Inspira Technologies has entered a distribution agreement with CIO MED GROUP for its product line in Central America.

Both entities have signed the deal for the marketing and deployment of the INSPIRAART device line and disposable kits in the region.

The product line includes the cardio-pulmonary bypass device, INSPIRAART100, which was recently submitted for approval from the US Food and Drug Administration.

The expected timeline for device approval is roughly six months or by the first half of next year.

The agreement also covers the INSPIRAART500 device and HYLA blood sensor technology, as well as disposable kits that will be used with these Inspira devices in the procedures.

INSPIRA ART500 and the disposable kits are intended for delivering acute respiratory support, part of Inspira’s vision to transform external breathing assistance for more than 20 million patients every year.

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The agreement is expected to generate up to $28m, primarily through recurring revenues from disposable kits over five years, subject to the receipt of regulatory approval.

Inspira Technologies president and co-founder Joe Hayon said: “In this agreement, we are expanding our offering of innovative products to eight countries in Central America, led by Mexico.”

In August of this year, Inspira announced the conclusion of a Usability Study for its INSPIRA ART100 blood circulation medical device in Boston, Massachusetts, US.

The study involved healthcare professionals in the country assessing and examining the device in a setting designed to consider the human aspects of the intended users, uses and environments.