New Generation Threads for Tissue Suspension Technique Milestones and best practice The best way to sell the device How to help physicians market the procedure March 2009

New Generation Threads for Tissue Suspension INTRODUCTION March 2009

Introduction The Silhouette Sutures were approved by the US FDA in November 2006 and the received the CE mark in March The first 25 clinical cases were performed in Q in Mexico. More than 6,000 Midface cases have been performed globally since then. The results show: Long lasting results of more than 3 years. No post op complication. Silhouette Sutures are currently sold in 28 countries. Scientific publications in renowned journals will provide a strong support for marketing the Silhouette Sutures in the US.

Introduction: Silhouette Sutures Edge The Silhouette Sutures have many inherent qualities that are conducive to their success. 1.It is the first truly safe and efficient thread device for tissue suspension. Barbed sutures have structural flaws and are potentially harmful. 2.The Silhouette Sutures procedure can be performed in a physician practice, under local anesthesia, in 45 minutes, with no more than 3 days downtime, at a reasonable cost for the patients. 3.The duration of the results is more than 3 years and counting. 4.The resorbable cones have two main benefits: Scientific tests show a lifting capability 10 times higher than barbed sutures. Coned sutures do not migrate in patients’ skin as barbed sutures do. They create a very significant collagen formation around the knots as they resorb, which support long lasting results. Coned sutures cannot harm even if the technique is performed poorly. The Silhouette Sutures is the first safe and efficient thread device providing the natural and long lasting rejuvenation results that patients want.

Introduction: Silhouette Sutures Challenges The Silhouette Sutures have initially suffered from comparison with poorly performing barbed sutures. After 6,000 clinical cases globally, there is no doubt that THE DEVICE IS VERY EFFICIENT. RESULTS ARE MAXIMIZED PROVIDED Physicians follow as closely as possible the official Silhouette Lift technique. Each and every step of the technique was improved through cadavers studies and formalized for the procedure. When precisely followed, THE SILHOUETTE LIFT TECHNIQUE BRINGS 100 % SATISFACTION RATIO. PHYSICIANS NEED TO SUCCEED THEIR FIRST CASE OR THEY WILL MISTAKENLY BLAME THE DEVICE. The Silhouette Sutures require a thorough understanding of the surgical technique inorder to get the best results. A good user becomes a regular client as a virtuous cycle starts.

New Generation Threads for Tissue Suspension SURGICAL TECHNIQUE March 2009

Surgical Technique: Introduction The first requirement to use or sell the Silhouette Sutures is to watch the video and the power point presentation as many times as possible. In Europe, where the marketing was launched long ago, physicians usually watch the video 3 times before their first case. Sales Representatives should watch the video even more to have a very good understanding of the technique. The ONLY WAY TO SELL THE DEVICE IS TO BE AS KNOWLEDGEABLE AS AN APPLICATION SPECIALIST, ABLE TO HELP THE PHYSICIAN IN THE OPERATING ROOM. The OFFICIAL TECHNIQUE we roll out has been fine tuned in the last three years and WE KNOW IT WORKS. Physicians using their own technique should be responsible for the results.

Surgical Technique: Critical Steps Here is a list of the major steps where the success of the procedure is at stake: 1.Marking : The Marking should be made with the patient standing, as it helps obtaining a symmetric result. It is critical to respect the right distances between the insertion line, the top of the eye and the exit points.

Surgical Technique: Critical Steps 2.Exit point: All exit points need to be higher than the mandibular line as shown on the picture below. If an exit point is below this line, then the pulling capability of the sutures will be substantially limited and the results will be disappointing. No exit point Below this line

Surgical Technique: Critical Steps 3.Sutures insertion: The importance of the plane. By using the introducer, the risk of being to superficial or to deep is minimized. The best way to know if you are in the right plane is to be able to move the introducer smoothly when it reaches the area in the picture below: This is where the introducer should be able to move smoothly. If the mobility is limited, the insertion is too deep. By checking the movement of the introducer,it is also easy to see whether the insertion is too superficial.

Surgical Technique: Critical Steps 3.Sutures insertion: The importance of the plane. The insertion plane is critical for the success of the procedure: If the suture is too superficial, the patient will feel some discomfort as some cones may be felt at the surface of the skin and some pimples could appear. If the suture is too deep, then the results will be disappointing as the tissues will not be lifted as they should. The right insertion plane is absolutely essential. If too deep, the results will not be satisfactory. If too superficial, there could be post op benign but annoying complications.This has been proven on cadavers studies.

Surgical Technique: Critical Steps 4.Insertion Plane: A good way to check Once the needle is inserted in the introducer and goes through the exit point, by elevating the needle, the physician can check that the needle is inserted at the same depth all along, from the insertion point to the exit point. Any wave or skin accumulation along the needle means that the insertion plane is not even. The needle must be atthe same depth from the insertion point to the exit point

Surgical Technique: Critical Steps 5.Insertion Plane: How to correct a mistake. In case a physician wants to correct the level of the insertion, he should take the introducer back, then change the plane and insert again.

Surgical Technique: Critical Steps 6.Where to cut the sutures at the exit point: It is required to cut the sutures right after the knot outside of the skin, as in the picture below, to avoid the risk of a cone going out of the skin through the exit point. If a suture is cut before a knot it is required to remove the cone that follows and get the following knot out of the skin. The suture is cut after A knot

Surgical Technique: Critical Steps 7. Tying the knot in the temporal fascia: risk of rupture After the sutures are inserted and the physician tie the knots, it is essential not to tie to strongly the first knot. This is the point of maximum tension. In case the knot is tied to hard, the suture might break. 8. How to address a rupture: it is recommended to leave the suture inside rather than trying to remove it if a rupture occurs. It is not an issue to leave a ruptured suture as it is made of biocompatible Polypropylene and the cones are resorbable. Further more, the sutures will not migrate, so it is no problem to leave it in the patient’s face. 9.When tying the knot in the temporal fascia, one should be careful of where to cut the knot. If a fraction of the suture remains and if it is sharp, it could create pain in the temporal area of the patient.

New Generation Threads for Tissue Suspension SELLING SILHOUETTE SUTURES March 2009

Marketing: How to sell the Silhouette Sutures The first and most important aspect is to LEARN THE TECHNIQUE. Watch the video many times, learn the power point. The best sales people in Silhouette Lift know all details of the procedure inside out. It is critical to ATTEND THE FIRST CASES OF YOUR CLIENT. If you know the technique, you will be very helpful and you will INCREASE significantly THE PROBABILITY OF SUCCESS. The procedure is perfect from a business standpoint: It requires some time and effort from the physician to master it. It is efficient and the results are excellent. The investment made by the physician to learn the procedure pays off if he does it often. By becoming an expert, the results get better and better. Physicians start including the sutures in more procedures. THEY BECOME REGULAR USERS.

Marketing: How to sell the Silhouette Sutures The Silhouette Sutures provide a satisfactory solution to strong patient needs: It is minimally invasive. It has a very low downtime of 2 to 4 days maximum. It provides natural rejuvenating results. It lasts 3 years at least. It is affordable as the procedure usually costs around USD 2,500/ 5,000 around the world. Like Botox patients are not shy to refer friends and family to a good physician, this is a procedure people are comfortable talking about. This is a great way for physicians to get referrals. The Silhouette Sutures are very efficient for physicians: Once mastered, the technique is easy to replicate. It is a quick procedure that is done under local anesthesia. It is affordable and so it can be sold in this economy. There is no post op follow up.

Marketing: Usual objections Below is a list of the usual objections from surgeons around the world, and ways to address them. 1.This is another ineffective thread product. The Silhouette Sutures have nothing in common with barbed sutures. Their coned structure addresses all the flaws of the previous generation of threads. The procedure has been done 6,000 times with satisfactory results. Scientific publications in the Annals of Plastic Surgery and in Aesthetic Plastic Surgery are on the way (the abstract of an article in “The Annals of Plastic Surgery” is available) and will confirm that the device works. This device is used for facial palsy in world famous reconstructive centers and it is covered by health insurance in France, Spain and Italy.

Marketing: Usual objections 2.I would rather perform a face lift. The Silhouette Sutures do not compete with face lift. Patients who do not want to do a face lift will not do it, it is an aggressive surgery, with a lot of downtime and it is very expensive. Very few surgeons do endoscopic facelift, may be not more than 10 /15 % of the plastic surgeons group. Due to the current economic conditions and the sharp fall in face lift procedures around the world, many plastic surgeons who used to do face lifts are performing Silhouette Lift as a more affordable alternative.

Marketing: Usual objections 3.It is an expensive device. The device cost for a procedure is around USD 900, but there is little incremental cost as only a nurse is needed during the procedure. If sold at USD 2,500 to USD 4,000, it becomes profitable for a 1 hour procedure with no post op follow up needed. 4.Other thread devices are cheaper Barbed sutures do not work, results are poor, they don’t last and they should not be sold in the US as Contour Thread lost its FDA approval.

Marketing: Usual objections 5.Results are not very spectacular. Results are what patients want, they get rejuvenation without anyone noticing they have done surgery. The Silhouette Sutures target the same age group and the same demand than the Botox patients. A minimally invasive, efficient and long lasting rejuvenation procedure at an affordable price.

New Generation Threads for Tissue Suspension HELPING YOUR CLIENTS TO SELL March 2009

Marketing: How to help physicans sell the procedure All the pros of the procedure described above are a great way for physicians to market the procedure. We also have leaflets for patients and a video for patients that can be seen on Silhouette Lift is now cited in a few thousands of web pages almost always positively, which will help patients to make a decision.

New Generation Threads for Tissue Suspension CONCLUSION March 2009

Conclusion: The future of Silhouette Sutures The Elevator lift was invented by Elisha Graves Otis in Since then we did not find a better solution to move people up and down a building. The Silhouette Sutures can become the “Tissue Elevator” providing a safe and efficient way to elevate sagging tissues. They should have a long way to go….