Lume Medical is developing a percutaneous vascular closure device for large bore procedures to address the unmet clinical need of closing femoral access in patients with severely calcified arteries. Their device utilizes a suture-based approach similar to the validated surgical fascia suture technique. The company is seeking $1.5 million in seed funding to support initial product development and a first-in-human clinical study.

1. Lume Medical Limited
Team
Eric Kramer, PhD
Vivian de Ruijter, MD
Katie Blevins, MD, PhD
Coulter Investment Forum
2019-10-21
eric@lumemedical.com

2. Large Bore Endovascular Procedures
VISION | NEED | TECHNOLOGY | PROGRESS | COMPETITION | IP | MARKET | BUSINESS STRATEGY | MILESTONES | TEAM
The Lume Vision: Standardizing percutaneous femoral vascular closure
Transcatheter Aortic Valve Replacement
(TAVR)
Endovascular Aneurysm Repair
(EVAR)

3. Patients with severely calcified arteries have no minimally invasive closure option!
Clinical Need
VISION | NEED | TECHNOLOGY | PROGRESS | COMPETITION | IP | MARKET | BUSINESS STRATEGY | MILESTONES | TEAM
Aging Population
132 Million >50 by 2030
U.S. Census Bureau, 2014
Open Surgery Minimally Invasive
Require percutaneous femoral access
Vascular Calcification
Complicates Access & Closure
2/3 patients display moderate-severe Ca2+
Hirsch, et al Circulation 2006
Increased Cost & Patient Impact
Hospital stays ≥ 1 day longer

4. Problem Statement
VISION | NEED | TECHNOLOGY | PROGRESS | COMPETITION | IP | MARKET | BUSINESS STRATEGY | MILESTONES | TEAM
S
N/A IN
CALCIFIED ARTERIES
due to needle deflection, vessel
dissection, and vessel tear. Can be
used by vascular surgeons,
interventional radiologists, and
interventional cardiologists
MINIMALLY INVASIVE
PERCUTANEOUS
CLOSURE
GOLD STANDARD
requires a surgeon, negatively
impacts patient's postoperative
recovery, and increases length
of hospital stay and associated
costs
SURGICAL
CUTDOWN
SURGICAL FASCIA
SUTURE TECHNIQUE
BAIL-OUT METHOD
currently requires a surgeon, but
offers benefits of not having to do a
full surgical cutdown by positively
impacting patient’s recovery and
decreasing length of hospital
stay/associated costs
Current Closure Technology is Limited

5. Fascia Suture Technique Clinical Insight & Surgical Predicate
VISION | NEED | TECHNOLOGY | PROGRESS | COMPETITION | IP | MARKET | BUSINESS STRATEGY | MILESTONES | TEAM
2. Place u-stitch around sheath 3. Remove sheath1. Locate fascia

6. Clinical Insight: Validated Technology
VISION | NEED | TECHNOLOGY | PROGRESS | COMPETITION | IP | MARKET | BUSINESS STRATEGY | MILESTONES | TEAM
Low Risk Solution
Conversion from surgical to percutaneous technology
Technical aspect designed for ease of use, predictability,
reproducibility, and accuracy
100%
SUCCESS
RATE
2006
Larzon
J Endovasc
Ther
2011
Harrison
Eur J Vasc
Endovasc Surg
2011
Montan
J Endovasc
Ther
2012
Mathisen
J Endovasc
Ther
2014
Dziekiewicz
Wideochir Inne
Tech
2015
Larzon
Eur J Vasc
Endovasc Surg
2016
Bountouris
Int Angiol
50%
Surgical Fascial Suture Technique
First described in 1996 by Ted Dietrich, MD at Arizona Heart Institute
Published in 7 peer reviewed articles with an average impact factor of 3.1
Clinically validated in 8+ countries in the EU and North America
Actively practiced in 3 centers in the US
CURRENT TECHNICAL SUCCESS RATE OF 96%
SURGICAL FASCIA
SUTURE TECHNIQUE
Clinically validated in
709ARTERIES
Our Approach
PERCUTANEOUSSURGICAL
>>>

7. Device Innovation (Open) Surgical Predicate Percutaneous Closure
VISION | NEED | TECHNOLOGY | PROGRESS | COMPETITION | IP | MARKET | BUSINESS STRATEGY | MILESTONES | TEAM

8. Competitive Landscape
VISION | NEED | TECHNOLOGY | PROGRESS | COMPETITION | IP | MARKET | BUSINESS STRATEGY | MILESTONES | TEAM
TRANSARTERIAL
SUTURE-BASED
ENDOVASCULAR
LARGEBORECLOSURE
(10-24French)PRODUCTS
MECHANISM
TRANSARTERIAL
PLUG-BASED
UNIQUE COMPETITIVE
ADVANTAGE
⃘ Over-the-sheath closure
⃘ No pre-procedure placement required
⃘ No foreign bodies left intra-arterial
⃘ Works with vessel calcification and varying
anatomy addressing the aging
population’s clinical
needs and allowing for
faster recovery and
return to daily activities
PRODUCT
BaroStitch
SMALL
BORE
LARGE
BORE
CALCIFIED
EXTRA-
ARTERIAL
RE-
ACCESS
VASCULAR
CONTROL
SINGLE
DEVICE
LIMITATIONS
⃘ Steep learning curve
⃘ Technical failure in calcified vessels due to
needle deflection, vessel dissection, or
vessel tearing → may lead to an increased
complication rate and length of hospital stay
⃘ Requires pre-procedure placement, which
may delay emergency
interventions
PRODUCTS
Abbott Prostar® XL
Abbott PerClose Proglide®
SMALL
BORE
LARGE
BORE
CALCIFIED
EXTRA-
ARTERIAL
RE-
ACCESS
VASCULAR
CONTROL
SINGLE
DEVICE
SMALL
BORE
LARGE
BORE
CALCIFIED
EXTRA-
ARTERIAL
RE-
ACCESS
VASCULAR
CONTROL
SINGLE
DEVICE
LIMITATIONS
⃘ Intra-arterial foreign body left post-
deployment → may lead to increased
stenosis, infection, and embolism rate
⃘ Limited opportunity to re-access same
location for future
potential endovascular
procedures
PRODUCTS
Essential Medical MANTA™
Vivasure Medical PerQseal®
InSeal Medical InClosure
NO-TOUCH
SUTURE-BASED

9. Modeling & Device Evaluation
VISION | NEED | TECHNOLOGY | PROGRESS | COMPETITION | IP | MARKET | BUSINESS STRATEGY | MILESTONES | TEAM

10. Regulatory Landscape
MARKET ASSESSMENT | REGULATORY PATHWAY | CLINICAL / EVIDENCE DEVELOPMENT PLAN | REIMBURSEMENT | COMMERCIALIZATION PLAN
●
●
●
○
○
○
●
●
●
Applicant Decision Date Device
VASORUM LTD 2016/07/20 CELT ACD VASCULAR CLOSURE DEVICE
REX MEDICAL, L.P. 2016/02/12 CLOSER VASCULAR SEALING SYSTEM
CARDIVA MEDICAL, INC. 2013/01/31 VASCADE VASCULAR CLOSURE SYSTEM
Cordis Corporation 2011/05/19 CORDIS EXOSEAL VASCULAR CLOSURE DEVICE
Cardiva Medical, Inc. 2010/04/08 QUICK-CLOSE VASCULAR SUTURING SYSTEM (QUICK-CLOSE SYSTEM)
MORRIS INNOVATIVE RESEARCH
INC
2007/08/20 FEMORAL INTRODUCER SHEATH AND HEMOSTASIS (FISH) DEVICE 5,6, AND 8 FRENCH
ABBOTT VASCULAR DEVICES 2005/12/21 STARCLOSE VASCULAR CLOSURE SYSTEM
ACCESS CLOSURE, INC. 2005/08/17 MATRIX VASCULAR CLOSURE SYSTEM (VSG)
Medtronic Vascular 2004/11/03 ANGIOLINK VASCULAR CLOSURE SYSTEM
St. Jude Medical, Inc. 2003/09/30 X-PRESS 6 FRENCH VASCULAR CLOSURE SYSTEM
SUB-Q, INC. 2002/03/25 QUICKSEAL FEMORAL ARTERIAL CLOSURE SYSTEM
Vascular Solutions, Inc. 2000/06/22 VASCULAR SOLUTIONS DUETT SEALING DEVICE
ABBOTT VASCULAR INC. 1997/04/30 PROSTAR 9 FR. PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM
TERUMO MEDICAL CORPORATION 1996/09/30 Angio Seal Vascular Closure Device
St. Jude Medical, Inc. 1995/09/29 VASOSEAL (TM)

11. Market Current
VISION | NEED | TECHNOLOGY | PROGRESS | COMPETITION | IP | MARKET | BUSINESS STRATEGY | MILESTONES | TEAM
60%
40%
512,000+
Procedures Breakdown Procedures
70%
30%
Beachhead Market
+150,000

12. Market Projected
VISION | NEED | TECHNOLOGY | PROGRESS | COMPETITION | IP | MARKET | BUSINESS STRATEGY | MILESTONES | TEAM
70%
30%
•

13. Business Strategy
VISION | NEED | TECHNOLOGY | PROGRESS | COMPETITION | IP | MARKET | BUSINESS STRATEGY | MILESTONES | TEAM
HOSPITAL
INCENTIVE
Current procedures are covered
by a lump-sum (DRG) payment
On average, hospitals lose
$5,940+
per EVAR/TAVR case
HOSPITAL VALUE
PROPOSITION
Converting surgical
cut-down to percutaneous closure
Saves Hospitals
$2690
per hospital day
saved
BUSINESS
MODEL
$750-1,000
AVERAGE SELLING PRICE
PER LARGE BORE DEVICE
B2B
direct to hospital
GLOBAL
LARGE BORE
MARKET OPPORTUNITY
$600M+
*Based on a
Market projection of
575,000 procedures in 2020
and ASP of $1000
GLOBAL
TOTAL MARKET
OPPORTUNITY
$4.2B+
*Based on a
Market projection of
17 million procedures in 2020
and ASP of $250
PHYSICIAN
INCENTIVE AND
VALUE PROPOSITION
Current procedures are covered
by a CPT payment
$135-$350-
$1,400
Add-on or
specific procedure

14. Follow-on Funding
VISION | NEED | TECHNOLOGY | PROGRESS | COMPETITION | IP | MARKET | BUSINESS STRATEGY | MILESTONES | TEAM
PHASE 1: Preclinical
2017
Product
Development
PHASE 3: Commercialization
Market
Launch
2023
PMA
Submission
2021
PHASE 2: Clinical
Product
Development
Clinicals
2020
Iterate & finalize device design
(v2)
Manufacturing
Design testing & validation
Certifications
Data Analysis
PRE-SEED $325K (non-dilutive) SEED: $1.5M SERIES A: $6M SERIES B: $15M SERIES C: $30M
IDE TO FDA
FIRST IN HUMAN
EARLY FEASIBILITY &
SAFETY STUDY
n=10, single center, FDA EFS
Endpoints: Success Rate,
Complications
PILOT
TRIAL
PIVOTAL
TRIAL
Finalize device design (v1)
Manufacturing
Design testing & validation
Certifications
Foreign regulatory partnership
Clinical partnership establishment
Seeking $1.5M Seed
funding through first-in-
human clinicals

15. Eric Kramer, PhD
MECHANICAL ENGINEERING
Product Design & Engineering
Manufacturing & Quality
CEO
Team
Jason T. Lee, MD
Vascular Surgery
Stanford University
Barry Cheskin
Co-founder, Powervision
Vasoseal
Vivian de Ruijter, MD
MINIMALLY INVASIVE SURGERY
Evidence Development
Clinical/Regulatory Strategy
Katie Blevins, MD, PhD
GENERAL SURGERY / BIOMEDICAL ENG.
Co-Founder, Surgical Advisor
VISION | NEED | TECHNOLOGY | PROGRESS | COMPETITION | IP | MARKET | BUSINESS STRATEGY | MILESTONES | TEAM
Gerard Von Hoffman
IP Strategy
Knobbe Martens
Chirag Chauhan, MS, MD
STRUCTURAL HEART / BIOMEDICAL ENG.
Co-Founder, Clinical Advisor

16. Lume Medical Limited
eric@lumemedical.com