<ul>
<li>ExThera Medical 同意支付 75 万美元罚款和 569 万美元没收款</li>
</ul>
<ul>
<li>前高管将认罪，面临 34 个月监禁的建议</li>
</ul>
<ul>
<li>检方表示高管隐瞒了 FDA 关于使用该设备治疗的患者死亡情况</li>
</ul>
<p>作者：内特·雷蒙德</p>
<p>波士顿，3 月 6 日（路透社）- 一家加州医疗技术初创公司及其一名前高管已同意解决刑事指控，因其隐瞒了涉及癌症患者的并发症和死亡报告，这些患者前往安提瓜接受其血液过滤设备的治疗。</p>
<p>波士顿的联邦检察官周四对 ExThera Medical Corp 及其前首席监管官 Sanja Ilic 提起了指控，Ilic 已同意认罪，承认未向美国食品药品监督管理局（FDA）报告不良事件。ExThera 成立于 2007 年，已签署为期三年的延缓起诉协议，承认其不当行为，同意支付 75 万美元罚款，并对公司作出 569 万美元的没收判决。检方已同意建议对 58 岁的 Ilic 判处 34 个月监禁，具体的认罪听证会日期尚未安排。</p>
<p>Ilic 的律师 Nicholas Johnson 来自 Oberheiden，没有回应置评请求。ExThera 的律师 Seth DuCharme 来自 Bracewell LLP，也没有回应置评请求。</p>
<p>检方表示，ExThera 罚款金额较小是由于其当前的财务状况。该协议包括考虑 ExThera 申请破产的条款，但 75 万美元将被保留在托管账户中，以支付与相关民事诉讼有关的任何款项。一组癌症患者及其在血液过滤后去世的亲属已在旧金山联邦法院起诉该公司及其支持的纽约私募股权公司，亿万富翁投资者 Alan Quasha 的 Quadrant Management。原告中包括佛罗里达州巴拿马城的 David Hudlow 和安大略省奥里利亚的 Kyle Chupp 的亲属，他们在 2024 年 4 月从安提瓜返回后仅相隔一天去世。</p>
<p>ExThera 的主要产品是 Seraph 100 血液过滤器，这是一种旨在去除血液中病原体的设备。该设备于 2020 年首次获得紧急使用授权，用于治疗 COVID-19 患者。</p>
<p>该公司在民事案件的法庭文件中表示，其对该设备提取肿瘤细胞的测试显示出 “令人鼓舞” 的结果，这促使 Quasha 接洽 ExThera，提供其过滤器用于在安提瓜的诊所治疗患者。</p>
<p>Quadrant Management 的律师没有回应置评请求。</p>
<p>检方表示，癌症患者支付了 45,000 美元前往那里，认为 ExThera 的设备可以帮助他们，其中一些人甚至暂停或推迟化疗以接受治疗。在治疗开始之前，Ilic 在 2023 年 12 月内部发送了一封电子邮件，描述了患者可能经历的 “危及生命” 的并发症，根据指控文件显示。随着治疗的开始，Ilic 得知患者出现严重健康状况，包括两名患者后来去世，但为了欺诈和误导 FDA，她隐瞒了这一信息，检方表示。</p>
<p>2025 年 1 月，《纽约时报》发表了一篇文章，记录了在安提瓜发生的事件，作者是约翰·卡雷鲁，一位以揭露 Theranos 欺诈行为而闻名的调查记者。</p>
<p>根据法庭文件，Ilic 在同月被解雇。检方表示，只有在公众报道 ExThera 的设备后，该公司才向 FDA 提交了关于两起死亡事件的不良报告。</p>
<p>在马萨诸塞州地区法院的案件为美国诉 Ilic 案，案号 26-cr-10055，以及美国诉 ExThera Medical Corporation 案，案号 26-cr-10056。</p>
<p>美国方面：马肯齐·奎宁和威廉·阿贝利二世，马萨诸塞州地区检察官办公室</p>
<p>Ilic 方面：Nicholas Johnson，Oberheiden</p>
<p>ExThera 方面：Seth DuCharme，Bracewell LLP</p>

标普全球医疗股指数 ETF - iShares

医疗业 ETF - Vanguard

动态生物技术与基因组 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 万美元罚款和 569 万美元没收款</li>
</ul>
</div><ul>
<li>Former executive to plead guilty, faces 34-month prison recommendation</li>
</ul>
<div class="lb-trans"><ul>
<li>前高管将认罪，面临 34 个月监禁的建议</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>检方表示高管隐瞒了 FDA 关于使用该设备治疗的患者死亡情况</li>
</ul>
</div><p>By Nate Raymond</p>
<div class="lb-trans"><p>作者：内特·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>波士顿，3 月 6 日（路透社）- 一家加州医疗技术初创公司及其一名前高管已同意解决刑事指控，因其隐瞒了涉及癌症患者的并发症和死亡报告，这些患者前往安提瓜接受其血液过滤设备的治疗。</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>波士顿的联邦检察官周四对 ExThera Medical Corp 及其前首席监管官 Sanja Ilic 提起了指控，Ilic 已同意认罪，承认未向美国食品药品监督管理局（FDA）报告不良事件。ExThera 成立于 2007 年，已签署为期三年的延缓起诉协议，承认其不当行为，同意支付 75 万美元罚款，并对公司作出 569 万美元的没收判决。检方已同意建议对 58 岁的 Ilic 判处 34 个月监禁，具体的认罪听证会日期尚未安排。</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 的律师 Nicholas Johnson 来自 Oberheiden，没有回应置评请求。ExThera 的律师 Seth DuCharme 来自 Bracewell LLP，也没有回应置评请求。</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>检方表示，ExThera 罚款金额较小是由于其当前的财务状况。该协议包括考虑 ExThera 申请破产的条款，但 75 万美元将被保留在托管账户中，以支付与相关民事诉讼有关的任何款项。一组癌症患者及其在血液过滤后去世的亲属已在旧金山联邦法院起诉该公司及其支持的纽约私募股权公司，亿万富翁投资者 Alan Quasha 的 Quadrant Management。原告中包括佛罗里达州巴拿马城的 David Hudlow 和安大略省奥里利亚的 Kyle Chupp 的亲属，他们在 2024 年 4 月从安提瓜返回后仅相隔一天去世。</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 的主要产品是 Seraph 100 血液过滤器，这是一种旨在去除血液中病原体的设备。该设备于 2020 年首次获得紧急使用授权，用于治疗 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>该公司在民事案件的法庭文件中表示，其对该设备提取肿瘤细胞的测试显示出 “令人鼓舞” 的结果，这促使 Quasha 接洽 ExThera，提供其过滤器用于在安提瓜的诊所治疗患者。</p>
</div><p>Quadrant Management’s lawyer did not respond to a request for comment.</p>
<div class="lb-trans"><p>Quadrant Management 的律师没有回应置评请求。</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>检方表示，癌症患者支付了 45,000 美元前往那里，认为 ExThera 的设备可以帮助他们，其中一些人甚至暂停或推迟化疗以接受治疗。在治疗开始之前，Ilic 在 2023 年 12 月内部发送了一封电子邮件，描述了患者可能经历的 “危及生命” 的并发症，根据指控文件显示。随着治疗的开始，Ilic 得知患者出现严重健康状况，包括两名患者后来去世，但为了欺诈和误导 FDA，她隐瞒了这一信息，检方表示。</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，《纽约时报》发表了一篇文章，记录了在安提瓜发生的事件，作者是约翰·卡雷鲁，一位以揭露 Theranos 欺诈行为而闻名的调查记者。</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>根据法庭文件，Ilic 在同月被解雇。检方表示，只有在公众报道 ExThera 的设备后，该公司才向 FDA 提交了关于两起死亡事件的不良报告。</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>在马萨诸塞州地区法院的案件为美国诉 Ilic 案，案号 26-cr-10055，以及美国诉 ExThera Medical Corporation 案，案号 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>美国方面：马肯齐·奎宁和威廉·阿贝利二世，马萨诸塞州地区检察官办公室</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>

血液过滤初创公司及其前高管因隐瞒死亡事件面临美国指控