Latest news with #Orthocell
News.com.au
10-07-2025
- Business
- News.com.au
Break it Down: Orthocell books first sales revenue in US for Remplir
Stockhead's Break it Down brings you today's leading market news in under 90 seconds. In this episode, host Tylah Tully takes a look at Orthocell (ASX:OCC), who have achieved first US revenue from Remplir, its flagship nerve repair product, after the company locked in FDA approval in April. Tune in to hear all about it. While Orthocell is a Stockhead advertiser, it did not sponsor this content. Originally published as Break it Down: Orthocell books first sales revenue in US for Remplir
News.com.au
10-07-2025
- Business
- News.com.au
Health Check: For ASX biotechs, the business of America remains business
A slew of medical device makers report good progress in the US Imagion shares almost double on positive FDA feedback Quiet drug developer PYC Therapeutics wins a friend The US healthcare system is mired down by kerfuffles over tariffs, drug pricing and cuts to regulatory and funding bodies, but for ASX biotechs the wheels of decision-making keep grinding. As President Calvin Coolidge (supposedly) said a century ago, 'the business of America is business' and that will never be Trumped. Among a slew of US-related disclosures, Orthocell (ASX:OCC) notes it has pocketed its first US revenue from its flagship nerve repair device, Remplir. The achievement follows Remplir's first surgical use in the US, for a foot repair in Ohio on June 26. The company also cites revenue from 'subsequent early surgical cases in Florida, sourced from the company's network of specialist distributors'. Orthocell's commercial traction comes just three months after the company won US Food and Drug Administration clearance for Remplir, which wraps around peripheral nerves and protects them during surgery. Yesterday Orthocell reported June quarter revenue of $2.73 million, up 22.8% on the record March quarter. This took annual revenue to $9.19 million, up 35.8%. Crucially, that does not include Remplir US revenue. First US revenue for Artrya, too Meanwhile, heart device maker Artrya (ASX:AYA) has announced its first US revenue for its Salix coronary plaque detection platform. This is by way of a US$600,000, five-year contract with the Georgia and Alabama based Tanner Health. Tanner has a network of five hospitals, cardiovascular centres, and 30 physician practices. 'This first revenue represents a major milestone for Artrya as it continues to transition to a revenue-stage business,' the company says. The FDA approved Artrya's device in March. So like Orthocell, it's not wasting any time in monetising the opportunity. Artrya is 'actively progressing' commercial discussions with other US hospital networks. The company is also girding for FDA clearance of a further module. US approval? Imagion that Imagion Biosystems (ASX:IBX) today almost doubled after the company said it had received positive FDA feedback on the company's proposed phase II imaging trial for HER-2 positive breast cancer. The company aims to detect cancers early with its Magsense imaging tech. Magsense combines the use of magnetically detectable nanoparticles with biological agents. The underlying tech, by the way, was created by a Los Alamos, New Mexico physicist called Edward R Flynn. The good doc tinkered with magnetic sensors after his wife contracted breast cancer. The company plans to lodge an Investigative New Drug Application – that is, assent to start a trial – with the FDA in the current quarter. Imagion says the agency provided 'positive feedback and constructive input regarding the study plan and outcomes.' 'I'm very pleased with the trajectory of our communications with the FDA', says Imagion exec chairman Bob Proulx. Investors were pleased as well: the FDA's kind words sent the stock up as much as 92% this morning. Imricor wins Northstar approval Coming back to heart health, Imricor Medical Systems (ASX:IMR) has won European regulatory approval for Northstar, as well as its second-generation ablation catheters and capital equipment. This was under the Continent's European Medical Device Regulation, a more stringent gateway than the old rules. Imricor has developed the world's only MRI-guided ablation catheter, which are single-use consumables. Consisting of a workstation and software, Northstar is key to making the magic happen. In mid-April the European gatekeepers approved the catheters under the old pathway. 'Investments in sales and marketing are beginning to pay dividends, with the number of hospitals in the active European pipeline increasing from seven to 26 over the past six months,' Imricor says. As always, the US presents the biggest market. There, the company has lodged vital documentation with the FDA as part of the Northstar approval process. The company aims to submit all its supportive clinical data by the first half of 2026. 'Approval of Northstar will mark the commercial entry point for Imricor in the US and enable Imricor's sales team to initiate site engagement and pipeline development,' the company says. Mach 7 maintains cruising altitude ProMedicus (ASX:PME) 'mini me' Mach7 Technologies (ASX:M7T) has affirmed its revenue forecast for the year to June 2025, albeit at the lower end of things. Mach 7 also expects to break even. On preliminary unaudited numbers, Mach 7 expects revenue of $33-34 million, in line with guidance of $33-36 million and 15-25% higher than previously. Management expects recurring revenue – subscription revenue and maintenance and support revenue – to be 20% higher. But CARR – contracted annual recurring revenue - should come in at $30-31 million, just below the guided $32-35 million. 'Mach 7 is in a strong financial position with no debt and expects to be operating cash flow positive for the 2024-25 year,' management chirps. Mach 7 provides medical imaging software, including image diagnosis and vendor-neutral image archiving. In crude terms Mach7 is 'same but different' to Pro Medicus – a key commonality being a US focus. But they don't compete directly, by and large. A key difference, of course, is that Mach 7 is worth $80 million, with $22 million of cash backing. Pro Medicus is valued at $33 billion, with its shares surging 140% over the last year. Mach 7 shares have decline 44% over his period. Sniffing a bargain, Mach 7 is lapping up its own shares by way of an ongoing share buyback. Mach 7's new CEO Teri Thomas officially started on July 1 and will update investors on July 29. Thomas headed breast imaging outfit Volpara Technologies, before it was taken over by a South Korean suitor last year. Why we like PYC Drug developer PYC Therapeutics (ASX:PYC) has maintained a low profile and that's partly because of its convoluted story over the years. But the Perth-based PYC now has a clearer focus on a portfolio of four rare disease candidates for rare inherited diseases, across three clinical trials. Growing investor awareness has pushed PYC's market cap to more than $840 million. Broker Bell Potter reckons there's room for more as PYC 'has continued to execute impressively in recent months.' PYC's trials cover the eye diseases retinitis pigmentosa type 11 (RP11) and autosomal dominant optic atrophy (ADOA), as well as polycystic kidney disease (PKD). The most advanced, RP11 is fully recruited should start a registrational phase 2/3 trial in the next six to nine months. This follows recent FDA feedback on trial design. 'Early data has impressed on measurements likely to be primary endpoints in the future registrational trial,' Bell Potter says. The trial would be the first ever pivotal study for RP11, which has no current treatment and affects 1500 to 3500 Americans. Bell Potter values PYC shares at $2.30, a 58% increment on their current value.
News.com.au
08-07-2025
- Business
- News.com.au
Biocurious: Nerve repair champion Orthocell is taking it slow and steady in the US fast lane
Orthocell is staging the US rollout of its Remplir device, including 'pausing' enlisting too many distributors at once In Remplir's first US commercial usage, an Ohioan surgeon has deployed the device successfully More than 300 investors tuned into Orthocell's update last week For Orthocell (ASX:OCC) co-founder and CEO Paul Anderson, winning US Food & Drug Administration (FDA) marketing approval is more like a waypoint in the commercialisation path, rather than the endgame. In early April the FDA green-lit the company's flagship nerve repair product Remplir, exposing the company to a potential US$1.6 billion-a-year market. The Perth-based Orthocell can't be accused of assuming the biotech gods will serve up commercial success on a platter. Anderson says Orthocell was preparing its rollout strategy two years ago, including strategic tie-ups with distributors and laying the groundwork with opinion-leading surgeons. 'You don't just get an FDA approval and expected things to happen, you must be ahead of the game,' Anderson says. A mere three months post approval, Orthocell last week reported the first US commercial use of Remplir, by a surgeon in Ohio for a foot repair. It's not a race Paradoxically, management is on a strategic 'go-slow' in the fast-paced, make-or-break US market. Having appointed 14 east coast distributors, the company has 'paused' the rollout of any more until the current complement is properly trained and supported. Orthocell has also focused on the parties with what Anderson dubs the best 'domain knowledge' – those who can lead the company to the key hospitals and influential surgeons. 'You can't be scattergun,' Anderson says. 'We have 14 distributors to train and educate, with 100 reps on the ground. 'It's important that we provide them with the best education to support the brand.' Orthocell is also not ignoring the dull-but-important stuff of obtaining state-by-state licensing, navigating hospital procurement and onboarding day surgery hospitals (a key market). Stitching up the suturing market A collagen cuff derived from porcine material, Remplir envelops a severed nerve and helps the healing process. The device is also approved locally and in New Zealand, Canada, Singapore, Thailand and Hong Kong. Remplir is the only product that mimics the outside of the nerve, called the epineurium. Given that, the device requires few or no stitches: a technique unchanged since the late nineteenth century. 'We are actively redefining the way surgeons approach nerve repair,' Anderson says. 'Remplir is the only product in the market that enables surgeons to connect nerves, to protect them from scar tissue and compression; and cap nerves (for amputations).' Published studies show that patients with no voluntary movement had 85% of their function restored two years post-surgery. They also had improved strength and range of motion, which Anderson dubs 'outstanding outcomes that represent everything Remplir has to offer". To date, 206 surgeons in over 166 local and Singaporean hospitals have used Remplir, including plastic reconstructive, orthopaedic, vascular and neurological surgeons. Better bang for revenue buck Naturally, a medical product needs to be clinically superior – but that's not enough to ensure financial success in a well-competed sector. As yesterday's update from US drug entrant Botanix Pharmaceuticals (ASX:BOT) shows, too many clipping-the-ticket intermediaries can spoil the revenue story. 'Unlike other medtechs, Orthocell has no royalty liabilities and as we get into revenue growth, investors will reap the reward,' chairman John Van Der Wielen says. 'Royalty liabilities significantly erode margins in the sector." He adds that most device makers outsource their manufacturing, resulting in margin erosion. Orthocell's process is being kept in house. Revenue growth 'will take care of profits' Orthocell last week disclosed record June quarter revenue of $2.73 million, 23% higher than the March quarter. Revenue has risen for five consecutive quarters, at a compound annual rate of 9.5%. However, this annual run rate of circa $9 million doesn't include any US Remplir revenue. Striate sales in Australia, New Zealand and Singapore grew 28%. Management won't predict US revenues or when the company achieves profits – but expect blank ink on the bottom line in the 'near future'. 'Our expenses are growing at a lower rate than revenue, so the 'jaws' eventually will cross over and push the business into profit,' Van Der Wielen says. 'Cash burn is reducing, revenue is increasing and I believe we have more than enough cash to take the business forward.' Over time, Orthocell has invested $80 million in developing its product platform. The company does not have to incur more sunk costs, leaving a largely variable distribution cost base. 'Premium' product at a discount price Tapping Remplir's cost advantages, Orthocell is pricing the 'premium' product at just below those of US competitors. 'We are making it easy for the hospitals to order our product,' Anderson says. Orthocell has set its US pricing at parity with what's charged in other countries. This is a poltically sage gambit that should please the Commander in Chief as he ponders his 'most favoured nation' drug policy. While obtaining US reimbursement is the be-all-and-end-all for most drug makers, Anderson notes a capacious user-pays capacity for nerve repair. 'The take-home message is there is enormous revenue to be gained, even if you don't have US reimbursement,' Anderson says. That said, hospitals should fund Remplir by a mechanism that allocates a bundle of cash per procedure, rather than for specific items. Passionately Australian Around 300 investors tuned into Orthocell's webcast last week – no doubt reflecting the stock's 270% surge over the past 12 months. As it hones its US push, one thing Orthocell won't be doing is ceding its manufacturing base in Perth, which has the capacity for 100,000 units annually. Remplir's long shelf life means it's easy to ship elsewhere. 'We are passionate manufacturers of this product in Australia – and that's because it's the right place to make it,' Anderson says. 'We have the best raw material in the world and a great gross margin and economies of scale.' Judging from his chairman's utterances, Anderson can approach his end-of-year salary review with confidence. 'As a board, we could not be happier with what we have achieved over the last 12 months,' Van Der Wielen says.
News.com.au
01-07-2025
- Business
- News.com.au
Health Check: And the EOFY biotech winner is … gasp … a pot stock
Bioxyne stars with a 720% gain in the 2024-25 year Paradigm shares soar 34% after $41 million convertible note deal Biotechs turn to debt funding The ASX biotech sector's best EOFY performer has come from left field: the local and European focused medicinal cannabis supplier Bioxyne (ASX:BXN). According to the Health Check Biotech Pulse – trademark pending – Bioxyne shares soared 720% in 2024-25, leaving its largely poorly performing pot peers in the dust. Bioxyne's fortunes have been driven by its Breathe Life Sciences arm, which purveys cannabis products including not just flowers and oils but pastilles, vapes, pessaries and suppositories (we kid you not). The company recently upgraded full-year revenue guidance from $25 to $28 million and promised positive cash flow and – gasp! – profitability. Amplia (ASX:ATX) took second place, with a 233% gain (300% over the last month). The stock soared after Amplia unveiled clinical trial results showing two 'complete responses' among a cohort of advanced pancreatic cancer patients. Orthocell (ASX:OCC) shares vaulted 220% on the back of US Food & Drug (FDA) approval of its novel nerve repair tool Remplir. Imricor Medical Systems (ASX:IMR) shares ended the year 189% to the good, as the company eyes FDA approval of its world's first MRI-guided ablation catheter. Other triple digit dazzlers were myelofibrosis drug developer Syntara (ASX:SNT) (up 130%), autism testing device play Blinklab (ASX:BB1) (up 116%) and the beloved radiology imaging tearaway ProMedicus (ASX:PME) (up 110%). Sorry – there's no prize for trying Sadly, there's still too much red ink in the rankings. In your columnist's opinion, investors have marked down many worthy stocks unfairly. But we're not in primary school and everyone doesn't get a ribbon for trying, so the record books will show that medication compliance group MedAdvisor (ASX:MDR) led the falls with an 82% decline. Other laggards are the multi-pronged Universal Biosensors (ASX:UBI) (down 76%), Proteomics International Laboratories (ASX:PIQ) (down 62%, see below), lung imager 4D Medical (ASX:4DX) (down 56%) and Clarity Pharmaceuticals (ASX:CU6) (down 51%). Shares in the busy Clarity shares peaked at $8.74 last October – a 70% gain for the year – but even after the subsequent sell off the company still bears an $800 million market cap. Strictly speaking, Opthea shares fared the worst after the company's infamous eye disease trail failure in March. Opthea shares never resumed trading, so the official records show a 73% gain when in fact the stock is worth next to nothing. Genetic Technologies and Nuheara are also missing from the laggards list, only because they went into administration and subsequently de-listed. Paradigm shifts to convertible notes With the equity capital raising outlook still looking shaky, Paradigm Biopharmaceuticals (ASX:PAR) has become the latest in a string of biotechs to tap alternative funding sources. The developer of a knee osteoarthritis (OA) drug candidate has tapped US$27 million ($41.2 million), by way of convertible notes. These have been issued to New York based alternative funder Obsidian Global Partners. Under the terms, Paradigm will draw an initial US$7 million to fund patient recruitment, trial operations and regulatory milestones. The balance of the facility is available at Paradigm's discretion, 'offering operational flexibility and strategic control over future funding needs'. Barring default, the notes are interest free. The cash will help to fund Paradigm's pivotal phase III trial of its repurposed drug candidate pentosan polysulphate sodium (PPS, or Zilosul). Investors have keenly awaited this trial initiation – and confirmation of how it will be funded. Reflecting this, Paradigm shares this morning surged 34%. The 466-patient study in underway across up to 15 Australian and 50 US sites. The company says it is now fully funded up to the interim analysis of the first 50% of patients, due in mid 2026. Last week Paradigm hedged its bets by paying as much as $16.5 million for Proteobioactives Pty Ltd ($500,000 upfront) This company owns an early-stage oral candidate for minor to mild OA, which combines PPS with a COX-2 inhibitor (Coxib). When debt is not a dirty word The term 'debt' can have unfortunate connotations – especially in the context of your columnist's household budget. But it can be cheaper than equity and has the benefit of being non-dilutive and more flexible with the timing of drawdowns. Often, it's simply more accessible than equity. The developer of better working anti-infectives, Recce Pharmaceuticals (ASX:RCE) last month availed of a US$20 million ($30 million) draw-down facility from the New York based Avenue Capital Group. Recce pockets an initial US$7.5 million and a further US$5 million between April and September this year. The remainder is available in calendar 2027, with all the amounts subject to 12.75% interest. The funds will support Recce's two phase III registrational studies on diabetic foot infections and acute bacterial skin and skin structure infections. Recce also recently raised $15.8 million of equity. Last month, dermatology group Botanix Pharmaceuticals (ASX:BOT) unveiled a circa US$30 million ($48 million) debt facility with Kreos Capital. Kreos is an arm of the world's biggest investment manager Blackrock. The facility provides for circa $US20 million to be drawn now, with the remainder to be tapped by October 2026 at the company's option. Under certain conditions, Kreos Capital can convert 20 percent of the loan into Botanix shares, at 33 cents apiece. Botanix developed Sofdra, a treatment for excessive underarm sweating and has started selling the product in the US. In mid-April Botanix also raised $40 million of equity, via an institutional placement. Proteomics secures non-dilutive $6 million Then there's non-dilutive grant funding. The Perth-based Proteomics today said it had secured a $6 million investment from the federally funded Bioplatforms Australia and the WA government. The funding will support developing an accredited protein biomarker analysis platform, in partnership with the University of Western Australia. Proteomics chips in $1 million over the three-year funding period. Proteomics has commercialised a predictive test for diabetic kidney disease and is developing assays for endometriosis, esophageal cancer and oxidative stress. Meso-blast off for FDA application? Stem-cell drug developer Mesoblast (ASX:MSB) says the company and the FDA are 'aligned' on what the company needs to do before it lodges a US marketing application for its heart disease candidate, Revascor. In late December Mesoblast won FDA approval for its childhood graft-versus-host disease (GvHD) candidate. This followed years of the company and the agency being decidedly 'unaligned'. Given the heart disease heart indication is much bigger than GvHD, today's news is more significant than it may appear at first blush. Mesoblast intends to file for accelerated approval by the end of the year. This is to treat ischemic heart failure patients with reduced ejection fraction and inflammation.
News.com.au
30-06-2025
- Business
- News.com.au
Health Check: Tetratherix breaks biotech IPO drought with 13pc gain on debut
Tetratherix's listed life starts on a solid note Dimerix pockets a $4.2 million milestone – with close to $1.4 billion to come Orthocell chalks up first commercial US procedure for its Remplir device Today's ASX debut of wound management house Tetratherix (TTX) has raised the hopes of other life-science plays that have eyed an IPO but have relegated the idea to the too-hard basket. Having downsized its offer from $35 million $25 million to banish the fast money, Tetratherix traded up to 13% above their $2.88 a share offer price. The company has developed an injected liquid polymer that hardens at body temperature and then biodegrades after the job is done. Yet to be approved, the platform-based tech targets novel applications including tissue healing, bone regeneration and surgical spacing (such as in prostate radiation therapy). CEO Will Knox dubs the platform as 'medical Lego', in that the products are built from the same polymer structure. 'That means you can use the same underlying biological performance and safety data in all regulatory applications. 'Our path to market is a lot faster and simpler because the data is interchangeable across the different applications.' Post raising, Tetratherix has cash of circa $30 million. This factors in two US Food & Drug Administration (FDA) approval applications, one further submission and 'multiple clinical trial readouts'. Tetratherix is the first life sciences IPO since late November 2024, when cryogenics play Vitrafy Life Sciences (ASX:VFY) and nerve repair house ReNerve (ASX:RNV) listed on the same day. Their shares are down 20% and 50% to date, respectively. Aptium is on IPO foot-ing The developer of an AI-powered tool for the podiatry market, the private Aptium is eyeing an IPO after a private whip-'round. Aptium's scanner provides real-time thermal and three and four dimensional analysis of motion and the shape of the foot. This enables 3D manufacturing of patient-specific insoles 'with precision-grade firmness and softness:. The tech also may detect diabetic foot ulcers early. Co-founded by biotech greybeards Dr Mel Bridges and Carl Stubbings, Aptium is seeking to tap $5 million in a private convertible note round. The company aspires to list within the next 18 months or so. Bridges has founded six companies, including ImpediMed (ASX:IPD) and the formerly ASX-listed Panbio. Stubbings was former CEO of Sienna Cancer Diagnostics, which merged with Bard1 to become Inoviq (ASX:IIQ). Aptium could test IPO appetite in more ways than one. That's because the company is 40% owned by Greg Creed, the former CEO of US giant Yum! Brands which owns KFC, Pizza Hut and Taco Bell. Dimerix pockets first milestone from Japanese partner Kidney drug developer Dimerix (ASX:DXB) has pocketed $4.2 million as its first milestone payment from Japan's Fuso, one of the company's four global partners. Signed in January this year, the Fuso compact could deliver up to $100 million of milestone payments. This is subject to progress on Dimerix's lead phase III program, for the kidney ailment focal segmental glomerulosclerosis. In October 2023 Dimerix inked distribution deals with the London-based Advanz Pharma (covering Europe, Canada, Australia and New Zealand). The company followed up in May last year by entering a Middle East licensing agreement with the Oman-based pharma group, Taiba. In its biggest deal, Dimerix last May signed up the Nasdaq-listed rare diseases house Amicus Therapeutics for the US honours. Collectively, the deals promise $1.4 billion of potential milestones, largely contingent on eventual FDA drug approval. The Amicus deal alone involves of US$520 million of success-based payments. The Fuso milestone became payable on opening of the first Japanese site for the Action 3 trial. Investors now expect likely follow-on deals in territories including China, Latin America and South Korea. LTR Pharma is full bottle on safety study Drug development is all about getting the small stuff right, such as whether the packaging is tickety-boo. In this vein, LTR Pharma (ASX:LTP) has affirmed that the bottle and pump components for its proposed nasal mist based erectile dysfunctional treatment meet accepted standards. LTR completed the so-called extractables study with co-development partner Aptar Pharma. The study confirmed that all detected compounds met International Council for Harmonisation safety thresholds – the standard adopted by the FDA and other agencies. A 'leachables' study is now underway, to support an FDA marketing submission. As the name suggests, the leachables study evaluates the potential migration of compounds from packaging into the liquid. This takes account of 'real-world' storage conditions, such as the back of the bedside drawer. The study will run for at least 24 months, after which the company can submit its FDA entreaty. Dubbed Spontan, LTR's treatment is based on the same active ingredient as current oral treatments but is much faster acting. LTR is also developing Oroflow, a spray treatment for a group of ailments that affect swallowing function. Orthocell hits the right nerve Nerve repair play Orthocell (ASX:OCC) reports the first use of its Remplir device in a US surgical procedure, to repair a foot injury. The FDA approved Remplir in April. The company says the first use is a crucial step in its US rollout, 'building surgical experience and knowledge of the product that will be key in driving product sales'. Remplir is a collagen 'wrap' that improves regeneration of damaged nerves and requires less stitching. The surgery took place at an unnamed Ohio hospital, sourced from Orthocell's network of 14 specialist distributors. These intermediaries have 'mature, direct-to-surgeon, hospital and other customer relationships' across 25 US states. Orthocell CEO Paul Anderson said the critical first step in the US rollout was 'getting Remplir into surgeons' hands for them to gain familiarity with its key features and benefits in clinical practice'. The company promises 'material' sales growth in the December half - which of course starts tomorrow – with the financial benefits reflected in the June half 2026 accounts. Orthocell estimates that surgeons carry out two million peripheral nerve repairs annually, equating to a US$3.5 billion market. This is across its approved markets of Australia/New Zealand, Singapore, the US, Europe/UK, Canada, Brazil, Japan, Hong Kong and Thailand.
