Feasibility Study for Bevonescein-Assisted Nerve Visualization in Head & Neck Surgery

Inclusion Criteria:

• Minimum of 16 years of age.

• Planning to undergo surgery in the Head and Neck.

• Study participant's primary surgical treatment is parotidectomy or thyroidectomy (unilateral or bilateral) or cervical neck dissection.

• Willing and able to provide written assent as required and written informed consentby a legally authorized representative after the nature of the study has beenexplained, and prior to any research-related procedures.

• Sexually active patients must be willing to use an acceptable method ofcontraception while participating in the study and for 30 days after receivingbevonescein.

• Females of childbearing potential must have a negative pregnancy test at screeningand be willing to have additional pregnancy tests during the study.

Exclusion Criteria:

• Patient has a history of prior surgery and/or radiation to the intended surgicalsite.

• Patient has abnormal cardiac rhythm not controlled with medication.

• Patient has moderate to severe renal impairment as indicated by a glomerularfiltration rate (GFR) < 60 mL/min.

• Patient has decreased hepatic function defined as AST/SGOT and ALT/SGPT that ishigher than 20% of the institution's normal laboratory limits, and/or the patienthas elevated total bilirubin that is higher than 20% of the institution's normallaboratory limits.

• Patient has unresolved acute toxicity from prior anti-cancer therapy, alopecia,neuropathy <= Grade 2, as well as other non-acute and stable anti-cancer therapytoxicities are acceptable.

• Patient has a history of fluorescein allergy.

• Patient has a history of drug-related anaphylactic or severe allergic reactions.

• Presense or history of any hypersensitivity to bevonescein or its excipients that,in the judgment of the Investigator, places the patient at increased risk foradverse effects.

• Presence of a concurrent disease or condition that may interfere with studyparticipation including recent (within 6 months of screening) NYHA Class III or IVheart failure, myocardial infarction, or cerebrovascular accident.

• Presence or history of any condition, that in the view of the Investigator, placesthe patient at high risk of poor treatment compliance or of not completing thestudy.

• Pregnant or breastfeeding at screening or planning to become pregnant (self orpartner) at any time during the study.

• Use of any investigational product or investigational medical device within 30 daysprior to screening, or requirement for any investigational agent prior to completionof all scheduled study assessments.