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Health & Biotech
The medical sector is rapidly evolving as new technologies and scientific breakthroughs challenge traditional standards of care.
Personalised treatments, genetic testing and precision medicine are replacing a one-size-fits all approach and along with regenerative medicine and 3-D printing changing the way conditions are treated.
The ASX healthcare landscape is filled with plenty of disruptors in the field of medical treatments.
EBR has developed the WiSE Cardiac Resynchronization Therapy (CRT) system, which holds the distinction of being the world’s first leadless pacing system for heart failure.
EBR focuses on treating heart failure patients with ventricular dyssynchrony, where the right and left sides of the heart are out of sync. In these patients, the right side of the heart beats, but the left side lags.
The standard treatment involves placing a lead outside the left ventricle to pace both sides simultaneously, but these leads can sometimes fail.
Roughly the size of a cooked grain of rice, EBR’s ground-breaking WiSE technology employs proprietary wireless techniques to administer pacing stimulation directly to the heart’s left ventricle and overcome problems associated with current standard of care.
EBR recently announced the US Food and Drug Administration (FDA) had accepted its final premarket approval (PMA) application for the WiSE CRT System.
The company anticipates FDA approval in Q1 CY2025, remaining on track for commercial launch in CY25.
Interest in the emerging field of psilocybin – the active ingredient in magic mushrooms – has grown in recent years with various research demonstrating that psychedelics-assisted therapy holds great promise for helping people with a range of existing treatment-resistant mental health conditions.
However, while psychedelics have shown great promise, they are not without potential side effects, including bad trips, and are also challenging to administer.
TYP is pioneering a precision approach to psychedelics, targeting precise drug blood levels in patients to minimise the risk of side effects, while maximising the benefits of treatment.
The company’s lead program TRP-8803 is an IV-infusion of psilocin addressing many of the current limitations associated with orally administered psilocybin used by most competitors in the field.
TYP has several trials underway and is initially targeting three conditions including binge eating disorder, fibromyalgia and irritable bowel syndrome.
The regenerative medicine company is redefining nerve repair with its trademarked product Remplir. OCC said the collagen wrap used for nerve repair surgery enables the reduction of damaging sutures, creation of an optimal healing microenvironment and facilitation of free gliding within the repair site during the critical healing period.
Remplir is approved for sale in Australia and New Zealand with OCC announcing this week Singapore’s Health Sciences Authority (HSA) had also approved the product, enabling sales to start in Q1 CY25.
OCC is also targeting approval in other countries for Remplir, with clearance by the US FDA anticipated early next year, providing access to the world’s largest healthcare market.
The company’s other on market product Striate+ is a trademarked collagen membrane designed to support dental guided bone and tissue regeneration procedures.
It is designed to improve clinical outcomes by providing a strong barrier that aids in the regeneration of bone and soft tissue around the implant site.
Striate+ is currently available for sale in the US, Europe, UK, Australia, New Zealand and Canada.
Orthocell CEO and managing director Paul Anderson said the company was delighted with the continued growth in demand for Remplir within the Australian and NZ markets.
“Increasing market traction is being driven by surgeon feedback indicating that we have a best in class product that shortens surgery times, reduces trauma at the operative site and provides surgeons and patients with more consistent and predictable outcomes at a sooner time point,” he said.
“This is providing the perfect impetus required to drive us into the US market with FDA clearance expected in Q1 2025.”
The Australian and Singaporean based medtech specialises in the development of 3D-printed bioresorbable implants for neurosurgical, orthopaedic, and maxillofacial procedures, aiding natural bone healing.
Executive chairman Mark Leong told Stockhead the company was redefining the future of medical innovation.
“With every breakthrough, Osteopore disrupts conventional medicine by empowering the body to heal itself—revolutionising patient recovery and minimising the need for multiple surgeries,” he said.
“This is not just progress, it’s the now and future of healthcare, where science and nature converge to change lives.”
PAR is transforming the way osteoarthritis (OA) is treated, diminishing its impact by maintaining sufferers’ functional mobility, reducing pain and the need for surgical intervention.
The company is primarily focused on development of injectable pentosan polysulfate sodium (iPPS/Zilosul), an FDA-approved drug, for treatment of diseases such as OA and Mucopolysaccharidosis (MPS) where inflammation plays a major pathogenic role.
PPS was developed in the 1940s and has been widely used to treat bladder inflammation along with prevention of deep vein thrombosis within the EU.
PAR recently announced it had received a detailed set of comments from the US FDA following its Type D meeting response submitted in April 2024, which will progress its Phase 3 (PARA_OA_012) trial of iPPS for knee OA.
The regulator confirmed its Phase 2 clinical data supported the safety and tolerability of the twice weekly 2mg/kg dose of iPPS to treat knee OA.
PAR’s Phase 2 clinical trial data demonstrated a single six-week course of subcutaneous iPPS can provide 12-month pain relief and improved function in knee OA sufferers.
Data also showed improvement in cartilage volume and thickness at six months following treatment compared to placebo.
Managing director Paul Rennie told Stockhead PAR was harnessing the potential of iPPS to address a significant unmet need in OA treatment by providing long-term pain relief and improved joint function.”
“By reducing pain and enhancing mobility, iPPS is not only offering patients a better quality of life but also potentially reducing alternative medication use for the symptoms for OA and even delaying the need for surgical intervention,” Rennie said.
LTP is revolutionising erectile dysfunction (ED) treatment with its innovative SPONTAN technology, a fast-acting intranasal spray designed to work in 10 minutes or less.
Current treatment for ED is phosphodiesterase 5 (PDE5) inhibitors, delivered in pill form and dominated by big pharma brands, including Viagra, developed by Pfizer, Levitra by Bayer and Cialis by Eli Lilly.
LTP’s lead asset is set apart from existing ED therapies, which can take up to an hour to work, by its mechanism of action – intranasal delivery of a PDE5 inhibitor.
The nasal cavity is a highly vascular part of the body supporting even and rapid absorption of the drug, empowering it to work within 10 minutes or less, at a lower dose than traditional PDE5 oral tablets.
LTP recently announced its first select group of patients receiving Spontan under the Therapeutic Goods Administration (TGA) Authorised Prescriber Scheme (APS).
In August 2024 LTP announced it had agreed to a co-development partnership with US-listed Aptar Pharma (~US$10bn market cap) to commercialise Spontan in the US as well as other key markets globally.
At Stockhead, we tell it like it is. While Imricor, Paradigm Pharmaceuticals, Tryptamine Therapeutics, Orthocell and Paradigm Biopharmaceuticals are Stockhead advertisers, the companies did not sponsor this article.
Health & Biotech
Health & Biotech
Health & Biotech
