Ino

Beyond Air® Receives Innovative Technology Contract from Vizient for LungFit®PH

Retrieved on: 
Monday, October 16, 2023
Atmosphere of Earth, The Queen's Award for Enterprise: Innovation (Technology) (2007), Nitric oxide, Hospital, AUC, Ino, Zenith Contract Services, DSM-IV codes, Patient safety, Patient, Atmosphere, Pharmaceutical industry, Nursing, Vizient, Inc.

Innovative Technology contracts are recommended after review and interaction with products submitted through Vizient’s Innovative Technology Program.

Key Points: 
  • Innovative Technology contracts are recommended after review and interaction with products submitted through Vizient’s Innovative Technology Program.
  • “We're very happy and honored to be awarded an Innovative Technology contract from Vizient for our LungFit device.
  • Through its Innovative Technology Program , Vizient works with hospital experts on its customer-led councils and task forces to evaluate products for their potential to bring real innovation to health care.
  • Vizient may award a contract to products deemed worthy of the Innovative Technology designation outside of the competitive bid cycle.

Bellerophon Therapeutics Announces Last Patient Has Completed Blinded Treatment in Phase 3 REBUILD Study for INOpulse® in Fibrotic Interstitial Lung Disease

Retrieved on: 
Thursday, May 11, 2023
Actigraphy, Ino, Nitric oxide, MVPA, Pulmonary fibrosis, Paul Fildes, Patient, Risk, Pulmonary hypertension, Therapy, Safety, Pharmaceutical industry

WARREN, N.J., May 11, 2023 (GLOBE NEWSWIRE) -- Bellerophon Therapeutics, Inc. (Nasdaq: BLPH) (“Bellerophon” or the “Company”), a clinical-stage biotherapeutics company focused on developing treatments for cardiopulmonary diseases, today announced that the last patient has completed blinded treatment in the ongoing Phase 3 REBUILD study of INOpulse®, a proprietary pulsatile nitric oxide delivery system, for the treatment of fibrotic interstitial lung disease (fILD).

Key Points: 
  • WARREN, N.J., May 11, 2023 (GLOBE NEWSWIRE) -- Bellerophon Therapeutics, Inc. (Nasdaq: BLPH) (“Bellerophon” or the “Company”), a clinical-stage biotherapeutics company focused on developing treatments for cardiopulmonary diseases, today announced that the last patient has completed blinded treatment in the ongoing Phase 3 REBUILD study of INOpulse®, a proprietary pulsatile nitric oxide delivery system, for the treatment of fibrotic interstitial lung disease (fILD).
  • The Company expects to report top-line results from this study in mid-2023.
  • A total of 145 fILD patients were enrolled and treated with either INOpulse at a dose of iNO45 or placebo.
  • For more information on the REBUILD Phase 3 study of INOpulse for the treatment of fILD, please visit ClinicalTrials.gov and reference Identifier NCT0326710 .

Bellerophon Therapeutics Announces $5 Million Registered Direct Offering

Retrieved on: 
Monday, March 6, 2023
Ino, Form, Sale, Therapy, Enterprise file synchronization and sharing, MVPA, Patient, Risk, Actigraphy, Pulmonary fibrosis, Nitric oxide, Safety, Pulmonary hypertension, Prospectus, Pharmaceutical industry

The offering is expected to close on March 7, 2023, subject to the satisfaction of customary closing conditions.

Key Points: 
  • The offering is expected to close on March 7, 2023, subject to the satisfaction of customary closing conditions.
  • The Company intends to use the proceeds of this $5 million offering to complete the Company’s REBUILD Phase 3 study and for working capital and general corporate purposes.
  • 333-239473) that was filed with the U.S. Securities and Exchange Commission (the “SEC”) on June 26, 2020 and declared effective on July 2, 2020.
  • A prospectus supplement related to the shares will be filed with the SEC and will be available on the SEC’s website at www.sec.gov .

VERO Biotech's Second Generation GENOSYL® Delivery System (DS) Receives FDA Approval in Anesthesia in the Surgical Suite

Retrieved on: 
Thursday, February 2, 2023
Aurora, DS, Health, Ino, Hospital, Children's Hospital, Pollution, OR, ICU, Children's Hospital Colorado, Patient, Pulmonary hypertension, Face, Anesthesia, University, Food, Temperature, Nitric oxide, Anesthesiology, Generation, Anschutz Medical Campus, FDA, MD, Environment, Regulation of food and dietary supplements by the U.S. Food and Drug Administration

ATLANTA, Feb. 2, 2023 /PRNewswire/ -- VERO Biotech Inc., a commercial-stage healthcare business dedicated to neonatal intensive care and the acute care hospital community, today announced FDA approval of its innovative second generation GENOSYL® Inhaled Nitric Oxide (iNO) delivery system for use with rebreathing anesthesia in the operating room setting. Second generation GENOSYL®DS is now the first and only device for iNO delivery that is approved for use in both rebreathing and non-rebreathing anesthesia methods, improving patient care, saving money for the hospital, and reducing environmental pollution from waste anesthetic gas.

Key Points: 
  • The advantages of rebreathing anesthesia have made this method the standard of care for anesthesia administration in the OR setting.
  • The loss of body heat and moisture can be key complications of anesthesia faced by every patient, especially smaller patients.
  • It is important to note the FDA approval of the GENOSYL DS for use with rebreathing anesthesia in the operating room setting is for the second generation device.
  • GENOSYL DS is the first tankless inhaled nitric oxide delivery system approved by the U.S. Food and Drug Administration (FDA).

Bellerophon Therapeutics Announces Completion of Enrollment in Phase 3 REBUILD Study for INOpulse® in Fibrotic Interstitial Lung Disease

Retrieved on: 
Wednesday, January 18, 2023
Therapy, Pulmonary fibrosis, Quality of life, Nitric oxide, Safety, Risk, Health, Luke Fildes, Ino, Actigraphy, NDA, Patient, Pulmonary hypertension, Walking, MVPA, Pharmaceutical industry

“We are pleased to have completed enrollment in this important study sooner than previously anticipated, which represents a significant milestone for Bellerophon, our INOpulse clinical development program, and the fILD patient community.

Key Points: 
  • “We are pleased to have completed enrollment in this important study sooner than previously anticipated, which represents a significant milestone for Bellerophon, our INOpulse clinical development program, and the fILD patient community.
  • Based on the earlier than expected enrollment completion, we now expect to report top-line results from REBUILD in mid-2023,” said Naseem Amin, M.D., Chairman of Bellerophon’s Board of Directors.
  • “This study will provide the randomized dataset to evaluate the change in moderate to vigorous physical activity (MVPA) following treatment with INOpulse in patients with fILD.
  • For more information on the REBUILD Phase 3 study of INOpulse for the treatment of fILD, please visit ClinicalTrials.gov and reference Identifier NCT0326710 .

VERO Biotech Receives FDA Approval of its Third Generation Tankless Inhaled Nitric Oxide Delivery System

Retrieved on: 
Monday, January 9, 2023
Partnership, Food, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Face, Ino, Hospital, Patient, Generation, Nitric oxide, Pulmonary hypertension, FDA, MPH, Rady Children's Hospital, Pharmaceutical industry

ATLANTA, Jan. 9, 2023 /PRNewswire/ -- VERO Biotech Inc., a commercial-stage healthcare business dedicated to neonatal intensive care and the acute care hospital community, today announced FDA approval of the newest generation of its tankless inhaled nitric oxide (iNO) delivery system. 

Key Points: 
  • ATLANTA, Jan. 9, 2023 /PRNewswire/ -- VERO Biotech Inc., a commercial-stage healthcare business dedicated to neonatal intensive care and the acute care hospital community, today announced FDA approval of the newest generation of its tankless inhaled nitric oxide (iNO) delivery system.
  • The new delivery system has a dual cassette bay within each console, and transitions cassettes automatically.
  • GENOSYL DS is the first tankless inhaled nitric oxide delivery system approved by the U.S. Food and Drug Administration (FDA).
  • Inhaled Nitric Oxide dilates pulmonary blood vessels and may be used to improve oxygenation in neonates with hypoxic respiratory failure and pulmonary hypertension.

Third Pole Therapeutics Receives $32M Strategic Equity Investment to Accelerate its Tankless Inhaled Nitric Oxide (iNO) Platform

Retrieved on: 
Wednesday, December 14, 2022
Electricity, National Center for Health Research, Pulmonary fibrosis, Pulmonary hypertension, Inflammation, Partnership, ILD, Travel, FDA, Nitric oxide, Hospital, Safety, COPD, Engineering, National Heart, Lung, and Blood Institute, Heart, Inhalation, Cystic fibrosis, Atmosphere, Chronic obstructive pulmonary disease, Lung, Ino, Therapy, Infection, Interstitial lung disease, Patient, NO, Pharmaceutical industry, Third Pole

Bill Athenson, CEO of Third Pole, stated, “We are thrilled to receive this investment, which raises Third Pole Therapeutics’ series B financing and commitments to date to over $85M.

Key Points: 
  • Bill Athenson, CEO of Third Pole, stated, “We are thrilled to receive this investment, which raises Third Pole Therapeutics’ series B financing and commitments to date to over $85M.
  • I am particularly pleased to welcome this strategic investor and partner given our closely aligned missions.
  • We have achieved the unprecedented technological advance of miniaturizing tankless, on demand NO generation into a book-sized, portable device.
  • Two decades later, Third Pole has successfully created a scalable technology that delivers nitric oxide for inhalation, instantly, on-demand, and in unlimited quantities.

Bellerophon Provides Clinical Program Update and Reports Third Quarter 2022 Financial Results

Retrieved on: 
Monday, November 14, 2022
FDA, Clinical trial, Trial of the century, Survival, Sarcoidosis, Interstitial lung disease, Data monitoring committee, Paul Fildes, PVR, Actigraphy, DMC, Moderate, Therapy, Patient, Pulmonary hypertension, Hepatic artery proper, Particle-size distribution, Safety, Security (finance), Food and Drug Administration, Annual report, Tesa SA, Research, Ino, Diagnosis, Public expenditure, Food, Pharmaceutical industry, MVPA, Bellerophon

WARREN, N.J., Nov. 14, 2022 (GLOBE NEWSWIRE) -- Bellerophon Therapeutics, Inc. (Nasdaq: BLPH) (Bellerophon or the Company), a clinical-stage biotherapeutics company focused on developing treatments for cardiopulmonary diseases, today provided a clinical program update and reported financial results for the third quarter ended September 30, 2022.

Key Points: 
  • WARREN, N.J., Nov. 14, 2022 (GLOBE NEWSWIRE) -- Bellerophon Therapeutics, Inc. (Nasdaq: BLPH) (Bellerophon or the Company), a clinical-stage biotherapeutics company focused on developing treatments for cardiopulmonary diseases, today provided a clinical program update and reported financial results for the third quarter ended September 30, 2022.
  • REBUILD Phase 3 Study: Phase 3 REBUILD registrational study enrollment of INOpulse for the treatment of fILD is approaching completion.
  • The reduced study size is 140 fILD patients who will be treated with either INOpulse at a dose of iNO45 or a placebo.
  • The Company specifically disclaims any obligation to update any forward-looking statements included in this press release.

Bellerophon Announces FDA Acceptance of Change to Ongoing Phase 3 REBUILD Study of INOpulse® for Treatment of Fibrotic Interstitial Lung Disease

Retrieved on: 
Tuesday, September 27, 2022
Inova Fairfax Hospital, Interstitial lung disease, Luke Fildes, Safety, Pulmonary fibrosis, Risk, FDA, Food, Nitric oxide, Data monitoring committee, Company, Compliance, Review, Therapy, Program, U.S. Securities and Exchange Commission, Patient, Public expenditure, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Clinical trial, Actigraphy, DMC, Annual report, Nasdaq, Private Securities Litigation Reform Act, Moderate, Ino, Security (finance), GLOBE, Pulmonary hypertension, Medical imaging, Pharmaceutical industry, MVPA

With this study size change, we believe that we are well-positioned to accelerate the completion of our Phase 3 REBUILD study, said Naseem Amin, M.D., Chairman of Bellerophons Board of Directors.

Key Points: 
  • With this study size change, we believe that we are well-positioned to accelerate the completion of our Phase 3 REBUILD study, said Naseem Amin, M.D., Chairman of Bellerophons Board of Directors.
  • For further details regarding the protocol and additional information on the REBUILD Phase 3 study of INOpulse for the treatment of fILD, please visit ClinicalTrials.gov and reference Identifier NCT0326710 .
  • Bellerophon Therapeutics is a clinical-stage biotherapeutics company focused on developing innovative therapies that address significant unmet medical needs in the treatment of cardiopulmonary diseases.
  • The Company is currently developing multiple product candidates under its INOpulse program, a proprietary pulsatile nitric oxide delivery system.

Bellerophon Provides Clinical Program Update and Reports Second Quarter 2022 Financial Results

Retrieved on: 
Monday, August 15, 2022
FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Ino, U.S. Securities and Exchange Commission, Survival, Trial of the century, Private Securities Litigation Reform Act, GLOBE, Diagnosis, Clinical trial, Poster, MVPA, Security (finance), Annual report, Annals of the American Thoracic Society, ST, PVR, Public expenditure, Patient, Therapy, Company, International Conference on the Holocaust and Genocide, Safety, Paul Fildes, Research, Sarcoidosis, University, Tesa SA, Nasdaq, Pulmonary hypertension, Conference, Hepatic artery proper, Food, Pharmaceutical industry, Aquaculture, Medicine, Bellerophon

WARREN, N.J., Aug. 15, 2022 (GLOBE NEWSWIRE) -- Bellerophon Therapeutics, Inc. (Nasdaq: BLPH) (Bellerophon or the Company), a clinical-stage biotherapeutics company focused on developing treatments for cardiopulmonary diseases, today provided a clinical program update and reported financial results for the second quarter ended June 30, 2022.

Key Points: 
  • WARREN, N.J., Aug. 15, 2022 (GLOBE NEWSWIRE) -- Bellerophon Therapeutics, Inc. (Nasdaq: BLPH) (Bellerophon or the Company), a clinical-stage biotherapeutics company focused on developing treatments for cardiopulmonary diseases, today provided a clinical program update and reported financial results for the second quarter ended June 30, 2022.
  • REBUILD Phase 3 Study: Enrollment is continuing in Bellerophons Phase 3 REBUILD registrational study of INOpulse for the treatment of fILD.
  • The Phase 3 program builds on positive top-line results from the Companys previously reported Phase 2 studies for INOpulse for the treatment of fILD.
  • The Company specifically disclaims any obligation to update any forward-looking statements included in this press release.