Latest news with #nerveRepair

News.com.au
10-07-2025
- Business
- News.com.au
Break it Down: Orthocell books first sales revenue in US for Remplir
Stockhead's Break it Down brings you today's leading market news in under 90 seconds. In this episode, host Tylah Tully takes a look at Orthocell (ASX:OCC), who have achieved first US revenue from Remplir, its flagship nerve repair product, after the company locked in FDA approval in April. Tune in to hear all about it. While Orthocell is a Stockhead advertiser, it did not sponsor this content. Originally published as Break it Down: Orthocell books first sales revenue in US for Remplir

News.com.au
08-07-2025
- Business
- News.com.au
Biocurious: Nerve repair champion Orthocell is taking it slow and steady in the US fast lane
Orthocell is staging the US rollout of its Remplir device, including 'pausing' enlisting too many distributors at once In Remplir's first US commercial usage, an Ohioan surgeon has deployed the device successfully More than 300 investors tuned into Orthocell's update last week For Orthocell (ASX:OCC) co-founder and CEO Paul Anderson, winning US Food & Drug Administration (FDA) marketing approval is more like a waypoint in the commercialisation path, rather than the endgame. In early April the FDA green-lit the company's flagship nerve repair product Remplir, exposing the company to a potential US$1.6 billion-a-year market. The Perth-based Orthocell can't be accused of assuming the biotech gods will serve up commercial success on a platter. Anderson says Orthocell was preparing its rollout strategy two years ago, including strategic tie-ups with distributors and laying the groundwork with opinion-leading surgeons. 'You don't just get an FDA approval and expected things to happen, you must be ahead of the game,' Anderson says. A mere three months post approval, Orthocell last week reported the first US commercial use of Remplir, by a surgeon in Ohio for a foot repair. It's not a race Paradoxically, management is on a strategic 'go-slow' in the fast-paced, make-or-break US market. Having appointed 14 east coast distributors, the company has 'paused' the rollout of any more until the current complement is properly trained and supported. Orthocell has also focused on the parties with what Anderson dubs the best 'domain knowledge' – those who can lead the company to the key hospitals and influential surgeons. 'You can't be scattergun,' Anderson says. 'We have 14 distributors to train and educate, with 100 reps on the ground. 'It's important that we provide them with the best education to support the brand.' Orthocell is also not ignoring the dull-but-important stuff of obtaining state-by-state licensing, navigating hospital procurement and onboarding day surgery hospitals (a key market). Stitching up the suturing market A collagen cuff derived from porcine material, Remplir envelops a severed nerve and helps the healing process. The device is also approved locally and in New Zealand, Canada, Singapore, Thailand and Hong Kong. Remplir is the only product that mimics the outside of the nerve, called the epineurium. Given that, the device requires few or no stitches: a technique unchanged since the late nineteenth century. 'We are actively redefining the way surgeons approach nerve repair,' Anderson says. 'Remplir is the only product in the market that enables surgeons to connect nerves, to protect them from scar tissue and compression; and cap nerves (for amputations).' Published studies show that patients with no voluntary movement had 85% of their function restored two years post-surgery. They also had improved strength and range of motion, which Anderson dubs 'outstanding outcomes that represent everything Remplir has to offer". To date, 206 surgeons in over 166 local and Singaporean hospitals have used Remplir, including plastic reconstructive, orthopaedic, vascular and neurological surgeons. Better bang for revenue buck Naturally, a medical product needs to be clinically superior – but that's not enough to ensure financial success in a well-competed sector. As yesterday's update from US drug entrant Botanix Pharmaceuticals (ASX:BOT) shows, too many clipping-the-ticket intermediaries can spoil the revenue story. 'Unlike other medtechs, Orthocell has no royalty liabilities and as we get into revenue growth, investors will reap the reward,' chairman John Van Der Wielen says. 'Royalty liabilities significantly erode margins in the sector." He adds that most device makers outsource their manufacturing, resulting in margin erosion. Orthocell's process is being kept in house. Revenue growth 'will take care of profits' Orthocell last week disclosed record June quarter revenue of $2.73 million, 23% higher than the March quarter. Revenue has risen for five consecutive quarters, at a compound annual rate of 9.5%. However, this annual run rate of circa $9 million doesn't include any US Remplir revenue. Striate sales in Australia, New Zealand and Singapore grew 28%. Management won't predict US revenues or when the company achieves profits – but expect blank ink on the bottom line in the 'near future'. 'Our expenses are growing at a lower rate than revenue, so the 'jaws' eventually will cross over and push the business into profit,' Van Der Wielen says. 'Cash burn is reducing, revenue is increasing and I believe we have more than enough cash to take the business forward.' Over time, Orthocell has invested $80 million in developing its product platform. The company does not have to incur more sunk costs, leaving a largely variable distribution cost base. 'Premium' product at a discount price Tapping Remplir's cost advantages, Orthocell is pricing the 'premium' product at just below those of US competitors. 'We are making it easy for the hospitals to order our product,' Anderson says. Orthocell has set its US pricing at parity with what's charged in other countries. This is a poltically sage gambit that should please the Commander in Chief as he ponders his 'most favoured nation' drug policy. While obtaining US reimbursement is the be-all-and-end-all for most drug makers, Anderson notes a capacious user-pays capacity for nerve repair. 'The take-home message is there is enormous revenue to be gained, even if you don't have US reimbursement,' Anderson says. That said, hospitals should fund Remplir by a mechanism that allocates a bundle of cash per procedure, rather than for specific items. Passionately Australian Around 300 investors tuned into Orthocell's webcast last week – no doubt reflecting the stock's 270% surge over the past 12 months. As it hones its US push, one thing Orthocell won't be doing is ceding its manufacturing base in Perth, which has the capacity for 100,000 units annually. Remplir's long shelf life means it's easy to ship elsewhere. 'We are passionate manufacturers of this product in Australia – and that's because it's the right place to make it,' Anderson says. 'We have the best raw material in the world and a great gross margin and economies of scale.' Judging from his chairman's utterances, Anderson can approach his end-of-year salary review with confidence. 'As a board, we could not be happier with what we have achieved over the last 12 months,' Van Der Wielen says.
Yahoo
04-07-2025
- Business
- Yahoo
Axogen Showcases Nerve Repair Vision at Goldman Sachs
Axogen, Inc. (NASDAQ:AXGN) is among the best growth stocks to invest in for the next 5 years. On June 11, 2025, Axogen, Inc. (NASDAQ:AXGN) presented at the Goldman Sachs 46th Annual Global Healthcare Conference, where a strategic vision was highlighted that is focused on solidifying the company's leadership in nerve repair solutions. The management remains confident about the giant's position in delivering strong growth while expanding the product portfolio. The company is undergoing a wave of transformative operational changes by adding new clinical application areas. With that being said, Axogen, Inc. (NASDAQ:AXGN) is working towards improving professional education activities and entering new areas. An orthopedic surgeon connecting peripheral nerves with AxoGuard Nerve Connector, showing the precision and care of AxoGuard's products. The future outlook of Axogen, Inc. (NASDAQ:AXGN) looks equally promising. The company aims to expand internationally by 2026, with sustained investments in Avance and complementary products, targeting regeneration and protection devices. It doesn't stop there; recognizing significant under-penetration in its existing markets, the company is committed to accelerating growth by advancing its commercial footprint and development initiatives. Axogen, Inc. (NASDAQ:AXGN) is a Florida-based company that develops and markets technologies for peripheral nerve regeneration and repair worldwide. The company's core offerings include Avance Nerve Graft, AxoGuard Nerve Connector, AxoGuard Nerve Protector, AxoGuard Nerve Cap, and AxoGuard HA+ Nerve Protector. Founded in 2002, the company is focused on improving patients' lives. While we acknowledge the potential of AXGN as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: The Best and Worst Dow Stocks for the Next 12 Months and 10 Unstoppable Stocks That Could Double Your Money. Disclosure: None. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
03-07-2025
- Business
- Yahoo
Axogen Showcases Nerve Repair Vision at Goldman Sachs
Axogen, Inc. (NASDAQ:AXGN) is among the best growth stocks to invest in for the next 5 years. On June 11, 2025, Axogen, Inc. (NASDAQ:AXGN) presented at the Goldman Sachs 46th Annual Global Healthcare Conference, where a strategic vision was highlighted that is focused on solidifying the company's leadership in nerve repair solutions. The management remains confident about the giant's position in delivering strong growth while expanding the product portfolio. The company is undergoing a wave of transformative operational changes by adding new clinical application areas. With that being said, Axogen, Inc. (NASDAQ:AXGN) is working towards improving professional education activities and entering new areas. An orthopedic surgeon connecting peripheral nerves with AxoGuard Nerve Connector, showing the precision and care of AxoGuard's products. The future outlook of Axogen, Inc. (NASDAQ:AXGN) looks equally promising. The company aims to expand internationally by 2026, with sustained investments in Avance and complementary products, targeting regeneration and protection devices. It doesn't stop there; recognizing significant under-penetration in its existing markets, the company is committed to accelerating growth by advancing its commercial footprint and development initiatives. Axogen, Inc. (NASDAQ:AXGN) is a Florida-based company that develops and markets technologies for peripheral nerve regeneration and repair worldwide. The company's core offerings include Avance Nerve Graft, AxoGuard Nerve Connector, AxoGuard Nerve Protector, AxoGuard Nerve Cap, and AxoGuard HA+ Nerve Protector. Founded in 2002, the company is focused on improving patients' lives. While we acknowledge the potential of AXGN as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: The Best and Worst Dow Stocks for the Next 12 Months and 10 Unstoppable Stocks That Could Double Your Money. Disclosure: None. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

News.com.au
19-06-2025
- Business
- News.com.au
Health Check: On Garfield the Cat Day, the biotech sector purrs with deals and breakthroughs
Orthocell says its Remplir nerve device blitzes the stitches Singular Health inks US physician network deal Clarity clearly is undervalued, say brokers Among other auspicious events, the 19th of June marks the end of slavery in the US, Garfield the Cat Day and the birthdays of former British PM Boris Johnson and royal temptress Wallis Simpson. So why not add a slew of meaningful life sciences announcements, including an HIV vaccine breakthrough, to the June 19 pantheon? Let's start with Orthocell (ASX:OCC), which reports 'compelling data' showing its Remplir nerve repair agent is superior to suture-only standard techniques. Stitching accounts for circa 90% of the 700,000 nerve repair procedures done in the US annually. A cuff that envelops the damaged peripheral nerves, Remplir reduces the use of stitching, which can compromise nerve repair. Orthocell's study used a rat sciatic nerve injury model, covering 48 rodents across four treatment groups. These cohorts covered repairs using one, three or six sutures, compared with one suture augmented with Remplir. The rats' nerve function and regeneration were evaluated up to 12 weeks post-treatment. The FDA ticked off Remplir in early April and the device is also approved in Canada, Hong Kong, Singapore, New Zealand and here. Thus, the study was pitched not so much as approval as supporting the US sales rollout. Orthocell cites a total addressable market in its target markets of US$3.5 billion, with its already-approved geographies accounting for US$1.8 billion. The US market is worth US$1.6 billion. Stem-cell hope for bone marrow transplant patients NeuroScientific Biopharmaceuticals (ASX:NSB) highlights previous clinical data showing its soon-to-be acquired stem cell platform is effective in preventing graft-versus-host disease (GvHD). The company is buying the asset, Stemsmart from the unlisted Perth-based Isopogen. The phase I work covered adults and children with life-threatening, steroid-resistant GvHD, a common complication of bone-marrow transplants. The data shows the treatment is safe and well tolerated, 'with no infusion related toxicities'. Furthermore, most adults and children had a 'complete or partial resolution of symptoms and improved survival'. Of the 10 children treated on compassionate grounds, all had survived 12 months post implant. Three of them were still alive six years post treatment. Turning to pancreatic cancer, Amplia (ASX:ATX) reports another patient with a 'complete response' in its 55-patient trial dubbed Accent. As close as dammit to a cure, a confirmed complete response formally is defined as all tumour lesions disappearing, with the effect maintained for at least two months. 'This is a rare outcome in advanced pancreatic cancer where the disease has spread to other parts of the body,' the company says. A Singularly fine US deal Imaging medtech outfit Singular Health Group Ltd (ASX:SHG) has signed a $2 million agreement with a US physician network to develop and use Singular's 3Dicom medical imaging tool. The compact is with Provider Network Solutions (PNS), covering physician networks in Puerto Rico, Florida, and Texas. It covers the initial deployment of 1000 3Dicom licences, at US$800 each. Singular pockets a further US$500,000 on 'satisfaction of AI model marketplace and image repository development and integration'. The company hope to expand to the remaining 30 states that PNS covers. 3Dicom converts magnetic resonance imaging and computed tomography scans to enable 'immersive visualisation' with three-dimensional images. Singular also said it had received $8 million of firm commitments in its recently-announced placement. Meanwhile, microbiome testing house Microba Life Sciences (ASX:MAP) is on trading halt pending a capital raising. EZZ girds for US launch Hitherto China and locally focused, health supplements outfit EZZ Life Science (ASX:EZZ) has launched four initial products into the US after winning FDA approval. To be sold under the new Ezzday banner, the products are made in the US and are tailor-made for American consumers. Seeing you asked, the remedies cover de-bloating/de-gassing, vaginal probiotics, skincare and colon detox. Readers can draw their own conclusions as to what that means about the State of the Nation in Trumpian times. Initially, the products will be sold via Amazon and Shopify. Locally EZZ sells via more than 600 chemists and globally via 750 ecommerce platforms, including China's Douyin and Tmall. The company values the US supplements market at US$100 billion a year, pipping China's US$80 billion opportunity. US health secretary Robert F Kennedy Junior (RFK Jr) has a special interest in health supplements, which at the very least shouldn't harm EZZ's US ambitions. EZZ shares have been on a tear – up 33% over the last month – but they are still well shy of the record $5 peak in October last year. HIV jab spells hope for end to '45-year pandemic' Speaking of RFK Jr, the FDA has approved a drug that is meant to protect against HIV with a single administration every six months. Yep – it's a vaccine – so maybe the health czar isn't as avowedly anti-vaxx as we all think. Marketed as Yeztugo by Gilead Sciences, lenacapavir is seen as the best hope of knocking HIV – in effect a 45-year pandemic – on its head. Clinicians say the drug is much more powerful than the current oral treatments and almost 100% effective. 'This is a historic day in the decades-long fight against HIV,' Gilead CEO Daniel O'Day said. 'Yeztugo is one of the most important scientific breakthroughs of our time and offers a very real opportunity to help end the HIV epidemic.' The drug has a list price of US$28,218 ($43,300). But Gilead may provide the vaccine free to non-insured patients. Have investors underestimated Clarity? Is radiopharmacy outfit Clarity Pharmaceuticals (ASX:CU6) a case of 'objects in this rear view mirror are closer than you think'? Following a series of clinical updates from Clarity, broker Canaccord values the company at $6.74 a share, a lofty 210% increment on the current price. In March, Wilsons ascribed an even ballsier $8.25 a share. All things being equal – and they never are – that would value Clarity at $2.6 billion. Sector champ Telix Pharmaceuticals (ASX:TLX) is worth around $8 billion, bearing in mind it has two FDA-approved prostate cancer imaging tools and a kidney cancer consent in the offing. Yesterday, Clarity said it has struck an agreement with US mob Spectronrx. Spectronrx will provide 400,000 patient-ready does of its copper isotope based 64Cu-SAR-bisPSMA (for diagnosing and potentially treating prostate cancer). In the nuclear medicine game, gaining access to nearby doses is half the battle. But this agent's generous half-life means it can be distributed across all 50 US states. Clarity recently announced promising phase II results for 64Cu-Sartate (neuroblastoma) and 64Cu-SAR-Bombesin (PSMA-negative prostate cancer). Another program, Secure, focuses on identifying and treating metastatic castration-resistant prostate cancer. Clarity currently has no approved products, but Canaccord expects 64Cu-SAR-bisPSMA to be on market by mid 2027. 'Recent commercial agreements should remind the market that this potential best-in-class asset could be closer than we think.' The firm reckons Clarity can win a 20% share of the US market, for US$520m in peak sales. Your columnist's nuclear science credentials – the ones plucked from a Weeties pack – are out of date. But it looks like Telix should have one eye on the rear-view mirror and the other on the road ahead.