Forum Archive Index - June 2004

["Cristine Kerr" <criskerr@optusnet.com.au>]

ASX Announcement Today:

 

Visiomed Group Ltd signs contract agreement with ITL Ltd to manufacture Funhaler.

 

Visiomed Group Ltd (ASX code:VSG) is pleased to advise that it has entered into an agreement appointing ITL Ltd (ASX code: ITL) as the contract manufacturer for the company's proprietary Funhaler (www.Funhaler.com).

 

Visiomed (www.visiomed.com.au), through wholly owned subsidiary InfaMed Ltd, owns the Funhaler, a children's incentive spacer for effective delivery of asthma drugs. The Funhaler is covered by international patents issued and pending.

 

ITL is an Australian-based medical products group with accredited manufacturing operations in Malaysia. ITL Manufactures a range of medical products for Australia, European and USA markets. ITL has capabilities in plastic injection moulding, manufacturing, assembly and packaging of medical devices to international quality standards required by regulatory health authorities.

 

The CEO of Visiomed, Dr Saliba Sassine, said the agreement with ITL as a manufacturer is an important precursor for the filing of a submission to the US FDA for clearance of the Funhaler for release into the USA market. The company expects to lodge an application for FDA approval in August-September this year.

 

Dr Sassine said the initial contract manufacturing requirements were modest and did not require a large commitment of capital. Commercial level production would begin once the FDA approvals have been obtained and once distributors or licensees have been selected.

 

About the Funhaler

 

The Funhaler is an Australian developed children's spacer that incorporates toys in its design to encourage children to take their asthma medication.

 

In a previously reported study at Princess Margaret Hospital, children were up to 60% more likely to medicate appropriately with the Funhaler compared with other spacers and that 38% of parents were more likely to present asthma medication to their children when regularly using the Funhaler.

 

Clinical studies involving the Funhaler are currently underway with support of a $1 million grant from the US National Institutes of Health. The Funhaler is protected by broad coverage patents issued and pending, with the important US patent issued with complete protection for all 56 claims sought (Reference: USPTO: 6,578,571).

 

About Visiomed Group

 

Visiomed develops and commercialises innovative medical devices targeted at applications in the diagnosis of skin cancer and other major diseases. It is also focused on childhood asthma through the Funhaler. Visiomed also has the exclusive world wide licenses for the MicroDERM System, a computer-based expert system for the imaging and diagnosis of melanoma.

 

For further information please contact Dr Saliba Sassine on (08) 9321 2712 or on 0412 533 966.

 

Yours sincerely,

Colin McDonald

Company Secretary

 

NB In case of types, please read the official ASX announcement.

 

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----- Original Message -----

From: Cristine Kerr

To: sharechat@sharechat.co.nz

Sent: Thursday, May 27, 2004 2:44 PM

Subject: Re: [sharechat] VSG - Visiomed - Related Info

ASX Announcement today:

' ... an entitlements issue to all ordinary shareholders of the company.

The Pro-rata entitlements issue is non-renounceable and will be offered to existing shareholders on the basis of one new share for every four shares held at 3.5c per share, plus a free attaching option for each share subscribed to excisable at 12c each on or before 30 March 2008. ... The issue will raise up to $1,488,180 before expenses.

The issue is to raise funds for the continued commercialization and development of the company's biomedical products, including clinical studies and regulatory approvals, and other working capital for the company.

A prospectus containing details of the entitlements issue will be lodged with ASIC and the ASX shortly, and a letter to all shareholders outlining the information contained in the prospectus will follow.

Yours faithfully,
Colin McDonald
Company Secretary ... '

----- Original Message -----

From: Cristine Kerr

To: sharechat@sharechat.co.nz

Sent: Thursday, May 27, 2004 11:50 AM

Subject: Re: [sharechat] VSG - Visiomed - Related Info

A news uptake from one of my info releases follows.

Hopefully Google News will pick it up now.

What a great start to the day!
_________________________________________________________________

News-Medical.net

New Australian asthma invention provides an incentive for children to inhale their medication correctly

Posted By: News-Medical in Medical Device News

Published: Wednesday, 26-May-2004

Parents with asthmatic children often experience difficulty with their children resisting medication, particularly using the recommended ‘spacer’ devices which separate the drug dispensing pMDI or ‘puffer’ and the mask through which children inhale their medicine. Many children find these standard spacer tubes threatening or, in the case of older children, boring.

For this reason parents would be interested to learn of an Australian invention, the Funhaler. The Funhaler was specifically designed to help parents with the daunting task of administering medication to asthmatic children. The Funhaler is a new paediatric spacer that can be fitted to a range of standard asthma medication delivery devices. The Funhaler introduces an incentive for children to inhale their medication correctly. As the children use the Funhaler a whistle sounds and a disk spins.

You can view (and hear) the Funhaler here: (http://www.funhaler.com). Children responded exceptionally well in clinical trials and the owner, Visiomed Group Limited (visiomed.com.au) have the data to support this claim. Two scientific papers describing these trials have been published on the Funhaler, including the leading European Paediatrics journal. The study found that use of the Funhaler significantly improved the frequency with which regular preventer medication is offered to asthmatic children. Using the Funhaler also improved the medication technique of children by 60%. Other trials have established that the Funhaler incentive module does not compromise drug delivery. Further trials of the device are in progress, funded by a major grant of about $1 million from the National Institute of Health in the US, and involving the Institute for Child Health Research which is headed by Australian of the Year, Fiona Stanley.

Market acceptance of the Funhaler is expected to be strong with key opinion leaders such as paediatricians and respiratory physicians and the Asthma Foundations in all Australian states supporting the Funhaler initiative. In a market research survey, 94% of parents preferred the Funhaler to a conventional spacer device.

Visiomed Group Ltd is concentrating on the enormous international markets for this device. For example they have recently signed a collaboration deal with Pari (one of the world's largest asthma device manufacturers) regarding incorporating the Funhaler incentive into their asthma spacer device, the Vortex spacer. Visiomed expects to submit applications for regulatory clearance of the device in the US (FDA) and Europe later this year. If successful, the Funhaler could be in these major markets next year. Visiomed also plans to make the Funhaler available in Australia soon.

But won’t children tire of the incentives in the Funhaler over time? The good news for parents is that Visiomed Group has anticipated this issue and designed the device to be modular. The Funhaler circuit allows possibility of interchanging new toys with old toys on the device. Because the Funhaler patents cover any toy in the circuit, the company hopes to be able to produce a number of alternative toys in the future without the need for separate patent protection. Patents for the Funhaler are already granted in a number of countries including Australia and the US. Who knows…if they are right….our children could be asking for Funhaler incentive toys for Christmas!

http://www.news-medical.net/view_article.asp?id=1920

----- Original Message -----

From: Cristine Kerr

To: sharechat@sharechat.co.nz

Sent: Wednesday, May 12, 2004 11:33 AM

Subject: Re: [sharechat] VSG - Related Info only

German deal to boost Funhaler sales
Posted on Thursday, March 11 @ 07:02:45 EST by shaboo

PERTH biotech Visiomed's Funhaler children's asthma device is poised to break into Europe after the company's first international development alliance with a German drug company

Pari, one of the world's first companies to develop devices that deliver inhaled medications, has struck an agreement to collaborate with Visiomed in adapting the Funhaler for sale in Europe.

The Funhaler, which incorporates a whistle and a glow-in-the-dark spinning disc, was developed by Perth molecular oncologist and Visiomed director Paul Watt, as a fun and easy way to encourage his two children to take their asthma medications.

But while it is the only device of its kind worldwide, Visiomed chief executive Saliba Sassine said he recognised it would be difficult to displace other inhalers in the marketplace.

Instead, Visiomed hopes to sell InfaMed, its paediatric respiratory devices arm, or license the Funhaler technology to established companies like Pari.

"People are going to trust their own products," Mr Sassine said. "But there is no reason we can't do a deal and get the royalties."

A $1 million Funhaler study, funded by the US National Institutes of Health and conducted by asthma researchers at the University of Western Australia and the Telethon Institute for Child Health Research, would further support the device, Dr Sassine said.

A previous study found that 73 per cent of parents reported successfully medicating their children with the Funhaler compared with 10 per cent of conventional spacer users.

It also showed parents were more likely to give the medication because it was a less stressful experience for both the child and the parent.

Visiomed is finalising production details for the Funhaler with Australian manufacturers and has entered collaborative agreements with asthma foundations around Australia to promote the product.

It expects to launch the Funhaler later this year.

Visiomed also anticipates FDA approval and is negotiating with a number of US companies to license out its technology or sell InfaMed.

Shares in the company, which is also involved in medical imaging, have traded between 2.6¢ and 6.9¢ over the past year. They closed yesterday down 0.2¢ at 6.7¢, valuing Visiomed at about $11.8 million.

http://www.insider.com.au/inside/html/modu...rticle&sid=1960

----- Original Message -----

From: Cristine Kerr

To: sharechat@sharechat.co.nz

Sent: Tuesday, May 11, 2004 3:17 PM

Subject: Re: [sharechat] VSG - Related Info only

It's another slow day, so here's some related market info (if you have time on your hands):

Independent Online
' ... Local News
Web posted on May 6, 2004 at 9:00:00 AM CET
Early detection of melanoma through self-examination can save lives
Angele Spiteri Paris
... As summer approaches, and more flesh is bared, the need to raise awareness on the danger of skin cancer becomes more and more vital. If detected early, malignant melanoma, the worst and most fatal type of skin cancer, can be easily treated by surgery.
However, if given time to spread, this cancer is even more deadly than other cancers since it does not respond to any other type of treatment, such as radiotherapy, said Malta Association of Dermatology and Venereology (MADV) president Joseph Pace. ...

... Dr Pace explained that melanoma is the most serious form of skin cancer, in terms of mortality. It can develop anywhere on the skin and in 30-40 per cent of cases this occurs within a pre-existing mole. It is most common for men to develop this type of cancer on their backs, while women’s legs are more susceptible to it, continued Dr Pace. Any new or pre-existing mole that changes shape or colour, or begins to itch, bleed or ooze must be checked immediately, he said. ...

... It is a common belief that melanoma can only develop on areas exposed to the sun. Dr Pace and the other two doctors speaking at the conference, quashed this notion, explaining that an irregular mole on any part of the body can become malignant and should therefore be treated with suspicion. ...

... Dr Boffa did not hesitate to remind the public that it is not sun exposure alone that causes melanoma, it is simply one of the known triggers. ... '
http://www.independent.com.mt/daily/newsview.asp?id=25199

Resesarch and Markets
6 May 2004
' ... Malignant melanoma is the deadliest form of skin cancer and is diagnosed in approximately 132,000 people worldwide each year (2000 data). The incidence of melanoma is increasing at a rate of 3- 5% per year. According to the American Cancer Society, the lifetime risk of malignant melanoma in the U.S. has risen from 1/1,500 people in 1935 to 1/74 people in 2000, with a forecast of 1/50 people by 2005. Melanoma currently affects nearly 200,000 people and in 1997 there were an estimated 40,300 new cases and 7,300 deaths. While melanoma is 85- 90% curable if identified and treated in its earliest stages, melanoma that has metastasized is deadly. Even after surgical removal, the five- year survival rate for metastatic melanoma is only 20- 50%. ... '
http://www.researchandmarkets.com/reports/c1748/

Keloland
Melanoma Monday
3 May 2004
' ... According to the American Cancer Society, some 55,000 new cases of melanoma--the deadliest form of skin cancer--will be diagnosed in 2004, and nearly 8,000 people are expected to die from it this year. On Monday, May 3, Sioux Falls dermatologists are offering free skin-cancer screenings at Lewis Drug at 41st Street and Minnesota Avenue. ... '
http://www.keloland.com/NewsDetail2820.cfm?Id=22,31708

4NI Co UK
NI youngsters warned of sun exposure dangers
10 May 2004
' ... Sandra Gordon, Melanoma Strategy Co-ordinator, said: “Malignant melanoma rates have risen remarkably in Northern Ireland over the past 25 years from an average of 48 cases per year in the mid 70s to 180 cases per year at present ... '
http://www.4ni.co.uk/industrynews.asp?id=28864

The Scotsman
Mon 10 May 2004
' ... Parents 'ignore cancer warnings over child sunburn'
MEDICAL FILE
... Skin-cancer cases have more than doubled in a decade. About 7,000 cases of malignant melanoma - the most serious form of the disease - are diagnosed each year in the UK, with about 1,600 deaths. Malignant melanoma is the third most common cancer among those aged 15 to 24. ... '
http://news.scotsman.com/health.cfm?id=531652004

Indystar
May 10, 2004
' ... Sun does damage on spring days, too
By Patricia Hagen
patricia.hagen@indystar.com
... About 1 million new cases of skin cancer will be diagnosed this year, says the American Academy of Dermatology, which designates May as Melanoma/Skin Cancer Detection & Prevention Month. About 96,000 of the new cases will be melanoma, which will claim the lives of about 7,910 people. ... '
http://www.indystar.com/articles/4/145042-3274-047.html

Mirror Co UK
' ... THIRD OF KIDS FACE SUN RISK May 10 2004
Parents let them burn
By Lorraine Fisher
... skin cancer cases have more than doubled in 10 years. Each year 65,000 patients are diagnosed with the disease in Britain. About 7,000 cases of malignant melanoma - the most serious form - are spotted, with around 1,600 deaths. ... '
http://www.mirror.co.uk/news/allnews/tm_ob...-name_page.html

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