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Anteris Technologies Global Corp. Interim / Quarterly Report 2008

Oct 16, 2007

33869_rns_2007-10-16_7cc4742b-26f1-469b-80e8-3238462877c7.pdf

Interim / Quarterly Report

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QUARTERLY REPORT

BioMedical Devices and Technologies 3 MONTHS ENDED 30 SEPTEMBER 2007

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17 October 2007

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QUARTER HIGHLIGHTS

  •  Issue of Prospectus offering new shares and attaching new options;

  •  Completion of pre-clinical 12 month Comparative Patch study;

  • Commencement of a new Pre-Clinical Animal Trial of bovine peritoneum and kangaroo tendons.

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bioMD Limited ABN 35 088 221 078

PO Box 7209 Cloisters Square WA 6850 • Tel +61 8 9262 6777 • Fax +61 8 9322 3433 E-mail: [email protected] • Web Site: www.biomd.com.au

QUARTERLY REPORT ON ACTIVITIES 3 months ended 30 September 2007

bioMD LIMITED

MANAGING DIRECTOR’S REPORT

The Company’s primary focus for this quarter has been the Phase II Human Clinical Trial in South Africa of ADAPT Tissue Processing Technology (TPT) treated bovine pericardium patches. These bioimplants will be used for the repair of congenital heart deformities.

Work has continued on the implementation of a Quality Management System to ISO13485, which sets out specific requirements for the design, development and manufacture of our patches treated with ADAPT TPT.

Our regulatory approvals process is being conducted contemporaneously with the Quality process to obtain TGA approval for export of our patches to South Africa for use in the human clinical trial.

PHASE II HUMAN CLINICAL TRIAL Of ADAPT TREATED CARDIOVASCULAR PATCHES

During the quarter, work has continued on the process of manufacturing our patches, which will be made from bovine pericardium and treated with the ADAPT TPT.

Significant progress has been made with our search for an approved production facility, and an announcement regarding this is expected during the next quarter.

Work has continued on the method of packaging and the labelling of our devices and this will be completed in the next month.

We were very encouraged by continuing positive pre-clinical results from our 12 month comparative patch study. The results confirmed that the ADAPT TPT produces a more durable and stable regenerative biomaterial than some of the other commercially available biomaterial patches.

We are pleased to welcome you all to our 2007 Annual General Meeting, which will be held:

at 11am on Tuesday 13 November

The Terrace Room, The Chifley on the Terrace Hotel 185 St Georges Terrace, Perth, WA

PRE-CLINICAL ANIMAL TRIAL Of BOVINE PERITONEUM AND kANGAROO TAIL TENDONS

A further pre-clinical trial has commenced to investigate the use of bovine peritoneum and kangaroo tendons, treated using the ADAPT TPT, for use in orthopaedic applications.

The tissue samples will be explanted at 12 weeks and 6 months. The implants will be assessed to determine the level of calcification and host cell infiltration.

POSITIVE RESULTS fROM A 12 MONTH COMPARATIVE PATCH STUDy

Pericardial patches treated with ADAPT were compared with two commercially available patch materials in a subcutaneous rat model.

Patches of each biomaterial were implanted in the same juvenile Wistar rats (body weight 160g) and explanted after 12 months.

The histology results of each of the explanted patches clearly indicate the ADAPT treated biomaterial patch was undergoing controlled andipogenesis and remodelling, whilst the commercially available products were already being compromised by recognised detrimental factors, such as fibrosis and calcification. These factors inhibit the durability and regeneration of the patches.

The use of biomaterials in orthopaedics is gaining momentum and is seen as one of the fastest growing segments of this market.

bioMD Limited ABN 35 088 221 078 PO Box 7209 Cloisters Square WA 6850 • Tel +61 8 9262 6777 • Fax +61 8 9322 3433 E-mail: [email protected] • Web Site: www.biomd.com.au

QUARTERLY REPORT ON ACTIVITIES 3 months ended 30 September 2007

bioMD LIMITED

The histology results of the three patches can be summarised as follows:

ADAPT Tissue Engineered Patch

The ADAPT treated pericardial patches showed advanced signs of angiogenesis inside the implant matrix (development of neocapillaries with circulating red blood cells) and adipogenesis (development of adipose – fat tissue).

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Host tissue fibroblasts infiltrated and migrated throughout the full thickness of the implant matrix. The edges of the implant were free from any dense layers of fibrous tissue.

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Commercially Available Patch A

Patch A revealed the presence of a few multinucleated foreign body giant cells.

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It also showed the development of a dense layer of fibrous tissue on the side of the implant. Infiltration by host fibroblasts was limited mostly to the edges of the patch.

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Commercially Available Patch B

Patch B revealed a dense layer of fibrous tissue surrounding the implant.

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The presence of lymphocytes distributed on the surface of the implant, as well as visible degeneration of certain areas on the edges of the implant, suggested an ongoing inflammatory response.

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bioMD Limited ABN 35 088 221 078 PO Box 7209 Cloisters Square WA 6850 • Tel +61 8 9262 6777 • Fax +61 8 9322 3433 E-mail: [email protected] • Web Site: www.biomd.com.au

QUARTERLY REPORT ON ACTIVITIES 3 months ended 30 September 2007

bioMD LIMITED

OffER Of NEW SHARES AND ATTACHING NEW OPTIONS

On 22 August 2007 bioMD issued a Prospectus offering new shares and attaching new options to eligible holders of options expiring at 30 August 2007.

The offer to optionholders is on the basis of 1 new share, at a price of 20 cents per new share, for every 10 expiring options held by optionholders at 30 August 2007.

For every 1 new share allotted, the applicant will receive 4 new options. Each new option issued will give the holder the right to subscribe for 1 fully paid ordinary share in bioMD at an exercise price of 25 cents at any time up to and including 30 August 2010.

CORPORATE OVERVIEW

  • bioMD’s market capitalisation at the end of the reported period was $10.12 million, based on a closing price of 12 cents.

  •  The consolidated group has $1.955 million in cash reserves and an average burn rate of $64,000 per month for the 3 months to 30 September 2007.

  • Notice of exercise for options expiring on 30 August 2007 were received to subscribe for a total of 35,494 fully paid ordinary shares.

  • A total of 1,000,000 BODAI and 63,069,132 BODO Options expired on 30 August 2007.

If fully subscribed, bioMD would issue 6,310,463 new Shares and 25,241,852 new Options, and would raise $1,262,092 which would be applied to working capital.

Acceptances close on 9 November 2007.

Shareholders who were not eligible for the offer can contact our office (tel 08 9262 6777) to obtain a copy of the Prospectus.

.

PRELIMINARy fINAL REPORT

On 28 August we released our audited financial results of the Company for the year ended 30 June 2007.

The operating loss after taxation of the consolidated entity amounted to $2.2 million, compared to the previous year’s loss of $1.2 million. Impairment losses amounted to $1.3 million (compared to $0.1 million in 2006).

bioMD Limited ABN 35 088 221 078 PO Box 7209 Cloisters Square WA 6850 • Tel +61 8 9262 6777 • Fax +61 8 9322 3433 E-mail: [email protected] • Web Site: www.biomd.com.au

Appendix 4C

Quarterly report for entities admitted on the basis of commitments

Introduced 31/3/2000. Amended 30/9/2001

Name of entity
bioMD Limited
ABN
36 088 221 078
Quarter ended (“current quarter”)
36 088 221 078 30 September 2007

Consolidated statement of cash flows

Cash flows related to operating activities
1.1
Receipts from customers
1.2
Payments for
(a) staff costs
(b) advertising and marketing
(c) research and development
(d) leased assets
(e) other working capital
1.3
Dividends received
1.4
Interest and other items of a similar nature
received
1.5
Interest and other costs of finance paid
1.6
Income taxes paid
1.7
Other - ATO refunds
Net operating cash flows
Current quarter
$A’000
Year to date
(3 months)
$A’000
-
(12)
-
(156)
-
(322)
-
23
-
-
257
-
(12)
-
(156)
-
(322)
-
23
-
-
257
(210) (210)
Current quarter
$A’000
Year to date
(3 months)
$A’000
1.8
Net operating cash flows (carried forward)
(210) (210)
Cash flows related to investing activities
1.9
Payment for acquisition of:
(a) businesses (item 5)
(b) equity investments
(c) intellectual property
(d) physical non-current assets
(e) other non-current assets
1.10
Proceeds from disposal of:
(a) businesses (item 5)
(b) equity investments
(c) intellectual property
(d) physical non-current assets
(e) other non-current assets
1.11
Loans to other entities
1.12
Loans repaid by other entities
1.13
Other (provide details if material)
Net investing cash flows
1.14
Total operating and investing cash flows
-
-
-
(5)
-
-
-
-
-
-
-
-
-
-
-
-
(5)
-
-
-
-
-
-
-
-
-
(5) (5)
(215) (215)
Cash flows related to financing activities
1.15
Proceeds from issues of shares, options, etc.
1.16
Proceeds from sale of forfeited shares
1.17
Proceeds from borrowings
1.18
Repayment of borrowings
1.19
Dividends paid
1.20
Other - option issue costs
Net financing cash flows
23
-
-
-
-
-
23
-
-
-
-
-
23 23
Net increase (decrease) in cash held
1.21
Cash at beginning of quarter/year to date
1.22
Exchange rate adjustments to item 1.20
1.23
Cash at end of quarter
(192)
2,147
-
(192)
2,147
-
1,955 1,955

Payments to directors of the entity and associates of the directors

Payments to related entities of the entity and associates of the related entities

1.24
1.25
Aggregate amount of payments to the parties included in item 1.2
Aggregate amount of loans to the parties included in item 1.11
Current quarter
$A'000
146
-
1.26 Explanation necessaryfor an understandingof the transactions
Consultancy services and superannuation contributions.

Non-cash financing and investing activities

  • 2.1 Details of financing and investing transactions which have had a material effect on consolidated assets and liabilities but did not involve cash flows

N/A

  • 2.2 Details of outlays made by other entities to establish or increase their share in businesses in which the reporting entity has an interest

N/A

Financing facilities available

Add notes as necessary for an understanding of the position. (See AASB 1026 paragraph 12.2).

3.1
Loan facilities
3.2
Credit standby arrangements
Amount available
$A’000
Amount used
$A’000
- -
- -

Reconciliation of cash

Reconciliation of cash
Reconciliation of cash at the end of the quarter (as
shown in the consolidated statement of cash flows) to
the related items in the accounts is as follows.
Current quarter
$A’000
Previous quarter
$A’000
4.1
Cash on hand and at bank
4.2
Deposits at call
4.3
Bank overdraft
4.4
Other (provide details)
744 1,447
1,211 700
- -
- -
Total: cash at end of quarter(item 1.23) 1,955 2,147

Acquisitions and disposals of business entities

5.1
Name of entity
5.2
Place of incorporation
or registration
5.3
Consideration for
acquisition or disposal
5.4
Total net assets
5.5
Nature of business
Acquisitions
(Item 1.9(a))
Disposals
(Item 1.10(a))

Compliance statement

  • 1 This statement has been prepared under accounting policies which comply with accounting standards as defined in the Corporations Act (except to the extent that information is not required because of note 2) or other standards acceptable to ASX.

  • 2 This statement does ~~/does not*~~ (delete one) give a true and fair view of the matters disclosed.

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Sign here: ............................................................ Date: .......17 October 2007 (Company Secretary)

Print name: .........Caroline L Bentley................................................