BIODEGRADABLE INJECTABLE ADHESIVE FOR

ORTHOPAEDICS

Presenter: Alicia L. Bertone, DVM, PhD; The Ohio State University

Medtech Insight Conference Nov 3, 2005 Dallas, Medtech Insight Conference Nov 3, 2005 Dallas, TxTx

ORTHOPAEDIC NEEDS:RESORBABLE BIOADHESIVE ANCHOR

• Synthetic hardening agents, PMMA and polymers, as well as Ca-based bone fillers/cements do not claim to be adhesive

• Ideal Product would:– adhere bone-to-bone; tendon and ligament-to-bone

– Be osteoconductive [Support bone formation]

– Serve as delivery device for osteoinductive substances

– Be biocompatible and bioabsorbable within bone healing time frame (months)

Current Bone Cement Limitations• PMMA - Nonabsorbable, exothermic,

nonadhesive• Calcium [Ca] phosphate compounds

– Prolonged Resorption Profile (Norian® SRS®, Synthes) (Apelt et al. (2004) Biomaterials 25:1439)

– May not be Injectable (Bone Source®, Stryker)

– May be Associated with Lethal Embolization when Injected (Bernard et al. (2004) Trans ORS:254)

BONE SOLUTIONS TECHNOLOGY

• Magnesium-based (87%) injectable formulation• Global exclusive licensing rights with Bindan Corp,

U.S. Patent 6533821, and all other refinements to this technology for human and vet applications

• 1 Patent awarded; 4 Patents filed including for adhesive qualities

• Key Components– MgO2

– MgKPO4

– Small amts TCP (Tricalcium Phosphate) and other binders of H2O

Magnesium Injectable Cement Adheres Bone and Tendon to Bone

• 16 Knee Joints, Femurs and Achilles from 8 mid-sized dogs

• Fracture Model– Femur

• Anterior Cruciate Ligament Models– Bone to Bone - Patellar

bone-tendon in Femur

– Tendon to Bone - Achilles in Tibia Bone Tunnel

Bone Plug7mm

Achilles Tendon

patellar ligament

Achilles

Groups and Biomaterials• Press-fit Control (n=16)• Ca Injectable Cement -

Ca Phosphate; (n=8; Norian® SRS®, Synthes, Paoli, PA)

• Mg Injectable Cement - Mg Phosphate; (n=8; Bone Solutions, Dallas, TX)

Bone Solutions

Cured Overnight

2 min set

10 min set

Groups Press-fit Ca (Norian®) Mg (Osteokrete®)

Bone-Bone 41.6a +/- 16.8

427.7b +/- 103.9

1025.6c(p<0.003) +/- 118.2

Tendon-Bone 12.9a +/- 0.03

101.6b +/- 23.1

338.2c (p<0.009) +/- 69.9

RESULTS- ACL MODEL

Table 1: ACL - Peak Tensile Load (N) to Failure

Magnesium Cement Adheres Screws to Bone

• Screw extraction torque greater than Ca product, PMMA, or Control (P<0.001)

Control Ca-BS PMMA Mag- BSI

Mechanism of Bonding

• Phosphate bonding• Expansion

In Vivo Horse Study

• 3-piece Fracture Model

• 3 treatments– Press fit– Ca Phosphate

cement (Bone Source, Stryker)

– Mag Cement (Osteokrete®, BSI)

Wk 4Ca

Wk 4Mg

Wk 4NONE

Wk 4Mg

BSI MG CEMENT IS OSTEOINDUCTIVE

In Vivo Horse Study• Computed Tomography

confirmed more bone in Mag Cement group

• Histology at 7 weeks showed Mag cement still present in some specimens– No inflammatory reaction– Normal bone formation– Good healing

Bone

Mg Cement

Nonreactive fibrous tissue

Current Strategy and Funding Needswww.bonesolutionsinc.com

• BSI is completing an initial angel round. An Offering Memorandum is available. Future funding, expected in 2006, after FDA 510 (k) submissions.

• Priority Use of Funds goes into science and completion of four FDA 510 (k)’s; bone void filler, bone cement, bone anchor, and dental cement. NAMSA, Toledo, OH, will complete initial 510 (k) animal testing.

• Veterinary launch 1Q 2006. Distributor selected.

• Market size potential covers over 100 CPT codes in initial targeted uses.

• BSI is also exploring CE Mark opportunities in Europe

Technical Advisory Board• Dr. Scott Rodeo, Orthopedics Hospital for Special Surgery, NY• Dr. Joseph Iannotti, Chairman, Orthopedics Department, The Cleveland

Clinic, Cleveland, OH• Dr. Jim Montgomery, Head Orthopedic Specialists, Dallas, TX• Dr. Tarek Souryal, Head, Sports Medicine Clinic of Dallas• Dr. Richard Steadman, Steadman-Hawkins Clinic (pending)• Dr. Michael A. Pikos, (DDS) MAP Implant Institute, a Diplomate of the

American Board of Oral and Maxillofacial Surgery, Diplomate of the American Board of Oral Implantology/Implant Dentistry. Palm Harbor, FLA.

• Dr. Edward Mills, (DDS) Head, Center Restorative Dentistry. • Dr. John Russo, (DDS, MHS), Fellow of the International Congress of Oral

Implantologists, Sarasota, FL• Dr. Alicia Bertone, Chair, BSI Technical Advisory Board, Professor, Ohio

State University, Columbus, OH

BSI Team

• John Albers, Chairman & CEO; Head of Fairfield Enterprises, Pharmaceutical Technologies Developer

• Tony Copp, COO & Director; 30 Years experience in Finance/EAC Ltd, focused on new technologies

• Tom Lally, President & Director, Inventor• Jim McNamara, Treasurer; Director IBM Finance/Marketing Executive• Drew Diaz, Director; Medical Device, International Sales Executive• Wade B. Hampton, Director, Medical Device, National Sales

Executive• Leo Basta, Boston Biomedical Associates, Regulatory Consultant• Dr. Alicia Bertone, Chair, Technical Advisory Board