QUALITY STATEMENT

Bone Solutions is committed to provide quality medical devices to the global medical device market-place that improve patient care, meet regulatory and customer requirements, while assuring the continual effectiveness and improvement of Bone Solutions’ Quality System.

News

  • 09/28/2017 - Bone Solutions Inc. announces 1st implantation of OsteoCrete® Magnesium-based bone void filler.
  • 09/19/2017 - Bone Solutions Inc. Launches OsteoCrete® Magnesium-based bone void filler
  • 03/04/2014 - Drew Diaz named President of Bone Solutions Inc. (BSI)
  • 06/22/2009 - Bone Solutions Inc.: Recipient of the North American Bone Graft Technology Leadership of the Year Award
  • 06/08/2009 - Bone Solutions Inc. (BSI) receives FDA 510(K) clearance for OsteoCrete®, a Magnesium-based bone void filler

ABOUT US

First OsteoCrete® delivery to Magnum Surgical on September 19, 2017. Magnum Surgical and its personnel are a distributorship and not employed by Bone Solutions, Inc.

BOARD OF DIRECTORS

  • Wade Hampton - Chairman / Board Member
  • Anthony Copp - Vice Chairman and Co-Founder / Board Member
  • Tom Lally - Co-Founder / Board Member
  • Drew Diaz - President and CEO / Board Member
  • James McNamara - Secretary / Board Member
  • Phil Holcomb - Board Member

Leadership

Drew M. Diaz – CEO

  • Over 30 years of experience working in leadership positions in healthcare and the medical device arena
  • Heart Test Laboratories Inc., Chief Executive Officer and cofounder (former)
  • Board member of three medical companies and organizations in the US.
  • Graduate of Texas A&M University and has attended Harvard University Business School Executive Training.

James McNamara Interim – CFO

  • Over twenty five years experience in marketing and business planning.
  • IBM, Director of Finance (former)
  • Adjunct professor of marketing at the College of St. Francis in Joliet, Illinois.
  • BS in Mathematics from DePaul University and an MBA in Finance from the University of Chicago.

Brandon Roller MD, PhD – CTO

  • Medical Doctorate -University of Missouri-Columbia
  • Resident - Wake Forest Baptist Medical Center
  • Arthrex® Product Development (former)

Frankie L Morris – Director of Project Management

  • Over fifteen years in product development & nine years medical device development and engineering.
  • Alliance Spine., Engineering Manager (former), Pioneer Surgical Technology, Senior Product Development Engineer (former)
  • Seven medical device patents & four pending in the United States (USPTO)
  • Over 15 medical devices in the market today which include ten different FDA 510K medical device clearances.
  • Studied Engineering at University of Toledo and Project Management at American Public University.

Clinical Advisors

BRANDON ROLLER, MD, PHD

  • Medical Doctorate -University of Missouri-Columbia
  • Resident - Wake Forest Baptist Medical Center
  • Arthrex® Product Development (former)

FRANCIS HORNICEK, MD, PHD

  • Professor and Chair, Department of Orthopedic Surgery UCLA Medical Center, Santa Monica
  • Former Chief of the Orthopedic Oncology Service at Massachusetts General Hospital (MGH)
  • Professor of Orthopedic Surgery at Harvard Medical School
  • Director MGH Stephan L. Harris Chordoma Center

STEPHEN SCHENDEL, MD

  • Professor of Surgery Emeritus at Stanford University Medical Center
  • Director of the California Craniofacial Institute

GARY PERLMUTTER, MD

  • Orthopedic Shoulder Surgeon, Massachusetts General Hospital
  • Clinical Instructor, Orthopedic Surgery, Harvard Medical School

PRODUCTS


Osteocrete® Technology

OsteoCrete® is the only FDA 510(k) cleared mixture with magnesium oxide biomaterial that is injectable, moldable, and biocompatible Bone Void Filler. Our patented proprietary process provides a unique combination of OsteoStimulative and high compression strength characteristics producing the ideal Bone Void Filler for bony voids or defects that are not intrinsic to the stability of the bony structure.

Next Generation Biomaterial:

  • ✓ Excellent handling and ease-of-use
  • ✓ Can be Molded to fit uncontained bone voids
  • ✓ Radiopaque to facilitate injection
  • ✓ Will resorb into both cancellous and cortical bone
  • ✓ Will provide 3-D structure, which plays a key Osteoconductive role in bone regeneration
  • ✓ Biocompatibility and safety
  • ✓ Award recipient of the North American Bone Grafting Technology of the Year 2009
  • ✓ Available in 5, 10 and 15cc Kits

Why Magnesium?
Facts about magnesium:

  • Approximately 60% of magnesium in the body resides in bone
  • Magnesium deficiency contributes to osteoporosis
  • Decreases number and function of osteoblasts
  • Increases the number of osteoclasts


Does magnesium oxide improve the reactivity of a calcium oxide cement?

  • Calcium magnesium oxide cement (CMPC) enhanced attachment/proliferation of cells and increased the cellular alkaline oxide activity when compared to the Calcium oxide Cement (CPC)1
  • CMPC promoted more new bone formation and mineralization when compared to a CPC or magnesium oxide cement (MPC)2
  • CMPC had a shorter setting time, higher compressive strength, and higher degradation rate compared with CPC alone3
  • CMPC had a higher cellular proliferation rate than CPC or MPC alone3
  • CMPC resulted in faster and more effective osteogenesis over CPC alone3

Why does Osteocrete resorb faster with improved bone replacement?

  • Increased proliferation of bone marrow stromal cells4
  • Stimulated proteins for enhanced bone regeneration4
  • Enhanced mineralization of extracellular matrix4
  • Improved attachment and growth of osteoblasts5
  • Initiated apatite layer formation on the scaffold5
  • Enhanced new bone formation through the scaffold5

Jia et al. Development of magnesium calcium phosphate biocement for bone regeneration. J. R. Soc. Interface. 2010; 7: 1171-1180.1
Zeng et al. Maxillary sinus floor elevation using a tissue-engineered bone with calcium-magnesium phosphate cement and bone marrow stromal cells in rabbits. Tissue Engineering. 2012; 18: 870-81.2
Wu et al. Self-setting bioactive calcium-magnesium phosphate cement with high strength and degradability for bone regeneration. ActaBiomaterialia. 2008; 4: 1873-1884.3
Yoshizawa et al. Magnesium ion stimulation of bone marrow stromal cells enhances osteogenic activity, stimulating the effect of magnesium alloy degradation. Acta Biomater. 2014; 10(6): 2834-42.4
Wong et al. Engineered polycaprolactone-magnesium hybrid biodegradable porous scaffold for bone tissue engineering. Materials International. 2014; 24: 561-567.5

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WHY SYNTHETIC

Synthetic offer freedom from inherent risks of allograft and xenograft products like prions, viruses, extraneous DNA and RNA, and animal antigens. They are often less expensive while providing the same clinical outcome, but all synthetic bone graft materials are not the same. There are those that resorb too quickly and do not provide a scaffold for new vital bone to grow on and into, and there are those that never resorb preventing the implant space from ever becoming all new vital bone. Therefore, attention to detail in the manufacture of bone graft products is essential to create a product that both resorbs and allows complete bone replacement of the implant material with vital bone in an ideal timeframe.

How do we do it

We maintain quality control throughout the process to ensure the best possible characteristics. Other marketers may just market and sell the final product as it arrives at their door and have no part in material production.

  • We source all materials used in the manufacture of our bone graft products in the USA
  • We source all the packaging for our products in the USA
  • We use well-known and recognized vendors for our raw materials, and they supply certificates of analysis with those raw materials to document the quality of those components.
  • Additionally, we conduct our own testing of raw materials to meet our high standards

Materials
Ideal raw materials are necessary to manufacture the best possible bone graft products. Good and/or bad tract minerals and impurities in raw materials can make their way into the final product. Finding new materials without any trace of impurities is not feasible. Knowing what these impurities are and at what level they occur allows these considerations to be interwoven into the final product performance at the outset of manufacturing. Intact, human bone contains carbonate and low levels of minerals that play important and specific roles in bone formation and maintenance. The key is getting the right ones and in the right concentrations. That takes a thorough understanding and a commitment to make the best possible graft material.

Specific characteristics created in manufacturing

Porosity increases surface area of product exposed to cellular action for maximum bioactivity. Micro porosity helps to wick up fluids and the essential growth components carried in them. Macro porosity of the correct dimensions (100-600 microns) encourages cells to grow on and in the pores of particles more than seen in comparable non-porous materials.

Sintering is one of the final stages in manufacturing synthetic bone graft materials, and it is critical to achieve the correct in vivo residence time for the graft material. Minimal or no sintering creates a soft product that will handle poorly and resorb too quickly resulting in a scaffold inadequate for osteoconductivity. The literature defines this as graft failure. Excessive sintering makes a product that is too hard and a product that will not be resorbed in an appropriate time period. Extreme sintering of certain bone graft products can create a product that will never resorb. Incomplete resorption results in a graft site that does not contain the normal ratio of mineral phase to collagen which creates the full strength of natural bone. Additionally, unchanged graft particles may be hard or impossible to drill through and will not accept implants properly.

Clinical Evidence

Case information for figures 1-4

  • 21 year old healthy female treated for post-traumatic tibial shortening and varus deformity after trauma in childhood.
  • Patient was treated by a distal tibial open wedge osteotomy for lengthening and alignment correction.
  • Tibia was stabilized with plates and locked screws.
  • 10 cc of Osteophil b-TCP mixed with bone marrow aspirate (BMA) was used to graft a 2cm tibial defect.

sWK rabbit, H&E stain showing bone apposition on Osteophil b-TCP ceramic granules, H&E, original magnification = 79x

sWK rabbit, H&E stain showing incorporation of Osteophil b-TCP ceramic granules into the healing defect, H&E, original magnification = 50x

References

Substituted hydroxyapatites for bone repair. Shepherd JH, Shepherd DV, Best SM. Journal of Material Science : Material Medicine. 2012; DOI 10.1007/S10856-012-4595-2.
Preparation and cellular response of porous A-type carbonated hydroxyapatite nanoceramics LiB, Lino X, Zheng L, He H, Wang H, Fan H, Zhang Z Materials Science and Engineering. 2012, C 32, 929-936.
Fabrication of low-crystalline carbonate apatite foam bone replacement based on phase transformation of calcite foam. Maruta M, Matsuya S, Ishikawa K. Dental Materials Journal. 2011, 30(1): 14-20.
Fabrication of carbonate apatite block based in internal dissolution precipitation reaction of dicalcium phosphate and calcium carbonate. Daitou F, Maruta M, Kawachi G, Tsuru K, Matsuya S, Terada Y, Ishikawa K. Dental Materials Journal. 2010, 29(3). 303-303.

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Resources

RESEARCH PAPERS

*All studies summaries are available upon request through customer service.

SYMBOLS GLOSSARY

Careers

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Follow all company policies and procedures as well as local, state and federal laws concerning employment to include, but not limited to: I-9 information, EEOC, Civil Rights and ADA.

DISTRIBUTORSHIPS

BSI is actively seeking highly motivated distributors. We value our distributors and view distributors as strategic partners.

For more information on becoming a distributor please contact us today.

Company Policy/Procedural Compliance
Follow all company policies and procedures as well as local, state and federal laws concerning employment to include, but not limited to: I-9 information, EEOC, Civil Rights and ADA.

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BONE SOLUTIONS INC.

5712 COLLEYVILLE BLVD., SUITE 210
COLLEYVILLE, TEXAS 76034

Phone: 817.809.8850
Email: customerservice@bonesolutions.net