Orbit Subretinal Delivery System Receives FDA Clearance: Indicated for Microinjection into the Subretinal Space at the Back of the Eye

Orbit Subretinal Delivery System has received FDA Clearance. The news was announced today by Gyroscope Therapeutics.

Orbit Subretinal Delivery System is indicated for microinjection into the subretinal space at the back of the eye. 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 approach also eliminates the need to create a retinotomy (a hole in the retina) in order to access the subretinal space. This clearance is based on injection of Balanced Salt Solution (BSS) or BSS PLUS®.*

“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. “Our mission is to develop gene therapies and delivery systems to help preserve sight and fight the devastating impact of blindness. The FDA clearance of the Orbit SDS is an important component in advancing towards this goal.”

The Orbit SDS is capable of delivering a controlled volume to a targeted subretinal delivery site. The Orbit SDS accesses the subretinal space via a suprachoroidal approach. This specially designed system enables cannulation of the suprachoroidal space with a flexible cannula. A microneedle inside the cannula is advanced into the subretinal space to enable targeted dose delivery.

The clearance authorizes the company to market and sell the Orbit SDS in the United States. In addition to developing the Orbit SDS for its own investigational medicines, Gyroscope plans to enter into licensing and collaboration arrangements involving the Orbit SDS with other companies who are developing gene and cell therapies to treat eye disease.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides our readership with breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

The ArthroFree system is the first FDA-cleared wireless camera for arthroscopy and general endoscopy, both areas of minimally invasive surgery. The system is designed to help surgeons work with aximum dexterity and focus.
The project, which was led by the University of Southern California, included large increases in representation among men of African, Hispanic and Asian ancestries, that were contributed in part by an ongoing collaboration between the U.S. Department of Veterans Affairs and DOE reports Argonne.
This innovative software turns smartphones into medical-grade stethoscopes, allowing people to capture, analyze, and share critical heart health data with medical personnel from the comfort of any location notes Sparrow BioAcoustics.
"Taewoong Medical becoming an Olympus group company is also a major milestone in our global growth strategy," said Henry Shin, CEO of STARmed. "We look forward to our products being made available to more patients through Olympus' global distribution network."
The company reports they have successfully met the six-month primary endpoint for the first-ever female patient implanted with the UroActive™ System, the first smart automated artificial urinary sphincter (AUS) to treat SUI.

By using this website you agree to accept Medical Device News Magazine Privacy Policy