Bio-scaffold International Pte Ltd - Singapore Institute of ...
Bio-scaffold International Pte Ltd - Singapore Institute of ...
Bio-scaffold International Pte Ltd - Singapore Institute of ...
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Trading to <strong>Bio</strong>technology Company- A Journey<br />
Dr.Margam Chandrasekaran- CEO & Chief Scientist,<br />
<strong>Bio</strong>-<strong>scaffold</strong> <strong>International</strong> <strong>Pte</strong> <strong>Ltd</strong>.<br />
© 2007 <strong>Bio</strong>-Scaffold <strong>International</strong> <strong>Pte</strong> <strong>Ltd</strong>
Presentation Outline<br />
• Introduction<br />
• Opportunity<br />
• Technology development<br />
• Milestones/ accolades<br />
• Strategic collaborations<br />
• Snap shot <strong>of</strong> design and results<br />
• Moving Forward<br />
4/12/2013 2<br />
© 2007 <strong>Bio</strong>-Scaffold <strong>International</strong> <strong>Pte</strong> <strong>Ltd</strong>
Introduction<br />
• <strong>Bio</strong>-Scaffold <strong>International</strong> <strong>Pte</strong> <strong>Ltd</strong> (formerly known as<br />
Rapid Tech <strong>Pte</strong> <strong>Ltd</strong>.<br />
– Incorporated in 1999 as a company dealing with Research<br />
Equipments mainly for Scientific and Clinical applications.<br />
– Changed focus to become biotech company developing<br />
medical devices for Global Markets in 2000.<br />
– Our vision is to deliver <strong>scaffold</strong>s and implants for repair /<br />
replacement <strong>of</strong> human tissues including bones, joints and<br />
ligaments.<br />
4/12/2013 3<br />
© 2007 <strong>Bio</strong>-Scaffold <strong>International</strong> <strong>Pte</strong> <strong>Ltd</strong>
Introduction<br />
• BSI works on a disruptive technology that can produce<br />
customized metallic and polymeric implants<br />
• First product is <strong>Bio</strong>scaff Alvelac, a porous biodegradable PLGA<br />
<strong>scaffold</strong><br />
• Future areas include rhinoplasty implants and spinal implants for<br />
orthopedics<br />
4/12/2013 4<br />
© 2007 <strong>Bio</strong>-Scaffold <strong>International</strong> <strong>Pte</strong> <strong>Ltd</strong>
BSI Focus - Tissue Engineering Scaffolds<br />
Regenerative<br />
Medicine<br />
With Scaffolds (<br />
Surgery)<br />
Without Scaffolds<br />
Tissue Engineering<br />
(in-vivo) Implants<br />
Tissue Engineering<br />
(ex vivo) followed<br />
by Surgery<br />
Cell therapy<br />
(internal<br />
medicine)<br />
© 2007 <strong>Bio</strong>-Scaffold <strong>International</strong> <strong>Pte</strong> <strong>Ltd</strong><br />
5
Opportunity/Need<br />
• Current <strong>scaffold</strong>s/implants are limited by either strength or<br />
porosity<br />
• Strength and porosity are contradicting properties required<br />
but both are important<br />
• Conventional methods have limitations and DISRUPTIVE<br />
technologies are required to address contradicting<br />
requirements<br />
• A typical example is artificial joints which suffer from<br />
incomplete osseo-integration due to poor porosity and <strong>of</strong>ten<br />
have high modulus leading to stress shielding<br />
4/12/2013 6<br />
© 2007 <strong>Bio</strong>-Scaffold <strong>International</strong> <strong>Pte</strong> <strong>Ltd</strong>
Mechanical Strength<br />
Why Would a Medical Practitioner Like a<br />
Material to Degrade in the Body?<br />
• Do not require a<br />
second surgery for<br />
removal<br />
• Avoid stress<br />
shielding<br />
• Offer tremendous<br />
potential as the basis<br />
for controlled drug<br />
delivery<br />
BONE<br />
BONE+PLATE<br />
Time<br />
Degradable Polymer<br />
Plate<br />
PLATE<br />
© 2007 <strong>Bio</strong>-Scaffold <strong>International</strong> <strong>Pte</strong> <strong>Ltd</strong>
Technology Development<br />
• BSI (formerly known as Rapid Tech <strong>Pte</strong> <strong>Ltd</strong>) collaborated with<br />
SIMTech (formerly known as GINTIC) in 2000 with LETAS Grant<br />
to develop technologies for fabricating <strong>scaffold</strong>s for Tissue<br />
Engineering.<br />
• A team <strong>of</strong> scientists (Dr. Tay Bee Yen, Dr. Margam<br />
Chandrasekaran, Ms Zhang Su Xia, Dr. Annie Chan, Mr<br />
Ramanath and Ms Myo) worked on the technology<br />
development for fabricating <strong>scaffold</strong>s with Engineered<br />
Porosity and Strength<br />
4/12/2013 8<br />
© 2007 <strong>Bio</strong>-Scaffold <strong>International</strong> <strong>Pte</strong> <strong>Ltd</strong>
Title: Process and material development <strong>of</strong> bio-polymeric <strong>scaffold</strong><br />
system for bone reconstruction (Industry Project)<br />
Objective: To develop suitable material and process for porous <strong>scaffold</strong> construction<br />
Key Milestones: Patent search on the latest development in tissue <strong>scaffold</strong> engineering<br />
Evaluation <strong>of</strong> biodegradable polymers for <strong>scaffold</strong><br />
Selective porosity generation<br />
Development <strong>of</strong> compatible ink and binder for processing<br />
Process development <strong>of</strong> 3D <strong>scaffold</strong> fabrication by freeform printing<br />
Key Achievements: Successfully developed a <strong>scaffold</strong> with graded porosity Patent<br />
application in progress for the developed secondary process<br />
Femur with graded<br />
pore<br />
Porous femur<br />
As printed femur<br />
© 2007 <strong>Bio</strong>-Scaffold <strong>International</strong> <strong>Pte</strong> <strong>Ltd</strong>
Success Story - 25<br />
Partner : Rapid-Tech<br />
Project Title : Process and Material Development <strong>of</strong> <strong>Bio</strong>-Polymeric Scaffold<br />
System for Bone Reconstruction<br />
Industry Cluster : <strong>Bio</strong>medical (October 2003)<br />
SIMTech’s Contributions<br />
Provided manufacturing expertise to develop US<br />
Food and Drug Administration - approved<br />
biocompatible polymer bone <strong>scaffold</strong>s using<br />
rapid prototyping-3D printing technique<br />
PCT Application WO<br />
Benefits/Achievements<br />
Developed process to fabricate <strong>scaffold</strong>s with non- uniform<br />
porosity so that strength is not compromised<br />
Patent application filed<br />
The <strong>scaffold</strong> provides the necessary pore architecture where it<br />
is required<br />
Rapid-Tech is proceeding to commercialize the technology<br />
New bones with biocompatible<br />
polymers resulting in less pain and<br />
Reduced surgical operation<br />
© 2007 <strong>Bio</strong>-Scaffold <strong>International</strong> <strong>Pte</strong> <strong>Ltd</strong>
Cell seeding – 0 day @38 x<br />
Cell seeding – 0 day @75x<br />
AkP staining <strong>of</strong> PLGA seeded with osteoblasts, 3 rd day, 38 x, 75 x<br />
© 2007 <strong>Bio</strong>-Scaffold <strong>International</strong> <strong>Pte</strong> <strong>Ltd</strong>
In-Vivo tests on rabbit: 1,3,6 month<br />
follow up in rabbits<br />
4 week 12 weeks 24 weeks<br />
© 2007 <strong>Bio</strong>-Scaffold <strong>International</strong> <strong>Pte</strong> <strong>Ltd</strong>
Key Milestones<br />
E<br />
v<br />
e<br />
n<br />
t<br />
s<br />
•LETAS grant for<br />
Collaboration with<br />
GINTIC A STAR<br />
• First prototype<br />
developed<br />
• Joint Patent<br />
filed with A<br />
STAR<br />
•TEC grant from Prime<br />
Minister’s Office for<br />
NUS-Rapid Tech<br />
collaboration<br />
• TEC<br />
Innovator<br />
Award<br />
Year<br />
© 2007 <strong>Bio</strong>-Scaffold <strong>International</strong> <strong>Pte</strong> <strong>Ltd</strong><br />
13
Scaffold for Dental application<br />
• The developed technology was used to fabricate a<br />
degradable <strong>scaffold</strong> which was validated on a dental<br />
application but can be scaled up for other applications<br />
• <strong>Bio</strong>scaff Alvelac is a unique <strong>scaffold</strong> designed to biomimic<br />
the alveolar bone for preservation <strong>of</strong> ridge after a tooth<br />
extraction for subsequent tooth restoration.<br />
– Applicable for patients opting for Delayed Implants<br />
– Eliminates the need for expensive bone grafting for subsequent tooth<br />
restoration<br />
– Provides a cheaper insurance option for patients who are undecided<br />
on tooth restoration<br />
– Supports Natural healing using synthetic solution<br />
4/12/2013 14<br />
© 2007 <strong>Bio</strong>-Scaffold <strong>International</strong> <strong>Pte</strong> <strong>Ltd</strong>
Bone Healing Process<br />
Without Alvelac TM placed in extracted<br />
socket (Loss in bone height 1 & width 2 ).<br />
With Alvelac TM inserted in extracted socket<br />
(both bone height & width preserved).<br />
SIDE VIEW<br />
Results Without Alvelac TM<br />
Results With Alvelac TM<br />
TOP VIEW<br />
SIDE VIEW<br />
TOP VIEW<br />
Height Loss<br />
Width Loss<br />
Height Preserved<br />
Width Preserved<br />
1. Decrease in Bone Height is up to 1.5mm within 3 months. Once bone is lost, it cannot be naturally replaced and this can cause<br />
complications for tooth restoration work.<br />
2. Width <strong>of</strong> alveolar ridge decreases as much as 50% within 12 months. This can compromise aesthetic and future tooth restoration.<br />
© 2007 <strong>Bio</strong>-Scaffold <strong>International</strong> <strong>Pte</strong> <strong>Ltd</strong>
Key Milestones<br />
E<br />
v<br />
e<br />
n<br />
t<br />
s<br />
•Laboratory In-vitro In-vivo<br />
tests completed<br />
•<strong>Bio</strong>compatibility tests<br />
completed<br />
•Clinical trials started<br />
•Audited for ISO 13485<br />
•MOU Signed with<br />
Saveetha University<br />
India<br />
• Provisional Patent filed<br />
for new manufacturing<br />
process<br />
•Pr<strong>of</strong>essional Enterprise<br />
(Prestige) Award<br />
Dr. Chandra seconded<br />
to company<br />
•Obtained FDA 510k<br />
•Awarded ISO 13485<br />
•Nominated for<br />
NSTA award<br />
•Launched test<br />
marketing in<br />
<strong>Singapore</strong><br />
Dr. Chandra joined the company<br />
as full time staff<br />
Dr. Su Chun Wei seconded to<br />
company<br />
•Clinical Report<br />
Signed<br />
•HSA registration<br />
•CE Certification<br />
Moving<br />
forward<br />
•, Taiwan Registration<br />
•India product<br />
registration<br />
Dr. Florencia & Ms Meiqian seconded to<br />
company<br />
•MOH France Registration<br />
• Test Marketing and<br />
Launch in<br />
• Taiwan<br />
2012/2013Marketing and<br />
Launch in<br />
• Taiwan Q4 2011<br />
Test Marketing<br />
and launch in<br />
India 2013<br />
Year<br />
© 2007 <strong>Bio</strong>-Scaffold <strong>International</strong> <strong>Pte</strong> <strong>Ltd</strong><br />
16
Going Global<br />
• Signed MOU with the Saveetha Medical and<br />
Educational Trust <strong>of</strong> the Saveetha University,<br />
Chennai (“Saveetha”), to collaborate on<br />
developing new applications through clinical<br />
trials<br />
• Joint effort in developing bio-<strong>scaffold</strong>s and<br />
evaluation <strong>of</strong> maxill<strong>of</strong>acial and cranial<br />
reconstructions with the use <strong>of</strong> bio-<strong>scaffold</strong> besides<br />
the clinical evaluation<br />
• Leverage on Sino-Indian ties to reach out to the<br />
global market and explore the development <strong>of</strong> new<br />
processes and applications in bio-<strong>scaffold</strong>s<br />
© 2007 <strong>Bio</strong>-Scaffold <strong>International</strong> <strong>Pte</strong> <strong>Ltd</strong><br />
17
Snapshot <strong>of</strong> design & results<br />
~70% Porosity with strength sufficient to withstand 200<br />
micro-strains<br />
a)<br />
b)<br />
1)<br />
2)<br />
3)<br />
Picture showing the 1) CAD file generated, 2) the<br />
<strong>scaffold</strong> as fabricated and 3) Micro CT <strong>of</strong> Cross<br />
Section showing interconnected porosity in the<br />
<strong>scaffold</strong><br />
c) d)<br />
Comparison <strong>of</strong> bone quality on healing a) micro CT <strong>of</strong> cadaver jaw bone, b)<br />
trabecular bone after healing with <strong>Bio</strong>scaff Alvelac, c) remnants <strong>of</strong> material<br />
using conventional xenograft d) healthy bone after 4 months <strong>of</strong> implanting with<br />
18<br />
<strong>Bio</strong>scaff Alvelac<br />
© 2007 <strong>Bio</strong>-Scaffold <strong>International</strong> <strong>Pte</strong> <strong>Ltd</strong>
Sample 31<br />
Sample 41<br />
Comparison<br />
• 2D XZ plane virtually cross-sectioned images (1.04um pixel resolution)<br />
Sample 31 (Competitor) vs Sample 41 (Alvelac)<br />
Osteocytes seen within sample 41.<br />
© 2007 <strong>Bio</strong>-Scaffold <strong>International</strong> <strong>Pte</strong> <strong>Ltd</strong>
Key Milestones and Moving Forward<br />
ALVELAC Launched<br />
in <strong>Singapore</strong>,<br />
Taiwan and UK<br />
Strategic Research<br />
Partnerships<br />
Registered with<br />
HSA : July 2009<br />
Strategic Research Collaboration<br />
with A STAR for developing the<br />
technology<br />
CE Mark obtained :<br />
Dec 2009<br />
Officially commercialized<br />
in <strong>Singapore</strong> / UK 2010/<br />
Taiwan 2012<br />
Strategic Clinical Collaboration with<br />
1. NUS, <strong>Singapore</strong><br />
2. Saveetha University, Chennai,<br />
India<br />
1.Launch Alvelac 2 for SINUS LIFT<br />
2. Launch ALVELAC Plus for BONE<br />
DEFECT<br />
3. Develop and preclinical testing <strong>of</strong><br />
<strong>scaffold</strong>s/implants for cosmetology<br />
Penetration into<br />
>16% <strong>of</strong> clinics in<br />
<strong>Singapore</strong><br />
Q & M (42 clinics),<br />
Aesthetics Dental,<br />
Smile Dental<br />
Market penetration<br />
into 123 clinics in<br />
<strong>Singapore</strong> ( >16%)<br />
Market seeding in<br />
India / Taiwan with<br />
KOL’s & published<br />
case studies<br />
Launch ALVELAC E (new design for<br />
improving usage experience)<br />
Exclusive rights to<br />
use the IP for 5<br />
years<br />
Exclusive rights to use<br />
the technology in Oral<br />
and Maxill<strong>of</strong>acial<br />
Applications<br />
Exclusive rights<br />
to use the<br />
technology in<br />
cosmetology<br />
Discussion with<br />
SPRING for<br />
potential funding<br />
on cosmetology<br />
development<br />
Launch in Spain and Germany<br />
UK, France<br />
distributors<br />
appointed<br />
MOU signed<br />
Case studies<br />
progressing<br />
Alvelac E under<br />
testing<br />
Patient size 20+ 20 (negative controls) with Cone Beam<br />
CT for assessment <strong>of</strong> height & width preservation and<br />
bone quality<br />
© 2007 <strong>Bio</strong>-Scaffold <strong>International</strong> <strong>Pte</strong> <strong>Ltd</strong><br />
Launch ALVELAC in India, France<br />
20
THANK YOU<br />
www.bio-<strong>scaffold</strong>.com<br />
© 2007 <strong>Bio</strong>-Scaffold <strong>International</strong> <strong>Pte</strong> <strong>Ltd</strong><br />
21
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