The startup brain4care, which developed and is now marketing the solution, has recently secured its second contract with Rede D\u2019Or, a hospital network with campuses in Rio de Janeiro, S\u00e3o Paulo, and other major cities in Brazil. Six other deals are as good as closed, and another 20 are at an earlier stage, says partner and CEO Pl\u00ednio Targa. He estimates that brain4care\u2014which is based out of S\u00e3o Carlos, in southeastern Brazil\u2014will need to sell 180 sensors to break even, a milestone he expects will be reached by mid-2020.<\/p>\n
The project to develop the device was born out of a personal struggle experienced by Rio de Janeiro\u2013born physicist and chemical engineer S\u00e9rgio Mascarenhas Oliveira, a retired USP professor, now 91 years old. In 2006 he was diagnosed with hydrocephalus, a condition characterized by an accumulation of fluid in the brain. Physicians initially thought the scientist had Parkinson’s disease. Mascarenhas was surprised at the difficulty in reaching a diagnosis, which typically requires an invasive procedure to be confirmed, and the following year began a research program at IFSC-USP that would lead to the development of the sensor. The project was codeveloped with researchers from several institutions, including the schools of medicine at the Federal University of S\u00e3o Carlos (UFSCar) and USP Ribeir\u00e3o Preto, and with physicians at the University of Porto\u2019s Hospital S\u00e3o Jo\u00e3o, in Portugal.<\/p>\n
![\"\"](\"https:\/\/revistapesquisa.fapesp.br\/wp-content\/uploads\/2019\/12\/067-069_Braincare_280-2.jpg\")
Miguel Boyayan <\/span><\/a> Physicist S\u00e9rgio Mascarenhas of USP, the inventor of the deviceMiguel Boyayan <\/span><\/p><\/div>\n In 2014, Mascarenhas and two colleagues\u2014biochemical and pharmaceutical engineer Gustavo Frigieri Vilela, who did his doctorate under him at USP S\u00e3o Carlos, and engineer Rodrigo Andrade\u2014took the decision to create the startup, which until last April was operating under the trade name Braincare. \u201cOur global trademark is now brain4care,\u201d says Targa, who joined in 2016 as an angel investor alongside Carlos Bremer\u2014both are engineers trained at USP S\u00e3o Carlos. \u201cWe are currently developing a business plan to enter the US market and hope to have a presence there by 2020,\u201d he says, noting that patents for the device have already been issued in the US and Europe.<\/p>\n Toward the end of 2017, the company received an injection of US$5 million from Miletus, an investment fund run by Hor\u00e1cio Lafer Piva, president of Brazilian-based pulp and paper producer and exporter Klabin. The fund became the company\u2019s sixth investor. \u201cThis is the first time the Klabin family has ventured to invest outside the pulp and paper business,\u201d Piva told the Brazilian daily Valor Econ\u00f4mico<\/em>. \u201cWe are highly focused on our business and our attention is not easily diverted from it. But this is a project with a worthy purpose, which is providing access to a new vital sign\u2014intracranial pressure.\u201d<\/p>\n Indeed, brain4care\u2019s founders and investors hope to make intracranial pressure, or ICP, as accessible as the five vital signs commonly monitored by physicians today\u2014temperature, blood pressure, heart rate, respiratory rate, and pain. \u201cThe company\u2019s new trade name fits within this context. Our brand concept suggests that by looking at the brain you can manage your overall health,\u201d explains Targa.<\/p>\n \u201cAs our research deepened, we found that intracranial pressure is related not only to neurological problems such as head injuries, hydrocephalus, and brain tumors, but also to heart disease, eclampsia [high blood pressure in pregnant women], and liver-related conditions, for example,\u201d he explains.<\/p>\n The sensor was collaboratively developed by researchers from multiple public universities<\/p><\/blockquote>\n New wireless solution<\/strong> An app displays real-time data at the bedside while also placing it in the cloud, where the data is processed and a report is automatically generated and made available to physicians and nurses, even when not on location. For hospitals, each sensor costs R$3,500 per month, with this fee covering as many monitoring sessions as necessary.<\/p>\n The equipment-as-a-service business model and the strategy to make ICP a newly adopted vital sign were developed in Silicon Valley in 2017, where brain4care was accelerated at Singularity University, a California-based innovation center. The investment from Miletus helped brain4care set up a more professional operation in S\u00e3o Carlos and open an office in S\u00e3o Paulo. \u201cThis took us from research startup to a full-fledged operational business,\u201d says Targa.<\/p>\n L\u00e9o Ramos Chaves<\/span><\/a> Intracranial pressure data is displayed on a tablet or bedside monitorL\u00e9o Ramos Chaves<\/span><\/p><\/div>\n Future challenges<\/strong> \u201cThe device certainly has great potential, and I\u2019m sure brain4care is further developing its sensor to deliver a numerical result using a mathematical algorithm to yield an absolute pressure reading,\u201d says Vieira J\u00fanior. \u201cThat would be highly valuable, as much of what we do today is based on ICP readings. We need them to make a diagnosis of intracranial hypertension.\u201d The medical community is eagerly awaiting robust clinical evidence of the usefulness of the device in bedside applications,\u201d says the physician.<\/p>\n At S\u00edrio-Liban\u00eas Hospital, a group led by neurointensivist F\u00e1bio Machado is designing a research project to compare the brain4care device with other available bedside ICP monitoring technologies. In addition to this study, there are currently 28 other ongoing research projects on the use of the device and intracranial pressure, says Pl\u00ednio Targa.<\/p>\n Around 300 researchers are involved, including professionals from universities such as USP Ribeir\u00e3o Preto, UFSCar, the Federal University of S\u00e3o Paulo (UNIFESP), and Stanford. \u201cScientific research is at the core of our business. If there are people looking to doing research on intracranial pressure, we\u2019re their partners of choice,\u201d says Targa.<\/p>\n Projects<\/strong>
\nThe health entrepreneurs hope the device will soon be available at clinics and even in ambulances. In February this year, the company obtained approval from the Brazilian Health Regulatory Agency (ANVISA) to market a new wireless version of the sensor, which requires neither a monitor nor wired connections. The signals are transmitted via Bluetooth from the device to a mobile phone, tablet, or computer.<\/p>\n![\"\"](\"https:\/\/revistapesquisa.fapesp.br\/wp-content\/uploads\/2019\/12\/067-069_Braincare_280-1.jpg\")
\nThe three devices supplied to S\u00edrio-Liban\u00eas Hospital are being used to monitor patients at the neurological ICU. \u201cWe are very excited about the partnership,\u201d says intensivist Jos\u00e9 Mauro Vieira J\u00fanior, head of quality and safety at the hospital. He admits the device still has its limitations, such as not providing an absolute value of pressure within the skull\u2014in healthy subjects, this should range from 5 to 15 millimeters of mercury (mmHg). Conventional invasive monitoring methods generate readings in numerical form, whereas the brain4care product does not. The sensor delivers information as graphs showing intracranial pressure pulse morphology\u2014as in an electrocardiogram\u2014and the ICP trend over the monitored period. Because of these limitations, the hospital has utilized brain4care\u2019s product in conjunction with other tests including transcranial Doppler ultrasonography monitoring, ultrasonographic measurement of optic nerve sheath diameter, computerized tomography scans, and electroencephalograms.<\/p>\n
\n1<\/strong>. Development of a minimally invasive device for monitoring intracranial pressure (no. 08\/53436-2<\/a>);\u00a0Grant Mechanism<\/strong>\u00a0Technological Innovation in Small Businesses (PIPE) program;\u00a0Principal Investigator<\/strong>\u00a0S\u00e9rgio Mascarenhas Oliveira (Sapra\/S.A.);\u00a0Investment<\/strong>\u00a0R$654,281.90.
\n2.<\/strong> Registration and marketing of a minimally invasive device for monitoring intracranial pressure (no. 11\/51080-9<\/a>);\u00a0Grant Mechanism<\/strong>Technological Innovation in Small Businesses (PIPE) program;\u00a0Principal Investigator<\/strong>\u00a0S\u00e9rgio Mascarenhas Oliveira (Sapra\/S.A.);\u00a0Investment<\/strong>\u00a0R$348,684.81.
\n3.<\/strong> Development of a noninvasive sensor, hardware, and software for monitoring intracranial pressure in patients with hydrocephalus and stroke (no. 12\/50129-7<\/a>);\u00a0Grant Mechanism<\/strong>Technological Innovation in Small Businesses (PIPE) program;\u00a0Principal Investigator<\/strong>\u00a0Gustavo Henrique Frigieri Vilela (Sapra\/S.A.);\u00a0Investment<\/strong>\u00a0R$358,784.13.
\n4.<\/strong> Development of a minimally invasive inductive sensor for monitoring intracranial pressure (no. 14\/50618-3<\/a>);\u00a0Grant Mechanism<\/strong>Technological Innovation in Small Businesses (PIPE) program;\u00a0Principal Investigator<\/strong>\u00a0S\u00e9rgio Mascarenhas Oliveira (Braincare);\u00a0Investment<\/strong>\u00a0R$913,895.75.
\n5.<\/strong> Braincare system for acquisition, storage, and analysis of healthcare data (no. 16\/01990-2<\/a>);\u00a0Grant Mechanism<\/strong>Technological Innovation in Small Businesses (PIPE) program;\u00a0Principal Investigator <\/strong>Deusdedit Lineu Spavieri J\u00fanior (Braincare);\u00a0Investment<\/strong>\u00a0R$737,309.60.<\/p>\n