Ciliary Motility Disorders

GOLETA, Calif.--( BUSINESS WIRE )-- Inogen, Inc. (Nasdaq: INGN ), a medical technology company offering innovative respiratory products for use in the homecare setting, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the SIMEOX 200 Airway Clearance Device, expanding the company’s ability to market and meet the various needs of patients with chronic respiratory diseases in the U.S. SIMEOX 200 is the next-generation of the original Simeox (currently available in select international markets). It is intended to promote and improve bronchial drainage by enhancing mobilization of bronchial secretions via high frequency oscillatory vibrations and intermittent negative pressure to the airway during exhalation. The device is intended to be prescribed for use in patients capable of independently generating cough. SIMEOX 200 is predominantly aimed to help patients with chronic lung diseases associated with mucus hypersecretion and mucus retention, such as Bronchiectasis, COPD (Chronic Obstructive Pulmonary Diseases), Cystic Fibrosis or Primary Ciliary Dyskinesia. “We are very excited to receive FDA clearance for the innovative SIMEOX 200 therapy for patients in the U.S.,” said Kevin Smith, President and Chief Executive Officer. “By tapping into our well-established network of healthcare providers, B2B partners, and our Direct-to-Patient team, we aim to bring this next-generation airway clearance device to patients within the next year and significantly expand our reach over time.” Traditional airway clearance therapies can be time consuming and constraining with mixed results. SIMEOX 200 provides an innovative alternative, delivering efficient bronchial drainage, specifically in low lung volumes, that can be administered in healthcare centers and institutions, as well as at home. Inogen plans to pursue a limited launch of SIMEOX 200 in targeted sites in 2025. About Inogen Inogen, Inc. (Nasdaq: INGN) is a leading global medical technology company offering innovative respiratory products for use in the homecare setting. Inogen supports patient respiratory care by developing, manufacturing, and marketing innovative best-in-class respiratory therapy devices used to deliver care to patients suffering from chronic respiratory conditions. Inogen partners with patients, prescribers, home medical equipment providers, and distributors to make its respiratory therapy products widely available, allowing patients the chance to manage the impact of their disease. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this communication that are not historical facts, including, but not limited to, statements regarding Inogen’s future business plans, market opportunities, financial outlook, growth strategies, and anticipated operational results, are forward-looking statements. Words such as “aims,” “believes,” “anticipates,” “plans,” “expects,” “will,” “intends,” “potential,” “possible,” and similar expressions are intended to identify forward-looking statements. Forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from currently anticipated results, including but not limited to, risks and uncertainties relating to market acceptance of its products; competition; its sales, marketing and distribution capabilities; its planned sales, marketing, and research and development activities; interruptions or delays in the supply of components or materials for, or manufacturing of, its products; seasonal variations; unanticipated increases in costs or expenses; risks associated with international operations; and the possibility that Inogen will not realize anticipated revenue from recent or future technology acquisitions or that expenses and costs related thereto will exceed Inogen’s expectations. For a detailed discussion of these and other risks that could impact Inogen’s operations and financial performance, please refer to the “Risk Factors” section of its Annual Report on Form 10-K for the period ended December 31, 2023, its Quarterly Report on Form 10-Q for the calendar quarter ended March 31, 2024 and in its other filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. Inogen disclaims any obligation to update these forward-looking statements except as may be required by law. For more information, please visit www.inogen.com . Inogen has used, and intends to continue to use, its Investor Relations website, http://investor.inogen.com/ , as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

FRIDAY, Dec. 20, 2024 -- Most children with likely primary ciliary dyskinesia (PCD) have asthma , according to a research letter published online Dec. 9 in JAMA Network Open . Joe Zein, M.D., Ph.D., from the Mayo Clinic in Scottsdale, Arizona, and colleagues conducted a case-control study to examine the association between PCD and asthma in children aged 18 years or younger. The combination of two diagnoses that are unlikely to occur together in the absence of PCD, specifically bronchiectasis and situs inversus totalis (B-SIT), was analyzed; individuals with B-SIT were then asked whether they also had a diagnosis of asthma. This study included 124 B-SIT patients and 142 controls matched for age, sex, ethnicity, and race: nine children with B-SIT and 27 controls from the Indiana Network for Patient Care Research (INPCR) cohort and 115 cases and 115 controls from the validation cohort, TriNetX. The researchers found that in the INPCR cohort, all nine B-SIT children and one control had asthma. In the TriNetX cohort, 84 with B-SIT and 12 controls had asthma. The adjusted odds ratio was 22.3 for patients with B-SIT having asthma. "In summary, children with PCD may need to be evaluated for asthma," the authors write. "Consideration should also be given to whether some children with asthma may have cardinal features of PCD." Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

The programme utilises Intellia’s CRISPR-based gene editing platform and DNA-writing technology. Credit: Natali _ Mis/Shutterstock. ReCode Therapeutics is set to secure up to $15m in additional funding from the Cystic Fibrosis Foundation to enhance its gene correction research programme. The initiative, conducted in collaboration with Intellia Therapeutics , aims to develop new treatments for cystic fibrosis (CF), including for patients with genotypes that are non-responsive or intolerant to existing cystic fibrosis transmembrane conductance regulator (CFTR) modulators. The programme utilises Intellia’s clustered regularly interspaced short palindromic repeats (CRISPR)-based gene editing platform and deoxyribonucleic acid (DNA)-writing technology along with the company’s selective organ targeting (SORT) lipid nanoparticle (LNP) delivery platform aiming at gene correction. The investment will propel the development of up to three gene correction programmes which are designed to address CF mutations not covered by current therapies. It will also enhance ReCode’s existing RCT2100 clinical programme, an investigational inhaled messenger ribonucleic acid (mRNA) therapy, currently in a Phase Ib multi-dose study for CF patients. ReCode Therapeutics CEO Shehnaaz Suliman stated: “This funding will support our gene correction approach, enabling us to significantly accelerate research in collaboration with Intellia and to advance the development of a potentially transformative treatment for CF. “Along with RCT2100, our inhaled mRNA programme, we are building a therapeutic franchise to expand disease-modifying treatment options for all people with CF.” In February 2024, the company announced a strategic collaboration with Intellia Therapeutics to develop gene editing therapies for CF. CF is a debilitating genetic disease leading to persistent lung infections and respiratory failure, stemming from mutations in the CFTR gene. The company’s lead programmes, RCT2100 and RCT1100, target CFTR gene mutations unresponsive to approved modulators and primary ciliary dyskinesia, respectively. Both are inhaled mRNA-based therapies formulated with ReCode’s SORT LNP delivery platform. In January 2023, Asklepios BioPharmaceutical entered a research partnership with ReCode to explore a single-vector gene-editing platform.