Forum Topics PNV PNV Comparison of Novosorb to Inte

Pinned straw:

Added 8 months ago

On today's call, DW is referring to a comparison study putting Novosorb head-to-head with Integra's animal-derived product. I think this might be it.

It looks like a big deal - particularly given the overall healthcare economics findings, which is going to be important to the payors, particularly the health funds in the US. However, healtcare economics may also influence guidance in nationalised systems like UK, and reimbursement systems like Medicare in Australia.

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Comparative Analysis of Animal-Derived vs Fully Synthetic Acellular Dermal Matrices in Reconstructive Surgery An Examination of Clinical, Aesthetic, and Economic Measures Timothy Olsen, MBA, Safi Ali-Khan, MD, and Derek Bell, MD, Annals of Plastic Surgery, Volume 92, Supplement 2, April 2024

Introduction: The fully synthetic skin substitute, NovoSorb Biodegradable Temporizing Matrix (BTM), may be a cost-effective alternative to the animal-derived Integra Dermal Regeneration Template (IDRT). However, the current literature insufficiently compares the two. Therefore, our study compared clinical, aesthetic, and economic outcomes in treating soft tissue wounds with IDRT, an animal-derived template, vs BTM, a fully synthetic template

Methods: Our single-center retrospective study compared outcomes of 26 patient cases treated with BTM (57.7%) or IDRT (42.3%) during 2011–2022.

Results: The mean surgery time was significantly shorter in BTM cases (1.632 ± 0.571 hours) compared with IDRT cases (5.282 ± 5.102 hours, P = 0.011). Median postoperative hospital stay was notably shorter for BTM placement than IDRT placement (0.95 vs 6.60 days, P = 0.003). The median postoperative follow-up length approached a shorter duration in the BTM group (P = 0.054); however, median follow-up visits were significantly lower in the BTM group compared with the IDRT group (5 vs 14, P = 0.012). The median duration for complete wound closure was shorter for BTM (46.96 vs 118.91 days, P = 0.011). Biodegradable Temporizing Matrix demonstrated a notably lower infection rate (0.0%) compared with IDRT (36.4%, P = 0.022). Integra Dermal Regeneration Template exhibited higher wound hypertrophy rates (81.8%) than BTM (26.7%, P = 0.015). Revisionary surgeries were significantly more frequent in the BTM group ( P < 0.001). Failed closure, defined as requiring one or more attempts, exhibited a significant difference, with a higher risk in the IDRT group (26.7%) compared with BTM (6.7%, P = 0.003). Biodegradable Temporizing Matrix showed a lower mean Vancouver Scar Scale adjusted fraction (0.279) compared with IDRT (0.639, P < 0.001). Biodegradable Temporizing Matrix incurred lower costs compared with IDRT but displayed a lower mean profit per square centimeter ($10.63 vs $22.53, P < 0.001).

Conclusion: Economically, although the net profit per square centimeter of dermal template may favor IDRT, the ancillary benefits associated with BTM in terms of reduced hospital stay, shorter surgery times, fewer follow-up visits, and lower revisionary surgery rates contribute substantially to overall cost-effectiveness. Biodegradable Temporizing Matrix use reflects more efficient resource use and potential cost savings, aligning with broader trends in healthcare emphasizing value-based and patient-centered care

mikebrisy
Added 8 months ago

There is also some great data to help the sales and marketing team:

  • Shorter average surgery time: 1.6 hours vs 5.3 hours
  • Shorter post-operative hospital stay: 0.95 vs 6.60 days
  • Few post-operative follow-up visits: 5 vs. 14
  • Faster time for wound closure: 47 days vs. 119 days
  • Lower infection rate: 0% vs. 36.4%
  • Lower rate of closure failures: 6.7% vs. 26.7%
  • Better scarring scores


Across the board, better for the patient and better for the healtcare system.

What's also important is that this is completely independent research. None of the authors have registered a conflict of interest, and there was no funding of the work by $PNV.

I'm not surprised David wants to announce it on the ASX!

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mikebrisy
Added 8 months ago

Of course, so as not to cherry-pick, the Profit per cm2 is $10.63 for BTM and $22.53 for IDRT.

In the main body of the paper, Profit is defined as "representing the difference between mean charge and mean cost per case, for BTM was $10.63, significantly lower than the corresponding value of $22.53 for IDRT (P < 0.001)."

What this means is that the hospitals in the study make more margin out of IDRT than from BTM. However, the study goes on to note that:

"In our economic analysis of two ADMs,we evaluated the cost-benefit ratio in the context of institutional adoption, primarily influenced by economic pressures: costs and revenue.Our findings reveal that although profit per square centimeter may favor IDRT, the ancillary benefits of BTM—such as reduced hospital stay, shorter surgery times, fewer outpatient visits, and quicker wound closure—substantially enhance overall cost-effectiveness, endorsing institutional adoption. Lower adverse event rates, including infection, revisionary surgery, and nonclosure, align with improved patient outcomes, potentially leading to enhanced reimbursements in value-based settings. Despite the correlation between improved aesthetics and patient satisfaction, heightened satisfaction is unlikely to drive increased template placement volumes and revenue, given the acute nature of burn and other soft tissue injuries. Our study emphasizes the role of cost considerations in the adoption of treatment approaches for dermal template repairs in extensive soft tissue defects, while also highlighting a compelling avenue for future research—a prospective examination of the correlation between patient satisfaction post-template placement and long-term revenue generation per patient.

Our findings endorse BTM, reflecting enhanced resource use and cost-effectiveness—an alignment with contemporary healthcare trends emphasizing value-based and patient-centered care. The study underscores the importance of a comprehensive approach that balances clinical efficacy with economic pragmatism in reconstructive decision-making."

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GazD
Added 8 months ago

This study is very interesting. But a few points to note from a clinical perspective:


  • its retrospective. Were the groups matched in any reasonable kind of a way? As a clinician the initial impulse assumption is that these cohorts were completely different with long surgical time being a surrogate for worse initial pathologies . As a shareholder I’d love to believe it’s down to BTM as theatres are incredibly expensive to run and this kind of difference if down to the product would be a massive (game changer) difference.
  • It’s also a small study which might suggest a fragility of results (again I haven’t looked at the actual paper so grain of salt)
  • this paper has the potential to be hugely impactful but I’d be very keen to compare the patient groups (usually table 1), if comparable very very interesting

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mikebrisy
Added 8 months ago

@GazD - very good points! Yes, there are significant differences in the populations, see below. (particularly BMI, where the two cohorts are almost diametrically opposed in a way in which you might think it could drive other outcomes.)

On selection:

"Patient data and outcome measurements were collected from a database of 519 patient cases treated with a skin graft by our Division of Plastic and Reconstructive Surgery's Burn Center. Twenty-nine (5.6%) underwent wound reconstruction with either BTM or IDRT between January 2011 and September 2022. Three patientswere excluded because of insufficient data: one succumbed to severe comorbidities, and two underwent amputations shortly after receiving a template placement."

I just checked and this paper was reported on HC a few days ago. In the commenary, one of the posters has said they've just submitted their own comparision study for publication. So, hopefully, there will be other indepedent studies to follow this us and build a more robust evidence base.

But definitely a promising paper, and as David says, the first peer-reviewed head to head comparison.

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RhinoInvestor
Added 8 months ago

I just wonder if there wasn't some sort of other major difference in the small study such as the ones they used the animal product on were serverely burnt hence the reason they had 5 hour procedures compared with the ones who used BTM which is why they only had 1.5 hour procedures. Agree with the concerns around the incredibly small sample size, but at least there is no apparent conflict of interest (or funding of the study by PNV). I'd like to see a bigger sample size but its certainly good news that there seem to be multiple people looking into it.

The point about profitability is a bit difficult to understand ... for state funded hospitals where profit isn't their main motivator you would think that the much lower cost of the BTM per cm2 would be a significant advantage for PNV.

DISC: Small holding IRL and Strawman (considering adding to the position)

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GazD
Added 8 months ago

To be honest these baseline differences completely confound the study in my view. But love to see something prospective and matched…

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