STACLEAR is The First Fillable Syringe FDA-Cleared For Intravitreal Use
WHY INVENT AN INTRAVITREAL SYRINGE?
Floaters In The Eye Reported
The Industry Responded
Insurance companies started requiring that retina specialists have their patients sign a liability waiver before the procedure in view of this new liability risk.
The FDA Takes Steps To Ensure Patient Safety
In 2018, the Food & Drug Administration (FDA) issued new, more stringent guidelines around compounding drugs for intraocular injections, adding regulatory risk.
TriboFilm Research Was Invited to Engineer a Better Syringe:
One that meets the Food & Drug Administration's strict particulate standards for intraocular medical devices.
After 3 Years of Research & Development,
We Achieved That Goal.
Why Stop at One Problem, When We Can Fix Them All?
Our team worked closely with ophthalmologists and compounding pharmacies to understand ALL their requirements:
"Improve dose accuracy with a smoother plunger movement."
"Make the markings large and easy-to-read."
"Reduce the need for priming to remove air bubbles."
"Remove dead space so we can reduce drug wastage."
"Extend the plunger cap to make it easier and safer to ship."
"Comply with FDA Guidance for 503B Facilities."
StaClear is the Result of Collaborative Design Thinking
How is StaCear Superior to Generic Syringes?
100X FEWER PARTICLES THAN GENERIC SYRINGES
Coating is anchored to the walls of the syringe versus liquid silicone oil in generic syringes.
A MORE CONTROLLED INJECTION EXPERIENCE
Elastomer piston ensures sealing integrity -- a risk in silicone-free syringes.
EASY-TO-READ GRADUATION MARKS
This enables precision dosing (0.25ml syringe with 0.01ml graduations) vs. generic options.
A ZERO DEAD SPACE SYRINGE DESIGN
Compare StaClear with syringes that require $10-15 of drug wastage due to dead space.
STACLEAR COMES READY-TO-USE!
Simply remove the tip cap and inject. No extra preparation steps -- saving valuable time.
ATTACHED NEEDLE - NO ASSEMBLY REQUIRED
This also reduces the need for overfill. A Luer Slip StaClear syringe has launched.
EXTENDED CAP
Protects the retracted plunger from accidental bumps during shipping.
OPHTHALMIC-SAFE MATERIALS
Meets chemical and biocompatibility standards for ophthalmic use.
Coming Soon!
StaClear 0.25 mL
LUER SLIP Syringe
Minimal dead space to reduce drug wastage.
The TriboFilm Research Team is Excited to Launch StaClear.
After years of R&D and a rigorous FDA process, it is gratifying to see significant market interest for StaClear, and receive positive client feedback.
Vinay Sakhrani
VP of Technology at TriboFilm Research & Co-Inventor
We have helped many medical device & pharma companies solve difficult lubricant challenges, but the StaClear product is my absolute favorite.
Jackson Thornton
Director of Technology at TriboFilm Research & Co-Inventor, StaClear
TriboFilm strives to earn customer satisfaction by consistently supplying safe, reliable, defect-free products that meet or exceed customer and regulatory requirements. To this end, we have established and are committed to the continual improvement of our Quality Management System, which is based on the requirements of 21 CFR Part 820 and ISO 13485:2016.
Dan Jonsen
Principal Scientist & Quality System Manager
One of my mentors receives an intravitreal injection once a month for wet AMD. Bringing this syringe to market is personally important to me.
Neesha Mirchandini
Director of Communications at TriboFilm Research
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This Research Was Funded by National Eye Institute.
