Nova Eye Medical Limited (ASX: EYE) (Nova Eye Medical or the
Company), a medical technology company committed to advanced
ophthalmic treatment technologies and devices, today announces that
it has been granted U.S. Food and Drug Administration (FDA) 510(k)
clearance for its new canaloplasty device, iTrack™ Advance.
The iTrack™ Advance has been cleared for microcatheterization
and viscodilation to reduce intraocular pressure (IOP) in adult
patients with primary open-angle glaucoma.
First introduced into the U.S. market in 2008, canaloplasty is a
stent-free, minimally invasive glaucoma surgery (MIGS) that works
with patient physiology to reduce intraocular pressure in glaucoma
patients. Specifically, canaloplasty uses an approach akin to
angioplasty to treat blockages in all parts of the eye’s drainage
channel, referred to as the conventional outflow pathway –
trabecular meshwork, Schlemm’s canal and collector channels – to
improve the physiologic outflow of aqueous humor. This is in
contrast to other MIGS procedures, which mechanically alter the
outflow of aqueous humor via a stent or tissue removal.
Canaloplasty was first brought to the ophthalmological fore in
2008, following the release of the Company’s original iTrack™
canaloplasty microcatheter, which has been used in more than
120,000 canaloplasty procedures globally.
The iTrack™ Advance leverages the same proprietary features of
the Company’s original iTrack™, including a 200-micron illuminated
canaloplasty microcatheter, but has been designed for improved
surgical efficiency. A key feature of the iTrack™ Advance is an
ergonomic handpiece.
The Company is grateful for the continued collaboration with a
multi-disciplinary group of surgeons, academics, and industry
partners, which has underpinned the development of the iTrack™
Advance. In particular, the Company was fortunate to benefit from
the expertise of prominent canaloplasty surgeon Dr. Mahmoud A.
Khaimi, Clinical Professor, James P. Luton, MD Endowed Chair in
Ophthalmology at Dean McGee Eye Institute, University of
Oklahoma.
Dr. Khaimi was today the first surgeon in the USA to perform
canaloplasty with the new iTrack™ Advance. The surgeries were
performed at the world-renowned Dean McGee Eye Institute.
“I’ve been given the great opportunity to pair hand in hand with
Nova Eye Medical to develop the iTrack™ Advance. We’ve taken the
original iTrack™ canaloplasty microcatheter and teamed it with an
ergonomic handpiece that facilitates improved access into the
canal.”
“Thanks to the handpiece, we can advance the microcatheter and
then retract it along the full circumference of Schlemm’s canal
with much greater efficiency than ever before,” added Dr.
Khaimi.
“Another important point is that surgeons will continue to
benefit from Nova Eye’s proprietary illuminated microcatheter
technology. First debuted with the original iTrack™ and now with
the iTrack™ Advance, it is the world’s only illuminated
canaloplasty microcatheter. Being able to track where the
microcatheter is at all times makes a significant impact during
surgery. I liken it to driving at night without headlights. You’d
never choose to drive without the assurance and safety of
headlights.” In the USA, the iTrack™ Advance has been cleared for
canaloplasty both with and without concurrent cataract surgery.
Given the enhanced ease-of-use and ergonomic design, along with the
more streamlined nature of the procedure, it is expected that the
iTrack™ Advance will continue to drive increased surgeon uptake of
the canaloplasty procedure.
According to Tom Spurling, Managing Director of Nova Eye
Medical, the Company will expand its sales and clinical teams in
the U.S. effective immediately, to support the U.S. market
introduction of iTrack™ Advance.
“The U.S. clearance of iTrack™ Advance is a significant
milestone for our business and comes at a time when, due to its
stent-free, tissue-sparing approach, the canaloplasty procedure is
rapidly being adopted into the glaucoma treatment algorithm by a
growing number of U.S. glaucoma surgeons and anterior segment
surgeons.”
“Our current priority is to get the device into the hands of
these adopting surgeons as quickly as possible,” added Mr.
Spurling.
The iTrack™ Advance will be officially launched in the USA at
the American Society of Cataract and Refractive Surgery (ASCRS) in
San Diego, May 5-8, 2023.
Outside of the USA, the iTrack™ Advance has been cleared for use
since June 2022 throughout Canada, Australia and Europe, including
Germany, where a multi-center, randomized study (“CATALYST”, CTN:
NCT05564091) is currently underway to evaluate the effectiveness of
canaloplasty with the iTrack™ Advance performed in combination with
cataract surgery, as compared to cataract surgery alone. The
CATALYST Study is expected to reinforce the clinical utility of
canaloplasty in the treatment of mild to moderate glaucoma
patients.
For more information about iTrack™ Advance, including important
safety information, visit https://itrack-advance.com/us
ABOUT NOVA EYE MEDICAL
Nova Eye Medical Limited is a medical technology company that
develops, manufactures and sells a portfolio of proprietary
ophthalmic treatment technologies and devices. Used by eye surgeons
in more than 100 countries globally, these technologies include the
iTrack™ portfolio of canaloplasty devices for the treatment of
glaucoma. The Company also manufactures and sells the proprietary
Molteno3® glaucoma drainage device for the treatment of severe or
complex glaucoma. With its sales headquarters based in Fremont,
California, Nova Eye Medical is supported by sales offices in
Adelaide, Australia and Berlin, Germany, and a global network of
more than 50 distribution partners. Manufacturing facilities are
located in Fremont, California and Dunedin, New Zealand.
ABOUT CANALOPLASTY
First introduced in 2008, canaloplasty is a surgical treatment
for glaucoma that targets the main sites of outflow resistance in
the conventional outflow pathway: the trabecular meshwork,
Schlemm’s canal, and the distal collector channels. Based on the
same principles as angioplasty, a flexible microcatheter is
cannulated 360 degrees around Schlemm’s canal during the procedure
to manually break and remove blockages. Next, viscoelastic fluid is
injected into Schlemm’s canal as the microcatheter is withdrawn to
dilate the distal outflow system and to improve the function of the
trabecular meshwork.
iTrack™ and iTrack™ Advance have a US Food and Drug
Administration (FDA) 510(k) and CE Mark (Conformité Européenne) for
the treatment of open-angle glaucoma.
The iTrack™ Advance canaloplasty device has been cleared for the
indication of fluid infusion and aspiration during surgery, and for
catheterization and viscodilation of Schlemm’s canal to reduce
intraocular pressure in adult patients with open-angle
glaucoma.
The iTrack™ canaloplasty microcatheter has been cleared for the
indication of fluid infusion and aspiration during surgery, and for
catheterization and viscodilation of Schlemm’s canal to reduce
intraocular pressure in adult patients with open-angle
glaucoma.
For additional information about the iTrack™ Advance, including
safety information, please visit: https://itrack-advance.com/us
Images are available at this link: https://bit.ly/3GAnwyR
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230411005839/en/
For media enquiries, please contact: Kate Hunt: Nova Eye Chief
Commercial Officer - khunt@nova-eye.com Giorgio Pirazzini: GP
Communications – giorgio@gpcommunications.eu
National Vision (NASDAQ:EYE)
Historical Stock Chart
From Apr 2024 to May 2024
National Vision (NASDAQ:EYE)
Historical Stock Chart
From May 2023 to May 2024