Iantrek, Inc. is gearing up to introduce the latest addition to its bio-interventional ophthalmic surgery (BIOS) platform: the AlloSpan Canal.
This news follows months after the medical technology (medtech) company’s U.S. commercial launch of another technology in this bio-intervention surgical category.
Big news! Where should we start?
With the basics—including a rundown on this BIOS platform.
What it is: A new bio-intervention surgical category derived from a combination of natural allogeneic biotissues and high-precision micro-interventional technology.
How this translates to Iantrek’s portfolio: Via the development of uveoscleral and trabecular minimally-invasive glaucoma surgery (MIGS) devices.
- Click here for more on how it utilizes scleral allograft tissues as a biocompatible and non-biodegradable material for reinforced and durable glaucoma surgical applications.
- See here for why scleral allografts are critical.
- And check out the basis for all of this research.
What other technologies are included in Iantrek’s portfolio?
Five (now six, if you count AlloSpan Canal) in varying stages of product development—with three already commercially available.
Take a look at these devices targeting the uveoscleral and trabecular meshwork (TM) pathways.
Worth noting: That recent commercial launch we referenced earlier was the AlloFlo Uveo, a first-of-its-kind surgical device targeting the uveoscleral pathway.
- Read more on how its design enables high precision, ab-interno homologous structural reinforcement to give ophthalmic surgeons an alternative route for draining fluids from the eye.
Alrighty, now to this AlloSpan Canal.
Referred to as a novel, bio-reinforced canal restoration platform, the AlloSpan Canal is designed to restore and maintain Schlemm’s canal—without leaving synthetic hardware in the eye.
How it does this: By combining two key components:
- Nitinol-guided canaloplasty
- Durable biological reinforcement
Give me a quick refresh on nitinol.
This is an alloy of nickel and titanium with key properties such as superelasticity and an ability to return to a pre-set shape (as a “shape memory alloy”), making it an ideal material for minimally-invasive implants needing to:
- Be inserted in a compact form
- Expand or confirm inside a sensitive (delicate) anatomy
- Such as within Schlemm’s canal via an ab interno insertion
Explain how it works.
AlloSpan Canal uses this (“TM-sparing”) nitinol-guided canaloplasty to position a scleral bio-implant made from homologous tissue with retained, naturally-expanding properties.
To be more precise: It natually expands (on average) by ~2.5 x with hydration in the canal.
- The resulting effect: The implant reinforces Schlemm’s canal structure to maintain outflow.
Check out this visual.
And how is this different from current MIGS methods?
While considered less invasive surgical approaches for lowering intraocular pressure (IOP), standard MIGS procedures not only target trabecular outflow, but also require surgeons to “choose between minimally disruptive canaloplasty procedures that provide transient expansion or permanent implants intended to maintain canal patency,” Iantrek noted.
The AlloSpan Canal avoids this “forced tradeoff” by providing a "durable, restorative treatment strategy.”
Noted. So has this been cleared by the FDA yet?
Good question.
According to Iantrek, AlloSpan Canal is classified as an “FDA-registered” minimally manipulated, homologous-use HCT/P (human cells, tissue, and cellular/tissue-based product)” and is in alignment with an established Category 1 procedural code.
Take note:
- “FDA-registered” is not the same as receiving FDA 510[k]) clearance or approval via pre-market authorization (PMA)
- This registration also indicates it’s not considered a traditional medical device (as most glaucoma implants are)
Also: Glance was unable to independently verify this registration status.
Does this classification extend to a specific category as well?
Yes … the company stated that as a HCT/P, AllSpan Canal aligns with an established Category 1 procedural code.
HCT/Ps under this category are considered lower risk, do not require FDA premarket review or approval, and must meet federal requirements as established by section 361 of the Public Health Service (PHS) Act and 1 CFR Part 1271.
Got it. So has there been any clinical research on this yet?
Outside of the United States: AlloSpan has apparently had success among “first-in-human cases.”
Within the U.S.: That’s currently in progress.
- Iantrek is reported to be initiating a controlled early access program for AlloSpan Canal “across a select number of U.S. clinical sites.”
No specific details on either were provided beyond this.
And the plan?
To use the clinical data from these initial cases to support:
- Surgeon experience
- Procedural refinement
- Real-world performance insights
The eventual goal: Expanding U.S. commercial access in 2027.