Ortho Regenerative Technologies Receives Clinical Hold Letter From the U.S. FDA

Ortho Regenerative Technologies Inc. (CSE: ORTH) (OTCQB: ORTIF) (“Ortho” or the “Company“), a clinical stage orthobiologics company focused on the development of novel soft tissue repair regenerative technologies.

Today the company announced that it has received a clinical hold letter from the U.S. Food and Drug Administration (“FDA”) related to its Investigational New Drug (IND) application to begin a phase I/II clinical trial for ORTHO-R, its drug/biologic combination product candidate used as an adjunct to standard of care surgery in rotator cuff tear repair.

The FDA has requested additional Chemistry, Manufacturing, and Control (“CMC”) related information. The Company is confident in its ability to address and provide the FDA with the required information and testing data over the coming four to six weeks.

“We appreciate the FDA’s guidance and assistance to Ortho, in the development of a first-in-class orthobiologics combination product to improve outcomes of standard of care surgery in rotator cuff tear repair,” said Claude LeDuc, President and Chief Executive Officer of Ortho. “We will work diligently to address the FDA’s questions as quickly as possible and look forward to continuing to work closely with them to secure IND approval. In parallel, we will continue working on our Phase I/II clinical trial preparation activities to ensure we minimize the impact on our overall timelines.”

Hot this week

Cartessa Aesthetics Partners with Classys to Bring EVERESSE to the U.S. Market

Classys, which is listed on the KOSDAQ, is one of South Korea's most distinguished aesthetic technology manufacturers, with devices distributed in 80+ markets globally. This partnership marks Classys's official entry into the American marketplace, with Cartessa Aesthetics as the exclusive distributor for EVERESSE, launched under the Volnewmer brand in current global markets.

Stryker Launches Next-Generation of SurgiCount+

Now integrated with Stryker's Triton technology, SurgiCount+ addresses two key challenges: retained surgical sponges and blood loss assessment. Integrating these previously separate digital solutions provides the added benefit of a more efficient, streamlined workflow for hospitals notes Stryker.

Nevro Receives CE Mark In Europe for It’s HFX iQ™ Spinal Cord Stimulation System

Nevro notes HFX iQ is the first and only SCS system with artificial intelligence (AI) technology that combines high-frequency (10 kHz) therapy built on landmark evidence that uses ongoing cloud data insights to deliver personalized pain relief

Recor Medical Reports: CMS Grants Distinct TPT Device Code and Category to Recor Medical for Ultrasound Renal Denervation

The approval of TPT offers incremental reimbursement payments for outpatient procedures performed with ultrasound renal denervation for Medicare fee-for-service beneficiaries. It becomes effective January 1, 2025, and is expected to remain effective for up to three years notes Recor Medical.

Jupiter Endovascular Reports | 1st U.S. Patient Treated with Jupiter Shape-shifting Thrombectomy Device

“Navigation challenges during endovascular procedures are often underappreciated and have led to under-adoption of life-saving procedures, such as pulmonary embolectomy. We have purpose-built our Endoportal Control technology to solve these issues and make important endovascular procedures accessible to more clinicians and their patients who can benefit from them,” said Carl J. St. Bernard, Jupiter Endovascular CEO. “This first case in the U.S. could not have gone better, and appears to validate the safety and performance we are seeing in our currently-enrolling European SPIRARE I study.”