36氪 was informed that HiSilicon (Suzhou) Biomedical Technology Co., Ltd. (hereinafter referred to as “HiSilicon”), an innovative medical device company in the field of Micro-Invasive Glaucoma Surgery (MIGS), has completed nearly 100 million yuan. A new round of financing, this round of financing was led by Delian Capital, followed by Rongquan Capital and Huaquan Capital, and the old shareholders Boyuan Capital and Taifu Capital continued to follow. Gelu Capital acted as exclusive financial advisor.
It is reported that this round of financing is mainly used to accelerate the national clinical multi-center trials of MicroCOGO® and PassCOGO® related products in the MIGS field of the company, and to accelerate the deployment of other multi-pipeline ophthalmic innovative product matrices.
Founded in September 2020, HiSilicon is headquartered in Biobay, Suzhou Industrial Park. It is a full-line product development innovative technology enterprise focusing on innovative minimally invasive surgical solutions in the field of glaucoma. The company’s fastest-moving product that has entered the clinical stage is the “MicroCOGO® Trabecular Mesh Micro-Stent Drainage System”, which is aimed at patients with early-stage open-angle glaucoma. According to Dr. Zhao Peng, the founder and CEO of HiSilicon, this is the smallest class III implant that a local company has entered the clinical stage. Medical device companies.
Zhao Peng said that during the design and finalization of the “MicroCOGO® Trabecular meshwork micro-stent drainage system”, we visited a large number of clinical first-line ophthalmologists in China, and received many awards from the team of Professor Sun Xinghuai from the Eye and ENT Hospital Affiliated to Fudan University. Advice and support from the hospital’s top ophthalmologists and scholars. On the basis of expert advice , a lot of experiments and optimizations have been carried out on the anti-blocking and diversion design of the stent part of the product, as well as the ergonomic design of the conveyor, to create a product that is ideal for Chinese and doctors .
At the same time, the company has developed a product “PassCOGO® Glaucoma Drainage System” for advanced severe patients with open-angle glaucoma, which has been accelerated into the clinical trial stage. This product belongs to the reconstruction of drainage pipeline, which can achieve long-term stable control of intraocular pressure by establishing a new drainage channel for aqueous humor under the anterior chamber and conjunctiva.
Photo courtesy of the enterprise
According to the “China Glaucoma Guidelines (2020)” data, in 2020, the number of primary glaucoma patients in the world will exceed 76 million, and the number of Chinese patients will exceed 21 million, making it the country with the largest number of glaucoma patients . Eye health has risen to a national strategic level since the 13th Five-Year Plan in 2016. In 2022, the 14th Five-Year Plan proposed for the first time to strengthen the prevention and treatment of key eye diseases in key groups, and clearly pointed out that it is necessary to improve the ability of early diagnosis and early treatment of glaucoma. With the accelerated aging of the population and the rising awareness of national health, the future glaucoma diagnosis and treatment market has huge growth potential.
At present, the main methods of clinical treatment of glaucoma in China are drug therapy and surgery . In the early stage, drugs (eye drops) were used for intervention, and in the later stage, the “gold standard” surgery “trabeculectomy” started in 1968. At present, all treatments are aimed at controlling intraocular pressure and preserving vision in a reasonable and effective way throughout the life cycle of patients. The above two treatment intervention methods have been used for many years, and there will be disadvantages such as drug effect drift, poor patient compliance, life-long medication, and adverse drug reactions for drug treatment methods. There are many problems such as long learning curve for doctors, large surgical trauma, large damage to the normal structure and function of the eye, and complicated complications.
In response to these pain points, experts, scholars, and enterprises in the field have been exploring and trying, hoping to find alternative surgical methods with lower complication rates and less trauma. In recent years, the new generation of MIGS surgery, which has become popular internationally and has been verified by more than one million patients, is attracting more and more attention. Due to the advantages of small surgical incision, short operation time, fast postoperative recovery, and low learning curve for doctors, it has attracted more and more attention from ophthalmologists .
It is understood that the new generation of MIGS, as an emerging means and trend of glaucoma treatment, has been applied on a large scale internationally. In the four years from 2018 to the present, more than one million glaucoma patients worldwide have undergone MIGS intervention and treatment. Among them, iStent under Glaukos and XEN under AbbVie are typical representatives.
Fan Zhongpeng, Director of Operations (COO) of HiSilicon, said that according to the principle of reducing intraocular pressure (IOP), it seems that the mainstream MIGS procedures and products can be divided into four types: ① Increase the trabecular meshwork pathway room Water outflow; ② suprachoroidal aqueous humor drainage; ③ subconjunctival aqueous humor drainage; ④ reduced aqueous humor production. Among them, the aqueous humor drainage of ① and ② MIGS surgical products mainly rely on the outflow channel of the original physiological aqueous humor, and the reduction of intraocular pressure is smaller than that of traditional trabeculectomy, which is suitable for patients with early and mid-stage open-angle glaucoma. The advantage is that it has less impact on the conjunctiva. . ③ The mechanism of action of the Chinese MIGS surgical product is similar to that of traditional trabeculectomy, and the magnitude of IOP lowering is also similar. The advantage is that the incidence of postoperative complications is less than that of trabeculectomy. An important feature of MIGS is that the incision is small, the postoperative recovery is quicker, and the impact on the quality of life is small.
At this stage, no domestic MIGS surgical products have been approved for listing in China. Only XEN, a subsidiary of AbbVie, has been approved for listing in Hainan in 2020 through the real-world data research path. A new generation of minimally invasive glaucoma surgery products for subconjunctival access drainage. In China, in addition to HiSilicon, there are Chaomu Technology, Mingche Bio, Longmu Medical, Sinovision, Migos, etc., which are developing a new generation of MIGS products.
Liu Zhiyong, Chief Technology Officer (CTO) of HiSilicon, has been engaged in research and development in large international medical device enterprise groups such as Medtronic for a long time. He said that the development of related medical device products in the field of ophthalmology, especially the “MicroCOGO® Trabecular mesh micro stent drainage system” The core technical challenges of the new generation of MIGS-related products represented by ” mainly lie in the ultra-fine precision manufacturing, mass production process and product yield control of core components. “When the device is small to a certain size, for example, the overall peripheral size is reduced to less than 300 microns, it will bring a series of systematic difficulties in processing, manufacturing, and assembly processes. Many challenges, for which there is no ready-made experience to refer to, are highly dependent on It is based on the long-term experience accumulation of industry practitioners in related fields and the transfer, learning and exploration of knowledge .”
In terms of team, the HiSilicon team has gathered a group of talents from Medtronic, MicroPort Medical, Philips and other companies, and the team size has exceeded 80 people. The company attaches great importance to the development of the combination of medicine and industry, and now has established cooperative relations with clinical experts from eye hospitals such as Eye and ENT Hospital Affiliated to Fudan University, Zhongshan Eye Hospital Affiliated to Sun Yat-sen University in Guangzhou, Beijing Tongren Hospital, Peking Union Medical College Hospital, and Eye Center of the Second Hospital of Zhejiang University. .
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