Molteni Therapeutics is an Italian company, spin-off of Molteni Farmaceutici, dedicated to the development of innovative medical devices based on Photodynamic Therapy (PDT). MT was established in 2006, but its roots date back to 1992, year of the birth of the Molteni Farmaceutici Research Department.
Molteni Therapeutics concentrates its activities on the design and development of new medical devices, as well as their application in every field of medicine, paying particular attention to the treatment of ulcers and injuries of various types.
Molteni Therapeutics believes that Photodynamic Therapy will soon become the best and most widespread supportive therapy to improve clinical outcomes in the treatment of ulcers since it is effective, safe and easy to use.
Molteni Therapeutics, after years of research in this field, has developed its own platform of innovative photosensitizing molecules and in 2013 concluded the process for obtaining the EC marking for its first medical device that employs Photodynamic Therapy and which is a useful support in the treatment of diabetic foot ulcers. Photodynamic Therapy using the new VULNOFAST® plus device has already been preliminarily tested in some centers in Italy and Germany and seems to give very promising results; those who have been able to experiment with the new therapy in patients are said to be surprised by the results and interested in investigating further.
Preliminary clinical experiences show that this device is able to favor rapid and complete healing of infected chronic diabetic foot ulcers (DFU), with an excellent safety and tolerability profile. In light of the clinical results obtained so far, this new therapeutic approach, added to the therapeutic options already available on the market today, leads to the increased efficacy of DFU therapy, reducing recurrences and extreme complications.
A randomized, double-blind, dose-response, placebo-controlled, multicentre, phase IIA study conducted on more than 60 patients with type 1 and 2 diabetes and infected foot ulcers (Italian centers involved: Careggi University Hospital, Florence; Institute for Hospitalization and Care of Scientific Nature Multimedica, Sesto San Giovanni, Milan; University of Siena, USL 3, Pistoia, Institute for Hospitalization and Care of a Scientific Nature, National Institute for Rest and Elderly Care, Ancona) demonstrated that treatment with the product results in a statistically significant dose-dependent reduction of the microbial load compared to placebo immediately after illumination. Alongside broad-spectrum antimicrobial action, good local and systemic tolerability is also demonstrated.
These important clinical outcomes have been confirmed by subsequent experience, in course of publication (), conducted on an even larger sample of DFU (centers involved: Florence, Arezzo, Stuttgart), after repeated applications of the product for two / three weeks. This experience has in fact shown a significant reduction not only of the bacterial load, but also of the extension of the wound surface (even in patients with deep wounds), with a good tolerability.
Molteni Farmaceutici has chosen to market this new product directly, without the collaboration of other companies. Proud of this product, fruit of its research, it decided to sell and make the medical device available on the Italian market, with a view to exporting it in Europe.
The treatment of diabetic ulcers (in particular of the Diabetic Foot Syndrome) with Photodynamic Therapy is a new therapeutic solution for patients who, even today, have a very high chance (about 20%) of needing amputation.