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The OsteoTE Skull Switcheroo

|Includes: PolarityTE, Inc. (PTE)
Summary

PolarityTE purports to have a product called OsteoTE which regenerates bone, and is "expected to launch in late 2018".

In their 10-K and other investor materials, the company shows before/after treatment pictures of a rabbit skull which had holes drilled in it.

Upon close inspection, their "before" image is from a different rabbit than the "after" images!

Page 17 of PolarityTE's (NASDAQ:COOL) 2017 10-K describes OsteoTE as their "autologous, homologous bone regeneration product". It then shows some images of remarkable bone regeneration experiments in rabbit skulls:

We noticed the third skull looked different from the others, so we pulled up higher-resolution versions from their latest investor presentation:

We then extracted the images from the PDF, and looked at them more closely (we omit image e. because it's the same as d. with some graphics over top):

Skull (c.) is clearly from a different rabbit than the other images. We circle some of the clear differences in bone structure below:

These images also make their way into the Jefferies 2018 Global Healthcare Conference.

July 30th Edit: These images are from two-dimensional x-rays compiled into three dimensional images, which are then turned into the two-dimensional pictures above. We shouldn't expect them to be identical. However the similarity between scan a. and scan d. are striking; almost every detail carries over. Scan c. however shares almost no details with the others, and also differs in proportion and shape.
September 7th Edit: We have consulted with a number of medical and research professionals, including a doctorate of comparative biology with extensive CT scanning experience, and they all agreed these images are from two different animals.

The company does not disclose their "before" image is from a different animal, misleading investors. It's very possible the "after" images are taken from skulls which only ever had one hole drilled into them.

This is the full relevant passage from the company's 10-K. We made some formatting changes to make the second paragraph easier to read:

OsteoTE

We are using our platform technology to develop OsteoTE, our autologous, homologous bone regeneration product. We are designing OsteoTE to utilize the patient’s own bone to target applications for bone repair, reconstruction, replacement, supplementation, and regeneration, including in the long bone (hard, dense bones that provide structure, strength and mobility such as the femur or humerus), craniomaxillofacial, spine, dental, hand, and foot/ankle markets. As with skin, we believe existing treatments for the repair of bone with autologous grafts suffer from significant limitations that we can address with OsteoTE. Below are preliminary images of OsteoTE bone regeneration in a preclinical model of a cranial defect.

Comparative Imaging of OsteoTE in Critical Sized Cranial Defect Model System.

(a.) Three-dimensional (3-D) micro computed tomography (micro-CT) native cranial bone displaying pre-defect left parietal and right parietal bones of in vivo model system at timepoint TPDN.

(b.) Gross image of surgically-created, complete, bi-parietal critical sized defects of both the left and right parietal bones within the in vivo model system at timepoint T0.

(c.) 3-D micro-CT of surgically-created, complete (full-thickness), bi-parietal critical sized defects of both the left and right parietal bones within the in vivo model system.

① Indicates the right parietal bone region with 8 mm diameter defect at timepoint T0 which was un-treated and maintained as the defect control throughout study.

② Indicates the left parietal bone region with 8 mm defect which was treated with OsteoTE and maintained as the defect-treated control throughout the study.

(d.) 3-D micro-CT of surgically-created, complete, bi-parietal critical sized defects of both the left and right parietal bones within the in vivo model system at 4 weeks post-procedure and intervention (timepoint TPPI-4WK).

❶ Indicates the un-treated right parietal bone region (defect control) at 4 weeks.

❷ Indicates the treated left parietal bone region (OsteoTE) at 4 weeks.

(e.) Depicts the relative margins of the primary bi-parietal defects (dotted circles) at time point T0; ROI (broken line box) indicates zoomed comparison of 4 weeks post-treatment defects of 3-D micro-CT and correlative 3-D thermal spectrum colored surface plot indicating relative surface depth and volumetric contour.

Abbreviations:

Pre-defect Native Timepoint (TPDN): timepoint at which native skull was imaged prior to creation of defect;

Defect Native Timepoint (T0): timepoint at which complete (full-thickness) 8 mm critically sized defects were created in parietal skull regions;

Post-procedure and intervention at 4 weeks timepoint (TPPI-4WK): timepoint at which 4 weeks have passed since the defects were created +/- treated with intervention.

For more coverage on PolarityTE, please follow us and see our previous report.

Disclosure: I am/we are short COOL.