Financial Performance - Revenue for the six months ended June 30, 2023, was RMB 18,914,000, an increase of 83.5% compared to RMB 10,306,000 for the same period in 2022[2] - Gross profit for the same period was RMB 14,638,000, up 106.5% from RMB 7,088,000 in 2022[2] - The company reported a loss of RMB (47,428,000) for the six months ended June 30, 2023, compared to a loss of RMB (44,850,000) in the prior year, reflecting a 3.2% increase in losses[2] - Revenue from the sale of medical devices and consumables reached RMB 18,914,000 in the six months ended June 30, 2023, compared to RMB 10,306,000 in the same period of 2022, representing an increase of 83.5%[17] - The group’s total income for the six months ended June 30, 2023, was RMB 6,929,000, compared to RMB 5,619,000 in the same period of 2022, reflecting an increase of 23.3%[19] - Other income included government grants of RMB 3,035,000, down from RMB 3,510,000 in the previous year, a decrease of 13.5%[19] - The group reported a net foreign exchange loss of RMB 3,179,000 for the six months ended June 30, 2023, compared to a loss of RMB 1,436,000 in the same period of 2022, indicating a deterioration in foreign exchange performance[20] - The group’s pre-tax loss for the six months ended June 30, 2023, included costs of sold inventory amounting to RMB 4,276,000, compared to RMB 3,218,000 in the same period of 2022, an increase of 32.9%[20] - The company reported a basic loss per share of RMB 0.18 for the six months ended June 30, 2023, compared to RMB 0.19 for the same period in 2022, with a weighted average of 239,110,000 shares issued during the period[25] Research and Development - Research and development expenses increased to RMB (34,330,000) from RMB (22,807,000), representing a 50.6% increase year-over-year[2] - The company has established a product development team with 98 internal R&D staff and 37 clinical operation team members as of June 30, 2023[51] - The company holds 131 patents and has 52 patent applications as of June 30, 2023, protecting its core technologies[51] - R&D expenses increased from RMB 22.8 million to RMB 34.3 million, a rise of RMB 11.5 million or 50.5%[60] - Employee costs accounted for RMB 18.5 million (53.8%) of total R&D expenses in 2023, compared to RMB 12.4 million (54.4%) in 2022[59] - Clinical trial expenses rose to RMB 4.0 million (11.8%) in 2023 from RMB 2.0 million (8.8%) in 2022[59] Clinical Trials and Product Development - The asthma cryoablation system and COPD cryospray treatment system entered the confirmatory clinical trial phase in March 2023[3] - Patient recruitment for the malignant stenosis cryoablation system confirmatory clinical trial has completed over 75%[3] - The company has submitted a registration application for its cryoadhesion treatment system[3] - The malignant stenosis cryoablation system is in confirmatory clinical trial stage as of June 30, 2023, with registration documents expected to be submitted to the National Medical Products Administration in Q3 2023 and approval anticipated in Q4 2024[37] - The benign stenosis cryoablation system is in feasibility clinical trial stage as of June 30, 2023, with registration documents expected to be submitted in Q4 2024 and approval anticipated in H1 2026[38] - The lung peripheral nodule cryoablation system is in preclinical research stage as of June 30, 2023, with registration documents expected to be submitted in H2 2026 and approval anticipated in H2 2027[39] - The cough cryo-spray treatment system is in feasibility clinical trial stage as of June 30, 2023, with registration documents expected to be submitted in H1 2025 and approval anticipated in H2 2026[40] - The tuberculosis cryo-spray treatment system is in feasibility clinical trial stage as of June 30, 2023, with registration documents expected to be submitted in H2 2025 and approval anticipated in H2 2026[41] - The frozen adhesion treatment system has submitted registration application as of June 30, 2023, with approval expected in Q1 2024[42] - The bladder cryoablation system received approval from the National Medical Products Administration in June 2022 and was commercialized in China in December 2022[42] Assets and Liabilities - Total non-current assets as of June 30, 2023, were RMB 47,365,000, a decrease from RMB 49,655,000 as of December 31, 2022[7] - Current assets decreased to RMB 209,313,000 from RMB 264,208,000, indicating a reduction in liquidity[7] - Total equity as of June 30, 2023, was RMB 221,654,000, down from RMB 259,389,000 at the end of 2022[10] - Trade receivables as of June 30, 2023, amounted to RMB 93,000,000, with a provision for impairment of RMB 74,000,000, resulting in a net trade receivable of RMB 19,000,000[27] - Trade payables as of June 30, 2023, were RMB 4,169,000, compared to RMB 1,763,000 as of December 31, 2022[29] - Total liabilities as of June 30, 2023, were RMB 10,033 million, a reduction from RMB 11,371 million as of December 31, 2022, representing a decrease of about 11.8%[73] - The current ratio improved to 8.0 as of June 30, 2023, compared to 5.8 as of December 31, 2022, indicating enhanced liquidity[74] - The quick ratio also increased to 7.1 as of June 30, 2023, from 5.3 as of December 31, 2022, reflecting better short-term financial health[74] - The debt-to-asset ratio decreased to 13.6% as of June 30, 2023, down from 17.4% as of December 31, 2022, suggesting a stronger equity position[74] Management and Governance - Liu Wei was appointed as an executive director effective from the date of approval at the shareholders' annual meeting on June 16, 2023[84] - Li Cuiqin resigned from her position as the employee representative supervisor and chairman of the supervisory board effective May 31, 2023[85] - Li Jiawei was elected as the employee representative supervisor and chairman of the supervisory board effective May 31, 2023[86] - The audit committee reviewed and confirmed that the interim financial results for the six months ended June 30, 2023, comply with relevant accounting standards and regulations[87] - The board did not recommend the distribution of an interim dividend for the reporting period[80] Market Outlook and Strategy - The company provided a positive outlook for the next quarter, projecting a revenue growth of 20%[91] - New product launches are expected to contribute an additional 10% to overall revenue in the upcoming fiscal year[91] - The company is investing in R&D, allocating 12% of its revenue towards new technology development[91] - Market expansion plans include entering three new international markets by the end of the fiscal year[91] - The company is considering strategic acquisitions to enhance its market position, targeting a 5% increase in market share[91] - The board emphasized the importance of maintaining operational efficiency, aiming for a 3% reduction in costs[91] - Customer satisfaction ratings improved by 8% following recent service enhancements[91] - The company plans to increase its marketing budget by 15% to support new product launches and market expansion efforts[91]

Financial Performance - Revenue for the year ended December 31, 2022, was RMB 27,149,000, an increase of 21.5% from RMB 22,426,000 in 2021[5] - Gross profit for 2022 was RMB 19,362,000, up from RMB 15,545,000 in 2021, reflecting a gross margin improvement[5] - The company reported a net loss of RMB 118,316,000 for 2022, a slight improvement from a loss of RMB 126,497,000 in 2021[5] - Cash and cash equivalents increased to RMB 226,422,000 in 2022 from RMB 157,867,000 in 2021, indicating improved liquidity[5] - Revenue increased from RMB 224 million for the year ended December 31, 2021, to RMB 271 million for the year ended December 31, 2022, representing a growth of RMB 47 million or 21.1%[41] - Overall gross profit rose from RMB 155 million for the year ended December 31, 2021, to RMB 194 million for the year ended December 31, 2022, with gross margin improving from 69.3% to 71.3%[42] - Other income and gains surged from RMB 44 million for the year ended December 31, 2021, to RMB 114 million for the year ended December 31, 2022, primarily due to increased government subsidies and currency exchange gains[43] - Research and development expenses decreased from RMB 898 million for the year ended December 31, 2021, to RMB 599 million for the year ended December 31, 2022, a decline of 33.3%[45] - Administrative expenses increased from RMB 508 million for the year ended December 31, 2021, to RMB 838 million for the year ended December 31, 2022, an increase of 65.0%[45] - Cash and cash equivalents rose from RMB 1,579 million as of December 31, 2021, to RMB 2,264 million as of December 31, 2022, an increase of 43.4%[52] - Capital expenditures for the year ended December 31, 2022, amounted to RMB 70 million, down from RMB 124 million for the year ended December 31, 2021[54] - Total debt increased to RMB 11,371 million as of December 31, 2022, from RMB 9,001 million in 2021, representing a 26.3% increase[56] - Current ratio decreased to 5.8 as of December 31, 2022, down from 6.7 in 2021, indicating a decline in short-term liquidity[57] - Quick ratio also decreased to 5.3 in 2022 from 6.3 in 2021, reflecting a similar trend in liquidity[58] - The debt-to-asset ratio rose to 17.4% in 2022 compared to 15.0% in 2021, suggesting an increase in leverage[57] - Capital commitments for property and machinery amounted to RMB 2,052 million as of December 31, 2022, up from RMB 1,094 million in 2021, indicating ongoing investment plans[59] - The company plans to retain all future profits for business operations and expansion, with no dividend policy in the foreseeable future[169] Product Development and Innovation - The company received approval for the bladder cryoablation system from the National Medical Products Administration in June 2022 and commercialized it in December 2022[10] - The endoscopic stapler was approved in August 2022 and commercialized in October 2022, marking it as one of the first of its kind in China[10] - The heart cryoablation system registration application was submitted in July 2022, with expected approval in Q2 2023[10] - The company aims to leverage its established commercialization capabilities to enhance product market entry following regulatory approvals[10] - The company has 15 additional products in the pipeline, with several in various stages of clinical development, including three products expected to complete clinical trials in Q2 2023[13] - The vascular intervention cryoablation products are in Phase III trials, with commercialization expected in the second half of 2025[13] - The company is committed to ongoing research and development to enhance its product offerings and maintain its competitive edge in the market[12] - The cardiac cryoablation system is designed for the treatment of paroxysmal atrial fibrillation and is expected to receive regulatory approval in Q2 2023[18] - The Cryofocus cryoablation system, aimed at treating hypertension, is undergoing confirmatory clinical trials with anticipated regulatory approval in H2 2025[18] - The pulmonary hypertension cryoablation system is currently in preclinical research, with expected regulatory approval in H1 2026[18] - The COPD cryo-spray treatment system entered confirmatory clinical trials in March 2023, with plans to submit registration documents in H2 2025 and seek approval in H2 2026[18] - The asthma cryoablation system is in confirmatory clinical trials, with expected registration submission in H2 2025 and approval in H2 2026[21] - The malignant stricture cryoablation system is in confirmatory clinical trials, with plans to submit registration documents in Q3 2023 and seek approval in Q4 2024[22] - The benign stricture cryoablation system is in feasibility clinical trials, with expected registration submission in Q4 2024 and approval in H1 2026[23] - The lung nodule cryoablation system is in preclinical research, with anticipated registration submission in H2 2026 and approval in H2 2027[24] - The cough cryo-spray treatment system is in feasibility clinical trials, with expected registration submission in H1 2025 and approval in H2 2026[25] - The tuberculosis cryo-spray treatment system is also in feasibility clinical trials, with plans for registration submission in H2 2025 and approval in H2 2026[26] - The company aims to expand its product portfolio based on its cryoablation technology and plans to selectively expand its global business[40] Market Outlook and Strategy - The company anticipates rapid industry growth driven by economic recovery, increased public health awareness, and an aging population in China[11] - The company focuses on minimally invasive cryoablation technology, primarily targeting urological, respiratory, and gastrointestinal diseases, with a comprehensive product portfolio established since its founding in 2013[12] - The cryoablation device market in China is experiencing strong growth, driven by factors such as an aging population, increasing chronic disease prevalence, and supportive government policies[12] - The aging population and the growing patient base are expected to further drive the demand for cryoablation devices in the coming years[12] - The company anticipates continued market expansion due to technological advancements and the increasing demand for cryoablation therapies[12] - Future outlook includes expansion into new markets and the development of innovative medical technologies[74] - The company is actively pursuing mergers and acquisitions to enhance its product offerings and market presence[75] - New product development is centered around minimally invasive medical devices, targeting structural heart disease[76] Corporate Governance and Management - Liu Wei was appointed as CFO and Secretary of the Board in December 2021, with responsibilities including financial planning and investor relations[91] - Duong has over 24 years of engineering experience, previously holding positions at various companies including Parker Hannifin Corporation and Endocare Inc.[93] - Liu Yulong has over 17 years of experience in the pharmaceutical and medical device industry, previously working at Medtronic and Anhui Anke Biotechnology[95] - Zhao Kuiwen has been with the company since September 2017, serving as the Chief Technology Officer and responsible for R&D activities[97] - Qu Jihong joined the company in March 2022 as Chief Medical Officer, focusing on product applications and international market strategies[98] - The management team has extensive experience, with key members holding advanced degrees in engineering and business[77] - The company emphasizes its commitment to expanding its market presence and enhancing its product offerings through strategic initiatives[98] - The board consists of two executive directors, two non-executive directors, and four independent non-executive directors, ensuring a balanced power structure[111] - The company has adopted a code of conduct for securities trading by directors and senior management, confirming compliance since the listing date[110] - The company has established a comprehensive training program for new employees to understand its corporate culture and policies[104] - The board has ensured compliance with the corporate governance code since the listing date, maintaining effective accountability[105] - The board of directors consists of both executive and independent non-executive directors, with a term of three years, subject to re-election[115] - The company has established three committees: Audit Committee, Remuneration Committee, and Nomination Committee to oversee various aspects of the company's affairs[124] Risk Management and Compliance - The company has implemented a comprehensive risk management policy to continuously identify, assess, and monitor key risks related to its strategic objectives[151] - The board is responsible for establishing and reviewing the effectiveness of the internal control system, which includes financial, operational, and compliance controls[152] - The audit committee reviews and approves the company's risk management policies to ensure alignment with corporate objectives[148] - The company conducts annual reviews of its risk management and internal control systems, deeming them effective and adequate[151] - Regular training is provided to management and sales teams regarding compliance with the "two-invoice system" and other applicable laws[152] - The company monitors the implementation progress of the "two-invoice system" across different provinces[152] - The company has established channels for independent non-executive directors to express opinions openly and confidentially when necessary[144] - The company has implemented strict internal control measures to handle sensitive data, including desensitization and prior board approval for data transmission[154] - As of December 31, 2022, the company reported no claims or allegations related to bribery or corruption, indicating effective internal controls[157] Environmental, Social, and Governance (ESG) - The board is responsible for overseeing ESG-related matters and regularly reviews ESG risks and performance[179] - The company aims to enhance its governance structure and risk management systems continuously[180] - In 2022, the company identified 18 ESG material issues, categorizing them into 6 highly important, 9 moderately important, and 3 generally important issues, focusing on sustainable long-term development[190] - The company has established a dedicated ESG working group to coordinate and execute ESG-related matters, reporting directly to the board of directors[185] - The company has committed to social responsibility and sustainable development, focusing on innovation in cryogenic technology and life sciences[184]

Financial Performance - Revenue for the year ended December 31, 2022, was RMB 27,149,000, representing a year-on-year increase of 21.1% from RMB 22,426,000[2] - Gross profit for the same period was RMB 19,362,000, up 24.6% from RMB 15,545,000 in 2021[2] - The net loss for the year was RMB 118,316,000, a decrease of 6.5% compared to a loss of RMB 126,497,000 in the previous year[4] - Other income increased to RMB 8,750,000 in 2022 from RMB 4,405,000 in 2021, representing a growth of about 98.5%[25] - The group reported a pre-tax loss of RMB 118,316,000 for 2022, slightly improved from a loss of RMB 126,497,000 in 2021[31] - Cumulative tax losses in mainland China amounted to RMB 574,129,000 as of December 31, 2022, compared to RMB 477,847,000 in 2021, reflecting an increase of 20.2%[31] - The group did not declare any dividends for the year, consistent with 2021[33] - The company reported a credit loss rate of 100% for trade receivables amounting to RMB 74,000, indicating a complete impairment expectation[38] - The company did not recommend the payment of a final dividend for the reporting period[95] Cash and Assets - Cash and cash equivalents increased by 43.4% to RMB 226,422,000 from RMB 157,867,000[2] - Total assets less current liabilities amounted to RMB 268,129,000, compared to RMB 203,404,000 in the previous year[7] - Trade receivables remained unchanged at RMB 74,000 for both 2022 and 2021, with no impairment losses recorded[34] - Other receivables decreased from RMB 19,970,000 in 2021 to RMB 17,858,000 in 2022, reflecting a reduction of approximately 10.6%[40] - The company’s accounts payable increased significantly from RMB 314,000 in 2021 to RMB 1,763,000 in 2022, marking a growth of over 461%[42] - Total other payables and accrued expenses rose from RMB 23,699,000 in 2021 to RMB 37,275,000 in 2022, an increase of approximately 57.3%[43] Research and Development - Research and development expenses for the year were RMB 59,933,000, down from RMB 89,827,000 in 2021[4] - The company has established a product development team consisting of 86 internal R&D staff and 37 clinical operation staff as of December 31, 2022[69] - The company has a total of 120 patents and 48 patent applications as of December 31, 2022, to protect its core technologies[69] - Employee costs increased by RMB 140 million, contributing to the rise in R&D expenses, which included a total of RMB 322.85 million for the year ended December 31, 2022, representing 53.8% of total R&D expenses[77][78] - The company plans to invest significantly in R&D to develop innovative solutions and improve operational efficiency[112] Product Development and Regulatory Approvals - The Cryofocus cryoablation system was designated as a "Breakthrough Device" by the U.S. Food and Drug Administration in December 2022[3] - The bladder cryoablation system received regulatory approval from the National Medical Products Administration in June 2022 and was commercialized in December 2022[48] - The endoscopic stapler was approved in August 2022 and commercialized in October 2022, targeting patients with acute gastrointestinal bleeding and perforations[49] - The cardiac cryoablation system is expected to receive regulatory approval in the second quarter of 2023 after submitting the registration application in July 2022[50] - The pulmonary hypertension cryoablation system is currently in preclinical research, with anticipated regulatory approval in the first half of 2026[52] - The COPD cryo-spray treatment system entered the confirmatory clinical trial phase in March 2023, with expected registration submission in the second half of 2025 and approval in the second half of 2026[53] - The asthma cryoablation system also entered the confirmatory clinical trial phase in March 2023, with similar timelines for registration submission and approval as the COPD system[54] Corporate Governance and Compliance - The Audit Committee has been established, consisting of one non-executive director and two independent non-executive directors, with the main function to provide independent opinions on financial reporting procedures and internal controls[98] - The annual financial performance for the year ended December 31, 2022, has been reviewed and deemed compliant with relevant accounting standards and regulations[98] - The consolidated financial statements for the year ended December 31, 2022, have been agreed upon by the external auditor, Ernst & Young, confirming consistency with the preliminary figures[99] - The company confirms compliance with corporate governance codes as per listing regulations[107] - The board of directors emphasizes the importance of adhering to the listing rules and corporate governance standards[112] Market and Strategic Outlook - The company aims to maintain strict control over outstanding receivables to minimize credit risk, with management regularly reviewing overdue balances[35] - The company has identified a significant market opportunity in minimally invasive procedures, focusing on both natural orifice transluminal endoscopic surgery and vascular intervention therapies[45] - Future outlook includes strategic market expansion and potential mergers and acquisitions to drive growth[112] - The company aims to leverage its subsidiary, Ningbo Shengjie Kang Biotechnology Co., Ltd., to enhance its market presence in the biotechnology sector[112] - The board is optimistic about achieving sustainable growth and profitability in the coming years[112]