Creates Pathway for Beneficiary Access to KidneyIntelX for Medicare Beneficiary Kidney Disease PopulationsNEW YORK, Jan. 13, 2021 (GLOBE NEWSWIRE) -- The Centers for Medicaid & Medicare (CMS) announced the establishment of the Medicare Coverage of Innovative Technology (MCIT) pathway (RIN: 0938-AT88), to provide a coverage pathway for Medicare beneficiaries nationwide to have faster access to new, innovative medical devices and diagnostic tests designated under the Breakthrough Device review program and with market authorization by the U.S. Food and Drug Administration (FDA). Under MCIT, national Medicare coverage can become effective on the date of FDA approval or clearance of a breakthrough designated device and will continue for a period of four years. After a four-year period, continued coverage for Medicare beneficiaries will be based on one of three methods, 1) case-by-case coverage, 2) a local coverage determination, or 3) a national coverage determination. “Having a clear path to national Medicare coverage for innovative products like KidneyIntelX provides a major catalyst to drive the robust research and clinical development programs necessary to address major unmet medical needs such as kidney disease,” stated Tom McLain, President, RenalytixAI. “MCIT will also encourage early engagement with FDA in developing new diagnostic tests and leverage the many benefits of Breakthrough Designation including priority review of needed technology. We appreciate the opportunity to work with FDA and CMS to tackle the critical issue of early stage prognosis to help slow or prevent kidney disease progression. This new coverage pathway will facilitate accelerated access to KidneyIntelX for Medicare beneficiaries and their primary care doctors to help assure a better quality of life and save lives.”RenalytixAI’s lead product, KidneyIntelX, was granted FDA breakthrough designation in May 2019. After working closely with the FDA review team assigned to KidneyIntelX the company submitted its DeNovo 510K application for clearance in August 2020. Assuming FDA clearance is received in 2021, Renalytix will opt in for the automatic four-year National Medicare coverage period. In addition to the MCIT coverage pathway for the test, Renalytix has already designed a prospective utility and outcome study. The aim of the 2,000-patient study is to further demonstrate the clinical value of KidneyIntelX testing in delaying or preventing the progression of early-stage diabetic kidney disease.About Kidney Disease Kidney disease is now recognized as a public health epidemic affecting over 850 million people globally. The Centers for Disease Control and Prevention (CDC) estimates that 15% of US adults, or 37 million people, currently have chronic kidney disease (CKD). Further, the CDC reports that 9 out of 10 adults with CKD do not know they have it and 1 out of 2 people with very low kidney function who are not on dialysis do not know they have CKD*. Kidney disease is referred to as a "silent killer" because it often has no symptoms and can go undetected until a very advanced stage. Each year, kidney disease kills more people than breast and prostate cancer. Every day, 13 patients in the United States die while waiting for a kidney transplant.* https://www.cdc.gov/kidneydisease/publications-resources/2019-national-facts.htmlAbout RenalytixAIRenalytixAI (NASDAQ:RNLX) is a developer of artificial intelligence-enabled clinical in vitro diagnostic solutions for kidney disease, one of the most common and costly chronic medical conditions globally. The Company’s lead product is KidneyIntelX.com (visit www.kidneyintelx.com) which is being designed to help make significant improvements in kidney disease prognosis, transplant management, clinical care, patient stratification for drug clinical trials, and drug target discovery. For more information, visit www.renalytixai.com.Forward-Looking StatementsStatements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Examples of these forward-looking statements include statements concerning: the potential for KidneyIntelX to receive regulatory approval from the FDA, the commercial prospects of KidneyIntelX, if approved, including whether KidneyIntelX will be successfully distributed and marketed, our ability to take advantage of the MCIT program, our expectations regarding reimbursement decisions and the ability of KidneyIntelX to curtail costs of chronic and end-stage kidney disease, optimize care delivery and improve patient outcomes. Words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “plans,” “seeks,” and similar expressions are intended to identify forward-looking statements. We may not actually achieve the plans and objectives disclosed in the forward-looking statements, and you should not place undue reliance on our forward-looking statements. Any forward-looking statements are based on management's current views and assumptions and involve risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. These risks and uncertainties include, among others: that KidneyIntelX is based on novel artificial intelligence technologies that are rapidly evolving and potential acceptance, utility and clinical practice remains uncertain; we have only recently commercially launched KidneyIntelX; and risks relating to the impact on our business of the COVID-19 pandemic or similar public health crises. These and other risks are described more fully in our filings with the Securities and Exchange Commission (SEC), including the “Risk Factors” section of our final prospectus filed with the SEC on July 17, 2020, and other filings we make with the SEC from time to time. All information in this press release is as of the date of the release, and we undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law. CONTACT: Media Contacts: United States: Jennifer Moritz Zer0 to 5ive for RenalytixAI (917) 748-4006 firstname.lastname@example.org Outside of the United States: Walbrook PR Limited Paul McManus / Lianne Cawthorne Tel: 020 7933 8780 or email@example.com Mob: 07980 541 893 / 07584 391 303
Renalytix AI (RNLX) saw a big move last session, as its shares jumped nearly 7% on the day, amid huge volumes.
Here's a roundup of top developments in the biotech space over the last 24 hours.Scaling The Peaks (Biotech Stocks Hitting 52-week Highs Jan. 5) * Curis, Inc. (NASDAQ: CRIS) * Endo International PLC (NASDAQ: ENDP) * Fulgent Genetics Inc (NASDAQ: FLGT) * Genmab 10 Sponsored ADR Ord Shs (NASDAQ: GMAB) * \I-Mab ADR (NASDAQ: IMAB) * Jaguar Health Inc (NASDAQ: JAGX) * Johnson & Johnson (NYSE: JNJ) * LeMaitre Vascular Inc (NASDAQ: LMAT) * Oncorus Inc (NASDAQ: ONCR) * Organogenesis Holdings Inc (NASDAQ: ORGO) * Pulse Biosciences Inc (NASDAQ: PLSE) * Renalytix AI PLC (NASDAQ: RNLX) (announced a partnership with Davita Inc (NYSE: DVA) aimed at slowing disease progression and improving health outcomes in with chronic kidney disease patients) * Shockwave Medical Inc (NASDAQ: SWAV) * Silence Therapeutics ADR Representing 3 Ord Shs (NASDAQ: SLN) * United Therapeutics Corporation (NASDAQ: UTHR) * Vincera Pharma Inc (NASDAQ: VINC)Down In The Dumps (Biotech Stocks Hitting 52-week Lows Jan. 5) * 4D Molecular Therapeutics Inc (NASDAQ: FDMT)Stocks In Focus Aerpio To Review Strategic Alternatives; Reports Positive Phase 2 Results For Glaucoma Treatment Aerpio Pharmaceuticals Inc (NASDAQ: ARPO) said it has initiated a process to explore and review a range of strategic alternatives focused on maximizing stockholder value.The company also announced topline results from a Phase 2 study of razuprotafib in glaucoma, showing that patients treated with razuprotafib twice daily plus latanoprost demonstrated a statistically significant change from baseline in diurnal mean interocular pressure at Day 28 of study, compared to those treated with latanoprost monotherapy.Further analysis showed the combo had a larger IOP reduction after longer duration dosing and produced larger IOP reductions in patients with higher starting IOP.The stock rallied 12.15% to $1.20 in after-hours trading.Hologic To Buy Privately-held Cancer Diagnostics Company For $230M Hologic, Inc. (NASDAQ: HOLX) announced an agreement to acquire Biotheranostics, Inc., a privately held, commercial-stage company that provides molecular diagnostic tests for breast and metastatic cancers, for approximately $230 million, subject to working capital and other customary closing adjustments."Acquiring Biotheranostics enables us to jump-start our entry into a large, fast-growing oncology adjacency that fits perfectly with our broader corporate focus and passion for women's health," said Kevin Thornal, Hologic's Division President, Diagnostics.Myriad to Review Strategic Alternatives For Autoimmune Business, Refocuses Efforts on High-growth International Markets Following completion of its strategic business unit and products review, Myriad Genetics, Inc. (NASDAQ: MYGN) said it's pursuing strategic alternatives for our Autoimmune business and realigning its International business unit to streamline operations, reduce complexity and cost, and concentrate on our biggest growth opportunities.The restructuring of International operations will focus direct selling efforts on high-growth market opportunities in Germany, France, and Japan, while the remaining international markets will be served through alternative business models, including authorized distributor partnerships.This realignment, the company said, will lead to about $5 million in incremental cost savings upon full implementation.AIM ImmunoTech Commences Study of Treatment For Post-COVID-19 Fatigue-like Symptoms AIM ImmunoTech Inc (NYSE: AIM) said it has dosed its first COVID-19 "Long Hauler" patient with the drug Ampligen, marking a significant milestone in its efforts to develop an effective therapeutic for people suffering from post-COVID-19 infection chronic fatigue-like symptoms. Additional patients are in the process of being enrolled.TransEnterix Preannounces Above-consensus Q4, FY20 Revenues Transenterix Inc (NYSE: TRXC) said it expects revenues for the fourth quarter to be about $1.1 million and full-year revenues to be $3 million to $3.2 million. This surrounded the consensus estimates for $1.04 million for the quarter and $3.11 million for 2020.Stealth's Pre-NDA Meeting Request For Cardiomyopathy Treatment Granted By FDA Stealth BioTherapeutics Corp (NASDAQ: MITO) said its plan to meet with the FDA's Division of Cardiology and Nephrology regarding its upcoming NDA submission for elamipretide for the treatment of cardiomyopathy in Barth syndrome."We are encouraged by the agency's acceptance of our Pre-NDA meeting request," said Reenie McCarthy, CEO of Stealth."We view this upcoming meeting as an important next step toward our goal of bringing elamipretide to patients suffering from this ultra-rare disease and hope that it may also inform our future development efforts in other rare cardiomyopathies."Illumina to Collaborate With Helix For Surveillance of Novel Strains of Coronavirus In U.S. Illumina, Inc. (NASDAQ: ILMN) announced a collaboration with Helix to augment national surveillance infrastructure in the U.S. to track the emergence and prevalence of novel strains of SARS-CoV-2 with support from the CDC. The combination of Illumina's sequencing technology and expertise and Helix's national COVID-19 testing footprint will significantly expand the country's existing surveillance efforts to detect and characterize emerging variants of SARS-CoV-2, the company said.Nektar Announces Departure of Chief Medical Officer Nektar Therapeutics (NASDAQ: NKTR) announced the appointment of Brian Kotzin, as interim chief medical officer, Head of Development effective immediately. This follows the decision by the incumbent, Wei Lin, to leave the company to pursue another opportunity.Offerings NeoGenomics, Inc. (NASDAQ: NEO) announced that it has commenced proposed underwritten public offerings of approximately $200 million worth of newly issued shares of common stock and $250 million worth of aggregate principal amount of convertible senior notes due 2028.The stock ended down 4.81% to $ 52.20 in after-hours trading.Eyegate Pharmaceuticals Inc (NASDAQ: EYEG) said it has entered into a securities purchase agreement in connection with a private placement with an affiliate of Armistice Capital for aggregate gross proceeds of approximately $8 million.On The Radar Moderna Inc's (NASDAQ: MRNA) coronavirus vaccine candidate will be reviewed by the European Medicines Agency's Committee For Medical Products For Human Use in a meeting. Although the regulator has given a deadline of Jan. 12 for making a decision regarding conditional approval for the vaccine in Europe, a verdict could come as early as Wednesday.See more from Benzinga * Click here for options trades from Benzinga * The Daily Biotech Pulse: Moderna Coronavirus Vaccine Receives Third Regulatory Nod, Gritstone Rallies On Hedge Fund Stake, aTyr's COVID-19 Drug Data * Attention Biotech Investors: Mark Your Calendar For January PDUFA Dates(C) 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.