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Recent BioUtah News & Events

Everything Happening in Utah Life Sciences

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 […]

May 25, 2023
BioUtah News
Altitude Lab Relocates to Gateway’s BioHive Hub

Altitude’s new facility will be housed within Recursion’s expanded headquarters and will promote increased collaboration in Downtown Salt Lake City’s rapidly growing biotech innovation ecosystem.SALT LAKE CITY, May 25, 2023 (GLOBE NEWSWIRE) — Altitude Lab announced today that its incubator program and facility will leave Research Park to grow its operation in the Gateway’s BioHive […]

May 25, 2023
BioUtah News
Clene Awarded Grant From National Multiple Sclerosis Society to Advance Development of CNM-Au8® in Non-Active Progressive Multiple Sclerosis

SALT LAKE CITY, May 25, 2023 (GLOBE NEWSWIRE) — Clene, Inc. (Nasdaq: CLNN), along with its subsidiaries “Clene” and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative disease, today announced that Clene has received a grant from the National Multiple Sclerosis Society (NMSS) via the […]

May 25, 2023
BioUtah News
Renalytix selects EVERSANA® to expand commercialization of KidneyIntelX for Early-Stage Kidney Disease Prognosis Detection in Patients with Type 2 Diabetes

Model expected to accelerate deployment of KidneyIntelX across key U.S. regions with high rates of diabetic kidney disease and established insurance coverage LONDON and CHICAGO, May 25, 2023 (GLOBE NEWSWIRE) — Renalytix (NASDAQ: RNLX) (LSE: RENX), the first company to develop and commercialize an artificial intelligence (AI) powered in-vitro diagnostic for kidney disease, has selected […]

May 25, 2023
BioUtah News
MedVenture Health Acquires Canyon Labs in Move to Bolster Services

In a strategic move to further enhance its service offering, MedVenture Health has announced the acquisition of Canyon Labs to add regulatory and laboratory testing services to its deep portfolio. SALT LAKE CITY, UT / ACCESSWIRE / May 19, 2023 / MedVenture Health, a specialized private investment firm devoted to the advancement of medical devices, […]

May 25, 2023
BioUtah News
Myriad Genetics Adds Folate Receptor Alpha to Precise™ Oncology Solutions Portfolio to Expand Treatment Options for Women Living with Ovarian Cancer

Biomarker offers another companion diagnostic option to establish eligibility for FDA-approved drug ELAHERE® SALT LAKE CITY, May 24, 2023 (GLOBE NEWSWIRE) — Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, today announced the addition of Folate Receptor Alpha (FRα) to its Precise™ Oncology Solutions portfolio. The new biomarker adds another […]

May 25, 2023
BioUtah News
Canary Speech Accelerates AI Speech Analysis Technology with Microsoft Cloud for Healthcare Integration

Digital vocal biomarker innovator integrates clinical-grade technology providing real-time speech analysis on Microsoft Cloud for Healthcare. PROVO, Utah, May 24, 2023 /PRNewswire/ — Canary Speech, Inc. announced today that it will apply the power of artificial intelligence (AI) voice analysis technology to address a variety of mental health challenges and enable early intervention, reduce healthcare […]

May 24, 2023
BioUtah News
Dynatronics Announces Planned Resignation of John Krier as CEO; Brian Baker Appointed President and CEO Successor after Transition

EAGAN, MN / ACCESSWIRE / May 18, 2023 / Dynatronics Corporation (NASDAQ:DYNT), a leading manufacturer of athletic training, physical therapy, and rehabilitation products, today announced that Chief Executive Officer and Director John Krier has informed the Board of his intention to resign from the company by the end of September 2023 to pursue other professional […]

May 18, 2023
Policy News
House Health Panel Advances Legislation on PBM’s, Generic Drugs

The Energy and Commerce Health Subcommittee on Wednesday voted to advance a series of healthcare bills, largely on a bipartisan basis. The bills included reforms to the practices of pharmacy benefit managers (PBMs), improving access to generic drugs, and increasing transparency into the prices that hospitals, laboratories, and insurance companies charge. Of particular interest to the life […]

May 18, 2023
BioUtah News
Teva Launches New “Pivot to Growth” Strategy

Return to growth by accelerating a strong innovative medicines portfolio Expand innovative pipeline and focus on core therapeutic areas with first-in-class and best-in-class opportunities Sustain generics powerhouse based on high-value and complex products Focus the business on areas with the greatest potential for growth and patient impact TEL AVIV, Israel–(BUSINESS WIRE)– Teva Pharmaceutical Industries Ltd. […]

May 18, 2023
BioUtah News
U.S. Patent Office Grants Additional Patent Protection For Exoskeleton Focal-Force Angioplasty Platform

Transit Scientific awarded increased U.S. patent protection for their novel exoskeleton focal-force angioplasty technology for use with standard off-the-shelf peripheral transluminal angioplasty (PTA) balloons. Park City, Utah USA, May 18, 2023. Transit Scientific, a Utah-based medical device company, today announced newly issued expanded U.S. patent protection for the XO exoskeleton sheath platform from the United States Patent and Trademark Office […]

May 18, 2023
BioUtah News
BD Launches World’s First Spectral Cell Sorter with High-Speed Cell Imaging

FRANKLIN LAKES, N.J., May 18, 2023 /PRNewswire/ — BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, announced the worldwide commercial launch of a new-to-world cell sorting instrument featuring two breakthrough technologies that enable researchers to uncover more detailed information about cells that was previously invisible in traditional flow cytometry experiments. […]

May 18, 2023
BioUtah News
Michele Baptista Joins CenExel Industry powerhouse brings expertise in early phase clinical trial services to CenExel site network

Salt Lake City, Utah — CenExel announces the addition of Michele Baptista as the new Senior Director of Business Development. In this new capacity, Michele will be responsible for developing, selling, and supporting CenExel’s 18-site network for early phase clinical trials, while also identifying new business opportunities and expanding CenExel’s customer base. Michele joins CenExel from WCG IRB, where she […]

May 18, 2023
BioUtah News
Biomerics Announces Merger with Precision Concepts Medical

Biomerics (“Biomerics” or the “Company”), the leading vertically integrated contract manufacturer for the interventional medical device market, announced today that it has entered into definitive agreements to merge with Precision Concepts’ Medical business (“Precision Concepts Medical”). The transaction includes the acquisition of the medical business of Precision Concepts International (“PCI”) as well as Precision Concepts […]

May 18, 2023
BioUtah News
Sera Prognostics Announces Retirement of President and CEO Dr. Greg Critchfield and Appointment of Board Member Zhenya Lindgardt as Interim CEO

SALT LAKE CITY, May 15, 2023 /PRNewswire/ — Sera Prognostics Inc., The Pregnancy Company® (NASDAQ: SERA), focused on improving maternal and neonatal health by providing innovative pregnancy biomarker information to doctors and patients, today announced the retirement of the Company’s President and CEO, Gregory C. Critchfield, M.D., M.S. Dr. Critchfield is retiring after 12 years […]

May 18, 2023
BioUtah News
Recursion Appoints David Mauro, M.D., Ph.D., as Chief Medical Officer

SALT LAKE CITY, May 16, 2023 (GLOBE NEWSWIRE) — Recursion (NASDAQ: RXRX), a leading clinical stage TechBio company decoding biology to industrialize drug discovery, today announced it has appointed David Mauro, M.D., Ph.D, as its Chief Medical Officer. Dr. Mauro will lead Recursion’s pipeline into and through clinical development, including its five programs currently in […]

May 18, 2023
BioUtah News
Nusano and PharmaLogic Announce Collaboration to Enable Next Generation Radiotherapeutics Development

SALT LAKE CITY and BOCA RATON, Fla. – May 15, 2023 – Nusano, Inc., a company reshaping the production of cancer-fighting radioisotopes, and PharmaLogic, a world-class contract development and manufacturing organization (CDMO) specializing in radiopharmaceuticals, today announced the two organizations will collaborate to advance the development of radiopharmaceuticals for diagnostic and therapeutic applications.   “PharmaLogic […]

May 18, 2023
BioUtah News
EY Announces Marcus Gerhardt and Florian Solzbacher of Blackrock Neurotech as Entrepreneur Of The Year® 2023 Mountain West Award Finalists

SALT LAKE CITY, May 8, 2023 – Ernst & Young LLP (EY US) today announced that Marcus Gerhardt, co-founder and CEO, and Florian Solzbacher, co-founder and President, of Blackrock Neurotech were named Entrepreneur Of The Year® 2023 Mountain West Award finalists. Now in its 37th year, Entrepreneur Of The Year is one of the preeminent […]

May 11, 2023
Policy News
Representative Blake Moore Stands Up for Innovation

The House Ways and Means Subcommittee on Health on May 10 held a hearing examining government policies that inhibit medical innovation and patient access. Utah Representative Blake Moore (R-UT), a member of the subcommittee, raised concerns about the lack of an expedited Medicare coverage pathway for breakthrough medical technologies. He specifically called out how repeal […]

May 11, 2023
BioUtah News
NUSANO ANNOUNCES IN-HOUSE STABLE ISOTOPE PROGRAM LED BY RENOWNED PHYSICIST SARKO CHEREKDJIAN

VALENCIA, Calif. and WEST VALLEY CITY, Utah – May 11, 2023 – Nusano, Inc., a company reshaping the production of cancer-fighting radioisotopes, today announced it is creating an in-house stable isotope program to enhance the company’s medical radioisotope production capabilities and decrease dependence on foreign supply chains. “Enriched, stable isotopes are foundational material for manufacturing […]

May 11, 2023
BioUtah News
Foldax, Inc. Receives Full Ownership Rights to Proprietary Polymer Patent Portfolio

SALT LAKE CITY–(BUSINESS WIRE)–Foldax® Inc. today announced that it has executed an agreement with Australia’s national science agency, CSIRO, for full ownership of a polymer technology patent family. Foldax has incorporated the polymer technology into its LifePolymer™ materials platform and has conducted testing, which indicates the materials are compatible with blood, with low adherence of […]

May 11, 2023
BioUtah News
Bruce Hunter named new Interim Chief Innovation and Economic Engagement Officer

By Xoel Cardenas, Sr. Communications Specialist, Office of the Vice President for Research The Partners for Innovation, Ventures, Outreach & Technology (PIVOT) Center at the University of Utah has named Bruce Hunter as the Interim Chief Innovation and Economic Engagement Officer. Hunter succeeds the role from Dr. Keith Marmer, who served as a leader for the university’s […]

May 11, 2023
BioUtah News
Recursion Enters into Agreements to Acquire Cyclica and Valence to Bolster Chemistry and Generative AI Capabilities

SALT LAKE CITY and TORONTO and MONTRÉAL, May 08, 2023 (GLOBE NEWSWIRE) — Recursion (NASDAQ: RXRX), a leading clinical stage TechBio company decoding biology to industrialize drug discovery, today announced it has signed agreements to acquire two companies in the AI-enabled drug discovery space: Cyclica and Valence. “Recursion has pioneered the massive, parallel generation of […]

May 11, 2023
BioUtah News
Vistim Labs Closes First Round of Funding

Vistim Labs Closes First Round of Funding

May 11, 2023
BioUtah News
Culmination Bio and Cofactor Genomics Leverage Largest Biobank in the U.S. for PREDAPT Precision Medicine Clinical Trial

Respective leaders in healthcare innovation and RNA diagnostics team up to identify patients who will benefit from immunotherapy

May 4, 2023
BioUtah News
BD Recognized by DiversityInc as a Top U.S. Company for Diversity in 2023 List

FRANKLIN LAKES, N.J., May 3, 2023 /PRNewswire/ — BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced that it has been named a “Noteworthy Company” in DiversityInc’s annual ranking of the top U.S. companies for diversity. Since 2001, the DiversityInc Top 50 survey has been the external validator for […]