Tele: 561.316.3330
Breaking Medical Device News

Saturday, October 16, 2021
HomeOrtho Regenerative Technologies IncOrtho RTi Confirms Timeline to Initiate Human Clinical Program After Meeting with...

Ortho RTi Confirms Timeline to Initiate Human Clinical Program After Meeting with the FDA

Ortho Regenerative Technologies Inc. “Ortho RTi“, is an emerging Orthopaedic and Sports Medicine Technology company.  Today the company announced that following a formal meeting with the FDA, its development program to date has exceeded expectations. As a result, the Company is in the position to submit its IND (Investigational New Drug) while completing its pivotal study and confirms the timeline to initiate the human clinical program by year-end.

“The review of our scientific and preclinical package and the meeting with the FDA went very well. Consequently, we are in a position to address whether we can adjust our timelines favorably as we progress towards the clinic. Furthermore, streamlined testing of our product around safety, toxicology, and characterization “CMC” (Chemistry Manufacturing and Controls) was deemed to be acceptable for our IND and eventual final submissions “BLA” (Biologics License Applications), saving Ortho RTi millions of dollars in additional expenses”, said Dr. Michael Buschmann, Ortho RTi’s Chief Scientific Officer. “As we reported recently, we can confirm that the results of the recently initiated pivotal study on Ortho-R will be used to augment the IND package with more information on the ideal dosage to take forward into patients”.

“2019 is shaping up to be a transformational year for Ortho RTi. With the confirmation of our development program and the recent completion of the surgeries in our pivotal study on Ortho-R, we are rapidly progressing towards demonstrating the clinical merits of using our lead biologic Ortho-R for rotator cuff repair”, said Dr. Brent Norton, Ortho RTi’s Chief Executive Officer.

Medical Device News Magazine
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Stay Connected


Don't Miss

Ganymed Robotics Awarded a €2.5M Grant from the EC through the EIC Accelerator Program

Ganymed Robotics is developing a radically new approach to surgical robotics by combining computer vision, a branch of artificial intelligence, and mechatronics.

Global Healthcare Exchange Announces Acquisition of Explorer Surgical

Explorer Surgical will operate as a wholly-owned subsidiary of GHX.

Arlington Scientific Broadens Product Portfolio and Further Expands its Product Offering Through the acquisition of Non-Mammalian Blocking Buffers

Arlington Scientific, Inc. (ASI) is pleased to announce that it has acquired the non-mammalian blocking buffer product line from Clark McDermith, former owner of...

Laborie Medical Technologies Acquires Pelvalon

Laborie was represented by Piper Sandler (financial advisor) and Simpson Thacher & Bartlett LLP (legal advisor). Pelvalon was represented by J.P. Morgan Securities LLC (financial advisor) and Dorsey & Whitney LLP (legal advisor).

Herculite Products, Inc. Promotes Two Employees to New Roles

Paul Flaherty Chief Strategy Officer and Marco Angelone is being promoted to the role of Chief Financial Officer.

Prof. Joseph Kvedar Added to the Sweetch Advisory Board Member

Prof. Josdeph Kvedar is the current chair of the board at the American Telemedicine Association (ATA), formerly VP of Connected Health at Mass-Gen Brigham, co-chair of the American Medical Association (AMA) Digital Medicine Payment Advisory Group, and author of The Internet of Healthy Things and The New Mobile Age.

Sid Bala Named President of HealthChampion

Sid Bala is the former president and chief executive officer of alligatortek, a custom software applications company that was acquired by HealthChampion in 2020 where he led them for 27 years after he founded the business

Cochlear Announces FDA Approval and Clearance of first-of-its-kind Remote Care Capabilities for Nucleus and Baha Systems

The FDA approval for the cochlear implant solution and FDA clearance for the Baha solution is the first step in commercializing the product offering, anticipated spring 2022, and complement Cochlear's existing Remote Care offerings.

By using this website you agree to accept Medical Device News Magazine Privacy Policy