Ortho Regenerative Technologies Well-positioned for Next Phase of Development
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.
- Raised C$6.7 million through four private placements, ensuring funding until 2022.
- Positive preclinical results demonstrated safety and effectiveness of ORTHO-R for rotator cuff repair.
- Received FDA designation for ORTHO-R as a drug/biologic, potentially increasing market appeal.
- Strengthened management team with the appointment of an expert in orthobiologics.
- Commenced cGMP clinical trial material manufacturing for upcoming clinical trials.
- None.
MONTREAL, March 2, 2021 /PRNewswire/ - 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.
Achieved and Planned Milestones 2021-2022
- In January 2021 Ortho-RTI entered into a global licensing with Hanuman Pelican, Inc. for the rights to commercialize the Buoy Suspension Fractional System, one of the best PRP systems available, in combination with ORTHO-R.
- The Company made changes to its Board of Directors in February designed to better position the Company for its next phase of growth.
- Completion of ORTHO-R cGMP clinical trial material manufacturing is expected in March.
- The Company plans to submit an Investigational New Drug (IND) Application for ORTHO-R in March of 2021, and to begin enrolling our multi-center Phase I/II trials in the US in Q2 2021
- Select US investment bankers and pursue a listing on the Nasdaq Stock Exchange in the second half of the year.
- Planning of ORTHO-R meniscus indication in the second quarter of 2021, with the start of a pivotal preclinical trial for ORTHO-R second soft tissue repair indication
- Begin preparations in 2022 for Phase III trials in the US, Canada, and EU planned for 2023.
- The Company plans to opportunistically evaluate additional potential partnerships throughout 2021 and 2022.
"We are pleased with all the progress made in 2020 to position Ortho RTI for the imminent transition into a clinical phase company. We now have adequate financing for the next 12-15 months - which includes the start of our upcoming multi-center Phase I/II trials in the United States - as well as the right management team in place to lead the company in its next phase of growth. The steps we took in 2020 were strategic building blocks, and we are now focused on the clinical development of ORTHO-R," said Claude LeDuc, President and Chief Executive Officer of Ortho RTI. "2021 will be transformational for the company as we advance the clinical development of our lead product. We also plan to explore a listing on the Nasdaq to help expand our reach to key US healthcare-focused investors, and to further solidify our financial footing. Our preclinical results are compelling, and now more than ever we believe that ORTHO-R has the potential to transform the standard of care for soft-tissue repairs, and provide better outcomes for hundreds of thousands of patients every year is now within reach."
About Ortho Regenerative Technologies Inc.
Ortho RTI 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. A multi- site US ORTHO-R Rotator Cuff Tear Repair Pilot Phase I/II clinical trial is being planned and organized. In parallel, an FDA IND submission is planned for Q1-2021. 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.
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:http://www.prnewswire.com/news-releases/ortho-regenerative-technologies-well-positioned-for-next-phase-of-development-301238278.html
SOURCE Ortho Regenerative Technologies Inc.
FAQ
What is Ortho Regenerative Technologies' stock symbol?
What milestones has Ortho Regenerative Technologies planned for 2021?
How much funding has Ortho Regenerative Technologies raised?
What are the expected clinical trials for ORTHO-R?
What is the significance of ORTHO-R receiving FDA classification?
