A Clinical Study of Outcomes in Foot and Ankle Bone Grafting Using map3® Cellular Allogeneic Bone Graft

map3® Cellular Allogeneic Bone Graft provides the desired osteoconductive, osteoinductive
and osteogenic potential capacities which are essential to optimal fracture healing when
bone grafts are implanted. It offers viable MAPC-class cells on a scaffold comprised of
demineralize bone matrix (DBM) and cortical cancellous chips. map3® Cellular Allogeneic
Bone Graft is considered an allograft, and as such, is indicated for bone repair for
orthopaedic indications where autograft is employed. The primary goal of this study is to
evaluate the outcomes in bone grafts of the foot or ankle using a stem cell modified
allograft (map3® Cellular Allogeneic Bone Graft). The study endpoints will be objectively
determined via x-rays and CT scan to assess bony fusion, extremity evaluation using the AFAS
and subjective patient scores for foot disabilities and quality of life.

Inclusion Criteria:

- Study subjects will be limited to patients with foot/ankle pathologies requiring
fusion, which include midfoot, hindfoot, ankle, double and triple arthrodesis using
open surgical technique with supplemental bone graft substitute.

- Life expectancy of at least twenty four (24) months

- Ability to give written informed consent

- All subjects will have a minimum age of eighteen (18) years and a maximum of eighty
(80) years.

- Both male and non-pregnant female subjects will be included.

- To facilitate follow-up, study subjects will be limited to the local geographic area
of the study site and must be willing to use the rehabilitation facility and physical
therapy schedule assigned by the surgeon.

- All subjects must be able to read, write, and comprehend instructions and guidelines
in English and understand (and sign as an acknowledgment of their understanding) an
informed consent declaration

Exclusion Criteria:

- Patients who have been diagnosed with Charcot foot

- Patients requiring osteotomies or undergoing a revision surgery for non-union

- Patients with additional lower limb injuries requiring concomitant procedures not
related to the current foot/ankle procedure

- Patients with soft tissue compromise involving open and/or infected wounds on the
study limb

- Patients requiring any other bone grafting product other than study product (map3®
Cellular Allogeneic Bone Graft) e.g. rhBMP2 (recombinant human bone morphogenetic
protein 2).

- Patients with confirmed diagnosis of abnormal lower limb vasculature or peripheral
vascular disease

- Patients with a high Body Mass Index ( BMI > 35)

- Diagnosis of osteonecrosis, metabolic bone diseases or gout

- Diabetic patients who are insulin dependent

- Patients who have received any treatment within the past 12 months which may
interfere with bone metabolism (bisphosphonates and/or calcitonin).

- Patients using glucocorticoids > 10 mg/day

- Chronic use (≥ 90 days) of non-steroidal anti-inflammatory drugs (NSAIDS)

- Patients with active cancer or a history of any cancer

- Known allergies to Dimethyl Sulfoxide (DMSO) and/or Human Serum Albumin (HSA)

- Pregnant or lactating females or who are capable of reproduction and will not take
acceptable measures to prevent reproduction during the study

- Patients who have tested positive for HTLV, HIV, hepatitis B or hepatitis C, have
rheumatoid arthritis, an autoimmune disease or are on chronic immunosuppressive
medications

- Require chronic use (≥ 90 days) of anticoagulation therapy

- Active smokers unwilling to comply with surgeons instructions to stop smoking seven
(7) days prior to surgery through three (3) month post-op visit

- History of alcohol or drug abuse within 90 days of screening

- Patients currently enrolled or have been enrolled in clinical studies evaluating
investigational devices, pharmaceuticals or biologics within 90 days of enrollment.

- Patients unable to give written informed consent and any vulnerable patient
population

- Inability to comply with all requirements of this investigation, as well as follow
the instructions of the physician