Bodycad Receives FDA 510K Clearance for Personalized Unicompartmental Knee System

QUEBEC CITY, March 29, 2017 /PRNewswire/ — Bodycad announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Bodycad Unicompartmental Knee System, enabling the commercial launch of this truly personalized orthopaedic restoration. Bodycad is the first Canadian company to receive FDA clearance for a joint reconstruction implant system.

Bodycad’s revolutionary Unicompartmental Knee System is designed to optimize personalized restoration of the patient’s unique anatomical features and kinematics. The system is based on proprietary 3D rendering of medical images of the patient’s anatomy. The restoration is delivered as a “procedure in a box” that completely revolutionizes the way orthopaedic implant and instrument applications are delivered and utilized in the operating room environment.

“The personalized restoration is created only after proper acquisition of data from the patient on an individualized level,” says Etienne Belzile, MD, orthopaedic surgeon and assistant professor at Laval University. “The benefit of personalized restoration is the possibility of a better fit to the individual, less trauma to the soft tissue, and potentially a faster recovery overall.”

Bodycad uses proprietary imaging algorithms to rapidly produce a precise 3D image of the patient’s knee. Its suite of Personalized Restoration Software enables a seamless integration of the image to implant process called the PREP (personalized restoration evaluation process). The efficient and rapid process is designed to increase patient satisfaction while improving economic quality metrics.

“Our proprietary software is based on 20 years of research in anthropometric data and is the first CAD/CAM software specifically developed for the personalization of orthopaedic implant and instrument design,” says Jean Robichaud, founder and CEO of Bodycad. “I am delighted to have FDA clearance to bring this important technological advancement to market. Our goal is to transform the way surgeons, patients and insurers think about the potential of mass customization to optimize patient care.”

About Bodycad

Bodycad is a Quebec City-based developer and manufacturer of personalized orthopaedics. Its personalized restorations offer patients a high level of conformity to their unique anatomy, with the potential for greater comfort, fit and durability that make the pursuit of orthopaedic perfection possible. Learn more at www.bodycad.com.

Contact

Andy McLeod
2035 rue du Haut-Bord
Quebec, Quebec, Canada
G1N 4R7
(418) 527.1388
info@bodycad.com

 

OrthAlign, Inc. Announces Milestone Achievement 60,000th Joint Arthroplasty Case

OrthAlign, Inc., a privately held U.S.-based medical device and technology company providing orthopedic surgeons with advanced precision technologies, announced another milestone achievement in its 60,000th completed joint arthroplasty case. This milestone reflects the continuing and rapid adoption of OrthAlign’s handheld precision alignment and positioning technology by surgeons throughout the world.

OrthAlign provides highly accurate, computer-assisted, handheld technologies for surgeons to receive real-time, actionable data for precise alignment and positioning of components in total knee, unicondylar knee, and total hip (both posterior and anterior) arthroplasty surgeries. Over 15 peer-reviewed clinical studies have been published to date, validating OrthAlign’s accuracy, simplicity of use, and benefits of use for the patient.

David W. Anderson, MD of the University of Kansas Medical Center in Kansas City, KS used KneeAlign to mark the 60,000th OrthAlign case milestone. “What I like about OrthAlign technology is that it is quick and easy to use and it doesn’t require all of the extra hassle and cost that comes with using robotics or other competing technologies,” said Dr. Anderson. “Furthermore, I’ve also noticed that my patients don’t have as much swelling when OrthAlign technology is used, as I don’t have to enter the femoral canal. I believe this is a good system for me, my OR staff, and most importantly, for my patients.”

“The global adoption rate of our products highlights the power of OrthAlign technology,” said Eric B. Timko, OrthAlign’s Chief Executive Officer and Chairman. “We are only scratching the surface with 60,000 cases and are confident that our efforts in expanding customer reach and portfolio expansion will further drive penetration of our technology. Congratulations to Dr. Anderson and the hundreds of other surgeons around the world who have adopted OrthAlign technology into their practices for better outcomes.”

About OrthAlign, Inc.

OrthAlign is a privately held medical device and technology company, developing advanced technologies that deliver healthier and more pain-free lifestyles to joint replacement patients, globally. We provide healthcare professionals with cutting edge, computer-assisted surgical tools that seamlessly and cost-effectively deliver vital data and clinical results to optimize outcomes for our patients. For more information regarding OrthAlign, please visit http://www.orthalign.com.

“ORTHALIGN®, ORTHALIGN PLUS®, KNEEALIGN®, KNEEALIGN® 2, HIPALIGN®, and UNIALIGN™ are registered trademarks of OrthAlign, Inc.”

Providence Medical Technology Receives New FDA 510(k) Clearances and Bolsters Executive Management Team

WALNUT CREEK, Calif., Mar 29, 2017 /PRNewswire/ — Providence Medical Technology, Inc., an innovator in tissue-sparing, cervical-fusion technology, announced the addition of two industry veterans to the commercial leadership team.  Scott Lynch has joined the company to lead Global Marketing, and Michael Scott is assuming International leadership.  Together, Mr. Lynch and Mr. Scott have over 40 years of relevant industry experience.

Mr. Lynch joins the company with over 22 years of medical device and 15 years of spine industry marketing experience having previously served as Vice President of Global Marketing at DFINE, VertiFlex, and Zimmer Spine.

Mr. Scott joins Providence following over 16 years at ArthroCare as Vice President of OUS Sports Medicine, Vice President of Asia Pacific Commercial Operations, and US Vice President ENT Sales at Smith & Nephew.

Providence also announced recent 510(k) clearances from the FDA for the standalone use of the CAVUX™ Cervical Cage-L System as well as approval for its ALLY™ Facet Screws.  These new clearances are complimentary to the company’s flagship DTRAX® Spinal System and are all provided terminally sterile for single-use to ensure efficiency and consistency.

Scott Lynch and Michael Scott are important additions to our Executive Management team at Providence.  Their veteran leadership and successful experience with high growth businesses make them an ideal fit for Providence at this exciting stage of our business,” said Jeff Smith, CEO of Providence Medical Technology.  “With these new 510(k) clearances, we are pleased to offer our surgeon customers stand-alone anterior stabilization and posterior non-segmental stabilization for their cervical fusions.”

The CAVUX™ Cervical Cage-L System is manufactured from medical grade titanium and available in a variety of sizes.  The implant offers proprietary grit-blasted and acid-etched surfaces, a large space for allogenic and autogenous bone graft and includes self-drilling and self-tapping screws for additional, standalone fixation.

The ALLY™ Facet Screws provide temporary stabilization as an adjunct to spinal fusion.  The titanium implants are available in a variety of sizes to accommodate patient anatomy and are intended to provide mechanical support and stability until spinal fusion is achieved.

Providence Medical Technology’s family of products for cervical spinal fusion includes instruments, intervertebral cages, orthopedic bone screws, and allograft bone.  All products are provided sterile for single use only.

About Providence Medical Technology, Inc.
Providence Medical Technology, Inc. is a privately-held medical device company developing innovative solutions addressing the $2 billion worldwide cervical spine market. The company’s focus is on commercializing the DTRAX® platform of single-use, tissue-sparing instruments and CAVUX™ and ALLY™ implants for cervical fusion, as well as other technologies that improve cervical spine procedures for both physicians and patients.

For more information, visit www.providencemt.com

 

SOURCE Providence Medical Technology, Inc.

Liquidmetal® Passes Implant Study

March 28, 2017

RANCHO SANTA MARGARITA, Calif.–(BUSINESS WIRE)–Liquidmetal® Technologies, Inc. (OTCQB: LQMT; the “Company”),announced today that it has passed additional pre-screening biocompatibility tests for use in medical implants and is now pursuing collaborations with medical implant companies.

In February of 2017, LQMT received long-term implantation results from parts 3, 10, 6 and 11 of the ISO 10993 (Biological Evaluation of Medical Devices) suite of tests, which include evaluation of genotoxicity, sub-chronic systemic toxicity, and pyrogenicity. LQMT alloy LM105 passed all of these tests well within the allowable limits. These results, combined with previously completed tests from ISO 10993 parts 10, 11, 4, and 5 which cover sensitization, irritation, acute systemic toxicity, hemocompatibility and cytotoxicity, indicate that the Liquidmetal process is compatible with a wide range of medical device requirements including long term implants.

“The results of these tests are very exciting and it positions the Company well to engage medical device customers in a broad range of implantable device applications including, cardiac rhythm, cochlear, spinal, and orthopedic implants among others. The Company will now focus on partnering with medical implant manufacturers to identify specific applications to further explore the use of Liquidmetal,” said Paul Hauck, Executive Vice President of Sales and Marketing at LQMT.

About Liquidmetal Technologies

Rancho Santa Margarita, California-based Liquidmetal Technologies, Inc. is the leading developer of bulk amorphous alloys. Amorphous alloys are unique materials that are distinguished by their ability to be injection molded and die cast into high performance applications for a broad range of markets. For more information, go to www.liquidmetal.com.

Contacts

Liquidmetal Technologies, Inc.
Otis Buchanan
Media Relations
949-635-2120
otis.buchanan@liquidmetal.com

Medeon Biodesign Announces Investing in Panther Orthopedics for Orthopedic Extremity Applications

TAIPEI, Taiwan, March 28, 2017 /PRNewswire/ — Medeon Biodesign, Inc., a Taiwan medical device company, is pleased to announce that the Company led and successfully closed the Series A investment of Panther Orthopedics, Inc., a San Jose, CA start-up pioneering innovative dynamic fixation solutions for orthopedic extremity applications.

The orthopedic extremity device market continues to expand rapidly, primarily due to procedure volume growth, lifestyle influences and favorable demographics. Nevertheless, the market need for better fixation products for both trauma and sports medicine in fracture fixation and joint stabilization applications is still under served. “Current options for fixation include cortical screw and suture button flexible fixation devices. However, many limitations associated with currently marketed products are not being addressed,” said Dr. Kathryn Stecco, CEO and co-founder of Panther Orthopedics. “We have developed an innovative platform for dynamic extremity fixation, which we believe will provide continuous compression during the healing period while still allowing micromotion. The intuitive design of our solutions is easy to use and intended to eliminate the need for most second surgery removal, providing significant benefits for both the patients and the entire healthcare system.”

“We are excited to lead the investment of Panther Orthopedics to address the long-standing need of better clinical fixation during the healing period for orthopedic extremity applications,” said Dr. Yue-Teh Jang, CEO of Medeon Biodesign. “We are impressed with the team’s extensive experience, profound knowledge of orthopedic applications and broad KOL networking. We are confident that the Panther Orthopedics’ unique and innovative dynamic fixation solutions will be very welcome by the clinical community in the near future.”

About Medeon Biodesign

Medeon Biodesign (TPEx: 6499) is a publicly traded company located in Taipei, Taiwan, and currently listed on Taipei Exchange. The company focuses on the development of medical devices for minimally invasive surgeries to treat diseases of sizable patient population, such as cardiovascular, peripheral vascular, orthopedic, neurosurgery, obesity, gastroenterology, hematology, nephrology, gynecology, urology, and plastic surgery. For more information, please visit www.medeonbio.com/en.

Contacts
Dr. Yi-Ju Chen
+886.2.2881.6686
ir@medeonbio.com

SOURCE Medeon Biodesign, Inc.

Related Links

http://www.medeonbio.com/en

Integra LifeSciences Announces Commercial Expansion of the Cadence® Total Ankle System

PLAINSBORO, N.J., March 28, 2017 (GLOBE NEWSWIRE) — Integra LifeSciences Holdings Corporation (NASDAQ:IART), a leading global medical technology company, today announced full commercial availability of its Cadence® Total Ankle System, a new ankle prosthesis developed in partnership with four world leading foot and ankle surgeons – Dr. Tim Daniels (University of Toronto), Dr. David Pedowitz (Rothman Institute, Philadelphia, Pa.), Dr. Selene Parekh (Duke University, Durham, N.C.) and Dr. Christopher Hyer (Orthopedic Foot & Ankle Center, Westerville, Ohio).

More than 200 Cadence total ankle procedures have been successfully performed in seven countries, since initial clinical use more than a year ago.  During this period, instrumentation updates and enhanced surgeon training were introduced, designed to further improve quality, patient safety, and procedural efficiency of the system.

Integra completed corrective actions required to close an FDA recall related to the clarification of the system surgical technique, which addressed a small percentage of intra-operative posterior tibial fractures occurring due to technique error.  The recall required no return of product, and since the implementation of the clarified surgical technique, no subsequent posterior tibial fractures have occurred in more than 100 procedures.

The Cadence system has garnered positive feedback among its users for advancements in implant and instrument design, along with a streamlined surgical technique.  Cadence incorporates several features to accommodate various patient anatomies, reduce potential clinical complications, and address common challenges associated with ankle arthroplasty procedure.  Key implant features include:

  • Side-specific, anatomical tibial components, designed to avoid fibular impingement.
  • Side-specific, anatomical talar components, designed to minimize resected talar bone and to preserve vascularity in the ankle.
  • Bearing insert components manufactured from a highly crosslinked ultra-high molecular weight polyethylene (HXL UHMWPE) for improved wear characteristics, and patent pending-biased sagittal profile options to address patients with subluxed talar anatomy.

“I’ve implanted over 50 Cadence Total Ankle prostheses.  I am very impressed with the versatility, reliability, reproducibility, and short-term outcomes of this implant,” said Dr. Tim Daniels. “The streamlined and reliable operative instruments and techniques of this procedure, combined with an anatomical design, offer significant advantages over other ankle systems on the market today.”

The Cadence Total Ankle System was previously available in a limited market release. The Cadence system is now fully available in the United States, Canada, and select European countries.  Integra plans to initiate several global post-market clinical studies with the Cadence system to further support product efficacy.

About Integra
Integra LifeSciences is dedicated to limiting uncertainty for clinicians, so they can concentrate on providing the best patient care.  Integra offers innovative solutions, including leading plastic and regenerative technologies, in specialty surgical solutions, orthopedics and tissue technologies.  For more information, please visit www.integralife.com.

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning the products and services provided by Integra. Such forward looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results. Among other things, the willingness of surgical professionals to use Integra products may affect the prospects for their use in surgical procedures. In addition, the economic, competitive, governmental, technological and other factors, identified under the heading “Risk Factors” included in Item IA of Integra’s Annual Report on Form 10-K for the year ended December 31, 2015 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.

CONTACT: Integra LifeSciences Holdings Company

Investors
Angela Steinway
609-936-2268
angela.steinway@integralife.com

Michael Beaulieu
609-750-2827
michael.beaulieu@integralife.com

Media
Laurene Isip
609-750-7984
laurene.isip@integralife.com

Researchers Find Knee Replacement Surgery May Have Minimal Effect on Quality of Life and Unattractive Economic Outcomes

(NEW YORK — April 1, 2017) Knee replacement surgery for patients with osteoarthritis, as currently used, provides minimal improvements in quality of life and is economically unattractive, according to a study led by Mount Sinai researchers and published today in the BMJ. However, if the procedure was only offered to patients with more severe symptoms, its effectiveness would rise, and its use would become economically more attractive as well, the researchers said.

“Given its limited effectiveness in individuals with less severely affected physical function, performance of total knee replacement in these patients seems to be economically unjustifiable,” said Bart Ferket, MD, PhD, Assistant Professor, Department of Population Health Science and Policy at the Icahn School of Medicine at Mount Sinai and lead author on the study. “Considerable cost savings could be made by limiting eligibility to patients with more symptomatic knee osteoarthritis. Our findings emphasize the need for more research comparing total knee replacement with less expensive, more conservative interventions, particularly in patients with less severe symptoms.”

About 12 percent of adults in the United States are affected by osteoarthritis of the knee. The annual rate of total knee replacement has doubled since 2000, mainly due to expanding eligibility to patients with less severe physical symptoms. The number of procedures performed each year now exceeds 640,000 at a total annual cost of about $10.2 billion, yet health benefits are higher in those with more severe symptoms before surgery.

A team of researchers from the Icahn School of Medicine at Mount Sinai and Erasmus University Medical Center in Rotterdam, the Netherlands, set out to evaluate the impact of total knee replacement on quality of life in people with knee osteoarthritis. They also wanted to estimate differences in lifetime costs and quality adjusted life years or QALYs (a measure of years lived and health during these years) according to level of symptoms.

They analyzed data from two U.S. cohort studies: one with 4,498 participants aged 45-79 with or at high risk for knee osteoarthritis from the Osteoarthritis Initiative (OAI), and the other involving 2,907 patients from the Multicenter Osteoarthritis Study (MOST). OAI participants were followed up for nine years and MOST patients were followed up for two years. Quality of life was measured using a recognized score of physical and mental function, known as SF-12, and using some osteoarthritis-specific quality of life scores.

They found that quality of life outcomes generally improved after knee replacement surgery, although the effect was small. The improvements in quality of life outcomes were found higher when patients with lower physical scores before surgery were operated on.

In a cost-effectiveness analysis, current practice was more expensive and in some cases seemed even less effective compared with scenarios in which total knee replacement was performed only in patients with lower physical function.

“Our findings show opportunity for optimizing delivery of total knee replacement in a cost-effective way, finding the patients who will benefit the most, delivering the treatment at the correct point in their disease progression, and optimizing the cost so we can deliver the benefit to all who need it,” said Madhu Mazumdar, PhD, Director of the Institute for Healthcare Delivery Science at the Mount Sinai Health System, Professor of Biostatistics, Department of Population Health Science and Policy at the Icahn School of Medicine at Mount Sinai, and co-author of the study.

Funding for the cohort studies used in the analysis was provided by the National Institutes of Health, Merck Research Laboratories, Novartis Pharmaceuticals Corporation, GlaxoSmithKline, and Pfizer. Dr. Ferket is supported by the American Heart Association. The researchers have no competing interests to disclose.

About the Mount Sinai Health System

The Mount Sinai Health System is an integrated health system committed to providing distinguished care, conducting transformative research, and advancing biomedical education. Structured around seven hospital campuses and a single medical school, the Health System has an extensive ambulatory network and a range of inpatient and outpatient services—from community-based facilities to tertiary and quaternary care.

The System includes approximately 7,100 primary and specialty care physicians; 12 joint-venture ambulatory surgery centers; more than 140 ambulatory practices throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and 31 affiliated community health centers. Physicians are affiliated with the renowned Icahn School of Medicine at Mount Sinai, which is ranked among the highest in the nation in National Institutes of Health funding per investigator. The Mount Sinai Hospital is in the “Honor Roll” of best hospitals in America, ranked No. 15 nationally in the 2016-2017 “Best Hospitals” issue of U.S. News & World Report.  The Mount Sinai Hospital is also ranked as one of the nation’s top 20 hospitals in Geriatrics, Gastroenterology/GI Surgery, Cardiology/Heart Surgery, Diabetes/Endocrinology, Nephrology, Neurology/Neurosurgery, and Ear, Nose & Throat, and is in the top 50 in four other specialties. New York Eye and Ear Infirmary of Mount Sinai is ranked No. 10 nationally for Ophthalmology, while Mount Sinai Beth Israel, Mount Sinai St. Luke’s, and Mount Sinai West are ranked regionally. Mount Sinai’s Kravis Children’s Hospital is ranked in seven out of ten pediatric specialties by U.S. News & World Report inBest Children’s Hospitals.”

For more information, visit http://www.mountsinai.org/, or find Mount Sinai on Facebook, Twitter and YouTube.

NuVasive Receives First-Ever FDA Clearance For Cervical Interbody Implant System Used In More Than Two Levels

SAN DIEGO, March 29, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the CoRoent® Small Interbody™ System indicated for intervertebral body fusion at multiple contiguous levels in the cervical spine. This marks the first U.S. clearance for a cervical cage to be used at up to four contiguous levels.

Cervical radiculopathy and myelopathy secondary to cervical degenerative discs are common diagnoses in adult patients and have been shown to cause significant disability and loss of productivity.1 As a result of this common condition, more than 200,000 cervical surgical procedures are performed in the U.S. per year.2

“This FDA 510(k) clearance is another key milestone for NuVasive as we continue to deliver new innovation to the spine market. The ability to treat multi-level cervical disc degeneration in patients displaying cervical radiculopathy and myelopathy is a meaningful advancement for spine surgeons,” said Jason Hannon, NuVasive’s president and chief operating officer. “This first and only clearance is an example of NuVasive’s commitment to defining the components necessary to properly address an unmet clinical need and expand our presence and competitive positioning in the cervical market.”

The NuVasive CoRoent Small Interbody System is an interbody cage manufactured from PEEK-Optima that provides stabilization of the spinal motion segment while fusion takes place. A hollow core allows for packing of autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft material to help promote a solid fusion. Rows of teeth on the surface of each end of the device serve to grip the adjacent vertebrae to resist migration and expulsion of the device. The device includes marker pins composed of titanium alloy or tantalum.

The implants included in the CoRoent Small Interbody System clearance are CoRoent Small (S), CoRoent Small Lordotic (SL), CoRoent Small Lordotic Plus (SLP), CoRoent Small Hyperlordotic (SHL), and CoRoent Small Contoured (SC).

About NuVasive

NuVasive, Inc. (NASDAQ: NUVA) is a world leader in minimally invasive, procedurally-integrated spine solutions. From complex spinal deformity to degenerative spinal conditions, NuVasive is transforming spine surgery with innovative technologies designed to deliver reproducible and clinically proven surgical outcomes. NuVasive’s highly differentiated, procedurally-integrated solutions include access instruments, implantable hardware and software systems for surgical planning and reconciliation technology that centers on achieving the global alignment of the spine. With $962 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries around the world. For more information, please visit www.nuvasive.com.

Forward-Looking Statements

NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA™ platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

1Grasso G: Clinical and radiological features of hybrid surgery in multilevel cervical degenerative disease. Eur Spine J 2015;24(Suppl 7):S842-8.
2American Associated of Neurological Surgeons. Artificial cervical disc surgery. [AANS web site]. May 2016. Available at: http://www.aans.org/Patient%20Information/Conditions%20and%20Treatments/-Artificial%20Cervical%20Disc.aspx. Accessed March 27, 2017.

 

CONTACT: Investor Contact: Suzanne Hatcher, NuVasive, Inc., 858-458-2240, investorrelations@nuvasive.com, Media Contact: Stefanie Mazer, NuVasive, Inc., 858-320-5243, media@nuvasive.com

Medtronic, DePuy Synthes Lead Cervical and Lumbar Artificial Disc Market

BY MILITARY NEWS

VANCOUVER, BC–(Marketwired – March 28, 2017) – According to a new series of reports on the U.S. spinal implants and vertebral compression fracture market by iData Research (www.idataresearch.com), the motion preservation segment will be the fastest growing in the market fueled by the release of a vast array of new devices in already established markets, most notably the cervical (CAD) and lumbar artificial disc (LAD) markets. Procedure number growth, as well as favorable reimbursement policies is expected for these devices driven by positive clinical results involving novel and emerging technologies.

However, traditional fixation procedures will limit growth of the artificial disc market. The traditional cervical, thoracolumbar and interbody fixation and fusion markets are currently the gold standard for treatment of many indications that artificial discs address. These devices cost less than artificial discs, which can be a major preference factor for many doctors and patients.

“Traditional fusion markets are expected to show consistent growth rate but will eventually begin to stabilize in value over the next several years as motion preservation and minimally invasive surgery (MIS) procedures become increasingly common,” explains Dr. Kamran Zamanian, CEO of iData. “As the U.S. spinal implant market grows in size, more competitors will enter the markets as well as existing competitors broadening their portfolios with new products including motion preservation implants.”

 

READ THE REST HERE

SafeOp Surgical Files for Ninth Patent

March 27, 2017

HUNT VALLEY, Md.–(BUSINESS WIRE)–SafeOp Surgical, Inc. (“SafeOp”), a privately held medical device company, today announced that it has filed its ninth patent application for innovations surrounding the monitoring of somatosensory-evoked potentials during surgeries. SafeOp developed and markets the EPAD™ system, a revolutionary neuromonitoring system that enables the detection of nerve damage and post-operative residual paralysis during surgical procedures. This latest filing is for the capability to reduce false positive alerts to nerve damage during surgeries. The company already holds patents for detection of nerve injury in the United States, Australia, Japan and China, and has several patents pending that include signal processing and high specificity in alerting to signal change, and on neuromuscular junction testing and spinal cord stimulator paddle placement.

“Electrical noise from nearby equipment often causes false alerts that are time consuming to deal with,” said Richard O’Brien, MD, MBA, SafeOp’s vice president of development and chief medical officer. “This new patent provides a method to condition the monitored responses and calculate an alert so that the likelihood of a false positive from a noisy signal is dramatically reduced while preserving the sensitivity of the monitoring to real changes.”

SafeOp’s EPAD™ system, which allows monitoring of both the spinal cord and peripheral nerves, was developed specifically for the rapid detection of perioperative nerve injury (“PNI”). PNI is a frequent complication of some surgeries (e.g., orthopedic, general, cardiac, or urological surgery), whereby peripheral nerves may be damaged due to unrecognized extended compression or stretching, or compromise of their blood supply. The EPAD™ system also allows easy-to-use quantitative monitoring of the neuromuscular junction to help detect another frequent complication, post-operative residual paralysis. This may occur when paralyzing agents have not sufficiently worn off at the end of surgery. The EPAD™ system provides real-time feedback, allowing caregivers to adjust the patient’s position in time to avoid nerve injury, or intervene when residual paralysis is present.

“We continue to innovate our EPAD™ system technology with powerful capabilities that will make it the most cost-effective intraoperative monitoring solution available,” said Gene Cattarina, SafeOp’s president and chief executive officer. “With its unique ability to economically and efficiently acquire somatosensory-evoked potentials, the EPAD™ is appropriate for all types of surgeries and an ideal low cost alternative to expensive insourced- and outsourced-driven neuromonitoring for certain spine and other surgeries.”

About SafeOp Surgical, Inc.

SafeOp Surgical, Inc. is a Hunt Valley, MD-based medical device company that has developed the FDA-approved EPAD™ system. The EPAD™ system enables simple-to-use neurological monitoring in a wide array of surgical procedures where full monitoring – which requires the continuous presence of a technologist and neurologist – may not be indicated, cost-effective or feasible. SafeOp currently markets the EPAD™ system to medical centers throughout the United States. For more information, visit SafeOp’s website at www.safeopsurgical.com.

Contacts

SafeOp Surgical, Inc.
Chris Brown, 410-773-9601
Cell: 214-213-9379
cbrown@safeopsurgical.com