Technical Comparison 6-Feb-2015

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1 Technical Comparison 6-Feb-2015 Criteria Features FUETOR NEOGRAFT ARTAS Harvesting Implantation System Scoring Rotating Punch Rotating Punch Rotating Punch Harvesting of Follicle Vacuum Assisted Vacuum Assisted Manual Titanium Coated Punch Yes No No Available Sizes 0.6, mm 0.8, 1.0, 1.25, 1.4mm Data Not Available Level of Desiccation No Desiccation High Data Not Available Chilled Wet Storage in the system Yes No No Physical Trauma to the follicles Low Low Low High Torque - low speed option (16:1) Yes No No Suction Control Yes Yes No Dual Harvesting Yes No No Depth Control Yes Yes Yes Harvesting speed_grafts per hr User Interface Touch Screen Electronics Electro-Mechanical Computer based Automatic Graft alignment No No Yes Patient Data Recording Yes No Yes Data retrieval Yes No Yes Sterilization Autoclave Autoclave Data Not Available Availability of Implanter Yes Yes Loading of Follicular Units on Implanter Suction Suction Knob Controlled Pusher Pressurised Piston Plunger Implantation principle Depth Control by Surgeon's Not applicable Available No control Choice Artas does not have Atraumatic_Tweezers Trauma to follicular units High any Implantation tool free Sizes Available 0.6, mm 0.8, , 1.4mm Possibility of air contamination No High Dual Implantation Yes No Sterilization EtO sterilized Autoclave Simultaneous Harvesting & Implantation Yes No No Wireless Foot Switch Control Yes No Not applicable Foot Print 380x x450mm 686x1220 Height mm 1727 Electrical Specification 1 phase/ v AC 1 phase/100v/115v- 230VAC Data Not Available Installation area required 6 ft x6 ft 6 ft x6 ft 10 ft x 10 ft Investment required INR 25 Lakhs (USD INR 40 Lakhs INR 1.20 Crores 40K) (USD 67K) (USD 200K) Cost Per Graft USD 1-2 USD USD 5-7 USD 7-10 Running Cost (Consumables only) INR 5,350 INR 8,000 INR 1,20,000 Local Support Available Not available Not available Training / Skill Required Low Low High Replacement Warranty Available Not available Data Not Available Page 1 of 7

2 Unique Selling Points Clinical Outcome Atraumatic harvesting and implantation - no forceps or tweezers are used the cells of follicular unit remains intact. About 20% more Tissue Viability with CBS technology means faster growth and better caliber of hair Harvesting & Implantation can be done simultaneous meaning, Direct Hair Transplant is possible No buried Grafts in FUETOR About 50% Less tissue loss than FUT procedures Patient Benefits Painless Procedure. No Visible Scars. Quicker Recovery. Better & Faster hair growth. Business Benefits 40% Less Investment than NEOGRAFT with more benefits. Value for Money INR 40Lacs where as FUETOR INR 25Lacs) Comparatively Less Running cost and sterile tools & accessories make it safe for the patient and promote an ethical surgical practice. (Sterile Consumables costs only INR 5350/-) Low learning curve as the system is fairly simple to prepare & operate. About 3 times less expensive than ARTAS system which even does not have an implanter It is maintenance-free. Replacement warranty which means the parts having manufacturing defects or malfunctioned will be replaced by new parts immediately. Fewer assistants required in the OT so low fixed cost in terms of their salaries. Premium Product and provides a competitive edge Comfort Office based procedure, no additional installations required. Less Fatigue for both surgeon and patient as the procedure is faster. Page 2 of 7

3 FUETOR Updates FEB 2015: CEO of FUETOR, Mr. Mangesh Patankar promotes the newly launched FUETOR automated hair transplant system by getting hair transplant done on him. JAN 2015: In a scientific study to check tissue viability of follicular units harvested with FUETOR against manual FUE, it is found that FUETOR has 18% - 20% better tissue viability than Manual FUE. Dec 2015: Renowned Automated FUE Expert Dr Kuldeep Saxena uses FUETOR. Nov 2015: Renowned Hair Transplant Surgeon Dr. Sandeep Sattur uses FUETOR. SEP 2014: Veol Medical Technologies Pvt. Ltd. is India s first medical device company to launch suction based advanced hair transplant system FUETOR. Page 3 of 7

4 Important Clinical Aspects Improve clinical outcome with FUETOR.. The principle of suction based FUE has been appreciated worldwide by many renowned hair transplant surgeons. The technological advancement is marching towards automated FUE because of many advantages. Automated FUE is the next preferred choice for hair transplantation not only for the Surgeons but are also being demanded by the patients themselves. The advantages and disadvantages of earlier automated FUE systems which run on Suction based harvesting are well known to the hair transplant surgeon s community. The major concerns has been a) De-hydration of Follicular Units b) Trauma on the tissue of Follicular Units during travel through long suction tubes c) Trauma to the Follicular Units during Handling d) Trauma to the Follicular Units during implantation because of pressurized air e) Buried grafts All of these major concerns have been addressed smartly by FUETOR system. The unique design of the CBS canister always maintains a fixed volume of Bio-fluid while maintaining a low temperature environment inside the canister. Thus providing the follicular unit all essential nutrients even while it is outside the human body till the time they are implanted back on the scalp. This also prevents any chance of de-hydration and improves the tissue viability of the harvested follicular units with FUETOR. In manual harvesting the follicular units get buried inside the scalp but suction based harvesting like in FUETOR, eliminates this risk of cyst formation. The CBS canister connects the rotor head of the harvester through a short length tube which is internally lubricated with a special coating. Since the tube is short and lubricated, the follicular units are in contact with the tubing only for a fraction of a second and do not get traumatized. During handling and especially during implantation, surgeons or OR staff normally use forceps and needles in Manual technique which again expose the tissue surround the follicular units to extreme trauma because of which the cells gets damaged hampering the growth of the hair. Neograft uses pressurized air to eject follicles from its implanter where the follicular units get traumatized. In addition to this, user doesn t have any control over the depth of implantation. FUETOR has addressed this issue through its Implanter by providing user-controlled ejection feature so that the surgeon can place the follicular units at the right depth. FUETOR reduces any chance of buried grafts significantly during implantation as well. Page 4 of 7

5 Features Unique features addresses concerns Quality of Hair Transplantation depends primarily on a) Good harvesting & storage of follicles b) Atraumatic handling of follicles c) Good implantation FUETOR system allows great flexibility to the surgeons to use the tools as per their comfort level and achieve good quality hair transplantation. These features are highlighted in brief. Chilled Bio-fluid Storage CBS technology During harvesting using other automated FUE systems, it is reported that the follicles get dried up losing their survival due to dehydration. FUETOR s innovative CBS canister which is attached to the harvester provides a storage medium which is conducive for the follicular grafts to survive longer. This technology has helped a lot in achieving better graft survival & quality but also in saving precious surgical time. The follicular units after scoring, gets collected in a natural environment which is a mixture of body fluid and saline. This prevents desiccation/dehydration of cells in follicular units. In addition to this advantage, the storage canister design brings a temperature differential of about 10 degree Celsius which helps in suspending the cellular metabolism which controls the life of the follicle outside body environment. A-traumatic and Controlled Implantation Implanter is one of its kinds and has a patented design. This feature in the implanter allows the surgeon to do atraumatic and controlled implantation with ease. This is a critical surgical step where the depth of the follicles which is to be inserted if not controlled can damage the follicles or may result in poor hair growth. The procedure of implantation using FUETOR is totally tweezers-free and follicular units are not exposed to any kind of physical trauma. Flexibility over controlling the Speed and Suction level The RPM of harvester can be controlled from as low as zero to 30,000rpm. There are two modes of harvesting possible using two different types of Rotor Head of Harvester i.e. 1:1 (standard) and 16:1 (premium). The premium version has a speed reduction providing high torque with low speed while the standard one offers high speed and low torque mode of operation. The control can be done using the touch screen control panel. The suction level has 10 steps and it can be adjusted depending on the tissue types and site of surgery with the touch screen control. Page 5 of 7

6 Simultaneous Harvesting and Implantation This feature has been provided to allow the use to do harvesting and implantation together in a coordinated manner. This helps significantly in reducing the gap between harvesting and implantation thereby reducing the exposure of follicles to outside body environment. When the time of exposure of follicular units/stem cells surrounding the follicle decreases, the viability or survival of follicular units are better. In simple words, surgeon practicing Direct Hair Transplantation technique will be able to use the system without changing their current practice. The overall surgical time also reduces thereby reducing fatigue for the surgeon and as well as for the patient. It has been observed that many surgeons develop spondylitis over a period due to prolonged surgery in one position. Thus FUETOR offers better health not only for the patient but also for the surgeon. Patient is exposed to anesthesia for a short period so the recovery time is less. Touch Screen & wireless User interface User can interact with the console through a touch screen GUI based interface. The GUI has been developed by a team of User Interface Design experts with intuitive controls which lets the user understand the information and use the controls with ease. With the help of the touch screen interface, user can feed in Patient & Doctor information such as Name/Sex/Age/Surgeon s name before starting a new surgery and also records the implantation count and surgeon s speed i.e. implantation per hour. The interface also shows the date and time. Surgeons usually give the patient intermediate breaks to get rid of fatigue and during this time they do not like to keep the system running. FUETOR provides a feature on its GUI which has a unique standby or pause button where the surgeon can pause the system anytime he wants to save power and resume the procedure after taking a break. A wireless foot switch controls has been provided for each side of the system to turn on/off the suction and rotation during harvesting and/or implantation. This facilitates a cable-free and barrier free OR floor which prevents potential accidental hazards. Data gets automatically saved and an USB interface has been provided to retrieve selected data. One can connect a pen drive or hard disc or a computer. Highly Precise & Reliable Tools The Titanium Nitride (TiN) coated punch is made out of bio-compatible surgical grade stainless steel with a precisely cut sharp edge helps in smooth scoring with least resistance. TiN coating helps in retaining the sharp edge for a longer period of time. There are three sizes of punch available i.e. 0.8mm, 0.9mm and 1.0mm. Page 6 of 7

7 Accessories (optional) Sterilizable Tool Holder The tool holder is made of surgical grade Stainless Steel and can be autoclaved. It holds the harvester, implanter and supports long tubing. Follicle Loading Tray This is designed to hold follicles and guide the follicles into the transfer tube of the implanter smoothly without damaging the follicles. Canister Latch Canister latch is held securely onto the body of harvester motor at one end while the other end latches onto the canister body. Other advantages Minimally Invasive & Less trauma to patient No-Pain & Quick Recovery No Visible Scarring Good for young patients and no limitation on the type of skin laxity Low learning curve and can be mastered with minimal training Plug & play system All consumables are supplied in EtO sterile packs. Quick fit connections allow the user to prepare the machine ready for surgery in less than 5 mins. Business perspective Minimum Consumables - Maximum Benefits Faster procedures Better patient & surgeon comfort Maintenance free Equipment Competitive edge over your competitors in terms of technology 50% less capital investment than other automated FUE systems such as Neograft or Artas Decreased fixed cost: Low overheads & less resources, medications etc. Local service and support is available Replacement Warranty: Parts under warranty will be directly replaced and not refurbished or repaired which will retain the quality of the system. NOTE: Surgeons are concerned about transection rate. Please note that, the Transection rate depends on the skill set of the surgeon and right choice of the following parameters during surgery depending on the anatomy and tissue properties of the patient. punch size, correct alignment of approach during scoring, Follicle curvature beneath the skin RPM of harvester rotor, Insertion and withdrawal technique, High density of hair per cm2 Page 7 of 7