Amedica Announces Patent Grant for Silicon Nitride and Other Ceramic Materials

Posted On April 3, 2018 By OrthoSpineNews In Regulatory /

SALT LAKE CITY, March 30, 2018 (GLOBE NEWSWIRE) — Amedica Corporation (Nasdaq:AMDA), an innovative biomaterial company which develops and manufactures silicon nitride as a platform for biomedical applications, is pleased to announce the issuance of a key material and process patent. US patent 9,925,295 was issued to Amedica March 27, 2018, covering “Ceramic and/or glass materials and related methods.” The patent covers various methods for improving the antibacterial, osteoconductive, and osteoinductive characteristics of silicon nitride and other ceramic materials, particularly to make them more suitable for use in manufacturing a variety of biomedical implants. Amedica now has 59 US patents and 6 foreign patents.

“This patent reflects the scientific inquiry and accomplishments in which Amedica has invested heavily during the past few years. Other biomaterials usually require surface textural engineering to make them suitable for applications such as spinal fusion. Silicon nitride is unique in having a favorable nanostructure in the “as-fired” state already. Therefore, our focus has been to move beyond surface topography toward engineering the precise surface chemistry of silicon nitride through thermal, chemical, and/or mechanical treatments to achieve a broad-based material platform that has applications throughout the biomedical space. The innovative strength of this patent has attracted several potential developing partnerships with other companies, both in spine and outside. From an intellectual property standpoint, this patent alone contributes to the lasting and refreshed value in Amedica, specifically our scientific knowledge and our ability to modify and control the material toward specific, desired product applications.” said Dr. Sonny Bal, CEO and Chairman at Amedica.

About Amedica Corporation
Amedica is focused on the development and application of medical-grade silicon nitride ceramics. Amedica markets spinal fusion products and is developing a new generation of wear- and corrosion-resistant implant components for hip and knee arthroplasty. The Company manufactures its products in its ISO 13485 certified manufacturing facility. Amedica’s spine products are FDA-cleared, CE-marked, and are currently marketed in the U.S. and select markets in Europe and South America through its distributor network and its OEM partnerships.

For more information on Amedica or its silicon nitride material platform, please visit www.amedica.com.

Forward-Looking Statements

This press release contains statements that constitute forward-looking statements within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties. For example, there can be no assurance that this patent will attract several potential developing partnerships with other companies, both in spine and outside. Other factors that could cause actual results to differ materially from those contemplated within this press release can also be found in Amedica’s Risk Factors disclosure in its Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 29, 2018, and in Amedica’s other filings with the SEC. Forward-looking statements contained in this press release speak only as of the date of this press release. We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.

Contact:
Amedica IR 
801-839-3502
IR@amedica.com

Zimmer Biomet Announces FDA Clearance of the Comprehensive® Augmented Baseplate for Shoulder Reconstruction

Posted On April 2, 2018 By OrthoSpineNews In Regulatory, Top Stories /

WARSAW, Ind., April 2, 2018 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced the completion of the first surgical case utilizing its Comprehensive^®Augmented Baseplate, which received FDA clearance on January 3, 2018. The case was performed by John W. Sperling, M.D., an orthopaedic surgeon at Mayo Clinic, who specializes in shoulder surgery. The Comprehensive Augmented Baseplate complements the Company’s Comprehensive^® Reverse Shoulder System by offering an alternative to bone grafting and eccentric reaming for patients with glenoid defects undergoing shoulder reconstruction.

This newly cleared baseplate boasts a simplified circular design at three augment heights (3mm, 5mm and 7mm buildup), allowing for augment placement in any orientation to accommodate various unique bone anatomies. Its circular design also allows bone ingrowth into the rim of the baseplate for optimal fixation.

The Comprehensive Augmented Baseplate is a component of the Comprehensive Reverse Shoulder System, a next-generation reverse shoulder prosthesis engineered to offer high-quality intraoperative flexibility and clinically proven technologies. The system aims to minimize the potential challenges of removing well-fixed humeral stems by allowing conversion to a reverse shoulder using any of the existing Comprehensive stems. Additionally, the Comprehensive Augmented Baseplate leverages Mayo Clinic’s patented methodology for the optimization of shoulder arthroplasty components developed by Dr. Sperling at Mayo Clinic, Rochester, Minn., to provide relevant sizing for a conservative approach to bone removal in order to preserve bone stock if a future revision procedure is necessary.

“The new Augmented Baseplate rounds out Zimmer Biomet’s Comprehensive Shoulder portfolio and provides solutions that help surgeons with difficult glenoid deformity cases,” said Orsa Britton, Vice President and General Manager of Zimmer Biomet’s global Extremities business.

About Zimmer Biomet
Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.

We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.

We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com, or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.

Cautionary Statement Regarding Forward-Looking Statements
This release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning Zimmer Biomet’s expectations, plans, prospects, and product and service offerings, including new product launches and potential clinical successes. Such statements are based upon the current beliefs and expectations of management and are subject to significant risks, uncertainties and changes in circumstances that could cause actual outcomes and results to differ materially. For a list and description of some of such risks and uncertainties, see Zimmer Biomet’s periodic reports filed with the U.S. Securities and Exchange Commission (SEC). These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in Zimmer Biomet’s filings with the SEC. Forward-looking statements speak only as of the date they are made, and Zimmer Biomet disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Readers of this release are cautioned not to rely on these forward-looking statements, since there can be no assurance that these forward-looking statements will prove to be accurate. This cautionary statement is applicable to all forward-looking statements contained in this release.

ZBH-Corp

SOURCE Zimmer Biomet Holdings, Inc.

Nanovis Announces FDA Clearance of FortiCore® PLIF and TLIF Spinal Interbodies with Nanosurface Features

Posted On March 29, 2018 By OrthoSpineNews In Regulatory, Spine, Top Stories /

Carmel, Ind. (March 28, 2018) – Nanovis, today announced the successful FDA clearance of its FortiCore^® TLIF and PLIF interbodies featuring a Nanosurface-enhanced deeply porous titanium scaffold intermolded with a PEEK core.

“Implant nano surface science has advanced from the early days when we simply created nanoroughness for implants because tissues have nanoroughness. Now we understand the mechanisms by which nanotopographies can interact with cellular signaling pathways. I’m delighted that with Nanovis’ implants, patients can now benefit from a carefully designed and controlled nanotopography that harnesses this groundbreaking research,” said Thomas Webster, PhD, Chemical Engineering Department Chair, Northeastern University, who with Chang Yao, PhD, were early pioneers in the use of nanosurfaces to enhance bone growth.

Nanovis’ foundational FortiCore interbody fusion platform is well proven with over 4,250 implanted to date. FortiCore interbodies have deeply porous interconnected titanium scaffolds intermolded with a PEEK core, giving surgeons important fixation and imaging advantages. Data comparing the osseointegration strength of the FortiCore scaffold, PEEK, and allograft to the strength of trabecular host bone was published in Spine in late 2016. Now the titanium scaffolds on the FortiCore TLIF and PLIF interbodies are enhanced with a carefully designed and controlled nanosurface.

“The timing for this clearance is very good because surgeons are searching for the best surface technologies. I’ve watched Nanovis methodically develop technology platforms in a surface on a surface bone fixation strategy. Now they offer the most advanced interbody fixation technology with the best imaging profile on the market,” said Dr. Alan McGee, Orthopedics Northeast, a participant in the alpha launch of FortiCore. “My partners and I have implanted over 300 FortiCore interbodies. I can tell my patients I’m giving them the most advanced technology available today, and they have recovered quickly and have been very satisfied. It’s easy for me to assess bone growth through and around the FortiCore implants with plain X-ray. It’s a struggle to assess bone growth through 3D printed titanium interbodies with plain X-ray and I’m hesitant to expose my patients to the extra radiation from an unnecessary CT scan. I’m encouraged by Nanovis’ pre-clinical data for this nanotechnology enhanced surface and look forward to upgrading my use.”

“The science behind this nano technology is very exciting and clearance of the surface provides Nanovis another highly differentiated platform designed to reduce fixation related complications across a wide range of implant systems. In the short term, this nanopatterned surface targets fixation related complications and in the intermediate term this nanopatterned surface is the foundation of a bactericidal program targeting infection related complications,” said Matt Hedrick, CEO, Nanovis.

About Nanovis

Nanovis’ clinical and scientific goals are to reduce fixation and infection related complications. The Company’s patented and proprietary regenerative technology platforms provide differentiated surface advantages enabling the potential for existing medical devices to achieve new outcomes. Nanovis is commercializing science-driven platforms: the deeply porous scaffold and nanopatterned surface on select FortiCore interbody fusion devices and developmental bactericidal technology.

For more information about Nanovis, FortiCore or other proprietary Nanovis science-enhanced technologies, please visit www.nanovisinc.com or call 1-317-507-1058.

Media Contact:

Matt Hedrick

1-317-507-1058

Matt.hedrick@nanovistechnology.com

Ceterix Orthopaedics Receives New Patent for Transosteal Anchoring Methods for Meniscal Root Repair

Posted On March 26, 2018 By OrthoSpineNews In Regulatory /

March 26, 2018

FREMONT, Calif.–(BUSINESS WIRE)–Ceterix Orthopaedics today announced the issuance of US Patent No. 9,913,638 relating to the company’s proprietary approach to knee meniscus and ACL repair, adding to an already expansive portfolio of innovative orthopaedic applications and issued patents.

Ceterix’s new patent further protects the company’s unique products and methods that allow surgeons to arthroscopically pass suture through soft tissue in very tight joint compartments. Specifically, the new patent describes the company’s method for securely fastening the knee’s meniscus during a meniscal root repair.

“We’re pleased that our approach, using the NovoStitch® Plus Meniscal Repair System, simplifies the procedure for surgeons and expands the tissue repair methods available to patients in need of meniscus repair,” stated John McCutcheon, president and CEO of Ceterix.

The meniscus is a crescent of soft cartilage that sits between the femur and tibia, cushioning the knee. The meniscus attaches to the tibia at its root but is subject to tearing at this attachment point. Historically, damage to the meniscal root was addressed with meniscectomy (complete or partial removal of the damaged tissue). However, meniscectomy has been shown to be associated with an increased risk of future complications. In a recent study, more than one-third of patients with a meniscal root tear who underwent meniscectomy required a total knee replacement within five years. In contrast, the same study revealed that patients who underwent meniscus root repair had no occurrences of knee replacement at the five-year mark¹.

Current methods of meniscal root repair involve the surgical creation of a tunnel through the tibia bone to reach the meniscus, affixing a suture to the soft tissue, and extending this suture through the bone tunnel to an anchor resting just beneath the skin in the lower leg.

The potential issue with the standard procedure is that it results in too much space between the meniscal root and the anchor itself. This greater distance may cause the suture to lose tension or displace over time, thus negatively affecting the success of the repair.

Ceterix, well-known for innovations in arthroscopic surgery, has obtained patent protection for an alternate approach for surgeons to use when repairing a torn meniscal root. Using the NovoStitch Plus Meniscal Repair System, surgeons can affix sutures to the meniscus and secure those sutures with an anchor placed inside the bone tunnel, closer to the site of the root repair, thereby retaining the necessary tension for long-term repair viability. Arthroscopic surgery is a minimally-invasive procedure in which an orthopaedic surgeon treats the damaged joint through small incisions using specialized tools guided by a tiny camera called an arthroscope. Meniscus surgery is the most common arthroscopic procedure in the United States, with roughly one million performed annually.

About Ceterix® Orthopaedics

Founded in 2010 with the vision of improving outcomes of arthroscopic procedures, Ceterix® Orthopaedics develops surgical tools that expand and improve what is possible for physicians who treat soft tissue joint injuries such as meniscus tears. Ceterix’s novel meniscal repair system enables surgeons to place suture patterns that were previously only possible in open procedures, or not at all. The NovoStitch Plus meniscal repair system has received 510k clearance in the United States and is indicated for approximation of soft tissue in meniscal repair procedures. The company is based in Fremont, Calif. and is backed by investors Versant Ventures, 5AM Ventures and CRG. For more information, please visit www.ceterix.com.

¹ Chung et al. Arthroscopy. 2015; 31(10):1941-50.

Contacts

for Ceterix Orthopaedics
Krysta Pellegrino, 650-255-6142
Krysta@healthandcommerce.com

Orthofix Receives FDA 510(k) Clearance of G-Beam Fusion Beaming System

Posted On March 22, 2018 By OrthoSpineNews In Regulatory /

March 22, 2018

LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix International N.V., (NASDAQ:OFIX), a global medical device company focused on musculoskeletal healing products and value added services, announced the U.S. Food and Drug Administration (FDA) 510(k)clearance for its new internal fixation system, the G-Beam™ Fusion Beaming System.

Designed primarily for the treatment of Charcot foot, a debilitating condition where the bones in the foot weaken and collapse, the G-Beam devices can be implanted in the medial and lateral columns of the foot to provide alignment, stabilization and fixation.

“In my practice I often see patients whose uncontrolled diabetes has led to the development of Charcot foot, an extremely disabling condition that if left untreated, can lead to amputation,” said Dr. William Grant, a podiatric surgeon from Virginia Beach, VA who designed the G-Beam system. “Using the G-Beam system allows us to anatomically realign the foot; enabling the bones to heal so these patients can return to a more normal independent lifestyle.”

When the use of internal fixation is recommended, the G-Beam system is designed to fuse the medial and/or lateral columns, as well as bones in the hindfoot, in order to restore a stable foot that may ultimately reduce the probability of an amputation. The system comes with single-use, sterile-packed implants and an efficient, compact instrumentation tray.

“The G-Beam Fusion Beaming System is the next step in working towards our objective of becoming a recognized premium solution provider in the Charcot and Diabetic foot market segments,” said Davide Bianchi, President of the Extremity Fixation business unit. “This system will allow us to establish ourselves in the internal fixation segment of Charcot treatment options, while leveraging our existing product lines, like TrueLok^™ and the TL-HEX^™.”

About Charcot Foot

Charcot foot is a chronic and progressive joint disease causing weakening of the bones in the foot. It is a serious condition that can lead to deformity, disability and even amputation. Charcot foot can occur in people who have severe neuropathy (the loss of protective sensation in the limb) or nerve damage, a common diabetic foot complication. The World Health Organization estimates that more than 422 million people suffer from diabetes and that the number will more than double in the next 20 years. The prevalence of diagnosed Charcot foot in patients with diabetes is reported to be 0.08–7.5%. However, some studies suggest higher prevalence with as many as 13% of all diabetic patients and 29% of the neuropathic patients affected. To learn more about Charcot foot visit limbhealing.com.

The G-Beam Fusion Beaming System will be on display during the American College of Foot and Ankle Surgeons (ACFAS) annual meeting in Nashville TN, March 22-25. Orthofix invites those attending ACFAS to visit Booth #653 to learn more about this new internal fixation system.

About Orthofix

Orthofix International N.V. is a global medical device company focused on musculoskeletal healing products and value-added services. The Company’s mission is to improve patients’ lives by providing superior reconstruction and regenerative musculoskeletal solutions to physicians worldwide. Headquartered in Lewisville, Texas, the Company has four strategic business units: BioStim, Extremity Fixation, Spine Fixation, and Biologics. Orthofix products are widely distributed via the Company’s sales representatives and distributors. For more information, please visit www.orthofix.com.

Forward Looking Statements

This communication contains certain forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements, which may include, but are not limited to, statements concerning the projections, financial condition, results of operations and businesses of Orthofix and its subsidiaries, are based on management’s current expectations and estimates and involve risks and uncertainties that could cause actual results or outcomes to differ materially from those contemplated by the forward-looking statements. The forward-looking statements in this release do not constitute guarantees or promises of future performance. Factors that could cause or contribute to such differences may include, but are not limited to risks described in the “Risk Factors” section of our Annual Report on Form 10-K for the fiscal year ended December 31, 2017, as well as in other reports that we file in the future. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to update or revise the information contained in this press release.

Contacts

Orthofix International N.V.
Investor Relations
Mark Quick, 214-937-2924
markquick@orthofix.com
or
Media Relations
Denise Landry, 214-937-2529
deniselandry@orthofix.com

Life Spine Announces FDA Clearance of PLATEAU®-LO Insert and Rotate Spacer System

Posted On March 20, 2018 By OrthoSpineNews In Regulatory, Top Stories /

March 20, 2018

HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today that the U.S. Food and Drug Administration (FDA) has given 510(k) marketing clearance to the PLATEAU-LO Insert and Rotate Spacer System.

“PLATEAU-LO is my go-to spacer for micro-invasive lumbar interbody fusions. The oblique lordosis and vast array of footprints cater to the wide variety of patient anatomies I see in my practice. I also find that the bulleted tip allows for very simple insertion, and the insert and rotate feature allows for restoration of disc height. These features are essential for good patient outcomes,” said Rebecca Kuo, MD of Joliet, IL.

“PLATEAU-LO is another great addition to our already robust interbody platform. By combining PLATEAU-LO with our AVATAR^® Percutaneous Screw System and the CENTRIC^®-T Pedicle-Based Retractor System it shows our keen interest in innovation around micro-invasive procedures and providing our customers with multiple options for optimal patient care,” said Mariusz Knap, Vice President of Marketing and Business Development for Life Spine.

PLATEAU-LO is available in PEEK material and is offered in 7° and 12° lordosis and multiple footprints options.

Key Features and Benefits of the system are:

Chamfered corners allow for ease of insertion and distraction
Oblique lordosis to better match patient anatomies and pathologies
Bullet tip simplifies insertion
Large, open graft windows maximize visibility and bone graft containment
Aggressive tooth pattern prevents graft migration

About Life Spine

Life Spine is dedicated to improving the quality of life for spinal patients by increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Life Spine, which is privately held, is based in Huntley, Illinois. For more information, please visit: http://www.lifespine.com.

Life Spine is a registered trademark.

Contacts

Life Spine
Omar Faruqi
Chief Financial Officer
ofaruqi@lifespine.com
847-884-6117

Exactech’s Vitamin E Acetabular Polyethylene Liner for Hip Replacement Gains FDA 510(k) Clearance

Posted On March 20, 2018 By OrthoSpineNews In Regulatory, Top Stories /

March 20, 2018

GAINESVILLE, Fla.–(BUSINESS WIRE)–Exactech, a developer and producer of bone and joint restoration products and biologic solutions for extremities, knee and hip announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the Novation XLE Vitamin E acetabular polyethylene liners for hip replacement surgery. These liners are designed to work in conjunction with the Novation® Crown Cup® Acetabular System including InteGrip® printed, 3-D porous material.

The advanced bearing material in the new XLE liners is designed for low wear and contains vitamin E. Oxidation in-vivo can contribute to polyethylene degradation in orthopaedic implant polyethylene. Vitamin E, a natural antioxidant, is blended into the raw material of Novation XLE liners to mitigate oxidative effects both before and after implantation.

This product complements Exactech’s Hip product family, which also includes the Alteon® HA Femoral Stem, Tapered Wedge Femoral Stem, Neck Preserving Stem and Monobloc Revision Stem.

About Exactech

Based in Gainesville, Fla., Exactech develops and markets orthopaedic implant devices, related surgical instruments and biologic materials and services to hospitals and physicians. The company manufactures many of its orthopaedic devices at its Gainesville facility. Exactech’s orthopaedic products are used in the restoration of bones and joints that have deteriorated as a result of injury or diseases such as arthritis. Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Additional information about Exactech can be found at http://www.exac.com.

Contacts

Exactech
Priscilla Bennett, 352-377-1140
Vice President, Corporate & Marketing Communication
media@exac.com

Trice Medical Achieves CE Mark and Health Canada Approval for Mi-Eye 2™, Performs First Cases in Toronto and the UK

Posted On March 16, 2018 By OrthoSpineNews In Recon, Regulatory /

MALVERN, Pa., March 16, 2018 (Newswire.com) – U.S. based, Trice Medical, announced today the completion of its first successful case performed in the United Kingdom, after receiving CE (Conformité Européenne) Mark of approval in Europe for the mi-eye 2™, as well as entry into Health Canada.

Today’s case was performed by Mr. Tony Andrade, a Consultant Orthopaedic Surgeon at Circle Reading Hospital. “This is a fantastic opportunity to be able to show patients what’s going on inside their joints and talk them through it live as you see the pathology. This is something that’s been needed for a long time to aid patient’s understanding of their condition. It’s useful not just for diagnostic purposes, but it allows for the delivery of injections into the appropriate targeted area.” said Mr. Andrade.

The early success of Trice Medical’s mi-eye 2, which was launched in the U.S. in 2017, has captured the attention of medical professionals who are embracing the technology as a new diagnostic modality. After the first year of commercial launch, the mi-eye is currently being used by over 200 institutions across the states. The disposable needle embedded with a wide-angle camera lens enables physicians to diagnose joint injuries right in their clinic, and provide their patients with immediate answers to the cause of their pain.

“Truly disruptive technology always provides value by enhancing care and lowering cost. This approach to diagnosis is such a proposition.” Stated Jon J.P. Warner, MD. Chief, MGH Shoulder Service and Professor of Orthopaedic Surgery at Harvard Medical School, regarding the mi-eye 2 technology.

“Trice is proud and excited to be commercializing the mi-eye 2 into Europe and Canada. MRI and Ultrasound will always be good options for patients with sports injuries. We are thrilled to add disposable in-clinic arthroscopy to the list of available tools physicians have to be able to assess joint injuries. In many countries, the mi-eye 2 has a chance to save weeks to months of the treatment pathway to surgery AND provide a dynamic image of the joint. The is truly an example of innovation in the new world of value-based medicine,” said Mark Foster, Chief Commercialization Officer and VP of Worldwide Sales at Trice Medical.

Additionally, Dr. Anthony Miniaci of the Cleveland Clinic Canada has completed the first cases performed by a surgeon in Toronto, ON. The advent of this technology in the Canadian market has the potential to provide patients with a dramatic amount of time saved in their overall continuum of care per injury.

Today’s patient had this to say about her experience, “I had an operation back in December but was still having some knee problems. I didn’t want to go through another general anesthetic operation so Mr. Andrade recommended the mi-eye procedure would be a good option…The experience overall was fantastic, and I didn’t feel any pulling, tugging or pressure. Mr. Andrade has now identified what we need to do next for my treatment. I would definitely recommend it to others.”

About the mi-eye 2™:

Trice Medical’s mi-eye 2, is a handheld, single-use, and disposable direct visualization tool. The mi-eye 2 was specifically designed for use in the clinic setting, consisting of a single stick percutaneous, and self-blunting design which deploys an integrated camera and a light source. The procedure is performed with local anesthetic and provides patients with an alternative to traditional diagnostic modalities, such as time-consuming and often inaccurate MRIs. The mi-eye is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. mi-eye 2 is available for prescription use only.

About Trice Medical:

Trice Medical was founded to fundamentally improve orthopedic diagnostics for the patient, and the physician providing instant answers. Trice Medical has pioneered fully integrated camera-enabled technology, the mi-eye 2, that provides a clinical solution optimized for the physician’s office. Trice Medical’s mission is to provide more immediate and definitive patient care, eliminating the false reads associated with current indirect modalities and significantly reduce the overall cost to the healthcare system.

Contact Trice Medical:

+1 (610) 989-8080

info@TriceMedical.com

Source: Trice Medical

New European patent approval for Episurf Medical

Posted On March 15, 2018 By OrthoSpineNews In Regulatory /

MAR 14, 2018

The European patent office EPO has announced its intention to grant another European patent for Episurf Medical (NASDAQ: EPIS B). The patent, entitled “Method and node for manufacturing a surgical kit for cartilage repair”, covers the medical image segmentation process used for joint damage visualisation as well as for manufacturing of Episurf Medical’s patient-specific joint implants and surgical instruments.

“A comprehensive patent portfolio supporting various aspects of our technology has for a long time been a prioritised area, and this patent forms an important part thereof. This grant follows previous approvals for this patent family in China and Australia”, comments Pål Ryfors, CEO, Episurf Medical.

For more information, please contact:

Pål Ryfors, CEO, Episurf Medical

Tel:+46 (0) 709 62 36 69

Email: pal.ryfors@episurf.com

About Episurf Medical

Episurf Medical is endeavoring to bring people with painful joint injuries a more active, healthier life through the availability of minimally invasive and personalized treatment alternatives. Episurf Medical’s Episealer® personalized implants and Epiguide® surgical drill guides are developed for treating localized cartilage injury in joints. Episurf Medical’s μiFidelity® system enables implants to be cost-efficiently tailored to each individual’s unique injury for the optimal fit and minimal intervention. Episurf Medical’s head office is in Stockholm, Sweden. Its share (EPIS B) is listed on Nasdaq Stockholm. For more information, go to the company’s website: www.episurf.com.

This information is information that Episurf Medical AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 11.30 CET on 14 March 2018.

Tags:

Episurf Medical , EpiSurf

About Us

Cerapedics Receives FDA IDE Approval to Initiate Study of P-15L Bone Graft for Transforaminal Lumbar Interbody Fusion Surgery

Posted On March 14, 2018 By OrthoSpineNews In Regulatory /

WESTMINSTER, Colo., March 14, 2018 /PRNewswire/ — Cerapedics, a privately-held orthobiologics company, today announced the company received approval from the U.S. Food and Drug Administration (FDA) to initiate an investigational device exemption (IDE) clinical trial evaluating the safety and efficacy of P-15L Peptide Enhanced Bone Graft compared to autograft in transforaminal lumbar interbody fusion (TLIF) surgery for degenerative disk disease.

Spinal fusion procedures such as TLIF involve joining and stabilizing one or more vertebrae to reduce pain and nerve irritation. A bone graft, which has historically been obtained from the patient’s pelvis, is placed in the interbody space to promote fusion. P-15L Bone Graft is based on proprietary synthetic small peptide (P-15) technology developed by Cerapedics to support bone growth through cell attraction, attachment and activation, and is designed to be used as a substitute for autologous bone.

“With regulatory approval to begin a new IDE study of P-15L Bone Graft in TLIF procedures, we are now in position to collect additional Level 1 human clinical data on our next-generation advanced drug-device combination bone graft,” said Glen Kashuba, chief executive officer of Cerapedics. “Several hundred thousand people in the U.S. need surgery for degenerative disk disease every year, and it is our goal to offer surgeons a safe and effective alternative to a patient’s own bone as well as address the evidence gap around commercial bone grafts often used in these procedures.”

The prospective, single-blinded, multi-center, randomized, non-inferiority pivotal IDE study will evaluate the safety and efficacy of P-15L Bone Graft compared to use of an autologous bone graft when applied in TLIF surgery. The study will include 364 patients with degenerative disk disease at up to 30 clinical trial sites across the U.S. Patients will be assessed prior to surgery and six weeks, three months, 12 months, and 24 months post-surgery. The primary endpoint for the study is composite clinical success at 24 months based on several factors including the achievement of radiographic fusion (assessed by CT), at least a 15-point improvement in the Oswestry Disability Index (ODI), no new or worsening persistent neurological deficit, and no subsequent surgical intervention at the index level. Clinical investigators are permitted to use any FDA cleared static PEEK interbody device and any FDA cleared pedicle fixation system delivered through either an open or minimally invasive TLIF technique.

“We are very pleased to be on the verge of initiating this milestone study,” said Jeffrey G. Marx, PhD, president and chief operating officer of Cerapedics. “We believe the FDA approved study design should allow for rapid enrollment and clear evaluation of the safety and efficacy of P-15L Bone Graft versus local autograft. We’re assembling an outstanding team of surgeon investigators whom we are excited to collaborate with.”

“Prior research of this proprietary P-15 technology has demonstrated potential benefits in fusion rates, neurological outcomes and safety in cervical and lumbar fusions,” said Paul M. Arnold, MD, neurosurgeon and vice chair of research in the Department of Neurosurgery at the University of Kansas Medical Center and principal investigator of the IDE study. “We are pleased to participate in a new study evaluating whether similar results can be achieved in a wider range of patients with degenerative disk disease utilizing the next generation P-15L product.”

In November 2015, Cerapedics received Premarket Approval (PMA) from the FDA for the use of i-FACTOR Bone Graft in anterior cervical discectomy and fusion (ACDF) procedures, becoming only the second PMA-approved bone graft in the spine. The company is initiating enrollment in the newly approved TLIF IDE study with the expectation that the results from the study will support a PMA application.

About Cerapedics

Cerapedics is an orthobiologics company focused on developing and commercializing its proprietary synthetic small peptide (P-15) technology platform. i-FACTOR Peptide Enhanced Bone Graft is the only biologic bone graft in orthopedics that incorporates a small peptide as an attachment factor to stimulate the natural bone healing process. This novel mechanism of action is designed to support safer and more predictable bone formation compared to commercially available bone growth factors. More information can be found at www.cerapedics.com.

Media contact:
Adam Daley
Berry & Company Public Relations
212-253-8881
adaley@berrypr.com

SOURCE Cerapedics

Regulatory

Amedica Announces Patent Grant for Silicon Nitride and Other Ceramic Materials

Zimmer Biomet Announces FDA Clearance of the Comprehensive® Augmented Baseplate for Shoulder Reconstruction

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Nanovis Announces FDA Clearance of FortiCore® PLIF and TLIF Spinal Interbodies with Nanosurface Features

Ceterix Orthopaedics Receives New Patent for Transosteal Anchoring Methods for Meniscal Root Repair

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Orthofix Receives FDA 510(k) Clearance of G-Beam Fusion Beaming System

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Life Spine Announces FDA Clearance of PLATEAU®-LO Insert and Rotate Spacer System

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Exactech’s Vitamin E Acetabular Polyethylene Liner for Hip Replacement Gains FDA 510(k) Clearance

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Trice Medical Achieves CE Mark and Health Canada Approval for Mi-Eye 2™, Performs First Cases in Toronto and the UK

New European patent approval for Episurf Medical

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Cerapedics Receives FDA IDE Approval to Initiate Study of P-15L Bone Graft for Transforaminal Lumbar Interbody Fusion Surgery

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