1. Blanca, what inspired you to co-found Triovance and focus on diabetic foot disease?
Diabetic foot disease is a pervasive and growing challenge, affecting up to 25% of people with diabetes at some point in their lives. Despite this, treatment outcomes have remained stagnant for decades, with standard-of-care healing rates stuck at around 40%. Diabetic ulcers often progress to infections, amputations, and can even be fatal—causing immense physical, emotional, and financial strain for patients and their families.
Like many others I’ve been impacted by the consequences of diabetic foot disease, having known someone who passed away after undergoing an amputation. I co-founded Triovance to deliver a novel solution that addresses the root causes of diabetic foot ulcers— impaired blood flow and reduced cellular regeneration—rather than just managing symptoms.
Drawing on more than 20 years’ experience in cell and gene therapy, we have developed a novel genetically modified skin substitute that addresses the root causes of diabetic foot disease. Our mission is to deliver a cost-effective, scalable solution that redefines the standard of care.
2. What makes TRV-01 different from current treatment options?
TRV-01 represents a paradigm shift, offering the first therapeutic solution designed to cure diabetic foot disease from within. Unlike conventional traditional therapies that only manage symptoms and often require extensive follow-up visits, hospitalizations, or invasive procedures, TRV-01 is a three- part therapeutic approach designed as a low-cost, non-invasive, scalable outpatient solution, requiring only one to two applications compared to the 16 or more often required with traditional treatments.
TRV-01 is cost-effective and scalable, differentiating it from other advanced therapies that are often prohibitively expensive or logistically challenging to implement. By reducing the need for hospital stays and lowering the overall treatment burden, TRV-01 promotes angiogenesis and improved cellular regeneration through the continuous secretion of insulin and VEGF directly into the wound bed. By curing from within, TRV-01 not only improves outcomes for patients but also reduces the financial strain on healthcare systems.
3. How does TRV-01 work?
TRV-01 is a full-thickness, non- immunogenic skin substitute designed to address the root causes of diabetic foot ulcers. Each cell in the skin graft is genetically engineered with a replicative- incompetent adenoviral vector to secrete two critical proteins: human insulin, which regulates inflammation, and vascular endothelial growth factor (VEGF), which improves blood flow directly at the wound site.
Together, these proteins act synergistically to promote healing. Additionally, TRV-01 provides an impermeable barrier that prevents infections and further tissue damage, creating an optimal environment for wound repair.
Preclinical studies show TRV-01 reduces advanced glycation end products and enhances vascular network formation, addressing critical issues caused by chronic hyperglycemia such as poor blood supply, impaired cellular function, and chronic inflammation that lead to diabetic foot disease. By enabling epithelialization and promoting angiogenesis, TRV-01 accelerates healing and restores the wound microenvironment. In diabetic models, treated wounds healed as quickly and completely as in non-diabetic conditions.
4. What milestones has Triovance achieved, and what’s next?
In the past year, we’ve made significant progress. Our preclinical studies have validated TRV-01’s safety and efficacy, demonstrating its ability to accelerate wound healing and restore tissue integrity in diabetic models. We’ve conducted our first pre-IND meeting with the FDA and addressed all suggestions. We’ve also optimized our manufacturing process to ensure scalability and cost-effectiveness, a critical step as we prepare for clinical trials.
Looking ahead, our immediate goal is to initiate a Phase 1b-IIa clinical trial in mid-2025, a milestone that will be pivotal for advancing TRV-01 toward regulatory approval. To achieve this, we are raising $6 million in Series A funding, which will support the production of GMP batches, toxicology studies, and other critical activities. In addition, we’re actively seeking a strategic partner to help make TRV-01 widely available.
5. What is your long-term vision for Triovance?
Our vision is to set a new global standard of care for diabetic foot disease by curing from within. Ultimately, we see tremendous potential in leveraging our proprietary technology platform to tackle other complex conditions tied to diabetes and chronic wounds as well.
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