Gastro.org 2013 Education Meeting

MAGNAMOSIS, INC
Anastomosis Market
1.5 billion
Sutures and Staples
MAGNAMOSIS
Easier
Faster
Better
Cheaper X 10
•
Identical radii (1”) convex / concave
surface design to allow self-orienting
mating via MIS technique
Sutures
Magnamosis
Staples
Surgical
Technique
Open
Laparoscopic
Open
Laparoscopic
Open
Laparoscopic
Endoscopic
SILS / NOTES
Ease of Use
OR time
High skill
30-60 min
Moderate skill
20-40 mins
Multiple skills
10-30 min
Quality
Strength
(vs leak)
Highly Variable
Burst 40-100 mmHg
Uniform
Burst 40-120 mmHg
Uniform
Burst 60-120mmHg
Cost
$
Suture type + time
$$$$
COGS high
$
COGS low
---Initial design: rare earth magnet rings encased in teflon
---Geometry of mating surfaces: gradient vs flat
---Open surgery in 16 pigs: magnamosis vs suture vs staples
---Magnamosis ≥ Sutures / Staples
---optimized design: 2 symetric, self align, concave-convex, polycarbonate
---Endoscopic / Laparoscopic in 21 pigs
---All anastomoses patent, well healed at 1-6 weeks
---excellent burst strength ≥ staples
• Magnamosis III: Delivery of a Magnetic
Compression Anastomosis Device Using
Minimally Invasive Endoscopic Techniques
•
Kelly D. Gonzales MD1†, Geoffrey Douglas, MD2†, Kullada O. Pichakron, MD2, Dillon
A. Kwiat, BS1, Salvador Guevara Gallardo, MD1, Jose Luis Encinas, MD1, Shinjiro
Hirose MD1, and Michael R. Harrison MD1
Redesigned Device to accommodate Standard Endoscopic Snare
Endoscopic / Laparoscopic Delivery technique tested in 8 pigs
Duodeno-colic Anastomosis well healed at 1-6 weeks
MAGNAMOSIS IV:
Magnet Compression Anastomosis
for minimally invasive colorectal surgery
J. Wall, M. Diana, J. Leroy, V. DeRuijter, KD. Gonzales, V. Lindner,
M. Harrison, J. Marescaux
Hybrid NOTES technique 11 pigs
Distal colon resection and anastomosis
Side-to-Side vs End-to-Side
Well healed colon anastomosis
At 10 days
Pure NOTES® transgastric and transrectal
sigmoidectomy withMagnetic compression
anastomosis (MAGNAMOSIS™)
in a porcine model.
Proof of concept (with video)
Joël Leroy MD, FRCS; Silvana Perretta MD; Michele Diana MD;
James Wall MD;Veronique Lindner MD, PhD;Michael Harrison MD, FACS
; Jacques Marescaux MD, (Hon) FRCS, (Hon) FACS, (Hon JSES)
IRCAD/EITS, Department of General, Digestive and Endocrine Surgery,
University Hospital of Strasbourg.
Surgical Stapler Market
• Worldwide $ 1.2 Billion (US $ 0.5 Billion)
• Annual Growth 9.6 %
• $ 1.55 Billion by 2014
• Covidien / Ethicon Dominate Market
• Enabling Technology MIS, SILS, NOTES
• COGS $ 180
Price $ 400- $ 800
MAGIC
Magnetic Anti Glycemic Ileal Conduit
Minimally Invasive Outpatient Procedure
for Type II Diabetes Mellitus
Type II Diabetes Mellitus
“Metabolic Syndrome”
“Insulin Resistence”
USA
24 Million Patients
$ 174 Billion / year
MAGIC
Clinical Rational
Bariatric Surgeries treat Diabetes
(metabolic syndrome) independent of
weight loss
Scott W R , Batterham R L Am J Physiol Regul Integr
Comp Physiol 2011;301:R15-R27
©2011 by American Physiological Society
MAGIC
Experimental
Rational
“Shortcut” for upper GI
secretions (gastric-biliarypancreatic)
to distal Ileum reverses
diabetes (metabolic
syndrome)
???? How make MAGIC ???
(Magnetic Anti-Glycemic Ileal Conduit)
MAGNAMOSIS MAKES “MAGIC”
Magnetic Compression Anastomosis Device
Magnamosis
IP
• US patent # 8,142,454 granted 3/27/2012
Filed Aug 11, 2008
CIP to 10/954,995 filed Sept 29, 2004
• Exclusive license from UCSF Oct 6, 2008
UCSF Royalty 2 % of Sales
Sublicense Magnamosis, Inc Dec 16,
2011
Magnamosis FTO
• Cope: patent # 5,690,656 June 27, 1997
– Ring magnet compression anastomosis
– Mating surfaces flat (no gradient)
• Cook Medical portfolio
– Double/triple barrel magnets over guidewire
– Stents to prevent stricture
– Delivery devices
Regulatory: FDA
• 510 (k) Predicate: NITI Compression
Anastomosis Ring (CAR)
– Filed Feb 2011
– Response May 2011
– Hired regulatory consultant (Secure Biomed
Evaluations/ Atlanta)
– Completed all required testing Sept 2011
– FDA requires GLP animal study March 2012
Regulatory: CE Mark
• Working with Regulatory Consultant
– Developing Quality System ISO 13485
– Literature Search
– Device Safety : Animal GLP protocol
– Select Notifying Body
– First -in-Human Collaboration IRCAD / Strasbourg