A Study to Investigate the Safety, Tolerability and Preliminary Efficacy of NGI226 Microparticles in Patients With Achilles Tendinopathy

Inclusion Criteria:

• Written informed consent must be obtained prior to all study specific screeningprocedures, as close to the start of the screening period as possible.

• Presence of clinically (local Achilles tendon pain on tendon-loading activities,pain on palpation at the level 2-6 cm proximal to the calcaneal insertion) andultrasound (local tendon thickening with hypoechogenicities and irregular fibreorientation) or MRI diagnosed mid-portion Achilles tendinopathy with symptomspresent ≥8 weeks but <12 months at screening.

• The Achilles tendinopathy must have been refractory to at least 6 weeks ofconservative treatment (physiotherapy, NSAIDS, RICE), but participants do not needto be in physiotherapy at the time of study entry.

Exclusion Criteria:

• Medical condition that would affect safety of peritendon injection (e.g., peripheralvascular disease, use of anticoagulant medication)

• History of recurrent, acute, symptomatic infections, including outbreaks of oral orgenital herpes (> 2 symptomatic infections or >2 courses of anti-infectivetreatments required in the last 6 months; active systemic infection during last 2weeks; known active infections (e.g. chronic or active Hepatis B or C, HIV) - simplecold excluded

• History or evidence of clinically significant cardiac or cardiovascular disease

• History of deep vein thrombosis, pulmonary embolism or evidence of primary orsecondary hypercoagulable states

• History of surgical intervention for the treatment of tendinopathy, history of anklesurgery, ankle arthritis, traumatic, inflammation or deformity of ankle

• History of full-thickness tear or complete rupture of the Achilles tendon