Applied Spine - Press Room

Applied Spine Technologies to Present at the Canaccord Adams Musculoskeletal Conference

2010-03-08T08:56:00.002-05:00

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.

Applied Spine Technologies Announces Latest Patent

2010-01-13T10:31:00.002-05:00

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.

Applied Spine Technologies Launches New Corporate Website

2010-01-07T09:36:00.000-05:00

Applied Spine Technologies Inc. a medical device company focused on motion preservation of the lumbar spine, today announced the launch of their new website design at http://www.appliedspine.com/ As part of the company’s practice to increase awareness of their Stabilimax® Dynamic Spine Stabilization System, the new design will help foster more open communication with patients suffering from back pain.

“As a consequence of recent IP grants, Applied Spine is able to share a broader range of information with patients and physicians wishing to learn more about the Stabilimax System, the composition of the technology, and our ongoing multi-center IDE clinical trial,” states Craig Corrance, CEO of Applied Spine.

A notable new feature of the website is a three scene animation depicting the functional aspects of the Stabilimax System from both an engineering and biomechanical perspective. “Stabilimax is a very sophisticated device, but unless deconstructed, it is challenging to explain,” said Ed Durkin, marketing consultant for Applied Spine. “Portraying the device in simultaneous motion represents a new approach to sharing characteristics of the Stabilimax System, particularly the function of the dual-spring design allowing for near-normal kinematic motion and measurable interpedicular travel.”

For the general public, especially those with chronic back pain due to spinal stenosis, the site offers an enhanced interactive questionnaire to help determine if they may indeed be a candidate to participate in the clinical trial. Patients who qualify have the opportunity to be referred to the nearest clinical study investigational site for consultation with a spine surgeon.

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.

Applied Spine Announces First Use Outside the U.S. of the Stabilimax® Dynamic Spine Stabilization System

2009-12-08T09:00:00.007-05:00

Applied Spine Technologies announced today the first two Stabilimax surgeries performed outside of the United States. The surgeries were performed in Johannesburg, South Africa, by Ajay Maharaj, MD, at Sunninghill Hospital. The Stabilimax Dynamic Spine System is currently part of an IDE multi-center, randomized, controlled clinical trial in the U.S.

Commenting on the procedure, Dr. Maharaj stated, "Our first Stabilimax implantations went exceedingly well. We are pleased to be the first facility outside of the United States to take part in utilizing this exciting new technology. Stabilimax offers an intriguing alternative to spinal fusion; the opportunity to stabilize the spine without eliminating motion for patients with spinal stenosis or herniated nucleus pulposus, in particular, is an area of great interest to me.”

Craig Corrance, Chief Executive Officer of Applied Spine adds, “We are very pleased to be partnering with Dr. Maharaj, as well as his colleagues Dr. Louis Nel and Dr Jack Eksteen, in broadening the company’s experience with our Stabilimax System. South Africa offers Applied Spine the opportunity to collect valuable clinical data; but we are also most excited with the chance to commercialize Stabilimax in South Africa, utilizing our CE Mark, for the growing number of surgeons interested in providing their patients with pedicle screw based motion preservation.”

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.

Applied Spine Technologies is Awarded New Patent

2009-11-30T09:00:00.003-05:00

Patent enables intraoperative assembly onto a pedicle screw for dynamic stabilization of the spine

Applied Spine Technologies, Inc. a medical device company focused on motion preservation of the lumbar spine, has been awarded a new patent titled "Mounting mechanisms for pedicle screws and related assemblies”.

U.S. patent No. 7,615,068, issued by the U.S. Patent and Trademark Office on November 10, 2009, claims a pedicle screw with a collet, snap ring, and set screw to accept and fix a spherical ball onto the pedicle screw.

“The two key elements of an optimal dynamic stabilization device are a connector that can change length, and a mechanism that permits dynamic angulation between the connector and the pedicle screws, as the patient bends,” said Bruce Robie, PhD, Vice President of Research and Development for Applied Spine. “With this patent, we now have protection of hardware that enables intraoperative assembly of an articulating sphere onto a pedicle screw, enabling dynamic angulation.”

“In conjunction with our previously issued intellectual property, this new patent offers us protection within critical elements of dynamic stabilization devices, particularly dynamic angulation. Interestingly, other devices that lack dynamic angulation capabilities have reported clinical failures. We believe, therefore, that our new patent significantly enhances the companies IP portfolio,” adds Craig Corrance, Applied Spine’s CEO.

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

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

Stabilimax® Dynamic Spine Stabilization System

2009-11-24T16:41:00.000-05:00

Stabilimax is a posterior lumbar spinal stabilization system designed to support an injured or degenerated spine without eliminating motion.

Indicated for patients receiving decompression surgery for the treatment of clinically symptomatic central or lateral spinal stenosis, the device utilizes a patented Dual-Spring mechanism intended to provide an optimal stiffness profile and near-normal kinematics by permitting interpedicular travel. Incorporating a standard pedicle screw insertion technique, the pedicle screws feature patented ball and socket connections, allowing flexion and extension while minimizing the load applied at the bone/screw interface.

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Applied Spine Technologies’ Stabilimax® Dynamic Spine System selected as "Best New Technology for 2009"

2009-11-18T11:33:00.002-05:00

Panel of 30 Independent Surgeon Judges Recognize Stabilimax in the Motion Preservation Category at the 2009 Spine Technology Awards

ROCKY HILL, Conn., Applied Spine Technologies, Inc. a medical device company focused on motion preservation of the lumbar spine, today announced their selection as a "Best New Technology for 2009" in the Motion Preservation category at the 2009 Spine Technology Awards held in San Francisco on November 9th.

The technologies were judged according to their likelihood to advance the care of back patients using cost-effective innovation. The 30 judges were selected for their clinical experience and independence. Sponsored by Orthopedics This Week, the largest circulation weekly publication in the industry, the 2009 Spine Technology Awards received submissions from 83 outstanding technologies representing more than 300 individual engineers, inventors and surgeons.

“We are pleased to receive this award, especially with so many interesting new technologies in the motion preservation category”, said Craig Corrance, CEO of Applied Spine Technologies.

About Applied Spine Technologies Inc., and Stabilimax

About the IDE Clinical Trial

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

Applied Spine Adds Investigational Site for IDE Trial

2009-10-28T11:59:00.004-04:00

Allegheny General Hospital newest site for Stabilimax^® IDE enrollment

ROCKY HILL, Conn., Applied Spine Technologies announces the first patient surgery at Allegheny General Hospital in Pittsburgh, Pennsylvania, as part of their FDA approved Investigational Device Exemption (IDE) clinical trial designed to evaluate the safety and effectiveness of the Stabilimax Dynamic Spine Stabilization System. The surgery was performed by Donald M. Whiting, M.D. on October 26th. Allegheny General Hospital is the latest clinical site to participate in the Stabilimax trial.

“We are very pleased to welcome Dr. Whiting and the entire spine team at Allegheny General as our newest investigational site,” said Craig Corrance, Chief Executive Officer of Applied Spine. “Allegheny General Hospital’s status as a nationally recognized comprehensive spine Center of Excellence reflects our strategy of partnering with leading U.S. spine facilities for the duration of our IDE clinical trial.”

About Applied Spine Technologies Inc., and Stabilimax

About the IDE Clinical Trial

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

Applied Spine Technologies Announces New Corporate Headquarters

2009-09-22T12:00:00.009-04:00

ROCKY HILL, Conn., Applied Spine Technologies Inc. a medical device company focused on motion preservation of the lumbar spine, announced today their plans to relocate the company to Rocky Hill, Connecticut and close their New Haven office. All employees and contracted support staff will report to the Cold Spring Business Center in Rocky Hill on September 28th.

Company CEO Craig Corrance sees a clear rationale for the move. “Early in the company’s life we had a real need to be in New Haven, more specifically near Yale University where our product evolved from, and we have enjoyed a terrific relationship with Yale developing the technology that ultimately became our Stabilimax System. But the new facility in Rocky Hill will allow us to expand, grow, and reach our objectives, offering us the chance to consolidate our three former separate office spaces into one purpose-fitted unit. This will be significantly more efficient for our team and result in a far more comfortable working environment.”

CFO Terry Brennan adds, “As the company moves closer to the commercialization of the Stabilimax System, it becomes increasingly important to have a building that is fitted to our specifications for product testing, management of surgical instruments and implants, and also be convenient for the growing number of surgeon and industry visitors to our site. Our new location is about a forty minute drive from Hartford’s Bradley International Airport, which makes it very suitable for day visits to Applied Spine.”

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

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