Sightnovo Pioneers Billion-Dollar Ophthalmic Precision Medicine Market with 'Companion Diagnostics + Innovative Therapeutics/Devices' Strategy

Ophthalmology is a medical track that covers three fields: services, devices, and pharmaceuticals, while simultaneously possessing the dual attributes of serious medical care and consumer-driven healthcare, with broad market prospects. According to Frost & Sullivan, China’s ophthalmic medical market size grew from 54.5 billion yuan in 2013 to 108.3 billion yuan in 2018, with an annual compound growth rate of 15.3%.

Since 2021, more than 40 companies in the ophthalmology sector have successively received financing, with a total funding amount exceeding 8 billion RMB, setting a new historical record. Among a large group of VC/PE firms, leading healthcare funds such as Northern Light Venture Capital, Temasek, Sequoia China, Qiming Venture Partners, and Tencent Investment are prominently present.

Among them, ophthalmic pharmaceutical and device companies are the absolute "leaders" in the ophthalmic healthcare sector. On one hand, nearly 90% of total financing events in ophthalmology in 2021 were concentrated in the ophthalmic pharmaceutical and device field. On the other hand, driven by the continuously increasing market demand and the wave of domestically produced alternatives, ophthalmic devices have become the fastest-growing segment in the ophthalmic industry chain, with an annual compound growth rate of 22.7%.

Today, the ophthalmology industry has undoubtedly entered a new stage of development in the field of pharmaceutical and device R&D. A group of technically solid and market-savvy domestic emerging brands continue to emerge.

Traditional methods for predicting, evaluating, and monitoring the efficacy of ophthalmic disease treatments have primarily relied on imaging techniques. However, with the advent of innovative therapies such as targeted ophthalmic drugs and gene therapy, as well as the increasing diversity of ocular drug delivery methods, the treatment of eye diseases is moving towards personalization and precision. Relying solely on imaging methods will no longer suffice to meet current patient treatment needs and disease management requirements. Innovative technologies and solutions are being developed in the market.

Regarding the future development direction of the ophthalmology market, Xia Chaoran, founder of Beijing Sightnovo Medical Technology Co., Ltd. (hereinafter referred to as "Sightnovo"), believes thatCombining imaging with molecular-level testing and examination to achieve higher levels of precision treatment and meet personalized needs may become a major approach to improving disease diagnosis and treatment outcomes in the future.

Xia Chaoran once pursued a Ph.D. in Engineering at Tsinghua University, focusing on the integration of medicine and engineering and its translation into practical applications; he also served as a visiting scholar at Harvard University and as an assistant researcher at the Chinese University of Hong Kong. Due to his insights into the pain points of the medical field and his value judgment of the medical track during his long-term cooperation with Tsinghua University and Peking Union Medical College Hospital, in 2018, Xia Chaoran decided to establish Sightnovo. With ophthalmology as the entry point and innovative medical devices as the main direction, the company moderately extends into pharmaceuticals. It translates and extends innovative technological achievements through three underlying technology platforms: testing and diagnosis, minimally invasive intervention, and drug-device combinations.

When talking about the future development of the ophthalmology market, Xia Chaoran said:"Ophthalmology is a highly innovative and valuable niche field, possessing the dual attributes of serious medical care and consumer-driven healthcare at the market level. Under the overarching principle of medical insurance cost control, it will enjoy long-term policy stability and market expansion potential. On the other hand, based on our assessment of resource advantages and understanding of the healthcare sector, we believe that precision medicine represents the future trend. Sightnovo aims to provide comprehensive, full-process precision medical products and decision-making services for ophthalmic patients, clinicians, and medical institutions. This is where the true opportunity and value lie."

With the aggravation of population aging and the increase in myopia rates, the incidence of common eye diseases such as wet age-related macular degeneration, diabetic macular edema, retinal vein occlusion, and choroidal neovascularization secondary to pathological myopia continues to grow. According to Frost & Sullivan statistics, the number of patients with four types of severe retinal diseases in China increased from 17.1 million in 2015 to 18.5 million in 2019, and is expected to reach 22 million by 2030.

Anti-VEGF drugs are the main treatment for the aforementioned diseases. In recent years, as anti-VEGF drugs have gradually been included in medical insurance lists of various countries, new opportunities for targeted drug development and emerging pharmaceutical companies have continued to arise. However, globally, there is almost a complete void in "companion diagnostics" specifically for ophthalmology.

Sightnovo Addresses the Clinical Pain Points of Blinding Fundus Vascular Diseases by Introducing the Concept of Companion Diagnostics to Fundus Disease Treatment. It has Developed a Companion Diagnostic System Based on Intravitreal Fluid Testing, Including the World’s First Precise Intravitreal Fluid Collection Device, In Vitro Diagnostic Reagents for Intravitreal Fluid, and Supporting Point-of-Care Testing Instruments.

To address the issue of poor tissue targeting in some fundus diseases with vitreous injections, Sightnovo has also developed a novel pressure-sensitive minimally invasive suprachoroidal drug delivery system. This is reported to be one of Sightnovo's key product pipelines, featuring a complete system of independent innovation technology and intellectual property rights. It has officially been granted patents in major countries around the world, including China, the United States, Germany, and Japan.

In addition, Sightnovo is also expanding its indications to include glaucoma, dry eye syndrome, allergic conjunctivitis, high myopia, and more, creating a precise diagnosis and treatment product pipeline covering a common disease spectrum. This includes in vitro diagnostic reagents, minimally invasive implantable devices, and more.

In clinical use, the disposable anterior chamber puncture device is an essential high-value consumable for precise targeted treatment in ophthalmology. It can be applied to precise anti-VEGF therapy, other targeted therapeutic drugs, immediate decompression of acute high intraocular pressure, acute angle-closure glaucoma, postoperative high intraocular pressure, and other difficult intraocular disease diagnoses such as endophthalmitis and intraocular tumors.

Anterior Chamber Paracentesis Product

The conclusion of the animal experiment report on the disposable anterior chamber puncture device developed by Sightnovo shows that the "puncture device" is significantly superior to the control group in terms of safety, convenience, and precision. The conclusion of the human trial report shows that the success rate of the experimental group using the "puncture device" for precise collection of aqueous humor during surgery was significantly higher than that of the control group. The operation process of the experimental group's device was simple and rapid, with better handling performance than the control group's device.

Currently, the product has completed the transformation of scientific and technological achievements as well as multi-center registration clinical trials, and is awaiting production.

Sightnovo has developed a novel pressure-sensitive suprachoroidal injection (SCS) system for suprachoroidal administration. This system provides a new approach for the treatment of fundus diseases and can be used for gene therapy, stem cell therapy, and more. Both its functions and structure are original designs, including an automatic dosage injection design capable of precisely injecting 0.1ml of medication; a micro-control precision injection design allowing micron-level displacement control to accurately reach the target ocular tissue; and a pre-filled drug/pencil-type design for convenient operation and use.

Product Schematic of Novel Pressure-Sensitive Suprachoroidal Injection System

Compared with intravitreal administration, SCS administration can increase tissue targeting of choroidal lesions; SCS injection of glucocorticoids improves efficacy without increasing the incidence of anterior segment side effects such as elevated intraocular pressure and cataracts; compared with existing products, the new injector has the advantages of fast, safe, and stable precise drug delivery.

Not only that, but the suprachoroidal injection technology extends as a platform-level technology, offering more possibilities for ophthalmology to pioneer minimally invasive interventional or implant treatments.

Most existing suprachoroidal intervention solutions require scleral incision for catheter insertion and subsequent suturing. The new suprachoroidal puncture device only requires injection of viscoelastic agents into the suprachoroidal space before catheter insertion, eliminating the need for scleral incision and suturing, greatly enhancing the level of minimal invasiveness, reducing surgical risks, and improving surgical safety. Sightnovo's technical solution enables precise targeted treatment for fundus diseases, including gene therapy, stem cell therapy, small-molecule chemical drugs, and biologics; precise localized radiotherapy for choroidal tumors; a novel suprachoroidal aqueous humor drainage device applicable to glaucoma treatment, as well as a new subconjunctival aqueous humor drainage device.

Speaking about the logic behind product development, Xia Chaoran said:"Any treatment process is a complementary medical system of diagnosis plus treatment. In fact, precision medicine can be roughly divided into four parts: one is the elucidation of pathogenesis; two is precise diagnostic methods; three is precise treatment methods; and four is precise disease course monitoring. From the explanation of pathogenesis to diagnosis, treatment, and monitoring, it is a systematic process."

The "companion diagnostics" + "innovative drugs/devices" services we currently provide are mainly carried out in accordance with the three parts of precision medicine: diagnosis, treatment, and monitoring. On this basis, corresponding support is also provided, such as offering better explanatory methods and related guidance services for pathogenic mechanisms associated with ophthalmology. It is a closed-loop and mutually integrated system.”

It is reported that the company has established cooperation with Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Tsinghua University, Peking University Health Science Center, Chinese Academy of Sciences, Academy of Military Medical Sciences, Peking University Medical Innovation Center, Youth Innovation Center for Health and Medicine, Zhongguancun Medical Engineering Transformation Center, and Zhongguancun Development Group. By deeply understanding clinical needs, they explore the possibilities of medical-engineering integration and clinical transformation, and continuously promote product implementation from academia, innovation, intellectual property, and incubation.

Currently, the company has received strong support and investment from well-known domestic investment institutions such as Tsinghua Hotang Venture Capital, Jiuyou Capital, and Zhong Development启航 Fund. The company has been awarded the China Medical Device Innovation and Entrepreneurship Conference Innovation Award, the third prize in the China Biomedical Innovation Achievement Transformation Project Competition; recognized as a Zhongguancun High-tech Enterprise; Haidian District Embryo Enterprise; Zhongguancun Golden Seed Enterprise; part of the Zhongguancun Eagle Talent Plan; and acknowledged as one of Beijing Haidian District's high-growth leading enterprises, among many other honors and titles.

Through Sightnovo, we can see that despite the high technical barriers in ophthalmology, emerging domestic brands are emerging and continuously filling the "domestic gaps" to meet market demands and even lead clinical innovation.

In the future, with the upgrading of consumption and the intensification of population aging, the demand in the ophthalmology field, which combines both medical and consumer attributes, will be even stronger. Enterprises based on the collaborative innovation model of integrating engineering with medicine and integrating pharmaceuticals with medicine will undoubtedly have continuous development momentum. They will further achieve systematic and sustainable output of innovative medical products, providing more possibilities for market development.