{"id":252160,"date":"2018-02-07T15:32:26","date_gmt":"2018-02-07T17:32:26","guid":{"rendered":"http:\/\/revistapesquisa.fapesp.br\/?p=252160\/"},"modified":"2018-02-26T16:25:21","modified_gmt":"2018-02-26T19:25:21","slug":"respiratory-control","status":"publish","type":"post","link":"https:\/\/revistapesquisa.fapesp.br\/en\/respiratory-control\/","title":{"rendered":"Respiratory control"},"content":{"rendered":"
\"\"

Eduardo Cesar<\/span><\/a> On the screen, the Timpel tomograph allows medical professionals to know the precise volume of air in the patient\u2019s lungsEduardo Cesar<\/span><\/p><\/div>\n

Two S\u00e3o Paulo companies have developed intensive care medicine equipment that is being sold to hospitals in Brazil and abroad.\u00a0 One of the companies is Timpel, whose name represents the Portuguese acronym for the product it created, an electric impedance tomograph (EIT) used to enable precision ventilation for patients who breathe with the help of mechanical ventilators.\u00a0 The other company is Magnamed, which makes two types of ventilators: one for intensive care units (ICUs) and the other for the emergency transport of patients with breathing problems.<\/p>\n

Timpel\u2019s tomograph functions by using the difference in resistance to an electrical current at a particular voltage (impedance) found among the various parts of the body. To make a diagnosis, a belt containing 32 electrodes is placed around the patient\u2019s thorax and linked to a monitor.\u00a0 \u00a0Low-intensity electrical pulses travel through the body and find varying resistances along the way.\u00a0 This allows the physician to determine the quantity of air that is entering the thorax and where it is going. \u201cBlood conducts electricity well,\u201d explains physician Carlos Carvalho, director of the Pulmonology Division of the Heart Institute (InCor), at the School of Medicine of the University of S\u00e3o Paulo (FM-USP), who participated in the clinical studies for creation of the tomograph.<\/p>\n

Medical professionals can check the monitor to determine whether air is being directed to both lungs, which is good, or to just one, a situation that can cause complications. It is now possible to control the volume, pressure and flow of injected oxygen, improving the prognosis and reducing the risk of pulmonary injury while enabling individualized treatment for each patient.\u00a0 \u201cNearly 40% of patients admitted to the ICU require artificial respiration, and of these, 40% die as a result of complications caused by the procedure,\u201d says pulmonologist Marcelo Britto Passos Amato of the FM-USP, who also took part in the clinical studies that led to the creation of the EIT. \u201cOur goal is to reduce those rates.\u201d<\/p>\n

Of the two devices developed by Magnamed, the first was OxyMag, a portable ventilator (artificial respirator) for patients being transported in any type of mobile ICU.\u00a0 \u201cThe device helps physicians and paramedics respond more quickly in emergencies,\u201d says electrical engineer Wataru Ueda, company president. \u201cOxyMag is light, weighing only 3.25 kilograms, is easy to handle and has a touch screen color display and a battery life of over six hours.\u00a0 With this apparatus, it\u2019s possible to ventilate extreme low-weight neonatal and pediatric patients as well as adults.\u201d<\/p>\n

\"\"

Eduardo Cesar<\/span><\/a> Test of ventilation equipment at MagnamedEduardo Cesar<\/span><\/p><\/div>\n

Research product<\/strong>
\nFlexiMag, on the other hand, is a mechanical ventilator to be used in ICUs.\u00a0 The device identifies when there is an absence of a respiratory stimulus: when it senses that the patient has not inhaled, it does the work for him, forcing the breathing.\u00a0 \u201cThe device quickly responds to any breathing difficulty the patient may have and offers better control of ventilation because the physician is able to see the volume, pressure and distribution of air in the lungs right on the screen,\u201d Ueda reports.<\/p>\n

New strategies in artificial ventilation began to be developed through a FAPESP-funded research project headed up by Amato from 2002 to 2008 (see Pesquisa FAPESP<\/em> Issue No.151<\/a>). Those strategies demonstrated the need for a device that allows real-time visualization and individualized treatment. \u201cIn the beginning, we weren\u2019t thinking that the study would result in a product,\u201d he recalls.\u00a0 \u201cWhen we realized that that was possible, we created Timpel in 2004.\u201d The company, incubated at the Center for Innovation, Entrepreneurship and Technology (Cietec), on the main campus of USP in S\u00e3o Paulo, included researchers from the School of Medicine, the Polytechnic School (Poli) and the Institute of Mathematics and Statistics (IME), all from USP.<\/p>\n

Timpel soon signed a partnership agreement with Dixtal Biom\u00e9dica, a company specializing in medical equipment for hospitals, to jointly develop the tomograph, which took nearly four years.\u00a0 \u201cIn 2008, that company was purchased by Philips, which did not want to purchase the EIT project because it was still under development,\u201d Carvalho says.\u00a0 \u201cWe managed to attract some investors so that Timpel could produce the device.\u201d<\/p>\n

Although it had been used on an experimental basis with patients in the respiratory ICU at the Hospital das Cl\u00ednicas of FM-USP and at InCor in 2006, sales of the EIT only began in 2015. \u201cUp to now in Brazil, we have sold more than 60 of the devices to private, public and university hospitals,\u201d says electrical engineer Rafael Holzhacker, Timpel director.\u00a0 \u201cWe have an established distribution network in Brazil.\u00a0 We opened Timpel Medical abroad, headquartered in the Netherlands, to facilitate logistics and provide local customer service.\u00a0 We have already obtained the CE brand for marketing it in the European market, and we have buyers in Spain, Germany, France and Sweden in addition to Peru, Chile, the United States and Canada, these last two for now limited to research, given the regulatory restrictions.\u201d Company sales in 2016 were R$972,000, and in the first six months of this year they have reached R$1.1 million.<\/p>\n

The history of Magnamed began in the garage of Ueda\u2019s mother\u2019s house, where he lived for six months in 2005.\u00a0 Then, in association with mechanical engineer Tatsuo Suzuki and electrical engineer Toru Kinjo, Ueda developed the business plan. \u201cIn the following year, the project was selected to be a part of Cietec,\u201d he recalls.\u00a0 \u201cThere, we conducted product R&D, putting the business concept into practice.\u00a0 It took two years of incubation, with research studies funded by agencies like FAPESP, CNPq [National Council for Scientific and Technological Development] and FINEP [Brazilian Innovation Agency].\u201d<\/p>\n

\"\"

Eduardo Cesar<\/span><\/a> OxyMag is a portable respirator for use in ambulances with ICU equipmentEduardo Cesar<\/span><\/p><\/div>\n

The Criatec seed capital investment fund, maintained with funds from the Brazilian Development Bank (BNDES) also contributed to the venture. In all, R$5 million were invested in Magnamed during those years. \u201cThat funding breathed new life into the business, which found itself needing funds to continue product development,\u201d says Ueda.\u00a0 \u201cIn late 2008, OxyMag was completed and the first Magnamed factory was set up in the city of Cotia (S\u00e3o Paulo).\u201d The device began to be sold in 2010.\u00a0 Sales of FlexiMag began in 2013.<\/p>\n

By August 2017, nearly 5,000 devices had been sold.\u00a0 \u201cIn 2011, 70% of Magnamed\u2019s sales volume came from exports,\u201d Ueda reports.\u00a0 \u201cToday, the situation is reversed: 70% of the sales, out of a total sales volume of R$34 million for 2016, were in the Brazilian market.\u201d The company was the official supplier of emergency ventilation equipment at the 2016 Summer Olympics in Rio de Janeiro, and it exports to more than 50 countries, especially in Latin America and Southeast Asia.<\/p>\n

Equipment market<\/strong>
\nNeither of the two companies is alone in the respective markets for the devices they developed.\u00a0 \u201cWe have major competitors in Brazil and abroad,\u201d Ueda says.\u00a0 \u201cBut FlexiMag offers faster response. And Oxymag is very versatile and one of the lightest on the market.\u00a0 Besides that, it uses a Magnamed-patented system, which ensures better performance, prevents failures and reduces maintenance costs.\u201d<\/p>\n

In the case of Timpel, Holzhacker says that the company is a pioneer in developing the electric impedance tomograph and holds more than 50 patents filed in major countries all over the world, protecting essential aspects of the technology.\u00a0 \u201cThere are two other companies in the world that are making similar devices: one in Germany and the other in Switzerland,\u201d he says. Now the company is preparing to take a giant leap forward to increase its market.\u00a0 It is seeking approval from the Food and Drug Administration (FDA), the federal agency in the United States that controls the consumption of foods, medications and medical devices. \u201cGiven the EIT\u2019s level of innovation and clinical potential, from the very beginning we\u2019ve focused on internationalization, fostering scientific collaboration projects with research centers in several countries, including the United States,\u201d Holzhacker explains. \u201cFDA approval is crucial for Timpel\u2019s ability to access the U.S. market, which represents more than 40% of the global market.<\/p>\n

The problem is that, since no company has as yet sold similar equipment in the United States, the FDA is treating the electric impedance tomograph as an innovation. \u201cThat is why the path to approval is more complicated than it would be for the process of medical equipment traditionally used,\u201d says Holzhacker. \u201cThe technical documents for the EIT have been drafted and submitted, and there is still some back-and-forth with FDA specialists on issues such as usability, among other things that are being resolved so that the equipment can be approved.\u201d<\/p>\n

Projects<\/strong>
\n1.<\/strong> High frequency neonatal electronic pulmonary ventilation (No. 09\/52357-4<\/a>); Grant Mechanism<\/strong>\u00a0Innovative Research in Small Businesses Program (PIPE); Principal Investigator<\/strong>\u00a0Toru Miyagi Kinjo (Magnamed); Investment<\/strong>\u00a0R$71,643.27.
\n2.<\/strong> High resolution signal acquisition and parallel processing of image reconstruction for Electrical Impedance Tomography (FAPESP \u2013 PIPE\/PAPPE 2013 Disbursement) (No.13\/50775-9<\/a>); Grant Mechanism\u00a0<\/strong>Innovative Research in Small Businesses Program (PIPE); Principal Investigator<\/strong>\u00a0Rafael Holzhacker (Timpel); Investment\u00a0 <\/strong>R$245,475.00.
\n3.<\/strong> New strategies in artificial ventilation: diagnosis and prevention of barotrauma\/biotrauma through electrical impedance tomography (EIT) (No. 01\/05303-4<\/a>);\u00a0Grant Mechanism<\/strong>\u00a0Thematic Project;\u00a0Principal Investigator<\/strong>\u00a0Marcelo Britto Passos Amato (USP);\u00a0Investment\u00a0 <\/strong>R$5,102,802.63.<\/p>\n","protected":false},"excerpt":{"rendered":"Small companies are developing hospital equipment for lung problems","protected":false},"author":20,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_exactmetrics_skip_tracking":false,"_exactmetrics_sitenote_active":false,"_exactmetrics_sitenote_note":"","_exactmetrics_sitenote_category":0,"footnotes":""},"categories":[1560,169],"tags":[228,247],"coauthors":[112],"class_list":["post-252160","post","type-post","status-publish","format-standard","hentry","category-innovative-research-in-small-business-pipe-en","category-technology","tag-engineering","tag-medicine"],"acf":[],"_links":{"self":[{"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/posts\/252160","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/users\/20"}],"replies":[{"embeddable":true,"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/comments?post=252160"}],"version-history":[{"count":0,"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/posts\/252160\/revisions"}],"wp:attachment":[{"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/media?parent=252160"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/categories?post=252160"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/tags?post=252160"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/coauthors?post=252160"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}