Orthocell (ASX: OCC) is a regenerative medicine company best known for Remplir, a collagen wrap that protects nerves and supports their healing during surgery. It has now released the first clinical results from using that product in robotic prostate cancer surgery, and the early readout is encouraging.

Orthocell says a pilot series of five patients showed good functional recovery even though each case was difficult, and the results will shape a larger prospective trial. For investors, the key detail is regulatory: no extra approvals are needed to use Remplir this way in any of the seven markets where it is already cleared, including the United States.

A Tough Test for a Nerve Wrap

Prostate surgery can leave men with urinary leakage and erectile problems, because the nerves controlling both run right beside the gland. Surgeons try to preserve them, but that is not always possible. This pilot group made it harder than most. Patients were aged 57 to 69, and most also had diabetes, high blood pressure or obesity. Every tumour had grown beyond the edge of the prostate, so surgeons removed the nerves on the affected side and could only partly preserve those on the other. Two cancers were high grade and three were intermediate. Recovery in a group like this is usually slow and uncertain.

What the Early Results Show

Patients were followed for about 12 months:

Remplir was placed in all five patients using the surgical robot, with no technical problems and no significant extra operating time.
No Remplir-related complications were reported during surgery or follow-up.
Three patients became pad-free, two within three to four months and one by six months. Two others did not reach that point, and both had urinary symptoms before surgery.
Four patients had erectile function before surgery. One now reports erections with oral medication alone, two report partial function with second-line treatment, and one has not recovered.
All five had undetectable PSA levels, including one patient with a small amount of tumour that could not be removed.

Why Five Patients Is Only a Start

The company itself calls this a pilot, and that is the right label. Five patients with no comparison group cannot prove Remplir caused the recoveries. Surgeon Dr Peter Chong said he was encouraged given how limited the nerve-sparing was, and noted the technique adds little operating time. Managing Director Paul Anderson said the series did its job by showing reliable placement and early safety data, with a larger, properly powered trial the logical next step. Our recent analysis of Orthocell (ASX: OCC) is available here, for readers wanting more background.

A Bigger Prize without New Paperwork

Remplir is approved in Australia, New Zealand, the United States, Canada, Singapore, Hong Kong and Thailand. That matters because nerve-sparing techniques are common in prostatectomy, and published research suggests up to 75% of patients may be eligible. Australian surgeons have already used the product in more than 300 prostatectomies, against roughly 12,000 robotic procedures performed locally each year. In the US, about 115,000 prostatectomies are done annually, most of them robotic. OCC estimates the new use could lift its US addressable market from US$1.6 billion to about US$2.0 billion. Several devices may be used in a single operation, which adds to the potential.

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Funding for the Next Phase

The company ended June with A$44.1 million in available funds, made up of A$5.0 million in cash and A$39.1 million in term deposits, and it carries no debt. That gives OCC room to run the larger study, although the trial design, timing and cost have not yet been disclosed. That evidence is meant to support surgeon education and wider adoption, starting with the US.

Risks Worth Weighing

A small pilot can flatter a product. Larger trials often show smaller effects, and recovery after prostate surgery varies widely between patients. Surgeon uptake, hospital purchasing and the cost of generating evidence will also shape how quickly this opportunity turns into sales. OCC’s own forward-looking statements warn that actual results may differ materially.

Share Price Reaction and the Longer View

OCC shares have had a rough year, down roughly 38% since January and well below a 52-week high of $1.49. Remplir’s rollout in existing markets continues, while the prostate work gives the company a longer-term clinical story to build on. What matters next is whether the larger trial confirms these early recoveries. If it does, prostatectomy could become a second major growth leg for the product.