Cockayne Syndrome

Trial will evaluate ilofotase alfa as a treatment to prevent renal damage in at-risk patients following open heart surgery Ilofotase alfa’s clinical record of renal protective effects supports therapeutic potential in underserved and high-need indication UTRECHT, The Netherlands--(BUSINESS WIRE)-- AM-Pharma B.V. today announced that the first patients have been treated in a Phase 2 clinical study evaluating the company’s proprietary recombinant alkaline phosphatase, ilofotase alfa, as a preventive treatment for cardiac surgery-associated renal damage (CSA-RD). With over 2 million open heart surgeries1 performed worldwide every year, CSA-RD represents a critical surgical complication for which there is no specific pharmacological therapy. CSA-RD is defined as the long-term loss of renal function in cardiac surgery patients and arises from acute kidney injury (AKI) immediately following the surgery. CSA-AKI occurs in approximately 1 out of 3 patients undergoing open heart surgery and is the predominant risk factor for death post-surgery, with 2-5% of patients requiring renal replacement therapy as a result. Ilofotase alfa has a proven safety and tolerability pro a strong record of renal protective effects as observed in previous clinical studies. Notably, prior Phase 2 and Phase 3 trials with ilofotase alfa demonstrated significant improvements in Major Adverse Kidney Events by day 90 (MAKE90) in sepsis-associated AKI. As recently reported in a publication2 on the REVIVAL Phase 3 trial, MAKE90 events were reduced to 57.2% of patients in the ilofotase alfa group compared to 64.7% in the placebo group. “Previous clinical trials showed ilofotase alfa had significant reno-protective effects in sepsis-associated AKI patients. Given the role of AKI in long-term renal impairment in cardiac surgery patients, ilofotase alfa preventative treatment could have substantial clinical benefits on renal function and potentially save lives,” said Peter Pickkers, MD, PhD, Principal Investigator in the Phase 2 study and Professor of Experimental Intensive Care Medicine at Radboud University Nijmegen Medical Centre, The Netherlands. The multicenter, double-blind, randomized, placebo-controlled Phase 2 trial will evaluate the efficacy and safety of ilofotase alfa as a preventive treatment in 150 patients scheduled for cardiac surgery and at risk for CSA-RD. Treatment will be administered intravenously before and after surgery, with a follow-up period of 60 days. The primary endpoint will be the ratio between pre- and post-surgery creatinine levels. Important exploratory endpoints will be the incidence of Major Adverse Kidney Events (MAKE) and the incidence and severity of AKI post-surgery. The trial is planned to end in Q4 2024 with a data readout expected in early 2025. Ilofotase alfa was recently evaluated in a Phase 1b pilot study as enzyme replacement therapy in hypophosphatasia (HPP) patients. “With the initiation of the Phase 2 trial in CSA-RD following the positive results from the Phase 1b study in HPP we have achieved important progress toward establishing ilofotase alfa’s potential through our updated clinical development strategy. We are confident in our new trajectory and remain committed to delivering a therapeutic solution for patients in these two severe, high-need conditions,” said Juliane Bernholz, PhD, Chief Executive Officer of AM-Pharma. “The clinical centers we are working with show great enthusiasm for our approach with ilofotase alfa and we look forward to the data readout.” About ilofotase alfa Ilofotase alfa is a proprietary recombinant alkaline phosphatase, constructed from two human isoforms of alkaline phosphatase, that has been shown to be stable and highly active in multiple clinical trials. The recombinant enzyme displays exquisite activity towards dephosphorylating and detoxifying damage-associated molecular patterns (DAMPs) and pathogen-associated molecular patterns (PAMPs) such as lipopolysaccharide (LPS), ATP, ADP and other extracellular substrates that drive acute inflammation, coagulation and microvascular ischemia found in kidney following sepsis or ischemia-induced damage. Research has shown that ATP dephosphorylation has a double effect in protecting against kidney injury. When the pro-inflammatory ATP is dephosphorylated, the resulting adenosine further reduces inflammation through the activation of the immunosuppressive adenosine A2a receptor pathway. In hypophosphatasia, ilofotase alfa addresses elevated levels of pyridoxal-5′-phosphate (PLP), inorganic pyrophosphates (PPi), two disease-related biomarkers that are related to bone mineralization and pain sensation, for example. About cardiac surgery-associated renal damage (CSA-RD) CSA-RD is a clinical complication that arises from acute kidney injury (AKI) following open heart surgery performed with the use of a cardiopulmonary bypass (CPB) pump. Apart from sepsis, this type of surgery is the most frequent cause of AKI. CSA-AKI occurs in about 1 in 3 patients undergoing this surgical procedure.3 Pre-operative and intra-operative measures can be taken to reduce the risk of AKI, and post-operative management strategies may also help mitigate further damage.4 However, there is currently no pharmacological therapy to prevent AKI, and the kidney injury can result in long-term renal impairment and the need for renal replacement therapy (RRT) such as dialysis. Notably, mortality can be up to 50% in CSA-AKI patients who require RRT post-operatively. About AM-Pharma AM-Pharma strives to develop medicines for patients confronted with severe medical conditions. Our proprietary asset, ilofotase alfa, is being developed for the treatment of patients with acute kidney injury (AKI) and has been granted FDA fast-track status. We also develop ilofotase alfa in the severe rare disease hypophosphatasia where ilofotase alfa has orphan drug status in the US and EU. With approximately 1,000 subjects evaluated to date in clinical trials, ilofotase alfa has a proven safety pro a demonstrated kidney benefit. We are a dedicated team driven to bring treatment options to severely ill patients, their families and acute care professionals. Find out more about us online at: . 1 2 Pickkers P et al., Intensive Care Med., 2024 3 Andújar A et al., Front. Nephrol., 2023 4 Ostermann M et al., J Clin Med., 2021 View source version on businesswire.com: Contacts Investors: Juliane Bernholz, Chief Executive Officer j.bernholz@am-pharma.com Media: Trophic Communications Gretchen Schweitzer or Priscillia Perrin +31 6 52 33 15 79 am-pharma@trophic.eu Source: AM-Pharma View this news release online at:

12月9日至12日，第65届美国血液学年会（ASH）在美国圣地亚哥隆重举行。作为全球血液学领域最大最全面的涵盖恶性与非恶性血液学的国际盛会之一，ASH每年都会吸引来自全球100多个国家的25000余名血液专家参会，分享最前沿的血液学进展和突破性临床数据。 本次大会，恒瑞医药自主研发的TPO受体激动剂海曲泊帕、PD-1抑制剂卡瑞利珠单抗、JAK1抑制剂SHR0302，及合作引进PI3Kδ抑制剂林普利塞等4款创新药的12项研究入围 [1] ，其中1项研究入选口头（Oral）报告，11项研究接收为壁报展示。 6项研究入选 新一代TPO-RA药物海曲泊帕大放异彩 海曲泊帕是中国自主研发的新一代口服小分子非肽类血小板生成素受体激动剂(TPO-RA)药物，在2021年6月获得国家药品监督管理局(NMPA)批准，用于治疗既往对糖皮质激素、免疫球蛋白等治疗反应不佳的慢性原发性免疫性血小板减少症(ITP)成年患者以及对免疫抑制治疗(IST)反应不佳的重型再生障碍性贫血(SAA)成年患者。此外其在肿瘤治疗所致血小板减少症(CTIT)及移植相关血小板减少症等领域也有诸多进展。本次ASH大会，该产品在ITP、再生障碍性贫血(AA)、CTIT、移植后等多个领域共有6项研究成果入选壁报展示，展现了血液学界的认可与肯定。 1.摘要号：1343 海曲泊帕联合环孢素A(CsA)治疗输血依赖型非重型再生障碍性贫血(TD-NSAA)患者的疗效 文章标题：The Efficacy of Hetrombopag Combined with Cyclosporine a in Patients with Transfusion-Dependent Non-Severe Aplastic Anemia 第一作者：宫跃敏(江苏省人民医院) 通讯作者：何广胜(江苏省人民医院) 本研究前瞻性收集24例接受海曲泊帕联合CsA治疗的TD-NSAA患者信息，将仅接受CsA单药治疗的79例患者作为历史对照。治疗24周时,海曲泊帕联合CsA组的总反应率(ORR)为74%, CsA单药组为16%(P<0.001)。海曲泊帕联合CsA组12周和48周的ORR也显著高于CsA组(43% vs 8%, P<0.001; 85% vs 30%, P=0.001)。海曲泊帕联合CsA组达到初始反应的中位时间为11.6周，显著短于CsA单药组(P<0.0001) 。CsA单药组有34%患者转化为重型再障(SAA)，联合组仅为8%(P=0.018)。研究表明，海曲泊帕联合CsA可提高TD-NSAA患者血液学反应的速度和强度，降低向 SAA 转化的风险。 2. 摘要号：5005 海曲泊帕联合环孢素A治疗新诊断输血依赖型非重型再生障碍性贫血(TD- NSAA)--一项前瞻性II期研究 文章标题：Adding Hetrombopag to Cyclosporine a to Patients with Newly Diagnosed Transfusion-Dependent Non-Severe Aplastic Anemia — a Prospective Phase 2 Study 第一作者：申舒培(中国医学科学院北京协和医院) 通讯作者：韩冰(中国医学科学院北京协和医院) 研究纳入6个月内诊断为输血依赖性非重型再生障碍性贫血(TD-NSAA)且既往未接受治疗的成人患者28例，给予海曲泊帕联合CsA治疗。结果显示，在3个月、6个月和随访结束时，海曲泊帕联合CsA组和CsA单药组的总反应率(ORR)分别为57.1% vs 16.7%(P=0.001)、68.2% vs 30.0%(P=0.006)和90.9% vs 46.6%( P<0.001)，完全反应率(CRR)分别为10.7% vs 0% (P=0.068)、22.7% vs 10.0% (P=0.217)和36.4% vs 16.6%(P=0.109)。研究表明，海曲泊帕联合CsA可改善新诊断TD-NSAA患者的血液学反应，且耐受性良好，复发率低。 3. 摘要号：2721 海曲泊帕或艾曲泊帕联合免疫抑制疗法一线治疗重型再生障碍性贫血的疗效及安全性对比 文章标题：Comparison between Hetrombopag and Eltrombopag Combined with IST As First-Line Treatment for Severe Aplastic Anemia 第一作者：杨文睿(中国医学科学院血液病医院) 通讯作者：张凤奎(中国医学科学院血液病医院) 一项回顾性研究纳入109例接受海曲泊帕(67例)或艾曲泊帕(42例)联合免疫抑制疗法(ATG+CSA)作为一线治疗的重型再生障碍性贫血患者，比较两种TPO-RA的疗效差异。结果显示，在3个月时，海曲泊帕组34例(50.7%)患者获得血液学反应(HR)，9例(13.4%)获得完全反应(CR)；艾曲泊帕组21例(50%)患者获得HR，5例(11.9%)获得CR，无统计学差异(P=0.973)。两组6个月缓解率及至首次缓解的中位时间也相似。安全性方面，接受艾曲泊帕治疗的患者在3个月和6个月时间接胆红素水平明显升高，而海曲泊帕组未见明显升高(P<0.001)。研究表明在标准IST基础上加用海曲泊帕或艾曲泊帕都可获得更深、更快的血液学缓解，而海曲泊帕的肝脏安全性优于艾曲泊帕。 4. 摘要号：1216 海曲泊帕联合重组人血小板生成素治疗重症免疫性血小板减少症的疗效观察 文章标题：Effect of Hetrombopag combined with rhTPO in Patients with Severe Immune Thrombocytopenia 第一作者：殷杰(苏州大学附属第一医院) 通讯作者：吴德沛(苏州大学附属第一医院) 这是一项前瞻性、开放标签、单中心研究，评估海曲泊帕联合重组人血小板生成素（rhTPO）用于重症ITP患者的短期升板效果。联合治疗后，血小板计数达到30、50、100×109/L的中位时间分别为4.5天、6天、7天。治疗7天后血小板计数中位值达103×109/L，15天后达214.5×109/L。治疗15天内，15%(3例)患者获得部分血小板反应(PLT >50 ×109/L)，85%(17例)患者获得完全血小板反应(PLT >100×109/L)，且安全性良好。研究结果表明早期给予海曲泊帕联合rhTPO治疗可快速提升重症ITP患者血小板计数，避免出血损害。 5. 摘要号：3539 海曲泊帕促进异基因造血干细胞移植(allo-HSCT)后血小板植入的有效性和安全性——一项前瞻性、多中心、随机对照临床试验 文章标题：Efficacy and Safety of Hetrombopag in Promoting Platelet Engraftment after Allogeneic Hematopoietic Stem Cell Transplantation:A Prospective,Multicenter,Randomized Controlled Clinical Trial 第一作者：冯一梅(陆军军医大学第二附属医院) 通讯作者：张曦(陆军军医大学第二附属医院) 接受allo-HSCT的患者在干细胞回输后第3天随机进入试验组和对照组。试验组：海曲泊帕2.5或5 mg/d；对照组：rhTPO 300 U/kg/d。中期分析结果：两组分别纳入26例受试者，试验组粒细胞和血小板植入的平均时间分别为15.26±3.37天和15.20±4.06天，1例(3.8%)受试者发P=生原发性血小板植入不良(PGF)。对照组粒细胞和血小板植入的平均时间分别为17.38±5.82天和18.18±4.62天，4例(15.4%)发生PGF。与对照组相比，试验组粒细胞(P=0.03)和血小板(0.01)的植入明显提前。血小板输注量，试验组vs对照组：3.92±3.45 vs 6.87±3.93U，P=0.0009。医疗费用支出，试验组(海曲泊帕) vs对照组(rhTPO)：2783.90±1020.04元vs12555.39±5222.33元，P<0.0001。本研究证实海曲泊帕可有效促进allo-HSCT后血小板的快速植入，缩短粒系与巨核系重建的时间差，减少血小板输注量，同时减轻移植患者的经济负担。 6. 摘要号：3970 海曲泊帕治疗淋巴瘤和多发性骨髓瘤肿瘤治疗所致血小板减少症的疗效分析 文章标题：Efficacy of Hetrombopag in Treatment of Cancer Therapy - Induced Thrombocytopenia in Lymphoma and Multiple Myeloma Patients 第一作者：陈俊丽(解放军总医院第五医学中心) 通讯作者：黄文荣(解放军总医院第五医学中心) 本研究回顾性纳入60例接受抗肿瘤治疗后发生≥2级血小板减少症的淋巴瘤和多发性骨髓瘤患者，其中81.7%为3/4级血小板减少症（PLT＜50×109/L）。海曲泊帕中位治疗时间为8天，血小板计数恢复至≥75×109/L、100×109/L的中位时间分别为 7天和9天。海曲泊帕治疗后，第3、5、10天血小板计数均值明显升高，分别为40.9、54.9、94.4×109/L。治疗期间，未发生海曲泊帕治疗相关不良事件。研究结果表明，对于发生≥2级CTIT的淋巴瘤和多发性骨髓瘤患者，海曲泊帕能够有效提升血小板水平，缩短血小板减少症的持续时间，且安全性良好。 4项研究入选 林普利塞淋巴瘤领域研究重磅亮相 林普利塞是我国首个高选择性PI3Kδ抑制剂，用于治疗既往接受过至少两种系统性治疗的复发或难治（R/R）滤泡性淋巴瘤（FL）成人患者，这也是恒瑞医药对外合作产品中第一个获批上市的创新药。本次ASH大会，林普利塞共有4项研究成果入选，其中1项入选口头报告，3项入选壁报展示。 由北京大学肿瘤医院淋巴瘤科团队牵头开展的“林普利塞治疗R/R 外周T/NK细胞淋巴瘤（R/R PTCL）的多中心II期临床研究”入选本次ASH大会口头报告环节。在这项R/R PTCL II期研究中，林普利塞单药治疗的ORR达到48% (30% CR)，达到主要终点，并且在PTCL各亚型中均观察到缓解。研究结果表明，林普利塞单药治疗R/R 外周T/NK细胞淋巴瘤获得了较高的缓解率 [2] ，且具有良好的耐受性和安全性。基于该研究结果，林普利塞新适应症上市申请于今年9月获国家药品监督管理局(NMPA)受理，用于治疗R/R PTCL患者。 林普利塞治疗R/R 外周T/NK细胞淋巴瘤的多中心II期临床研究入选2023 ASH大会口头报告 另外3项入选壁报展示的研究如下： 1. 摘要号：1732 林普利塞联合吉西他滨和奥沙利铂在R/R DLBCL的多中心、单臂Ib/II期研究 文章标题：Linperlisib in Conjunction with Gemcitabine and Oxaliplatin in Relapsed/Refractory Diffuse Large B-Cell Lymphoma: A Multicenter, Single-Arm Phase Ib/II Study 第一作者：孙鹏(中山大学肿瘤防治中心) 通讯作者：李志铭(中山大学肿瘤防治中心) 这是一项多中心、单臂Ib/II期研究，入组了39例组织学确认的R/R 弥漫性大B细胞淋巴瘤(DLBCL)患者，接受林普利塞80 mg/d口服，联合6个周期GEMOX(吉西他滨1000 mg/m2，IV，第1天，Q3W；奥沙利铂100 mg/m2 IV，第2天，Q3W)，21天一个周期，然后林普利塞单药治疗直至疾病进展、发生无法耐受的毒性或退出研究。截至2023年2月，中位随访24.1个月，ORR达到53.8%，中位至缓解时间为1.3个月(范围：1.2-4.0)，中位DoR为5.7个月，中位PFS为5.4个月(95% CI：1.8-6.7)。中位OS未达到，1年OS为65.5%。该研究结果表明林普利塞联合GEMOX方案在R/R DLBCL患者中显示出良好的安全性和积极的疗效，为进一步探索林普利塞与其他方的联合潜力奠定了基础。 2. 摘要号：1722 复发/难治性 B细胞恶性肿瘤患者接受林普利塞单药治疗的Ib期研究 文章标题：A Phase Ib Study of Linperlisib Monotherapy in Patients with Relapsed or Refractory B-Cell Malignancies 第一作者：刘薇(中国医学科学院血液病医院) 通讯作者：邱录贵(中国医学科学院血液病医院) 本研究共纳入43例R/R B细胞恶性肿瘤患者，接受林普利塞治疗。截至2023年1月10日，中位随访时间为24.7个月(范围：0.8-30.6)。所有患者的ORR为46.5%，DCR为72.1%。整个患者队列的中位DoR为9.3个月(95% CI：5.4-NR)，中位PFS为8.3个月(95% CI：3.7-NR)。未达到中位OS，1年和2年OS率分别为79.1%和76.7%。研究结果表明，林普利塞在一系列R/R B细胞恶性肿瘤(包括DLBCL、MCL、MZL、FL和SLL/CLL)中均表现出广泛的抗肿瘤活性。进一步证明了林普利塞作为单药或与其他药物联合治疗的合理性。 3. 摘要号：1677 PI3Kδ抑制剂林普利塞作为≥3线治疗复发/难治性滤泡淋巴瘤：单臂、开放标签的II期研究的亚组分析 文章标题：PI3Kδ Inhibitor Linperlisib As a ≥ 3-Line Treatment for Relapsed or Refractory Follicular Lymphoma: A Subgroup Analysis of a Phase II, Single-Arm, Open-Label 第一作者：苏航(解放军总医院第五医学中心) 通讯作者：邱录贵(中国医学科学院血液病医院) 本研究纳入了既往入组到开放性标签、单臂的II期试验(林普利塞口服80 mg/d，QD，28天为一个周期)并接受过至少两种全身治疗的来自中国25个研究中心的84例R/R FL患者。比较既往接受过>3线和≤3线治疗的疗效及安全性差异。结果表明，共67例患者达到缓解，既往治疗线数 >3线的ORR为83.7%，既往治疗线数≤3线的ORR为75.6%。与接受≤3线既往治疗的患者相比，接受≤3线既往治疗的患者获得的DCR更高(41[95.3%] vs 37[90.2%])。>3线既往治疗的中位DoR为12个月(95% CI：7.3-15.9)，而≤3线既往治疗的DoR为13个月(95% CI：9.2-NE)。>3线既往治疗的中位PFS为11.9个月(95% CI：9.1-19.4)，≤3线既往治疗的中位PFS为13.3个月(95%CI：8.2-NE)。两组均未达到OS。该亚组分析显示，无论治疗线如何，林普利塞均可使接受至少2种既往系统治疗的R/R FL患者获益。AE耐受良好。有必要进行进一步大规模样本的试验。 各有1项研究入选 卡瑞利珠单抗和SHR0302获血液学界认可 1、摘要号：4447 卡瑞利珠单抗联合苯达莫司汀和吉西他滨(BeGe)治疗复发/难治性经典霍奇金淋巴瘤(R/R cHL)的一项II期试验 文章标题：Clinical Observation of Camrelizumab （CAM） Combined with Bendamustine and Gemcitabine （BeGe） in Relapsed/Refractory Classical Hodgkin Lymphoma (cHL): A Phase II Trial 第一作者：白敏(山西省肿瘤医院) 通讯作者：苏丽萍(山西省肿瘤医院) 这是一项开放标签、多中心、探索性临床研究，计划入组准备接受自体造血干细胞移植的R/R cHL患者，接受卡瑞利珠单抗联合苯达莫司汀和吉西他滨（BeGe）治疗2个周期。截至2023年5月，共有17例患者入组，其中12例为难治性患者。经2个周期CAM + BeGe治疗后，ORR为94.0%(16/17)，CR率为64.7%(11/17)，PR率为29.4%(5/17)。截至2023年6月，已有7例患者进行了自体造血干细胞移植，1年PFS为86.3%，1年OS为94.1%。该研究结果提示卡瑞利珠单抗联合BeGe方案在R/R cHL患者获得了良好的疗效和可控的安全性，且对干细胞采集无明显影响，值得进一步探索。 2、摘要号：3554 新型JAK1抑制剂SHR0302治疗慢性移植物抗宿主病：一项I期临床试验 文章标题：A Novel JAK1 Inhibitor SHR0302 for Treatment of Chronic Graft-Versus-Host Disease: A Phase I Clinical Trial 第一作者：邱慧颖（上海市第一人民医院） 通讯作者：宋献民（上海市第一人民医院） 这是一项开放标签Ⅰ期临床研究。研究纳入了年龄18-70岁且在allo-HSCT后确诊为首发中度/重度慢性移植物抗宿主病（cGVHD）、需要全身免疫抑制治疗的患者。cGVHD根据美国国立卫生研究院（NIH）标准确诊。SHR0302的剂量探索采用“3+3”设计，剂量分别为：1mg/d、2mg/d、4mg/d、6mg/d和8mg/d。截至2023年5月，18例患者在剂量递增期间入组，中位随访时间为17.3个月(范围：1.8-31.7个月)。中位持续治疗时间为6.3个月(范围：1.5-23.2个月)，没有患者出现因剂量减少/停药或因不良事件(AE)而死亡的情况。第4周客观缓解率(ORR)和完全缓解（CR）率分别为94.4%和27.8%，第24周ORR和CR率分别为82.4%和64.7%。24个月无事件生存率(EFS)为72.2% (95% Cl：51.4%-93.0%)。8例(44.4%)患者在24周时停用泼尼松，4例(22.2%)CR患者在24周评估前停用了包括SHR0302在内的所有免疫抑制剂。研究结果表明，SHR0302联合泼尼松治疗既往未治疗的cGVHD具有令人鼓舞的疗效和可控的安全性，提示SHR0302联合治疗有望成为初始cGVHD的最新选择。 总结 本次ASH大会，恒瑞医药12项创新药重磅研究在国际学术舞台精彩亮相，是中国血液学领域研发创新力量的重要展现。作为一家创新型国际化制药企业，恒瑞医药多年来深入践行“科技为本、为人类创造健康生活”的使命，致力于推动医药创新成果惠及更多患者。目前，公司已有13款自主研发的1类创新药、1款自主研发的2类新药及2款合作引进创新药在国内获批上市。另有80多个自主创新产品正在临床研发，270项临床试验在国内外开展。 未来，恒瑞医药将继续坚持“以患者为中心”的理念，重创新，强研发，力争研制出更多更好的新药，服务健康中国，惠及全球患者。 声明：本文仅为展示医学研究最新进展，不代表对于治疗方法和药品的推荐，相关药品的使用请咨询专业医师。 参考文献： [1].https://ash.confex.com/ash/2023/webprogram/start.html. [2].非头对头比较

ROSWELL, Ga., Dec. 4, 2023 /PRNewswire/ -- Roivios Ltd., a medical device company pioneering a revolutionary treatment to reduce poor surgical outcomes associated with Acute Kidney Injury (AKI), today announces that the final patient has been enrolled in the BIPASS-AKI study for the JuxtaFlow Renal Assist Device (RAD). The Institute of Cardiovascular Diseases, Sremska Kamenica in Serbia was the highest enrolling site, led by principal investigator Prof Dr Milovan Petrovic, cardiac surgeon Prof Dr Lazar Velicki and urologist Dr Dimitrije Jeremic. Additional study sites include The American Heart Hospital in Bielsko Biala, Poland and The Institute for Cardiovascular Diseases Dedinje, Serbia. "When we began this feasibility trial, we anticipated the use of the JuxtaFlow RAD to be an exciting moment," said Prof. Petrovic. "We frequently perform cardiac surgery on patients with renal impairment and they are among our most complicated cases, so we are proud to have enrolled several patients into this study to contribute insights into this novel therapy in advance of its pivotal trial." Cardiac surgery-associated AKI (CSA-AKI) occurs in up to 73% of patients who have pre-existing renal insufficiency documented as part of their standard pre-surgical workup1. This type of AKI then impacts a patient's ability to recover from surgery, leading to a longer and more costly hospital stay, a higher risk of morbidity and mortality, and a more frequent need for chronic dialysis treatment2-5. The JuxtaFlow RAD is used in the hospital setting and is designed to enable the kidneys to function optimally and thereby improve overall patient outcomes. "The mission of Roivios is to give clinicians the tools to protect, preserve and improve kidney function. Cardiac surgery is a major stress on the kidneys, and today these patients have few options. Our team is inspired to design a system that would assist critical renal function during times of acute stress, employing an innovative solution that enhances the kidneys' own natural function to support recovery.", said John Erbey, PhD, Chief Executive Officer of Roivios. "We are incredibly excited to have completed the first step in providing this novel therapy for at-risk patients and serve as the bridge to their successful recovery. We look forward to sharing this BIPASS-AKI data shortly and then continuing to partner with hospitals, surgeons, and critical care teams around the world who share our vision for reducing this all-too-frequent adverse event of surgery." The BIPASS-AKI feasibility trial was being conducted pursuant to the regulations of both ALIMS in Serbia and URPL in Poland. Ten patients were enrolled between September and December. The JuxtaFlow RAD is not commercially available in any geography. The system is limited by United States law to Investigational Use Only and is not available for sale in the United States. For more information about the JuxtaFlow RAD system, please visit For more information about BIPASS-AKI, see Contact John Erbey, PhD, Chief Executive Officer [email protected] Shen W, Aguilar R, Montero AR, et al. Acute Kidney Injury and In-Hospital Mortality after Coronary Artery Bypass Graft versus Percutaneous Coronary Intervention: A Nationwide Study. Am J Nephrol. 2017;45(3):217-225. Bowdish ME, D'Agostino RS, Thourani VH, et al. STS Adult Cardiac Surgery Database: 2021 Update on Outcomes, Quality, and Research. Ann Thorac Surg. 2021;111(6):1770-1780. Robert AM, Kramer RS, Dacey LJ, et al. Cardiac surgery-associated acute kidney injury: a comparison of two consensus criteria. Ann Thorac Surg. 2010;90(6):1939-1943. Palomba H, de Castro I, Neto AL, Lage S, Yu L. Acute kidney injury prediction following elective cardiac surgery: AKICS Score. Kidney Int. 2007;72(5):624-631. Brown JR, Kramer RS, Coca SG, Parikh CR. Duration of acute kidney injury impacts long-term survival after cardiac surgery. Ann Thorac Surg. 2010;90(4):1142-1148. About Roivios Roivios® is a medical device company pioneering a novel renal assist device designed to reduce or eliminate acute kidney injury (AKI) in patients who are at elevated risk. Initially focused on meeting an unmet need of cardiac surgery associated-acute kidney injury (CSA-AKI) in the coronary artery bypass and surgical valve population, our pioneering renal assist device has the potential to address a range of poor outcomes. Our first product, the JuxtaFlow Renal Assist Device, is the world's first negative pressure renal assist device, featuring a patented catheter and unique energy delivery system. SOURCE Roivios, ltd