InVivo Therapeutics Announces Sixth Patient Conversion in The INSPIRE Study of the Neuro-Spinal Scaffold™

Posted On January 25, 2017 By OrthoSpineNews In Biologics, Neuro /

CAMBRIDGE, Mass.–(BUSINESS WIRE)–

InVivo Therapeutics Holdings Corp. (NVIV) today announced that the patient enrolled in December in the INSPIRE study of the Neuro-Spinal Scaffold has improved from a complete AIS A spinal cord injury to an incomplete AIS B spinal cord injury in the time between discharge and the one-month evaluation. This is the sixth out of the eleven patients (54.5% conversion rate) in follow-up to have had an AIS grade improvement. Two patients who have not yet converted are early in follow-up, with conversion possible before the six-month endpoint. The INSPIRE conversion rate is considerably higher than rates observed in a range of SCI natural history databases.

Domagoj Coric, M.D., of Carolina Neurosurgery and Spine Associates, said: “I have been encouraged by the data generated to date in the INSPIRE study, including the two conversions in patients that I have implanted with the Neuro-Spinal Scaffold.” Dr. Coric, Chief of Neurosurgery at the Carolinas Medical Center and a member of the INSPIRE Study Steering Committee performed the implantation with his partner at Carolina Neurosurgery and Spine Associates, Samuel Chewning, M.D.

“The AIS conversion rate observed thus far in the INSPIRE study has exceeded expectations,” CEO and Chairman Mark Perrin said. “We look forward to following this patient’s progress, and we’re hopeful that we will continue to observe positive INSPIRE results as we work towards completing enrollment.”

About The INSPIRE Study

The INSPIRE Study: InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold™ for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury, is designed to demonstrate the safety and probable benefit of the Neuro-Spinal Scaffold™ for the treatment of complete T2-T12/L1 spinal cord injury in support of a Humanitarian Device Exemption (HDE) application for approval. The FDA has recommended that InVivo include a control arm in the study as part of a Study Design Consideration. We are in discussions with the FDA on this recommendation, and we continue to believe that our current study design is sufficient to demonstrate safety and probable benefit in support of a HDE application for marketing approval. For more information, refer to https://clinicaltrials.gov/ct2/show/study/NCT02138110.

About the Neuro-Spinal Scaffold™ Implant

Following acute spinal cord injury, surgical implantation of the biodegradable Neuro-Spinal Scaffold within the decompressed and debrided injury epicenter is intended to support appositional healing, thereby reducing post-traumatic cavity formation, sparing white matter, and allowing neural regeneration across the healed wound epicenter. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device (HUD) designation and currently is being evaluated in the INSPIRE pivotal probable benefit study for the treatment of patients with complete (AIS A) traumatic acute spinal cord injury.

About InVivo Therapeutics

InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In 2011, the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. In 2015, the company’s investigational Neuro-Spinal Scaffold received the 2015 Becker’s Healthcare Spine Device Award. The publicly-traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.

Safe Harbor Statement

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as “believe,” “anticipate,” “intend,” “estimate,” “will,” “may,” “should,” “expect,” “designed to,” “potentially,” and similar expressions, and include statements regarding the safety and effectiveness of the Neuro-Spinal Scaffold, the timing of additional enrollments, and the expectation for application for an HDE. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the company’s ability to successfully open additional clinical sites for enrollment and to enroll additional patients; the timing of the Institutional Review Board process; the company’s ability to commercialize its products; the company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the company’s products and technology in connection with the treatment of spinal cord injuries; the availability of substantial additional funding for the company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and other risks associated with the company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the company’s Annual Report on Form 10-K for the year ended December 31, 2015, and its other filings with the SEC, including the company’s Form 10-Qs and current reports on Form 8-K. The company does not undertake to update these forward-looking statements.

View source version on businesswire.com: http://www.businesswire.com/news/home/20170124005502/en/

Stryker reports 2016 results and 2017 outlook

Posted On January 25, 2017 By OrthoSpineNews In Financial /

GlobeNewswire•January 24, 2017

Kalamazoo, Michigan – January 24, 2017 – Stryker Corporation (SYK) reported 2016 operating results for the fourth quarter and full year and 2017 outlook:

Fourth Quarter Highlights
Net sales grew 16.2% to $3.2 billion (16.8% constant currency)

Orthopaedics	5.3	%	or	5.7% constant currency
MedSurg	31.1	%	or	32.1% constant currency
Neurotechnology and Spine	8.7	%	or	8.6% constant currency

Reported net earnings per diluted share decreased 2.9% to $1.34
Adjusted net earnings per diluted share⁽¹⁾ increased 14.1% to $1.78

Full Year Highlights
Net sales grew 13.9% to $11.3 billion (14.3% constant currency)

Orthopaedics	4.7	%	or	5.1% constant currency
MedSurg	25.6	%	or	26.3% constant currency
Neurotechnology and Spine	9.9	%	or	9.8% constant currency

Reported net earnings per diluted share increased 15.1% to $4.35
Adjusted net earnings per diluted share⁽¹⁾ increased 13.3% to $5.80

“I am pleased with our performance in both the fourth quarter and the full year 2016,” said Kevin A. Lobo, Chairman and Chief Executive Officer. “Fourth quarter organic sales growth of 6.7% versus a strong prior year is impressive and was balanced across Orthopaedics, MedSurg and Neurotechnology and Spine. In addition, we executed well on acquisitions and delivered leveraged adjusted earnings gains. We enter 2017 with good momentum across our businesses and look forward to building on this success.”

Sales Analysis

Consolidated net sales of $3.2 billion and $11.3 billion increased 16.2% and 13.9% as reported in the quarter and full year and 16.8% and 14.3% in constant currency, as foreign currency exchange rates negatively impacted net sales by 0.6% and 0.4%. Excluding the 10.1% and 7.9% impact of acquisitions, net sales increased 6.7% and 6.4% in constant currency, including 8.2% and 7.8% from increased unit volumes partially offset by 1.5% and 1.4% in lower prices. The acquisitions of Sage Products LLC and Physio-Control International, Inc., contributed $258 million and $740 million to our consolidated net sales in the quarter and full year.

Orthopaedics net sales of $1.2 billion and $4.4 billion increased 5.3% and 4.7% as reported in the quarter and full year and 5.7% and 5.1% in constant currency, as foreign currency exchange rates negatively impacted net sales by 0.4% in both periods. Excluding the 0.4% and 0.3% impact of acquisitions, net sales increased 5.3% and 4.8% in constant currency, including 7.8% and 6.9% from increased unit volumes partially offset by 2.5% and 2.1% in lower prices.

MedSurg net sales of $1.4 billion and $4.9 billion increased 31.1% and 25.6% as reported in the quarter and full year and 32.1% and 26.3% in constant currency in the quarter and full year, as foreign currency exchange rates negatively impacted net sales by 1.0% and 0.7%. Excluding the 23.8% and 19.1% impact of acquisitions, net sales increased 8.3% and 7.2% in constant currency, including 8.9% and 7.8% from increased unit volumes partially offset by 0.6% in lower prices in both periods.

Neurotechnology and Spine net sales of $526 million and $2.0 billion increased 8.7% and 9.9% as reported in the quarter and full year and 8.6% and 9.8% in constant currency, as foreign currency exchange rates positively impacted net sales by 0.1% in both periods. Excluding the 1.9% and 1.4% impact of acquisitions, net sales increased 6.7% and 8.4% in constant currency, including 8.1% and 9.8% from increased unit volumes partially offset by 1.4% in lower prices in both periods.

Earnings Analysis

Reported net earnings decreased 2.3% in the quarter to $510 million and increased 14.5% to $1.6 billion in the full year. Reported net earnings per diluted share decreased 2.9% in the quarter to $1.34 and increased 15.1% to $4.35 in the full year. Reported net earnings includes charges for the amortization of purchased intangible assets, restructuring-related activities, Rejuvenate and ABG II recall, acquisition and integration related activities and certain tax matters. The effect of each of these matters on reported net earnings and net earnings per diluted share appears in the reconciliation of actual results to adjusted results. Excluding the impact of these charges increases gross profit margin in the quarter from 66.1% to 66.3% and for the full year from 66.2% to 66.6% and increases operating income margin in the quarter from 20.9% to 27.7% and for the full year from 19.1% to 25.5%.

Excluding the impact of the items described above, adjusted net earnings⁽²⁾ of $675 million and $2.2 billion increased 14.2% and 12.6%, in the quarter and full year. Adjusted net earnings per diluted share⁽¹⁾ of $1.78 and $5.80 increased 14.1% and 13.3% in the quarter and full year.

Stryker Brings Mobility Zone To Farmers Insurance Open To Kick Off 2017 Tournament Schedule, Its First-Ever Activation In Southern California

Posted On January 24, 2017 By OrthoSpineNews In Recon, Sports Medicine /

MAHWAH, N.J., Jan. 24, 2017 /PRNewswire/ — Stryker Orthopaedics kicks off its fourth consecutive year as the “Official Joint Replacement Products of the PGA TOUR® and PGA TOUR Champions” this week with an appearance at the Farmers Insurance Open in La Jolla, Calif., starting Thursday and marking the first time the company has activated in the Southern California market. Throughout the season, Stryker will continue to advance its mission to educate golf fans about the importance of joint health with a newly designed Mobility Zone, featuring an enhanced Stryker Challenge.

As the premiere feature of the Mobility Zone, the new Stryker Challenge will invite visitors to take a shot at surgery with a hands-on experience introducing Art H. Ritis, a life-size model that aims to provide tournament goers a basic understanding of joint replacement surgery and Stryker’s products. The revamped Mobility Zone allows visitors to speak with local surgeons to further understand potential treatment options for joint pain. In addition, fans will have the opportunity to enter for the chance to win a trip for two to the TOUR Championship and walk inside the ropes as an Honorary Observer.^1,2

“We are excited to kick off another season and to present our new Mobility Zone and the 2017 Stryker Challenge,” said Bill Huffnagle, President, Stryker’s Joint Replacement Division. “These efforts we make here on the golf course with fans further proves that Stryker is dedicated to educating consumers across the nation about making important strides to better healthcare decisions.”

As a continuation of a successful relationship that began in 2015, Stryker will extend its collaboration with K9s For Warriors, a nonprofit organization dedicated to providing service canines to military veterans suffering from Post-Traumatic Stress Disability, traumatic brain injury or other military trauma as a result of military service post 9/11. Last year, the company donated five service dogs over the course of the year to veterans suffering from PTSD. In 2017 alongside K9s for Warriors, Stryker will give a new leash on life to military heroes by sponsoring service canines and empowering warriors to return to civilian life with dignity and independence. Fans at tournaments can also stop by the Mobility Zone to support the cause by purchasing the same hat that PGA TOUR professional and longtime brand ambassador, Fred Funk wears on TOUR. With each purchase, Stryker will make a donation to the K9s For Warriors organization.

To further encourage and motivate tournament goers to stay active on the course, Stryker will host the Health Walk at the Farmers Insurance Open. The Health Walk is an additional ongoing initiative the company offers at select TOUR events, providing insightful health tips and facts along the course for fans to follow as they watch rounds of golf.

For additional information on the Stryker Challenge as well as K9s For Warriors involvement, please visit: www.StrykerChallenge.com.

Healthcare Professionals (HCPs) are not eligible to enter the Stryker Challenge Sweepstakes or participate in any of these promotions. HCPs are defined as those individuals or entities involved in the provision of health care services and/or items to patients, which purchase, lease, recommend, use, arrange for the purchase or lease of, or prescribe Stryker’s products.
No purchase necessary to enter or win Sweepstakes. Void where prohibited by law. For official rules visit StrykerChallenge.com. Open to legal residents of the US & US Territories, 21+ as of date of entry. Sweepstakes begins at 12:01 am ET on 1/11/17 and ends at 11:59 pm ET on 8/27/17. Sponsored by Stryker.

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world.

About PGA TOUR

The PGA TOUR is the world’s premier membership organization for touring professional golfers, co-sanctioning more than 130 tournaments on the PGA TOUR, PGA TOUR Champions, Web.com Tour, PGA TOUR Latinoamérica, Mackenzie Tour-PGA TOUR Canada and PGA TOUR China.

The PGA TOUR’s mission is to entertain and inspire its fans, deliver substantial value to its partners, create outlets for volunteers to give back, generate significant charitable and economic impact in the communities in which it plays, and provide financial opportunities for TOUR players.

Worldwide, PGA TOUR tournaments are broadcast to more than 1 billion households in 226 countries and territories in 32 languages. Virtually all tournaments are organized as non-profit organizations in order to maximize charitable giving. In 2015, tournaments across all Tours generated a record $160 million for local and national charitable organizations, bringing the all-time total to $2.3 billion.

The PGA TOUR’s web site is PGATOUR.COM, the No. 1 site in golf, and the organization is headquartered in Ponte Vedra Beach, FL.

SOURCE Stryker Orthopaedics

Advanced Orthopedics and Sports Medicine Institute President Dr. Michael Greller Elected Chief of Staff at CentraState Medical Center

Posted On January 24, 2017 By OrthoSpineNews In Sports Medicine /

FREEHOLD, N.J., Jan. 24, 2017 /PRNewswire/ — President Michael J. Greller, MD, FAAOS, CPE of AOSMI, a medical practice that offers a wide variety of orthopedic services, has been elected as Chief of Staff at CentraState Medical Center. The state-of-the-art facility includes an acute-care hospital, three senior living communities, and a health and wellness campus as parts of its nonprofit community health organization, in addition to a family medicine residency program.

Dr. Greller, a well-known medical professional, board certified orthopedic surgeon, and sports injury specialist, has been a member of the staff at CentraState Medical Center since 2000, serving as Chairman of Credentials and Vice Chairman of the Department of Orthopedic Surgery. He specializes in advanced treatment of orthopedic pain and rehabilitation and performs a variety of orthopedic surgical procedures. He was also one of the first New Jersey orthopedic surgeons to carry out computer-assisted joint replacements in the tri-state area and continues to train in the latest technologies to improve both patient outcomes and patient satisfaction. Dr. Greller’s main goal is to assist patients in achieving a thorough and speedy recovery while enhancing their overall sense of wellbeing.

In addition to his new role at CentraState, Dr. Greller will remain as President and Managing Partner at AOSMI. “Staying involved in direct practice is professionally rewarding; seeing patients growing stronger and regaining health is a great reminder of why we do what we do every day,” Greller explains. “But it is also important for orthopedic professionals in administrative roles to maintain a deep and current understanding of the patients our teams are treating.”

Greller also served as Secretary/Treasurer of the Medical Staff of CentraState and most recently served a term as Assistant Chief of Staff. His expertise and treatment specialties will be a significant asset to CentraState Medical Center, which is dedicated to excellence in serving the community. Dr. Greller’s expertise includes working with professional athletes, high-level Division 1 college athletes, and high school athletes. He also served as a team physician for the NY/NJ Comets, a National Pro Fastpitch women’s softball team, and as a physician for the US Open Tennis Tournament. Dr. Greller, an Associate Professor at Temple University in the School of Podiatric Medicine, also enjoys educating individuals in medicine and treatment of specific ailments.

To learn more about the services and professionals at AOSMI, you can visit their website, or call 732-720-2555. The practice is also active on social media, including Facebook and Twitter, or follow Dr. Greller directly on Twitter.

Media Contact Name: Brittany Maynard
Media Contact Email: 142912@email4pr.com
Media Phone Number: 732-720-2555

SOURCE Advanced Orthopedics and Sports Medicine Institute

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Amendia, Inc. Leadership Strengthens – Appointment of EVP & CFO

Posted On January 24, 2017 By OrthoSpineNews In Spine /

MARIETTA, GA (PRWEB) JANUARY 24, 2017

Amendia, Inc., designer, developer, and manufacturer of spinal implant and instrument solutions, announces the appointment of Steven F. McAllister as Executive Vice President and Chief Financial Officer.

Steve has over 30 years of medical device experience in both the U.S. and international markets. Beginning his career at Howmedica, Inc., he has since served in various finance, IT, and business planning leadership roles at DePuy Spine, Biomet Spine and Bone Healing, and, most recently, InVivo Therapeutics Corporation.

At InVivo Therapeutics, Steve served as Chief Financial Officer and was responsible for leading the company to a successful IPO. Prior to that, Steve spent six years at Biomet as the Vice President of Finance and Administration for the Spine and Bone Healing Technologies division.

“We are honored to welcome Steve to the Amendia team,” said Chris Fair, Amendia’s CEO. “His global exposure, formidable leadership experience, and proven ability to deliver results make him a natural fit as our new EVP and CFO of Amendia.”

“I am excited to work with an outstanding team and look forward to finding ways to expand on the great work that Amendia has already accomplished,” said McAllister.

Mr. McAllister received a Bachelor of Science in Accounting from Fairleigh Dickinson University in New Jersey.

About Amendia

Headquartered in a state-of-the-art manufacturing facility in Marietta, Georgia, Amendia is a leading designer, developer, and manufacturer of medical devices used in spinal surgical procedures. Amendia’s vertically-integrated strategy focuses on improving surgical outcomes with innovative solutions. For more information, please visit http://www.amendia.com.

University of Helsinki Finland has developed nanofibers and thin-film biomaterials as orthopedic scaffolds to help regenerate bones and to help implants

Posted On January 24, 2017 By OrthoSpineNews In Biologics /

Posted on January 22, 2017 by adminedit

Chemists at the University of Helsinki have created a method of using nanofibers and thin-film biomaterials as orthopedic scaffolds to help regenerate bones and to help implants settle into their new home. The nanofibers are made of electrospun hydroxyapatite, a naturally occuring mineral form of calcium apatite.

Bone is a fibrous nanocomposite material with a complex hierarchical system of different macro-, micro- and nanostructures. The structure elegantly supports the bone cell functions and facilitates bone remodeling by cellular activity. Injuries and diseases, e.g. osteoporosis, can cause bone fractures and loss that need to be treated with orthopedic implants.

In future, it may be possible to use nanofibres to improve the attachment of bone implants, or the fibres may be used directly to scaffold bone regeneration. This would aid the healing of fractures and may enable the care of osteoporosis. This is detailed in a new dissertation.

In his doctoral research, Jani Holopainen of the Department of Chemistry at the University of Helsinki has developed processes for fibrous and thin-film biomaterials that can be used as scaffolding for bone regeneration and in other bone impants. He also studied the apparatus used for nanofibre production.

SYNTHETIC BONE-LIKE MATERIAL
– At best, bone-reforming scaffolds that regenerate at the same rate as bones could be used as implants. The scaffolds activate the bone cells to generate new bone that slowly replaces the disintegrating scaffold and the impant exits the body naturally without separate removal surgery, Jani Holopainen says.

READ THE REST HERE

New Laser Spine Institute Research Proves Efficacy of Minimally Invasive Spine Surgery

Posted On January 23, 2017 By OrthoSpineNews In Spine /

January 18, 2017 (TAMPA, Fla.) – A new research analysis released recently by Laser Spine Institute, the leader in minimally invasive spine surgery, cites surgical outcomes, proclivity to return to work and self-reported pain levels of patients who underwent outpatient minimally invasive spine surgery laminotomy foraminotomy decompression (LFD). The report, titled Advantages of Minimally Invasive Decompression Through Laminotomy and Foraminotomy, evaluated 500 Laser Spine Institute patients suffering from lumbar spinal stenosis over a two-year period.

“Our analysis of minimally invasive spine surgery laminotomy and foraminotomy procedures provides evidence that our patients encounter fewer complications, resulting in improved outcomes regardless of patient demographics,” said Reginald J. Davis, M.D., FACS, Director of Clinical Research, Laser Spine Institute. “This is among the largest outpatient outcome studies of its kind, and it proves that our minimally invasive procedures are an optimal solution for patients in need of relief from chronic back pain.”

According to the report, open back surgery has traditionally been the treatment of choice for lumbar stenosis, but this procedure can lead to spinal instability, which may require repeat surgeries. Because of the smaller incision and more direct technique, minimally invasive spine surgery reduces trauma to the muscle tissue and produces sufficient decompression to reduce levels of pain and disability. Additional key findings from the report show that when compared to procedures performed by other providers, Laser Spine Institute’s minimally invasive treatment of lumbar stenosis reflected shorter operative times, less blood loss, reduction in patient pain levels following surgery, as well as facilitating patients’ return to work faster.

The findings were recently presented by Chairman, Department of Surgery, Michael C. Weiss, D.O., FAOAO, at the Society for Minimally Invasive Spine Surgery Annual Forum ’16, one of the premier conferences for the industry.

“I was excited to present evidence that our outpatient minimally invasive spine procedures result in fewer complications and improved patient outcomes,” Chairman Weiss said. “The Annual Forum is an important venue to share information and findings on minimally invasive surgery options as a more modern solution to providing relief for patients suffering from neck and back pain.”

For more information about Laser Spine Institute visit LaserSpineInstitute.com.

For additional research findings and to download the abstract, click here.

Media Contact: Hailey Fitch, Edelman

Phone: 407-377-6650

Email: hailey.fitch@edelman.com

About Laser Spine Institute

Headquartered in Tampa, Florida, Laser Spine Institute currently operates seven regional surgery centers across the country, in Tampa, Florida; Scottsdale, Arizona; Philadelphia; Oklahoma City; Cleveland; St. Louis and Cincinnati. Laser Spine Institute has helped more than 60,000 patients find relief from debilitating neck and back pain caused by spinal stenosis, degenerative disc disease, pinched nerves, bone spurs, bulging/herniated discs, sciatica and other chronic conditions. Ninety-nine percent of patients say they would refer a friend or family member to have surgery at Laser Spine Institute. Additionally, Laser Spine Institute has been repeatedly recognized by Voyance Health as a National APEX Quality Award winner for outstanding patient satisfaction and reports an enterprise patient satisfaction score of 96. In 2015, the company’s Philadelphia facility received Gold-level designation for excellence in patient-centered care from Planetree, a mission-based, not-for-profit organization that partners with health care organizations around the world and across the care continuum to transform how care is delivered.

Laser Spine Institute has been named a top employer by Modern Healthcare, Tampa Bay Times, Tampa Bay Business Journal, Philly.com and okc.BIZ and a Most Admired Company by BestCompaniesAZ.

7D Surgical Receives FDA 510(K) and Health Canada MDL Clearance for Its Breakthrough Image Guidance System for Spine Surgery

Posted On January 23, 2017 By OrthoSpineNews In Regulatory, Spine /

TORONTO, Jan. 23, 2017 /PRNewswire/ — 7D Surgical announced today that it has received both 510(k) clearance from the U.S. Food and Drug Administration (FDA) and a medical device license from Health Canada enabling the North American commercial launch of its innovative Machine-vision Image Guided Surgery (MIGS™) system for spine surgery, the 7D Surgical System.

The 7D Surgical System employs cutting-edge 3D optical technologies and machine vision algorithms to eliminate the long-standing barriers to adoption of existing surgical navigational platforms. This new technology can easily register spinal surgery patients automatically using only visible light. Unlike time-consuming conventional image guided surgery (IGS) systems that depend on intraoperative radiation, this new platform can achieve an incredibly fast surgical workflow for spine procedures.

“When navigating the spine, surgeons traditionally have had two time-consuming and expensive IGS options: systems that rely on intraoperative radiation emitting devices or systems that utilize laborious manual point matching techniques,” said Beau Standish, Chief Executive Officer of 7D Surgical. “We believe the inefficiencies of these systems have limited the adoption of IGS in spine procedures to less than 20%. 7D Surgical’s MIGS™ system has now removed these barriers, providing surgeons and their hospitals with a superior product option.”

The 7D Surgical System enables near-instantaneous Flash Registration™ of the patient’s anatomy. “Guided by our product philosophy of ‘surgeons designing for surgeons’, we have achieved an unprecedented entire workflow time of less than 20 seconds for de novo spinal registration, unheard of in the spinal IGS world where such registration can interrupt surgery for up to 30 minutes,” said Dr. Victor Yang, President and Chief Scientific Officer of 7D Surgical, Senior Scientist at Sunnybrook Research Institute, and Staff Neurosurgeon at Sunnybrook Health Sciences Centre in Toronto, where prototype MIGS™ technology has been used in more than 160 patients in clinical trials.

The MIGS™ navigation technology is embedded in an onboard overhead surgical light, which eliminates line of sight frustrations in the operating room, and is manifested in simplified yet powerful software, which is controlled by the surgeon using only a foot pedal. “Our surgeons don’t rely on non-sterile personnel to operate the technology. Our surgeons are in total control,” said Yang.

“Image guided surgery technology has finally caught up to the needs of a practicing spine surgeon,” said Dr. Frank Cammisa, Chief Emeritus of the Spine Service at Hospital for Special Surgery in New York City. “7D Surgical’s new MIGS™ system appears to provide a faster, radiation-free alternative to existing options. It could be an important new tool in expanding the use of IGS in spine procedures.” He added, “The 7D Surgical System reduces the overall cost and footprint required to navigate the spine. It’s a win-win for the surgeon and the hospital.”

With both U.S. and Canadian regulatory authorization, 7D Surgical has commenced execution of its North American commercialization strategy. “We are delighted to have achieved these regulatory milestones in line with our expectations and planning,” said Standish. “We are confident that in demonstrating the speed and efficiency of our MIGS™ system, we will convince more surgeons to employ IGS in their spine procedures.”

About 7D Surgical

7D Surgical is a privately-owned Toronto based company that develops advanced optical technologies and machine vision-based registration algorithms to improve surgical workflow and patient care. 7D Surgical’s flagship FDA 510(k)-cleared and Health Canada approved MIGS™ system delivers profound improvement to surgical workflows in spine surgery, providing the promise of similar future advancements in other surgical specialties.

Contact:
Beau Standish, CEO
7D Surgical
+1 647 484-0078
www.7Dsurgical.com
140332@email4pr.com

Forward-looking Statements

This press release contains forward-looking statements regarding, among other things, statements pertaining to expectations, goals, plans, objectives, and future events. 7D Surgical intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934, and the Private Securities Reform Act of 1995. In some cases, forward-looking statements can be identified by the following words: “may,” “can,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “promise,” “continue,” “ongoing,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements are based on the current estimates and assumptions of our management as of the date of this press release and are subject to risks, uncertainties, changes in circumstances, assumptions, and other factors that may cause actual results to differ materially from those indicated by forward-looking statements, many of which are beyond 7D Surgical’s ability to control or predict. Given these uncertainties, undue reliance should not be placed on these forward-looking statements. 7D Surgical does not undertake any obligation to release publicly any updates or revisions to these forward-looking statements to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events.

“MIGS™”, “Flash Registration™,” as well as the “7D” logo, whether standing alone or in connection with the words “7D Surgical” are protected trademarks of 7D Surgical.

SOURCE 7D Surgical

Biology trumps bionics: An alternative to total knee replacement

Posted On January 23, 2017 By OrthoSpineNews In Biologics, Sports Medicine /

Published on January 20, 2017 – By Kevin R. Stone, M.D.

If you have severe knee pain or chronic knee inflammation and swelling which cannot be improved by minor surgery or physical therapy, a doctor may recommend that you have total knee replacement surgery. For many people, after years of agony, this operation is a godsend. The procedure relieves pain and greatly enhances their quality of life, allowing them to return to work and resume activities that they have not been able to enjoy in years.

But artificial knee replacements are not a perfect solution. Studies have shown that up to 50% of recipients still have some pain after the procedure. Surgeons are reluctant to perform knee replacements on younger people because the parts don’t last. Subsequent replacements are more complex and wear out even faster.

Many of the arthritic patients I see are under 70 years old and have years of playing sports and being active ahead of them. Therefore I like to do everything possible to rebuild their knee joint with biologic tissues rather than artificial materials to help delay the time in which an artificial joint replacement is necessary.

This regenerative approach to healing is the new frontier in modern medicine as researchers all over the world look for ways to rebuild and regenerate tissues and organs, harnessing the body’s natural ability to heal itself. In many cases these solutions are a long way off, but in orthopedics, we have been practicing them for years.

A BioKnee is an alternative to an artificial knee replacement. It combines three key procedures that rebuild, regenerate or biologically replace the damaged parts of the knee.

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Camber Spine Technologies Announces 510(k) Clearance For Their Siconus(TM) SI Joint Fixation System

Posted On January 23, 2017 By OrthoSpineNews In Regulatory, Spine /

WAYNE, Pa., Jan. 23, 2017 — (Healthcare Sales & Marketing Network) — Camber Spine Technologies, today announced that it has received 510(k) clearance for their Siconus™ SI Joint Fixation System. Siconus™ becomes the second product in the Camber Spine Technologies portfolio to treat sacroiliac disease, as a complement to the Prolix™ custom machined allograft implant.

“The Siconus™ SI Fusion Screw System is an important addition to our growing portfolio of devices and completes our exclusive SI Fusion product portfolio.” said Daniel Pontecorvo, Founder and CEO of Camber Spine Technologies. “Siconus™ provides superior compression across the SI Joint over multiple turns of the threaded fixation implants. When used with the Prolix™ SI Joint Fusion System, the combined solution offers a direct visualization and insertion of a machined allograft spacer into the SI joint, followed by a lateral approach compression and fixation implants. The combined solution may be the only MIS SI Joint Fusion technology to foster a True Fusion of the SI Joint.”

The Siconus™ SI Fixation System is intended to provide fixation and stabilization of large bones, including the sacrum and ilium. It is intended for use in skeletally mature patients as an adjunct to sacroiliac joint fusion in the treatment of the degenerative sacroiliitis, or sacroiliac joint disruptions.

Siconus™ was developed under a collaborative agreement with the Institute for Musculoskeletal Science & Education (IMSE), an independent, full-service product development and engineering services company.

About Camber Spine

Camber Spine Technologies, LLP, is a fast-growing musculoskeletal implant company founded in 2010 bringing innovative, best-in-class products to the market, providing surgeons and their patients with better treatment options. The company is committed to delivering surgeon inspired new technologies to the spine market. Camber is an ISO 13485 certified medical device company. Camber Spine Technologies, located in Wayne, Pennsylvania, markets a line of proprietary musculoskeletal products nationwide through its exclusive distributor, S1 Spine. For further information please visit www.cambermedtech.com. For inquiries about Siconus™ or distribution opportunities please call 484.427.7060.

All of Camber Spine Technologies’ products are proudly MADE IN THE USA.

Source: Camber Spine Technologies

Month: January 2017