Legacy ONMD. We are located at 6385 Old Shady Oak Road, Suite 250, Eden Prairie, MN 55344 and reachable by telephone on 800-918-7189.

Legacy ONMD was incorporated in the State of Delaware on November 20, 2015. Its wholly-owned subsidiary, OneMedNet Technologies (Canada) Inc. (“ONMD Canada”), was incorporated on October 16, 2015 under the provisions of the Business Corporations Act of British Columbia. ONMD Canada’s functional currency is the Canadian dollar.

Recent Developments

Closing of Business Combination

On November 7, 2023, following the approval of the Merger Agreement and the transactions contemplated thereby at the special meeting of the shareholders of Data Knights held on October 17, 2023 (the “Special Meeting”), Merger Sub merged with and into Legacy ONMD pursuant to the Merger Agreement (the “Merger”), with Legacy ONMD surviving the Merger as a wholly-owned subsidiary of Data Knights. Following Closing, Data Knights changed its name to “OneMedNet Corporation.”

The Business Combination was accounted for as a reverse recapitalization in accordance with U.S. generally accepted accounting principles (“GAAP”). Under this method of accounting, Data Knights was treated as the acquired company and Legacy ONMD was treated as the acquirer for financial statement reporting purposes.

Lock-up Agreements

Effective April 25, 2022, in connection with the execution of the Merger Agreement, certain stockholders of OneMedNet and certain of OneMedNet’s officers and directors (such stockholders, the “Company Holders”) entered into a lock-up agreement (the “Lock-up Agreement”) pursuant to which the Company Holders are contractually restricted, during the Lock-up Period (as defined below), from (i) lending, offering, pledging, hypothecating, encumbering, donating, assigning, selling, contracting to sell, selling any option or contract to purchase, purchasing any option or contract to sell, granting any option, right or warrant to purchase, or otherwise transferring or disposing of, directly or indirectly, any Lock-Up Shares (as defined below), (ii) entering into any swap or other arrangement that transfers to another, in whole or in part, any of the economic consequences of ownership of the Lock-Up Shares, or (iii) publicly disclosing the intention to do any of the foregoing, whether any such transaction described in clauses (i), (ii), or (iii) above is to be settled by delivery of Lock-Up Shares or other securities, in cash or otherwise (any of the foregoing described in clauses (i), (ii), or (iii), a “Prohibited Transfer”)any of (A) their shares of Common Stock received in connection with the Merger and (B) any of their shares of Common Stock paid as dividends or distributions with respect to such securities or into which such securities are exchanged or converted (collectively, the “Lock-up Shares”). Effective November 7, 2023, the newly appointed officers and directors of OneMedNet Corporation entered into a Lock-Up Agreement.

The “Lock-up Period” means the period commencing at Closing and ending on the earliest of: (a) six months from the Closing, and (b) the date after the Closing on which the Company consummates a liquidation, merger, capital stock exchange, reorganization, or other similar transaction with an unaffiliated third party that results in all of the Company’s stockholders having the right to exchange their shares of Common Stock for cash, securities, or other property.

In addition, the Sponsor is subject to a lock-up pursuant to a letter agreement (the “Sponsor Lock-up Agreement”), entered into on May 6, 2021, at the time of the IPO (as defined below), among Data Knights, the Sponsor and each of the individuals who was a member of Data Knights’ board of directors and/or management team (each, an “Insider” and collectively, the “Insiders”), who agreed that it, he or she shall not transfer any founder shares which means the 2,875,000 shares of Data Knights Class B common stock, par value $0.0001 per share, initially held by the Sponsor, or shares of Common Stock issuable upon conversion thereof) until the earlier of (A) six months after the Closing of the Business Combination or (B) subsequent to the closing of the Business Combination, (x) if the last reported sale price of the Common Stock equals or exceeds $12.00 per share (as adjusted for stock splits, stock dividends, right issuances, reorganizations, recapitalizations and the like) for any 20 trading days within any 30-trading day period commencing at least 150 days after the Business Combination, or (y) the date on which the Company completes a liquidation, merger, capital stock exchange, reorganization or other similar transaction that results in all of our stockholders having the right to exchange their shares of common stock for cash, securities or other property. Further, the Sponsor and each of the Insiders agreed further in the Sponsor Lock-Up Agreement that he, she or it shall not transfer any private placement units, the private placement shares, the private placement warrants or shares of Common Stock issued or issuable upon the exercise of the private placement warrants, until 30 days after the completion of the Business Combination.

PIPE Registration Rights Agreements

At the Closing of the Business Combination and funding of the private investment in public equity (“PIPE”) pursuant to the PIPE SPA (as defined below), the PIPE Investors (as defined below) each executed a PIPE Note (as defined below) and a PIPE Warrant (as defined below) in the amount corresponding to each PIPE Investor’s investment amount and in accordance with the terms set forth in the PIPE SPA as well as a registration rights agreement (the “PIPE Registration Rights Agreement”). We are required to register the offer and sale of these securities to satisfy the registration rights we have granted in the PIPE Registration Rights Agreement. At the Closing of the Business Combination, OneMedNet, Data Knights and the Sponsor entered into a registration rights agreement (the “Registration Rights Agreement”), pursuant to which, among other things, the Company is obligated to file a registration statement to register the resale of certain securities of the Company held by the Holders (as defined in the Registration Rights Agreement) and the Sponsor. The Registration Rights Agreement also provides the Holders and the Sponsor with “piggy-back” registration rights, subject to certain requirements and customary conditions.

Voting Agreement and Sponsor Support Agreement

In connection with entry into the Merger Agreement, Data Knights entered into voting agreements (the “Voting Agreements”) with certain stockholders of Legacy ONMD representing approximately 55% of the outstanding voting power of Legacy ONMD’s equity securities (the “Legacy ONMD Stockholders”) pursuant to which the Legacy ONMD Stockholders agreed to (i) vote their Legacy ONMD equity securities in favor of the approval of the Merger Agreement and the Business Combination, (ii) be bound by certain covenants and agreements related to the Business Combination and (iii) take other customary actions to cause the Business Combination to occur.

In connection with entry into the Merger Agreement, Data Knights, the Sponsor and Legacy ONMD entered into a sponsor support agreement (the “Sponsor Support Agreement”) pursuant to which the Sponsor agreed to vote its Data Knights securities in favor of the approval of the Merger Agreement and the Business Combination and to take other customary actions to cause the Business Combination to occur.

Executive Employment Agreements

In connection with the Closing of the Business Combination, the Company entered into employment agreements (the “Employment Agreements”) with executive officers: Aaron Green (President), Lisa Embree (former Chief Financial Officer), and Paul Casey (former Chief Executive Officer). The Employment Agreements provide for at-will employment that may be terminated by the Company with or without cause, by the executive with or without good reason, or mutually by the parties. See Item 11, “Executive Compensation—Executive Employment Arrangements” for additional information on current employment agreements of our executive officers.

PIPE Stock Purchase Agreement

On June 28, 2023, Data Knights entered into a Securities Purchase Agreement (the “PIPE SPA”) with certain investors (collectively referred to herein as the “PIPE Investors”) for a PIPE financing in the aggregate original principal amount of $1,595,744.70 and the purchase price of $1.5 million. Pursuant to the PIPE SPA, Data Knights issued and sold to each of the PIPE Investors a new series of senior secured convertible notes (the “PIPE Notes”), which are convertible into shares of Common Stock at the PIPE Investor’s election at a conversion price equal to the lower of (i) $10.00 per share, and (ii) 92.5% of the lowest volume weighted average trading price (“VWAP”) for the ten (10) Trading Days (defined as a day on which the Common Stock is traded on a trading market) immediately preceding the Conversion Date (defined as any date) , subject to the floor price of $1.14 (representing 20% of the closing price of the Common Stock on the last trading day before the closing of the Business Combination), or the alternative conversion ratio of the greater of the floor price and the lesser of 80% of the VWAP of the Common Stock as of the trading day and 80% of the price computed as the quotient of the sum of the VWAP of the Common Stock for each of the three trading days with the lowest VWAP of the Common Stock during the fifteen consecutive trading day period ending and including the trading day immediately preceding the delivery or deemed delivery of the applicable conversion notice, divided by three. All such determinations are to be appropriately adjusted for any stock dividend, stock split, stock combination, reclassification or similar transaction that proportionately decreases or increases the Common Stock. The PIPE Investors’ $1.5 million investment in the PIPE Notes closed and funded contemporaneous to the Closing of the Business Combination. Effective immediately prior to the Closing, Data Knights issued the PIPE Notes to the PIPE Investors pursuant to the private offering rules under the Securities Act. In conjunction with the issuance of the PIPE Notes, Data Knights also issued and sold to each of the PIPE Investors 95,745 warrants to purchase Common Stock at an exercise price of $10.00 per share (the “PIPE Warrants”).

Government Regulation

Many aspects of our businesses are regulated by federal and state laws, rules and regulations. Accordingly, we maintain a robust compliance program aimed at ensuring we operate our business in compliance with all existing legal requirements material to the operation of our businesses. There are, however, occasionally uncertainties involving the application of various legal requirements, the violation of which could result in, among other things, fines or other sanctions. See “Risk Factors” for additional detail.

Regulation of Patient Information. Our information management services relate to the processing of information regarding patient diagnosis and treatment of disease and are, therefore, subject to substantial governmental regulation. In addition, the confidentiality of patient-specific information and the circumstances under which such patient-specific records may be released for inclusion in our databases or used in other aspects of our business is heavily regulated. Federal, state and foreign governments are contemplating or have proposed or adopted additional legislation governing the possession, use and dissemination of personal data, such as personal health information and personal financial data, as well as security breach notification rules for loss or theft of such data. Additional legislation or regulation of this type might, among other things, require us to implement additional security measures and processes or bring within the legislation or regulation deidentified health or other data, each of which may require substantial expenditures or limit our ability to offer some of our services.

In particular, personal health information is recognized as a special, sensitive category of personal information, subject to additional mandatory protections. Violations of data protection regulations are subject to administrative penalties, civil money penalties and criminal prosecution, including corporate fines and personal liability.

Data Privacy

Certain of our operations are subject to regulation under the administrative simplification provisions of the Health Insurance Portability and Accountability Act of 1996, as amended (“HIPAA”). Federal regulations related to HIPAA contain minimum standards for electronic transactions and code sets and for the privacy and security of protected health information. Patient health information is among the most sensitive of personal information, and it is critically important that information about an individual’s healthcare is properly protected from inappropriate access, use and disclosure. Real World Evidence - information that allows us to examine actual practices and outcomes - is essential to increase access to care, improve outcomes, and lower costs.

OneMedNet uses a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while generating and analyzing information on a scale that helps healthcare stakeholders identify disease patterns and correlate with the precise treatment path and therapy needed for better outcomes. We employ a wide variety of methods to manage privacy requirements, including:

We have relied on expertise in the industry with de-identifying data. Our capabilities allow us to render data non-identified while still maintaining data utility, thus protecting privacy while still advancing innovation. Not only do we make use of de-identification techniques with respect to the data we hold, but we also share our expertise in this area with policymakers, regulators and others to help them understand de-identification methodologies and practical considerations to avoid re-identification risk. We operate in more than 100 countries around the world, many of which have data protection and privacy laws and regulations based on similar core principles (e.g., openness, accountability, security safeguards, etc.). We apply those principles globally and augment our practices to address local laws, contractual obligations and other data privacy requirements.

Our Compliance team, led by our Chief Compliance Officer, is comprised of privacy professionals and privacy law experts who drive our strategy and develop and manage our policies and standards. The Compliance team provides subject matter expertise related to the proper management of all data types. In addition, our Compliance team liaises with our Legal, Information Technology, Information Security and other teams so that privacy requirements are addressed in technology, contracting, offerings and other business activities.

The OneMedNet Privacy Policy (the “Privacy Policy”) is our foundational privacy policy. It explains how, when applicable, we collect, hold, use and disclose personal information, including that of our personnel, consumers, healthcare professionals, patients, medical research subjects, clinical investigators, customers, suppliers, vendors, business partners and investors.

Regulatory Quality Compliance (FDA 21 CFR Part 11)

OneMedNet provides high-quality, de-identified, regulatory-grade imaging and clinical data; as such OneMedNet adheres to all applicable local and Federal regulatory quality requirements, including but not limited to FDA 21 CFR Part 11. OneMedNet maintains a rigorous and ongoing internal quality management system to enable the organization to produce high quality regulatory compliant clinical data for our clients and consumers. This program includes:

Human Capital Resources

Our workforce is comprised of approximately 20 employees (as of December 31, 2023), including approximately 0 part-time employees (references herein to “employees” include to the employees of our subsidiaries). Our Board of Directors and its committees oversee human capital matters through regular reporting from management and advisors.

Diversity, Equity and Inclusion

We are committed to fostering a culture of inclusion that embraces and supports our patients, colleagues, partners, physicians and communities. Our policies prohibit discrimination on the basis of age, gender, disability, race, color, ancestry, citizenship, religion, pregnancy, sexual orientation, gender identity or expression, national origin, medical condition, marital status, veteran status, payment source or ability, or any other basis prohibited by federal, state or local law.

Compensation and Benefits

We provide competitive compensation and benefits programs to help meet the needs of our employees. In addition to salaries, these programs (which vary by location of the employee) include a 2022 Stock Option Plan, health care and insurance benefits, health savings and flexible spending accounts, paid time off, family leave, family care resources, and employee assistance programs, among many others.

Facilities

Prior to the Closing of the Business Combination, the Company’s executive offices were located at Unit G6, Frome Business Park, Manor Road, Frome, United Kingdom, BA11 4FN and its telephone number was +44 203 833 4000. The Company agreed to pay ARC Group Ltd., an affiliate of the Sponsor, up to an amount of $10,000 per month for office space, secretarial and administrative support. For the years ended December 31, 2023 and 2022, we had incurred $90,000 and $120,000 in fees under this agreement, respectively. Upon completion of our Business Combination, the Company ceased paying these monthly fees.

After the Closing of the Business Combination, our headquarters is located at 6385 Old Shady Oak Road, Suite 250, Eden Prairie, MN 55344 and our telephone number is (800) 918-7189, where we lease and occupy our office space with an aggregate floor area of approximately 67 square feet from unrelated third parties under operating lease agreements. We believe our current office space is adequate for our current operations and our anticipated future needs.

Implications of Being an Emerging Growth Company

As a company with less than $1.235 billion in revenues during our last fiscal year, we qualify as an emerging growth company as defined in the Jumpstart Our Business Startups Act (“JOBS Act”) enacted in 2012. As an emerging growth company, we expect to take advantage of reduced reporting requirements that are otherwise applicable to public companies. These provisions include, but are not limited to:

Available Information

We file with, or furnish to, the SEC reports, including our annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and amendments to those reports pursuant to Section 13(a) or 15(d) of the Exchange Act. These reports are available free of charge via EDGAR through the SEC website (www.sec.gov) and are also available free of charge on our corporate website (https://www.onemednet.com) as soon as reasonably practicable after they are electronically filed with or furnished to the SEC. The foregoing website addresses are provided as inactive textual references only. The information provided on our website (or any other website referred to in this Amended Form 10-K) is not part of this report and is not incorporated by reference as part of this Amended Form 10-K.

Item 1A. Risk Factors

An investment in our securities involves a high degree of risk. The risks and uncertainties we have described in this Amended Form 10-K are not the only ones we face. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also affect our business, financial condition, and results of operations. We may not be successful in preventing the material adverse effects that any of the following risks and uncertainties may cause.

You should carefully consider the following risks, as well as the other information contained in this Amended Form 10-K, including our historical financial statements and related notes included elsewhere in this Amended Form 10-K. Any one of these risks and uncertainties has the potential to cause material adverse effects on our business, prospects, financial condition and operating results which could cause actual results to differ materially from any forward-looking statements expressed by us and a significant decrease in the value of our Common Stock and warrants. Refer to “Cautionary Statement Regarding Forward-Looking Statements.”

Risks Related to Our Business

We have a history of operating losses and may never achieve profitability in the future.

We have experienced net losses in each annual period since inception. We generated net losses of $33.8 million and $30.5 million for the years ended December 31, 2023 and 2022, respectively. As of December 31, 2023, we had accumulated losses of approximately $91.4 million.

We expect to continue to incur significant losses in the development, marketing, sale and delivery of our services. If we do not grow our revenues or if we lose existing customers, we expect to continue to incur losses from operations for the foreseeable future. Because of the numerous risks and uncertainties associated with the development, marketing, sale and delivery of our iRWD^TM services, we may experience larger than expected future losses and may never become profitable. Moreover, there is a substantial risk that we may not be able to successfully commercialize our iRWD^TM services, which would make it unlikely that we would ever achieve profitability.

OneMedNet believes it has demonstrated its quality and responsiveness in clinical imaging and curation of Real-World Data based upon success in compiling one of the largest networks of imaging centers (comprised of hospitals, imaging centers and clinics) throughout the United States covering more than 15 million patients to date. On the global front, OneMedNet works with hospitals and life science companies around the world including in Ireland, United Kingdom, Ghana, Denmark and South Korea and growing. We base these claims on our understanding of our competition in the United States and globally. However, if we were to lose these relationships with our network of imaging centers or lose our customers or our competitors’ technology surpasses ours, our competitors could claim a greater market share domestically or abroad, which could reduce our growth and our profits, which could harm our business, financial position, results of operations and prospects.

The report of our independent registered public accounting firm for the fiscal years ended December 31, 2023 and 2022 contains an explanatory paragraph regarding substantial doubt about our ability to continue as a going concern.

As stated above, we have experienced net losses in each annual period since inception. We generated net losses of $33.8 million and $30.5 million for the years ended December 31, 2023 and 2022, respectively. As of December 31, 2023, we had an accumulated deficit of approximately $91.4 million. In their audit report for the fiscal year ended December 31, 2023 included in this report, our auditors have expressed their concern as to our ability to continue as a going concern. Our ability to continue as a going concern is dependent upon our ability to generate cashflows from operations and obtain financing. We intend to continue funding our operations through equity and debt financing arrangements, which may be insufficient to fund our capital expenditures, working capital and other cash requirements in the long term. There can be no assurance that the steps management is taking will be successful.

One significant customer represented 51% and 29% of our revenues for 2023 and 2022 respectively and is expected to continue to represent a significant portion of our forecasted revenue for 2024.

Change Healthcare represented 51% and 29% of our revenues in 2023 and 2022, respectively. Change Healthcare is expected to continue to represent a significant portion of our forecasted revenue for 2024. If we fail to maintain and grow our relationship with Change Healthcare, we could lose a significant portion of our revenue for 2023, which would materially adversely affect our results of operations and our business. If OneMedNet were to lose this significant customer, its revenue may significantly decline. In addition, revenue from this significant customer may vary from period to period depending on the timing of renewing existing agreements or entering into new agreements for additional OneMedNet products as well as other unforeseen risks and variables discussed in this Amended Form 10-K. The loss of this significant customer could adversely affect its business, results of operations and financial condition. You should not rely on our historical relationship with these companies as an indication of our future performance.

We may encounter difficulties in managing our attempted growth of our business, which could negatively impact our operations.

As we expand, market, sell and deliver our service offerings, we anticipate that we will need to increase our service development, sales and marketing and administrative headcount. Such an evolution may impact our strategic focus and our deployment and allocation of resources. Our ability to manage our operations and growth effectively depends upon the continual improvement of our procedures, reporting systems and operational, financial and management controls. We may not be able to implement administrative and operational improvements in an efficient or timely manner and may discover deficiencies in existing systems and controls. If we do not meet these challenges, we may be unable to execute our business strategies and may be forced to expend more resources than anticipated addressing these issues.

We may acquire additional technology and complementary businesses in the future. Acquisitions involve many risks, any of which could materially harm our business, including the diversion of management’s attention from core business concerns, failure to effectively exploit acquired technologies, failure to successfully integrate the acquired business or realize expected synergies or the loss of key employees from either our business or the acquired businesses.

We may be unable to execute our business objectives and growth strategies successfully or sustain our growth and, as a result, this could have a material adverse effect on our operating results.

The highly complex nature of our industry requires that we effectively execute and manage our business objectives and growth strategies, such as expanding our marketing and commercialization of our services in the U.S. and internationally, adding new customers, and increasing our service delivery capacity. However, we may not be able to execute these strategies as effectively as anticipated. Our ability to execute on these strategies depends on a number of factors, including, without limitation:

To the extent we are unable to execute our growth strategies in accordance with our expectations, this could have a material adverse effect on our business, financial condition, and future results of operations.

The Real World Data and Real World Evidence business market continues to evolve and is highly competitive, and we may not be successful in competing in this industry or establishing and maintaining confidence in our long-term business prospects among current and future partners and customers.

The Real World Data and Real World Evidence business market in which we compete continues to evolve and is highly competitive. To date, we have focused our efforts on our expertise in clinical imaging innovation solutions that connect healthcare providers and patients and satisfy a crucial need for the life sciences. We offer direct access to clinical images and associated contextual patient records. OneMedNet proved the commercial and regulatory viability of iRWD^TM, a promising emerging market, that exactly matches OneMedNet’s life science partners’ case selection protocol. OneMedNet has the immediate ability to quickly search and extensively curate multi-layer data from a federated group of healthcare facilities and to provide fast access to curated medical images that has proved the commercial and regulatory viability of imaging Real World Data and covers the complete value chain in imaging Real World Data, validated by an increasing federated network of providers. However, Real World Data and Real World Evidence has been increasingly adopted, and our current competitors have, and future competitors may have, greater resources than we do and may also be able to devote greater resources to the development of their current and future technologies. These competitors also may have greater access to customers and may be able to establish cooperative or strategic relationships amongst themselves or with third parties that may further enhance their resources and competitive positioning.

Developments in improvements in Real World Data and Real World Evidence curation by competitors may materially adversely affect the sales, pricing and gross margins of our business. If a competing technology or process is developed that has superior operational or price performance, our business will be harmed. Similarly, if we fail to accurately predict and ensure that our Real World Data and Real World Evidence offering can address customers’ changing needs or emerging technological trends, or if our customers fail to achieve the benefits expected from our Real World Data and Real World Evidence offering, our business will be harmed.

We must continue to commit resources to develop our Real World Data and Real World Evidence technology in order to establish a competitive position, and these commitments will be made without knowing whether such investments will result in products potential customers will accept. There is no assurance we will successfully identify new customer requirements, develop and bring our Real World Data and Real World Evidence to market on a timely basis, or that products and technologies developed by others will not render our Real World Data and Real World Evidence obsolete or noncompetitive, any of which would adversely affect our business and operating results.

If we are unable to attract and retain key employees and qualified personnel, our ability to compete could be harmed.

We depend on the talents and continued efforts of our senior management and key employees. The loss of members of our management or key employees may disrupt our business and harm our results of operations. Further, our ability to manage further expansion will require us to continue to attract, motivate and retain additional qualified personnel. Competition for this type of personnel is intense, and we may not be successful in attracting, integrating and retaining the personnel required to grow and operate our business effectively. There can be no assurance that our current management team or any new members of our management team will be able to successfully execute our business and operating strategies.

Our inability to expand our development, use and adoption of artificial intelligence, or issues presented in our development, use and adoption of artificial intelligence, could harm our reputation, expose us to liability and cause us to lose customers.

We currently incorporate certain AI capabilities into our solutions, and we endeavor to continue researching and developing AI capabilities within our solutions. As with many innovative and disruptive technologies, AI presents risks, challenges, and unintended consequences, many of which cannot be fully appreciated currently. These risks, challenges and unintended consequences could negatively affect further adoption of AI in our solutions, impacting our ability to compete effectively within the regulatory-grade imaging RWD industry. AI algorithms and the training methodologies for such algorithms may contain flaws, which could result in ineffective, inadequate, or inaccurate AI capabilities, or could impair customer or partner acceptance of our solutions leveraging such AI capabilities. Should we develop and incorporate flawed AI capabilities within our solutions, such flaws would negatively impact our brand and reputation, increase costs to develop and implement new AI capabilities, or lead to a decline in sales revenue. Such impacts would harm our business, financial condition, and results of operations.

Because AI is an emerging technology with a developing legal and regulatory landscape both in the United States and globally, incorporating AI into our solutions and internal business processes could result in an increased risk of litigation and regulatory non-compliance due to changes in laws or regulations, including, but not limited to, intellectual property, privacy, or data protection. Our obligations to comply with current and future legal and regulatory obligations in the United States and worldwide could require us to incur significant costs to achieve compliance, which could negatively impact our business, financial condition and results of operations, or may hinder our ability to incorporate AI capabilities into our solutions or distribute our solutions in certain markets.

As we continue to develop ways to leverage AI capabilities within our internal business operations to create economic efficiencies for our business, the use of AI capabilities in our internal business operations could present risks and challenges. While we strive to use AI in an ethical and compliant manner, we may be unsuccessful in identifying and/or resolving ethical or legal issues before they arise, which could increase our legal and regulatory risks, including, but not limited to, data privacy and security, leading to the improper transmission of proprietary or sensitive information, whether or not intentional. We could fail to implement and maintain the AI tools we develop, may incur significant research and development costs without achieving the anticipated economic efficiencies we desire, and/or may fail to establish adequate AI governance processes safeguards, which could negatively impact our business, financial condition, and results of operations.

A material breach in security relating to the Company’s information systems and regulation related to such breaches, cyber-attacks, or other disruptions could adversely affect the Company, expose us to liability and affect our business and reputation.

Information security risks have generally increased in recent years, in part because of the proliferation of new technologies and the use of the Internet, and the increased sophistication and activity of organized crime, hackers, terrorists, activists, cybercriminals and other external parties, some of which may be linked to terrorist organizations or hostile foreign governments. Cybersecurity attacks are becoming more sophisticated and include malicious software, ransomware, attempts to gain unauthorized access to data and other electronic security breaches that could lead to disruptions in critical systems, unauthorized release of confidential or otherwise protected information and corruption of data, substantially damaging the Company’s reputation. Any person who circumvents the security measures could steal proprietary or confidential information or cause interruptions in the Company’s operations.

We are increasingly dependent on our information technology systems and infrastructure for our business. We, our collaborators and our service providers collect, store, and transmit sensitive information including intellectual property, proprietary business information, and personal information in connection with our business operations. The secure maintenance of this information is critical to our operations and business strategy. Some of this information could be an attractive target of criminal attack by third parties with a wide range of motives and expertise, including organized criminal groups, “hacktivists,” disgruntled current or former employees, nation-state and nation-state supported actors, and others. Cyber-attacks are of ever-increasing levels of sophistication, and despite our security measures, our information technology and infrastructure may be vulnerable to such attacks or may be breached, including due to employee error or malfeasance.

We have implemented information security measures to protect our systems, proprietary information, and sensitive data against the risk of inappropriate and unauthorized external use and disclosure and other types of compromise. However, despite these measures, and due to the ever-changing information cyber-threat landscape, we cannot guarantee that these measures will be adequate to detect, prevent or mitigate security breaches and other incidents and we may be subject to data breaches through cyber-attacks, malicious code (such as viruses and worms), phishing attacks, social engineering schemes, and insider theft or misuse. Any such breach could compromise our networks, and the information stored there could be accessed, modified, destroyed, publicly disclosed, lost or stolen. If our systems become compromised, we may not promptly discover the intrusion.

Any security breach or other incident, whether real or perceived, could cause us to suffer reputational damage. Such incidents could result in costs to respond to, investigate and remedy such incidents, notification obligations to affected individuals, government agencies, credit reporting agencies and other third parties, legal claims or proceedings, and liability under our contracts with other parties and federal and state laws that protect the privacy and security of personal information. The Company’s failure to prevent security breaches, or well-publicized security breaches affecting the Internet in general, could significantly harm the Company’s reputation and business and financial results.

If we are unable to adequately protect or expand our intellectual property related to our current or future products, our business prospects could be harmed.

Our success, competitive position and future revenues will depend in part on our ability to obtain and maintain intellectual property protection for our products, methods, processes and other technologies, to preserve our trade secrets, to prevent third parties from infringing on our proprietary rights and to operate without infringing the proprietary rights of third parties.

We will be able to protect our proprietary intellectual property rights from unauthorized use by third parties only to the extent that our proprietary rights are effectively maintained as trade secrets. Our industry involves complex legal and factual questions, and, therefore, we cannot predict with certainty whether we will be able to ultimately enforce our proprietary intellectual property rights. Therefore, any intellectual property rights that may be challenged, invalidated or circumvented, and may not provide us with the protection against competitors that we anticipate. The degree of future protection for our proprietary intellectual property rights is uncertain because legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep our competitive advantage.

If we fail to comply with the extensive legal and regulatory requirements affecting the health care industry, we could face increased costs, penalties and a loss of business.

Our activities, and the activities of our collaborators, partners and third-party providers, are subject to extensive government regulation and oversight both in the United States and in foreign jurisdictions. The FDA and comparable agencies in other jurisdictions directly regulate many of our most critical business activities, including product manufacturing, advertising and promotion, product distribution, adverse event reporting and product risk management. States increasingly have been placing greater restrictions on the marketing practices of healthcare companies and have instituted pricing disclosure and other requirements for companies in the health sciences industry. In addition, health sciences companies have been the target of lawsuits and investigations alleging violations of government regulations, including claims asserting submission of incorrect pricing information, improper promotion of products, payments intended to influence the referral of federal or state healthcare business, submission of false claims for government reimbursement, antitrust violations, violations of the U.S. Foreign Corrupt Practices Act, the U.K. Bribery Act and similar anti-bribery or anti-corruption laws, or violations related to environmental matters. There is also enhanced scrutiny of company-sponsored patient assistance programs, including insurance premium and co-pay assistance programs and donations to third-party charities that provide such assistance. Violations of governmental regulation by us, our customers, and our partners may be punishable by criminal and civil sanctions, including damages, fines and penalties and exclusion from participation in government programs. Actions taken by federal or local governments, legislative bodies and enforcement agencies with respect to these legal and regulatory compliance matters could also result in reduced demand for our products. We cannot ensure that our compliance controls, policies, and procedures will in every instance protect us from acts committed by our employees, collaborators, partners or third-party providers that would violate the laws or regulations of the jurisdictions in which we operate. Whether or not we have complied with the law, an investigation into alleged unlawful conduct could increase our expenses, damage our reputation, divert management time and attention and adversely affect our business, and any settlement of these proceedings could result in significant payments by us. Risks relating to compliance with laws and regulations may be heightened as we continue to expand our global operations, which may result in additional regulatory burdens and obligations.

Our collection, use, and disclosure of personal information is subject to U.S. state and federal privacy and security regulations, and our failure to comply with those regulations or to adequately secure the information we hold could result in significant liability or reputational harm.

The privacy and security of personal information stored, maintained, received, or transmitted, including electronically, is a major issue in the U.S. and abroad. Numerous federal and state laws and regulations, including state privacy, data security and breach notification laws, federal and state consumer protection and employment laws, the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and the Genetic Information Nondiscrimination Act of 2008, govern the collection, dissemination, use, and confidentiality of personal information, including genetic, biometric, and health information. These laws and regulations are increasing in complexity and number, may change frequently, and sometimes conflict. Penalties for violations of these laws vary but can be severe.

While we strive to comply with all applicable privacy and security laws and regulations, including our own posted privacy policies, these laws and regulations continue to evolve, and any failure or perceived failure to comply may result in proceedings or actions against us by government entities or others or could cause us to lose customers, which could have a material adverse effect on our business. Recently, there has been an increase in public awareness of privacy issues in the wake of revelations about the data collection activities of various government agencies and in the number of private privacy-related lawsuits filed against companies. Concerns about our practices with regard to the collection, use, retention, disclosure, or security of personal information or other privacy-related matters, even if unfounded and even if we are in compliance with applicable laws, could damage our reputation and harm our business.

Our operations could be damaged or adversely affected as a result of natural disasters and other catastrophic events.

Our operations could be adversely affected by events outside of our control, such as natural disasters, wars, health epidemics such as the COVID-19 pandemic, and other calamities. We cannot assure you that any backup systems will be adequate to protect us from the effects of fire, floods, typhoons, earthquakes, power loss, telecommunications failures, break-ins, war, riots, terrorist attacks or similar events. Any of the foregoing events may give rise to interruptions, breakdowns, system failures, technology platform failures or internet failures, which could cause the loss or corruption of data or malfunctions of software or hardware as well as adversely affect our ability to provide services.

Our ability to utilize our net operating loss and tax credit carryforwards to offset future taxable income may be subject to certain limitations.

In general, under Section 382 of the Internal Revenue Code, a corporation that undergoes an “ownership change” is subject to limitations on its ability to use its pre-change net operating loss carryforwards (“NOLs”) to offset future taxable income. An “ownership change” is generally defined as a greater than 50 percentage point change (by value) in its equity ownership by certain stockholders over a three-year period. If we have experienced an ownership change at any time since our incorporation, we may already be subject to limitations on our ability to utilize our existing NOLs and other tax attributes to offset taxable income or tax liability. In addition, the Business Combination and future changes in our stock ownership, which may be outside of our control, may trigger an ownership change. Similar provisions of state tax law may also apply to limit our use of accumulated state tax attributes. As a result, even if we earn net taxable income in the future, our ability to use these or our pre-change NOL carryforwards and other tax attributes to offset such taxable income or tax liability may be subject to limitations, which could potentially result in increased future income tax liability to us. The Company has not yet conducted a formal study of whether, or to what extent, past changes in control of the Company impacts its ability to utilize NOL carryforwards because such NOL carryforwards cannot be utilized until the Company achieves profitability.

There is also a risk that changes in law or regulatory changes made in response to the need for some jurisdictions to raise additional revenue to help counter the fiscal impact from unforeseen reasons, including suspensions on the use of net operating losses or tax credits, possibly with retroactive effect, may result in our existing net operating losses or tax credits expiring or otherwise being unavailable to offset future income tax liabilities.

We are subject to many hazards and operational risks that can disrupt our business, some of which may not be insured or fully covered by insurance.

Our operations are subject to many hazards and operational risks inherent to our business, including: (a) general business risks; (b) warranty liability; and (c) damage to third parties (e.g., our vendors), our infrastructure or properties caused by fires, floods and other natural disasters, power losses, telecommunications failures, terrorist attacks, riots, cyberattacks, public health crises such as the COVID-19 pandemic (and other future pandemics or epidemics), human errors and similar events. As a result of the COVID-19 outbreak, or similar pandemics, we have and may in the future experience disruptions that could severely impact our business and the business of our customers.

Our insurance coverage may be inadequate to cover our liabilities related to such hazards or operational risks. For example, we do not currently maintain cybersecurity insurance and our insurance providers may take the position that our coverage, under present circumstances, does not extend to business interruptions. In addition, we may not be able to maintain adequate insurance in the future at rates we consider reasonable and commercially justifiable, and insurance may not continue to be available on terms as favorable as our current arrangements. The occurrence of a significant uninsured claim or a claim in excess of the insurance coverage limits maintained by us could have a material adverse effect on our business, financial condition and results of operations.

Risks Related to Our Common Stock

Our Common Stock may be subject to extreme volatility.

The trading price of our Common Stock may be subject to extreme volatility. We cannot predict the magnitude of future fluctuations in the trading price of our Common Stock. The trading price of our Common Stock may be affected by a number of factors, including events described in this section entitled, “Risk Factors” and in our other periodic reports filed with the SEC from time to time, as well as our operating results, financial condition and other events or factors. Any of the factors listed below could have a material adverse effect on your investment in our securities. Factors affecting the trading price of our securities may include:

Broad market and industry factors may materially harm the market price of our securities irrespective of our operating performance. The stock market in general, and the Nasdaq in particular, have experienced price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of the particular companies affected. The trading prices and valuations of these stocks, and of our securities, may not be predictable. A loss of investor confidence in the market for retail stocks or the stocks of other companies which investors perceive to be similar to the Company could depress our share price regardless of our business, prospects, financial conditions or results of operations. A decline in the market price of our securities also could adversely affect our ability to issue additional securities and our ability to obtain additional financing in the future.

Following certain periods of volatility in the market price of our securities, we may become subject to securities litigation. We have experienced, and may in the future experience, additional litigation following periods of volatility. This type of litigation may result in substantial costs and a diversion of management’s attention and resources.

We are currently listed on The Nasdaq Capital Market. If we are unable to maintain listing of our securities on Nasdaq or any stock exchange, our stock price could be adversely affected and the liquidity of our stock and our ability to obtain financing could be impaired and it may be more difficult for our stockholders to sell their securities.

Although our Common Stock is currently listed on The Nasdaq Capital Market, we may not be able to continue to meet the exchange’s minimum listing requirements or those of any other national exchange. If we are unable to maintain listing on Nasdaq or if a liquid market for our Common Stock does not develop or is sustained, our Common Stock may remain thinly traded.

On February 7, 2024, the Company received written notice (the “MVLS Nasdaq Notice”) from Nasdaq indicating that for the preceding 30 consecutive business days, the market value of the Company’s listed securities (“MVLS”) did not maintain a minimum market value of $50,000,000 (the “Minimum MVLS Requirement”) as required by Nasdaq Listing Rule 5450(b)(2)(A). In accordance with Nasdaq Listing Rule 5810(c)(3)(C), the Company had a compliance period of 180 calendar days, or until August 5, 2024, to regain compliance with the Minimum MVLS Requirement. Compliance could have been achieved if the Company’s MVLS closed at $50,000,000 or more for a minimum of ten consecutive business days at any time during the 180-day compliance period, in which case Nasdaq would notify the Company of its compliance and the matter would be closed.

If the Company did not regain compliance with the Minimum MVLS Requirement by August 5, 2024, Nasdaq would have provided written notification to the Company that its Common Stock was subject to delisting. At that time, the Company could have appealed the relevant delisting determination to a hearings panel pursuant to the procedures set forth in the applicable Nasdaq Listing Rules. The Company sought to apply for a transfer to The Nasdaq Capital Market, and on August 15, 2024, the Company received approval from Nasdaq to list the Common Stock and Public Warrants on The Nasdaq Capital Market. The Common Stock and Public Warrants were transferred from The Nasdaq Global Market to The Nasdaq Capital Market at the opening of business on August 19, 2024, and continue to trade under the symbols “ONMD” and “ONMDW,” respectively.

On March 26, 2024, the Company received written notice (the “Bid Price Nasdaq Notice”) from Nasdaq notifying the Company that, for the 30 consecutive business days prior to the date of the Bid Price Nasdaq Notice, the Common Stock did not meet the minimum bid price of $1.00 per share requirement (the “Minimum Bid Price Requirement”) as required by Nasdaq Listing Rule 5450(a)(1). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company had a compliance period of 180 calendar days, or until September 23, 2024, to regain compliance with the Minimum Bid Price Requirement. Compliance could have been achieved if the closing bid price of the Company’s Common Stock was at least $1 for a minimum of ten consecutive business days. On June 10, 2024, the Nasdaq staff determined that for the prior 11 consecutive business days, from May 23, 2024, to June 7, 2024, the closing bid price of the Company’s Common Stock had been at $1.00 per share or greater. Accordingly, the Company regained compliance with Listing Rule 5450(a)(1), and this matter was closed.

On June 20, 2024, the Company received a delinquency notification letter from Nasdaq (the “Q1 2024 Form 10-Q Nasdaq Notice”), which indicated that, as a result of the Company’s delay in filing its Quarterly Report on Form 10 Q for the fiscal quarter ended March 31, 2024 (the “Q1 2024 Form 10-Q”) by the applicable due date, the Company was not in compliance with Nasdaq Listing Rule 5250(c)(1) (the “Periodic Report Rule”), which requires Nasdaq-listed companies to timely file all required periodic financial reports with the SEC. The Q1 2024 Form 10-Q Nasdaq Notice stated that the Company had 60 calendar days to submit to Nasdaq a plan to regain compliance with the Periodic Report Rule. If Nasdaq accepted the Company’s plan to regain compliance, then Nasdaq could have granted the Company up to 180 calendar days from the prescribed due date of the Form 10-Q to regain compliance.

On September 9, 2024, the Company received a delinquency notification letter from Nasdaq (the “Q2 2024 Form 10 Q Nasdaq Notice”), which indicated that, as a result of the Company’s delay in filing its Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2024 (together with the Q1 2024 Form 10-Q, the “Delinquent Filings”) by the applicable due date, the Company was not in compliance with the Periodic Report Rule, which requires Nasdaq listed companies to timely file all required periodic financial reports with the SEC.

On September 10, 2024, the Company received a notification letter from Nasdaq (the “Nasdaq Compliance Plan Notice”), which responded to the Company’s plan to regain compliance regarding its delinquent Q1 2024 Form 10 Q, granting the Company an exception until October 31, 2024 to file the Delinquent Filings with the SEC and regain compliance with the Periodic Report Rule. In the event the Company does not regain compliance with the Periodic Report Rule by October 31, 2024, Nasdaq will provide written notification that the Company’s securities will be delisted. At that time, the Company may appeal Nasdaq’s determination to a hearings panel.

On October 8, 2024, the Company received a delinquency notification letter from Nasdaq (the “Second MVLS Nasdaq Notice”) indicating that for the preceding 30 consecutive business days, the Company’s MVLS was below the minimum of $35 million required for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(b)(2). The staff at Nasdaq also noted in the Second MVLS Nasdaq Notice that the Company is not in compliance with Nasdaq Listing Rule 5550(b)(1), which requires listed companies to maintain a minimum stockholders’ equity of $2.5 million, and Nasdaq Listing Rule 5550(b)(3), which requires listed companies to maintain a minimum of $500,000 of net income from continuing operations. In accordance with Nasdaq listing rule 5810(c)(3)(C), the Company has 180 calendar days, or until April 7, 2025, to regain compliance with the Minimum MVLS Requirement. Compliance may be achieved if the Company’s MVLS closes at $35 million or more for a minimum of ten consecutive business days at any time during the 180-day compliance period, in which case Nasdaq will notify the Company of its compliance and the matter will be closed, If the Company does not regain compliance by the end of the 180-day compliance period, Nasdaq staff will provide written notice to the Company that its securities are subject to delisting. At that time, the Company may appeal any such delisting determination to a hearings panel.

On October 16, 2024, the Company received a delinquency notification letter from Nasdaq (the “Second Bid Price Nasdaq Notice,” and together with the MVLS Nasdaq Notice, the Bid Price Nasdaq Notice, the Q1 2024 Form 10-Q Nasdaq Notice, the Q2 2024 Form 10 Q Nasdaq Notice, the Nasdaq Compliance Plan Notice, and the Second MVLS Nasdaq Notice, the “Nasdaq Notices”) notifying the Company that, for the 30 consecutive business days prior to the date of the Second Bid Price Nasdaq Notice, the Common Stock did not meet the Minimum Bid Price Requirement as required by Nasdaq Listing Rule 5550(a)(2). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has 180 calendar days, or until April 14, 2025, to regain compliance. The Second Bid Price Nasdaq Notice notes that to regain compliance, the Common Stock must maintain a minimum closing bid price of $1.00 for at least ten consecutive business days at any time during the 180-day compliance period. In the event the Company does not regain compliance by the end of the 180-day compliance period, the Company may be eligible for additional time to regain compliance. To qualify for additional time, the Company must (i) meet the continued listing requirement for the market value of its publicly held shares and all other initial listing standards for the Nasdaq Capital Market, with the exception of the bid price requirement and (ii) provide written notice of its intention to cure the deficiency during the second compliance period by effecting a reverse stock split, if necessary. If the Company meets these requirements, the Company may be granted an additional 180 calendar days to regain compliance. However, if it appears to Nasdaq that the Company will be unable to cure the deficiency, or if the Company is not otherwise eligible for the additional cure period, Nasdaq will provide written notice to the Company that its securities are subject to delisting. At that time, the Company may appeal any such delisting determination to a hearings panel.

The Nasdaq Notices received have no immediate effect on the Company’s continued listing on the Nasdaq Capital Market or the trading of the Company’s Common Stock, subject to the Company’s compliance with the other continued listing requirements. The Company is presently evaluating potential actions to regain compliance with all applicable requirements for continued listing on the Nasdaq Capital Market. There can be no assurance that the Company will be successful in maintaining the listing of its Common Stock on the Nasdaq Capital Market.

The listing rules of Nasdaq require listing issuers to comply with certain standards in order to remain listed on its exchange. If, for any reason, we should fail to maintain compliance with these listing standards and Nasdaq should delist our securities from trading on its exchange and we are unable to obtain listing on another national securities exchange, a reduction in some or all of the following may occur, each of which could have a material adverse effect on our stockholders:

Our principal stockholders will continue to have significant influence over the election of our Board of Directors and approval of any significant corporate actions, including any sale of the Company.

Our founders, executive officers, directors, and other principal stockholders, in the aggregate, beneficially own a majority of our outstanding stock. These stockholders currently have, and likely will continue to have, significant influence with respect to the election of our Board of Directors and approval or disapproval of all significant corporate actions. The concentrated voting power of these stockholders could have the effect of delaying or preventing an acquisition of the Company or another significant corporate transaction.

We could be subject to securities class action litigation.

In the past, securities class action litigation has often been brought against companies following a decline in the market price of their securities. In 2020, 22% of securities class action litigation filings were against defendants in the health technology and services sector, which accounted for 22% of new filings. If we face such litigation, it could result in substantial costs and a diversion of management’s attention and resources, which could harm our business.