Half Yearly Report and Accounts
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KarmelSonix Ltd (`KSX' or `the Company') has continued to achieve significant development and commercial milestones over
the first six months of the current financial year. The achievement of these milestones has further consolidated the Company's
ambitions to become a leading developer and producer of non-invasive clinical solutions and products for the monitoring and
management of a range of respiratory conditions, including asthma, sleep apnoea and emphysema. The asthma products are
the first to reach the commercial marketplace.
On 7th November 2007 KSX announced it had received regulatory clearance from the US Food and Drug Administration
(FDA) for its first product, the WIM-PCTM. This clearance from the FDA allows KSX to market and use the WIM-PCTM within
the United States and constituted an important milestone in the commercialisation of the product.
In addition, as part of the marketing program, approx. 30 post market clinical validation studies are currently being planned to
roll out across the US, Europe and Australia. A number of these studies have already commenced and others are expected to
be commenced over the next few months. Data is expected to be collected and analysed from these studies on a progressive
basis and will commence shortly.
European CE Mark regulatory approval. This marketing campaign will then extend to
Australia once TGA approval has been given, which is expected shortly. Through the Australian office of KSX the Asian
marketing campaign has also commenced with initial presentations completed in Japan, Taiwan, Hong Kong and the
Philippines.
Discussions with potential corporate partners and distributors are continuing having identified several suitable potential
partners with specific expertise within specific markets, rather than general device distributors with broad coverage but who
lack specific market and product focus. KSX management believe it is essential that any corporate partners and / or
distributors of the KSX products have specific knowledge and expertise in the pulmonary and respiratory markets rather than
the general devices market.
The Personal Wheezeometer which is a diagnostic tool for home based personal asthma assessment is also being developed
within the planned budget and timeframe. KSX believes the Personal Wheezeometer will become its flagship product with a
working prototype to be available in the third quarter of 2008.
Acoustic Severe Asthma Monitor (ASAM) at the Alfred Hospital in Melbourne. The technology being developed was
funded, in part, by a grant received from VISTECH (The Victorian Israeli Government's Technology Fund). The novel
ASAM technology which allows for both non-invasive passive and transmissive acoustic technologies to monitor patients with
severe asthma is being tested in a series of human trials involving 30 patients separated into three different patient groups.
The KSX R D team is continuing to work at a very high level of activity to ensure the bringing to market of the full suite of
respiratory products from hospital to home (H2H). The department currently has development and commercialisation projects
underway for 5 further products in addition to the PulmoTrack
The development of the WHolter which is a diagnostic tool being developed for assessing nocturnal asthma, a new market in
asthma diagnostics, is progressing on time and on budget, with the Company expecting to finalise the prototype by second
quarter 2008. The functionality of the WHolter makes it ideal as a research tool in the Pharmaceutical industry where currently
there are over 300 asthma trials being undertaken by such companies around the world.
As announced on 28th February 2008 a clinical study was completed confirming the importance of combining the two
technologies. This study's findings will be presented at the American Thoracic Society (ATS) Conference in Toronto in May
2008. The ATS Conference is a key meeting, held every May in North America with over 16,000 pulmonologists in
attendance.
In the 15 infants who were monitored continuously for an average of 12 hours there were 411 reflux events of which 31%
were associated with (preceded by or followed by) a cough. Only about one quarter of these coughs were identified by the
parent staying next to the child and less than half of the parental detected coughs (i.e.
Wrong (delayed) parental detection may have caused the impression that the reflux event preceded the cough, whereby in
reality it was the cough that preceded (and likely caused) the reflux. According to the Study's Principal investigators, in 3 of
the infants the use of the WIM technology helped prevent an unnecessary major operation (fundoplication) intended to re-
attach the oesophagus into the stomach to prevent the reflux.
Recently, KSX added further to the Executive team with the appointment of a Marketing Director, Mr Hagai Ben-Asher. The
role of Marketing Director has been made to further strengthen the KSX Sales and Marketing department led by VP of Sales
and Marketing, Mr Israel Tal. Bolstering this team is essential as the commercialisation and rollout of the KSX suite of
products continues. Mr Ben-Asher will be responsible for the Company's overall branding and idenity, specific product
marketing campaigns, the Company's presence at events such the ATS conference in March and the KSX information
newsletter, which will be provided to the broader pulmonology and respiratory community.
The Company has made substantial progress on several important fronts in the last 6 months and this is expected to
continue. With the release of the PulmoTrack and receipt of regulatory approvals it is expected that commercial negotiations
will be concluded, thereby enabling sales activities to be ramped up in the second half of the year. These are expected to
grow initially from a small base with the subsequent release of additional products.
Since commencing operations some 15 months ago the executive team has been considerably expanded. Overall staff
numbers between Melbourne and Haifa (Israel) have increased to approx. 30 full time and equivalent staff. Haifa is the
operational head office of the Company with the core R D, product development and sales and marketing activities being
driven from Haifa into the key markets within the Northern Hemisphere (USA Europe).
KarmelSonix Ltd recorded revenue of $375,984 for the period ended 31 December 2007 (2006: $23,038), the majority of this
revenue is a result of interest earnt on company bank accounts. This increase was primarily the result of a capital raising in
August 2007 that raised approximately A$5.5M, before costs.
This interim financial report does not include all notes of the type normally included in an annual financial report and therefore
cannot be expected to provide as full an understanding of the financial performance, financial position and financing and
investing activities of the entity as the full financial report.
Accounting Standards include Australian equivalents to International Financial Reporting Standards (A-IFRS). Compliance
with AASB134 Interim Financial Report ensures that the financial statements and notes of the entity comply with
International Financial Reporting Standards equivalent IAS34 Interim Financial Reporting .
No other matters or circumstances have arisen since the end of the reporting period, other than the above, which significantly
affected or may significantlyaffect the operations of the economic entity, the result of those operations or the state of affairs of
the economic entity in subsequent financial years.
On the 9 January 2008 KarmelSonix Ltd received formal regulatory approval from the EU - CE Mark, allowing for clinical sale
of the WIM-PCTM throughout Europe and follows US FDA regulatory approval received in November 2007. As a result, the
marketing and sales process for the WIM-PCTM will commence in Europe.
Liability limited by a scheme approved under Professional Standards Legislation.
PKF is a national association of independent chartered accounting and consulting firms, each trading as PKF. PKF Australia Ltd
is also a member of PKF International, an association of legally independent chartered accounting and consulting firms.
INDEPENDENT AUDITOR'S REVIEW REPORT
TO THE MEMBERS OF KARMEL SONIX LIMITED
We have reviewed the accompanying half-year financial report of Karmel Sonix Limited, which comprises the
condensed balance sheet as at 31 December 2007, and the condensed income statement, condensed statement
of changes in equity and condensed cash flow statement for the half-year ended on that date, other selected
explanatory notes and the directors' declaration of the consolidated entity comprising Karmel Sonix Limited and
the entities it controlled at 31 December 2007 or from time to time during the half-year ended on that date.
The directors of Karmel Sonix Limited are responsible for the preparation and fair presentation of the half-year
financial report in accordance with Australian Accounting Standards (including the Australian Accounting
Interpretations) and the Corporations Act 2001. This responsibility includes establishing and maintaining internal
control relevant to the preparation and fair presentation of the half-year financial report that is free from material
misstatement, whether due to fraud or error; selecting and applying appropriate accounting policies; and making
accounting estimates that are reasonable in the circumstances.
Our responsibility is to express a conclusion on the half-year financial report based on our review. We conducted
our review in accordance with Auditing Standard on Review Engagements ASRE 2410 Review of an Interim
Financial Report Performed by the Independent Auditor of the Entity, in order to state whether, on the basis of the
procedures described, we have become aware of any matter that makes us believe that the financial report is not
in accordance with the Corporations Act 2001 including: giving a true and fair view of Karmel Sonix Limited's
financial position as at 31 December 2007 and its performance for the half-year ended on that date; and
complying with Accounting Standard AASB 134 Interim Financial Reporting and the Corporations Regulations
2001. As the auditor of Karmel Sonix Limited, ASRE 2410 requires that we comply with the ethical requirements
relevant to the audit of the annual financial report.
A review of a half-year financial report consists of making enquiries, primarily of persons responsible for financial
and accounting matters, and applying analytical and other review procedures. A review is substantially less in
scope than an audit conducted in accordance with Australian Auditing Standards and consequently does not
enable us to obtain assurance that we would become aware of all significant matters that might be identified in an
audit. Accordingly, we do not express an audit opinion.
Who eat fruits physical well known, but what kind of the most nutritious fruit, and the health of our most useful may not be known. Perhaps we can find the proverbial Western one answer: Apple a day after a doctor away from me. (An apple a day, keep the doctor away). Apple really so wonderful effect?
Compared with other fruits, apples contain a valuable element of pectin, it is kind of soluble fibre, a medium-size apple contains five grams on these fibers, larger part of oil should be more than cholesterol and with it, will help cholesterol excreted from the human body to achieve the purpose of lowering cholesterol deposition. In addition, the timing of today no fresh peak owners, because the lack of gallbladder stimulate consumption and less from the bile, bile constantly under concentrated, it is easy to form gallstones. Apple pectin in the will and cholesterol in the gallbladder from the combination, can be diluted bile, the effect of prevention of gallstones.
Keen to maintain body weight loss of men and women not know that Apple pectin in the water after expansion, so drink plenty of water before eating apple, will be very easy Baodu if daily breakfast and lunch Xianqi an apple before eating, drinking a cup of water, so they will not eat Taibao. Can be said to be both easy and economical method of slimming thin.
However, we should pay attention to the existence of Apple Pectin only meat, it s best to eat the whole apple; even if Apple juice, and do not remove the flesh, or nutritional effects will be greatly reduced, so the market sold on the generally clear apple juice the relative lack of pectin components.
Pengguanpi help cancer
Apple also the effectiveness of a more alarming, according to the National Cancer Institute in 2001 released a report that food containing flavonoids, may reduce the risk of cancer half, and the density of Apple containing flavonoids all fruit 1974. In addition, published in the 2000 Nature in June, from Cornell University confirmed by the experiments, Pengguanpi contain antioxidant substances can inhibit the proliferation of cancer cells by 43
Researchers are not yet aware that Apple is a major element of what cancer. But research has proved tied to Apple cancer prevention effects.
Five big benefits tied to Apple
1. Containing a large number of pectin can reduce the accumulation of cholesterol.
2. Rich in calcium, phosphorus, iron, zinc and vitamins A, B and C.
3. Containing antioxidants promote lung health, the prevention of lung disease.
4. Lot of fiber, can promote digestion and help weight loss.
5. Containing flavonoids and boron, can help prevent heart disease, stroke and strengthen bone health.
4 thin nutrition Apple recipes
Apple asparagus salad
Ingredients: Apple a jade green asparagus 4 (250 grams).
Sauces: salad dressings (Kuril sauce) 2 tablespoons.
Practices:
1. Apple to Percutaneous tablets bubble in brine and then cold water rinse.
2. Green asparagus into a hot wash water soak ice water, drained and cut into strips after.
3. Apple and the Green asparagus home intraday, Linshang salad dressings can be eaten.
Apple Pickles
Ingredients: 1 apple, cucumber, red and white radishes the 150 grams, 100 grams of garlic.
Sauces: white pepper 1 / 2 teaspoon sugar 2 teaspoons of salt a little.
Practices:
1. Apple, cucumber, red and white radishes, garlic cleaned pelletizing.
2. Materials slightly pickled in salt for 10 minutes, wash with cold water and drained.
3. White pepper, sugar after cooling boil, add all the materials can be soaked on the 1st.
Apple Tremella soup
Ingredients: Apple one, two Tremella 4, 4 cups of water.
Sauces: Bingtangshui 1 / 2 cup.
Practices:
1. Addition Beattie after Apple cut off about 1 / 5 of the superstructure.
2. Second half of removing the flesh into cup pulp pelletizing.
3. Tremella soft foam, and rock sugar, pulp, water steamed into the rotten apple cup after Shing it will.
Apple sushi
Ingredients: rice 3 / 4 bowls, 40 grams of ham, cucumber 1 / 4, Apple 1 / 3
Seasoning: 1 tablespoon of sushi vinegar, seaweed half.
Practices:
1. Apple, cucumber washed after cutting, to soak in brine after Drain.
2. Ham cut into strips.
3. Meat sushi rice vinegar, after the overlay layer placed apples, cucumber and ham, rolled into tube-shaped, sliced can be.
Shin Min Daily News
(Editor: Su-ya)
Related: Half Yearly Report and Accounts
Additional information:
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