PORTFOLIO

Stress urinary incontinence is a disease that touches 1 in 5 women over the age of 40 and 1 in 10 women after childbirth. Incontinence is the involuntary leakage of urine that can happen anywhere and anytime in daily life when you are laughing, coughing, sneezing, or exercising. Stress urinary incontinence is due to a muscle problem. The pelvic floor and/or the sphincter muscle are not strong enough anymore to efficiently close the urethra when the intra-abdominal pressure suddenly increases. Nowadays available surgical therapies only treat the symptoms but not the cause of stress urinary incontinence. The so-called sling procedure is efficient but carries risks of serious complications, whereas the injection of Bulkamid is a minimal invasive intervention with a low risk of complications but the treatment is not very efficient on a long-term. Therefore, our aim is to develop a new injectable, minimal invasive therapy for stress urinary incontinence that strengthens the weak muscles to achieve a long-lasting relief for the patients with a low risk of complications.
The project funded by the Gebert Ruef foundation will help us to design the prototype in a rabbit model and to evaluate its functionality in a mini pig model. A successful completion of the project will result in the incorporation of our start-up company.

The novelty of our therapy is that it induces neo-muscle tissue formation. Our material is injected in the same way as Bulkamid and forms, as Bulkamid does, a stable bulk in the submucosal space of the urethra. The bulk reduces the inner diameter of the urethra and therefore the patient feels an immediate relief. The action of Bulkamid stops here. However, the bulk created by our material induces neo-muscle formation, so that the degrading bulk is replaced over time by new functional muscle tissue. The new muscle tissue strengthens the weak sphincter muscle achieving a long-lasting continence. Therefore, our therapy not only treats the symptom of stress urinary incontinence but also the cause. Furthermore, our controlled release platform technology that can induce neo-muscle tissue formation has potential to diversified to other indications for example cartilage regeneration.

The project is completed. We have proven stable bulk formation and muscle regeneration in a rabbit and a mini pig model. Despite the successful results, we did not incorporated our start-up yet. We learned that our new therapy will not be accepted on the cost level by hospitals. Hospitals calculate a budget of around 1000 Euro for an incontinence therapy. This price is too low to cover development and production fees of our material. Therefore, we are looking for a new indication where the willingness to pay is higher. A new indication is identified in cartilage, we are currently elaborating a new business plan and evaluating our product in a goat model. Now, we are looking at finding co-founders to join at the incorporation of our start-up, specifically we want to strengthen our team with co-founders with both experience in drug development and business.
The patent describing the production of the injectable material entered into the national phase in Europe and in the US in May 2018.

E. Vardar et al (2019). « A bioactive injectable bulking material; a potential therapeutic approach for stress urinary incontinence. » Biomaterials 206:41-48;
E. Vardar et al. (2018). «Microfluidic production of bioactive fibrin micro-beads embedded in crosslinked collagen used as an injectable bulking agent for urinary incontinence treatment.» Acta Biomater 67:156-166

Venture.ch business idea competition 2016, amongst the Top5; access via venture.ch
TERMIS business plan completion 2016, winner; access via termis.org/eu2016
Venture Leader Life Sciene event Boston 2017