Developing Novel Bone Cements - The Trendlines …...bone biopsy included when performed) using...
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Developing Novel Bone Cements January 2020 Company Presentation
Transcript of Developing Novel Bone Cements - The Trendlines …...bone biopsy included when performed) using...
Developing Novel Bone Cements
January 2020
Company Presentation
Legal disclaimer
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IMPORTANT NOTICE
This presentation has been prepared by Setbone Medical Ltd. (the “Company”) solely for informational purposes. The information contained herein has been prepared to assist prospective investors in making their own evaluation of the Company and does not purport to be complete or to contain all of the information a prospective or existing investor may desire. In all cases, interested parties should conduct their own investigation and analysis of the Company and the data set forth in this information. The Company has prepared this presentation based on information available to it, including information derived from public sources that have not been independently verified. The Company makes no representation or warranty as to the accuracy or completeness of this information and shall not have any liability for any representations (expressed or implied) regarding information contained in, or for any errors omissions in, this presentation. This presentation includes certain statements and estimates provided by the Company with respect to the projected future performance of the Company. Such statements, estimates and projections reflect various assumptions by management concerning possible anticipated results, which assumptions may or may not be correct. No representations are made as to the accuracy of such statements, estimates or projections. This presentation may contain statements that are not historical facts, referred to as “forward looking statements.” The Company’s actual future results may differ materially from those suggested by such statements. No assurance can be given that future events will occur or that projections will be achieved. Past performance is not a reliable indication of future performance. This presentation is not, and nothing in it should be construed as, an offer, invitation or recommendation in respect of the Company’s securities, or an offer to sell, or a solicitation of an offer to buy, the Company’s securities in any jurisdiction. Neither this presentation nor anything in it shall form the basis of any contract or commitment. Prospective investors should not construe the contents of this presentation as business, legal, tax, investment or other advice. Each prospective investor should make his, her or its own inquiries and consult his, her or its own advisors as to the appropriateness and desirability of an investment in the Company and as to business, legal, tax and related matters concerning an investment in the Company.
An investment in the Company shall be allowed only to such number and category of investors in accordance with applicable laws and regulations and pursuant to a predetermined process. Accordingly, detailed information in connection with the investment shall be revealed and delivered only to a limited number of qualifying investors as provided by law.
SetBone Medical - Who We Are
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What we do
Developing novel PMMA (Poly methyl methacrylate) based bone
augmentation cement for use in various applications in orthopedic procedures.
First application; Vertebral Compression Fractures (VCF) treatment.
What stage
Working product made of final materials.
Tested on cadaver.
Next milestones: V&V, FIH.
Investors
The Trendlines Group
Israel Innovation Authority
Confidential
SetBone Team
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Dr. Royi KaufmannPh.D, CEO and Co-Founder
Managerial and R&D experience developing polymeric-based products
Ph.D., physical chemistry, Weizmann Institute of Science; M.A., biotechnology, Tel-Aviv University
Nimrod Kaufmann Co-Founder
Founder and CEO, Inspiro Medical Ltd., acquired by Opko Health Inc.; 15+ years’ medical device and orthopedic implant development
B.Sc. mechanical engineering, Ben-Gurion University of the Negev
Dr. Ely AshkenaziClinical Advisor
Expert in spinal neurosurgery, deputy director of the Center for Spine Surgery of Medical Center “Assuta”
M.D. Hebrew University, Jerusalem;practiced in neurosurgery of spine,Montefiore Hospital, NY, U.S.
Osteoporosis and Vertebral Compression Fractures
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Osteoporosis leads to 1.5 million fractures each year in the United States. 750,000 are vertebral compression fractures
1 in 2 women and 1 in 5 men over the age of 50 will have osteoporosis
Normal Osteoporosis
Vertebral Compression Fractures
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Osteoporotic vertebra loses strength and collapses (VCF).
VCF causes spinal deformity and pain.
In many cases conservative treatment does not help.
More than 100,000 VCF’s are invasively treated in the US
every year1.
1. Balloon Kyphoplasty Market Share,Size 2019 - 2025 Global Insights
State Of The Art Invasive Treatments for VCF
7Balloon insertion Balloon Inflation Cement injection Bone Stabilization
Vertebroplasty
Injection of a liquid bone cement into fractured vertebra
Kyphoplasty
Insertion and inflation of a balloon into vertebra to create void,
prior to injecting a liquid bone cement,
to create a cavity and restore disc height
Main Disadvantage of Current Cement;High Risk of Cement Leakage
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Cement leakage into disc space.2
Increases risk of new fracture of adjacent vertebral bodies.
Cement extravasation into the epidural or foraminal space. 3
Risk of paraplegia due to cement leakage. 2,3
Pulmonary embolism. 2,3
In rare cases can lead to cardiac perforation
1. Edward P. Lina, Sven Ekholma; Cement Leakage into the Disc Increases the Risk of New Fracture of Adjacent Vertebral Body, AJNR 2004 25: 175-180
2. Aykut Akpinar, Necati UclerEmail; Cement leakage and complication of liposarcoma spinal metastasis during vertebral augmentation procedure: a case report, Journal of Medical Case Reports2016
3. Ann Saudi Med. 2011 May-Jun; 31(3): 294–297.
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Additional Disadvantages of Current PMMA Cement
Very limited time for proper cement filling,
need to complete cement injection in few minutes, before
hardened, while safely confirm that there is no leakage.
requires on-site preparation and starts hardening right
after mixing
Cement properties changes constantly,
makes it more difficult for surgeons to work with.
The SetBone Bone Cement
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PMMA based bone cement,
with two phases of solid:
Initial phase
Ready to use (no mixing needed),
flexible amorphous solid filler.
Final phase
Fully hardened after exposed to body
temperatureR
ead
y to
use
Flex
ible
So
lid
Stiff S
olid
37oC
SetBone Cement Delivery
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Kyphoplasty procedure performed as today.
Same instrumentations. Same approach.
SetBone cement, ready-to-use pre-filled
delivery system (bone filler), packed in a
sterile blister tray.
No preparations required.
Bone Filler
SetBone Cement
SetBone Cement Advantages
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Reduce risk of leakage.
No working time limitations. Surgeon can work safely and
achieve good vertebral filling.
Ready to use. No on site preparation needed.
Consistent material properties during injection.
Same procedure. Same approach. Same access tools.
Low polymerization heat; no damage to tissue.
The SetBone cement as a platform
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Potential products
Kyphoplasty/Vertebroplasty
Fenestrated screw cement augmentation
Bone void filler
Potential technologies
3D printing
Integrate with robotics
Regulatory Pathway
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A 510(k) with clinical study route. Based on a
Q-Sub and discussions with the FDA.
Kyphoplasty SystemsMarket and Forecast ($m)
15Source: Meddevicetracker; Spinal Motion Preservation Devices US, 5EU Markets, Japan, and RoW, April 2018
Kyphoplasty Systems MarketShare by Supplier ($M); 2017
16Source: Meddevicetracker; Spinal Motion Preservation Devices US, 5EU Markets, Japan, and RoW, April 2018
The Others category includes Aegis Spine, Alphatec Spine, Becton Dickinson, CookMedical/Cook Group, Heraeus Medical/Heraeus Holding, Joline, Merit Medical, Panmed,Spine Wave, Tecres Medical, and Teknimed, among others.
Company Product
DePuy Synthes/Johnson & Johnson
Synflate
Globus Medical Affirm
Medtronic Kyphon BalloonKyphoplasty Platform
Stryker IVAS
Reimbursement Codes in Place
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CPT Code DescriptionOutpatient
hospital
Physician
Office
Kyp
ho
.
22524 Percutaneous vertebral augmentation, including cavity creation (fracture reduction and
bone biopsy included when
performed) using mechanical device, 1 vertebral body, unilateral or bilateral
cannulation (e.g., kyphoplasty); Lumbar including imaging
$6,750 $7,604
+22525 each additional thoracic or lumbar
vertebral body, including imaging
$3,364 $4,756
Ve
rte
bro
. 22511 Percutaneous vertebroplasty (bone biopsy included when performed), 1 vertebral body,
unilateral or bilateral injection, inclusive of all imaging guidance; lumbosacral
$2,862 $4,135
+22512 each additional thoracic or lumbar vertebral body $218 $975
Overall cost for procedure up to $13,000.1
1. Cost utility analysis of balloon kyphoplasty and vertebroplasty,The University of Toledo Digital Repository, 2013.
