2. RemeOs™ alloy = Mg-Ca-Zn
• Magnesium and magnesium alloys are light metals, which are characterized by low
density, high specific strength, and strong specific stiffness. The fracture toughness of
magnesium is greater than that of ceramic biomaterials such as hydroxyapatite. The
Young’s elastic modulus and compressive yield strength of magnesium are closer to
those of cortical bone.
• Especially, Mg2+ is present in large amounts in the human body and involved in many
metabolic reactions and biological mechanisms. The human body usually contains
approximately 35g per 70kg body weight and the human body’s daily demand for Mg
is about 350 mg/day.
• It has been shown that magnesium enhances osteogenesis response and increases new
bone formation.
• It is well known that pure magnesium has poor mechanical properties, and the
mechanical properties of magnesium can be effectively improved by the appropriate
selection of alloying elements.
• Ca is an important element of human bones. The mechanical properties and
biocompatibility can be adjusted by controlling the Ca content and processing
treatment.
• Zn is one of the abundant nutritional elements in the human body. Additionally,
it improves the mechanical properties and corrosion resistance of Mg alloys
• The mechanical properties and corrosion rate of the Mg-Zn-Ca alloys can be tailored by
the Zn and Ca content.

3. Magnesium alloy absorption: Chemistry
• RemeOs™ absorbable metal is magnesium (Mg), calcium (Ca) and Zinc
(Zn) alloy, which degrades from the surface due to physiological fluids
according to the following reaction1) to form magnesium hydroxide,
magnesium-containing calcium phosphates and as a by-product
hydrogen gas
 Mg2+, Zn2+ and Ca2+ ions are dissolved from Mg alloy implant,
 Local pH near the surface of the Mg could be >10
 As a result, a magnesium-containing calcium phosphate precipitates from the physiological
fluids and deposits on the surface of the magnesium implant. Phosphate containing Mg/Ca
degradation layer is tightly attached to the matrix and creates an osteopromotive layer
1)

4. Biological interface & osteopromotion

5. 5
Enhanced bone growth verified in vivo
No biological activity
with Titanium control
group in 6 weeks or 12
weeks timepoint
(orange circle)
Strong new bone growth
already in 6 weeks time
point and in 12 weeks time
point implant overgrown
with new bone (green
circle)
Histology of an ovine tibia, 12 weeks after Mg-alloy bi-cortical implantation. Methylene-blue/basic fuchsin staining. Osteoconduction of a newly
formed bone (nBpink/red color) with direct bone-implant contact was detected
6
weeks
12
weeks
RemeOs™ Titanium

6. 12weeks
6 weeks
0 weeks
6
In vivo strength retention over healing period
• Strength retention > 12 weeks in vivo
large Animal model and no statistical
difference between installation and 12 weeks
pullout force (p = 0.08, ⍶ = 0.05)
• No effect of degradation products
(including H2) on the strength retention
• According to the IVIVC correlation, 12 weeks
in large animals corresponds to min 30
weeks in human
high resolution micro-computed tomography
In Vivo Pull-out testing in large animal model
Data on File

7. 7
Safety and Efficacy of Absorbable metal verified in
clinical use
PRE-OP POST-OP WEEK 6 WEEK 12 WEEK 24 WEEK 52
Bioresorbable metal screw visible (blue
arrow)
Bioresorbable metal screw
head completely resorbed in
52 weeks follow-up point
WEEK 130
Data on File (Clinical Trial)
Male,
30
y

8. 8
Absorption zone in X-rays
PRE-OP WEEK 2 WEEK 6 WEEK 12 WEEK 24 WEEK 52 WEEK 130
Absorption zone (white arrow)
Absorbable metal screw visible (blue arrow)
Removed Syndesmosis screw and its removal hole (orange arrow)
Data on File (Clinical Trial)
Female,
47y

9. 9
Clinical results from three-year follow-up
 Indication: Medial malleolar fracture fixation
 Patient enrolled: 20 patients through 12 weeks follow-up, 19
patients up to 130 weeks follow-up
All primary end points achieved1)
RESULTS:
 In 6 weeks, 90% of the fractures were healed
 After 12 weeks complete consolidation in all patients
 No adverse events or intraoperative complications
 All patients regained mobility in the ankle joint
 No pain in any of the patients after 6 weeks
 Normal levels of Mg and Ca in blood
 Normal wound healing; no swelling, erythema, oedema nor
infections
 No loosening of the implant
 No removal operations2)
1) A lean bioabsorbable magnesium-zinc-calcium alloy ZX00 used for operative treatment of medial malleolus fractures, Patrick Holweg, Valentin Herber, Martin Ornig, Gloria Hohenberger, Nicolas Donohue, Paul Puchwein, Andreas Leithner, and Franz Seibert, Bone &
Joint Research 2020 9:8, 477-483
2) Herber V, Labmayr V, Sommer NG, Marek R, Wittig U, Leithner A, Seibert F, Holweg P. Can Hardware Removal be Avoided Using Bioresorbable Mg-Zn-Ca Screws After Medial Malleolar Fracture Fixation? Mid-Term Results of a First-In-Human Study. Injury. 2022
Mar;53(3):1283-1288. doi: 10.1016/j.injury.2021.10.025. Epub 2021 Oct 30. PMID: 34758916.
Patients with medial malleolar fractures: pre-operative to after surgery
Female,
47y
The patients who also received Titanium implants, 71% of the Titanium hardware in had to be
removed
PRE-OP WEEK 2 WEEK 6 WEEK 12 WEEK 24 WEEK 52 WEEK 130
Male,
30y
Female,
64y

10. 10
Technological Characteristics of RemeOs™
• Bioactive and osteopromotive properties:
• Mg has been shown to have osteoconductive and osteopromotive properties 1,2,3,4
• Initiates apatite layer formation and supports osseointegration1,2,3,4
• The new bone formation has been confirmed both in preclinical and clinical studies 1,2,4
• Absorption:
• Fixation stability (strength retention) for a minimum of 8 weeks
• Slow surface absorption increases load distribution to the healed bone
• No need for a removal operation
• Full disappearance in 2-3 years
1) N. G. Grün et al., “Comparison of a resorbable magnesium implant in small and large growing-animal models,” Acta Biomater., vol. 78, pp. 378–386, 2018.
2) 2)Holweg P, et al. A lean magnesium-zinc-calcium alloy ZX00 used for bone fracture stabilization in a large growing-animal model. Acta Biomater. 2020;113:646-659.
3) 3) Holweg P, et al. A lean bioabsorbable magnesium-zinc-calcium alloy ZX00 used for operative treatment of medial malleolus fractures, Bone & Joint Research 2020 9:8, 477-483
4) 4) J. L. Wang, et al., “Biodegradable Magnesium-Based Implants in Orthopedics—A General Review and Perspectives,” Adv. Sci., vol. 7, no. 8, 2020.

11. Clinical application of
Mg-based absorbable
metal for fracture
fixation in the adult
skeleton
Patients with a full set of X-rays (op, 2, 6, 12, 24, 52, 130 weeks follow-up)
Data on File (Clinical Trial)
High-resolution CT images are available by request for medical professionals

12. OP 6w
2W 24w
12w 52w 130w
Male, 30 years old
OP 6w
2W 24w
12w 52w 130w
Female, 47 years old
Female, 64 years old
OP 6w
2W 24w
12w 52w 130w

13. OP 6w
2W 24w
12w 52w 130w
Male, 43 years old
OP 6w
2W 24w
12w 52w 130w
Male, 46 years old
Male, 29 years old
OP 6w
2W 24w
12w 52w 130w

14. OP 6w
2W 24w
12w 52w 130w
Female, 45 years old
OP 6w
2W 24w
12w 52w 130w
Male, 56 years old
Male, 35 years old
OP 6w
2W 24w
12w 52w 130w