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Clinical Education

Scientists, in collaboration with leading aesthetic specialty physicians, are advancing a non-invasive "cool" way to gently and effectively reduce fat bulges in discrete body areas, such as abdominal fat, love handles (flanks) and back fat. Based on breakthrough research by renowned dermatologists at Massachusetts General Hospital, an affiliate of Harvard Medical School, CoolShape has designed a new technology that delivers precisely controlled cooling to target and eliminate fat cells. With this new, non-invasive method of Cryolipolysis™, you and your patients will notice a measurable fat reduction in two to four months following a single CoolShape Procedure.

While not a substitute for liposuction, the CoolShape Procedure is ideal for patients who are looking for a non-invasive alternative to reduce unwanted fat. The CoolShape Procedure using cryolipolysis is fundamentally different from other minimally or non-invasive modalities that rely on traumatic cell death. Using selective cryolipolysis, the CoolShape Procedure induces apoptosis only in targeted fat cells to gently and gradually reduce the fat layer while sparing all other tissue.

Scientific Studies and Publications

Cryolipolysis™ is the non-invasive cooling of adipose tissue to induce lipolysis without damage to other surrounding tissue. The proof of concept – that precise cold can be engineered to target and eliminate only fat cells – is based on early experiments conducted by the inventors of the concept, scientists Dieter Manstein, MD, and R. Rox Anderson, MD, of the Wellman Center of Photomedicine at Massachusetts General Hospital in Boston, a teaching affiliate of Harvard Medical School.
Read about cryolipolysis and the Zeltiq™ Procedure in the following peer reviewed articles, trade publications and clinical studies.

"Selective Cryolysis: A Novel Method of Non-Invasive Fat Removal."

This initial work by Drs. Manstein and Anderson and their team focused on the effect of controlled cooling on subcutaneous fat in an experimental animal model. They demonstrated that:

·   At 3.5 months... approximately 80% of the upper fat layer thickness, or 40% of the total fat layer thickness, was removed in the cold exposure site.

·   In their article published in the peer-reviewed journal Lasers in Surgery and Medicine in November 2008, the authors reported that:

·   Prolonged, controlled local skin cooling can induce selective damage and subsequent loss of subcutaneous fat, without damaging the overlying skin.

·   There was no evidence of increased blood lipid levels at multiple intervals up to 90 days post-procedure.

·   Lipid-laden mononuclear cells at 2 weeks and beyond strongly suggest that the adipocytes are undergoing apoptosis and being removed by phagocytosis.

"Cryolipolysis for Noninvasive Fat Cell Destruction: Initial Results from a Pig Model."

This early research led by Brian Zelickson, MD, of the University of Minnesota Medical School, examined whether cryolipolysis can selectively damage subcutaneous fat without damaging the overlying skin or causing an increase in lipid levels. Dr. Zelickson and his study team validated the following results:

·   Fat layer reduction of up to 1 cm after a single Zeltiq exposure.

·   Direct observations of fat layer reduction after cold exposure were confirmed by both gross pathology and ultrasound imaging measurements. These tissue changes directly correlated with the progressive loss of fat cells in the treated area during the same 90 day period, as judged by blinded histology slide examination of a time series of samples in the same tissue of gross fat layer loss.

·   Cholesterol and triglyceride levels did not exceed normal bounds up to 90 days post-procedure during which time the fat layer reductions took place.

·   No damage to overlying skin or surrounding structures confirmed by both clinical observation and histology review.

The study data were presented as a poster session at the November, 2008 annual meeting of the American Society for Dermatologic Surgery.

"A Prospective Clinical Study of Noninvasive Cryolipolysis for Subcutaneous Fat Layer Reduction."

The objective of this study was to evaluate the Procedure for fat layer reduction from the flanks (love handles) and back (back fat pads) of humans when used by clinicians in an environment representative of routine clinical practice. The multi-center, prospective, non-randomized, IRB-approved study was led by distinguished experts Jeffrey Dover, MD, director of SkinCare Physicians in Chestnut Hill, MA, and Elizabeth Tanzi, MD, co-director of the Washington Institute of Dermatologic Laser Surgery in Washington, DC.

Based on data from male and female subjects over 18 years of age with clearly visible fat on the flank or back appropriate for treatment with cryolipolysis, study results corroborated earlier research showing that precisely controlled cooling with the device causes a gradual reduction of targeted fat cells through induced apoptosis without harming surrounding tissues.

In this interim report of the initial group of treated subjects, clinical results, photographic evaluation and physician assessment demonstrated that:

·   Subjects were comfortable during the procedure and did not require pain medication.

·   Cryolipolysis results in a visible contour change in a majority of subjects.

·   100% of a subset of ultrasound-evaluated subjects demonstrated a measurable reduction; the average for the group was 22.4% fat layer reduction 4 months post-procedure.

·   Noticeable cosmetic efficacy was more consistently observed in properly selected subjects.

·   27 of 28 (96%) properly selected subjects (discrete fat bulges) had discernable efficacy.

·   Additional procedures using optimized cooling parameters and device enhancements will study the effects for reducing fat in other parts of the body.

An interim report of available subject data from this multi-center study of non-invasive cryolipolysis for subcutaneous fat layer reduction in humans was presented as a poster session at the November, 2008 annual meeting of the American Society for Dermatologic Surgery. Comprehensive data from the prospective clinical study was announced as a podium presentation at the April, 2009 annual conference of the American Society for Laser Medicine and Surgery.

"Efficacy and Neurological Effects of Noninvasive Cryolipolysis in Humans."

This clinical investigation was designed to determine if fat reduction in humans caused by cold exposure is associated with local sensory function or nerve fiber changes. Conducted by leading plastic surgeon Sydney R. Coleman, MD, New York University School of Medicine; Kulveen Sachdeva, MD, San Ramon Regional Medical Center, California; and Barbara M. Egbert, MD, Stanford University Medical Center; et al, the study was published in the peer reviewed journal Aesthetic Plastic Surgery in March, 2009.

The study results demonstrated the efficacy of and neurologic response to cryolipolysis for fat removal in human subjects as follows:

·   Ultrasound Measurements: Non-invasive cryolipolysis resulted in substantial fat reductions within 2 months of treatment without damage to the skin.

·   Neurologic Evaluation and Sensory Testing: Transient reduction in sensation occurred in 6 of 9 subjects assessed by neurologic evaluation. However, all sensation returned by a mean of 3.6 weeks post-treatment. There were no lasting sensory alterations or observations of skin damage in any subjects evaluated.

·   Nerve Biopsy Assessment: Special staining techniques to highlight epidermal nerve fibers demonstrated no significant long-term change in nerve fiber structure.

·         References

·         1. Manstein D, Laubach H, Watanabe K, Farinelli W, Zurakowski D, Anderson R. Selective cryolysis: a novel method of non-invasive fat removal. Laser Surg Med. 2008,40:595-604.

·         2. Manstein D, Laubach H, Watanabe K, Anderson R. A novel cryotherapy method of non-invasive, selective lipolysis. Abstract presented at the 28th Annual Conference of the American Society for Laser Medicine & Surgery; April 2-6, 2008; Orlando, Fla.

·         3. Zelickson B, Egbert BM, Preciado J, Allison J, Springer K, Manstein D. Cryolipolysis for noninvasive fat cell destruction: initial results from a pig model. Poster presented at 2008 Annual Meeting of the American Society for Dermatologic Surgery; November 6-9 2008; Orlando, Fla.

·         4. Dover J, Burns J, Coleman S, et al. A prospective clinical study of noninvasive cryolipolysis for subcutaneous fat layer reduction: interim report of available subject data. Prospective poster presented at 2008 Annual Meeting of the American Society for Dermatologic Surgery; November 6-9, 2008; Orlando, Fla.

·         5. Riopelle J, Tsai M, Kovach B. Lipid and liver function effects of the cryolipolysis procedure in a study of male love handle reduction. Abstract accepted for the 29th Annual Conference of the American Society for Laser Medicine & Surgery; April 1-5, 2009; Washington, D.C.

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