Press Releases
Synergy Biomedical Launches BIOSPHERE® Flex SP Extremities, Synthetic Bioactive Bone Graft.
March 22, 2022
WAYNE, Pa.--(BUSINESS WIRE)--Synergy Biomedical, LLC, a developer of innovative biomaterial products, today announced the launching of BIOSPHERE® FLEX SP EXTREMITIES, Synthetic Bioactive Bone Graft. Using Synergy’s proprietary BIOSPHERE® Technology, BIOSPHERE® FLEX SP Extremities is a sheet putty composed of innovative spherical bioactive glass granules combined with a porous collagen/sodium hyaluronate carrier. This product addition adds to the already highly successful Synergy FLEX sheet putty product portfolio. Flex SP Extremities expects to be an integral solution into the Upper and Lower Extremity market.
BIOSPHERE® FLEX SP EXTREMITIES is a third-generation bioactive glass bone graft solution. Specifically developed to maximize the bone healing potential of bioactive glass. Utilizing the well-known and trusted 45S5 bioactive glass composition that has been proven to be an effective bone graft material. FLEX SP EXTREMITIES is a sheet putty that is easy to handle, flexible and moldable (once hydrated) to aid in surgical placement. Designed to accommodate bone marrow aspirate and is available in small and medium sizes.
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March 22, 2022
WAYNE, Pa.--(BUSINESS WIRE)--Synergy Biomedical, LLC, a developer of innovative biomaterial products, today announced the launching of BIOSPHERE® FLEX SP EXTREMITIES, Synthetic Bioactive Bone Graft. Using Synergy’s proprietary BIOSPHERE® Technology, BIOSPHERE® FLEX SP Extremities is a sheet putty composed of innovative spherical bioactive glass granules combined with a porous collagen/sodium hyaluronate carrier. This product addition adds to the already highly successful Synergy FLEX sheet putty product portfolio. Flex SP Extremities expects to be an integral solution into the Upper and Lower Extremity market.
BIOSPHERE® FLEX SP EXTREMITIES is a third-generation bioactive glass bone graft solution. Specifically developed to maximize the bone healing potential of bioactive glass. Utilizing the well-known and trusted 45S5 bioactive glass composition that has been proven to be an effective bone graft material. FLEX SP EXTREMITIES is a sheet putty that is easy to handle, flexible and moldable (once hydrated) to aid in surgical placement. Designed to accommodate bone marrow aspirate and is available in small and medium sizes.
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Synergy Biomedical Launches BIOSPHERE® MIS II, Next Generation Minimally Invasive Bone Graft Delivery System
March 1, 2022
WAYNE, Pa.--(BUSINESS WIRE)--Synergy Biomedical, LLC, a developer of innovative biomaterial products, today announced the launching of BIOSPHERE® MIS II, Next Generation Minimally Invasive Bone Graft Delivery System. Synergy continues to add solutions for surgeons with new innovative biomaterial products to an already successful portfolio. Leveraging off the proven success of the first-generation design, BIOSPHERE® MIS II utilizes a pre-loaded bone graft cannula and a streamlined trigger-based system as a bone graft delivery solution that is optimized for the unique challenges of minimally invasive surgery.
BIOSPHERE® MIS II is a low-profile graft delivery system that allows me to place graft in difficult to access locations without obstructing my view. My favorite feature is being able to control the amount of graft that is delivered by simply deploying the trigger handle,” stated Dr. Barcohana, M.D. (Spine surgeon at the Southern California Orthopedic Institute in alliance with UCLA Health). “MIS II is a Next Generation System that provides me with the solutions I need when facing the unique challenges of minimally invasive spinal surgery.”
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March 1, 2022
WAYNE, Pa.--(BUSINESS WIRE)--Synergy Biomedical, LLC, a developer of innovative biomaterial products, today announced the launching of BIOSPHERE® MIS II, Next Generation Minimally Invasive Bone Graft Delivery System. Synergy continues to add solutions for surgeons with new innovative biomaterial products to an already successful portfolio. Leveraging off the proven success of the first-generation design, BIOSPHERE® MIS II utilizes a pre-loaded bone graft cannula and a streamlined trigger-based system as a bone graft delivery solution that is optimized for the unique challenges of minimally invasive surgery.
BIOSPHERE® MIS II is a low-profile graft delivery system that allows me to place graft in difficult to access locations without obstructing my view. My favorite feature is being able to control the amount of graft that is delivered by simply deploying the trigger handle,” stated Dr. Barcohana, M.D. (Spine surgeon at the Southern California Orthopedic Institute in alliance with UCLA Health). “MIS II is a Next Generation System that provides me with the solutions I need when facing the unique challenges of minimally invasive spinal surgery.”
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Synergy Biomedical Announces Publication of Core Scientific Study on Its BioSphere® Bone Graft Technology
January 26, 2022
WAYNE, Pa.--(BUSINESS WIRE)--Synergy Biomedical, LLC, a developer of innovative bone graft products for spine and orthopedic surgery, announced the publication of a basic science study describing the findings and scientific strategies of controlling the bone formation response of bioactive glass. This study was conducted by Synergy’s founder, Mark Borden Ph.D. and a team of clinical and basic science collaborators, and is published in the Journal of Biomedical Materials Research, Part B: Applied Biomaterials.
“This pivotal paper documents the innovative work conducted in the early history of Synergy Biomedical that identified bioactive glass spheres as an optimal particle for bone regeneration,” stated Kevin Booth, CEO of Synergy Biomedical. “The study highlights Synergy’s strategic approach to understand and optimize biomaterial properties in order to bring next-generation bone graft products to the market. This strategy has differentiated our products and technology in a market full of first-generation bone graft materials.”
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January 26, 2022
WAYNE, Pa.--(BUSINESS WIRE)--Synergy Biomedical, LLC, a developer of innovative bone graft products for spine and orthopedic surgery, announced the publication of a basic science study describing the findings and scientific strategies of controlling the bone formation response of bioactive glass. This study was conducted by Synergy’s founder, Mark Borden Ph.D. and a team of clinical and basic science collaborators, and is published in the Journal of Biomedical Materials Research, Part B: Applied Biomaterials.
“This pivotal paper documents the innovative work conducted in the early history of Synergy Biomedical that identified bioactive glass spheres as an optimal particle for bone regeneration,” stated Kevin Booth, CEO of Synergy Biomedical. “The study highlights Synergy’s strategic approach to understand and optimize biomaterial properties in order to bring next-generation bone graft products to the market. This strategy has differentiated our products and technology in a market full of first-generation bone graft materials.”
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Synergy Biomedical Announces FDA Clearance of BIOSPHERE® FLEX
September 28, 2018
COLLEGEVILLE, PA--(BUSINESS WIRE)--Synergy Biomedical, LLC, a developer of innovative biomaterial products, announced today that it has received FDA 510(k) clearance of BIOSPHERE® FLEX and is targeting a launch in the 4th quarter of 2018. Based on Synergy’s BioSphere® Technology, BIOSPHERE® FLEX is composed of porous, bioactive glass granules combined with a porous collagen and sodium hyaluronate scaffold. The porosity of BIOSPHERE® FLEX bone graft was specifically designed to absorb bone marrow aspirate.
“The FDA clearance of BIOSPHERE® FLEX adds a key product to Synergy’s synthetic bone graft portfolio,” stated Dr. Mark Borden, Ph.D., President/CEO of Synergy Biomedical. “The BIOSPHERE® product line provides surgeons with a variety of bone graft forms that can be tailored to their surgical technique. This includes BIOSPHERE® PUTTY which is a robust bone graft material that can be used alone or combined with autograft, BIOSPHERE® MIS PUTTY which was specifically designed for minimally invasive surgery, and BIOSPHERE® FLEX which was developed to be used by surgeons who prefer to mix in bone marrow aspirate.”
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September 28, 2018
COLLEGEVILLE, PA--(BUSINESS WIRE)--Synergy Biomedical, LLC, a developer of innovative biomaterial products, announced today that it has received FDA 510(k) clearance of BIOSPHERE® FLEX and is targeting a launch in the 4th quarter of 2018. Based on Synergy’s BioSphere® Technology, BIOSPHERE® FLEX is composed of porous, bioactive glass granules combined with a porous collagen and sodium hyaluronate scaffold. The porosity of BIOSPHERE® FLEX bone graft was specifically designed to absorb bone marrow aspirate.
“The FDA clearance of BIOSPHERE® FLEX adds a key product to Synergy’s synthetic bone graft portfolio,” stated Dr. Mark Borden, Ph.D., President/CEO of Synergy Biomedical. “The BIOSPHERE® product line provides surgeons with a variety of bone graft forms that can be tailored to their surgical technique. This includes BIOSPHERE® PUTTY which is a robust bone graft material that can be used alone or combined with autograft, BIOSPHERE® MIS PUTTY which was specifically designed for minimally invasive surgery, and BIOSPHERE® FLEX which was developed to be used by surgeons who prefer to mix in bone marrow aspirate.”
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Synergy Biomedical Announces Issuance of Core Patent for Next Generation, Bioactive Bone Grafts
November 10, 2014
COLLEGEVILLE, Pa. (BUSINESS WIRE) Synergy Biomedical, LLC, a developer of novel biomaterial products for orthopedic and spine surgery, announced today that it was issued a core patent (U.S. Patent 8,871,235) that broadly covers the use of its novel BIOSPHERE® particles in a variety of bone healing products. Synergy's innovative approach to improving bioactive glass is based on using spherical particles with a bimodal size range. In this form, the bone healing response is significantly improved through the optimal release of dissolution ions and particle packing.
"Bioactive glass has had a long history of successful clinical use as a bone graft material. Synergy is the first company to develop products using a next generation, spherical form of bioactive glass that improves healing," stated Mark Borden, Ph.D., president and CEO of Synergy. "The issuance of our recent patent provides Synergy with extended coverage of our innovative BIOSPHERE® technology. The new patent covers our full developmental pipeline including various bone graft forms, resorbable and non-resorbable cements for fracture repair and joint reconstruction, as well as porous constructs for bone fusion."
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November 10, 2014
COLLEGEVILLE, Pa. (BUSINESS WIRE) Synergy Biomedical, LLC, a developer of novel biomaterial products for orthopedic and spine surgery, announced today that it was issued a core patent (U.S. Patent 8,871,235) that broadly covers the use of its novel BIOSPHERE® particles in a variety of bone healing products. Synergy's innovative approach to improving bioactive glass is based on using spherical particles with a bimodal size range. In this form, the bone healing response is significantly improved through the optimal release of dissolution ions and particle packing.
"Bioactive glass has had a long history of successful clinical use as a bone graft material. Synergy is the first company to develop products using a next generation, spherical form of bioactive glass that improves healing," stated Mark Borden, Ph.D., president and CEO of Synergy. "The issuance of our recent patent provides Synergy with extended coverage of our innovative BIOSPHERE® technology. The new patent covers our full developmental pipeline including various bone graft forms, resorbable and non-resorbable cements for fracture repair and joint reconstruction, as well as porous constructs for bone fusion."
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Synergy Biomedical Announces Expanded FDA Clearance of BIOSPHERE PUTTY for Spine Indications
July 17, 2014
COLLEGEVILLE, Pa.--(BUSINESS WIRE) --Synergy Biomedical, LLC (www.synergybiomedical.com), a developer of novel biomaterial products, announced today that it has received 510(k) clearance from the US Food and Drug Administration to market BIOSPHERE® PUTTY as a bone graft extender for use in the posterolateral spine.
"We are very pleased to receive the expanded spine indication for BIOSPHERE PUTTY," stated Dr. Mark Borden, Ph.D., President/CEO of Synergy. "The expanded clearance will give spine surgeons access to a next generation bioactive bone graft product that can be used in challenging spine fusion surgery. The clearance will also allow us to greatly expand our growing distribution network, and get the product into more surgeon's hands."
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July 17, 2014
COLLEGEVILLE, Pa.--(BUSINESS WIRE) --Synergy Biomedical, LLC (www.synergybiomedical.com), a developer of novel biomaterial products, announced today that it has received 510(k) clearance from the US Food and Drug Administration to market BIOSPHERE® PUTTY as a bone graft extender for use in the posterolateral spine.
"We are very pleased to receive the expanded spine indication for BIOSPHERE PUTTY," stated Dr. Mark Borden, Ph.D., President/CEO of Synergy. "The expanded clearance will give spine surgeons access to a next generation bioactive bone graft product that can be used in challenging spine fusion surgery. The clearance will also allow us to greatly expand our growing distribution network, and get the product into more surgeon's hands."
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Synergy Biomedical Launches BioSphere Putty, a Next Generation Bioactive Bone Graft
June 18, 2013
COLLEGEVILLE, Pa. (BUSINESS WIRE) Synergy Biomedical, LLC (www.synergybiomedical.com) announced today that it has recently received FDA clearance and will be launching its first bone graft product, BioSphere™ Putty. Utilizing a specialized form of 45S5 bioactive glass with a unique sphere shape and a narrow size range, BioSphere™ Putty provides an optimized bone graft material that outperforms other bioactive products. The spherical shape of the BioSphere™ particles provides uniform and repeatable resorption and ion release. In addition, the 3-D packing of the spheres in a bone defect creates an optimal porosity that allows bone formation throughout the implant. Biosphere™ Putty is composed of bioactive glass spheres that are combined with a moldable phospholipid carrier. The Putty has the highest bioactive glass composition on the market, provides excellent handling, and is resistant to irrigation. This combination results in a high performance bone graft that provides faster and more robust bone formation.
"The use of spherical particles has allowed Synergy to identify an optimal form of bioactive glass that improves bone formation," stated Mark Borden, Ph.D., CEO and founder of Synergy Biomedical. "We are excited to introduce a next generation bone graft product to the orthopaedic community that represents an advancement in bone grafting technology," stated Dr. Borden.
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June 18, 2013
COLLEGEVILLE, Pa. (BUSINESS WIRE) Synergy Biomedical, LLC (www.synergybiomedical.com) announced today that it has recently received FDA clearance and will be launching its first bone graft product, BioSphere™ Putty. Utilizing a specialized form of 45S5 bioactive glass with a unique sphere shape and a narrow size range, BioSphere™ Putty provides an optimized bone graft material that outperforms other bioactive products. The spherical shape of the BioSphere™ particles provides uniform and repeatable resorption and ion release. In addition, the 3-D packing of the spheres in a bone defect creates an optimal porosity that allows bone formation throughout the implant. Biosphere™ Putty is composed of bioactive glass spheres that are combined with a moldable phospholipid carrier. The Putty has the highest bioactive glass composition on the market, provides excellent handling, and is resistant to irrigation. This combination results in a high performance bone graft that provides faster and more robust bone formation.
"The use of spherical particles has allowed Synergy to identify an optimal form of bioactive glass that improves bone formation," stated Mark Borden, Ph.D., CEO and founder of Synergy Biomedical. "We are excited to introduce a next generation bone graft product to the orthopaedic community that represents an advancement in bone grafting technology," stated Dr. Borden.
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Synergy Biomedical Announces Issuance of Key Patent for Improved Bioactive Bone Grafts
August 19, 2013
COLLEGEVILLE, Pa. (BUSINESS WIRE) Synergy Biomedical, LLC (www.synergybiomedical.com) announced today that it has recently received FDA clearance and will be launching its first bone graft product, BioSphere™ Putty. Utilizing a specialized form of 45S5 bioactive glass with a unique sphere shape and a narrow size range, BioSphere™ Putty provides an optimized bone graft material that outperforms other bioactive products. The spherical shape of the BioSphere™ particles provides uniform and repeatable resorption and ion release. In addition, the 3-D packing of the spheres in a bone defect creates an optimal porosity that allows bone formation throughout the implant. Biosphere™ Putty is composed of bioactive glass spheres that are combined with a moldable phospholipid carrier. The Putty has the highest bioactive glass composition on the market, provides excellent handling, and is resistant to irrigation. This combination results in a high performance bone graft that provides faster and more robust bone formation.
"The use of spherical particles has allowed Synergy to identify an optimal form of bioactive glass that improves bone formation," stated Mark Borden, Ph.D., CEO and founder of Synergy Biomedical. "We are excited to introduce a next generation bone graft product to the orthopaedic community that represents an advancement in bone grafting technology," stated Dr. Borden.
Click here for full article
August 19, 2013
COLLEGEVILLE, Pa. (BUSINESS WIRE) Synergy Biomedical, LLC (www.synergybiomedical.com) announced today that it has recently received FDA clearance and will be launching its first bone graft product, BioSphere™ Putty. Utilizing a specialized form of 45S5 bioactive glass with a unique sphere shape and a narrow size range, BioSphere™ Putty provides an optimized bone graft material that outperforms other bioactive products. The spherical shape of the BioSphere™ particles provides uniform and repeatable resorption and ion release. In addition, the 3-D packing of the spheres in a bone defect creates an optimal porosity that allows bone formation throughout the implant. Biosphere™ Putty is composed of bioactive glass spheres that are combined with a moldable phospholipid carrier. The Putty has the highest bioactive glass composition on the market, provides excellent handling, and is resistant to irrigation. This combination results in a high performance bone graft that provides faster and more robust bone formation.
"The use of spherical particles has allowed Synergy to identify an optimal form of bioactive glass that improves bone formation," stated Mark Borden, Ph.D., CEO and founder of Synergy Biomedical. "We are excited to introduce a next generation bone graft product to the orthopaedic community that represents an advancement in bone grafting technology," stated Dr. Borden.
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