Latest news with #Remplir
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.
West Australian
11-05-2025
- Business
- West Australian
Orthocell's easy cell into the US as it secures 12 distributors for nerve repair device Remplir
Orthocell's easy cell into the US as it secures 12 distributors for nerve repair device Remplir
News.com.au
04-05-2025
- Business
- News.com.au
ASX health April winners and losers: Sector rises 2pc in stronger month for markets
The S&P/ASX 200 Health Care Index rose 2.16% in April with the S&P/ASX 200 rallying 3.6% Morgans healthcare analyst Iain Wilkie said April was a marked improvement on recent months Several approvals during April, including for EBR and Orthocell, helped boost sentiment in the sector The S&P/ASX 200 Health Care Index was stronger in April, rising 2.16% after being the second-worst performing sector in March. Healthcare followed the broader market upward with the S&P/ASX 200 rallying 3.6% in April as the local bourse held firm against ongoing global geopolitical tensions and economic headwinds. Morgans healthcare analyst Iain Wilkie told Stockhead April was a marked improvement on recent months, partly due to US President Donald Trump softening his stance on tariffs late in April and easing tensions around a potential trade war with China. Wilkie said April marked a solid month of regulatory approvals with EBR Systems (ASX:EBR) gaining US FDA approval for its WISE CRT system – the world's first and only wireless solution for pacing the left side of the heart. Orthocell (ASX:OCC) scored a hattrick of three regulatory approvals in April for its flagship nerve repair product Remplir, including in Canada, Thailand and the US markets. The latest approvals add to pre-existing approvals for Remplir in Australia, New Zealand and Singapore, equating to a significant total addressable market of US$1.8 billion. Regulatory applications for the EU and UK are on track to be submitted in the next six to 12 months. Wilkie said the approvals were also reassuring amid concerns about recent changes at the FDA with reported mass layoffs under Tesla CEO and billionaire Elon Musk's Department of Government Efficiency (DOGE), which were quickly followed by a partial rehiring. "It's good momentum for the sector and shows approvals are still getting through the FDA in time," Wilkie said. "We will see what happens in the next few months." How ASX biotechs performed in April CODE COMPANY PRICE 1 MONTH RETURN % MARKET CAP ICR Intelicare Holdings $ 0.01 66.7% 4 NSB Neuroscientific $ 0.05 35.1% 7 AVR Anteris Technologies $ 8.55 31.5% 270 CC5 Clever Culture $ 0.02 28.6% 30 SHG Singular Health $ 0.30 22.9% 77 CHM Chimeric Therapeutic $ 0.01 20.0% 14 IXC Invex Ther $ 0.08 19.1% 6 4DX 4Dmedical Limited $ 0.32 18.5% 135 IMR Imricor Med Sys $ 1.62 17.4% 476 COV Cleo Diagnostics $ 0.41 17.1% 52 DVL Dorsavi Ltd $ 0.01 16.7% 5 DXB Dimerix Ltd $ 0.48 15.7% 425 IDT IDT Australia Ltd $ 0.12 15.0% 49 PME Pro Medicus Limited $ 229.41 14.8% 24,998 AVH Avita Medical $ 3.10 14.0% 369 LDX Lumos Diagnostics $ 0.03 12.5% 21 PGC Paragon Care Limited $ 0.42 12.0% 712 EYE Nova EYE Medical Ltd $ 0.11 10.0% 31 1AI Algorae Pharma $ 0.01 9.1% 10 ECS ECS Botanics Holding $ 0.01 8.3% 16 MVP Medical Developments $ 0.60 8.1% 71 AHX Apiam Animal Health $ 0.41 8.0% 79 ALA Arovella Therapeutic $ 0.09 7.5% 103 OCC Orthocell Limited $ 1.60 6.7% 391 AT1 Atomo Diagnostics $ 0.02 5.9% 13 PNV Polynovo Limited $ 1.21 5.7% 888 IDX Integral Diagnostics $ 2.42 5.7% 871 NAN Nanosonics Limited $ 4.80 5.5% 1,486 CYP Cynata Therapeutics $ 0.20 5.4% 44 VBS Vectus Biosystems $ 0.08 5.3% 4 RHT Resonance Health $ 0.04 5.1% 16 RMD ResMed Inc. $ 36.68 4.9% 54,516 ALC Alcidion Group Ltd $ 0.09 4.9% 117 SIG Sigma Health Ltd $ 3.02 4.9% 35,436 ACL Au Clinical Labs $ 3.12 4.7% 621 COH Cochlear Limited $ 274.59 4.7% 17,937 OCA Oceania Healthc Ltd $ 0.57 4.6% 424 HLS Healius $ 1.46 4.3% 1,106 CU6 Clarity Pharma $ 2.20 4.3% 850 FPH Fisher & Paykel H. $ 31.51 4.2% 19,006 SNZ Summerset Grp Hldgs $ 10.55 4.1% 2,537 TRU Truscreen $ 0.03 3.7% 16 ARX Aroa Biosurgery $ 0.44 3.5% 159 TLX Telix Pharmaceutical $ 27.13 2.3% 9,853 AFP Aft Pharmaceuticals $ 2.34 1.7% 245 CYC Cyclopharm Limited $ 1.17 1.7% 133 SHL Sonic Healthcare $ 26.08 1.2% 12,538 CSL CSL Limited $ 251.13 0.7% 123,518 REG Regis Healthcare Ltd $ 6.81 0.7% 2,208 PCK Painchek Ltd $ 0.04 0.0% 66 SPL Starpharma Holdings $ 0.09 0.0% 38 AVE Avecho Biotech Ltd $ 0.01 0.0% 16 VFX Visionflex Group Ltd $ 0.00 0.0% 10 ACR Acrux Limited $ 0.02 0.0% 9 EPN Epsilon Healthcare $ 0.02 0.0% 8 IVX Invion Ltd $ 0.10 0.0% 8 PAB Patrys Limited $ 0.00 0.0% 5 TD1 Tali Digital Limited $ 0.00 0.0% 3 OSX Osteopore Limited $ 0.02 0.0% 3 IMC Immuron Limited $ 0.07 -0.7% 15 CUV Clinuvel Pharmaceut. $ 11.36 -0.9% 580 BOT Botanix Pharma Ltd $ 0.45 -1.1% 904 EBO Ebos Group Ltd $ 34.20 -1.2% 7,017 NOX Noxopharm Limited $ 0.08 -1.2% 22 M7T Mach7 Tech Limited $ 0.34 -1.5% 84 ONE Oneview Healthcare $ 0.29 -1.7% 216 RAC Race Oncology Ltd $ 1.05 -1.9% 212 CTE Cryosite Limited $ 0.78 -1.9% 38 PTX Prescient Ltd $ 0.05 -2.1% 38 NEU Neuren Pharmaceut. $ 11.66 -2.3% 1,573 SDI SDI Limited $ 0.84 -2.3% 100 RHC Ramsay Health Care $ 33.26 -2.5% 7,860 VHL Vitasora Health Ltd $ 0.04 -2.6% 60 MYX Mayne Pharma Ltd $ 7.03 -2.8% 571 ILA Island Pharma $ 0.16 -3.0% 38 MX1 Micro-X Limited $ 0.06 -3.2% 37 IMM Immutep Ltd $ 0.27 -3.6% 394 OIL Optiscan Imaging $ 0.14 -3.6% 113 PYC PYC Therapeutics $ 1.18 -3.7% 714 IRX Inhalerx Limited $ 0.03 -3.8% 5 CGS Cogstate Ltd $ 1.33 -4.3% 227 VLS Vita Life Sciences.. $ 1.82 -4.5% 99 AGH Althea Group $ 0.02 -4.5% 19 AHC Austco Healthcare $ 0.28 -5.1% 100 TRJ Trajan Group Holding $ 0.81 -5.3% 128 HMD Heramed Limited $ 0.02 -5.3% 15 EMV Emvision Medical $ 1.96 -6.2% 164 NYR Nyrada Inc. $ 0.10 -7.0% 23 TRI Trivarx Ltd $ 0.01 -7.1% 7 IPD Impedimed Limited $ 0.04 -7.3% 71 NUZ Neurizon Therapeutic $ 0.12 -7.7% 69 EZZ EZZ Life Science $ 1.43 -7.7% 65 LGP Little Green Pharma $ 0.12 -8.0% 36 MSB Mesoblast Limited $ 1.80 -8.4% 2,367 BMT Beamtree Holdings $ 0.22 -8.5% 62 PSQ Pacific Smiles Grp $ 1.76 -8.6% 284 IIQ Inoviq Ltd $ 0.37 -8.6% 45 NXS Next Science Limited $ 0.10 -9.1% 26 PER Percheron $ 0.01 -9.1% 10 EMD Emyria Limited $ 0.03 -9.7% 15 ANN Ansell Limited $ 30.30 -10.5% 4,512 ATH Alterity Therap Ltd $ 0.01 -11.1% 78 OSL Oncosil Medical $ 0.00 -11.1% 16 CMP Compumedics Limited $ 0.31 -11.6% 58 AGN Argenica $ 0.68 -11.8% 93 MDR Medadvisor Limited $ 0.10 -12.7% 57 PAR Paradigm Bio. $ 0.29 -13.6% 121 VIT Vitura Health Ltd $ 0.07 -13.8% 48 TYP Tryptamine Ltd $ 0.03 -13.9% 45 BIT Biotron Limited $ 0.00 -14.3% 4 BP8 Bph Global Ltd $ 0.00 -14.3% 1 IME Imexhs Limited $ 0.34 -15.0% 17 NC6 Nanollose Limited $ 0.03 -15.0% 9 ACW Actinogen Medical $ 0.03 -15.6% 83 DOC Doctor Care Anywhere $ 0.08 -15.8% 30 UBI Universal Biosensors $ 0.06 -15.9% 16 AYA Artryalimited $ 0.63 -16.0% 76 EOF Ecofibre Limited $ 0.02 -16.0% 7 TRP Tissue Repair $ 0.22 -17.0% 12 MAP Microbalifesciences $ 0.17 -17.1% 82 CSX Cleanspace Holdings $ 0.39 -17.2% 29 ZLD Zelira Therapeutics $ 0.38 -17.4% 5 LTP Ltr Pharma Limited $ 0.38 -18.5% 73 RCE Recce Pharmaceutical $ 0.29 -18.7% 78 IBX Imagion Biosys Ltd $ 0.01 -18.8% 3 SOM SomnoMed Limited $ 0.45 -18.9% 95 GSS Genetic Signatures $ 0.41 -19.0% 110 CVB Curvebeam Ai Limited $ 0.10 -20.0% 39 CBL Control Bionics $ 0.04 -20.0% 11 CTQ Careteq Limited $ 0.01 -20.0% 3 GLH Global Health Ltd $ 0.09 -21.7% 5 RAD Radiopharm $ 0.02 -22.2% 51 CDX Cardiex Limited $ 0.06 -22.7% 23 UCM Uscom Limited $ 0.02 -23.3% 6 RGT Argent Biopharma Ltd $ 0.13 -23.5% 8 RHY Rhythm Biosciences $ 0.06 -23.8% 19 NTI Neurotech Intl $ 0.03 -24.2% 25 CMB Cambium Bio Limited $ 0.23 -24.6% 4 BDX Bcaldiagnostics $ 0.08 -24.9% 30 IMU Imugene Limited $ 0.02 -25.0% 172 1AD Adalta Limited $ 0.01 -25.0% 4 FRE Firebrickpharma $ 0.07 -25.3% 15 MVF Monash IVF Group Ltd $ 0.84 -26.0% 334 SNT Syntara Limited $ 0.06 -26.3% 99 PIQ Proteomics Int Lab $ 0.36 -28.0% 54 ANR Anatara Ls Ltd $ 0.01 -28.6% 1 ATX Amplia Therapeutics $ 0.05 -30.0% 21 EBR EBR Systems $ 1.22 -30.3% 464 PEB Pacific Edge $ 0.08 -31.8% 61 HIQ Hitiq Limited $ 0.03 -32.4% 11 CAN Cann Group Ltd $ 0.02 -36.0% 10 ADR Adherium Ltd $ 0.01 -36.4% 5 MEM Memphasys Ltd $ 0.01 -44.4% 12 NeuroScientific Biopharmaceuticals (ASX:NSB) rose 35.1% after sealing a deal to acquire StemSmart, a patented stem cell tech from Isopogen WA, giving it full rights to produce next-generation cell therapies using mesenchymal stromal cells (MSCs). Early trial results in Crohn's patients are promising, showing the treatment is safe, effective, and potentially life-changing. To fund the move, NeurosScientific has raised $3.5 million. It also has refreshed its board, including industry veterans and a new chief scientific adviser. Oncology drug developer Chimeric Therapeutics (ASX:CHM) was up 20% in April. The company announced that Emory Winship Cancer Institute in Atlanta was open to enrol patients in the phase 1/2 multi-centre clinical trial (NCT06055439) for CHM CDH17 cell therapy. The phase 1/2 trial is a two-stage study designed to determine a recommended phase II dose of CHM CDH17 and evaluate its safety and objective response rate in patients with advanced colorectal cancer, gastric cancer, and intestinal neuroendocrine tumours (NETs). Imricor Medical Systems (ASX:IMR) also had a strong month, up 17.4% after positive news including launching its pivotal European clinical trial for ventricular tachycardia (VISABL-VT) – marking a series of world-first milestones – and securing CE Mark certification for its Advantage-MR system under the European Union's new Medical Device Regulation (MDR). Imricor is pioneering real-time interventional cardiac MRI (iCMR) ablations – using MRI instead of traditional x-ray fluoroscopy to treat cardiac arrhythmias faster, safer and more effectively. Health-imaging stock ProMedicus (ASX:PME) was up 14.8% in April. The company announced owned US subsidiary Visage Imaging, Inc. had signed a multi-year research collaboration deal with UCSF. "I think ProMedicus just got oversold and it went down to around $150 at one point from just shy of $300," Wilkie said. "These sorts of quality stocks always come back to the fore."
Mercury
23-04-2025
- Business
- Mercury
StockTake: Orthocell
Don't miss out on the headlines from Stockhead. Followed categories will be added to My News. Regenerative medicine developer Orthocell (ASX:OCC) has appointed the first four US distributors for its flagship nerve repair product Remplir. The appointments follow FDA clearance for Remplir which landed earlier this month, and Orthocell are expecting first sales in the US very soon. Today, the US' nerve repair market is valued at US$1.6 billion. Orthocell will tap this market through distributors in Michigan, Virginia, Colorado and Indiana. Orthocell aims to appoint up to 10 US distributors by the end of June this year. Watch the video to hear more. This video was developed in collaboration with Orthocell, a Stockhead advertiser at the time of publishing. This video does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions. Originally published as StockTake: Orthocell to enter the US market
