Surgical Navigation Systems in the US Driven by the Increasing Adoption of Ambulatory Surgical Centers: Technavio

December 23, 2016

LONDON–(BUSINESS WIRE)–According to the latest market study released by Technavio, the surgical navigation systems market in the US is expected to grow at a CAGR of almost 6% during the forecast period.

This research report titled ‘Surgical Navigation Systems Market in the US 2016-2020’ provides an in-depth analysis of the market in terms of revenue and emerging market trends. This market research report also includes up to date analysis and forecasts for various market segments and all geographical regions.

One of the most important factors driving this market is the expansion of outpatient settings. Studies have proved computer-assisted surgeries to be more precise and less risky, resulting in improved quality of life for the patient. The procedures are pre-programmed into a surgical navigation system, and can be carried out in outpatient settings with the assistance of an experienced surgeon. This has resulted in an increased number of ambulatory surgical centers (ASCs) where even the most complex spinal surgeries can be performed in a safe and sterilized setting.

Other key drivers for this market are the growing popularity of minimally invasive surgeries, ever broadening applications of surgical navigation systems, and innovative marketing strategies used by vendors. Due to the increasing demand for surgical navigation systems, manufacturers are focusing on developing portable and lightweight systems equipped with the latest, cutting-edge software capabilities.

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Based on application, the report categorizes the surgical navigation systems market in the US into the following segments:

  • Neurosurgical navigation systems
  • Orthopedic surgical navigation systems
  • ENT surgical navigation systems
  • Spine surgical navigation systems

Neurosurgical navigation systems

The neurosurgical navigation systems market represents the largest segment of the surgical navigation systems market in the US. This system is ideal for surgeries related to cranial tumors and neurological disorders. There has been an increase in the use of frameless stereotaxy and MRI image-guided navigation for obtaining brain biopsies and in tumor resurrection procedures. This has clearly demonstrated improved surgical outcomes for complex spinal surgeries,” says Barath Palada, one of the lead analysts at Technavio for medical devices research.

With the increase in the volume of neurosurgical procedures across the US and high adoption of minimally invasive surgeries, the demand for neurosurgical navigation systems is on the rise. These systems have also shown to lessen the extent of neurological functioning when compared to traditional surgeries. This is mainly due to the availability exact mapping for a variety of cortical functions like sensory, motoric, speech, and language functions, and for visualizing subcortical pathways for both benign and malignant brain tumors.

Orthopedic surgical navigation systems

The orthopedic surgical navigation market represents the second largest surgical navigation systems in the US. Statistics show that the number of people suffering from musculoskeletal diseases is growing. The American Academy of Orthopedic Surgeons (AAOS), hospital discharge data has shown that an increasing number of patients are undergoing knee replacements and this rate has jumped up by 120% over a 10-year period, and overall hip replacement cases have also doubled in the past decade.

In this scenario, with a growing number of orthopedic surgeries, the surgical navigation system will be ideal for several procedures including joint arthroplasties, total hip arthroplasty, total shoulder arthroplasty, limb-salvage techniques and fracture surgeries. Computer-assisted orthopedic surgery (CAOS) system comprises of 3D image-guided and non-image based navigation systems, intraoperative fluoroscopic navigation, robotic-assistance tools, and intraoperative visualization devices.

ENT surgical navigation systems

The ENT surgical navigation market represents the newest and fastest growing segment in the surgical navigation systems market in the US. With the rising number of ASCs, the outpatient setting of the surgical navigation system is establishing itself as a popular option for most patients opting for ENT. In 2015, 92% of the ear and 87% of the nasal surgeries were performed in ASCs in an outpatient setting,” says Barath.

ENT navigation systems are especially beneficial as these surgeries include working with delicate anatomies, such as optic nerves, blood vessels, eyes, and the nasal region, which are beyond the view of the endoscope. These systems help in precise navigation of surgical instruments through complex sinus passages without causing any damage to the surrounding anatomy.

Spine surgical navigation systems

Spinal fusion surgeries are performed to relieve pain arising due to injury, degenerative disc disease, spinal curvatures or arthritis. This surgery is most commonly carried out through surgical navigation systems in the US. Additionally, extremely precise placement of implants like pedicle screws is assured by computer assisted navigation when compared to other conventional surgeries. This is especially true during treatment of spinal instability caused by degenerative disc disease, spinal stenosis, spondylolisthesis, deformity, fractures, tumors, and infection. Usage of CT-guided or 3D fluoroscopy-based navigation systems has clearly demonstrated an increase in the accuracy up to 98% and lessen the need for re-operating.

The top vendors highlighted by Technavio’s research analysts in this report are:

  • B. Braun Melsungen
  • Brainlab
  • GE Healthcare
  • Medtronic
  • Stryker

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About Technavio

Technavio is a leading global technology research and advisory company. The company develops over 2000 pieces of research every year, covering more than 500 technologies across 80 countries. Technavio has about 300 analysts globally who specialize in customized consulting and business research assignments across the latest leading edge technologies.

Technavio analysts employ primary as well as secondary research techniques to ascertain the size and vendor landscape in a range of markets. Analysts obtain information using a combination of bottom-up and top-down approaches, besides using in-house market modeling tools and proprietary databases. They corroborate this data with the data obtained from various market participants and stakeholders across the value chain, including vendors, service providers, distributors, re-sellers, and end-users.

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Technavio Research
Jesse Maida
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Vivex Biomedical, Inc. Receives Level II HCPCS Q-Code for Cygnus™, a Human Amniotic Tissue Allograft

ATLANTA Dec. 20, 2016 /PRNewswire

Vivex Biomedical, Inc. (Vivex) is a biomaterials developer focused on creating treatment options and creative solutions to advance clinical, surgical and therapeutic patient care. It has made significant progress in a short time, bringing together the brightest minds in the scientific community and from the orthopaedic and material science industries. With its focus on continued innovation in next-generation biomaterials, Vivex is creating a new standard in patient care and delivering groundbreaking health products to meet the needs of a diverse, rapidly expanding market.

“Vivex is very excited to receive this unique Level II HCPCS Q-Code for Cygnus, one of our premiere amniotic tissue allografts,” commented Michele Pablos, Vice President of Sales and Marketing. “Our goal is to make our products more affordable based on the operating needs of all payers, and this is a huge step in making that goal a reality.”

“Cygnus, an amniotic tissue matrix with innate regenerative capability to support healing, is a product that is available in multiple sizes for multiple uses. Cygnus’ amnion patch is an immune-privileged tissue with proven clinical success in regenerative healing, and we look forward to providing more payers with the opportunity to use it.”

This Q-code set is available for use by an array of payers, and is maintained by the Centers for Medicare and Medicaid Services (CMS).

About Vivex Biomedical, Inc., Powered by UMTB:

Vivex Biomedical, Inc. is a regenerative biologics company, dedicated to creating new standards in patient care. Since 2014, Vivex and UMTB (founded 1970) have strived for methods to translate creative collaborations into treatments for real problems.

In collaboration with multiple partners, Vivex is on the cutting edge of scientific development. Translating innovation into treatments for real problems further expands surgical options. All research and development is focused on making strides in the field of musculoskeletal regenerative medicine, with major areas of investigation including: cartilage, bone, and skin. Innovative vision provides a platform that assists in the regeneration of all these tissue types in a personalized but scalable transplantation model.

Vivex is constantly working closely with services that support the advancement of allograft transplantation, specifically services that are committed to providing care and compassion to donor families while inspiring communities to share life by donating. Partnering with others ensures that families are offered the appropriate options and support for donation, including Life Alliance, the Lions Eye Bank, Brain Bank, and Medical Examiners.


Under Trump, the medical device industry will likely be the first to benefit from tax cuts




Integra LifeSciences Announces Approval of Two-for-One Stock Split

PLAINSBORO, N.J., Dec. 22, 2016 (GLOBE NEWSWIRE) — Integra LifeSciences Holdings Corporation (NASDAQ:IART) today announced that its stockholders approved a two-for-one stock split and an increase from 60 million to 240 million authorized shares of the Company’s common stock at a special meeting of stockholders held on Wednesday, December 21, 2016.

Holders of record, as of the close of markets on December 21, 2016, will be entitled to receive one additional share of common stock for each share held.  The shares are expected to be distributed on January 3, 2017.  The adjusted stock price is expected to be reflected on the NASDAQ stock market on January 4, 2017.

About Integra LifeSciences
Integra LifeSciences Holdings Corporation, a world leader in medical technology, 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

Statements made at the upcoming conferences may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve risks and uncertainties that could cause actual results to differ from predicted results. Forward-looking factors that may be discussed include, but are not limited to, future financial performance, new product development, governmental approvals, market potential and resulting sales as well as potential therapeutic applications, and additional acquisitions. These risks and uncertainties include market conditions and other factors beyond the Company’s control and the economic, competitive, governmental, technological and other factors identified under the heading “Risk Factors” included in item 1A 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. These forward-looking statements are made only as the date thereof, and the Company undertakes no obligation to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise.



Integra LifeSciences Holdings Corporation

Investor Relations:

Angela Steinway
(609) 936-2268   

Michael Beaulieu
(609) 750-2827

Smith & Nephew wins prestigious Galien Award for PICO Negative Pressure Wound Therapy innovation

21 December 2016

Smith & Nephew, (LSE:SN, NYSE:SNN), the global medical technology business, has been awarded the 2016 French Galien Award for PICO; the novel single-use negative pressure wound therapy (NPWT) system.

The Prix Galien acknowledges significant advances in pharmaceuticals and medical devices which deliver real improvements to human life. The prize, awarded in the Medical Disability Compensation and Return to Social Life category, rewards Smith & Nephew’s determination to improve the daily lives of patients and professionals with the management of wounds.

Managing Director of Smith & Nephew SAS (France), Bertrand L’Huillier, said: “Receiving the Galien Award is a huge honour and recognition of our contribution to medical research and ability to innovate.  It is also a great encouragement to continue our investment to support healthcare professionals in their daily efforts to improve the lives of patients worldwide.

Improving community healthcare and patient outcomes

Managing wounds, whether chronic, acute or post-surgical, has a significant impact to a patients’ quality of life as well as a financial impact on the health economy[i]. Chronic wounds are often hard to heal, resulting in a cycle of pain, anxiety, frequent home visits and reduced quality of life. However, with the availability of the PICO system in the community, the lives of patients with wounds are significantly improved[i].

A study of 326 community based patients whom received PICO treatment for pressure ulcers, leg ulcers, diabetic foot ulcers, trauma wounds and dehisced surgical wounds, showed that prior to using PICO wound dressings were being changed four times a week[ii]. This fell to two dressing changes a week when using PICO, and to 1.8 times a week, on average, in the four-week follow-up period. Fewer dressing changes resulted in considerable cost savings; the total cost of care using PICO was three times less than the baseline[iii].

About PICO

PICO is a novel, canister-free single use system that offers portable, accessible and affordable NPWT, overcoming many of the disadvantages of conventional NPWT devices. PICO’s unique dressing technology not only absorbs and locks exudate but is designed to move exudate away from the wound and aids evaporation of fluidiv. The PICO pump maintains negative pressure at -80mmHg through the wound bed and dressing[iv]. The PICO system can be used up to 7 days depending on levels of exudate, and includes two dressings.

PICO is cleared for use in hospital and homecare settings in Europe, US, Canada, and Australia. In Japan PICO is cleared for use in open wounds only. For more information about the PICO system and the NPWT portfolio of products from Smith & Nephew, please visit Clinicians and patients may also refer to the 24/7 Negative Pressure Wound Therapy hotline, 0800 9155394 (UK) and 1800 303 622 (Ireland).

About the Prix Galien

Each year, the Prix Galien rewards therapeutic innovations made available to healthcare professionals and patients as well as pharmaceutical research.  The honor committee includes the most prominent figures in the scientific world, including several Nobel Prize winners.  The Prix Galien is regarded as the highest distinction awarded each year to pharmaceutical research.

Recognition at the French Galien Awards means that Smith & Nephew will now be able to enter PICO into the international Galien Awards, held in 2018.

A full press pack, containing clinical and product imagery, videos, and background information is available on this page.


Beth Lowes or Rachel Cunningham 0208 995 5832
ROAD Communications on behalf of

About Smith & Nephew

Smith & Nephew is a global medical technology business dedicated to helping healthcare professionals improve people’s lives. With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma & Extremities, Smith & Nephew has around 15,000 employees and a presence in more than 100 countries. Annual sales in 2015 were more than $4.6 billion. Smith & Nephew is a member of the FTSE100 (LSE:SN, NYSE:SNN).

For more information about Smith & Nephew, please visit our website, follow @SmithNephewplc on Twitter or visit SmithNephewplc on

To learn more about what we do to help reduce surgical site complications, please visit

Forward-looking Statements

This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading margins, market trends and our product pipeline are forward-looking statements. Phrases such as “aim”, “plan”, “intend”, “anticipate”, “well-placed”, “believe”, “estimate”, “expect”, “target”, “consider” and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith & Nephew, these factors include: economic and financial conditions in the markets we serve, especially those affecting health care providers, payers and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls or other problems with quality management systems or failure to comply with related regulations; litigation relating to patent or other claims; legal compliance risks and related investigative, remedial or enforcement actions; disruption to our supply chain or operations or those of our suppliers; competition for qualified personnel; strategic actions, including acquisitions and dispositions, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational nature. Please refer to the documents that Smith & Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith & Nephew’s most recent annual report on Form 20-F, for a discussion of certain of these factors. Any forward-looking statement is based on information available to Smith & Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith & Nephew are qualified by this caution. Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith & Nephew’s expectations.

◊Trademark of Smith & Nephew.


[i] Reducing the burden of chronic wounds in the community with single-use NPWT’ JCN supplement 2015, Vol 29, No 5

[ii] Hurd et al., Use of a portable, single-use negative pressure wound therapy device in home care patients with low to moderately exuding wounds: A case series. Ostomy Wound Management, March 2014.

[iii] Hampton J, Providing cost-effective treatment of hard-to-heal wounds in the community through use of NPWT. British Journal of Community Nursing, Vol 20, No 6, Community Wound Care, June 2015.

[iv] Malmsjö M, Huddleston E, Martin R. Biological effects of a disposable, canisterless negative pressure wound therapy system. Eplasty 2014;14:e15.

Hospitals And Surgery Centers Play Tug-Of-War Over America’s Ailing Knees

Five years ago, Dr. Ira Kirschenbaum, an orthopedic surgeon in the Bronx who replaces more than 200 knees each year, would have considered it crazy to send a patient home the same day as a knee replacement operation.

And yet there he was this year, as the patient, home after a few hours. A physician friend pierced his skin at 8 a.m. at a Seattle-area surgery center. By lunch, Kirschenbaum was resting at his friend’s home, with no pain and a new knee.

“I’m amazed at how well I’m doing,” Kirschenbaum, 59, said recently in a phone interview, nine weeks after the operation.

What felt to Kirschenbaum like a bold experiment may soon become far more standard. Medicare, which spends several billions of dollars a year on knee replacements for its beneficiaries — generally Americans 65 and over — is contemplating whether it will help pay for knee replacement surgeries outside the hospital, either in free-standing surgery centers or outpatient facilities.

The issue is sowing deep discord in the medical world, and the debate is as much about money as medicine. Some physicians are concerned that moving the surgeries out of hospitals will land vulnerable patients in the emergency room with uncontrolled pain, blood clots or other complications.

But proponents of the change say it can give patients more choice and potentially better care, as well as save Medicare hundreds of millions of dollars. Already, an “overwhelming majority” of commenters said they want to allow the surgeries out of hospitals, according to recent rule-making documents.

The final decision, which could come within a year, would also act as a test of sorts for Donald Trump and his new administration. They will weigh whether to limit government controls, as Trump has often suggested, or to bend to pressure from hospitals and doctors, many of whom oppose the change.



CartiHeal Announces FDA IDE Approval of Its Agili-C Implant for the Treatment of Joint Surface Lesions

KFAR SABA, Israel, Dec. 20, 2016 /PRNewswire/ — CartiHeal (2009) Ltd., developer of a cell-free, off-the-shelf implant for use in cartilage and osteochondral defects, announced today the FDA approval of the Investigational Device Exemption (IDE) application submitted by CartiHeal for their Agili-C™ implant, towards a PMA application.

The 2 year-long pivotal study will involve a minimum of 250 patients in US and OUS centers. The study is aimed to show superiority of the Agili-C™ implant over surgical standard of care, i.e. microfracture and debridement, in the treatment of cartilage/osteochondral defects in both osteoarthritic knees and in knees without degenerative changes, making it the first approved study of such broad indications using a single implant.

The study is designed as a prospective, multicenter, open-label, randomized and controlled trial, involving up to 3 lesions in the same joint and with a total treatable area of 1-7cm2.

Agili-C™ was implanted in a series of clinical trials conducted in leading centers in Europe and Israel, in over 220 patients with cartilage lesions in the knee, ankle and great toe. In these trials the implant was used for the treatment of a wide spectrum of cartilage lesions, according to its CE Mark, from single focal lesions to multiple and large defects in patients suffering from osteoarthritis.

Results of these prior investigations demonstrated the potential for cartilage regeneration and remodeling of the underlying subchondral bone, along with pain and symptom relief.

“Pivotal studies performed to date were always focused on small, focal and isolated cartilage lesions in a narrowly defined patient group, which does not represent most of the ‘real-life’ cases,” explains Dr. Ken Zaslav, President of the International Cartilage Repair Society (ICRS) and a member of CartiHeal’s Clinical Advisory Board. “Based on the robust clinical data of the Agili-C™ implant, FDA has allowed  for the first time, treatment indications ranging from single focal defects to multiple defects in osteoarthritis of the knee, which is what us surgeons see on a daily basis.  Moreover, this exciting study will compare two control modes in a single arm:  microfracture for the treatment of focal lesions and debridement for patients with osteoarthritis.”

“Over the last few years we’ve conducted a series of clinical studies in leading centers to learn which kind of patients can  benefit from the Agili-C™ implant,” says Nir Altschuler, CartiHeal’s founder and CEO.  “Together with our Clinical Advisory Board we designed a study that targets a large patient population who can potentially benefit from this implant. We are very pleased that FDA approved our study design, and believe that the Agili-C™ implant will prove to be an ideal treatment for a variety of cartilage lesions in patients who wish to return to a painless and active lifestyle, and currently don’t have good alternatives.”

About CartiHeal

CartiHeal, a privately-held medical device company headquartered in Israel, develops proprietary implants for the treatment of cartilage and osteochondral defects in traumatic and osteoarthritic joints.

Backed by extensive pre-clinical and clinical data, its flagship product Agili-C™, an aragonite-based biodegradable scaffold, has been shown to promote restoration of hyaline cartilage and remodeling of its underlying subchondral bone through a natural process, without the use of cells or growth factors.

Clinical results in the knee, ankle and big toe demonstrated the potential of significant improvement in pain reduction, as well as reduction in related symptoms – through a simple, single-step implantation procedure.

In the United States, the Agili-C is an investigational device that is limited to use in the IDE study.  It is not available for sale.

Media Contact:
Caty Pearl

SOURCE CartiHeal (2009) Ltd.

Mazor Robotics Receives Order for Three Mazor X Systems from a Leading Mid-Atlantic Health Care Organization

December 22, 2016

CAESAREA, Israel–(BUSINESS WIRE)–Mazor Robotics Ltd. (TASE:MZOR; NASDAQGM:MZOR), a pioneer and a leader in the field of surgical guidance systems, today announced a three-system order for the Mazor X from a first-time customer, a leading mid-Atlantic health care organization which will install the systems at three of its medical centers.

“The level of enthusiasm following the launch of the Mazor X system at the NASS conference in October remains high and continues to generate considerable momentum,” commented Ori Hadomi, Chief Executive Officer. “This is the second multi-system order during the fourth quarter, both representing new customers, and demonstrating the co-marketing activities with our commercial partner are increasing the market’s awareness for our advanced surgical guidance systems.”

The Company will announce the total number of system orders for the fourth quarter on January 5, 2017.

About Mazor Robotics

Mazor Robotics (TASE: MZOR; NASDAQGM: MZOR) 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 more accurate and secure manner. For more information, please visit

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. Any statements in this release about future expectations, plans or prospects for the Company, including without limitation, statements regarding the market momentum for the Mazor X system, the benefits of the cooperation with Mazor’s commercial partner, and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “will” and similar expressions are forward-looking statements. These statements are only predictions based on Mazor’s current expectations and projections about future events. There are important factors that could cause Mazor’s actual results, level of activity, performance or achievements to differ materially from the results, level of activity, performance or achievements expressed or implied by the forward-looking statements. Those factors include, but are not limited to, the impact of general economic conditions, competitive products, product demand and market acceptance risks, reliance on key strategic alliances, fluctuations in operating results, and other factors indicated in Mazor’s filings with the Securities and Exchange Commission (SEC) including those discussed under the heading “Risk Factors” in Mazor’s annual report on Form 20-F filed with the SEC on May 2, 2016 and in subsequent filings with the SEC. For more details, refer to Mazor’s SEC filings. Mazor undertakes no obligation to update forward-looking statements to reflect subsequent occurring events or circumstances, or to changes in our expectations, except as may be required by law.


EVC Group
Michael Polyviou, 212-850-6020
Doug Sherk, 415-652-9100

Intrinsic Therapeutics announces the Filing of PMA Application for its Barricaid® Anular Closure Device for Lumbar Discectomy Patients.

BOSTON, Dec. 21, 2016 /PRNewswire/ — Intrinsic Therapeutics, Inc. announced today that the filing of its Pre-Market Approval (PMA) application with the Food & Drug Administration (FDA) for the Barricaid® Anular Closure device is complete.  Barricaid has been shown to improve the outcomes of patients undergoing discectomy for herniated lumbar discs to relieve sciatica pain.

“Approximately 1 million discectomies are performed every year around the globe and 40% of these patients will leave the operating room after discectomy with a large hole remaining in the outer rim of the disc, the anulus,” said Professor Douglas Klassen, Chief of Neurosurgery at St. Bonifatius Hospital, Lingen, Germany. “By simply sealing these large defects, patient outcomes can be improved significantly.”

The Barricaid Anular Closure device, designed to prevent repeat disc herniations in patients undergoing back surgery to treat sciatica, is the first of its kind to be the subject of a prospective, randomized, superiority trial involving patients who are at higher risk for revision discectomy surgery to alleviate recurrent pain resulting from reherniation.  The PMA submission was based on the 2-year outcomes of 554 trial participants.  Inclusion criteria for the study ensured enrollment of only subjects with a high risk of reherniation, subsequent reoperation, and rehospitalization.

“Today, quality patient care and the utilization of healthcare resources are scrutinized more than ever,” said Dr. Matthew McGirt, a Neurosurgeon at Carolina Neurosurgery & Spine Associates in Charlotte, North Carolina. “Technologies that demonstrate fewer repeat surgeries when compared to traditional treatment will fit into the paradigm of improving outcomes and conserving healthcare resources.”

Further supported by the clinical success demonstrated in earlier single-arm studies, Barricaid today stands alone as a unique treatment device for patients wishing to minimize risk of reherniation and resultant reoperations.  Additional benefits include reduction in serious adverse events, episodic pain events and early hospital readmissions (at 30, 60 and 90 days).

“We are thrilled to have reached this important milestone and move into the next phase with FDA,” said Cary Hagan, Intrinsic’s President and Chief Executive Officer. “Parallel to the PMA approval process, we continue to focus our efforts on market access including reimbursement pathways for this compelling new technology with a sharp focus on delivering a solid Health Economic proposal to payers and hospital systems.”

About Intrinsic Therapeutics

Intrinsic Therapeutics is a medical device company focused on delivering a safe treatment to improve efficacy in patients who are at a disproportionately high risk of requiring repeat surgeries due to reherniation following lumbar discectomy surgery.  Intrinsic currently markets and sells the Barricaid in Europe, Australia, the Commonwealth of Independent States, the Middle East and selected countries in other regions around the world. In the United States, Intrinsic Therapeutics is seeking regulatory approval of the Barricaid Anular Closure device.  See for more information.

Barricaid is a registered trademark of Intrinsic Therapeutics, Inc.

This press release contains forward-looking statements. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements, including, without limitation, statements relating to the potential approval by the FDA of the Company’s PMA submissions for the Barricaid Anular Closure device and the success of the Company’s launch preparedness efforts. These forward-looking statements are based upon Intrinsic’s current expectations. Actual results could differ materially from these forward-looking statements as a result of certain factors, including, without limitation, risks associated with the commercialization and market acceptance of, and customer demand for, the Barricaid Anular Closure device; the uncertain and time-consuming regulatory process, including the risks that the Company may be required to complete additional clinical trials in order to obtain approval of its PMA submissions; that the Company may otherwise encounter unanticipated difficulties complying with the regulatory requirements related to the Barricaid Anular Closure device or that the Company’s PMA submissions might not be approved by the FDA in a timely manner or at all; that the Company may not have the resources to support multiple regulatory submissions; adverse market and economic conditions; and other risks  You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Intrinsic does not undertake any obligation to update any forward-looking statements as a result of new information, future events, changed assumptions or otherwise.

Cary P. Hagan, CEO
Intrinsic Therapeutics, Inc.
+1 781 932-0222

SOURCE Intrinsic Therapeutics, Inc.


Carevature’s Limited Market Launch in US Brings Promise of Less Trauma and Quicker Recovery to Spinal Decompression Surgery Patients

TEL AVIV, Israel, Dec. 20, 2016 /PRNewswire/ — Carevature announced today that its Dreal™ line of products has begun helping surgeons in the US achieve better outcomes in spinal decompression surgeries. Over 400 patients worldwide have been treated in clinical use, with outstanding safety and recovery results. Six centers in Massachusetts, New Hampshire, Connecticut and Texas, are currently taking part in Dreal™’s limited market release.

Traditional spinal decompression surgeries help patients with back or limb pain by removing the tissue (usually bone) that’s putting pressure on the spinal nerves. In order to access the problematic tissue, surrounding tissue often needs to be removed. This can compromise spinal stability, and may require a spinal fusion procedure to connect the treated vertebrae and restore stability.

Carevature’s Dreal™’s unique curved design enables orthopedic surgeons and neurosurgeons to perform better spinal decompression more quickly and with less trauma to the area. Preservation of the surrounding tissue may reduce the need for spinal fusion procedures or simplify these procedures when fusion cannot be avoided.

Use of Dreal™ reduces operating room time and hospitalization time for spinal decompression patients. Spinal decompression patients treated with Dreal™ can be released from the hospital much faster than those treated with standard surgical tools. Avoidance of spinal fusion procedures can save the healthcare system tens of thousands of dollars per patient.

“I am using the Dreal™ for all my decompression cases” said Richard Guyer, MD, spine surgeon, co-founder of the Texas Back Institute in Plano, TX and past president of the North American Spine Society.

“This is the only device that allows the surgeon to decompress severely stenotic neuroforamen from the inside out while still leaving the anatomy intact and eliminating the need for fusion.  There have been other devices but none are as easy to use as this, as it requires no new skills. While hundreds of thousands of lumbar decompressions are performed in the US every year, I believe that this device has the potential of reducing the number of fusions in these patients.”

“This is a significant milestone for the entire Carevature team,” said Yosi Weitzman, Carevature Founder and CEO.  “It is exciting to see our hard work and dedication, make a difference to patients’ lives and well-being.  We look forward to introducing Dreal™ to more centers as part of our full commercial launch, planned for 2017.”

About Carevature

Carevature Medical Ltd. is a privately held medical device company, dedicated to the development of advanced orthopedic surgery solutions. Carevature Medical was founded in 2011 and is headquartered in Rehovot, Israel.

Carevature is now focused on its flagship line of products for spinal indications, Dreal™, the first and only curved device powerful enough to efficiently cut bone and small enough to be used in spine surgery and neurosurgery.

Shani Sarid 


SOURCE Carevature Medical Ltd.