NATIONAL PRODUCT AGAINST COVID-19 IS LAUNCHED
Solis System, the “artificial lung” is developed in record time
Albert Einstein once said, "in the midst of the difficulty lies the opportunity". And with the characteristic of an innovative company, Braile Biomédica once again showed the strength of the National Industry, which is ahead of time and lives up to its strong purpose of caring for people, developing and manufacturing a pioneering product in Brazil to assist patients in the treatment of Covid-19, in just 6 months.
The SOLIS System was developed in partnership with the Eldorado Institute and Embrapii (Brazilian Industrial Research and Innovation Company) and consists of Extracorporeal Membrane Oxygenation, ECMO, a form of extracorporeal breathing.
It will be used in critically ill patients with Covid-19 when mechanical ventilation is no longer working, helping to keep the patient alive until the disease has resolved.
The Solis System can simultaneously perform the function of the lung and the heart in patients in which one of these organs or both - has temporarily lost the ability to perform these functions.
The product development process was complex, but the technology and the pressure of the pandemic, linked to the know-how of the companies involved made it possible to make it a reality in record time.
According to Fernando Oliveira, Product Development Specialist at Braile Biomédica, the design of the Solis electromedical system took six months from the decision to do so until Anvisa's registration published in the Official Gazette of the Union. In any other period without the pandemic At Covid-19, a project of this complexity would take an average of two years to complete. “Despite this drastic reduction in development time, the quality and safety of the product has not been sacrificed at any time! This achievement in such a short time was only possible due to the strategy taken in the development in the face of the pandemic: simplifications of the product architecture using technologies already available on the market; easier negotiation with entities to obtain financing; creation of a task force with the Eldorado Institute with a significant increase in qualified labor for development activities; greater commitment by suppliers to meet the deadlines and framework of the project in RDC No. 349/2020 by Anvisa which significantly reduced the duration of the product registration process.”
The SOLIS System is indicated for adults or children also in cases of heart transplantation, myocardial infarction, cardiac arrest and acute respiratory failure, a condition also caused by the new coronavirus, in which there is inflammation of the bronchi and impairment of the alveoli, small structures that make up the respiratory system, and work by bringing oxygen into the bloodstream.
PRODUCT IS ALREADY SAVING LIVES
The official launch of the Solis System will be on January 26, but the product is already being marketed. The first system went directly to the state of Ceará, with prospects for new sales to the state this January, 2021.
For Denes Andrade, Managing Partner of Resmedical (Braile's distributor in Ceará), “having a Braile national product at this moment makes a huge difference and makes us proud to have been the first company in Brazil to acquire this product to serve patients in our region. "
Henrique Mello, National Commercial Manager, reflects on the difference that the Solis System will make. “Manufactured by a local company, it will make it possible to expand treatment nationwide. "
According to Henrique, making a brief retrospective, Brazil and France started the treatment of ECMO at the same time, mid-2009, as an alternative for the treatment of the H1N1 pandemic. Since then, France and other developed countries have spread the technique and in Brazil the treatment is restricted to small niches. “We hope that the SOLIS Braile System will support the evolution of the treatment, thinking not only at the current moment of facing COVID, but also for the other therapies that apply. "
Expectations for foreign trade are also encouraging. As a company recognized internationally for the quality and accessibility of its products, Braile Biomédica has been receiving requests from different parts of the world in search of effective solutions for the treatment of Covid-19 since the beginning of the pandemic. One of them was ECMO, a form of extracorporeal breathing, one of the only effective treatments for critically ill patients. According to the Foreign Trade Coordinator, Milena Fachini dos Santos Bossa "We already have requests from Germany, Ukraine, Colombia and Venezuela and after the launch we should receive much more".
Braile Biomédica believes that life always comes first and bets strongly on this product to help people from our country and the world to win the fight for life.