Ortho Regenerative $ORTH Increases FDA Regulatory Lead For Soft Tissue Repair Trials With 7 Clinics Already Activated - $12 BILLION Market

Have you ever torn a:

● muscle ● rotator cuff ● meniscus ● cartilage

How about someone you know? Or a favourite athlete? We wouldn’t blame you if you thought the care and repair of these kinds of injuries is standard and highly successful …. but you would be wrong.

There is a MASSIVE problem with surgery failure rates for each of these as follows:

● Rotator Cuff 50-60%

● Meniscus 20-40%

● Cartilage 15-35%

Ortho Regenerative Technologies $ORTH $ORTIF believes it has found the solution to this multi-billion dollar problem thanks to its proprietary RESTORE technology platform which dramatically improves the success rate of orthopedic and sports medicine surgeries.

$ORTH IS IN THE REGULATORY LEAD FOR REGENERATIVE PRODUCTS

More than just lip service $ORTH has made some key announcements in the last few months as follows:

1. Received FDA Clearance To Proceed With U.S. Clinical Trial.

2. Entered Into A Material Transfer Agreement With A Global Strategic Medical Company For Its Rotator Cuff Tear Repair Phase I/II U.S. Clinical Trial

3. Received Key U.S. Patent For Its Soft Tissue Repair Platform

4. Received A $500,000 Grant To Advance 2nd Platform Development For Meniscus

5. 7 Clinical Trial Sites Already Fully Activated

The importance of these are as follows: 3RD PARTY VALIDATION -

$ORTH AGREEMENT WITH A GLOBAL STRATEGIC MEDICAL COMPANY FOR ITS ROTATOR CUFF TEAR REPAIR PHASE I/II U.S. CLINICAL TRIAL The $ORTH Material Transfer Agreement ("MTA") is with an undisclosed, industry-leading, global strategic medical company for the exclusive use of their proprietary platelet-rich plasma ("PRP") system in Ortho's upcoming ORTHO-R rotator cuff tear ("RCT") repair, phase I/II U.S. clinical trial. The Strategic Company will provide the PRP system disposable kits for all enrolled patients in the study as well as technical and training support. $ORTH, in return, has provided the Strategic Company with a right of "first offer" to distribute ORTHO-R in combination with their proprietary PRP System. KEY U.S. COMPOSITION AND METHOD PATENT FOR ORTHO-R SOFT TISSUE REPAIR PLATFORM The Company’s announcement of the receipt of Key U.S composition and method patent for ORTHO-R Soft tissue repair platform is of critical importance for the following 3 reasons: ●New patent issued by U.S. Patent and Trademark Office protects core IP until 2035 ● Positions Company as leading player in the dynamic regenerative medicine market ● Enables delivery of PRP in soft tissue repair surgery in a proprietary way RECEIVES $500,000 AXELYS GRANT TO ADVANCE ORTHO-M DEVELOPMENT FOR MENISCUS REPAIR The company announced that it has received, through its partnership with Polytechnique Montreal, a $500,000 non-dilutive grant from Axelys, to advance the development of its second technology platform indication, ORTHO-M, for meniscus repair. ● Meniscus indication confirms potential for proprietary technology platform across multiple soft tissue injuries ● Grant to accelerate development of second clinical indication ORTHO REGENERATIVE TECHNOLOGIES INITIATES PATIENTS RECRUITMENT FOR ITS U.S. PHASE I/II ROTATOR CUFF TEAR REPAIR CLINICAL TRIAL ● Contracting procedures completed for 6 of the 10 clinical trial sites ● 7 sites fully activated, with ongoing patients' screening and recruitment The following clinical sites are currently recruiting and screening patients for randomization in the Phase I/II study: ● Rothman Institute, PA, ● OrthoIndy Research Foundation, IN ● University Orthopedics, PA ● Tucson Orthopedics, AZ ● Holy Cross Orthopedic Institute, FL ● OrthoVirginia Institute, VA, (site activation imminent) ● Remaining four sites to be activated over the coming months. $ORTH IS ATTACKING AND IN THE LEAD OF A MULTI BILLION $$ MARKET In terms of Soft Tissue Re