![gyroscope system gyroscope system](http://www.pics4all.jeppix.eu/public/downloads/AN/AN_Optical_Gyroscope_Systems.png)
![gyroscope system gyroscope system](https://i.pinimg.com/originals/77/34/cc/7734cc71cb802e82a7a17538fa8158ff.png)
The clearance authorises the company to market and sell the Orbit SDS in the United States. A microneedle inside the cannula is advanced into the subretinal space to enable targeted dose delivery. This specially designed system enables cannulation of the suprachoroidal space with a flexible cannula. The Orbit SDS accesses the subretinal space via a suprachoroidal approach. The Orbit SDS is capable of delivering a controlled volume to a targeted subretinal delivery site. The pitch and roll rotary position sensors are mounted along two orthogonal gimbals. The FDA clearance of the Orbit SDS is an important component in advancing towards this goal.” The sensors for pitch and roll are part of a gyroscope system having a vertical spin axis. “Our mission is to develop gene therapies and delivery systems to help preserve sight and fight the devastating impact of blindness. “The Orbit SDS is exquisitely designed to target the subretinal space, with the aim of providing precise and consistent dosing,” said Khurem Farooq, Chief Executive Officer. This clearance is based on injection of Balanced Salt Solution (BSS) or BSS PLUS. The approach also eliminates the need to create a retinotomy (a hole in the retina) in order to access the subretinal space. The microinjection procedure is designed to avoid damaging the structure of the eye by preventing the need for a vitrectomy, a procedure that involves removing the vitreous (the gel-like substance that fills the eye). The Orbit SDS is indicated for microinjection into the subretinal space at the back of the eye. Our ultimate goal for our patients is Vision For Life. Food & Drug Administration (FDA) has granted 510(k) clearance for the Orbit Subretinal Delivery System (Orbit SDS). We are discovering and developing innovative medicines to preserve people’s sight and fight the devastating impact of blindness around the world. Gyroscope Therapeutics, a clinical-stage retinal gene therapy company, today announced that the U.S. GT005 is delivered to patients in Cohorts 1 to 4 using the standard transvitreal procedure and in Cohorts 5 to 7 using Gyroscope’s proprietary Orbit TM subretinal delivery system. Gyroscope Therapeutics announces FDA Clearance for Orbit Subretinal Delivery System. The microinjection procedure is designed to avoid damaging the structure of the eye by preventing the need for a vitrectomy