The eye is an important sensory organ for the human body to obtain external information, and about 80% of the external information is obtained through the eye, and its importance is self-evident.
With the influence of multiple factors such as the aging of the mainland population structure and improper living habits, the incidence of eye diseases such as glaucoma, cataracts and macular degeneration in China has continued to increase.
Among them, glaucoma, as the second blinding disease and the first irreversible blinding disease in the world, has a high rate of early missed diagnosis and misdiagnosis because of its hidden incidence and atypical clinical symptoms. And as a progressive disease that is currently incurable, the later stage of glaucoma will be accompanied by increased intraocular pressure and atrophy of the optic nerve, resulting in irreversible blindness. According to the "China Glaucoma Guidelines (2020)" issued by the Ophthalmology Society of the Chinese Medical Association, there are more than 20 million glaucoma patients in the mainland at this stage, of which more than 1/4 of the patients are blind.
In addition, compared with the diagnosis and treatment of eye diseases such as cataracts and macular degeneration, the diagnosis and treatment methods and progress of glaucoma diseases are relatively slow. And similar to most chronic diseases, there is currently no cure for glaucoma in the clinic. However, early detection and rational treatment can maintain visual function for the vast majority of patients for life, so the prevention of blindness in glaucoma must emphasize early detection, early diagnosis and early treatment.
In the face of such a huge and unmet clinical demand, practitioners in related fields have never stopped exploring better solutions. Among them, micro-invasive Glaucoma Surgery (MIGS) has shown a rapid development trend in Europe and the United States because of its advantages of small trauma, few complications, short doctor learning curve, etc., and also attracts many innovators and entrepreneurs to focus on this. Hessgaide (Suzhou) Biomedical Technology Co., Ltd. (hereinafter referred to as "Hessgaide"),located in Suzhou Biobay, is one of the leaders.
Recently, through a dialogue with the founding team of Hessgate, Arterial Network tried to understand its layout and innovation in the field of glaucoma treatment and even the entire field of ophthalmology.
The second journey,
From "Industry-University- to Production-Research"
The founding team of Hessgaide is not the first time to start a business, but is an entrepreneurial veteran in the process of national development of the "double creation" strategy.
In 2014, under the domestic "double creation" boom, scientific researchers and innovation teams from various fields actively embarked on the road of transforming scientific research achievements, trying to bring innovative technologies from the laboratory to the market. In this wave, similar to many entrepreneurs with scientific research attributes, the founding team of HiSilicon from universities and R&D centers of top 500 enterprises is also actively exploring and trying in different fields, and in this process, the team also deeply understands what kind of scientific and technological innovation is clinically necessary.
Therefore, in the process of "secondary entrepreneurship", the team also realized that the real opportunity must be aimed at the "hard needs that have not yet been met" in the clinic. The team started a business for the second time and was cautious about the choice of track. First of all, the relevant techniques have great clinical demand and value; secondly, product development has hard-core technology challenges, and the threshold is high and the moat is deep; and then the team's accumulation and experience can have the ability to deeply cultivate the selected track.
Under the influence of this change of thinking, the team began to frequently gather with front-line doctors and friends in the clinical department to discuss the clinical status quo and problems encountered, study and compare the development trends of various medical device fields at home and abroad, and finally choose to focus on the field of ophthalmic instruments and the exploration of minimally invasive glaucoma treatment options.
"China's glaucoma patients exceed 20 million people, the blindness rate over 40 years old is more than 30%, with the aging and the popularization of electronic products caused by excessive use of the eye, it can be expected that the incidence of glaucoma will be higher, limited by the physiological structure of the eye, the accuracy of ophthalmic surgical instruments is very high, and the clinical pursuit of smaller wounds and ultra-high precision instrument size control." The Hessgaide team said in the interview.
In 2020, the team officially founded Hessgaide (Suzhou) Biomedical Technology Co., Ltd., focusing on the development of full-pipeline products for minimally invasive surgical solutions in the field of glaucoma, and firmly opened a new journey.
Focusing on the glaucoma MIGS procedure,
Recreate a 10 billion scale market
In the exchange with the founding team of Hessergaide, the author also compared the development process of the domestic minimally invasive interventional coronary stent system.
In 2003, there were more than 20 million patients with coronary heart disease in mainland China, but only 70,000 to 80,000 patients underwent coronary angiography every year, and only 20,000 to 30,000 people received interventional treatment. At that time, the clinical treatment of coronary heart disease was mainly drug treatment and surgical bypass surgery, drug treatment is the basic therapy of coronary heart disease, which can not only alleviate the symptoms of angina and stabilize the condition, but also delay or alleviate the development process of coronary atherosclerosis.
Surgical bypass surgery, on the other hand, is to establish a bypass that restores coronary blood flow with a section of the patient's own vein or artery vascular connection to the narrowed or occluded coronary artery in the case of open chest.
With the clinical application of minimally invasive interventional device products in China, coronary stents and related products with their short course of treatment, small trauma and significant efficacy, rapidly developed into a first-line mainstream surgical method, starting from 20,000 cases per year, gradually developing to today's annual up to 1 million cases of coronary stent surgery, the clinical use of coronary stents is nearly 2 million sets per year, an increase of dozens of times, creating a number of listed companies such as Lepu and minimally invasive medical, with a market size of up to 20 billion. In the same period, the number of coronary artery bypass surgeries in the country has only increased from about 4,000 to less than 50,000 per year.
At present, the clinical treatment of glaucoma, like the coronary heart disease of 20 years ago, more than 20 million people with disease, compared with the higher fatality rate of coronary heart disease, glaucoma also has a large proportion of irreversible blindness rate. And in the current stage of clinical treatment of glaucoma, it is also similar to the development stage of coronary heart disease treatment 20 years ago, mainly for drug treatment and surgical treatment. In the early stage, many drug interventions are used, and in the later stages, intraocular pressure is controlled by surgical means. However, both therapies have certain limitations, and in addition to a variety of systemic and local adverse effects and drug compliance problems, drug therapy also requires long-term or lifelong medication.
As the gold standard for glaucoma surgery, trabecular resection is the same as coronary artery bypass surgery in the treatment of coronary heart disease, and there are problems such as long doctor learning curves, vision loss, cataracts, infections, mild upper eyelid drooping (eyelid drooping), and low probability of secondary surgery.
With the improvement of high-precision processing technology and processing capacity in the medical device industry, MIGS instruments for minimally invasive glaucoma surgery have begun to be applied to clinical practice and develop rapidly. With its advantages of small incisions, effective blood pressure reduction, high safety, fast healing, and reduced risk of complications, MIGS devices have gradually become a hot topic in the field of glaucoma treatment.
At present, the mainland has not yet domestic glaucoma minimally invasive surgical products officially approved for listing, at this stage XEN drainage tube this imported product, is the mainland's only internal road inlet through the subconjunctival passage drainage of minimally invasive glaucoma surgery products, domestic glaucoma minimally invasive surgical products have obvious deficiencies. From this point of view, Hessgaide's layout in the field of minimally invasive surgery for glaucoma is expected to accelerate the completion of the shortcomings and gaps in the minimally invasive surgical products of glaucoma in mainland China.
According to reports, in the field of minimally invasive glaucoma surgery, Hiserguad has formed a relatively complete product solution for minimally invasive glaucoma surgery according to the early, middle and late stages of the development of glaucoma. Among them, for the open-angle glaucoma disease, the peripheral diameter of the implantable stent MicroCOGO developed by Hessgaide is only less than 300 microns, and the minimum diameter of the included pathway design reaches the scale of about 30-40 microns, behind which also fully reflects the ability and basis of Hessgaide in micron-level 3D ultra-fine processing.
As one of the most complex and sophisticated organs in the human body, the product development of implantable devices is extremely difficult, and most of the related research and attempts in the past have been folded, and most of them are subject to the shortcomings and shortcomings of the supply chain in the ultra-micro fine processing capacity.
In order to solve this problem, in the technical demonstration stage before the establishment of the company, the founding team of HiSilicon ged has carried out close cooperation and exchanges with front-line clinicians such as professor Sun Xinghuai of Shanghai Wuguan Hospital, and is fully familiar with the actual clinical needs and doctors' operating habits. In the Hessgaide team, R&D talents from multinational companies such as Medtronic and Philips are gathered to ensure the technical advantages in product research and development.
Clinical acceleration, to the market
Thanks to the outstanding performance and technical foundation of the company's products, less than a year after its establishment, HiSilicon Cade has completed the angel round and the pre-A round of financing, and quickly established a precision machining and manufacturing center in Nantong and a research and development center in Shanghai, laying the foundation for the subsequent mass production of products.
At present, Hessgaide has also planned to open a number of its products in the national multi-center clinical trials within the year, and cooperate with more than ten large-scale tertiary hospitals in China.
In addition to promoting the clinical progress and registration of existing products, in terms of product research and development, Hessiged will further enrich the product line of minimally invasive surgery for glaucoma. According to reports, at present, HiSilicon Ged is planning to try to carry out the research and development of pharmaceutical and device combination products and glaucoma early screening intelligent hardware products, and launch more innovative products of great significance in the diagnosis and treatment of glaucoma.
Based on the accumulation of existing underlying technology, Hessgate will continue to break the ice in the field of more imported monopoly products in the field of ophthalmology. In the process of development, talent resources have always been the primary demand for the development of Hessgaide, and Hessgaide also hopes to have more outstanding talents join the team.
"With every effort we make, we care for every line of light for patients." This is not only Hessgaard's vision, but also hessgaide's original intention.