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Health in the blue mantle

Komlux has finalized its Blanket Lux, equipment 88 for the treatment of jaundice, a disease that affects 200,000 babies a year in Brazil

MIGUEL BOYAYANMantle woven with optical fibers is used directly on the baby’s skin without heatingMIGUEL BOYAYAN

One of the pioneer products developed under the Program for Technological Innovation in Small Companies (PIPE) is ready to go onto the market. It is the mantle for phototherapy for newly born children made by a company called Komlux, from Campinas. With the commercial name of Blanket Lux, the equipment is only waiting for certification by the Ministry of Health, which will be carrying out the last inspection in the new building put up by the company. Komlux is also getting ready for ISO 9000 certification, a prerequisite for obtaining the CE mark of the European Economic Community. “The expectation is to open up a profitable market in the medical area in Brazil and abroad as well”, says Cícero Lívio Omegna de Souza Filho, who owns and runs the company, which has already received orders for delivery in March this year.

Blanket Lux is a mantle woven with optic fibers that gives off blue light for phototherapic treatment of newly born children with hyperbilirubinemia, better known as physiological jaundice, caused by the incapacity of the baby’s organism to eliminate bilirubin from the blood. Under normal conditions, this biliary pigment is filtered by the placenta or eliminated by the liver. In the most serious cases, jaundice can cause damage to the central nervous system and deafness, its most visible effect being the presence of a yellow hue in the skin. Jaundice is common in Brazil, affecting about 5% of the total of children born each year, which is equivalent to 200,000 babies.

Phototherapy is the treatment most used nowadays to eliminate bilirubin. Light decomposes the substance, which is eliminated by the organism. But the drawbacks are great: for hours or days, the baby remains in its cot, with just a diaper and its eyes blindfolded, submitted to the light that comes from fluorescent or halogen lamps. The lamps cannot be very close or they will cause burns, the heat causes discomfort, and the baby spends more time in hospital.

The mantle solves many of these drawbacks: it can be used directly on the baby’s skin, it is small, it is connected to a fiber thread that keeps it away from the body, reducing the risks. Besides the comfort, it reduces hospital costs, filters out the heat and the undesirable bands from the spectrum of light, above all infrared and ultra violet, letting through just the blue light that solves the problem of bilirubin.

Portable mantle
The innovation in the mantle is that it was made with modified optic fibers. They emit light laterally along the mantle, in a controlled manner. With the phototherapic mantle, there is no need to interrupt treatment for breast-feeding, as in the conventional system. It is portable and can be used at home. “The great advantage of the mantle is that it can be used inside the incubator, in the case of premature babies, for example”, explains Professor Fernando Facchini, from the Center for Integral Assistance for Women’s Health (Caism), of the State University of Campinas (Unicamp). In fact, the idea of producing the mantle was his. “I was interested in using an optic fiber mantle – which already exists abroad – and was looking for a way of producing it in Brazil. Then I tried Unicamp’s Bioengineering Center, and they indicated Komlux for me.”

The challenge of producing the equipment in Brazil was launched in 1997. Two and a half years went in research and six months for the launching in the market. “The mantle is suitable for nurseries in Brazil and abroad”, says Omegna Filho. The price is estimated at R$ 3,300, including the distribution of the product, while a similar Japanese product called Homeda costs US$ 4,000. The conventional treatment, with halogen phototherapy, comes to between R$ 2,000 and R$ 4,000.

In the second half year, when Omegna Filho expects to have the marketing system for the mantle consolidated and the certification stage behind him, the expectation is to sell the whole of Komlux’s productive capacity, which is 50 sets (mantle plus light source) per month. “Actually, in the light of the acceptance we have seen with the product, we believe that demand will be much greater than this volume.” Blanket Lux was presented to the participants at the XVII Brazilian Congress of Perinatology, which took place in Florianópolis (SC), in November last year.

“Its debut for a specialized public was very successful and prompted an interest from the market in niches which we hadn’t even thought about”, says Omegna Filho. This is the case of a large health cooperative, which identified in the mantle the solution for its problems of extending in-patient treatment in maternity wards, since residential use of the product is common practice in the United States, where it goes under the name of biliblanket.

New product
Komlux is also developing two types of videoendoscope, one with a rigid tube to be applied in otorhinolaryngology (nose, ear and throat), and another, flexible, for the clinical investigation of the stomach and intestines. The two projects also have the support of PIPE. The endoscope is an instrument that makes it possible to observe places with limited access. The major use of it is in medicine, to visualize cavities of the body.

Komlux’s endoscope is coupled to a video camera, allowing the images to be recorded on videotapes, for future analyses or for a database. The reduction in the prices of the cameras, monitors and video recorders, as well as accessories for digitalizing images and manipulating them in microcomputers, has made its large scale use feasible. According to Omegna, the estimate is to sell from 50 to 100 sets per month of videoendoscopes with a rigid tube, when it is launched commercially in 2003. The price also promises to be competitive. The endoscope and the whole of Komlux’s video system will cost from R$ 3,500 to R$ 4,000, while a similar product today cost the double: the camera system alone is R$ 3,500.

Omegna Filho’s optimism is based on figures. The company today sells around R$ 180,000 a month, after almost having doubled its income in a year and a half. The prospects for the optic fiber market, in which it operates with a line of 200 products, keep on growing. When Professor Hugo Frangnito, from the Institute of Physics at Unicamp, and Professors Pedro Mangabeira Albernaz and Aníbal Arraes, from the Federal University of São Paulo (Unifesp), sought out Komlux to develop the videoendoscope to be used in otorhinolaryngology, they wanted to simplify the existing apparatus.

Komlux’s alternative is a piece of equipment that looks like a pen, with microcameras that capture the images and send them to a video monitor or to a computer, where they are analyzed. He is going to have models for various specialties. The apparatus for the mouth is now ready and ones for the ear and for the larynx are under way. Another piece of equipment that is ready, the fruit of expanding the research, is the intra-oral, to assist dentists in several functions.

The research carried out by Komlux to assemble a prototype of flexible endoscopes, intended for examinations of the esophagus, stomach and intestine, is being carried out in partnership with the Center for Diagnostics of Diseases of the Digestive Apparatus (Gastrocentro) at Unicamp.

Sticking to fiber
The most immediate results of these projects are the new factory in Campinas, with its 1,100 m2, almost the double of the former space, 600 m2, and the increase in the number of employees, from 19 to 40. But Omegna Filho knows that, on his own, he will not succeed in getting into this market that is dominated by multinationals. “I believe that we should not waste energy on fighting for the distributor market with companies that are already established. I prefer to keep our identity in the area of development and applications in optic fibers”, he says. He adds that, since the embryonic stage of the projects, he has already started to look for partners and customers, for the product to be in a condition to go into the market as soon as it leaves the prototype stage.

Exemplary career path

Cícero Omegna Filho dreamt of being an engineer, but ended up qualifying as a systems analyst. He saw the world of optic fibers come into his life during the traineeship he did in 1977, as a technician in electronics in the Institute of Physics at Unicamp. In 1986, Komlux was born in the basement of his house and had mechanical engineer Marco Kairala as a partner. The company was formed to produce dental tips for photopolymerization, equipment that dries in seconds the paste used for reconstructing teeth. This project was later sold to the multinational company 3M and the partnership dissolved.

Omegna Filho carried on with Komlux and won a three month breathing space when he signed a service contract with Elebra, also from Campinas, where he had already worked in the area of producing optic fiber for telecommunications. But the successive economic plans left the company hard up, and in 1993 only three employees were left over from the ten that there were in 1989. That year, Omegna Filho went to the United States to prospect for new business. And he almost stayed there, because he received an invitation for business consultant Abraham Szule for him to set up his company in American territory.

But, one week after going back to Campinas, he was looked up by researchers from Unicamp and from Unifesp to develop endoscopes with applications in medicine. Until then, his experience with this equipment had been limited to the rigid model, to meet the orders from Iochpe-Maxion, which were used to inspect the inside of the combustion chamber of diesel engines used in tractors.

“The arrival of the researchers made it possible to do an about turn in the company’s specialization, which left behind telecommunications for the biomedical area”, says Omegna Filho. In this same period, between 1994 and 1995, the development of the product started, with the support of the Ministry of Science and Technology (MCT), through the Support Program for Scientific and Technological Development. Omegna Filho was a member of the MCT’s Technical Instrumentation Group for two years, which allowed him to visit several universities and understand their needs.

He opened the doors of his company to the culture of research. He succeeded in getting six grants for Komlux from the MCT’s Program for Qualification of Human Resources for Strategic Activities. At that moment, the first conclusion from these partnerships was already beginning to become evident: “There is no point in channeling resources exclusively into equipment and industrial installations, the essential thing is to train people.” The second came now, when he was preparing himself for the great challenge of marketing and advertising the mantle. “My company has always had an umbilical relation with universities and research, and it would certainly not have survived on its own.” 

The Projects
1. Project and Development of Equipment for Neonatal Phototherapy based on Corrugated Optic Fiber (nº 97/07515-1); Modality Program for Technological Innovation in Small Companies (PIPE); Coordinator Cícero Lívio Omegna de Souza Filho – Komlux; Investments R$ 169,209.40 and US$ 125,296.00
2. Development of a Videoendoscope with Gradient Optics (nº 97/07514-5); Modality Program for Technological Innovation in Small Companies (PIPE); Coordinator Cícero Lívio Omegna de Souza Filho – Komlux; Investments R$ 167,287.00 and US$ 79,500.00