PURPOSE

The purpose of this document is to describe the BioReFeel device and the method to be followed for safe product use.

USERS

BioReFeel must be administered exclusively by properly trained, qualified, or accredited healthcare professionals in accordance with national regulations.

PRODUCT DESCRIPTION

BioReFeel is a pre-filled syringe containing an injectable, viscoelastic, biodegradable gel with volumizing action. It is composed of bio-fermented Hyaluronic Acid, Phenoxyethanol, Ethylhexylglycerin, Sodium Hydroxide, Succinic Acid, and Amino Acids.

The device is clear, colorless, homogeneous, viscoelastic, sterile, pyrogen-free, latex-free, and has a physiological pH. Each package includes:

• 1 sterile single-use pre-filled syringe (2.4 mL)
• 2 sterile disposable needles (29G, 13 mm)
• Instructions for use
• Patient leaflet
• Implant card
• 2 adhesive traceability labels

STERILITY

The BioReFeel syringe is sterilized by filtration. Needles are sterilized by irradiation.

INTENDED USE

The product is an injectable implant indicated for increasing facial tissue volume. It is recommended for the correction of severe wrinkles or for redefining the shape of cheekbones or tear troughs. Aesthetic indications: improvement of skin aging, correction of severe wrinkles, reshaping of cheekbones or tear troughs. Depending on the area to be treated and tissue support, the product should be injected between the mid and deep dermis. Based on the required corrections, one or more treatment sessions may be needed. Thanks to its viscoelastic properties, the product distributes evenly in the injected tissue and, being a biodegradable implant, is reabsorbed within four weeks.

MODE OF ACTION

Thanks to the action of Hyaluronic Acid, a major component of the extracellular dermal matrix, the product hydrates the skin and adds volume to tissues. Hyaluronic Acid’s unique structure allows it to retain up to 1000 times its weight in water, enabling it to add volume and lift tissue. The combination of amino acids in the formulation enhances the action of Hyaluronic Acid, resulting in synergistic effects and improved outcomes—supporting skin hydration, the filling of cutaneous depressions, and the restoration of soft tissue volume, thereby improving overall skin appearance.

PRECAUTIONS FOR USE

Before treatment, the patient's suitability must be assessed through proper medical history. The injection of fillers into soft tissues is a medical procedure that involves a risk of infection and must be performed in a suitable environment, with all the usual precautions for such procedures. The practitioner must have adequate knowledge of facial anatomy. Check the expiration date and packaging integrity before use. Do not use the product after the expiration date or if the internal packaging is damaged. Do not use the syringe if its contents show signs of separation, bubbles, or cloudiness. Do not use syringes or needles if they are damaged or have been unintentionally opened. Do not use or attempt to straighten a bent needle; discard and replace it.

APPLICATION METHOD

Ensure the outer packaging is undamaged, then open it. Read the instructions for use enclosed in the package. Cut out and complete the implant card. Ensure the blister is intact before opening. Verify that the lot number on the syringe label matches that on the adhesive label in the IFU. Ensure the product is not expired. Remove makeup, creams, or residue from the face. Sanitize hands using alcohol-based or chlorhexidine products. Remove the pre-filled syringe and one of the sterile needles. Check the needle packaging, then open it. Ensure the syringe is intact, then attach the needle. Sanitize the injection area. Perform the injection using the most appropriate technique as outlined in the “DOSAGE AND ADMINISTRATION” section. Clean any blood leakage using alcohol-based or chlorhexidine products. After treatment, apply one adhesive label to the implant card and give it to the patient. Repeat the process with the second card for patient records. Keep the patient for about 10 minutes to monitor for adverse events. Dispose of the product according to national regulations.

DOSAGE AND ADMINISTRATION

BioReFeel is intended for injection only by licensed medical specialists or qualified professionals in accordance with local legislation. These professionals must be proficient in injection techniques and knowledgeable about the anatomy and physiology of the injection site and surrounding areas. Conduct a full medical history and inform the patient about indications, expected outcomes, contraindications, precautions, and potential side effects. Ensure skin is properly cleaned and disinfected. Makeup must be completely removed. Use sterile technique and inject using the needles provided. Injection methods can include fan, bolus, or linear retrograde techniques. The choice is at the physician's discretion. Inject into the mid or deep dermis. Clinical studies show no adverse effects up to 2.4 mL. Do not exceed 2.4 mL per session or 14.4 mL annually (maximum 6 sessions/year). Avoid overcorrection. If blanching appears during injection, stop immediately. Do not inject near vessels or nerves. Wait 15 minutes post-injection to detect potential vascular occlusion. Space treatments at least 15 days apart. Avoid superficial injection to prevent irregular results. Stop injection before withdrawing the needle. Massage treated areas gently to ensure uniform distribution. Prepare the syringe by removing the cap, attaching a sterile needle, removing the needle cap, and pushing the plunger until the product appears. Inject slowly with minimal pressure. Aspirate before injection to confirm extravascular positioning. Massage area post-injection for even product distribution. Discard any unused product and used needles.

IMPLANT CARD AND TRACEABILITY LABEL

After treatment, the physician must place one traceability label on the back of the implant card, complete the card, and give it to the patient. Include: patient name or ID, treatment date, and healthcare provider name/address. Attach the second label to the patient’s medical file. The second implant card serves as a backup.

CONTRAINDICATIONS

Do not use BioReFeel in the following cases:

• Patients with acute allergies, history of anaphylaxis, or multiple severe allergies
• Known hypersensitivity to product components
• Pregnancy or breastfeeding
• Patients under 18 years of age
• Skin diseases, autoimmune disorders, heart conditions, epilepsy, porphyria, liver failure, or those under related treatment
• Inflammatory/infectious skin conditions at injection site
• Combined with chemical peels, laser, ultrasound, or dermabrasion
• In superficial epidermis, blood vessels, lips, or where other fillers may be present

ADVERSE EFFECTS

Inform patients about potential side effects immediately or after some time:

• Inflammatory reactions: redness, swelling, itching
• Vascular issues: occlusion, irregularities
• Allergic reactions: rash, anaphylaxis
• Severe cases: necrosis, vision loss, stroke

Stop treatment and consult a specialist if symptoms appear. Report all effects.

INCOMPATIBILITIES

Avoid contact with quaternary ammonium salts or related instruments.

WARNINGS

Check expiration. Do not freeze. Do not reuse or resterilize. Dispose properly after use.

DISPOSAL

Dispose of used needles and syringes according to healthcare and national regulations. The manufacturer assumes no liability for misuse or off-label use. The user is responsible for verifying product suitability.

Legend of International Symbols

01 Caution 02 Sterilized using aseptic processing techniques 03 Refer to instructions 04 Sterilized by irradiation (needles) 05 Single sterile barrier system 06 Do not resterilize 07 Do not reuse 08 Protect from sunlight 09 Temperature limits 10 Fragile 11 Do not use if package is damaged 12 Use by 13 Keep dry 14 Batch number 15 Unique Device Identifier 16 Manufacturer 17 Manufacturing date 18 CE Mark 19 Pre-filled syringe 20 Needle 21 Patient name or ID 22 Treatment date 23 Healthcare facility/provider 24 Website for patient info 25 Near Field Communication