PROJECT OF BIOITECH
The Bioitech research project was founded in 1998 on the basis of scientific
works on injectable tissue augmentation. The parties involved in this
project have been able to count with the expert advice of the laboratiory
of Biochemistry and Pharmacology, at some universities in southern Brazil.
The Implementing Plan of the research project has responded to some
principles carried out at all stages of the process, from design to
the finished product:
-Testing in the lab and clinical trial in compliance with the Helsinki
-Focusing on the clinical performance of the product.
-Particular attention given to security.
The first phase of the study was to examine all issues relating to the
The requirements taken into consideration in the design phase, before
the beginning of the realization of the product have been evaluated
for completeness and adequacy in order to secure the expected requirements.
We have excluded from the study at beginning all polymers that once
implanted in the body were not subject to total breakdown or absorption.
Experimental and clinical studies in this phase were brought forward
Particular attention has been given to products with the same function,
currently on the market.
We have also carefully studied the aspect concerning the filling, polymers
with carrier function, the active principles and their possible forms:
Hydrogel microspheres, suspension, etc.
We checked out, that the model initially proposed represents actually
the best base in the light of the problems foreseen.
In any case, had been provided for some alternatives, able to overcome
difficulties that could arise during subsequent stages of the trial.
The project has been realized in different phases:
Stage 1: Study of materials and existing products and/or
Phase II: Laboratory Study on Guinea Pigs
Phase III: clinical study on patients
Phase IV: laboratory tests in accordance with EEC regulations
V stage: publication of patent, scientific publications and creation
of Bioitech in order to industrialize the medical devices