Orthocell Ltd (ASX:OCC, OTC:ORHHF) earlier this week updated investors on the continued adoption of its Remplir device in radical prostate cancer surgeries, with more than 100 procedures now completed in Australia.
The company said the technology is being adopted by urologists to help reduce the incidence of urinary incontinence and erectile dysfunction. It noted that this marks an important step in validating Remplir’s clinical utility in nerve protection during surgery.
Orthocell told investors that increased usage of Remplir could significantly expand its total addressable market in the United States from USD 1.6 billion to just under USD 2.0 billion. It highlighted that more than 120,000 nerve-sparing prostate cancer surgeries are conducted in the US each year, compared to around 14,000 in Australia.
The company also confirmed that it had secured FDA approval for Remplir in April this year. It is currently preparing for a targeted product launch in the US, with early sales expected within the next one to two quarters. It said preparations include the development of a distributor network, engagement with key opinion leaders, and discussions with hospital value analysis committees to gain payer access.
Orthocell emphasised its continued investment in real-world clinical data to support product uptake. It is currently building an evidence package to further inform and encourage adoption among urological surgeons in the US and internationally.
Managing Director and CEO Paul Anderson said, “We’re delighted that Australian urologists are starting to adopt our product. To have our product used in the protection of those nerves is a really fantastic outcome for us.”
The company added that it would continue to report data to the market as clinical use grows.
Proactive: Orthocell's Remplir device is on track for expansion as more than 100 surgeries in Australia have now been conducted using the device. All the details on this stride are with the company's Managing Director, Paul Anderson. Paul, it's been quite a while. How are you?
Paul Anderson: Oh, look, I'm very well. Thank you. And thanks for the opportunity to come and chat with you today.
Proactive: Paul, more Australian urologists are adopting the technology during radical prostate cancer surgery. This is quite a step forward, and it will present a significant opportunity to expand your total addressable market in the US from around USD 1.6 billion to just under USD 2 billion. Quite a step. The market's really happy. Where do we go from here?
Paul Anderson: So we're delighted that the Australian urologists are starting to adopt the use of our product in these fantastic surgeries designed to reduce the incidence of urinary incontinence and reduce the incidence of erectile dysfunction. And so to have our product used in the protection of those nerves is a really fantastic outcome for us.
This really shows the wonderful utility of this product and the adaptability into different peripheral nerve indications throughout the body. So we're really excited about the uptake and the organic growth. And of course, in addition to that, we're really excited about the increase in this global addressable market. You know, there's over 120,000 radical prostatectomies that are nerve-sparing done in the US each year, to complement the 14-odd thousand done per year here in Australia. So these are significant market opportunities for us. And what we're seeing now is an adoption and adoption of this product for this really exciting indication.
Proactive: Paul, investors are definitely feeling the momentum picking up and your excitement as well. Your share price is up some 7% at the time of this recording. Now, we've seen 100 surgeries conducted by surgeons across Australia. How do you see that number continuing to grow in the next few months?
Paul Anderson: Yeah. So we as a company have always invested in good quality clinical research and the collection of real-world data and the reporting to the market of that data, and this is no different. We are looking to support this really exciting indication with a good evidence-based approach. So understanding how to go about generating the data and then understanding how we go and disseminate that data to the urology community, not just in Australia but across the world.
Proactive: Paul, you laid out to the market this morning your intentions to grow Remplir in the US. You're hoping to support a targeted US product launch in the medium term. What are we looking at in terms of timelines here, and how big could we go in the US and globally?
Paul Anderson: Yeah. Look, it is an exciting global opportunity. And we look at it as that. I mean, I think the important thing to recognise though is that we've just received FDA approval in April of this year — late April. And so we've been busily working and developing our key opinion leader network, developing our distributor network, and enabling us to get access to the payers via value analysis committees in all the hospitals.
And so that will, in due course, over the next quarter or two, start to result in significant early sales. And of course, we're laser-focused on that. And in the meantime, given this exciting development of over 100 patients treated in such a short period of time here in Australia, we're looking to build the clinical package and the evidence to support the use of this technology in the US with urological surgeons also.
Proactive: Certainly quite a fair bit to look forward to in the next few weeks. We'll continue keeping a close eye on the development and the expansion of Remplir across the country and internationally. It's been great having you back here at Proactive. This was Orthocell Managing Director and CEO Paul Anderson. Thank you so much.
Paul Anderson: Thanks very much for your time.