Safety and Efficacy Study of Polydioxanone (PDS) Plates in Rhinoplasty

Inclusion Criteria:

- Males and females between 18 and 65 years of age.

- Subjects requesting primary or secondary rhinoplasty and requiring a CSE graft
performed through an endonasal approach.

- Subjects willing to undergo PDS plating.

- Subjects with either ear conchal or septal cartilage available for grafting purposes.

- Willingness and ability to comply with protocol requirements, including returning for
follow-up visits and abstaining from exclusionary procedures for the duration of the
study.

- Willingness and ability to comply with the PI's standard preoperative and
postoperative rhinoplasty instructions.

- Subjects of childbearing potential must have a negative urine pregnancy test result at
Visit 1 and be willing able to use an acceptable method of birth control (e.g.,
barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical
sterilization, abstinence) during the study. Women will not be considered of
childbearing potential if one of the following is documented on the medical history:

- postmenopausal for at least 12 months prior to study drug administration

- without a uterus and/or both ovaries

- has had a bilateral tubal ligation for at least 6 months prior to study drug
administration.

- absence of an other physical condition according to the PI's discretion

- Willingness and ability to provide written photo consent and adherence to photography
procedures (i.e., removal of jewelry and makeup).

- Willingness and ability to provide written informed consent prior to performance of
any study related procedure.

Exclusion Criteria:

- Subjects who are pregnant, nursing, planning to become pregnant, and/or not using a
reliable form of birth control.

- Subjects with a significant systemic illness or illness localized to the areas of
treatment.

- Subjects with previous history of nasal implants.

- Subjects with previous or current history of nasal infections.

- Subjects who have history of blood thinners (aspirin, ibuprofen, naprosyn, herbal
supplements, Vitamin E) within the two weeks prior to surgery.

- Subjects who have smoked within the two weeks prior to surgery.

- Subjects who have had alcohol or illicit drugs one week prior to surgery.

- Subjects who have eaten or drank anything after midnight the night prior to surgery.

- Subjects with current history of chronic drug or alcohol abuse.

- History of autoimmune disease.

- Concurrent therapy that, in the investigator's opinion, would interfere with the
evaluation of the safety or efficacy of the study medication.

- Subjects who anticipate the need for surgery, other than the study procedure, or
overnight hospitalization during the study.

- Subjects who, in the Investigator's opinion, have a history of poor cooperation, non
compliance with medical treatment or unreliability.

- Enrollment in any active study involving the use of investigational devices or drugs.