Ortho Regenerative Technologies Inc.'s Profile

A clinical stage 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.

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END OF DAY ALERT: Ortho Regenerative Technologies (ORTH: CSE) (ORTIF: OTCQB) Up 16% On 72K Shares
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August 20
Ortho Regenerative Technologies Inc.
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ORTH
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Ortho Regenerative Technologies Inc.'s Bulletin

  Most complex, and majority of additional information on characterization at point of care and CMC related data submitted accepted by the FDA Supplemental clarifications on methods of characterization assessing impurities, including additional proposed testing method from the FDA to be addressed in coming weeks Clinical aspects are all good and still targeting patient enrolment this Fall MONTREAL , Aug. 20, 2021 /PRNewswire/ - Ortho Regenerative Technologies Inc . (CSE: ORTH) (OTC: ORTIF) (" Ortho " or the " Company "), a clinical-stage orthobiologics company focused on the development of novel soft tissue repair regenerative technologies, today announced that the U.S. Food and Drug Administration ("FDA") has extended the clinical hold on the Company's Investigational New Drug ("IND") application to proceed with the initiation of a U.S. Phase I/II clinical trial of ORTHO-R in rotator cuff tear repair. The FDA has accepted the three most complex requested additional information submitted in response to the initial clinical hold letter received in early June 2021 . The FDA has however requested supplemental clarifications on two advanced methods of characterization of impurities. "We are pleased to see that the FDA has accepted the recently submitted sterility and endotoxin level testing on the autologous PRP/ORTHO-R preparation workflow, as well as the identification of the drug substance following reconstitution in water, rather than in PRP", said Claude LeDuc , President and CEO of Ortho. "We are already working with our CMC experts, on the new CMC clarifications requested by the FDA. They relate to advanced methods of characterization used in the CMC processes, to assess impurities. We will continue interacting with the Agency as required and are confident that we can address the last few remaining deficiencies, to the full and final satisfaction of the FDA over the coming weeks". Our planned Phase I/II clinical trial is a prospective, randomized, controlled and blinded study to evaluate the safety and efficacy of ORTHO-R + standard of care surgery vs standard of care surgery alone in rotator cuff tear repair. The clinical trial will enroll a total of 78 patients at ten clinical sites throughout the U.S., starting during Fall 2021. About Ortho Regenerative Technologies Inc. Ortho is a clinical stage 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 proprietary 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 drug/biologic implant combination 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 proprietary 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. Considering the significant potential of our technology platform, Ortho continues to assess new therapeutic target uses outside of the soft tissue repair field. Further information about Ortho 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. Forward-Looking Statements 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.  View original content to download multimedia: https://www.prnewswire.com/news-releases/ortho-regenerative-technologies-announces-extension-of-fda-clinical-hold-of-ortho-r-investigational-new-drug-application-301359681.html SOURCE Ortho Regenerative Technologies Inc.  
  MONTREAL , July 21, 2021 /CNW Telbec/ - Ortho Regenerative Technologies Inc . (CSE: ORTH) (OTCQB: ORTIF) (" Ortho " or the " Company "), a clinical stage orthobiologics company focused on the development of novel soft tissue repair regenerative technologies, today announced the voting results from its Annual General and Special Meeting of Shareholders ("AGM") held via videoconference on July 21, 2021 . Election of Directors The following nine (9) nominees were elected as Directors of the Company to hold office until the next Annual Meeting of Shareholders or until their successors are elected or appointed: Mr. Michael AtkinMr. Pierre LaurinMr. Claude LeDucDr. Brent NortonMr. Patrick O'DonnellMr. Steve SaviukMr. Tom E.S. WrightMr. Howard P. WalthallMr. Tim Cunningham Appointment of Auditors Ernst & Young LLP was appointed as auditor of the Company to hold office until the next Annual Meeting of Shareholders, and the Board of Directors was authorized to fix the auditor's remuneration. Equity Incentive Plan The Equity Incentive Plan, as more particularly described in the Circular, was approved by a resolution of Disinterested Shareholders. The purpose of this Plan is to allow for certain discretionary bonuses and similar awards as an incentive and reward for selected Eligible Participants related to the achievement of long-term financial and strategic objectives of the Corporation and the resulting increases in shareholder value. This Plan is intended to promote a greater alignment of interests between the shareholders of the Corporation and the selected Eligible Persons by providing an opportunity to acquire Shares as long-term investments and proprietary interests in the Corporation. About Ortho Regenerative Technologies Inc. Ortho is a clinical stage 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 proprietary 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 drug/biologic implant combination 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 proprietary 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. Considering the significant potential of our technology platform, Ortho continues to assess new therapeutic target uses outside of the soft tissue repair field. Further information about Ortho 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. Forward-Looking Statements 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.  
Submission of first Investigational New Drug ("IND") application to the US FDA for the initiation of a phase I/II clinical trial for testing ORTHO-R for rotator cuff tear repair DTC eligibility secured in the U.S. for the Company's common shares Addition of three U.S. industry veterans to its Board of Directors $150,000 government grant received to support ORTHO-R research MONTREAL , June 29, 2021 /CNW Telbec/ - Ortho Regenerative Technologies Inc . (CSE: ORTH) (OTCQB: ORTIF) (" Ortho " or the " Company "), a clinical stage orthobiologics company focused on the development of novel soft tissue repair regenerative technologies, today reported its financial results and highlights for the first quarter of its 2022 fiscal year ended on April 30, 2021 . "The filing of our IND with the FDA for our U.S. based Phase I / II clinical trial for testing ORTHO-R for rotator cuff tear repair was achieved in the first quarter.  Following receipt of a clinical hold letter from the FDA on June 4 , 2021, we are currently addressing the supplemental information requested by the FDA and anticipate submitting our formal response shortly. The FDA is then expected to respond to our supplemental IND information within the following 30 days.", said Claude LeDuc , President and CEO of Ortho. "While waiting for our IND clearance, we continue progressing on our Phase I/II clinical trial preparation activities to ensure minimal impact on the overall timeline for executing the Phase I/II trial.  Assuming clearance of our IND application by the FDA later this summer and based on the quality and number of US clinical centers who have indicated their interest in participating in the Ortho-R trial, we are optimistic in being able to complete our Phase I/II clinical trial enrollment activities without materially impacting our timelines." Commenting on the first quarter 2022 results, Luc Mainville , Ortho's Senior Vice-President and Chief Financial Officer, said: "We continue to commit most of our financial resources toward our ORTHO-R clinical program. Following successful financings completed last year, we have significantly improved our cash position compared to the first quarter 2021. This has enabled us to continue advancing our lead program and will help fund further progress expected over the coming quarters. First Quarter 2022 ORTHO-R Program Highlights In April 2021 , the Company submitted an IND application to the U.S. Food and Drug Administration for the initiation of a Phase I/II clinical trial of ORTHO-R in rotator cuff tear repair. First Quarter 2022 Corporate Highlights Cash position has increased from $54,000 at the end of Q1-21 to $1,613,000 as at the end of Q1-22; In March 2021 , the Company announced that its common shares were eligible for electronic clearing and settlement through the Depository Trust Company ("DTC") in the United States . DTC is a subsidiary of the Depository Trust & Clearing Corporation, a U.S. company that manages the electronic clearing and settlement of publicly traded companies; In February 2021 , the Company appointed Patrick O'Donnell to its Board of Directors and announced the retirement of Prof. Michael Buschmann and Prof. Caroline Hoemann from its Board of Directors. Patrick O'Donnell is the President and Chief Executive Officer of HD LifeSciences, a prominent life sciences executive with over 25 years of experience guiding companies in both the pre-commercial and commercial stages. Mr. O'Donnell brings a comprehensive understanding of the medical device, orthobiologics and biomaterial industries in the orthopedic, spine, neurosurgery, and sports medicine markets; In February 2021 , the Company retained Westwicke, an ICR company, as its investor relations advisors for the U.S. markets; and In April 2021 , the Company secured a $150,000 government grant to support ongoing ORTHO-R research over the next 2 years. First Quarter 2022 Subsequent Events In June 2021 , Mukesh Ahuja , the Company's Vice-President Clinical and Medical Affairs transitioned into a consultant role while assuming the same functions for the Company; In June 2021 , the Company appointed Messrs. Howard Walthall and Tim Cunningham to its Board of Directors. Concurrent with their appointments, each of them received 100,000 incentive share options at an exercise price of $0.36 per share and expiring June 15, 2029 . Vesting of the options will take place as per the Company's plan. Mr. Walthall is a seasoned life sciences executive whose multi-faceted experience includes cellular biologics, tissue engineering, medical devices, and allografts. He has an extensive background in regenerative medicine, orthopedics and advanced wound care and has overseen multiple highly successful product development projects and new product launches. Mr. Cunningham brings over 30 years of extensive finance and operations leadership experience in the biotechnology and software industries to his work with his public and private Danforth clients, as a CFO with a demonstrated record of success in building startup enterprises into industry leaders and scaling larger entities globally; and In June 2021 , the Company received a clinical hold letter from the U.S. Food and Drug Administration ("FDA") related to its Investigational New Drug application to begin a phase I/II clinical trial for ORTHO-R, its drug/biologic combination product candidate used as an adjunct to standard of care surgery in rotator cuff tear repair. The FDA requested additional Chemistry, Manufacturing, and Control related information. Financial Statements and MD&A Ortho's financial statements and Management's Discussion and Analysis for the three-month period ended April 30, 2021 , are available on SEDAR at www.sedar.com . About Ortho Regenerative Technologies Inc. Ortho is a clinical stage 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 proprietary 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 drug/biologic implant combination 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 proprietary 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. Considering the significant potential of our technology platform, Ortho continues to assess new therapeutic target uses outside of the soft tissue repair field. Further information about Ortho 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. Forward-Looking Statements 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.
SEDAR Interim Financial Statements Ortho Regenerative Technologies Inc (C:ORTH)Shares Issued 34,872,899Last Close 6/29/2021 $0.32Tuesday June 29 2021 - SEDAR Interim Financial Statements This filing is available at: http://www.stockwatch.com/News/Sedardoc.pdf?docid=4875783