Traumatic brain injury (TBI) causes acute deficits in cerebral perfusion which may lead to secondary injury and worse outcomes. Inhaled nitric oxide (iNO) is a vasodilator that increases cerebral blood flow and is clinically used for hypoxic respiratory failure in neonates and adults. The investigators will perform a randomized controlled trial of iNO treatment in TBI patients acutely after injury. The investigators will then assess perfusion changes with optic neuromonitoring, blood biomarkers, and 6 month clinical outcomes.

Start Date01 Dec 2024

Sponsor / Collaborator

University of Pennsylvania

NCT04231760 / Not yet recruitingPhase 1/2IIT

The Effect of Inhaled Nitric Oxide on Pulmonary Gas-exchange in COPD

Chronic Obstructive Pulmonary Disease (COPD) is a lung disorder commonly caused by smoking, which makes breathing more difficult. When COPD patients exercise, they are not efficient breathers and this leads to serious breathing difficulties, which often causes these patients to stop exercise at low intensities. Even though patients with a mild form of COPD have relatively well preserved lung function, they still have inefficient breathing during exercise. The investigators think that these individuals have problems exchanging fresh gas (i.e., oxygen) into the blood stream because of poor lung blood vessel function. The investigators will test whether inhaled medications, specifically nitric oxide, can improve lung blood vessel function and decrease breathing difficulties during exercise. With this research, the investigators will understand more about breathing efficiency and lung blood vessel function in individuals with mild COPD, and find out whether improving lung blood vessel function helps COPD patients breathe easier and exercise longer. Understanding the reasons behind the feeling of difficult breathing may lead to more effective therapy and improved quality of life in COPD patients.

Start Date01 Dec 2024

Sponsor / Collaborator

University of Alberta

NCT06402565 / Not yet recruitingPhase 1

A Randomized, Controlled, Evaluator-Blinded Study to Assess the Safety and Efficacy of NOX1416 in the Treatment of Chronic, Non-Healing, Diabetic Foot Ulcers

The goal of this multi-center, randomized, placebo-controlled, evaluator-blinded study is to assess the safety and efficacy of NOX1416 in the treatment of chronic, non-healing, diabetic foot ulcers (DFUs). Subjects will be randomized to receive treatment with NOX1416 or placebo, as an adjunct to Standard of Care (SOC).
The primary objective of the study is to demonstrate the safety and tolerability of NOX1416 as adjunct to SOC. The secondary objective is to evaluate the clinical benefit of daily NOX1416, as an adjunct to standard of care SOC. Each site will assign a physician (or designee) to serve as the blinded evaluator who is responsible for assessing the study endpoints. The blinded evaluator will not be involved in the clinical care of subjects.

Start Date30 Nov 2024

Sponsor / Collaborator

NOxy Health Products, LLC

[+1]

100 Clinical Results associated with Nitric oxide (inhaled)

100 Translational Medicine associated with Nitric oxide (inhaled)

100 Patents (Medical) associated with Nitric oxide (inhaled)

3,672

Literatures (Medical) associated with Nitric oxide (inhaled)

01 Jun 2025·Archivos Argentinos de Pediatria

Massive pulmonary thromboembolism in an adolescent with SARS-CoV-2 infection

Article

Author: Castillo Acevedo, Cecilia ; Acuña Aguirre, Carlos ; Chauriye Kuncar, Verónica ; Díaz Espejo, Piaignacia

Thromboembolic events incidence is low in pediatrics; high suspicion and explicit management algorithms are essential. We present a 12-year-old female patient with two weeks of dyspnea, orthopnea, and ankle edema. Tests showed metabolic acidosis, hyperlactatemia, elevated D-dimer, and positive SARS-CoV-2 CRP. The echocardiogram showed severe right ventricular dysfunction and supra-systemic pulmonary hypertension. Chest CT angiography showed extensive bilateral pulmonary thromboembolism. Anticoagulant therapy was started. She presented with hemodynamic instability. Adrenaline, norepinephrine, milrinone, and nitric oxide were started. The clinical picture was extremely severe in the first 24 hours. It was decided to perform systemic thrombolysis with alteplase, which led to an improvement. Cardiorespiratory stabilization and anticoagulation are the mainstays of therapy in massive pulmonary thromboembolism. Fibrinolytic therapy is used in selected high-risk cases. In this patient, systemic reperfusion therapy with alteplase was performed with no significant complications.

01 Dec 2024·Environmental Pollution

Nitric oxide and ascorbic acid confer cadmium (Cd) tolerance by improving plant terpenoid metabolism and epigenetically modifying DNA methylation

Article

Author: Ardebili, Zahra Oraghi ; Ebadi, Mostafa ; Iranbakhsh, Alireza ; Oraghi Ardebili, Zahra ; Farahani, Fatemeh ; Haghighat, Setareh

This study investigated the efficacy of incorporating nitric oxide (NO; 10 μM) and ascorbic acid (Asc; 10 μM) into the culture medium to confer cadmium (Cd; 5 μM) tolerance in thyme (Zataria multiflora). The phytotoxicity of Cd resulted in a decrease in shoot biomass, which NO or Asc mitigated. Adding Asc and NO to the culture medium was associated with substantial DNA hypomethylation. The NO + Cd and Asc + Cd treatments were accompanied by an increase in the unmethylation percentages, about 3-fold higher than the control. The hemi-methylation percentages in the Asc-supplemented seedlings also displayed an upward trend. The transcriptional upregulation in the γ-terpinene synthase (TPS) gene resulted from the applied elicitors, especially NO. In response to the NO and Asc treatments, the transcription of two cytochrome P450 monooxygenase genes (CYP71D178 and CYP71D180) went up. Incorporating Asc or NO into the culture medium enhanced the concentrations of proline, carvacrol, and thymol metabolites. Employing NO or Asc mitigated the 43% decrease in protein content due to the Cd cytotoxicity. The NO and Asc applications improved the activity of the phenylalanine ammonia-lyase (PAL) enzyme. NO and Asc utilization increased the accumulation of flavonoids. NO and Asc also up-regulated the activities of two enzymatic antioxidants (catalase and peroxidase). Collectively, this study provided novel insight into how Asc or NO confers Cd tolerance by epigenetically remodeling DNA methylation, transcriptionally up-regulating terpenoid and phenylpropanoid metabolism, increasing proline concentration, and improving antioxidants.

01 Oct 2024·Molecular Neurobiology

Ivermectin Exerts Anticonvulsant Effects Against Status Epilepticus Induced by Lithium-Pilocarpine in Rats via GABAA Receptor and Neuroinflammation Modulation: Possible Interaction of Opioidergic Pathways and KATP Channel with Nitrergic System

Article

Author: Afsahi, Sahar ; Mohammad Jafari, Razieh ; Dehpour, Ahmad Reza ; Ebrahim Soltani, Zahra ; Toutounchian, Samaneh ; Manavi, Mohammad Amin

Status epilepticus (SE) is a critical medical emergency marked by persistent or rapidly repeating seizures, posing a threat to life. Using the lithium-pilocarpine-induced SE model, we decide to evaluate the anti-seizure effects of ivermectin as a positive allosteric modulator of GABA_A receptor and the underlying mechanisms involved. Lithium chloride was injected intraperitoneally at a dose of 127 mg/kg, followed by the administration of pilocarpine at a dose of 60 mg/kg after a 20-h interval in order to induce SE. Subsequently, the rats received varying amounts of ivermectin (0.3, 1, 3, 5, and 10 mg/kg, i.p.) 30 min before the onset of SE. To study the underlying molecular mechanisms, we had pharmacological interventions of diazepam (1 mg/kg), glibenclamide and nicorandil as ATP-sensitive potassium channel blocker and opener (both 1 mg/kg, i.p.), naltrexone and morphine, as opioid receptor antagonist and agonist (1 mg/kg and 0.5 mg/kg, i.p., respectively). In addition, three nitric oxide inhibitors, namely, L-NAME (10 mg/kg, i.p.), 7-NI (30 mg/kg, i.p.), and aminoguanidine (100 mg/kg, i.p.), were administered to the rats in the experiment. Finally, we use ELISA and western blotting, respectively, to examine the amounts of pro-inflammatory cytokines (TNF-α and IL-1β), nitrite, and GABA_A receptors in the rat hippocampal tissue. The study found that ivermectin, at doses of 3, 5, and 10 mg/kg, exerts anti-seizure effects and decrease Racine's scale SE score. Interestingly glibenclamide and naltrexone reduced the anti-seizure effects of ivermectin, and from other hand diazepam, nicorandil, morphine, L-NAME, 7-NI, and aminoguanidine, enhance the effects when co-administrated with subeffective dose of ivermectin. Additionally, the study found that ivermectin decreased the elevated levels of TNF-α and IL-1β following SE, while increased the reduced expression of GABA_A receptors. Overall, these findings suggest that ivermectin has anti-seizure effects in a SE seizure which may be mediated by the modulation of GABAergic, opioidergic, and nitrergic pathways and K_ATP channels.

News (Medical) associated with Nitric oxide (inhaled)

10 Oct 2024

·www.prnewswire.com

Mallinckrodt Announces an Expanded Rollout of the INOmax® EVOLVE™ DS Delivery System in U.S. Hospitals

– The INOmax EVOLVE DS is our next-generation nitric oxide delivery system that combines mini-cylinder technology, automation, integration, and interaction into one device1 – – The INOmax EVOLVE DS is now available for contracting and distribution for use in U.S. hospitals – DUBLIN, Oct. 10, 2024 /PRNewswire/ -- Mallinckrodt plc, a global specialty pharmaceutical company, today announced the rollout of the U.S. Food and Drug Administration (FDA) cleared INOmax® EVOLVE™ DS delivery system for the delivery of INOmax® (nitric oxide) gas, for inhalation. This nationwide rollout follows the successful introduction of the INOmax EVOLVE DS Pilot program. The INOmax EVOLVE DS is our next-generation inhaled nitric oxide delivery system with a fully integrated design and includes a primary delivery system, a monitoring system, an electronic blender, automated backup delivery, mini-cylinders, and more.1 The INOmax EVOLVE DS is intended to help meet the needs of neonatal intensive care unit (NICU) patients and healthcare professionals by offering improved automation, which enhances safety features, and a streamlined design that elevates the user experience.1 Please see Applications and Device Warnings below. INOmax is an FDA-approved treatment that is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.2 INOmax is contraindicated in the treatment of neonates dependent on right-to-left shunting of blood.2 Please see additional Important Safety Information for INOmax below. "We are excited to enter the nationwide rollout phase of our next-generation INOmax delivery system for NICU patients and the hospital staff responsible for their care," said Lisa French, Executive Vice President & Chief Commercial Officer. "This innovation milestone reflects our long-standing commitment to providing delivery system options with comprehensive safety features.1 We will continue to work closely with our customers to support availability of the INOmax EVOLVE DS delivery system." A few of the many INOmax EVOLVE DS features include1: 1.4-lb mini-cylinders Automated pre-use checkout Pre-high-calibrated NO/NO2 gas sensor modules and automatic low calibration Automatic cylinder switching when empty Electronic blender with automatic activation when a minimum amount of oxygen flow has been detected Electronic medical record connectivity that transfers over 100 data parameters3 Touchscreen display with an easy-to-use interface The comprehensive INOmax EVOLVE DS Pilot program provided users the opportunity for an extensive review of our next-generation delivery system. We appreciate each hospital's feedback including one Respiratory Therapist's (RT) statement that, "After using the INOmax EVOLVE DS during the pilot introduction, and in current use, it is evident that Mallinckrodt took the input from bedside RTs into account. The smaller cylinders and streamlined design make it easier to move the device around the hospital and store supplies."1 INOmax has a well-established efficacy and safety profile with more than 20 years on the market and over 875,000 patients treated globally.2,4 In 2023, the INOmax EVOLVE DS was awarded the Human Factors and Ergonomics Society Stanley Caplan User-Centered Product Design Award, presented to teams that have demonstrated outstanding innovation and design for products, software, and systems. Mallinckrodt accepted the award on February 15, 2024. If a customer is interested in learning more about the INOmax EVOLVE DS, they can reach out to their local representative or visit INOmax.com for the latest updates. APPLICATIONS The INOmax EVOLVE DS delivery system delivers INOmax (nitric oxide) gas, for inhalation. The EVOLVE DS must only be used in accordance with the indications, usage, contraindications, and warnings and precautions described in the INOmax package insert and labeling and is indicated for use in term and near term (>34 weeks gestation) neonates with hypoxic respiratory failure (HRF) associated with clinical or echocardiographic evidence of pulmonary hypertension. The EVOLVE DS is indicated for a maximum of 14 days of use. DEVICE WARNINGS Abrupt discontinuation of INOmax can lead to worsening oxygenation and increasing pulmonary artery pressure (rebound pulmonary hypertension syndrome). To avoid abrupt discontinuation, use the eINOblender as a backup immediately to reinstate INOmax therapy and refer to the INOmax package insert. Do not discontinue INOmax delivery if the high NO2 alarm activates. Assess the delivery system for proper setup while maintaining INOmax delivery and verify INOmax and/or FiO2 are appropriate. Do not use equipment that is not specified as part of the system or that is not designed for INOmax mixtures. Using equipment that is not specified can cause the system to malfunction. If an alarm occurs, safeguard the patient first before performing troubleshooting procedures. Use only INOmax, pharmaceutical grade NO. Rx Only For technical assistance or for information on the INOmax EVOLVE DS delivery system, call (877) 566-9466. IMPORTANT SAFETY INFORMATION (Cont'd) Abrupt discontinuation of INOmax may lead to increasing pulmonary artery pressure and worsening oxygenation. Methemoglobinemia and NO2 levels are dose dependent. Nitric oxide donor compounds may have an additive effect with INOmax on the risk of developing methemoglobinemia. Nitrogen dioxide may cause airway inflammation and damage to lung tissues. In patients with pre-existing left ventricular dysfunction, INOmax may increase pulmonary capillary wedge pressure leading to pulmonary edema. Monitor for PaO2, inspired NO2, and methemoglobin during INOmax administration. INOmax must be administered using a calibrated FDA-cleared Nitric Oxide delivery system. Please see Full Prescribing Information . ABOUT MALLINCKRODT Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market, and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, hepatology, nephrology, pulmonology, ophthalmology, and oncology; immunotherapy and neonatal respiratory critical care therapies; analgesics; and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit . CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS This release contains forward-looking statements, including with regard to INOmax (nitric oxide) gas, the INOmax EVOLVE™ DS delivery system, the potential of these products to improve health and treatment outcomes, their potential impact on patients and the availability of the INOmax EVOLVE™ DS delivery system in U.S. hospitals in the future. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: the effects of Mallinckrodt's recent emergence from bankruptcy; satisfaction of, and compliance with, regulatory and other requirements, including the clinical guidelines and protocols, and hospital policies and practices; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; changes in market demand; issues with product quality, manufacturing or supply, or patient safety issues or adverse side effects or adverse reactions associated with INOmax (nitric oxide) gas and the INOmax EVOLVE™ DS delivery system; and other risks identified and described in more detail in the "Risk Factors" section and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Mallinckrodt's most recent Annual Report on Form 10-K , Quarterly Reports on Form 10-Q, and other filings with the SEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law. CONTACT Media Inquiries Green Room Communications 908-577-4531 [email protected] Investor Relations Derek Belz Vice President, Investor Relations 314-654-3950 [email protected] Mallinckrodt, the "M" brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners. ©2024 Mallinckrodt. US-2400582 10/24 References 1 INOmax EVOLVETM DS Operation Manual. Mallinckrodt Pharmaceuticals. 2 INOmax. Package insert. INO Therapeutics LLC; 2023. 3 EVOLVE DS. Serial Data Protocol for versions 01.04.09 and later. Technical Bulletin. TB-23001. Mallinckrodt Pharmaceuticals. 2023. 4 Data on File – Ref-01753. Mallinckrodt Pharmaceuticals. SOURCE Mallinckrodt plc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

01 May 2024

·www.biospace.com

Beyond Cancer Selected to Present on the Clinical Development of Ultra-High Concentration Nitric Oxide (UNO) Therapy at the 2024 American Society of Clinical Oncology Annual Meeting

Company to host an event featuring key opinion leaders (KOLs) on Friday, May 31st in Chicago to highlight the ongoing clinical development of UNO HAMILTON, Bermuda, May 01, 2024 (GLOBE NEWSWIRE) -- Beyond Cancer, Ltd., a clinical stage biotechnology company developing ultra-high concentration nitric oxide (UNO) as an immunotherapeutic for solid tumors, today announced being selected to present on the clinical development program of its Ultra-High Concentration Nitric Oxide (UNO) at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 31 – June 4, 2024 at the McCormick Place Convention Center in Chicago, Illinois. In addition, the Company will host a KOL event that will highlight the ongoing clinical development of UNO (additional details below). Company Sponsored Event: Beyond Cancer will host an event on May 31, 2024 featuring Key Opinion Leaders who will discuss the clinical development program for UNO, including new data from the Phase 1 trial. The event will take place at the Hyatt Regency McCormick Place, from 6:00 p.m. – 8:00 p.m. Central Time. To learn more and register for the company sponsored event please contact Matt Johnson at mjohnson@beyondcancer.com. ASCO Annual Meeting Presentations: Title: A phase 1, multi-center, safety, feasibility, and preliminary efficacy study evaluating a single dose of UNO101 in relapsed or refractory, unresectable, primary, or metastatic cutaneous and subcutaneous malignancies Session Date and Time: Saturday, June 1, 2024 at 9:00 a.m. – 12:00 p.m. Central Time Session Type and Title: Poster Presentation/Developmental Therapeutics - Immunotherapy Abstract Number: TPS2686 Authors: Frederick M. Dirbas, Amichay Meirovitz, David Greenberg, Edith Dekel, Gavin Choy, Jedidiah M. Monson Title: Effect of UNO101 on tumor microenvironment in relapsed or refractory, unresectable, primary, or metastatic cutaneous and subcutaneous malignancies Session Type and Title: Publication Only; New Targets and New Technologies Abstract Number: e14575 Authors: Amichay Meirovitz, David Greenberg, Mark Pegram, Jedidiah M. Monson A copy of the ePublication can be accessed on the Science and Technology page of the Company’s website after May 23, 2024 at 5:00 p.m. ET when made available by ASCO. About Nitric Oxide Nitric Oxide (NO) is a potent molecule, naturally synthesized in the human body, proven to play a critical role in a broad array of biological functions. In the airways, NO targets the vascular smooth muscle cells that surround the small resistance arteries in the lungs. Currently, exogenous inhaled NO is used in adult respiratory distress syndrome, post certain cardiac surgeries and persistent pulmonary hypertension of the newborn to treat hypoxemia. Additionally, NO is believed to play a key role in the innate immune system and in vitro studies suggest that NO possesses anti-microbial activity not only against common bacteria, including both gram-positive and gram-negative, but also against other diverse pathogens. About UNO Therapy for Solid Tumors Cancer is the second leading cause of death globally, with tumor metastases responsible for approximately 90% of all cancer-related deaths. Current cancer treatment modalities generally include chemotherapy, immunotherapy, radiation, and/or surgery. Ultra-high concentration Nitric Oxide (UNO) therapy is a completely new approach to preventing relapse or metastatic disease. In vitro murine data show that local tumor ablation with UNO stimulates an anti-tumor immune response in solid tumor cancer models. Beyond Cancer, Ltd. believes that UNO has the potential to prevent relapse or metastatic disease with as little as a single 5-minute treatment and with limited toxicity or off-target effects. About Beyond Cancer, Ltd. Beyond Cancer, Ltd. is a development-stage biopharmaceutical and medical device company utilizing ultra-high concentration nitric oxide (UNO) via a proprietary delivery platform to treat primary tumors and prevent metastatic disease. Nitric oxide at ultra-high concentrations has been reported to show anticancer properties and to potentially serve as a chemosensitizer and radiotherapy enhancer. A first-in-human study is underway in patients with solid tumors. Beyond Cancer is also conducting preclinical studies of UNO in multiple solid tumor models to inform additional treatment protocols. For more information, visit . Forward Looking Statements This press release contains “forward-looking statements” concerning the potential safety and efficacy of inhaled nitric oxide and the ultra-high concentration nitric oxide product candidate, as well as its therapeutic potential in a number of indications; and the potential impact on patients and anticipated benefits associated with inhaled nitric oxide and the ultra-high concentration nitric oxide product candidate. Forward-looking statements include statements about expectations, beliefs, or intentions regarding product offerings, business, results of operations, strategies or prospects. You can identify such forward-looking statements by the words “expects,” “plans,” “anticipates,” “believes” “expects,” “intends,” “looks forward,” “projects,” “goal,” “assumes,” “targets” and similar expressions and/or the use of future tense or conditional constructions (such as “will,” “may,” “could,” “should” and the like) and by the fact that these statements do not relate strictly to historical or current matters. Rather, forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause actual results to differ materially from any future results expressed or implied by the forward-looking statements. These forward-looking statements are only predictions and reflect views as of the date they are made with respect to future events and financial performance. Many factors could cause actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including risks related to the ability to raise additional capital; the timing and results of future pre-clinical studies and clinical trials concerning the ultra-high concentration nitric oxide product candidate; the potential that regulatory authorities, including the FDA and comparable non-U.S. regulatory authorities, may not grant or may delay approval for the ultra-high concentration nitric oxide product candidate; the approach to discover and develop novel drugs, which is unproven and may never lead to efficacious or marketable products; obtaining, maintaining and protecting intellectual property utilized by products; competition from others using similar technology and others developing products for similar uses; dependence on collaborators; and other risks, which may, in part, be identified and described in the “Risk Factors” section of Beyond Air, Inc.’s most recent Annual Report on Form 10-K and other of its filings with the Securities and Exchange Commission, all of which are available on Beyond Air, Inc.’s website. Beyond Cancer and Beyond Air undertake no obligation to update, and have no policy of updating or revising, these forward-looking statements, except as required by applicable law. CONTACTS: Corey Davis, PhD LifeSci Advisors, LLC Cdavis@lifesciadvisors.com (212) 915-2577 Matt Johnson, Head of Corporate Development & Strategy Beyond Cancer, Ltd. Mjohnson@beyondcancer.com

ImmunotherapyASCOPhase 1

27 Feb 2024

·www.biospace.com

Third Pole Therapeutics Announces Successful Completion of Feasibility Study with eNOfit™ Portable Inhaled Nitric Oxide Delivery System

WALTHAM, Mass., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Third Pole Therapeutics, a privately held company developing critical life-sustaining therapies for people living with cardiopulmonary and infectious diseases, announced today the successful completion of an early feasibility study (EFS) performed under an Investigational Device Exemption granted by the FDA. This study evaluated eNOfit™, a miniaturized, portable inhaled nitric oxide (iNO) generator and delivery system for the ambulatory treatment of patients suffering from pulmonary hypertension (PH) associated with Interstitial Lung Disease (ILD). “The successful completion of our EFS which validated the safe and practical use of our eNOfit™ system, enables us to confidently move into larger randomized placebo-controlled safety and efficacy studies. This is a significant milestone for Third Pole and a major step forward in validating the delivery of iNO for home and travel use, to improve the quality of life of the millions of patients suffering from PH due to chronic lung diseases like ILD and COPD. Importantly, this value creating milestone will trigger the final funding of Third Pole’s Series B investment round.” said Bill Athenson, CEO of Third Pole. “In addition to Third Pole’s eNOcare™ device, in development to increase access and affordability of nitric oxide for in hospital use, the eNOfit™ device is a two-pound, portable NO generation and delivery device for outpatient use. There is a significant need for new ways to treat patients living with PH-ILD and PH-COPD outside the hospital. We look forward to acquiring the clinical data to support the use of eNOfit™ in at-home and ambulatory settings from Third Pole’s upcoming trials. The trials are expected to confirm that the same clinical benefits of nitric oxide in PH observed over the last 30 years in hospitalized patients, can be achieved in out-of-hospital patients as well", said Dr. Rajan Saggar, Professor of Medicine, Director Pulmonary Hypertension Program, Co-Director Pulmonary Vascular Disease Program, Lung & Heart-Lung Transplant and Pulmonary Hypertension Programs, David Geffen School of Medicine, UCLA. The Group 3 Pulmonary Hypertension cohort includes ILD and COPD patients with PH 1,2. In healthy people, deoxygenated blood returning to the heart from all organs and tissues is pumped by the right heart through the pulmonary arteries into the lungs. Within the lungs, the pulmonary arteries divide into smaller vessels to take in oxygen and remove carbon dioxide in the air sacs (alveoli). The oxygen-rich blood then returns to the left side of the heart, where it is pumped back to organs and tissues. Normally, the blood flows easily through the pulmonary arteries, but in PH, the arteries become stiff, damaged, and narrow. This makes blood flow much more difficult and causes the blood pressure in the lungs to rise (PH) and the right heart to work harder. Over time, the right heart can fail, leading to a poor prognosis and death. Patients with Group 3 PH-ILD suffer from shortness of breath, fatigue, and fainting episodes. They have a difficult time doing normal chores and must take breaks while doing activities of daily living. As their disease advances, they are often dependent on supplemental oxygen to maintain adequate oxygenation levels at rest and on exertion. Inhaled nitric oxide relaxes smooth muscle within the pulmonary vasculature, increasing the diameter of pulmonary arteries and decreasing their resistance to blood flow. Inhaled nitric oxide has been shown in the clinic to reduce the load on the right heart but this benefit has yet to be demonstrated in patients outside the hospital. About Third Pole Therapeutics Third Pole Therapeutics develops and delivers critical life-sustaining cardiopulmonary therapies. Warren Zapol, M.D., Third Pole's founder, invented the first use for iNO for the treatment of persistent pulmonary hypertension in new-born infants (blue babies). Since then, in addition to blue babies, hundreds of thousands of pediatric and adult patients experiencing elevated pulmonary pressure, inflammation, and poor oxygenation during and after heart surgery have been treated with inhaled nitric oxide, creating a $600 million iNO industry, concentrated in large hospitals and developed markets. Two decades later, Third Pole has successfully created a scalable technology that generates and delivers NO for inhalation, instantly, on-demand, and in unlimited quantities. Last year, Third Pole announced an agreement for a $32M strategic equity investment to accelerate the development of its tankless iNO platform from one of the largest healthcare companies in the world to enhance their product offering in the cardiopulmonary device market. Third Pole was chosen as “best in class” technology that will solve the cost and logistical hurdles which have prevented widespread iNO use in various markets in the U.S. and abroad that lacked the training and infrastructure required to transport, maintain, return, and refill large cylinders of compressed gas safely. Third Pole's two innovative platforms include eNOfit™, a miniaturized wearable device for home and travel and eNOcare™, a lightweight portable in-hospital device. Both make NO by combining electricity and ambient air, creating a "make it and take it" therapy, free from the hazards of compressed gas storage. These broadly patented, versatile platforms and derivative products have the potential to rapidly capture the entire existing tank-based market and expand beyond current indications to treat interstitial lung disease (ILD), chronic obstructive pulmonary disease (COPD), cystic fibrosis, heart failure, stroke, and life threatening, refractory viral and bacterial infections. For more information, please visit . Third Pole’s product development has been generously supported by awards from the National Heart, Lung, and Blood Institute of the National Institutes of Health and the National Center for Advancing Translational Sciences of the National Institutes of Health. Contact: Third Pole Therapeutics Elizabeth Holmberg, Chief Financial Officer 908-310-0596 eholmberg@pole3.com

100 Deals associated with Nitric oxide (inhaled)

External Link

KEGG	Wiki	ATC	Drug Bank
-	Nitric oxide (inhaled)	R07AX01	DB00435

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hypoxic respiratory failure	CN	INO Therapeutics LLC	08 Mar 2022
COVID-19	IN	SaNOtize Research & Development Corp.Startup	09 Feb 2022
Pulmonary Arterial Hypertension	JP	AIR WATER MEDICAL INC	16 Jul 2008
Hypertension, Pulmonary	IS	Linde Healthcare AB	01 Aug 2001
Hypertension, Pulmonary	EU	Linde Healthcare AB	01 Aug 2001
Hypertension, Pulmonary	LI	Linde Healthcare AB	01 Aug 2001
Hypertension, Pulmonary	NO	Linde Healthcare AB	01 Aug 2001
Neonatal respiratory failure	IS	Linde Healthcare AB	01 Aug 2001
Neonatal respiratory failure	LI	Linde Healthcare AB	01 Aug 2001
Neonatal respiratory failure	NO	Linde Healthcare AB	01 Aug 2001
Neonatal respiratory failure	EU	Linde Healthcare AB	01 Aug 2001
Respiratory Insufficiency	US	MALLINCKRODT HOSP PRODUCTS IP LTD	23 Dec 1999

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Phase 3	LK	SaNOtize Research & Development Corp.Startup	20 Nov 2021
Persistent Fetal Circulation Syndrome	Phase 2	US	Mallinckrodt Plc	01 Aug 1998
Pneumonia, Aspiration	Phase 2	US	Mallinckrodt Plc	01 Aug 1998
Respiratory Distress Syndrome, Newborn	Phase 2	US	Mallinckrodt Plc	01 Aug 1998
Respiratory Failure	Phase 2	US	Mallinckrodt Plc	01 Aug 1998
Respiratory Insufficiency	Phase 2	US	Mallinckrodt Plc	01 Aug 1998
Blood Platelet Disorders	Preclinical	US	Mallinckrodt Plc	25 Apr 2018
Inflammation	Preclinical	US	Mallinckrodt Plc	25 Apr 2018
Acute Chest Syndrome	Preclinical	FR	Mallinckrodt Plc	01 Dec 2008
Respiratory Distress Syndrome, Adult	Preclinical	US	Mallinckrodt Plc	01 Sep 2000

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00515281 (NOVA2, CTgov)	Phase 2/3	Bronchopulmonary Dysplasia \| Leukomalacia, Periventricular \| Cerebral Intraventricular Hemorrhage \| Obstetric Labor, Premature	273	inhaled nitric oxide (INO Control (Short iNO))	arypizpusl(unrmcwnpde) = sygufcwiye dmubtpzwfz (ceqqvneuqd, uxhmuzrdgh - sjslpvvkbf) View more	-	17 Oct 2024
				oxygen+inhaled nitric oxide (INO Treatment (Long iNO))	arypizpusl(unrmcwnpde) = nytvvhyhia dmubtpzwfz (ceqqvneuqd, lbttrmhfzc - diyaorkldh) View more
ATS2024	Not Applicable	airway disease	-	Inhaled Nitric Oxide (Bilateral lung injury)	yparlspbey(iigzzizjga) = gbkbeddamk udibyooxtx (krjrzqqbwv, 2 - 8) View more	-	19 May 2024
				Inhaled Nitric Oxide (Asymmetrical lung injury)	yparlspbey(iigzzizjga) = aahvzzxifc udibyooxtx (krjrzqqbwv, 1 - 2) View more
ATS2024	Not Applicable	COVID-19	-	High flow nasal oxygen (HFNO)	sbscvtckwc(hvmulahzxi) = qjkahufldl wodxmkghxk (hsfktkrnfh, 1.47% - 2.1%)	-	19 May 2024
				High flow nasal oxygen (HFNO) + inhaled nitric oxide (iNO)	wcfcqhiwrp(ziwmjebaym) = tplanxtask uzdxniypav (ghqelymexc ) View more
NCT03873298 (Pubmed) Manual	Phase 2	Lung Diseases, Interstitial pulmonary hypertension	44	nitric oxide	(bfzmqjtrtw) = fniqnnvfrm sfjtisfhhe (ysoeyxpdzg, 265 - 409)	Positive	10 May 2024
				Placebo	(bfzmqjtrtw) = emwzqkmdby sfjtisfhhe (ysoeyxpdzg, 250 - 407)
NCT03044314 (OVATION, CTgov)	Phase 4	Hypertension, Pulmonary	27	nitric oxide administration+Iloprost	lqanssugyy(enehgdlbcz) = pyyusxecfq bjkhfmysxi (pgfjweitak, zarqgryhzo - cardkcvnoj) View more	-	02 Apr 2024
NCT03081052 (Pubmed)	Phase 4	-	231	Inhaled Epoprostenol	baptesvhbr(xzvetpmypi) = fvqunfsfhf jklhwopzpc (fpknamhuoa )	-	04 Jul 2023
				Nitric Oxide	baptesvhbr(xzvetpmypi) = keykjzplrz jklhwopzpc (fpknamhuoa )
EHA2023	Phase 2	refractory acute lymphoid leukemia in relapse Consolidation	110	mini-HCVD + InO	liinmdozmx(ytmlpsfdax) = unlcwkxgqz sbrhmnkhxi (yskvsmofwu ) View more	-	08 Jun 2023
				mini-HCVD + InO + blina	liinmdozmx(ytmlpsfdax) = uabvbfsoux sbrhmnkhxi (yskvsmofwu ) View more
ATS2023	Not Applicable	Hypertension, Pulmonary	-	Inhaled Iloprost	praeihhgtj(rxjzfvucjo) = pgmvllynae tiltlcvgzw (emmkeunaqk, 12.2)	-	21 May 2023
				Inhaled Nitric Oxide	praeihhgtj(rxjzfvucjo) = wndeiuuuou tiltlcvgzw (emmkeunaqk, 12.2)
ATS2023	Not Applicable	COVID-19	-	Inhaled Nitric Oxide	tnsrdbwasr(pueldedado) = ugwfzdcbrp xxuemuduti (wxhlcgqjfx ) View more	-	21 May 2023
O131 (EBMT2023)	Not Applicable	Pre B-cell acute lymphoblastic leukemia	51	Blina	(ayhuiijicp) = tixbwfuqpz nrrisivtdn (gfvposwvuy ) View more	Positive	23 Apr 2023
				Ino	(ayhuiijicp) = ztxflkztph nrrisivtdn (gfvposwvuy ) View more

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