Executive Summary
Endotech Corporation is a medical technology company dedicated to improving long term stability
in patients undergoing endovascular aneurysm repair (EVAR). Endotech developed its patented
device, the Endostaple and Delivery System, for securing grafts placed during endovascular treatment
of abdominal aortic aneurysms (AAAs).
Current endografts have a failure rate of 4 – 5% per year. This failure rate is unacceptably high to the
clinical community and the FDA. The ongoing complications are generally related to current design
of endografts which are too rigid compounded by inadequate attachment of endografts to the aortic
wall. The resulting failure, whatever the specific cause, of the graft can lead to re-intervention and
death. Dr. Hugh Trout’s lifesaving solution mechanically secures endografts through stapling and
permanently stabilizes these grafts to the aortic wall. Moreover Dr. Trout’s concept for an improved
and redesigned flexible endograft, securely attached by his patented Endostaple, will prevent deadly
movement, kinking and failure of endografts while creating an even larger market for the Endostaple
itself.
These advancements will help hundreds of thousands of patients with currently unstable grafts and
will create better outcomes for new AAA patients.
Founder and Lead Medical Officer
Hugh H. Trout III, M.D FACS, Founder of Endotech, is a well-known and respected practicing
clinical surgeon with over 40 years of experience in repair of carotids and aneurysms. He holds 13
patents on devices designed to improve treatment of AAA. He is the author of 32 peer reviewed
journal articles and has co-authored two books, Reoperative Vascular Surgery, and, The Basic Science
of Vascular Surgery.
Dr. Trout is the inventor of the Endotech staple. He pioneered its integration with a laser delivery
device and saw game changing results. This integration has the potential to make breakthrough
improvements in helping both past and current AAA patients. These patients need improved and
permanently secure grafts to ensure complete and long-term recovery. Dr. Trout is currently in
private practice. He is a Clinical Professor of Surgery at The George Washington School of Medicine
and at the Uniformed Services University of Health Sciences.
Indication & Market Size
Disease Classification
Abdominal aortic aneurysms are balloon-like enlargements of the aorta formed from the expansion
of the blood vessel wall. This could be as a result of a genetic predisposition, as a consequence of
smoking, aortic infection or atherosclerosis, the hardening and thickening of arteries. If untreated,
the aneurysm is at risk of rupture. Ruptures are fatal in over 85% of cases.
Treatment Challenges
Endovascular aneurysm repair is a minimally invasive technique to repair AAAs. EVAR emerged as
an alternative to open surgical aneurysm repair, but not without complications, including endoleaks
(leakage around the graft) and graft migration from where the new graft is placed. It is this inherent
instability resulting in the 4 – 5% failure rate that turned out to be the dangerous status quo that Dr.
Trout wanted to target and eradicate. While working as a vascular surgeon, Dr. Trout saw an
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opportunity to bring the positive long term clinical results seen in the open surgical procedure to
those of the safer, quicker, and less expensive EVAR procedures by developing his endostaple
technology.
Global Rate of Incidence
There are currently approximately 140,000 patients treated worldwide for AAA on an annual basis.
About 75% of those are treated with EVAR procedures. Added to the re-intervention rate, this
yields approximately 110,000 EVAR procedures worldwide per year that are addressable with the
Endotech device. Experts anticipate that this number will continue to grow by a minimum of 8%
yearly for the foreseeable future. With a projected selling price of $6,000 per Endotech System, this
represents a market size of $660MM in 2014 alone.
Market Breakdown: Total New Cases Per Year
AAA
140,000
EVAR
105,000
75% of all AAA cases
Re-intervention
5,000
4 - 5% of all EVAR cases
Endostaple
110,000
EVAR + Re-intervention
Total MKT Size ($6K/case): $660,000,000
When coupled with Dr. Trout’s redesigned endograft that requires the Endostaple, the market for
the Endotech System increases even more. It also spawns a sizable new market (>$1B) for newly
designed endografts.
Endotech Product
Endostaple Saves Lives
Unlike other technologies, the Endostaple can attach any endograft to the full thickness of any aorta,
including even heavily calcified aortas. This is accomplished using Endotech’s proprietary delivery
system. The system delivers the Endostaple to the site over an optical fiber and uses a medical laser
to burn a precise, clean small hole through the graft and the aortic wall as the staple is simultaneously
inserted and deployed. The ability to reach a wider audience greatly expands the technology’s
potential commercial impact and the number of lives saved.
Current Endografts
Current endografts are not securely attached to the full thickness of the aorta. Moreover, these
endografts have an ongoing failure rate of 4 – 5% per year. More secure attachment will allow better
design of endografts in a manner that will transform treatment of almost all abdominal aortic
aneurysms.
Preclinical Development
Dr. Trout raised $8M to bring the Endotech technology through design and the early pre-clinical
development, completing an FDA approved calf study. Given the results, the FDA encouraged the
company to move forward as quickly as possible to overcome deficiencies in current AAA graft
devices. The company has secured FDA approval to insert Endostaples in 15 patients in a
preliminary study as soon as clinical Endostaple Systems are built and validated. The regulatory path
to commercialization will be through the 510(k) regulations.
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