Bridge-Enhanced ACL Repair-Safety Study (BEAR Trial)

This is a first-in-human trial for evaluation of the safety (Primary Objective) and
short-term efficacy (Secondary Objective) of the MIACH™ ACL scaffold and will be carried out
in form of an observational study of 20 patients: 10 experimental and 10 control.

Inclusion Criteria:

- Complete ACL tear, confirmed by MRI

- Time from injury to screening must be less than or equal to 90 days

- ACL tissue present on pre-operative MRI

Exclusion Criteria (before surgery):

- Prior surgery on affected knee

- History of prior infection in affected knee

- Regular use of tobacco or nicotine in any form

- Use of corticosteroid within last 6 months

- Ever underwent chemotherapy treatment

- History of sickle cell disease

- History of anaphylaxis

- Any condition that could affect healing (Diabetes, inflammatory arthritis, etc)

- Diagnosis of posterolateral corner injury (LCL complete tear, Biceps femoris tendon
avulsion, tear of the arcuate ligament, tear of the popliteus ligament)

- Diagnosis of Grade III medial collateral ligament injury

- Diagnosis of complete patellar dislocation

Exclusion Criteria (during surgery):

- ACL deemed normal on arthroscopic inspection

- Time from injury to surgery is greater than 90 days (for Comparator group) and greater
than 30 days (for Experimental group)

- Experimental Group: Less than 50 percent of ACL remaining

- Displaced bucket handle meniscal injury requiring repair

- Diagnosis of full-thickness chondral injury on either condyle

- Grade III medial collateral ligament injury