Miromatrix Biological Mesh for Ventral Hernia Repair

Miromatrix Medical Inc. has developed a new biologic mesh, called MIROMESH®. MIROMESH
received FDA 510(k) clearance with an indication for reinforcement of soft tissue on March
31, 2014 under K134033. Miromatrix Biologic Mesh is a non cross-linked, acellular surgical
mesh that is derived from the highly vascularized porcine liver. This study will serve to
provide clinicians with high-quality clinical data in order to provide them with a higher
degree of confidence when selecting MIROMESH for ventral hernia repair.

Inclusion Criteria:

- between 18 and 80 years old on the day of study enrollment

- ventral or incisional hernia greater than 9 cm2 for which the physician anticipates
ability to achieve midline fascia closure following a retro-rectus repair/component
separation

- hernia classified as CDC class 1 or 2 preoperatively

- able and willing to sign the consent form and comply with all study visits and
procedures

- commit to non-smoking for at least 4 weeks prior to procedure

Exclusion Criteria:

- sensitivity to porcine material

- scheduled for a concomitant procedure of a wound classified as other than clean

- immunocompromised or at risk of immunosuppression (i.e. be HIV positive, be
experiencing organ rejection, be a recent or anticipated chemotherapy recipient) as
determined by the Investigator

- BMI ≥40

- A1C level ≥10.0

- participating in another clinical study

- cirrhosis, and/or ascites

- diagnosed with a collagen vascular disorder

- American Society of Anesthesiology (ASA) Class 4 or 5

- allergic to tetracycline or kanacmycin

- life expectancy of less than 2 years at the time of enrollment

- any condition in the opinion of the Investigator that would preclude the use of the
study device, or preclude the subject from completing the follow-up requirements