Abstract: The invention is related to a coated contact lens, especially a coated silicone hydrogel contact lens, which comprises an anterior surface, an opposite posterior surface, and a layered structural configuration from the anterior surface to the posterior surface. The layered structural configuration comprises an outer anterior surface hydrogel layer, an inner layer, and an outer posterior surface hydrogel layer. The inner layer is a lens bulk material. The coated contact lens has a superior lens surface softness and a good lens surface hydrophilicity while optionally having a desirably-lower polyquaternium-1 uptake.

Abstract: Described herein are compositions composed of micronized particles derived from one or more components present in placental tissue in combination with one or more bone grafts. The compositions have numerous medical applications. Methods for making and using the micronized compositions are also described herein.

Abstract: A cell or tissue embedding device having an aqueous gel serving as an immunoisolation layer, the aqueous gel containing, as components thereof, a denatured polyvinyl alcohol resin having an activated carbonyl group and a crosslinking agent is highly capable of supplying a physiologically active substance.

Abstract: Provided herein are methods and compositions for stabilization of active agents. The active agents are distributed, mixed or embedded in a silk fibroin matrix, thereby retaining the bioactivity of the active agents upon storage and/or transportation. In some embodiments, the storage-stable vaccine-silk compositions are also provided herein.

Abstract: Stable, non-caking, pharmaceutical composition in the form of powder for oral solution comprising methylprednisolone sodium succinate and methods of making such compositions. The compositions comprise lyophilized methylprednisolone sodium succinate mixed with one or more water-soluble pharmaceutically acceptable excipients.

Abstract: A health management device for a user is described. The device may include a flexible body having an interior surface and an exterior surface. The interior surface may be configured to be adhered to a user skin. The device may further include a sensor attached to the interior surface. The sensor may be configured to measure user biometric information. Further, the device may include a processor configured to determine a user contraction level based on the user biometric information. The processor may additionally determine that the user contraction level is greater than a first threshold. The processor may perform a predefined action responsive to a determination that the user contraction level is greater than the first threshold. The predefined action may include causing a pharmaceutical disbursement unit to disburse a predefined quantity of medicine into the user skin.

Abstract: The present invention is directed to methods for inhibition of HIV reverse transcriptase, treatment of infection by HIV, prophylaxis of infection by HIV, and the treatment, prophylaxis and/or delay in the onset or progression of AIDS or ARC by administering a compound of structural Formula I or a pharmaceutically acceptable salt or co-crystal thereof, wherein X is —F or —Cl, less frequently than once daily.

Abstract: A method of preparing sterile human placental allografts by providing a human placental tissue from a donor within 24 hours to 72 hours post-childbirth; removing any visible blood, blood clots, and/or blood components from the human placental tissue without scraping or scrubbing the human placental tissue to preserve structural integrity of the human placental tissue; washing the human placental tissue in an isotonic solution while maintaining the structural integrity of the human placental tissue; dehydrating the human placental tissue thereby forming the dehydrated human placental tissue; resizing the dehydrated human placental tissue into dehydrated human placental tissue portions having predetermined sizes; and sterilizing the dehydrated human placental tissue portions of step (e) thereby forming the sterile human placental allograft. Also disclosed is a sterile human placental allograft produced by the method.

Abstract: Described are methods, cell growth substrates, and devices that are useful in preparing cell-containing graft materials for administration to patients. Tubular passages can be defined in cell growth substrates to promote distribution of cells into the substrates. Also described are methods and devices for preparing cell-seeded graft compositions, methods and devices for preconditioning cell growth substrates prior to application of cells, and cell seeded grafts having novel substrates, and uses thereof.

Abstract: A composite material is disclosed including: a first material including a plurality of crosslinked first polymer chains including a plurality of first polymer monomeric units; a coating layer on the surface of the first material, wherein the coating layer includes a plurality of adhesion polymer chains, wherein the plurality of adhesion polymer chains includes a plurality of the first polymer monomeric units and a plurality of first bond-forming units, wherein the adhesion polymer chains are interwoven with the first polymer chains; and a second material including a plurality of second polymer chains, wherein the coating layer is disposed in-between the first and the second material and contacting the surface of the first and the second material, and a portion of the second polymer chains includes a plurality of second polymer monomeric units and second bond-forming units; wherein the first and the second bond-forming units form one or more bonds.

Abstract: The invention relates to the use of germ cells for obtaining a micro hair follicle and to the use thereof for evaluating the effect of cosmetic, pharmaceutical or dermatological products and also for the prophylactic or therapeutic treatment of a state of reduced pilosity.

Abstract: A delivery system for delivering a drug depot to a site within a patient, the system comprising: a cannula; a delivery stylet configured and dimensioned to be receivable by and slidable forwardly and backwardly within the cannula including to a position wherein a distal portion of the stylet protrudes beyond the distal end of the cannula; a drug depot retainable by the stylet at the distal end of the stylet, the drug depot being visualizable by a diagnostic imaging beam or modality; and an actuator for ejecting the drug depot from the stylet to a site within the body using fluid pressure. Also disclosed are methods using, and uses of, the delivery system, including for treating scoliosis.

Abstract: The invention relates to biocompatible polymer gel compositions useful in facilitating and maintaining hemostasis. The biocompatible polymeric gel composition is comprised of (a) one or more than one polyanionic polymer, (b) one or more than one polycationic polymer, and (c) a solvent. A preferred composition includes sodium alginate, chitosan, and water to produce an adhesive hemostatic device that is useful in facilitating and maintaining rapid hemostasis.

Abstract: An implantable tendon protection system includes a body adapted to be implanted within a bursa overlying a tendon of a patient to protect the tendon. The body may be fixed to the tendon with adhesive, sutures, staples, and/or anchors. A surgical kit is provided with such a tendon protection system and an insertion cannula. Methods of protecting a tendon of a patient are also disclosed.

Abstract: Provided is a system that enables training for catheter surgery without using radiation. The system offering training for catheter surgery includes: a light source; a blood vessel model to which a catheter having a fluorescent agent applied thereto is inserted; a tank in which the blood vessel model is placed; a filter for rejecting white light that is not transmitted through the blood vessel model, of illuminating light from the light source; a camera for imaging fluorescence transmitted through the filter; a driver for changing the attitude of the light source; and a computer that performs a process of reversing black and white of an image signal output from the camera.

Abstract: The invention disclosed herein is directed to a porous wound healing foam composition that is made from an extracellular matrix of a mammal, method of making, and method of using.

Abstract: A system and method for automatically calculating an accurate recommended dosage for hormone replacement therapy and automating the life cycle of a patient's treatment over time. The system and method can automatically acquire relevant patient parameters and apply a consistent formulaic approach to help reduce incorrect dosage determinations. A pellet insertion size may be determined and documented based on a calculated dosage, and an insertion side and lot numbers may be tracked and managed. In addition, corresponding revenues may be tracked and profitability may be reported for hormone replacement therapy practices.

Abstract: Embodiments of the invention provide multi-stage biodegradable drug delivery platforms and methods for the subcutaneous delivery of therapeutic agents (TA). Embodiments of the platform may be configured to subcutaneously deliver a first dose of a first TA which is absorbed into the body and/or blood stream (BBS) to produce a first therapeutic effect for a first selectable time period (STP), and subsequently after a second STP, deliver a second dose of a second TA which is absorbed into the BBS to produce a second therapeutic effect for a third STP. An embodiment of the platform may comprise a body having a tissue-penetrating end, a primary cavity having a first TA dose and a shell having a secondary cavity having a second TA dose. The first TA dose is released after the first STP and the second TA dose is released after the second STP by biodegradation of the shell.

Abstract: The invention is generally related to a soft hydrogel ocular insert that is composed of at least one hydrogel material in fully hydrated state and can be comfortable for wearing. The hydrogel material comprises polymer chains, which are derived from at least one arylborono-containing hydrophilic copolymer and at least one mucoadhesive polymer, and cyclic boronic ester crosslinks for crosslinking those mucoadhesive polymer chains and arylborono-containing hydrophilic copolymer chains to form a 3-dimensional polymer network. Those cyclic boronic ester crosslinks can be hydrolyzed slowly in the tear of the eyes of a patient, resulting in the disintegration (dissolution) of the 3-dimensional polymer network and thereby providing mucoadhesisve polymers and optionally drugs impregnated in the hydrogel ocular insert in a controlled manner.

Abstract: The present invention relates to microparticles comprising moxidectin and a biodegradable polymer, wherein the microparticles comprising moxidectin have a shape allowing a moxidectin drug to be uniformly distributed in spherical biodegradable polymer particles, and the average particle diameter of the microparticles is 80-130 ?m. The present invention relates to: extended release microparticles capable of continuously maintaining a heartworm disease prevention effect for 3 months to 6 months by administering microparticles comprising moxidectin; and a preparation method therefor. In addition, the present invention is prepared such that the average diameters of the particles have a predetermined micrometer size, and thus reduces a foreign body sensation and pain during administration into an animal through injection, thereby enabling administration through injection to be facilitated.

Abstract: Disclosed herein is a bio-resistant article comprising a porous metal substrate; a self-assembled monolayer disposed on the substrate; wherein the self-assembled monolayer comprises a coupling agent that has a first end that is reactively bonded to the porous metal substrate and a second end that is reactively bonded to a zwitterionic polymer. Disclosed herein too is a method comprising disposing upon a porous metal substrate a self-assembled monolayer; and bonding the zwitterionic polymer to the self-assembled monolayer.

Abstract: A balloon retention urinary catheter includes a porous and spongy distal tip. In one method, a polymer is mixed with sacrificial particles and the mixture is molded in the form of the tip, and then cured. The cured tip is then placed in a solvent in which the sacrificial particles elute from the tip but in which the polymer is insoluble. Once the particles elute out of the polymer in the tip, a softer porous polymeric structure results. The tip may be structured to be softer prior to use or for transformation to a softer state once in the bladder.

Abstract: Tissue product compositions and methods for treating a patient are provided. The tissue product composition may include a flowable carrier including a hyaluronic acid based material and acellular tissue matrix particles mixed within the carrier. Methods of producing the tissue product composition and an injection device filled with the tissue product composition are also provided.

Abstract: Embodiments of the invention provide swallowable devices, preparations and methods for delivering drugs and other therapeutic agents within the GI tract. Many embodiments provide a swallowable device for delivering the agents. Particular embodiments provide a swallowable device such as a capsule for delivering drugs into the intestinal wall or other GI lumen. Embodiments also provide various drug preparations that are configured to be contained within the capsule, advanced from the capsule into the intestinal wall and degrade to release the drug into the bloodstream to produce a therapeutic effect. The preparation can be operably coupled to delivery means having a first configuration where the preparation is contained in the capsule and a second configuration where the preparation is advanced out of the capsule into the intestinal wall. Embodiments of the invention are particularly useful for the delivery of drugs which are poorly absorbed, tolerated and/or degraded within the GI tract.

Abstract: A method for fabricating an article of manufacture includes forming a plurality of layers of the article based on a digital model of the article. Each layer of the plurality of layers may be formed by depositing at least two materials that differ from one another. The at least two materials may be deposited separately or simultaneously. The at least two materials may define separate regions of the layer and, thus, define distinct features of the article, and/or the at least two materials may be mixed or one of the materials may be dispersed throughout the other to define a blended zone in the layer. Blended zones of adjacent layers may be superimposed to define three-dimensional blended zones. A blended zone may be graded to provide transition between separate regions of the article that are formed from two or more different materials. Articles fabricated by such processes are also disclosed.

Abstract: Implantable materials may be used as spacers for separating tissues to reduce a dose of radioactivity received by one of the tissues. Applications include introducing a hydrogel spacer to a position between a first tissue location and a second tissue location to increase a distance between the first tissue location and the second tissue location, Further, there may be a step of administering a dose of radioactivity to at least the first tissue location or the second tissue location and/or a step of visualizing margins of the hydrogel spacer. A hydrogel spacer may comprise a polysaccharide and a radioopaque agent and may be used for fiducial marking.

Abstract: The invention relates to a method for manufacturing a calcified tissue substitute, the method comprising: reacting ground nacre, monocalcium phosphate, and water to produce brushite; grinding the brushite; reacting ground nacre with the ground brushite in disodium hydrogenphosphate solution. The invention also relates to a calcified tissue substitute manufactured by the method, use of the calcified tissue substitute for repairing a calcified tissue, and a delivery device for delivering the calcified tissue.

Abstract: Provided herein are synthetic living tissue structures comprising multiple layers of fibers deposited in solidified form from a 3D bioprinter, together with kits and methods of use related thereto. The fibers comprise a plurality of mammalian cells dispensed within a solidified biocompatible matrix. The structural integrity of the fiber is maintained upon and after deposition without any additional crosslinking. The fiber is continuously bioprinted through at least two layers of the structure. In one aspect, synthetic muscle tissue structures exhibit a readily assayable contractile functionality.

Abstract: Gold implant having a cross-section in the range of 20-100, preferably in the range of 20-40 ?m for use in therapy to prevent or reduce capsular contracture. Further, the invention relates to a method of producing a gold-coated implant.

Abstract: The present invention concerns a thermosensitive polymeric hydrogel comprising at least one thermosensitive copolymer, one aqueous solution, and a mucoadhesive excipient, wherein said thermosensitive polymeric hydrogel further comprises at least one immunostimulatory adjuvant and/or at least one cytokine and/or at least one chemokine and/or atleast one heat shockprotein. Another object of the invention is a thermosensitive polymeric hydrogel according to the invention for use in the treatment of tumors or metastasis in a subject having a cancer, preferably a metastatic cancer.

Abstract: The inventions provided herein relate to compositions, methods, delivery devices and kits for repairing or augmenting a tissue in a subject. The compositions described herein can be injectable such that they can be placed in a tissue to be treated with a minimally-invasive procedure (e.g., by injection). In some embodiments, the composition described herein comprises a compressed silk fibroin matrix, which can expand upon injection into the tissue and retain its original expanded volume within the tissue for a period of time. The compositions can be used as a filler to replace a tissue void, e.g., for tissue repair and/or augmentation, or as a scaffold to support tissue regeneration and/or reconstruction. In some embodiments, the compositions described herein can be used for soft tissue repair or augmentation.

Abstract: Provided herein are novel methods and composition utilizing adipose tissue-derived stromal stem cells for treating fistulae.

Abstract: The present invention relates to a method for modifying release of a therapeutically active agent from an elastomeric matrix, comprising providing a core comprising an elastomeric matrix and a therapeutically active agent; dipping the core to a coating solution of an elastomer, wherein the elastomer comprises 20-35 wt-% of a filler, calculated from the total amount of filler and elastomer; curing the dipped core to provide a coated core. In this method the dipping is provided as a continuous process by pulling the core through the coating solution, using a pulling speed suitable for providing a coating thickness of ?-IOO the filler is selected from silica, titanium dioxide, barium sulphate, carbon and mixtures thereof; the elastomer comprised in the core and the elastomer comprised in the coating solution are independently selected from poly(dimethyl) siloxanes, polyethylene vinyl acetates (EVAs), polyurethanes (PUs), polyhydroxyethyl methacrylates (PHEMAs) and polymethyl methacrylates (PMMAs).

Abstract: Among other things, the present disclosure provides compositions and methods for an elastomeric cross-linked polyester material. Such an elastomeric cross-linked polyester material, in some embodiments, comprises a plurality of polymeric units of the general formula (-A-B-)p, wherein p is an integer greater than 1; and a plurality of urethane cross-links each of which covalently links two polymeric units to one another, which two linked polymeric unit each had at least one free hydroxyl or amino group prior to formation of the crosslink.

Abstract: Implants are placed in turbinate mucosal tissue using a surgical device having a proximal grip portion and a distal hollow sharp needle portion that is manipulated using the grip portion and inserted submucosally into mucosal turbinate tissue. One or more biodegradable, drug-eluting solid implants are disposed within the needle. The implants have one or more implant withdrawal-discouraging, mucosal tissue-engaging surface features along their length. An actuator disposed within the device is used to deliver one or more of the implants from the needle into the mucosal turbinate tissue and submucosally bury at least one such tissue-engaging feature therein.

Abstract: An organ implant, such as a heart implant, including a support structure having a plurality of pores and defining passages configured for the growth of blood vessels; and stem cells from at least one soft tissue source of a patient deposited into the pores of the support structure is described. The implant is configured to repair a portion of an organ of the patient.

Abstract: A microfilter comprising a polymer layer formed from epoxy-based photo-definable dry film, and a plurality of apertures each extending through the polymer layer. A method of forming a microfilter is also disclosed. The method includes providing a first layer of epoxy-based photo-definable dry film disposed on a substrate, exposing the first layer to energy through a mask to form a pattern, defined by the mask, in the first layer of dry film, forming, from the exposed first layer of dry film, a polymer layer having a plurality of apertures extending therethrough, the plurality of apertures having a distribution defined by the pattern, and removing the polymer layer from the substrate.

Abstract: 3D native tissue-derived scaffolding materials are made in various formats, including but not limited to hydrogel, sponge, fibers, microspheres, and films, all of which function to better preserve natural extracellular matrix molecules and to recapitulate the natural tissue environment, thereby effectively guiding tissue regeneration. Tissue-derived scaffolds are prepared by incorporating a homogenized tissue-derived suspension into a polymeric solution of synthetic, natural, or hybrid polymers. Such tissue-derived scaffolds and scaffolding materials have a variety of utilities, including: the creation of 3D tissue models such as skin, bone, liver, pancreas, lung, and so on; facilitation of studies on cell-matrix interactions; and the fabrication of implantable scaffolding materials for guided tissue formation in vivo.

Abstract: The present invention relates to a biomaterial comprising adipose-derived stem cells (ASCs), a ceramic material and an extracellular matrix. In particular, the biomaterial according the present invention secretes osteoprotegerin (OPG), and comprises insulin-like growth factor (IGF1) and stromal cell-derived factor 1-alpha (SDF-1?). The present invention also relates to methods for producing the biomaterial and uses thereof.

Abstract: The present invention relates to a hemostatic composition and a method for preparing thereof, and more specifically, relates to a hemostatic composition comprising a cross-linked hyaluronic acid derivative matrix which is suitable to be used for hemostasis and a method of preparation of such a composition.

Abstract: A pharmaceutical paste formulation containing an active ingredient, an API solubilizer, a cross-linking agent, a consistency improver, a rheology modifier, a humectant, and a liquid base.

Abstract: Described herein are biomaterials, systems, and methods for guiding regeneration of an epiphyseal growth plate or similar interfacial tissue structures. In one aspect, the disclosed technology can include a biologic material that can comprise one or more of a hydrogel carrier for growth factors and MSCs, chondrogenic and immunomodulatory cytokines, microparticles for prolonged and spatially controlled growth factor delivery; and/or porous scaffold providing mechanical support. The implanted material can be applied via various different modalities depending on the nature of the physeal injury. One modality is an injectable hydrogel and another modality is an implantable hydrogel infused scaffold.

Abstract: The present disclosure relates to a vaginal system that prevents pregnancy comprised of segesterone acetate and ethinyl estradiol and is configured for thirteen 28-day product-use cycles.

Abstract: The present invention relates to porous composite materials and objects such as 3D scaffolds, in particular to bioactive and bioresorbable scaffolds that can be transformed at body temperature.

Abstract: An ophthalmic composition or dosage form can include a therapeutically effective amount of a copper-containing agent that is sufficient to increase corneal lysyl oxidase activity in an eye of a subject in an amount sufficient to treat myopic progression and a pharmaceutically acceptable carrier. The composition or dosage form can be used to treat or prevent progression of myopia by administering a therapeutically effective amount of the composition to an eye of a subject during a treatment period.

Abstract: The invention relates to an inhibitor of Factor XII (FXII) for use in treating or preventing chronic kidney disease, renal fibrosis, glomerulosclerosis, renal scarring, ischemia/reperfusion injury in native or transplant kidneys and/or acute kidney injury, a kit for use in treating or preventing chronic kidney disease, renal fibrosis, glomerulosclerosis, renal scarring, ischemia/reperfusion injury in native or transplant kidneys, acute kidney injury, renal fibrosis as a result of rejection of a kidney transplant/allograft, and/or fibrosis of a kidney transplant/allograft as a result of rejection or recurrent underlying disease comprising one inhibitor of Factor XII, and an anti-Factor XII (FXII) antibody or antigen binding fragment thereof for use in treating or preventing chronic kidney disease, renal fibrosis, glomerulosclerosis, renal scarring, ischemia/reperfusion injury in native or transplant kidneys and/or acute kidney injury comprising one inhibitor of Factor XII.

Abstract: Provided is an oral care composition and methods of making and using the same. The composition may include an orally acceptable vehicle, including pectin in an amount of from about 0.1% to about 1% by weight, an anticaries agent; and a moisturizing agent.

Abstract: An interbody implant system for use in the spine includes a base comprising two or more bone contacting surfaces, at least one recess in at least one of the two or more bone contacting surfaces, the recess configured for containing a tooth, a deployable tooth to provide fixation between the base and the anatomy of a subject, a break-away bridge between the tooth and the base for providing a first relative position between the tooth and the base, and a locking mechanism for providing a second relative position between the tooth and the base.

Abstract: Biomaterials, implants made therefrom, methods of making the biomaterial and implants, methods of promoting bone or wound healing in a mammal by administering the biomaterial or implant to the mammal, and kits that include such biomaterials, implants, or components thereof. The biomaterials may be designed to exhibit osteogenic, osteoinductive, osteoconductive, and/or osteostimulative properties.

Abstract: This invention relates to a drug delivery system for administration of poorly water soluble pharmaceutically active substance, a pharmaceutical composition comprising such a drug delivery system, and a method for the preparation of such a drug delivery system. The invention also relates to a method for controlling the particle size and/or particle shape and/or particle size distribution in such a drug delivery system, and to a method for increasing the drug loading capacity of the particles. Furthermore the invention also relates to the use of such a drug delivery system for the preparation of a medicament for the treatment of cancer.