NOVAGENIT® performed a technological and commercial feasibility analysis for the development of an anti-adhesion and anti-bacterial post-surgery lyophilized membrane. Activities performed:
1. Standardization of the Manufacturing Process for lyophilized HA-PLA, including the activity carried out to select the viscosity as the most representative parameter of its stability.
2. Stability testing at accelerated conditions (25°C) of lyophilized HA-PLA irradiated at 25kGy showed stability after 6 months with respect to viscosity control parameter; since experiments were carried out on a single lot, additional tests are needed in phase2 to corroborate the results.
3. Anti-bacterial tests have confirmed the efficacy of lyophilized HA-PLA supplemented with Vitamin C against 4 main pathologic strains. NOVAGENIT® will confirm during phase 2 these results on a wider sample, challenging the new formulation with various pathogenic bacterial families. The tests performed on metallic nanoparticles, including silver, have not shown positive results thus leading to the decision to focus on silver citrate during phase2.
4. According to the commercial feasibility analysis, NOVAGENIT® has run a btm-up survey on 41 surgeons. The survey has confirmed that the identified key product’s characteristics fit to the customers’ needs.
5. Analysts’ report on the WW anti-adhesion market confirms the market to grow from 1.4B$ in 2014 to 2.2B$ in 2020, with a CAGR of 7,8%.
6. NOVAGENIT® has built a business plan, considering the market price for equivalent products, the expected manufacturing unit cost and the sales forecast over 3 years following the completion of the project. The business plan shows positive cash flow and ROI prospects. Comparing NOVAGENIT® sales forecast with the TAM, the company is expected to outperform the market over the forecast period, with steady market share growth till 2020.
7. The commercial feasibility analysis has also identified a path towards the enlargement of the sales channel, in order to extend the commercialization from the orthopaedic to the cardiovascular and abdominal/pelvic segments, markets keen on value both the anti-bacterial and anti-adhesion product performances.
