PolyNovo’s NovoSorb BTM technology has demonstrated promising first-in-human results as a novel delivery platform for pancreatic islet cell transplants in Type 1 diabetes, potentially redefining treatment approaches.
- First-in-human trial shows 3-year survival of transplanted islet cells using NovoSorb BTM
- NovoSorb creates a vascularised skin site allowing cell monitoring and topical immunosuppression
- Trial participants with longstanding Type 1 diabetes showed improved glycaemic control
- NovoSorb’s cell delivery platform could open a new business segment beyond wound care
- Collaboration underway with global cell therapy leaders targeting a $34 billion market
A New Frontier in Diabetes Treatment
PolyNovo Limited has announced compelling first-in-human results for its NovoSorb Biodegradable Temporizing Matrix (BTM) technology, marking a potential paradigm shift in treating Type 1 diabetes (T1D). Presented by Professor Toby Coates AO at a major European endocrinology congress, the proof-of-concept INCEPTR trial demonstrated that human pancreatic islet cells transplanted into a pre-vascularised skin site created by NovoSorb BTM survived and functioned effectively for over three years.
This innovative approach contrasts with the current standard of care, where islet cells are transplanted into the liver, a method plagued by a 75% cell loss within 48 hours and limited options for monitoring or retrieving transplanted cells. NovoSorb’s ability to form a vascular bed in the skin offers a more accessible and controllable environment for cell therapy.
Clinical Trial Insights and Patient Outcomes
The INCEPTR trial involved three participants with longstanding T1D who had previously undergone kidney transplants. NovoSorb BTM was implanted under local anaesthesia to create a vascularised site in the inner bicep, into which cadaveric human islet cells were transplanted. Two of the three patients showed positive c-peptide levels at three months, indicating functioning transplanted cells, while all participants exhibited improved glycaemic control over 12 months. Remarkably, one patient maintained normal blood sugar levels without additional cell infusions for over 2.5 years.
Professor Coates highlighted the unique advantages of NovoSorb BTM, including the ability to monitor the islet grafts in vivo and apply topical immunosuppression, potentially reducing systemic side effects. This contrasts sharply with hepatic transplantation, where monitoring and intervention are challenging.
Strategic Implications for PolyNovo
PolyNovo’s Chairman David Williams described these results as a “red-letter day,” signaling the emergence of a new business silo focused on cell delivery alongside its established wound care operations. The technology’s regulatory advantage, both NovoSorb and the islet cells are already approved, could accelerate market entry and adoption.
PolyNovo is actively collaborating with Beta Cell Technologies and other international partners, including Breakthrough T1D in Denmark and the Garvan Institute in Sydney, to further develop this cell therapy platform. The global cell therapy market is projected to reach USD 34 billion by 2034, positioning NovoSorb BTM as a potentially significant player.
Looking Ahead
While the trial’s small size limits broad conclusions, the durable graft function and improved patient outcomes provide a strong foundation for expanded research. PolyNovo plans to accelerate development pathways with expert guidance from Professors Coates and Greenwood, the latter being the original inventor of NovoSorb BTM.
As the company prepares for upcoming shareholder engagement and further clinical milestones, NovoSorb BTM’s success in this novel application could redefine cell therapy delivery and offer new hope for people living with Type 1 diabetes.
Bottom Line?
NovoSorb BTM’s promising clinical results could soon transform PolyNovo’s growth trajectory and the future of diabetes treatment.
Questions in the middle?
- Can larger trials confirm NovoSorb BTM’s long-term efficacy and safety in diverse patient populations?
- What regulatory hurdles remain for NovoSorb’s expanded use in cell therapies beyond wound care?
- How quickly can PolyNovo scale partnerships to capture a share of the growing cell therapy market?