Lithea AB has been selected for funding under INNOWWIDE Call 4, an EU programme supporting innovative SMEs in preparing for international market entry and global expansion. The selection marks an important milestone in Lithea’s strategy to bring its lead technology to the U.S. market.

The project focuses on preparing U.S. clinical entry for LIT1001, Lithea’s novel intratumoral implant for the treatment of osteosarcoma – a rare and aggressive bone cancer that primarily affects children and young adults. Over a six‑month period, Lithea will carry out a structured market and clinical feasibility project together with its U.S. partner Aixial US Inc.

The INNOWWIDE project will include:

• identification and engagement of leading U.S. sarcoma centres and key clinical experts,
• assessment of regulatory requirements and expectations with the U.S. Food and Drug Administration (FDA),
• adaptation of clinical and operational workflows to U.S. hospital practice, and development of a concrete plan for initiating a first clinical study in the United States.

The overall objective is to de‑risk U.S. clinical entry and establish a solid foundation for subsequent clinical development, partnerships and future financing activities.

“Being selected for INNOWWIDE funding is a strong validation of both our technology and our international strategy. It enables us to systematically prepare the next major step for LIT1001 and bring us closer to patients with significant unmet medical needs,” says Ludvig Sjöberg, CEO of Lithea AB.

The project aligns closely with INNOWWIDE’s mission to support European innovations in international market validation and further strengthens Lithea’s position as a leading company in localized, bone‑targeted cancer therapies.

Download this press release as pdf: PR Lithea AB – Lithea awarded EU funding under INNOWWIDE Call 4 2026