Accelerating Regenerative Heart Therapies by Closing the Gap Together
Heart failure affects more than 60 million people worldwide. For patients with end‑stage disease, heart transplantation can be the only viable option—but a persistent shortage of donor organs leaves many without access to life‑saving treatment.
Today, Ibnova Therapeutics, the first spin‑out company from the Novo Nordisk Foundation Center for Stem Cell Medicine, reNEW, announced its incorporation in Denmark. Ibnova is advancing vascularised engineered heart tissue therapies for people living with severe heart failure, a condition where today’s treatments remain insufficient for too many patients.
Founded on world‑leading regenerative cardiology research from reNEW Melbourne, Ibnova brings discovery, venture creation, and early translational readiness together from day one through a close collaboration with reNEW, BioInnovation Institute (BII), and Novo Nordisk Foundation Cellerator.
An integrated model for translation
Advanced cell and tissue therapies do not follow a simple, linear path to patients. Success depends on aligning scientific discovery early with company building, process development, quality, scalability, and regulatory readiness. Ibnova represents the first joint regenerative medicine effort enabled across three Novo Nordisk Foundation initiatives. Together, this integrated model is designed to reduce friction, shorten timelines, and keep patient impact at the centre.
- reNEW provides regenerative biology expertise and scientific continuity, supporting maturation of the therapeutic assets.
- BII, including its Venture Lab platform, supports venture creation and early translation, helping build a company with clear clinical and commercial ambition.
- Cellerator embeds CMC, process development, analytics, and GMP‑readiness thinking from the earliest stages to support progression toward first‑in‑human trials.
“We are excited to advance the clinical translation of high-impact research into safe patient therapies. Supporting Ibnova Therapeutics through this cross-organizational collaboration marks a significant step forward in meeting the urgent need for effective cell therapy treatments for heart failure.” said Thomas Carlsen, CEO, Cellerator.
From discovery in Australia to company formation in Denmark
Ibnova is founded on research originating at reNEW’s Melbourne node, led by Professor Enzo Porrello (reNEW Melbourne, Murdoch Children’s Research Institute) in partnership with Professor James Hudson (QIMR Berghofer Medical Research Institute, Brisbane).
Over nearly a decade, their collaboration has advanced lab‑grown heart tissue engineered from human stem cells, with preclinical studies demonstrating safety and efficacy in animal models. Ibnova aims to progress toward first‑in‑human clinical trials within three to five years, with potential applications for both children and adults living with severe heart disease.
As the company establishes its presence in Denmark, the coordinated support structure is designed to preserve scientific ambition while strengthening the pathway to clinical development and patient access.
“With Ibnova, we can now bridge the hardest gap in medicine: turning breakthrough biology into a clinical-ready therapy. By combining Australia’s discovery engine with Denmark’s innovation ecosystem, we’re building a focused path to first-in-human trials by aligning manufacturing readiness, regulatory strategy, and clinical partnerships,” said Andrew Laskary, co-founder and CSO of Ibnova.
Early manufacturability as a foundation
For engineered cell and tissue therapies, manufacturability and quality are often the difference between promising science and a viable clinical product. By integrating CMC and quality by design thinking early, the collaboration aims to reduce late‑stage risk and enable a clearer route to patients.
“For advanced cell and tissue therapies, manufacturability cannot be an afterthought,” said Sarah Callens, CTO, Cellerator. “By analytical development, process development, and CMC readiness early, we help ensure that promising science can become therapies that are scalable, robust, and suitable for real‑world clinical use.” This early focus reflects Cellerator’s mission to build translational readiness from day one.
Venture creation with clinical reality in mind
Through BII’s Venture Lab programme, Ibnova is supported with infrastructure and expertise to translate early science into a venture designed for clinical progress. This includes strengthening the team, clarifying development and funding pathways, and ensuring early decisions align with future clinical and commercial requirements.
From deep science to patient impact
For reNEW, Ibnova exemplifies its mission to advance leading stem cell science into new therapies while maintaining scientific rigor throughout the translational journey.
“We are so proud of this team and the amazing preclinical progress they have made and will watch in anticipation as this moves along the value chain,” said Professor Melissa Little, CEO of reNEW. “I am also very excited about the growing opportunities available within the Danish innovation ecosystem. Bringing together BII with Cellerator to support a spin-out company in the cell therapy space is a unique opportunity.”
Fast‑tracking regenerative heart therapies to patients
Ibnova builds on world‑first work from Professors Enzo Porrello and James Hudson, advancing engineered human heart tissue from stem cells toward clinical application. The next milestone is progression toward first‑in‑human trials within three to five years.
“We are incredibly excited to announce the launch of Ibnova Therapeutics and move our heart patch technology toward clinical trials. This would not have been possible without the support of reNEW and our Novo Nordisk Foundation ecosystem partners in Denmark, Cellerator and BII,” Porrello said.
By bringing discovery, venture creation, and early CMC focus together from the start, Ibnova represents a new model for translating regenerative medicine—focused on delivering meaningful impact for patients who urgently need new options.
