High-end medical device manufacturer Medeon Biodesign recently announced that it has received notice from its Japanese licensing partner, Terumo Medical Corporation, indicating a delay in the market launch schedule of their jointly developed large-bore vascular closure device, Cross-Seal. The delay is attributed to the impact of the pandemic and ongoing supply chain challenges, raising concerns that the original targets may not be met. In response, Medeon has issued a “milestone waiver notice.”

Medeon emphasized yesterday (18th) that the Cross-Seal asset transfer agreement between the two parties remains in effect. The companies are in close communication regarding follow-up measures and are actively seeking the most appropriate resolution, aiming to reach a mutually acceptable arrangement through negotiations.

The Cross-Seal is the first and successfully licensed product among several advanced medical devices developed by Medeon. It was licensed to Terumo in 2018 in a deal valued at US$50 million, under which Medeon has received upfront payments and milestone-based payments at various stages. Medeon noted that over US$10 million in payments from the partnership has yet to be realized.

Medeon further explained that there are two generations of the Cross-Seal device developed in collaboration with Terumo. The first-generation product has already obtained FDA clearance in the United States, but Terumo has not yet commenced sales. Development of the next-generation version has faced delays in recent years due to the pandemic and supply chain disruptions.

Resource: 益安新醫材上市 有變數