ASX Health Quarterly Wrap: Control Bionics reports strong US revenue, LTR Pharma makes FDA progress

Some of the ASX’s most exciting health small caps rolled out their quarterly results this week, including Control Bionics, LTR Pharma, Lumos Diagnostics and EMvision Medical Devices.

LTR Pharma held a successful pre-IND meeting with the US FDA during the March quarter. Pic: Getty Images

Special Report: ASX quarterly season is upon us again, with listed companies opening a window to their performance and key activities over the three months to March 31.

It’s a key time for investors to zero in on the finer details of ASX-listed firms and get a sense of what is on the horizon.

Here, we wrap up report highlights from four standout stocks in the ASX health sector.

Control Bionics (ASX:CBL)

• Revenue for Control Bionics' US business over six months to end of March highest since FY23
• Best quarter of revenue in Australia since 2022, driven by improved NDIS approval times
• Completes investment in Neuro Elite Athletics, the company behind NeuroBounce program for athletes

The assistive technology medical device company reported revenue for its US business over the six months to end of March was the highest since FY23, up 20% over the previous corresponding period (pcp).

Control Bionics attributed the growth to a code approval under the Healthcare Common Procedure Coding System (HCPCS) by the Centers for Medicare & Medicaid Services (CMS) in the US for its key product Neuronode, a watch-like device to assist cognitive people with physical disabilities.

The company said it also achieved a $700,000 in cost savings in North America with margin expansion.

Control Bionics said two well-established US operators now have its NeuroNode devices with their sales team and were actively marketing in the US.

The company also reported its best quarter of revenue in Australia since 2022 with improved NDIS approval times and a strong sales pipeline driving the success.

While the backlog continues to be cleared Control Bionics said it has almost $1 million in applications awaiting NDIS approval.

During the quarter it completed its investment in Neuro Elite Athletics, which is the company behind the NeuroBounce program for athletes.

During the quarter its launch customer Utah Prep Academy in the US delivered strong results, measurably improving explosive power and vertical leap for elite athletes with Control Bionics' NeuroStrip.

A new cloud-deployed version of NeuroStrip has been launched, providing access to a new SaaS revenue stream along with hardware sales.

Cash receipts for the quarter were the highest in 12 months, exceeding $1.6m and up from $1.4m in Q2 FY25, driven by improved sales in the US and Australia.

During the quarter founder Peter Ford stepped down from the board and was replaced by Dr Stephanie Phillips, who has more than three decades of clinical, academic and leadership experience in anaesthesia and critical care.

Control Bionics finished the quarter with cash of $1.7m.

"We are delivering strong sales, cash collection and meaningful progress on our growth initiatives,"  CEO Jeremy Steele said.

"We’ve found strong commercial appetite for our core IP, the NeuroNode, through our NeuroNode Only strategy. We’ve rolled out this technology now to multiple distributors (both in pilot and contract phases) in multiple geographies.”

LTR Pharma (ASX:LTP)

• Developer of a nasal spray-mist erectile dysfunction treatment LTR Pharma successfully holds pre-IND meeting with US FDA 
• Chief scientific & clinical adviser Professor Eric Chung receives prestigious award for his presentation on SPONTAN 
• LTR announces in quarter new ED nasal spray targeting the US personalised healthcare sector called ROXUS 

The developer of a nasal spray-mist erectile dysfunction treatment said it delivered significant progress across its regulatory, commercial and scientific objectives during the March quarter.

In March, LTR Pharma held a successful pre-IND meeting with the US Food & Drug Administration. Key outcomes included:

• Endorsement of its non-clinical (toxicology) and chemistry, manufacturing and controls (CMC) development plans
• Agreement on a pivotal efficacy/safety study and a multi-dose pharmacokinetic study; and
• Clear guidance on the pathway to market through the 505(b)(2) regulatory process.

Following the meeting LTRPharma has initiated CMC studies with Aptar Pharma, started extractables and leachables studies required for regulatory documentation and developed specific protocols for the upcoming clinical studies.

During the quarter the company's novel intranasal formulation of vardenafil for ED SPONTAN was recognised at the Urological Society of Australia and New Zealand’s (USANZ) Annual Scientific Meeting.

Chief scientific and clinical adviser Professor Eric Chung was awarded the BAUS Trophy — the event’s highest honour — for his presentation of SPONTAN’s clinical results.

LTR Pharma said the scientific recognition, voted on by a panel of leading urologists, reinforces SPONTAN as a best-in-class, fast-acting ED therapy, while also attracting strong international interest from urologists and key opinion leaders.

During the quarter the company announced a new ED nasal spray targeting the US personalised healthcare sector called ROXUS, representing a expansion of the company's product portfolio.

LTR Pharma also continued to expanded its Australian commercial operations during the quarter through several initiatives and partnerships.

Key expenditure for the quarter was continued investment in the joint venture with Restorative Sexual Health for a new online healthcare platform, providing comprehensive men’s health services through telehealth.

The company ended the March quarter with cash position of $32.8m.

Lumos Diagnostics (ASX:LDX)

• Lumos revenue of US$3.5 million for Q3 FY25, up 21% compared to the prior quarter
• Hologic foetal fibronectin project scope of work expansion was signed and forecast to generate additional  fee revenue
• FebriDx CLIA Waiver Study continues with around 351 patients tested to-date, including 37 bacterial-positive patients

The developer of rapid point-of-care diagnostic technologies reported revenue of US$3.5m for the quarter,  up 21% compared to the prior quarter as it works to build sustainable growth.

Revenue generated during the quarter from the services business was US$2.8m. Lumos said its foetal fibronectin (fFN) development agreement with leading women’s health company Hologic (NASDAQ: HOLX) and the intellectual property licensing revenue associated with the Hologic IP deal generated the majority of revenue.

During the quarter the Hologic fFN project scope of work expansion was signed and is forecast to generate an additional US$600,000 to US$800,000 in fee revenue.

Revenue from its products business was US$700,000 for Q3, up 17% on Q2 revenue. Following additional sales in the UK and growing adoption in the US, FebriDx sales continue to grow with revenue increasing 48% on pcp.

Additional FebriDx distribution partnership agreements completed in the US with MedPro Associates and the US Defense Logistics Agency (DLA) during the quarter.

FebriDx CLIA Waiver Study continues with around 351 patients tested to-date, including 37 bacterial-positive patients. Completion of the the study and an application for CLIA waiver labelling for FebriDx with the FDA is forecast by calendar year end.

In late March, Lumos completed and lodged an application with the Australian Government Department of Health and Aged Care for the inclusion of FebriDx on the Medicare Benefits Schedule.

Operating cashflow improved, with an operating cash outflow of US$1.3m, compared with US$3.7m in Q2 FY25.

Lumos ended the quarter with a cash balance of US$4m.

Post quarter Lumos has made significant progress with US Medicare payor coverage for FebriDx, with reimbursement secured with four of the seven Medicare Administration Contractors, and discussions ongoing with the remaining three.

EMvision Medical Devices (ASX:EMV)

• EMvision kicks off pivotal clinical trial for emu bedside brain scanner
• Trial will support US FDA de novo clearance for emu device 
• EMvision undertakes proof-of-concept testing for First Responder scanner

Neuro-diagnostics medical devices company EMvision started its pivotal clinical trial for its first commercial device the emu bedside brain scanner during the March quarter.

The trial is designed to support US FDA de novo (new device) clearance for the emu device, with Royal Melbourne Hospital (RMH) the first of six sites to be activated.

The RMH is a world-class comprehensive stroke centre and home to the Melbourne Brain Centre – the largest brain research collaboration in the southern hemisphere.

An emu device has also been shipped to the first US site, University of Texas Health Science Center at Houston (UTHealth) Medical School and Memorial Hermann-Texas Medical Center (TMC).

After quarter-end, EMvision shipped an emu to the Mayo Clinic in the US, with site initiation and training set for early May.

During the quarter EMvision also undertook proof-of-concept testing of its portable device First Responder to detect strokes and traumatic brain injury.

Under an existing ethics approval, the First Responder device wastested in remote locations, in collaboration with the Royal Flying Doctor Service (RFDS) and the Australian Stroke Alliance (ASA).

EMvision plans to attend several leading industry event to showcase its technology.   The company finished the quarter with cash reserves of $12.58m with activities over the remainder of FY25 to be supported by $800,000 of payments under a ASA grant program.

At Stockhead we tell it like it is. While Control Bionics, LTR Pharma, Lumos Diagnostics and EMvision Medical Devices are Stockhead advertisers at the time of publishing they did not sponsor this article.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

Originally published as ASX Health Quarterly Wrap: Control Bionics reports strong US revenue, LTR Pharma makes FDA progress