reshaping treatment paradigms - live and invest …...-straightforward development, relatively short...

36
www.lcmd.com Reshaping Treatment Paradigms Corporate Presentation © Life Care Medical Devices 2017

Upload: others

Post on 12-Jul-2020

3 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: Reshaping Treatment Paradigms - Live and Invest …...-Straightforward development, relatively short time to market 22 23 Surgical Sealants, Adhesives & Other Markets •First medical

www.lcmd.com

Reshaping

Treatment Paradigms

Corporate Presentation © Life Care Medical Devices 2017

Page 2: Reshaping Treatment Paradigms - Live and Invest …...-Straightforward development, relatively short time to market 22 23 Surgical Sealants, Adhesives & Other Markets •First medical

Forward Looking Statements

This presentation contains forward-looking statements regarding our prospective performance. Forward-looking statements are based on assumptions and describe future plans, strategies, and expectations of our company. Accordingly, actual results may differ materially from anticipated results. Some of the factors that could cause our actual results to differ from our expectations include, without limitation: our ability to receive FDA and foreign regulatory approvals for our product candidates, including the LapCap2®

Laparoscopic Access Device & Life Care LCMI; risks associated with scientific research, including conducting clinical and product-related trials; the unpredictability of the size of the markets for, and market acceptance of, any of our products, including the LapCap2® Laparoscopic Access Device & Life Care LCMI; our ability to produce and sell any approved products and the price we are able realize for those products; our ability to enter into and maintain collaborations with, and our dependence on, third parties for the development and commercialization of our products, including the LapCap2®Laparoscopic Access Device & Life Care LCMI; our ability to complete future proposed acquisitions and integrate acquired products into our operations; our ability to manage our limited cash resources; our need to obtain additional funding and our ability to obtain future funding on acceptable terms; our ability to retain and hire necessary employees and to staff our operations appropriately; our ability to protect the intellectual property we have developed or in-licensed; and our dependence on the success of the LapCap2®Laparoscopic Access Device & Life Care LCMI. Data presented herein may be the result of clinical studies that have yet to be reviewed by the FDA or other international government authority.

2

Page 3: Reshaping Treatment Paradigms - Live and Invest …...-Straightforward development, relatively short time to market 22 23 Surgical Sealants, Adhesives & Other Markets •First medical

Corporate Overview

• Focused on R&D, production and distribution of non-invasive & minimally-invasive technologies

• Life Care Magnetic Induction Technologies:

- Issued patents

- Numerous pending patents

- Multiple uses and applications

- 510(k) FDA clearance for treatment of numerous tissue conditions

• LapCap2®: Poised to become standard of care for laparoscopic access world-wide

• 1st-Revenue & near-term revenue opportunity, extensive follow-on product pipeline

• Experienced Management Team and Board of Directors

3

Page 4: Reshaping Treatment Paradigms - Live and Invest …...-Straightforward development, relatively short time to market 22 23 Surgical Sealants, Adhesives & Other Markets •First medical

Management Team and Board of Directors

4

Patrick Adams - Chairman• CEO of PVG Asset Management and the Managing Member of Choice

Investment Management

Richard J. Prati – President & Chief Executive Officer

Dr. Camran Nezhat - Chief Medical Officer

Dr. Farr Nezhat• World-renowned authority in advanced laparoscopic and robotic surgery

based in New York City

Dr. Nickolay Kukekov• Co-founder and a principle at Highline Research Advisors, which is an

affiliate of Corinthian Partners LLC

Trevor Moss • Seasoned senior executive and company director with extensive

international experience

Hartman King• Associate at Camp One Ventures

Board of Directors

Richard J. Prati - President and Chief Executive Officer• Over 20 years of proven financial leadership and operational

execution on Wall Street in numerous industries with turnaround expertise

Robin Stephens – Managing Director – MIS• 30 years of medical device experience with leadership from

development through manufacturing and commercialization

Jacques Du Preez – Operations Director – MIS• Over 25 years of operations and finance experience and more than

a decade in medical device experience

Dr. Camran Nezhat - Chief Medical Officer• Internationally renowned laparoscopic surgeon at Stanford

University Medical Center Palo Alto CA, scientist, philanthropist and innovator

Jerry DeCiccio – Financial Controller• Over 25 years as finance officer at public companies, as well as Big

4 CPA, start-up, small and large-cap accounting & operating experience

W. David Mannheim - General Counsel• Senior Partner at Wyrick Robbins with extensive corporate

experience of start-up to large cap companies within health care

Management

Page 5: Reshaping Treatment Paradigms - Live and Invest …...-Straightforward development, relatively short time to market 22 23 Surgical Sealants, Adhesives & Other Markets •First medical

Current Products – 2 FDA-Approved Devices

• Physiologic indications

• New category for aesthetics

5

• Facilitates laparoscopic access

• Can be utilized in virtually every laparoscopic procedure

• Opens the door for entry into surgical markets

510k clearance: “to assist with veress needle entry…”

Life Care Magnetics LCM-1

510k clearance: “to generate deep heat within body tissues for the treatment of medical conditions…”

• CE-Mark

Page 6: Reshaping Treatment Paradigms - Live and Invest …...-Straightforward development, relatively short time to market 22 23 Surgical Sealants, Adhesives & Other Markets •First medical

Life Care Medical Devives (LCMD)

6

TECHNOLOGY & INNOVATION

The Markets –Electromagnetic Induction

Page 7: Reshaping Treatment Paradigms - Live and Invest …...-Straightforward development, relatively short time to market 22 23 Surgical Sealants, Adhesives & Other Markets •First medical

Well Established and Growing Markets

7

• United States skin rejuvenation market: >$3.7 billion

• >12% annual growth in minimally invasive aesthetic procedures

• Projected to >350,000 practitioners as new entrants seek cash pay procedures

1. 1. American Society of Plastic Surgeons;

11%

26%

9%25%

29%

Toxins

Surface

Treatments

Injectable

Fillers

Modern Energy

Devices

Lasers

Skin Rejuvenation Treatment Options

Life Care Magnetic Induction Products

Page 8: Reshaping Treatment Paradigms - Live and Invest …...-Straightforward development, relatively short time to market 22 23 Surgical Sealants, Adhesives & Other Markets •First medical

Fueling Entry into Advanced Surgical Markets

• Minimally invasive treatment of

continence

• $3 billion surgical incontinence

market

• Urinary incontinence affects 44% of

people >65-years-old

• Bowel incontinence affects 6% of

adult population, up to 50% of

patients in nursing facilities

• Vaginal Tightening

8

• $5 billion market for tissue sealants

• Innovative elastic polymer

adhesives

• Wound closure under pressure

while blood flows

Follow-on products: solutions to medical challenges

Page 9: Reshaping Treatment Paradigms - Live and Invest …...-Straightforward development, relatively short time to market 22 23 Surgical Sealants, Adhesives & Other Markets •First medical

Life Care Medical Devices

9

TECHNOLOGY & INNOVATION

Modern Magnetics and Medicine

Page 10: Reshaping Treatment Paradigms - Live and Invest …...-Straightforward development, relatively short time to market 22 23 Surgical Sealants, Adhesives & Other Markets •First medical

Modern Magnetics and Medicine

10

Delivery

Epidermis

Dermis

Subdermal Fat

Muscle

Lasers IPL RF LCMI

1970 1990 1995 2000 2008 2012

US

A novel approach: energy induced in discreet planes beneath the tissue surface*

*All other platforms drive energy directly into tissues – perpendicular to the surface

Page 11: Reshaping Treatment Paradigms - Live and Invest …...-Straightforward development, relatively short time to market 22 23 Surgical Sealants, Adhesives & Other Markets •First medical

Life Care Magnetics Innovation

Uniform, planar heat is generated

Magnetics induces currents in moist, conductive tissues; an Electron Vortex forms in the dermal and muscle layers

11

Energy is transduced parallel to the surface

Page 12: Reshaping Treatment Paradigms - Live and Invest …...-Straightforward development, relatively short time to market 22 23 Surgical Sealants, Adhesives & Other Markets •First medical

The Continuum of Muscle Action

12

Toned SpasticFlaccid

Clinical results suggest LCMI relaxes

spastic muscle, and appears to tighten

flaccid muscle suggesting improved

muscle tone as reflected by aesthetic

appearance

Page 13: Reshaping Treatment Paradigms - Live and Invest …...-Straightforward development, relatively short time to market 22 23 Surgical Sealants, Adhesives & Other Markets •First medical

Clinical Results

13

1 week after 1st treatment2 passes

Page 14: Reshaping Treatment Paradigms - Live and Invest …...-Straightforward development, relatively short time to market 22 23 Surgical Sealants, Adhesives & Other Markets •First medical

Clinical Results

14

Baseline 1 week after 2nd tx 1 week after 3rd tx

Three passes each tx

Page 15: Reshaping Treatment Paradigms - Live and Invest …...-Straightforward development, relatively short time to market 22 23 Surgical Sealants, Adhesives & Other Markets •First medical

Clinical Results

15

Before After

30 days after 1st tx2 passes

Page 16: Reshaping Treatment Paradigms - Live and Invest …...-Straightforward development, relatively short time to market 22 23 Surgical Sealants, Adhesives & Other Markets •First medical

LCMI Addresses Age-old Problems in Aesthetics

Laser IPL Radiofrequency Ultrasound LCMI

Skin tightening

Muscle toning

No pain/pain reduction

No downtime

No bruising

No tissue damage

16

Moderate effect Significant effect

Page 17: Reshaping Treatment Paradigms - Live and Invest …...-Straightforward development, relatively short time to market 22 23 Surgical Sealants, Adhesives & Other Markets •First medical

17

Life Care Magnetics

Medical Effects

• Pain reduction

• Restoration of mobility

• Correction of contracture

• Reduce muscle spasm

PhysiologicAesthetic*

• Reduction of skin folds

• Improved tone and texture

• Reduction of skin laxity

• Improved muscle tone

*As shown in clinical studies. Device is FDA cleared for delivery of therapeutic heat to tissues.

Page 18: Reshaping Treatment Paradigms - Live and Invest …...-Straightforward development, relatively short time to market 22 23 Surgical Sealants, Adhesives & Other Markets •First medical

Physician Economics

Cost per treatment Conservative Projected Revenue per month

$500-$1,000 $25,000 - $50,000

~10,000 dermatologists, plastic surgeons; treat average of 200 patients/mo1

At 3 patients per day (15 per week) = 60 per month x $500 = $30,000/month

Monthly lease options: $15k up front:

• Revenue Share (e.g. $100 per session to LCMD, ~$400 to Physician)• Only Paying if using – so assured positive free cash flow, and incentive to

utilize

1Kythera

18

Page 19: Reshaping Treatment Paradigms - Live and Invest …...-Straightforward development, relatively short time to market 22 23 Surgical Sealants, Adhesives & Other Markets •First medical

Aesthetic Practice: Patients and Physicians

The Value Proposition for Patients

• Improved skin tone and texture

• Immediate and long term results

• No pain – pain reduction

• No downtime

• No bruising, no tissue damage

• Slight erythema resolves < 1hr

• New device modality with vastly superior cost/efficacy

The Value Proposition For Physicians / Medical Spas

• Substantial incremental cashflow

• No limitations - skin type or pigmentation

• Short procedure options

• Multiple anatomical locations possible

• Simple operation, minimal training necessary

• Outstanding safety profile

19

Page 20: Reshaping Treatment Paradigms - Live and Invest …...-Straightforward development, relatively short time to market 22 23 Surgical Sealants, Adhesives & Other Markets •First medical

Life Care Medical Devices

20

TECHNOLOGY & INNOVATION

Product Pipeline

Page 21: Reshaping Treatment Paradigms - Live and Invest …...-Straightforward development, relatively short time to market 22 23 Surgical Sealants, Adhesives & Other Markets •First medical

What is Worse Than Death?

21

Page 22: Reshaping Treatment Paradigms - Live and Invest …...-Straightforward development, relatively short time to market 22 23 Surgical Sealants, Adhesives & Other Markets •First medical

Incontinence – Large Addressable Market

Potential for minimally invasive restoration of continence

• $3 billion market

• Urinary – 44% of people >65-years-old

• Bowel – high unmet need

- 6% of adult population, more than 50% of patients in nursing facilities

- Straightforward development, relatively short time to market

22

Page 23: Reshaping Treatment Paradigms - Live and Invest …...-Straightforward development, relatively short time to market 22 23 Surgical Sealants, Adhesives & Other Markets •First medical

23

Surgical Sealants, Adhesives & Other Markets

• First medical adhesive based on elastic polymers sealed with magnetic induction

• Closes surgical incisions under pressure or while blood is flowing

• Vaginal Tightening

• Cartilage, nasal passage transformation

$5 billion+ market potential

23

LCMD adhesive is a futuristic polymer (left) that latches tightly onto

tissues with its anchoring tendrils (right, magnified 1500x by scanning

electron microscopy).

LCMD tissue adhesive and sealant is applied to the bare lung tissue

(center) following excision (left), forming a leak proof, elastic seal (right).

Page 24: Reshaping Treatment Paradigms - Live and Invest …...-Straightforward development, relatively short time to market 22 23 Surgical Sealants, Adhesives & Other Markets •First medical

Robust IP Portfolio & Regulatory Approvals

• Life Care LCMI- Issued and pending patents covering methods, devices and compositions

- FDA 510(k) – K121123, therapeutic application of heat to tissues

- IP portfolio favors future product development

• LapCap2- Access to three granted US patents to distribute LapCap2 globally

- Filed design and innovation patents related to LapCap2

- FDA 510(k) – K070651 for Standard size

- CE Marking – for Standard, Small & Large sizes

- ISO 13485 – certified by BSi

24

Page 25: Reshaping Treatment Paradigms - Live and Invest …...-Straightforward development, relatively short time to market 22 23 Surgical Sealants, Adhesives & Other Markets •First medical

Life Care Medical Devices

25

TECHNOLOGY & INNOVATION

Minimally Invasive Surgery

Page 26: Reshaping Treatment Paradigms - Live and Invest …...-Straightforward development, relatively short time to market 22 23 Surgical Sealants, Adhesives & Other Markets •First medical

Well Established and Growing Markets

• 1 million+ gynecological laparoscopic procedures annually in the US

• Can be used for both robotic and non-robotic procedures

• ~5 million gynecological lap procedures globally

• Global laparoscopic surgeries utilizing Veress is ~12.5 million equating to a $500+ million market opportunity

26

Myomectomies5%

Endometriosis Resection

7%

Ovarian Cysts9%

LGT 3%

Sacrocolpopexy6%

Hysterectomy 51%

Female Sterilization

19%

~1M US Laparoscopic Gynecological Surgeries

LapCap2 - initial target is gynecological laparoscopic procedures

Page 27: Reshaping Treatment Paradigms - Live and Invest …...-Straightforward development, relatively short time to market 22 23 Surgical Sealants, Adhesives & Other Markets •First medical

Laparoscopic Entry Associated Complications

• Most common reason for procedural failure?- Inadequate pneumoperitoneum longer OR time increased complications

• 5-10% of cases failed entry attempts increase procedure time = greater risks

27

0.0%

25.0%

50.0%

75.0%

100.0%

1 2 3 4+

Pneumoperioneum achieved Complication rate

Veress Needle TechniqueComplication Rate

Complication Rate and Costs

~3,150 annual

complications in the us

~$40 Million in ICU

related injuries

1. Assumes ~1M gynecologic laparoscopic surgeries per year US. (S2N Estimates)

2. Assumes additional mean LOS 3.5 days at $3500k/day ICU cost per day

http://laparoscopy.blogs.com/prevention_management_3//2011/04/laparoscopic-access.html

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3304260/

Page 28: Reshaping Treatment Paradigms - Live and Invest …...-Straightforward development, relatively short time to market 22 23 Surgical Sealants, Adhesives & Other Markets •First medical

USA Distribution Strategy

28

FOCUSED ON REDUCTION IN COMPLICATION RATES

Distribution agreement with Progressive Medical Inc. (PMI) for sales in USA

PMI is a Specialized Private Medical Device Distributor with 75 U.S. Sales Reps

Focused on Laparoscopic/Minimally-Invasive Devices

Heavy Emphasis on Safety and Consistency for Access

Concentrating on University & Teaching Hospitals to teach LapCap as Standard

Method for Laparoscopic Access to Interns, Residents, & New Surgeons

Working with Top Surgeons: Dr Camran Nezhat, Dr. Chuck Miller, and other

Leading Key Opinion Leaders (KOLs)

Page 29: Reshaping Treatment Paradigms - Live and Invest …...-Straightforward development, relatively short time to market 22 23 Surgical Sealants, Adhesives & Other Markets •First medical

Rest of World Distribution Opportunity

29

NEW COUNTRY EFFORTS

Discussions with Multiple Distributors in the EU including the UK,

Germany and France

Negotiating Currently with an Israeli Distributor who is testing the

product

We have Distributor Requests from Mexico, Colombia, Brazil,

Ecuador, and Chile

We are in active discussions with several distributors in China

We are discussing a contract with one of the largest device

distributors in Japan

Page 30: Reshaping Treatment Paradigms - Live and Invest …...-Straightforward development, relatively short time to market 22 23 Surgical Sealants, Adhesives & Other Markets •First medical

Life Care Medical Devices

30

Financial Forecast Snapshot

Page 31: Reshaping Treatment Paradigms - Live and Invest …...-Straightforward development, relatively short time to market 22 23 Surgical Sealants, Adhesives & Other Markets •First medical

Potential for Meaningful Revenue Generation

31

0

20

40

60

80

100

120

140

2016 2017 2018 2019 2020

Sale

s in

$ M

illio

ns

Potential Sales

LCM-1

LapCap2

Total Rev

Based on:• progressive

adoption of LapCap2

• 5 magnetic induction units/month scaling to

• 20 / month by end 2017

• ramping incremental 120 units annually through 2020

Page 32: Reshaping Treatment Paradigms - Live and Invest …...-Straightforward development, relatively short time to market 22 23 Surgical Sealants, Adhesives & Other Markets •First medical

Current Offering and Capitalization

32

Preferred Shares Offering 2mm shares @ $2.50 per share =$5mm

100% warrant coverage, 8% PIK dividend. Minimum 33% discount

to IPO price.

~10mm Shares Outstanding @ $2.50 (current offer price) = ~$25mm pre$

>$25mm & 10 years spent developing 2 products we have ready for sale today.

Late 2013 initiated management restructuring. Costs & Expenditures reduced by

>60%, thus repositioning the company for success.

January 2014 – raised ~$1.5mm at 50¢. May 2015 – raised $750k at $1.50

Between June 2015 – March 2016 – raised roughly $750k between $2.00-$3.00

We expect to bring LCMD back on the public markets by Q3 or Q4 2017

Page 33: Reshaping Treatment Paradigms - Live and Invest …...-Straightforward development, relatively short time to market 22 23 Surgical Sealants, Adhesives & Other Markets •First medical

Medical Device Value Indicators – Recent Exits

33

Year Company Acquirer Amount

2014 $250 M

2014 $600 M

2013 $294 M

2013 $240 M

2012 $91 M

Page 34: Reshaping Treatment Paradigms - Live and Invest …...-Straightforward development, relatively short time to market 22 23 Surgical Sealants, Adhesives & Other Markets •First medical

Life Care Medical Devices

34

2017e 2018e

Revenue Range $4mm - $10mm* $12mm - $30mm

COGS/OPEX $7mm - $9mm $9mm-$24mm

Pre-Tax Income ($3mm) –$1mm $3mm - $6mm

Forecast Financial Metrics with $5mm Capital Raise by end of Q1 2017

* At 75 to 90 units shipped on the magnetics side, we anticipate we will hit cash flow break-even

Page 35: Reshaping Treatment Paradigms - Live and Invest …...-Straightforward development, relatively short time to market 22 23 Surgical Sealants, Adhesives & Other Markets •First medical

Comp Table: Public & Private Medical Device & Aesthetics Companies

35

Comparable/

Acquirer

TICKER 1/6/2017

Market Cap

Private

Valuation

Company Highlights and Commercial Prospects

Life Care Medical**(based on current cap

table with ~10mm shares)

LCMD*(*Reserved)

$25MM** (Based on

current

Offering)

2 FDA-Approved Medical Devices available for sale today. RF through electro-magnetic

induction. New technology, cost-effective, not painful, can reach & tone muscle, & pipeline of

new Indications also revenue-generating LapCap2 - Laparoscopic device w/ CE-Mark

Miramar Labs MRLB $40MM Aesthetic treatment for underarm hair, underarm sweat, excess sweat

Viveve Medical VIVE $55MM Recently Received FDA-approved, Uses RF energy for vaginal tightening

PAVmed Inc. PAVM $80MM Pre-revenue. Five disparate medical devices expected to be approved by end of 2017, and

first revenue expected in 2018. IPO May 2016

Cynosure, Inc. CYNO $1.1B $294MM Broad-range of lasers products for a variety of aesthetic applications

Zeltiq Aesthetics ZLTQ $1.7B $91MM Focused on CoolSculpting Technology to freeze and eliminate fat cells

Ulthera/Merz Private PRIVATE $600MM Ultrasound Technology - effective and can reach muscle layer, but expensive/painful

Alma Lasers/Fosun FOSUY $12B $240MM Laser Technology - various types - expensive and surface treatment

Solta Medical/Valeant VRX $5.2B $250MM Laser Technology - various types - expensive and surface treatment

Page 36: Reshaping Treatment Paradigms - Live and Invest …...-Straightforward development, relatively short time to market 22 23 Surgical Sealants, Adhesives & Other Markets •First medical

www.lcmd.com

Reshaping

Treatment Paradigms

Corporate Presentation© Life Care Medical Devices 2017