What exactly is the Technosphere® Platform?

One of the largest organs in your body are the lungs. Picture the size of a full tennis court and that is roughly the surface area of both lungs in a typical adult. Running through those lungs are airways whose total length measures 1,500 miles – that’s the distance between Chicago and Las Vegas, New York to Albuquerque, and Los Angeles to Nashville.

Simply put, the lungs create a wonderful platform for effective drug delivery. MannKind’s Technosphere technology recognizes this and provides the distinct advantage of rapid, deep lung drug delivery. The effect is similar to intravenous delivery (I.V.; within a vein) and has the added benefit of bypassing the liver which can be especially helpful in reducing systemic side effects.

Examining it closer, it helps to look at inhalation, air flow travel, and the exhale. When you breathe in, air is drawn into the lung and flows down curving, narrowing airways that end in the air sacs or alveoli. When air is exhaled, the flow is reversed. Between the end of an inhalation and the start of exhalation, the air in the lung is stationary. To reach the deep lung, inhaled particles must be carried by the air stream and have enough momentum to continue through the stationary air to collide with the lung surface.

Particles that can reach the lung have aerodynamic diameters between 0.5 µm and 5-6 µm (1 µm is 1 micro-meter or about 0.00004 inches). Particles that are larger than 6 µm will leave the air stream and hit the back of your mouth and throat; smaller than 0.5 µm wouldn’t have the ability to reach the lungs and would simply get exhaled.

“The average Technosphere particle is about 2-2.5 µm which is in the middle of the respirable range,” explains Marshall Grant, PhD, MSc, Executive Director, Clinical Pharmacology & Research for MannKind Corporation. “The particle size distribution is a major reason Technosphere powders are highly efficient in delivering drug to the lungs than other dry powder inhalers (DPIs).”

The Technosphere particles in FDA-approved Afrezza® (insulin human) Inhalation Powder and Tyvaso DPI™ (treprostinil) Inhalation Powder are manufactured by different processes and possess different characteristics. But both are made up of small crystals of FDKP (fumaryl diketopiperazine), MannKind’s proprietary molecule. FDKP provides high solubility and fast dissolution at physiologic pH – and more importantly – can crystallize and form particles in the range appropriate for optimum delivery to the lungs.

When Technosphere powder reaches the lung surface, the FDKP and drug dissolve. The FDKP is then rapidly cleared from the lung into systemic circulation. The FDKP is not metabolized, but rather excreted primarily in the urine. Another value of Technosphere powders has been their versatility – they are compatible with a wide range of doses with different types of drugs.

MannKind’s Technosphere powders are delivered into the lung’s airstream via an inhalation device or DPI (dry powder inhaler). The breath-powered inhalers (Dreamboat® being the most common version) provide excellent delivery efficiency and are proven to deliver up to 70% of the dry-powder dose deep into the lungs. Our DPI are designed to be simple, easy to use and discreet. For patients, imagine having a drug in the convenient form of an inhaler that fits in the palm of your hand. This approach allows patients to not only take control of their health but do it while going about their day and enjoying life more humann.

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NTM Lung Disease on the Rise

“I cough every morning upon waking, so I don’t feel rested.” “Imagine not being able to breathe.” “Anxiety ruins everything about you – it’s not a normal life.” “You just exist from day to day and week to week.” These are a sampling of comments about the most bothersome symptoms from living with Nontuberculous Mycobacteria (NTM) shared in a study from NTM Info & Research, Inc. The statements are unfortunately typical and those with NTM often have unpredictable day-to-day health functioning and reduced quality of life.

NTM lung disease is a serious infection that is caused by bacteria that are common in the environment and can cause lung damage. The reality is that we are all exposed to these bacteria in our day-to-day lives – more than 120 species of mycobacteria have been identified. These common bacteria exist in water and soil particles that are in the air, wet places like hot tubs, steamy bathrooms, dishwashers, and even the dewy ground we walk on at the park. But not everyone is at risk of getting NTM lung disease just because they are exposed.

Those predisposed often have underlying conditions such as asthma, COPD, and bronchiectasis, which makes them prone to NTM infection. NTM is not considered to be contagious. Women over the age of 65 make up the majority of those impacted, with a predominance in those of Caucasian and Asian descent.

A rare disease, NTM can often be difficult to diagnose. Many will experience coughing, fatigue, weight loss and shortness of breath – all of which are common with other lung disease symptoms and other conditions like tuberculosis. With NTM, symptoms often worsen, and that is a marker not to be ignored.

It is estimated that some 86,000 individuals are living with NTM lung diseases, and it is on the rise growing 8% each year. Coastal regions including Gulf States have higher rates of infection accounting for 70% of annual NTM cases.

While no cure is available, treatments to manage NTM are available. Treatment for NTM involves antibiotic and multidrug regimens with duration lasting from months to years with tolerability and adverse reactions to treatment which often leads to a lack of adherence to therapy.

There is a valuable need to develop medicines that are well tolerated and effective that lends to consistent patient use and alleviates symptoms of NTM lung disease. MannKind continues to progress MNKD-101 (Clofazimine) for the treatment of NTM.

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Release Details

Innovative Diagnostic Technology Playing Significant Role in Improving Detection for Better Cardiac Care

09/05/18
PDF Version

PALM BEACH, Florida, September 5, 2018 /PRNewswire/ --

MarketNewsUpdates.com News Commentary 

Heart disease is one of the leading causes of death in the western world. In Europe and the U.S. alone, it is estimated 15 to 20 million patients a year visit the emergency departments of hospitals reporting chest pain that could be a sign of an acute myocardial infarction, commonly referred to as a heart attack. Efficient and quick diagnosis helps identify patients who may or may not be suffering from a heart attack allowing those with heart issues and conditions to receive the proper treatment. Like any good diagnostic tool, it can save lives and save money that hospitals need for other treatments. Early detection of heart attack by measuring very low levels of troponin released in the early stages of a heart attack is a vital unmet medical need for point of care. Cardiac health care is constantly improving as the latest advancements have allowed innovative and new devices to pinpoint and address cardiac issues earlier on. Active companies in the markets this week include Zenosense, Inc. (OTC:ZENO), MannKind Corporation (NASDAQ:MNKD), BioTelemetry Inc. (NASDAQ:BEAT), Irhythm Technologies Inc. (NASDAQ:IRTC), Boston Scientific Corporation (NYSE:BSX).

Zenosense, Inc. (OTCPK:ZENO) BREAKING NEWS: Zenosense, a healthcare technology company focused on the development and commercialization of the MIDS Cardiac™ hand-held technology for the early detection of heart attack at the Point of Care, is pleased to announce that its MIDS Medical Ltd. joint venture ("MML") has entered a staged funding for the next phase of development of MIDS Cardiac.  

On 31 August, 2018 MML entered into an agreement with a third party investor for funding of up to an aggregate amount of $1,200,000 ("Agreement"). This funding is expected to cover the costs of the next crucial development phase of the MIDS Cardiac microfluidic test strip which aims to embody a high sensitivity ("HS") troponin assay or a similar assay to prove the MIDS system on a live test.

As reported on June 19, 2018 the patented MIDS technology has successfully detected commercial assay beads at a level approximately four times better than the threshold advised by MML's assay consultants as required for a HS troponin assay.

The next phase development plan includes;

-    Design and create an active version of the MIDS microfluidic strip, including the closer integration of the MIDS magnetic sensors to improve the detection levels even further;

-    In conjunction with a leading assay development Company contracted to MML design, develop and embody a live HS assay on the MIDS test strip;

-    Refinements of electronic circuitry and software, system testing and data collection; and

-    The creation of compliance dossier.

MML's work is ongoing and it plans to expand its development operations by engaging a number of specialists in the fields of electronics, microfluidics and software development to carry out the work required. The outcome of this next phase is intended to prove to industry that the MIDS magnetic detection method can detect and accurately quantify a live HS assay on the MIDS microfluidic test strip. If successfully completed, the Company believes this will demonstrate that MIDS Cardiac can be used at the Point of Care for HS Troponin testing and is ready for final device development.  

HS Troponin testing for myocardial infarction at the Point of Care would meet a critical unmet medical need. It is expected to be of intense interest to global diagnostic majors and the proof of concept should also open up substantial opportunities for the MIDS system to be applied to numerous other immunoassay tests.   Read this and more news for Zenosense athttp://www.marketnewsupdates.com/news/zeno.html

Other recent and current developments in the healthcare industry include:

MannKind Corporation (NASDAQ:MNKD) recently announced a distribution agreement for Afrezza® with Tanner Pharma Group, a global provider of integrated specialty access solutions. The agreement names Tanner as a distributor of Afrezza® outside of the United States in regions the product is not yet registered. Afrezza® (insulin human) Inhalation Powder is a rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus. "Al Mann had a vision of making Afrezza available to all people living with diabetes around the world and this agreement helps accelerate that access to Afrezza on a named patient access basis in underserved international markets," said Michael Castagna, Chief Executive Officer of MannKind. "Our partnership with Tanner Pharma to distribute Afrezza provides us a strong partner with a track record of success in working with physicians, hospitals and ministries of health to provide medicine that is not currently available in their country." The distribution will be managed by TannerGAP, Inc. ("TannerGAP"), a wholly owned subsidiary of Tanner Pharma Group.

BioTelemetry Inc. (NASDAQ:BEAT) recently announced the release of its next-generation wireless blood glucose monitor for diabetes management. As an industry pioneer, BioTel Care developed the first FDA-cleared, cellular-enabled glucometer which supports real-time transmission and consolidation of patient data in an FDA-cleared cloud.  Building on the success of this technology, BioTel Care is launching its next-generation blood glucose monitor, which includes an innovative touch-screen user interface, enabling patients to easily test blood glucose levels while capturing additional personal health data.  The monitor's remote capabilities allow patients to quickly communicate a wide range of relevant health information to their care providers.  Clinicians can access and track their patients' data through the BioTel Care cloud and can provide immediate feedback, as needed, directly to their patients via the new monitor's messaging feature.  Patients can also track their own data with informative graphical summaries available on the monitor.  Both clinicians and patients will benefit from the system's ability to be paired with other connected health devices, providing the option to consolidate various types of health information into a single, cloud-based repository.

iRhythm Technologies Inc. (NASDAQ:IRTC) recently announced that results of the mHealth Screening to Prevent Strokes (mSToPS) study, which showed increased detection of asymptomatic atrial fibrillation (AF) in high-risk individuals using Zio by iRhythm, have been published in the Journal of the American Medical Association (JAMA). Utilizing an innovative home-based study design, electrocardiogram (ECG) recording and analysis were carried out using the FDA-cleared Zio by iRhythm ambulatory continuous monitoring patch to evaluate detection of asymptomatic AF, also known as silent AF. At one-year, primary results showed that AF was newly diagnosed in 6.7 percent of patients who were actively monitored by the Zio service versus 2.6 percent in the observational control group receiving routine care. In addition, 4.0 percent of patients in the Zio monitored group were found to have potentially actionable arrhythmias other than AF including ventricular tachycardia, pause, AV block, and symptomatic supraventricular tachycardia. Researchers at the Scripps Translational Science Institute (STSI) conducted the study in partnership with collaborators, Aetna and Janssen Pharmaceuticals.

Boston Scientific Corporation (NYSE:BSX) recently announced it is acquiring Cryterion Medical, Inc., a privately-held company developing a single-shot cryoablation platform for the treatment of atrial fibrillation (AF). The addition of this cryoballoon platform positions the company as the first to have both cryothermal and radiofrequency (RF) single-shot, balloon-based ablation therapies in its portfolio. Boston Scientific has been an investor in Cryterion since its inception in 2016 and the transaction price for the approximately 65 percent remaining stake not already owned by Boston Scientific consists of $202 million in up-front cash. The quickly expanding global electrophysiology (EP) market is estimated to reach $5 billion in 2018. Additionally, single-shot ablation therapies are believed to be the fastest growing sub-segment within the EP market, with rates well into in the double digits, and trending toward more than $1 billion over the next few years. Patients with AF - a common heart rhythm disorder - are often treated with anti-arrhythmic drugs as well as cardiac ablation. Ablation therapy is the process of delivering RF (heating) or cryothermal (cooling) energy to the areas of the heart muscle responsible for the abnormal heart rhythm. Both types of energy can be used to isolate pulmonary veins, which are often the source of AF.  

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