Bio XT Maximising the Material Performance of Resorbable Implants

Transcription

1

2 Bio XT Maximising the Material Performance of Resorbable Implants OMTEC, 17 th June 2015

3 What is Bio XT? Bio XT is a proprietary biomaterials processing technology Alternative to injection moulding or compression moulding Bio XT is applicable to resorbable polymers and biocomposite blends Optimises material microstructure, to deliver very high strength self reinforcement physically oriented but chemically unchanged. Maximizes inherent mechanical properties, yielding improved strength and toughness 102% increase in torsional strength for market leading predicate suture anchor

4 Proxy Biomedical A Company Overview Proxy Biomedical is a leading innovator in the design, development and manufacture of implantable biomaterials products 13 years providing services to medical device OEMs Key Markets Orthopedics, Vascular, General Surgery, Women s Health Products 5 FDA cleared, 6 CE Mark (e.g. MotifMESH, VitaMESH) End to End Solutions Engaged with multiple companies on design, development and volume manufacturing of implantable biomaterials

5 Why Use Resorbable Implants? Advantages 1. No Reoperation Necessary reduced risk of infection reduced healthcare cost 2. Promotes Tissue Regeneration material modulus closer to that of native tissue than metal avoids stress shielding customisable degradation time appropriate to indication for use induces gradual load transfer to growing tissue during critical healing phase (Wolff s Law) osteoconductive ceramics (e.g. β TCP) can be introduced to formulation, improving the quality of osseous tissue formed Disadvantages 1. Strength Limitation Precludes certain indications for use Limited opportunity for porous designs Larger size implant may be needed, compared to non resorbable counterpart 2. Foreign Body Reaction Localised ph drop seen in early adoption; owing to implantation of large solid implants (especially PLLAbased)

6 Bio XT Addresses Strength Limitations 1. Stronger resorbable products, for load bearing indications, for which only nonresorbable products are currently considered suitable reduce risk of breakage upon insertion replace PEEK with resorbable polymer or biocomposite equivalents develop resorbable product solutions for more load bearing indications 2. Porous products, facilitating osteoconductivity for higher quality tissue regeneration, without compromising product strength 3. Lower profile products, using less material Lower OD profile for less invasive use with easier revision Higher ID to improve torque rating of drive mechanism

7 Evolution in Design of Resorbable Anchors Arthrex Bio Interference Screw Stryker Biosteon Screw Smith & Nephew Healicoil Trend towards composite resorbable biomaterials Improves bone in growth but higher challenge in achieving strength Recent trend towards more porous constructs Minimize implanted material Promote greater tissue in growth

8 Bio XT Comparative Torsional Test Setup 1. Market leading suture anchor screw (85% PLLA/ 15% β TCP; dimensions 5.5 mm ɸ x 15 mm length) was used as a control device Figure 1: Proxy Bio XT Circular Porous Design is Replicate of Biocomposite Predicate Product; while Elliptical Porous Design is Replicate of PEEK Predicate Product. 2. Torsional strength is of key clinical relevance determines the incidence of breakage upon insertion determines the degree of interference fit employable in securing the suture, which in turn determines pull out strength 3. Screws were inserted into Sawbones high density polyurethane foam block 4. Screws were inserted into pre drilled and tapped hole, with orthogonally aligned driver

9 Bio XT Comparative Torsional Test Performance

10 Bio XT Comparative Torsional Test Performance

11 Bio XT in your Company? Indications for Use Sports Medicine Suture Anchor Interference Screw Trauma CMF Plate & Screw Systems Extremities Pins & Screws IM Fixation Devices Spinal Anterior Fusion Plates Materials Resorbable Polymer PLLA PLGA 85:15 PLGA 82:18 PLDLLA 70:30 other Biocomposite PLLA & HA PLLA & β TCP PLGA & β TCP & CaSO 4 other

12

13