After a long approval process, Monmouth Junction N.J.-based Cytosorbents Corp. received clearance to bring its Cytosorb blood purification technology to treat cytokine storm and deadly inflammation in critically ill and cardiac surgery patients, to the Mexican market. The COVID-19 pandemic may delay marketing plans to roll-out the product in the Latin American country.

“This is not the first market in Latin America that we have entered,” Vince Capponi, chief operating officer at Cytosorbents, told BioWorld. “When you look at it geographically, that is the fastest growing area for market expansion for us, considering the number of countries we are registering and actually starting sales.”

The company is already selling devices in markets like Chile, Panama, Peru and Costa Rica. It is also moving forward with regulatory approvals with Anvisa, the Brazilian health care surveillance agency, to enter that country.

“From the regulatory standpoint, Mexico is very demanding, along with Brazil, which is fairly demanding,” said Capponi.

Cytosorbents is working with Fresenius Medical Care AG, from Bad Homburg, Germany, as its key partner to distribute its product in Mexico. The companies have worked together before in several European markets. The push into Mexico is part of a year-old agreement that also covers South Korea.

“There are approximately 129 million people in Mexico and 52 million people in South Korea. Throughout both countries, there is an increasing burden of illness and rising health care costs associated with deadly inflammatory conditions such as sepsis,” Cytosorbents said in 2019, when it reported the partnership with Fresenius.

“We are excited to expand our partnership with Cytosorbents to introduce Cytosorb to the Mexican health care system,” Alfredo Merino, senior vice president of business strategy at Fresenius Medical Care North America, and CEO at Fresenius Medical Care Mexico, said at the time the partnership was reported.

“In the country each year, hundreds of thousands of lives are lost at a tremendous human and economic cost from hyperinflammatory conditions such as sepsis, trauma, acute liver disease and lung injury due to a lack of effective therapies. We hope to change this with Cytosorb,” said Merino.

Mexico is uncharted territory for Cytosorbents but the insight Frenesius can provide coupled with that company’s recent acquisition of Nxstage Medical Inc., from Lawrence, Mass., for $2 billion and of Xenios AG, from Heilbronn, Germany, in late 2016 may be key drivers to succeed.

“Fresenius is there to help us through the regulatory processes, etc., something we would never have done before on our own, since we did just not have a good understanding of that particular market,” said Capponi. “We have now leveraged that relationship with Fresenius, which is now managing the sales of the product.”

A key factor for the Mexican expansion is the footprint of the Nxstage dialysis device in the Latin American market.

“For us, the Nxstage machine is not only a standard dialysis, but also used in the ICUs in the hospitals. Fresenius is actually positioned quite well to penetrate the market with our device in Mexico, because of their presence in Mexico, but also because of their acquisitions as well as the strong partnerships that we have with them,” said Capponi.

According to the Mexican Secretary of Health, there are 3,826 ICU units in Mexico. The figure is increasing day after day, as the country gets ready for a possible tsunami of COVID-19 patients. The country has recorded more than 14,600 cases and about 378 are in critical condition.

COVID-19 could delay the entrance of Cytosorb into Mexico but at the headquarters of Cytosorbents in New Jersey, the company is already preparing its first shipment of the Cytosorb device to that country.

“Obviously with just the recent approval (by Cofepris), under very normal circumstances, we would have a straight roll-out program, which is what we do to enter these markets,” said Capponi. “Fresenius is gearing up to do that, but obviously with COVID-19, everybody is being very focused on driving and providing care in the ICUs. From that perspective, we probably will be impacted in the short term, in respect to the roll-out program,” he said.

“We are running our facility here on a 24/7 basis and everybody is extremely busy at this point. I would say that COVID-19 probably has been a little bit of a distraction for everyone, but at the same time, I know that Fresenius is working on putting the product into the country and we are about to make the shipment here very shortly,” he said.

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