BME Introduces the HammerLock™ Shape Memory Device for Hammertoes.
October 18, 2010
SAN ANTONIO, October 18, 2010 — BioMedical Enterprises, Inc. (BME), a privately held medical device company and leader in orthopedic shape memory implant technology, announces the nationwide launch of the HammerLockTM Intramedullary Nitinol Fixation System for use in the correction of hammertoes.
A hammertoe is a permanent and sometimes painful deformity of the proximal joint of the 2nd through 5th toes. Hundreds of thousands of people seek treatment each year for this condition and surgical intervention is often necessary to bring relief to the patient. The most common correction method involves the use of a thin wire to stabilize the joint. This method, which leaves the wire exposed for several weeks, results in complications and is an inconvenience for the patient.
The BME HammerLockTM stabilizes the proximal joint of the toe without the need for exposed wires. Formed out of the biocompatible shape memory alloy Nitinol, the HammerLockTM is designed to change shape when exposed to body heat. After being placed internally across the joint in its closed, spear-like shape, the implant morphs as it warms to normal limb temperature to provide strong fixation of the proximal joint of the toe. Its spring-like behavior then compresses the joint long-term resulting in an optimal environment for healing.
Made by Texas-based BME, the only Nitinol small bone fixation manufacturer in the U.S., the HammerLockTM was carefully designed with the feedback of dozens of foot surgeons from across the country resulting in an advanced, robust implant that provides secure fixation. In addition, the implant's patent-pending storage and deployment system sets a new standard for quick, simple and precise insertion minimizing operating room time.
"The new BME HammerLockTM intramedullary implant has improved my patient outcomes for hammertoe surgery," says Dr. Jeremy McVay. "It is easy to implant and comes in a variety of sizes to better suit each patient. The superior design provides better compressive capabilities compared to others on the market."
Mr. Keith M Peeples, President and CEO of BME stated, "Patients and surgeons have asked for another new intramedullary device for the treatment of hammertoes and the BME HammerLockTM has proven to be an excellent next step. This is the first of many new products being delivered from the BME drawing board."
BioMedical Enterprises, Inc., (BME) originally founded as a biomedical research firm specializing in bone healing, is now a reconstructive bone fusion product company and the worldwide leader in the understanding of memory metal and its orthopedic applications. BME was the first company to introduce above body temperature shape changing memory metal staples to the U.S., the first to develop and patent a method of controlling their compressive forces and the only U.S.-based memory metal small bone implant manufacturer. For more information, visit http://www.bmeortho.com.
CONTACT:
Eric Marcano, Marketing Manager
BioMedical Enterprises, Inc. (BME)
Tel: (800) 880-6528
Fax: (210) 677-0355
www.bmeortho.com
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Announces U.S. Launch of Barbed OSStaple™ (BOSS)
June 16, 2008
SAN ANTONIO, June 16, 2008 – BME (BioMedical Enterprises, Inc.), a privately held medical device company and leader in orthopaedic shape memory implant technology, today announced the launch of the Barbed OSStaple™ (BOSS), a nitinol implant designed for internal fixation ofbone.
The BOSS is an orthopaedic nitinol implant with barbs on the legs for bone adhesion. Like the BME OSStaple™ product line, the BOSS nitinol staple changes shape when heated above body temperature to provide compression between two bones. The BOSS is ideal for upper and lower extremity procedures, especially when surgeons want the added security of barbed legs to stabilize the implant.
Made of nitinol, a biocompatible alloy possessing shape memory and super-elastic properties, the BOSS implant is inserted at room temperature. Using BME's patented OSSforce™ Implant Controller, the implant is safely heated above body temperature. During this process, the implant's legs and back change shape to compress bone. In addition, the movement of the legs causes the barbs to anchor more securely in bone. After heating, the nitinol structure transforms into a state approximately 20% stronger than 316L stainless steel. Due to nitinol's unique properties, the implant continues to maintain a compressive force in bone over time.
The BOSS implant, along with BME's OSSAnchor™ Grip soft tissue anchor, are the first orthopaedic nitinol implants to feature barbs for improved pull-out resistance, a new surface treatment that minimizes metal ion release, and a roughened surface texture for bone in-growth.
A national launch of the Barbed OSStaple™ will begin at the American Orthopaedic Foot and Ankle Society summer meeting in Denver, Colorado being held June 25-28.
BME is a medical device company that addresses the changing needs in musculoskeletal medicine. BME focuses on minimally invasive orthopaedic instrumentation and implants that elicit a biologic response. BME's focus on memory metal internal fixation implants is changing the shape of orthopaedic medicine. Its specialized history of musculoskeletal research services will continue to produce unique, state of the art orthopaedic products that provide better outcomes for patients and more convenience to surgeons. For more information visit http://www.bme-tx.com.
U.S. Launch of the OSSArc™ Anatomic Residual Compression Implant
October 31, 2007
SAN ANTONIO, October 31, 2007 – BME (BioMedical Enterprises, Inc.), a privately held medical device company and leader in orthopaedic shape memory implant technology, today announced the November launch of the OSSArc™, the first nitinol implant adapted for irregular bone surfaces and metaphyseal anatomy.
The OSSArc™, an enhancement of BME’s highly successful OSStaple™ implant, allows the surgeon to secure the legs of the implant parallel to the osteotomy or fusion interface while its unique sloping back creates a low profile construct that minimizes any potential soft tissue irritation by reducing the implant’s prominence. The OSSArc™ is ideal for procedures (such as Akin osteotomies and Jones fractures in the foot and phalangeal and metacarpal fractures in the hand) that can be a challenge with other methods of fixation.
Made of nitinol, a biocompatible alloy possessing shape memory and super-elastic properties, the OSSArc™ implant is inserted while in its malleable state at room temperature. Using BME’s patented OSSforce™ Implant Controller, the implant is safely heated above body temperature. During this process, the implant’s legs close and its s-shaped back shrinks providing uniform compression while the alloy’s structure transforms into a state approximately 20% stronger than 316L stainless steel. Due to nitinol’s unique properties, the implant continues to maintain a compressive force over time through long-term active reduction.
BME recently received a patent award from the United States Patent and Trademark Office for 61 claims providing protection for their innovative OSSforce™ Implant Controller technology. The OSSArc™ Implants and the OSSforce™ Implant Controller will be showcased by BME at the Podiatry Institute’s Annual Sanibel Conference being held November 1-3, 2007 in Fort Myers, Florida.
BME is a medical device company that addresses the changing needs in musculoskeletal medicine. BME focuses on minimally invasive orthopaedic instrumentation and implants that elicit a biologic response. BME's focus on memory metal internal fixation implants is changing the shape of orthopaedic medicine. Its specialized history of musculoskeletal research services will continue to produce unique, state of the art orthopaedic products that provide better outcomes for patients and more convenience to surgeons.
Product Information
CONTACT:
Eric Marcano, Marketing Manager
BioMedical Enterprises, Inc. (BME)
Tel: (800) 880-6528
Receives FDA Clearance for Spine Use of Memory Metal Implants
October 22, 2007
SAN ANTONIO, October 22, 2007 -- BioMedical Enterprises, Inc. (BME), a privately held medical device company and leader in orthopedic shape memory implant technology, today announced that the U.S. Food and Drug Administration (FDA) has given 510(k) marketing clearance to the OSSpine™ for use in anterior fixation of the cervical spine to provide enhanced biomechanical stability & bone graft retention. The patent-pending OSSpine™ builds on the extremity bone fusion success of BME’s OSStaple™ and OSSplate™, and joins the Step OSStaple™ and the OSSArc™ dynamic residual compression implants as the most recent additions to BME's OSSforce™ Fixation System.
Made of nitinol, a biocompatible alloy possessing shape memory and super-elastic properties, the OSSpine™ implant is inserted while in its malleable state at room temperature. Using BME’s patented OSSforce™ Implant Controller, the implant is safely heated to activate its shape change and impart compression forces across the fusion site. During this process, the implant’s legs close and it’s s-shaped back shrinks providing uniform compression while the alloy’s structure transforms into a state approximately 20% stronger then 316L stainless steel. The OSSpine™ implant actively compresses the fusion construct compensating for any graft subsidence that may occur during healing.
BME was recently awarded a patent from the United States Patent and Trademark Office for 61 claims providing protection for their innovative OSSforce™ Implant Controller technology. The OSSpine™ implants and the OSSforce™ Implant Controller will be showcased by BME at the North American Spine Society (NASS) 22nd Annual Meeting being held October 23-27, 2007 in Austin, Texas.
BioMedical Enterprises, Inc. (BME) is a medical device company that addresses the changing needs in musculoskeletal medicine. BME focuses on minimally invasive orthopaedic instrumentation and implants that elicit a biologic response. BME's focus on memory metal internal fixation implants is changing the shape of orthopaedic medicine. Its specialized history of musculoskeletal research services will continue to produce unique, state of the art orthopaedic products that provide better outcomes for patients and more convenience to surgeons. For more information visit http://www.bme-tx.com.
Product Information
CONTACT:
Eric Marcano, Marketing Manager
BioMedical Enterprises, Inc. (BME)
Tel: (800) 880-6528
Fax: (210) 677-0355
http://www.bme-tx.com
Patent Award for System and Method of Controlling Nitinol Implants
July 31, 2007
SAN ANTONIO, TX, July 31, 2007 -- BioMedical Enterprises, Inc. (BME), global leader in orthopaedic memory metal implant technology, announced today that the U.S. Patent Office awarded BME with the patent for “System and Method for Force, Displacement and Rate Control of Shape Memory Material Implants.” Covering 61 claims, patent number 7,240,677 provides protection for BME’s innovative OSSforce™ Implant Controller technology.
The issued patent provides BME market exclusivity for years to come for the control of memory materials used in medicine. The patent covers instruments, methods and thus implants formed of shape memory material where the shape change is controlled. This patent covers any form of heat energy source such as, electrical resistive heating, conductive heating or inductive heating. This advanced technology for the use of shape memory materials, including nitinol, allows the surgeon for the first time to fully control a shape changing implant.
BME’s OSSforce™ Implant Controller is BME’s first product utilizing the features described and claimed in the issued patent. These features give surgeons control over BME's extensive line of bone fusion devices such as the OSStaple™ and OSSplate™ . These devices, formed from nitinol, have a pre-programmed shape. When implanted in one configuration the OSSforce™ controls the extent of return of the implant to a second configuration.
The musculoskeletal application of the OSSforce™ Implant Controller gives surgeons the ability to control the activation rate of the implant and the forces applied across the bone fusion interface. Implant forces can be decreased in osteoporosis cases to protect against iatrogenic fractures or can be increased in the healthy skeleton to provide maximum bone fixation. In the correction of deformities, the surgeon can change the shape of the implant to adjust for the growing adolescent. These variables are controlled while keeping the implant temperature below the point of thermal necrosis of tissue.
BioMedical Enterprises, Inc. (BME) is a medical device company that addresses the changing needs in musculoskeletal medicine. BME focuses on minimally invasive orthopaedic instrumentation and implants that elicit a biologic response. BME's focus on memory metal internal fixation implants is changing the shape of orthopaedic medicine. Its specialized history of musculoskeletal research services will continue to produce unique, state of the art orthopaedic products that provide better outcomes for patients and more convenience to surgeons. For more information visit http://www.bme-tx.com.
Product Information
CONTACT:
Eric Marcano, Marketing Manager
BioMedical Enterprises, Inc. (BME)
Tel: (210) 677-0354
Fax: (210) 677-0355