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#Financials
Added a month ago

OCC reported financials that were flatter than the market expected. Still burning cash but moving in the right direction, 18 months on same growth trajectory and 2 years cash reserves. Also expanding market for Remplir into Singapore

The good

Orthocell reports increasing half-yearly revenue of $3.2 million, up 51% from the half year ended 31 Dec 2022 of $2.1 million

Increasing revenue primarily driven by 68% growth in product sales in the half year to 31 Dec 2023.

Half-yearly revenue has grown on average by 23%, compounded for the last two half years following Striate+™ US and Remplir™ AUS product launches in Q2 FY23.

Orthocell entered into a Royalty Agreement with the University of Western Australia to exchange all royalty entitlements for shares in Orthocell.

The Company issued UWA 1.70 million fully paid ordinary shares at a deemed issue price of $0.35 per share . As a result of the issue, UWA will hold 2.35 million shares (1.18%) in OCC on an undiluted basis

Strengthening the Board. Since the new chair, John Van Der Wielen, joined the board, a focus on improved governance and board renewal has taken place. The Board is now majority independent. With an experienced Board and Management Team, market leading products and a strong balance sheet, Orthocell is well positioned to grow product sales alongside its distribution partners, BioHorizons and Device Technologies.

Nerve repair study to support US regulatory approval has commenced and is on track for completion,with results expected 3Q CY2024 • Study provides information regarding mechanism of action that it is not possible to collect in human clinical trials and will support product marketing initiatives, as well as international regulatory approval and reimbursement strategies.

Pivotal tendon repair study shows OrthoATI™ is as effective as surgery in the treatment of lateral epicondylitis • Randomised clinical trialshowed OrthoATI patients experienced almost complete resolution of pain by 1-month post-treatment compared to 6 months after treatment in the surgery group. • The Company will look to appoint a US based corporate adviser to assist the Company in securing a strategic partner to progress OrthoATI without the need for significant investment in the near term. 6. Strong balance sheet with $19.6m cash at bank at the end of the quarter • Well positioned to continue to gain commercial traction with Striate+™ now approved in US, EU/UK and AUS; Remplir™ approved in AUS and Company well-funded to gain US regulatory approval Remplir.

The not so good

Cash receipts received from customers, inclusive of GST, for quarter ended 31 Dec 2023 were $896k, ($898k in the prior quarter). In line with the Company’s expectations, net cash used in operating activities for the quarter was $2.4m.

BioHorizon’s update Sales to BioHorizons have continued to build momentum with 14% growth in Striate+ revenue (salesrevenue plus license revenue) from $1.5M in the half-year ended Jun 2023 to $1.7M in the half year ended 31 Dec 2023 and a 21% growth in Striate+ revenue from $1.4M in the half year ended 31 Dec 2022 to $1.7M in the half year ended 31 Dec 2023.

Device Technologies update Sales to Device Technologies have continued to build momentum with 58% growth in Remplir revenue from $282K in the half year ended Jun 2023 to $445K in the half year ended Dec 2023 and 154% growth in Remplir revenue from $175K in the half year ended Dec 2022 to $445K in the half year ended Dec 2023

Orthocell’s global expansion strategy for its market leading peripheral nerve repair product Remplir, continues to build with the submission of its regulatory application to the Health Services Authority of Singapore for approval to market and sell the Product. • Remplir is now generating and growing revenue in Australia, pending application for use in the US, and Singapore is expected to be the 3rd country in which Remplir is available for sale. • US approvals process progressing according to plan with the Remplir US 510k regulatory study on track for completion and data read out in Q3 CY24, with US regulatory application on track for submission in Q4 CY24 and approval expected shortly thereafter.

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#Business Model/Strategy
Last edited 2 months ago

 When does a high profile board appointment add value? I can understand Fiona Wood but Kim Beazley? Does the reputation give the small cap company a foot in the door. 2,000,000 unlisted options exercisable at $0.40 (yesterday’s closing price) and expiring 5 years from date of issue in addition to director fees.

Orthocell has appointed the Hon Kim Beazley AC, former Australian US Ambassador and Governor of Western Australia, Deputy Prime Minister, and Minister for both Defence and Finance, as an Independent Non-Executive Director to the Board.

• Mr Beazley has unrivalled experience engaging strategic partners in the US and will be a key adviser as Orthocell pursues priority clinical, regulatory and commercial activities for its regenerative medicine product portfolio internationally.

• His appointment is preceded by two high-profile additions to the Board in 2023, including Independent Chairman, Mr John Van Der Wielen, and Independent Non-Executive Director, Professor Fiona Wood AM.

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#ASX Announcements
Added 5 months ago

Successful OrthoATI™ clinical trial on tennis elbow from OCC. Great result appears to better surgery in cost and recovery time. Plenty of funds available to progress but "The Company will be reviewing its options to progress OrthoATI™ without the need for significant investment in the near term."

• Study demonstrates that the tendon cell therapy (OrthoATI™) is as effective, and potentially better than surgery for severe, chronic treatment-resistant lateral epicondylitis (tennis elbow)

• OrthoATI™ patients experienced almost complete resolution of pain by 1-month post-treatment compared to 6 months after treatment in the surgery group

• Notably, participants in the OrthoATI™ group demonstrated a statistically significant improvement of return of function in half the time than the surgery group

• Participants in the OrthoATI™ group returned to work on average one month (32 days) earlier than the surgery group

• Study indicated that OrthoATI™ may be a better alternative to surgery, as it is minimally invasive and cost effective

• Study results to be presented by lead study investigator and Clinical Professor Eugene Ek at the 83rd Australian Orthopaedic Association Annual Scientific Meeting

• Based on the successful study outcomes, Orthocell will look to appoint a US based corporate adviser to assist the Company in securing a strategic partner to progress OrthoATI™ 

Initial market sizing undertaken by Orthocell suggests that OrthoATI™ could be applicable to >350,000 tennis elbow patients per year in the US alone, which equates to a multi-billion market opportunity1 . Ongoing work by Orthocell aims to assess the savings to the health system that may be delivered by OrthoATI™ when accounting for more effective pain relief and return of function, return to work and avoidance of surgical costs. OrthoATI™ can be used in both pre-surgical and post-surgical applications, not only in treating tennis elbow, but many other tendon injuries and is at the forefront of a significant and increasing market opportunity.

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#Business Model/Strategy
stale
Last edited 12 months ago

OCC announce trial for nerve repair and appoints specialist US-based nerve surgeons to medical

advisory board. Building a good diverse product base and well cashed up to bring products to market.

Orthocell commences a comparator study to support product marketing initiatives and international regulatory and reimbursement strategies

• This study is an integral part of Orthocell’s comprehensive development program in nerve repair and regeneration

• Study to be undertaken in collaboration with Professor Bill Walsh, at University of New South Wales, with a target study completion Q1 2024

• Follows regulatory approval of Remplir for peripheral nerve repair in Australia in February 2022 and inclusion on the Prosthesis List for reimbursement in November 2022

Remplir has the potential to become the leading device in the US in an addressable market estimated to be worth more than US$1.1 billion per annum1

• With recent appointments of key US-based surgeons Professor Christopher Dy and Professor David Brogan to the Medical and Scientific Advisory Board, Orthocell is ideally positioned to drive its innovative nerve repair medical device into international markets, including the USA

Professors Christopher Dy and David Brogan are orthopaedic surgeons, specializing in the treatment of nerve injuries, while also leading a comprehensive research program that is directly relevant to patients, clinicians, scientists, and policy-makers. Their translational research is focused on the epidemiologic, economic, and clinical analysis of peripheral and brachial plexus nerve injuries.


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#Media
stale
Added one year ago

Article in the West Australian about Striate+

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#Bull Case
stale
Added 2 years ago

Big deal after close today. $23.1M AUD up front for an exclusive license for one of the company's products. MC $59M. It is going to be interesting to see what the company plans to do with the funds. No details about the revenue stream (I hope there is one) for manufacture which will be kept by OCC in WA.

Orthocell signs Striate+™ global exclusive license and manufacturing agreement with BioHorizons. The term of the licence is linked to the term of the supply and distribution agreement (25 years)

BioHorizons Implant Systems Inc. (BioHorizons), one of the largest dental implant companies in the world. BioHorizons, Inc. is part of Henry Schein, Inc. (NASDAQ: HSIC) BioHorizons products are available in 90 markets around the world.

Clinical studies have shown Striate+ supported transition from two stage to single-stage dental procedures, reducing the procedure time by several months. This is of significant interest to patients and clinicians due to potential improvements in efficiency and efficacy of dental procedures. BioHorizons will market and distribute Striate+ alongside its innovative and evidence-based dental implants and tissue regeneration products, to continue to improve the life of patients with missing teeth

In consideration for the license granted, BioHorizons agrees to pay Orthocell AU $23.1 million1 (USD $16 million) • Orthocell will grant BioHorizons an exclusive licence of intellectual property (IP) relating to Striate+TM, a resorbable collagen membrane, manufactured by Orthocell, used for dental guided bone and tissue regeneration procedures •

Orthocell will supply BioHorizons with Striate+ products embodying the IP and grant exclusive distribution rights of those products globally • Striate+™ is manufactured by Orthocell at its quality-controlled Good Manufacturing Practices (GMP) licensed facility in WA, using the Company’s proprietary SMRT manufacturing technology. 

Disc: held in RL

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#Industry/competitors
stale
Added 2 years ago

OSX (up 10%) another ASX regenerative microcap announced a big research deal with Singaporean institutions that looks to be in direct competition to OCC’s dental striate product.

Osteopore secures lead role in Clinical-industrial Partnership with National Dental Centre Singapore and A*STAR research institutes through A$19m project, develops next generation jaw implant to access the A$1.26b dental bone graft and membrane market


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#ASX Announcement
stale
Added 3 years ago

Further progress on the ACL collagen rope development. Next trial on sheep for closer model to humans. Avoids hamstring tendon harvest to simplify procedure. 

“Approximately 15,000 ACL knee reconstructions are done annually in Australia and up to 200,000 per year in the United States,” 

“harvesting the patient’s tendon significantly extends surgery time, introduces donor site pain, morbidity and potentially nerve damage. Tendon harvest can result in donor-site tendon tears and/or rupture during rehabilitation, prolonging recovery time. There is also a limited amount of healthy graft tissue available, which may compromise the repair or inhibit the opportunity for subsequent repairs.”

Promising data for CelGro® collagen rope for Anterior Cruciate Ligament reconstruction
• Pre-clinical study data in rabbits indicate that a novel CelGro® collagen ‘rope’ is a viable alternative to conventional autologous tendon grafts for Anterior Cruciate Ligament (ACL) reconstruction
• CelGro® collagen rope promoted ligamentisation and exhibited tissue architecture that mimics native ACL
• CelGro® collagen rope integrated with the host bone tunnel and was biomechanically comparable to hamstring tendon autograft
• Results position CelGro® collagen rope as the potential first off-the-shelf biological device for ACL reconstruction
• In light of these results, Orthocell plans to advance development of this technology and will commence a larger animal study followed by first-in-human trials

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#New Patent in USA 15/2/21
stale
Last edited 3 years ago

Orthocell receives new US patent for CelGro®

~ New US divisional patent granted for CelGro®

~ Patent covers the method of manufacture of collagen medical devices and as an aid in the surgical repair of soft tissue injuries

~ CelGro® patents have been previously granted in the US, Canada, Europe, China, Japan, Singapore, Australia and New Zealand

~ CelGro® dental (recently renamed Striate+) approved for use in US, Europe and Australia

~ Global addressable market for CelGro® is in excess of >US$10bn1 and growing.

DISC: I Hold

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