Biopsy

Central California’s Community Regional Medical Center is the First in the State to Offer Next Generation Robotic Bronchoscopy for Early Diagnosis and Treatment of Lung Cancer

Retrieved on: 
Tuesday, January 30, 2024

Community Regional is the first hospital in California to use this new technology.

Key Points: 
  • Community Regional is the first hospital in California to use this new technology.
  • Lung cancer is the second most common cancer in the United States and the leading cause of cancer deaths in the country.
  • But today, it can be difficult for physicians to properly find and biopsy lung nodules, delaying diagnosis and complicating treatment.
  • “Lung cancer can be a particularly lethal killer in the periphery of the lung, where it’s difficult to locate and remove,” said Dr. Hegde.

500th Use of the Galaxy System™ in the United States Conducted at CHI Memorial in Tennessee

Retrieved on: 
Wednesday, January 24, 2024

SAN CARLOS, Calif., Jan. 24, 2024 (GLOBE NEWSWIRE) -- Medical robotics innovator Noah Medical today announced that the 500th use of its Galaxy System in the United States was conducted at CHI Memorial in Chattanooga by Dr. Krish Bhadra.

Key Points: 
  • SAN CARLOS, Calif., Jan. 24, 2024 (GLOBE NEWSWIRE) -- Medical robotics innovator Noah Medical today announced that the 500th use of its Galaxy System in the United States was conducted at CHI Memorial in Chattanooga by Dr. Krish Bhadra.
  • CHI Memorial is also the first hospital in Tennessee to adopt the Galaxy technology.
  • The procedure marks an important step for Noah in the commercial rollout of its image-integrated robotic assisted bronchoscopy system in the U.S.
  • To learn more about Noah Medical and the Galaxy System, please visit noahmed.com .

Precipio’s Q4-2023 Cash Burn From Operations (unaudited) drops below $100K for the full quarter

Retrieved on: 
Tuesday, January 23, 2024

Cash Burn From Operations (CBFO) declined by over 90% from the previous quarter, from approximately $1M/quarter in Q3-2023 to below $100k/quarter in the following recent quarter Q4-2023.

Key Points: 
  • Cash Burn From Operations (CBFO) declined by over 90% from the previous quarter, from approximately $1M/quarter in Q3-2023 to below $100k/quarter in the following recent quarter Q4-2023.
  • Precipio’s end of quarter cash balance changed from approximately $1.5M at the end of Q3-2024, to approximately $1.4M as of Dec 31, 2023.
  • Notwithstanding the above mentioned “seasonal” effects, the Q4-2023 CBFO results demonstrate the company’s ability to approach cash flow breakeven.
  • “Seeing the results of our business impact cash flow in this way is extremely promising, and further validates our business model.

Sagimet Biosciences Announces Positive Topline Results from Phase 2b FASCINATE-2 Clinical Trial of Denifanstat in Biopsy-Confirmed F2/F3 NASH

Retrieved on: 
Monday, January 22, 2024

SAN MATEO, Calif., Jan. 22, 2024 (GLOBE NEWSWIRE) --  Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors designed to target dysfunctional metabolic and fibrotic pathways, today announced positive topline results from its FASCINATE-2 Phase 2b clinical trial of denifanstat versus placebo in biopsy-confirmed non-alcoholic steatohepatitis (NASH) patients with stage 2 or stage 3 fibrosis (F2/F3) at week 52. In this trial, denifanstat, an oral, selective FASN inhibitor, showed statistically significant improvements relative to placebo on both of the primary endpoints of NASH resolution without worsening of fibrosis with ≥2-point reduction in NAS, and ≥2-point reduction in NAS without worsening of fibrosis. Denifanstat-treated patients also showed statistically significant fibrosis improvement by ≥ 1 stage with no worsening of NASH, and a greater proportion of MRI-derived proton density fat fraction (MRI-PDFF) ≥30% responders relative to placebo.

Key Points: 
  • “Denifanstat is designed to reduce the three main drivers of NASH, including fat accumulation, inflammation, and fibrosis, both independently and in parallel.
  • “Sagimet is committed to creating novel approaches to target dysfunctional metabolic pathways, and we believe these positive results represent a major advancement in that endeavor.
  • “Denifanstat is the only FASN inhibitor currently in clinical development for the treatment of NASH with related fibrosis.
  • Moreover, the safety profile supports the further development of denifanstat in NASH patients.”

Elicio Therapeutics to Present ELI-002 7P (AMPLIFY-7P) Trial in Progress Poster on Phase 1/2 Study of Lymph Node-Targeted Vaccine at ASCO GI Symposium

Retrieved on: 
Wednesday, January 17, 2024

The poster describes AMPLIFY-7P, a Phase 1 and randomized Phase 2 study of ELI-002 7P, an investigational therapeutic cancer vaccine, administered as an adjuvant monotherapy treatment for patients with KRAS-mutated pancreatic ductal adenocarcinoma (“PDAC”).

Key Points: 
  • The poster describes AMPLIFY-7P, a Phase 1 and randomized Phase 2 study of ELI-002 7P, an investigational therapeutic cancer vaccine, administered as an adjuvant monotherapy treatment for patients with KRAS-mutated pancreatic ductal adenocarcinoma (“PDAC”).
  • “We are progressing our AMP-powered, lymph node-targeted cancer vaccine, ELI-002 7P, as a monotherapy in an adjuvant setting for patients with pancreatic cancer, and recently dosed the first patient in the randomized Phase 2 cohort.
  • AMPLIFY-7P is a Phase 1 and Phase 2 study of ELI-002 7P in patients with RAS mutated pancreatic and colorectal tumors after locoregional treatment.
  • A Phase 2 interim analysis is planned using group sequential design for control of overall alpha 0.10.

DermTech Announces Positive Topline Results From a Study Evaluating the DermTech Melanoma Test (DMT) Across All Skin Types

Retrieved on: 
Thursday, January 18, 2024

DermTech, Inc. (NASDAQ: DMTK) (DermTech or the Company), a leader in precision dermatology enabled by a non-invasive skin genomics technology, today reported positive topline results from a study evaluating the foundational gene expression assay component of the DermTech Melanoma Test (DMT) across all skin types in the real-world clinical setting.

Key Points: 
  • DermTech, Inc. (NASDAQ: DMTK) (DermTech or the Company), a leader in precision dermatology enabled by a non-invasive skin genomics technology, today reported positive topline results from a study evaluating the foundational gene expression assay component of the DermTech Melanoma Test (DMT) across all skin types in the real-world clinical setting.
  • The peer-reviewed study entitled, “Non-invasive gene expression analysis rules out melanoma with high negative predictive value regardless of skin phototype” was presented at the Winter Clinical Dermatology Conference (January 12-17, 2024).
  • “This study demonstrated that regardless of a patient’s skin type, the DMT can help clinicians rule out melanoma non-invasively, with an NPV of over 99%,” said Loren Clarke, M.D., chief medical officer, DermTech.
  • “This is significant progress toward making this test available for patients with Fitzpatrick skin types IV-VI, which is important because ruling out melanoma in individuals with these skin types can be particularly challenging.”

Cleveland Diagnostics Completes $75M Financing to Advance its Early-detection Oncology Testing Platform

Retrieved on: 
Wednesday, January 17, 2024

Cleveland Diagnostics, Inc. , a clinical-stage biotechnology company developing next-generation diagnostic tests for the early detection of cancers announced the closing of over $75M in growth capital financing.

Key Points: 
  • Cleveland Diagnostics, Inc. , a clinical-stage biotechnology company developing next-generation diagnostic tests for the early detection of cancers announced the closing of over $75M in growth capital financing.
  • The financing will accelerate Cleveland Diagnostics’ commercial and corporate development goals.
  • Cleveland Diagnostics’ portfolio of oncology related tests will be expanding beyond prostate cancer into additional indications in 2024.
  • In connection with the financing, Jee will join the Cleveland Diagnostics Board of Directors.

Introduction of Breast Imaging Legislation Will Benefit Thousands of Arizonans

Retrieved on: 
Monday, January 22, 2024

PHEONIX, Jan. 22, 2024 /PRNewswire/ -- Susan G. Komen®, the world's leading breast cancer organization commends Representative David Cook (R-Globe) for working with Komen to eliminate financial barriers to earlier breast cancer detection by ensuring that everyone has equitable access to diagnostic and supplemental breast imaging.

Key Points: 
  • House Bill 2411 , introduced by Rep. Cook, eliminates the patient out-of-pocket costs for medically necessary diagnostic and supplemental breast imaging including MRIs, ultrasounds, and diagnostic mammograms.
  • It is critical that Arizona eliminates financial barriers that limit access to critical diagnostic and supplemental breast imaging service," said Rep. Cook.
  • An estimated 12% of individuals are called back for additional imaging after an abnormal screening mammogram and require diagnostic imaging.
  • This diagnostic or supplemental imaging is often crucial for individuals previously diagnosed with breast cancer or those considered high-risk.

Single Pass and Mermaid Medical Group Announce Exclusive US Distribution Deal for Biopsy Closure Device

Retrieved on: 
Monday, January 22, 2024

The Single Pass biopsy closure device is a state-of-the-art medical device designed to enhance patient care and improve procedural outcomes.

Key Points: 
  • The Single Pass biopsy closure device is a state-of-the-art medical device designed to enhance patient care and improve procedural outcomes.
  • Under this exclusive distribution agreement, Mermaid Medical Group will serve as the sole distributor of Single Pass's biopsy closure device in the United States.
  • "We are thrilled to partner with Mermaid Medical Group for the exclusive distribution of our biopsy closure device in the United States," said Bill Colone, CEO at Single Pass.
  • The exclusive distribution agreement between Single Pass and Mermaid Medical Group marks a significant milestone in the advancement of biopsy closure technology.

PNU Researchers Reveal Cutibacterium acnes as a Potential Cause of Lichen Striatus Hypopigmentation

Retrieved on: 
Wednesday, January 17, 2024

The gram-positive bacterium Cutibacterium acnes has previously been associated with various skin conditions, including acne vulgaris and post-inflammatory hypopigmentation.

Key Points: 
  • The gram-positive bacterium Cutibacterium acnes has previously been associated with various skin conditions, including acne vulgaris and post-inflammatory hypopigmentation.
  • There could, therefore, be a potential association between C. acnes and the observed skin microbiota of patients with LS with and without hypopigmentation.
  • Comparing patients with LS with and without hypopigmentation, the researchers discovered a quadrupled presence (23.26% versus 5.29% of the entire microbiota) of Cutibacterium acnes in the former.
  • Title of original paper: Association between the skin microbiome and lichen striatus hypopigmentation: Cutibacterium acnes as a potential cause