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Corner Growth Acquisition Corp   (COOL)
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    Sector  Technology    Industry Software & Programming
   Industry Software & Programming
   Sector  Technology
 



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SkinTE

Our first product, SkinTE, is registered with the FDA and is now commercially available for treatment of defects of the skin. SkinTE is created from a small piece of the patient’s own tissue, which is extracted, and then manufactured using our proprietary technology platform to expand and regenerate full-thickness, fully functional skin with what we believe to be the critical layers, including epidermis, dermis and hypodermis, and appendages including hair follicles and glands. Each package of SkinTE is patient-specific and designed for a single application. We believe SkinTE offers a compelling alternative to current standards of care for skin regeneration.

PolarityTE designed SkinTE for use by physicians and other healthcare professionals in the treatment of patients who have suffered from an event, disease, or process, or who have an acquired defect that has resulted in the functional loss or absence of the skin. Specifically, SkinTE is designed for the treatment of chronic wounds such as diabetic foot ulcers, acute wounds such as traumatic injuries, chronic burn wounds or scars, acute burn wounds, scars of the integument, and defects from medical or surgical resection or reconstruction events which require skin coverage.

SkinTE was registered as a 361 HCT/P with the FDA pursuant to Section 361 of the Public Health Service Act and 21 CFR 1271. An HCT/P is defined as articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient. Products that qualify as 361 HCT/Ps are not subject to the FDA’s pre-market clearance or approval requirements, but rather can be immediately listed for commercial use with the FDA and are then subject to post-market regulatory requirements such as compliance with current good tissue practices (cGTP), adverse event and deviation reporting, and post-market inspections by the FDA. For more information on the 361 HCT/P regulatory pathway, please see “Government Regulation” and “Risk Factors – Risks Related to Registration and/or Regulatory Approval of Our Product Candidates and Other Government Regulations.”

Limitations of Current Wound Treatments

Current clinical standards and practice adhere to the concept that tissue should be replaced with like, or homologous, tissue. For example, skin should be replaced with skin whenever possible in settings where patients have suffered the loss of such tissue. Understanding this, medical professionals are left with a decision to attempt to temporize a wound bed with cadaveric skin (allograft), utilize the patient’s own skin (autograft), or apply a variety of skin substitutes in order to provide a skin-like barrier while the margin of the wound heals through secondary intention and contraction. Presently, harvest and placement of autologous full-thickness skin results in the best outcome within wound beds because it most closely resembles the full-thickness skin that was lost. Full-thickness harvest of skin, however, also inherently results in a full-thickness skin defect at the donor site, which requires primary closure (skin edge approximation and suturing) so as not to leave a gaping wound behind. There is a limit on how much autologous full-thickness donor skin can be harvested without leaving behind a non-closable wound. As a result, medical professionals can only harvest small, elliptically-shaped pieces of such skin from areas of redundancy, which are referred to as full-thickness skin grafts, or FTSGs.

Due to these limitations, medical professionals often rely on split-thickness skin grafts, or STSGs, which harvest only the top layer of the patient’s own skin as a means to get more skin for better coverage of voids. Following harvest of the top layer of skin for an STSG—which leaves behind the many necessary structures, cellular elements and tissue interfaces from the STSG donor site—patients are often left with an incomplete top layer of skin covering the initial defect (recipient site) and a remaining bottom layer at the donor site. In this setting, both donor and recipient sites contain incomplete skin, which can result in dysfunctional, painful scar tissues that can result in lifelong morbidities.

Because of the limitations of STSGs and FTSGs, medical professionals and companies have continued to investigate skin substitutes and skin alternatives for use in place of a patient’s own skin, such as a cultured form of manipulated autograft, allograft (cadaveric tissues), xenograft (animal tissues) and alloplast or synthetic materials. To our knowledge, no skin substitute has been able to replicate the appearance of native skin, or regenerate full-thickness skin or the cutaneous appendages (hair follicles, sweat glands, sebaceous glands, etc.), which are necessary for the development of full-thickness, functionally polarized, hierarchically organized skin. In its Local Coverage Determination for the Application of Skin Substitutes (L36466), the Centers for Medicare and Medicaid Services, or CMS, acknowledges that “sufficient data is available to establish distinct inferiority [of current skin substitutes] to human skin autografts and preclude their designation as skin equivalence.” The CMS determination also finds that “without the component of the recipient’s own distinct epithelium and cellular skin elements, permanent skin replacement or coverage by the graft cannot be accomplished.”

Our Wound, Burn and Skin Reconstruction Treatment Solution – SkinTE

PolarityTE designed SkinTE to address the limitations from which current wound and burn treatment methods suffer. We designed SkinTE to combine the advantages of autologous STSGs with those of FTSGs. Notably, SkinTE is designed to provide not only the large surface area treatment capability of STSGs, but also the restoration and smaller, less morbid donor site associated with FTSGs. In essence, we believe our minimally manipulated SkinTE product can provide an expandable form of a FTSG.

SkinTE is composed of small viable cellular and tissue-based units, which we call MPFUs, that retain all of the components of skin that we believe are required to regenerate full-thickness skin. The initial processes underlying the function of SkinTE are analogous to those responsible for the healing of an autologous skin graft, namely imbibition, inosculation, and neo-vascularization. During imbibition, SkinTE, and the small cellular and tissue based units that comprise it, survive through the direct application of the SkinTE “paste” on the wound bed, exchanging nutrients and waste within the fluid of the wound bed. Inosculation is the stage in which the capillaries and blood vessels already present within the wound bed begin to align and connect with those present within the graft. Neovascularization marks the ingrowth of new blood vessels into the wound bed and out of the graft, with vasculogenesis describing the formation of new vessels from cellular precursors present within the wound and graft, and angiogenesis referring to the sprouting of new vessels from pre-existing ones. Due to their size and composition, we design the small cellular and tissue based units within SkinTE to have reduced metabolic demand and to be capable of surviving through diffusion, and to readily excrete metabolic waste, resulting in what we believe can be less ischemic damage when compared to FTSGs. Reduction in ischemic damage has the potential to decrease scar formation and provide a more functional result. Following completion of the initial stages of integrating and healing within the wound bed, the SkinTE product is designed to begin forming and organizing discrete areas of full-thickness skin. We have observed in preclinical animal testing that these regenerative centers of full-thickness skin then expand out radially across the wound, eventually coalescing with each other and the margins of the wound.

As compared to the currently marketed skin substitutes of which we are aware, each SkinTE tissue-product is derived entirely from the patient’s own skin and is not combined with any other tissue-engineered substitutes. We believe these differences allow SkinTE to regenerate all of the important layers of the skin as well as the necessary cutaneous appendages for the development of functionally-polarized, hierarchically organized autologous, homologous skin.

SkinTE is designed as an all-in-one system to make the process as simple and efficient as possible for the user—whether that individual is a surgeon, medical doctor, physician assistant or nurse in an operating room, wound clinic, emergency department, doctor’s office or forward operating military facility. When a new clinical center or practice is activated to begin using our SkinTE product, we ship a supply of all-inclusive harvest boxes (see the image furthest to the left above) to the facility for convenient on-site, off-the-shelf storage for that user and facility. Each harvest box contains all the materials and instruments needed to perform the relatively standard skin excision procedure to obtain the tissue sample, and all of the pre-paid/pre-completed shipping labels, and a one-touch NanoCool® shipping box that maintains the temperature within the harvest box as it is delivered to a PolarityTE biomedical manufacturing facility.

At our manufacturing facility, we use proprietary techniques to create a paste-like product from the small piece of healthy patient tissue that preserves the original tissue’s microenvironment and allows new cells to integrate into existing, healthy cells, with similarly organized assembly and interface development. Following manufacturing at our facility, the SkinTE product is shipped back to the provider at a time that best suits the patient and provider’s scheduling and location needs (i.e. operating room, procedure clinic, in-patient bedside, out-patient doctor’s office). Our goal is to be able to return the ready-to-use SkinTE product to physicians as early as the same day. In our limited time selling SkinTE, we have observed that the majority of return requests have been for return within 24-72 hours from tissue harvest. At application time, once the patient wound bed is prepared per clinical guidelines, SkinTE is dispensed onto the surface of the wound bed (see the image in the middle above). The wound is dressed using a non-adherent, occlusive, non-absorbent dressing placed directly over the SkinTE product (see the image furthest to the right above), with recommended dressings that we include in the deployment box.

   

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