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1 NUTAS 产品介绍 Non-invasive Ultrasound Tumor Ablation System--NUTAS 沈阳长江源科技发展有限公司 Shenyang Changjiangyuan Technology Development Co., Ltd.

2 内容概要 Contents 治疗原理 Therapy Principles 技术特点 Technical Features 研发历程 R&D Process 临床表现 Clinical Performance

3 NUTAS 系统原理是将聚焦超声声源发出的超声, 以人体正常组织可接受的能量透过患者体表, 幵将能量聚集于非常小的病灶区域, 使病变组织瞬间杀灭的治疗系统 NUTAS therapy principle is to transmit ultrasound which is emitted by focused ultrasound source through body surface with acceptable energy of normal tissue, then energy is accumulated in a very small area, so as to ablate diseased tissue instantly. ultrasound sound Ultrasound emission body surface focal point target tumor tissue

through body surface with acceptable energy of normal tissue, then energy is accumulated in a very small area, so as

4 NUTAS 系统可根据肿瘤的大小形态边界, 以聚焦声束的移劢, 肿瘤进行点线面体的照射, 从而完整切除肿瘤 According to size, shape and boundary of tumor, ultrasound probe will move in a way of focused beam, and irradiate to tumor point, line and body, therefore tumor is completely ablated.

tumor, ultrasound probe will move in a way of focused beam, and

5 技术特点 Technical Features 丌开刀, 丌流血术后恢复快总体治疗费用低治疗时间短激活机体肿瘤免疫系统无辐射无化学损伤可重复治疗 no bleeding speedy recovery overall low-cost short-time treatment stimulate body tumor immune system no radiation no chemical injury repeatable treatment

speedy recovery overall low-cost short-time treatment stimulate body

6 技术特点 Technical Features 有创外科手术 Invasive surgery 微创介入治疗 Minimally invasive interventional treatment 无创治疗 Non-invasive treatment

7 新一代 NUTAS New Generation of NUTAS

8 新一代 NUTAS New Generation of NUTAS

9 新一代 NUTAS New Generation of NUTAS

10 新一代 NUTAS New Generation of NUTAS

11 研发历程 R&D process 2000 核心技术升级 Upgrade of core technology 2005 标准化工作 standardization 2006 第一代系统样机成型 the first generation of prototype molding 第二代系统成型 the second generation of prototype molding 通过 ISO9001 和初步审核通过国家药监局武汉医疗器械治疗监督建业中心的注册检验 Pass ISO9001&13485 preliminary review Pass registration inspection of Wuhan medical equipment quality supervision and inspection center of SFDA

过 ISO9001 和 13485 初步审核通过国家药监局武汉医疗器械治疗监督建业中心的注册检验 Pass ISO9001&13485 preliminary

研发历程 R&D process 2007 临床准备工作 Clinical preparation 2008 一期临床结束 conclude first-phase clinical work; 2011 第三代系统成型, 开始开展动物实验及人体临床准备工作 The third generation system is

12 研发历程 R&D process 2007 临床准备工作 Clinical preparation 2008 一期临床结束 conclude first-phase clinical work; 2011 第三代系统成型, 开始开展动物实验及人体临床准备工作 The third generation system is completed, begins to carry out animal experiment and human body clinical preparation. 在中国医科大学第一附属医院进行临床验证 It has accomplished clinical validation in First Affiliated Hospital of China Medical University. 第四代系统成型筹备出口认证工作 The fourth generation system is formed It is about to prepare for export certification

13 研发历程 R&D process 2012 产品获得 CE 认证证书 Obtain CE certificate

14 长江源科技的超声肿瘤治疗系统具有原创性, 属于当今世界领先的数字医疗产品 With its original creativity, NUTAS is regarded as leading digital medical product worldwide.

15 2007 年长江源的 NUTAS 系统被辽宁省鉴定为省级科学技术研究成果, 鉴定为国际先进水平 In 2007, NUTAS is authenticated as provincial scientific & technological research achievement by Liaoning Province. Province and is appraised as being at international advanced level.

scientific & technological research achievement by Liaoning

16 2007 年, 由国家科技部选派 13 家高新企业作为中国先进技术的代表, 赴莫斯科参加俄罗斯中国国家展, 长江源的 NUTAS 系统受到两国领导人的关注 In 2007, State Ministry of Science and Technology assigns 13 high-tech enterprises, on behalf of China advanced technology representatives, to attend China National Exhibition in Russia, where NUTAS has received attention of leaders from the two countries.

high-tech enterprises, on behalf of China advanced technology representatives, to attend China

18 同年 6 月, 在俄罗斯圣彼得堡举办国际经济论坛中, 长江源公司再一次成为国务院选中的 19 家单位之一公司 NUTAS 系统在国际上受到广泛关注 In 2007, State Ministry of Science and Technology assigns 13 high-tech enterprises, on behalf of China advanced technology representatives, to attend China National Exhibition in Russia, where NUTAS has received attention of leaders from the two countries.

20 NUTAS at Medical Fair

21 临床表现 Clinical Performance 长江源科技是全球第一家对单一病症进行独立临床验证的单位 ; Changjiangyuan Technology is global first company to conduct independent clinical validation on single disease; 是国内首家严格按照国家药监局关于超声肿瘤治疗系统的临床试验指导原则进行临床的单位 Changjiangyuan Technology is the first company to carry out clinical trials strictly in accordance with SFDA guiding principles for ultrasound tumor treatment system (SFDA (2003) File No. 222).

22 临床表现 Clinical Performance 一期临床 First phase 中国医科大学附属第一医院年 China Medical University

23 临床表现 Clinical Performance 一期临床结果 First phase result 总有效率达 98% 以上 Total effective rate has reached up to 98%

24 临床表现 Clinical Performance 一期临床结果 (51 例 ) First phase result 未发现一例 : 治疗区皮肤起水疱红肿 ; 皮肤溃烂 ; 皮肤表皮破溃 ; 局部皮肤坏死 No case of adverse event is found, such as: skin blisters on treatment area; skin swelling and ulcerating; burst of epidermis skin; local skin necrosis due to deep skin damage.

25 临床表现 Clinical Performance 二期研发 Second phase 北京军区总医院 The Military General Hospital of Beijing PLA 成立乳腺肿瘤治疗中心 Set up NUTAS breast tumor treatment center 2011 至今 now

26 临床表现 Clinical Performance 最新研发结果 Latest R&D result 实现治疗区域内肿瘤细胞完全坏死 Has achieved complete necrosis of tumor cells in target region. 肿瘤细胞丧失增殖侵袭和转移的能力 Make necrotic tumor cells lose the ability of proliferation, invasion and metastasis. 现已满足为早期乳腺癌患者进行保乳治疗的条件 Has already met the conditions of breast-conserving treatment for early-stage breast cancer patients.

27 患者 1 Patient 1 超声提示 : Ultrasound hints: 1. 左乳腺异常区域伴钙化, 考虑 BI-RADS 3-4 级 There are regional abnormalities with calcifications on the left breast, which is BI-RAOS level 右乳腺未见明确占位性病变, 符合 BI-RADS 1 级 No clear space occupying lesion on the right breast, which is BI-RAOS level 1. 穿刺病理 : Needle Biopsy: 左乳腺浸润性癌, 形态符合浸润性导管癌 Invasive carcinoma on the left breast, invasive ductal carcinoma.

28 患者 1 Patient 1 NUTAS 治疗后第 4 天, 进行乳腺癌改良根治术, 术后在切除的乳腺癌组织靶区边界及周围正常组织分别多次取材, 分别用 10% 中性甲醛液固定, 石蜡包埋行大切片 H.E 染色 ; Modified radical mastectomy is conducted after 4 days of NUTAS treatment. Then it shall repeatedly sample removed breast cancer tissue, target region boundary and surrounding normal tissue, respectively fixed by 10% neutral formalin, and perform large section HE staining with paraffin embedding;

29 患者 1 Patient 1 NUTAS 治疗前后可以看到治疗区域灰度变化明显 The grey level change in treatment area is obvious before and after NUTAS treatment.

30 患者 1 Patient 1 治疗前后乳房外观对比, 皮肤无明显变化 Breast appearance comparison before and after treatment: no obvious change on skin.

31 患者 1 Patient 1 治疗靶区癌细胞坏死明显, 未治疗区域有癌细胞残留, 分界明显 Cancer cells in treatment area shows obvious necrosis and residual cancer cells could be observed in non-treated region. Their boundary is clear.

32 患者 1 Patient 1 治疗靶区癌细胞坏死明显, 癌细胞残影, 细胞核碎裂坏死 Cancer cells in target region shows obvious necrosis (karyorrhexis) with cancer cells fragments.

33 患者 1 Patient 1 未治疗区域癌细胞残留 Residual cancer cells could be seen in non-treated region.

34 患者 1 Patient 1 结论 Conclusion: 第 1 例患者 HE 染色病理结果显示 80% 癌细胞坏死, 治疗靶区边缘有癌细胞残留, 治疗靶区内部癌细胞完全坏死, 分界明显 Pathology result of HE staining of the first case shows 80% of cancer cells necrosis. There are cancer cell fragments around treatment target margin, cancer cells are completely necrotized in treatment area with distinct boundary. 原因为 : 对肿瘤区域扩大丌足, 某些细小分支未包含在靶区之内, 应通过乳腺增强核磁影像确定肿瘤组织大小和形态, 并进行适当扩大 The reason is due to inadequate expansion of the tumor area. We should enhance breast MRI images to confirm the size and shape of tumor tissue and expand it appropriately so that some tiny branches can be involved in the treatment area.

35 患者 2 Patient 2 超声提示 : Ultrasound hints: 1. 左乳腺异常区域, 考虑 BI-RADS 3-4 级 Abnormal area on the left breast, which is BI-RADS 右乳腺未见明确占位性病变, 符合 BI-RADS 1 级 No explicit space occupying lesion on the right breast, which is BI-RADS level 1. 穿刺活检 : Needle biopsy: 浸润性导管癌 II 级 Invasive ductal carcinoma stage II.

36 患者 2 Patient 2 NUTAS 治疗后第 4 天, 进行乳腺癌改良根治术, 术后在切除的乳腺癌组织靶区边界及周围正常组织分别多次取材, 分别用 10% 中性甲醛液固定, 石蜡包埋行大切片 H.E 染色 ; Modified radical mastectomy is conducted after 4 days of NUTAS treatment. Then it shall repeatedly sample removed breast cancer tissue, target region boundary and surrounding normal tissue, respectively fixed by 10% neutral formalin, and perform large section H.E. staining with paraffin embedding;

37 患者 2 Patient 2 NUTAS 治疗前后可以看到治疗区域灰度有变化 Gray changes can be observed in treatment area before and after NUTAS treatment.

38 患者 2 Patient 2 治疗前后乳房外观对比, 皮肤无明显变化, 针孔为局部麻醉注射 Comparison of breast appearance before and after treatment shows no obvious change on skin. The pinhole is for local anesthetic injection.

39 患者 2 Patient 2 病理报告示, 左乳腺浸润性导管癌,II 级, 部分为导管内癌伴小叶癌化, 并见大片出血及退变坏死, 其内散在慢性炎细胞及坏死的癌细胞残影, 大部分癌细胞核已破碎, 结构丌清楚, 残余的癌细胞大部分胞核细微结构丌清楚, 胞浆略红, 此均为退变改变周围正常组织未见明显改变, 可见散在的慢性炎细胞浸润 Pathological report reveals left breast invasive ductal carcinoma, stage II, part of which belongs to intraductal carcinoma with lobular cancerization. Massive hemorrhage, degeneration and necrosis is observed and scattered in fragment of chronic inflammatory cells as well as necrotic cancer cells. Most cancer cell nucleus has been broken and structure is not clear. In residual cancer cells, most karyon fine structure is not clear with cytoplasm being slightly red. All the above is degeneration changes. There is no obvious change in surrounding normal tissues, and sporadic chronic inflammatory cell infiltration can be observed.

40 患者 2 Patient 2 癌细胞残影 Cancer cell fragments

41 患者 2 Patient 2 癌细胞残影 Cancer cell fragments

42 患者 3 Patient 3 超声提示 : Ultrasound hints: 1. 右乳腺异常区域及右乳腺低回声结节, 考虑 BI-RADS 3 级 Abnormal area as well as node of low level echo on the right breast, which is BI-RADS level 左乳腺未见明确占位性病变, 符合 BI-RADS 1 级 No explicit space occupying lesion on the left breast, which is in line with BI- RADS level 1. 穿刺活检 : Needle Biopsy: 病理示 : 浸润性导管癌 II 级, 部分为中 - 高级别导管内癌 Invasive ductal carcinoma stage II, part is medium-high level intraductal carcinoma.

43 患者 3 Patient 3 NUTAS 治疗后第 6 天, 进行乳腺癌改良根治术, 术后在切除的乳腺癌组织靶区边界及周围正常组织分别多次取材, 分别用 10% 中性甲醛液固定, 石蜡包埋行大切片 H.E 染色 ; Modified radical mastectomy is conducted after 6 days of NUTAS treatment. Then it shall repeatedly sample removed breast cancer tissue, target region boundary and surrounding normal tissue, respectively fixed by 10% neutral formalin, and perform large section HE staining with paraffin embedding;

44 患者 3 Patient 3 NUTAS 治疗前后可以看到治疗区域灰度有一定变化 The grey level in treatment area has some change before and after NUTAS treatment.

45 患者 3 Patient 3 治疗前后乳房外观对比, 皮肤无明显变化 Breast appearance comparison before and after treatment: no obvious change on skin.

46 患者 3 Patient 3 HE 染色未见明确癌组织, 只能见到少量癌细胞残影癌床部位 : 乳腺组织, 部分区域可见大片状出血退变坏死, 局部可见扩张的管腔, 腔内有泡沫状组织细胞聚集, 周围可见导管残影及明显退变的丌典型细胞, 未见明确癌组织 Pathological report shows that no explicit cancer tissue can be observed, but only a small amount of cancer cell fragments. The cancer bed field: part area shows large piece bleeding, degeneration and necrosis in mammary tissue. Lumen expands in local in which foamy tissue cells has gathered, surrounding has duct residual fragments as well as obvious degenerative atypical cells. No explicit cancer tissue is found.

47 患者 3 Patient 3 周围组织 : 皮肤未见癌组织浸润累及, 皮下局部导管上皮增生, 间质及导管周围散在慢性炎细胞浸润 ; 纤维血管及脂肪组织, 局部间质可见出血退变及慢性炎细胞浸润 ; 乳腺增生症伴腺病, 局部导管上皮增生伴柱状细胞病变, 个别扩张的导管内可见泡沫状组织细胞聚集 ; 部分导管和小叶周围有少量慢性炎细胞浸润 Surrounding tissue: infiltrating involvement of cancer tissue cannot be seen on the skin, subcortical ductal epithelial hyperplasia, chronic inflammatory cells infiltration scattered around mesenchyme and duct; bleeding, degeneration and chronic inflammatory cells infiltration could be seen in local mesenchyme around fibre, blood vessel and adipose tissue; cyclomastopathy with adenopathy, local ductal epithelial hyperplasia with cytopathy of columnar cell, foamy tissue cells has gathered in individual dilated duct; part of ducts and lobules are surrounded by a small amount of chronic inflammatory cell infiltration.

48 患者 3 Patient 3 治疗区域无明确癌组织, 可见癌细胞残影 No explicit tumor tissue in target region could be seen but only some cancer cell fragments.

49 患者 3 Patient 3 癌细胞残影 Cancer cell fragments

50 患者 3 Patient 3 癌细胞残影 Cancer cell fragments

51 患者 2 & 患者 3 Patient 2 & Patient 3 结论 Conclusion: 第 2 例和第 3 例为正确治疗后的结果, 对治疗靶区进行合理扩大, 并改进了治疗点排布方案根据正确治疗后的 HE 染色病理结果显示, 未见明确癌细胞, 只见少量癌细胞残影, 癌组织被完全杀死 The second case and the third case are results after proper treatment, which has expanded the treatment area reasonably and increased treatment dose appropriately. The pathology result of HE staining shows cancer cells are ablated completely and only part of cancer cell fragments could be seen.

52 NUTAS 的保乳优势 NUTAS Advantages in Breast-conserving Therapy 1. 无需开刀 : 患者能够完全避免开刀手术的风险和痛苦, 更丌会带来手术过程中引起的种植性转移 ; No surgery: patients can completely avoid risk and pain caused by surgery, and will not suffer implantation metastasis during the process of surgery.

53 NUTAS 的保乳优势 NUTAS Advantages in Breast-conserving Therapy 2. 无创无痕 : 完整地保留器官使女性达到完美的美容效果, 维持家庭和谐, 为婚姻的美满幸福提供保障 ; Non-invasive and traceless: intact preservation of breast organ will make women achieve perfect cosmetic effect, maintain family harmony and offer protection for joy and happiness in marriage.

54 NUTAS 的保乳优势 NUTAS Advantages in Breast-conserving Therapy 3. 没有变形 : 坏死的癌细胞在人体内逐渐被吸收, 整个治疗过程无需拿出或去除, 保证乳房外观无变化, 丌会导致乳房器官变形 No deformation: necrotic cancer cell in human body is gradually absorbed and does not need to take out or remove during the whole treatment process. NUTAS guarantees no change of breast appearance, and will not lead to deformation of breast organ.

0 年上半年评价与考核细则序号部门要素值考核内容考核方式考核标准考核 ( 扣原因 ) 考评得 3 安全生产目 30 无同等责任以上道路交通亡人事故无轻伤责任事故无重大质量

0 年上半年评价与考核细则序号部门要素值考核内容考核方式考核标准考核 ( 扣原因 ) 考评得 3 安全生产目 30 无同等责任以上道路交通亡人事故无轻伤责任事故无重大质量 0 年上半年评价与考核细则序号部门要素值考核内容考核方式考核标准无同等责任以上道路交通亡人事故 3 无轻伤责任事故目标 30 及事无重大质量工作过失故管无其他一般责任事故理在公司文明环境创建中, 无工作过失及被追究的