Products & Pipeline
Core Technology
The Company’s core technology consists of proprietary sensors, signal conditioning hardware, and extensive array of signal processing algorithms for automatic detection and quantification of wheezes, cough and respiration. The technology also includes protection of the inner-body signal against interferences from background noisy acoustic environments which is found in pulmonary function testing laboratories. The quantification of wheezes is based on their duration, namely, the percentage time a patient wheezes (e.g. 12 seconds of wheeze in a minute is equivalent to a WheezeRate of 20%). The WheezeRate correlates with the extent of airway narrowing and conventional measures of asthma. The detection of cough facilitates coughcounting and determination of cough distribution over time.
The Current Product Range
Based on its core technology, the Company is bringing to market a suite of products to supply solutions for major aspects of the disease, from the mild to the severe, from hospital to home, from young to old, during rest and during exercise (i.e. exerciseinduced asthma) and from awake to asleep (nocturnal asthma). Below are brief descriptions of the products, their intended use and market, their current status, and the timeline for rollout. The products are listed in the order of their commercialisation onset.
The Personal Wheezometer - The Company’s flagship product is a hand-held device for home use. When placed on the neck with its sensor over the trachea, it picks up the breathing sounds and determines if wheezes are present. A thirty second determination indicates the momentary wheeze rate. Should it be high, the patient (or parent) is instructed to seek medical help. The Personal Wheezometer prototype was completed in June 2008 and had an initial launch at the annual conference of the American Thoracic Society (ATS) in San Diego in May 2009, and a follow-up launch of the production WheezoMeter at the annual Congress of the European Respiratory Society (ERS) in Vienna in September 2009. This product has received European CE Mark clearance and Australian TGA approval for sale in these jurisdictions. Today’s WheezoMeter product line includes the Clinical WheezoMeter, two Personal WheezoMeters (adult and child), and retrieval software.
The WHolter - is a 24 hour ambulatory digital data-logger / recorder. It is intended to be used for tracking wheezing and coughing for evaluation of nocturnal asthma, occupational asthma and persistent cough and, in the patient’s own allergen environment. The WHolter™ will also be incorporated as a component in the first phase of the WIM-GER™. The development work has been completed and the product had a soft launch at the ERS Conference in Vienna in September 2009. Sales of the WHolter to PFT labs, sleep labs and WHolter™ monitoring dispensing clinics commenced in 2010.
The Wireless PT - is an add-on option to the PulmoTrack to facilitate ease of use and to reduce the cost of manufacturing. This product was launched at ERS in Vienna in September 2009.
The WIM-GER - is a combination of iSoneas WHolter and the ZePhir Impedance and pH monitor of Sandhill Scientific Inc. This joint venture collaboration resulted from a KarmelSonix-sponsored study that revealed the two types of relationships between asthma and cough, on the one hand, and Gastro-Esophageal Reflux (GER) on the other.
The ASAM - or Acoustic Severe Asthma Monitor is a novel continuous monitor for minute by-minute assessment of the severe asthma patient, typically in an ambulance, the Emergency Room, the Intensive Care Unit (ICU), and during recovery in the paediatric or internal medicine ward. The device combines the wheeze detection core technology outlined above, and the advanced active acoustics technology developed by the Company.
Is Isonea developing "Me Too" products? I am hesitant to answer this question, however to be fair although there do exist many other Asthma Monitoring devices on the market today, Isonea's core technology processes algorithms measured by acoustic signals which to my understanding does make it unique among currently marketed wheeze measuring devices.
AsthmaSense™
"There’s never been an asthma management tool like AsthmaSense™. For the first time, the AsthmaSense app brings together everything you need to manage your asthma, and may help to prevent attacks."
One Screen, One Stop
AsthmaSense is a take-anywhere journal that reminds you to take medication or test your breathing. It allows you to record symptoms, medication use and peak flow measurements from a single screen. You can also access your emergency contact information and automatically make a call, if needed.- Once screen does it all. Learn more about this potentially life saving app:
- Easy to use for managing asthma anytime, anywhere
- For use with children or adults
- Set reminders for medication use and peak flow testing
- See when medications are due
- Log diary actions quickly with a single tap
- Record symptoms and breathing function
- Selectively silence reminders as needed
- Select reminder tones for individual users
- Record unscheduled medication use
- Record missed medications, as well as edit or update the journal
- Review up to one month of peak flow, symptoms and medication adherence
- Receive status alerts when your asthma is “not well controlled” or “poorly controlled” according to National Institute for Health guidelines
- Keep emergency contact information and phone numbers in easy reach
- Manage one or multiple users with one smartphone
FDA:
The Personal Wheezometer is intended to be a home use version of the Pulmo Track and Pulmo Track model 2010 (WIM-PC) providing wheeze-rate information for both home and clinical settings.
Personal Wheezometer: is intended for quantifying the presence of wheezing. This device should be used under the guidance of a physician or qualified healthcare professional for monitoring acoustic pulmonary functions. - FDA 510 (k) summary - 21/09/2009
Patents
4 of the 7 key patents were invented by the company founder, Noam Gavriely and assigned to Karmel Medical Acoustic Technologies Ltd which I note ceased being a substantial holder in November 2011.
1. Are these key patents now licensed to iSonea from Karmel Medical Acoustic Technologies Ltd or Noam Gavriely or were they re-assigned to Isonea during the recent name change phase?
To my knowledge KarmelSonix presented a total of 14 patents of which 6 were already granted, 4 patents were pending and another 4 were in preparation as of 2009
The WheezoMeter, PulmoTrack and WHolter are all protected by two patents as shown in this flyer which were filed in 1996 and 1997 respectively giving patent protection through to 2016 and 2017 - Only 3-4 more years remaining of patent protection is quite concerning as it not only decreases the value of the technology and/or license to a potential partner but would also deter lucrative partnerships from being established? This forms the predominant basis for my own decision not to invest in ISN and I would certainly be happy to hear from others on this very topic.
R&D
Isonea have provided the one document titled, November 2010 on their website under the heading, "Clinical Study"
I'd like to see more peer reviewed material made available and more information related to the study programs planned for 2012.
Management
One of the reasons I don't like companies changing their names is due to the transparency issues as a result. Maybe it's just the sceptic in me however on first observation, it appears to me that presentations announced to the market as far back as KSX - 2009 Announcements and 2010 Announcements are similar to some of the more recent releases in 2011 and aerly 2012.
Although I'm yet to take any position in Isonea I have decided to cut Mr thomas a bit of slack - I have been quite critical of him on a public forum, however I have since had a small change of heart as I do believe that Mr Thomas is doing the best he can with the limited resources available, and we certainly can't blame him for the volatility in global markets which haven't done ISN's share price any favors. Further, Mr Thomas has put his money where his mouth is, so as long as he holds that position, there is at least one positive indicator from the company's CEO.
Mike Thomas
Mr. Thomas has over 22 years of experience in the healthcare industry in various executive positions. He is the President & CEO of Appian Partners, a healthcare advisory firm focused on strategy development and implementation for medical device and healthcare services firms ranging in size from early stage start up to Fortune 50 global conglomerates. Prior to that, he was President and CEO of Sleep Solutions, Inc., (SSI) a venture capital backed medical device manufacturer and national healthcare service provider. He raised over $50MM in venture capital funding to develop and launch a new industry in the $5 billion Sleep Medicine market. He successfully lobbied the largest Managed Care Organizations (MCOs) and the Centers for Medicare and Medicaid Services (CMS) to alter their medical policy and approve reimbursement for in home sleep apnea diagnostic testing services. Mr. Thomas was also a member of the Board of Directors for AdvaMed, the world's largest and most prestigious medical device association. While a BOD member for AdvaMed, he participated in the successful renegotiations with the FDA for the MEDUFMA II legislation (the FDA's regulatory approval process for medical devices), with leaders on Capitol Hill regarding the Remote Monitoring legislation, and sat on the BOD sub committee for International Affairs. Prior to SSI, he was Executive Vice President of Sales and Marketing for National Sleep Technologies Inc. (NST). As an executive and Board member, he identified and closed 12 acquisitions representing over 80 sleep labs that led to NST becoming the largest U.S. sleep-testing company at that time. He helped create the first national brand in the highly fragmented sleep apnea diagnostic lab testing services market. He recruited and managed a sales and marketing team that achieved a same-store sales growth rate that was 2 times greater than the industry average for four consecutive years. He helped raise over $15MM in venture capital financing and eventually sell the company to a wholly owned subsidiary of GE Medical (NYSE: GE). Previous to SSI, Mr. Thomas was instrumental as the Vice President of Sales in building sales and marketing for Patient InfoSystems, Inc., (NASDAQ: PATI) a healthcare I.T. start-up specializing in the development of disease management programs for the healthcare industry. During his tenure, he hired, trained and managed a national sales force and was instrumental in taking the company public within two years of its formation. Having held various sales and marketing positions, including seven years with Merck and Glaxo Wellcome, he has earned numerous awards for sales and management achievements. Mr. Thomas graduated from Cornell University with a bachelor's degree in Microbiology.
Appian Partners - Mike Thomas
Prior to Appian Partners, Mr Thomas was President and CEO of Sleep Solutions Inc which has since changed its name to NovaSom in September 2010. novaSom is a privately held diagnostic-service provider for home testing and evaluation of sleep-disordered breathing, including obstructive sleep apnea.
Another note worthy point to Mr Thomas's Sleep Solutions past connection is that Johnson & Johnson Development Corporation were a major investor during Mr Thomas's time as the head honcho, so I'm happy to concur on that note that he might indeed have some good connections in the rights places.
Dr. Ross Macdonald
Dr. Macdonald brings extensive local and international biomedical experience in general management, technology commercialisation, capital raising, and business development, including licensing, mergers and acquisitions.
He was formerly Managing Director and CEO of Living Cell Technologies Ltd (ASX: LCT; OTCQX: LVCLY), a development stage biotechnology company focused on therapeutics for type-1 diabetes, Parkinson’s disease, and stroke.
Dr. Macdonald is currently a Member of the Investment Committee of Uniseed Management Pty Ltd, a venture fund established to commercialise research outcomes from the Universities of Queensland, Melbourne and New South Wales, and serves as a Director for pharmaceutical development companies Telesso Technologies Ltd (ASX: TEO) and Hatchtech Pty Ltd.
Previously he was Vice President, Business Development for Sinclair Pharmaceuticals Ltd, Vice President of Corporate Development for Stiefel Laboratories, Inc., and was Vice President of Business Development for Connetics Corporation when it was acquired by Stiefel. He was also
Vice President of Research & Development for F.H. Faulding & Co, Ltd, Australia’s largest and oldest pharmaceutical company.
Dr. Stewart Washer
Dr Washer has 15 years of senior executive and Board experience at medical device, drug development and agrifood companies. He was a venture partner with Inventages, a Nestlé fund and is currently Investment Manager with IB Managers, which manages Australian life-science funds. Dr. Washer was previously the CEO of Calzada Ltd (ASX: CZD); the founding CEO of Phylogica Ltd (ASX: PYC); CEO of Celentis; and managed the commercialization of intellectual property from AgResearch in New Zealand.
He has held a number of Board positions, including Chairman of Resonance Health Ltd (ASX: RHT) and Hatchtech Pty Ltd; and Director of iCeutica Pty Ltd and AusBiotech Ltd. He was also a Senator with Murdoch University and is currently a Director of Healthlinx Ltd (ASX: HTX) and Immuron Ltd (ASX: IMC).
Mr. Donal O’Dwyer
Mr O'Dwyer brings extensive worldwide sales, marketing, product development and manufacturing operations experience in the healthcare products and medical device industries. He was formerly Worldwide President of Cordis Cardiology, a Johnson & Johnson Company, during which time he re-established their position as a leader in international cardiology with the development and launch of the revolutionary Cypher coronary stent. He oversaw the growth of that business from USD500M per annum to over USD2B per annum.
Mr. O’Dwyer is currently Deputy Chairman of the Board at Mesoblast Limited (ASX: MSB; OTC ADR: MBLTY), the world’s leading developer of biological products for regenerative medicine. He is also a member of the Board at Cochlear, the leading global hearing solution company. Previously, he was President of the Cardiovascular Group, Europe, for Baxter Healthcare. He was chairman of the Board of AtCor Medical and has served as Director on the Boards of Angioblast Systems and Sunshine Heart.
Medical Advisory Board.
Dr Lynn M. Taussig, M.D., - Medical Advisor
Dr Taussig Special Advisor to the Provost for the Life Sciences at the University of
Denver and the retired president and CEO of National Jewish Medical and Research Center has accepted the post.
Dr. Taussig is a renowned authority on asthma and is the author of more than 180 scientific
publications and six books and monographs. For eleven years, he was the Chair of the Steering Committee of the National Institute of Health's Childhood Asthma Research and Education Network. He currently chairs another steering committee and two Data Safety Monitoring Boards for the National Institute of Health’s National Heart, Lung and Blood Institute (NHLBI).
Prior to assuming his positions at National Jewish Medical and Research Center, he was
Professor and Chair, Department of Pediatrics and Director, Steele Children's Research Center at the University of Arizona Health Sciences Center. He is the recipient of 44 honors and awards from schools, universities and communities around the world.
The following presentation provides further details relating to the current board and management team at Isonea:
Presentation - March 2012
Presentation - March 2012
Partnerships
iSonea Ltd recently announced a collaboration with Qualcomm Life Inc., a wholly owned subsidiary of Qualcomm Incorporated, to design and market a home and mobile asthma monitoring
platform. The new technology will combine iSonea’s proprietary Acoustic Respiratory Monitoring (ARM) ™ devices and mobile health asthma management systems with Qualcomm Life’s 2net™ Platform.monitoring data to a cloud‐based portal for physicians and caregivers,to improve asthmamanagement and outcomes. This wireless solution leverages Qualcomm Life's 2net Hub, a plug‐and‐play connectivity gateway to the cloud‐based 2net Platform data server, to collect and transmit patient health data from iSonea’s monitoring devices. The technology will ultimately allow physicians to securely access patient monitoring data, review treatment progress and medication adherence and adjust patient action plans accordingly. Family and caregivers will be able to view trends for reassurance about patient care.
Financial Resources
The funding agreement with Bergin, whilst essential to continue ramp up sales strategy and progress clinical studies through 2012, this year may also prove the make or break for Isonea imo. Without attracting a funding partner to speed up future progress they may lose the last of their foothold in this highly competitive landscape, and as I said before, if the technology holds so much promise the big players should be knocking at the door.
Net Loss for financial year 2011 - ($6,677,311)
Net Loss for financial year 2010 - ($5,939,761)
Net Loss for financial year 2009 - ($6,701,092)
Net Loss for financial year 2008 - ($11,678,053)
Net Loss for financial year 2007 - ($5,123,912)
Revenue FY2010 - $348,493 - Cost of goods (269,886)
Revenue FY2011 - $332,087 - Cost of goods (239,770)
* Medicare reimbursements for pulmonary rehabilitation to be reduced significantly as reported by ATS in December 2011. How will this effect Isonea's Sales & Marketing strategy?
Medicare Cuts Pulmonary Rehabilitation Reimbursement
The Medicare final rule for the Hospital Outpatient Prospective Payments System included steep cuts in reimbursement for pulmonary rehabilitation. CMS finalized its proposal to cut reimbursement for pulmonary rehabilitation (G0424 Pulmonary Rehabilitation for patients with COPD) from $62 to $38. Patients who have diseases other than COPD should be reported with the timed, 15 minute G0237, G0238 codes or the group code, G0239. The ATS believes CMS based its decision on faulty data. CMS based its decision on data collected from hospital cost reports.
Source of information:
Overview of Medical device Regulations
FDA - Device Classification
FDA applications submitted by Karmel Sonix
Operator Manual - PulmoTrack 2020-3020
WheezoMeter video demonstration - The Doctors - 03/09/2010
Applications for Medical Device Product Code "BZM" (Calculator, Pulmonary Function Interpretator (Diagnostic)
Application for Reimbursement Code - 17/11/2009
ATS Coding & Billing Quarterly - December 2011
Product Broshure - WheezeRate - A new paradigm in Asthma Management - 07/07/2009
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