Aytu BioScience Announces Manufacture and Delivery of Healight(TM) Devices for Use in COVID-19 Clinical Study – Yahoo Finance
August 18th 2020 Posted at Low T
Comments Off on Aytu BioScience Announces Manufacture and Delivery of Healight(TM) Devices for Use in COVID-19 Clinical Study – Yahoo Finance |
Delivery of Investigational Endotracheal Ultraviolet-A Light Catheter Devices Enables Near-Term Initiation of Planned Clinical Studies in Severely Ill COVID-19 Patients
ENGLEWOOD, CO / ACCESSWIRE / August 17, 2020 / Aytu BioScience, Inc. (NASDAQ:AYTU), a specialty pharmaceutical company (the "Company") focused on commercializing novel products that address significant patient needs, today announced the delivery of Healight investigational devices. The delivery of these pilot scale Healight devices, designed and developed by Sterling Medical Devices ("Sterling"), enables the initiation of COVID-19 investigational clinical studies, which are expected to begin in the near-term.
Since Aytu signed a master services agreement with Sterling in April for Healight, the Company, Sterling, and its collaborators have sourced Healight device components and finalized design of the investigational devices for use in upcoming clinical studies.
Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, "A significant amount of work has gone into the development of the Healight investigational device, and we thank all of our collaborators for their efforts. We are looking forward to taking the next steps and advancing Healight as quickly as possible. As the COVID-19 pandemic continues, the investigation and development of novel potential therapies remains a high priority for numerous companies, and Aytu is proud to be part of this important effort. If Healight demonstrates safety and effectiveness in upcoming, planned studies, we are hopeful it can become an important tool in the COVID-19 fight."
The Healight technology platform employs proprietary methods of administering intermittent ultraviolet (UV) A light via a novel respiratory tract device. Pre-clinical findings indicate the technology's significant impact on reducing a wide range of viral and bacterial loads, including the coronavirus HCoV-229E. Recently published pre-clinical data have been the basis of discussions with the FDA for a path to enable human use for the potential treatment of SARS-CoV-2 in intubated patients in the intensive care unit (ICU). Beyond the initial pursuit of a potential SARS-CoV-2 ICU indication, additional experimental studies of mixed infection suggest broader potential clinical applications for the technology across a range of viral and bacterial pathogens. This may include nosocomial bacteria implicated in ventilator-associated pneumonia (VAP).
About Aytu BioScience, Inc.
Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex Sprinkle, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu also distributes a COVID-19 IgG/IgM rapid test. This coronavirus test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma.
Aytu also operates a subsidiary focused on consumer health, Innovus Pharmaceuticals, Inc. ("Innovus"), a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the company's proprietary Beyond Human marketing and sales platform.
Story continues
Aytu's strategy is to continue building its portfolio of revenue-generating Rx and consumer health products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about
About Sterling Medical Devices
Founded in 1998, Sterling Medical Devices (SMD), specializes in the product design and engineering of medical devices for the healthcare industry. Dedicated to resolving their clients' medical device design and engineering challenges, SMD addresses the whole development process, including, product design and human factors, systems, software, electronics, mechanical, quality, compliance, and global regulatory submissions. The company utilizes the latest tools and technology to streamline the engineering process to speed regulatory registrations, clearances, and/or approvals of Class I, II, and III devices. To date, the company has spearheaded the production of over 1,100 projects for more than 300 clients. SMD is internationally recognized and is FDA QSR 21 CFR Part 820 and Part 11 compliant, ISO 13485 registered, and IEC 62304, ISO 14971, IEC 60601, and IEC 62366 compliant. For more information, please visit http://www.sterlingmedicaldevices.com or call 201.227.7569 x2.
Forward-Looking Statement
This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: market and other conditions, the regulatory and commercial risks associated with introducing the COVID-19 rapid test, the effectiveness of the COVID-19 rapid rest, market acceptance of the National Cancer Institute or other independently conducted studies' testing results, the regulatory, clinical, manufacturing, and commercial risks associated with the investigational Healight device, effects of the business combination of Aytu and the Commercial Portfolio and the merger ("Merger") with Innovus Pharmaceuticals, including the combined company's future financial condition, results of operations, strategy and plans, the ability of the combined company to realize anticipated synergies in the timeframe expected or at all, changes in capital markets and the ability of the combined company to finance operations in the manner expected, the diversion of management time on Merger-related issues and integration of the Commercial Portfolio, the ultimate timing, outcome and results of integrating the operations the Commercial Portfolio and Innovus with Aytu's existing operations, risks relating to gaining market acceptance of our products, obtaining or maintaining reimbursement by third-party payors for our prescription products, the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, our anticipated future cash position and future events under our current and potential future collaboration. We also refer you to the risks described in ''Risk Factors'' in Part I, Item 1A of the company's Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.
Contact for Investors:
James CarbonaraHayden IR(646) 755-7412james@haydenir.com
SOURCE: Aytu BioScience, Inc.
View source version on accesswire.com: https://www.accesswire.com/601817/Aytu-BioScience-Announces-Manufacture-and-Delivery-of-HealightTM-Devices-for-Use-in-COVID-19-Clinical-Study
- Erectile Dysfunction: A Look at the Most Common Causes - Feed Leader - October 8th, 2020
- Aytu BioScience Announces Fiscal Q4 2020 Net Revenue of $14.9 Million, an Increase of 82% Sequentially, and 766% Year-Over-Year - BioSpace - October 8th, 2020
- Indianapolis Low T Center & Men's Clinic | Sleep Apnea ... - September 28th, 2020
- Whats Causing My Low Testosterone? - September 28th, 2020
- Safety Concern With Fingolimod to Ocrelizumab Switch in MS - Medscape - September 24th, 2020
- Could This Device Help Save Covid-19 Patients Before the ICU? - Houstonia Magazine - September 6th, 2020
- Equipping the Immune System to Fight Against COVID-19 - BioSpace - August 28th, 2020
- Aytu BioScience Announces Regulatory Approval of ZolpiMist(R) by Australian Therapeutic Goods Administration - Yahoo Finance - July 31st, 2020
- Aytu BioScience Announces Regulatory Approval of ZolpiMist(R) by Australian Therapeutic Goods Administration - BioSpace - July 30th, 2020
- Maybe its low testosterone? - The Durango Herald - July 29th, 2020
- Low Testosterone: Symptoms, Diagnosis & Treatment ... - July 27th, 2020
- New Osteoporosis Recommendations From AACE Help Therapy Selection - Medscape - July 23rd, 2020
- Hormone therapy no cure-all for 'low T' in ageing men - Health24 - July 20th, 2020
- Low Testosterone (Low T): Causes, Symptoms, Diagnosis ... - July 19th, 2020
- Signs of Low Testosterone in Men Under 30 - July 19th, 2020
- Strain engineering of the magnetic multipole moments and anomalous Hall effect in pyrochlore iridate thin films - Science Advances - July 15th, 2020
- Does Low Testosterone Cause Night Sweats? - July 11th, 2020
- Aytu BioScience Announces Distribution Partnership with Apollo Med Innovations to Expand Distribution of COVID-19 IgG/IgM Rapid Test in United States... - July 10th, 2020
- Low T Therapy Market Report 2020 Global Industry Analysis, Trends, Market Size and Forecasts Up to 2027: AbbVie, Endo International, Eli Lilly - 3rd... - June 29th, 2020
- Ego might drive men to testosterone therapy, but it helps with certain conditions - The Columbus Dispatch - June 14th, 2020
- What Are T-Cells and Can They Protect You from COVID-19? - Labmate Online - June 11th, 2020
- Viewpoint: Time to stop thinking of testosterone as a 'magic male molecule' - Genetic Literacy Project - May 22nd, 2020
- Is Testosterone Therapy Safe for Women? - HealthCentral.com - May 17th, 2020
- Aytu BioScience to Report Fiscal Q3 FY 2020 Results and Business Update - Yahoo Finance - May 7th, 2020
- Peek on Low T Therapy Market Future, Extensive Studies and Prediction of Top Manufacturers Condition: AbbVie, Endo International, Eli Lilly - 3rd... - May 4th, 2020
- COVID-19: T cells offer clues to the potential power of Roche's Actemra - FierceBiotech - May 4th, 2020
- T Cell Counts and Cytokine Storms May Hold Key to Effective COVID-19 Treatment - Technology Networks - May 4th, 2020
- New clues on how to treat COVID-19 from T cell counts - The Nation - May 4th, 2020
- Treating low testosterone levels - Harvard Health - April 30th, 2020
- Low T Symptoms Quiz: Do I Have Low Testosterone Quiz ... - April 30th, 2020
- Low T Treatment in Texas | SynergenX | Licensed ... - April 30th, 2020
- Hypogonadism - Wikipedia - April 30th, 2020
- Does Insurance Cover Low T Treatment - Mantality Health - April 30th, 2020
- Peek on Low T Therapy Market Future, Extensive Studies and Prediction of Top Manufacturers Condition: AbbVie, Endo International, Eli Lilly -... - April 30th, 2020
- Aytu BioScience Signs Development Agreement with Sterling Medical Devices to Advance the Development of Healight as a Potential Coronavirus Treatment... - April 27th, 2020
- Aytu BioScience Announces Exclusive Distribution Agreement for COVID-19 IgG/IgM Rapid Test with Singapore-Based Biolidics Limited - Yahoo Finance - April 27th, 2020
- Aytu BioScience Submits Notice of Commercialization to the FDA, Allowing for Company's Distribution of its 2-10 Minute COVID-19 IgG/IgM Point-of-Care... - March 24th, 2020
- No, not everything about mens sexual behaviour can be explained by testosterone - Scroll.in - March 23rd, 2020
- Aytu BioScience Expands Its Distribution Rights for Coronavirus 2019 (COVID-19) Point-of-Care Rapid Test to Canada and Mexico - Yahoo Finance - March 20th, 2020
- Aytu BioScience Announces Acceleration of U.S. Availability of COVID-19 IgG/IgM Rapid Test Based on Updated FDA Policy - Yahoo Finance - March 20th, 2020
- Aytu BioScience's Coronavirus Rapid Test Featured on NBC and Fox News (VIDEOS): ''Englewood Company Says It Can Get COVID-19 Test Results in 2-10... - March 17th, 2020
- Getting Testosterone Down To The 'T' - Qrius - March 14th, 2020
- Indiana Regenerative Medicine Institute Offers Innovative Approaches in Regenerative Medicine, Hormone Replacement and Pain Management - Carmel... - March 5th, 2020
- Low Testosterone - Symptoms & Treatment | Everyday Health - February 27th, 2020
- Lost revenue from low T fares must be recouped - Boston Herald - February 27th, 2020
- Low T Therapy Market 2020-2027 Worldwide Analysis and Prediction by Leading Players: AbbVie, Endo International, Eli Lilly, Pfizer - News Parents - February 25th, 2020
- Aytu BioScience to Report Fiscal Q2 FY 2020 Results and Business Update - Yahoo Finance - February 6th, 2020
- The Signs a Testosterone Booster is Needed - Science Times - January 26th, 2020
- New Guideline for Testosterone Treatment in Men With 'Low T' - Medscape - January 11th, 2020
- Expert Insights on Osteoporosis From the ACR/ARP 2019 Annual Meeting - Rheumatology Advisor - November 26th, 2019
- 8 Awful Things That Happen to You After You Turn 30 (And What You Can Do to Stop Them) - Mandatory - November 19th, 2019
- Homeless with HIV: A place to heal becomes a matter of life or death - OregonLive - November 18th, 2019
- The Truth About Low Testosterone Levels, According to Experts - menshealth.com - October 14th, 2019
- Is That Rash a Sign Your Treatment Isn't Working? - HivPlusMag.com - October 14th, 2019
- Low T Specialist - Dallas, TX & Frisco, TX: Men's T-Clinic ... - October 7th, 2019
- Low Testosterone Therapy (TRT) and Treatment from Low T Center - October 6th, 2019
- Low T Center - Men's Health Clinic - Testosterone Replacement - September 13th, 2019
- 5 Best Testosterone Supplements For Men Over 50 - September 11th, 2019
- What does a low T cell count mean? - Doctor.ndtv.com - May 1st, 2019
- Low T Symptoms | Low Testosterone | Signs of Low T - March 7th, 2019
- Low T Treatment in Texas & Illinois | SynergenX Health ... - February 18th, 2019
- The Lowdown on Low-T - Discover Health - Rush University ... - February 18th, 2019
- The Low T Scam? - Testosterone Centers of Texas - Low T ... - February 18th, 2019
- Low Testosterone (Low T) | Evaluation and Treatment Plan ... - February 12th, 2019
- Low T Center in San Diego CA - Kingsberg Medical - January 8th, 2019
- Low T 99 - Testosterone Therapy: Bellevue, Seattle, Tacoma ... - December 31st, 2018
- Low T | Low testosterone | Entourage Medical - December 26th, 2018
- Low T - Regional Urology - November 6th, 2018
- Men, Low T, and the Facts | Lifespan - October 2nd, 2018
- You've Heard About "Low T" But What About "Low E"? - April 23rd, 2018
- Low T 99 - 10 Photos - Health & Medical - 1239 120th Ave NE ... - April 23rd, 2018
- 7 Symptoms of Low Testosterone in Women - Low T Treatment ... - March 12th, 2018
- Low T-Helper (CD4) Cell Level - Symptoms and Diagnosis - March 3rd, 2018
- ED Clinic Nashville TN, Erectile Dysfunction Treatment, Low T - February 10th, 2018
- Low-Testosterone (Low-T) - Controversy Over ... - AARP - January 10th, 2018
- Low testosterone symptoms | Effects of low testosterone - December 17th, 2017
- Low Testosterone (Low T) Treatments - onhealth.com - November 11th, 2017
- Erectile Dysfunction/Low T Men's Health Georgia - August 20th, 2017
- Low T - Testosterone Replacement Therapy - Ehormones - August 17th, 2017
- Buckeye PMR Low T - Do You Have Low Testosterone?! - August 17th, 2017
Recommendation and review posted by Alexandra Lee Anderson
Both comments and pings are currently closed.