EZECH
BONE
®
The hand of the Lord was on me, and he brought me out by the Spirit of the Lord and set me in the middle of a valley; it was full of bones.. bones that were very dry. He asked me, “Son of man, can these bones live?”.. Then he said to me, “Prophesy to these bones and say to them, ‘Dry bones, hear the word of the Lord! This is what the Sovereign Lord says to these bones: I will make breath enter you, and you will come to life.. Then you will know that I am the Lord.’” So I prophesied as I was commanded. And as I was prophesying, there was a noise, a rattling sound, and the bones came together, bone to bone.. and tendons and flesh appeared on them and skin covered them.. Then he said to me, “Prophesy to the breath; prophesy, son of man, and say to it, ‘This is what the Sovereign Lord says: Come, breath, from the four winds and breathe into these slain, that they may live.’” So I prophesied as he commanded me, and breath entered them; they came to life and stood up on their feet- a vast army. [Ezekiel 37: 1-10]
Ezechbone®
Granule
&
Ezechbone®
Cement
Specially Designed for Medical Applications
Codeveloped by NCKU/JMD
National Cheng-Kung University
Joy Medical Devices Corp
ISO13485, GMP, MOEA-Certified Biotech Company
Jiin-Huey Chern Lin
Northwestern University Biological materials Ph.D.
Academic
National Cheng-Kung University (NCKU) Dept. of Materials Sci. and Engineering/ Professor; Center for Biomaterials Research/ Director, Tainan, Taiwan
Northwestern University Dept. of Biological Materials/ Assistant Professor; Dept. of Materials Science/ Visiting Professor, Chicago, Illinois, USA
National Yang Ming Chiao Tung University, School of Dentistry/ Visiting Specialist, Taipei, Taiwan.
Industrial collaborations
Joy Medical Devices Corp. President/Technology Founder, Taiwan South Science Park, Kaohsiung, Taiwan
International journal publications and patents
100+ SCI papers, 70+ US patents, 100+ non-US patents
Tel: +886-6-275-4412
Email: chernlin@mail.ncku.edu.tw
Chien-Ping Ju
Marquette University Materials Science Ph.D.
Academic
NCKU Dept. of Materials Sci. and Engineering/ Professor
University of Illinois at Urbana-Champaign, Senior Researcher, Urbana-Champaign, Illinois, USA
Southern Illinois University, Senior Scientist/ Adjunct Professor, Carbondale, IL, USA
Industrial collaborations
Joy Medical Devices Corp. Technology Founder/ CTO
Kawasaki Steel/ Visiting Research Professor- Development of advanced carbonaceous heat shields for space shuttle, Chiba, Japan
Corium Corp./ Operations Manager- Development of Tokamak fusion reactor first-wall material, Champaign, IL, USA
International journal publications and patents
100+ SCI papers, 70+ US patents, 100+ non-US patents
Tel: +886-6-275-4412
Email: cpju@mail.ncku.edu.tw
2018
Ezechbone® Technology received International Outstanding Inventor Award
-The highest biotechnology award
(國際傑出發明家獎最高生技大賞)
(國際傑出發明家獎最高生技大賞)
2022
NCKU Materials Research and Physician Team received
The 19th National Innovation Award (國家新創獎)
The 19th National Innovation Award (國家新創獎)
2024 & 2025 received National Innovative Improvement Award
(國家新創精進獎)
(國家新創精進獎)
Why is
Ezechbone® Granule
the top choice as a bone substitute material?
Ezechbone® Granule CBS-400, a Ca-based bone regeneration material with a delicate design in chemistry, micro and nano-scaled structure and morphology, is co-developed by National Cheng-Kung University (NCKU) Innovation Headquarters Center for Biomaterials Research (CBR) and Joy Medical Devices Corporation (JMD), an ISO 13485, GMP and MOEA-certified Biotech and New Pharmaceutical Company located at South Science Park, Kaohsiung, Taiwan.
CBS-400 is a fully synthetic, inorganic and 100% bioresorbable bone graft material without any content of animal or human source. The implant device has been approved for clinical use for orthopedic and dental applications by TFDA. Thanks to its unique performance, CBS-400 is further approved for exclusive use for treating the challenging intraarticular and periarticular fractures.
The delicately and proprietarily-designed CBS-400 is featured by its outstanding multi-efficacies in hemostasis, suppressed-inflammation, enhanced-bone regeneration, and being substantially free from post-op adhesion and abnormal bone formation or synostosis. To our knowledge, Ezechbone® Granule CBS-400 is currently the only bone graft material that combines all these crucial factors- for a successful surgery involving bone healing- in one single product!
Ezechbone® Granule CBS-400 has demonstrated a superior hemostatic efficacy, supported by the consistently-observed hemostatic performance in 1000+ clinical cases in sternotomy, spine, orthopedic, plastic and dental surgeries conducted in NCKUH and dental clinics. For rather complicated sternotomy cases, the application of CBS-400 may drastically reduce the bleeding of patients, wherein the total POD-1 chest drainage may be reduced by as much as 80% than the average POD-1 drainage under similar conditions conducted at the same hospital.
Rabbit implantation study reveals that CBS-400 causes less inflammation than the so-called “gold standard” autologous bone graft (Autograft) all the time from 4W to 12W post-implantation. Inflammation-related cells or fibrous tissues at implant-new bone interface are rarely observed in CBS-400-implanted area, while numerous inflammation cells are frequently observed in autologous bone-implanted site.
Head-to-head comparison in early-stage (1W, 2W) inflammatory response further shows that CBS-400 induces much less inflammatory response than Autograft. The comparison in very-early-stage (30 min) inflammatory response among Sham, Ezechbone® Granule CBS-400 and other commercial Ca-based graft materials implanted in rat tibia, again, demonstrates the much less inflammatory responses induced by CBS-400 than Sham and other commercial products.
Being a 100% inorganic, synthetic Ca-based material without any organic source, Ezechbone® Granule CBS-400 demonstrates outstanding osteoinductive features and at the same time substantially avoiding any negative effects, such as disease transfer and inflammatory reactions commonly observed in organic/osteoinductive products such as BMP and DBM.
Histopathological examinations show that CBS-400 takes a short-cut healing route by substantially bypassing the traditionally-suggested inflammatory healing path, while quickly and directly facilitating new bone formation throughout entire implantation site, even in deep interior of surgically-created bone void as early as 1W post-implantation, demonstrating a unique osteoinductive efficacy.
CBS-400 always integrates seamlessly with surrounding bone tissue substantially without triggering inflammatory or other undesired tissue reactions. Fibrous tissues are rarely observed at implant-bone interface.
During bone healing process, CBS-400 induces new bone formation much faster than even the “gold standard” autologous bone graft by as much as >15 times at 1W and >5 times at 2W post-implantation. At 12W, the osseointegration process is nearly complete.
Major synthetic bone substitute products on the market have certain potential disadvantages, such as inconsistent biocompatibility, resorbability and material properties, and the risk of inducing ectopic bone formation or abnormal synostosis. Ezechbone® Granule CBS-400 is ideal for treating acute and non-union intraarticular and periarticular fractures, wherein adhesion is often a serious threat. The implanted CBS-400 granules contacting bone cause fractures to fast heal. Among soft tissues, CBS-400 is naturally absorbed substantially without causing inflammation or other side effects such as abnormal bone growth and callus formation. Clinically CBS-400 has demonstrated excellent intra/peri-articular fracture healing and avoiding abnormal ectopic bone formation or synostosis in both acute and non-union cases conducted at NCKUH. This TFDA-approved specialty-use product (exclusively for treating intraarticular/periarticular fractures) distinguishes itself from all major competitors for this challenging indication.
Osteoporosis has been a major worldwide public health issue. 40% in women and 15% in men older than 50 might suffer from one of osteoporosis-related fractures. In an osteoporotic goat spine implantation study, CBS-400 demonstrates a high potential of treating osteoporotic bone voids and fractures. The CBS-400-induced new trabecular network becomes much denser than osteoporotic control goat and comparable to healthy control goat. The CBS-400-induced trabecular architecture recovers to the normal level at 6M post-implantation without signs of osteoporosis-related delay in bone maturing process.
Too good to be true?
But it’s true!
Ezechbone® Granule—Intraarticular and Periarticular Fractures
is ideal for treating acute and non-union joint fractures. The implant contacting bone causes the bone to fast heal, while the implant contacting soft tissues is naturally dissolved without causing inflammation or other side effect.
TFDA approval number: 衛部醫器製字第 007722 號
Ezechbone® Granule studies
Ezechbone® Cement
Unique Features
Ezechbone® Cement CBC-400 is an
all synthetic, inorganic and fully resorbable calcium-based
cement material without any content from human or animal source.
Without adding any polymeric or additives, Ezechbone® Cement CBC-400 is nondispersive when contacting blood/body fluid and able to harden in-situ under fluid containing environment, avoiding the dangerous cement leak/cement embolism risks. Its setting mechanism involves fast growth of different types of Ca-based nano-sized whiskers with specific preferred orientations bridging individual Ca-based particles at the very early stage.
When implanted in rabbits, CBC-400 is always intimately integrated with surrounding bone and eventually replaced by the natural, newly-formed bone substantially without triggering inflammatory or other undesirable tissue reactions. Fibrous tissues are rarely observed at implant-bone interface.
Comparison in 45 min post-op inflammatory reactions in rats between Ezechbone® Cement CBC-400 and sham control show that the overall inflammatory reaction of CBC-400 group is drastically less than sham.
CBC-400 can be safely and effectively delivered into deep surgical sites using JMD’s proprietary minimally invasive cement delivery system, JBranch ™, especially for spine surgery.
Nondispersive behavior of Ezechbone® Cement
Ezechbone® Cement paste directly injecting in water after mixing for 1 min
demonstrates its unique nondispersive characteristic
to largely reduce cement embolism risks.
Two specific spine applications are emphasized:
(1) Spinal fusion
Ezechbone® Cement CBC-400 may be either injected into cage cavity prior to insertion of the cage into spine, or injecting in-situ using an endoscope. The unique performance of CBC-400 in spinal fusion, including its nondispersive behavior during setting in blood/body fluid,
has now made this practice a routine at NCKUH.
(2) Adjacent vertebral fracture (AVF) preventive treatment
Why preventive?
It is reported that, although more than 50% of primary spinal surgeries are “considered successful”,
no more than 30%, 15%, and 5%
of the patients experience a successful outcome after the second, third, and fourth surgeries, respectively.
Other rather shockingly studies have suggested that having first VCF can drastically increase the risk of future VCFs. For example, Lindsay et al. reported that having 1 or more VCFs leads to a 5-fold increase in the patient’s risk of developing another vertebral fracture. Other studies indicate that
having 1 compression fracture increases the risk of another compression fracture by 5-fold, and having 2 or more compression fractures increases the risk of having another fracture by a staggering 12-fold!
Combining unique properties and clinical performance of Ezechbone® Cement CBC-400 and the brilliant minimally-invasive delivery system, Ezechbone® Cement-Spine & JBranchTM Cement Dispenser Kit has been approved to market by TFDA as a specialty device for use in spine surgery. The Kit is ideal for use in various spinal surgeries, such as acute-stage or nonunion vertebroplasty, spinal fusion, preventive OVCF/AVF, repair/ rescue of a failed surgical procedure often resulted from a prior malfunctioned implanted device and/or the failure of a PMMA bone cement treatment.
In a safe, conservative and minimally-invasive way, Ezechbone® Cement-Spine & JBranchTM Cement Dispenser is especially ideal to treat an elderly and/or highly osteoporotic patient with chronic, persistent back pains or under a health condition inappropriate for a major spine surgery.
TFDA approval number: 衛部醫器製字第006193號
In 2019, 10 consecutive vertebral compression fracture patients, all happened to be elderly female, with an average age of 79.6±8.9 y/o were collected. Out of the 10 patients, 5 (50%) had prior osteoporotic vertebral fractures. The underlying diseases of the patients included chronic kidney failure, end-stage renal disease (ESRD), hyperparathyroidism, bladder cancer, multiple myeloma, chronic heart failure, adrenal or thyroid insufficiency, Parkinson’s disease, and vertebra-basilar insufficiency, among others. All these patients belong to a patient group with multiple comorbidities. Osteoporosis of these patients was quite serious, with an average T-score of -3.84±0.94 based on BMD scans.
The surgery involved performing a conventional vertebroplasty by injecting PMMA bone cement into the fractured vertebra to provide an immediate load-bearing capacity and relieve the patient’s pain, and, at the same time, strengthening the adjacent vertebrae with Ezechbone® Cement CBC-400 in attempt to reduce the risk of future AVF. CBC-400 cement was delivered using a proprietary minimally invasive cement delivery system, JMD JBranchTM system. Each patient was followed up for at least 1 year, and the longest being tracked for nearly 6 years. The average follow-up time was 2.83±1.87 years. 6 of these 10 patients had passed away due to unrelated causes.
From the records traced, NONE of these patients had ever encountered any new fracture in the adjacent vertebrae that were filled with Ezechbone® Cement CBC-400. Based on this result, it can be seen that preventively strengthening adjacent osteoporotic vertebrae with Ezechbone® Cement CBC-400 during conventional PMMA vertebroplasty for OVCF can effectively reduce the risk of future adjacent vertebral fractures.
Ezechbone® Cement studies
Joy Medical Devices Corporation
喜樂醫療器材股份有限公司
Global HQ: 1F., No.63, Luke 2nd Rd., Luzhu Dist., Kaohsiung City 821, Taiwan (R.O.C.)
Local Address: 高雄市路竹區路科二路63號1樓
Tel: +886-7-695-5637 (ext. 20)
Fax: +886-7-695-5639
Email: 37c.jmd@gmail.com