In the 'internal roll' neural intervention track innovation breakthrough, 3 stenosis ischemia products support more than 100 million revenue

"On a high certainty track, you have a lot of people coming in at the same time and you can get an inroll very quickly. Innovative enterprises should make plans for the future, jump out of the high certainty track, and explore the layout in the immature field, which may receive multiple returns. Then when people see the value of the track and start doing it, you've built a moat of time and technology."

The stenosis ischemia of nerve intervention, even the whole nerve intervention market, is the general manager of Sanuo Shenchang Kang Xiaoran said "immature field".

And it is. At present, neural intervention is still in the early stage, and the rate of domestic production is low. Although more than 100 types of neurointerventional devices have been approved in 2022, and domestic enterprises have made breakthroughs in some categories, such as spring rings, suction catheters and thrombectomy scaffolds, from the perspective of the whole category, it is still dominated by foreign investment. At the same time, the acute ischemia and pathway market in neural intervention is highly homogenous, while stenosis ischemia lacks more safe and effective treatment methods.

Breaking out of the limitation of domestic substitution, Sanoshenchang has developed a new path, taking the lead in the development of intracranial stenosis and ischemia, and its innovative intracranial low pressure balloon, intracranial drug stent and other products have been approved successively, laying its leading position. In 2022, the company's revenue exceeded 100 million. At the same time, the company adheres to the whole category layout of neural intervention driven by innovation, and implements the development strategy of "deep cultivation ischemia, innovation bleeding, breakthrough pathway". Among the seven neurointerventional devices that have been marketed by Sanoshenchang, three have been the world's first.

Make 80% of the products,

Achieve 20% differentiated innovation

Different from the coronary intervention market that can be driven by a single product, neurological intervention is complicated and the surgical volume is still relatively limited, and the ceiling of a single product is relatively low. At the doctor level, more perfect and diversified product portfolio is needed to deal with different diseases such as ischemia and bleeding. At the enterprise level, a complete product line is conducive to rapid entry into the market.

Sanoshenchang focuses on four subdivisions of acute ischemia, stenosis ischemia, bleeding and access, and hopes to provide 80% of the instruments for neurointerventional surgery. At the same time, the company adheres to innovation-driven, and 20% of 80% devices are innovative products with strong differentiation competitiveness.

Kang Xiaoran firmly believes that only bright flagship products can hold up the layout of the whole industry line of the enterprise, otherwise do everything, but do the same, will be lost.

"Medical devices are not cutting-edge science, but more applied science. Enterprises should tap clinical needs and make differentiated innovation by comprehensively deploying innovative technologies and resources." Sanoshenzhang has established five underlying technology platforms, including catheter extrusion and precision machining platform, alloy wire micro-braid platform, metal pipe cutting and post-treatment platform, electronic graft surface treatment platform and drug carrier technology platform. The company has been authorized and applied for more than 80 patents.

Based on the accumulation of underlying technologies and years of experience in cardiovascular intervention development of the parent company SinoHealthcare, Sinoshenchang can quickly respond to clinical needs. In the process of close cooperation with domestic famous hospitals such as Tiantan Hospital, Changhai Hospital and Xuanwu Hospital, the first opportunity we seize is intracranial stenosis ischemia.

Deep ploughing and ischemia,

Capture the highly underrated intracranial stenosis market

From the perspective of clinical needs, there are about 13 million stroke patients in China, among which ischemic stroke patients account for about 80%, and among these patients, the proportion of stenosis ischemia is up to 46.6%.

Kang Xiaoran recalled: "Many years ago, Professor Miao Zhongrong from Beijing Tiantan Hospital told the R&D team of SinoHealthcare that he was envious that there were so many companies and so many rich products for coronary artery intervention, but ischemic products in nerve intervention were limited. Only bare stents and balloons could solve the problem of intracranial vascular stenosis and opening. In-stent restenosis and the high recurrence rate of ischemic stroke often present clinicians with a very difficult situation."

In coronary intervention, coronary drug stents replace bare metal stents in a short time due to their superiority in curative effect. There is also an opportunity to develop drug-coated stents for neural intervention due to the commonality between ischemic vascular diseases.

However, the intracranial vascular environment of human body is complex, with small and fragile vessel diameter, and the physiological structure is different from that of coronary vessels. The drugs carried in the coated stent will come into contact with cerebrospinal fluid and brain tissue, etc., and the above factors have higher requirements for stent design, coating technology, drug dose and concentration, etc. First, the effective concentration of the drug should be reached within a controllable time to ensure the effectiveness of treatment. Second, the drug itself will not cause neurotoxicity to the brain tissue.

Sanol has independently developed the world's first NOVA drug-eluting stent for the treatment of intracranial stenosis. The NOVA scaffold is a flexible, thin-wall stainless steel scaffold with an open-loop design and a composite surface of an electron graft substrate and a biodegradable drug coating of rapamycin. The scaffold reaches the lesion site through its rapid exchange balloon catheter delivery system, providing anti-proliferation, accurate positioning, good adherence to the wall, and low incidence of recenosis.

Premarket clinical studies of the NOVA intracranial drug stent demonstrated a 68.5% reduction in restenosis and a significant 88.4% reduction in the recurrence rate of ischemic stroke at 1 year after implantation of the NOVA stent compared to the bare metal stent. The corresponding results were published in the international authoritative journal of neurology, JAMANeurology, which is the highest academic impact paper so far with domestic neurointerventional devices as the main research subject.

In 2021, NOVA intracranial drug-eluting stent was approved for market by the Innovation Device Channel of the Food and Drug Administration, and in 2022, it was selected as the Important Scientific Progress of 2021 by the Chinese Academy of Medical Sciences.

In the field of intracranial stenosis ischemia, Sanoshenchang has never stopped the breakthrough pace from 0 to 1, and the product layout continues to advance in depth. The world's first self-expanding drug stent developed by the company complements the NOVA spherical expansion drug stent.

Spherical expansion drug stents are more suitable for straight vessels with heavy plaque load, while self-expansion drug stents can treat perforator rich vessels and tortuous vessels, and the product can be released through microcatheter, greatly reducing the difficulty of operation. The self-expanding drug stent developed by Sanoshenchang satisfies the combined effect of stent self-adherent expansion after microcatheter release and drug coating prevention of vascular restenosis, achieving a technical breakthrough of "1+1 > 2".

First of all, the self-expanding stent has a variety of specifications and models, providing more suitable instrument selection for different blood vessel sizes. Secondly, the radial support and vascular compliance of the stent were specially optimized for the vascular design of intracranial stenosis, and the vascular molding effect was good. All the full-size self-expanding stents of Sanoshenchang can be matched with 0.021 inch microcatheter, and the operation of stent push and release is convenient, greatly reducing the learning curve of the instruments for doctors, and effectively improving the safety of the surgical process.

According to Kang Xiaoran, "The self-expanding stent itself has a large deformation ratio, with the maximum diameter of 4.5 mm after free release, but it needs to be compressed to 0.5 mm in the early delivery to enter the matching microcatheter, and the scaffold deformation ratio is up to 9 times. "If the drug coating technology is not up to standard, many problems such as coating rupture, delamination, and particle release may occur during such huge deformation and long-distance microcatheter delivery, which not only affects the therapeutic effect, but also causes significant safety risks as the fragments of the drug coating may block distal blood vessels or branches."

Biodegradable drug rapamycin is sprayed on the surface of the underlying stent using electronic grafting technology. A special physical structure of "interlacing and interlacing" is formed between polymers of the coating. The mechanical integrity of the coating is greatly improved, and the purpose of preventing vascular restenosis is achieved through lasting drug release.

In February 2023, the self-expanding stent was enrolled in a registered clinical trial. It only took 7 months from the first patient to the completion of enrollment. The product is expected to be approved for market next year.

In the dominant field of intracranial ischemia, except for stenosis ischemia, for acute ischemia, the intracranial thrombus aspiration system, thrombectomy stent and other products developed by Sanoshenzhang are in the process of being successively approved and marketed.

Innovation bleeding, breakthrough access

According to the development trend of neurointerventional market segment, Sanol is constantly improving its product strategic layout. In the bleeding plate spring coil and tight mesh bracket "two dominant" circumstances, Sanuo Shenchang independently developed a number of innovative products to achieve category breakthrough; In the highly competitive channel market, the company will seize market share with differentiated products.

The appearance of tight mesh stent changes the treatment of aneurysm from "tamponade" to "vascular reconstruction". Based on the precise judgment of clinical needs, the coated tight mesh stent developed by Sanoshenchon has the world's smallest external diameter through the tight mesh stent 4.0mm and below diameter can be compatible with 0.017 inch microcatheter. One is to facilitate the delivery of doctors without relying on the experience and technology of mature doctors; Second, it is convenient to access the distal cerebral blood vessels, such as the middle cerebral artery and the anterior cerebral artery, so as to more safely expand the use of the close-mesh stent.

At the same time, the coated dense mesh bracket uses a new alloy material, which can achieve full development under X-ray, without the need to mix with platinum wire, providing better mechanical support performance while reducing the complexity of the process.

Furthermore, Sanoshenchang applied special anticoagulant polymer to the close-mesh stent through the electronic graft surface treatment technology platform. The thickness of the anticoagulant coating is only about 35nm, which can further improve the safety of the clinical application of the close-mesh stent. After stent implantation, the patient is expected to further shorten the duration of postoperative DAPT (dual antiplatelet therapy) or further apply SAPT (monoclonal platelet therapy) anticoagulant strategy.

In previous animal experiments conducted by Sanoshenchon, hundreds of animals were treated with a single anticoagulant instead of double anticoagulant therapy after surgery, and none of the animals had problems with in-stent thrombosis. At present, Sanoshenchang's innovative coating stent with dense mesh has entered the clinical stage.

In addition, existing close-mesh stents are mainly used for unruptured aneurysms, and there is no clear evidence-based medical evidence for the efficacy of ruptured aneurysms. Once aneurysms rupture and hemorrhage occur, the fatality rate can be as high as 60.2% to 73.3%. In addition to the breakthroughs in safety and effectiveness, Sanocon's coated close-mesh stent is also expected to expand its indications to the treatment of ruptured aneurysm, and the company will further carry out related extended clinical trials in the future.

In the access plate, the previous domestic intracranial access catheter was all through the femoral artery approach (TFA), compared with the radial artery approach (TRA), which has higher safety, significantly improved patient comfort and shortened hospital stay.

TRA has been widely applied in the field of coronary interventional diagnosis and treatment, and the application rate of TRA coronary interventional treatment in China has reached 96.37% in 2020. However, its development in the field of neural intervention lags behind significantly. Sanoshenchang's APEXTRA access catheter is the first intracranial access catheter approved by NMPA in China for the radial artery approach, and has been approved for market on March 31. The introduction of corresponding new products will further promote the development of neural intervention pathways to safer and more comfortable TRA routes.

Carry out the layout of the whole industrial chain,

The products have been used in more than 1500 clinical centers

At present, Sanoshenchang has established a sales network covering the whole country, and the listed products are used in more than 1500 clinical centers across the country.

In the product strategy of "80%, 20%" of Sanoshenchang, 20% of innovative products bring more profit increase and brand effect to the company, and 80% of the whole line of products need strict quality control and cost efficiency to support rapid clinical penetration and transformation.

In the past two years, Sanuo Shenchang has invested 200 million yuan to build a R&D, production and operation base of more than 10,000 square meters in Suzhou. The company around the core process of products gradually to the upstream of the industrial chain. Taking conduit conduit as an example, core links such as pipe extrusion, spring weaving and hot remolding are all completed independently in Suzhou base. Mastering upstream technology and core components can not only guarantee product quality, but also quickly form scale effect and meet clinical requirements for rapid iteration of device products.

In addition to meeting local clinical needs, Sanol attaches great importance to the development of globalization. This year is the year of "building momentum" of the company, and will start overseas declaration of a series of products one after another.

The overseas clinical regulatory resources, marketing team and marketing experience of Sinochem, the parent company, have laid a solid foundation for Sinochem to go overseas. In the field of coronary stent, SinoHealthcare is the first domestic enterprise approved by FDAIDE in the United States to conduct multi-center large-scale randomized controlled clinical trials in the world. Sinohealthcare has a layout in the United States, Japan, Europe, Southeast Asia and other countries or regions, and has formed a certain business volume.

Standing on the shoulders of Sanofi,

Talent, technology and other multi-dimensional support

Looking at the industrial layout and development path of Sinochem, the influence of the parent company Sinochem is reflected in all aspects. In 2017, Sanuo Medical established neurological Intervention Division. In 2020, with the growing scale of neurointervention business, Sanol Medical officially established Sanol Shenchang in Suzhou, focusing on the layout and development of neurointervention segments.

"Sanofi is the trunk of a big tree," Kang said. "New businesses such as nerve intervention and valve intervention are branches that grow out. The trunk continues to provide nutrition and support for the branches. Without SinoHealthcare's more than 10 years of experience in cardiovascular intervention, including core platform technologies such as drug coating, stent, balloon and surface modification, as well as global clinical trials and organizational structure, we would not have fully developed in the field of neurological intervention in a short period of time."

The core team of Sanol Shenchang are all from Sanol Medical, with more than 10 years of teamwork experience. General Manager Kang Xiaoran joined SinoHealthcare in 2007. He has been trained in product development, quality management, regulatory and clinical functions, and participated in several innovative product R&D and global regulatory and clinical operation management key projects. The senior R&D director of Sanol Shenchang participated in the 0-1 development process of many innovative products of Sanol Medical. The Vice President of Production Operations has more than 10 years of quality management experience at Sano Healthcare.

At the same time, the global technical experts of Sinochem also form the expert advisory team of Sinochem to provide forward-looking technical guidance for the development of innovative neurointerventional products.

High-potential track layout,

Build a moat of technology and time

After the explosive growth in 2020, the neurological intervention industry has fallen into a "downturn". While the track is winding up, the collective mining is approaching. Will the living space of the neural intervention enterprises be narrowed?

According to the statistical analysis of Guosen Securities, China's neural intervention market will exceed 30 billion yuan in 2030.

Kang Xiaoran believes that the so-called fierce competition or internal volume, either the product threshold is not high enough, or supply exceeds demand, the dilemma of neurological intervention in the latter, the growth of surgery volume cannot match the market speed of many similar products. The development of neurointerventional devices is accompanied by the continuous optimization and iteration of therapeutic concepts and surgical techniques. Enterprises should have the courage to carry out forward-looking layout and select suitable high-potential courses according to their own advantages.

In terms of market maturity, although neural intervention started late, it developed rapidly. With the continuous penetration of stroke treatment into the grassroots, thousands of stroke centers of different levels have been established in China, and the number of doctors who can carry out neurointerventional surgery is increasing rapidly. In hospitals with a certain volume of coronary interventional surgery, neurological intervention will also gradually develop. In the future, the volume of neurological interventional surgery can accommodate the joint development of many enterprises in different segments.

“在高确定性的赛道，往往很多人在同一时间涌入，便会很快形成内卷的局面。而创新企业要做好面向未来的规划，跳出高确定性的赛道，在尚未成熟的领域探索布局，可能会收到成倍的回报。之后当大家看到赛道的价值并开始去做的时候，你已经搭建起时间与技术的护城河。”

神经介入中的狭窄缺血、甚至整个神经介入市场，便是赛诺神畅总经理康小然口中“尚未成熟的领域”。

事实的确如此。目前我国神经介入仍处于发展初期，国产化率较低。尽管2022年百余款神经介入器械获批，国产企业在弹簧圈、抽吸导管、取栓支架等部分品类上实现突破，但从全品类来看，仍是外资主导。同时，神经介入中急性缺血及通路市场同质化竞争严重，而狭窄缺血却缺乏更为安全有效的治疗手段。

跳出国产替代的局限，赛诺神畅另辟蹊径，率先发展颅内狭窄缺血领域，创新颅内低压球囊、颅内药物支架等产品陆续获批，奠定其领先地位。2022年，公司营收过亿。同时，公司坚持以创新为驱动进行神经介入全品类布局，实施“深耕缺血、创新出血、突破通路”的发展战略。在赛诺神畅已上市的7款神经介入器械中，有3款都实现了全球首创。

做80%的产品，
实现20%的差异化创新

与单品即可驱动的冠脉介入市场不同，神经介入术式复杂且手术体量仍较为有限，单品的天花板相对较低。在医生层面，需要更完善、多样的产品组合来应对缺血、出血等不同疾病情况；在企业层面，完善的产品线有利于快速进入市场。

赛诺神畅围绕急性缺血、狭窄缺血、出血、通路四大细分领域进行全品线布局，公司希望能提供神经介入手术过程中80%的器械。同时，公司坚持创新驱动，在80%的器械中有20%是具有强差异化竞争力的创新产品。

康小然坚信，亮眼的旗舰产品才能撑起企业全产业线的布局，否则什么都做、但做得都差不多，会泯然众人矣。

“医疗器械并不是尖端科学，更多是应用科学，企业要挖掘临床需求，将所掌握的创新技术、资源综合调配，做出差异化创新”。赛诺神畅已建立5大底层技术平台——导管挤出及精密加工平台、合金丝材微编织平台、金属管材切割及后处理平台、电子接枝表面处理平台及药物载体技术平台，公司已获授权及在申请中的专利共超80项。

基于底层技术的积累，在母公司赛诺医疗多年心血管介入发展经验的基础上，赛诺神畅可快速响应临床需求。与国内天坛医院、长海医院、宣武医院等知名医院紧密合作的过程中，公司抓住的第一个机会点便是颅内狭窄缺血。

深耕缺血，
抓住被严重低估的颅内狭窄市场

从临床需求来看，我国约有1300万脑卒中患者，其中缺血性卒中患者约占80%，而在这部分患者中狭窄缺血占比高达46.6%。

康小然回忆到：“多年前北京天坛医院缪中荣教授便向赛诺医疗研发团队表示，很羡慕冠脉介入有这么多的公司、这么多丰富的产品，而在神经介入中缺血产品有限，只有裸支架和球囊来解决颅内血管狭窄开通的问题，而支架内再狭窄、缺血性卒中再发生率高往往让临床医生面临非常棘手的情况。”

在冠脉介入中，冠脉药物支架因其在疗效上的优越性在短时间内取代了金属裸支架。因缺血性血管疾病之间的共通性，神经介入也有发展药物涂层支架的机会。

但人体颅内血管环境复杂，血管直径狭小、脆弱，同冠脉血管间亦存在生理结构上的差别，涂层支架所载药物会接触到脑脊液、脑组织等，以上因素对支架设计、涂层技术、药物剂量浓度等都有着更高的要求。其一，药物要在可控的时间内达到药物有效浓度，保证治疗有效性；其二，不会因药物自身对脑组织等带来神经毒性。

赛诺神畅自主研发出全球首个专用于颅内狭窄治疗的NOVA药物洗脱支架。NOVA支架平台以柔顺的薄壁不锈钢为主体，采取开环设计，表面采用电子接枝底层及雷帕霉素可降解药物涂层的复合设计，通过其快速交换球囊导管输送系统到达病变部位，具有抗增殖、精准定位、贴壁良好、再狭窄发生率低等优势。

NOVA颅内药物支架的上市前临床研究证实，相比于金属裸支架，患者在植入NOVA支架后1年的再狭窄率可降低68.5%，同时缺血性卒中的再发生率显著降低88.4%。相应结果发表于国际神经权威期刊JAMANeurology，是迄今为止以国产神经介入器械产品为研究主体的最高学术影响文章。

2021年NOVA颅内药物洗脱支架获药监局创新器械通道批准上市，2022年入选中国医学科学院2021年度重要科学进展。

在颅内狭窄缺血领域，赛诺神畅从未停下从0到1的突破步伐，产品布局不断向着纵深推进。公司自主开发的全球首款自膨式药物支架，与NOVA球扩药物支架互为补充。

球扩药物支架更适合较直、斑块负荷较重的血管，而自膨药物支架可处理富穿支血管、迂曲血管，产品经微导管释放，大大降低手术操作难度。赛诺神畅研发的自膨式药物支架同时满足经微导管释放后支架自行贴壁扩张和药物涂层预防血管再狭窄的综合效果，实现了“1+1＞2”的技术突破。

首先，该自膨药物支架的规格型号丰富，针对不同血管尺寸提供更为适合的器械选择。其次，支架的径向支撑力及血管顺应性为颅内狭窄病变血管进行特殊优化设计，血管成型效果良好。赛诺神畅全尺寸的自膨药物支架均可匹配0.021英寸的微导管，支架推送、释放操作方便，大幅降低了医生对于器械的学习曲线，有效改善手术过程中的安全性。

据康小然介绍：“自膨药物支架本身的形变比大，自由释放后最大的直径为4.5毫米，而在前期输送时需要压缩到0.5毫米以进入匹配的微导管，支架形变比高达9倍。如果药物涂层技术不过关，在如此巨大的形变作用和长距离微导管内输送过程中容易出现涂层破裂、分层及微粒释放等众多问题，不仅影响治疗效果，同时药物涂层的碎片还可能堵塞远端血管或分支，造成巨大的安全隐患。”

赛诺神畅的自膨药物支架采用电子接枝底层技术，将可降解药物雷帕霉素喷涂在底层支架表面，涂层高分子间形成“交错对插”的特殊物理结构，大大提高其涂层机械完整性，同时通过持久的药物释放达到预防血管再狭窄的目的。

2023年2月该自膨药物支架已完成注册临床试验入组，从首例患者入组到完成入组仅花费了7个月的时间，产品预计将于明年获批上市。

在优势的颅内缺血领域，除狭窄缺血外，针对急性缺血，赛诺神畅开发的颅内血栓抽吸系统、取栓支架等产品均在陆续批准上市的过程中。

创新出血，突破通路

根据神经介入细分市场的发展趋势，赛诺神畅在不断完善自身的产品战略布局。在出血板块弹簧圈、密网支架“两家独大”的情况下，赛诺神畅自主研发多款创新产品实现品类突破；在竞争激烈的通路市场，公司将以差异化产品抢占市场份额。

密网支架的出现，让动脉瘤治疗手段从“填塞”变为“血管重建”。基于对于临床需求的精准判断，赛诺神畅开发的涂层密网支架拥有全球最小的通过外径，4.0mm规格及以下直径的密网支架均可兼容0.017英寸的微导管。一是方便医生输送，而无需依赖成熟医生的经验和技术；二是方便进入大脑远端血管，如大脑中动脉、大脑前动脉等，更安全地拓展密网支架的使用场景。

同时，该涂层密网支架采用了新型合金材料，能够在X光下实现全显影，无需再与铂金丝材等混编，在降低工艺复杂度的同时提供了更优的力学支撑性能。

再者，赛诺神畅通过电子接枝表面处理技术平台将特殊抗凝血聚合物应用到密网支架上，抗凝涂层厚度仅约35nm，可进一步提升密网支架临床应用的安全性。患者植入支架后有望进一步缩短术后DAPT（双联抗血小板治疗）时程或进一步术后仅应用SAPT（单抗血小板治疗）的抗凝策略。

在此前赛诺神畅开展的动物实验中，上百头的动物在术后都没有采用双重抗凝治疗，只需使用一种抗凝药物，试验动物均未出现支架内血栓的问题。现阶段，赛诺神畅的创新涂层密网支架已进入临床入组阶段。

此外，现有的密网支架主要用于未破裂动脉瘤，对已破裂动脉瘤的疗效尚无明确的循证医学证据。动脉瘤一旦发生破裂出血，其病死率可高达60.2%-73.3%。除在安全性、有效性上的突破外，赛诺神畅的涂层密网支架还有望拓展适应症至破裂动脉瘤的治疗上，公司未来将进一步开展相关的拓展性临床试验。

在通路板块，此前国内的颅内通路导管都是经股动脉入路（TFA），相比之下经桡动脉入路（TRA）拥有更高的安全性，且显著提高患者舒适度、缩短住院时间等。

TRA在冠脉介入诊疗领域的应用越来越广泛，2020年中国TRA冠脉介入应用率已达到96.37%。但其在神经介入领域的发展明显滞后。赛诺神畅的APEXTRA通路导管是国内第一款经NMPA批准专用于经桡动脉入路的颅内通路导管，已于3月31日批准上市，相应新产品的引入将进一步促进神经介入通路向更安全舒适的TRA路线发展。

开展全产业链布局，
产品在超1500家临床中心应用

目前，赛诺神畅已建立覆盖全国的销售网络，上市产品在全国超过1500家临床中心使用。

在赛诺神畅“80%、20%”的产品战略中，20%的创新产品为公司带来更多利润增量及品牌效应，80%的全线产品需要具备严格的质量控制及成本效率才能支撑快速的临床渗透转化。

过去两年间，赛诺神畅共投入2亿元在苏州建成超1万平米的研发生产运营基地。公司围绕产品核心工艺环节逐步往产业链上游延伸。以通路导管为例，从管材挤出、绕簧编织、热覆成型等核心环节均在苏州基地自主完成。掌握上游工艺技术及核心部件不仅保障了产品品质，还能快速形成规模效应并满足临床对于器械产品的快速迭代需求。

而除满足本土临床需求外，赛诺神畅高度重视全球化发展。今年是公司“蓄势”的一年，将陆续开启系列产品海外申报。

母公司赛诺医疗在海外的临床法规资源、营销团队及市场化经验，都为赛诺神畅的出海奠定了坚实的基础。在冠脉药物支架领域，赛诺医疗是国内首家获得美国FDAIDE批准，在全球进行多中心大规模、随机对照临床试验的企业，赛诺医疗在美国、日本、欧洲、东南亚等国家或地区都有布局，且已形成一定的业务体量。

站在赛诺医疗的肩膀上发展，
人才、技术等多维度支持

综合来看赛诺神畅的产业布局和发展路径，母公司赛诺医疗的影响体现在方方面面。2017年，赛诺医疗成立神经介入事业部。2020年，随着神经介入业务规模不断壮大，赛诺医疗在苏州正式成立赛诺神畅，专注神经介入细分领域的布局及发展。

康小然比喻道：“赛诺医疗是大树的树干，公司神经介入、瓣膜介入等新兴业务都是长出来的树杈，树干持续为树杈提供营养和支撑。如果没有赛诺医疗在心血管介入领域十余年的积累，包括细分到药物涂层、支架、球囊、表面修饰等核心平台技术，及在全球开展临床试验、搭建组织架构等经验，我们难以在短时间内于神经介入领域全面开花。”

赛诺神畅的核心团队均来自赛诺医疗，拥有十多年的团队合作经历。总经理康小然于2007年加入赛诺医疗，在公司内部历经产品研发、质量管理、法规临床等职能历练，并参与多款创新产品研发及全球化法规临床运营管理关键项目；赛诺神畅高级研发总监参与了赛诺医疗多款创新产品从0到1的开发过程；公司生产运营副总裁在赛诺医疗具有十多年的质量管理经验。

同时，赛诺医疗的全球技术专家也组成了赛诺神畅的专家顾问团队，为创新神经介入产品开发提供前瞻性的技术指导。

布局高潜力赛道，
搭建技术与时间的护城河

在2020年的爆发式增长后，神经介入行业陷入“低迷”，赛道内卷的同时集采逼近，神经介入企业的生存空间是否被缩窄？

据国信证券统计分析，2030年中国神经介入市场规模将超300亿元。

康小然认为，所谓的竞争激烈或内卷，要么是产品门槛不够高，要么是供大于求，神经介入的困境在后者，手术量的增长无法匹配众多同类产品的上市速度。神经介入器械的发展伴随着治疗理念和手术技术的不断优化迭代，企业要有勇气进行前瞻性布局，并根据自身的优势选择适合的高潜力赛道。

从市场成熟度上看，神经介入虽然起步晚，但发展迅速。随着脑卒中治疗不断向基层渗透，我国已建立上千家不同级别的卒中中心，可开展神经介入手术的医生数量快速增加。在已具备一定冠脉介入手术体量的医院，神经介入也会逐步发展起来，未来神经介入手术量可容纳不同细分领域的多家企业共同发展。

随着创新产品陆续推进，赛诺神畅步入“收获期”，在优势领域与后来者之间的距离足以让公司不断强化技术与时间的护城河。未来，赛诺神畅将会沿着核心定位——以创新为驱动的神经介入全品线供应商不断向前，开发更多创新器械满足临床及患者需求。