PolarityTE, Inc. (Nasdaq: PTE) today announced cost per
product data from the protocol-specified interim analysis in the
Company’s ongoing randomized controlled trial (RCT) evaluating
SkinTE for the treatment of diabetic foot ulcers (DFUs), which
previously reported statistically significant wound closure rates
of 72% for SkinTE plus the standard of care (SOC) vs 32% for the
SOC alone (p=0.005).
Key Findings
- Favorable cost for SkinTE vs. data
reported for skin substitute products: The SkinTE DFU RCT
interim analysis demonstrated mean total product cost per treated
wound of $1,311.20, which is 61% lower than the mean cost of
product per treated wound reported by Samsell, et al.
- Higher wound closure rate vs. data
reported for skin substitute products: The 12-week wound
closure rate in the SkinTE DFU RCT interim analysis was 72%, which
is 60% greater than the mean 12-week healing rate reported by
Samsell, et al.
Mean total product cost per patient was calculated based on the
current pricing for SkinTE multiplied by the number of applications
required per patient. SkinTE mean total product cost per treated
wound was $1,311.20, with 1.08 mean applications per patient.
A study published by Samsell, et al. in the Journal of Wound
Care (September 2019) entitled, “Health economics for treatment of
diabetic foot ulcers: a cost-effectiveness analysis of eight skin
substitutes,” reviewed the cost of eight widely used skin
substitute products.1 Although SkinTE was not included in the study
and the DFU RCT interim analysis reported on a smaller patient
population, the cost of SkinTE appears to compare favorably to
other products reviewed in the study.
In the Samsell, et al. study, the mean healing rate was 45% at
12 weeks (ranging from 28-62%) and 54% at 16 weeks (ranging from
33-68%) with skin substitutes, including products such as human
fibroblast‑derived dermal substitutes, human acellular dermal
matrices, bioengineered living cellular constructs, human placental
membrane allografts, and collagen bilayer matrices. The mean cost
of product per treated wound was $3,368 (ranging from $1,007.17 to
$7,822.27). The mean number of applications required to treat one
DFU was 4.45 and ranged from 1.2 to 10.1.
As noted above, the SkinTE DFU RCT interim analysis data
demonstrated mean total product costs of $1,311.20, which is 61%
lower than the mean cost of product per treated wound reported by
Samsell, et al. Moreover, the mean of the number of applications
reported by Samsell et al. is four times greater than the 1.08
applications per patient in the SkinTE DFU RCT interim analysis.
Finally, the 12-week wound closure rate in the SkinTE DFU RCT
interim analysis was 72%, which is 60% greater than the mean
12-week healing rate reported by Samsell, et al.
Richard Hague, President and Chief Operating Officer at
PolarityTE commented, “It is important to note the DFU RCT interim
analysis data is based on a limited set of 25 patients treated with
SkinTE. However, we are encouraged by the data we’ve seen so far
and look forward to reporting results from the completed study in
due course.” Mr. Hague continued, “We appreciate that the variable
costs of skin substitutes combined with the high number of
applications required to close a wound can create a challenging
environment for patients, providers, and payors alike. We are
heartened by the potential cost savings SkinTE offers all parties
as a result of the low number of applications required to close
DFUs in the interim analysis.”
Nikolai Sopko, MD, PhD, Chief Scientific Officer commented, “The
devastating impact of DFUs on patients is significant and the cost
of DFUs to the US healthcare system is extensive. We view this data
as highlighting the potential for SkinTE to provide cost savings
for the treatment of DFUs.”
As of September 15, 2020, approximately 78 patients have been
enrolled in the Company’s DFU RCT, which has a target enrollment of
102 patients. The Company expects enrollment to complete by the
first quarter of 2021, with top line data available by the second
quarter of 2021.
1 Samsell B, McLean J, Cazzell S, Dorsch K, Moyer PM, Moore M.
Health economics for treatment of diabetic foot ulcers: a
cost-effectiveness analysis of eight skin substitutes. J Wound
Care. 2019;28(Sup9):S14-S26. doi:10.12968/jowc.2019.28.Sup9.S14
About PolarityTE®
PolarityTE is focused on transforming the lives of patients by
discovering, designing and developing a range of regenerative
tissue products and biomaterials for the fields of medicine,
biomedical engineering and material sciences. Rather than
manufacturing with synthetic and foreign materials within
artificially engineered environments, PolarityTE manufactures
products from the patient's own tissue and uses the patient's own
body to support the regenerative process. From a small piece of
healthy autologous tissue, the company creates an easily
deployable, dynamic and self-propagating product designed to
regenerate the target tissues. PolarityTE's innovative methods are
intended to promote and accelerate growth of the patient's tissues
to undergo a form of effective regenerative healing. Learn more at
www.PolarityTE.com – Welcome to the Shift®.
About SkinTE™
SkinTE is a human cellular and tissue-based product derived from
a patient’s own skin (autologous) intended for the repair,
reconstruction, replacement, or supplementation of skin tissue.
Aseptic surgical procedures and handling during skin harvest, wound
preparation, and SkinTE deployment are mandatory.
SkinTE is currently marketed as a human cell, tissue, and
cellular and tissue-based product regulated solely under Section
361 of the Public Health Service Act (PHS Act) and 21 CFR Part 1271
(i.e., as a 361 HCT/P). PolarityTE plans to file an investigational
new drug application (IND) with FDA followed by a biologics license
application (BLA) to have SkinTE regulated as a biologic under the
federal Food Drug & Cosmetic Act and Section 351 of the PHS Act
(i.e., as a 351 HCT/P), and will propose to FDA a plan for
transitioning SkinTE from a 361 HCT/P to a 351 HCT/P.
Important Safety Information
SkinTE is donated human tissue for autologous, single
application use only. SkinTE has not been evaluated for infectious
substances. SkinTE may contain trace amounts of antibiotics (e.g.,
gentamicin), which may potentially cause an adverse effect in
patients who are hypersensitive or allergic to antibiotics. For
patients sensitive to or allergic to gentamicin, alternative
processing is available with prior notice. Patients with multiple
comorbidities, or who have any condition that could compromise
recipient site vascularity and wound healing, should be carefully
evaluated prior to using SkinTE. Such conditions may prevent
successful outcomes or lead to suboptimal results. Failure to
ensure proper aseptic technique may result in contamination of the
harvested skin, donor site, tissue product and/or wound bed, and
could result in potential adverse events including local, regional,
or systemic infection, failure of the graft to take upon
deployment, failure of skin to heal and/or regenerate, deleterious
effects on potential surrounding or adjacent reconstructions
including infection, failure of adjacent grafted material to take
and heal, the need for further surgical operations(s), and/or
debridement or other serious injuries or death. Failure to follow
instructions may lead to suboptimal outcomes, product failure
and/or patient harm. Outcomes may vary. Risks also include those
associated with skin grafting such as graft failure, infection,
and/or effects adjacent tissue or reconstructions.
Forward Looking Statements
Certain statements contained in this release are
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. They are generally
identified by words such as "believes," "may," "expects,"
"anticipates," "intend," "plan," "will," "would," "should" and
similar expressions. Readers should not place undue reliance on
such forward-looking statements, which are based upon the Company's
beliefs and assumptions as of the date of this release. The
Company's actual results could differ materially due to the impact
of the COVID-19 pandemic and FDA regulatory matters, which cannot
be predicted, and the risk factors and other items described in
more detail in the "Risk Factors" section of the Company's annual
report on Form 10-K, quarterly reports on Form 10-Q, and other
filings with the SEC (copies of which may be obtained at
www.sec.gov). Subsequent events and developments may cause these
forward-looking statements to change. The Company specifically
disclaims any obligation or intention to update or revise these
forward-looking statements as a result of changed events or
circumstances that occur after the date of this release, except as
required by applicable law. Our actual results could differ
materially due to risk factors and other items described in more
detail in the "Risk Factors" section of the Company's Annual
Reports and other filings with the SEC (copies of which may be
obtained at www.sec.gov).
POLARITYTE, the POLARITYTE logo, SKINTE, WHERE SELF REGENERATES
SELF and WELCOME TO THE SHIFT are trademarks or registered
trademarks of PolarityTE, Inc.
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version on businesswire.com: https://www.businesswire.com/news/home/20200916005275/en/
Investors: Rich Haerle VP, Investor Relations PolarityTE,
Inc. ir@PolarityTE.com (385) 315-0697
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