Design Team Vipul Nanavati, MD James M. Paci, MD Frederick W. Werner, MME Levi G. Sutton, MS

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1 Design Team Vipul Nanavati, MD James M. Paci, MD Frederick W. Werner, MME Levi G. Sutton, MS SUNY Upstate Medical University Scott Macfarlane Office of Technology Transfer

2 Anatomically shaped implant for treating midshaft clavicle fractures Precurved implant matches natural curvature of 90% of adult clavicles Prototypes made and tested Developed by a team of doctors and engineers at Upstate Medical University Patents pending in US and EPO Patentable according to International Search Report Annual market: $ M (US and EU)

3 180, ,000 clavicle fractures per year in US and Europe combined 2.6-5% of all fractures (6.8M) are clavicle fractures per 100,000 in population Midshaft clavicle fractures account for 69 to 81% of all clavicle fractures ~125,000 to 290,000 per year in US and Europe

4 1. Non-operative treatment* Long healing time Frequent failure to heal fully Misalignment of fragments results in deformity and possible shoulder dysfunction * See - Nonoperative Treatment Compared with Plate Fixation of Displaced Midshaft Clavicular Fractures: A Multicenter, Randomized Clinical Trial, Canadian Orthopaedic Trauma Society, The Journal of Bone and Joint Surgery, Inc. (2007)

5 2. Current surgical treatment Plates Improved outcomes, but * Large incisions required Complication rate is high Frequently need to remove hardware * See - Arno Frig, Paavo Rillmann, Thomas Perren, Martin Gerber, & Christian Ryf, Intramedullary Nailing of Claivicular Midshaft Fractures With the Titanium Elastic Nail: Problems and Complications, The American Journal of Sports Medicine, Vol. 37, No. 2 (Feb 2009)

6 3. Current surgical treatment Non-anatomic intramedullary nails Types: Flexible titanium, Waveon, Straight Ineffective securing of current implants causes: Implant migration Misalignment due to implant constraints Rotational instability about the fracture site Poor healing

7 An anatomical implant shaped to match the natural curvature of 90% of adult clavicles for insertion into the intramedullary canal* * Intramedullary is a medical term meaning the inside of a bone. The intramedullary canal in the clavicle contains bone marrow (also referred to as the medullary cavity).

8 Matching the natural curvature of 90% of adult clavicles results in: Easier insertion into midshaft fractured clavicle (nail follows path of medullary cavity*) Better healing bone retains natural shape for more cosmetically appealing healing outcomes Less surgery can be inserted through small incision and stay in place (no need to remove) Fewer complications during wound healing * The medullary cavity (medulla, innermost part) is the central cavity of bone shafts where red bone marrow and/or yellow bone marrow (adipose tissue) is stored.

9 Current prototypes: Anatomical fit verified using actual clavicles

10 Anatomical shape avoids disruption of fracture environment Pre-curvature meets anatomic requirements dictated by clavicle geometry Upstate implant can support early loading seen during rehabilitation Locking fixation on medial and lateral ends of clavicle provide rotational stability Well secured clavicle nail can resist even torques due to shoulder abduction Surgical approach conforms to current standards for implant device insertion and locking Small incisions are less invasive and reduce medical complications

11 Cost for implant kit: $2-3,000 (based on comparable implant kits) Includes implant ( nail and screws) and disposables such as drill bits, reamers, k-wires, etc Price for competitor s implant kit $ ~125,000 to 290,000 mid-shaft clavicle fractures per year in US and Europe Market size: $ M per year Assumes price per kit of $2,500

12 Patent applications pending in US and EPO Parent PCT Patent # WO 2011/ A2 Favorable International Search Report Claims 1-12, 20 searched Claims 1-12 judged patentable Broad independent claim: 1. An intramedullary device, comprising: a pre-curved rod having a proximal end and a distal end, defining a nail body there between, said nail body having a longitudinal axis and a radial axis; and a fixation site at at least one region of the intramedullary device.