La cruzada de Cuperscience: nueva ronda de inversión busca financiar estudios clínicos para registrarse ante la FDA

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CONTENIDO RELACIONADO

Ya no basta con sumar renovables: Generadoras de Chile planteó a la ministra Rincón los nuevos desafíos del sistema eléctrico

Seguridad operacional, señales económicas claras, predictibilidad para la inversión e institucionalidad marcaron la reunión entre el gremio y la ministra de Energía, frente a una matriz que cambió con rapidez por la llegada de energías renovables y almacenamiento.

Cuperscience está en proceso de levantamiento de capital para conseguir cerca de US $1,5 millones para recibir la aprobación de la FDA Food and Drug Administration.

El objetivo es hacer que su tratamiento de uso tópico para las heridas de pie diabético, y que evita amputaciones en la extremidad, ingrese al mercado de EE.UU.

El año 2014 Cuperscience realizó un estudio clínico en 30 pacientes con heridas de pie diabético que se extendió hasta 2015, en el que probaron su innovador tratamiento: Cupersan Gel y Cupersan Clean, productos de uso tópico en base a cobre que se aplican en las lesiones abiertas acelerando su cicatrización. Y los resultados fueron sorprendentes: heridas que llevaban meses sin sanar comenzaron a presentar mejoras al cabo de tres sesiones.

Esto motivó a la startup a ofrecer su producto en hospitales y Cesfam de todo Chile. A la fecha, lo han usado en 554 centros de salud, en todos con excelentes resultados, por lo que el siguiente paso estaba claro: debían internacionalizar el tratamiento. “Y para vender en EE.UU. necesitamos la aprobación de la FDA (Food and Drug Administration)”, cuenta Rafael Méndez, CEO y fundador de Cuperscience. 

La misión no es fácil: necesitan conseguir US $1,5 millones. Por esta razón, iniciaron una ronda de inversión para conseguir capital.

“Estaremos en este proceso desde diciembre hasta marzo. La idea es conocer a los potenciales inversionistas y contarles de nuestro plan porque, buscamos alguien que no solo que aporte con dinero, también con experiencia, contactos y que sea parte del equipo”, dice Méndez, lo que en la industria se llama Smart Money.

Los trámites de la FDA

Toda esta gestión tiene un foco muy claro: cumplir con los requerimientos que solicita la Administración de Medicamentos y Alimentos de los EE.UU., más conocida como Food and Drug Administration o FDA.

 “Lo primero que tenemos que hacer es contratar un representante de registro, que es el puente entre nosotros y la FDA y quien habla por nosotros frente al organismo. Y a esa empresa ya la tenemos”, cuenta Méndez.  

Luego, la FDA revisa las certificaciones de seguridad, efectividad y la calidad del producto. “Hay que demostrar que somos capaces de mantener la calidad en el tiempo y que el lote uno sea igual que el lote 100. En nuestro caso producimos en el laboratorio farmacéutico Knop, que cumple con todas las normas internacionales de manufactura, por lo que eso también ya lo tenemos resuelto”.

Tras ello deben demostrar la seguridad, que no sea tóxico o haga daño a las personas. Eso lo comprueban a través de un estudio de biocompatibilidad. “Se realizan en laboratorios aprobados por la FDA y allí evalúan el producto in vitro en líneas celulares”.

Europa y más

Para esa evaluación, la empresa tiene que viajar a España y costear el laboratorio. Además, allá se hará un estudio clínico en 200 pacientes para comprobar la efectividad del tratamiento. 

“Se hacen dos grupos de estudio, en uno se aplica el tratamiento estándar y el otro el de Cupersan, y al final del proceso se comparan los resultados para medir qué tan bien funciona tu producto”, detalla el CEO de Cuperscience. 

“Pero estamos confiados. Tenemos la experiencia de uso en Chile de 2020 y 2021 y eso nos da respaldo”, opina.

En paralelo, además de buscar la aprobación de la FDA gestionarán la autorización del EMA -Agencia Europea de Medicamentos-, para comercializar en Europa. A eso se suman las gestiones para expandirse a más países de América. 

“Cerramos un acuerdo con un distribuidor para 6 países de Centroamérica y estamos en negociaciones con un distribuidor de Uruguay que extendería las ventas a 18 países en el continente”, comenta. 

Antonia Carrillo
Antonia Carrillohttps://www.diariosustentable.com/
Antonia Carrillo. Periodista de la universidad Diego Portales. Me gusta andar en bicicleta y hacer yoga. Creo que la sustentabilidad es lo más importante para mejorar el sistema y el planeta. Por eso estudié periodismo: para dedicarme por completo a visibilizar las acciones necesarias para crear un mundo mejor y sustentable. En periodismo encontré la posibilidad de expresarme, de expandir mi visión sobre el tema que más me importa, el medio ambiente.

SUSCRIBETE

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} #mlb2-12234090.ml-form-embedContainer .ml-form-embedWrapper .ml-form-embedBody .ml-form-fieldRow .custom-control, #mlb2-12234090.ml-form-embedContainer .ml-form-embedWrapper .ml-form-embedBody .ml-form-horizontalRow .custom-control { position: relative; display: block; min-height: 1.5rem; padding-left: 1.5rem; } #mlb2-12234090.ml-form-embedContainer .ml-form-embedWrapper .ml-form-embedBody .ml-form-fieldRow .custom-radio .custom-control-input, #mlb2-12234090.ml-form-embedContainer .ml-form-embedWrapper .ml-form-embedBody .ml-form-horizontalRow .custom-radio .custom-control-input, #mlb2-12234090.ml-form-embedContainer .ml-form-embedWrapper .ml-form-embedBody .ml-form-fieldRow .custom-checkbox .custom-control-input, #mlb2-12234090.ml-form-embedContainer .ml-form-embedWrapper .ml-form-embedBody .ml-form-horizontalRow .custom-checkbox .custom-control-input { position: absolute; z-index: -1; opacity: 0; box-sizing: border-box; padding: 0; } #mlb2-12234090.ml-form-embedContainer .ml-form-embedWrapper .ml-form-embedBody .ml-form-fieldRow .custom-radio .custom-control-label, #mlb2-12234090.ml-form-embedContainer .ml-form-embedWrapper .ml-form-embedBody .ml-form-horizontalRow .custom-radio .custom-control-label, #mlb2-12234090.ml-form-embedContainer .ml-form-embedWrapper .ml-form-embedBody .ml-form-fieldRow .custom-checkbox .custom-control-label, #mlb2-12234090.ml-form-embedContainer .ml-form-embedWrapper .ml-form-embedBody .ml-form-horizontalRow .custom-checkbox .custom-control-label { color: #000000; font-size: 12px!important; font-family: 'Open Sans', Arial, Helvetica, sans-serif; line-height: 22px; margin-bottom: 0; position: relative; vertical-align: top; font-style: normal; font-weight: 700; } #mlb2-12234090.ml-form-embedContainer .ml-form-embedWrapper .ml-form-embedBody .ml-form-fieldRow .custom-select, #mlb2-12234090.ml-form-embedContainer .ml-form-embedWrapper .ml-form-embedBody .ml-form-horizontalRow .custom-select { background-color: #ffffff !important; color: #333333 !important; border-color: #cccccc; border-radius: 4px !important; border-style: solid !important; border-width: 1px !important; font-family: 'Open Sans', Arial, Helvetica, sans-serif; font-size: 14px !important; line-height: 20px !important; margin-bottom: 0; margin-top: 0; padding: 10px 28px 10px 12px !important; width: 100% !important; box-sizing: border-box !important; max-width: 100% !important; height: auto; display: inline-block; vertical-align: middle; background: url('https://assets.mlcdn.com/ml/images/default/dropdown.svg') no-repeat right .75rem center/8px 10px; -webkit-appearance: none; -moz-appearance: none; appearance: none; } #mlb2-12234090.ml-form-embedContainer .ml-form-embedWrapper .ml-form-embedBody .ml-form-horizontalRow { height: auto; width: 100%; float: left; } .ml-form-formContent.horozintalForm .ml-form-horizontalRow .ml-input-horizontal { width: 70%; float: left; } .ml-form-formContent.horozintalForm .ml-form-horizontalRow .ml-button-horizontal { width: 30%; float: left; } .ml-form-formContent.horozintalForm .ml-form-horizontalRow .ml-button-horizontal.labelsOn { padding-top: 25px; } .ml-form-formContent.horozintalForm .ml-form-horizontalRow .horizontal-fields { box-sizing: border-box; float: left; padding-right: 10px; } #mlb2-12234090.ml-form-embedContainer .ml-form-embedWrapper .ml-form-embedBody .ml-form-horizontalRow input { background-color: #ffffff; color: #333333; border-color: #cccccc; border-radius: 4px; border-style: solid; border-width: 1px; font-family: 'Open Sans', Arial, Helvetica, sans-serif; font-size: 14px; line-height: 20px; margin-bottom: 0; margin-top: 0; padding: 10px 10px; width: 100%; box-sizing: border-box; overflow-y: initial; } #mlb2-12234090.ml-form-embedContainer .ml-form-embedWrapper .ml-form-embedBody .ml-form-horizontalRow button { background-color: #000000 !important; border-color: #000000; border-style: solid; border-width: 1px; border-radius: 4px; box-shadow: none; color: #ffffff !important; cursor: pointer; font-family: 'Open Sans', Arial, Helvetica, sans-serif; font-size: 14px !important; font-weight: 700; line-height: 20px; margin: 0 !important; padding: 10px !important; width: 100%; height: auto; } #mlb2-12234090.ml-form-embedContainer .ml-form-embedWrapper .ml-form-embedBody .ml-form-horizontalRow button:hover { background-color: #333333 !important; border-color: #333333 !important; } #mlb2-12234090.ml-form-embedContainer .ml-form-embedWrapper .ml-form-embedBody .ml-form-checkboxRow input[type="checkbox"] { box-sizing: border-box; padding: 0; position: absolute; z-index: -1; opacity: 0; margin-top: 5px; margin-left: -1.5rem; overflow: visible; } #mlb2-12234090.ml-form-embedContainer .ml-form-embedWrapper .ml-form-embedBody .ml-form-checkboxRow .label-description { color: #000000; display: block; font-family: 'Open Sans', Arial, Helvetica, sans-serif; font-size: 12px; text-align: left; margin-bottom: 0; position: relative; vertical-align: top; } #mlb2-12234090.ml-form-embedContainer .ml-form-embedWrapper .ml-form-embedBody .ml-form-checkboxRow label { font-weight: normal; margin: 0; padding: 0; position: relative; display: block; min-height: 24px; padding-left: 24px; } #mlb2-12234090.ml-form-embedContainer .ml-form-embedWrapper .ml-form-embedBody .ml-form-checkboxRow label a { color: #000000; text-decoration: underline; } #mlb2-12234090.ml-form-embedContainer .ml-form-embedWrapper .ml-form-embedBody .ml-form-checkboxRow label p { color: #000000 !important; font-family: 'Open Sans', Arial, Helvetica, sans-serif !important; font-size: 12px !important; font-weight: normal !important; line-height: 18px !important; padding: 0 !important; margin: 0 5px 0 0 !important; } #mlb2-12234090.ml-form-embedContainer .ml-form-embedWrapper .ml-form-embedBody .ml-form-checkboxRow label p:last-child { margin: 0; } #mlb2-12234090.ml-form-embedContainer .ml-form-embedWrapper .ml-form-embedBody .ml-form-embedSubmit { margin: 0 0 20px 0; float: left; width: 100%; } #mlb2-12234090.ml-form-embedContainer .ml-form-embedWrapper .ml-form-embedBody .ml-form-embedSubmit button { background-color: #000000 !important; border: none !important; border-radius: 4px !important; box-shadow: none !important; color: #ffffff !important; cursor: pointer; font-family: 'Open Sans', Arial, Helvetica, sans-serif !important; font-size: 14px !important; font-weight: 700 !important; line-height: 21px !important; height: auto; padding: 10px !important; width: 100% !important; box-sizing: border-box !important; } #mlb2-12234090.ml-form-embedContainer .ml-form-embedWrapper .ml-form-embedBody .ml-form-embedSubmit button.loading { display: none; } #mlb2-12234090.ml-form-embedContainer .ml-form-embedWrapper .ml-form-embedBody .ml-form-embedSubmit button:hover { background-color: #333333 !important; } .ml-subscribe-close { width: 30px; height: 30px; background: url('https://assets.mlcdn.com/ml/images/default/modal_close.png') no-repeat; background-size: 30px; cursor: pointer; margin-top: -10px; margin-right: -10px; position: absolute; top: 0; right: 0; } .ml-error input, .ml-error textarea, .ml-error select { border-color: red!important; } .ml-error .custom-checkbox-radio-list { border: 1px solid red !important; border-radius: 4px; padding: 10px; } .ml-error .label-description, .ml-error .label-description p, .ml-error .label-description p a, .ml-error label:first-child { color: #ff0000 !important; } #mlb2-12234090.ml-form-embedContainer .ml-form-embedWrapper .ml-form-embedBody .ml-form-checkboxRow.ml-error .label-description p, #mlb2-12234090.ml-form-embedContainer .ml-form-embedWrapper .ml-form-embedBody .ml-form-checkboxRow.ml-error .label-description p:first-letter { color: #ff0000 !important; } @media only screen and (max-width: 400px){ .ml-form-embedWrapper.embedDefault, .ml-form-embedWrapper.embedPopup { width: 100%!important; } .ml-form-formContent.horozintalForm { float: left!important; } .ml-form-formContent.horozintalForm .ml-form-horizontalRow { height: auto!important; width: 100%!important; float: left!important; } .ml-form-formContent.horozintalForm .ml-form-horizontalRow .ml-input-horizontal { width: 100%!important; } .ml-form-formContent.horozintalForm .ml-form-horizontalRow .ml-input-horizontal > div { padding-right: 0px!important; padding-bottom: 10px; } .ml-form-formContent.horozintalForm .ml-button-horizontal { width: 100%!important; } .ml-form-formContent.horozintalForm .ml-button-horizontal.labelsOn { padding-top: 0px!important; } } function ml_webform_success_12234090() { var $ = ml_jQuery || jQuery; $('.ml-subscribe-form-12234090 .row-success').show(); $('.ml-subscribe-form-12234090 .row-form').hide(); } fetch("https://assets.mailerlite.com/jsonp/756599/forms/112709122495874564/takel")

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