Sightnovo Files IPO Prospectus: Disruptive Products Drive Integrated Precision Diagnosis and Treatment in Ophthalmology

At the 2022 China International Fair for Trade in Services (CIFTIS), a pair of delicate instruments resembling syringes caught the attention of attendees.

"Accurate quantitative collection of trace anterior chamber fluid in the eye, and precise suprachoroidal injection through a scleral thickness of only about one millimeter..." According to reports, these two products are respectively named"Disposable Anterior Chamber Puncture Device"And"Resistance-Sensing Suprachoroidal Injection Device"The ophthalmic medical device is an innovative technological medical product brought by Sightnovo (hereinafter referred to as "Sightnovo") in collaboration with Peking Union Medical College Hospital.Is expected to provide new possibilities for precise ophthalmic diagnosis and treatment in the new era.

Among them, the "Disposable Anterior Chamber Puncture Device" is mainly used for puncture and drainage of aqueous humor in the anterior chamber of the eye and for aqueous humor collection.It is an essential consumable for achieving precise intraocular targeted therapy based on the detection of aqueous humor biomarkers.

"Resistance-sensing suprachoroidal injection device" is used for suprachoroidal drug delivery.Internationally, it has achieved micro-level precise positioning and visual recognition operations targeting the suprachoroidal space for the first time.Provides a safer and minimally invasive option for precise drug delivery and minimally invasive interventional treatment via the suprachoroidal pathway.

Sightnovo Products on Display at the 2022 China International Fair for Trade in Services

In the view of Xia Chaoran, founder of Sightnovo,Based on the aforementioned innovative devices, a comprehensive diagnostic and treatment system for fundus diseases can be developed, through"Companion Diagnostics, Implantable Therapeutic Devices, Drug-Device Combinations"and other methods to achieve, and evenCan pioneer some entirely new treatment methods.

"For example, the company is currently in the research and development stage of a minimally invasive external (ab externo) suprachoroidal shunt system for glaucoma treatment that does not require scleral incision or suturing."It is a brand-new MIGS procedure,Drug Delivery Systems for Gene Therapy and Localized Treatment of Intraocular Tumors via Minimally Invasive Suprachoroidal CatheterizationIt is also the world's first surgical procedure."Highly likely to profoundly transform and optimize existing clinical treatment protocols."

In fact, since its establishment, Sightnovo hasPeking Union Medical College Hospital, Tsinghua University, Chinese Academy of Medical Sciences, Chinese Academy of Sciences, etc.The institution has established in-depth cooperation and long-term contact, focusing on combining self-developed and original medical achievements to address unmet clinical needs. Currently, the company is building its capabilities around clinical specialties such as ophthalmology, particularly in retinal diseases.An integrated solution from diagnosis to treatment and monitoring,Providing comprehensive, full-process medical decision support and services for ophthalmic patients and doctors.

01

Disruptive Products Solve Clinical Challenges

The eyeball is one of the organs with the highest water content in the human body. The cavity inside the eyeball, also known as the vitreous body, is a liquid cavity system. Based on this anatomical feature of the human eyeball,Traditional treatment methods often involve injecting the drug solution directly into the vitreous body,Rely on the free flow of "water" to achieve drug diffusion.

This method of administration, although simple,There are issues such as poor tissue targeting, drug clearance through aqueous humor drainage, and short half-life.Therefore, in clinical practice, frequent drug administration is usually required to achieve the purpose of maintaining efficacy, which not only demands substantial medical resources but also increases potential risks such as intraocular infection and puncture injury. More critically,Intravitreal injection of glucocorticoid drugs can also easily lead to complications such as glaucoma and cataracts.

In response to the aforementioned issues, a treatment method involving suprachoroidal injection has emerged.

The so-called suprachoroidal space (SCS) refers to the potential space between the choroid and the sclera. Injection into the SCS,Can deliver drugs more precisely to the key tissues (retina and choroid) where the disease occurs.While enhancing therapeutic efficacy, it avoids the occurrence of anterior segment side effects such as increased intraocular pressure and cataracts caused by the clearance of glucocorticoid drugs through aqueous humor drainage.

However, the reason why suprachoroidal injection has not been widely adopted lies inThe thickness of the sclera is generally about one millimeter.How to precisely puncture this one-millimeter dense tissue without damaging the underlying choroid and retina, which are only a few tenths of a millimeter thick, has been a long-standing challenge.

This time, the "Resistance-sensing Suprachoroidal Injection Device" displayed by Sightnovo at the China International Fair for Trade in Services has overcome this industry challenge.

It is reported that the above products canAchieve precise positioning, safe, and quantitative suprachoroidal injection.Specifically, while achieving precise suprachoroidal space (SCS) puncture positioning, the device can also open the potential SCS by injecting liquid or viscoelastic agents. The drug can then diffuse throughout the entire SCS and penetrate the retina through the choroid.To achieve a treatment method with better tissue targeting and fewer side effects,Enhance safety and efficacy.

Sightnovo Resistance-Sensing Suprachoroidal Injection Device

Not only that, but the suprachoroidal injection system is also a highly extensible platform-level technology.Provides more possibilities for ophthalmology to develop minimally invasive implantation and interventional treatments based on this cavity system.

According to Xia Chaoran, most of the existing suprachoroidal intervention solutions require scleral incision for catheter insertion.Suturing is required after the procedure.Sightnovo's new suprachoroidal puncture device only requires injecting viscoelastic agents into the suprachoroidal space before inserting a microcatheter as thin as a hair.Without scleral incision and suturing,Can greatly improve the minimally invasive level, reduce surgical risks, and increase surgical safety.

Specifically AchievableIncluding precise targeted treatments for fundus diseases such as gene therapy, stem cell therapy, small-molecule chemical drugs, and biologics; precise localization and local targeted therapy for choroidal tumors; and the development of novel suprachoroidal aqueous humor drainage devices and subconjunctival aqueous humor drainage devices for glaucoma treatment.

More notably, this innovative principle of precise positioning and punctureIt is also expected to be promoted and applied in precise puncture and clinical surgery scenarios in other parts of the human body, bringing about a disruptive transformation.

For example, in painless childbirth, this technology can be used to more accurately and safely inject anesthetics into the epidural space of the lumbar vertebrae, blocking spinal nerve roots and reducing the risks caused by imprecise drug delivery during labor. This is particularly promising in China, where there is a relative shortage of anesthesiologists, through...Reduce the operational difficulty of epidural anesthesia and improve safety,Promote the Popularization of Painless Childbirth.

02

Hardware and Software Integration to Create a "Precision Medicine" Closed Loop

If the "Suprachoroidal Injection Device" is Sightnovo's disruptive achievement in the field of ocular drug injection therapy, then the "Disposable Anterior Chamber Puncture Device" showcased at the same time at the CIFTIS exhibitionAn important tool for achieving precise diagnosis of ophthalmic diseases.

Aqueous SamplingIt is a precondition and foundation for the precise diagnosis of numerous eye diseases, but currently, there is a lack of dedicated aqueous humor sampling devices and standardized procedures in clinical settings, facing challenges such as the need for special environments for sampling.There are potential risks of infection, puncture injuries, and legal issues.

As the world's first intraocular fluid collection device, Sightnovo's "Disposable Anterior Chamber Puncture Device" utilizes core technologies such as precise negative pressure control.Achieved precise quantitative collection and drainage of micro-anterior chamber fluid in the eye with one-hand operation.The procedure can be performed in general settings such as outpatient clinics or treatment rooms, and it reduces the risks of infection and puncture injuries.

Human trial data show that, compared with the method of using traditional syringes to extract aqueous humor from the anterior chamber of the eye, the experimental group using the "trocar" for precise intraoperative collection of aqueous humor has a higher volume of collected aqueous humor.More precise, controllable, and with a better operational experience,Can be widely applied to the efficacy prediction of precise anti-VEGF treatment, immediate decompression of acute high intraocular pressure, as well as the diagnosis and treatment monitoring of complex intraocular diseases such as endophthalmitis and lymphoma.

As early as January 2020, the disposable anterior chamber puncture device entered the special approval process for Class II innovative medical devices in Zhejiang Province.In August this year, the product has been successfully approved for marketing in Zhejiang Province through the registrant system.

Sightnovo Disposable Anterior Chamber Puncture Device

It is worth mentioning that, from the perspective of intraocular fluid testing, SightnovoIndependently developed aqueous humor test kits and matching detection instruments.With a series of products, patientsThe entire process from aqueous humor sampling to obtaining test results is expected to be completed within half a day.Enables POCT (Point-of-Care Testing) based on aqueous humor. Combined with rapidly advancing ophthalmic imaging examination methods,It is expected to establish a more precise and refined new diagnostic system based on multi-dimensional disease markers.

“Achieved 'China-produced substitution' to avoid the 'stranglehold' issue, while also being highly disruptive."Zhao Chan, Assistant to the Director of Ophthalmology and Associate Chief Physician at Peking Union Medical College Hospital, commented on the 'Disposable Anterior Chamber Puncture Device' and 'Resistance-Sensing Suprachoroidal Injection Device,' stating, 'This disruptive innovation not only represents our mastery of the latest and most advanced technologies and products…'"This also means that we are expected to lead the development direction of certain fields in ophthalmology internationally, achieving a shift from technology introduction to technology export.These innovative works are in line with China's "Four Orientations" science and technology development strategy.

According to Xia Chaoran, besides hardware facilities, Sightnovo alsoIndependently built the data detection system Smart QC,Achieve real-time automatic upload of diagnosis and treatment data throughout the year with information security guarantees to assist in mutual recognition of medical insurance cost control results.

Under this system, the results of multiple treatments for patients, as well as the results of cross-hospital treatmentsAll can achieve organic interaction.The hospital's daily internal quality assessment and results can be compared inter-institutionally with other hospitals' data after desensitization, achieving externalization of internal quality control, enhancing the department's quality control level, and also helping to provide patients with more precise and dynamic full-cycle treatment plans.

"In the ophthalmology industry, the integration of diagnosis and treatment is a precondition for the realization of precision medicine, and Sightnovo's strategic focus is on'Companion Diagnostics + Drug-Device Combination'"Summer stated, 'Sightnovo is expected to achieve a breakthrough first, providing patients with more precise diagnosis and treatment plans.'"

In Zhao Chan's view,Precision medicine can be roughly divided into four parts:First, the elucidation of pathogenesis; second, precise diagnostic methods; third, precise treatment methods; fourth, precise disease progression monitoring. Correspondingly, Sightnovo has achieved an integrated closed-loop of "precision medicine" from accurate diagnosis, to precise treatment, and then to precise disease monitoring in the fields of biopsy sampling, point-of-care testing, and injectable drug delivery.