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Synergy Biomedical Announces Regulatory Clearance and Launch of BIOSPHERE PUTTY in Australia
March 6, 2018
COLLEGEVILLE, Pa. (BUSINESS WIRE) Synergy Biomedical, LLC, a developer of orthobiologic and biomaterial products, announced that it has received Therapeutic Goods Administration (TGA) clearance in Australia for its bioactive bone graft, BIOSPHERE PUTTY. BIOSPHERE PUTTY is an advanced synthetic bone graft product that has previously received FDA and CE Mark clearances, and has been on the market since 2013.
“We are very pleased with our TGA clearance and are excited to launch this innovative, synthetic bone graft in Australia,” indicated Dr. Mark Borden, Ph.D., President/CEO of Synergy. “This clearance enables more surgeons worldwide access to our next-generation bone graft technology.”
“The launch of BioSphere Putty in Australia represents a significant milestone in expanding our distribution across the globe,” stated Kevin Booth, VP of Sales. “The Australian market provides Synergy with a sizable opportunity to grow our BioSphere Putty sales.”
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March 6, 2018
COLLEGEVILLE, Pa. (BUSINESS WIRE) Synergy Biomedical, LLC, a developer of orthobiologic and biomaterial products, announced that it has received Therapeutic Goods Administration (TGA) clearance in Australia for its bioactive bone graft, BIOSPHERE PUTTY. BIOSPHERE PUTTY is an advanced synthetic bone graft product that has previously received FDA and CE Mark clearances, and has been on the market since 2013.
“We are very pleased with our TGA clearance and are excited to launch this innovative, synthetic bone graft in Australia,” indicated Dr. Mark Borden, Ph.D., President/CEO of Synergy. “This clearance enables more surgeons worldwide access to our next-generation bone graft technology.”
“The launch of BioSphere Putty in Australia represents a significant milestone in expanding our distribution across the globe,” stated Kevin Booth, VP of Sales. “The Australian market provides Synergy with a sizable opportunity to grow our BioSphere Putty sales.”
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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.”
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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.”
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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