Press Room

Wednesday, May 26, 2010

Applied Spine Technologies Awarded Two New Patents, Expanding Stabilimax^® IP Portfolio

Sixth, seventh patent awards in recent months for the spinal motion preserving device.

ROCKY HILL, Conn. -- Applied Spine Technologies, Inc., a medical device company focused on motion preservation of the lumbar spine, was awarded two new patents by the U.S. Patent and Trademark Office on May 11, 2010.

The first, titled ‘Dynamic spine stabilizer’ (U.S. patent No. 7,713,287), sites both stiffness and travel in a spring based dynamic stabilization device.

The second, titled ‘Spring junction and assembly methods for spinal device’ (U.S. patent No. 7,713,288), sites a connection between the spring and cap assembly of the device.

“A key feature of a dynamic stabilization device is its ability to permit relative movement between the vertebral bodies, what some call interpedicular travel.” said Bruce Robie, PhD, Vice President of Research and Development for Applied Spine. “Our intellectual property focuses on springs to achieve meaningful travel. The ‘Spring Junction’ patent protects geometry to create a spring based dynamic stabilization device, and the ‘Dynamic Spine Stabilizer’ patent protects a range of stiffness and travel values to ensure its clinical utility.’

“Being involved in a PMA/IDE for a spinal motion preservation technology is a time consuming and expensive exercise, never more so than in today’s difficult climate”, said Craig Corrance, President and CEO of Applied Spine. “It has, therefore, been particularly satisfying for the Applied Spine team to receive five additional patents during the past 6 months, with several more notable patents due to mature in the near future.”

“The significance of these multiple method and apparatus awards is that it recognizes not only the unique qualities of the Stabilimax device, but also the distinct differentiation advantage we enjoy in comparison to competitors in this space. Expansion of Applied Spine’s US and international IP portfolio continues to add strategic value to the company, as it comes at a time when the clinical community has developed a greater appreciation for the importance of interpedicular travel in dynamic stabilization devices such as Stabilimax.”

About Applied Spine Technologies Inc., and Stabilimax

Applied Spine Technologies Inc., headquartered in Rocky Hill, Connecticut, is developing the Stabilimax Dynamic Spine Stabilization System, a posterior dynamic stabilization device designed to support an injured or degenerated spine without eliminating motion. Stabilimax is expected to offer numerous advantages over current spinal fixation products and even new artificial disc products—including a much less invasive and less traumatic implant procedure, maintenance of spine motion and disc function, and the potential to prevent or slow adjacent-segment disc disease.

About the IDE Clinical Trial

Applied Spine Technologies, Inc. is currently conducting a multi-center, randomized, controlled clinical trial in the U.S. to compare posterior dynamic stabilization using the Stabilimax Dynamic Spine Stabilization System to traditional spinal fusion stabilization to treat degenerative lumbar spinal stenosis. AST has enrolled more than 100 patients to date.

Stabilimax is an investigational device in the United States. It is limited by United States (U.S.) Federal Law for investigational use only.

Tuesday, April 13, 2010

IDE Trial Data for Applied Spine Technologies Stabilimax System to be Presented at Spine Arthroplasty Society Meeting in New Orleans

ROCKY HILL, Conn. -- Applied Spine Technologies, Inc., a medical device company focused on motion preservation of the lumbar spine, today announced that new information regarding the Stabilimax^® Dynamic Spine Stabilization System will be featured in two podium presentations and four poster presentations at the forthcoming Spine Arthroplasty Society (SAS) meeting in New Orleans on April 27th - 30th, 2010.

Podium Presentations:

12-24 Month Results from a US IDE Trial Evaluating a Lumbar Posterior Dynamic Stabilization (PDS) System
N. Anand¹, M. Lorio², R. Rosemann¹
¹Cedars-Sinai Medical Center, Los Angeles, United States, CA, ²Neuro-Spine Solutions, Bristol, TN

Clinical Assessment of Adjacent Level Effects (ALE) Induced by Stabilimax Lumbar Posterior Dynamic Stabilization (PDS) Implant through Measurement of Range of Motion (ROM) and InterPedicular Travel (IPT)
S.H. Kitchel¹, N.C. Wharton², A.K. Khandha³
¹Oregon Health and Sciences University, Department of Orthopedic Surgery, Eugene, OR, ²Medical Metrics, Inc, Houston, TX, ³Applied Spine Technologies, Rocky Hill, CT

Poster Presentations:

An analysis of PostOp Performance of the Stabilimax posterior dynamic stabilization (PDS) implant through measurement of Range of Motion (ROM) and InterPedicular Travel (IPT)
Castellvi AE, Khandha A, Wharton N, Ferrara L, Anand N, Cheng J

Quantity and Quality of Motion in Stenosis Patients
Anand N, Robie B, Wharton N, Ferrara L, Yonemura K, Castellvi AE

A comparison of Range of Motion (ROM) and Forces in a single level vs. multi-level lumbar Posterior Dynamic Stabilization (PDS) implant - Finite Element (FE) study
Ambati D, Nayak A, Kiapour A, Goel VK, Khandha A

Effects of Different Posterior Dynamic Systems (PDS) on Graded Facetectomies
Parikh R, Kiapour A, Goel VK, Mhatre D, Castellvi AE, Khandha A

Thursday, April 8, 2010

Applied Spine Technologies Awarded New Patent

ROCKY HILL, Conn. -- Applied Spine Technologies, Inc., a medical device company focused on motion preservation of the lumbar spine, has been awarded a new patent titled “Spinal Stabilization Device with Weld Cap”.

U.S. patent No. 7,699,875, issued by the U.S. Patent and Trademark Office on April 20, 2010, claims geometry for a spring based spinal stabilization device including members to mechanically connect the spring to other structural components.

“Enabling a motion preserving device to shorten and lengthen -- frequently referred to as interpedicular travel -- is a key feature of clinically viable dynamic stabilization devices and springs are one of the best ways to enable interpedicular travel. The challenge associated with the use of springs is connecting the spring to the pedicle screws in a way that can survive the millions of loading cycles expected of the device,” said Bruce Robie, PhD, Vice President of Research and Development for Applied Spine. “This patent protects geometry to take a relatively standard coil spring and incorporate it successfully into a functional dynamic stabilization device.”

“One of the documented clinical benefits of our Stabilimax device is its allowance of significant interpedicular travel,” said Craig Corrance, President and CEO. “The issuance of this patent recognizes the uniqueness associated with our device and adds yet another layer to our patent portfolio, complementing previously issued patents on spring based dynamic stabilization devices and devices that enable dynamic angulation. In combination with two additional notices of allowance already received from the Patent Office, our I.P. portfolio is in a stage of growth, and our expectation is that it will have an increasing impact on pedicle based dynamic stabilization devices over the coming months and years.”

About Applied Spine Technologies Inc., and Stabilimax^®

Applied Spine Technologies Inc., headquartered in Rocky Hill, Connecticut, is developing the Stabilimax Dynamic Spine Stabilization System, a posterior dynamic stabilization device designed to support an injured or degenerated spine without eliminating motion. Stabilimax is expected to offer numerous advantages over current spinal fixation products and even new artificial disc products—including a much less invasive and less traumatic implant procedure, maintenance of spine motion and disc function, and the potential to prevent or slow adjacent-segment disc disease.

About the IDE Clinical Trial

Applied Spine Technologies, Inc. is currently conducting a multi-center, randomized, controlled clinical trial in the U.S. to compare posterior dynamic stabilization using the Stabilimax Dynamic Spine Stabilization System to traditional spinal fusion stabilization to treat degenerative lumbar spinal stenosis. AST has enrolled more than 100 patients to date.

Stabilimax is an investigational device in the United States. It is limited by United States (U.S.) Federal Law for investigational use only.

Monday, March 8, 2010

Applied Spine Technologies to Present at the Canaccord Adams Musculoskeletal Conference

Applied Spine Technologies, Inc. www.appliedspine.com, a medical device company focused on motion preservation of the lumbar spine, today announced that Craig Corrance, President and Chief Executive Officer, will be presenting at the annual Canaccord Adams Musculoskeletal Conference. The event will be held in New Orleans at the Sheraton New Orleans Hotel.

Mr. Corrance’s presentation scheduled for Tuesday, March 9, 2010 at 9:20 AM (CST), will include an overview of the Company with an emphasis on the Stabilimax® Dynamic Spine Stabilization System IDE Clinical Trial, and the resulting strategic direction.

About Applied Spine Technologies Inc., and Stabilimax®

Applied Spine Technologies Inc., headquartered in Rocky Hill, Connecticut, is developing the Stabilimax Dynamic Spine Stabilization System, a posterior dynamic stabilization device designed to support an injured or degenerated spine without eliminating motion. Stabilimax is expected to offer numerous advantages over current spinal fixation products and even new artificial disc products—including a much less invasive and less traumatic implant procedure, maintenance of spine motion and disc function, and the potential to prevent or slow adjacent-segment disc disease.

About the IDE Clinical Trial

Applied Spine Technologies, Inc. is currently conducting a multi-center, randomized, controlled clinical trial in the U.S. to compare posterior dynamic stabilization using the Stabilimax Dynamic Spine Stabilization System to traditional spinal fusion stabilization to treat degenerative lumbar spinal stenosis. AST has enrolled more than 100 patients to date.

Stabilimax is an investigational device in the United States. It is limited by United States (U.S.) Federal Law for investigational use only.

Wednesday, January 13, 2010

Applied Spine Technologies Announces Latest Patent

Applied Spine Technologies Announces Latest Patent
Second patent award in six weeks enables natural motion of dynamic stabilization devices

ROCKY HILL, Conn. -- Applied Spine Technologies, Inc. www.appliedspine.com , a medical device company focused on motion preservation of the lumbar spine, has been awarded a new patent titled "Pedicle Screw Assembly with Bearing Surfaces".

U.S. patent No. 7,635,379, issued by the U.S. Patent and Trademark Office on December 22, 2009, claims geometry that permits intraoperative assembly of a sphere onto a pedicle screw to enable dynamic angulation of a dynamic stabilization device.

"Dynamic angulation is a critical feature of dynamic stabilization devices, enabling the devices to move naturally with the spine in all planes. It is achieved by mounting a sphere onto the end of a pedicle screw and then permitting the dynamic connector to rotate about the sphere, as with the Stabilimax® System," said Bruce Robie, PhD, Vice President of Research and Development for Applied Spine. "This patent builds upon our existing Intellectual Property portfolio and protects mounting geometry to allow placement of a sphere onto a pedicle screw for the purposes of enabling dynamic angulation."

"At Applied Spine we recognize that there are many ways to achieve dynamic stabilization" said Craig Corrance, President and CEO. "We therefore continue to pursue patents that cover a variety of means for accomplishing the key elements, particularly dynamic angulation and dynamic connectors that allow for change of device length. This patent, in conjunction with patent # 7,615,068, granted on November 10, 2009, validates our approach and bodes well for several pending patent applications."

About Applied Spine Technologies Inc., and Stabilimax®

Applied Spine Technologies Inc., headquartered in Rocky Hill, Connecticut, is developing the Stabilimax Dynamic Spine Stabilization System, a posterior dynamic stabilization device designed to support an injured or degenerated spine without eliminating motion. Stabilimax is expected to offer numerous advantages over current spinal fixation products and even new artificial disc products—including a much less invasive and less traumatic implant procedure, maintenance of spine motion and disc function, and the potential to prevent or slow adjacent-segment disc disease.

About the IDE Clinical Trial

Applied Spine Technologies, Inc. is currently conducting a multi-center, randomized, controlled clinical trial in the U.S. to compare posterior dynamic stabilization using the Stabilimax Dynamic Spine Stabilization System to traditional spinal fusion stabilization to treat degenerative lumbar spinal stenosis. AST has enrolled more than 100 patients to date.

Stabilimax is an investigational device in the United States. It is limited by United States (U.S.) Federal Law for investigational use only.

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