PARADIGM BioDevices, Inc.

www.paradigmbiodevices.com

Bone graft is the most important consideration for spine fusion, yet it is often overlooked. No spinal implant device, robot, or navigation system can ever make up for selection of a deficient bone graft. However, iliac crest bone graft is the undisputed "Gold Standard" that can help a deficient implant. Bone graft is crucial for successful fusion and minimization of dreaded non-unions. Since the 1990s, industry has placed emphasis on development of bone substitutes, many lacking the natural quality advantages and safety profile of ICBG. Most bone substitutes and synthetic composites are predicated on either invalidated data or completely deficient studies, yet annual bone substitute costs have still escalated above $3B in the US. How does something cost so much for less? Paradigm BioDevices is driven by data to advance MIS techniques that make the "Gold Standard" even better. Level 1 FDA studies confirm - iliac crest bone graft is the best bone graft available and blinded, randomized, independent studies & Yale Orthopedic Data Access (YODA) confirm ICBG can be utilized with "less complications & adverse events... than BMP-2," as well as other synthetics and composites. These findings, as well as other recent data, contradict the fear that has been fostered and promulgated toward autograft contributing to one of the greatest misconceptions in spine surgery & orthopedics. Excessive expense on bone graft substitutes is both avoidable and worthwhile. Our Quickdraw MIS Bone Harvester offers a safe, data-driven premium quality autograft, and is a true Value-Based Care Solution. MIS ICBG - Safe. Reliable. Natural. Simple to Understand. Cost Effective.

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Bone graft is the most important consideration for spine fusion, yet it is often overlooked. No spinal implant device, robot, or navigation system can ever make up for selection of a deficient bone graft. However, iliac crest bone graft is the undisputed "Gold Standard" that can help a deficient implant. Bone graft is crucial for successful fusion and minimization of dreaded non-unions. Since the 1990s, industry has placed emphasis on development of bone substitutes, many lacking the natural quality advantages and safety profile of ICBG. Most bone substitutes and synthetic composites are predicated on either invalidated data or completely deficient studies, yet annual bone substitute costs have still escalated above $3B in the US. How does something cost so much for less? Paradigm BioDevices is driven by data to advance MIS techniques that make the "Gold Standard" even better. Level 1 FDA studies confirm - iliac crest bone graft is the best bone graft available and blinded, randomized, independent studies & Yale Orthopedic Data Access (YODA) confirm ICBG can be utilized with "less complications & adverse events... than BMP-2," as well as other synthetics and composites. These findings, as well as other recent data, contradict the fear that has been fostered and promulgated toward autograft contributing to one of the greatest misconceptions in spine surgery & orthopedics. Excessive expense on bone graft substitutes is both avoidable and worthwhile. Our Quickdraw MIS Bone Harvester offers a safe, data-driven premium quality autograft, and is a true Value-Based Care Solution. MIS ICBG - Safe. Reliable. Natural. Simple to Understand. Cost Effective.

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Country

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State

Massachusetts

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City (Headquarters)

Rockland

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Employees

1-10

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Founded

1997

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Estimated Revenue

$5,000,000 to $10,000,000

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