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#Management
stale
Added one year ago

Nice to see director buying Dr Elliott doubling her holding on market trades (38k purchase for context)


Information or documents not available now must be given to ASX as soon as available. Information and documents given to ASX become ASX’s property and may be made public.

Name of entity PolyNovo Limited ABN 96 083 866 862

Introduced 30/09/01 Amended 01/01/11

Appendix 3Y Change of Director’s Interest Notice

 Appendix 3Y

Change of Director’s Interest Notice

Rule 3.19A.2

  We (the entity) give ASX the following information under listing rule 3.19A.2 and as agent for the director for the purposes of section 205G of the Corporations Act.

Name of Director Dr Robyn Elliott Date of last notice  30 June 2023

  Part 1 - Change of director’s relevant interests in securities

Direct N/A

31 October 2023

In the case of a trust, this includes interests in the trust made available by the responsible entity of the trust

Note: In the case of a company, interests which come within paragraph (i) of the definition of “notifiable interest of a director” should be

disclosed in this part.

Direct or indirect interest

No. of securities held prior to change

Class

Number acquired by Dr Elliot Number disposed

42,789 ordinary fully paid shares

 Nature of indirect interest

 Note: Provide details of the circumstances giving rise to the relevant interest.

(including registered holder)

  Date of change

    Ordinary fully paid shares.

 32,000 ordinary fully paid shares.

 Nil.

 Note: If consideration is non-cash, provide details and estimated valuation

No. of securities held after change

$38,080.00 paid by Dr Elliott to acquire 32,000 shares at $1.19 per share via on market trade.

Value/Consideration

 Across all holdings:

74,789 fully paid ordinary shares.

  + See chapter 19 for defined terms.

 01/01/2011

Appendix 3Y Page 1

ME_206737525_4


Appendix 3Y

Change of Director’s Interest Notice

Shares acquired via on-market trade.

 Example: on-market trade, off-market trade, exercise of options, issue of securities under dividend reinvestment plan, participation in buy- back

Nature of change

    Part 2 – Change of director’s interests in contracts

Note: In the case of a company, interests which come within paragraph (ii) of the definition of “notifiable interest of a director” should be disclosed in this part.

Detail of contract N/A Nature of interest N/A

  Name of registered holder N/A (if issued securities)

 Date of change N/A N/A

 No. and class of securities to which

  Note: Details are only required for a contract in relation to which the interest has changed

interest related prior to change

  Interest acquired N/A

Interest disposed N/A

 Value/Consideration N/A Note: If consideration is non-cash, provide details

and an estimated valuation

 Interest after change N/A Part 3 – +Closed period

  Were the interests in the securities or contracts detailed No above traded during a +closed period where prior written clearance was required?

If so, was prior written clearance provided to allow the N/A trade to proceed during this period?

  If prior written clearance was provided, on what date was N/A this provided?

  + See chapter 19 for defined terms.

 Appendix 3Y Page 2

01/01/2011

ME_206737525_4


#ASX Announcements
stale
Last edited one year ago

This is a handy tip in and I particularly like that 3 Indian sites are being added to the trial… getting subsidized access for surgeons in India can only help towards opening up this market


BARDA increases funding US$10 million

PolyNovo Limited ABN 96 083 866 862

2/320 Lorimer Street Port Melbourne

VIC Australia 3207

P +61 (0) 3 8681 4050 F +61 (0) 3 8681 4099

PolyNovo is pleased to announce that it has received additional funding of $US10 million from the Biomedical Advanced Research and Development Authority (“BARDA”) for the Pivotal Trial program of NovoSorb® BTM. This increases the total funding commitment from BARDA to $US25 million. The contract is a cost-plus monthly reimbursement arrangement. PolyNovo will continue to contribute to the trial through the provision of product, employee resources and infrastructure support.

The NovoSorb® BTM Pivotal Trial is gathering data on the effectiveness of NovoSorb® BTM for treating full thickness burns. Successful completion of this trial will enable PolyNovo to file a PMA application for use in full thickness burns and may lead to BARDA buying NovoSorb® BTM for disaster management.

NovoSorb BTM is already indicated for full thickness burns outside of the U.S. and has the CE Mark for the EU market, including an indication for use in full thickness burns, other surgical wounds, and reconstruction procedures.

PolyNovo’s BARDA contract, funded by the U.S. Department of Health and Human Services (Office of the Assistant Secretary for Preparedness and Response), commenced 28 September 2015. The first patient was enrolled in September 2021, with patients currently being recruited from 22 U.S. burn centres and 1 site in Canada. An additional 5 U.S. sites, 4 Canadian sites and 3 Indian sites are in the process of being enrolled to participate in the trial.

To date, 71 patients have been enrolled out of a target 120. Recruitment is expected to be completed in FY24.

Director of Clinical Operations, John Cockwill said, “Our partnership with BARDA over the past decade has been extraordinary. Together, we have pioneered innovation in the medical device industry, pushing boundaries and saving many lives. It's been a journey of dedication, collaboration, and the relentless pursuit of excellence. Our shared vision has driven technological advancements but has also made for a profound impact on healthcare worldwide."

Chairman, David Williams said “BARDA and PolyNovo have a clear end game to bring our technology to as many patients as possible. It is an honour for us to know that our technology will play an important part in the US preparedness for mass disasters.”

 

 Chief Executive Officer, Swami Raote said “BARDA has been partnering with us and the FDA on this program in the most collegial way. We appreciate their consistent engagement and guidance in helping us construct, navigate, and execute a complex, large-scale multi-centre trial to secure FDA approval for our life saving and life changing technology.”

This announcement has been authorised by PolyNovo Company Secretary Jan-Marcel Gielen.

Further information:

David Williams

Chairman

Mobile: + 61 414 383 593

About PolyNovo®

Swami Raote

CEO

Mobile: +1 904 314 6346

 PolyNovo is a disruptive medical device company, focused on Advanced Wound Care that designs, develops, and manufactures dermal regeneration solutions (NovoSorb BTM, NovoSorb MTX) using its patented NovoSorb biodegradable polymer technology. Our development program covers Breast Sling, Hernia, and Orthopaedic applications. For further information see polynovo.com

About NovoSorb®

NovoSorb® BTM is a dermal scaffold for the regeneration of the dermis when lost through surgery, trauma or burn. NovoSorb® is a novel range of bio-resorbable polymers that can be produced in many formats including film, fibre, foam, and coatings. NovoSorb’s unique properties provide excellent biocompatibility, control over physical properties, and a programmable bio-resorption profile.

Reach

PolyNovo supplies approximately 638 hospitals directly in Australia, Hong Kong, India, Ireland, the Middle East, New Zealand, Singapore, the United Kingdom, and the United States. Other countries, such as Canada, Germany, France and Spain are serviced by a distributor.

 

#ASX Announcements
stale
Added 2 years ago

From the JP Morgan presentation

nice to see the use cases and a bit of a tear jerker


https://vimeo.com/777351297



#Management
stale
Added 2 years ago

Well it was nice to hear from Swami Raote (incoming CEO) this morning.


He struck me as a very experienced leader with the learnings to take PolyNovo to the next level internationally.


I particularly enjoyed the conversation between David & Swami on distribution models etc. The fact that margins remain at 80-85% even when using a distributor was a mindbending titbit from David.


Swami also mentioned the challenge and opportunity of adapting an approach to the developing world where a huge need for burns and wound treatments exists.

This company has such an opportunity in front of it!

#ASX Announcements
stale
Added 3 years ago

ASX Announcement

Record Q3 Indicative Trading Result in US, Australia, and UKI

PNV today announced selected unaudited trading results for March 2022 quarter.

Group Results

The Company had a record (unaudited) March quarter revenue of AUD 12.26M up 59.3% on STLY of

AUD 7.69M.

YTD revenue was AUD 30.42M with a run rate circa $48m per annum. Revenue included income of AUD

1.00M from BARDA and AUD 108K from a Victorian State Government grant.

Cash at 31 March EXCLUDING any proceeds from the sale of the Lorimer Street property was AUD 3.80M, an increase of AUD 517k over cash at 31 December. Proceeds from the Lorimer Street property of AUD $6.35m are expected to be received on 13 June 2022.

Chairman of PolyNovo David Williams said “More sales reps equals a wider geographical footprint and increased sales. More reps and the diminishing effects of Covid, have driven record sales in US, UKI and Australia."

US

The US had record quarterly sales of AUD 9.53M (USD 6.89M) an increase of 79.4% on STLY.

YTD sales of AUD 23.73M (USD 15.03M) are an increase of 65.9% over STLY of AUD 14.31M (USD 9.14M).

In the quarter we added a further 15 accounts bringing the total number of accounts to 169.

Australia and New Zealand

ANZ rebounded strongly in March quarter with sales of AUD 1.16M an increase of 81.9% over STLY of AUD 635K and brings total sales YTD to AUD 2.38M. Access to hospitals and face to face conferences are returning.

PolyNovo Limited ABN 96 083 866 862

2/320 Lorimer Street Port Melbourne

VIC Australia 3207

P +61 (0) 3 8681 4050 F +61 (0) 3 8681 4099

 

 United Kingdom and Ireland

The UKI had record sales for the March quarter. The Salesforce was increased from 3 to 5 and a further territory manager for Northern England and Scotland will commence in April.

Although relatively small compared with the market opportunity, sales during March Quarter were a record AUD 248K (GBP 135K) an increase of 55.2% on STLY including record results for February of AUD 91K up 152.3% and March AUD 127K up 62.0% versus STLY. YTD sales are AUD 562K (GBP 304K).

Europe

Progress was made in understanding and developing our distributor network. Sales in March were encouraging with total March revenue of AUD 114K (EU 75K) and YTD sales of AUD 512K (EU 325K).

Other

Clinical Trial programmes remain on track including recruitment for the pivotal burn trial and enrolment of the first patients for the DFU trial. We are also on track to file for the 510K approval for the Matrix product during this financial year and work on the prototypes for Hernia development and new designs for BTM are also on track as per the half year update.

During the quarter the emissions generated by the Australian operations of the Group were certified as carbon neutral, meeting the requirements of the Climate Active Carbon Neutral Standard for Organisations.