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Recent BioUtah News & Events

Everything Happening in Utah Life Sciences

July 27, 2023
BioUtah News
DEVICE FOR TREATING CHALLENGING BONE FRACTURES CLEARED BY FDA

A new system for fixing bone fractures, called the Bone Bolt System, has been approved for market by the U.S. Food and Drug Administration (FDA), the University of Utah Orthopaedic Innovation Center (OIC), Department of Orthopaedics and Spencer Fox Eccles School of Medicine announced on July 20, 2023. “This achievement demonstrates the commitment by the […]

July 27, 2023
BioUtah News
Owlet Appoints Executive Jonathan Harris as New Company President and Chief Revenue Officer

LEHI, Utah–(BUSINESS WIRE)– Owlet, Inc. (“Owlet” or the “Company”) (NYSE: OWLT), a pioneer of smart baby monitoring, today announces the appointment of executive Jonathan Harris as its new President and Chief Revenue Officer. Harris joins Owlet at a pivotal time in its business – one month after receiving clearance from the U.S. Food and Drug […]

July 27, 2023
Policy News
Bloom Surgical Awarded Competitive Grant from the NSF

Funding accelerates development of device for resolving visual disruptions in robotic procedures Salt Lake City, UT, June 1, 2023 – Bloom Surgical, Inc., a Utah-based surgical device startup, has been awarded a U.S. National Science Foundation Small Business Innovation Research grant for $256,000 to conduct research and development work on a novel micro-mechanical wiping mechanism […]

July 27, 2023
BioUtah News
Myriad Genetics Announces Inclusion of Breast Density to MyRisk® with RiskScore® Breast Cancer Risk Assessment

RiskScore is the first validated risk model that includes breast density, personal/family history and genetic markers. This comprehensive model is expected to identify more patients that could benefit from a change in their breast care.

July 27, 2023
BioUtah News
BD Receives FDA 510(k) Clearance for Updated BD Alaris™ Infusion System

BD Alaris™ Infusion System is the only modular and most comprehensive infusion system on the U.S. market that includes large volume pumps, syringe pumps, patient-controlled analgesia (PCA) pumps, respiratory monitoring, auto-identification, dose error reduction software and EMR interoperability BD Alaris™ Infusion System’s unique “One System” platform securely connects all patient modules to provide care teams […]

July 27, 2023
BioUtah News
Renalytix Announces Middle East Distribution Agreement with Vector Pharma

Distribution agreement opens kidneyintelX.dkd testing to address early-stage kidney disease in region with one of the highest incidence rates for type 2 diabetes globally

July 20, 2023
Policy News
Rep. Moore Calls For Increased Transparency in the NCD Process

Utah U.S. Rep. Blake Moore (R-UT) signed onto a letter to HHS/CMS, led by House Ways and Means Committee Chair Jason Smith (R-MO) and House Energy and Commerce Committee Chair Kathy McMorris-Rodgers (R-WA), calling for increaed transparency in the NCD process following the agency’s recent release of the TCET notice. In part, the letter states, […]

July 20, 2023
BioUtah News
Owlet Appoints Healthcare Executive Melissa Gonzales to Board of Directors

LEHI, Utah–(BUSINESS WIRE)– Owlet, Inc. (NYSE: OWLT, “the Company”), the pioneer of smart baby monitoring, is pleased to announce the addition of Melissa Gonzales to the Company’s Board of Directors. Gonzales brings more than 20 years of consumer and provider healthcare experience to Owlet, further advancing the Company as a leader in infant monitoring solutions. […]

July 20, 2023
BioUtah News
Co-Diagnostics, Inc. Awarded Funding for Co-Dx PCR Home Platform from NIH RADx® Tech Program

The Company intends to use the funds awarded by the National Institutes of Health for completion of its upper respiratory panel multiplex on Co-Dx PCR Home™ platform SALT LAKE CITY, July 13, 2023 /PRNewswire/ — Co-Diagnostics, Inc. (Nasdaq: CODX) (the “Company” or “Co-Dx”), a molecular diagnostics company with a unique, patented platform for the development […]

July 20, 2023
BioUtah News
Co-Diagnostics, Inc. Announces Recent Grant Awards

The Company intends to use funds awarded by the Bill & Melinda Gates Foundation toward completion of tuberculosis and HPV tests for its Co-Dx PCR Home™ platform  SALT LAKE CITY, July 18, 2023 /PRNewswire/ — Co-Diagnostics, Inc. (Nasdaq: CODX) (the “Company” or “Co-Dx”), a molecular diagnostics company with a unique, patented platform for the development of […]

July 20, 2023
BioUtah News
ELEVAR THERAPEUTICS ANNOUNCES FDA ACCEPTANCE FOR FILING OF NEW DRUG APPLICATION FOR RIVOCERANIB IN COMBINATION WITH CAMRELIZUMAB AS A FIRST-LINE TREATMENT FOR UNRESECTABLE HEPATOCELLULAR CARCINOMA

FORT LEE, NEW JERSEY, July 17, 2023 – Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. And a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced that the U.S. Food and Drug Administration (FDA) accepted a new drug application […]

July 20, 2023
BioUtah News
Stuart Goldblatt Joins CenExel as CEO

Salt Lake City, July 17, 2023 /GlobeNewswire/ — The CenExel Board of Directors is delighted to announce that Stuart Goldblatt has joined CenExel as our new CEO effective July 17, 2023. Tom Wardle will transition to the role of Executive Chairman, CenExel Board of Directors. Said Tom Wardle, “We are very excited to have a […]

July 13, 2023
BioUtah News
Late-Breaking KidneyIntelX Evidence Released at 83rd American Diabetes Association Scientific Sessions

12 Months KidneyIntelX™ in vitro prognostic testing continued to demonstrate clinical actions that lead to improvement in both diabetes (A1C reductions) and kidney health (eGFR slope improvement) in patients with Type 2 Diabetes and Chronic Kidney Disease LONDON and SALT LAKE CITY, July 07, 2023 (GLOBE NEWSWIRE) — Renalytix plc (NASDAQ: RNLX) (LSE: RENX) today […]

July 13, 2023
BioUtah News
Recursion Announces Collaboration and $50 Million Investment from NVIDIA to Accelerate Groundbreaking Foundation Models in AI-Enabled Drug Discovery

Companies to collaborate on software for biotech and pharmaceutical companies to create improved patient treatments faster SALT LAKE CITY, TORONTO and MONTRÉAL, July 12, 2023 (GLOBE NEWSWIRE) — Recursion (NASDAQ: RXRX), a leading clinical stage TechBio company decoding biology to industrialize drug discovery, today announced a $50 million investment by NVIDIA, which was executed as […]

July 13, 2023
BioUtah News
FDA Approves ARUP Laboratories’ AAV5 DetectCDx™, a First-Ever Companion Diagnostic Immunoassay for a Gene Therapy

SALT LAKE CITY—ARUP Laboratories today announced that the U.S. Food and Drug Administration (FDA) has approved AAV5 DetectCDx™ as a companion diagnostic to aid in the selection of adult patients eligible for treatment with ROCTAVIAN™ (valoctocogene roxaparvovec-rvox). ROCTAVIAN™, a new gene therapy developed by BioMarin Pharmaceutical Inc., received contemporaneous FDA approval for the treatment of […]

July 13, 2023
BioUtah News
IONIQ is “Best Diagnostic Testing Solution 2023”

Salt Lake City, UT, July 7, 2023 –Medtech Breakthrough has awarded IONIQ Sciences the “Best Diagnostic Testing Solution of 2023″ (link). Our mission is to “break through” the screening status quo to catch cancer early. You and your doctor could know in just 20 minutes with no needles, no radiation, and no surgery. Watch this […]

July 13, 2023
BioUtah News
BioUtah Members Can Get Discounted Registration to the 2023 RESI conference

BioUtah partnered with Life Science Nation to get you the Super Early Bird prices to the largest early-stage life science partnering conference called Redefining Early-Stage Investments (RESI). RESI takes place across 3-days from September 18th – 20th in a hybrid format. The first day on September 18th is onsite at the Boston Park Plaza Hotel […]

July 6, 2023
BioUtah News
Myriad Genetics Announces New $90 Million Asset-Based Credit Facility

SALT LAKE CITY, July 06, 2023 (GLOBE NEWSWIRE) — Myriad Genetics, Inc., (NASDAQ: MYGN), a leader in genetic testing and precision medicine, today announced that it has established a new $90 million asset-based credit facility (the “ABL Facility”) with JPMorgan Chase Bank, N.A. as administrative agent and issuing bank, and the other lender parties thereto […]

July 6, 2023
BioUtah News
Renalytix Appoints Financial Executive Catherine Coste to its Board of Directors

LONDON and SALT LAKE CITY, July 03, 2023 (GLOBE NEWSWIRE) — Renalytix plc (NASDAQ: RNLX) (LSE: RENX), the first company to commercialize an FDA approved artificial intelligence (AI) enabled prognostic blood test for individuals with Type 2 diabetes and chronic kidney disease, announces the appointment of Catherine Coste to the Company’s Board of Directors, effective June 30, 2023. […]

June 29, 2023
BioUtah News
CancerVAX Reports Significant Progress on Universal Cancer Vaccine Development at UCLA

Three separate teams of physician scientists at UCLA working on three different parts of the project have made significant progress and are ready to merge their work into a complete proof-of-concept vaccine construct

June 29, 2023
BioUtah News
Ultradent Adds New Cordless Prophy Handpiece

Ultradent Products, Inc. is announcing the addition of the Ultrapro™ Tx Cordless handpiece to its prestigious Ultrapro™ Tx prophylaxis family

June 29, 2023
BioUtah News
CLENE ANNOUNCES PUBLICATION OF PHASE 2 CNM-AU8® CLINICAL DATA FOR THE TREATMENT OF ALS IN LANCET’S ECLINICALMEDICINE

Peer-reviewed publication includes data from the CNM-Au8 Phase 2 RESCUE-ALS trial and its open-label-extension, up to 120 weeks of patient follow-up

June 29, 2023
BioUtah News
Recursion Celebrates Opening of Its Canadian Headquarters in Toronto with Government Officials and the Biotech Ecosystem

Recursion Celebrates Opening of Its Canadian Headquarters in Toronto with Government Officials and the Biotech Ecosystem

June 29, 2023
BioUtah News
Intermountain Health Opens New Outpatient Surgery Center on TOSH Campus in Murray

Intermountain Health Opens New Outpatient Surgery Center on TOSH Campus in Murray

June 15, 2023
BioUtah News
CancerVAX Reports Positive Progress on Kids Cancer Immunotherapy Treatment

UCLA research team has successfully created 7 pre-clinical monoclonal antibody candidates for targeting Ewing sarcoma

June 15, 2023
BioUtah News Federal News
FDA Issues Final Guidance on Content of Premarket Submissions for Device Software Functions

On June 13, the U.S. Food and Drug Administration (FDA) issued the final guidance: Content of Premarket Submissions for Device Software Functions. The final guidance provides information regarding the recommended documentation sponsors should include in premarket submissions for the FDA’s evaluation of the safety and effectiveness of device software functions. The guidance replaces the FDA’s […]

June 15, 2023
BioUtah News Policy News
Denali Therapeutics, Alucent Biomedical, Present to Utah Life Sciences Innovation Caucus

Utah legislators on Wednesday, June 14, held a meeting of the Utah Life Sciences Innovation Caucus (ULSIC) at the state capitol. BioUtah President and CEO, Kelvyn Cullimore, kicked off the meeting and introduced representatives from Denali Therapeutics and Alucent Biomedical who presented before the ULSIC. Cindy Dunkle, chief people officer for Denali, described the company’s […]

June 14, 2023
BioUtah News
Recursion’s Phase 2 Trial for the Treatment of Cerebral Cavernous Malformation has Fully Enrolled

Recursion’s small molecule is the first therapeutic candidate to be advanced to an industry-sponsored Phase 2 clinical trial for cerebral cavernous malformation (CCM). CCM is a devastating neurovascular disease with approximately 360,000 symptomatic patients in the United States and EU5.

June 14, 2023
BioUtah News
Myriad Genetics Announces Research Collaboration to use Minimal Residual Disease Testing Platform

Myriad to support MD Anderson researchers studying metastatic renal cell carcinoma treatment selection and response

June 8, 2023
BioUtah News
Merit Medical Announces Acquisition of Dialysis Catheter Portfolio and the BioSentry® Biopsy Tract Sealant System from AngioDynamics, Inc. and Acquisition of the Surfacer® Inside-Out® Access Catheter System from Bluegrass Vascular Technologies, Inc.

Acquisitions broaden Merit’s therapeutic platform with diverse dialysis product solutions and expand its access catheter offering Acquisitions projected to add approximately $30 million of revenue, on an annualized basis, in key strategic markets that leverage existing commercial footprint Merit re-affirms full-year 2023 financial guidance on stand-alone basis and updates full-year 2023 financial guidance to include […]

June 1, 2023
BioUtah News
KOLOSIS BIO AND MTF BIOLOGICS FORGE STRATEGIC PARTNERSHIP TO ENTER SURGICAL INCISION MARKET

SALT LAKE CITY, Utah – May 30, 2023 (OrthoSpineNews)- Kolosis BIO (Kolosis), a leading provider of biologics solutions, and MTF Biologics, a global tissue processor and nonprofit organization, are excited to announce their partnership in the surgical incision market. This strategic collaboration represents Kolosis BIO’s expansion into a new area of healthcare, while providing MTF […]

May 31, 2023
BioUtah News
Sera Prognostics Announces Commercial Changes and Actions to Optimize Business for Market Success Toward Accelerating Test Adoption and Revenue

Aligning Management Team given New Refined Commercial Focus on Institutions Starting with Recent Appointment of Board Member Zhenya Lindgardt as Interim President and CEO Engages Leading Strategy House to Evaluate Best Pathways Toward Targeting Enhanced Revenue Generation at Significantly Reduced Operating Costs Nadia Altomare Expected to Move from Chief Commercial Officer to Consulting Role to […]