Title: Presentation to the Dow Jones Healthcare Ventures Conference
1- Presentation to the Dow Jones Healthcare Ventures
Conference - Redwood City, CA
- September 27, 2005
2Lower Success Rate of Initial Surgeries Resulting
in Second and Third Surgeries for the Same
Problem - Wide Variance Indicates Need for New
Orthopedic Solutionsto Augment Current Practices
or Introduce new Alternatives
3Whats Out there Today?
- Synthetic hardening agents, PMMA and polymers, as
well as Ca-based bone fillers/cements do not meet
this need - Ideal Product would
- adhere bone-to-bone tendon and ligament-to-bone
- Be osteoconductive (Support bone formation) and
potentially osteoinductive (bone creation) - Serve as delivery device for osteoinductive
substances - Be biocompatible, bioabsorbable within bone
healing time frame (months), have powerful
mechanical properties
4The Bone Solutions Technology
- Patented, Magnesium-based injectable formulation
- Key Components
- MgO Magnesium Oxide
- MgKPO4 Magnesium Potassium Phosphate
- Small amounts TCP (Tricalcium Phosphate) and
other ingredients - Additional Filed Patents have added further
adhesive qualities
5The BSI Product
- 100g powder 25g H2O
- Mix 1 min no special
- equipment, Injectable needle
- Sets 10-15 min adjustable
- Short Exothermic peak, Under 50 C
- Fibers, antibiotics, osteoinductive agents can be
added to serve as an osteo-biologic delivery
system
6BSIs Injectable Formulation Adheres Bone to Bone
and Tendon to Bone
- Biomechanical properties affirmed in canine model
of anterior cruciate ligament repair and femur
fracture. - Table 1 ACL - Peak Tensile
Load (N) to Failure
7Extraction Torque Test Proved Mechanical
Properties
- Mean extraction torque
- Control
- 67.75 /- 8.77 Nm
- Norian
- 61.35 /- 15.14 Nm
- Bone Solution
- 97.50 /- 17.77 Nm
- PMMA
- 71.80 /- 12.31 Nm
8Repeated Measures ANOVA
- Control vs Norian P 0.05
- Control vs Bone Solution P
- Control vs PMMA P 0.05
- Norian vs Bone Solution P
- Norian vs PMMA P
- Bone Solution vs PMMA P
9Biocompatibility/Proliferative
- Metatarsal Fracture Model using 8 Horses just
concluded showing that BSIs product was
clinically biocompatible, clinically
non-inflammatory - In this study, BSIs product showed formation of
bone or bone proliferation compared to a Ca based
product or nothing.
10Initial Indications of Proliferation
- Indications of bone formation, bone remodelling,
and bone healing occurred through four weeks, and
persisted through seven weeks for the BSI treated
injury versus the Ca product or nothing.
-
11Flexibility for the Orthopedic Surgeon
- Set Time for any Surgical Use with BSIs product
can be pre-determined in each case by the
orthopedic surgeon - Use of a CO 2 laser allows total control by the
surgeon, another unique feature of the BSI product
12Next Steps for BSI
- Accelerate completion of FDA 510(k) approval in
sequence as a bone void filler/cement/anchor
filler expected 2Q 2006 - Launch veterinary market sales to start initial
revenue by December 2005
13BSI Team
- John Albers, Chairman, Head of Fairfield
Enterprises, Pharmaceutical Technologies
Developer - Tony Copp, CEO, 30 Years experience in
Finance/EAC Ltd, focused on new technologies - Tom Lally, President, Inventor
- Jim McNamara, IBM Finance/Marketing executive
- Drew Diaz, Medical Device International Sales
Executive - W.B. Hamption, Medical Device, National Sales
Executive
14Technical Advisory Board
- Dr. Scott Rodeo, Orthopedics Hospital for Special
Surgery, NY - Dr. Joseph Iannotti, Head, Orthopedics
Department, Cleveland Clinic, Cleveland, OH - Dr. Jim Montgomery, Head Orthopedic Specialists,
Dallas, TX - Dr. Tarek Souryal, Head, Sports Medicine Clinic
of Dallas - Dr. Adam Starr, Southwestern Medical Center,
Dallas - Dr. Richard Steadman, Steadman-Hawkins Clinic
(pending) - Dr. Michael A. Pikos, MAP Implant Institute, Palm
Harbor, FLA. (pending)
15Current Strategy and Funding Needs
- BSI, www.bonesolutionsinc.com, is now completing
its round of 1.2 MM, and has a remaining need
for 600,000 at 0.12 per share. An Offering
Memorandum is available. Future fundings are
expected. Current investors are Management and
Angels - Use of Funds goes into the science and completion
of FDA 510 (k)s - Discussions with potential distributors and
manufacturers of our initial vet sales
packages/human sales work underway as well