Infection prevention specialist Nanosonics (ASX: NAN) has been granted ‘De Novo’ clearance by the US Food and Drug Administration (FDA) for its innovative CORIS system designed to improve cleaning outcomes for flexible endoscopes.

🧪 Establishes CORIS as a completely new category for endoscope cleaning technology in the US
💊 Marks a key step in the company’s commercialisation efforts for CORIS in the lucrative American market
🧬 First phase of commercialisation push remains on track for the first quarter of FY26

“CORIS represents a significant opportunity for the organisation and the FDA de novo clearance marks a key milestone for the Company and an important step in bringing this much needed innovation to market.” – Michael Kavanagh, Nanosonics Chief Executive Officer and President

Medical device business EMVision (ASX: EMV) has successfully tested its ‘First Responder’ brain scanner in aeromedical conditions, marking a key step toward faster stroke and traumatic brain injury diagnosis for patients in remote and rural areas.

🚁 Testing performed in collaboration with the Royal Flying Doctor Service (RFDS) and the Australian Stroke Alliance, with scans successfully completed in-flight
🏥 Demonstrates ability for the scanner to withstand physical stress, environmental conditions, and operational constraints unique to aeromedical retrieval
🩺 Planning separate study with the Melbourne Mobile Stroke Unit (MSU) to test the device alongside standard CT scans during emergency stroke response

“These studies are a key step in the development program of the EMVision First Responder device and learnings generated will inform progress from the current advanced prototype to production equivalent commercial units. We are excited by the opportunity to have a substantial positive impact in the reduction of the global burden of stroke.” — Scott Kirkland, EMVision Chief Executive Officer

Biotechnology business AdAlta (ASX:1AD) has secured its first external investment for the group’s ‘East to West’ growth strategy centred on in-licensing immunotherapies for solid cancers from the ‘East’ (Asia) and providing a pathway for these products to reach ‘Western’ markets.

🧬 SYNthesis BioVentures Fund (SYNBV) is investing up to $2 million in seed financing in AdCella, an unlisted subsidiary of AdAlta
💊 Facilitates accelerated planning and preparation for three previously announced cellular immunotherapy assets being considered for licensing by AdCella
🩺 SYNBV has a right to invest a further $5.5 million in the newly launched Series A funding round for AdCella
⚕️ AdAlta will own at least 75% of AdCella immediately prior to the Series A funding round

“This Agreement between AdAlta and SYNBV is a watershed event for our Company, with it being a clear vote of confidence in our “East to West” cellular immunotherapy strategy. The seed financing provided by SYNBV to our AdCella subsidiary represents AdCella’s first instalment of external funding and is the outcome we anticipated when we first signed our Memorandum of Understanding with SYNBV." - Tim Oldham, AdAlta Chief Executive Officer and Managing Director

Shares in Aussie retailer Myer (ASX:MYR) have been moving lower, but why?

#myer #shopping #stocks #finktock #finance #ASX #ASXstocks

Clinical stage drug development company Syntara (ASX: SNT) has unveiled its next-generation topical anti-fibrotic drug known as SNT-9465, which is designed to improve the appearance and structure of skin scars. The company is now planning clinical trials in 2025 with results expected early next year.

💊 Seeks to provide easier and more effective daily treatment option compared to expensive and painful existing standards of care for scar treatment
🧪 Phase 1a/b clinical trials to commence in Q2 2025 to assess safety and early effectiveness in treating hypertrophic scars
💉 Results will support an FDA Investigational New Drug (IND) application,
paving the way for a global development program

“With a cost-effective and efficient clinical development strategy, we aim to deliver an IND ready program with evidence supporting safety and efficacy in 2026. The work underway with UWA and the Fiona Wood Foundation will allow us to expand the label indications into other scar types” – Gary Phillips, Syntara Chief Executive Officer

Tesla’s (NASDAQ: TSLA) share price is down by nearly 40% since the start of the year and things might have just gotten worse.

#Tesla #Elon #EVs #BYD #stocks #fintok #finance #techstocks

Cleo Diagnostics (ASX: COV) is advancing the commercialisation push for its ovarian cancer detection test with technology transfer activities taking the group closer to FDA approval in the US. The group is concluding negotiations with Contract Manufacturing Organisations (CMOs) as it assesses the optimal option for bringing the test to market.

🧪 Marks a critical milestone for the manufacturing pathway of the diagnostic test
💊 Cleo is now aiming to bring to market a diagnostic test kit which is compliant with the US Food and Drug Administration (FDA)
🧬 Negotiations with CMOs are in advances stages as Cleo weighs up the most suitable commercialisation option based on manufacturing capability, regulatory compliance, and ability to scale

“The commencement of technology transfer marks a pivotal milestone in CLEO`s strategic pathway toward commercialisation. During this phase, we refine and scale our assay technology, to ensure the Company is well positioned to progress its Ovarian Cancer test from prototype production to a commercially available, FDA-compliant diagnostic kit.” – Dr Richard Allman, Cleo Diagnostics Chief Executive Officer

There could be a new massive gold company in town, that is if a newly proposed $2.4 billion acquisition gets shareholder approval....

#finance #stocks #copper #mining #copperminers #ASX #ASXstocks #miners