Burst Biologics Spinal Fusion Registry

Spinal fusion surgery remains the most common intervention despite the increasing prevalence
of various motion preservation and alternative stabilization devices for patients who are
unresponsive to conservative treatment and experience back and/or leg pain and decreased
function/quality of life. Donor site morbidity and availability limit the use of autogenous
bone and over the past two decades' surgeon interest in alternative bone grafts has steadily
increased. Bone morphogenic proteins, synthetic bone graft substitutes, and various allograft
products are widely available to surgeons. Limitations on the use of allografts in the past
were mainly attributed to less than optimal donor screening and processing techniques which
removed viable components needed to aid in the bone healing process.

In recent years, the focus and scientific advances in various allograft processing techniques
have allowed the retention of various viable cytokines, growth factors, and cell populations
which result in enhanced osteogenic and osteoinductive properties. Rigorous donor bone
screening and meticulous testing has virtually eliminated the risk of disease transmission.

A unique proprietary cryoprotection processing technique (Progenokine®) for allograft tissue
was developed by Smart-Surgical, Inc. and a complete line of allograft products was created
and is now marketed by Burst Biologics (dba). In addition, rigorous standardized laboratory
assay techniques and statistical analysis provide consistency and uniformity of the
biologically active components of Burst allograft products.

This prospective registry was designed as an observational study to ascertain how
commercially available Burst Products are being used by surgeons performing spinal fusion as
well as determining relevant patient outcomes.

Inclusion Criteria:

- Patient aged 18 years or older

- Patient diagnosed with a degenerative spine disorder, has failed conservative
treatment, and has decided to undergo surgery.

- The surgeon has determined that a Burst Biologic product is or was clinically
indicated.

- Patient capable of understanding the content of the Informed Consent Form

- Patient willing and able to participate in the registry protocol including follow-up
visits and clinical evaluations.

- Patient who has agreed to participate in the registry by providing consent according
to the applicable local law and the declaration of Helsinki.

Exclusion Criteria:

The following are relative contraindications for the use of Burst Products, however the
investigator surgeon is solely responsible for the determination of patient eligibility for
surgery:

- Severe vascular or neurological disease

- Uncontrolled diabetes

- Severe degenerative disease (other than degenerative disc disease)

- Hypercalcemia, abnormal calcium metabolism

- Existing acute or chronic infections, especially at the site of the operation

- Inflammatory bone disease such as osteomyelitis

- Malignant tumors

- Patients who are or plan to become pregnant.