<ul>
<li>ExThera Medical 同意支付 75 萬美元罰款和 569 萬美元沒收款</li>
</ul>
<ul>
<li>前高管將認罪，面臨 34 個月監禁的建議</li>
</ul>
<ul>
<li>檢方表示高管隱瞞了 FDA 關於使用該設備治療的患者死亡情況</li>
</ul>
<p>作者：內特·雷蒙德</p>
<p>波士頓，3 月 6 日（路透社）- 一家加州醫療技術初創公司及其一名前高管已同意解決刑事指控，因其隱瞞了涉及癌症患者的併發症和死亡報告，這些患者前往安提瓜接受其血液過濾設備的治療。</p>
<p>波士頓的聯邦檢察官週四對 ExThera Medical Corp 及其前首席監管官 Sanja Ilic 提起了指控，Ilic 已同意認罪，承認未向美國食品藥品監督管理局（FDA）報告不良事件。ExThera 成立於 2007 年，已簽署為期三年的延緩起訴協議，承認其不當行為，同意支付 75 萬美元罰款，並對公司作出 569 萬美元的沒收判決。檢方已同意建議對 58 歲的 Ilic 判處 34 個月監禁，具體的認罪聽證會日期尚未安排。</p>
<p>Ilic 的律師 Nicholas Johnson 來自 Oberheiden，沒有回應置評請求。ExThera 的律師 Seth DuCharme 來自 Bracewell LLP，也沒有回應置評請求。</p>
<p>檢方表示，ExThera 罰款金額較小是由於其當前的財務狀況。該協議包括考慮 ExThera 申請破產的條款，但 75 萬美元將被保留在託管賬户中，以支付與相關民事訴訟有關的任何款項。一組癌症患者及其在血液過濾後去世的親屬已在舊金山聯邦法院起訴該公司及其支持的紐約私募股權公司，億萬富翁投資者 Alan Quasha 的 Quadrant Management。原告中包括佛羅里達州巴拿馬城的 David Hudlow 和安大略省奧裏利亞的 Kyle Chupp 的親屬，他們在 2024 年 4 月從安提瓜返回後僅相隔一天去世。</p>
<p>ExThera 的主要產品是 Seraph 100 血液過濾器，這是一種旨在去除血液中病原體的設備。該設備於 2020 年首次獲得緊急使用授權，用於治療 COVID-19 患者。</p>
<p>該公司在民事案件的法庭文件中表示，其對該設備提取腫瘤細胞的測試顯示出 “令人鼓舞” 的結果，這促使 Quasha 接洽 ExThera，提供其過濾器用於在安提瓜的診所治療患者。</p>
<p>Quadrant Management 的律師沒有回應置評請求。</p>
<p>檢方表示，癌症患者支付了 45,000 美元前往那裏，認為 ExThera 的設備可以幫助他們，其中一些人甚至暫停或推遲化療以接受治療。在治療開始之前，Ilic 在 2023 年 12 月內部發送了一封電子郵件，描述了患者可能經歷的 “危及生命” 的併發症，根據指控文件顯示。隨着治療的開始，Ilic 得知患者出現嚴重健康狀況，包括兩名患者後來去世，但為了欺詐和誤導 FDA，她隱瞞了這一信息，檢方表示。</p>
<p>2025 年 1 月，《紐約時報》發表了一篇文章，記錄了在安提瓜發生的事件，作者是約翰·卡雷魯，一位以揭露 Theranos 欺詐行為而聞名的調查記者。</p>
<p>根據法庭文件，Ilic 在同月被解僱。檢方表示，只有在公眾報道 ExThera 的設備後，該公司才向 FDA 提交了關於兩起死亡事件的不良報告。</p>
<p>在馬薩諸塞州地區法院的案件為美國訴 Ilic 案，案號 26-cr-10055，以及美國訴 ExThera Medical Corporation 案，案號 26-cr-10056。</p>
<p>美國方面：馬肯齊·奎寧和威廉·阿貝利二世，馬薩諸塞州地區檢察官辦公室</p>
<p>Ilic 方面：Nicholas Johnson，Oberheiden</p>
<p>ExThera 方面：Seth DuCharme，Bracewell LLP</p>

標普全球醫療股指數 ETF - iShares

醫療業 ETF - Vanguard

動態生物技術與基因組 ETF - Invesco

<ul>
<li>ExThera Medical agrees to $750,000 fine and $5.69 million forfeiture</li>
</ul>
<div class="lb-trans"><ul>
<li>ExThera Medical 同意支付 75 萬美元罰款和 569 萬美元沒收款</li>
</ul>
</div><ul>
<li>Former executive to plead guilty, faces 34-month prison recommendation</li>
</ul>
<div class="lb-trans"><ul>
<li>前高管將認罪，面臨 34 個月監禁的建議</li>
</ul>
</div><ul>
<li>Prosecutors said executive concealed from FDA deaths of patients treated with device</li>
</ul>
<div class="lb-trans"><ul>
<li>檢方表示高管隱瞞了 FDA 關於使用該設備治療的患者死亡情況</li>
</ul>
</div><p>By Nate Raymond</p>
<div class="lb-trans"><p>作者：內特·雷蒙德</p>
</div><p>BOSTON, March 6 (Reuters) - A California medical technology start-up and one of its former executives have agreed to resolve criminal charges that they concealed reports of complications and deaths involving cancer patients who traveled to Antigua to be treated with its blood filtration device.</p>
<div class="lb-trans"><p>波士頓，3 月 6 日（路透社）- 一家加州醫療技術初創公司及其一名前高管已同意解決刑事指控，因其隱瞞了涉及癌症患者的併發症和死亡報告，這些患者前往安提瓜接受其血液過濾設備的治療。</p>
</div><p>Federal prosecutors in Boston on Thursday filed charges against ExThera Medical Corp and its ex-chief regulatory officer, Sanja Ilic, who has agreed to plead guilty to failing to report adverse events to the U.S. Food and Drug Administration. ExThera, which was founded in 2007, entered into a three-year deferred prosecution agreement under which it admitted wrongdoing, agreed to pay a $750,000 fine and to the entry of a $5.69 million forfeiture judgment against the company. Prosecutors have agreed to recommend that Ilic, 58, be sentenced to 34 months in prison, according to her plea deal. A date for her plea hearing has not been scheduled.</p>
<div class="lb-trans"><p>波士頓的聯邦檢察官週四對 ExThera Medical Corp 及其前首席監管官 Sanja Ilic 提起了指控，Ilic 已同意認罪，承認未向美國食品藥品監督管理局（FDA）報告不良事件。ExThera 成立於 2007 年，已簽署為期三年的延緩起訴協議，承認其不當行為，同意支付 75 萬美元罰款，並對公司作出 569 萬美元的沒收判決。檢方已同意建議對 58 歲的 Ilic 判處 34 個月監禁，具體的認罪聽證會日期尚未安排。</p>
</div><p>Ilic’s lawyer, Nicholas Johnson of Oberheiden, did not respond to a request for comment. Seth DuCharme, ExThera’s attorney at Bracewell LLP, also did not respond to a request for comment.</p>
<div class="lb-trans"><p>Ilic 的律師 Nicholas Johnson 來自 Oberheiden，沒有回應置評請求。ExThera 的律師 Seth DuCharme 來自 Bracewell LLP，也沒有回應置評請求。</p>
</div><p>Prosecutors said the small size of ExThera’s fine was due to its current financial condition. The agreement includes terms contemplating the prospect that ExThera files for bankruptcy, but the $750,000 would be held in escrow to pay any amounts owed in related civil litigation. A group of cancer patients and relatives of people who died after having their blood filtered have sued the company and the New York-based private equity firm that backed it, billionaire investor Alan Quasha’s Quadrant Management, in San Francisco federal court. Among the plaintiffs are relatives of David Hudlow of Panama City, Florida, and Kyle Chupp of Orillia, Ontario, who died just a day apart in April 2024 after returning home from Antigua, where they had undergone a blood-filtering procedure.</p>
<div class="lb-trans"><p>檢方表示，ExThera 罰款金額較小是由於其當前的財務狀況。該協議包括考慮 ExThera 申請破產的條款，但 75 萬美元將被保留在託管賬户中，以支付與相關民事訴訟有關的任何款項。一組癌症患者及其在血液過濾後去世的親屬已在舊金山聯邦法院起訴該公司及其支持的紐約私募股權公司，億萬富翁投資者 Alan Quasha 的 Quadrant Management。原告中包括佛羅里達州巴拿馬城的 David Hudlow 和安大略省奧裏利亞的 Kyle Chupp 的親屬，他們在 2024 年 4 月從安提瓜返回後僅相隔一天去世。</p>
</div><p>ExThera’s main product was the Seraph 100 blood filter, a device designed to remove pathogens from the blood. The device was initially granted an emergency use authorization to treat COVID-19 patients in 2020.</p>
<div class="lb-trans"><p>ExThera 的主要產品是 Seraph 100 血液過濾器，這是一種旨在去除血液中病原體的設備。該設備於 2020 年首次獲得緊急使用授權，用於治療 COVID-19 患者。</p>
</div><p>The company in court papers in the civil case has said that its testing of the device to extract tumor cells showed “encouraging” results, which led to Quasha approaching ExThera about supplying its filters for use in treating patients in Antigua at a clinic there.</p>
<div class="lb-trans"><p>該公司在民事案件的法庭文件中表示，其對該設備提取腫瘤細胞的測試顯示出 “令人鼓舞” 的結果，這促使 Quasha 接洽 ExThera，提供其過濾器用於在安提瓜的診所治療患者。</p>
</div><p>Quadrant Management’s lawyer did not respond to a request for comment.</p>
<div class="lb-trans"><p>Quadrant Management 的律師沒有回應置評請求。</p>
</div><p>Prosecutors said cancer patients paid $45,000 to travel there believing ExThera’s device could help them, with some even suspending or delaying chemotherapy to undergo treatment. Just prior to starting treatments there, Ilic in December 2023 had circulated an email internally that described potentially “life-threatening” complications patients could experience, according to charging documents. As treatments began, Ilic learned about patients developing serious health conditions, including two patients who later died, but concealed that information from the FDA in order to defraud and mislead it, prosecutors said.</p>
<div class="lb-trans"><p>檢方表示，癌症患者支付了 45,000 美元前往那裏，認為 ExThera 的設備可以幫助他們，其中一些人甚至暫停或推遲化療以接受治療。在治療開始之前，Ilic 在 2023 年 12 月內部發送了一封電子郵件，描述了患者可能經歷的 “危及生命” 的併發症，根據指控文件顯示。隨着治療的開始，Ilic 得知患者出現嚴重健康狀況，包括兩名患者後來去世，但為了欺詐和誤導 FDA，她隱瞞了這一信息，檢方表示。</p>
</div><p>In January 2025, the New York Times published an article documenting what had been occurring in Antigua written by John Carreyrou, an investigative journalist best-known for having brought to light fraudulent practices at Theranos while reporting at the Wall Street Journal.</p>
<div class="lb-trans"><p>2025 年 1 月，《紐約時報》發表了一篇文章，記錄了在安提瓜發生的事件，作者是約翰·卡雷魯，一位以揭露 Theranos 欺詐行為而聞名的調查記者。</p>
</div><p>Ilic was fired that same month, according to court papers. Prosecutors said only after public reporting on ExThera’s device did the company file adverse reports with the FDA about the two deaths.</p>
<div class="lb-trans"><p>根據法庭文件，Ilic 在同月被解僱。檢方表示，只有在公眾報道 ExThera 的設備後，該公司才向 FDA 提交了關於兩起死亡事件的不良報告。</p>
</div><p>The cases in the U.S. District Court for the District of Massachusetts are U.S. v. Ilic, No. 26-cr-10055, and U.S. v. ExThera Medical Corporation, No. 26-cr-10056.</p>
<div class="lb-trans"><p>在馬薩諸塞州地區法院的案件為美國訴 Ilic 案，案號 26-cr-10055，以及美國訴 ExThera Medical Corporation 案，案號 26-cr-10056。</p>
</div><p>For the United States: Mackenzie Queenin and William Abely II of the U.S. Attorney’s Office for the District of Massachusetts</p>
<div class="lb-trans"><p>美國方面：馬肯齊·奎寧和威廉·阿貝利二世，馬薩諸塞州地區檢察官辦公室</p>
</div><p>For Ilic: Nicholas Johnson of Oberheiden</p>
<div class="lb-trans"><p>Ilic 方面：Nicholas Johnson，Oberheiden</p>
</div><p>For ExThera: Seth DuCharme of Bracewell LLP</p>
<div class="lb-trans"><p>ExThera 方面：Seth DuCharme，Bracewell LLP</p>
</div>

血液過濾初創公司及其前高管因隱瞞死亡事件面臨美國指控