Forum Archive Index - May 2004

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

Visiomed Group Limited's ASX Announcement - 10.5.04 - reproduced here but recommend reading the original announcement.

' ... Visiomed Group Limited receives Ethics Committee Approval for MicroDERM Clinical Trial

Announcement Highlights:

. Visiomed Receives Ethics Committee approval for MicroDERM clinical trial in Australia
. Resuls will support world's first application for clearance of predictive expert system for melanoma.

Australian Medical Imaging company Visiomed Group Limited (ASX Code: VSG) advises that it has received approval from the Royal Australian College of General Practitioners National Research and Evaluation Ethics Committee to commence the MicroDERM clinical study.

The study is entitled, "A Retrospective Multi Centre Study to Compare the Effectiveness of Visiomed MicroDERM Predicting Atypical Malanocytic Skin Lesions".

The objective of the study is to prove the MicroDERM Expert System predictive capabilities in the diagnosis of atypical malanocytic skin lesions. These are lesions that ae likely, or have the potential to develop into skin cancers.

Visiomed has secured a number of Australian clinical sites in addition to the European clinical study that is already under way.

The data collected in these studies will be used for regulatory submissions to governments outside Australia for approval of the Expert System.

The early prediction or diagnosis of malanocytic skin lesions can substantially improve survival rates. In Australia, more than 1,000 people a year die from melanoma and in the USA the mortality rate from melanoma is approximately 10,000 per annum.

Visiomed is awaiting a decision by the US FDA for clearance of MicroDERM as a sophisticated medical imaging, documentation, retrieval and patient management system which will pave the way for sales of MicroDERM in the USA the world's biggest market for medical and diagnostic devices.

Once FDA clearance is obtained, Visiomed will be able to enter the US market.

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

Yours faithfully
Colin McDonald
Company Secretary ... '

NB FDA clearance anticipated by 30th June for MicroDERM. Results of clinical trials will accompany second FDA submission for MicroDERM's Expert System (predictive/diagnostic software)

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

From: Cristine Kerr

To: sharechat@sharechat.co.nz

Sent: Monday, May 10, 2004 1:18 PM

Subject: Re: [sharechat] VSG Upside Potential Looking Good.

7.5.04 Dr Saliba Sassine has just topped up his holdings by 75,623 shares (purchased on market) at an average price of 5.8c each.

Securities held by Dr Saliba Sassine prior to change + after change:

1) 420,000 shares held directly
2) Prior to change: 2,538,000 shares, After Change: 2,613,623 shares held indirectly by Asea Consulting & Capital Pty Ltd
3) 2,870,000 listed options held directly
4) 1,000,000 listed options held indirectly by Asea Consulting & Capital Pty Ltd
5) 4,500,000 unlisted options held directly

Ah, I do like to see Directors taking a keen financial interest in their companies, don't you?

Regards,
Cris

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

From: Cristine Kerr

To: sharechat@sharechat.co.nz

Sent: Monday, May 03, 2004 9:52 AM

Subject: Re: [sharechat] VSG Upside Potential Looking Good.

Visiomed released their Jan-Mar 2004 Qtrly Report last Friday and I've had an opportunity to read and summarise this morning:

 

Receipts from customers were $117,000 for the quarter. I was hoping for higher revenue for Siemens equipment, however, in view of Visiomed only having the rights since mid last November, this result was not unexpected.

 

Expenditure ($611,000) is a little down compared to average expenditure ($660,500) for the first two quarters. Long-term cash position is an issue with $887,000 (sufficient to fund just over 4 months at current rate of cash burn. Visiomed have provided details of *additional funds received and anticipated for this quarter (see Item 5 below), have stated a commitment to further reducing expenditure, and have provided information on some very promising potential earnings sources (refer page 7 of the report which I have summarized at Items 1-6 below):

 

1) Negotiations for the sale or licensing of the Funhaler business and patent portfolio to USA interests are progressing well.

 

2) A number of parties have expressed an interest in participating in a placement in the Company. Although no specific proposal is being considered at this time, directors have in place a plan to raise funds to ensure the Company has the working capital required for its operations depending on the timing of the sale of the Funhaler.

 

3) The first cash proceeds from the Visiomed Imaging radiography equipment distribution business will be received in the June 2004 quarter.

 

4) Significant expenditure has been incurred during this quarter on the FDA approval process and payments to US consultants advising on the proposed Funhaler sale. These costs are not of a recurring nature. Expenditure has been substantially in accordance with the Company's anticipated expenses.

 

5) The company has received *further grant funding of $52,000 since the end of the quarter and *expects to additionally receive approximately $130,000 being proceeds from the sale of the Boorara tenements and tax R&D rebates.

 

6) The Company monitors its cash position very closely and is taking steps to ensure that there are sufficient funds to meet working capital and other requirements. The Company also expects a significant reduction in operating costs as a result of the implementation of a planned restructuring of operational activities.

 

Personal observation:

 

Re Item 5 - grant funding will increase Visiomed's cash position to $939,000 and with Boorara a cash position of $1,069,000. Payments to US consultants will decrease - Visiomed states this is non-recurring expenditure - i.e.; Expenditure of $611,000 less Consulting Fees $83,000 = Anticipated expenditure of $528,000 per subsequent quarter, however; it is unclear if payments to consultants will cease or scale down gradually this quarter.

 

At current cash burn rate = sufficient to fund over 5 months and depending on speed of reduction for Consulting Fees - sufficient to fund 6-7 months. (NB May be other cost containment areas being explored by Visiomed as well.)

 

Other factors for consideration:

 

. If Visiomed succeed in their commitment to reduce expenditure this time frame would be extended though by how much is unknown.

. Prospect of income resulting from sale or licence of Funhaler in the near future is looking very promising.

. VSG will be receiving their first cash proceeds from Imaging distribution business this quarter - refer Item 3 - however, the potential $ are unknown.

 

All in all, to me, Visiomed's cash position looks OK for at least six months. I'm expecting Funhaler to be secured soon. If that doesn't happen, I'd be personally pleased to see a Capital Raising following approval of Visiomed's 1st FDA submission for Microderm as this is likely to be a catalyst for SP growth.

 

Regards,

Cris

 

NB Recent comment by Citgroup re Biotech sector: "While we expect a more muted sector sentiment over 2004, we do believe that positive stock specific news will be rewarded," Citigroup said.

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

From: Cristine Kerr

To: sharechat@sharechat.co.nz

Sent: Wednesday, April 28, 2004 9:26 AM

Subject: Re: [sharechat] VSG Upside Potential Looking Good.

Dr Sassine has a successful track-record in this sector.

I'm impressed with the number and scope of significant outcomes and activities VSG have been able to achieve on the funds they've had available to them..I'm not expecting any fireworks with the Qtrly report, but nor am I expecting anything adverse. Lessons learnt - I think VSG will take pains to ensure the ASX are totally satisfied (in advance) this quarter.

Recent Significant Activities:

1) Funhaler: Co-development alliance on Funhaler with Pari GmbH (leading worldwide manufacturer of delivery products for asthma, chronic lung disease & cystic fibrosis - Germany, Japan, UK, Canada currently involved in more clinical trials for new nebulizer respiratory medications than all other brands combined, including trials by large pharma companies such as Astra Zeneca and Separcor Inc). Co-development trial is for Funhaler to be incorporated into Pari's delivery devices - VSG view is to sell or licence Funhaler - co-development trial already funded under NIH $1M grant awarded to VSG's collaborating asthma researchers at Univ of WA.

2) Microderm nearing FDA approval - minor edits outstanding - expected by end financial year. (The last thing I read on FDA stated that a high percentage of FDA committee are specialist dermatologists.) FDA clearance will pave the way for sales of Microderm in the US. Visiomed has initiated a search for suitable partners and distributors in the US. VSG has already received an expession of interest from one suitably positioned party. (NB Huge market - sadly, around 10,000 Americans die from Melanoma every year.) European clinical studies have already commenced. Visiomed has secured a number of Australian clinical sites for Aust studies to support FDA approval. (NB Significantly; these studies are retrospective not prospective = very short time frame.)

Price will catch up to the vision and I am personally anticipating sooner rather than later.

Regards,
Cris

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

From: Cristine Kerr

To: sharechat@sharechat.co.nz

Sent: Tuesday, April 27, 2004 3:04 PM

Subject: Re: [sharechat] VSG Upside Potential Looking Good.

Someone bought up big today:

 

Visiomed Group Limited (VSG)
Date Time Price ($) Quantity Value ($) Conditions
27-04-2004 02:51 PM $0.064 150000 $9,600.000  
27-04-2004 02:29 PM $0.064 10000 $640.000  
27-04-2004 02:29 PM $0.064 50000 $3,200.000  
27-04-2004 01:56 PM $0.065 38180 $2,481.700  
27-04-2004 12:42 PM $0.062 2107388 $130,658.056 Crossed
27-04-2004 12:29 PM $0.062 68500 $4,247.000  
27-04-2004 12:26 PM $0.063 31500 $1,984.500 Crossed
27-04-2004 10:30 AM $0.063 8500 $535.500 Crossed
27-04-2004 10:23 AM $0.063 91500 $5,764.500  
26-04-2004 03:40 PM $0.064 100000 $6,400.000 

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

From: Cristine Kerr

To: sharechat@sharechat.co.nz

Sent: Tuesday, April 27, 2004 1:57 PM

Subject: Re: [sharechat] VSG Upside Potential Looking Good.

ASX: VSG - Update lodged with ASX today at 12.38pm

 

VSG

12:38 PM

On track for FDA Clearance of Microderm Submission

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

From: Cristine Kerr

To: sharechat@sharechat.co.nz

Sent: Tuesday, April 20, 2004 3:53 PM

Subject: Re: [sharechat] VSG Upside Potential Looking Good.

I have asked Visiomed when shareholders can expect an update.

Visiomed will be posting out a newsletter to shareholders in the near future.

 

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

From: Cristine Kerr

To: sharechat@sharechat.co.nz

Sent: Monday, April 19, 2004 7:53 AM

Subject: Re: [sharechat] VSG Upside Potential Looking Good.

FDA application has been lodged - approval was anticipated around late April.

 

Everyone here knows my thoughts on this one.

 

My expert TA analysis - higher highs, higher lows and poised for another upturn especially in consideration of anticipated FDA approval.

 

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

From: Lazy Haggis

To: sharechat@sharechat.co.nz

Sent: Monday, April 19, 2004 5:46 AM

Subject: [sharechat] VSG Upside Potential Looking Good.

Latest April 04 Aegis Equities Comments.

Through the acquisition of Visiomed AG, VSG has not only secured full
control over the microDERM device but also has rights to any other IP
developed within the German company. This includes some interesting surgical
navigation technology that VSG may be able to commercialise in the future.
The Funhaler provides a potential spinout product that can help fund VSG's
other ventures.

VSG has managed to build its patent portfolio over the last year, an
important first step to eventual commercialisation. A recent study was
published in the influential British Journal of Dermatology detailing the
diagnostic use of the MicroDERM system and this should help it achieve US
regulatory approval as higher value diagnostic device. VSG also forged
closer links with Siemens AG, one of the world's largest and most recognised
engineering and medical imaging companies, announcing an exclusive
Australian dealership for a range of Siemens medical imaging systems. VSG is
also a significant participating collaborator with Siemens in the
development of ultrasound-based surgical navigation systems for spinal
procedures.

Lazy Haggis

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