CVB - CurveBeam AI

CurveBeam AI is a fully integrated developer and manufacturer of specialised medical imaging (CT) equipment and supporting clinical assessment software aids that, through the use of image analysis, artificial intelligence (AI), and deep learning AI (DLAI), are designed (subject to relevant regulatory clearances being obtained) to automate the analysis of the high-quality images generated on its CT platform to assist in the clinical assessment and management of musculoskeletal health conditions.

The business today has over 50 employees with corporate headquarters in Melbourne Australia, and manufacturing facilities and operating headquarters in Hatfield, Pennsylvania in the U.S.

It is anticipated that CVB will list on the ASX during August 2023.

And slow out of the blocks .... 31c after 35 minutes trading
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CurveBeam AI commences trading on ASX and provides business update

Highlights
• CurveBeam AI lists on the ASX today under ticker code ‘CVB’ after raising A$25m at A$0.48 per share under its IPO.
• CurveBeam AI is releasing its Appendix 4E to ASX today and has achieved A$11.48m pro forma revenue (unaudited) in FY23, driven by sales of HiRise™. This represents ~55% growth on the prior year with a US sales team of three.
• CurveBeam AI expects its co-marketing and distribution agreement with Stryker Corporation’s (NYSE: SYK) Foot and Ankle division for the US territory, which launched with the Stryker FLEX financing option in May 2023, to drive sales growth going forward through Stryker’s expanded market reach and financing options.
• Since 1 July 2023, Stryker has taken orders for two HiRise™ devices, representing a total of three devices booked or sold year to date by Stryker for calendar year 2023.
• Notably the Company sold and installed a HiRise™ system at the Hospital for Special Surgery located in New York in June 2023, a globally recognised orthopaedic specialty centre.
• The company as of the end of FY23 had 40 HiRise placed globally in hospitals and orthopaedic practices. With the two sales from Stryker so far this FY, and one HiRise sold by the company (Duke University), as of today there are globally 43 HiRise systems either placed or to be placed.
• CurveBeam AI and Stryker continue to work collaboratively to drive sales of the HiRise™ device to hospitals and group orthopaedic practices. The potential addressable market for the HiRise™ device in the US alone is A$10b.
• In addition to targeting sales growth in the US, the Company has recently established a German subsidiary, CurveBeam AI GmbH, to launch direct sales into Germany.
• CurveBeam AI is progressing the development of a CT bone mineral density analysis and reporting software module. Subject to regulatory clearance, the BMD module is targeting to be available to HiRise™ customers as a SaaS product in late FY25 and has the potential to generate future revenues of between A$150-200k per device per annum at a 90%+ gross margin.
• CurveBeam AI has developed an AI diagnostic tool to assess bone fragility and fracture risk called OssView®. In a clinical trial of 2,000 women, OssView® significantly outperformed BMD which is the current gold standard diagnostic (p=0.005). OssView® at the wrist has received Breakthrough Device Designation from the FDA.
• CurveBeam AI has recently published the world’s first application of a deep learning AI (DLAI) algorithm, called OssView® 2, to aid in determining fracture risk using images derived from high resolution peripheral quantitative CT (HR-pQCT) scans of the wrist.

...ah, that's better. Settle down
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three days in:

One to tip toe about.

gg

Garpal Gumnut said:

One to tip toe about.

Click to expand...

Not a tulip?

no point in cuttin'n'pasting, but Tim B brings in a few points that are useful...

Dr Boreham's Crucible: Is this the only POTUS-approved ASX AI play? - Stockhead

Curvebeam debuted well under par, trading as low as 33 cents on IPO day, but briefly hit 54 cents this week after big name investors were...

stockhead.com.au

You must have been reading over my shoulder. Just placed CVB into a watchlist for a possible longer term spec position.

some gung-ho fund manager reckons there's potential here...
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Producing weight-bearing scanning machines for orthopedic surgeons to use, he says it can use AI to help surgeons make better informed clinical decisions.

“Scanning patients while standing gives surgeons a better understanding of ligaments and bones, and allows orthopaedic practices to earn money from scans done in their own clinics."
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so far, not ahead since IPO, but I'd be happy to stand corrected, as should the patients.

AGM

Y23 CURVEBEAM AI HIGHLIGHTS
AGM PRESENTATION
• StraxCorp and CurveBeam merger completed in Q1 FY23
• Pre-IPO round closed Q3 FY23 – raised $25m
• The pre-IPO round showed a number of new institutional investors join our register.
• Listed on ASX - raised A$25m in August 2023 – (ASX: CVB)
• FY23 proforma revenue A$11.48m, circa 55% growth on FY22
• Foot & Ankle division of Stryker continues to build a strong prospects pipeline
• Primary company focus for FY24 is to place HiRise™ as quickly as possible –especially in the US market and to launch BMD SaaS model once FDA clearance is achieved.

forward, onward
• Deploying IPO capital to support HiRise™ placements for the rest of FY24
• The company focus remains
1. Driving growth in HiRise™ placements – especially in the US
2. Enhanced HiRise™ platform, especially for PSI & BMD functionality
3. Target launch for BMD SaaS business by the end of FY25
• FY24 orders – Company remains optimistic regarding the outlook for Stryker driven placements and sales. Timing of when sales are closed & booked remains outside the Company’s control
• Advancing enhanced HiRise™ platform for robotic system datasets to target
• Accelerating orders – Robotic Hip & Knee users in a group practice need validation from Stryker that HiRise™ can be used for other robotic datasets
• Improve diagnostic information for conditions identification around the hip & Knee
• US FDA filing bone mineral density (BMD) SaaS module – FDA clearance remains on late FY25 target

Curvebeam to rename to Hockeystick LightSabre ... slashing its way up Dec tipping comp... now 36c

Dona Ferentes said:

CVB ... slashing its way up Dec tipping comp... now 36c

Click to expand...

and to 40c ... not much conviction, though

Dona Ferentes said:

and to 40c ... not much conviction, though

Click to expand...

Q out ... down


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4C SUMMARY OF KEY ACTIVITIES

• Purchase orders for (4) HiRise up from (2) in prior corresponding period
• HiRise (7) POs for the 6-month period to 31 Dec. 2023 versus (4) in the PCP.
• Foot & Ankle division of Stryker continues to build a strong prospects pipeline
• Continuing development of an enhanced HiRise™, a higher X-ray energy CT with clearer images for a broader range of patient body types, required for custom protocols for hip and knee robotic surgical systems.
• Development and validation of the enhanced HiRise™ is expected to be completed by Q4 FY24 for knees, with hips to follow soon after. This is targeted to satisfy the requirements of several large group orthopaedic practices in the Company’s pipeline and to support a step change in Stryker’s HiRise™ placements in the US.
• Targeting FDA clearance mid-CY25 for the enhanced HiRise™ bone mineral density software module, with submission now expected in H2 CY24.
• Company undertook several cost reduction initiatives during Q2 FY24.
• Company Directors believe that the company continues to have sufficient working capital for at least 24 months from its Aug. 2023 IPO based on current expectations.
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it's all about validation, upgrades, customisation. Is there a finish line?

Half Year Financial Statements Released Period Ended 31 Dec 2023

Executive Summary
o Revenue
o H1 FY2024 revenue was $3.53m, versus $2.18m for the comparative period H1 FY2023, and $5.57m for the pro-forma revenue for H1 FY2023.
o Pro-Forma comparative period included:
§ Deliveries of back orders following the COVID related chip shortage in FY22, clearing in early FY23.
§ Clearance of first and second generation discontinued products.
o HiRise™ orders
o 7 Purchase Orders versus 4 in H1 FY2023.
o Enhanced HiRise™
o The company continues development of an enhanced HiRise™, a higher X-ray energy CT with clearer images for a broader range of patient body types, required for custom protocols for hip and knee robotic surgical systems.
o The enhanced HiRise™ has been targeted to address feedback from group orthopaedic practices in the Company’s US prospect pipeline, who have not been
willing to commit until CurveBeam’s device can deliver the required datasets for keyrobotic surgical systems for knee and hip surgery. Once in place, the enhanced HiRise is expected to bring a step change in orders and adoption.


CurveBeam AI CEO Greg Brown said: “During our first half year as a listed company we have endeavored to respond to our circumstances and preserve cash as much as we can, while expeditiously developing an enhanced HiRise™ to meet market requirements. We continue to get consistent market feedback from orthopaedic surgeons that the HiRise™ offers an appealing solution, for group practice settings, to deliver in one visit a diagnosis and surgical plan. The company expects the enhanced HiRise™ to meet the specifications needed for fabricating custom cut guides for the various body types needed by Patient Specific Instrumentation and robotic surgical systems. The Company continues to target the use of the enhanced HiRise™ datasets in routine Total Knee Replacement planning, including robot assisted procedures by Q4 FY24. With this milestone we are targeting a step change in demand for the HiRise™.”

.... lots of proforma accounts ..
... and issues to "meet the market". It's not IBM

peter2 said:

You must have been reading over my shoulder. Just placed CVB into a watchlist for a possible longer term spec position.

Click to expand...

as did i , today ( this afternoon )

would like it a fair bit cheaper .. but how much risk do i want to take on

definitely a speccie from my point of view ( currently ) , but i will be watching for sales and contracts ( and really wary in case this becomes a R&D black-hole )

CVB has seen a bit of a fall , early 24 and no real recovery since.



The Jan 25 Quarterly generated some interest:

Summary of key activities
• During Q2 FY25, CurveBeam AI received purchase orders (POs) for ten devices, representing around A$5m in future sales. Eight of the POs were HiRise™ with five POs from Stryker. This is a record quarter for purchase orders of HiRise™.
• Total device POs were up 150% from four in the prior corresponding period.
• Thirteen POs were received for the six-month period to 31 December 2024 versus seven in the pcp, up almost 100%.
• Following the signing of a non-binding Term Sheet during December, the Company has since entered a definitive agreement with Stryker Australia and New Zealand, announced to the ASX yesterday. This expands commercial arrangements with Stryker into CurveBeam AI’s home market and New Zealand.
• Cash outflows from operations for Q2 FY25 was A$2.7m versus A$5.3m in Q2 FY24 and A$4.7m in Q1 FY25. Receipts from customers was the highest recorded in a quarter to date at A$2.6m.
• Cash at the end of Q2 was A$8.8m, with a further A$6.0m of cash receipts expected in H2 FY25 from existing POs.
• The Company is continuing to complete validation of the enhanced HiRise™, required for custom protocols for hip and knee robotic surgical systems. The validation made steady progress over the holiday period, and it continues into early 2025 with the first 5 matched datasets, of 10 currently being processed.
• BMD regulatory strategy progressed during the quarter. As advised, the company completed a Q-Sub meeting on the proposed new BMD (MDCT) file with the FDA on 17 December 2024. The BMD (MDCT) file remains a 510(k) class II pathway, but additional comparison with BMD obtained via dual energy X-ray has been requested by the FDA for around 20-25% of the trial patients. This expanded FDA trial requirement will need additional time, estimated at 6 months, to collect the additional testing and prepare the file. FDA submission for the BMD module is now targeted for mid-2025, with FDA clearance targeted for H1 CY26.
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galumay added some of his take on CVB when the company was raised in the PME thread:

Too early to see if its actually an investible business IMO, share count is a worry, looks like they had a consolidation then a massive CR, cash burn is furious, especially when you add back in gov grants. The biggest red flag for me is the AI nonsense, its neither artificial nor intelligent! Its just enhanced data sorting and recognition.

Click to expand...

...my level of sophistication only extends to having a good chuckle when unnecessary nonsense is added:
"Thirteen POs were received for the six-month period to 31 December 2024 versus seven in the pcp, up almost 100%." - wow! Never knew that

CVB is my pick for the March tipping comp. ( i do NOT hold currently )

one of those gambles

downside risks include it relies on device sales AND software packages ( two potential R&D black holes ) , although making some revenue it is still loss-making , ALSO it seems to be applying for patents ( which can be a whirlwind of problems to come ) also since it is still burning cash .. a capital raise in any meaningful spike is a possibility

now yes , there is potential for growth ( and profit ) it seems to be non-invasive medical diagnosis ( an area i prefer to standard healthcare

short term there is a flicker of light at the end of the tunnel , so there MIGHT be the chance of a take-over offer , or just genuine investor interest

sub 10 cents would tempt me to research deeper , but has been placed on my watch-list