October 12, 2020

CTL Amedica Secures US Patent for Articulating Implant Insertion System

https://www.prweb.com/releases/ctl_amedica_secures_us_patent_for_articulating_implant_insertion_system/prweb17455078.htm

The U.S. Patent and Trademark Office has granted CTL Amedica Corporation patent number 10,765,529 for articulating intervertebral devices, related tools, systems and methods. The system solves many complex challenges that are associated with traditional TILF procedures.

CTL Amedica’s newly patented technology provides surgeons with an articulating implant insertion tool that is streamlined, innovative and dynamic.

That’s why we partnered with Dr. Nitin Kukkar and Jon Wing to co-develop these instruments – as an innovative solution to the complex challenges of TLIF procedures.

DALLAS (PRWEB) OCTOBER 08, 2020

The United States Patent and Trademark Office has granted CTL Amedica Corporation patent number 10,765,529 for articulating intervertebral devices, related tools, systems and methods.

CTL Amedica’s newly patented system solves many complex challenges that are associated with traditional transforaminal lumbar interbody fusion (TLIF), an operation performed on the lower back to remove intervertebral disc material and join two or more vertebrae together using screws and interbody cages. In particular, the placement of a curved TLIF cage is often more challenging, given the overall implant footprint. CTL Amedica’s technology provides surgeons with an articulating implant insertion tool that is streamlined, innovative and dynamic. It allows for minimum tissue disruption, controlled re-positioning and more efficient deployment of compatible, curved TLIF cages.

“When a minimally invasive TLIF is performed, direct visualization of the disc space isn’t available during implantation. Lack of visualization may make proper implant placement extremely difficult and labor-intensive,” explains Daniel Chon, CTL Amedica president and CEO. “That’s why we partnered with Dr. Nitin Kukkar and Jon Wing to co-develop these instruments – as an innovative solution to the complex challenges of TLIF procedures.”

The TLIF instruments include articulating options that allow a greater range of interbody movement during the insertion period, as well as a preferred entry angle into the prepared disc space.

CTL Amedica is a forward-thinking medical device design, development and manufacturing company. CTL Amedica maintains a Texas-based headquarters and in-house manufacturing facility, along with a Pennsylvania-based R&D Center of Excellence. A leader in the medical device technology and biomaterials space, CTL Amedica provides a full line of cervical, thoracic and lumbar fusion and fixation products. In addition, it is the world’s exclusive provider of silicon nitride spine products. Silicon nitride demonstrates unique bacteriostatic properties, provides superior imaging across all modalities and promotes an enhanced osteogenic response. For more information, visit https://www.ctlamedica.com/.

September 2, 2020

FDA grants CTL Amedica 510k clearance for MONDRIAN LIF Cage System

DALLAS (PRWEB) SEPTEMBER 02, 2020

CTL Amedica Corporation is proud to announce that it has received official 510k clearance from the U.S. Food and Drug Administration (FDA) to market its MONDRIAN™ Lumbar Interbody Fusion (LIF) Cage System featuring TiCro™ surface technology, a unique and innovative approach to titanium interbody fusion devices.

“Using our CEZANNE™ LIF System and other cutting-edge CTL Amedica products as a foundation, our team created the MONDRIAN™ LIF Cage System, a revolutionary new product that utilizes our proprietary TiCro™ technology, which has an aggressive macro surface and unique geometry that enhances interlocking properties and increases bone ingrowth surface area,” says Daniel Chon, CTL Amedica Corporation president and CEO. “With multiple material offerings, 15 different cage configurations, 34 footprints, 7 lordotic options and 7,160 part combinations, the sheer breadth of this clearance is a tremendous accomplishment and a testament to our team’s dedication to ‘moving the needle’ in product innovation and design. We’re grateful for the clearance and look forward to presenting the MONDRIAN™ LIF Cage System to the market soon.”

The MONDRIAN™ LIF Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease at one or two adjoining levels from L2-S1. The system is designed to be used with supplemental fixation cleared for use in the lower back. The robust fusion system features a large graft window, distinct radiographic markers, a self-distracting bullet tip, a bi-convex profile and lateral aperture.

“The MONDRIAN™ LIF Cage System is available in a wide variety of sizes and configurations to better accommodate anatomical variation,” adds Chon. “This enables greater intraoperative flexibility, which can result in shorter, more efficient procedures, possibly improving success rates and recovery time for patients.”

Of the robust MONDRIAN™ LIF offerings, the titanium bullet TLIF and PLIF with TiCro™ technology are scheduled for limited launch in Q4 of 2020, with other implant formats soon to follow.

CTL Amedica Corporation is a forward-thinking medical device design, development and manufacturing company. CTL Amedica maintains a Texas-based headquarters and in-house manufacturing facility, along with a Pennsylvania-based R&D Center of Excellence. A leader in the medical device technology and biomaterials space, CTL Amedica provides a full line of cervical, thoracic and lumbar fusion and fixation products. In addition, it is the world’s exclusive provider of silicon nitride spine products. Silicon nitride demonstrates unique bacteriostatic properties, provides superior imaging across all modalities and promotes an enhanced osteogenic response. For more information, visit https://www.ctlamedica.com/.

https://www.prweb.com/releases/fda_grants_ctl_amedica_510k_clearance_for_mondrian_lif_cage_system/prweb17366678.htm

February 24, 2020

CTL Amedica Corp Granted Patent for Screw Offset Blocking Mechanism: Newly Patented Tech Implemented in MONET Anterior Cervical Fusion System

Chris J. Stewart

DALLAS (PRWEB) FEBRUARY 11, 2020

CTL Amedica Corporation has been granted an official patent from the United States Patent and Trademark Office for a screw offset blocking mechanism, which has been thoughtfully designed for and implemented in the company’s newly released MONET™ Anterior Cervical Fusion System. CTL Amedica plans to implement the robust blocking mechanism in future cervical and lumbar plating systems. The US Patent for the offset blocking mechanism – number 10,543,101 – was issued Jan. 28, 2020.

“Cervical surgeries make up more than half of all spine surgeries worldwide, and integrated technologies continue to flourish throughout the entire orthopedic implant sector, so we’re particularly pleased to announce this new patent. The blocking technology can be utilized in current and future products and may have licensing possibilities down-the-road,” says Daniel Chon, CTL Amedica Corporation president and CEO. “Due to its fundamental application throughout the entire orthopedic fixation arena, screw blocking technology is one of the most competitive and intellectually protected areas of medical device development today. CTL Amedica’s newly patented technology is one of many core development investments our company is making, and is also a testament to our team’s determination and dedication to excellence.”

The cervical area refers to the seven vertebral segments in the spine that make up the neck and connect the brain to the spinal cord. The newly patented, offset screw blocking mechanism can be found in the FDA-cleared, integrated MONET™ Anterior Cervical Fusion System, which features both titanium and PEEK cage options. The MONET™ also features integrated, anterior plating options, including low-profile, four-screw configurations, as well as zero-profile, two-screw assemblies. These construct options provide surgeons with the true intra-operative flexibility required to accommodate each patient’s individual anatomy.

CTL Amedica Corporation is a forward-thinking medical device design, development and manufacturing company. CTL Amedica maintains a Texas-based headquarters and in-house manufacturing facility, along with a Pennsylvania-based R&D Center of Excellence. A leader in the medical device technology and biomaterials space, CTL Amedica provides a full line of cervical, thoracic and lumbar fusion and fixations products. In addition, it is the world’s exclusive provider of silicon nitride spine products. Silicon nitride demonstrates unique bacteriostatic properties, provides superior imaging across all modalities and promotes an enhanced osteogenic response. For more information, visit https://www.ctlamedica.com/.

Original Article: https://www.beckersspine.com/surface-technology/item/48239-ctl-amedica-wins-patent-for-screw-offset-blocking-mechanism-designed-for-cervical-fusion-system.html?utm_medium=email

February 11, 2020

CTL Amedica wins patent for screw offset blocking mechanism designed for cervical fusion system

Written by: Alan Condon

CTL Amedica was recently granted a patent for a screw offset blocking mechanism designed for its Monet anterior cervical fusion system.

Three insights:

1. The Monet system has both titanium and PEEK cage options.

2. The device features integrated anterior plating options, including low-profile, four-screw arrangements and zero-profile, two-screw designs.

3. CTL Amedica aims to integrate the blocking mechanism into cervical and lumbar plating systems.

Original Post:

https://www.beckersspine.com/surface-technology/item/48239-ctl-amedica-wins-patent-for-screw-offset-blocking-mechanism-designed-for-cervical-fusion-system.html?origin=SpineE&utm_source=SpineE&utm_medium=email&oly_enc_id=7232A3704301B1R

April 24, 2019

World’s Only Provider – Silicon Nitride

CTL Medical Corporation has entered into a definitive agreement with Amedica Corporation (NASDAQ: AMDA) to purchase its commercial spine business, which includes its complete portfolio of spine-related patents and 510ks, as well as any technological advancements directly related to the spine that result from it. The deal will make CTL Medical the world’s exclusive provider of silicon nitride spine products and give it unique access to markets like Braziland Australia, and widen its European footprint, further strengthening its position as a global leader serving the spine industry.

“This will help solidify us as the world’s next leader in spine,” said Daniel Chon, CTL Medical president and CEO. “Amedica has made great strides in silicon nitride development and we look forward to being the world’s exclusive provider. At CTL Medical, our goal is to create products that continue to improve outcomes for both the surgeon and the patient. Silicon nitride technology is backed by extensive science, clinical findings, and published research that clearly show its benefits. We will have the ability to apply this technology across our entire product line and fold-in the Taurus, Preference and Valeo brands developed by Amedica.”

According to Dr. Sonny Bal, chairman of Amedica’s board of directors, silicon nitride is “ideal” for spinal implant technology.

“We now have sufficient scientific evidence — including long-term clinical data — to show that Amedica’s silicon nitride is the ideal biomaterial for spinal implants; with unique anti-bacterial properties, proven mechanisms of bone healing, and clinical outcomes showing faster spinal fusion,” noted Bal.

He added that Amedica will continue silicon nitride research and development for other biomedical applications.

The agreement is expected to close during the third quarter of 2018. After it is completed, CTL Medical Corp. will be known as CTL Amedica.

CTL Medical Corporation is a medical device company headquartered in Dallas that designs, develops and manufactures spinal implants and instruments tailored to fit the unique needs of surgeons and patients in the United States and beyond. CTL Medical Corporation has an in-house manufacturing facility, an R&D Center of Excellence, and a full line of cervical, thoracic and lumbar products. For more information, visit https://ctlamedica.com/.

October 3, 2018

AMEDICA ANNOUNCES CLOSING OF THE SALE OF ITS SPINE BUSINESS TO CTL MEDICAL

SALT LAKE CITY, Oct. 03, 2018 (GLOBE NEWSWIRE) — Amedica Corporation (NASDAQ:AMDA) today announced that it has completed the previously-announced sale of its spine business to CTL Medical, a Dallas, TX-based privately held medical device manufacturer, on October 1, 2018, all as more fully described below.

As previously announced, Amedica and CTL Medical entered in an asset purchase agreement, dated September 5, 2018, whereby CTL Medical agreed to acquire all of Amedica’s commercial spine business for total consideration of up to $10 million. As a result of the closing, CTL Medical is now the exclusive owner of Amedica’s portfolio of metal and silicon nitride spine products, which are presently sold under the brand names of Taurus, Preference, and Valeo, with access to future silicon nitride spine technologies. Manufacturing, R&D, and all intellectual property related to the core biomaterial technology of silicon nitride remains with Amedica in Salt Lake City. Amedica will serve as CTL’s exclusive OEM provider of silicon nitride products.

“We are pleased to have closed this transaction so quickly after the September announcement. Amedica is now free of the considerable costs and complexity attendant to retail spine sales, allowing the company to focus on the core biomaterials and OEM business instead. We will fully support CTL spine sales in terms of clinical and basic science, surgeon education, and any other necessary sales support. Most importantly, as a debt-free company, Amedica can now focus on revenue opportunities outside of spine where our R&D program is particularly strong, such as in the dental and arthroplasty markets,” said Dr. Sonny Bal, Chairman of the Board at Amedica Corporation. “In our opinion, this is the leanest, most efficient, and overall best position that Amedica has ever been in as a company, from a cash position or otherwise, with multiple strategic options going forward,” added Dr. Bal.

Daniel Chon, President and CEO of CTL Medical noted, “The depth of science behind silicon nitride research continues to impress us. We, at CTL Medical, the only company to possess such highly differentiated biomaterial in spine, are extremely bullish on the outlook and opportunities in our industry. The closing of the acquisition now gives us the green light to unleash the talents of our engineers to drive innovation by applying the attributes of silicon nitride across our entire product portfolio. The sheer amount of energy, interest, and excitement that this acquisition has created is already noticed worldwide and was clearly visible during the North American Spine Society (NASS), hosted in Los Angeles last week. The responses from our global partners, surgeons and distributors were extremely positive and equally encouraging. We believe that as our two organizations come together, each with distinct strengths, as one pulls from the front and the other pushes from the back, a new era, movement, and momentum in our industry will be seen and felt.”

The description of the asset purchase agreement and the transaction set forth above is qualified in its entirety by reference to the full text of the agreement, which was included as part of the Company’s Form 8-K filed with the Securities and Exchange Commission on September 6, 2018.

About Amedica

Amedica is an innovative biomaterials and OEM company that develops and commercializes silicon nitride for various biomedical applications including orthopedic, dental and arthroplasty.

About CTL Medical

CTL Medical is a forward thinking medical device design, development and manufacturing company that produces a full line of cervical, thoracic, and lumbar products (hence “CTL”) at its manufacturing headquarters in Dallas, Texas.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (“PSLRA”). Such forward-looking statements include but are not limited to statements about the benefits of the transaction, including future accretive value to CTL and Amedica’s future financial results, operating plans, objectives, expectations and intentions, and other statements that are not historical facts. These forward-looking statements are subject to risks and uncertainties that may cause actual results or events to differ materially from those projected, including but not limited to the risks that the benefits from the transaction may not be fully realized or may take longer to realize than expected, including as a result of changes in general economic and market conditions, interest and exchange rates, monetary policy, laws and regulations and their enforcement, and the degree of competition in the geographic and business areas in which Amedica and CTL operate; the ability of CTL to promptly and effectively integrate Amedica’s commercial spine business; the reaction to the transaction of the companies’ customers, employees, and counterparties; and the diversion of management time on transaction-related issues. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management’s current estimates, projections, expectations and beliefs. Amedica undertakes no obligation to publicly revise or update the forward-looking statements to reflect events or circumstances that arise after the date of this report.

April 5, 2018

CTL Medical Secures FDA Clearance for Cage

CTL Medical, a Dallas-based medical device manufacturing and service company, has secured US Food and Drug Administration (FDA) clearance and approval to market its new MATISSE Titanium-PEEK ACIF cage system with the company’s proprietary TiCro surface technology in the practice of spinal fusion surgery.

The company claim that the MATISSE cage offers the increased bone ingrowth of Titanium, and the post-operative fusion visibility of PEEK. CTL Medical further announce that the Titanium-PEEK interbody device offers surgeons a 200% greater endplate contact surface area, as well as geometric surface morphology for increased mechanical locking at the cage and bone interface.

The press release states that the implant includes a tapered leading edge for easy insertion and a large graft area to further promote bony fusion. The device is available in a variety of sizes and configurations to accommodate variations in vertebral levels and patient anatomy.

“The MATISSE Titanium-PEEK cage with TiCro represents several improvements over earlier models,” states Rose Moore, vice-president of marketing for CTL Medical. “The MATISSE device line now offers three material options to satisfy surgeons and their patients ever changing needs. As with previous models, the Matisse Titanium-PEEK system offers streamlined instrumentation and a variety of footprints, heights, and lordotic profiles to accommodate variations in patient anatomy.”

MATISSE Titanium-PEEK Cage with TiCro is indicated for use in skeletally mature patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms at one-disc level. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. MATISSE Titanium-PEEK Cage with TiCro is to be used with supplemental fixation.

The use of cage devices in spinal surgery began with clinical trials in 1989, and since then, multiple implant improvements have debuted – leading to easier procedures, benefitting both spine surgeons and overall patient success and recovery times.

See original story here: https://spinalnewsinternational.com/ctl-medical-matisse-acif-cage/

April 4, 2018

CTL Medical Corp. received FDA clearance for its SEURAT Universal Pedicle Screw System

CTL Medical Corp. received FDA clearance for its SEURAT Universal Pedicle Screw System. Here are four notes.
1. The SEURAT Universal Pedicle Screw System is intended for spine fusion.
2. The system encompasses polyaxial and monoaxial; open and minimally invasive surgery; single and dual thread profile; solid and cannulated; and hex and hexalobe screws.
3. CTL Medical will launch the system in the second half of this year.
4. This clearance represents the second for CTL Medical in the first quarter of 2018.

See original story here: https://www.beckersspine.com/orthopedic-a-spine-device-a-implant-news/item/40595-ctl-medical-earns-fda-clearance-for-screw-system-4-notes.html

July 17, 2017

Thought Leaders’ Corner | Health Care Innovations News July 2017

Today’s healthcare technologies are worth the money invested as they represent innovative progress on several fronts. Whether we’re talking about AI, 3D printing, medical devices and wearables, they’re examples of an investment in the future application of both medicine and health.

There are multiple ways in which healthcare technologies will benefit both patients and the physicians who care for them. Take medical devices and wearables as an example. We are just starting to scratch the surface of intraoperatively, customized medical devices, but the ability to custom design and immediately print a sterile surgical implant based on a specific patients anatomy is steadily becoming a reality.

And the comprehensive information that current wearables can provide is critical. They can chart, track, accumulate data and send urgent notifications on a whole host of illnesses that already require monitoring. Improving these technologies to benefit a patient’s well-being, while contributing to the efficiencies of a physician, is a win-win proposition.

Likewise, hospital systems and medical groups are seeing the benefit of upgrading their healthcare technologies and continuing to innovate. It’s an extremely competitive field, and these organizations must be able to appeal to patients as the resource with the most innovative healthcare solutions available to the public. Much like those of us in the device field, hospital administrators and CTOs are actively engaged in finding technological solutions that streamline complex practice workflows.

The future of modernized healthcare is dependent on progress, and that’s where we hope to continue participating.

CTL’s CEO Daniel Chon’s comments.. here