18:07:31 EDT Thu 25 Apr 2024
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Ortho Regenerative Technologies Inc
Symbol ORTH
Shares Issued 51,038,776
Close 2022-06-23 C$ 0.29
Market Cap C$ 14,801,245
Recent Sedar Documents

Ortho talks Ortho-R, omits Q1 P&L from NR

2022-06-24 09:49 ET - News Release

Mr. Philippe Deschamps reports

ORTHO REGENERATIVE TECHNOLOGIES REPORTS ITS FIRST QUARTER 2023 RESULTS

Ortho Regenerative Technologies Inc. has released its financial results and highlights for the first quarter of the 2023 fiscal year ended on April 30, 2022.

"Ortho delivered important milestones during the first quarter of 2023. We signed a material transfer agreement with a global company, closed an oversubscribed private placement and secured key patents that will protect our core IP for many years to come. More importantly, we made significant progress in advancing our U.S. phase I/II rotator cuff tear clinical trial," said Philippe Deschamps, president and chief executive officer. "With seven clinical centres now screening and recruiting patients, enrolment of first patients is imminent and will accelerate in the coming weeks. We expect one additional centre to start screening patients shortly and the remaining two over the coming months, at which point we will have our 10 sites actively screening and recruiting patients, thus providing a steady flow of patients for enrolment in our study."

Commenting on the first quarter 2023 results, Luc Mainville, Ortho's senior vice-president and chief financial officer, said: "The closing of the $3.2-million oversubscribed private placement has allowed us to accelerate our phase I/II U.S. clinical trial-related activities during the first quarter of 2023. All our efforts and resources are now focused on enrolling patients as quickly as possible now that screening and recruiting is officially under way."

First quarter 2023 Ortho-R program highlights:

  • In February, 2022, the company entered into a material transfer agreement with an undisclosed, industry-leading, global strategic medical company for the exclusive use of its proprietary platelet-rich plasma (PRP) system in its Ortho-R rotator cuff tear repair, phase I/II U.S. clinical trial.

First quarter 2023 corporate highlights:

  • In April, 2022, the company closed an oversubscribed non-brokered private placement and issued 16 million units at a price of 20 cents per unit for total gross proceeds of $3.2-million with approximately $560,000 of insiders' subscriptions. Each unit consisted of one Class A share of the company and one common share purchase warrant exercisable into one share in the capital of the company at the price of 35 cents per warrant share for a period of 24 months from closing.
  • In April, 2022, the company granted two million share purchase options and 551,938 restricted share units (RSUs) to its CEO Mr. Deschamps. Fifty per cent of the options and RSUs will vest annually and equally over the first three years following the date of grant. The balance of the options and RSUs will vest based on achievements of predetermined operational and corporate milestones.
  • In March, 2022, the company appointed Mr. Deschamps as its new chief executive officer following the retirement of Claude LeDuc.

First quarter 2023 subsequent events:

  • In June, 2022, the company initiated patient recruitment and reported on the progress for its U.S. phase I/II rotator cuff tear repair clinical trial.
  • Effective May 1, 2022, Dr. Jonathan Sackier was hired as a consultant to serve as the company's new senior vice-president, medical affairs. Dr Sackier is an experienced surgeon and serial entrepreneur, having developed and commercialized several of his inventions and those of other inventors by taking them from concept, through Food and Drug Administration and other regulatory bodies and to market. Dr. Sackier has also deep experience at designing and executing clinical trials.
  • In May, 2022, the company received, through its partnership with Polytechnique Montreal, a $500,000 non-dilutive grant from Axelys, to advance the development of its second technology platform indication, Ortho-M, for meniscus repair.
  • In May, 2022, the company issued 500,000 warrants with an exercise price of 35 cents per common share and expiring April 30, 2023, as compensation to non-related parties providing social media support and other corporate services.
  • In May, 2022, the company received a key U.S., Canadian and European composition and method patent from the U.S. Patent and Trademark Office for its Ortho-R soft tissue repair platform protecting its core intellectual property until 2035.

First quarter 2023 financial statements and MD&A

Ortho's financial statements and management's discussion and analysis for the three-month period ended April 30, 2022, are available on SEDAR.

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. Its proprietary Restore technology platform is a proprietary mucoadhesive 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, the company's 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 tendinopathies, 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 its technology platform, Ortho continues to assess new therapeutic target uses outside of the soft tissue repair field.

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