Latest news with #Remplir
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
