Renejix CDMO Partner for Small Molecule Oral Dosage Forms Renejix CDMO Partner for Small Molecule Oral Dosage Forms

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[{"orgOrder":0,"company":"BioStem Technologies","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"BioStem Technologies, Inc. Receives TRIP (TRG Rapid Inquiry Program) Response for VENDAJE\u2122","therapeuticArea":"Trauma (Emergency, Injury, Surgery)","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"March 2021","url1":"","url2":"","graph1":"Trauma (Emergency, Injury, Surgery)","graph2":"Approved"},{"orgOrder":0,"company":"BioStem Technologies","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"BioStem Announces Publication of a Standardized Method to Evaluate Growth Factor Elution from Placental Tissue Allografts","therapeuticArea":"Trauma (Emergency, Injury, Surgery)","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"September 2022","url1":"","url2":"","graph1":"Trauma (Emergency, Injury, Surgery)","graph2":"Approved"},{"orgOrder":0,"company":"BioStem Technologies","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Center for Medicare Services Established National Pricing of Vendaje\u2122 in All MAC regions","therapeuticArea":"Trauma (Emergency, Injury, Surgery)","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"January 2023","url1":"","url2":"","graph1":"Trauma (Emergency, Injury, Surgery)","graph2":"Approved"},{"orgOrder":0,"company":"BioStem Technologies","sponsor":"NovaBay Pharmaceuticals","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"NovaBay Pharmaceuticals Announces Agreement with BioStem Technologies to Commercialize Amniotic Tissue Allograft as Avenova\u00ae Allograft","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"September 2023","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Approved"},{"orgOrder":0,"company":"BioStem Technologies","sponsor":"Undisclosed","pharmaFlowCategory":"D","amount":"$2.0 million","upfrontCash":"Undisclosed","newsHeadline":"BioStem Technologies Closes Oversubscribed $2M Private Placement","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"November 2023","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Approved"}]

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            Details:

            The proceeds will be used to complete clinical trials to support product performance, expand brand awareness and product distribution, including Vendaje Optic (amniotic tissue allograft), a structural tissue allograft composed of the amnion layer of the placental membrane.

            Lead Product(s): Amniotic Tissue Allograft

            Therapeutic Area: Ophthalmology Product Name: Vendaje Optic

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Undisclosed

            Deal Size: $2.0 million Upfront Cash: Undisclosed

            Deal Type: Private Placement November 03, 2023

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            Under the agreement, NovaBay has been granted the right to commercialize BioStem Technologies’ Vendaje Optic (amniotic tissue allograft) as Avenova® Allograft, which is intended for use as a protective covering during the repair of ocular surfaces.

            Lead Product(s): Amniotic Tissue Allograft

            Therapeutic Area: Ophthalmology Product Name: Vendaje Optic

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: NovaBay Pharmaceuticals

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Licensing Agreement September 11, 2023

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            VENDAJE is a structural tissue allograft composed of the dehydrated human amniotic membrane of the placental membrane. VENDAJE is intended for homologous use as a protective covering for soft tissue wounds.

            Lead Product(s): Dehydrated Human Amniotic Membrane

            Therapeutic Area: Trauma (Emergency, Injury, Surgery) Product Name: Vendaje

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 24, 2023

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            Details:

            The study investigates a standardized method to quantify the elution of growth factors and cytokines in BioStem’s dehydrated amniotic membrane (Vendaje®) and dehydrated amnion/chorion (Vendaje AC®) placental derived allografts as a function of surface (cm2).

            Lead Product(s): Dehydrated Human Amniotic Membrane

            Therapeutic Area: Trauma (Emergency, Injury, Surgery) Product Name: Vendaje

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 13, 2022

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            Details:

            The TRIP response indicated that VENDAJE™ does meet the criteria in 21 CFR 1271.10(a) for regulation solely under Section 361 of the Public Health Service Act and 21 CFR 1271.

            Lead Product(s): Dehydrated human amniotic membrane allograft

            Therapeutic Area: Trauma (Emergency, Injury, Surgery) Product Name: Vendaje

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 25, 2021

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