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Health & Biotech
When Renerve (ASX:RNV) makes its initial public offering (IPO) on the ASX at 12pm (AEDT) on Tuesday, it will join Orthocell (ASX:OCC) as one of only two nerve-repair companies to be listed on the local bourse.
Having undertaken a $750k pre-IPO raise in September, the company has raised $7 million at 20 cents/share when it hits the ASX.
US companies dominate the nerve-repair market with Axogen (Nasdaq:AXGN) along with Integra Lifesciences Holdings (Nasdaq:IART) both prominent.
CEO Dr Julian Chick told Stockhead that Renerve was developing porcine collagen-based products to repair and regenerate damaged peripheral nerves and related soft tissue.
Peripheral nerves are the network of nerves outside the central nervous system, responsible for transmitting signals between the brain, spinal cord and the rest of the body.
He said they make us walk, run, jump and eat, and they tend to get damaged quite a lot.
The company’s trademarked Nervalign was approved by the US Food and Drug Administration (FDA) in 2022 and has been launched in the US market. It is a cuff to prevent scarring and inflammation when a nerve is being fixed.
“It is used for no better term like a Band-Aid, to protect a nerve that has been severed and repaired,” Chick said.
He said Nervalign products have been specifically designed to protect the nerve for two to four months and then get naturally absorbed, so avoiding need for further surgery and potential risk of longer-term issues.
Next in Renerve’s development pipeline is a nerve conduit designed to guide nerves to grow in a straight path, preventing branching, tree-like growth, where a small portion of damaged nerve has been removed.
It is intended for small gaps of approximately one centimetre with Renerve planning to submit an FDA approval application for the conduit in 2025 via the 510(k) predicate device pathway.
“It comes basically as a straw, which is used to bridge small gaps,” Chick explained.
“Nerves are great in the sense they will regrow and regenerate, but the downside is that when they do that, they have a propensity to branch and create nerves that are going to nowhere.
“The purpose of the conduit is to provide a protective environment for that nerve to repair itself.”
The company also has a Nervalign replacement nerve, for when there is a need to replace the nerve specifically.
“The idea is to have a portfolio of products which will give the surgeon multiple options that they may require depending on the type of injury and damage,” Chick said.
Renerve was founded in 2017 by Chick, chief scientific officer Dr David Rhodes and Royal Melbourne Hospital neurosurgeon Dr Alex Adamides.
With a PhD in neuromuscular physiology, Chick has been involved in 16 start-ups and has launched four tissue products in the US.
Rhodes has a PhD in biochemistry and more than 20 years’ experience in healthcare and biotechnology industries, including developing technologies through to market approval.
Chick is also the chairman of pot play Cann Group (ASX:CAN) and co-founded erectile dysfunction company LTR Pharma (ASX:LTP), where he is an independent non-executive director.
Renerve is targeting an estimated peripheral nerve-repair market of US$1.6 billion per annum, which is growing at ~17% per annum.
“A lot of that is driven by the need to look after nerves,” Chick said.
“More surgeons are training in nerve repair and there are better products coming to market.
“In the US, there are an estimated 900,000 nerve traumas per annum.”
The only other nerve repair company listed on the ASX, Perth-based Orthocell is the maker of nerve-repair product Remplir, which is approved and reimbursed in Australia, New Zealand and Singapore.
The product is a collagen wrap designed to enhance the effectiveness of nerve-repair surgeries.
Remplir is placed around damaged or repaired peripheral nerves during surgery for protection from surrounding tissue, reducing the risk of scarring or adhesion.
It aims to support healing by creating an environment conducive to nerve regeneration, while maintaining healing and ensuring proper regrowth and functional restoration.
Orthocell’s regulatory and growth strategy for Remplir continues to progress. The company is undertaking a US market authorisation study and is due to submit a US 510(k) application with the FDA in December with approval expected by late Q1 CY25.
The approval of Remplir in Australia and New Zealand has resulted in record revenue growth for the company over the last two quarters.
With sales expected in Singapore from early 2025 and pending approvals in other jurisdictions, further growth for Orthocell is anticipated.
The OCC share price has risen more than 62% YTD.
Note: While Renerve and Orthocell are Stockhead advertisers, the companies did not sponsor this article.
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