Avaí Bio and Austrianova begin San Raffaele diabetes cell trial

The joint venture Insulinova has convened its first steering committee with OSR to evaluate encapsulated beta-cell replacement for insulin-dependent diabetes.

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A large scientific apparatus crafted from clear glass and metal, featuring multiple circular reaction chambers filled with a white bubbly suspension, is brightly illuminated by a horizontal light tube in a blurred laboratory setting.

Avaí Bio and Austrianova have held the inaugural joint steering committee meeting with Ospedale San Raffaele (OSR) for their shared diabetes cell therapy programme, marking the formal start of experimental work under the three-party collaboration.

The meeting brought together senior researchers from all three organisations, including Prof. Lorenzo Piemonti, Director of the Diabetes Research Institute at OSR, and Dr. Brian Salmons, Chief Executive of Austrianova. The session was used to align on experimental priorities and an initial development roadmap.

The programme

Avaí Bio and Austrianova established Insulinova as an equally owned joint venture to pursue encapsulated cell-based therapies for diabetes. Under the OSR collaboration, the partners will test whether Austrianova's proprietary Cell-in-a-Box encapsulation platform can maintain the viability and function of stem cell-derived beta cells developed by OSR's Beta Cell Differentiation Unit.

The immediate scientific question is a straightforward but critical one: can encapsulated beta cells survive and continue to produce insulin under controlled laboratory conditions? If the data are encouraging, the programme would progress to assessing whether encapsulation can provide meaningful immune protection for transplanted cells, a persistent obstacle in beta-cell replacement strategies.

Chris Winter, Chief Executive of Avaí Bio, described the meeting as an opportunity to generate "the data needed to assess how the two technologies perform together." Prof. Piemonti was candid about the programme's early stage, saying the immediate priority is "to establish whether the approach can preserve beta-cell viability and function under well-controlled experimental conditions," with those data determining whether further development is warranted.

Market context and competitive landscape

Beta-cell replacement and encapsulation technology represent a long-pursued but technically difficult avenue in type 1 diabetes research. The field has attracted renewed attention following the approval of Vertex Pharmaceuticals' exa-cel gene-editing cell therapy in late 2023 and the broader excitement around stem cell-derived islet transplantation. Several academic and commercial groups, including Sernova, ViaCyte (now part of Vertex) and Uppsala-based Convacell, have explored encapsulation or immune-shielding approaches with varying results, and none has yet achieved a fully immune-protected, long-term functioning implant in humans at commercial scale.

The Insulinova programme is at an early preclinical stage and should be understood in that context. Avaí Bio is a small-cap OTCQB-listed company, and Austrianova, headquartered in Singapore, is a specialist cell encapsulation firm. Neither organisation has disclosed funding committed to the programme, timelines to preclinical data readouts, or a projected path to clinical trials. Investors and clinicians will look for the initial viability and function data as the first meaningful signal of whether the Cell-in-a-Box platform is compatible with OSR's stem cell-derived beta cells before drawing conclusions about the programme's broader potential.

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