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- Successful FDA meeting confirms safety profile of Ortho-R and requirements to file IND submission to initiate Phase I/II human trial by fiscal year-end
- Initiation of non-brokered placement of up to $1.0 million of unsecured convertible debentures units
KIRKLAND, QC, July 3, 2019 /CNW Telbec/ - Ortho Regenerative Technologies Inc. (CSE: ORTH) ("Ortho RTi" or the "Company"), an emerging Orthopaedic and Sports Medicine technology company, today reported its financial results for the first quarter of 2020 ended April 30, 2019. The Company also announced a non-brokered placement of up to $1,000,000 of unsecured convertible debentures units.
"Our meeting with the FDA confirmed that we are well positioned to file our IND and initiate our first human trial on Ortho-R for rotator cuff repair before the end of our current fiscal year", said Claude LeDuc, President and Chief Executive Officer of Ortho RTi. "The net proceeds from our non-brokered private placement will allow us to maintain the program momentum as we get set to begin the clinical portion of our program, a clear catalyst and value creation event".
First Quarter 2020 Highlights
- In February 2019, the Company announced the initiation of a 6-month pivotal animal study on Ortho-R for rotator cuff repair.
- In February 2019, the Company announced that, following a meeting with the FDA, its development program has exceeded expectations and that it can submit its IND (Investigational New Drug) while completing its pivotal study. The timeline to initiate human clinical program is by fiscal year end.
Subsequent events to Q1 2020
- In June 2019, the Company nominated Mr. Claude LeDuc as its new President and CEO. Mr. LeDuc has cumulated 32 years of senior executive, CEO, COO experience with private and Fortune 500 medical device and bio-pharma companies.
- In June 2019, the Company appointed Messrs. Pierre Laurin and Claude LeDuc to its Board of Directors effective as of June 19, 2019. Both are well-known and seasoned industry veterans with a long track record of developing strategic biotherapeutic partnerships and successfully raising the capital required to develop world leading technologies.
Financial Statements and MD&A
Ortho RTi's financial statements and Management's Discussion and Analysis for the three-month period ending April 30, 2019 are available on SEDAR at www.sedar.com
Non-Brokered Private Placement:
- Up to $1,000,000 of unsecured convertible debenture units (the "Units").
- Each Unit consists of one 10% unsecured convertible debenture in the principal amount of $1,000 (each, a "Debenture") and 2,000 Class "A" share purchase warrants (each, a "Warrant") "), with an exercise price of $0.50, expiring 24 months after the date of issuance of such Warrants, representing a 70% warrant coverage.
- Debentures will be convertible at $0.35 per share (the "Conversion price").
- The Debentures will automatically convert into Common Shares of the Company at the Conversion Price in the event that the volume weighted average price (VWAP) over any 20 consecutive trading days is greater or equal to $1.00.
- The net proceeds from the Private Placement will be used to fund research and development costs and for general corporate purposes.
- The securities issued under the Private Placement will be subject to a four-month hold period in accordance with applicable securities legislation.
- The Corporation may pay a commission or finder's fee to eligible parties in connection with the Private Placement, in compliance with applicable securities laws.
About Ortho Regenerative Technologies Inc.
Ortho RTi is an emerging Orthopaedic and Sports Medicine biologics company dedicated to the development of novel therapeutic soft tissue repair technologies to dramatically improve the success rate of sports medicine surgeries. Our proprietary biopolymer has been specifically designed to increase the healing rates of sports related injuries to tendons, meniscus, ligaments and cartilage. The polymer can be directly placed 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 bioactivity and residency of our proprietary biopolymer, Ortho RTi continues to assess its potential for therapeutic uses outside of the soft tissue repair. 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.
For further information: Claude LeDuc, President and Chief Executive Officer, (514) 693-8804, [email protected]; Frederic Dumais, Director Communications and Investor Relations, (514) 782-8803, [email protected]