MikroElena Ophthalmic Surgical Robot
MikroElena represents Dessight Biomedical’s flagship ophthalmic surgical robot, achieving 3-micron motion precision to enable procedures beyond human physiological capabilities. The system completed Asia’s first robot-assisted retinal surgery in July 2023 and became the first ophthalmic robot in China to enter NMPA’s Innovative Medical Device pathway in March 2025.
Product Overview
Developed to address fundamental limitations in vitreoretinal surgery, MikroElena compensates for natural human hand tremor (approximately 100 microns) while enabling precise manipulation within anatomical structures measuring as small as 100-200 microns.
The system targets the substantial unmet need in ophthalmic surgery, where retinal specialists face challenges including limited depth perception, surgeon fatigue during prolonged procedures, and the technical barriers preventing many ophthalmologists from performing complex vitreoretinal interventions.
Key Features
3-Micron Motion Precision: The system filters physiological tremor and amplifies surgeon movements at approximately 30x finer resolution than unaided manual control, enabling access to previously untreatable anatomical targets.
Master-Slave Control Architecture: Surgeons operate through an intuitive control interface while the robotic system executes scaled, tremor-filtered movements at the surgical site.
Flexible Mechanism Design: Proprietary flexible structural elements and miniaturized instruments enable stable operation within the confined intraocular space.
100-Micron Microneedle Capability: The system accommodates hair-thin needles for subretinal injection procedures, including gene therapy and cell therapy delivery applications.
Technical Specifications
MikroElena achieves 3-micron motion precision with 100-micron needle compatibility, enabling subretinal injection success rates that improve from 85.5% to 100% versus unassisted manual technique.
| Parameter | Specification |
|---|---|
| Motion Precision | 3 microns |
| Needle Compatibility | 100 microns outer diameter |
| Control Method | Master-slave teleoperation |
| Target Anatomy | Retina, vitreous, subretinal space |
Clinical Applications
MikroElena addresses conditions affecting over 40 million patients in China with fundus diseases, with 300,000 new cases annually. Key applications include:
Macular Surgery: The macular region measures 1.5mm diameter and 200 microns thickness, containing 80% of visual information processing cells. This “forbidden zone” of ophthalmology requires precision exceeding manual surgical capabilities.
Subretinal Injection: Clinical data demonstrates improvement in subretinal injection success rates from 85.5% to 100% with robotic assistance. This capability is critical for emerging gene therapy and cell therapy applications requiring precise subretinal delivery.
Retinal Vein Procedures: Fundus blood vessels measure approximately 100 microns in diameter, making cannulation extremely challenging for unassisted manual procedures.
Membrane Peeling: The system provides stable, controlled movements for delicate membrane dissection procedures.
Regulatory Status
| Region | Status | Date |
|---|---|---|
| China (NMPA) | Innovative Medical Device Pathway | 2025-03 |
| Europe (CE) | Not Applied | - |
| United States (FDA) | Not Applied | - |
MikroElena entered NMPA’s Innovative Medical Device Special Review “Green Channel” in March 2025, becoming the first ophthalmic surgical robot in China to achieve this designation. The company is conducting multi-center registration clinical trials to support commercial approval.
Clinical Validation
Asia’s First Robot-Assisted Retinal Surgery (July 2023): Performed at Zhejiang Provincial People’s Hospital, the procedure involved subretinal injection of 400 microliters of thrombolytic medication using a 100-micron diameter microneedle. The surgery was completed in approximately three minutes with successful drug delivery to the targeted subretinal location.
Multi-Center Clinical Trials: MikroElena became the first ophthalmic robot in China to enter multi-center registration clinical trials, with multiple procedures completed across leading hospitals demonstrating consistent safety and efficacy outcomes.
Frequently Asked Questions
What procedures can MikroElena perform?
MikroElena assists vitreoretinal surgeries including macular membrane peeling, subretinal injection, and retinal vein procedures. The system is particularly suited for surgeries requiring precision below 100 microns, where natural hand tremor limits manual technique.
How does MikroElena compare to manual surgery?
Clinical data shows MikroElena improves subretinal injection success rates from approximately 85% to 100%. The system enables procedures on anatomical structures previously considered inaccessible due to size constraints, potentially expanding treatable conditions and improving outcomes.
When will MikroElena be commercially available?
As of early 2026, MikroElena is in registration clinical trials following entry into NMPA’s innovative device pathway. The expedited review process suggests potential commercial approval in the near term, though specific timing depends on clinical trial completion and regulatory review.
Can MikroElena be used for gene therapy delivery?
Yes. Subretinal injection capability makes MikroElena suitable for delivering gene therapy and cell therapy products that require precise placement beneath the retina. The system’s precision addresses a key bottleneck in translating emerging retinal therapeutics to clinical practice.
Sources
Publicly available references used for the data on this page. See data methodology for verification standards.