Denervation

NeoChord, Inc. Appoints New Chief Executive Officer to Lead Commercialization Efforts and Study Novel First-Line Therapy for Mitral Valve Regurgitation

Retrieved on: 
Thursday, February 22, 2024

MINNEAPOLIS, Feb. 22, 2024 /PRNewswire/ --  NeoChord is a privately held, medical technology company and the world-leader in beating heart delivery of artificial chords in the treatment of mitral valve regurgitation.

Key Points: 
  • MINNEAPOLIS, Feb. 22, 2024 /PRNewswire/ --  NeoChord is a privately held, medical technology company and the world-leader in beating heart delivery of artificial chords in the treatment of mitral valve regurgitation.
  • The company appointed Todd Berg as Chief Executive Officer to oversee clinical and commercial programs for transeptal and transapical repair of damaged mitral valve chords resulting in regurgitation.
  • Berg has over 30 years of experience successfully developing and commercializing novel medical therapies and holds over 100 U.S. patents.
  • The opportunity to develop a first-line therapy for mitral valve disease, by resolving regurgitation early in the disease state, is incredibly compelling," said Berg.

NeoChord, Inc. Appoints New Chief Executive Officer to Lead Commercialization Efforts and Study Novel First-Line Therapy for Mitral Valve Regurgitation

Retrieved on: 
Thursday, February 22, 2024

MINNEAPOLIS, Feb. 22, 2024 /PRNewswire/ --  NeoChord is a privately held, medical technology company and the world-leader in beating heart delivery of artificial chords in the treatment of mitral valve regurgitation.

Key Points: 
  • MINNEAPOLIS, Feb. 22, 2024 /PRNewswire/ --  NeoChord is a privately held, medical technology company and the world-leader in beating heart delivery of artificial chords in the treatment of mitral valve regurgitation.
  • The company appointed Todd Berg as Chief Executive Officer to oversee clinical and commercial programs for transeptal and transapical repair of damaged mitral valve chords resulting in regurgitation.
  • Berg has over 30 years of experience successfully developing and commercializing novel medical therapies and holds over 100 U.S. patents.
  • The opportunity to develop a first-line therapy for mitral valve disease, by resolving regurgitation early in the disease state, is incredibly compelling," said Berg.

Recor Medical to Present Latest Clinical Data on Paradise® Ultrasound Renal Denervation at TCT Annual Meeting

Retrieved on: 
Friday, October 20, 2023

Recor Medical, Inc. (“Recor”), a subsidiary of Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”), will present data from several clinical studies of the Paradise® Ultrasound Renal Denervation (uRDN) system in the treatment of hypertension at the 2023 Transcatheter Cardiovascular Therapeutics (TCT) annual meeting in San Francisco.

Key Points: 
  • Recor Medical, Inc. (“Recor”), a subsidiary of Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”), will present data from several clinical studies of the Paradise® Ultrasound Renal Denervation (uRDN) system in the treatment of hypertension at the 2023 Transcatheter Cardiovascular Therapeutics (TCT) annual meeting in San Francisco.
  • A late-breaking presentation of a six-month pooled analysis of individual patient data from the RADIANCE™ Global Clinical Trial Program will be presented by Dr. Ajay Kirtane on Thursday, October 26, at 2:00 PM PDT.
  • Six-month results from the RADIANCE II pivotal trial will be presented by Prof. Michel Azizi at 9:27 AM PDT.
  • The Paradise Ultrasound RDN system previously received CE mark and has been successfully introduced in Europe and is an investigational device in the United States and Japan.

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

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.

EuroPCR 2023 | 6 Month Outcome of the SMART Study: satisfactory BP control achieved with reduced medication burden

Retrieved on: 
Friday, May 19, 2023

It demonstrates that msRDN can effectively control blood pressure while greatly reducing the dosage of antihypertensive drugs.

Key Points: 
  • It demonstrates that msRDN can effectively control blood pressure while greatly reducing the dosage of antihypertensive drugs.
  • In the 6 months follow-up with a strict drug regimen, the msRDN group demonstrated effective blood pressure control.
  • OSBP control rate of the msRDN group was 95% with significantly reduced drug burden compared to the sham group.
  • The result is a resounding prove that patients in the msRDN group can achieve satisfactory BP control with markedly lower anti-hypertensive drug dosage.

Gene therapy candidate for amyotrophic lateral sclerosis (ALS) demonstrates bioactivities in a murine model of the disease

Retrieved on: 
Monday, March 13, 2023

Thus, long-term supplementation of the s-KL protein via gene therapy technology is an attract new measure for treatment of this deadly disease.

Key Points: 
  • Thus, long-term supplementation of the s-KL protein via gene therapy technology is an attract new measure for treatment of this deadly disease.
  • The technology was licensed on an exclusive worldwide basis from the Universitat Autonomo de Barcelona in Barcelona, Spain.
  • The overexpression of the SOD1 gene in humans is called "familial ALS" and occurs in 5%-10% of all ALS cases.
  • The delivery and expression of the s-KL protein by the s-KL gene may be an effective therapy in this degenerative neuromuscular disease" said Dr. Sinkule.

Verve Medical Announces Results of Feasibility Trial for Transurethral Renal Pelvic Denervation for Uncontrolled Hypertension

Retrieved on: 
Wednesday, November 16, 2022

The Verve trial demonstrated the efficacy and safety of this minimally invasive, non-vascular renal pelvic denervation.

Key Points: 
  • The Verve trial demonstrated the efficacy and safety of this minimally invasive, non-vascular renal pelvic denervation.
  • We are pleased that we were able to complete this feasibility study of renal denervation for people with uncontrolled hypertension.
  • Verve Medical, headquartered in Phoenix, AZ, is an early-stage medical device company that is committed to developing novel transurethral (natural orifice) renal denervation devices to ameliorate uncontrolled hypertension and associated diseases for the benefit of patients worldwide.
  • Verve Medical and Verve RPD are registered trademarks of Verve Medical, Inc.
    View source version on businesswire.com: https://www.businesswire.com/news/home/20221116006004/en/

AEON Biopharma Reports Positive Topline Results from Phase 2 Clinical Trial of ABP-450 (prabotulinumtoxinA) in Cervical Dystonia

Retrieved on: 
Friday, September 23, 2022

IRVINE, Calif., Sept. 23, 2022 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. (“AEON” or the “Company”), a private clinical-stage biopharmaceutical company focused on the development of its proprietary botulinum toxin complex ABP-450 (prabotulinumtoxinA) injection for therapeutic indications, today announced positive topline results from its Phase 2 clinical study of ABP-450 for the treatment of cervical dystonia (CD), a chronic and debilitating neurologic condition affecting the muscles of the neck.

Key Points: 
  • ABP-450 contains a 900 kDa botulinum toxin type-A complex produced by the bacterium Clostridium botulinum.
  • AEON is a clinical stage biopharmaceutical company focused on developing ABP-450 (prabotulinumtoxinA) injection for the treatment of debilitating medical conditions with an initial focus on the neurology and gastroenterology markets.
  • This press release contains forward-looking statements that are based on managements belief and assumptions and on information currently available to management.
  • These and other important factors may cause actual results, performance, or achievements to differ materially from those expressed or implied by these forward-looking statements.

ReCor Medical to Present RADIANCE II US Pivotal Trial Data in Late-Breaking Presentation at TCT Conference

Retrieved on: 
Wednesday, September 14, 2022

ReCor Medical, Inc. ("ReCor"), a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd., today announced late-breaking data from its RADIANCE II U.S. FDA IDE pivotal trial will be presented at the 34th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation.

Key Points: 
  • ReCor Medical, Inc. ("ReCor"), a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd., today announced late-breaking data from its RADIANCE II U.S. FDA IDE pivotal trial will be presented at the 34th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation.
  • ReCor will also have a symposium on the Paradise Ultrasound Renal Denervation (uRDN) System, two moderated posters and an exhibit at the conference.
  • ReCor Medical, headquartered in Palo Alto, CA, a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd., is a medical technology company focused on transforming the management of hypertension.
  • Otsuka Medical Devices Co., Ltd. is a subsidiary of Otsuka Holdings Co., Ltd. ( www.otsuka.com/en ), a global healthcare company listed on the Tokyo Stock Exchange (JP 4578).

AEON Biopharma Raises $30 Million from Insiders

Retrieved on: 
Wednesday, August 3, 2022

AEON expects to opportunistically revisit the capital markets in the near future in order to further strengthen its capital position and advance its clinical trials.

Key Points: 
  • AEON expects to opportunistically revisit the capital markets in the near future in order to further strengthen its capital position and advance its clinical trials.
  • AEON licenses ABP-450 from Daewoong Pharmaceutical Co., which provides AEON exclusive development and distribution rights for therapeutic indications in certain territories, including the United States, Canada and the EU, among other international territories.
  • This press release contains forward-looking statements that are based on managements belief and assumptions and on information currently available to management.
  • The forward-looking statements in this press release are made only as of the date hereof.