Periodic Reporting for period 1 - EyeAccess (Direct Selective Laser Trabeculoplasty (DSLT): Accessible glaucoma care in seconds)
Berichtszeitraum: 2022-01-01 bis 2022-12-31
Our DSLT technology offers a unique innovation for glaucoma and OHT patients, providing groundbreaking advantages with the potential to revolutionize first-line glaucoma care as it’s automated, intuitive, simple, extremely fast, and non-contact – both doctor and patient-friendly. This disruptive technology doesn’t require expertise or skill, involves simply pressing a button and delivering the treatment in seconds. Our practical solution will overcome growing demand and poor supply by enabling any ophthalmologist, optometrist, and in the future, any eye care provider to treat many more patients. DSLT will broaden the scope of accessibility for both doctors and patients. Doctors who previously could not treat due to their level of specialization or patients who couldn’t be adequately treated with available options will now have a viable solution.
Our main objectives are:
1. To build a commercially viable, high-quality product.
Based on the doctor’s (users) recommendations obtained through the clinical studies, we will improve Eagle’s functionality. To increase profit margin, we will reduce the product’s COGS by developing advanced production and automatic testing tools and by an ongoing process of lowering the cost of the various components, namely the critical ones.
2. To map the commercial activities required for establishing the commercial value chain. In addition, to manage the marketing activities planned before and throughout the initial phase of the controlled launch of the Eagle device in EU. We must ensure that the company is fully prepared for the controlled launch, planned in 10 ophthalmic centers, led by key opinion leaders (KOL). Consequently, establish initial centers of excellence prior to the first year of launch in 2023.
3. To manage the project innovation activities, including team management, investors, and shareholders relationship, communicating and dissemination activities to the public, and patients, and IPR
management.
4. To obtain high-quality clinical data to prove the safety and efficacy of Eagle towards regulatory approvals and marketing acceptance in various countries.
5. To obtain regulatory approvals that are mandatory before the device selling initiation in these markets after the initial launch in Europe towards geographical scale-up.
Our main objectives are:
1. To build a commercially viable, high-quality product.
Based on the doctor’s (users) recommendations obtained through the clinical studies, we will improve Eagle’s functionality. To increase profit margin, we will reduce the product’s COGS by developing advanced production and automatic testing tools and by an ongoing process of lowering the cost of the various components, namely the critical ones.
2. To map the commercial activities required for establishing the commercial value chain. In addition, to manage the marketing activities planned before and throughout the initial phase of the controlled launch of the Eagle device in EU. We must ensure that the company is fully prepared for the controlled launch, planned in 10 ophthalmic centers, led by key opinion leaders (KOL). Consequently, establish initial centers of excellence prior to the first year of launch in 2023.
3. To manage the project innovation activities, including team management, investors, and shareholders relationship, communicating and dissemination activities to the public, and patients, and IPR
management.
4. To obtain high-quality clinical data to prove the safety and efficacy of Eagle towards regulatory approvals and marketing acceptance in various countries.
5. To obtain regulatory approvals that are mandatory before the device selling initiation in these markets after the initial launch in Europe towards geographical scale-up.
From January 2022 to December 2022, BELKIN vision continued to work on Five Work Packages for which the specific objectives are reported below:
WP1: concentrate on building a commercially viable, high-quality product.
We worked on improving Eagle’s functionality, reducing the product’s COGS by developing advanced production and automatic testing tools and by an ongoing process of lowering the cost of the various components, namely the critical ones.
WP4: In this WP we aimed to obtain high-quality clinical data to prove the safety and efficacy of Eagle towards regulatory approvals and marketing acceptance in various countries. The clinical data from our First-in-Human trial has been published earlier this year. The European GLAUrious (which was ended), Will provide solid clinical evidence of Eagle's performance which is ultimately required for the device’s regulatory approvals and commercialization. Agility PMCF was initiated and the Zhuiguang trials is due to start in 2023.
WP5: Obtaining the CE marking in May 2022, which enabled our first commercial sale in Germany. Its maintenance will be continued. Submission to the FDA was postponed to January 2023 and NMPA green path is underway.
WP1: concentrate on building a commercially viable, high-quality product.
We worked on improving Eagle’s functionality, reducing the product’s COGS by developing advanced production and automatic testing tools and by an ongoing process of lowering the cost of the various components, namely the critical ones.
WP4: In this WP we aimed to obtain high-quality clinical data to prove the safety and efficacy of Eagle towards regulatory approvals and marketing acceptance in various countries. The clinical data from our First-in-Human trial has been published earlier this year. The European GLAUrious (which was ended), Will provide solid clinical evidence of Eagle's performance which is ultimately required for the device’s regulatory approvals and commercialization. Agility PMCF was initiated and the Zhuiguang trials is due to start in 2023.
WP5: Obtaining the CE marking in May 2022, which enabled our first commercial sale in Germany. Its maintenance will be continued. Submission to the FDA was postponed to January 2023 and NMPA green path is underway.
WP2: Map the commercial activities required for establishing the commercial value chain. In addition, managed the marketing activities before and throughout the initial phase of the controlled launch of the Eagle device in the EU. We have ensured that the company is fully prepared for the controlled launch. Worked on the establishment and identification of initial centers of excellence prior to the first year of launch in 2023.
WP3: Managed the project innovation activities, including team management, investors, and shareholders relationship, communicating and dissemination activities to the public, and patients, and IPR management.
WP3: Managed the project innovation activities, including team management, investors, and shareholders relationship, communicating and dissemination activities to the public, and patients, and IPR management.