Profound RECERTIFICATION & CONSUMABLES

Does the Profound Require Consumables? Yes

What Consumables are Required? Handpiece Cartridge Tips

Does Syneron Candela Require a Recertification Fee for the Purchase of Consumables? Yes

What is the Cost of the Recertification Fee? $35,000

Profound PRODUCT SPECIFICATIONS

Bi-polar Radio Frequency: 460 ± 5 kHz

Maximum Output Voltage: 84 VRMS; 5W per channel

Channel: Dermal – 5 independent pairs of bi-polar micro-needles

Chanel: SubQ – 7 independent pairs of bi-polar micro-needles

Mode: PID temperature control

Target Temperature Range: 65-75˚C (149  167˚F) ± 1˚C

Treatment Duration: 3-5 seconds, 0.2 second increments

User Interface: GUI  color touch screen

System Dimensions: 29.5 x 18.5 x 17.5 inches

System Weight: 55 lbs

Electrical Requirements: 100  240 VAC; 2.5 A; 50-60 Hz; single phase

Profound MANUFACTURER NOTES

Handpieces

Subdermal Q Body Handpiece – for the body (to destroy fat and tighten skin)

Dermal Face Handpiece – for the face (to provide a dramatic lift and tightening result)

What can you treat with Profound?

• Both Dermal & Adipose Tissues
• Cellulite
• Wrinkles

What will your patients experience?

• 1st device to create all 3 skin fundamentals: Elastin. Collagen. Hyaluronic Acid.
• Yields 100% response rate* in a clinical study
• Heats the adipose tissue and remodels the septae

What are the main advantages for your practice?

• Single treatment procedure with a 100% response rate* in a clinical study
• FDA cleared for treatment of facial wrinkles and the appearance of cellulite
• A comprehensive treatment for Dermal & SubQ layers
• Yields predictable results with complete control over depth, temperature and time of treatment

What are the indications for Profound treatment?

Profound is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles.

What can patients expect from Profound treatment?

Ideally, skin rejuvenation treatment should result in good aesthetic outcome with minimal risk of complications. Neoelastogenesis and neocollagenesis should be clinically correlated with less skin laxity, greater elasticity and increased dermal volume.

Profound was developed to improve the efficacy and predictability of nonsurgical treatments. Studies have shown that a single Profound treatment has a 100% response rate for rhytides and 95% for laxity at 6 months after treatment*. Patients can return to normal activities within 24 hours after treatment.

Minimal to moderate erythema is to be expected with resolution within 2-12 hours. Generalized edema may occur following reatment, which resolves within 1 to 5 days. Profound treatment is associated with minimal downtime compared to surgical face lift in which patients experience scarring at surgical margins, erythema, edema, and ecchymosis, and a return to normal activities on suture removal at 7 to 10 days.

Why is Profound a unique, novel device for treating skin laxity and increasing dermal volume, particularly of the jawline and submental area?

The Profound system incorporates temperature sensors embedded within the micro-needles and a realtime temperature feedback algorithm to reach and maintain an optical dermal temperature of 67°C for 3-4 seconds, regardless of skin impedance or thermal conditions.

Only Profounds temperature-based feedback algorithm can predictably meet the desired thermal endpoint. With this unique approach, a vigorous wound healing response is initiated with a profound increase in elastin and collagen observed at 10 weeks after treatment; thereby, resulting in greater clinical efficacy for rhytid and skin laxity treatment.

What is the effect of temperature on the dermal remodeling process?

To be effective, non-surgical skin rejuvenation procedures need to trigger the dermal remodeling process, so that a global wound healing response is triggered and new elastin and collagen will proliferate. Loss of elastin and collagen due to genetics and aging results in skin laxity and loss of elasticity. It is known from the literature that partially denaturizing collagen is much more effective at triggering neocollagenesis than fully denatured collagen.1,2 Partially denatured collagen can heal 38% faster than fully denatured collagen and produces a more profound wound healing response. Dosimetry studies have shown that to consistently produce partially denatured collagen, it is important to reach and maintain a target dermal temperature at an optimal range of 67°C – 74°C for 3-4 seconds.

Only with Profound is it possible to accurately reach and maintain the exact thermal dose of energy (temperature and time at temperature) needed to partially denature collagen and create the fastest healing response for dermal remodeling.

What is Profound treatment?

Profound is a minimally invasive bipolar RF system with patented Real Time Temperature Control that utilizes 5 pairs of micro-needle electrodes, deployed into the dermis, to precisely deliver fractionated thermal injuries in the deep reticular dermis, where the concentration of collagen is the highest. Fractionated thermal zones are created within the dermis, without thermal impact to the epidermis. Thermal injury to treated areas stimulates would healing, dermal remodeling and new elastin, collagen, and hyaluronic acid formation, resulting in visible skin improvement.

What percentage of your patients will respond to treatment?

Profound treatment has a 100% response rate for rhytides and 95% for laxity at 6 months after treatment*. * Based on results of a clinical study in 20 patients, measuring improvement in Fitzpatrick Wrinkle Scale at 3 months compared to baseline based on independent review of photographs.

What types of treatments can be performed with Profound?

Profound can be used to treat nasolabial and melolabial folds, jowls, submental, submandibular redundancy and neck strands by repairing the dynamic properties of the skin, elastin, collagen and hyaluronic acid, and restoring dermal volume loss.