Overview of The Business and Business Strategy

Ortho Regenerative Technologies Inc. born from the acquisition of intellectual property form the Montreal Polytechnique for its innovative chitosan-based biopolymer, has changed the company name to ChitogenX Inc. to better reflect the opportunity afforded its proprietary chitosan/biologic combination product in one of the most dynamic and promising areas of medicine the $9B regenerative medicine market.

Regenerative Medicine Overview

The concept of regenerative medicine is to provide us with tools to return anatomy and physiology to a more normal appearance and behaviour. Although there are many definitions, of what constitutes regenerative medicine, the following is succinct:

Regenerative Medicine is a clinical stage interdisciplinary field of research and clinical applications focused on the repair, replacement or regeneration of tissues or organs to restore impaired function resulting from any cause, including congenital defects, disease, trauma and aging. It uses a combination of several technological approaches that moves it beyond traditional transplantation and replacement therapies. These approaches may include, but are not limited to, the use of soluble molecules, gene therapy, stem cell transplantation, tissue engineering and the reprogramming of cell and tissue types.

Combinations of these approaches can 1) improve the natural healing process in areas of the body it is needed most, 2) take over the function of a permanently damaged organ, 3) heal or repair a damaged organ or tissue, or 4) deliver healing "accelerators" chemicals that might inspire repair to specific damaged areas of the body.

Regenerative medicine is a relatively new and rapidly expanding field that brings together experts in biology, chemistry, materials and computer science, engineering, genetics, robotics, and other fields to find solutions to some of the most challenging medical problems faced by humankind. We believe ChitogenX is at the forefront of this rapidly expanding field.

The Global Regenerative Medicine Market was a $US9B market in 2021 and is projected to grow at 22.8% CAGR through 2030. It is one of the most dynamic markets in medicine today. The musculoskeletal and tissue healing segment accounted for about 60% share of the regenerative medicine market in 2021. Cell therapies are used in the treatment of musculoskeletal diseases such as bone tissue replacement, cartilage, tendon, and ligament repair and replacement.

Regenerative medicine is applicable in cardiovascular, oncology, dermatology, musculoskeletal, wound healing, ophthalmology, neurology, and others. The musculoskeletal application segment accounted for the largest share in 2021, whereas cardiovascular is expected to be the fastest-growing segment, registering a CAGR of 24.3% during the forecast period (2022-2030).

The delivery of a tissue scaffold, cellular or molecular therapy or any combination thereof makes a fundamental assumption; that the substance(s) will stay where they were placed and function as desired; if they wander off-target, the desired enhanced healing might not occur and furthermore, the potential exists for off-target effects.

Providing a reliable, biologically safe transport mechanism that would allow the targeted body system to receive the regenerative material to aid in body system repair is, therefore, a mission-critical goal and a problem that requires solving.

ChitogenX's chitosan/biologic combination product is just such a solution. Our Patented Drug/ Biologic/ Combination technology platform, is a muco-adhesive CHITOSAN based biopolymer matrix, specifically designed to be combined with biologics such as Platelet-Rich Plasma (PRP), Bone Marrow Aspirate Concentrate (BMAC), or other biological products to augment and accelerate the regeneration of new tissue in various potential indications.

Business Strategy (in priority order)

  • Perform Rotator Cuff Tear Repair proof of concept U.S. phase I/II clinical trial program to establish regenerative medicine platform
  • Seek development partnerships commitment to fuel company development
  • Leverage Polytechnique partnership to obtain non-dilutive grants to drive proof of concept in multiple potential indications
  • Leverage our proprietary platform beyond orthopedic applications by seeking R&D and/or development partners for each high potential application
  • Explore the potential of launching a medical grade Chitosan to supply specialty medical markets.