CSIMarket
Corner Growth Acquisition Corp   (COOL)
Other Ticker:  
 
    Sector  Technology    Industry Software & Programming
   Industry Software & Programming
   Sector  Technology

Corner Growth Acquisition Corp

Business Description



PolarityTE™ is a commercial-stage biotechnology and regenerative biomaterials company 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. We believe that our PolarityTE platform technology is a new approach to pragmatic and functional tissue regeneration that has the potential to address many of the challenges currently facing the regenerative medicine and cell therapy markets. Recognizing the natural complexity of human tissue, our core “TE” platform begins with a small piece of the patient’s own, or autologous, healthy tissue, rather than artificially manipulated individual cells. From this small piece of healthy autologous tissue, we create an easily deployable, dynamic and self-propagating product designed to enhance and stimulate the patient’s own cells to regenerate the target tissues. Rather than manufacturing with synthetic and foreign materials within artificially engineered environments, we manufacture with the patient’s own tissue and use the patient’s own body to support the regenerative process to create the same tissue from which it was derived. We believe that our innovative method promotes and accelerates growth of the patient’s tissues to undergo a form of effective regenerative healing.

We believe our core “TE” platform has applications across many indications, including the regrowth of skin, bone, cartilage, fat, muscle, blood vessels and neural elements, as well as solid and hollow organ composite tissue systems. Our first product, SkinTE™, is registered with the United States Food and Drug Administration, or the FDA, pursuant to the regulatory pathway for human cells, tissues, and cellular and tissue-based products (HCT/Ps) regulated solely under Section 361 of the Public Health Service Act, or 361 HCT/Ps, which permits qualifying products to be marketed without first obtaining FDA marketing authorization or approval. SkinTE is commercially available for the repair, reconstruction, replacement and regeneration of skin (i.e., homologous uses) for patients who have suffered from wounds, burns or injuries that require skin coverage over both small and large areas of their body.


We believe that living systems require more than a simple singular input, like a growth factor, stem cell or nano-particle, to produce a complex output. We have designed, engineered and developed our technology platform to allow us to induce, maintain and promote the complete development of cellular entities, their products and tissue elements in a way that mirrors regenerative healing in the body. We aim to maintain and promote key dynamic processes that drive integrative regeneration of our tissue products once deployed back to the patient to improve upon common issues seen with other tissue products, such as immune system rejection, inflammation, and other adverse reactions.

SkinTE, our first of the core “TE” tissue products, was registered with the FDA on August 14, 2017, and is now commercially available for the repair, reconstruction, replacement or regeneration of skin in patients who have or require treatment of acute and chronic wounds, burns, surgical reconstruction events, scar revision, or removal of dysfunctional skin grafts. We have initiated a staged-commercial release of SkinTE to select medical institutions, and expect to scale up manufacturing efforts during 2018 following the buildout of our 200,000 ft2 biomedical manufacturing facility.

In preclinical testing, we observed that SkinTE regenerated full-thickness skin complete with all of its layers (epidermis, dermis, hypodermis) and functional appendages, including hair follicles, sweat glands and sebaceous glands. Thus far, in the early stages of the human clinical application of SkinTE, we have observed results that are correlative with our preclinical observations. We intend to target sales of SkinTE toward the wound care market, which according to MedMarket Diligence LLC is expected to exceed 250 million wounds worldwide by 2020.

Because we do not expect our product candidates to require time-intensive, costly, multi-phase clinical trials or prior marketing approval or authorization like other therapeutics, biologics and devices, we plan to develop and commercialize several products simultaneously. As we believe our innovative platform technology has wide applicability—not only to regenerate multiple human tissues, organs, and composite structures, but also across other complex interacting biological systems (such as the immune system)—we believe that over time we can become a leader in the global regenerative medicine market, which according to Stratistics MRC is expected to exceed $100 billion by 2022.

We are a company built and run by physicians for patients and the physicians who care for them. We believe that developing tangible regenerative products requires an intimate knowledge of the realities that exist within the trenches of medicine. Our management team’s expertise is the result of years of medical training and clinical practice, extensive direct experience in the field at major reconstructive surgery and burn centers, and, collectively, hundreds of articles published in peer-reviewed journals and other publications. Our founders, Chief Executive Officer, Dr. Denver Lough, and Chief Operating Officer, Dr. Edward Swanson, left the Department of Plastic and Reconstructive Surgery at the Johns Hopkins University School of Medicine to launch the Company and pursue their passion to impact the lives of patients on a much larger scale, and to address many of the clinical problems they encountered on a daily basis. Dr. Michael W. Neumeister, our Chief Medical Officer, is Professor and Chairman of the Department of Surgery at Southern Illinois University School of Medicine, and Dr. Stephen Milner, our Chief Clinical Officer, is former Professor of Plastic and Reconstructive Surgery and Pediatrics at the Johns Hopkins University School of Medicine and former Director of the Johns Hopkins Burn Center. Dr. Maurice Nahabedian, our Chief Surgical Officer, is Chairman of this year’s meeting of the American Society of Plastic Surgeons, is former Professor and Section Chief of Plastic Surgery at MedStar Washington Hospital Center, and former Vice Chairman of the Department of Plastic Surgery at the Georgetown University.

We believe that our expertise is further bolstered by the vast knowledge and experience of our Clinical Board of Advisors, composed of leaders across a variety of medical and surgical specialties, including professors, chairmen of departments, and national surgical society presidents at a number of medical institutions, such as former President of the American Burn Association and Chairman of the American Board of Plastic Surgery, Dr. Martin C. Robson.

 

In addition to our Clinical Board of Advisors, we have assembled a Military and Mass Casualty Board led by Major General (U.S. Army – Retired) Jay Hood, who served as the Commander of First Army Division East, the Chief of Staff, United States Central Command and the Commander of Joint Task Force Guantanamo, among other high-level leadership positions during his 36 years of distinguished service. We intend to leverage the expertise of our Military and Mass Casualty Board to identify ways to use our technology platform to develop regenerative products with the potential to address the complex and devastating injuries of military service members, wounded warriors, veterans, and mass casualty victims.

Limitations of Current Wound Care and Regenerative Medicine Technologies and Products

To date, many wound care, regenerative medicine and tissue engineered products have focused on “large scale manufacturable materials” and “off the shelf” designs for products as opposed to employing a more patient-specific approach. Many products utilize animal-derived tissues, referred to as xenografts, or cadaveric-derived tissues, referred to as allografts, in part to allow for a robust supply chain of sourced raw materials. However, we believe these skin substitutes do not result in actual tissue regeneration.

We believe that, prior to PolarityTE, the evolving field of regenerative medicine has been characterized by tremendous potential, but has also been wedded to approaches that are fraught with significant challenges. We believe the approach to regenerative medicine that our predecessors and competitors employ has anchored itself within tissue engineering algorithms that—while potentially profitable because of mass production and scalability—are incongruent with living cells, dynamic tissues and reactive systems. Some current regenerative medicine approaches aim to isolate a single cellular population to regenerate a tissue, such as adipose-derived stem cells. Other approaches aim to deliver a molecule to manipulate cell function, such as driving cell growth and expansion, or coaxing one cell type to become another. The final prominent current approach aims to create some form of a scaffold that recapitulates the appearance of the target tissue with specific properties designed to mimic that tissue, such as polymers with similar mechanical properties of bone, and allow or encourage a targeted cellular function and tissue integration, such as 3-D printing of scaffolds and nano-particles.

We believe these approaches incorrectly focus on the synthesis and/or engineering of singularities (i.e. a type of cell, a type of molecule, and/or type of matrix) in an attempt to build a complex tissue from the ground up, which we believe creates an incomplete system without interactions, diverse cells and molecules, or a natural environment to direct organization.

Our Solution — The PolarityTE Core “TE” Platform Technology

We believe each person’s cells and tissues have vastly different and dynamic profiles (genomic, transcriptomic, proteomic, metabolomic etc.), and therefore different requirements when it comes to the regenerative potential and/or healing capacity of tissue-based systems. With this in mind, we designed our core “TE” platform technology to focus not on singularities but on regenerating complete tissue systems.

Our core “TE” platform and self-complexing intelligent regenerative materials technologies are based on our ability to create minimally polarized functional units, or MPFUs, which contain polarizing multi-cellular aggregates capable of expanding, proliferating and synthesizing those cells, materials, factors and/or systems we believe are necessary for integrative full-thickness three-dimensional tissue regeneration, not simply two-dimensional cell sheets. Instead of starting with artificial materials, synthetic factors and/or altered cell suspensions, our platform begins with the patient’s own (autologous) tissue and those components, appendages and substrates we believe are necessary for the development of an expandable and self-propagating complete system.

With SkinTE, often within 24-48 hours of the initial skin harvest, our product is applied to the patient, whose body then provides a receptive environment and nutrients for controlled healing. By both preserving the tissue’s natural microenvironment and using the patient’s body as an intrinsic bioreactor—which means using the body’s own natural biological healing process rather than a manufactured or engineered environment to support the regenerative process—we believe a patient’s own tissue can be regenerated, along with its natural coloring and texture, layers and structure, hair and appendages. We have designed our technology platform to use the patient’s own healthy tissue, in part to increase the likelihood that the patient’s immune system will identify the regenerating tissue as its own so that our product is neither rejected nor reacted to adversely. We believe that our platform has the potential to transform tissue regeneration, including potential regeneration of multiple tissue substrates, such as skin, bone, muscle, fat, cartilage, nerves, and blood vessels.

Our product pipeline focuses on the development of regenerative products for a variety of tissue types and organ systems which are commonly altered, injured or destroyed by a variety of diseases, pathologies, traumatic events and medical interventions. We believe that our biomaterials platform capabilities extend to applications across many indications, including bone, cartilage, muscle, blood vessels and neural elements as well as solid and hollow organ composite tissue systems. The key attributes of our platform technology include the following:

Patient-Generated Cell Source: The human body often identifies and rejects foreign cells, creating the potential for tissue rejection, additional surgery, and foreign or allogeneic body reactions like residual scarring. We address this by using healthy autologous tissue taken from the patient to regenerate cells that the body identifies as “self” rather than foreign. Our goal is to allow a recipient to receive our product and generate new tissue without triggering an allogeneic, or foreign tissue, rejection, wherein the patient’s immune system destroys the transplanted tissue.

Stem Cell Niche Utilization for Functional Tissue with Full Thickness and Layer Regeneration: We utilize techniques for capturing the “stem cell niche,” the microenvironment within a particular tissue that interacts with stem cells to signal cell growth, development, renewal and differentiation. While the stem cell niche historically has often been left behind by the commonly used split-thickness autograft methodology, we believe that it is necessary for the regeneration of functional tissue. Without the stem cell niche, we believe new tissue will form a scar and lose the functionality of the original tissue from which it was regenerated. By including the stem cell niche within the autologous tissue that is harvested, we believe the natural function of the small piece of tissue is preserved as it regenerates into a larger piece that can fill the patient’s wound. This is designed to minimize painful scarring, or lesions, that often accompanies autologous regeneration without the stem cell niche, to allow for the regeneration of the tissue’s normal layers and appendages, and to provide full-tissue coverage without relying on secondary surgery or in-growth of the surrounding tissue. We believe inclusion of the stem cell niche allows us to regenerate tissue with its naturally complex layers intact.

Polarity Maintenance and Enhancement to Harness Stem Cell Niche Regeneration: A cell’s polarity refers to its interactive communication with neighboring cells, including the direction in which a cell should grow. This enables cells and tissues to carry out specialized functions. Our platform carefully maintains and enhances the polarity of the stem cell niche in order to harness its regenerative capacity by mirroring the way tissue develops in the human body. By maintaining and enhancing the polarity of regenerating tissue, our platform is designed to preserve the natural cell and three-dimensional tissue structure, and thereby the functionality of regenerated tissues and appendages.

Patient as Bioreactor: Instead of using a manufactured or engineered environment to support the regenerative process, our platform uses the human body as a bioreactor by applying our product to the patient and allowing regeneration to occur there. We believe this allows the patient’s own body to provide the ideal nutrients and extracellular environment for controlled healing of the regenerative tissue. This approach also reduces turnaround time back to the patient, as our manufacturing process does not involve growing cells in an industrial, synthetic bioreactor.




View Company Supplier View Company Competition View Company Customers
       
Economy


Advance Monthly Sales

Consumer Price Index CPI

Producer Price Index PPI

Retail Inventories

Personal Income

Gross Domestic Product GDP

Money Supply

Industrial Production

Productivity

Employment Situation

US International Trade

Factory Orders

Durable Goods

Construction Spending

Housing Starts

Vehicle Unit Sales

Stocks


Event Calendar

ASCK's Profile

Stock Price

ASCK's Financials

Business Description

Fundamentals

Charts & Quotes

ASCK's News

Suppliers

ASCK's Competitors

Customers & Markets

Economic Indicators

ASCK's Growth

Company Segments

Screening


Stock Performance

Growth Rates

Profitability

Valuation

Dividend

Financial Strength

Efficiency

Largest Companies

Management Effectivness

Industries


At a Glance

Performance

Growth Rates

Profitability

Valuation

Financial Strength

Markets


At a Glance

Stocks

Cryptocurrencies

Sectors & Industries

Commodities

Currencies

Help


Sitemap

Advertise

About us

Glossary


Financial Terms

Technical Analysis

Fundamental Analysis

Energy Terms

Manufacturing Terms

Transportation Terms

Health Care

Insurance Terms

Economy Terms

Hotel & Leisure Terms

CSIMarket Company, Sector, Industry, Market Analysis, Stock Quotes, Earnings, Economy, News and Research.    Copyright © 2021 CSIMarket, Inc. All rights reserved. This site uses cookies to make your browsing experince better. By using this site, you agree to the Terms of Service and Privacy Policy - UPDATED (Read about our Privacy Policy)

Intraday data delayed per exchange requirements. All quotes are in local exchange time. Intraday data delayed 15 minutes for Nasdaq, and other exchanges. Fundamental and financial data for Stocks, Sector, Industry, and Economic Indicators provided by CSIMarket.com
CSIMarket.com 1500 N. University Drive, Coral Springs, FL 33071