Biliary disease

EndoTheia Announces Successful Clinical Study Results for a Novel Medical Device for Endoscopic Surgery

Retrieved on: 
Tuesday, July 18, 2023

EndoTheia, Inc. has announced the completion of a successful first-in-human clinical study performed at Vanderbilt University for their groundbreaking technology that radically improves minimally invasive endoscopic surgery.

Key Points: 
  • EndoTheia, Inc. has announced the completion of a successful first-in-human clinical study performed at Vanderbilt University for their groundbreaking technology that radically improves minimally invasive endoscopic surgery.
  • EndoTheia is pleased to report that all primary and secondary endpoints were successfully met with no adverse events.
  • This news follows the company’s recent announcement that the FDA recently named EndoTheia’s ENT endoscopic surgery technology a Breakthrough Device .
  • “ EndoTheia is pleased to report the success of this first-in-human clinical study.

Julie Sanchez, MD, FACS, is recognized by Continental Who's Who

Retrieved on: 
Tuesday, February 21, 2023

AUSTIN, Texas, Feb. 21, 2023 /PRNewswire/ -- Julie Sanchez, MD, FACS, is being recognized by Continental Who's Who as a Top Pinnacle Healthcare Provider for her contributions to the Medical Field.

Key Points: 
  • AUSTIN, Texas, Feb. 21, 2023 /PRNewswire/ -- Julie Sanchez, MD, FACS, is being recognized by Continental Who's Who as a Top Pinnacle Healthcare Provider for her contributions to the Medical Field.
  • Dr. Sanchez earned a Bachelor of Science degree in General Biology from the University of Texas at Austin in 1989.
  • According to Dr. Sanchez, she loves her job every day because she can help children get the specialized care they need.
  • She is associated with the Travis County Medical Association and in 2020, was recognized as the Pediatric Surgeon of Texas by Physician Preferred Magazine.

EndoTheia Inc. Announces FDA Breakthrough Device Designation for Technology to Improve Endoscopic Surgery

Retrieved on: 
Tuesday, January 10, 2023

EndoTheia Inc. , a Nashville-based medical device company, announced today that it has gained priority status from the FDA by receiving a Breakthrough Device designation from the agency for its technology that radically improves minimally invasive flexible endoscopic surgery.

Key Points: 
  • EndoTheia Inc. , a Nashville-based medical device company, announced today that it has gained priority status from the FDA by receiving a Breakthrough Device designation from the agency for its technology that radically improves minimally invasive flexible endoscopic surgery.
  • The designation will streamline the regulatory process, enabling EndoTheia to rapidly bring its innovative solution to doctors and patients.
  • EndoTheia’s Breakthrough Device leverages foundational technology that was originally invented at Vanderbilt and the University of Tennessee.
  • S. Duke Herrell, III, MD, FACS, Co-Founder and Chief Medical Officer of EndoTheia , added, "We are excited that the FDA has recognized the huge potential of EndoTheia’s technology through Breakthrough Device designation .

Perspectum Announces American Medical Association (AMA) Issues Two Unique Category III CPT® Codes Priced Appropriately by the Centers for Medicare & Medicaid Services (CMS) for Noninvasive Biliary Anatomy Assessment With MRCP+

Retrieved on: 
Tuesday, July 5, 2022

Effective July 1, 2022, the Centers for Medicare & Medicaid Services (CMS) has issued appropriate reimbursement for the MRCP+ procedure.

Key Points: 
  • Effective July 1, 2022, the Centers for Medicare & Medicaid Services (CMS) has issued appropriate reimbursement for the MRCP+ procedure.
  • CPT 0723T has been assigned to APC 1511 New Technology Level 11, reimbursement range $900-$1000, effective July 1, 2022.
  • MRCP+ is an image analysis tool that enhances MRCP data to provide visualization and quantitative assessment of the biliary system.
  • The guidelines reference MRCP+ as a novel technique to automatically segment biliary anatomy and provide quantitative biliary tree metrics.

Albireo Enrolls First Patient in Phase 3 Clinical Trial of Odevixibat in Biliary Atresia

Retrieved on: 
Tuesday, July 14, 2020

BOLD is the largest, prospective intervention trial ever conducted in biliary atresia, expanding the development of odevixibat to a second rare cholestatic liver disease indication.

Key Points: 
  • BOLD is the largest, prospective intervention trial ever conducted in biliary atresia, expanding the development of odevixibat to a second rare cholestatic liver disease indication.
  • Two clinical sites in the United States are currently active for patient enrollment in the second odevixibat Phase 3 pivotal trial.
  • Odevixibat has received orphan drug designation for biliary atresia in theUnited States and European Union.
  • EMA also has granted orphan designation to odevixibat for the treatment of Alagille syndrome, biliary atresia and primary biliary cholangitis.

Primary Biliary Cholangitis - Pipeline Review, H1 2020: Allwegan Plc, GenKyoTex SA, Kowa Co Ltd & PRISM Pharma Co Ltd - ResearchAndMarkets.com

Retrieved on: 
Wednesday, January 29, 2020

The "Primary Biliary Cholangitis (Primary Biliary Cirrhosis) - Pipeline Review, H1 2020" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Primary Biliary Cholangitis (Primary Biliary Cirrhosis) - Pipeline Review, H1 2020" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • The latest Pharmaceutical and Healthcare disease pipeline guide Primary Biliary Cholangitis - Pipeline Review, H1 2020, provides an overview of the Primary Biliary Cholangitis (Gastrointestinal) pipeline landscape.
  • The Primary Biliary Cholangitis (Gastrointestinal) pipeline guide also reviews of key players involved in therapeutic development for Primary Biliary Cholangitis (Primary Biliary Cirrhosis) and features dormant and discontinued projects.
  • Formulate corrective measures for pipeline projects by understanding Primary Biliary Cholangitis (Gastrointestinal) pipeline depth and focus of Indication therapeutics.

The Global Primary Biliary Cholangitis Therapeutics Market Had a Significant Market Share in 2018 Which Is Expected to Continue During the Forecast Period, 2019-2023 - ResearchAndMarkets.com

Retrieved on: 
Friday, July 12, 2019

This will boost the sales of primary biliary cholangitis therapeutics and lead to the expansion of the global primary biliary cholangitis therapeutics market at a CAGR of close to 10% during the forecast period.

Key Points: 
  • This will boost the sales of primary biliary cholangitis therapeutics and lead to the expansion of the global primary biliary cholangitis therapeutics market at a CAGR of close to 10% during the forecast period.
  • Global Primary Biliary Cholangitis Therapeutics Market: About this market
    Primary biliary cholangitis is a chronic autoimmune disease in which intrahepatic bile ducts are damaged over a period of time.
  • This primary biliary cholangitis therapeutics market analysis considers sales of OCALIVA, ursodiol, and others.
  • Global Primary Biliary Cholangitis Therapeutics market: Overview
    To increase the awareness of the indication, various organizations and the vendors in the global primary biliary cholangitis therapeutics market are conducting awareness campaigns.

Data released at The Liver Meeting ® 2018 Shows MRCP+ is a Promising Non-Invasive Technology for Quantitative Evaluation of Hepatobiliary Diseases

Retrieved on: 
Monday, November 12, 2018

Two abstracts highlight the use of Perspectum Diagnostics' MRCP+ as a non-invasive technology for the evaluation of hepatobiliary diseases.

Key Points: 
  • Two abstracts highlight the use of Perspectum Diagnostics' MRCP+ as a non-invasive technology for the evaluation of hepatobiliary diseases.
  • Accurate assessment of the biliary system is essential in diagnosis and monitoring of hepatobiliary diseases like Primary Sclerosing Cholangitis (PSC) and is integral to liver transplant preparation and post-transplant evaluation.
  • The technology enhances data from conventional MRCP without needing to inject contrast agent, enabling 3D visualization of ducts.
  • This new data, presented at AASLD's The Liver Meeting 2018, highlight the utility of quantitative MRCP, MRCP+, in assessing the usefulness of biomarkers such as MMP7, and also as a non-invasive technology for the stratification of hepatobiliary diseases.