Latest Market Entry News

Osteopore Limited has gained Swiss market approval for its 3D-printed bioresorbable implants under the EU Medical Device Regulation, completing its European product portfolio and strengthening its partnership with Zimmer Biomet.

HITIQ Limited is set to debut its PROTEQT concussion management system in the UK on August 4, 2025, uniquely integrating with NHS 111 telehealth services to offer free medical guidance. This launch marks HITIQ’s first international consumer market entry and a strategic step in its global expansion.

Imricor Medical Systems has secured key European regulatory approvals for its second-generation NorthStar system and initiated its commercial launch, while US FDA submissions progress amid some delays.

Orthocell Limited has reported a record FY2025 revenue of A$9.19 million, driven by strong sales of its nerve repair product Remplir™ in Australia and a promising US market launch following FDA clearance.

Almonty Industries has filed for a Nasdaq listing and launched a U.S. public offering to fund its tungsten oxide facility and strengthen its global supply position amid rising geopolitical tensions.

EVE Health Group has placed its first commercial purchase order for Dyspro™, a cannabinoid-based pharmaceutical targeting painful menstruation, signaling a key step toward market entry. The product is set for manufacturing and distribution within weeks, tapping into a rapidly growing global women’s health market.

Terragen Holdings has been granted a US patent for its microbial feed supplements, reinforcing its position in the animal probiotics market and supporting plans for US market entry.

Neurizon Therapeutics has inked a pivotal global licensing deal with Elanco Animal Health, unlocking critical intellectual property and data to accelerate the development and commercialisation of its lead drug candidate NUZ-001 for neurodegenerative diseases including ALS.

Echo IQ has initiated a pivotal clinical validation study with the Mayo Clinic Platform to test its EchoSolv HF software, marking the final step before its planned FDA submission in late 2025.

Green Critical Minerals’ McIntosh Graphite Project Pre-Feasibility Study confirms robust economics with a post-tax NPV of A$235 million and a 32.5-year mine life, underpinning plans for staged development and market entry.

LTR Pharma has successfully completed the extractables study for its intranasal erectile dysfunction spray SPONTAN, confirming safety compliance and initiating the next phase of leachables testing to support FDA approval.

Memphasys Limited has submitted its CE Mark application for the Felix™ sperm separation device, targeting regulatory clearance within 6-12 months to unlock the lucrative European IVF market and accelerate approvals in other key regions.