Recent BioUtah News & Events

Foldax Appoints Scott Huennekens to Board of Directors

PolarityTE, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved its investigational new drug (IND) application for the evaluation of SkinTE for the treatment of chronic cutaneous ulcers.

Co-Diagnostics, Inc. announced that CoSara Diagnostics Pvt Ltd has received clearance by the Central Drugs Standard Control Organization (“CDSCO”) in India to manufacture and sell its SARAGENE™ Human Papillomavirus High-Risk (HPV-HR) Real-Time PCR test as an in vitro diagnostic (“IVD”)

New Peripheral Vascular Microcatheters Save Procedure Time and Advance Treatment Capabilities

Positive Study Results Published for KidneyIntelXTM in Monitoring Patient Response to New Drug Therapy

Premier Neurology Facility in Colorado Joins the CenExel Centers of Excellence

CenExel Clinical Research, Inc. announced the acquisition of California Neuroscience Research.

Nexus Spine announced key appointments to its leadership team that includes David Ivanko as Vice President of Quality Engineering and Manufacturing and Andrew Shepherd as Vice President of Marketing.

Seventh KidneyIntelX implementation partnership for Renalytix focused on underserved populations with high disease burden

To help fight the pandemic, the FDA has been issuing EUAs and exercising enforcement discretion for medical devices needed to diagnose, treat, or prevent COVID-19. Last month, the agency issued two draft guidances related to transition plans to regular compliance for COVID-19 related medical devices that fall under EUAs or Agency Enforcement Policies that have […]

PARK CITY, Utah and HERZLIYA, Israel, Jan. 6, 2022 /PRNewswire/ — BlueWind Medical™, Ltd., developer of the innovative RENOVA™ iStim implantable neuromodulation device for treatment of Overactive Bladder, today announced additions to its leadership team in preparation for commercialization of the RENOVA product line. The company has added Mike Ruger as Vice President of Sales, Sandra […]

National program establishes early care management, technology innovation and large health system engagement as a strategic priority for supporting the 34 million U.S. individuals living with diabetes

Series A Financing Funds Multiple Programs to Phase 1 and IND stage

Definitive merger agreements provide the Company with all existing and future assets, future product iterations, and intellectual property rights of the platform, creating a fully integrated product line and streamlining commercialization

In a sign that our BioHive is truly buzzing, the Salt Lake Tribune, recently ran an article on advances in breast cancer detection, highlighting the innovative breast cancer screening technology being developed by IONIQ Sciences. The article notes that IONIQ has teamed up with IONIQ scientific advisor and University of Utah assistant professor, Dr. Benjamin […]

Publication in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions Found TRIA Aortic Heart Valve Provided Sustained Improvement in Heart Valve Function to One-Year with Good Safety Profile

PolarityTE has submitted its complete response to the U.S. FDA clinical hold correspondence regarding its Investigational New Drug (IND) Application for SkinTE® with a proposed indication for chronic cutaneous ulcers.

Myriad Genetics Promotes Nicole Lambert to Chief Operating Officer

Teiko.bio Launches with $11.6 Million Series A Financing to Advance High-Dimension Immune Profiling for Clinical Trials and Diagnostics Development.

Rosivo closes seed-round paving the path for commercialization of patented cartilage implant technology

On Tuesday, December 14, the Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing on the nomination of Dr. Robert Califf to be FDA Commissioner. In his testimony, Califf, who briefly led the FDA during President’s Obama’s second term, said his first priority as FDA Commissioner would be the pandemic response and applying […]

Pfizer and Arena Pharmaceutical on Dec. 13 announced that the companies have entered into an agreement under which Pfizer will acquire Arena, a clinical stage company developing innovative potential therapies for the treatment of several immuno-inflammatory diseases.  Under the terms of the agreement, Pfizer will acquire all the outstanding shares of Arena for $100 per […]

IONIQ Sciences, Inc. announced it has been awarded “Most Innovative Non-Invasive Lung Cancer Testing Solution” and “Best Medical Technology Company 2021” by Global 100.

Powerful combination of key patents comes as the Company looks ahead to topline results from a Phase 3 registration study in ALS in second half of 2022.