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Ortho Regenerative Technologies Inc. announced a successful Type A meeting with the U.S. FDA regarding CMC elements necessary for IND clearance. The FDA confirmed that the company can proceed with elemental impurity testing using standard reference material. IND clearance is anticipated in November 2021, with patient enrollment for a Phase I/II clinical trial for ORTHO-R expected by year-end. The trial will assess the safety and efficacy of ORTHO-R in rotator cuff tear repair, enrolling 78 patients across ten U.S. clinical sites.
Ortho Regenerative Technologies Inc. (CSE: ORTH; OTC: ORTIF) announced that the FDA has extended the clinical hold on its Investigational New Drug (IND) application for the Phase I/II clinical trial of ORTHO-R in rotator cuff tear repair. The FDA accepted three complex requests for additional information but requested supplemental clarifications regarding impurity characterization methods. Clinical aspects are positive, with plans to start patient enrollment this Fall 2021 at ten U.S. sites. The company is collaborating with CMC experts to address the FDA's requests.
Ortho Regenerative Technologies has submitted all requested Chemistry, Manufacturing, and Control (CMC) data to the FDA in response to a clinical hold on its IND application for ORTHO-R, aimed at improving rotator cuff tear repair outcomes. The company is confident that this comprehensive data package will satisfy FDA inquiries. Meanwhile, preparation for Phase I/II clinical trials is underway, with seven leading U.S. clinical sites already pre-qualified for the trial process.
Ortho Regenerative Technologies Inc. (CSE: ORTH, OTCQB: ORTIF) has appointed Howard Walthall and Tim Cunningham to its Board of Directors as the company prepares to initiate its first U.S. multisite clinical trial for its Ortho-R rotator cuff repair technology. Both appointees bring extensive experience in building successful biotech companies. The Board has also approved the granting of 100,000 incentive share options to each new member at an exercise price of Cdn $0.36 per share, vesting over the next 18 months.
On June 4, 2021, Ortho Regenerative Technologies Inc (CSE: ORTH, OTCQB: ORTIF) announced it received a clinical hold letter from the FDA regarding its Investigational New Drug application for ORTHO-R, a product intended for rotator cuff tear repair. The FDA requested additional Chemistry, Manufacturing, and Control (CMC) data. Ortho aims to provide this information within four to six weeks and will continue its Phase I/II clinical trial preparations, indicating confidence in meeting FDA requirements. The company focuses on innovative soft tissue repair technologies, enhancing surgical outcomes.
Ortho Regenerative Technologies Inc. (CSE: ORTH; OTC: ORTIF) has submitted an Investigational New Drug (IND) application to the FDA for its Phase I/II clinical trial of ORTHO-R, a hybrid implant aimed at improving rotator cuff tear repair. The trial, expected to enroll 78 patients, will compare ORTHO-R combined with standard care versus standard care alone. With over 600,000 rotator cuff surgeries annually in the U.S., the unmet need for effective treatments highlights significant commercial potential. ORTHO-R is designed to enhance healing rates through a biodegradable Chitosan-based scaffold.
Ortho Regenerative Technologies Inc. (CSE: ORTH, OTCQB: ORTIF) announced its common shares are now eligible for electronic clearing and settlement through the Depository Trust Company (DTC) in the U.S. This DTC eligibility will facilitate trading for U.S. investors, improving execution speed and liquidity, thereby broadening the investor base. The company is dedicated to developing novel soft tissue repair technologies, including their RESTORE platform and the Ortho-R implant aimed at enhancing healing rates for musculoskeletal injuries. Future clinical trials and FDA submissions are planned.
Ortho Regenerative Technologies Inc. (CSE: ORTH, OTCQB: ORTIF) announced its achievements in 2020 and plans for 2021, focusing on advancing its regenerative technologies for soft tissue repair. The company successfully raised C$6.7 million through private placements and reported positive preclinical results for its lead product, ORTHO-R. With over $2 million in cash, it aims to submit an IND application and initiate Phase I/II trials in 2021. The company is also exploring a Nasdaq listing to enhance investor access.
Ortho Regenerative Technologies Inc (OTCQB: ORTIF) has launched a 12-month online investors outreach campaign via AGORACOM to enhance its visibility and shareholder engagement. The initiative will feature a dedicated Ortho RTI HUB, expected to go live on February 17, offering dynamic content and social media interaction. The company plans to pay $80,000 for the services, initiating with $20,000 already paid. This campaign aims to attract new investors and keep current shareholders informed as the company approaches key clinical milestones.
Ortho Regenerative Technologies Inc. has appointed Westwicke, an ICR company, as its investor relations advisors for U.S. markets. This strategic move aims to enhance the company's public profile and reach within the U.S. investment community. CEO Claude LeDuc expressed confidence in Westwicke's expertise, anticipating multiple value-creation catalysts and milestones in 2021. Ortho RTI is dedicated to developing innovative soft tissue repair technologies, including the RESTORE platform and ORTHO-R implant, targeting improved orthopedic and sports medicine outcomes.
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