Malaysia’s first nitinol alloy producer

Nitium Technology as Nitinol producer

• Nickel-titanium (nitinol) alloy is one of the most promising metallic

materials to emerge in the field of shape memory alloys (SMAs) and
functional materials.
• Many recent metal-processing technologies aim at the most cost-
effective and reliable techniques for manufacturing nitinol with complex
shapes and superior properties.
• One of the important routes that may be able to provide these
properties is metal injection moulding (MIM). MIM is one of the unique
powder metallurgy (PM) techniques
• Using MIM and with the collaboration with Universiti Teknologi MARA
(UiTM), Nitium Technology is the ASEAN’s first Nitinol manufacturer.
• As an ISO 13485 certified company, Nitium has developed the world’s
first porous nitinol dental implant.
• Nitium aims to diversify the technology to produce nitinol for other
industries as well.
How do we reduce the cost of Nitinol?

1. Nickel and 4.
Titanium powder Binder

Dental implant
“Final Part”
Dental
implant
“Brown Part” Other Nitinol products
3. 1. Depending on the composition,
Feedstock
we can either produce shape
2. memory type or superelastic
residual
nitinol mixtures
2. Using MIM, we can mould part
into any intricate shapes
Nitinol 3. The residual nitinol from the
implant manufacturing can be
Dental Dental
implant implant
re-melt
“Green Part” “Sintered 4. Other Nitinol parts can be
Part”
Re-melt and re-cast produced

MIM enables low cost manufacturing

Metal Injection Moulding Process and high homogeneity nitinol
Comparison with others
How did other manufacturers do?
A. B.
Nickel and
Pure Nickel Titanium
plates

or Nitinol ingot

Pure Titanium

C.
VS Additional machining

Metal Injection Moulding in Europe - Technological trends and business

situation, F Petzoldt, WORLDPM2018 Congress, Beijing, China, September
16-20, 2018

By powder metallurgy (PM) such as

by MIM or Isostatic pressing (IP),
Nitium can reduce the risk of
contamination and inhomogeneity
of the end product as inherent in
other methods. Besides, PM is a Starting from pure Nickel and pure Titanium block/ingots, they use Vacuum Induction Melting (A) -
which is expensive and the melt could be contaminated by carbon originating from a graphite crucible,
relatively low-cost manufacturing or - the Vacuum Arc Melting (B) which is also expensive and lead to inhomogeneity; to produce Nitinol
method. ingot. The ingot is then need to be processed – either by rolling or forging or drawing or extrusion (C) as
well as machining to obtain the final products
Global Nitinol producers

List of Shape Memory Alloy (SMA) manufacturers

UK Italy
Germany
Johnson Matthey plc Euroflex Gmbh Saes Getters S.P.A.
Nanoshel llc Japan
Daido Steel Co. Ltd
Furukawa electric co. ltd
USA Nippon Seisen Co. Ltd
Alb Materials Inc.
ATI Alloys & Components China
Lumenous Peiertech
Boston centerless
Seabird Metal Material Co. Ltd.
Confluent Medical Technologies Sunrise Titanium Technology
Dynalloy Inc. Xian Saite Metal Limited
Fort Wayne Metals
Metalwerks Pmd, Inc Taiwan
Precision Castparts Corp. M & T(Taiwan) Co. Ltd.
Stanford Advanced Materials
Ultimate NiTi Technologies India
Malaysia SMA Wires India

Despite the list, most of them only focus on producing SMA wire. Only
handful of manufacturers are known to have produced the custom nitinol
parts (brown-highlighted companies).
With MIM, Nitium aims to be the first player in Asia.
Nitinol by Nitium Technology for bone implant applications

Combined
market size
~ $67.2 Bil

Metal Injection Moulding Process

Nitinol by Nitium Technology for aerospace industry

Thermal protection System

Inconel alloy
Thermal conductivity The lower thermal
= 11.4 W/mK conductivity we can produce
TPS = porous nitinol with;
better heat
resistant 2.6418 W/mK (ave)
Inconel honeycomb Which is superior
Metallic Thermal Protection System
Thermal conductivity (effective)
than Inconel
by NASA Langley Research Center = 3.0 W/mK
Philip A Cruden
Billion Planet Quest (LaRC) honeycomb!

For space rovers Variable Geometry chevron

Nitinol bearings and flexible tyre Nitinol VGC used by Boeing

Nitinol by Nitium Technology for ISS

International Space Station Water Recycling System

“Stress Corrosion Evaluation of Various

Metallic Materials for the International Space
Station Water Recycling System”

https://ntrs.nasa.gov/api/citations/20150006942/
downloads/20150006942.pdf

Potential alloys;
Inconel 625
Hastelloy® C-276
titanium (Ti) commercially pure (CP)
Ti 6Al-4V
extra-low interstitial (ELI) Ti 6Al-4V
Cronidur 30
Nitinol
Nitinol by Nitium Technology for O&G industry

Base material (pipe)

Weld overlay material

INCONEL 625
Submarine pipe:
Commercial Nickel-Titanium (nitinol) is ~50% cheaper than Inconel
Nitinol has potential to replace Inconel 625
Nitium’s Awards and Recognitions

Second place MedTech Innovator’s top 20 Asia Pacific Start-ups Winner Gold Medal Award
Asian Entrepreneurships Award (AEA) MedTech Innovator APAC 2021, K-Startup Grand Challenge 2018 Internationale Fachmesse Ideen,
2020, Japan Los Angeles/Singapore Ministry of SMEs & Startup, Erfindungen & Neuheiten 2017
South Korea (IENA2017), Germany

Gold Medal Award Gold Medal and Special Award Alumni Contributor
International Invention, Innovation & International Conference & Exposition On MTDC symbiosis program National Advanced Materials Technology
Technology 2017 (ITEX2017), Malaysia Inventions by Institution of Higher Learning Roadmap 2021-2030 (NAdMTR)
2017 and 2019, Malaysia

Grant recipient of: License and certification: Coverage:

National Technology and Establishment license ISO 13485:2016

Innovation Sandbox
The product: Nitident Tuah Dental Implant System

World’s first porous nitinol (nickel-titanium) dental implant

by
Why porous nitinol?
3
Almost all dental implants in the market are made Current method
from titanium alloy and produced by conventional
machining methods1.
to produce
Due to the method, the implant surface is smoothed dental implant
and polished, which prevents the cells from
attaching to the surface, hence inhibiting bone- 1 2 +
implant integration (process known as
Osseointegration)2.
To create the surface roughness, dental implants
need to undergo additional surface treatments3,
which significantly increases the cost.

Surface treatment Methods There are several techniques to increase the

Titanium plasma sprayed
Hydroxyapatite (HA)
Resorbable Blast media
Wet short Blasting Al oxide
Recrystallized HA
TiO2 coated
Titanium nitride coating
Sand-Blasted grit Acid Beta Tri-Cl phosphate SLA and NaCl solution
surface roughness of the implant. The key is that
etching coating the more rough the surface is, the better the
TiO porous anodic TiO2 blast + fluoride HF acid Soluble blast media bone-implant integration becomes. Currently, the
oxidation differences between one dental implant and
Acid etching + CaP coating CaP coating Texturing another are only limited by what kind of surface
Sandblasted Ti-zirconium ceramic Gold discharge treatments they have gone through apart from
coating
the physical design, such as the dimension,
Acid etching Ti-niobium ceramic coating Titanium bead sintering
internal connection, and thread design. Up to this
Laser sintering and Anodic spark disposition Plasma rich growth factors point, the dental implant industry is pretty much
treatment
saturated as there has been no significant
Conditioning/hydroxylation Acid etching Normal sand blasted
innovation for years.
Why porous nitinol? the fractures. Because of this, the main
players are looking for other alloys that Zirconium Titanium
have excellent pseudo-elasticity by
Bone Straumann
properties and one of the promising alloy Unfortunately, porous
4 (Swiss)
Osseoincorporation However, due toishigh Nickel Titanium (NiTi) alloy .
5 5
nitinol dental implant is
us
Poro stiffness, having the extremely difficult and
As the industryporous
becomesstructure on expensive
Tantalum to produce6
Titanium
saturated, poroustitanium
structure significantly Zirconium Titanium
by
reduces its strength, by
Zimmer Biomet
dental implant is identified as the
Straumann
(USA)
next milestone which
of may lead to
implant
Bone 5 (Swiss)
fractures.
technology. Furthermore,
Existence of porosity the mismatch
not only in stiffness
Tantalum Titanium
between
provides built-in surfacetitanium and by
bone could result in a
roughness for Osseointegration Zimmer Biomet
As the industry becomes
but also saturated, stress-shielding
enables bone in-growth effect. (USA)
porous-structure inside
dental theimplants are This effect
implant surface known can cause 6

identified as theas next milestone in

Osseoincorporation
implant technology.
The existence of porosity not only
provides built-in surface roughness
for Osseointegration but also enables
bone in-growth inside the implant
surface, known as the
Osseoincorporation4 process.
osteopenia,
4 process. resulting in Failed attempt Porous NiTi Implant
by TSU, Russia (using SHS technique)
implant failure. Because
of this, the main players
are looking for other
alloys that have excellent
pseudo-elasticity properties, and one of the most
promising alloys is Nickel Titanium (Nitinol or 6
5 Failed attempt Porous nitinol Implant by
NiTi) alloy .
TSU, Russia
Our solution
7

With metal injection moulding7, we have found the solution.

Nitium Technology not only developed the world’s first porous nitinol dental implant, but also reduces more than 60% of the average
production cost of dental implants.
Food and Drug Administration (FDA)
Test Standard / Compliance Status (section 510(k) FD&C Act)
Region : United State
MEM Elution (Cytotoxicity) GLP, ISO 10993 Completed Product code: DZE

Requirements for dental implant

Class II
MTT Assay (Cytotoxicity) GLP, ISO 10993 Completed Regulation Number:
Acute Systemic Toxicity GLP, ISO 10993 Completed 872.3640
Design Dossier: NDA, eCTD
Intracutaneous GLP, ISO 10993 Completed
European Commision (CE)

according to:
Irritation GLP, ISO 10993 Completed MDR 2017/745
Region: Europe
AMES (Genotoxicity) GLP, ISO 10993 Completed Product code: MD0403
Micronucleus (Genotoxicity) ISO17025, ISO 10993 Completed Class IIa
Articles/Annexes:
Sensitization GLP, ISO 10993 Completed II, V, VI
Design Dossier:
Corrosion ASTM F2129 Completed NB-MED/2.5.1/Rec5
Implantation GLP, ISO 10993: part 6 Completed
Dynamic fatigue ISO 14801 Completed

Sterile barrier validation ISO 1980-16 Completed

Multicenter Clinical Trial (105 patients) ICH GCP / ISO 14155 On-going (complete in Q2 2022)

List of completed validations and verifications

Competition– Direct comparison and conclusive evidences

Surface roughness
Surface comparison;
roughness comparison; Porous dental
Porous implant
dental design
implant comparison;
design comparison;
Trabaecular
Trabaecular Metal Metal
Our
Ourproduct provides
nitinol dental 60% more
implant provides Our product is the first
surface area surface
60% more to the cells
areacompare
to the cells porous dental implant with

VS
tocompare
19.9% from Straumann
to 19.9% latest
from Straumann the threaded body. It
product
latest product ensures the primary
(3 times better
(3 times integration)
better integration)
stability after the
≈ $150 ≈ $400
≈ $400 implantation
Our product is the first porous dental process. ≈ $1200
≈ $1200
(Bone-implant integration does not
implant with the threaded body. It
happen spontaneously, so threaded
Surface roughness
Surface parameter
roughness parameter Surface roughness
Surface parameter
roughness parameter
ensures the primary stability design after the to stay in
helps implant
implantation process. place)
(Bone-implant integration does not happen
spontaneously, so threaded design helps implant
to stay in place)
Anti-corrosion;
Anti-corrosion;
In pitting
In pitting corrosion
corrosion testing
testing
Mechanical strength;
Mechanical strength; (ASTMF2129),
(ASTMF2129), the the average
average
breakdown
breakdown potential
potential of of
In static compression test, our test,
In static compression dental implant
Porous
Astra 3.5mm
Astra 3.5mmsystem can endured
nitinol more
dental load system
implant than both
can the our implant
implant is 677mV
is 677mV
which is well above

> >
TM TM
OsseospeedOsseospeed which is well above
Astra Osseospeed
endured more
TM andload
Nobel’s
thanSpeedy
both Astra
568.8N 568.8N 600mV
600mV threshold
threshold as aas a
Replace Osseospeed
TM . Furthermore,and
TM theNobel’s
systemSpeedy
survived
minimum
minimum requirement
requirement
at least 2Replace
million cycles
TM at 50% Ultimate
. Furthermore, the system
suggested
suggested by FDAby FDA
in itsin its
Tensile Strength
survived(UTS) which
at least is 4 times
2 million max
cycles at
NiTiDent 3.5mm Nobel 3.5mm
Nobel 3.5mm guideline
guideline - “Biological
- “Biological
value of mastication
50% Ultimate load for anterior
Tensile Strengthteeth
(UTS)
596.3N 3.5mm Speedy Replace
SpeedyTM
ReplaceTM Responses
Responses to Metal Implant”
to Metal
553.4N 553.4N (for 3.5mmwhich is 4 times max value of mastication load for
implant)
596.3N as acceptable
Implant” corrosion
as acceptable
anterior teeth (for 3.5mm implant)
resistance
corrosion resistance
 Competition– Direct comparison and conclusive evidences

Histopathological Evaluation; Osseoincorporation evidence;

Surface roughness comparison; Porous
Subject: 10 New Zealand White Rabbits
dental implant design comparison;
In another comparative animal Trabaecular Metal
Standard: GLP, ISO10993:6, ISO17025 (UKAS)
study on New Zealand White Rabbits
Our product provides 60% more Our product is the first
surface area to the cells compare
showed that there is bone in-growth inside
porous dental implant
the implant (marked by the red spotSITI with area in
NADIA
to 19.9% from Straumann latest the threaded body. It
product the picture). In the same study, none were
ensures the primary
(3 times better integration) observed with commercially available
stability after the
≈ $150 ≈ $400 Straumann implants.
implantation process. ≈ $1200
(Bone-implant integration does not
happen spontaneously, so threaded
✓ bone-
Which means, the Porous
POROUS Nickel Titanium ingrowth-
design helps implant to stay in
Surface roughness parameter
Titanium
Surface roughness parameter
nitinol is 48% more
Subject:
VS 12 New Zealand place)
400x
Grade 5 SITI NADIA
biocompatible than White Rabbits
Anti-corrosion;
5.28/600 10.93/600 industry standard
Standard:
ISO10993:6 In pitting corrosion testing
titanium alloy!
Mechanical strength; (ASTMF2129), the average
Superior bone-implant-contact (BIC);
breakdown potential of
In static compression test, our dental implant
Astra 3.5mm our implant is 677mV
system SOLID
can endured more load than both
✓ Titanium
bone-
S Nickel Titanium
OsseospeedTM ingrowth- which is well above
Astra Osseospeed and Nobel’s Speedy
>
TM
568.8N 600mV threshold as a
VS
400x
ReplaceTM. Furthermore, the system survived 400x
minimum requirement
at least 2 million cycles at 50% Ultimate
suggested by FDA in its
Tensile Strength (UTS) which is 4 times max
NiTiDent 3.5mm Nobel 3.5mm guideline - “Biological
value of mastication load for anterior teeth
100 µm

596.3N Speedy ReplaceTM Responses to Metal Implant”

553.4N (for 3.5mm implant)
as acceptable corrosion
Far more BIC Straightness
resistance= less BIC
LID Titanium
Other products

ASEAN’s first PVS dental impression materials

Certifications and IPs

Ce rtif icate MY 20 I 1 81 1 03037 2

The management system of

Nitium Technology Sdn. Bhd.

B-1-1 6, Vista Alam, Jalan lkhtisas 14l1 , Seksyen 14
40000 Shah Alam, Selangor
MALAYS!A
g
**,
has been assessed and cefffied as meeting the requirements of

sG$
ISO 13485:2016 Patents Country Year
A Method of Producing Dental Malaysia 2015
For the following activities

Design, Development, Manufacture and Distribution of sterile Alloy

Denta! lmplant System and Blood Glucose Monitoring System
(Blood Glucose Strips and Blood Glucose Meter)
Implant Article With Nickel
Titanium Alloy
This certificate is valid from 03 June 2020 until 02 June 2023
lssue 1. Certified since 03 June 2020
(PI 2015700327)
Method For Producing Porous Malaysia 2018
Medical Implant
Authorised by
(PI 2018703906)
Medical ,Device
다공성 의료용 임플란트의 제 South 2019
AUTHORITY
MALAYSIA

조 방법 Korea
(10-2019-0132057)
sGS (lVlalaysia) sdn. Bhd., conformity Assessment Body MDfucAB-003
Lot 3 & Lot 4, Persiaran Jubli perak, Seksyen 22
40300 Shah o''-'
f lil,j;Bfliff Tffi$::,*
Page 1 of 1

ffi@
This document is issued by the Company subjectto its General Conditions of
Certification Services accessible at www.sgs.comfterms_and_conditjons.htrn.
Attention is drawn to the limitations of liability, indemnification and jurisdictional
issues sstablished therein. The auhenticity of this document may be verified at
ht$://wlvw.sgs.com/en/certified-clients-and-products/certilie&client-directory.
Any unauthorized alteration, forgery or falsification of the content or appearance
of ttris document is unlarivful and offenders may be prosecuted to the fullest
extent of the law,
 Our location:
17 A-1, Jalan Reko Sentral 1,
Taman Reko Sentral, 43000, Kajang,
Selangor, Malaysia
MDA establishment license: MDA-1175-K120
www.nitiumtech.com