Orthocell is finally stepping onto the US stage. Here's why that matters.
The All Ords may be ticking higher today, but one small-cap healthcare stock is making a much bigger move and for a specific reason.
So, what’s got investors watching Orthocell Limited (ASX: OCC)?
Orthocell, a regenerative medicine company based in Perth, has officially recorded its first revenue in the United States. The company’s flagship product, Remplir, has now been used in real surgical cases in Ohio and Florida. That’s not just a regulatory box ticked. It’s actual product in hospitals, used by surgeons, and generating income.
Even more impressively, this milestone comes just three months after receiving US FDA 510(k) clearance. In the medical world, that’s a lightning-fast pivot from approval to revenue. It shows not just preparedness, but confidence in execution.
Remplir is a collagen wrap used to support nerve healing. It reduces the need for sutures, which can trigger inflammation and scarring, and creates a better environment for nerves to regenerate. Clinical studies have backed it too, confirming faster recovery and better-quality nerve tissue when compared to traditional methods.
Why now?
The timing couldn’t be better. Orthocell has already built momentum in Australia, where over 200 surgeons across 165 hospitals have adopted Remplir. That local success has translated into five straight quarters of record revenue, including $2.73 million in the June quarter alone, up 22.8% on the previous quarter.
And that’s before a single dollar of US sales was counted.
With the American nerve repair market valued at US$1.6 billion, the potential uplift in revenue is significant. Orthocell now has 14 specialist US distributors in place, covering 25 states. That means it’s not just shipping product. It’s building relationships with surgeons and hospitals across the country.
Bigger markets. Bigger goals.
Orthocell isn’t stopping at the US. The company has also secured regulatory approval for Remplir in Canada, Hong Kong, and Thailand, and continues to expand its footprint with other products like Striate+, used in dental bone regeneration.
Cash in the bank? Just over $28.5 million with no debt. That puts Orthocell in a strong position to grow without needing to raise funds in the short term.
And with manufacturing capacity for over 100,000 Remplir units annually, scale shouldn’t be a problem.
The takeaway
Orthocell’s first US sales aren’t just a win. They’re a signal. This company isn’t playing catch-up. It’s executing a global strategy backed by science, sales infrastructure, and surgeon demand.
With early traction, strong balance sheet support, and a product addressing a real surgical pain point, Orthocell could be shaping up as one of the most promising small cap plays in the medtech space.
This ASX biotech just started treating US kids with its cell therapy and it's not stopping there
Mesoblast isn’t just making progress. It’s delivering on something real.
While most ASX biotechs are still chasing approvals or prepping for trials, Mesoblast (ASX: MSB) has already taken the leap. And in the US, no less.
Just three months after getting the green light from the FDA, its lead treatment Ryoncil is being used in US hospitals. The first three children with a rare and often fatal condition called steroid-refractory acute graft versus host disease (SR-aGvHD) have officially started treatment.
This isn’t a small pilot or compassionate access case. Ryoncil is now commercially available in the United States. Kits are being shipped through Cencora, and the rollout is underway.
A big head start
Not only is Ryoncil the first mesenchymal stromal cell therapy approved by the FDA, but Mesoblast has locked in 7 years of orphan drug exclusivity. That means no competing stem cell product for this disease can enter the US market during that time.
Even beyond that, the company has biologic license exclusivity until 2036, plus more than 1,000 patents backing its IP and manufacturing process. That’s a serious moat.
And insurance? Covered. The US government has now signed off on mandatory Medicaid coverage for Ryoncil starting 1 July 2025. That opens access to around 40% of American kids. The rest are mostly covered through private health plans.
Mesoblast estimates that over 104 million Americans already have access to Ryoncil through either private or public cover.
More than one shot
While Ryoncil is making headlines, it’s not the only thing in Mesoblast’s pipeline.
The company is pushing forward with rexlemestrocel-L, a second-generation cell therapy for chronic heart failure and lower back pain. Both are huge markets with limited treatment options, and early results from Phase 3 trials have shown real promise.
Mesoblast is already in talks with the FDA to map out an accelerated approval path including discussions on a confirmatory trial to follow if approval is granted.
Not short on cash either
This kind of rollout takes money and Mesoblast has it.
In the latest quarter, it raised A$260 million in fresh funds and finished with US$182 million in cash. That gives it a financial runway of more than three years, without needing to scramble for capital.
Final take
Mesoblast has crossed a rare line it’s gone from a biotech story to a commercial one. It’s got an FDA-approved product. It’s treating patients. It has payer support. And it's still pushing more therapies forward.
That doesn’t happen often in this sector. Especially not from an ASX stock.
(Source: Company Announcements)
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