Latest news with #Orthocell
News.com.au
12-05-2025
- Business
- News.com.au
Health Check: Greenland and Canada can wait; Trump declares war on drug prices instead
The Prez reckons US drug prices could fall up to 80% by referencing them against other countries' lower costs Vitura Health eyes 20% underlying earnings improvement this financial year Orthocell wins Hong Kong approval for Remplir Donald Trump is having another crack at drastically reducing drug prices, a move that could advantage some patients but lead to others being denied life-saving treatments. As with all Trumpian pronouncements, the proposed execution and the likely consequences are unclear at this juncture. In his favourite conduit – Truth Social – Trump rekindled the 'most favoured nation' concept, by which drug prices would be references to the cheapest countries. 'I will be signing one of the most consequential Executive Orders in our Country's history. Prescription Drug and Pharmaceutical prices will be REDUCED, almost immediately, by 30% to 80%,' he declared. 'I will be instituting a MOST FAVORED NATION'S POLICY whereby the United States will pay the same price as the Nation that pays the lowest price anywhere in the World.' As CNN reports, his previous attempt in late 2020 was blocked by the federal courts and rescinded by Joe Biden when he came to power. 'It would have applied to Medicare payments for certain drugs administered in doctors' offices,' CNN says. 'However, it is unclear what payments or drugs the new directive would apply to.' The policy would provide welcome savings to the nation's public Medicare system. It's estimated the first iteration would have saved US$86 billion a year. But if pharma companies aren't being adequately compensated for the humungous cost of drug development, fewer therapies would become available. Not surprisingly, big pharma will object and they have the lobbying power to make a big noise. Meanwhile, the Prez intends to impose tariffs on imported pharmaceuticals, but he is yet to outline what he has in mind. Vitura's strategy rethink hits the jack-pot Medical cannabis intermediary Vitura Health (ASX:VIT) reports the first green sprouts from last year's 'strategy reset' and recent acquisitions. With the local medical pot sector riven with oversupply, Vitura has a differentiated strategy of running telehealth, clinics and an online purchasing platform. It sure beats growing the stuff. After a wobbly period Vitura is reaping the benefits, as outlined in today's comprehensive – albeit convoluted – financial update. In short, Vitura forecasts that June quarter revenue will support an 'annualised revenue rate' of more than $138 million, 11% higher than the previous year's $124 million. Management forecasts current-year earnings before interest, tax depreciation and amortisation (ebitda) to improve 20%, compared with the previous year's subdued $6.2 million. Vitura's revenue and ebitda have increased 'successively' in the months of February, March and April. 'We've got the fundamentals of the business back on track and we're looking forward to continuing that momentum into the near and mid-term future,' CEO Geoff Cockrill says. The strategy manifesto targeted 10% growth in revenue for the 12 months to June 2025, as well as a 3% improvement in its ebitda margin and a 10% operating expenditure efficiency gain. While the revenue run rate is on target, actual current-year revenue should fall 'slightly short'. Vitura owns the Canview marketplace, Doctors on Demand telehealth business, CDA Clinics (medical cannabis telehealth) and a medical cannabis online marketplace. In February Vitura acquired the Queensland-based medicinal cannabis clinic chain Candor Medical for $5.9 million. The update also reflects a full year's contribution from the company's 50% interest in the Releaf Group, acquired last November. Vitura shares have lost about one-quarter of their value over the last 12 months, but this morning popped up about 4%. Orthocell wins Hong Kong approval Having won FDA approval in early April for its flagship nerve repair product Remplir, Orthocell (ASX:OCC) now has the go-ahead to sell in the 'strategically important' Hong Kong market. The company notes the go-ahead from the territory's authorities was due in the December quarter – but came only one month after Orthocell lodged its application. This swift turnaround was testament to Remplir's product quality and supportive clinical data, the company said. A collogen wrap, Remplir is used in nerve repair surgery to achieve a better result. Not surprisingly, Orthocell will focus its attention on the capacious, US$1.6 billion-a-year US market, where it is 'making significant progress towards imminent first sales'. But Hong Kong is a tempting morsel, with the assent adding to approvals in Singapore and Thailand, Australia, New Zealand and Canada. The company is eyeing European and UK approval within the next six months. Outside Of the US, the company will use specialist distributors 'with minimal additional internal resources required'. Orthocell cites a US$3.5 billion a year global opportunity, with its approved jurisdictions accounting for US$1.8 billion. Radiopharm ups it dosage in early cancer trial Radiopharm Theranostics (ASX:RAD) has won approval to continue its phase I dose escalation trial for a variety of solid cancers, without any modifications. An independent group that reviews of unblinded study data, the Data Safety and Monitoring Committee deemed the trial to be safe after probing data from the first four patients in the first cohort. The study can advance to a second cohort, at double the dose. The trial tests out the lutetium isotope-based 177Lu-RAD204, which targets cancers expressing the PD-L1 protein biomarker. The trial started out with non-small cell lung cancer. It is being expanded to other tumour types including small-cell lung cancer, triple-negative breast cancer, cutaneous melanoma, head and neck squamous cell carcinoma and endometrial cancer. The company is conducting the trial across four local clinical sites, with the second cohort due to be enrolled in mid 2025. Avita Medical expands from burns, but still burns cash Engorged by new product approvals, wound care house Avita Medical (ASX:AVH) is chalking up impressive revenue – but still is incurring heavy loses. Avita on Friday said unaudited revenue for the March quarter leaped 65% year on year, to $US18.3 million ($28.6 million). This was on the back of sales of its Recell spray-on-skin, invented by legendary Perth burns surgeon Professor Fiona Wood. This revenue was supplemented by its more automated Recell Go kit, recently approved by the FDA. Avita also benefits from leasing revenue from its Recell processing device, its Permeaderm wound dressing and its Cohealyx collage-based dermal matrix. But commercialisation comes at a cost, with Avita reporting a net loss of US$13.8 million compared with a US$18.6 million deficit previously. Avita ended March with cash and equivalents of US$25.8 million and can 'continue its planned operations for at least the next 12 months'. Avita says its product extensions have expanded its reach from its initial US$455 million-a-year addressable burns market to a US$3.5 billion burns and trauma sector. But since inception the company has lost US$374 million, so it hasn't been an easy journey. Avita shares today lost 6%, taking the post-announcement retreat to around 20%.
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
Perth Now
06-05-2025
- Business
- Perth Now
Crown boss to offload $7m mansion for penthouse downsizer
It's just as well blue-chip businessman John Van Der Wielen doesn't get too emotionally attached to his properties — otherwise, letting go of his recently listed Attadale residence might be a challenge. The luxurious five-bedroom, four-bathroom home, set on a sprawling 974sqm riverside block, has hit the market with a price in the $7 million range. Mr Van Der Wielen, who chairs both Crown Perth and the wildly successful nerve regeneration biotech Orthocell, is looking to downsize to a penthouse apartment. He and his wife Robin — founder of Perth-based Flower Box Home Fragrance — are ready for a more 'lock-up-and-leave' lifestyle to accommodate their frequent travels. Despite the many fond memories created in the home, Van Der Wielen admits he's never been one to get too sentimental about real estate — even after living in Sydney (twice), London (twice) and Luxembourg. 'I've moved around a lot in the past 20 years,' he said. 'Selling houses has never worried me because I don't get too emotionally attached.' This pragmatic approach likely makes it easier to part with the spectacular three-level residence, which features panoramic river views, a private lift, smart wiring, commercial-grade ducted air conditioning, underfloor heating in the ensuite, and advanced security systems. The luxurious five-bedroom, four-bathroom home is set on a sprawling 974sqm riverside block. Credit: supplied The home also includes multiple fireplaces, a heated magnesium pool and a six-car garage complete with a full bathroom. Mont Property's Matthew Podesta said the property was a finalist in the Housing Industry Association's awards when it was built. 'This home rivals some of the finest international luxury hotels — its craftsmanship, premium fixtures, and impeccable finishes truly set it apart,' he said. The home was a finalist in the Housing Industry Association's awards when it was built. Credit: supplied John Van Der Wielen's home in Attadale Credit: supplied Van Der Wielen's frequent travel for Orthocell — whose board includes esteemed names such as Professor Fiona Wood and Kim Beazley — is part of what motivates the move. He also serves as a non-executive director with the Royal Flying Doctor Service. With his granddaughter now based in Scotland, he anticipates spending more time in the UK and is even considering purchasing a property there. Still, no matter how far his travels take him, the former Hamilton Hill High School student says Perth will always be home. John Van Der Wielen's home in Attadale. Credit: supplied
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
