Clinical Trials
40
2 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
1983
Active, not recruiting
1
2.5%
Completed
18
45.0%
Enrolling By Invitation
1
2.5%
No Longer Available
1
2.5%
Recruiting
5
12.5%
Terminated
4
10.0%
Unknown
1
2.5%
Withdrawn
9
22.5%
No approval data available
- Novadip Biosciences has recruited the first pediatric patients for its pivotal phase 3 trial of NVD003, a tissue regenerative treatment for congenital pseudoarthrosis of the tibia (CPT). - The trial aims to enroll 12 children across eight sites in the EU and US by Q1 2026, with previous studies showing seven of eight CPT patients achieved durable bone union. - CPT affects less than 3.5 in 150,000 live births and often leads to multiple failed surgeries and potential limb amputation without effective treatment. - The company plans to launch an adult phase 3 trial in Q3 2026 for bone non-union, targeting market availability by 2027 for pediatric patients.
- Anuncia Medical has received FDA Breakthrough Device Designation for its ReFlow EVD, designed to manage brain swelling and elevated intracranial pressure through a novel noninvasive flushing mechanism. - The ReFlow EVD allows nurses to perform noninvasive flushing procedures without requiring a neurosurgeon, potentially reducing prolonged ICU stays, additional surgeries, and costly EVD replacements in over 100,000 annual procedures. - Beyond the ReFlow EVD, Anuncia is expanding its CSF management portfolio and partnering with organizations like NeuroKids.org to improve hydrocephalus care globally, including in underserved regions of Africa.