Agoracom Blog Home

Posts Tagged ‘Soft Tissue Repair’

Ortho Regenerative Technologies $ORTH.ca $ORTIF Announces Submission of Investigational New Drug Application for ORTHO-R

Posted by AGORACOM-AB at 9:30 AM on Tuesday, April 6th, 2021
Ortho
  • Phase I/II clinical trial initiation for rotator cuff tear repair in the U.S. anticipated in Q2 2021

MONTRÉAL, April 6, 2021  – Ortho Regenerative Technologies Inc . (CSE: ORTH) (OTC: ORTIF) (” Ortho RTI ” or the ” Company “), a clinical stage orthobiologics company focused on the development of novel soft tissue repair regenerative technologies, today announced that it has submitted an Investigational New Drug (“IND”) application to the U.S. Food and Drug Administration (“FDA”) for the initiation of a Phase I/II clinical trial of ORTHO-R in rotator cuff tear repair.

“The IND submission for our first ORTHO-R human trial is a key milestone for the Company. It brings us one step closer to the enrollment of our first patient, a recognized value creation event in our industry”, said Claude LeDuc , President and CEO of Ortho RTI.

“There is a clear need for improved rotator cuff tear repair treatments, as estimates have put the re-tear (or non healing) rate at an average of 50%. With more than 600,000 patients undergoing rotator cuff surgery every year in the U.S., this represents an enormous commercial opportunity, and as demonstrated in 2020 by our GLP preclinical program results, we strongly believe that ORTHO-R can help address these significant unmet needs and meaningfully improve the success rate of these surgeries.”

Read More: https://agoracom.com/ir/OrthoRegenerativeTechnologies/forums/discussion/topics/758565-ortho-regenerative-technologies-announces-submission-of-investigational-new-drug-application-for-ortho-r/messages/2310949#message

Ortho Regenerative Technologies $ORTH.ca $ORTIF Well-positioned for Next Phase of Development

Posted by AGORACOM-AB at 3:43 PM on Tuesday, March 2nd, 2021
Ortho

MONTREAL , March 2, 2021 – Ortho Regenerative Technologies Inc . (CSE: ORTH) (OTCQB: ORTIF) (” Ortho RTI ” or the ” Company “), a clinical stage orthobiologics company focused on the development of novel soft tissue repair regenerative technologies, today provided a review of 2020 calendar year activities and a look forward at planned future milestones as the Company transitions from preclinical to clinical stage.

2020 Achievements

  • Completed four non-brokered private placements that raised an aggregate C$6.7 million . The company now has more than $2 million cash on hand to fund its regulatory and clinical stage projects through 2022.
  • In March and July, Ortho RTI announced positive preclinical results that confirmed the safety profile and demonstrated statistically significant improvement over standard of care for rotator cuff repair.
  • Following a request for designation to the FDA, ORTHO-R was classified in August as a drug/biologic, which management believes will enhance its long-term market potential.
  • In October, the Company appointed Mukesh Ahuja , MBBS, MSc as Vice-President Clinical and Medical Affairs, who brings extensive expertise in orthobiologics clinical development.
  • In October, Ortho RTI shares began trading on the OTCQB market, facilitating better access for US investors and improved trading liquidity.
  • In November, Ortho RTI initiated the scale-up and manufacturing of cGMP clinical trial material to be used in the upcoming ORTHO-R Phase I/II rotator cuff tear repair clinical trial in the US.

Read More: https://agoracom.com/ir/OrthoRegenerativeTechnologies/forums/discussion/topics/756371-ortho-regenerative-technologies-well-positioned-for-next-phase-of-development/messages/2306048#message

ORTHO REGENERATIVE TECHNOLOGIES $ORTH.ca $ORTIF ADDS PATRICK O’DONNELL TO BOARD OF DIRECTORS

Posted by AGORACOM-AB at 11:40 AM on Thursday, February 25th, 2021
Ortho

Montreal, QC, February 24, 2021 – Ortho Regenerative Technologies Inc. (CSE: ORTH, OTCQB: ORTIF) (“Ortho RTI” or the “Company”), a clinical stage orthobiologics company focused on the development of novel soft tissue repair regenerative technologies, announced today the appointment of Patrick O’Donnell to its Board of Directors, effective immediately. 

“We are very pleased to welcome Patrick to the Ortho RTI Board of Directors to help lead a very important transition in the development of our company, as we prepare to start our first U.S. multisite Ortho-R rotator cuff tear repair Phase I/II clinical trial”, said Claude LeDuc, President and Chief Executive Officer of Ortho RTI. “Ortho RTI will greatly benefit from Patrick’s company-building experience as well as his expertise in the development and management of strategic partnerships fund-raising, commercial, clinical, regulatory and reimbursement strategies, all specific to our industry. We are looking forward to his insightful contribution to our Board”. 

Commenting on his appointment to Ortho RTI’s Board of Directors, Mr. O’Donnell said: “I am happy to be joining the Board of Directors of Ortho RTI. The Company’s proprietary technology platform has the potential to help address significant unmet medical needs in a multitude of soft tissue repair related indications. I am excited to help Ortho RTI develop into an orthobiologics industry leader”. 

Read More: https://agoracom.com/ir/OrthoRegenerativeTechnologies/forums/discussion/topics/755959-ortho-regenerative-technologies-adds-patrick-o-donnell-to-board-of-directors/messages/2305098#message