SynMax® bone graft substitute

Valid from October 2021 SynMax® bone graft substitute and PermaPro® membrane – 100% synthetic Bone tissue augmentation Inspiring excellence in oral reconstruction

SEM analysis and histological structure of SynMax® Physicochemical properties of suitable bone grafts SEM analyses of SynMax® demonstrate a very rough surface and a matrix of interconnected pores with a very high porosity of approx. 80 %. The interconnected pores of SynMax® provide an ideal network of cavities for the ingrowth and migration of cells and blood vessels, thus promoting the formation of new vital bone. SEM analysis of PermaPro® Engineered for open healing Impervious to bacteria: dense structure, reduced bacterial attachment, efficient barrier against bacterial and cellular penetration SEM picture of PermaPro® at 30-fold magnification. SEM picture of SynMax® at 1000-fold magnification, showing microporous structure. SEM picture of SynMax® at 100-fold magnification, showing macroporous structure. Histological structure of SynMax® – homogenous bi-phasic composition 60 % hydroxyapatite (HA) and 40 % beta-tricalcium phosphate (β-TCP). Every particle is composed of HA and β-TCP. HA (hydroxyapatite) β-TCP (beta-tricalcium phosphate)

Bi-phasic composition of SynMax® ensures controlled resorption SynMax® acts as a temporary, osteoconductive scaffold and is gradually replaced by new bone as part of the natural remodelling process. 100 75 50 25 0 (%) 0 3 6 9 12 Time (months) β-TCP (beta-tricalcium phosphate) HA (hydroxyapatite) Bone formation Regeneration slow resorption/integration -› volume stability fast resorption -› space for regenerating bone Manufactering process of SynMax® – 100% synthetic bone graft substitute Sintering > 1000 °C Packaging / γ-sterilization Sterile product in double pouch Granulation / cutting Foaming / solidification Porous ceramic body Ceramic slurry

SynMax® and PermaPro® – synthetic alternatives SynMax® – osseous integration with following controlled resorption [1, 2] Commonly used bone substitutes are human bone, i.e. autografts or allografts, bone material from other species or synthetic materials. While autografts are considered the “gold standard” with regard to biocompatibility their use is hampered by concomitant donor site pain and morbidity and volume limitations of how much material can be harvested. Therefore, considerable efforts are made to investigate the use of materials from alternative sources and to develop techniques that do not rely on harvesting autogenous bone but do in result in sufficient bone formation within a short time frame. SynMax® is a fully synthetic, safe and biocompatible material that, when brought into an osseous environment, serves as an osteoconductive scaffold to support the ingrowth and fusion of adjacent, vital bone. SynMax® is composed of 60 % hydroxyapatite and 40 % beta-tricalcium phosphate. After implantation, the material undergoes a natural remodeling and is gradually resorbed and replaced by new bone. PermaPro® – high-density PTFE barrier membrane PermaPro® is an exceptionally thin, non-resorbable, biologically inert and biocompatible membrane made of high-density polytetrafluoroethylene (PTFE). PermaPro® maintains its structural characteristics both during the initial implantation and over the whole healing time. Due to its dense structure, the membrane acts as an efficient barrier against bacterial and cellular penetration, and may therefore be left in place for open healing in certain indications. The use of PermaPro® is especially recommended for regeneration of bone defects outside the ridge contour because it offers a higher stability and superior space-maintaining properties compared to resorbable (collagen) membranes. In addition, open healing with PermaPro® in socket or ridge preservation enables maintenance of the soft tissue architecture and contours since no primary wound closure is required. Due to the missing flap closure, the mucogingival line will not be displaced and the attached/keratinized gingiva will be preserved.

Product properties of SynMax® and PermaPro® SynMax® – synthetic resorbable bone graft substitute 100 % synthetic, no risk of disease transmission, high safety Controlled resorption due to biphasic composition Very rough surface and high porosity supports integration and bone formation PermaPro® – synthetic non-resorbable PTFE membrane 100 % synthetic PTFE barrier membrane Ultra-thin (~0.08 mm) Impervious to bacteria due to dense structure Easily removable due to minimal tissue ingrowth into the surface structure No need for primary soft tissue closure (indication-dependent) [3, 4] Easy recovery thanks to blue color Rounded edges for minimal tissue trauma Easy fixation with sutures or pins SynMax® is also extremely suitable for use in combination with platelet concentrates/L-PRF, since its material characteristics allow excellent binding and release kinetics of signaling molecules/growth factors.

Ideal for the following indications – regeneration and augmentation The aim of any tissue regeneration technique, and bone grafting in particular, is to achieve formation of living and reactive tissue able to undergo a sustained state of remodelling to maintain the mechanical and the biologic function over time. The use of bone augmentation techniques is frequently required prior to the placement of dental implants under unfavourable local conditions when the native bone volume is insufficient, for example following bone atrophy, periodontal disease, tooth extraction, or trauma. SynMax® – synthetic resorbable bone graft substitute Sinus lift Ridge augmentation Intraosseous defects Extraction sockets Osseous defects Furcation defects PermaPro® – synthetic non-resorbable PTFE membrane PermaPro® is a temporarily implantable membrane for use as a spacecreating barrier in GBR and GTR. Socket and ridge preservation (open healing) Horizontal/vertical ridge augmentation Fenestration and dehiscence defects Intraosseous defects (1 to 3 walls) Regeneration of extraction sockets Filling the socket with SynMax® in combination with PermaPro® membrane regenerates bone and so retains the volume and shape of the bone over time. Regeneration of periodontal osseous defects A tooth with a good prognosis can be retained by regenerating lost bone, with the support of biomaterials such as SynMax® in combination with PermaPro® membrane. Preference for PermaPro® over a collagen membrane Higher form stability Augmentation outside the ridge contour Synthetic nature – no religious or dietary conflicts Exposure – situations where primary wound closure is not desired (indication dependent)

Safe and reliable synthetic alternative to bone material – respectively membranes from other species [1–5] High patient acceptance Due to the synthetic nature, any risk of disease transmission is eliminated. Alternatives if a patient has ethical or safety concerns with the application of allogeneic or xenogeneic materials. If a resorbable bone grafting material is preferred (e. g. young patients).

Headquarters CAMLOG Biotechnologies GmbH | Margarethenstr. 38 | 4053 Basel | Switzerland Phone +41 61 565 41 00 | Fax +41 61 565 41 01 | | SynMax® and PermaPro® are manufactured by botiss biomaterials GmbH. SynMax® and PermaPro® are registered trademarks of CAMLOG Biotechnologies GmbH. BioHorizons® is a registered trademark of BioHorizons. They may, however, not be registered in all markets. As applicable, BioHorizons products are cleared for sale in the European Union under the EU Medical Device Directive 93/42/EEC and the human tissues and cells Directive 2007/47/EC. We are registered to ISO 13485:2016, the international quality management system standard for medical devices, which supports and maintains our product licenses with Health Canada and in other markets around the globe. Original language is English. ©BioHorizons. All rights reserved. Not all products shown or described in this literature are available in all countries. Rights to changes reserved · M-0517-FLY-EN-GLO-BHCL-00-102021 References [1] Binderman et al. Haim Tal, IntechOpen. April 4th 2012. [2] Jelusic et al. Clin Oral Implants Res. 2017 Oct;28(10):e175-e183. [3] Zafiropoulos et al. Medicina (Kaunas). 2020 Apr 28;56(5):216. [4] Papi et al. Antibiotics (Basel). 2020 Mar 3;9(3):110. [5] Lorenz et al. Int J Implant Dent. 2017 Sep 5;3(1):41. Ordering information SynMax® (synthetic bone substitute) PermaPro® (synthetic PTFE membrane) 15 x 20 mm 20 x 30 mm 30 x 40 mm Art. No. Volume Particle size BM1013.1005 0.5 cm3 500–1000 µm BM1013.1010 1.0 cm3 500–1000 µm BM1014.1005 0.5 cm3 800–1500 µm BM1014.1020 2.0 cm3 800–1500 µm Art. No. Product size BM2005.1520 15 x 20 mm BM2005.2030 20 x 30 mm BM2005.3040 30 x 40 mm