Abstract: Methods for producing a fibrin matrix comprising a fusion peptide are described herein. In some embodiments, the method includes providing three different components, including a first component containing fibrinogen or a fibrinogen precursor and optionally, transglutaminase or a transglutaminase precursor, a second component containing thrombin or a thrombin precursor, and a third component containing a fusion peptide. In these embodiments, neither the first component nor the second component includes the fusion peptide. In some embodiments, the first or second components are premixed with the third component. The first, second and third components are mixed to form a fibrin matrix comprising a covalently linked fusion peptide. The mixing is carried out in a time frame of not more than 5 days. A kit for producing the fibrin matrix comprising a covalently linked fusion peptide is also described herein.

Abstract: A pharmaceutical formulation for use in a spinal fusion method, comprising a composition for forming a matrix, a kit comprising the composition, a pharmaceutical product obtainable from the pharmaceutical formulation, and an interbody spinal fusion cage containing the pharmaceutical formulation or the pharmaceutical product are described herein. The composition comprises at least a first matrix material precursor component and a second matrix material precursor component that are able to crosslink to form the matrix under appropriate conditions, a bioactive factor that is biologically active for stimulating bone formation between two vertebrae and for effecting or supporting spinal fusion. The bioactive factor is PTH, optionally a PTH fusion peptide. The bioactive factor is releasably incorporated in the matrix upon crosslinking of the matrix material precursor components.

Abstract: The invention relates to a discharge device (1) comprising a tank housing (3) having at least one outlet (4) at one end and having a drive means at the opposite end. A connector (6) can be placed over the outlet (4) on the discharge device. The connector comprises a releasable mounting device that can be released by manual pressure on two opposite side surfaces of the connector. One guide surface (9) is provided on each of the two opposite side surfaces, each being oriented diagonally to the longitudinal axis (L) of the discharge device (1) and spaced in the direction of the discharge device. The connector is placed over the outlet on the discharge device in a mounting position. The guide surfaces (9) are moved radially toward each other in a released position by pressure (F) on the side surfaces.

Abstract: Methods for making biomaterials for use as a tissue sealant, kits containing precursors for forming the biomaterials, and the resulting biomaterials are described herein. The biomaterials are formed from a composition comprising at least a first and a second precursor molecule, wherein: i) the first precursor molecule is a poly(ethylene glycol) based polymer having x nucleophilic groups selected from the group consisting of thiol or amino groups, wherein x is greater than or equal to 2 ii) the second precursor molecule is of the general formula: A-[(C3H6O)n—(C2H4O)m—B]i wherein m and n are integers from 1 to 200 i is greater than 2 A is a branch point B is a conjugated unsaturated group The precursors are selected based on the desired properties of the biomaterial. Optionally, the biomaterials contain additives, such as thixotropic agents, radiopaque agents, or bioactive agents.

Abstract: Methods for making biomaterials for use as a tissue sealant, kits containing precursors for forming the biomaterials, and the resulting biomaterials are described herein. The biomaterials are formed from a composition comprising at least a first and a second precursor molecule, wherein: i) the first precursor molecule is a poly(ethylene glycol) based polymer having x nucleophilic groups selected from the group consisting of thiol or amino groups, wherein x is greater than or equal to 2 ii) the second precursor molecule is of the general formula: A-[(C3H6O)n—(C2H4O)m—B]i wherein m and n are integers from 1 to 200 i is greater than 2 A is a branch point B is a conjugated unsaturated group The precursors are selected based on the desired properties of the biomaterial. Optionally, the biomaterials contain additives, such as thixotropic agents, radiopaque agents, or bioactive agents.

Abstract: Supplemented matrices comprising a PTH releasably incorporated therein, optionally containing a granular material, which are used to heal bone fractures, particularly bone fractures with a risk of becoming delayed unions or non-unions, are described herein. The PTH is incorporated either through covalent linkage to the matrix or through non-covalent interaction with the matrix and/or the granules. These supplemented matrices decrease the time of healing compared to autograft and or trigger healing of bone fractures which otherwise would not heal. The matrices are biocompatible, preferably biodegradable, and can be formed in vitro or in vivo, at the time of implantation. The PTH may be a part of a fusion peptide. PTH can be incorporated into the matrices with full retention of its bioactivity. PTH can be releasably incorporated in the matrix.

Abstract: The application relates to a dispensing device (1) containing at least one chamber (5, 5?) for receiving a fluid (B, B?), a plunger unit (6) including at least one piston (7, 7?), locking mechanism and counter-locking mechanism as well as a catching mechanism and counter-catching mechanism. The locking mechanism and the counter-locking mechanism can be brought into a locking position (L), in which a movement of the plunger unit (6) in one or both directions is substantially prevented. The catching mechanism and the counter-catching mechanism can be brought into an engagement position (E), in which the locking mechanism and the counter-locking mechanism cannot be brought into the locking position (L). Furthermore, the application relates to a kit (19) containing the dispensing device (1) and to a method of operating the device (1) or kit (19).

Abstract: A method of local treatment of specific bone defects such as osteoporosis or bone cysts comprises the step of local administration of a formulation comprising a fusion peptide containing a first domain comprising PTH or BMP 2 or BMP 7, and a second domain comprising a covalently crosslinkable substrate domain; and a material suitable of forming a biodegradable matrix suitable for cellular growth or in-growth, wherein the fusion peptide is covalently linked to the matrix. In one embodiment, the matrix contains one or more contrast agents, and is preferably formed in the absence of a growth factor. The matrix may be used in the treatment of fluid-filled cysts such as Tarlov cysts, ovarian cysts, arachnoid cysts, aneurysmal bone cysts or hepatic cysts.

Abstract: Methods for making biomaterials for augmentation of soft and hard tissues, kits containing precursors for forming the biomaterials, and the resulting biomaterials are described herein. The biomaterials are formed from at least a first and a second precursor component. The first precursor component contains at least two nucleophilic groups, and the second precursor component contains at least two electrophilic groups. The nucleophilic and electrophilic groups of the first and second precursor components form covalent linkages with each other at physiological temperatures. The precursors are selected based on the desired properties of the biomaterial. In the preferred embodiment, the first precursor is a siloxane. Optionally, the biomaterials contain additives, such as thixotropic agents, radiopaque agents, or bioactive agents. In the preferred embodiment, the biomaterials are used to augment at least one vertebra of the spine (vertebroplasty).

Abstract: Compositions for wound healing, use of the compositions, and kits and methods of using thereof are described herein. In a preferred aspect, the compositions are suitable for use in a method for forming a fibrin matrix or foam that can be applied or injected at the site of need. In another preferred aspect, the compositions are also suitable for use in methods for forming enhanced controlled delivery fibrin matrices that can be administered as gels or foams.

Abstract: Injectable radio-opaque compositions for tissue augmentation and in particular hard tissue augmentation, and kits and methods of using thereof are described herein. The injectable compositions form porous, biologically degradable, fibrin matrices. The compositions are formed from fibrinogen, thrombin or another agent that causes the fibrinogen to crosslink, and strontium salts. Optionally an iodinated contrast agent is further incorporated in the composition. In certain aspects, the compositions have substantially no exothermicity when forming the matrix and the resulting matrices exhibit mechanical properties typically seen in elastomers. Adequate radio-opacity is achieved through the incorporation of strontium salts in combination or not with iodinated contrast agents.

Abstract: Methods for making biomaterials for augmentation of soft and hard tissues, kits containing precursors for forming the biomaterials, and the resulting biomaterials are described herein. The biomaterials are formed from at least a first and a second precursor component. The first precursor component contains at least two nucleophilic groups, and the second precursor component contains at least two electrophilic groups. The nucleophilic and electrophilic groups of the first and second precursor components form covalent linkages with each other at physiological temperatures. The precursors are selected based on the desired properties of the biomaterial. In the preferred embodiment, the first precursor is a siloxane. Optionally, the biomaterials contain additives, such as thixotropic agents, radiopaque agents, or bioactive agents. In the preferred embodiment, the biomaterials are used to augment at least one vertebra of the spine (vertebroplasty).

Abstract: Methods for making biomaterials for augmentation of soft and hard tissues, kits containing precursors for forming the biomaterials, and the resulting biomaterials are described herein. The biomaterials are formed from at least a first and a second precursor component. The first precursor component contains at least two nucleophilic groups, and the second precursor component contains at least two electrophilic groups. The nucleophilic and electrophilic groups of the first and second precursor components form covalent linkages with each other at physiological temperatures. The precursors are selected based on the desired properties of the biomaterial. In the preferred embodiment, the first precursor is a siloxane. Optionally, the biomaterials contain additives, such as thixotropic agents, radiopaque agents, or bioactive agents. In the preferred embodiment, the biomaterials are used to augment at least one vertebra of the spine (vertebroplasty).