Knotless Tissue Repair and Attachment Devices

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Presentation transcript:

Knotless Tissue Repair and Attachment Devices 1250 S. Tamiami Trail Suite 303 Sarasota, FL 34239 US www.ziptekglobal.com

Knotless Tissue Repair and Attachment Devices $5,000,000 Series “A” Offering Contingent on FDA Approval 510k Filed-Completed First Review Providing Requested Additional Information R Knotless Tissue Repair and Attachment Devices Patent # 9307979

What Does Ziptek Make? Patented! 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. It is a knotless tissue repair device used for tissue-to-tissue and tissue-to-bone repair. The U.S. Soft Tissue Repair Market, per annum, is about $2-3 billion. Patented! Initially focused on Rotator Cuff Repair Market There are over 21 other Indications For Use(IFUs) filed with the FDA application

Most Common form of failure is rip through Traditional Suture vs ZipE® Repair The Advantage ZipE® Tissue Repair Traditional Tissue Repair Knotted or knotless Most Common form of failure is rip through Increased contact surface area for lower failure rates Prevents rip through Like Tying a Bow Like a Carpet Floor Tack

The ® Advantage! Suture Ripthrough-Traditional Repair ZipE® Capture Stabilization 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.

Patents 7 Patents Issued 3 More Expected Within 6-12 Months 11 Countries plus E.U.(28)- Patentable Material Filed 2 Foreign Patents Have Already Been Issued Patent # 9307979

Patent Pending-Patentable WIPO* -Driver* -Method* -Screw* Multi-Purpose Driver Capture Holster Capture Pusher 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)

ZipE® Surgical Procedure Steps Fast! Secure Repeatable Consistent

ZipE® Surgical Procedure Steps

Testing Test Certification Status Biocompatibility 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 Degradation Studies ASTM F1635 Sterilization Validation ISO 11135 EO Residuals Shelf life -post accelerated aging ASTM F1980 Passed* ASTM 2096 – 11 Seal Package Validation ISO 11607 -1:2006 ASTM F88/F88M-15 Finalizing bubble burst testing Specific testing categories that have been performed and passed include: *1 year passed

William F Bennett MD Orthopedic Surgeon Founder Bio 20-plus years experience in this domain Intellectual Property-knotless devices Driver of knotless market evolution Early arthroscopic rotator cuff repair specialist ~Earliest to file a knotless device patent Numerous issued patents in this domain Numerous publications in this domain 2nd and 3rd generation products in development Preparing for “Biologics” integration Principal Ziptek Mexico Sa De Cv! Biomedical Engineers Ziptek Mexico Sa De Cv has won multiple Grants enabling Ziptek LLC to accelerate further product design Dr. Bennett CV Hermosillo, Sonora, Mexico

Concept to Market 20 years 510k FDA Application Filed! Aug 2016 New Patents Issued 1995 2000 2010 2020 2017 New patents Filed Ziptek Funded 2014 R 3 PATENTS Issued 2000-2003 Decision To Commercialize 2009 First business plan Ziptek LLC Incorporated 2012 Market Entry! FDA Approval Expected late 1st Or early 2nd quarter Capture idea born! First knotless Patent Application filed, May 1995 Testing Completed Passed Biocompatibility Performance Testing Degradation Studies Package Validation Sterilization Validation EO Residuals Shelf Life Trademark accepted By the FDA-2016 Negotiated Operational Agreement with Mexican Biomed engineer, PhD and partner 2010 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!!

Why Invest? ~2-3 Billion per year- U.S. Soft Tissue Repair Market U.S. Rotator Cuff ~500,000, Ankle Ligament- ~1,000,000 cases/year ZipE® is a Disruptive technology platform- only device that prevents rip through which is the highest failure mode for all other devices on the market. -multiple Indications For Use (IFU~21) -multiple device pipelines -multiple surgical disciplines ZipE® Engineering is One of a Kind! 2.5:1 force ratio!

Why Invest? 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, Mexico Ziptek LLC is positioning itself for rapid growth- by introducing ZipE® to Surgeons through ongoing orthopedic research projects -Florida Orthopedic Training program- contact area cadaveric study -Mexico’s Federal Orthopedic Program– sheep model healing -Colorado Orthopedic Training and Research Foundation- sheep model vascularity -European Groups-Worldwide Distribution network interested-ongoing

Why Invest in Us? AAOS 2016 Annual Meeting Distributor Sample of Who wants to be Notified with FDA Approval

Orthopedic Sports Surgeon Why Invest in Us? Testimonial Sample USA Dubai Canada 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 the care 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. Don Johnson M.D. Orthopedic Sports Surgeon I 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)

New Funding Round Rapid growth to access national and international markets Buildout of Infrastructure to include a sales force and inventory Introduce to Surgeons- at meetings and by exhibiting by sponsorships and training Prosecuting ongoing patent and foreign regulatory approval “Work-Around” patent applications filed- grab majority Global control of this domain $30,000,000 30 20 10 2017 2018 2019 2020 Revenue in Millions(US Dollars)

$5,000,000 Series “A” Offering Filed to FDA August 2016 Completed First Review Providing Requested Additional Information *FDA Approval Contingency *With Ziptek FDA Approval this milestone will be achieved at ~1/30th the average cost for other 510k approvals Thank You!

Ziptek Surgical Brochure www.ziptekglobal.com Investor Intro Letter Ziptek Surgical Brochure Management