BELKIN Laser Files IPO Prospectus for Its One-Second Automated Glaucoma Treatment Platform

Glaucoma is a group of blinding eye diseases characterized by optic disc atrophy and cupping, visual field defects, and decreased visual acuity. With elevated intraocular pressure and optic nerve atrophy, glaucoma leads to irreversible blindness.Currently, glaucoma has become the second leading cause of blindness worldwide.。

According to WHO projections, the global number of primary glaucoma cases will reach 79.64 million in 2020, with 11.2% of patients progressing to blindness. In China, the total number of individuals with primary glaucoma is projected to reach 21.82 million, accounting for 27.4% of the global burden.。

Although blindness caused by glaucoma is irreversible, lowering intraocular pressure through appropriate therapeutic interventions can still control disease progression and delay visual field damage. Current treatment modalities for glaucoma include eye drops, oral intraocular pressure-lowering medications, laser therapy, and surgery.Pharmacotherapy is typically the primary treatment modality for glaucoma; however, it presents several challenges, including poor patient adherence, adverse effects, and high costs. Furthermore, medication availability remains a significant barrier to glaucoma treatment in resource-limited settings.。

According to BELKIN Laser statistics,MiddleChina accounts for 20% of the global glaucoma prevalence, with over 20 million patients, yet there are only 500 glaucoma specialists and 36,000 ophthalmologists.。The professional barriers established by current surgical and laser treatments mean that only a few experts can perform surgeries on patients. The imbalance between supply and demand highlights the gap in patients' treatment needs.。

On the other hand,Selective Laser Trabeculoplasty (SLT), while overcoming issues such as medication adherence and side effects in glaucoma treatment, requires traditional SLT devices to be operated by specialized glaucoma specialists using a gonioscope in contact with the cornea. This contact may pose potential risks of corneal abrasion and infection.. Meanwhile,SLT cannot be used to treat angle-closure glaucoma—“Asian” glaucoma has also become a major obstacle to the widespread adoption of this treatment.。

Is there a better solution?

From its establishment in 2013 to 2019, after six years of intensive product development,BELKIN Laser has developed the BELKIN Laser DSLT (Direct SLT), a fully automated one-second laser treatment device for glaucoma that requires only the press of a button to administer therapy. The DSLT not only reduces the learning curve for physicians in operating the equipment but also enhances operational efficiency in glaucoma treatment.。

The ease of use of DSLT enables more cataract surgeons, general ophthalmologists, and optometrists to provide glaucoma care to patients, eliminating the need for specialized techniques and skills required for traditional selective laser trabeculoplasty (SLT). Meanwhile, DSLT can simultaneously treat both angle-closure and open-angle glaucoma, thereby expanding the scope of laser therapy and addressing the aforementioned challenges in glaucoma treatment.。

To date, BELKIN Laser has secured Series B financing co-led by Rimonci Capital and Santen Ventures, Inc., with participation from BioLight Life Sciences, CR-CP Life Science Fund (China Resources Zhengda Life Science Fund), and C-Mer Eye Care Holdings. Among these investors, CR-CP Life Science Fund was the largest contributor in this round. BELKIN’s cumulative funding has reached $12.25 million, which will be used to support clinical trials in China and Europe.

After co-authoring an article on “The Interaction Between Laser Radiation and Human Tissue” with glaucoma specialist Dr. Mordechai Goldenfeld, Professor Belkin, Founder and Medical Director of BELKIN Laser, conceived the idea of developing a rapid and user-friendly laser treatment for glaucoma—marking the genesis of DSLT.

Michael Belkin, Founder and Medical Director of BELKIN Laser

Through the relentless exploration of the BELKIN Laser team, the DSLT, a one-second fully automated laser treatment device for glaucoma, was finally born, turning Professor Belkin’s initial concept into reality.

DSLT is extremely easy to use; simply pressing the operation button delivers a 120-nanosecond laser pulse to the limbus in approximately one second, avoiding direct contact with the patient’s eye. By irradiating the trabecular meshwork (TM), the ocular drainage area located at the back of the eye, DSLT enhances aqueous humor outflow, thereby lowering intraocular pressure and eliminating the primary risk factor for glaucoma.

DSLT Product Schematic Diagram

How Does DSLT Achieve Glaucoma Treatment Within One Second? Daria Lemann-Blumenthal Tells VCBeat That BELKIN Laser Possesses Unique, Differentiated Technology.DSLT’s complex image acquisition technology and ocular algorithm tracking technology empower the automated recognition system to achieve precise localization of the treatment area in glaucoma patients. By automatically detecting eye movements, the system performs real-time correction of the treatment area, thereby enhancing treatment precision.。

In 2014,BELKIN Laser completed the proof-of-concept study over a six-month period with 28 patients, and published the findings in the Israeli Journal of Glaucoma.This trial divided patients into two groups, with the study group undergoing gonioscopy-free procedures using the BELKIN method, and the control group undergoing gonioscopy via the conventional internal SLT approach.The results showed that traditional SLT therapy had the same efficacy as DSLT, but DSLT caused fewer side effects. Meanwhile, after one year of follow-up, there was no significant difference in the reduction of intraocular pressure between SLT and DSLT.。

Clinical Validation-Related Data

In 2019, BELKIN Laser conducted the GLAUrious multicenter randomized controlled clinical trial under the support of the European Commission’s Horizon 2020 program to evaluate the non-inferiority of DSLT compared to SLT.Studies have shown that DSLT is safer and more effective, and can lower intraocular pressure in patients with primary open-angle glaucoma.。

Through multi-dimensional horizontal comparison, it is not difficult to find thatCompared to traditional treatment methods, BELKIN’s solution offers distinct advantages. It is applicable to all types of glaucoma, overcomes compliance issues, and can be used as a first-line therapy. The ease of operation of the BELKIN system breaks down professional barriers in glaucoma treatment, empowering more physicians to manage glaucoma patients. Technologically, BELKIN’s solution prevents intraocular pressure fluctuations from damaging the cornea, ocular surface, or anterior segment structures, and does not cause blurred vision post-treatment.。

A Multidimensional Comparison of the Advantages and Disadvantages of Glaucoma Treatment Modalities

It should be noted that,A clinical trial, the LiGHT trial, was recently published in The Lancet. The trial data demonstrated the safety and efficacy of selective laser trabeculoplasty. Parameter comparisons indicated that laser therapy is superior to eye drops in the treatment of glaucoma.agent therapy.

Following the completion of proof-of-concept and first-in-human trials in Israel, BELKIN Laser is currently conducting the GLAUrious multicenter randomized controlled clinical trial in Europe and Israel, with completion expected in early 2022. BELKIN Laser is also set to obtain commercial approval in Europe and the United States in 2021 and 2022, respectively, and its DSLT commercial device is anticipated to launch in 2022.

BELKIN Laser, an innovative non-contact external laser therapy for glaucoma, has filed for patent protection in various countries and with international patent organizations. Meanwhile, the method for automatic laser positioning and ocular delivery has been granted patents in China and other countries. Currently, BELKIN Laser has submitted additional patent applications.。

In fact, Daria Lemann-Blumenthal, CEO of BELKIN Laser, has had a lifelong connection with the company. Her father, Professor Michael Blumenthal, served as a mentor to Professor Belkin for many years. It was her father’s influence on her in ophthalmic research, combined with Professor Belkin’s passion for the field, that ultimately brought them together again.

Prior to joining BELKIN Laser,Daria Lemann-Blumenthal served as CEO of Ein-Tal, Israel’s largest private hospital, for six years.Meanwhile, Daria Lemann-Blumenthal holds a Bachelor of Laws degree, earned her Ph.D. from the Hebrew University of Jerusalem, and obtained an Executive MBA from Tel Aviv University.

These experiences not only equipped Daria Lemann-Blumenthal with extensive expertise in management, business development, project management, and team leadership, but also endowed her with a more forward-looking perspective. Daria Lemann-Blumenthal told VCBeat that when Rad Biomed Accelerator approached her to gauge her interest in leading a new company, she was drawn to BELKIN Laser due to its potential to restore vision for millions of people, and decisively chose to join the company.

BELKIN Laser CEO Daria Lemann-Blumenthal

Professor Belkin, Founder and Medical Director of BELKIN Laser, has established deep roots in ophthalmic research, helping BELKIN Laser build a robust professional barrier.Professor Belkin is an internationally renowned scientist and entrepreneur, and the inventor of the ExPRESS Glaucoma Shunt and Optonol.

In the realm of academic research, Professor Belkin serves as Professor Emeritus of Ophthalmology at Tel Aviv University. In 2004, he established the Institute of Ophthalmology at Tel Aviv University and leads the Ophthalmic Technology Laboratory at the Sheba Medical Center. Additionally, Professor Belkin holds a Master of Science degree from the University of Cambridge and a Doctor of Medicine degree from the Hebrew University of Jerusalem.。

BELKIN Laser boasts a team of talented executives and engineers, each with 20 years of expertise in their respective fields, under the leadership of Chief Operating Officer Eli Makdasi, who brings 20 years of experience in the medical device industry.BELKIN Laser adopts a classic corporate startup structure, characterized by efficient internal communication and a strong emphasis on inter-team collaboration.

BELKIN Laser Team

“Our advisory team shares any ideas that emerge during the R&D process,” said Daria Lemann-Blumenthal. A culture of open and collaborative communication is a key factor enabling the BELKIN Laser team to continually achieve breakthroughs in product development.

Daria Lemann-Blumenthal told VCBeat that Dr. Zachary Sacks, IP Manager at BELKIN Laser, is highly skilled at transforming innovative ideas from the team into patents.

From the first application of lasers in ophthalmology to lower intraocular pressure in the 1970s, to the FDA’s initial approval of Selective Laser Trabeculoplasty (SLT) in 2001 and its rapid adoption by clinicians, the efficacy of laser therapy in glaucoma management has been continuously validated. With the passage of time, this technology has become increasingly mature.

In the future, as population aging intensifies, the prevalence of glaucoma and associated treatment costs will continue to rise. Whether traditional technologies can meet this challenge has become a critical issue warranting in-depth consideration in the field of glaucoma treatment.It is worth mentioning that,Both academia and industry are conducting innovative research and trials on glaucoma treatment technologies, aiming to disrupt the current treatment paradigm and gradually conquer the extremely complex challenges in glaucoma management.The glaucoma market is poised for significant future growth, and BELKIN Laser’s innovative breakthroughs in glaucoma treatment offer valuable insights and reference points.