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September 29, 2016 OrthoSpineNews

WESTMINSTER, Colo., Sept. 29, 2016 /PRNewswire/ — Cerapedics, a privately-held orthobiologics company, today announced the company completed an $11 million Series D financing. The funds will be used to expand commercialization of i-FACTOR™ Peptide Enhanced Bone Graft, which was approved by the U.S. Food and Drug Administration (FDA) in November 2015 for use in anterior cervical discectomy and fusion (ACDF) procedures in patients with degenerative cervical disc disease. Additionally, the proceeds will be used to further the development of Cerapedics’ synthetic small peptide (P-15) technology for fusion in the lumbar spine.

“As we close our Series D financing, Cerapedics is well on its way to becoming one of the most innovative and successful private orthobiologics companies in the industry,” said Glen Kashuba, CEO of Cerapedics. “We look forward to accelerating our commercialization efforts in the U.S. following outstanding feedback from surgeons across the country who have been among the first to use i-FACTOR grafts in cervical spine procedures, and are also focused on expanding our presence in international markets in the near future.”

i‐FACTOR bone graft is based on P-15 technology developed by Cerapedics to support bone growth through cell attachment and activation. It is the first bone graft to be approved for use in the cervical spine by the FDA and may be used as a substitute for autologous bone in ACDF procedures. The U.S. surgical market for biologic bone substitutes is estimated to be about $1.5 billion.

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

Related Links

http://www.cerapedics.com


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September 29, 2016 OrthoSpineNews

ORLANDO, Fla., Sept. 29, 2016 (GLOBE NEWSWIRE) — Mazor Robotics Inc., a developer of innovative guidance systems and complementary products, and The Center for Musculoskeletal Disorders (CMD), today announced the first installation of the Renaissance system in an ambulatory outpatient setting in the Northeast.

CMD, located in Englewood, NJ, is a joint private practice including The Center for Spinal Disorders, The Center for Hand Disorders and The Center for Pain Management. CMD’s spine surgeons, Drs. Jonathan Lewin, Seth Grossman and Vagmin Vora, assisted by Isaac Abramchayev, PA, will be using Renaissance. Drs. Steven Horowitz and Jonathan Simhaee, who head the pain management division, also support the new technology, along with the orthopedic head of the practice, Dr. Raz Winiarsky.

“With Mazor’s Renaissance system, we now have a unique opportunity to provide spine surgery patients access to the latest technology in an outpatient setting,” said Spine Surgeon Dr. Jonathan Lewin. “The system is a great addition to our comprehensive care practice.”

“The technology is innovative and forward thinking. The pre-operative platform helps put the surgeon at ease about placement of metal hardware around very vital structures,” said the practice’s PA, Isaac Abramchayev. “The intra-operative hardware is precise and easy to apply into the normal routine. For too long, spinal surgery has relied on estimation and guessing. This technology is set to theoretically and practically change the way spinal surgery is approached from a surgical and perioperative team standpoint.”

The Renaissance system uses advanced 3D planning and mechanical guidance with 1.5mm accuracy to provide surgeons with a powerful solution for minimally invasive and percutaneous fusions, complex spinal deformity and trauma cases. Access Mazor Robotics series of ‘How Renaissance Works’ videos here.

About Mazor

Mazor Robotics believes in healing through innovation by developing and introducing revolutionary technologies and products aimed at redefining the gold standard of quality care. Mazor Robotics Guidance Systems enable surgeons to conduct spine and brain procedures in a precise manner. For more information, please visithttp://www.MazorRobotics.com.

About The Center for Musculoskeletal Disorders (CMD)

The Center for Musculoskeletal Disorders (CMD) is a formalized joint practice including The Center for Spinal Disorders, The Center for Hand Disorders and The Center for Pain Management. Since the three centers have long worked together to provide cohesive care to the community, our newly integrated practice will continue our steadfast servitude to our patients. Our specialty-trained physicians and staff share the common philosophy of highly personalized care. We stress non-surgical solutions whenever possible and use cutting-edge medical and surgical techniques to customize advanced treatments for our patients’ needs.


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September 29, 2016 OrthoSpineNews

By ALTERG – September 28, 2016

Is it possible for those with osteoarthritis (OA) to avoid or delay hip and knee replacement surgery through physical therapy and exercise? Studies show that minimizing OA pain and getting people moving improve function and may delay the need for surgery. With the help of technology, physical therapists can encourage movement by decreasing or eliminating pain for these OA patients.

OA is the breakdown of cartilage that results in pain, swelling, decreased range of motion and stiffness. The most common chronic joint condition, OA impacts more than 27 million Americans. One in four Americans will develop hip OA by age 85, and one in two will develop knee OA in his or her lifetime.

Many people with OA feel the condition is inevitable, can’t handle the pain and become sedentary while waiting for a surgical intervention. Consider the pain cycle: Pain -> Decreased Movement-> Loss of Flexibility and Strength -> Deconditioning -> Poor Lower Extremity Mechanics. This pain cycle often leads to a sedentary lifestyle, which also results in an increased risk for diabetes, weight gain/obesity, coronary artery disease (CAD), hypertension and falls.

The vision of the American Physical Therapy Association (APTA) is to transform society by optimizing movement to improve the human experience. For those with OA, a physical therapist can help patients break the pain cycle and improve their quality of life by:

  • Encouraging mobility
  • Helping improve flexibility and strength
  • Helping maintain cartilage health
  • Helping normalize gait

Because cartilage is avascular and aneural, there is not a lot of blood flow in cartilage or excessive pain until it breaks down enough to expose the bony layer beneath it. Cartilage exists to absorb shock and withstand pressure, and loading it enough is important for cartilage health, just as load is important for all body tissue. While excessive loading is detrimental to someone with OA, moderate exercise with loads that are pain-free have proven beneficial.

 

READ THE REST HERE


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September 29, 2016 OrthoSpineNews

by Stacy Lawrence

Verb Surgical is working on what it sees as “Surgery 4.0”: the next iteration of surgery that incorporates robotics, advanced visualization, machine learning, data analytics and connectivity. It expects that its technology could translate into real access for billions globally who currently don’t have access to surgery by lowering costs and reducing the training threshold.

Along with Johnson & Johnson’s ($JNJ) Ethicon and Alphabet’s ($GOOG) Verily, Verb expects to have a fully working prototype surgical system by year end. Ethicon already divulged earlier this year that there was a prototype of the robotic system. A surgical system isn’t expected to be on the market, though, until 2020.

“We envision a future in surgery where we move from having a mainframe computer to a PC on every desk to a cell phone in every pocket,” Verb President and CEO Scott Huennekens toldFierceMedicalDevices. “Everybody has access at a much lower cost with a much lower threshold for training.”

He said that Ethicon is specifically contributing its surgical instrumentation, while Verily and Google are bringing to the table data analytics and machine learning tech. The expectation is that these surgical systems will talk to each other–and learn systematically.

 

READ THE REST HERE


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September 28, 2016 OrthoSpineNews
 September 28, 2016

LONDON–(BUSINESS WIRE)–Brainlab, a global leader in medical technology, announced today that it has solidified its position as the dominant force in orthopedic surgical planning, adding 20 new TraumaCad® sites in the United Kingdom in the past 12 months. With consistent annual sales growth in the U.K. of approximately 10 percent, TraumaCad is now available in nearly 70 percent of hospitals in the U.K.

“Before we started using TraumaCad, in January 2016, my colleagues and I were well aware of its excellent reputation amongst our colleagues elsewhere,” said Simon Royston, Sheffield Teaching Hospitals, NHS Trust. “We have found it very intuitive to use and it has been a step-up in the ease and quality of our pre-operative planning. The training and technical support from Brainlab has been superb, all the way from pre-installation to the present.”

Installed at over 2,000 locations worldwide, TraumaCad surgical planning by Brainlab, provides orthopedic surgeons with a comprehensive digital solution for performing pre-operative planning and simulations. The procedure-oriented application includes an extensive digital template library and offers a full set of wizards and measurement tools. Using digital images, surgeons can perform measurements, assess prostheses, simulate osteotomies, and visualize fracture reductions.

“Our explosive growth in TraumaCad sales is not only a great validation of the quality and reputation of our technology, but it is also an important recognition of the growing demand for hospitals and clinics to stay ahead of the curve in orthopedic treatments,” said Ian Wilson, Sales Manager, on behalf of Brainlab. “In most cases, the UK hospitals and clinics that have purchased TraumaCad in the past year or two have replaced other digital templating solutions.”

For more information on TraumaCad, visit www.traumacad.com

About Brainlab

Brainlab, headquartered in Munich develops, manufactures and markets software-driven medical technology, enabling access to advanced, less invasive patient treatments.

Core products center on information-guided surgery, radiosurgery, precision radiation therapy, digital operating room integration, and information and knowledge exchange. Brainlab technology powers treatments in radiosurgery and radiotherapy as well as numerous surgical fields including neurosurgery, orthopedic, ENT, CMF, spine and trauma.

Privately held since its formation in Munich, Germany in 1989, Brainlab has more than 11,000 systems installed in about 100 countries. Brainlab employs 1,350 people in 19 offices worldwide, including 385 Research & Development engineers, who form a crucial part of the product development team.

Contacts

Brainlab
Anna Bliss
T: +49 89 99 156 8172
anna.bliss@brainlab.com


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September 28, 2016 OrthoSpineNews

Kristen Thometz | September 28, 2016

New technology developed in Chicago could lead to major advances in healing broken bones and other sports medicine injuries.

Using a commercially available 3-D printer and custom ink formulation, Northwestern University researchers created a synthetic bone capable of stimulating new bone growth.

“Ideally, it would be great if we could have these printers in a hospital setting where we can provide them the hyper-elastic bone ink, and then they can make patient-specific implants that day,” said Ramille Shah, assistant professor in the department of materials science and engineering, and surgery transplant division at Northwestern University.

“I think that is a possibility with this material.”

When used in recent studies, these 3-D printed bones successfully repaired spinal injuries in rodents and a large skull defect in a monkey. Those findings are being published Wednesday in the peer-reviewed journal Science Translational Medicine.

Printing a better bone

Shah heads a research lab at Northwestern that has spent the last several years working on developing 3-D printable materials, including the development of 3-D inks for both biomedical and non-biomedical applications.

Through this work researchers developed a “unique 3-D ink formulation” that makes it possible to print 3-D objects primarily composed of the main mineral found in natural bone tissue, Shah said. The other component of the 3-D ink is both biocompatible and biodegradable.

The printed product, which researchers are calling hyper-elastic bone, is “highly elastic,” even though it’s primarily made up of material that tends to be “very brittle,” Shah said.

 

READ THE REST HERE


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September 28, 2016 OrthoSpineNews

SAN JOSE, Calif., Sept. 28, 2016 /PRNewswire/ — SI-BONE, Inc., a medical device company that pioneered the use of the iFuse Implant System® (“iFuse”), a minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced that Blue Cross Blue Shield (BCBS) of Nebraska has updated its medical policy to provide coverage for minimally invasive SI joint fusion using CPT 27279.  BCBS of Nebraska becomes the second BCBS plan following Michigan to establish a positive coverage policy for MIS SI joint fusion.  The new policy is based on a review of published clinical literature available as of March, 2016 and states: “fusion/stabilization of the sacroiliac joint for the treatment of back pain is scientifically validated when the patient has had a positive result with dual diagnostic blocks using 2 anesthetic agents with different duration of action and has tried and failed therapeutic injections and has tried and failed 12 weeks of conservative management which must consist of documented physical therapy and nonsteroidal anti-inflammatory medications.”

References cited within the new coverage policy consisted of published studies specific to iFuse1,2.  iFuse is the only SI joint fusion device with a patented triangular profile that resists joint motion and is supported by more than 45 peer-reviewed positive publications.  No other SI joint fusion device has peer-reviewed published evidence supporting safety and effectiveness, and iFuse is the only such device commercially available in the United States with an indication citing clinical studies that demonstrate improved pain, patient function and quality of life.

“BCBS of Nebraska joins BCBS of Michigan along with a growing list of leading edge private insurers as well as Medicare nationwide to provide coverage for iFuse.  This positive coverage decision provides access to appropriate care for Blue Cross Blue Shield members throughout Nebraska who have been suffering with chronic SI joint dysfunction due to degenerative sacroiliitis or SI joint disruption,” said Michael Mydra, Vice President, Health Outcomes & Reimbursement, SI-BONE.

“I see patients in my practice on a regular basis who have suffered from chronic sacroiliac joint dysfunction for years and no longer respond to non-surgical treatment.  Many of these patients are surgical candidates,” said John Hain, MD at Nebraska Spine Hospital in Omaha, Nebraska.  “I am pleased that I can now offer my BCBS Nebraska patients the only minimally invasive procedure supported by two year outcomes data and give them a chance to have a better quality of life.”

About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading sacroiliac joint medical device company dedicated to the development of tools and products for patients with low back issues related to certain SI joint disorders.  The company develops, manufactures and markets minimally invasive products for the SI joint.  SI-BONE, Inc. received original 510(k) clearance in November 2008 from the Food and Drug Administration (FDA) to market its iFuse Implant System. The CE mark for European commercialization was obtained in November 2010.

The iFuse Implant System is a minimally invasive surgical option that uses titanium implants with a porous surface creating an interference fit designed to help decrease joint motion, and allow for biological fixation to support long-term fusion.  iFuse is the only commercially available SI joint fusion device in the United States with published evidence that demonstrates safety, effectiveness and economic benefits, including three large multicenter prospective studies, two of which are randomized controlled trials (RCTs). Currently, there are more than 45 peer-reviewed publications supporting positive clinical outcomes, safety, biomechanics, and the economic value of iFuse (www.si-bone.com/results).  It is the only SI joint fusion product with a unique FDA clearance recognizing that clinical studies demonstrate improved pain, patient function and quality of life.

The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis.  This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.  Clinical studies have demonstrated that treatment with the iFuse Implant System improved pain, patient function, and quality of life.  There are potential risks associated with the iFuse Implant System.  It may not be appropriate for all patients and all patients may not benefit.  For information about the risks, visit: www.si-bone.com/risks


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September 28, 2016 OrthoSpineNews

By CASEY ROSS

BRECKSVILLE, Ohio — Get in, get a new knee, go home.

As treatments get less invasive and recovery times shrink, a new kind of hospital is cropping up — the “bedless hospital.”

They have all the capabilities of traditional hospitals: operating rooms, infusion suites, and even emergency rooms and helipads. What they don’t have is overnight space.

“It reduces cost, and it reduces the risk of infection,” said Dr. Akram Boutros, CEO of MetroHealth System, which just opened a $48 million bedless hospital near Cleveland that he expects will serve about 3,000 people in the first year. “People go home to a less-risky environment, where they tend to get better faster.”

The growth in outpatient healthcare is a fundamental shift in US medicine. MetroHealth, which gets part of its funding from taxpayers and serves a large Medicaid population, has expanded outpatient visits from 850,000 to 1.2 million in the last four years, a 40 percent increase.

Outpatient visits, experts say, subsidize more expensive inpatient treatment.

But some observers worry that the development of bedless hospitals is part of a financial shell game hospitals must play to make the dollars match up with the care they offer. And they wonder if such facilities are diverting resources away from a large population of patients who still require more complex treatment.

“The untold story is what’s happening to all of those patients who do still need to be in the hospital,” said Harold Miller, chief executive of the Center for Health Care Quality and Payment Reform. “And are the places where they are going getting paid enough to support good care?”

READ THE REST HERE


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September 28, 2016 OrthoSpineNews

Zacks – September 28, 2016

Share price of Intuitive Surgical Inc. ISRG rallied to a 52-week high of $720.94 on Sep 27, eventually closing a tad lower at $720.19. This represents a strong year-to-date return of about 31.86%, much better than the S&P 500’s return of 5.67% over the same time frame.

Currently, Intuitive Surgical carries a Zacks Rank #3 (Hold). The stock has a market cap of 27.22 billion and a long-term expected earnings growth rate of 11.26%.

Key Catalysts

We believe that growing adoption of Intuitive Surgical’s da Vinci system among physicians for general surgery, oncology, urology and gynecology procedures is a key growth catalyst. Moreover, increasing procedural volume outside the U.S. presents a significant growth opportunity for the company. Further, the integrated Table Motion product line has gained traction within a short span of time. This will likely boost top-line growth.

Meanwhile, increased spending on product development and higher investment in expanding the company’s footprint in international markets (particularly in Europe) are prudent moves to drive long-term growth.

Intuitive Surgical had impressed in the second quarter of 2016 with exceptional global procedure growth, solid capital placement, strong product margin and new product launches. Notably, the company reported adjusted earnings of $4.86 per share, which beat the Zacks Consensus Estimate by 65 cents.


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September 28, 2016 OrthoSpineNews

TORONTO, ON–(Marketwired – September 27, 2016) – Titan Medical Inc. (TMD.TO) (TITXF), a medical device company focused on the design and development of a robotic surgical system for application in minimally invasive surgery (MIS), today provided an update of corporate activities and operational progress.

On September 20 2016, Titan completed a public offering of units which raised approximately US $7.2 million from US and Canadian investors. As a result of the transaction, management currently anticipates closing the third quarter ending September 30, 2016 with approximately US $8.5 million in cash.

“As a result of the recent fund raising, we have initiated active discussions with our principal development partners to implement key components of the SPORT Surgical System’s development plans within our current financial resources,” said John Hargrove, Chief Executive Officer. “At this point, we believe the resources we have on hand enable us to move forward with the advancement of human factors and usability studies of the surgical system.”

As part of the succession plan for senior management, Titan has engaged an executive search firm for the purpose of assisting in the identification and qualification of a Chief Operating Officer, whose responsibilities will include capital markets involvement, and a Vice President of Engineering to assist in product development and project management.

In addition to the operational activities, that management is focused on, the Board continues its active search to recruit a new Chairperson. We are also continuing an ongoing program of board renewal. As we achieve operational and development milestones, as well as the progress regarding our Chairperson search, we will promptly inform our shareholders.

About Titan Medical Inc.

Titan Medical Inc. is a Canadian public company focused on the design and development of a robotic surgical system for application in minimally invasive surgery (“MIS”). The Company’s SPORT™ Surgical System, currently under development, includes a surgeon-controlled robotic platform that incorporates a 3D high-definition vision system and multi-articulating instruments for performing MIS procedures through a single incision. The surgical system also includes a surgeon workstation that provides a surgeon with an advanced ergonomic interface to the robotic platform for controlling the instruments and provides a 3D high-definition endoscopic view of inside a patient’s body. The SPORT™ Surgical System is designed to enable surgeons to perform a broad set of surgical procedures for general abdominal, gynecologic, and urologic indications. For more information, visit the Company’s website at www.titanmedicalinc.com.

Forward-Looking Statements

This news release contains “forward-looking statements” which reflect the current expectations of management of the Company’s future growth, results of operations, performance and business prospects and opportunities. Wherever possible, words such as “may”, “would”, “could”, “will”, “anticipate”, “believe”, “plan”, “expect”, “intend”, “estimate”, “potential for” and similar expressions have been used to identify these forward-looking statements. These statements reflect management’s current beliefs with respect to future events and are based on information currently available to management. Forward-looking statements involve significant risks, uncertainties and assumptions. Many factors could cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements, including, without limitation, those listed in the “Risk Factors” section of the Company’s Annual Information Form dated March 30, 2016 (which may be viewed at www.sedar.com). Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in the news release are based upon what management currently believes to be reasonable assumptions, the Company cannot assure prospective investors that actual results, performance or achievements will be consistent with these forward-looking statements.