After going to Capitol Hill yesterday to try to rally support from House Democrats, President Biden announced a framework for a $1.75 T “Build Back Better” social spending plan. The framework, which comes after months of negotiations with party moderates and progressives who have not seen eye-to-eye on policies and pay-fors, is still subject to […]
CMS Proposes MCIT Repeal On September 13, CMS issued a proposed rule to repeal the Medicare Coverage of Innovative Technology (MCIT) pathway initally finalized in a January 14, 2021 rule. The MCIT pathway would have provided four years of immediate Medicare coverage for FDA-designated breakthrough medical devices and diagnostics that have been market authorized – […]
Congressional committees this week got down to business writing the details of the Biden Administration’s $3.5 trillion “Build Back Better” reconciliation bill. Of particular interest to the life sciences industry was consideration of drug price control provisions in the House Energy and Commerce and Ways and Means Committees. In its version of “Build Back Better,” […]
Last month, BioUtah News and Events reported that the U.S. Ski and Snowboard Team would be using R-Zero’s hospital-grade, whole-room ultraviolet light disinfection system called Arc to mitigate against COVID-19 and other pathogens in their training rooms. […]
On Tuesday, the House Democrats passed a budget blueprint on a party line vote. That blueprint allows Committees in the House to start writing the administration’s $3.5 trillion social spending or “care infrastructure” legislation. Democrats hope to move the spending measure as a reconciliation measure in the Fall. Under the reconciliation process, only 51 votes […]
BioHive on Wednesday was front and center as U.S. Representative Blake Moore (R-UT-1) toured Edwards Lifesciences, BD and Stryker – all leading medical device manufacturers in Utah that provide thousands of good-paying, stable jobs. During the visits, Moore was able to see first-hand the work that these companies do to innovate and produce life-changing technologies. “We […]
PolarityTE on July 28 announced final data from a multi-center randomized controlled trial evaluating treatment of Diabetic Foot Ulcers (DFU) with its investigational product SkinTE®. The trial met the primary endpoint of wound closure at 12 weeks and secondary endpoint of Percent Area Reduction (PAR) assessed at 4, 6, 8, 10, and 12 weeks. Nikolai […]
PolarityTE recently announced that the China National Intellectual Property Administration (CNIPA) issued a Notification of Allowance for Chinese Patent Application No. 201580075326.3. The allowed claims relate to skin-regenerative compositions utilizing PolarityTE’s minimally polarized functional unit (MPFU) technology as well as methods of making a skin-regenerative composition utilizing the MPFU technology. This most recent allowance further […]
PolarityTE on Monday announced the submission of an investigational new drug application (IND) to the FDA seeking authorization to commence a clinical trial to evaluate its SkinTE product for the proposed indication of treatment of chronic cutaneous ulcers. SkinTE is PolarityTE’s human cellular and tissue-based product derived from a patient’s own skin. David Seaburg, Chief Executive […]
Last week, Foldax presented on the company’s innovative Tria valve at the 2021 Transcatheter Valve Technologies (TVT) meeting. View the slides HERE. The presentation titled “Foldax Biopolymer Valves: An Alternative to Tissue Based Leaflet Valves” was given by Foldax investigator, Dr. David Heimansohn, chief of surgery at St. Vincent/Ascension in Indiana and was well received. […]
U.S. Senator Mike Lee (R-UT) on July 16 toured Stryker’s Neurovascular Division with division President, Mark Paul, joined by BioUtah President and CEO, Kelvyn Cullimore and members of the Senator’s staff. During the tour, Lee learned about the innovative, best-in-class technologies manufactured at the Salt Lake City facility to treat stroke patients. Stroke is the […]
Co-Diagnostics has added to its suite of intellectual property protection after being awarded a patent from the Republic of Korea’s Intellectual Property Office for the Company’s CoPrimer™ technology. Developed in 2013, Co-Diagnostics’ solely-owned CoPrimer technology received its first patent from the US Patent Office in 2018, and underpins the company’s molecular diagnostic test products that […]