OminiWell

🚨 A pivotal shift in drug development The U.S. Food and Drug Administration (FDA) has released draft guidance supporting New Approach Methodologies (NAMs) as alternatives to animal testing; marking a major step toward human-centric drug development. At OminiWell, this aligns directly with our mission. Human-relevant models, such as organoids and organ-on-chip systems, offer: ➡️ Better prediction of human responses ➡️ Improved safety before clinical trials ➡️ Faster paths to market With clear validation principles now outlined, the regulatory pathway for NAMs is becoming stronger than ever. This is more than progress: It’s a shift toward more predictive, efficient, and ethical science. https://lnkd.in/eWXrt7RQ #NAMs #DrugDevelopment #FDA #OrganOnChip #Biotech #Innovation

OminiWell team is thrilled to be heading to AusMedtech 2026 at Crown Towers, Perth, from 19–21 May! This year’s theme, Medtech Unlocked, marks the pivotal shift for our industry, moving beyond potential to achieve global scale and commercial success. We looking forward to joining medtech pioneers, researchers, and investors at Australia’s leading meeting place to navigate the road to market and advance our medtech ecosystem together. We can't wait to explore the partnerships that will unlock our future and shape the next era of healthcare. Hope to see you there! https://lnkd.in/g6ZGkGxc #AusMedtech2026 #AM26 #Medtech #MedtechUnlocked #Innovation

Wishing everyone a Merry Christmas and a Happy New Year 🎄 May the festive season bring you joy, rest, and renewed energy as we look forward to an exciting year ahead ✨

🚀🚀 🚀On 16 December 2025, the U.S. Senate passed the FDA Modernization Act 3.0 — another step towards broader adoption of human-relevant, non-animal nonclinical testing. This strengthens the pathway for NAMs (advanced in vitro systems, computational models, and organ-on-a-chip). At OminiWell, we’re advancing BioTwin™ to model tissue microenvironments using complex, multicellular co-culture systems for disease modelling and therapeutic development. #FDAModernization #OrgansOnChips #HumanRelevantScience #NonclinicalTesting #BiotechInnovation #DrugDevelopment https://lnkd.in/e9SzgNXc

🌟 We are thrilled to share that OminiWell has been recognised as a Fearless Impact Prize at the 2025 Fearless Innovator Grant Program Awards! It’s an honour to stand alongside so many incredible women-led ventures who are scaling, innovating, and fearlessly shaping the future. 💡✨ A huge thank you to Women in Innovation_sa and the generous sponsors for backing founders who dare to push boundaries. Special gratitude to Oranje. brand + creative for supporting OminiWell with a brand development package — a powerful step as we continue building the future of personalised medicine with our BioTwin Chip technology. Congratulations to all the Fearless Innovator and the winners — your bold visions inspire us all! 🚀 #FearlessInnovator #OminiWell #WomenInInnovation #PersonalisedMedicine #BioTwinChip #FearlessFuture Sylvia C.

20 Finalists. One Fearless Night. Meet our 2025 Fearless Innovators This year’s finalists are a powerhouse group of women-led ventures solving real-world problems - from gamified mental health tools to AI-driven cancer platforms, sustainable tourism to zero-waste design. On Friday 22 August, they take the stage at the 2025 Fearless Innovator Awards Night at the National Wine Centre. We’ll award $120,000 in grants to South Australia’s leading female founders - presented by Katherine Bennell-Pegg, Australia’s first female astronaut and the first to qualify under the Australian flag. Book now: https://lnkd.in/gZqb97T6 2025 Finalists Snapshot!: Natalie Radford + Courtney Radford: SKOOT Community Access Award-winning transport services supporting people with disabilities. Her work puts dignity and independence first. Jo Schneider: DVE Business Solutions Helping organisations future-proof their workforce through smart systems and strategic leadership. Isobel Marshall + Jasmine Beger: ACRO A platform supporting women through midlife with health education and a menopause-conscious supplement. Clair Crowley: Ocean Kind Creating Circular solutions for the fishing industry - South Australia’s first facility of its kind. Victoria Braithwaite: The Family Cook Nutritious meals for older Australians - bridging care, comfort, and culture. Christel Cherryadi ✨: Mirror XR AI and extended reality for wellbeing and therapeutic care. Rachel Titley: She Farmer Equipping regional women with tools and know-how to thrive in agriculture. April Benjamin: My Colourful Mind (MCM) Game-based tool making mental health conversations safer and more empowering. Laura Tolson: Lateral Vision Immersive media and spatial tech creating bold visual experiences. Cathy Domoney: The Backyard Peace Project (BYPP) Supporting emotional resilience and fearless leadership - from the backyard out. Tamsin Simounds: Jump Proof Tackling one of women’s most common - and least talked about - health challenges: bladder leakage. Sanjam Kohli: Chefadora A digital platform celebrating cultural food stories through taste and tech. Kelly Kuhn: Juggle House Experiences + River Murray Dark Sky Tours Stargazing tours showcasing regional South Australia. Rebecca Starling: The Star Hunch Board A tool that makes complex conversations visible and solvable. Sylvia C.: OminiWell Precision oncology helping clinicians personalise cancer treatment. Tiffany Murray: ROOM Curated homewares that feel personal, intentional and made to belong. Kat Bidstrup: Think Digital Immersive tech solving problems in agriculture and rural education. Lauren Moularadellis: The Lumia Group Reimagining laundry care with fragrance, performance, and planet-positive packaging. Amy Smith: Secure State Cybersecurity using AI and data to protect environments and support decisions. Eloise Hall: TABOO A certified social enterprise selling premium period products to help end period poverty.

My dear LinkedIn friends: I’m proud to be a 2025 Fearless Innovator Grant Program Finalist! Honoured to be recognised among so many brilliant, bold female founders. Let’s celebrate together at the 2025 Fearless Innovator Grant Awards Night: Date: Friday 22 August, 2025 Time: 6:00–10:00pm Venue: National Wine Centre Grants Awarded: $120,000 Tickets: Donors attend free | Early Bird $150 (until 31 July) Booking Link: https://lnkd.in/gfRsbAZR #innovation #personalisedmedicine #curecancer #organonachip #nonanimalexperiment #cancerresearch

🚨 FDA to Phase Out Animal Testing Requirements for Monoclonal Antibodies and Other Drugs 🚨 A pivotal moment in biomedical research and drug development: The U.S. FDA has announced its plan to phase out the mandatory animal testing requirement for monoclonal antibodies and certain other drugs. This landmark change reflects a growing shift toward innovative, human-relevant models in preclinical testing. 🔗 Read the full announcement: https://lnkd.in/gBHEfUvb https://lnkd.in/gyXnqTrg https://lnkd.in/dsxXxaY4 At OminiWell, we’re committed to building a future where: ✅ Testing is faster, more predictive, and human-relevant ✅ Ethical research and personalised medicine converge ✅ Animal models are no longer the default, but the exception We welcome open conversations and partnerships with researchers, CROs, biotech and pharma innovators to co-develop the next generation of human-centred research platforms. 📩 Let’s connect if you’re ready to be part of this transition. #OminiWell #FDA #OrganOnAChip #MonoclonalAntibodies #BioTwinChip #FutureOfMedicine #HumanRelevantScience #CROCollaboration #PersonalisedMedicine #EndAnimalTesting #complexcellculture

🚨 FDA to Phase Out Animal Testing Requirements for Monoclonal Antibodies and Other Drugs 🚨 A pivotal moment in biomedical research and drug development: The U.S. FDA has announced its plan to phase out the mandatory animal testing requirement for monoclonal antibodies and certain other drugs. This landmark change reflects a growing shift toward innovative, human-relevant models in preclinical testing. 🔗 Read the full announcement: https://lnkd.in/gBHEfUvb https://lnkd.in/gyXnqTrg https://lnkd.in/dsxXxaY4 At OminiWell, we’re committed to building a future where: ✅ Testing is faster, more predictive, and human-relevant ✅ Ethical research and personalised medicine converge ✅ Animal models are no longer the default, but the exception We welcome open conversations and partnerships with researchers, CROs, biotech and pharma innovators to co-develop the next generation of human-centred research platforms. 📩 Let’s connect if you’re ready to be part of this transition. #OminiWell #FDA #OrganOnAChip #MonoclonalAntibodies #BioTwinChip #FutureOfMedicine #HumanRelevantScience #CROCollaboration #PersonalisedMedicine #EndAnimalTesting #complexcellculture