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Synergy Biomedical Receives CE Mark for BIOSPHERE PUTTY
February 28, 2017
COLLEGEVILLE, Pa.--(BUSINESS WIRE) --Synergy Biomedical, LLC, a developer of innovative bone graft products for spine and orthopedic surgery, announced today that it has received CE Mark clearance in the European Union for its next generation bone graft, BIOSPHERE PUTTY.
“When it comes to selecting the best bone graft strategy for each patient, there are a wide array of options for surgeons. BIOSPHERE PUTTY is an elegant bone graft solution that is based on scientifically valid principles”
Originally launched in the U.S. in 2013, BIOSPHERE PUTTY is a synthetic bone graft product that utilizes a unique form of bioactive glass in combination with a moldable phospholipid carrier. Based on the Company’s patented BioSphere Technology, BIOSPHERE PUTTY has been shown in vivo to significantly improve the healing potential of bioactive glass due to its spherical particle shape and optimized, bimodal size range.
“Since its introduction, BIOSPHERE PUTTY has been very well received by surgeons due to its successful clinical use and excellent intraoperative handling,” stated Dr. Mark Borden, Ph.D., President/CEO of Synergy. “We are very pleased to receive our CE Mark and are looking forward to introducing a truly next generation, synthetic bone graft product to the European community.”
Under its cleared European indication, BIOSPHERE PUTTY is intended to be used as a bone graft material for filling bony voids or gaps of the skeletal system. This includes the use of the product for interbody and posterolateral fusion, and general bone defect filling in the extremities and pelvis. The product may be used alone or in combination with autograft or allograft.
“When it comes to selecting the best bone graft strategy for each patient, there are a wide array of options for surgeons. BIOSPHERE PUTTY is an elegant bone graft solution that is based on scientifically valid principles,” said Erik Westerlund MD, FACS, Director of the Ortho-Neuro Integrated Spine Surgery Program at St. Francis Hospital in the U.S. “It applies an advanced and refined understanding of bioactive glass to drive a purposeful cellular level response and to provide an ideal physical environment for even and predictable bone ingrowth. My clinical experience with BIOSPHERE PUTTY over the past two years has been excellent, with consistently successful long-term outcomes in a wide range of spinal applications. It is an extremely thoughtful and equally versatile bone graft solution.”
BIOSPHERE PUTTY is the first of several bone graft products being developed by Synergy Biomedical that utilize patented bioactive glass spheres that have been shown to improve the bone healing potential of bioactive glass. BIOSPHERE PUTTY provides surgeons with a moldable bone graft material that is easy to use and compatible with a variety of bone grafting techniques.
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February 28, 2017
COLLEGEVILLE, Pa.--(BUSINESS WIRE) --Synergy Biomedical, LLC, a developer of innovative bone graft products for spine and orthopedic surgery, announced today that it has received CE Mark clearance in the European Union for its next generation bone graft, BIOSPHERE PUTTY.
“When it comes to selecting the best bone graft strategy for each patient, there are a wide array of options for surgeons. BIOSPHERE PUTTY is an elegant bone graft solution that is based on scientifically valid principles”
Originally launched in the U.S. in 2013, BIOSPHERE PUTTY is a synthetic bone graft product that utilizes a unique form of bioactive glass in combination with a moldable phospholipid carrier. Based on the Company’s patented BioSphere Technology, BIOSPHERE PUTTY has been shown in vivo to significantly improve the healing potential of bioactive glass due to its spherical particle shape and optimized, bimodal size range.
“Since its introduction, BIOSPHERE PUTTY has been very well received by surgeons due to its successful clinical use and excellent intraoperative handling,” stated Dr. Mark Borden, Ph.D., President/CEO of Synergy. “We are very pleased to receive our CE Mark and are looking forward to introducing a truly next generation, synthetic bone graft product to the European community.”
Under its cleared European indication, BIOSPHERE PUTTY is intended to be used as a bone graft material for filling bony voids or gaps of the skeletal system. This includes the use of the product for interbody and posterolateral fusion, and general bone defect filling in the extremities and pelvis. The product may be used alone or in combination with autograft or allograft.
“When it comes to selecting the best bone graft strategy for each patient, there are a wide array of options for surgeons. BIOSPHERE PUTTY is an elegant bone graft solution that is based on scientifically valid principles,” said Erik Westerlund MD, FACS, Director of the Ortho-Neuro Integrated Spine Surgery Program at St. Francis Hospital in the U.S. “It applies an advanced and refined understanding of bioactive glass to drive a purposeful cellular level response and to provide an ideal physical environment for even and predictable bone ingrowth. My clinical experience with BIOSPHERE PUTTY over the past two years has been excellent, with consistently successful long-term outcomes in a wide range of spinal applications. It is an extremely thoughtful and equally versatile bone graft solution.”
BIOSPHERE PUTTY is the first of several bone graft products being developed by Synergy Biomedical that utilize patented bioactive glass spheres that have been shown to improve the bone healing potential of bioactive glass. BIOSPHERE PUTTY provides surgeons with a moldable bone graft material that is easy to use and compatible with a variety of bone grafting techniques.
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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.
click here for full article
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.
click here for full article
