Renal artery

Autonomix Announces Positive Findings from Preclinical Study Demonstrating Potential to Improve Renal Denervation

Retrieved on: 
Tuesday, April 9, 2024
Blood pressure, Ethanol, Collateral damage, Disease, Nervous system, Patient, Renal artery, Pain, AMIX, Hypertension, Pharmaceutical industry

THE WOODLANDS, TX, April 09, 2024 (GLOBE NEWSWIRE) -- Autonomix Medical, Inc. (NASDAQ: AMIX) (“Autonomix” or the “Company”), a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated, today announced the successful completion of an animal study evaluating the Company’s proprietary catheter-based sensing technology for use in the renal artery.

Key Points: 
  • The preclinical porcine model study was designed to assess the ability of the Company’s catheter-based sensing technology to effectively sense and target individual nerves surrounding the renal artery.
  • These results strongly demonstrate the potential of Autonomix’s sensing technology to successfully locate nerves around the renal artery.
  • These nerves include those responsible for regulating blood pressure and are the target of recently approved renal denervation procedures for hypertension.
  • The successful completion of this preclinical study provides us with confidence in the potential of our sensing technology to ultimately make renal denervation safer, faster, and more effective.

CalciMedica Presents Data from Preclinical Studies of Auxora in Acute Kidney Injury at the 29th International AKI & CRRT Conference

Retrieved on: 
Wednesday, March 13, 2024
CRRT, Conference, Pneumonia, CRAC, Disease, Incidence, GFR, AKI, Patient, Physiology, COVID-19, Renal artery, Biomarker, Hemofiltration, T helper 17 cell, Mortality, Indiana University, Cell biology, Glomerular filtration rate, Respiratory failure, Doctor of Philosophy, Acute kidney injury, Ischemia, Kidney, Poster, Stage 2, Blood, Animal, Hospice and palliative medicine, Pharmaceutical industry

LA JOLLA, Calif., March 13, 2024 /PRNewswire/ -- CalciMedica Inc. (CalciMedica or the Company) (Nasdaq: CALC), a clinical-stage biopharmaceutical company focused on developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for acute and chronic inflammatory and immunologic diseases, last evening presented data from preclinical studies of Auxora™ in acute kidney injury (AKI) at the 29th International Acute Kidney Injury and Continuous Renal Replacement Therapy Conference (AKI & CRRT) in San Diego, CA. David Basile, Ph.D., Professor of Anatomy, Cell Biology and Physiology at Indiana University, gave an oral and poster presentation entitled "The Store-Operated Calcium Channel Inhibitor Auxora Improves Renal Function Following Ischemia-Induced Acute Kidney Injury in Rats."

Key Points: 
  • In rats with kidney injury akin to Stage 3 AKI, the rats treated with placebo died while those on Auxora survived and showed modest recovery of GFR.
  • We are excited as these studies support clinical observations of Auxora that suggest the drug may be beneficial for AKI patients."
  • The data presented at AKI & CRRT was from a series of studies referred to as Study 1 and Study 2.
  • These results indicate that Auxora has the ability to hasten the recovery of kidney function and improve survival in rat models of AKI.

SoniVie announces enrollment completion in the REDUCED-1 pilot study with TIVUS™ Ultra-Sound Renal Denervation

Retrieved on: 
Wednesday, January 31, 2024
Hypertension, Renal artery, Ultrasound, TEL, Patient, Safety, FDA, Physician, Blood pressure, Pharmaceutical industry

TEL AVIV, Israel, Jan. 31, 2024 /PRNewswire/ -- SoniVie, an Israeli company developing a novel, proprietary Therapeutic Intra-Vascular Ultrasound (TIVUSTM) System to treat a variety of hypertensive disorders, announced that on January 8th 2024, the last patient was treated with its Renal Artery Denervation TIVUS™ technology, as part of its FDA IDE-approved pilot study to treat hypertension (The REDUCED-1 Study).

Key Points: 
  • The REDUCED-1 Study had two enrollment cohorts that were conducted under an identical protocol in the United States and in Israel.
  • Twenty-five patients were enrolled in the U.S. and 15 patients were enrolled in Israel.
  • Renal Denervation with TIVUS™ is a minimally invasive procedure that uses high-frequency non-focused Ultra-Sound energy to ablate nerves in the renal arteries.
  • This causes a reduction in the nerve activity, which may decrease blood pressure.

SoniVie announces enrollment completion in the REDUCED-1 pilot study with TIVUS™ Ultra-Sound Renal Denervation

Retrieved on: 
Wednesday, January 31, 2024
Hypertension, Renal artery, Ultrasound, TEL, Patient, Safety, FDA, Physician, Blood pressure, Pharmaceutical industry

TEL AVIV, Israel, Jan. 31, 2024 /PRNewswire/ -- SoniVie, an Israeli company developing a novel, proprietary Therapeutic Intra-Vascular Ultrasound (TIVUSTM) System to treat a variety of hypertensive disorders, announced that on January 8th 2024, the last patient was treated with its Renal Artery Denervation TIVUS™ technology, as part of its FDA IDE-approved pilot study to treat hypertension (The REDUCED-1 Study).

Key Points: 
  • The REDUCED-1 Study had two enrollment cohorts that were conducted under an identical protocol in the United States and in Israel.
  • Twenty-five patients were enrolled in the U.S. and 15 patients were enrolled in Israel.
  • Renal Denervation with TIVUS™ is a minimally invasive procedure that uses high-frequency non-focused Ultra-Sound energy to ablate nerves in the renal arteries.
  • This causes a reduction in the nerve activity, which may decrease blood pressure.

Recor Medical Announces U.S. Launch and First Commercial Cases of Paradise Ultrasound Renal Denervation Therapy

Retrieved on: 
Friday, November 10, 2023
Health, Medical Devices, General Health, Radiology, Clinical Trials, Cardiology, Biotechnology, Medicine, Arm, Food and Drug Administration, Disease, DRS, Hypertension, Food, M.B.B.S, RDN, Physician, Structural heart disease, Surgeon, Mortality, Cardiovascular disease, TRIO, Cleveland Clinic, Multimedia, Patient, Renal artery, Kaleida Health, Division, FDA, Master of Science, Gates Vascular Institute, Intervention, Biomedical sciences, University, MD, Doctor of Philosophy, Hospital, NewYork-Presbyterian Hospital, Blood pressure, Medical imaging, Pharmaceutical industry, Buffalo, Paradise

Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”), today announced the first commercial uses of Recor’s Paradise™ Ultrasound Renal Denervation (uRDN) system for the treatment of hypertension, the first FDA approved renal denervation therapy in the United States.

Key Points: 
  • Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”), today announced the first commercial uses of Recor’s Paradise™ Ultrasound Renal Denervation (uRDN) system for the treatment of hypertension, the first FDA approved renal denervation therapy in the United States.
  • The first commercial procedures took place at NewYork-Presbyterian/Columbia University Irving Medical Center in New York City by Drs.
  • Paradise uRDN delivers two to three doses of 360-degree ultrasound energy — lasting seven seconds each — through the main renal arteries to the surrounding nerves.
  • “This new renal denervation technology for a high-risk patient population – individuals with difficult to control hypertension – has been long awaited.

Verve Medical Announces FDA Approval of IDE for Pivotal Trial of RPD™ Renal Pelvic Denervation System for Treatment of Uncontrolled Hypertension

Retrieved on: 
Tuesday, July 11, 2023
Medical Devices, FDA, Health, Clinical Trials, Cardiology, Biotechnology, Blood pressure, Renal artery, Medicine, US Foods, Kidney failure, Heart failure, Hypertension, Stroke, Urethra, Artery, Natural orifice transluminal endoscopic surgery, Death, Denervation, Patient, Pivotal, Paratriathlon, Safety, Pharmaceutical industry, Verve

Verve Medical, Inc. (Verve) announced today that the Company has received approval from the US Food & Drug Administration (FDA) to initiate its Natural Orifice via renal pelvis denervation (NOVEL- Denervation) Pivotal IDE trial for the treatment of uncontrolled hypertension to lower blood pressure.

Key Points: 
  • Verve Medical, Inc. (Verve) announced today that the Company has received approval from the US Food & Drug Administration (FDA) to initiate its Natural Orifice via renal pelvis denervation (NOVEL- Denervation) Pivotal IDE trial for the treatment of uncontrolled hypertension to lower blood pressure.
  • The Verve RPD , NOVEL Pivotal trial will be an up to 300 patients, 2/1 randomized, sham-controlled, double-blinded study to determine the safety and efficacy of the Verve RPD minimally invasive, non-vascular renal pelvic denervation system to treat hypertension.
  • In contrast to other renal denervation approaches in the renal artery, Verve’s method accesses the renal nerves through the natural orifice of the urethra, like a common urology procedure.
  • Renal denervation is a simple, minimally invasive procedure designed to treat hypertension.

Kalos Medical Receives Korean MFDS Innovative Medical Device Designation for DENEX Hypertension Treatment System

Retrieved on: 
Wednesday, June 28, 2023
Renal artery, MFDS, Electrode, Hypertension, Safety, Pharmaceutical industry, Health, Food

SEOUL, Korea, June 28, 2023 (GLOBE NEWSWIRE) -- Kalos Medical Inc. (“Kalos Medical”), a developer of innovative medical devices treating hypertension and other chronic illnesses, announced on June 23rd that South Korea’s Ministry of Food and Drug Safety (“MFDS”) designated the company’s DENEX hypertension treatment system as an Innovative Medical Device, a designation that recognizes medical devices that significantly improve safety and efficacy compared to existing medical devices and treatments.

Key Points: 
  • SEOUL, Korea, June 28, 2023 (GLOBE NEWSWIRE) -- Kalos Medical Inc. (“Kalos Medical”), a developer of innovative medical devices treating hypertension and other chronic illnesses, announced on June 23rd that South Korea’s Ministry of Food and Drug Safety (“MFDS”) designated the company’s DENEX hypertension treatment system as an Innovative Medical Device, a designation that recognizes medical devices that significantly improve safety and efficacy compared to existing medical devices and treatments.
  • The DENEX system is an innovative medical device that treats hypertension using minimally invasive renal denervation technology.
  • Similar to the U.S. Food and Drug Administration’s Breakthrough Device designation, the Innovative Medical Device designation is MFDS’s formal recognition of high-value medical devices that have the potential to provide more effective treatment of serious medical conditions than the current standard of care.
  • Peter Chang, CEO of Kalos Medical, remarked, "We are delighted to have received the Innovative Medical Device designation and, with it, the recognition that the DENEX renal denervation system is an innovative, high technology solution, with improved safety and efficacy compared to existing hypertension treatments."

Ronovo wins resounding KOL accolades in latest Carina™ RAS Platform animal labs

Retrieved on: 
Wednesday, March 1, 2023
Hardware, Other Health, Technology, Robotics, Surgery, General Health, Professional Services, Medical Devices, Hospitals, Venture Capital, Other Technology, Science, Veterinary, Other Science, Research, Health, Zhengzhou University, Cadaver, Phlebotomy, KOL, Jiaotong University, Gynaecology, Urology, Hospital, RAS, Patient, Salpingo-oophorectomy, Laparoscopy, Hysterectomy, Surgeon, Operating, Fudan University, Renal artery, Multimedia, Dissection, Bleeding, MIS, Instrument, Uterine artery, Dentistry, Pharmaceutical industry

Recently, Ronovo Surgical invited top gynecology and urology surgeons to evaluate the performance of its newly unveiled Carina™ RAS Platform, the first modular robotic-assisted surgery (RAS) platform developed in China for laparoscopic procedures.

Key Points: 
  • Recently, Ronovo Surgical invited top gynecology and urology surgeons to evaluate the performance of its newly unveiled Carina™ RAS Platform, the first modular robotic-assisted surgery (RAS) platform developed in China for laparoscopic procedures.
  • View the full release here: https://www.businesswire.com/news/home/20230301005036/en/
    Image: Carina™ RAS Platform being configured for animal lab.
  • The small footprint of each bedside module is designed to improve the surgical team’s ability to efficiently utilize precious OR space.
  • KOL feedback from these latest evaluations represents a major milestone in readiness for human clinical trials, which are planned for later this year.

SoniVie Raises $60m in Round C Financing, and Appoints New Board Members

Retrieved on: 
Monday, January 9, 2023
The Company, TEL, Stroke, Kidney failure, Medtech, Risk, Patient, Hypertension, Renal artery, Axon Sports, Physician, Therapy, Blood pressure, Pharmaceutical industry, Wiśniewski

TEL AVIV, Israel, Jan. 9, 2023 /PRNewswire/ -- SoniVie Ltd. ("SoniVie" or the "Company"), a medical device company developing a proprietary solution to treat hypertension, announced today the completion of a $60 million series C round financing. The financing was led by Andera Partners, with participation from Supernova Invest and Omega Funds. Current SoniVie shareholder TechWald also participated.

Key Points: 
  • In conjunction with the financing, the Company appointed two renowned medtech experts to its Board of Directors, Raymond W. Cohen and Zeev Zehavi, as independent directors.
  • The proceeds from SoniVie financing are envisioned to be used to reach clinical and regulatory milestones and to support TIVUS™ renal artery denervation program.
  • Raphaël Wisniewski of Andera Partners commented, "SoniVie TIVUS™ has the potential to provide patients and physicians with a safe, efficient and easy to use device.
  • We are thrilled to support this talented management together with our syndicate partners and our new board members".

SoniVie Raises $60m in Round C Financing, and Appoints New Board Members

Retrieved on: 
Monday, January 9, 2023
The Company, TEL, Stroke, Kidney failure, Medtech, Risk, Patient, Hypertension, Renal artery, Axon Sports, Physician, Therapy, Blood pressure, Pharmaceutical industry, Wiśniewski

TEL AVIV, Israel, Jan. 9, 2023 /PRNewswire/ -- SoniVie Ltd. ("SoniVie" or the "Company"), a medical device company developing a proprietary solution to treat hypertension, announced today the completion of a $60 million series C round financing. The financing was led by Andera Partners, with participation from Supernova Invest and Omega Funds. Current SoniVie shareholder TechWald also participated.

Key Points: 
  • In conjunction with the financing, the Company appointed two renowned medtech experts to its Board of Directors, Raymond W. Cohen and Zeev Zehavi, as independent directors.
  • The proceeds from SoniVie financing are envisioned to be used to reach clinical and regulatory milestones and to support TIVUS™ renal artery denervation program.
  • Raphaël Wisniewski of Andera Partners commented, "SoniVie TIVUS™ has the potential to provide patients and physicians with a safe, efficient and easy to use device.
  • We are thrilled to support this talented management together with our syndicate partners and our new board members".