Based on its analysis of the bone graft market, Frost & Sullivan recognizes Bone Solutions, Inc. (BSI) with the North American Frost & Sullivan Award for Technology Leadership of the Year for its development of OsteoCrete™. The OsteoCrete™ is a revolutionary grafting material for attaching ligaments and tendons to bone and bone-to-bone. On May 21, 2009 OsteoCrete received FDA 510(k) clearance as a bone void filler for long bone and pelvis applications.
OsteoCrete™ is composed of magnesium oxide (Mg), monopotassium phosphate, and a small component of tricalcium phosphate. This compound provides an osteoconductive, biologic scaffold onto which new bone can form during the window of healing. The Mg gives the cement a powerful binder quality that theoretically allows it to resist tensile forces at time zero, thereby potentially limiting graft-tunnel motion. Several in vivo animal and bench test studies have shown OsteoCrete™ to have a peak tensile load to failure that is up to three times higher that of calcium-based bone cements in both bone-bone and tendon-bone attachments.
“BSI’s commercialization, following its FDA clearance, is the first solution under its magnesium technology platform for orthopedic surgeries and other orthobiologics applications,” says Frost & Sullivan Research Analyst Aarti Shetty. “This disruptive adhesive technology has lucrative potential in human markets, as it potentially represents the first compound that can attach bone to bone, as well as ligaments and tendons to bone.”
OsteoCrete™ makes use of this technology platform in humans as a bone void filler, and this platform could revolutionize sports medicine injury repair, as well as several key segments of orthopedics and orthobiologics.
Over the last decade, end users have increasingly accepted the clinical application of these bone fillers/cements as bone substitutes in trauma and orthopedic surgery. Scientists have intensively investigated Ca-phosphate compounds including tricalcium phosphates, Ca sulfates and hydroxyapatite.
Researchers are also exploring the potential of injectable Ca-based pastes as delivery vehicles for proteins such as bone morphogenetic protein (BMP) 2 for fractures. However, their slow absorption rate and non-adhesive qualities limit their utility to being carriers for other materials that may promote bone formation and providing a scaffold for bony ingrowth. Biomechanically, cements do not offer adhesive properties and are weak under tension.
“Increasing evidence shows that Mg-based implants promote bone formation during healing (osteoconduction), and may ultimately show in future FDA filings the ability of growing new bone (osteogenisis) and Mg-based alloys are being studied as orthopedic biomaterials,” notes Shetty. “Looking to the future, BSI is also investigating alternative new products based on its magnesium-oriented technology, as Mg-based bone void filler may be less prone to other complications associated with Ca-based biomaterials such as the activation of clotting.”
Owing to the application breadth, BSI has large, fragmented addressable markets, totaling $3 billion globally. The company is exploring licensing or joint venturing for various orthopedic applications, including trauma for synthetic bone grafts, sports medicine, extremities, maxillofacial/cranial, and dental.
Following its FDA 510 (k) clearance, BSI plans to complete a series of four additional 510(k) approvals as bone void filler for cranial applications, for maxillofacial applications, and for non-load bearing spine applications, as well as a bone anchor, to broaden its scope of product application. The company has already started implementing its plans in discussing marketing, distribution, and potential strategic relationships with key orthopedic companies.
“BSI's strategy is to follow new FDA clearances for its 510 (k) filings, and rapidly deploy its magnesium-oriented platform technology across a spectrum of surgical procedures such as anterior cruciate ligament (ACL)/rotator cuff/extremities, shoulder repair, cementless knee and hip, maxillofacial/cranial applications and dental implants,” observes Shetty. “BSI’s technology may supplement bio-absorbable screws, or fully replace screws and plates now used for major knee and shoulder surgeries, allowing for more rapid recoveries.”
Each year, Frost & Sullivan presents this award to the company that has demonstrated excellence in technology leadership within its industry. It has demonstrated technology leadership by excelling in all stages of the technology life cycle—incubation, adaptation, take-up, and maturity—to ensure a continuous flow of improvements. By innovating leading-edge concepts, the company has pioneered client applications.
Frost & Sullivan’s Best Practices Awards recognize companies in a variety of regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analysis, and extensive secondary research in order to identify best practices in the industry.
About Bone Solutions, Inc.
Bone Solutions Inc. (‘BSI’) (bonesolutionsinc.com) intends to establish its magnesium-based platform as the ‘one stop bone-, tendon- and ligament-injectable, biodegradable adhesive technology’ for surgeries at hospitals, clinics and other private surgical centers within the orthopedic industry. The Company believes it is revolutionizing a new solution for orthopedic surgeons for human uses with a magnesium-based platform that may attach—for the first time in orthopedic medical history—bone to bone, as well as ligaments and tendons to bone.
About Frost & Sullivan
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