Fuisz Announces Allowance for Keystone Patent in the Field of Breath-based Medical Diagnostics

Bay Harbor Island, Florida, UNITED STATES

Bethlehem, PA, June 05, 2017 (GLOBE NEWSWIRE) --

Fuisz Pharma LLC announced today that it has received a notice of allowance for the patent application titled “Method and System to Amplify and Measure Breath Analytes” (Appl. No. 13/423,527).

This allowed patent provides systems and methods for the successful implementation of breath diagnostics. It addresses the pollutant contamination that can skew analyte results in breath analysis. Without addressing the contamination associated with ambient air conditions, multi-center verification studies are not possible.  In the patented Fuisz system, a wash out precursor step employs a predetermined gas composition.  This wash out step removes environmental factors, and allows for consistent, validatable measurement results regardless of geographical location and ambient air conditions.  In addition, the allowed claims teach a new method of amplifying breath analytes, by using penetration enhancers, bronchodilators etc. to increase analyte concentration in the breath.

Joseph Fuisz, Managing Member for Fuisz Pharma LLC commented: “There are enormous advantages in breath diagnostic systems for public health and there is an increasing appreciation for the potential of breath based devices in the public health community.   This is driven by (i) the inherent ease and non-invasive nature of patient breath sampling, combined with (ii) the increasing sensitivity of analytical techniques and (iii) the increasing understanding of the correlation of breath-contained analytes to underlying disease states.”

Mr. Fuisz continued: “However, to develop and to validate breath-based systems for FDA approval, it is necessary to eliminate contaminants associated with the local environment.   Such contaminants are recognized in peer reviewed literature as skewing breath diagnostic results.   Here we have a novel solution to this problem, viz, the use of an initial universal washout step wherein a predetermined known gas mixture is used to washout the lung prior to breath sample collection for measurement.   The step is simple, non-invasive, and effective to remove the effects of local contamination.   This allows for universally accurate measurements in breath diagnostics.”

Richard Fuisz M.D., Member of Fuisz Pharma LLC stated: “The promise of breath diagnostics is clear, exciting and make no mistake, it is the future.  However, validation, commercialization and underlying FDA approval of individual breath-based markers will require successful multi-center studies for large numbers of patients.   Such approvals, and their subsequent clinical application, can only succeed where local ambient conditions are nulled out of results.   This is a challenge peculiar to breath:  breath testing is effected by ambient conditions in a way that blood may not be.”  

Dr. Fuisz continued:  “This keystone patent will allow for the exciting promise of breath diagnostics to move forward in repeatable form, wherein results can be validated for approval and yield a commercially approved system that works the same regardless of location, New York, Denver, London etc.  When that day arrives, as surely it will, a new standard in health screening will be achieved. There will be far less need for venous blood or ‘sticking fingers.’”

Fuisz principals Richard Fuisz and Joseph Fuisz are long active in drug delivery systems.  Richard Fuisz was the primary inventor of the Fuisz Technologies’ shearform matrix quick dissolve tablet (e.g. US 4,855,326).  Richard and Joseph became inventors on the largest wet cast thin film drug delivery patent estate, which has been successfully employed to protect Suboxone® thin film from generic entrants (e.g. US 7,824,588).  They also developed and patented a novel method of achieving sustained drug release in extruded sheets (US 8,613,285), which was acquired by a global consumer products company.  They patented new ways of delivering botanical actives by hot melt extrusion (US 9,125,434).  And they developed a method of making monolayer films with bilayer functionality (US 8,617,589) acquired by a leading oral thin film company.   The Fuiszes have been active in diagnostics systems, including the diagnostic diaper (US 4,700,714), the programming of bodily fluid analyzers (US 7,824,612), and a method for managing metadata from bodily fluid analyzers (US 20150002297).

Fuisz Pharma LLC is a private pharmaceutical technology company originated by Joseph Fuisz (https://en.wikipedia.org/wiki/Joseph_Fuisz) and Richard Fuisz (https://en.wikipedia.org/wiki/Richard_Fuisz). The Fuiszes have made substantial contributions in drug delivery including orally dissolving tablets and novel particle coating systems at Fuisz Technologies; inventing and developing thin film drug delivery technologies at Kosmos Pharma and MonoSol Rx, as well as independently developing extruded sheet technology, and have extensive experience working with big and specialty pharma. Fuisz Pharma is also active in diagnostic systems. http://www.fuisz.com/.


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