Ortho Regenerative Technologies Reports its First Quarter 2021 Results
- Preclinical results confirm safety of Ortho-R and statistical significance over standard of care for rotator cuff repair.
- Ortho-R development program entering US clinical trial regulatory process with FDA.
- Entered into strategic agreement with Ingenew Pharmaceuticals to expand Ortho Regenerative Technologies' proprietary biopolymer platform to include the delivery of therapeutics.
- Closed $1.1 Million Private Placement, including $400,000 from management and Board members.
MONTREAL, June 30, 2020 /CNW Telbec/ - Ortho Regenerative Technologies Inc. (CSE: ORTH) ("Ortho RTI" or the "Company"), an emerging orthobiologics company, today reported its financial results and highlights for the first quarter of 2021 ended April 30, 2020.
"One of the key highlights of the quarter was undoubtedly the MRI results of our pivotal preclinical study for rotator cuff repair. It demonstrated a decrease in tendon gap in both ORTHO-R treated groups compared to the standard of care control group. A decreased tendon gap is indicative of faster restoration of tissue structure, observed by a more normal MRI signature. The histopathology showed equivalent safety compared to standard of care surgery", said Claude LeDuc, President and CEO of Ortho RTI.
"These preclinical results not only confirmed the safety profile of ORTHO-R and its statistically significant effect over standard of care but also confirmed the potential of our proprietary platform to address soft tissue repair unmet clinical needs", added Mr. LeDuc. "We are expecting more results to come from the histology statistical report by the end of July. Since March 2020, we have initiated interactions with the US FDA to confirm the regulatory pathway necessary to initiate patient enrolment this fall. Our first rotator cuff tear repair clinical study will take place in 10 orthopedic investigation centers across the US".
Commenting on the results of the first quarter of 2021, Luc Mainville, Ortho RTI's Senior Vice-President and Chief Financial Officer, said: "The closing of the $1.1 million private placement led by members of management and Board members has allowed us to continue funding the progress of our ORTHO-R rotator cuff program. The first quarter 2021 expenses included R&D spending related to the completion of our preclinical trial, and US clinical trial preparation expenses. Total expenses also included a non-cash non-recurrent salary adjustment paid to management for having converted their salaries into various debenture financings over the past year. Finally, our financial expenses also increased due to the addition of debentures over the last year. With our lead development program shortly entering human trial stages, we expect equity financings to be facilitated going forward".
First Quarter 2021 Ortho-R Program Highlights
- In March 2020, the Company announced positive results following completion of its pivotal preclinical study in Rotator Cuff Tear repair. The results confirmed the safety profile of ORTHO-R as well as statistical significance over standard-of-care.
First Quarter 2021 Financial and Other Corporate Highlights
- In April 2020, the Company closed a non-brokered private placement of convertible debenture units (the "Units"). The Company issued 1,060 Units at a purchase price of $1,000 per Unit for total gross proceeds of $1,060,000. Each Unit consisted of one 10% unsecured convertible debenture in the principal amount of $1,000 (each, a "Debenture") convertible at a $0.30 price per Class "A" share of the Company ("Common Shares") and 2,000 Class "A" share purchase warrants (each, a "Warrant"), expiring 24 months after the date of issuance of such Warrants. Each Warrant will entitle the holder thereof to purchase one Common Share at an exercise price of $0.50. Both the Debentures and the Warrants have a maturity date of April 21, 2022. In the event that the volume weighted average price of the Company's shares over any 20 consecutive trading days is greater or equal to $1.00, the Corporation may give notice that the Warrant maturity will be accelerated. In such case, the Warrant maturity date will be set 30 days following such notice. The Chief Executive Officer, the Senior Vice-President and Chief Financial Officer, one Director and two senior staff members all participated in the Private Placement for an aggregate amount of $400,000. Total contribution from insiders in the last three private placements amounts to $2.1 million representing 66% of the Private Placements.
First Quarter 2021 Subsequent Events
- In June 2020, the Company announced the appointment of Mr. Michael Atkin as its new independent Chairman of the Board. Ortho RTI founder Mr. Steve Saviuk served as Chairman during the 2015-2017 and 2019-2020 periods, and continues to serve the Company as a Board Director; and
- In May 2020, the Company entered into a strategic and licensing agreement with Ingenew Pharmaceuticals Inc. to explore the expansion of the scope of Ortho's proprietary technological platform applications to include the delivery of therapeutics.
Financial Statements and MD&A
Ortho RTI's financial statements and Management's Discussion and Analysis for the three-month period ended April 30, 2020 are available on SEDAR at www.sedar.com.
About Ortho Regenerative Technologies Inc.
Ortho RTI is an emerging orthobiologics company dedicated to the development of novel therapeutic soft tissue repair technologies to dramatically improve the success rate of orthopedic and sports medicine surgeries. Our proprietary RESTORE technology platform, is a muco-adhesive CHITOSAN based biopolymer matrix, specifically designed to deliver biologics such as Platelet-Rich Plasma (PRP) or Bone Marrow Aspirate Concentrate (BMAC), to augment and guide the regeneration of new tissue in various musculoskeletal conditions. Ortho-R, our lead Chitosan-PRP hybrid biologic implant product, is formulated and designed to increase the healing rates of occupational and sports related injuries to tendons, meniscus, and ligaments. Other formulations are being developed for cartilage repair, bone void filling and osteoarthritis treatment. The Chitosan-PRP combination ORTHO-R implant can be directly applied into the site of injury by a surgeon during a routine operative procedure without significantly extending the time of the surgery and without further intervention. An Ortho-R Rotator Cuff Tear Repair US clinical trial is being prepared and coordinated. In parallel, a Pre-Request for Designation was submitted to the FDA in March 2020, to explore the feasibility of obtaining a Device designation regulatory path versus a Biologics designation regulatory path. We are expecting a response in July 2020 and are planning for an IDE or IND FDA submission during Q3 2020. Considering the significant potential of our technology platform, Ortho RTI continues to assess new therapeutic target uses outside of the soft tissue repair field. Further information about Ortho RTI is available on the Company's website at www.orthorti.com and on SEDAR at www.sedar.com. Also follow us on LinkedIn and Twitter.
This news release may contain certain forward-looking statements regarding the Company's expectations for future events. Such expectations are based on certain assumptions that are founded on currently available information. If these assumptions prove incorrect, actual results may differ materially from those contemplated by the forward-looking statements contained in this press release. Factors that could cause actual results to differ include, amongst others, uncertainty as to the final result and other risks. The Company disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, other than as required by security laws.
NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATIONS SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.
SOURCE Ortho Regenerative Technologies Inc.
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