CTN Cryolipo Clinical Studies. Summary

Transcription

1 CTN Cryolipo Clinical Studies Summary

2 Key data of the study The first series of clinical studies using CTN Cryolipo equipment 42 patients 13 months Finland years Number of people in the test group Total duration of the tests and follow up Location where the tests were carried out When the tests and follow ups where done The average age of the patients 28 The average Body Mass Index of the participants

3 Demographics The profile of the participants 30 women and 12 men participated in the tests and follow up The average age of the female participants was 41 The average age of the male participants was 36 The group s average BMI in the beginning of the trials was 28 and 26 in the end of the follow up The follow up was ended after three months from the last administered treatment 30 females 12 males

4 Cryolipolysis A non-invasive method of fat removal Cryolipolysis is a process where fat cells are destroyed by using a controlled, prolonged exposure to sub-zero temperatures in the chosen treatment area. Stage 1. The vacuum of the Cryolipo applicator safely pulls the tissue of treated area between the cooling plates. Stage 2. Cooling lasts 50 minutes whilst the temperature of the treated tissue is monitored and maintained at the ideal level (between -1 to -2 degrees Celcius) Stage 2 Stage 1 Stage 3 Stage 3. The 50 minute cooling period is followed by 5 minutes of variable vacuum massage to restore the blood flow. Stage 4 Stage 4. The post-treatment discipline should be followed prior to repeating the treatment in the same area after 30 days.

5 Microscopic pictures of fat cell crystallisation When exposed to sub-zero temperatures for prolonged period of time, the fat cells crystallise. An average of 26% of the fat cells in the treated area will be crystallised during the recommended 50 minute cooling period

6 Microscopic pictures of dissolving fat cells Crystallisation of fat cells causes apoptosis. The cell membranes are destroyed and the fat cells are dissolved into lipids. Liver converts lipids into blood sugar, thus removing them efficiently at a steady pace. This steady metabolic process also reduces the appetite, which helps patients to maintain a healthier diet and reduce calorie intake.

7 Weight loss results in 90 days The average weight loss percentage of the 30 women that participated in contrast to the average weight loss % of the 12 men after 3 months. 5 Weight reduction chart % Women had an average weight loss of 2.8% after first month 3.9% after second month 4.6% after third month Men had an average weight loss of 2.1% after first month 3.4% after second month 4.9% after third month Women Men 1 month 3 months 2 months 1 month 2 months 3 months

8 Reduction in diameter Measured results after 90 days from last treatment The diameter of the waist, thighs, and under arms of the participants were measured prior to the treatment and again every 30 days. The target area can be treated once every 30 days, and so each participant had their problem area treated 3 times during the 2 month treatment trial followed by a 3 month monitoring of the results. Those who chose their waist for treatment noticed an average reduction of 8.4 centimeters. The average reduction for the thigh area was 3.3 centimeters. The under arm area had an average reduction of 2.1 centimeters WAIST THIGHS UNDER ARM Reduction in cm

9 Body Mass Index Average BMI reduction The average BMI of all 42 participants was 28. After a 4 month period, the average had dropped to 25,5. The chart on the right illustrates the average BMI decline rate of all participants Number of months

10 BEFORE AND AFTER PICTURES Female patients years after two treatments days from first

11 Male patients years after two treatments days from first

12 Female patient 44 years before and after 50 days two treatments

13 Female patient 48 years before and after 94 days three treatments

14 Female patient 48 years before and after 35 days one treatment

15 Female patient 42 years before and after 31 days one treatment

16 Key features for successful treatment Good results require controlled treatment protocol and post-treatment discipline The keys to achieve good results from Cryolipo treatments are listed below: Professional equipment is a must for both treatment efficiency and patient safety. Reliable temperature control is imperative. Minimum treatment time to obtain results is 40 minutes and recommended cooling time 50 minutes followed by a 5 minutes variable vacuum massage The subcutaneous tissue temperature should be maintained between -1 and -2 degrees Celcius for the duration of the treatment Post treatment protocols have a clear impact on the results. Exercise, sufficient intake of water and healthy diet greatly enhances and improves the results. Post treatment discipline Sufficient treatment time Cryolipolysis Treatment Focus Points Correct temperature control

17 Extreme treatment parameter tests Extreme treatment settings and duration were tested with six volunteers TEST GROUP 1) 3 women and 3 men between years of age 2) Lowest BMI 24 and highest 30 3) Treated area abdomen and flanks (love handles) TREATMENT SETTINGS USED 1) Minimum temperature setting -6 Degrees Celsius 2) Maximum vacuum pressure 100% 3) Duration of cooling process 60 minutes + 10 minutes RESULTS 1) No adverse effects on two patient with BMI ) Strong bruising and some tissue hardening on two patients with BMI ) Bruising lasted for 2 weeks 3) Severe bruising and tissue hardening on patients with lower BMI ) Bruising lasted for 20 days 2) Tissue hardening was treated with massage and thermal gel. No tissue damage. 3) Mild frost bites on the skin, redness and slight discoloration lasted for ca. 30 days.

18 Non-invasive cryolipolysis for subcutaneous fat reduction does not affect serum lipid levels or liver function tests. Abstract BACKGROUND AND OBJECTIVE Cryolipolysis provides a method of non-invasive fat reduction that significantly reduces subcutaneous fat without injury to adjacent tissues. Preliminary animal and human data have suggested that cryolipolysis has no effect on serum lipid profiles or liver tests. This study was intended to more fully document any effect of this procedure on lipid and liver-related blood tests. STUDY DESIGN/MATERIALS AND METHODS Forty subjects with fat bulges on their flanks ("love handles") were treated bilaterally with a non-invasive device that precisely cools tissue to achieve a reduction in the fat layer. Serum lipid levels and liver tests were measured prior to treatment, and at 1 day and 1, 4, 8, and 12 weeks post-treatment. RESULTS No meaningful changes in mean values were observed for any blood lipid level or liver test at any point over the 12-week follow-up period. CONCLUSION Cryolipolysis, when used for reduction of subcutaneous flank fat, is not associated with changes in serum lipids or liver test results

19 Global treatment data and side effects Over 2000 treatments done by 15 th February 2015 with Monolith Quattro SIDE EFFECTS RECORDED 1) Severe bruising in 3% of patients (28 cases in total, bruising subsided in 17 days max.) Note: All cases with patient BMI below 26 2) Frost bites on skin in 1% of patients (8 cases in total, discoloration lasted for up to 3 weeks) Note: 7 out of these patients were smokers, BMI below 28 in all cases 3) Tissue hardening in 4% of patients (35 cases in total, back to normal within 8 days) 4) Allergic skin reaction (rash) in 2% of patients (19 cases in total, subsided in 3 weeks max.) No other side affects reported.

20 The leader in non-surgical technology