Health Check: It’s payday for two device makers as higher US reimbursement flows

It's payday for Impedimed and Avita Medical on the back of two key US reimbursement decisions. Pic: Getty Images
- Impedimed and Avita Medical have won a ‘pay rise’ from private and public US payors
- Orthocell posts record revenue – an entrée perhaps, with US sales main course to come
- Gut disorders house Immuron outlines a packed October schedule
Few of us work solely for money.
As with the late Queen, perhaps we’re motivated by a lifetime devotion to duty. Or like the Pope, a higher spiritual calling.
Or as with parking inspectors, the perverse joy of inflicting suffering on fellow humans.
Maybe we simply don’t like golf.
That said, it’s nice to be paid and the same applies to device companies spruiking their wares in the US.
On that note, ImpediMed (ASX:IPD) and Avita Medical (ASX:AVH) today announced key US reimbursement wins, in the private and public sectors respectively.
The Centers for Medicare & Medicaid Services (CMS) has granted burns and wounds management Avita a so-called New Technology Add-On Payment.
The payment applies to procedures using Recell for non-burn full-thickness acute wounds, resulting from trauma or surgery.
Recell aims to supplant skin grafting, which requires clinicians to harvest large chunks of patient skin.
Of course, surgeons are devoted to the higher calling of healing the wounded. But in the US hospital system it’s the dollars that count.
The bottom line is that the add-on payments mean hospitals can receive up to US$4875 in additional payments per procedure.
This is over and above existing CMS reimbursement.
Avita CEO Jim Corbett notes the add-on payment applies to only select technologies, which “underscores the clinical value and innovation of Recell.”
Private pay is no impediment for Impedimed
In the case of Impedimed, the fifth-biggest US health insurer has decreed the company’s Sozo device to be worthy of coverage.
Sozo is “medically necessary” for assessing lymphoedema, the insurer says.
Lymphoedema is the build-up of fluid in the limbs, typically as a result of treating breast cancer.
Clinicians traditionally have measured the resulting limb swelling with a tape measure, believe it or not.
The coverage means that more than 86% of the US populace – more than 300 million people – can be reimbursed for this treatment.
“We expect these changes, together with [earlier announced wins] to have a meaningful effect for commercialisation of Sozo,” the company says.
Impedimed shares advanced 8% on the news.
Orthocell posts sixth record quarter
In an early bird September quarter update, Orthocell (ASX:OCC) reports $3 million of revenue for the stanza, 9% higher than the June quarter.
The device maker has now posted six consecutive quarters of revenue record growth.
But that’s likely only to be the entrée, with US sales of Orthocell’s flagship nerve repair device Remplir yet to flow in earnest.
The quarter’s revenue flowed mainly from Remplir sales in Australia and Singapore.
These geographies approved Remplir earlier than the US Food & Drug Administration (FDA), which greenlit the device last April.
Orthocell CEO Paul Anderson dubs the quarter’s performance as “tangible confirmation that surgeons are growing increasingly comfortable using Remplir in nerve repair procedures”.
Meanwhile, Orthocell’s US Remplir rollout remains on target.
During the quarter, US surgeons undertook their first cases using Remplir, a collagen ‘wrap’ that protects peripheral nerves during these procedures.
Orthocell finished the quarter with “robust” cash of $27 million and no debt.
The company will release its ‘official’ quarterly results in the next week or two.
Our gut feeling is that Immuron is busy
Having reported record sales for the year to June 2025, Travelan maker Immuron (ASX:IMC) also says it’s off to a bright start for the current year.
In a missive to shareholders, CEO Stephen Lydeamore says September (first) quarter sales should exceed those of the previous first quarter.
The company will bare all in mid-October.
More broadly, it’s a busy period for Immuron across its three therapies in development.
This month, Immuron expects to announce top-line results from its clinical study with the Uniformed Services University in the US.
The trial tests the ability of Travelan to combat diarrhoea for soldiers on deployment.
Lydeamore hopes the trial will enable Travelan to be recommended in traveller’s diarrhoea guidelines.
This will increase Travelan’s market potential, as well as enhancing the company’s long-standing relationship with the US Department of Defense.
Separately, Immuron is progressing an Investigational New Drug (IND) application to the FDA.
This is to initiate a phase II trial to treat Clostridioides difficile infections.
The company hopes to lodge its application in the next couple of weeks.
Locally, Immuron this month plans to launch ProIBS, as a complementary medicine for irritable bowel syndrome.
Immuron’s therapies derive from the natural immune-boosting qualities of colostrum, the first milk delivered by cows to their calves.
At Stockhead, we tell it as it is. While Orthocell is a Stockhead client, the company did not sponsor this article.
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