Elixir Medical Corp.

EuroPCR 2026: Elixir Medical’s DynamX® Bioadaptor Demonstrates Significantly Lower Event Rates Than Drug-Eluting Stent in Long-Term Follow-Up, Including Reduction in Cardiovascular Death Paris, France, May 19, 2026 (GLOBE NEWSWIRE) -- Significantly lower TLF rates (2.8% versus 7.8%, p=0.020) with DynamX® compared to Resolute Onyx DES with no new events in bioadaptor arm between 3 and 4 years 88% reduction in Cardiovascular Death (0.5% versus 3.7%, p=0.020) with DynamX® compared to DES PARIS – May 19, 2026 – Elixir Medical , a developer of transformative technologies to treat cardiovascular and peripheral disease, today announced four-year results from the large 445-patient BIOADAPTOR Randomized Controlled Trial (RCT), comparing the DynamX ® Coronary Bioadaptor System to standard of care Resolute Onyx™ Drug-Eluting Stent (DES) at 34 centers in Japan, Europe, and New Zealand. The data were presented at a late-breaking clinical trial session during the EuroPCR 2026 conference in Paris. “Interventional cardiologists typically use a drug-eluting stent (DES) during percutaneous coronary intervention (PCI) to open the heart blockage and keep the artery open. These interlocked mesh-like tubes, however, permanently cage the artery, limiting its function and contributing to an annual 2-3% increase in adverse clinical events over time,” - said Professor Stefan Verheye, M.D., Ph.D., interventional cardiologist at ZNA Cardiovascular Center in Antwerp, Belgium and leading DynamX ® investigator. “The bioadaptor is a new type of unlocking, adaptive implant designed to keep the artery open while restoring normal vessel function, its compliance and pulsatility.” Late-breaking four-year results presented at EuroPCR highlight durable clinical outcomes with the DynamX ® bioadaptor, with no new target lesion failure (TLF) or cardiovascular death (CVD) events observed between years three and four, maintaining a very low plateauing rate of adverse events compared to the continued annual increase seen with DES. DynamX ® demonstrated a 66% lower TLF rate (2.8% versus 7.8%; p=0.020) compared to DES, reflecting significant clinical benefit and long-term durability of PCI treatment with bioadaptor. The TLF reduction was driven by improvement across all components of the device-related combined endpoint, including: 88% lower cardiovascular death (0.5% versus 3.7%, p=0.020), a statistically significant reduction Numerically lower target vessel myocardial infarction (0.9% versus 1.8%) Numerically lower clinically driven target lesion revascularization (1.4% versus 2.8%) These findings highlight a key differentiation of the bioadaptor implant from drug-eluting stents: while DES outcomes continue to accrue adverse events over time, DynamX ® demonstrates stabilization of event rates following restoration of vessel function at 6 months post-procedure. Substantial clinical improvement was also observed in the left anterior descending (LAD) artery, with TLF rates dramatically lower with DynamX ® compared to DES (2.7% versus 10.6%; p=0.021), potentially reflecting an amplified impact of restoring vessel function in this hemodynamically critical coronary vessel responsible for about 50% of heart blood supply. “The DynamX ® bioadaptor represents a significant advancement in PCI by providing functional restoration of the artery,” – remarked Shigeru Saito, M.D., trial principal investigator and director of the Division of Cardiology and Catheterization Laboratory at Shonan Kamakura General Hospital in Kamakura, Japan. “Furthermore, the significant finding in reducing cardiovascular mortality marks a major achievement in how we treat cardiovascular disease and improve patient outcomes.” PCI procedures have been successful at improving the conductance of blood through diseased, blocked coronary arteries. Stents establish luminal diameter and improve the acute mechanical result of PCI compared to balloon angioplasty. However, DES do not restore the physiology of the vessel wall because they create rigid scaffolding. This constrains vessel elasticity and prevents return to a more normal, pulsatile function. The DynamX ® bioadaptor first achieves the initial objective of opening the artery in establishing luminal diameter to improve blood flow. Unlike DES, it transitions to a different structure following an initial period of healing where it unlocks and provides the essential radial dynamic support to the diseased artery, allowing the treated segment to recover pulsatility and compliance. “The four-year BIOADAPTOR-RCT data presented today, and the results from the 2,400 patient INIFINITY-SWEDEHEART RCT have shown consistently across multiple randomized clinical trials significantly lower, plateauing clinical events with DynamX ® bioadaptor compared to DES treatment, demonstrating the clear benefit of restoring a key function of arteries, hemodynamic modulation, with this breakthrough technology.” - said Motasim Sirhan, CEO of Elixir Medical. About BIOADAPTOR RCT Trial The BIOADAPTOR RCT is an international, single-blind, randomized controlled (1:1) trial comparing a sirolimus-eluting bioadaptor with a contemporary zotarolimus-eluting stent in 445 patients in 34 centers in Japan, Europe, and New Zealand. Both arms had large randomized multi-modality imaging subgroups of 50 patients each to document standard effectiveness benchmarks of establishing and maintaining artery flow lumen measured by percent diameter stenosis (%DS) and late lumen loss (LLL), and the new effectiveness benchmarks of restoring artery hemodynamic modulation, including pulsatility, vessel compliance, adaptive flow volume, and plaque stabilization and regression. Clinical follow-up will continue through five years. BIOADAPTOR RCT trial is part of Elixir Medical’s robust DynamX ® bioadaptor clinical evidence program consisting of nine company-sponsored and investigator-initiated studies involving over 9,000 patients. About DynamX ® Sirolimus Eluting Coronary Bioadaptor System The DynamX ® bioadaptor is the first coronary implant technology designed to restore coronary artery hemodynamic modulation as demonstrated by restored vessel pulsatility, compliance, and adaptive increase in blood flow volume, and providing plaque stabilization and regression. With its unique mechanism of action (MOA), it addresses the shortcomings of drug-eluting stents and bioresorbable scaffolds (BRS) with remarkably low clinical event rates that showed a plateau from six months through four-year clinical follow-up. The DynamX ® Sirolimus Eluting Coronary Bioadaptor System is CE-marked. The DynamX ® Sirolimus Eluting Coronary Bioadaptor System is an investigational device, limited by Federal (or United States) law to investigational use. About Elixir Medical Elixir Medical Corporation, a privately held company based in Milpitas, California, develops disruptive platforms to treat coronary and peripheral artery disease. Our transformative technologies have multiple applications across the cardiovascular space capable of delivering improved clinical outcomes for millions of patients. Elixir Medical was named to Fast Company’s prestigious list of the World’s Most Innovative Companies of 2025. Visit us at and on LinkedIn . ### Media Contact: Richard Laermer RLM PR elixir@rlmpr.com (212) 741-5106 X 216

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.ft4 { font-family: MLJNAR+SimSun; font-size: 16.720000; font-weight: bold; color: black; font-style: inherit } .ft5 { font-family: MLJNAR+SimSun; font-size: 16.720000; font-weight: 0; color: black; font-style: inherit } .ft6 { font-family: MLJNAR+SimSun; font-size: 19.200000; font-weight: 0; color: black; font-style: inherit } .ft7 { font-family: DGFMOR+TimesNewRomanPSMT; font-size: 16.720000; font-weight: 0; color: black; font-style: inherit } .ft8 { font-family: MLJNAR+SimSun; font-size: 14.400000; font-weight: bold; color: black; font-style: inherit } 证券代码：301201 证券简称：诚达药业 公告编号：2026-005 诚达药业股份有限公司2025年年度报告摘要 一、重要提示 本年度报告摘要来自年度报告全文，为全面了解本公司的经营成果、财务状况及未来发展规划，投资者应当到证监会指定媒体仔细阅读年度报告全文。 所有董事均已出席了审议本报告的董事会会议。 众华会计师事务所（特殊普通合伙）对本年度公司财务报告的审计意见为：标准的无保留意见。 非标准审计意见提示 □适用不适用 公司上市时未盈利且目前未实现盈利□适用不适用 董事会审议的报告期利润分配预案或公积金转增股本预案 适用□不适用 公司经本次董事会审议通过的利润分配预案为：以公司当前总股本154,713,824股剔除回购专户中的已回购股份3,244,700股后的股本151,469,124股为基数，向全体股东每10股派发现金红利2元（含税），送红股0股（含税），以资本公积金向全体股东每10股转增0股。 董事会决议通过的本报告期优先股利润分配预案 □适用□不适用 二、公司基本情况 1、公司简介 股票简称诚达药业股票代码301201股票上市交易所深圳证券交易所联系人和联系方式董事会秘书证券事务代表姓名杨晓静吴忠杰办公地址浙江省嘉兴市嘉善县惠民街道黄河路36号浙江省嘉兴市嘉善县惠民街道黄河路36号传真0573-841859020573-84185902电话0573-844680330573-84468033电子信箱zjb@chengdapharm.comir@chengdapharm.com 2、报告期主要业务或产品简介 公司主营业务涵盖为跨国制药企业及医药研发机构提供关键医药中间体、原料药CDMO研发生产服务，左旋肉碱系列产品、原料药的研发、生产和销售以及干细胞药物的研发。报告期内，公司坚持“强化CDMO”的业务发展战略，稳固左旋肉碱系列产品的全球市场地位，并战略性布局生物细胞治疗领域，致力于打造“小分子CDMO+原料药+生物创新药”多元化业务结构。 公司CDMO业务主要为客户提供公斤级别到吨位级别的关键医药中间体、原料药的工艺研发、工艺优化、分析方法开发和验证、注册文件编制和申报、稳定性研究、定制生产等服务，可以满足不同客户质量体系的要求，客户群覆盖了多家国际知名制药企业，并且已进入多家跨国药企（MNC）的供应链体系。CDMO定制业务所服务的终端药物包括抗病毒、抗肿瘤及免疫机能调节、抗感染、神经系统、心血管、消化道及代谢等重大疾病治疗领域。报告期，公司围绕两大高增长赛道——减肥类产品（尤其是小分子GLP-1药物中间体）与小核酸类药物（涵盖单体及递送系统关键中间体）进行战略性布局。经过前期的技术攻关、样品试制等研发储备阶段，公司目前已成功打通从实验室到产业化落地的关键环节，正式迈入“订单落地、商业化出货”的实质性业务增长期。具体而言，在减肥品类方面，针对小分子GLP-1药物中间体，公司已具备生产能力，相关产品可满足下游客户的采购需求；在小核酸类产品方面，公司可提供高质量的单体及递送系统中间体，满足小核酸药物（如siRNA、ASO）的定制化生产需求。公司左旋肉碱系列产品包括L-肉碱、L-肉碱盐酸盐、乙酰L-肉碱盐酸盐、丙酰L-左旋肉碱盐酸盐、DL-肉碱盐酸盐、L-肉碱酒石酸盐、L-肉碱富马酸盐、L-肉碱乳清酸盐、L-肉碱（50％）等，主要用于食品添加剂、饲料添加剂领域，公开报道的主要功效包括但不限于：1、促进脂肪代谢，肉碱能够加速脂肪酸进入线粒体，使脂肪酸更容易被分解和利用，从而促进脂肪代谢；2、减少脂肪堆积，肉碱能够帮助身体将多余的脂肪酸转化为能量，减少脂肪在身体内的堆积；3、提高运动能力，肉碱能够增加肌肉中的肌酸储备，提高运动能力，延缓肌肉疲劳；4、在维持婴儿生命及促进婴幼儿发育的某些生理过程，如生酮作用、氨代谢等方面均具有一定的功能；5、有利于心脏和血管的保健，不断运动的心脏细胞其能量来源至少2/3是来自脂肪的氧化，而左旋肉碱是脂肪氧化不可或缺的关键物质；6、促进动物生长、提高肉质品质、增强繁殖能力等。 公司原料药业务布局中枢神经药物、心血管药物、糖尿病药物、抗炎药物、重症肌无力药物、妇科用药等多个适应症。左卡尼汀适用于因体内左卡尼汀缺乏产生的一系列并发症状，如心肌病、骨骼肌病、心率失常、高脂血症、低血压和透析中肌痉挛等。公司左卡尼汀原料药已获得中国NMPA、美国FDA、日本PMDA、韩国MFDS、意大利AIFA、英国MHRA、加拿大HC、希腊等国家药政管理部门的审评通过，并取得了欧洲CEP认证证书，覆盖了全球主流市场的质量体系认证，产品质量得到了客户的广泛认可。布立西坦原料药已获得韩国MFDS审评通过，并取得了欧洲CEP认证证书；报告期内，达格列净原料药已通过了中国NMPA的GMP符合性检查，实现商业化生产销售。另外，基于成熟的合规体系，公司积极开展创新药原料药业务，将CDMO服务能力直接嵌入到客户的创新药研发与生产链条中。报告期内引进开展了5个创新药原料药项目的研发，部分已经完成了中试批的生产。 已进入注册程序的在研化学原料药和中间体项目情况 序号品种名称适应症注册市场进展情况1艾拉戈克钠子宫内膜异位症和子宫肌瘤大出血美国已申报备案登记，尚未启动审评2布立西坦癫痫患者部分发作性癫痫美国已申报备案登记，尚未启动审评3利伐沙班用于预防静脉血栓美国已申报备案登记，尚未启动审评4布立西坦癫痫患者部分发作性癫痫欧盟已获批，取得CEP证书5左旋肉碱、左旋肉碱酒石酸盐防治左卡尼汀缺乏印度已获批6艾拉戈克钠子宫内膜异位症和子宫肌瘤大出血中国已申报备案登记，已受理7(S)-2-(1-溴-8-氨基咪唑并[1,5-a]吡嗪-3-基)吡咯烷-1-羧酸苄酯阿卡替尼关键中间体美国已申报备案登记84-(2-吡啶基氨甲酰基)苯硼酸阿卡替尼关键中间体美国已申报备案登记93-硝基-4-[[(四氢-2H-吡喃-4-基)甲基]氨基]苯磺酰胺维奈克拉关键中间体美国已申报备案登记101 -{[2-（4-氯苯基）-4,4-二甲基-1-环己烯-1-基]甲基}哌嗪二盐酸维奈克拉关键中间体美国已申报备案登记 公司全资孙公司玖乾诚生物主要从事生物细胞药的研发、生产、销售，建有约6000平米的研发平台和GMP生产中心，满足中美GMP双标准，配备自动化BMS/EMS控制系统及进口核心设备，覆盖研发、生产、质检的全产业链。报告期内，公司细胞治疗心梗开通后心衰适应症项目（以下简称“心梗项目”）、治疗脑梗后亚急性期后遗症适应症项目（以下简称“脑梗项目”）已按照CDE法规要求建立了人脐带间充质干细胞种子库、主细胞库及工作细胞库，建立了货架式细胞产品的质量标准，完成了CMC工艺质量研究及工艺验证；启动UMSC01细胞注射液的非临床研究，完成UMSC01细胞注射液的非临床药效学、药代动力学及毒理学的给药研究，为IND申报做准备。 3、主要会计数据和财务指标 （1）近三年主要会计数据和财务指标 公司是否需追溯调整或重述以前年度会计数据 □是否 元 2025年末2024年末本年末比上年末增减2023年末总资产2,349,883,099.722,436,460,004.08-3.55%2,455,325,018.15归属于上市公司股东的净资产2,094,443,605.422,143,050,905.40-2.27%2,277,123,782.242025年2024年本年比上年增减2023年营业收入406,371,974.56333,131,182.3821.99%414,301,764.07归属于上市公司股东的净利润-11,925,796.02-28,103,664.3757.56%90,980,328.72归属于上市公司股东的扣除非经常性损益的净利润-26,692,917.25-57,671,784.9953.72%53,817,789.32经营活动产生的现金流量净额34,017,747.4228,648,375.7818.74%192,072,387.64基本每股收益（元/股）-0.0787-0.184957.44%0.5881稀释每股收益（元/股）-0.0787-0.184957.44%0.5881加权平均净资产收益率-0.56%-1.29%0.73%0.04% （2）分季度主要会计数据 单位：元 第一季度第二季度第三季度第四季度营业收入76,307,845.00106,145,144.75102,641,733.71121,277,251.10归属于上市公司股东的净利润-1,399,981.9814,224,358.313,948,949.87-28,699,122.22归属于上市公司股东的扣除非经常性损益的净利润-5,854,136.868,753,165.201,003,520.20-30,595,465.79经营活动产生的现金流量净额-22,961,570.5646,352,480.8243,070,987.66-32,444,150.50 上述财务指标或其加总数是否与公司已披露季度报告、半年度报告相关财务指标存在重大差异 □是否 4、股本及股东情况 （1）普通股股东和表决权恢复的优先股股东数量及前10名股东持股情况表 单位：股 报告期末普通股股东总数12,962年度报告披露日前一个月末普通股股东总数14,295报告期末表决权恢复的优先股股东总数0年度报告披露日前一个月末表决权恢复的优先股股东总数0持有特别表决权股份的股东总数（如有）0前10名股东持股情况（不含通过转融通出借股份）股东名称股东性质持股比例持股数量持有有限售条件的股份数量质押、标记或冻结情况股份状态数量葛建利境内自然人27.17%42,031,360.0031,523,520.00不适用0.00黄洪林境内自然人12.62%19,528,000.0014,646,000.00不适用0.00深圳市晟泰投资管理有限公司－深圳前海晟泰投资企业（有限合伙）其他5.25%8,116,797.000.00不适用0.00嘉善汇诚股权投资合伙企业境内非国有法人2.15%3,328,640.000.00不适用0.00（有限合伙）WANG ZHE境外自然人1.91%2,950,000.000.00不适用0.00嘉善和诚股权投资合伙企业（有限合伙）境内非国有法人1.70%2,632,000.000.00不适用0.00银华基金－中国人寿保险股份有限公司－万能A－银华基金国寿股份成长股票型组合万能A可供出售单一资产管理计划其他1.18%1,823,460.000.00不适用0.00光大证券资管－兴业银行－光证资管诚达药业员工参与创业板战略配售集合资产管理计划其他0.94%1,452,744.000.00不适用0.00中国建设银行股份有限公司－富国精准医疗灵活配置混合型证券投资基金其他0.69%1,071,868.000.00不适用0.00方形军境内自然人0.67%1,033,900.000.00不适用0.00上述股东关联关系或一致行动的说明1、“诚达药业股份有限公司回购专用证券账户”未在前十名股东持股情况中列示，截至2025年12月31日，“诚达药业股份有限公司回购专用证券账户”持股数为3,244,700股，占公司总股本的比例为2.10%；2、股东卢刚先生持有嘉善汇诚股权投资合伙企业（有限合伙）33.02%的股份，并担任其执行事务合伙人；公司控股股东葛建利女士系卢刚先生母亲。股东卢瑾女士持有嘉善和诚股权投资合伙企业（有限合伙）29.48%的股份，并担任其执行事务合伙人；公司控股股东葛建利女士系卢瑾女士母亲。股东黄洪林妹妹的配偶施照云持有嘉善汇诚4.09%的股份，股东黄洪林配偶的弟弟蔡洪根持有嘉善汇诚3.12%的股份；3、除上述信息外，公司未知其他前10名股东之间是否存在关联关系或一致行动人关系。 持股5%以上股东、前10名股东及前10名无限售流通股股东参与转融通业务出借股份情况 □适用不适用 前10名股东及前10名无限售流通股股东因转融通出借/归还原因导致较上期发生变化 □适用不适用 公司是否具有表决权差异安排 □适用不适用 （2）公司优先股股东总数及前10名优先股股东持股情况表 公司报告期无优先股股东持股情况。 （3）以方框图形式披露公司与实际控制人之间的产权及控制关系 5、在年度报告批准报出日存续的债券情况 □适用不适用 三、重要事项 无

Coronary stents were first developed in the mid 1980s, revolutionizing coronary artery disease treatment for patients. While stents are still used in patients today, only incremental developments in their technology have been made over the last 30 to 40 years. One company, Elixir Medical, is trying to change that. The company focuses on re-imagining how new medical technologies will breathe new life into vascular interventions, reshaping the space for decades to come, and developing disruptive platforms to treat coronary and peripheral artery disease. Elixir’s newest device, the DynamX Bioadaptor, aims to not only improve clogged arteries for patients, but over time actually make the artery stronger. The novel scaffolding device is readily available in Europe and parts of Asia, it is currently undergoing FDA testing in the U.S. Vinayak Bhat, COO of Elixir Medical , connected with MD+DI about the adverse events rates of traditional coronary stents, how the DynamX Bioadaptor differs from conventional stents and what vessel restoration means for aging patients and long-term health outcomes, and ongoing pre-clinical and clinical trials of the device. Can you explain in practical terms how the DynamX Bioadaptor's "vessel restoration" mechanism works differently from traditional stents? Bhat: When plaque builds up in the arteries with coronary artery disease, stents have done a great job in terms of restoring blood flow to these coronary arteries. But what it does not necessarily do is restore the entire functionality of the heart. When the heart pumps blood into the aorta to go across the entire body, the first exit it takes is towards the coronary arteries. So it supplies blood there first before it goes to the brain or rest of the body. Like on an airplane, they say if the mask drops down, even if you love your child more than yourself, you first put the mask on yourself and then on the child. It is the same way here. Nature has designed the coronary arteries in a certain way and the functions, there is hemodynamic modulation in the heartbeat, and with every beat the vessel expands and contracts, there are sheer stressors, which are the communication channel for cells to respond to the changes. So the functionality of the arteries is not just to pass blood, but also do all of these other things in terms of modulation for the entire functionality of the coronary structure. When we put in a stent, like we have been doing for the last 30+ years, you restore blood flow but take away the natural ability of arteries to expand and contract with every heart beat. That is the important functionality of the vessel. This has an impact on clinical events down the line. What we have designed with the Bioadaptor is an implant that is three coils held together by a bioresorbable polymer coating. You implant it in the coronary artery when there is a lesion. Six months after implantation, for the first six months it works like a stent to restore blood flow, but once that job is done, the bioresorbable polymer coating is gone and these coils unlock from each other, allowing restoration of the arteries. With every heartbeat, now the vessel expands and contracts like it's supposed to do. Because of that, you have an impact on the plaque that is behind, there is no compliance mismatch. All of these have an important function in terms of reducing coronary events down the line. Currently with traditional stents, every year after the first year, there is a 2-3% chance of clinical events. Events like repeat heart attack, hospitalization, etc. By restoring the functionality by treating it with a Bioadaptor, we have impacted and made a change to that. And now we have clinical data to essentially prove that, from randomized clinical studies. With over 35 patents behind this technology, what were the most critical engineering breakthroughs that enabled this scaffolding approach? What technical challenges did you have to overcome? Bhat: We had the good fortune of being around for two decades in this space. We have developed stents, fully bio dissolvable scaffolds, and we have a unique group of individuals with medical backgrounds, strong technical backgrounds, drug delivery and polymer science experts, so if you look at problem statements holistically and then come up with solutions that can address the root cause of the issue. So when we set out to develop the Bioadaptor, it took us over 100 iterations just in terms of coming up with the right configuration to ensure that the restoration will be clinically similar to what a natural coronary artery gets. So all of these iterations on the bench, and we develop multiple versions. One version that can unlock within three months, one version that can unlock within six months, really to have an understanding of what it takes to ensure restoring of the natural modulation of the artery. Over multiple iterations, a huge challenge was being in a space that has so many stents with just incremental iterations. To take that function and create a new category of device was a pretty interesting challenge. We went about doing the development on the bench, development in preclinical trials, then moving on to multiple clinical studies where we were looking at proof of concept mechanistically to show that it would work. Only then did we go on to do not one, but two randomized clinical studies in two different geographies to show the effect of this device on patients. What does the long-term safety profile look like for the DynamX Bioadaptor beyond the six-month landmark analysis? Bhat: We have now two first-in-man smaller studies, 50 patients each. After that, we did a 450 patient randomized clinical study, which now has 3-year follow up data. After that, we did a 2,400 patient randomized study in much sicker patients. Those patients now have a 2-year follow up. Long term data now shows not just safety but excellent efficacy of the Bioadaptor as compared to the traditional standard of care. The second study showed superiority in a landmark analysis. The first study showed an over 50% reduction in clinical events at three years. The second study showed the same. So two independent randomized studies showing a significant impact in terms of superior outcomes. Now, long-term data gives us great confidence in new technology. In addition to these new studies, we have also conducted a post-market, 5,000 patient global study which is ongoing. A lot  of physicians are doing their own studies with the device. There is a wealth of data in terms of long-term safety on the Bioadaptor in addition to efficacy. What's the adoption experience been like in European and Asian markets? Bhat: When we initially started with the Bioadaptor, every physician who looks at it says it makes a lot of sense. When nature wants the vessel to hemodynamically modulate, we should be using devices that essentially mimic that. But, they were not really certain that just by making these changes we would impact, because traditional stents have been around for the last 30 years and people felt that that was as good as it can get. They thought these other clinical events we were seeing were just disease progression. Initially there was hesitation, but as there is more clinical data that comes out, the adoption has been excellent. We have tens of thousands of patients in the Middle East and Europe who have been treated. In Asia, patients have a say in which devices they get. A lot of patients come into physicians saying they want our Bioadaptor. They want a device that has long-term benefits. So it is getting a lot of traction moving in that direction. What does the competitive landscape look like? How are established stent manufacturers responding to this disruptive technology? Bhat: The competitive landscape as we entered the market, we didn't want to compete with the stent as just another product with incremental value. Now that we have clinical data showing superiority, we are positioning ourselves as a premium product from a pricing and outcomes perspective. We have no direct competitors to what the Bioadaptor can do. There are 20 to 30 companies that work in the drug-eluting stent space, and we are not necessarily competing with them, but creating a new category of therapy for patients. When it comes to value, the value of the Bioadaptor is for all patients that have coronary artery disease. Given this is a premium product, in many cases, physicians are using the Bioadaptor for more complex cases. Is there anything else you would like to expand on? Bhat: Elixir is uniquely positioned, and FDA has given us breakthrough device designation for the Bioadaptor. FDA has been very collaborative, and very impressed with our innovation in a space that has been dormant for a long time. We are working very closely with them to try and bring this technology to U.S. patients as soon as possible, so this is very exciting for us as an organization and a company. Before you implant the device,  you need to treat calcification. We have created a simple yet innovative mechanism based on physics principles where without requiring an external energy source, we can crack the calcium, even in the arteries, and then implant the Bioadaptor. So that is also another technology that Elixir has developed. And traction in terms of the takeoff of this product is looking really good. It is exciting times for the organization.