Dialysis

Inspira™ Announces 95% Accuracy Results for HYLA™ Blood Sensor, Planning FDA Submission for Clearance in 2024

Retrieved on: 
Tuesday, December 26, 2023

This breakthrough, in achieving 95% accuracy compared to standard blood gas analyzers, brings continuous and real-time blood monitoring capabilities compared to traditional blood gas analyzer systems used in hospitals that typically require intermittent blood draws.

Key Points: 
  • This breakthrough, in achieving 95% accuracy compared to standard blood gas analyzers, brings continuous and real-time blood monitoring capabilities compared to traditional blood gas analyzer systems used in hospitals that typically require intermittent blood draws.
  • This sensor technology is designed to be integrated with the Company's INSPIRA ART100 and was submitted to the FDA in September 2023, with clearance anticipated in the first half of 2024.
  • The HYLA™ Blood Sensor line (the "Blood Sensor") is set to transform intensive care unit (ICU) operations, offering continuous, real-time blood data collection and analysis.
  • This approach has enabled to define the Blood Sensor's disposable materials and methods, with HYLA's planned razor blade business model.

Jemincare Announces 6 Approvals of Clinical Trials for its Innovative Drugs

Retrieved on: 
Tuesday, December 26, 2023

On December 20, NMPA has approved a clinical trial for JMKX003801 to treat serious infection caused by Gram-negative bacteria.

Key Points: 
  • On December 20, NMPA has approved a clinical trial for JMKX003801 to treat serious infection caused by Gram-negative bacteria.
  • Drug resistance of antibiotics, especially carbapenem resistance, in Escherichia coli, Klebsiella pneumoniae, Acinetobacter baumannii and Pseudomonas aeruginosa has risen year by year.
  • On December 12, NMPA has approved a clinical trial for JMKX003142 to treat renal edema.
  • On December 12, FDA has approved a clinical trial for JMKX000197 to treat BCG-unresponsive non-muscle-invasive bladder cancer, and earlier on October 19, NMPA has approved the clinical trial.

Xlife Sciences AG paves the way for the next successful out-licensing and announces cooperation with Quant Biomarkers AG for the development of advanced biomarkers for kidney diseases

Retrieved on: 
Wednesday, December 20, 2023

Subsequent therapy slows the progression towards dialysis or kidney replacement, but does not lead to a curation of the disease.

Key Points: 
  • Subsequent therapy slows the progression towards dialysis or kidney replacement, but does not lead to a curation of the disease.
  • Xlife Sciences AG, through its portfolio company x-kidney diagnostics GmbH, has identified biomarkers that predict kidney failure at its pre-clinical stages.
  • Concurrently, Quant Biomarkers AG is actively pursuing intellectual property rights for specific combinations of kidney biomarkers, intending to use them for both diagnostic and prognostic purposes.
  • Oliver R. Baumann, CEO of Xlife Sciences AG, stated «Our collaboration with Quant Biomarkers AG represents a pivotal moment in our mission to transform healthcare through innovation.

Outstanding 12-month first-in-human data from Xeltis’ aXess hemodialysis vascular conduit trial presented at VEITHsymposium 2023

Retrieved on: 
Friday, November 17, 2023

The data was presented yesterday by Prof. Dr. Frans Moll at the 50th Annual VEITHsymposium in New York.

Key Points: 
  • The data was presented yesterday by Prof. Dr. Frans Moll at the 50th Annual VEITHsymposium in New York.
  • At 12 months, 100% secondary patency, 78% primary assisted patency and 0% infections were observed in data from 20 patients implanted with the aXess conduit.
  • This performance builds on the very encouraging 6-month data presented in April 2023 at the Vascular Access Society Congress in Porto, Portugal.
  • aXess is a restorative conduit which enables the creation of a new, long-term living vessel for hemodialysis vascular access.

Outset Medical (OM) Investigated for Possible Securities Law Violations: Hagens Berman, National Trial Attorneys, Encourages Investors with Losses to Contact the Firm’s Attorneys

Retrieved on: 
Thursday, November 16, 2023

SAN FRANCISCO, Nov. 16, 2023 (GLOBE NEWSWIRE) -- Hagens Berman urges Outset Medical, Inc. (NASDAQ: OM) investors who suffered substantial losses to submit your losses now .

Key Points: 
  • SAN FRANCISCO, Nov. 16, 2023 (GLOBE NEWSWIRE) -- Hagens Berman urges Outset Medical, Inc. (NASDAQ: OM) investors who suffered substantial losses to submit your losses now .
  • In late July 2022, Outset disclosed the FDA cleared the 510(k) application of Tablo for patient use in the home.
  • More recently, on Oct. 12, 2023, Outset Medical reported disappointing preliminary Q3 2023 revenues and slashed its FY 2023 revenue guidance.
  • “We’re focused on investors’ losses and investigating whether Outset may have misled investors about Tablo’s near-term prospects,” said Reed Kathrein, the Hagens Berman partner leading the investigation.

Microbix Clot-Buster Drug Fully-Funded For Return to U.S. Market

Retrieved on: 
Thursday, November 16, 2023

A further payment of US$ 2.0 million has been received by Microbix relating to this reconfirmation.

Key Points: 
  • A further payment of US$ 2.0 million has been received by Microbix relating to this reconfirmation.
  • Kinlytic is already approved for clinical use in the U.S. and the parties’ work is to validate new manufacturing for the drug and to re-enter the market by way of a supplemental biologics licensing application (“sBLA”).
  • As detailed in May, Microbix will receive further milestone and royalty payments tied to the re-launch of Kinlytic.
  • We are now delighted to be working closely with Sequel leadership to restore availability of this clinically-important biologic drug.

XPHOZAH® (tenapanor) Granted Orphan Drug Designation by U.S. FDA for the Treatment of Pediatric Hyperphosphatemia

Retrieved on: 
Wednesday, November 15, 2023

WALTHAM, Mass., Nov. 15, 2023 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to XPHOZAH® (tenapanor) for the treatment of pediatric hyperphosphatemia.

Key Points: 
  • WALTHAM, Mass., Nov. 15, 2023 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to XPHOZAH® (tenapanor) for the treatment of pediatric hyperphosphatemia.
  • XPHOZAH is a single tablet taken twice daily that offers a first-in-class mechanism of action that blocks phosphate absorption through its primary pathway.
  • “We are pleased that the FDA has recognized the important need among pediatric patients with hyperphosphatemia for treatment options,” said Mike Raab, president and chief executive officer of Ardelyx.
  • In October, XPHOZAH was approved by the FDA to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy.

SeaStar Medical Reports Third Quarter 2023 Financial Results and Provides a Business Update

Retrieved on: 
Tuesday, November 14, 2023

DENVER, Nov. 14, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, reports financial results for the three and nine months ended September 30, 2023 and provides a business update.

Key Points: 
  • DENVER, Nov. 14, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, reports financial results for the three and nine months ended September 30, 2023 and provides a business update.
  • “Recent clinical and regulatory successes have significantly improved and strengthened our company’s prospects,” said Eric Schlorff, SeaStar Medical CEO.
  • SeaStar Medical expects regulatory approval for the SCD-ADULT in the first half of 2025 and commercial launch in the second half of 2025.
  • The Company issued two convertible notes each for $0.5 million in August 2023 and a third convertible note for $0.5 million in September 2023.

Unicycive Announces Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, November 14, 2023

LOS ALTOS, Calif., Nov. 14, 2023 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY) (the “Company” or “Unicycive”), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the third quarter ended September 30, 2023, and provided a business update.

Key Points: 
  • LOS ALTOS, Calif., Nov. 14, 2023 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY) (the “Company” or “Unicycive”), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the third quarter ended September 30, 2023, and provided a business update.
  • We also remain very active within the the medical community with a booth at Kidney Week and positive results published on the phosphate binding capacity for OLC,” concluded Dr. Gupta.
  • Unicycive believes that results from this pivotal trial will enhance the OLC data package from preclinical studies and our previously disclosed bioequivalence study.
  • Dr. Kenkare-Mitra brings Unicycive expertise spanning research, preclinical and clinical development, translational medicine, manufacturing, and regulatory.

ProKidney Announces Positive Interim Data from RMCL-002 Phase 2 Clinical Trial of Renal Autologous Cell Therapy (REACT®) for Diabetic CKD and Provides Corporate Updates

Retrieved on: 
Monday, November 13, 2023

Positive interim Phase 2 data demonstrate the potential of REACT® to preserve kidney function in moderate and high-risk diabetic CKD patients.

Key Points: 
  • Positive interim Phase 2 data demonstrate the potential of REACT® to preserve kidney function in moderate and high-risk diabetic CKD patients.
  • Updated interim REACT RMCL-002 study data support continued investigation of REACT’s potential to benefit patients with moderate and high-risk diabetic CKD.
  • The ongoing Phase 2 clinical study assessed adverse events and changes in kidney function as measured by estimated glomerular filtration rate (eGFR), as primary study endpoints.
  • Further, you may listen to the presentation by dialing 1-877-407-0784 (US) or 1-201-689-8560 (International) and entering the Conference ID: 13742672.