BroncAblate智衡导管接入BroncAblate智衡主机，先端通过盐水灌注有效降低阻抗，经自然腔道(支气管) 将射频能量精准稳定送达肺部肿瘤病灶中心，通过射频消融灭活肿瘤组织，带来创伤更小、获益更佳的 肺部肿瘤精准靶向超微创介入疗法，成功填补该领域的全球空白。 格隆汇6月23日丨堃博医疗-B(02216.HK)公告，董事会欣然宣布，继BroncAblate智衡一次性使用肺部射 频消融导管(国械注准20253010767)(下称"BroncAblate智衡导管")在中国获批上市后(详情请见本公司日 期为2025年4月二11日的公告)，本公司的核心产品，自主研发的BroncAblate智衡肺部射频消融系统主机 部分(国械注准20253011204)(下称"BroncAblate智衡主机")正式获得中国国家药品监督管理局(NMPA)批 准上市。至此，BroncAblate智衡肺部射频消融系统这款全球首款经自然腔道(支气管)射频消融肺癌治疗 器械正式进入商业化进程。 BroncAblate智衡主机结合BroncAblate智衡导管，为全球首款通过大规模、高质量临床研究确证的经自 然腔道肺癌射频消融介入治疗器械 ...

其中指出，强化标准引领创新，进一步完善高端医疗器械标准体系。加快发布医用外骨骼机器人、放射 性核素成像设备等相关标准。加快推进医用机器人、人工智能医疗器械、高端医学影像设备等领域的基 础、通用标准和方法标准等制修订工作，积极筹建医用机器人、人工智能医疗器械标准化技术委员会。 2025年3月31日，国家药监局综合司就《关于优化全生命周期监管支持高端医疗器械创新发展的举措》 公开征求意见，提出优化全生命周期监管，支持高端医疗器械创新发展。 其中，境内第三类医疗器械产品248个，进口第三类医疗器械产品34个，进口第二类医疗器械产品19 个，港澳台医疗器械产品7个。 华泰证券认为，医疗领域设备更新利好政策将逐步对医疗设备业务产生需求端的拉动作用。设备更新政 策将持续三年，未来有可能拓展到内镜或其他领域，医疗设备公司尤其是头部公司将持续受益。另一方 面，设备更新政策将有助于促进终端医院采购恢复正常，过去压抑已久的需求将逐渐得到释放，看好未 来医疗设备市场的持续复苏。 医疗器械相关产业链港股： 启明医疗-B(02500)、爱康医疗(01789)、微创机器人-B(02252)、沛嘉医疗-B(09996)、微创医疗(0085 ...

报名：首届全球眼科大会 | 议程更新 报名：首届全球心血管大会 | 奖项申报 报名：首届全球骨科大会 | 奖项评选 合作伙伴征集：2025全球手术机器人大会 2025年4月8日至11日， 第91届中国国际医疗器械（春季）博览会（CMEF） 将在上海国家会展中心拉开帷幕。作为亚太地区规模最大的医疗科技展会，CMEF始终 是行业风向标，不仅汇聚全球创新技术，更见证着产业发展的新趋势。本届展会预计吸引 全球30多个国家和地区的近 5000家 企业，携 数万款 前沿产品集中亮相 ，以"创新科技，智领未来"为主题，共同探讨医疗科技的突破与未来。 CMEF不仅是一场产品与技术的集中展示，更是医疗行业生态的一次深度联动。从人工智能驱动的医学影像，到手术机器人赋能精准医疗，从智慧医院建设，到国 产医疗设备的崛起，CMEF2025通过高规格论坛、产业对话和技术展示，构建起全方位的交流平台，为行业发展提供新的思路与动能。 在这一医疗科技的年度盛会上，哪些企业将携最新技术亮相？哪些创新产品值得重点关注？ 思宇梳理了本届CMEF的亮点企业，一起来看它们如何在这场科技盛宴 中抢占先机！ P.S. 展位图附于文末，感兴趣的读者可按图索骥 ...

Financial Performance - Revenue for the year ended December 31, 2024, was $8,131,000, a decrease of 21% compared to $10,255,000 in 2023[4] - Gross profit for the same period was $6,139,000, down 15% from $7,227,000 in the previous year[4] - The net loss for the year was $15,303,000, representing a 46% improvement from a loss of $28,092,000 in 2023[4] - Total comprehensive loss for the year was $16,129,000, compared to $28,695,000 in 2023, reflecting a substantial improvement[9] - The company reported a significant reduction in adjusted net loss, from $27,536,000 in 2023 to $15,067,000 in 2024, a decrease of 45%[4] - The company reported a pre-tax loss of $15,303,000 for 2024, compared to a loss of $28,091,000 in 2023, indicating an improvement of 45.5%[40] - The company’s total revenue for the reporting period was $8.1 million, with annual losses narrowing from $28.1 million in fiscal 2023 to $15.3 million, a year-on-year reduction of 46%[56] - Total customer contract revenue for 2024 was $8,131,000, a decrease of 20.7% from $10,255,000 in 2023[22] Cash and Assets - Cash and bank balances decreased by 11% to $139,346,000 from $156,647,000 year-over-year[4] - Cash and cash equivalents fell significantly from $83,564,000 in 2023 to $46,473,000 in 2024, a decline of about 44.5%[10] - Total assets less current liabilities decreased from $186,647,000 in 2023 to $169,477,000 in 2024, a decline of approximately 9.2%[11] - Non-current assets totalled $24,105,000 in 2024, slightly up from $23,153,000 in 2023, indicating a growth of about 4.1%[10] - The capital debt ratio as of December 31, 2024, was 0.2%, significantly lower than 1.3% in 2023[111] Sales and Revenue Breakdown - Revenue from the sale of medical devices and consumables dropped from $11,984,000 in 2023 to $7,571,000 in 2024, a decrease of approximately 36.5%[21] - Revenue from major customers included $1,547,000 from Customer B and $1,432,000 from Customer C in 2024, while Customer A contributed $6,317,000 in 2023[20] - Revenue from mainland China decreased to $3,214,000 in 2024 from $6,465,000 in 2023, representing a decline of 50.3%[22] - Revenue from the European Union increased to $2,628,000 in 2024 from $1,848,000 in 2023, showing a growth of 42.2%[22] - Other countries/regions generated $2,289,000 in revenue for 2024, up from $1,942,000 in 2023, an increase of 17.8%[22] Product Development and Innovation - The company launched the BroncQCT® software, which enhances the efficiency of CT image reading for lung diagnostics, receiving approval for market entry in March 2025[6] - Clinical trials for the BroncAblate® system demonstrated its safety and effectiveness in treating lung tumors, with results published in a leading journal[5] - The company is focused on developing and upgrading interventional treatment products for lung diseases, particularly lung cancer and severe COPD, to enhance patient quality of life and potentially extend survival[50] - The company launched several innovative products and clinical procedures in the respiratory intervention field, with successful clinical applications in multiple hospitals across various provinces[53] - The company’s innovative product, the BroncAblate® system, demonstrated safety and efficacy in treating lung tumors, as published in the journal Respirology[52] Market Expansion and Regulatory Approvals - The company achieved a 29% year-over-year increase in overseas sales revenue, expanding its presence to 37 countries/regions by the end of 2024[7] - The company has obtained 66 registration certificates overseas, including two new FDA registrations for Biostar® and BroncTru®[7] - The company’s overseas market expansion included new registrations in Poland and Saudi Arabia in 2024[54] - The company has obtained 83 registration certificates for its products both domestically and internationally, with several products currently in the global registration process[92] Cost Management and Expenses - The cost of sales for the same period was $2.0 million, down 34.2% from $3.0 million in the previous year, indicating effective cost management[102] - Sales and distribution expenses were $8.5 million, a decrease of approximately $3.0 million or 26.1% year-on-year, reflecting effective optimization of sales expenditure[105] - Total administrative expenses decreased by 18.6% to approximately $7.3 million in 2024 from $8.9 million in 2023[108] - R&D expenses for the year ended December 31, 2024, were approximately $11.5 million, a decrease of 43.1% compared to $20.2 million in 2023[106] Employee and Management Information - The company had 200 employees as of December 31, 2024, with 178 based in China and 22 overseas[130] - Total employee costs for the reporting period were approximately $14.6 million, down from $22.6 million in the same period of 2023[130] - The company reported a significant narrowing of losses compared to the same period last year, with total management compensation decreasing from $726,000 in 2023 to $354,000 in 2024[47] Corporate Governance and Compliance - The audit committee reviewed the annual consolidated financial statements for the year ending December 31, 2024, and found them compliant with applicable accounting standards[132] - The company has complied with all applicable corporate governance codes during the reporting period, except for the separation of the roles of Chairman and CEO[123] - The company is listed on the Hong Kong Stock Exchange, indicating its compliance with local regulations[146] Future Outlook and Strategic Plans - The company plans to selectively expand its global business, leveraging its competitive products to provide quality medical services worldwide[99] - The company aims to strengthen the penetration and influence of its treatment products in the Chinese market while focusing on the pre-market clinical trials of its in-development products[98] - The company is reallocating funds to enhance operational efficiency and capitalize on new market opportunities, particularly in the development of core products[140] - The company aims to strengthen its competitive position in the respiratory disease treatment sector through innovation and strategic resource allocation[142]

Broncus Holding Corporation 堃博醫療控股有限公司 堃博醫療控股有限公司 Broncus Holding Corporation 中期報告 2024 （於開曼群島註冊成立的有限公司） 股份代號 : 2216 Interim Report 中期報告 2024 野 1 堃博醫療控股有限公司 | --- | --- | |-------|--------------------------| | | | | 目錄 | | | | | | 2 | 公司資料 | | 4 | 財務摘要 | | 5 | 業務摘要 | | 7 | 管理層討論及分析 | | 23 | 其他資料 | | 37 | 中期簡明綜合損益表 | | 38 | 中期簡明綜合全面收益表 | | 39 | 中期簡明綜合財務狀況表 | | 41 | 中期簡明綜合權益變動表 | | 43 | 中期簡明綜合現金流量表 | | 45 | 中期簡明綜合財務資料附註 | | 63 | 釋義 | 二零二四年中期報告 2 公司資料 | --- | --- | |---------------------------------|---------- ...

各位投资人各位分析师大家早上好我是公共医疗董事长徐鸿这里我代表公司给各位汇报一下上半年的一个业绩的一个总体的情况概览这些情况分为四个部分第一个部分是我们的整体耗材的这些销售同比增长是29%主要来源于我们InterVapor的销售的增量 目前为止在中国已经覆盖了180家医院这180家医院主要还是大部分的目前还是以试用的阶段进入禁区的大概有10家医院开始在常规化的开展相关的手术 同时呢这个物权这个vapor和物权呢是在28个省市呢已经获得了阳光挂网突阔是我们最近这个拿证的一个产品大概在23个省市有阳光挂网的这个情况 物权和图库开始实现一些多用途的场景的一个临床的应用物权主要是在我们的化痰和抗炎药物的注入图库是在比如像冷冻活检配合冷冻活检以及我们简化版的BT-BNA术师上有了比较好的应用的场景 第二个方面是我们的国产化的效益国产化截止到目前为止我们之前在美国所开发和生产的产品目前只剩下LAMPRO这款产品还没有完成最后的国产化预计我们应该是在9月初也就是下个月月初的时候我们应该可能会拿到国家局的产品注册证 截至9月拿到证之后我们应该会也就是全面的已经完成了我们的进口产品的国产化由于国产化的调整我们整个毛利率是提升至 ...

Financial Performance - Revenue for the first half of 2024 decreased by 29% to $3.704 million compared to $5.234 million in the same period of 2023[3] - Gross profit for the first half of 2024 decreased by 27% to $2.954 million compared to $4.026 million in the same period of 2023[3] - Net loss for the first half of 2024 narrowed by 46% to $7.943 million compared to $14.731 million in the same period of 2023[3] - Revenue for the first half of 2024 decreased to $3.704 million, compared to $5.234 million in the same period of 2023, reflecting a decline of 29.2%[6] - Gross profit for the first half of 2024 was $2.954 million, down from $4.026 million in 2023, a decrease of 26.6%[6] - Net loss for the first half of 2024 was $7.943 million, an improvement from the $14.731 million loss in 2023, reflecting a 46.1% reduction in losses[6] - Total comprehensive loss for the first half of 2024 was $8.290 million, compared to $16.602 million in 2023, showing a 50.1% improvement[7] - Revenue from external customers in Mainland China decreased to $2.359 million in H1 2024 from $4.251 million in H1 2023, a decline of 44.5%[17] - Total revenue from external customers dropped to $3.704 million in H1 2024 from $5.234 million in H1 2023, a decrease of 29.2%[17] - Revenue for the six months ended June 30, 2024, was $3.7 million, a decrease from $5.2 million in the same period last year[52] - Adjusted net loss for the six months ended June 30, 2024 was $7.832 million, compared to $14.291 million in the same period in 2023[67] R&D and Product Development - R&D expenses for the first half of 2024 decreased by 37% to $6.491 million compared to $10.232 million in the same period of 2023[3] - R&D costs for the first half of 2024 were $6.491 million, a reduction of 36.6% compared to $10.232 million in 2023[6] - R&D costs decreased to $6.491 million in H1 2024 from $10.232 million in H1 2023, a reduction of 36.6%[23] - R&D expenses decreased by 37% to $6.5 million, reflecting cost optimization and focus on core product development[59] - The company's lung cancer intervention product, the Zhiheng RF-II radiofrequency ablation system, is the world's first bronchoscopic intervention product with an indication for lung cancer and has submitted for regulatory review in China[5] - The key clinical study for the Targeted Lung Denervation (TLD) system for acute COPD treatment has enrolled over 80 subjects across multiple medical centers in China[5] - The company's TLD radiofrequency ablation system, developed in collaboration with West China Hospital, is in a key clinical trial phase with over 80 subjects enrolled across 20 research centers as of June 30, 2024[34] - The TLD system is expected to complete all subject follow-ups by July 2026, with clinical trial reports and data to be released no earlier than that date[34] - The company's product pipeline includes InterVapor® and TLD, targeting severe and acute COPD, with InterVapor® already holding CE and NMPA certifications[32] - The Zhihang RF-II radiofrequency ablation system, developed in collaboration with Guangzhou Medical University, is the world's first bronchoscopic intervention product for lung cancer treatment[36] - The Zhihang RF-II completed its clinical trial BRONC-RF-II in March 2023, demonstrating safety and efficacy, and has been submitted for regulatory approval[37] - The company has three navigation products: LungPoint, LungPoint Plus/Archimedes Lite, and LungPro/Archimedes system, covering different hospital needs[39] - The LungPro/Archimedes system, approved in the US, EU, and China, represents an upgrade to the LungPoint VBN system, enabling precise navigation for peripheral lesions[40] - The company focuses on developing innovative technologies for lung disease navigation, diagnosis, and treatment, leveraging international technology and local R&D cost advantages[41] Product Commercialization and Market Penetration - The InterVapor® thermal vapor therapy system has been commercially applied in over 60 hospitals in China, with approximately 180 hospitals having access to or trialing the technology[4] - The disposable thermal vapor therapy catheter for InterVapor® has obtained sunshine procurement prices in 28 provinces and cities, with gradual implementation of local medical insurance coverage[4] - The BroncTru® disposable bronchoscopic puncture dilation catheter has been clinically applied in multiple medical centers across China since its launch in September 2023[4] - The company's InterVapor® thermal vapor treatment system is the world's first and only non-implantable medical device for treating chronic obstructive pulmonary disease (COPD) and has been commercialized in over 60 hospitals in China[33] - The InterVapor® system has been approved for commercialization in multiple regions including Europe, China, and Australia, with over 180 hospitals in China having used or trialed the technology[33] - The company's InterVapor® system has been listed on the centralized procurement platforms in 28 provinces in China, facilitating hospital procurement and pricing negotiations[33] - The Woquan® disposable endoscope nebulization microcatheter has been used in over 1,000 surgeries in the first half of 2024, primarily for airway anesthesia and nebulized drug delivery[37] - The BroncTru® disposable bronchoscopic puncture dilation catheter was approved by Zhejiang Medical Products Administration in September 2023 and has been widely adopted in top medical centers[38] - Sales of medical consumables increased by 29% to $2.3 million, driven by higher market penetration of products like InterVapor® and BroncTru in China[53] Operational Efficiency and Cost Management - The company has improved production efficiency and optimized production processes, steadily increasing capacity to meet growing business demands[5] - Cost of sales decreased by 38% to $0.8 million, primarily due to cost optimization and localization of production processes[54] - Gross margin improved to 80% from 77%, attributed to reduced production costs following the localization of InterVapor® and navigation products[55] - Administrative expenses decreased by 22% to $3.6 million, driven by cost control measures[61] - Total employee costs (excluding share-based compensation) for the reporting period were $7.9 million, down from $12.6 million in the same period in 2023[74] Financial Position and Liquidity - Total assets minus current liabilities as of June 30, 2024, were $178.002 million, down from $186.647 million at the end of 2023[8] - Cash and cash equivalents as of June 30, 2024, were $89.652 million, an increase from $72.845 million at the end of 2023[8] - Total equity attributable to owners of the parent company as of June 30, 2024, was $177.191 million, down from $185.370 million at the end of 2023[10] - Cash and bank balances, including term deposits over three months, totaled $146.3 million as of June 30, 2024, ensuring sufficient liquidity for operations and development[62] - Net cash used in operating activities was $8.8 million, a reduction from $15.9 million in the same period last year[63] - The company's capital-to-debt ratio decreased to 1.06% as of June 30, 2024, from 1.27% at the end of 2023[64] Market and Industry Trends - The global and Chinese COPD patient populations are projected to increase to 258.4 million and 109.6 million respectively by 2025[32] - Lung cancer is the most common cancer globally in 2022, with nearly 2.5 million new cases (12.4% of all cancers) and 1.8 million deaths (18.7% of all cancer deaths)[35] - China has the highest lung cancer incidence globally, with 1.06 million new cases in 2022 (22% of global cases) and 733,300 deaths (28.4% of all cancer deaths in China)[35] - The five-year survival rate for stage III lung cancer patients is 12.6%, while for stage IV patients it is only 2.9%[35] Corporate Governance and Compliance - The company complied with the Corporate Governance Code, except for the separation of Chairman and CEO roles, which are currently held by Mr. Xu Hong[68] - The company has established a high-standard quality management system in compliance with ISO13485, NMPA GMP, FDA OSR, and EU MDR regulations[43] - No significant contingent liabilities as of June 30, 2024[65] - No significant litigation or arbitration involving the company during the reporting period[73] - The company did not purchase, sell, or redeem any of its listed securities during the reporting period[70] - The company did not issue any equity securities or sell treasury shares for cash during the reporting period[71] - The company has no specific plans for major investments or acquisitions of significant capital assets or other businesses beyond the expansion strategy disclosed in the prospectus dated September 13, 2021[75] Use of Proceeds and Capital Allocation - The net proceeds from the global offering amounted to approximately HKD 1,620.1 million, with HKD 642.3 million utilized as of June 30, 2024, and an unused balance of HKD 977.8 million[76] - The company plans to allocate 29.0% of the net proceeds (HKD 469.2 million) for the development and commercialization of InterVapor®, with HKD 256.0 million remaining unused as of the reporting period[76] - 20.9% of the net proceeds (HKD 339.4 million) are allocated for the development and commercialization of RF-II, with HKD 274.2 million remaining unused as of the reporting period[76] - 18.5% of the net proceeds (HKD 299.9 million) are allocated for the R&D of other candidate products, with HKD 81.1 million remaining unused as of the reporting period[76] - 9.2% of the net proceeds (HKD 149.2 million) are allocated for the expansion of production lines at the company's manufacturing plant, with the full amount remaining unused as of the reporting period[76] - 13.2% of the net proceeds (HKD 213.2 million) are allocated for mergers, acquisitions, or investments in new product lines, with HKD 194.0 million remaining unused as of the reporting period[76] - 9.2% of the net proceeds (HKD 149.2 million) are allocated for working capital and other general corporate purposes, with HKD 23.3 million remaining unused as of the reporting period[76] Other Income and Expenses - Total other income increased to $3.333 million in H1 2024 from $2.387 million in H1 2023, driven by higher bank interest income[21] - Other income and gains increased by $1.0 million to $3.5 million, mainly due to higher interest income[56] - Tax expense remained stable at $2 thousand in both H1 2024 and H1 2023[24] - The company received $0.1 million in government subsidies during the reporting period, compared to $0.05 million in the same period last year[50] Employee and Organizational Structure - The company had 208 employees as of June 30, 2024, with 183 in China and 25 overseas[74] - No significant investments, acquisitions, or disposals in subsidiaries, associates, or joint ventures during the reporting period[72] Dividends and Shareholder Returns - No interim dividends were declared or paid in H1 2024, consistent with H1 2023[25] - The company has not declared or paid any interim dividend for the six months ended June 30, 2024[79] Post-Reporting Period Events - The company is not aware of any significant post-reporting period events from June 30, 2024, to the date of the announcement[79] Non-IFRS Financial Measures - The company has adopted non-IFRS financial measures to provide useful information for comparing operating performance across different periods[66]

Financial Overview - The company has utilized approximately HKD 548.9 million from the global offering proceeds, with an unutilized balance of about HKD 1,071.2 million remaining as of December 31, 2023[25]. - Revenue for the year ended December 31, 2023, was $10,255,000, representing an 8.9% increase compared to $9,413,000 in 2022[55]. - Gross profit decreased slightly to $7,227,000, down 1.2% from $7,315,000 in the previous year[55]. - The net loss for the year was $(28,092,000), a marginal increase of 0.2% from $(28,036,000) in 2022[55]. - Cash and cash equivalents decreased by 16.9% to $156,647,000 from $188,435,000[55]. - In 2023, the company’s sales and distribution expenses were $11.5 million, reflecting a growth of 2.7% compared to $11.2 million in 2022, while sales revenue increased[189]. Compliance and Governance - The company has confirmed compliance with the relevant laws and regulations, with no significant litigation or arbitration issues reported during the period[31]. - The company has not engaged in any purchases, sales, or redemptions of its listed securities during the reporting period[27]. - The company has adhered to the disclosure requirements under the Listing Rules regarding related party transactions[8]. Product Development and Innovation - The company believes that the intellectual property developed for its lung robot will play a crucial role in maintaining its competitive advantage in the lung medical robotics market[20]. - The core product, the RF-II radiofrequency ablation system for lung cancer treatment, has completed pre-market clinical trials, confirming its safety and efficacy[83]. - The innovative TLD radiofrequency ablation energy system for treating acute exacerbations of COPD completed its first clinical trial surgery in July 2023, with over 40 subjects enrolled across more than 20 research centers by December 31, 2023[87]. - The RF-II product is expected to drive the commercialization of the company's navigation platform post-launch[83]. - The company has 19 products at various stages of development, including several innovative interventional pulmonary treatment products unique to China or globally[122]. - The InterVapor® device received registration from the National Medical Products Administration in October 2023, marking a significant milestone for commercialization[119]. - The clinical trial for the TLD product is a multi-center study involving 189 patients with moderate to severe chronic obstructive pulmonary disease, expected to complete follow-ups by July 2026[141]. - The company has developed InterVapor® and InterVapor Plus for the treatment of chronic obstructive pulmonary disease and lung cancer, respectively[133]. Market Presence and Strategy - The company aims to expand sales of diagnostic consumables and focus on R&D for lung disease treatment products[62]. - The company's navigation products have achieved a market share of 40% in China[89]. - The company is expanding its market presence with its products covering multiple countries, including the US, UK, Germany, France, and India[121]. - The company aims to enhance awareness of its navigation platform among hospitals, doctors, and patients through systematic training and education, aiming to expand its sales network[181]. - The company is committed to advancing its localization strategy, which has shown significant results in 2023, further reducing operational costs[99]. Clinical Trials and Research - A government-funded clinical trial for targeted segmental vapor ablation therapy for emphysema has been initiated in Germany, expected to complete by 2025[73]. - The clinical trial data for RF-II was presented at the European Respiratory Society conference, supporting its safety and efficacy in lung cancer treatment[116]. - The clinical trial for InterVapor® was completed in March 2023, with plans to use data collected in China for registration applications in the US and EU[127][128]. - As of December 31, 2023, the clinical history of InterVapor® includes five major trials, with the NEXT-STEP trial completed in June 2020 and the VAPORIZE trial's report finalized by September 2021[135]. Future Outlook - The company plans to continue adapting to external environmental changes and optimizing its business and R&D pipelines amid industry challenges[98]. - The RF-II product is expected to be commercialized within seven years from the start of its development process[138]. - There are no significant plans for major investments or acquisitions beyond the disclosed expansion strategies[67]. - The company aims to optimize its R&D pipeline and deepen market penetration while focusing on cost reduction and efficiency improvements[85]. Customer and Market Insights - The top five customers contributed 78% of total revenue, with the largest customer accounting for 62%[47]. - The global population suffering from chronic obstructive pulmonary disease (COPD) was 233.6 million in 2022, projected to rise to 258.4 million by 2025, with China accounting for 107 million and expected to reach 109.6 million[196]. - The five-year survival rate for stage III lung cancer patients is only 12.6%, highlighting the need for early diagnosis and treatment solutions[175].

Financial Performance - For the fiscal year ending December 31, 2023, the company reported revenue of $10,255,000, representing an 8.9% increase compared to $9,413,000 for the previous year[3]. - The gross profit for the same period was $7,315,000, showing a slight decrease of 1.2% from $7,227,000 in the prior year[3]. - The net loss for the year was $28,092,000, which is a marginal improvement of 0.2% compared to a net loss of $28,036,000 in the previous year[3]. - The company's revenue for the fiscal year 2023 was $10,255,000, an increase from $9,413,000 in 2022, representing a growth of approximately 8.9%[9]. - The cost of goods sold for 2023 was $3,028,000, compared to $2,098,000 in 2022, indicating an increase of about 44.4%[9]. - The company's net loss for the fiscal year 2023 was $28,092,000, slightly higher than the net loss of $28,036,000 in 2022[10]. - The company reported other income and gains of $6,019,000 in 2023, up from $4,785,000 in 2022, reflecting an increase of approximately 25.8%[9]. - The company’s research and development expenses for 2023 were $20,154,000, compared to $19,167,000 in 2022, showing an increase of about 5.1%[9]. - The adjusted net loss for 2023 was $27,536 thousand, compared to $26,913 thousand in 2022, indicating an increase in losses year-over-year[135]. - The company did not declare or pay any dividends during the current year, consistent with 2022[46]. Product Development and Clinical Trials - The company completed the confirmatory clinical trial for the RF-II product, achieving a success rate of 99.35% and a complete ablation rate of 93.8% after six months[5]. - The innovative TLD radiofrequency ablation system for treating acute exacerbations of chronic obstructive pulmonary disease (COPD) has completed its first clinical trial procedure in July 2023, with over 40 patients enrolled across more than 20 research centers[5]. - The InterVapor® thermal vapor treatment system is the world's first and only medical device for treating chronic obstructive pulmonary disease without implants, with clinical trials confirming its feasibility for lung cancer treatment[64]. - The RF-II radiofrequency fusion system is the first global product for endobronchial intervention specifically for lung cancer[64]. - The company has developed a comprehensive intervention platform for respiratory diseases, addressing clinical needs for lung disease treatments[63]. - The TLD product, developed in collaboration with Sichuan University, aims to treat chronic obstructive pulmonary disease (COPD) and has completed initial clinical trials with over 40 patients enrolled by the end of 2023, expecting full enrollment by July 2026[80][82]. - InterVapor® has completed clinical trials including STEP-UP, NEXT-STEP, VAPORIZE, and BTVA Registry, with a total of 239 patients enrolled across 17 research centers by the end of 2023, reporting no serious device-related adverse events[73][74]. - The RF-II clinical trial BRONC-RF-II was completed in March 2023, with results submitted to NMPA for medical device market review[78]. - The TLD clinical trial is a prospective, randomized, single-blind, sham-controlled study involving over 20 research centers in China, with the first surgery completed in July 2023[82]. Market Expansion and Product Commercialization - As of December 31, 2023, the company has obtained various national and provincial qualifications, including recognition as a National High-tech Enterprise and a Zhejiang Province Technology-based SME[7]. - The company's market share for its navigation products in China reached 40%[8]. - The InterVapor® product has been commercialized in over 20 hospitals in China, with approximately 100 hospitals engaged in using or trialing the technology[8]. - The company has expanded its product coverage to multiple countries, including the United States, United Kingdom, Germany, France, and India[8]. - The company plans to utilize clinical data collected in China to apply for registration in the US and EU[67]. - The company is focusing on regulatory compliance and post-market clinical research to strengthen the clinical evidence for its products[109]. - The company aims to expand its market presence and enhance its product offerings through strategic initiatives[160]. - The company is actively pursuing new strategies for market expansion and potential acquisitions[160]. Financial Position and Assets - Total assets decreased from $214,525 thousand in 2022 to $186,647 thousand in 2023, representing a decline of approximately 13%[13]. - Non-current assets increased from $19,076 thousand in 2022 to $23,153 thousand in 2023, reflecting an increase of about 21%[12]. - Current assets decreased from $202,866 thousand in 2022 to $172,652 thousand in 2023, a reduction of approximately 15%[12]. - Cash and cash equivalents decreased significantly from $106,756 thousand in 2022 to $83,564 thousand in 2023, a decline of around 22%[12]. - Total liabilities increased from $7,417 thousand in 2022 to $9,158 thousand in 2023, indicating an increase of approximately 23%[12]. - The company's equity decreased from $213,458 thousand in 2022 to $185,370 thousand in 2023, a decline of about 13%[13]. - The company reported a significant increase in intangible assets from $5,910 thousand in 2022 to $8,970 thousand in 2023, representing an increase of approximately 52%[12]. - The company's total non-current liabilities rose from $1,067 thousand in 2022 to $1,277 thousand in 2023, an increase of about 20%[13]. - The company's total current liabilities increased from $7,417 thousand in 2022 to $9,158 thousand in 2023, reflecting a rise of approximately 23%[12]. Research and Development - The company is focused on research and development, particularly in the field of chronic obstructive pulmonary disease and lung cancer treatments[160]. - The company is increasing its investment in artificial intelligence and machine learning to accumulate clinical data and enhance the performance of its navigation systems[108]. - Research and development costs amounted to approximately $20.2 million for the year ended December 31, 2023, up from $19.2 million in 2022, representing a growth of 5.1% driven by an increase in clinical trial expenses from $0.6 million to $1.5 million[120]. Corporate Governance and Compliance - The company has adhered to all applicable corporate governance codes during the reporting period, ensuring high standards of corporate governance[139]. - The board of directors includes both executive and independent non-executive members, ensuring diverse governance[162]. - The company emphasizes the importance of adhering to corporate governance guidelines as per the Listing Rules[160]. Employee and Management Information - As of December 31, 2023, the company had a total of 308 employees, with 266 located in China and 42 overseas[145]. - Total employee costs for the reporting period were approximately $22.6 million, compared to $22.4 million in the same period of 2022[146]. - The company paid a total of $681,000 in compensation to key management personnel in 2023, a decrease of 41% from $1,154,000 in 2022[61]. Future Outlook - The company anticipates commercial launch of RF-II within seven years from the start of its development process[79]. - The company plans to expand into robotic minimally invasive surgery through the development of its own flexible surgical robots[105]. - The company aims to address the significant market demand for minimally invasive solutions for lung diseases driven by aging populations and environmental factors[105].

Financial Performance - Revenue for the six months ended June 30, 2023, was $5,234,000, representing a 62.6% increase compared to $3,218,000 in 2022[6] - Gross profit for the same period was $4,026,000, up 63.5% from $2,462,000 in the previous year[6] - The net loss for the period improved to $(14,731,000), a decrease of 8.3% from $(16,060,000) in 2022[6] - The adjusted net loss under non-IFRS was $(14,291,000), a reduction of 5.4% compared to $(15,111,000) in the prior year[6] - Other income and gains totaled approximately $2.5 million, representing a 362.6% increase from about $0.5 million in the same period last year[130] - The company reported a net loss of $14.7 million for the six months ended June 30, 2023, an improvement from a net loss of $16.1 million in the same period last year[151] - The adjusted loss for the period, excluding share-based payments, was $14.29 million, down from $15.11 million in 2022, indicating a 5.4% reduction[186] - The total employee costs for the six months ended June 30, 2023, were $5.814 million, accounting for 56.8% of total expenses, compared to $4.452 million in the same period last year[133] - The company's research and development costs for the six months ended June 30, 2023, were approximately $10.2 million, up 12.0% from $9.1 million in the same period last year, primarily due to an increase in employee costs[155] Product Development and Clinical Trials - The company completed the confirmatory clinical trial follow-up for its core product RF-II in Q1 2023, involving 126 subjects with a success rate of 99.35% and a complete ablation rate of 92.06% at 6 months post-procedure[23] - The design of InterVapor® for lung cancer treatment has been completed and submitted for type testing in July 2023[32] - The company has initiated clinical trials for its new product in China, with registration trials starting in January 2023 and expected to complete by December 2026[24] - The company reported a low incidence of common complications such as pneumothorax and bleeding in its lung cancer thermal ablation treatment[23] - The RF-II clinical trial has completed enrollment of all subjects, with 126 participants undergoing 12-month follow-up analysis, showing a technical success rate of 99.35% and a complete ablation rate of 92.06% at 6 months post-procedure[55][63] - The company completed the first clinical surgery for the lung-targeted denervation (TLD) ablation system in July 2023, with a total of 189 patients planned for the trial, expected to conclude by the end of 2025[82] - The company is conducting a pre-market clinical trial for the lung-targeted denervation (TLD) ablation system, aiming to enroll 189 patients across over 20 research centers in China, with completion expected in Q4 2024[55] Market Expansion and Strategy - The company aims to become a global leader in transforming lung disease treatment[10] - The company has expanded its product coverage to 33 countries and regions globally, including the US, UK, Germany, France, Singapore, Thailand, India, and South Korea as of H1 2023[31] - The company is addressing the growing global demand for minimally invasive solutions for chronic obstructive pulmonary disease and lung cancer due to increasing prevalence driven by aging populations and air pollution[20] - The company plans to expand the sales of LungPoint Plus and other medical consumables in China, leveraging its experience in sales and marketing[148] - The company plans to expand its sales network by providing more physician training and patient education, promoting equipment installation, and deepening hospital penetration, in response to the growing market demand for minimally invasive treatment solutions for lung diseases[124] Regulatory and Compliance - The company is subject to the requirements of maintaining a register of interests and short positions as mandated by the Securities and Futures Ordinance[199] - The report highlights the importance of compliance with regulatory requirements regarding shareholder disclosures[199] - The company continues to evaluate its performance using non-IFRS measures to provide investors with useful information for comparing operational performance across different years[184] Shareholder Information - The company's major shareholder, Mr. Kai Guo Wei, holds 2,999,396 shares, representing 0.57% of the total shares[176] - Mr. Zhao Yi Wei holds 13,021,588 shares, accounting for 2.47% of the total shares[176] - The largest shareholder, Mr. Jian Zhen Jun, has a controlled interest in 118,628,244 shares, which is 22.50% of the total shares[176] - The company reported significant shareholder interests as of June 30, 2023, in accordance with the Securities and Futures Ordinance[199] Employee and Operational Insights - The company has a total of 314 employees as of June 30, 2023, categorized by function[14] - The company has begun transferring production processes to China to leverage lower labor and material costs, with the production of H-Marker starting in June 2021[113] - The company anticipates that the localized production of InterVapor® in China will be fully operational after receiving regulatory approval in Q3 2023[113] Miscellaneous - The company did not declare or pay any dividends during the reporting period and has no plans to declare any interim dividends[167] - The company continues to explore opportunities to expand its product line, although there are no specific plans for significant investments or acquisitions at this time[173] - The document indicates that the interests and short positions of certain individuals, excluding directors and senior executives, must be disclosed to the company and the stock exchange[199] - The content lacks detailed insights into the company's strategic initiatives or future guidance[199][200]