Columbus, OH, United States
Columbus, OH, United States

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Patent
Nanofiber Solutions | Date: 2014-03-17

A biocompatible textile and methods for its use and fabrication are disclosed. The textile may be fabricated from electrospun fibers forming windings on a mandrel, in which the windings form openings having a mesh size between adjacent windings. The textile may also be fabricated by the addition of solvent-soluble particles incorporated into the textile while the windings are formed. Such particles may be removed by exposing the textile to a solvent, thereby dissolving them. Disclosed are also replacements for animal organs composed of material including at least one layer of an electrospun fiber textile having a mesh size. Such replacements for animal organs may include biocompatible textiles treated with a surface treatment process.


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 230.00K | Year: 2016

DESCRIPTION provided by applicant The long term objective of this application is to bring a trachea patch to the market to treat tracheal stenosis or narrowing of the airway which left untreated is a life threatening condition that affects both young children and adults Currently otolaryngologists have only two major options for treating tracheal stenosis One is a complex surgical procedure known as slide tracheoplasty that few surgeons in the country are truly qualified to perform The other is to open the trachea wider and hold it open with a graft of rib cartilage Both are difficult time consuming procedures with potential complications We have a U S patent application submitted on a trachea patch biomaterial that overcomes the four major technical hurdles required to replace rib cartilage grafting mechanical integrity suturable resorbable and air tight There is currently nothing on the market even remotely resembling the idea of a synthetic patch for tracheal stenosis While the academic tissue engineering community has focused primarily on regenerating an entire trachea with highly complex strategies arguably leading to technology in search of an application we have focused instead on identifying a specific patient indication with an unmet need and designed a technology to fill that void Co investigators Weatherly and Detamore have worked together for nearly a decade and after preliminary studies in rabbits and partnering with Nanofiber Solutions in together as a team we are at an inflection point where a large animal study is necessary to translate the technology to the clinic Therefore the current Phase I SBIR project is highly focused with a single Specific Aim To demonstrate proof of concept safety with engineered trachea patches to repair induced defects in sheep tracheas We will test the hypothesis that covering induced trachea defects with our engineered trachea patches will allow sheep to survive with minimal tracheal stenosis Completion of the Phase I project will strategically position us to incorporate FDA guidance and embark on a full scale efficacy study in sheep in a Phase II SBIR that will allow us to proceed to the clinic Compared to rib cartilage grafting our trachea patch holds the following advantages No surgery to remove rib tissue saving operating room time and cost and eliminating potential complication infection and morbidity at the rib site attractive to patients and insurance companies Easy to use as it i andquot plug and playandquot for surgeons who perform rib cartilage grafting attractive to surgeons No biologics or drugs are required attractive to investors for FDA approval For several reasons we focus initial clinical translation on the pediatric population with laryngotracheal stenosis In the simplest terms our goal is to fix tracheas for kids around the world with narrowed airways to help them survive and breathe normally again PUBLIC HEALTH RELEVANCE The proposed technology will help surgeons to treat patients who have difficulty breathing due to narrowed airways a potentially life threatening condition Currently surgeons perform either a very complicated surgery or they open front of the trachea with an incision and use rib cartilage to hold the trachea open The technology is an off the shelf trachea patch that will replace the need to harvest rib cartilage allowing the patient to breathe normally without the need to harvest cartilage from the rib


Patent
Nanofiber Solutions | Date: 2016-05-04

A composition may comprise a plurality of polymeric electrospun fiber fragments, and a carrier medium comprising an effective amount of chitosan. Such a composition may further include a plurality of polymeric electrospun fiber fragment clusters. A kit may comprise a first component of a plurality of polymeric electrospun fiber fragments, and a second component of a carrier medium comprising an effective amount of chitosan. A method of treatment may comprise injecting into a portion of a body a composition which may comprise a plurality of polymeric electrospun fiber fragments, and a carrier medium comprising an effective amount of chitosan. The treatment may be directed to one or more of joint inflammation, osteoarthritis, a tissue injury, a muscle tear, a ligament tear, a tendon tear, a void, incontinence, an aneurysm, and a tumor.


Patent
Nanofiber Solutions | Date: 2015-11-13

The development and construction of implantable artificial organs, and a process for manufacturing three-dimensional polymer microscale and nanoscale structures for use as scaffolds in the growth of biological structures such as hollow organs, luminal structures, or other structures within the body are disclosed.


Patent
Research Institute At Nationwide Childrens Hospital Inc. and Nanofiber Solutions | Date: 2014-03-14

The invention provides for engineered intestinal construct and methods of making these constructs. The invention also provides for methods of treating short bowel syndrome or methods of repairing an intestine after resection comprising inserting an engineered intestinal construct into the intestine of a subject in need.


Patent
Nanofiber Solutions | Date: 2016-04-29

A scaffold may comprise a first polymeric electrospun fiber comprising a first material having a first degradation rate, and a second polymeric electrospun fiber comprising a second material having a second degradation rate different from the first degradation rate. The first degradation rate may substantially correspond to a cell infiltration rate, and the second degradation rate may be slower than the first degradation rate. Such a scaffold may be manufactured by electrospinning a first polymer fiber having a first degradation rate by ejecting a first polymer solution from a first polymer injection system onto a mandrel, and electrospinning a second polymer fiber having a second degradation rate different from the first degradation rate by ejecting a second polymer solution from a second polymer injection system onto a mandrel. Wound healing may be improved by applying such a scaffold to a portion of a wound.


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 250.00K | Year: 2015

DESCRIPTION provided by applicant Short bowel syndrome SBS a major clinical problem affecting patients of all ages results from the functional or anatomic loss of extensive segments of small intestine SBS has an overall year survival of and in newborn infants with less than of expected intestinal length year survival is only Current treatment options are inadequate and associated with severe complications and death Patients with SBS require total parenteral nutrition TPN to survive Currently over SBS patients per year are on home TPN in the US alone Annual costs of home TPN exceed $ per year per patient $ billion year In addition the use of TPN is associated with numerous central venous catheter associated infectious and thrombotic complications resulting in additional high costs Thus SBS represents an extremely costly and deadly burden to society At present the treatment for SBS is mainly supportive Although small bowel transplantation is an option the results are suboptimal with year and year survival rates of and respectively and the required life long immunosuppression causes substantial secondary complications Novel approaches for the treatment of patients with SBS are critically needed Our approach to this unsolved medical problem is the production of tissue engineered intestine TEI using the patientandapos s own intestinal cells combined with a synthetic nanofiber based scaffold resulting in a novel solution to this unmet clinical need In this project we will accomplish three specific aims necessary to move towards commercialization Aim Determine the optimal cell isolation and cell seeding methodology for structural formation of TEI Aim Optimize enteric nervous system ENS development in TEI Aim Develop an in vivo culture standard operating procedure SOP for development of TEI This Phase I SBIR project will allow us to collect the pivotal data needed to scale up to a large animal model in Phase II and to license the technology to a commercial partner in Phase III for commercialization PUBLIC HEALTH RELEVANCE In this work we will develop robust and healthy tissue engineered intestine using nanofiber scaffolds combined with intestinal stem cells for patients suffering from short bowel syndrome SBS Our initial clinical indication is necrotizing enterocolitis NEC which affects premature babies and has a mortality rate of nearly


Grant
Agency: NSF | Branch: Standard Grant | Program: | Phase: | Award Amount: 180.00K | Year: 2013

This Small Business Innovation Research (SBIR) Phase I project proposes to develop an artificial trachea made from synthetic nanofibers that is seeded with the patient?s own stem cells in the operating room using a disposable, closed system seeding chamber. There currently are no commercially available solutions to large tracheal lesions that may occur from large tumors or traumatic injuries. The research objectives of this project are to develop a reproducible stem cell seeding protocol, determine the efficacy of seeded tracheal grafts versus non-seeded tracheal grafts and characterize the mechanical properties of the neotrachea after implantation for specified time points. It is anticipated that the stem cell seeded tracheal graft will become fully accepted by the patient?s body and facilitate the body to regenerate a new trachea on the implanted nanofiber scaffold.


The broader impact/commercial potential of this project is that the results of this project will not only save the lives of patients with tracheal lesions that currently have no other viable options, but it will advance the field of regenerative medicine and have significant benefits on the commercial development of other tissue engineered organs. By creating scaffolds with synthetic polymers, we are able to create the framework of nearly any type of organ in the body ranging from blood vessels to tracheas to skin. If we can develop a robust, fast, efficient method to seed these scaffolds with stem cells from the intended patient in the operating room, then we have the potential to recreate organs for any patient without the risk of rejection, without the need for an organ donor, and without the need to be a waiting list. The ability to repair or regenerate tissue/organs addresses a market size estimated to be several hundred billion dollars annually. This platform technology will create a new paradigm of regenerative medicine and advance patient care to new levels.


Grant
Agency: NSF | Branch: Standard Grant | Program: | Phase: | Award Amount: 652.63K | Year: 2015

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is focused on developing a customizable tissue engineered tracheal implant for tracheal transplantation and reconstruction surgery. Current surgical solutions for these patients are limited by problems with the availability of suitable cadaveric tissue, as well as with unsatisfactory long-term survival of the engrafted tissues due to issues with both revascularization and immune rejection. The combination of an inert biomaterial scaffold and autologous cells avoids any concerns with graft rejection, while allowing for the reliable production of tracheal grafts. Nanofiber Solutions expects this new device will enable as many as 6,500 life-saving procedures annually. A successful Phase 2 project will demonstrate long-term performance of the nanofiber tracheal implant and the mechanisms of action in a large animal model as well as a humanitarian device exemption (HDE) application with the FDA to initiate a clinical trial. This trachea implant product addresses a $600 million dollar opportunity. Other tissue engineered products based on this technology platform address billions of dollars more in market opportunity.

The proposed project is focused on developing a customizable tissue engineered tracheal implant for tracheal transplantation and reconstruction surgery. The trachea has challenging mechanical and biological requirements, and despite many attempts there currently is no fully functional artificial trachea. The fully synthetic tracheal scaffold is seeded with autologous stem cells harvested from the patient?s bone marrow. To prepare for an FDA submission and initial human clinical trials, we will accomplish three technical objectives in this Phase II work: 1) Optimize the use of a closed system, disposable seeding chamber to allow uniform cell seeding throughout the scaffold, 2) Develop a commercial manufacturing process for the production and placement of support ribs on the tracheal graft, and 3) Elucidate mechanisms of tracheal regeneration in vivo of intraoperatively seeded tracheal implants.


Grant
Agency: National Science Foundation | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 624.63K | Year: 2015

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is focused on developing a customizable tissue engineered tracheal implant for tracheal transplantation and reconstruction surgery. Current surgical solutions for these patients are limited by problems with the availability of suitable cadaveric tissue, as well as with unsatisfactory long-term survival of the engrafted tissues due to issues with both revascularization and immune rejection. The combination of an inert biomaterial scaffold and autologous cells avoids any concerns with graft rejection, while allowing for the reliable production of tracheal grafts. Nanofiber Solutions expects this new device will enable as many as 6,500 life-saving procedures annually. A successful Phase 2 project will demonstrate long-term performance of the nanofiber tracheal implant and the mechanisms of action in a large animal model as well as a humanitarian device exemption (HDE) application with the FDA to initiate a clinical trial. This trachea implant product addresses a $600 million dollar opportunity. Other tissue engineered products based on this technology platform address billions of dollars more in market opportunity. The proposed project is focused on developing a customizable tissue engineered tracheal implant for tracheal transplantation and reconstruction surgery. The trachea has challenging mechanical and biological requirements, and despite many attempts there currently is no fully functional artificial trachea. The fully synthetic tracheal scaffold is seeded with autologous stem cells harvested from the patient?s bone marrow. To prepare for an FDA submission and initial human clinical trials, we will accomplish three technical objectives in this Phase II work: 1) Optimize the use of a closed system, disposable seeding chamber to allow uniform cell seeding throughout the scaffold, 2) Develop a commercial manufacturing process for the production and placement of support ribs on the tracheal graft, and 3) Elucidate mechanisms of tracheal regeneration in vivo of intraoperatively seeded tracheal implants.

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