Abstract: A bioremodelable encasement structure comprising a pouch formed from at least one sheet of bioremodelable material, the pouch including an internal region that is configured to receive a device therein, the bioremodelable material comprising mesothelial tissue.

Abstract: A covering for delivering a therapeutic agent to a surgical site is provided. The covering may include a single or multi-compartment structure configured to at least partially retain the therapeutic agent until the covering is placed at a surgical site. Upon placement, the covering may facilitate transfer of the therapeutic agent to the surgical site. In some embodiments, the covering comprises an antimicrobial agent, a hemostatic agent, an anti-inflammatory agent, and/or a growth factor.

Abstract: The present invention provides hydrogels and compositions thereof for vocal cord repair or augmentation, as well as other soft tissue repair or augmentation (e.g., bladder neck augmentation, dermal fillers, breast implants, intervertebral disks, muscle-mass). The hydrogels or compositions thereof are injected into the superficial lamina propria or phonatory epithelium to restore the phonatory mucosa of the vocal cords, thereby restoring a patient's voice. In particular, it has been discovered that hydrogels with an elastic shear modulus of approximately 25 Pa are useful in restoring the pliability of the phonatory mucosa. The invention also provides methods of preparing and using the inventive hydrogels.

Abstract: A biphasic material and devices comprising the same are provided for the development of conductive conduits that may be used for the treatment of peripheral nerve injury. These devices or conduits are designed such that repeated electric field gradients can be initiated to promote neurite and axonal outgrowth. Conducting conduits using doped synthetic and/or natural polymers create specifically patterned high and low conducting segmented materials, which are mechanically used to produce the electrical properties needed for nerve conduits. These electrical properties stimulate neurite outgrowth and axonal repair following a peripheral nerve transection.

Abstract: The present invention provides engineered polypeptide conjugates (e.g., antibody-drug-conjugates, toxin-(biocompatible polymer) conjugates, antibody-(biocompatible polymer) conjugates, and bispecific antibodies) comprising acyl donor glutamine-containing tags and amine donor agents. In one aspect, the invention provides an engineered Fc-containing polypeptide conjugate comprising the formula (Fc-containing polypeptide)-T-A, wherein T is an acyl donor glutamine-containing tag engineered at a specific site or comprises an endogenous glutamine made reactive by the Fc-containing polypeptide engineering, wherein A is an amine donor agent, and wherein the amine donor agent is site-specifically conjugated to the acyl donor glutamine-containing tag or the endogenous glutamine. The invention also provides methods of making engineered polypeptide conjugates using transglutaminase.

Abstract: The present invention relates to a resorbable polymeric mesh implant, that is intended to be used in the reconstruction of soft tissue defects. The mesh implant comprises at least a first and a second material, wherein the second material is substantially degraded at a later point in time than the first material following the time of implantation. The mesh implant is adapted to have a predetermined modulus of elasticity that gradually is decreased until the mesh implant is completely degraded and subsequently resorbed. Due to the gradual decrease in the modulus of elasticity of the inventive mesh implant, the regenerating tissue may gradually take over the load applied to the tissue defect area.

Abstract: The present invention relates to a pH buffered bioactive glass, and its preparation process and use. The pH buffered bioactive glass comprises SiO2, CaO, Na2O, and P2O5, and further comprises solid acidic particles or a Tris buffer solution. The pH buffered bioactive glass can regulate the pH of formulations comprising bioactive glass, and has a good therapeutic effect with a low dosage.

Abstract: The invention is a method of extracting cannabinoid from root balls of the cannabis plant. The root balls are repeatedly cleaned using water, dried, and ground into a powder. A solvent is added to the ground powder and purified, ideally using a sieve method.

Abstract: Medical devices, such as stents, fabricated at least in part from a polymer composite including a biodegradable elastomeric phase dispersed within a biodegradable polymeric matrix are disclosed. The composite is composed of a polyurethane block copolymer including soft polymer blocks and a hard polymer blocks.

Abstract: The present invention is based on the discovery of a cell-based system to identify novel modulators of splicing or splicing dependent processes. The cell-based system of the present invention utilizes a fast and highly sensitive reporter, that responds to defects in the splicing machinery itself and is sensitive to changes in the signals that regulate splicing dependent processes such as those that modulate the EJC, splicing-dependent export, localization or translation efficiency. The present invention further uses the cell-based screen to identify several small molecules that modulate both constitutive and alternative splicing. Accordingly, the present invention includes general or alternative splicing inhibitors identified using the assay described herein. The present invention also provides methods of treating a subject having a condition associated with aberrant target RNA expression.

Abstract: Inside-out gelation process to generate hydrogel microcapsules (aka microbeads). Methods of encapsulating biological material in the microbead 3-dimensional hydrogel matrix are described herein. The process generally comprises formation of a mixture of a hydrogel precursor compound, an optional biological material, and a divalent cation. The mixture is then combined with alginate, to generate an alginate shell around droplets of the mixture, followed by gelation of the hydrogel precursor core, and removal of the temporary alginate shell to yield self-sustaining microbeads.

Abstract: The invention relates to a method for modification of a biocompatible component. The method of the invention includes the steps of a) providing a biocompatible component at least partly covered by metallic oxide; and b) treating at least a part of the component, which part is covered by the metallic oxide, with an aqueous composition that includes oxalic acid; whereby a modified metallic oxide, is obtained. The invention also relates to a biocompatible component-including a substrate having a surface with a) a microstructure including pits separated by plateus and/or ridges; and b) a primary nanostructure being superimposed on the microstructure, the primary nanostructure having depressions arranged in a wave-like formation.

Abstract: An osteoimplant includes at least partially demineralized cancellous bone as a substrate, which is impregnated with demineralized cortical bone matrix (DBM). The implant may include a binding agent to adhere the DBM to the cancellous bone substrate, and may also include a soft tissue barrier that covers a portion of the external surface of the implant. The cancellous bone substrate may be selectively demineralized, so as to provide regions with greater malleability, and other regions with greater structural properties.

Abstract: An implant for a living body is designed so that the drug release level can be adjusted to make it possible to perform treatment corresponding to the severity of disease state and the effectiveness of the drug on each individual. The implant includes a drug, and is inserted into a target part of a living body to effect sustained release of the drug, the implant including a photoactive agent that accelerates the release of the drug when irradiated with laser light. The implant is inserted into a living body, and laser light is appropriately applied to the implant to adjust the release level of the drug released into the living body. An eye disease or the like is treated using the above method.

Abstract: A bioremodelable encasement structure comprising a pouch formed from at least one sheet of bioremodelable material, the pouch including an internal region that is configured to receive a device therein, the bioremodelable material comprising mesothelial tissue.

Abstract: A bone repair composition including a cancellous bone matrix with cortical and/or cancellous bone particles loaded therein; and a kit comprising the cancellous bone matrix and the cortical and/or cancellous bone particles.

Abstract: The present invention pertains to copolymers having one or more polyisobutylene segments and one or more biodegradable polymer segments, to methods of making such copolymers, to medical articles that contain such copolymers, and to methods of making such medical articles. According to certain aspects of the invention, copolymers are provided, which comprise a plurality of polyisobutylene segments and a plurality of biodegradable polymer segments. According to certain aspects of the invention, copolymers are provided, which comprise urethane linkages, urea linkages, amide linkages, ester linkages, anhydride linkages, carbonate linkages, linkages commonly described as “click” chemistry linkages, and combinations of two or more types of such linkages.

Abstract: The invention encompasses methods of decreasing the lumenal diameter of a blood vessel by contacting the vessel with a myosin light chain phosphatase inhibitor.

Abstract: The invention is directed to methods for accelerating the healing of connective tissue injuries and disorders. In particular, the invention is directed to accelerating the healing of injuries and disorders of tendons and ligaments. Such methods utilize novel compositions including, but not limited to, extraembryonic cytokine-secreting cells (herein referred to as ECS cells), including, but not limited to, Amnion-derived Multipotent Progenitor cells (herein referred to as AMP cells) and conditioned media derived therefrom (herein referred to as Amnion-derived Cellular Cytokine Solution or ACCS), including pooled ACCS, and Physiologic Cytokine Solution (PCS).

Abstract: Provided are a multilayer separator capable of improving interlayer peel strength and exhibiting excellent permeability due to a high degree of alignment, and a method of manufacturing the same. The method of manufacturing a multilayer separator includes: manufacturing a precursor film by co-extruding and molding a polypropylene based resin melt having a melt index (2.16 kg, 230° C.) of 0.3 to 5 g/10 min and a polyethylene based resin melt having a melt index (2.16 kg, 190° C.) of 0.1 to 1.5 g/10 min so as to be alternately laminated; and heat-treating and stretching the manufactured film, wherein a melt index ratio (A/B) of the polypropylene based resin melt (A) and polyethylene based resin melt (B) is 2 to 10.

Abstract: A surgical stapling apparatus including a cartridge assembly defining a first tissue contacting surface, an anvil assembly defining a second tissue contacting surface, and a surgical buttress releasably secured to at least one of the first tissue contacting surface and the second tissue contacting surface is provided. The buttress provides a uniform profile to be used on both the anvil and cartridge of a loading unit.

Abstract: The present invention relates to scaffolds composed of a protein backbone cross-linked by a synthetic polymer. Specifically, the present invention provides PEGylated-thiolated collagen scaffolds and PEGylated albumin scaffolds and methods of generating and using same for treating disorders requiring tissue engineering.

Abstract: Osteoinductive and osteoconductive compositions for bone graft which utilize less allograft tissue, and methods for their production, are provided. The compositions and methods contain a combination of fibers of demineralized bone matrix from allograft bone and fibers of non-allograft bone material. The fibers of non-allograft bone material comprise non-fibrous demineralized bone matrix particles embedded within or disposed on the fibers of non-allograft bone material. The non-allograft fibers of the composition contain a bone void filler of collagen and one or more ceramics embedded with demineralized bone matrix particles. In some embodiments, the composition also contains a bioactive agent.

Abstract: The invention comprises a combination of biological elements that will naturally remodel in vivo based on applied mechanical forces. The final composition will possess mechanical properties similar to cartilage or a disc, and significantly less stiff than bone or implants comprised of metals or plastics. The equilibrium stress conduction will minimize unnatural forces on neighboring healthy discs.

Abstract: There are provided compositions for extended release of a nucleic acid agent, comprising a lipid-saturated matrix formed with a biodegradable polymer. Also provided are methods of producing the matrix compositions and methods for using the matrix compositions to provide controlled release of the nucleic acid agent.

Abstract: A method and device for local delivery of a water-insoluble therapeutic agent to the tissue of a normal or diseased body lumen is disclosed. An expandable structure of a medical disposable device, such as a balloon of a balloon catheter, is coated with a non-durable coating which comprises poly(HEMA) complexed with iodine and has a substantially water-insoluble therapeutic agent dispersed therein. The medical disposable device is inserted into a body lumen, and expanded to contact the non-durable coating against the body lumen and deliver the substantially water-insoluble therapeutic agent to the body lumen tissue.

Abstract: The present invention relates to a method for preparing capsules comprising a liquid core, a stiffened intermediate envelope and a gelled external envelope, comprising a step of forming a multi-component liquid drop, a gelification step and a stiffening step. The present invention also relates to a method for preparing capsules comprising a liquid core and a stiffened envelope, comprising a step of forming a multi-component liquid drop, a gelification step, a stiffening step and a depolymerizing step.

Abstract: Described herein are compositions comprising decellularized extracellular matrix derived from skeletal muscle or other suitable tissue, and therapeutic uses thereof. Methods for treating, repairing or regenerating defective, diseased, damage, ischemic, ulcer cells, tissues or organs in a subject preferably a human, with diseases, such as PAD and CLI, using a decellularized extracellular matrix of the invention are provided. Methods of preparing culture surfaces and culturing cells with absorbed decellularized extracellular matrix are provided.

Abstract: A method for controlling generation of biologically desirable voids in a composition placed in proximity to bone or other tissue in a patient by selecting at least one water-soluble inorganic material having a desired particle size and solubility, and mixing the water-soluble inorganic material with at least one poorly-water-soluble or biodegradable matrix material. The matrix material, after it is mixed with the water-soluble inorganic material, is placed into the patient in proximity to tissue so that the water-soluble inorganic material dissolves at a predetermined rate to generate biologically desirable voids in the matrix material into which bone or other tissue can then grow.

Abstract: This invention relates to a pharmaceutical formulation containing z-butylidenephthalide and a polymer, e.g., a polyanhydride. Also disclosed is use of this formulation to treat tumor.

Abstract: The present invention provides a plasticized dehydrated or freeze-dried bone and/or soft tissue product that does not require special conditions of storage, for example refrigeration or freezing, exhibits materials properties that approximate those properties present in normal hydrated tissue, is not brittle, does not necessitate rehydration prior to clinical implantation and is not a potential source for disease transmission. The invention replaces water in the molecular structure of the bone or soft tissue matrix with one or more plasticizers allowing for dehydration of the tissue, yet not resulting in an increase in brittleness of the plasticized product, and resulting in compressive and/or tensile properties similar to those of normal hydrated bone. Replacement of the chemical plasticizers by water prior to implantation is not required and thus, the dehydrated bone or soft tissue plasticized product can be placed directly into an implant site without significant preparation in the operating room.

Abstract: A nanoformulation that includes nanoparticles. Each nanoparticle includes a shell in which a glycosaminoglycan (GAG is encapsulated. The GAG is ionically or covalently bonded to the shell. The GAG is selected from the group consisting of sulfated non-anticoagulant heparin (SNACH), super-sulfated non-anticoagulant heparin (S-SNACH), and a combination thereof. The shell includes Poly (lactic-co-glycolic acid) (PLGA), Polyethylene Glycol (PEG)-PLGA, maleimide-PEG-PLGA, chitosan, chitosan-PLGA, methoxy-polyethyleneglycol-poly (lactide-co-glycolide) (MPEG-PLGA)-(maleimide-PEG-PLGA), PLGA-Polycaprolate, or calcium alginate. A method of using the nanoformulation to treat a cancer in a subject includes administering to the patient a therapeutically effective amount of the nanoformulation for treating the cancer.

Abstract: Tissue anchors include a flat, broad, and large contact surface for engagement with a portion of tissue. Several embodiments of composite tissue anchors include a support element and an overlay element. Tissue anchor assemblies include two or more tissue anchors, a connector, and a cinching mechanism. In some embodiments, the tissue anchors included in the tissue anchor assemblies are of different types, sizes, and/or shapes.

Abstract: Disclosed is a substance delivery carrier for an extracellular-matrix-producing cell in the bone marrow, which comprises a retinoid. Also disclosed in an agent for treating myelofibrosis by utilizing a substance capable of regulating the activity or proliferation of an extracellular-matrix-producing cell in the bone marrow.

Abstract: The present invention provides for a stabilized biodegradable polymeric composition useful as a controlled release delivery system for peptide agents. The compositions of the present invention comprise a) a beneficial salt of a peptide agent formed with a strong acid that minimizes or prevents the interaction/reaction between the peptide agent and the polymer in an organic solution; b) a biodegradable polymer; c) a pharmaceutically acceptable organic solvent; and d) optionally one or more excipients. The present invention also relates to a method of manufacturing and a method of use thereof.

Abstract: A system is provided, including a plurality of donor cells and a first alginate structure that encapsulates the plurality of donor cells. The first alginate structure has a guluronic acid concentration of between 64% and 74%. The system additionally includes a second alginate structure that surrounds the first alginate structure, the second alginate structure having a mannuronic acid concentration of between 52% and 60%. A selectively-permeable membrane is coupled at least in part to the second alginate structure. Other embodiments are also described.

Abstract: Stable nanoparticle compositions comprising buprenorphine and at least one biodegradable polymer. The disclosure also provides methods of controlling pain in an animal and methods of treating addiction in a human utilizing the stable nanoparticle compositions, as well as pharmaceutical formulations comprising the stable nanoparticle compositions. The stable nanoparticle compositions are capable of releasing buprenorphine over several days, weeks, or months following administration. The stable nanoparticle compositions of buprenorphine utilize biodegradable polymers capable of degrading into non-toxic components in the body of an animal and may be excreted in the urine of the animal following their metabolism in the body. The stable nanoparticle compositions can advantageously provide sustained release of buprenorphine in the body after a single administration without the need for surgical removal of implanted matrices subsequent to depletion of the drug.

Abstract: The present invention provides combination therapy methods of treating proliferative diseases (such as cancer) comprising a first therapy comprising administering to an individual an effective amount of a taxane in a nanoparticle composition, and a second therapy which may include, for example, radiation, surgery, administration of chemotherapeutic agents (such as an anti-VEGF antibody), or combinations thereof. Also provided are methods of administering to an individual a drug taxane in a nanoparticle composition based on a metronomic dosing regime.

Abstract: An implant that facilitates the fusion of a first bone part with a second bone part includes an implant body that extends between the first bone part and the second bone part. The implant body includes a first portion that fits within a first receiving aperture in the first bone part, and the implant body includes a second portion that fits within a second receiving aperture in the second bone part. At least one of the first portion and the second portion can be made of bone. Additionally, at least the second portion is formed to have a non-circular cross-sectional shape to inhibit relative motion between the bone parts and the implant body.

Abstract: The present invention relates to a method for preparing a porous scaffold for tissue engineering. It is another object of the present invention to provide a porous scaffold obtainable by the method as above described, and its use for tissue engineering, cell culture and cell delivery. The method of the invention comprise the steps consisting of a) preparing an alkaline aqueous solution comprising an amount of at least one polysaccharide and one cross-linking agent b) freezing the aqueous solution of step a) c) sublimating the frozen solution of step b) characterized in that step b) is performed before the cross-linking of the polysaccharide occurs in the solution of step a).

Abstract: A bioerodible patch comprising at least one bioadhesive layer and at least one non-bioadhesive layer, wherein the bioadhesive layer comprises at least one polyaphron dispersion and at least one bioadhesive polymer, and wherein the polyaphron dispersion comprises at least one pharmaceutically active agent.

Abstract: A vascular graft with trim lines is described, the trim lines providing a guide for precision shaping of the cuff. The trim lines may be printed or otherwise disposed on a surface of the cuff or included on a template designed for disposition over the cuff. The trim lines may also be disposed on a side of a pocket into which the cuff is positioned for trimming. Also described is an apparatus and method for precise trimming of a vascular graft.

Abstract: The invention provides systems, modules, bioreactor and methods for the automated culture, proliferation, differentiation, production and maintenance of tissue engineered products. In one aspect is an automated tissue engineering system comprising a housing, at least one bioreactor supported by the housing, the bioreactor facilitating physiological cellular functions and/or the generation of one or more tissue constructs from cell and/or tissue sources. A fluid containment system is supported by the housing and is in fluid communication with the bioreactor. One or more sensors a associated with one or more of the housing, bioreactor or fluid containment system for monitoring parameters related to the physiological cellular functions and/or generation of tissue constructs; and a microprocessor linked to one or more of the sensors. The systems, methods and products of the invention find use in various clinical and laboratory settings.

Abstract: An implant and a process for preparing such an implant are disclosed. The implant includes a mesh including a biodegradable polymeric coating having glass transition temperature of about 26° C. to about 36° C. The polymeric coating includes a first polymeric component including a lactone and a second polymeric component including a polyether. The first polymeric component is present in an amount from about 90% to about 99% of the polymeric coating and the second polymeric component is present in an amount from about 1% to about 10% of the polymeric coating.

Abstract: A nonaqueous, single-phase vehicle that is capable of suspending an active agent. The nonaqueous, single-phase vehicle includes at least one solvent and at least one polymer and is formulated to exhibit phase separation upon contact with an aqueous environment. The at least one solvent may be selected from the group consisting of benzyl benzoate, decanol, ethyl hexyl lactate, and mixtures thereof and the at least one polymer may be selected from the group consisting of a polyester, pyrrolidone, ester of an unsaturated alcohol, ether of an unsaturated alcohol, polyoxyethylenepolyoxypropylene block copolymer, and mixtures thereof. In one embodiment, the at least one solvent is benzyl benzoate and the at least one polymer is polyvinylpyrrolidone. A stable, nonaqueous suspension formulation that includes the nonaqueous, single-phase vehicle and an active agent, and a method of forming the same, are also disclosed.

Abstract: Disclosed in certain embodiments is a controlled release oral dosage form comprising a therapeutically effective amount of a drug susceptible to abuse together with one or more pharmaceutically acceptable excipients; the dosage form further including a gelling agent in an effective amount to impart a viscosity unsuitable for administration selected from the group consisting of parenteral and nasal administration to a solubilized mixture formed when the dosage form is crushed and mixed with from about 0.5 to about 10 ml of an aqueous liquid; the dosage form providing a therapeutic effect for at least about 12 hours when orally administered to a human patient.

Abstract: Microcapsules including a capsule shell encapsulating a suspension of a therapeutically effective amount of liver cells in physical contact with a liver cell stimulating amount of erythropoietin.

Abstract: Dosage forms and drug delivery devices suitable for administration of pharmaceutical compounds and compositions, including the oral drug administration of compounds.

Abstract: A suspension and a cake composition are provided in which agglomeration of the active ingredient that is caused when silicone oil and/or silicone oil derivative is contained therein can be suppressed without a special treatment, such as sonication. The suspension contains, in a dispersion medium, an active ingredient of a specific mean primary particle size, and silicone oil and/or silicone oil derivative. The cake composition contains an active ingredient of a specific mean particle size, and silicone oil and/or silicone oil derivative.

Abstract: Provided are tissue scaffolds colonized by vertebrate cells expressing, a transgenic bioactive molecule, where the vertebrate cells are unable to undergo mitosis. Also provided are methods of growing tissue in a mammal and methods of delivering a transgenic bioactive molecule to a tissue of a mammal, using the tissue scaffolds. Additionally, methods of making the tissue scaffolds are provided.