聯合 國

證券 交易委員會

華盛頓， 特區20549

形式 10-K/A

（修正案 號1）

（馬克 一）

☒ 根據1934年《證券交易所法》第13或15（d）條提交的年度報告

截至本財政年度止12月31日, 2023

或

☐ 根據1934年《證券交易所法》第13或15（d）條提交的過渡報告

爲 從_到_的過渡期

委員會 文件號： 001-40386

ONEMEDNET 公司

（確切的 章程中規定的註冊人名稱）

註冊者的 電話號碼，包括地區代碼： (800) 918-7189

證券 根據該法案第12（b）條登記的：

證券 根據該法案第12（g）條登記：無

指示 如果註冊人是《證券法》第405條規定的知名經驗豐富的發行人，則勾選標記。是的 不是 ☒

指示 如果註冊人無需根據該法案第13條或第15（d）條提交報告，則勾選標記。是的 不是 ☒

指示 勾選註冊人（1）是否已提交證券交易所第13或15（d）條要求提交的所有報告 過去12個月內的1934年法案（或要求登記人提交此類報告的較短期限內），和（2） 在過去90天內一直遵守此類提交要求。是的 不是 ☒

指示 檢查註冊人是否已以電子方式提交了根據規則需要提交的所有交互數據文件 S-t法規第405條（本章第232.405條）在過去12個月內（或註冊人 被要求提交此類文件）。 是 沒有

指示 通過勾選註冊人是否是大型加速文件夾、加速文件夾、非加速文件夾、小型報告夾 公司，或新興成長型公司。請參閱「大型加速文件夾」、「加速文件夾」的定義 《交易法》第120億.2條中的「小型報告公司」和「新興成長公司」。

如果 新興成長型公司，如果註冊人選擇不使用延長的過渡期來遵守規定，請通過勾選標記表示 根據《交易法》第13（a）條規定的任何新的或修訂的財務會計準則。 ☐

指示 檢查註冊人是否已提交其管理層對其有效性評估的報告和證明 根據《薩班斯-奧克斯利法案》（15 USC）第404（b）條對其財務報告的內部控制7262（b））由註冊人 編制或出具審計報告的公共會計師事務所。 ☐

如果 證券是根據該法案第12（b）條登記的，通過複選標記表明登記人的財務報表是否 文件中包含的內容反映了對之前發佈的財務報表錯誤的更正。 ☒

指示 勾選這些錯誤更正是否是需要對基於激勵的薪酬進行恢復分析的重述 根據§240.10D-1（b），註冊人的任何執行官員在相關恢復期內收到。 ☐

指示 通過勾選註冊人是否是空殼公司（定義見該法案第120億.2條規則）。是的否 ☒

作爲 截至2024年6月28日，非關聯公司持有的註冊人普通股總市值爲美元9.7 百萬（基於 2024年6月28日普通股收盤價0.98美元）。

作爲 2024年10月31日，有 28,175,172 普通股，面值美元0.0001 每股已發行和發行，以及 註冊人已發行和發行的0股優先股，每股面值0.0001美元。

解釋性 注意

OneMedNet 特拉華州的公司(f/k/a data Knight Acquisition Corp.)正在提交本修正案第1號(This 對截至2023年12月31日的年度報告Form 10-K/A的「修訂」(經如此修訂，“經修訂 表10-K/A「)，已於2024年4月9日提交給美國證券交易委員會(」美國證券交易委員會「)(以下簡稱」該委員會“) 「原始表格10-K」)，以重申原始表格10-K的全部內容，包括重新陳述其合併的 原表格所載的2023年、2023年和2022年12月31日終了年度財務報表，包括附註 10-k，並取代由BF BorgersCPA PC(BF)編寫的獨立註冊會計師事務所報告 Borgers“)與獨立註冊會計師事務所的報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。這項修正案是由於以下命令而提交的 2024年5月3日，暫停BF Borgers在美國證券交易委員會前出庭和執業，並糾正 原始表格10-K，Withum受聘取代BF Borgers成爲其獨立註冊會計師事務所。

這 表格10-k重申了2023年原始表格10-k以及因可轉換票據、認購證、 基於股票的薪酬費用以及去SPAC交易，包括相關負債和資本重組，以及相關的 重新審計公司2023財年和2022財年財務報表。

作爲 除非另有說明或上下文另有要求，否則在本修訂後的表格10-k中使用的「我們」、「我們」、 「我們的」、「ONMD」、「OneMedNet」和「公司」指OneMedNet Corporation（f/k/a Data 騎士收購公司），一家特拉華州公司及其合併後的子公司在業務合併生效後 Data Knights Acquisition Corp.（「Data Knights」）和OneMedNet Corporation（「Legacy ONMD」）（「業務 合併」）根據日期爲2022年4月25日的合併協議和計劃（「合併協議」），由以下各方 Data Knights，Data Knights Merger Sub，Inc.，一家特拉華州公司，也是Data Knights的全資子公司（「合併子公司」）， Legacy ONMD，Data Knights，LLC，特拉華州一家有限責任公司（「贊助商」或「買家代表」） 以及保羅·凱西（Paul Casey）以賣方代表的身份於2023年11月7日結束。

ONEMEDNET 公司

年度 截至2023年12月31日的年度Form 10-K/A報告

索引

警示 關於前瞻性陳述的註釋

一定的 我們不時作出的聲明，包括這份經修訂的表格10-k所載的聲明，均爲「前瞻性聲明」。 1995年《私人證券訴訟改革法》和《證券法》第27A條所指的聲明 經修訂的1933年《證券法》(以下簡稱《證券法》)和經修訂的《1934年證券交易法》(簡稱《證券交易法》)第21E條 行動“)。本修正後的表格10-k中除有關歷史事實的陳述外，其他所有陳述均爲前瞻性陳述。 這份經修訂的表格10-k中的前瞻性陳述僅爲預測。我們的這些前瞻性陳述在很大程度上是基於 根據我們目前對未來事件和財務趨勢的預期和預測，我們認爲這些事件和財務趨勢可能會影響我們的業務、財務 條件和操作結果。在某些情況下，您可以通過「預期」等術語來識別這些前瞻性陳述。 「相信」、「繼續」、「可能」、「取決於」、「估計」、「期望」 「打算」、「可能」、「正在進行」、「計劃」、「潛在」、「預測」、「項目」 「應該」、「將會」、「將會」或這些術語的否定或其他類似的表達，儘管不是 所有前瞻性聲明都包含這些話。我們的這些前瞻性陳述是基於我們目前的預期和預測 關於我們認爲可能會影響我們的財務狀況、運營結果、戰略、短期和長期的未來事件和趨勢 業務運營和目標，以及財務需求。

我們 運營涉及風險和不確定性，其中許多超出了我們的控制範圍，其中任何一項或其組合都可能 對我們的經營業績以及前瞻性陳述最終是否被證明正確產生重大影響。我們已經根據 這些前瞻性陳述主要基於我們當前對未來事件和趨勢的預期和預測，我們認爲這些事件和趨勢可能會 影響我們的財務狀況、運營結果、業務戰略、短期和長期業務運營和目標， 和財務需求。本修訂後的表格10-k中的前瞻性陳述包括但不限於反映管理層的陳述 對未來財務業績和運營支出的預期（包括我們繼續作爲持續經營企業的能力、提高 額外資本以及在未來的運營中取得成功）、預期增長、盈利能力和業務前景以及運營費用。

前瞻性 陳述只是當前的預測，並且受到已知和未知的風險、不確定性和其他可能導致我們的風險的因素的影響。 實際結果、活動水平、績效或成就與此類陳述的預期存在重大差異。 這些因素包括，我們認爲可能導致實際結果與其他因素不同的未知風險和不確定性 這些前瞻性陳述在「風險因素」標題和本修訂後的表格10-k中的其他地方列出。 新的風險和不確定性時有發生，我們不可能預測所有的風險和不確定性 可能對前瞻性陳述產生影響，包括但不限於與以下方面相關的風險和不確定性：

這些 前瞻性陳述受到許多風險、不確定性和假設的影響，包括「風險」中描述的風險、不確定性和假設 因素。”此外，我們在競爭激烈且瞬息萬變的環境中運營。新的風險不時出現。是 我們的管理層無法預測所有風險，也無法評估所有因素對我們業務的影響或影響程度 任何因素或因素組合可能導致實際結果與任何前瞻性陳述中包含的結果存在重大差異 我們可能會做出。鑑於這些風險、不確定性和假設，本修訂本中討論的前瞻性事件和情況 表格10-k可能不會發生，實際結果可能與前瞻性報告中預期或暗示的結果存在重大不利差異 報表

你 不應依賴前瞻性陳述作爲對未來事件的預測。儘管我們相信期望反映了 前瞻性陳述是合理的，我們不能保證未來的結果、活動水平、績效或事件 以及前瞻性陳述中反映的情況將實現或發生。此外，除法律要求外，均不 我們或任何其他人對前瞻性陳述的準確性和完整性承擔責任。我們沒有義務 在本修訂後的表格10-k日期後以任何原因公開更新任何前瞻性陳述，以符合這些陳述 實際結果或我們期望的變化。

你 應閱讀本修訂後的表格10-k以及我們通過引用納入本修訂後的表格10-k中的文件，並理解 我們的實際未來結果、活動水平、表現以及事件和情況可能與我們的情況存在重大差異 期望。由於許多已知和未知的風險和不確定性，我們的實際結果或績效可能會存在重大差異 這些前瞻性陳述所表達或暗示的內容，包括「風險因素」部分所描述的內容 從第18頁開始以及本修訂表格10-k的其他地方。

部分 我

項目 1.業務

公司 概述

OneMedNet 是全球臨床成像創新提供商和監管級成像真實世界數據（「iRWD」）的策展人^TM”) OneMedNet的創新解決方案將醫療保健提供者和患者聯繫起來，滿足生命科學領域的關鍵需求 提供直接訪問臨床圖像和相關的上下文患者記錄。OneMedNet的創新技術得到證實 對新興市場真實世界數據（定義如下）成像的商業和監管可行性，並提供監管級 以圖像爲中心的iRWD^TM 這完全符合OneMedNet的生命科學合作伙伴病例選擇協議並鋪平了道路 對於真實世界證據（定義如下）。

OneMedNet 成立是爲了解決醫療保健提供者之間共享臨床圖像的缺陷。這導致了ONN的初始 產品束^TM 圖像交換使與ONN最大的十多年來成功共享圖像 客戶是愛爾蘭共和國。

OneMedNet 通過響應對真實世界數據（定義如下）（「RWD」）和真實數據的需求和利用來繼續創新 世界證據（RWE），特別是專注於臨床圖像及其相關背景臨床記錄的數據。我們能夠 利用內部技術能力以及OneMedNet從第一年起就強大的醫療保健提供商安裝基礎 帶有BEAM的產品^TM 推出iRWD，成爲生命科學公司首個RWD解決方案^TM2019年。

OneMedNet 提供創新解決方案，釋放臨床圖像檔案中包含的重要價值。隨着不斷髮展的聯邦網絡 OneMedNet在95多個醫療保健機構中擁有快速搜索和廣泛管理來自聯邦機構的多層數據的能力 一群醫療保健機構。「醫療機構」一詞專門指醫院、綜合交付 爲OneMedNet提供成像的網絡（「IDT」）和成像中心，OneMedNet代表了我們數據的核心來源。在 目前，OneMedNet與超過95個向我們提供監管級成像的機構合作。OneMedNet可以訪問更多內容 超過95個設施，因爲這些簽約設施有200多個地點，包括辦公室和診所， Total可從200多個客戶生成監管級圖像。這些客戶中，都是數據提供者，也有一些是數據 購買者。

最初， 這一切都是爲了解決患者護理提供者的多樣化訪問需求。這一重點系統性地演變爲快速解決 圖像分析和研究人員、臨床醫生、監管機構、科學家等的需求不斷增長。聯邦網絡允許OneMedNet 訪問以下數據以作爲RWD提供給研究。

房 世界數據是在常規護理提供背景下收集的任何數據，與臨床期間收集的數據形成鮮明對比 研究設計以不代表現實世界護理和結果的方式控制變異性的試驗。

一 推動其使命的關鍵要素是OneMedNet相信我們有一個獨特的機會來對 改善數千萬人的生活，同時提高客戶的業務生產力。首先，OneMedNet的 iRWD^TM 產品在使生命科學公司提供更安全、更有效的患者護理方面發揮着重要作用 儘早上市。在iRWD中使用我們精心策劃的去識別臨床數據^TM 提供生命科學產品開發， 生命科學公司通過驗證和監管審批流程，以更有意義的方式爲患者護理進步做出貢獻。 此外，生命科學改進了生命科學公司的產品開發和驗證流程，這使各方受益。

顯著 現有文件表明，真實世界數據可以爲更廣泛、更有代表性的患者群體提供更廣泛的見解。 因此，美國食品和藥物管理局（「FDA」）制定了監管批准的真實世界數據指南。 利用高度可靠和優質的真實世界數據，嚴格遵守所有非常具體的數據分層要求 可以補充或取代臨床試驗。

OneMedNet 涵蓋真實世界數據成像的完整價值鏈;它始於我們10多年的聯合提供商網絡，並得到支持 由專家內部臨床團隊管理的多方面數據策展流程進行。此外，我們還與生活攜手共進 科學合作伙伴制定病例選擇方案，並在需要時製作病例報告表以供監管機構批准。我們 專注於通過OneMedNet的iRWD支持生命科學進步來創造價值^TM 它擁有解鎖的鑰匙 無限的患者護理進步。我們相信我們釋放了以研究級圖像爲中心的iRWD的力量^TM 策劃的是 滿足每個隊列要求並經得起前瞻性臨床試驗的嚴格要求。

今天， 生命科學公司，包括製藥公司、人工智能（「AI」）開發人員、醫療器械企業、 和臨床研究組織在獲取豐富、高質量的患者數據方面面臨着同樣廣泛的挑戰，這些數據明確 符合他們精確的隊列規格。患者診斷的很大一部分涉及臨床成像，大約 按大小計算，90%的醫療保健數據與成像相關。從歷史上看，大部分成像價值都來自於其最初的審查， 圖像檔案的進一步收益非常有限。

我們 幫助提供商「充分發揮成像檔案的價值」。^TM 通過利用OneMedNet的iRWD^TM 提供， 提供商可以通過簡化的數據訪問來極大地改善他們的研究工作。醫療保健提供者，例如醫院、診所 成像中心還可以通過在明確定義和去識別數據中共享去識別數據來加速生命科學患者護理創新 和安全的方式。作爲回報，收入就會產生並應用於關鍵且可能沒有資金的提供商項目。

的 OneMedNet差異

我們 相信OneMedNet十多年來一直是提取、保護和傳輸醫療數據業務的領導者。這樣做需要 專業知識：

實現 所有基本要素的內部專業知識是一項挑戰，我們相信這會阻止許多組織嘗試此類冒險。 我們爲這一雄心勃勃的成就感到自豪，同時不斷努力保持最先進的專業知識。OneMedNet嚴格遵守 在所有互動和活動中遵守最高水平的專業和道德標準以及適用法規。

我們 相信OneMedNet是監管級成像RWD策展人領域的領導者。這樣做需要AI/ML方面的專業知識 技術、數據隱私/安全以及臨床患者狀況和醫療保健記錄保存方面的專業知識。擁有或實現， 所有基本學科的專業知識是一項具有挑戰性的成就。OneMedNet在我們的臨床圖像交換方面取得了重大領先 該解決方案在十多年前幫助該公司成立。所有數據在聯邦OneMedNet iRWD中保持「本地」^TM 提供商網絡-這意味着所有數據都保留在本地，直到特定的去識別數據獲得特定生命的許可 科學研究機會。

OneMedNet的 競爭優勢

我們 相信OneMedNet iRWD^TM 提供最好的先進技術、臨床專家策展和服務。醫學成像 並使用最先進的AI/ML技術在每個網絡站點對相關臨床數據進行索引。這通常包括電子產品 健康記錄（「EHR」）、放射學、心臟病學、實驗室、病理學等。我們的內部臨床團隊進行密集的策展 數據，以便結果滿足生命科學數據收集協議（「DPP」）的規範和要求-無論 複雜性的。

我們 相信OneMedNet通過以下三種主要方式釋放成像和EHR數據的價值：

OneMedNet的 使用多步驟質量控制流程對數據進行完全去識別，並且超出了受保護的健康信息（「PHI」） 包括個人可識別信息（「PRI」）、網站可識別信息等。重要的是，生命科學 用戶以他們所需的確切格式接收數據。不需要數據篩選或操縱。數據已經準備好了 使用.此外，OneMedNet具有獨特的知識、工具和經驗組合，可以：

最後， OneMedNet擁有一支由經驗豐富、訓練有素的數據策展人組成的團隊。這個團隊意識到它的複雜性和關鍵性 臨床數據，並且可以與提供商和生命科學專家有效溝通。

行業 背景

一 由塔夫茨藥物開發研究中心撰寫的2016年分析發表在《健康經濟學雜誌》上， 將藥物推向市場的成本（包括批准後的研究和開發）高達驚人的28.7億美元。與此同時一個 塔夫茨藥物開發研究中心2018年的研究指出，新藥開發的時間軸從12.8 平均藥物的壽命爲17.2年，而僅影響數百名患者的超孤兒藥物則爲17.2年。這就給了生活的責任 科學組織將找到更快地爲患者提供治療的方法，尤其是那些無法等待17年的患者 進行可能挽救生命的治療。了解患者如何實際使用藥品可以幫助整個行業的利益相關者 醫療保健生態系統做出重要且可能挽救生命的實時決策。

真實 世界數據是觀察性數據，通常在批准的醫療產品上市時收集，並由「REAL」使用 真實生活中的患者，而不是臨床試驗或真實患者的真實世界圖像。FDA引用了幾個潛在的來源 真實世界數據，包括電子病歷、索賠、疾病和產品登記。有多種類型的數據，包括結構化的 以及非結構化數據、臨床和賬單數據、交易數據和索賠數據、患者生成的數據以及從其他 可以闡明患者健康狀況的來源以及更多。隨着對醫療數據的依賴呈指數級增長，OneMedNet 注意到對信息的依賴增加了，這些信息來自多個額外來源，包括電子病歷、索賠、登記處、 臨床試驗、患者和提供商調查、可穿戴設備等。這些額外的來源包括物聯網(IoT)、 社交媒體論壇和博客。真實世界數據有可能打破效率低下的問題，填補以下信息孤島中的空白 醫療保健生態系統中的所有利益相關者，包括提供者、付款人、製造商、政府實體和患者。此信息 反過來，分享使各方能夠獲得新的見解，支持基於價值的護理，並提供更好的健康結果。

商業化 一種藥物需要其開發商利用各種真實世界數據來源來識別患者群體並完善銷售和營銷 針對這些人群的戰略以及許多其他事業。從歷史上看，這種做法涉及購買大量數據 來自數據聚合器或數據平台，即使不是直接來自源本身，有時對質量沒有太多了解 數據。準備這些數據進行分析既昂貴又耗時;因此，許多組織會將該過程外包 提供給顧問或第三方供應商。此外，準備這些數據供未經培訓的顧問分析的過程可能會產生一個 靜態分析，難以針對後續問題或潛在差異進行修改或初始化。

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 數字圖像的發展促進了OneMedNet提供的真實世界數據中醫學成像的可用性 分析以提高診斷的準確性並使用人工智能算法對大型醫學圖像數據庫進行被動篩查 例如OneMedNet應用的那些。算法還可以幫助從具有病理學的醫學圖像中識別其他有價值的診斷測試。

房 世界證據是通過分析得出的有關醫療產品的使用和潛在受益或風險的臨床證據 根據FDA的定義，真實世界數據。真實世界證據可以通過不同的研究設計或分析生成，包括但 不限於隨機試驗，包括大型簡單試驗、務實試驗和觀察性研究（前瞻性和/或回顧性）。 真實世界證據和真實世界數據的差異集中在最終用例上。真實世界數據可以採取索賠、EHR、 實驗室、數據等。這種見解通常用於更好地了解患者的旅程或疾病的自然史（如何 如果不及時治療，疾病就會進展。）

房 相比之下，World Evidence建立在許多這些數據集的基礎上，併爲提交做好準備，作爲監管審查的一部分，例如 例如，向FDA或歐洲藥品管理局（「EMA」）提供支持，以支持客戶的臨床試驗申請。 當數據（特別是成像數據）提交給FDA時，該機構要求以下內容：

一 現實世界證據一直被嚴重依賴的領域與腫瘤學批准有關。FDA腫瘤學卓越中心 在2021年的美國臨床腫瘤學會上提交了一份對此的分析報告，研究了包含Real 世界數據和真實世界證據。該分析研究了2011-2020年間提交的94份申請，結果顯示 在此期間，納入真實世界數據以支持監管決策的情況大幅增加。僅在2020年，就有 有28份關於腫瘤學產品的提交包含真實世界的數據。在腫瘤學背景之外，可能是最值得注意的 最近一個依賴真實世界證據的批准例子是FDA 2021年7月批准了Astella Pharma的一個新適應症 S公司推出的預防肺移植患者器官排斥反應的藥物計劃(或他克莫司)。那裏的批准 是基於一項非干預性研究，提供了有效的真實世界證據。FDA的新聞稿宣佈了這一批准 他指出，批准具有重要意義，因爲它反映了一項設計良好的非干預性研究如何依賴於符合目的的研究 與適當的對照相比，真實世界的數據可以被認爲是足夠的，並且根據FDA的規定得到很好的控制。“

一個 最近值得注意的另一項批准是FDA於2021年12月批准了補充BLA（生物許可申請） Orencia®預防移植物抗宿主病。該應用程序包括來自隨機臨床試驗的數據，以及其他 使用國際中心的真實世界數據進行的一項基於登記的臨床研究提供了有效性證據 血液和骨髓移植研究。該登記研究分析了54名接受Orencia®預防治療的患者的結果 移植物抗宿主病與標準免疫抑制藥物聯合治療的162名患者 單獨使用藥物，並在該適應症中顯示出療效。

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 正在推動蛋白質結構識別的突破性飛躍，法規的進步正在爲醫療保健研究組織提供 訪問真實世界數據以加速臨床試驗流程。我們相信人工智能技術具有無與倫比的潛力 提供創新的試驗設計和收集、組織和分析臨床試驗產生的越來越多的數據。 人工智能在臨床試驗中有許多應用，無論是短期還是長期。人工智能技術使對轉型至關重要的創新成爲可能 臨床試驗，例如無縫結合I期和II期、開發新型以患者爲中心的終點以及收集和分析 真實世界數據。

OneMedNet 相信人工智能工具還能爲醫院和衛生系統帶來更廣泛的好處。加拿大滑鐵盧大學Alexander Wong教授 人工智能和醫學成像研究主席指出，人工智能的好處包括減輕放射科負擔的潛力 在評估掃描和預測未來對綜合醫院和重症監護病牀的需求以及對設備的需求方面， 作爲呼吸機和呼吸機、藥品、口罩和呼吸機喉舌，以及協助勞動力規劃。

跨 一組多樣化的成像模式、數字圖像通常包括元數據和/或註釋，其中可能包括受保護的健康信息 (例如， 患者姓名、出生日期）。儘管診斷圖像通常不需要像 基因組數據，研究人員還必須刪除面部特徵或其他可以識別患者的特徵。

數字 圖像分析可通過分析大量組織樣本或其他醫學圖像來支持研究和開發 通過將患者腫瘤的一部分移植到人源化中來運行分子篩選，對生物標誌物和治療反應進行建模 小鼠或源自類似微型器官的幹細胞的3D組織培養物。這些模型使研究人員能夠進行受控 實驗室實驗可以爲治療方法提供信息，並通過將預測的治療反應與實際臨床結果聯繫起來 該數據傳輸到EHR、索賠和其他真實世界數據來源。同樣，臨床前研究可以通過安全性評估來了解 在動物模型或動物分子生物標誌物或解剖異常研究中進行，以最大限度地減少人類研究的負擔 參與者研究結果還可以通過根據預測的反應對參與者進行分層並確定來爲臨床試驗優化提供信息 適當的資格標準。

評價 監管決策背景下的真實世界證據不僅取決於對用於生成的方法的評估 證據還包括基礎現實世界數據的可靠性和相關性;這些結構可能會提出不同的類型 的考慮。真實世界證據是指從真實世界分析中得出的有關產品風險和收益的證據 世界數據。例如，FDA使用了來自其最大的多站點Sentinel系統的真實世界數據和真實世界證據 致力於醫療產品安全的全球分佈式數據庫，用於監測受監管產品的安全性，而不是上市後 問題研究它已經針對涉及五種產品的九個潛在安全問題進行了此類處理。

房 世界證據是通過分析得出的有關醫療產品的使用和潛在受益或風險的臨床證據 真實世界數據。真實世界證據可以通過不同的研究設計或分析生成，包括但不限於隨機化 試驗，包括大型簡單試驗、務實試驗和觀察性研究（前瞻性和/或回顧性）。

不像 傳統臨床試驗，可以策劃必要的數據元素並強制收集，創建真實世界證據 需要評估、驗證和彙總通過常規臨床實踐獲得的各種（通常是不同的）數據來源。 不同的利益相關者以多種不同的方式使用真實世界證據。

從 真實世界數據到真實世界證據

的 創建真實世界證據需要結合強大的分析、經過驗證的方法和豐富的可用知識 真實世界數據源（例如， 現有質量註冊中心中捕獲哪些數據，可以通過EHR捕獲哪些數據 和病例報告表或聲明，以及哪些患者組織捕獲相關患者隊列的數據）。該過程包括幾個 步驟，總結如下：

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.