German dialysis products company Fresenius Medical Care has entered a strategic global partnership with US-based medical research firm Humacyte over the investigational human acellular vessel Humacyl.

Under the agreement, Fresenius Medical Care will gain exclusive global rights to commercialise the haemodialysis product designed for patients with end-stage renal disease (ESRD).

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The company will be able to market, sell and distribute the product following approval from health authorities.

As part of the deal, Fresenius Medical Care will also make an equity investment of $150m, which will fetch the company a 19% fully diluted ownership stake in Humacyte.

“Under the agreement, Fresenius Medical Care will gain exclusive global rights to commercialise the haemodialysis product designed for patients with end-stage renal disease (ESRD).”

The move is expected to provide global ESRD patients with access to Humacyte’s bioengineered human acellular vessels, after approval of the product.

Subject to customary closing conditions, the transaction is expected to be completed next month.

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Fresenius Medical Care North America chief medical officer Franklin Maddux said: “Our exclusive rights to distribute this innovative technology to dialysis patients worldwide may have significant benefits not only to patients but health systems as well.

“With the potential for fewer anticipated complications and interventions compared to synthetic grafts, we may see increased safety for patients and reduced medical and economic burdens to the healthcare system.”

Currently, Humacyte is evaluating its product in Phase III clinical trials in the US and Europe for vascular access during haemodialysis and expects Humacyl to be more effective than existing synthetic grafts and fistula.

Humacyte CEO and chairman Carrie Cox said: “Our partnership will allow Humacyte to focus on advancing the potential for Humacyl as a substantial breakthrough in the science of regenerative medicine, and to continue our development of an exciting future pipeline.”