ASX Quarterly Health Wrap: Lumos lands US$317m deal as ReNerve and Vitrafy hit key milestones

• Lumos inks US distribution deal valued up to US$317 million in Q1 FY26 for its point-of-care test FebriDx to distinguish between bacterial and non-bacterial respiratory infections
• ReNerve’s launches its EmpliQ human tissue product range in Q1 FY26 with first sale of the EmpliQ dermal product 
• Vitrafy successfully delivers first production unit of its second generation cryopreservation unit VCU2 in Q1 FY26

The latest quarterly reporting season is underway, with investors tuning in to see how ASX-listed companies performed during the first months of FY26, and importantly what signals they’re sending for the year ahead.

Quarterlies offer a crucial opportunity to gauge business momentum and future prospects, particularly for the healthcare sector. After years of underperformance despite solid fundamentals, healthcare has been one of the market’s long-suffering segments.

While the broader market rose 10%, the ASX healthcare sector declined 4% in FY25. However, recent gains suggest the sector’s fortunes may be shifting with a stronger start to FY26 and up in October so far.

Analysts have also noted a pick-up in capital raisings across the sector – a sign of renewed risk appetite and positive sentiment for emerging names.

Here’s a look at some of the ASX healthcare companies with reports out late this week, including ReNerve (ASX:RNV) and Vitrafy Life Sciences (ASX:VFY), both of which listed on the Aussie bourse on November 26, 2024.

Lumos Diagnostics (ASX:LDX)

• Lumos inks six-year exclusive deal valued at up to US$317 million with PHASE Scientific for distribution of FebriDX in US subject to CLIA waiver
• Company lodges CLIA Waiver submission with the US Food and Drug Administration for use of FebriDx in broader range of healthcare settings 
• Product revenue of US$1.2 million for quarter was up 300% on prior year with services revenue US$2.2 million. 

During the quarter Lumos signed a six-year US$317 ($487 million) exclusive distribution agreement for FebriDx in the US with PHASE Scientific, representing one of the largest distribution agreements by an Australian point-of-care (POC) diagnostics company.

FebriDx is a simple, POC test that can quickly distinguish between bacterial and non-bacterial acute respiratory infections to help clinicians make faster, more accurate treatment decisions and supports antibiotic stewardship by reducing unnecessary prescriptions.

Lumos also lodged a FebriDx CLIA waiver submission with the US Food and Drug Administration (FDA) in August. The waiver would enable FebriDx to be used in a broader range of healthcare settings – such as physician offices, urgent-care and outpatient clinics not certified for high-complexity lab testing.

Feedback from the FDA is expected between November 2025 and February 2026.

Lumos said work continues with Nasdaq-listed women’s health company Hologic to develop the next generation of its fetal fibronectin (fFN) diagnostic test for detecting pre-term birth.

Hologic is the only manufacturer of the product globally with Phase 2 of the project,  including additional scope of works in progress.

Lumos reported product revenue of US$1.2 million up 300% on prior year and services revenue US$2.2m.  Revenue of US$3.4m for the quarter was consistent with the previous corresponding quarter (pcp).

A loan facility for up to US$3.3m (A$5m) was secured from two major shareholders to support working capital needs, if required, through to and beyond the anticipated granting of the CLIA waiver.

Operating cash inflow for Q1 was US$1.8m before including US$1 million in funds from the exercise of options. The company ended the quarter with a cash balance of US$4.5m, up by US$2.5 million over 30 June 2025.

ReNerve

• ReNerve’s EmpliQ product range launched in Q1 FY26 with first sale of the EmpliQ dermal product 
• Advances made in first conduit product with successful prototype production of NervAlin nerve guide matrix 
• NervAlign nerv cuff sales increase 38% on pcp to $66,000 as company gains approval in more hospitals

During the quarter ReNerve launched its EmpliQ human tissue product range, and achieved the first sale of the EmpliQ dermal product.

Developed with US-based Berkeley Biologics, the EmpliQ range complements ReNerve’s existing and future NervAlign products for nerve repair and replacement.

ReNerve said the market availability of these products will contribute to ongoing sales growth and form an important part of its broader commercial strategy.

The company is also working to advance its nerve repair portfolio, finalising production hardware and processes for its first conduit products, with initial batches expected in early 2026.

ReNerve also achieved successful prototype production of its NervAlign nerve guide matrix, a next-generation nerve graft replacement designed to simplify surgery and eliminate the need for nerve harvesting, ahead of GMP manufacturing and clinical trials in 2027.

Sales for the quarter of the NervAlign nerve cuff totalled $66,000, an increase of 38% on pcp as the company gains approvals in more hospital systems.

The company reported $44,000 in customer receipts for the quarter, with interest income up $30,000 from term deposit maturities. Staff costs rose to $555,000 following new hires in Australia and a full quarter of US sales costs.

R&D spending increased slightly to $343,000 as development progressed. Net cash outflows included $66,000 for R&D-related equipment, $13,000 in final IPO costs, and $9,000 in rent.

ReNerve made payments totalling $269,000 for directors’ fees, salary and associated payroll costs of non-executive and executive directors and ended the quarter with a $3.27m cash balance.

Vitrafy Life Sciences 

• Vitrafy successfully delivers the first production unit of its second generation cryopreservation unit VCU2 in Q1 FY26
• Board and executive renewal started during quarter to support the next phase of growth and commercialisation
• Build out of Vitrafy’s US operations progresses with key appointments ahead of market launch later this quarter

The cryogenics play successfully delivered the first production unit of its second-generation cryopreservation device VCU2 during Q1 FY26, marking a major milestone in its path to commercialisation. The device incorporates user feedback and has been designed for scalable, mass production.

Factory acceptance testing and scaled manufacturing preparations are now underway, with the VCU2 and new LifeChain software platform are set to be unveiled at the Company’s AGM on November 20 in Melbourne.

During the quarter Vitrafy started a board and executive renewal process targeted at positioning the company with the appropriate mix of skills and capabilities to support its next phase of growth and commercialisation.

Dr Leigh Farrell was appointed as an independent non-executive director and is expected to assume the role of chair, subject to shareholder approval at the AGM.  Current chair Sonia Petering is retiring along with non-executive director Associate Professor John McBain.

The CEO transition from Kate Munnings to co-founder Brent Owens was completed in September.

Vitrafy said the build out of its US operations was progressing with the appointment during the quarter of Diana King as senior vice president of commercial operations and Chris Conese as director of sales.  The company plans further hires to build its US operations ahead of the planned market launch in the country later this quarter.

In aquaculture, following the cryopreservation cycle completed in May where Vitrafy cryopreserved 745 salmon milt packs for Huon Aquaculture and another Tasmanian producer, Vitrafy said it completed the spring fertilisation run in September.

The company reported around two million eggs were fertilised using its crypopreservation technology — an increase from 500,000 last calendar year, reflecting improved fertilisation yield achievable through its tech and growing contribution of assisted reproduction on annual breeding volumes.

In partnership with the U.S. Army Institute of Surgical Research (USAISR), Vitrafy began the second phase of its platelet cryopreservation study. The phase will examine the post–thaw viability of cryopreserved platelets using the Vitrafy cryopreservation technology across three formulations.

Quarterly cash expenditure decreased to $4.2m,  with a net cash burn of ~$3.7 million after receipts and interest. The company said it remained well funded to execute its commercial strategy.

At Stockhead, we tell it like it is. While Lumos Diagnostics and ReNerve are Stockhead advertisers, they did not sponsor this article.