RAINMED(02297)

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润迈德(02297) - 董事会会议召开日期
2025-08-18 08:49
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責,對其準確性或完整性亦不發表任 何聲明,並明確表示,概不就因本公告的全部或任何部份內容而產生或因倚賴該等內容而引致的任何損失承擔任何責 任。 Rainmed Medical Limited 潤邁德醫療有限公司 (於開曼群島註冊成立的有限公司) (股份代號:2297) 董事會會議召開日期 潤邁德醫療有限公司(「本公司」)董事會(「董事會」)謹此宣佈,本公司將於二零二五年八 月二十八日(星期四)舉行董事會會議,藉以(其中包括)考慮並批准本公司及其附屬公司截 至二零二五年六月三十日止六個月之未經審計的中期業績及其刊發,並考慮派發中期股息 (如有),以及處理其他事項。 承董事會命 潤邁德醫療有限公司 董事會主席兼執行董事 霍雲飛 香港,二零二五年八月十八日 於本公告日期,董事會由執行董事霍雲飛先生、朱則柯先生及段靜女士;非執行董事霍雲龍博士、王霖先生及衡磊先 生;及獨立非執行董事廖船江先生丶陳雪峰先生及趙暉先生組成。 ...
深圳同创伟业资产管理股份有限公司减持润迈德-B1300万股 每股作价0.3448港元
Zhi Tong Cai Jing· 2025-08-18 08:25
香港联交所最新资料显示,8月15日,深圳同创伟业资产管理股份有限公司减持润迈德-B(02297)1300万 股,每股作价0.3448港元,总金额为448.24万港元。减持后最新持股数目为6792.1万股,最新持股比例 为4.85%。 本次交易涉及其他关联方:深圳市同创伟业创业投资有限公司、黄荔。 ...
润迈德(02297) - 截至二零二五年七月三十一日止股份发行人的证券变动月报表
2025-08-04 09:29
股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年7月31日 狀態: 新提交 致:香港交易及結算所有限公司 公司名稱: 潤邁德醫療有限公司 呈交日期: 2025年8月4日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02297 | 說明 | | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 3,800,000,000 | HKD | | 0.0001 | HKD | | 380,000 | | 增加 / 減少 (-) | | | | | | | HKD | | | | 本月底結存 | | | 3,800,000,000 | HKD | | 0.0001 | HKD | | 380,000 | 本月底法定/註冊股本總額: ...
智通港股股东权益披露|6月30日



智通财经网· 2025-06-30 00:07
Core Insights - The latest shareholder equity disclosures for several companies, including Runmind-B, Asia Pacific Financial Investment, UBTECH, Baolong Commercial, and Youbo Holdings, were made on June 30, 2025 [1] Group 1: Runmind-B (02297) - Shenzhen Futian Tongchuang Weiye Great Health Investment Fund reduced its holdings from 83.304 million shares to 81.939 million shares, representing a decrease in ownership from 5.94% to 5.85% [2] - Huang Li decreased his holdings from 113 million shares to 111 million shares, with ownership dropping from 8.05% to 7.95% [2] - Shenzhen Tongchuang Weiye Venture Capital also reduced its holdings from 113 million shares to 111 million shares, with a similar decrease in ownership percentage [2] Group 2: Asia Pacific Financial Investment (08193) - Zhu Xiaoge and Liu Shengnan both reduced their holdings from 54.3772 million shares to 46.6372 million shares, resulting in a decrease in ownership from 19.43% to 16.67% [2] Group 3: UBTECH (09880) - Wang Lin's holdings remained stable at approximately 29.893 million shares, maintaining an ownership percentage of 8.05% [2] Group 4: Baolong Commercial (09909) - Xu Huafang decreased his holdings from 19.192 million shares to 18.942 million shares, with ownership dropping from 2.99% to 2.95% [2] Group 5: Youbo Holdings (08N22069) - Tang Yuantao slightly increased his holdings from 359 million shares to 360 million shares, with ownership increasing from 70.12% to 70.14% [2]
2025年中国血管介入手术机器人产业链、市场规模、研究单位与成果分析及发展趋势研判:血管介入手术机器人在中国具有较大的发展潜力[图]
Chan Ye Xin Xi Wang· 2025-06-09 02:09
Core Viewpoint - The vascular interventional surgery robot market is rapidly growing, driven by technological advancements, capital investment, and increasing demand, with significant potential for development in China due to the high prevalence of cardiovascular diseases [1][4][8]. Industry Definition and Classification - Vascular interventional surgery robots assist doctors in performing diagnostic and therapeutic procedures guided by medical imaging, utilizing tools such as needles, guidewires, and catheters. They can be classified based on functionality and application techniques, with coronary intervention being the most developed area globally [2][4]. Current Industry Development Status - The vascular interventional surgery robot market has seen substantial growth, with the global market size increasing from $0.03 billion in 2016 to $1.8 billion in 2022, and projected to reach approximately $5.3 billion by 2024 and over $10 billion by 2025 [4][6][8]. Market Potential in China - The vascular interventional surgery robot market in China is still in its early stages, with a market size of approximately $0.29 million in 2022, expected to grow to about $8.58 million by 2025, driven by the high incidence and mortality rates of cardiovascular diseases [8][19]. Industry Chain - The industry chain for vascular interventional surgery robots includes upstream components and materials, midstream equipment manufacturing and system integration, and downstream clinical applications and services [10]. Competitive Landscape - The competitive landscape includes both international and domestic companies. Notable international players have received FDA and CE certifications, while domestic companies are beginning to achieve significant milestones, such as the approval of the first domestic vascular interventional surgery robot by Yidu Medical [12][17][18]. Future Development Trends - The future of vascular interventional surgery robots is expected to feature enhanced feedback and advanced force control capabilities, integrating advanced imaging navigation functions, and expanding applications across various types of vascular interventions [19].
润迈德(02297) - 2024 - 年度财报
2025-04-29 08:31
Financial Performance - The company reported a revenue of RMB 39.8 million for the year ended December 31, 2024, a decrease of 45.6% compared to RMB 73.2 million in 2023[9]. - Gross profit for the same period was RMB 23.9 million, down 50.8% from RMB 48.6 million in 2023, resulting in a gross margin of 59.9%[9]. - The loss attributable to shareholders was RMB 113.5 million, a slight improvement of 2.0% from RMB 115.8 million in the previous year[9]. - The adjusted loss per share based on non-Hong Kong Financial Reporting Standards was RMB 0.10, reflecting an 11.1% increase from RMB 0.09 in the previous year[9]. - The net loss for the year ended December 31, 2024, was RMB 1.153 billion, compared to a net loss of RMB 1.171 billion for the year ended December 31, 2023[37]. - Cash used in operating activities for the year ended December 31, 2024, was RMB 843 million, significantly impacted by high R&D, administrative, and sales expenses[38]. - Cash and cash equivalents decreased by 59.3% to RMB 54,607,000 from RMB 134,085,000 in 2023[10]. - Total assets decreased by 19.2% to RMB 463,060,000 from RMB 573,308,000 in 2023[10]. - The company's available distributable reserves as of December 31, 2024, amount to approximately RMB 418.1 million, a decrease from RMB 805.2 million in 2023[157]. Product Development and Innovation - The company’s caFFR system has over 95% accuracy and a convenient operation process taking less than five minutes, establishing its leading position in the domestic FFR measurement market[4]. - The caIMR system received approval from the National Medical Products Administration in April 2023, becoming the first commercially approved minimally invasive IMR measurement product globally[4]. - The company plans to expand the indications for the caFFR system to include acute STEMI, acute NSTEMI, and HFpEF patients, broadening its market reach[4]. - The company aims to launch an interventional surgical robot that integrates all clinical applications for automated PCI processes, enhancing clinical value[6]. - Future product launches include the caFFR system's expanded indications for acute STEMI, acute NSTEMI, and HFpEF patients, expected to be completed by 2025[24]. - The company has established a distribution network of 257 domestic distributors covering over 550 hospitals across 21 provinces in China[16]. - The production capacity is expected to support the annual production of 11,375 consoles and 1,130,765 pressure sensors[19]. - The company plans to integrate existing production and R&D facilities on a newly acquired land of approximately 20,000 square meters to enhance overall capabilities[19]. Corporate Governance and Board Structure - The board of directors is composed of three executive directors, three non-executive directors, and three independent non-executive directors, ensuring a balanced power structure[178]. - The company has appointed independent non-executive directors with extensive experience in financing and investment[70]. - The board's composition includes professionals with backgrounds in finance, law, and engineering, which supports a well-rounded strategic approach to business decisions[61][68]. - The company has established mechanisms to ensure independent viewpoints are provided to the board[194]. - The company has adopted corporate governance practices in line with the listing rules, ensuring high standards of governance to protect shareholder interests[177]. - The company has a diverse board with members holding degrees from prestigious institutions, including Tsinghua University and RMIT, ensuring a high level of expertise[60][66]. - The board diversity policy aims to enhance effectiveness by considering various diversity aspects, including gender, age, and professional qualifications[195]. - The company has achieved a gender ratio of 61% female employees and at least one female director on the board[196]. Financial Management and Risks - The company faces several major risks and uncertainties, some of which are beyond its control[85]. - The company has incurred significant operating losses since its inception and may continue to do so in the foreseeable future as it expands product development and seeks regulatory approvals for its pipeline products[88]. - The company may face challenges in recruiting patients for clinical trials, which could delay clinical development activities[91]. - Rising market prices for raw materials and components may adversely impact the company's financial condition[91]. - The company may face potential product liability claims, and its insurance may not be sufficient to cover all liabilities[91]. - The company actively communicates with stakeholders and aims to enhance operational management and sustainable development based on stakeholder feedback[98]. Employee and Director Management - The company aims to enhance employee skills through continuous education and training programs[49]. - The company has adopted a pre-IPO stock option plan to attract and retain skilled personnel for future growth and expansion[49]. - All directors actively participate in continuous professional development to enhance their knowledge and skills[198]. - The company maintains a proactive approach to director training and development to ensure compliance and effective governance[199]. - The term for executive directors is three years, with specific notice periods for termination outlined in service agreements[190]. - Independent non-executive directors are evaluated annually for their independence, ensuring they provide unbiased opinions[192]. Market Position and Strategy - The company aims to become a global leader in vascular interventional robotic surgery and a respected company worldwide[182]. - The company plans to continue expanding in both the Chinese and global markets to maximize shareholder value and will support capital expenditures through various financing channels[48]. - The company has established partnerships with various investment entities, including Shenzhen Tongchuang Weiye, which holds approximately 96.3% partnership interest in Tongxiang Haoguan[129]. - The company is indirectly owned by Ping An Group, which holds 100% of Ping An Capital and 72,000,000 shares in Ping An Investment[131]. Compliance and Legal Matters - The group has established compliance policies and procedures to ensure adherence to applicable laws and regulations, with no significant non-compliance events reported during the reporting period[165]. - There are no significant legal proceedings or arbitrations involving the company as of December 31, 2024[166]. - The independent auditor for the year ending December 31, 2024, is Shinewing (HK) CPA Limited, which has been appointed for the upcoming annual general meeting[151]. Shareholder Information - As of December 31, 2024, the total number of issued shares is 1,167,799,000[122]. - The top five customers accounted for 49.8% of the total revenue for the year ending December 31, 2024, compared to 43.8% in 2023[163]. - The largest single customer represented 22.1% of the total revenue for the year ending December 31, 2024, up from 14.2% in 2023[163]. - The company has a significant shareholder structure, with Shanghai Jinglin Equity Investment Management holding approximately 5.05% of the shares[127]. - The company has not reported any significant changes in its main business activities during the reporting period[80].
润迈德(02297) - 2024 - 中期财报
2024-09-27 09:47
Financial Performance - Revenue decreased by approximately 46.6% from RMB 504 million for the six months ended June 30, 2023, to RMB 268 million for the six months ended June 30, 2024[3]. - Gross profit fell by about 49.9% from RMB 373 million for the six months ended June 30, 2023, to RMB 187 million for the same period in 2024, with a gross margin decline from 74.0% to 69.5%[4]. - The company recorded a loss of RMB 427 million for the six months ended June 30, 2024, compared to a loss of RMB 480 million for the same period in 2023[10]. - Net cash used in operating activities was RMB 412 million for the six months ended June 30, 2024, primarily due to significant R&D, administrative, and sales expenses[11]. - The company reported a basic and diluted loss per share of RMB 0.04, unchanged from the previous year[55]. - The loss attributable to shareholders for the six months ended June 30, 2024, was RMB 41,646,000, compared to RMB 47,479,000 for the same period in 2023, representing a decrease of approximately 12.4%[87]. Expenses and Cost Management - Research and development expenses decreased by approximately 18.3% from RMB 226 million for the six months ended June 30, 2023, to RMB 185 million for the same period in 2024[5]. - Sales expenses reduced by about 22.9% from RMB 384 million for the six months ended June 30, 2023, to RMB 296 million for the same period in 2024[6]. - General and administrative expenses decreased significantly from RMB 373.21 million for the six months ended June 30, 2023, to RMB 233.56 million for the six months ended June 30, 2024, representing a year-on-year decline of approximately 37.4%[8]. - Employee benefit expenses dropped by RMB 122.01 million, primarily due to a reduction in salaries and administrative staff[8]. - The company is focusing on cost control measures to manage expenses effectively amid declining sales[6]. Revenue Sources and Market Performance - FlashPressure caFFR pressure sensor sales dropped from RMB 40.6 million in 2023 to RMB 21.1 million in 2024[3]. - FlashAngio caFFR system sales decreased significantly from RMB 3.9 million in 2023 to RMB 15,000 in 2024[3]. - The company reported a total of RMB 308,000 in installation and training service revenue for the six months ended June 30, 2024, down from RMB 439,000 in 2023[3]. - Revenue from product sales dropped to RMB 26,560 thousand, down 46.8% from RMB 49,935 thousand year-over-year[74]. - Revenue from the Chinese market was RMB 26,497 thousand, a significant decline of 47.4% from RMB 50,366 thousand in the same period of 2023[77]. Research and Development - The R&D team consists of over 100 members, accounting for approximately one-third of the total workforce, focusing on innovative products in precision intervention therapy[22]. - The company continues to focus on research and development, particularly in the areas of coronary artery disease and related technologies[118]. - The proprietary consumables for the caFFR system have patient self-pay prices ranging from RMB 10,200 to RMB 12,000 in 33 provinces and regions, with 24 provinces including it in medical insurance reimbursement lists[21]. - The company is actively working to include the caIMR system's proprietary consumables in medical insurance reimbursement lists[21]. Corporate Governance and Shareholding - The board of directors consists of three non-executive directors, three independent non-executive directors, and three executive directors, ensuring a balanced distribution of power and authority[33]. - The company has adopted the corporate governance code and has complied with all provisions except for the separation of roles between the chairman and CEO, which is currently held by the same individual[33]. - As of June 30, 2024, Mr. Huo Yunfei holds 214,749,000 shares, representing approximately 18.39% of the company[39]. - The total shareholding of major shareholders indicates a significant concentration of ownership, with the top three shareholders holding over 50% of the shares[42][43]. - The company is subject to regulatory disclosures under the Securities and Futures Ordinance, ensuring transparency in shareholding[41]. Assets and Liabilities - Total assets increased to RMB 600,794 thousand as of June 30, 2024, compared to RMB 573,308 thousand on December 31, 2023, representing an increase of approximately 4.3%[57]. - Current liabilities surged to RMB 108,543 thousand, a significant increase from RMB 40,982 thousand, reflecting a rise of approximately 164.5%[58]. - The company recorded a total equity of RMB 480,257 thousand as of June 30, 2024, down from RMB 520,012 thousand, representing a decrease of about 7.6%[58]. - The company's total liabilities reached RMB 120,537 thousand, up from RMB 53,296 thousand, indicating a significant increase of approximately 126.3%[58]. Strategic Plans and Market Expansion - The company plans to continue expanding in the Chinese and global markets, focusing on product development and growth through internal development, mergers, and acquisitions[16]. - The company aims to enhance its competitive advantage in the FFR and IMR fields, expand IVD product coverage, and penetrate both domestic and overseas markets to achieve healthy growth and high-quality development in 2024[31]. - The company is exploring opportunities for mergers and acquisitions to strengthen its market position[120]. Compliance and Regulatory Matters - The company is committed to ensuring compliance with local regulations and standards[120]. - The company is subject to the Securities and Futures Ordinance of Hong Kong[120]. - The company has maintained a policy of regularly monitoring liquidity risks and ensuring sufficient cash and cash equivalents to meet its operational needs[71].
润迈德(02297) - 2024 - 年度业绩
2024-09-10 12:40
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責,對其準確性或完整性亦不發表任 何聲明,並明確表示,概不就因本公告的全部或任何部份內容而產生或因倚賴該等內容而引致的任何損失承擔任何責 任。 1 Rain Med Rainmed Medical Limited 潤邁德醫療有限公司 (於開曼群島註冊成立的有限公司) (股份代號:2297) 有關截至2023年12月31日止年度的 年度報告補充公告 茲提述潤邁德醫療有限公司(「本公司」,連同其附屬公司統稱「本集團」)於2024年4月29日 刊發截至2023年12月31日止年度的年度報告(「2023年年報」)。除文義另有所指外,本公告 所用詞彙與2023年年報所界定者具有相同涵義。 本公司謹此就全球發售所得款項淨額約78.6百萬港元(「所得款項淨額」)於2023年12月31日 前的用途提供進一步資料。下表載列所得款項淨額擬定用途及其截至2023年12月31日的動 用情況概要: | --- | --- | --- | --- | --- | --- | |----------------------------------------------- ...
润迈德(02297) - 2024 - 中期业绩
2024-08-30 09:55
Financial Performance - Revenue for the six months ended June 30, 2024, was RMB 26.9 million, a decrease of 46.6% compared to RMB 50.4 million in the same period of 2023[1] - Gross profit for the same period was RMB 18.7 million, down 49.9% from RMB 37.3 million, resulting in a gross margin of 69.5%, compared to 74.0% in 2023[1] - The adjusted loss attributable to shareholders for the six months ended June 30, 2024, was RMB 40.2 million, a decrease of 4.5% from RMB 42.1 million in 2023[1] - Operating loss for the six months was RMB 44.7 million, compared to RMB 55.3 million in the same period last year[2] - The company reported a net loss of RMB 42.7 million for the period, compared to a net loss of RMB 48.0 million in 2023[2] - The company reported a loss attributable to shareholders of RMB 41,646 thousand for the six months ended June 30, 2024, compared to a loss of RMB 47,479 thousand for the same period in 2023, representing a decrease of approximately 12.9%[22] - The basic loss per share remained at RMB 0.04 for both the six months ended June 30, 2024, and 2023, indicating no change in performance on a per-share basis[22][23] - The loss for the six months ended June 30, 2024, was RMB 42.7 million, an improvement from a loss of RMB 48.0 million for the six months ended June 30, 2023[53] Revenue and Sales - Revenue for the six months ended June 30, 2024, was RMB 26,868 thousand, a decrease of 46.7% compared to RMB 50,374 thousand for the same period in 2023[11] - Product sales accounted for RMB 26,560 thousand, down 46.8% from RMB 49,935 thousand in the previous year[11] - Revenue decreased from RMB 50.4 million for the six months ended June 30, 2023, to RMB 26.9 million for the six months ended June 30, 2024, representing a year-on-year decline of approximately 46.6%[34] Expenses and Costs - Research and development expenses for the period were RMB 18.5 million, down from RMB 22.6 million in the previous year[2] - Employee benefit expenses decreased to RMB 45,550 thousand, down 30.3% from RMB 65,347 thousand in the same period last year[16] - Sales expenses decreased by approximately 22.9% to RMB 29.6 million for the six months ended June 30, 2024, from RMB 38.4 million for the same period in 2023, mainly due to reduced employee benefits and marketing development expenses[48] - General and administrative expenses significantly decreased by approximately 37.4% to RMB 23.4 million for the six months ended June 30, 2024, from RMB 37.3 million for the same period in 2023, primarily due to a reduction in employee benefits[50] Assets and Liabilities - Total assets as of June 30, 2024, amounted to RMB 600.8 million, an increase from RMB 573.3 million as of December 31, 2023[5] - Cash and cash equivalents were RMB 117.9 million, down from RMB 134.1 million at the end of 2023[5] - Trade receivables increased to RMB 7,831 thousand as of June 30, 2024, from RMB 3,691 thousand as of December 31, 2023, reflecting a growth of approximately 112.9%[25] - The net amount of trade and other receivables rose to RMB 17,698 thousand as of June 30, 2024, compared to RMB 10,350 thousand as of December 31, 2023, marking an increase of about 71.3%[25] - Trade payables decreased to RMB 1,552 thousand as of June 30, 2024, from RMB 3,447 thousand as of December 31, 2023, a decline of approximately 54.9%[31] - The company had a debt balance of RMB 25.5 million as of June 30, 2024, with unused bank financing of RMB 480.1 million[56] Corporate Governance - The company has adhered to all provisions of the corporate governance code, except for the deviation regarding the roles of the Chairman and CEO being held by the same individual, Mr. Huo Yunfei[61] - The Audit Committee, consisting of three independent non-executive directors, has reviewed the unaudited interim financial information for the six months ending June 30, 2024[64] - The company is committed to maintaining high standards of corporate governance to enhance shareholder value and accountability[61] - The company will continue to review and monitor its corporate governance practices to ensure compliance with the corporate governance code[61] - The company has established a standard code for securities trading by directors, which all directors confirmed compliance with during the reporting period[61] - The company has a diverse board composition, ensuring a balanced distribution of power and authority[61] Research and Development - The company continues to invest in the research, development, and commercialization of medical devices related to caFFR systems, caIMR systems, and IVD products[7] - The caFFR system has achieved over 95% accuracy and a convenient operation process of less than five minutes, establishing itself as a leading FFR measurement product in the domestic market[32] - The caIMR system received approval from the National Medical Products Administration in April 2023, becoming the world's first minimally invasive IMR measurement product approved for commercialization[32] - The company plans to expand the indications for the caFFR system to include acute STEMI, acute NSTEMI, and HFpEF patients, enhancing its product offerings[32] - The Flash Robot vascular interventional navigation surgical system is currently in the research and refinement stage, with successful animal trials completed in February 2022[42] - The company has obtained 85 II-class registration certificates for biochemical diagnostic reagents, covering major diagnostic categories such as liver function and kidney function[43] Market Strategy and Expansion - The company aims to enhance its competitive advantage in the FFR and IMR fields and expand its IVD product coverage and market presence in the second half of the year[44] - The company is actively pursuing overseas market layouts and strengthening domestic market penetration to achieve healthy growth and high-quality development in 2024[44] - The company plans to continue expanding in both China and global markets, focusing on product development and growth through internal development, mergers, and acquisitions[57] - As of June 30, 2024, the company has established a distribution network of 185 domestic distributors covering over 350 hospitals across 21 provinces, four autonomous regions, and four municipalities in China[34] - The company has sold and installed core products in over 700 hospitals, with more than 1,400 hospitals having used the core products in China[34] Other Financial Information - The company did not declare any interim dividend for the six months ended June 30, 2024[1] - The company has not declared or paid any dividends for the six months ended June 30, 2024, and 2023[29] - Other income increased from RMB 1.5 million for the six months ended June 30, 2023, to RMB 7.3 million for the six months ended June 30, 2024, primarily due to increased government subsidies[51] - Income tax expense changed from a credit of RMB 0.5 million for the six months ended June 30, 2023, to an expense of RMB 0.3 million for the six months ended June 30, 2024, mainly due to profit generated from interest income[52] - The company has capital commitments of RMB 283.7 million related to construction and services for its industrial park as of June 30, 2024[57]
润迈德(02297) - 2023 - 年度财报
2024-04-29 08:38
Financial Performance - Revenue for the year ended December 31, 2023, was RMB 73.2 million, a decrease of 12.4% from RMB 83.6 million in 2022[12] - Gross profit for 2023 was RMB 48.6 million, down 30.5% from RMB 69.8 million in 2022, resulting in a gross margin of 66.3% compared to 83.5% in the previous year[12] - The loss attributable to shareholders for 2023 was RMB 115.8 million, a significant reduction of 91.4% from RMB 1.35 billion in 2022[12] - The adjusted loss attributable to shareholders under non-HKFRS for 2023 was RMB 108.3 million, compared to RMB 100.9 million in 2022, reflecting a 7.3% increase[12] - The basic and diluted loss per share for 2023 was RMB 0.10, a 93.3% improvement from RMB 1.50 in 2022[12] - The company reported a revenue decline of approximately 12.4%, from RMB 836 million in 2022 to RMB 732 million in 2023, primarily due to contributions from the caFFR and caIMR systems[21] - Gross profit decreased by approximately 30.4% from RMB 698 million in the year ended December 31, 2022, to RMB 486 million in the year ended December 31, 2023, with gross margin dropping from 83.5% to 66.3%[34] - The company reported a comprehensive loss for the year ending December 31, 2023, with no dividends declared or distributed[104] Product Development and Innovation - The caFFR system has over 95% accuracy and a convenient operation process taking less than five minutes, establishing its leading position in the domestic FFR measurement market[6] - The caIMR system received approval from the National Medical Products Administration in April 2023, becoming the first commercialized minimally invasive IMR measurement product globally[6] - The company plans to expand the indications for the caFFR system to include acute STEMI, acute NSTEMI, and HFpEF patients[6] - The company aims to develop an interventional surgical robot to automate the entire PCI process, enhancing clinical value and precision in medical treatment[8] - The company plans to expand its IVD product line, having already obtained 85 II-class registration certificates for biochemical diagnostic reagents[30] - The Flash Robot vascular intervention navigation surgical system is currently in the research and refinement stage, with successful animal testing completed as of December 31, 2023[29] Financial Position and Assets - Non-current assets increased by 134.9% to RMB 204,093,000 from RMB 86,897,000 in 2022[13] - Cash and cash equivalents rose by 47.2% to RMB 134,085,000 compared to RMB 91,118,000 in the previous year[13] - Total assets decreased by 17.0% to RMB 573,308,000 from RMB 690,330,000 in 2022[13] - Cash used in operating activities was RMB 1,243 million for the year ended December 31, 2023, primarily due to significant R&D, administrative, and sales expenses[46] - Cash generated from investing activities was RMB 1,803 million, mainly due to proceeds from the sale of short-term bank deposits amounting to RMB 4,793 million[46] - The fair value loss on financial liabilities related to redeemable preferred shares decreased significantly from RMB 1,210.9 million in 2022 to zero in 2023[44] - The company expects future liquidity needs to be met through net proceeds from global offerings, available cash, and cash generated from operations[46] Market and Distribution - The company has established a distribution network of 144 domestic distributors covering over 700 hospitals across 22 provinces in China[22] - The group’s top five customers accounted for 43.8% of total revenue for the year ended December 31, 2023, down from 49.4% in 2022, with the largest single customer contributing 14.2% of total revenue, compared to 12.9% in 2022[194] - The group’s top five suppliers represented 69.6% of total purchases for the year ended December 31, 2023, significantly up from 16.9% in 2022, with the largest single supplier accounting for 59.7% of total purchases, compared to 5.1% in 2022[195] Research and Development - The R&D team consists of over 100 members, focusing on innovative products in the field of interventional precision diagnosis[23] - Research and development expenses decreased by approximately 6.4% from RMB 441.7 million in 2022 to RMB 413.3 million in 2023, primarily due to capitalized R&D expenditures[36] Management and Governance - The executive director and CEO, Mr. Huo Yunfei, has over seven years of experience in the medical device industry and founded Suzhou Runxin Medical Device Co., Ltd. in August 2014[64] - The executive director and co-CEO, Mr. Lv Yonghui, has over 20 years of experience in the medical device industry, previously serving as the deputy general manager at Lepu Medical Technology (Beijing) Co., Ltd.[66] - The CFO and co-company secretary, Mr. Zhang Liang, has over 16 years of senior management experience, particularly in compliance, investment, and financing[70] - The company has established a remuneration committee to formulate remuneration policies in accordance with the Listing Rules[132] - The company has received annual independence confirmations from all independent non-executive directors, affirming their independence[128] Employee and Human Resources - The group employed 406 full-time employees as of December 31, 2023, with total employee benefits expenses amounting to RMB 7.48 million during the reporting period[62] - The company invests in continuous education and training programs for employees to enhance their skills and knowledge[62] - Employee performance evaluations are conducted to determine salary, promotion opportunities, and career development[62] Risks and Challenges - The company has faced significant financial risks and uncertainties, particularly related to capital needs and product development[107] - Future growth largely depends on the successful development and commercialization of pipeline products, with potential delays or additional costs if clinical trials do not meet regulatory standards[112] - The company faces risks related to the acceptance of its products by doctors and hospitals, which could negatively impact operational performance if not widely recognized in the market[112] - Regulatory approval processes are lengthy, costly, and unpredictable, and delays in obtaining necessary approvals could severely impair the company's ability to generate revenue[122] Corporate Social Responsibility - The company is committed to environmental protection and has implemented effective measures for resource efficiency, waste reduction, and energy conservation[120] - Charitable donations and contributions totaled RMB 250,000 for the year ended December 31, 2023[200]