Competitive Overview. 1.K-Wires. Arrowhead Med Technologies
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- Stanley Lambert
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1 Competition
2 Competitive Overview Product Name 1.K-Wires 2.StayFuse 3.Smart Toe 4.ProToe 5.HammerLock 6.ArrowLock 7.Trim-It Pin 8.DigiFuse 9.Arthroplasty Company Tornier MMI-Styrker Wright Medical BME, San Antonio Arrowhead Med Technologies Arthrex MetaSurg Inertia (meaning old habits)
3 Nextra System Overcomes First Generation, Competitive Product Limitations and Growth Opportunity Company Stability Compression Reversibility/ Adjustable Angulation 2011 Procedures 1 Launch Market Share Nextra Implant Nextremity Solutions 2,000 (2012) 2012 Kirschner-wire Various _ 341, % Smart toe (Nitinol) Stryker _ 52,388 3, % Trim-it Resorbable Pin Arthrex _ 38, % ProToe Wright Medical 23, * 4.4% StayFuse Tornier _ 28, % Others, including non-implant reconstruction procedures 49, % 3 Focus on orthopaedic surgeons. ** 32% non-union rate, according to Scott R. AOFAS Poster Presentation, Company estimates. 2. idata, U.S. Market for Small Bone & Joint Orthopedic Devices, June Piper Jaffray, Stryker Research Report, 6 June 2011.
4 K-Wire Arthrodesis K-Wires Healthy joint needlessly disrupted High morbidity Non-fusion Infection rate as high as 18% 1 Chronic pain Migration Revisions frequent and traumatic Second procedure required Wire Remains for 4 to 6 weeks Healthy Joint Disrupted 1 Augoyard M, Meusnier T, Peyrot J., Proximal Interphalangeal Arthrodesis, Using Intramedullary Bone Fastener, Smart Toe: Clinical and X-ray Review, [Clinical white paper]. Lyon, France: Memometal Technologies; 2007.
5 Existing Date Regarding K-wire 2.5% Failure Rate 1 18% Infection Rate 2 20% Non-union Rate 3 More Supporting Data New Data Released 4 Retrospective Comparison of Protoe to K-Wire 253 patients (190 K-wire, 63 ProToe) Non-union rate Pro-Toe- 31.7% K-wire- 74.7% Time to union Pro-Toe 9.3 weeks K-wire 8.6 weeks No significant difference in fusion rates Nextradesis 2 weeks post-op 1 Zingas C. Foot and Ankle International Caterini R. Foot and Ankle Int Reese AT. JR Coll Surg Edinb Scott R. AOFAS Poster Presentation, 2012
6 Stay-Fuse From Tornier Website The StayFuse device is an interlocking two piece titanium screw that snaps together for intramedullary fusions of small bones. The new gold implant is exclusively designed for hallux IPJ fusions. The StayFuse device is a replacement for 1.1 mm K-wires, and can be used for fusions or fracture fixation of fingers, toes and small bones. No: - Pin Tract Infection - Pin Exposure - Joint disruption For treatment of hammertoe deformity Eliminates risk of pin tract infection No post-op implant exposure No healthy joint disruption Biocompatible titanium material Available in a variety of diameters & lengths
7 Stay-fuse Tornier StayFuse The StayFuse device is an interlocking two piece titanium screw that snaps together for intramedullary fusions of small bones. The new gold implant is exclusively designed for hallux IPJ fusions. The StayFuse device is a replacement for 1.1 mm K-wires, and can be used for fusions or fracture fixation of fingers, toes and small bones. Strengths No Pin Tract Infection No Pin Exposure No Joint disruption Weaknesses Can not be removed No angle floating toe Lock mechanism easy to damage Assembly alignment difficult Company Stability Compression Reversibility/ Adjustable Angulation Stayfuse Tornier
8 Smart-Toe Memometal, Inc Memphis, TN One piece device No Post-Op exposure No joint disruption No pin tract infection Compressive feature Resists rotation ADVANTAGES One piece implant ( no "connection" required) No post-op implant exposure No healthy joint disruption Eliminates risk of "pin tract" infection Compressive feature reduces non-union occurrence Shape resists rotation
9 Smart-Toe Memometal, Inc Memphis, TN Competitive Assessment Strengths No Post-Op exposure No joint disruption No pin tract infection Resists rotation Weaknesses Comments from Surgeons: Fuses slower than k-wire Cracking of bone Time to implant Excessive swelling Over resection caution Not adjustable Freezing Requirement: storage and handling Not Reversible Not Removal-able Long term instability Company Stability Compression Reversibility/ Adjustable Angulation Nextra Implant Nextremity Solutions
10 Pro-Toe Wright Medical Surgical Simplicity Operational Efficiency Patient Satisfaction
11 Pro-Toe Wright Medical Strengths Weaknesses Surgical Simplicity Operational Efficiency Christmas tree end security Pull-out, unstable Compression Not adjustable Not removal (tissue destructive burns bridges) Not reversible 1-piece limits control Company Stability Compression Reversibility/ Adjustable Angulation Nextra Implant Nextremity Solutions
12 BME BioMedical Enterprises, Inc. San Antonio, TX Hammerlock Secure, stable compressive fixation No disruption of adjacent joints Reduce risk infection Simple Fast Reproducible Saves OR time & costs Description & Technology The HammerLock is the most advanced intramedullary implant system for hammertoe fusions. Made of the shape memory alloy Nitinol, the HammerLock implant provides secure and stable form of compressive fixation without the need to disrupt adjacent joints nor the need risk infection due to exposed wires. In addition, our proprietary insertion system ensures the procedure is simple, fast and reproducible saving time and costs in the operating room. Features Advanced shape memory intramedullary implant design.a ggressive barbs maintain compression while minimizing stress on cortical walls. Anatomical proportions for proper reduction of smaller phalangeal segments. Three sizes in straight and angled versions for proper fit in a wide variety of cases. Innovative HammerBlock deployment system for fast, precise, no-touch insertion.made in the U.S.A.
13 Hammerlock BME BioMedical Enterprises, Inc. San Antonio, TX Strengths One Piece Implant price Weaknesses Removal Insertion issues Adjustment After deployment 1-piece implants are easier to manufacture, not better for patient (toes are not one-pc) Nextra Implant Company Stability Compression Nextremity Solutions Reversibility/ Adjustable Angulation
14 Arrowhead Arrowhead Medical Device Technologies Collierville, TN Ease of Use Simplicity Strength of Implant
15 Competitor #6 Competitive Assessment: Arrowhead Medical Strengths Implant Strength ss One piece Simple Weaknesses Removal: cut bone, cut implant, use cannulated drill around shaft Lacks compressive ability One-piece design limits control Stability Migration during surgery /post-op Nextra Implant Company Stability Compression Nextremity Solutions Reversibility/ Adjustable Angulation
16 Competitor #7 Competitive Assessment: Trim-It Pin Strengths No Pin Exposure No Pin Tract Infection One piece Simple Similar to K-Wire technique Trim-It Drill Pin Arthrex Weaknesses Absorption can be a problem Lacks compressive ability One-piece design limits control Stability Migration during surgery /post-op Company Stability Compression Reversibility/ Adjustable Angulation Nextra Implant Nextremity Solutions
17 DigiFuse (MetaSurg) Nextra Implant Company Stability Compression Nextremity Solutions Reversibility/ Adjustable Angulation
18 Thank You
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