www.ziptekglobal.com - PowerPoint Presentation

Slide1

www.ziptekglobal.com

1250 S.

Tamiami Trail Suite 303Sarasota, FL 34239 US

Knotless Tissue Repair and

Attachment Devices

RSlide2

$5,000,000 Series “A” Offering

Contingent on FDA Approval

510k Filed-Completed First ReviewProviding Requested Additional Information

R

Knotless Tissue Repair and

Attachment Devices

Patent # 9307979Slide3

What Does

Make?

The ZipE® is a surgical button or “capture” that slides along a suture with protuberances in a forward direction and is prevented from moving backwards along its path, similar to a Zip-Tie, and is the backbone of the technology platform for Ziptek’s knotless tissue repair devices and is used for tissue-to-tissue and tissue-to-bone repair.

The U.S. Soft Tissue Repair Market, per annum, is about $2-3 billion.

The is a registered trademark Patented!

Initially focused on Rotator Cuff Repair Market

There are over 21 other Indications For Use(IFUs) filed with the FDA applicationSlide4
Slide5

Increased contact surface area for lower

failure rates

Prevents rip through

Traditional Tissue

RepairZipE® Tissue Repair

Whether knotted or knotless

Most Common form of failure is rip through

Like Tying a Bow Like a Carpet Floor Tack

Traditional Suture vs

ZipE

® Repair

The AdvantageSlide6

The ® Advantage!

All devices on the market suffer from high rates of failure due to rip through. This video shows how the ZipE

® stabilizes the tissue, helps prevent this form of failure, and creates increased contact surface area allowing for improved tissue healing. The rate of non-healing and re-tears can be higher than 60%, or about a $300 million/year U.S. expenditure on failed rotator cuff surgery.

Suture

Ripthrough-Traditional Repair

ZipE

® Capture StabilizationSlide7

Patents

7 Patents Issued 3 More Expected Within 6-12 Months11 Countries plus E.U.(28)- Patentable Material Filed2 Foreign Patents Have Already Been Issued

Patent # 9307979Slide8

Capture Holster

Capture Pusher

Multi-Purpose DriverPatent Pending-Patentable WIPO*-Driver*-Method*

-Screw*

Our other patents open up additional realms for further applications -special screws -driver*Deemed patentable by WIPO-filed in 11 countries plus E.U.(28)Slide9

ZipE® Surgical Procedure Steps

Fast!

SecureRepeatableConsistentSlide10

ZipE® Surgical Procedure StepsSlide11

Test

Certification

StatusBiocompatibility

21 CFR Part 58 Compliance

Good Laboratory Practice for Nonclinical / Lab Studies

ISO 10993-13 tests

Passed

Performance testing

Biomechanical- static and cyclic loading

USP 39-NF 33:2016 <881> Tensile Strength

Passed

Degradation Studies

ASTM F1635

Passed

Sterilization Validation

ISO 11135

Passed

EO Residuals

ISO 11135

Passed

Shelf life -post accelerated aging

ASTM F1980

Passed*

ASTM 2096 – 11

Passed

Seal Package Validation

ISO 11607 -1:2006

ASTM F88/F88M-15

Passed

Finalizing bubble burst testing

ASTM 2096 – 11

Passed

Specific testing categories that have been performed and passed include:

*1 year passed

Safety and Performance TestingSlide12

William F Bennett MDOrthopedic Surgeon

Founder Bio20-plus years of experience with rotator cuff repair and knotless devices Significant Intellectual Property- -one of the earliest to file

-and a market driving factor Early arthroscopic rotator cuff repair specialist -developed and published surgical techniques, classification systems and outcome studiesNumerous issued patents and publications in this domainStarted Ziptek Mexico Sa De Cv! -with Professor Ramses Galaz PhD Biomedical Engineer, -partner both

Ziptek LLC and Ziptek Mexico Sa De Cv

Ziptek Mexico Sa De Cv has won multiple Grants enabling Ziptek LLC to accelerate further product design 2nd

and 3

rd

generation products in development

Preparing for “Biologics” integration

Hermosillo, Sonora, Mexico

Dr. Bennett CVSlide13

Concept to Market20 years

According to data from the Journal of the American Academy of Orthopedic Surgeons, with FDA approval In January, 2017,

Ziptek will have achieved this milestone using 1/30th of average cost to get approval!!2017

Trademark accepted

By the FDA-2016R

Market Entry!

FDA Approval

Expected late 1

st

Or early 2nd quarter

510k FDA Application

Filed! Aug 2016

Capture idea born!

First knotless Patent

Application filed, May 1995

3 PATENTS Issued

2000-2003

Decision

To

Commercialize

2009

First business plan

Negotiated

Operational Agreement with Mexican

Biomed engineer, PhD and partner

2010

Ziptek

LLC

Incorporated

2012

Ziptek

Funded

2014

Testing Completed Passed

Biocompatibility

Performance Testing

Degradation Studies

Package Validation

Sterilization Validation

EO Residuals

Shelf Life

1995

New patents

Filed

New Patents

IssuedSlide14

Why Invest?

ZipE® -is a disruptive and complementary technology platform -only device that prevents rip through- the highest failure mode found with other devices on the market

-multiple Indications For Use (IFU~21) -multiple device pipelines -multiple surgical disciplinesU.S. Soft Tissue Repair Market- ~2-3 Billion per year -multiple IFUs - broad patent languageU.S. Rotator Cuff ~500,000 reimbursed surgical cases Ankle Ligament- ~1-2,000,000 injuries/yearZipE® Engineering is One of a Kind! 2.5:1 force ratio!Slide15

Patent language covers indications outside of orthopedics - -Patentable material filed in 11 Countries plus E.U.(28)

Ziptek Mexico Sa De Cv- Mexican support company -Founder William F Bennett MD- Sonora, MexicoZiptek LLC is positioning itself for rapid growth- by introducing ZipE

® to Surgeons through orthopedic research projects -Florida Orthopedic Training program- contact area cadaveric study-started -Mexico’s Federal Orthopedic Program– sheep model healing -Colorado Orthopedic Training and Research Foundation- sheep model vascularity -European Groups-Worldwide Distribution network- wants samples-validateWhy Invest?Slide16

At the Recent 2016 AAOS Annual Meeting

This is a sample of distributors who want to be notified with FDA Approval

Why Invest in Us?Slide17

Testimonial Sample

Don Johnson M.D.Orthopedic Sports SurgeonI have reviewed the product that Bill has been developing the past couple of years, and feel that it has great potential to be a significant improvement in the knotless anchor sphere.

Director, Sports Medicine Clinic Carleton University (colleague)William. D. Murrell, Jr., M.D.Shoulder and Sports

Surgeon

I have worked with Bill on worldwide distribution planning for the Ziptek implant. In my opinion, also being a primary shoulder surgeon, the device should revolutionize thecare of rotator cuff repair.

Consultant

Orthopaedic

Sports Medicine

DHBMC

Dubai, United Arab Emirates

Marcos V. Masson M.D.

Shoulder Surgeon

I have looked at the patents, the prototypes and the technique-the key is simplicity- with the avoidance of knot tying more surgeons will adopt the technique.

USA

Dubai

CanadaSlide18

A New Funding Round

Allows for -rapid growth with interested national and international parties -buildout of infrastructure, to include key sales force executives -the development of a regional inventory

-for the rapid introduction to Surgeons at meetings, by exhibiting, by sponsoring and training -the continued prosecution of ongoing patent and foreign regulatory approval -for a robust Global “Work-Around”patent that is presently pending at WIPO

2017

2020

Revenue in Millions(US Dollars)

2018

2019

10

20

30

$30,000,000Slide19

$5,000,000 Series “A” Offering

Filed to FDA August 2016Completed First Review

Providing Requested Additional Information

*FDA Approval Contingency for Funding

*With Ziptek’s FDA Approvalthis milestone will be achieved at ~1/30th

the average cost for other 510k approvals

Thank You!Slide20

Investor Intro Letter

www.ziptekglobal.com

Ziptek Surgical BrochureManagementPhoto Time!