Wednesday, December 28, 2016

News: 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. www.carevature.com


Contact:

Shani Sarid 
+972-523392383


Published at PRNewsWire

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

Image result for Intrinsic Therapeutics, Inc.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 http://www.in-thera.com 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.

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



Published at PRNewsWire

News: 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.  

CartiHealThe 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 | Caty@pearlcom.co.il | +972-548081020



Published at PRNewsWire

News: ZipLine® Medical Receives China Food and Drug Administration (CFDA) Approval for Non-Invasive Zip® Skin Closure System

CAMPBELL, Calif.--()--ZipLine® Medical, Inc., an innovator in skin closure, today announced China Food and Drug Administration (CFDA) approval and commercial availability of its Zip® Surgical Skin Closure device in the region. This clearance will give the company access to the $543 million Chinese wound closure device market serving over 40 million procedures, including growing specialties where the Zip has shown significant benefit, such as orthopedics for total joint replacement and obstetrics for Cesarean-section and hysterectomy procedures. ZipLine Medical recently featured the Zip at the prestigious 11th International Congress of the Chinese Orthopaedic Association, held in Beijing.
“The non-invasive Zip closure is ideally suited for the healthcare market in China, in light of its large and growing procedure volume, need for cost-effective and efficient solutions, and appreciation of aesthetics”
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The Zip is a non-invasive, efficient and easy-to-use wound closure device that replaces traditional sutures, staples and glue for surgical incisions and lacerations. It results in a comfortable, secure wound and the device’s unique force distribution system results in high patient comfort and excellent scar quality. The Zip’s micro-adjustability and reversibility provide surgeons with precise control and flexibility during closure. Because application and removal are simple, clinicians can delegate the closure task and, at the clinician’s discretion, patients may remove the Zip at home. Unlike staples or sutures, there are no skin punctures with the Zip, so scarring is minimal and there are no added pathways for bacteria to enter. The Zip’s benefits have been demonstrated in clinical studies in orthopedic total-joint arthroplasty, cardiothoracic surgery, electrophysiology and dermatology.
Image result for ZipLine Medical
“The non-invasive Zip closure is ideally suited for the healthcare market in China, in light of its large and growing procedure volume, need for cost-effective and efficient solutions, and appreciation of aesthetics,” said ZipLine Medical’s President and Chief Executive Officer John Tighe. “We look forward to working with our team of distribution partners across China to bring the speed, safety, comfort and convenience of Zip to Chinese patients.”

ABOUT ZIPLINE MEDICAL
Image result for ZipLine Medical
ZipLine Medical is an innovator in cost-effective, non-invasive surgical skin closure devices that deliver high patient satisfaction and surgeon efficiency. Zip Surgical Skin Closure devices have been used in more than 50,000 cases and in over 30 countries worldwide. ZipLine Medical was founded by Amir Belson, M.D., and is headquartered in Campbell, CA. For more information, visit www.ziplinemedical.com.

Zip® Surgical Skin Closure devices are classified by the U.S. FDA as ‘Class I, 510(k) Exempt’ and have received the CE Mark in addition to CFDA approval.

Contacts

Chronic Communications, Inc.
Michelle McAdam, 310-902-1274

Published at BusinessWire

News: Anika Wins CE Mark Approval For ORTHOVISC®-T To Relieve Pain and Restore Function of Tendons Damaged by Chronic Injury

BEDFORD, Mass.--()--Anika Therapeutics, Inc., (NASDAQ: ANIK), a global, integrated orthopedic medicines company specializing in therapeutics based on its proprietary hyaluronic acid “HA” technology, today announced that it received CE Mark approval for ORTHOVISC-T (sodium hyaluronate for peritendinous injection), a treatment indicated to relieve pain and restore function in tendons affected by chronic lateral epicondylosis. ORTHOVISC-T is designed to provide lubrication to the site of the damaged tendons to promote tendon gliding and to provide an environment to support tendon repair. ORTHOVISC-T is the latest addition to Anika’s product portfolio, which includes, among other products, HYALOFAST®, a biodegradable, hyaluronic acid-based scaffold for hyaline-like cartilage regeneration to treat cartilage injuries and defects. Both HYALOFAST and ORTHOVISC-T are CE Marked and pending regulatory submission in the United States.
“We’re excited to announce the timely European approval of ORTHOVISC-T for the treatment of pain associated with one of the most common overuse injuries to connective tissues, the condition commonly described as tennis elbow,” said Charles H. Sherwood, Ph.D., President and Chief Executive Officer. “The availability of ORTHOVISC-T not only promises to help millions of people in Europe find relief from this painful condition, it also expands our global foothold in orthopedic medicine and provides real-world clinical experience to inform our path towards regulatory submission in the U.S.”
ORTHOVISC-T is administered via injection into the site of injury to relieve pain and restore function of tendons damaged by chronic injury and overuse, as often seen in tennis elbow. ORTHOVISC-T consists of a biocompatible, non-animal-derived and non-inflammatory formulation of hyaluronic acid similar to those found in the company’s best-selling viscosupplements, ORTHOVISC and MONOVISC®.
“Degenerative overuse injuries to tendons are a leading cause of pain and restricted activity, and, until now, treatments were limited to oral medications, physical and/or occupational therapy, and corticosteroid injections,” said Peter M. Prokopis, M.D., Hand and Upper Extremity Specialist at Sports Medicine North, a Massachusetts-based sports medicine clinic. “ORTHOVISC-T is a natural and effective solution that not only relieves pain, but also addresses the source of pain and discomfort and promotes natural resolution of the symptoms and ultimate recovery.”
About Anika Therapeutics, Inc.
Anika Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated orthopedic medicines company based in Bedford, Massachusetts. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions with clinically meaningful therapies along the continuum of care, from palliative pain management to regenerative cartilage repair. The Company has over two decades of global expertise developing, manufacturing, and commercializing more than 20 products based on its proprietary hyaluronic acid (HA) technology. Anika’s orthopedic medicine portfolio includes ORTHOVISC®MONOVISC®, and CINGAL®, which alleviate pain and restore joint function by replenishing depleted HA, and HYALOFAST®, a solid HA-based scaffold to aid cartilage repair and regeneration. For more information about Anika, please visit www.anikatherapeutics.com.
Forward-Looking Statements
The statements made in the last sentence of the first paragraph of this press release, which are not statements of historical fact, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, those relating to the pendency of the Company’s regulatory submissions for Hyalofast and Orthovisc-T in the United States. The Company’s actual results could differ materially from any anticipated future results, performance, or achievements described in the forward-looking statements as a result of a number of factors including (i) the Company’s ability to successfully commence and/or complete clinical trials of its products on a timely basis or at all; (ii) the Company’s ability to obtain pre-clinical or clinical data to support domestic and international pre-market approval applications or 510(k) applications, or to timely file and receive FDA or other regulatory approvals or clearances of its products; (iii) that such approvals will not be obtained in a timely manner or without the need for additional clinical trials, other testing or regulatory submissions, as applicable; (iv) the Company’s research and product development efforts and their relative success, including whether we have any meaningful sales of any new products resulting from such efforts; (v) the cost effectiveness and efficiency of the Company’s clinical studies, manufacturing operations, and production planning; (vi) the strength of the economies in which the Company operates or will be operating, as well as the political stability of any of those geographic areas; (vii) future determinations by the Company to allocate resources to products and in directions not presently contemplated; (viii) the Company’s ability to successfully commercialize its products, in the U.S. and abroad; (ix) the Company’s ability to provide an adequate and timely supply of its products to its customers; (x) the Company’s ability to continue to successfully manage Anika Therapeutics S.r.l.’s business; and (xi) the Company’s ability to achieve its growth targets. Additional factors and risks are described in the Company’s periodic reports filed with the Securities and Exchange Commission, and they are available on the SEC’s website at www.sec.gov. Forward-looking statements are made based on information available to the Company on the date of this press release, and the Company assumes no obligation to update the information contained in this press release.

Contacts

For Investor Inquiries:
Anika Therapeutics, Inc.
Sylvia Cheung, 781-457-9000
Chief Financial Officer
or
For Media Inquiries:
Pure Communications
Susan Heins, 864-286-9597

Published at BusinessWire

Tuesday, December 27, 2016

News: Stryker Orthopaedics to compensate additional eligible U.S. patients who had surgery to replace their Rejuvenate Modular-Neck and/or ABG II Modular-Neck Hip Stems

Kalamazoo, Michigan - December 19, 2016 - Stryker Corporation (NYSE:SYK) announced that Howmedica Osteonics Corp. (referred to as "Stryker Orthopaedics"), a subsidiary of Stryker Corporation, and Court-appointed committees of attorneys representing Rejuvenate Modular-Neck and ABG II Modular-Neck plaintiffs in New Jersey Multicounty and Federal Multidistrict litigations reached an agreement to compensate additional eligible U.S. patients who had surgery to replace their Rejuvenate Modular-Neck hip stem and/or ABG II Modular-Neck hip stem, known as a revision surgery, prior to December 19, 2016.  This follows an initial 2014 Settlement Program that covered patients who had a revision surgery prior to November 3, 2014.  In that initial program, over 95% of eligible patients enrolled.  Under this new agreement, additional patients are now eligible to participate and may apply for compensation.

The Settlement Agreement will help bring to a close significant Rejuvenate Modular-Neck and ABG II Modular-Neck litigation activity in the U.S.  However, some lawsuits will remain and Stryker Orthopaedics will continue to defend against remaining claims. For more information about the Settlement Program, please visit strykermodularhipsettlement.com.

Based on the information that has been received to date, no additional charge to earnings is being recorded in connection with entering into the Settlement Agreement. The final outcome of this matter is dependent on many variables that are difficult to predict. The ultimate cost to entirely resolve this matter may be materially different than the amount of the current estimate. It is expected that a majority of the payments under the Settlement Agreement will be made by the end of 2017.

Settlement Program
For eligible U.S. Patients Who Had Surgery to Remove Their Rejuvenate Modular-Neck Hip Stem and/or ABG II Modular-Neck Hip Stem Prior to December 19, 2016.The Settlement Program is available to eligible United States patients who had revision surgery for reasons related to the voluntary recall of the modular-neck hip stems prior to December 19, 2016. Patients eligible for compensation under the Settlement Program should speak with their attorney, if they have one, or contact the Settlement Program claims administrator at www.strykermodularhipsettlement.com or 1-855-382-6404. Patients do not need an attorney to participate in the Settlement Program.

For U.S. Patients Who Have Not Had Surgery to Remove their Rejuvenate Modular-Neck Hip Stem and/or ABG II Modular-Neck Hip Stem Prior to December 19, 2016.  The existing Broadspire program offering support for recall-related care continues to be available. Patients are encouraged to visit patients.stryker.com/modularneckstems or call 1-888-317-0200 for more information. Patients do not need an attorney to participate in the Broadspire program.

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.  Please contact us for more information at www.stryker.com.

Contacts
For investor inquiries please contact:
Katherine A. Owen, Stryker Corporation, 269-385-2600 orkatherine.owen@stryker.com
For media inquiries please contact:
Yin Becker, Stryker Corporation, 269-385-2600or yin.becker@stryker.com

Published at Stryker News

News: Amedica Announces Positive Scientific Data and Re-files FDA Submission

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SALT LAKE CITY, UT--(Marketwired - Dec 19, 2016) -  Amedica Corporation (NASDAQAMDA), a company that develops and commercializes silicon nitride ceramics as a biomaterial platform, announced encouraging results from a recent study showing rapid bone growth into porous silicon nitride. Explants of the company's porous silicon nitride from a large-animal model demonstrated bone healing into the material just four weeks after implantation. "We anticipate these preliminary findings will be confirmed with additional retrieval data in the near future. The porous silicon nitride sample used in this study is the cancellous-structured ceramic (CsC) used in the center of our composite cervical implants that were the subject of recent FDA communications," said Dr. B. Sonny Bal, CEO and President of Amedica Corporation. 
Amedica has re-filed an application with the FDA, with a modified CsC-based cervical implant that is comparable to Amedica's own commercially-available Valeo®C cervical implants. "With this submission, the goal is to introduce our proprietary CsC technology platform into the U.S. market without further delay," said Dr. Bal.
About Amedica Corporation
Amedica is focused on the development and application of spinal interbody implants made with medical-grade silicon nitride ceramic. Amedica markets spinal fusion products and is developing implants for other biomedical applications, such as wear- and corrosion-resistant hip and knee bearings, and dental implants. The Company's products are manufactured in its ISO 13485 certified manufacturing facility, and it has a partnership with Kyocera, one of the world's largest ceramic manufacturers. Amedica's FDA-cleared and CE-marked spine products are currently marketed in the U.S. and select markets in Europe and South America through its distributor network, and OEM and private label partnerships.
For more information on Amedica or its silicon nitride material platform, please visit www.amedica.com.
Forward-Looking Statements 
 This press release contains statements that constitute forward-looking statements within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated within this press release. A discussion of those risks and uncertainties can be found in Amedica's Risk Factors disclosure in its Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 23, 2016, and in Amedica's other filings with the SEC. Amedica disclaims any obligation to update any forward-looking statements.


Contacts:
Amedica IR 
801-839-3502

Published at MarkeWired

News: Providence Medical Technology Announces New Equity Financing Of $10.5 Million

ProvidenceWALNUT CREEK, Calif., Dec. 19, 2016 /PRNewswire/ -- Providence Medical Technology, Inc., an innovator in tissue-sparing, cervical-fusion technology, today announced the closing of $10.5 million in new equity financing for the company.  The proceeds will be used to further commercialize and expand its portfolio of cervical-fusion technology.

Providence's family of cervical-fusion products now includes DTRAX® Spinal Systems, CAVUX™ Cervical Cages, ALLY™ ScrewSystems, and BIOLOGIX™ Allograft Bone. The Company's cervical-fusion products are provided in sterile packaging for single use and fill critical gaps in the continuum of cervical spine care.

New investor MVM Life Science Partners ("MVM") led the financing and will join the Providence Board of Directors. Stanmore Medical Investments, Aphelion Capital, and existing private investors also participated in the round.

Dr. Bali Muralidhar, a partner at MVM said, "Providence's unique product suite addresses key unmet needs in cervical spine fusion surgery. MVM is delighted to support the business through the next phase of growth and to be working with such a high-quality CEO and management team." Providence Chief Executive Officer Jeff Smith commented, "I am thrilled MVM is joining our group of supportive investors. MVM's deep scientific expertise and success globally commercializing medical technologies make them an ideal partner for Providence."

"We are excited by the continued growth of our business and wide adoption of our innovative, cervical-fusion technology," said Smith. "With our expanding product offering and growing body of clinical evidence, surgeons are increasingly choosing Providence. We are so pleased that our products are resulting in positive patient outcomes and resonating with spine surgeons and hospital administrators alike."

MVM Life Science Partners LLP, founded in 1997, is a leading global healthcare Venture Capital / Private Equity firm based in London and Boston who manages four funds totaling over US$700 million. MVM invests across the Life Sciences market including biopharmaceuticals, diagnostics, drug delivery, gene therapy, medical devices, OTC medicines, research tools and vaccines. The MVM team has broad experience across the Life Science and Venture Capital / Private Equity markets. For more information: www.mvm.com

Providence Medical Technology, Inc. is a privately-held medical device company developing innovative solutions addressing the $2 billion worldwide cervical spine market. The company is focused on commercializing the DTRAX platform of single-use, tissue-sparing instruments and CAVUX implants for cervical fusion, as well as other technologies that improve cervical spine procedures for both physicians and patients. For more information, visit www.providencemt.com.

Published at PRNewsWire


News: Latest Australian Joint Registry Data Confirm Positive Early Results For the ATTUNE® Knee System

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SOLOTHURN, Switzerland--()--DePuy Synthes, part of the Johnson & Johnson Family of Companies, today announced that implant survivorship data from the 2016 Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) confirm positive early results for DePuy Synthes’ ATTUNE® Knee System.1 These data add to recent UK Joint Registry evidence which indicate that survivorship for the ATTUNE Knee compares favorably to other cemented knee systems in its class.2 In addition, recently-presented interim data on two studies suggest improved patient reported outcomes measures with the ATTUNE Knee compared to other leading knee systems.3

“These promising early results are encouraging for patients, healthcare providers and payers, and underline the importance of our robust evidence generation program for the ATTUNE Knee”
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Per the 2016 AOANJRR, in which 4,831 ATTUNE Knees are being tracked, the ATTUNE Knee estimated cumulative percent revision was 0.5% (ATTUNE Cruciate Retaining Knee) and 0.4% (ATTUNE Posterior Stabilized Knee) at one year.1 This compares favorably to the overall class of cemented total knee arthroplasty (TKA) at one year, which has an estimated cumulative percent revision of 1.0%.1
In addition, interim results from an ongoing study of patients implanted with ATTUNE Posterior Stabilized (PS)TKA Knees showed a reduced incidence of symptomatic crepitus that was half of that compared to non-ATTUNE PS TKA Knees at a minimum of one year .4
“There is a steady cadence of evidence for the ATTUNE Knee that suggests improved outcomes and functional performance3,5” said Paul Voorhorst, Vice President of Clinical Research for DePuy Synthes Joint Reconstruction. “We are committed to ongoing monitoring of both the outcomes and economic benefits of this new technology.”
A large U.S. hospital administrative database review showed results that ATTUNE Knee patients in this review had a 39% lower adjusted odds of discharge to a skilled nursing facility compared to patients in this review who received a TKA with a Triathlon®Knee.6

“These promising early results are encouraging for patients, healthcare providers and payers, and underline the importance of our robust evidence generation program for the ATTUNE Knee,” said Christina Farup, Vice President, Health Economics and Market Access, Johnson & Johnson Medical Devices. “We designed the ATTUNE Knee System with both patients and providers in mind to help health care systems increase patient satisfaction, improve clinical outcomes and reduce overall health care costs.”
The ATTUNE Knee evidence generation program gathers information from many sources, including other joint registries. In addition to the AOANJRR, the National Joint Registry for England, Wales, Northern Ireland and the Isle of Man (NJR) also indicated that the ATTUNE Knee System compares favorably to other cemented total knee systems in its class.2 Per the 2016 NJR, the ATTUNE Knee estimated cumulative percent revision was 1.39% at 3 years (98.61% survivorship) for 4,463 knees, comparing favorably to the class of Cemented TKA that has an estimated cumulative percent revision of 1.50%.2
Advancements in TKA surgery systems, such as the ATTUNE Knee, may not only benefit patients, but the healthcare system as a whole because patients may be able to leave the hospital sooner and return to normal activity. A 2013 study published in The Journal of Bone and Joint Surgery found that societal savings, such as decreased disability costs, return to independent living, and increased work productivity, far exceeded direct costs [of TKA surgery].7
Global thought-leader surgeons, engineers, and experts in fields of study such as kinematics, anthropometrics, polyethylene wear and design collaborated to develop and test the ATTUNE Knee System. Extensive research and science has gone into the design to help improve functional outcomes for patients, performance for surgeons, and efficiency for providers.
About DePuy Synthes
DePuy Synthes, part of the Johnson & Johnson Family of Companies, provides one of the most comprehensive portfolios of orthopaedic solutions in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, neurological, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.
The third party trademarks used herein are the trademarks of their respective owners.
©Johnson & Johnson Medical Limited. 2016. All rights reserved.
Registered Office: Johnson & Johnson Medical Limited, PO BOX 1988, Simpson Parkway, Livingston, West Lothian, EH54 0AB, United Kingdom. Incorporated and registered in Scotland under company number SC132162
References:
1. Australian Orthopaedic Association National Joint Replacement Registry Annual Report. (2016). Tables KT9 and KT22. Retrieved from: https://aoanjrr.sahmri.com/documents/10180/275066/Hip%2C%20Knee%20%26%20Shoulder%20Arthroplasty
2. National Joint Registry for England, Wales, Northern Ireland and the Isle of Man Annual Report. (2016). Tables 3.28 and 3.24 (a). Retrieved from: http://www.njrcentre.org.uk/njrcentre/Portals/0/Documents/England/Reports/13th%20Annual%20 Report/07950%20NJR%20Annual%20Report%202016%20ONLINE%20REPORT.pdf
3. Hamilton, W., Himden, S., Brenkel, I., Clatworthy, M., Dwyer, K., Lesko, J. and Kantor, S. Early Patient Reported Outcomes With New Primary vs. Contemporary Total Knee Arthroplasty: A Comparison of Two Worldwide, Multi-Center Prospective Studies. International Society for Technology in Arthroplasty (ISTA): e-Poster, 5-8 October 2016, Boston, MA. Based on interim data. The leading knee systems included: 89% P.F.C.® SIGMA®, 3% Zimmer NexGen®, 7% Stryker Triathlon®, 1% Other.
4. Toomey, S., Daccach, J., Shah, J., Himden, S., Lesko, J. and Hamilton, W. Comparing the Incidence of Patellofemoral Complications in a New Total Knee Arthroplasty (TKA) System vs. Currently Available Products in Two, Worldwide, Multi-Center, Prospective Clinical Studies. While not statistically significant, the trend is promising and follow-up is ongoing. Based on interim data.
5. Clatworthy, M. (2015). An Early Outcome Study of the ATTUNE® Knee System vs. the SIGMA® CR150 Knee System. DePuy Synthes Companies White Paper. DSUS/JRC/0814/0418(1). In an IRB approved early outcomes study, physiotherapists collected data on 40 patients implanted with ATTUNE Knees and 40 patients with SIGMA® CR150 Knees. The results demonstrated that patients implanted with the ATTUNE Knee had statistically significant improvements in some early outcomes, other outcomes demonstrated a trend favoring the ATTUNE Knee, and some outcomes were equivalent.
6. Etter, K., Lerner, J., de Moor, C, Yoo, A., Kalsekar, I. (2016). PMD10-Comparative Effectiveness of ATTUNE® Versus Triathlon®Total Knee Systems: Real-World Length of Stay and Discharge Status." Value in Health 19(3): A298. Premier Perspective™ Database analysis including 38 hospitals, representing 1,178 primary, unilateral TKAs with the ATTUNE® Knee and 5,707 primary, unilateral TKAs with Triathlon™. The analysis found that the patients implanted with the ATTUNE Knee had statistically shorter length of stay and were more frequently discharged home vs. a skilled nursing facility compared to the TKAs with Triathlon®.
7. Ruiz D, Koenig L, Dall T, et al. The Direct and Indirect Costs to Society of Treatment for End-Stage Knee Osteoarthritis. J Bone Joint Surg Am., 2013; 95: 1473-80.

Contacts

DePuy Synthes

Jennifer Holden
Sr. Manager, Communications

News: OrthoSpace Announces Publication of Positive Results for the InSpace™ System in the Treatment of Massive Rotator Cuff Tears

OrthoSpace announced the publication of positive results for their InSpace System in the surgical treatment of massive rotator cuff tears (MRCTs). The system was demonstrated to improve shoulder function and reduce pain in a challenging patient population.

orthospace.co.il
OrthoSpace Ltd. ("OrthoSpace" or "Company") today announced a publication in the December issue of Musculoskeletal Surgery citing positive results for their InSpace System in the surgical treatment of massive rotator cuff tears (MRCTs). Patients undergoing the InSpace procedure experienced durable improvements in shoulder function and reductions in shoulder pain at 12 months of follow-up, demonstrating the benefits of InSpace as an effective alternative to existing surgical treatments.

The InSpace System consists of a biodegradable balloon spacer that is implanted in the subacromial space of the shoulder. InSpace is designed to address the challenges of MRCTs where surgery often fails and for which there is not current consensus or definitive guidelines for optimal surgical treatment. The procedure may be performed arthroscopically, or under fluoroscopy guidance, as presented in the study.
Patients with advanced age, diminished health status and comorbidities such as cardiovascular disease may be at a higher risk for complications when subjected to general anesthesia. The option to receive InSpace under fluoroscopy guidance addresses the unmet needs associated with this patient population, as the procedure is performed under local anesthesia.
“InSpace has been demonstrated to improve patient shoulder function and reduce pain in a difficult-to-treat population where conservative options have been exhausted and surgery under anesthesia would pose high risks to the patient,” said Enrico Gervasi, M.D., the study’s principal investigator and the Director of Orthopedic and Trauma Surgery at Latisana Civil Hospital at Udine, Italy. “Further, the procedure is technically easy to perform, taking only ten minutes to deploy the spacer, and can be performed under local anesthesia in the outpatient setting."
This ongoing clinical study of the InSpace System will ultimately enroll up to 45 patients, all of whom will be followed for up to 24 months. The study population consists of elderly patients who are not candidates for surgery under general anesthesia and who did not respond to conservative treatment, including steroid injections and physical therapy. This publication represents a planned interim analysis of the first 15 patients enrolled, who were considered evaluable upon reaching 12 months of follow-up. All 15 patients in this cohort experienced overall improvements in shoulder function, as measured by the Constant Score and the American Shoulder and Elbow Surgeons Evaluation Form (ASES). Of these patients, 85% showed a clinically significant improvement in their Constant Score. Improvements were observed beginning at 6 weeks post treatment and sustained for at least 12 months post-treatment. Additionally, patients reported significant improvements in pain scores.
“We are pleased with these results from Dr. Gervasi and colleagues. These data reinforce and continue to build on the existing data supporting the use of InSpace for patients with massive rotator cuff tears,” said Itay Barnea, CEO of OrthoSpace. “The cases represent an unmet clinical need, and we are proud to offer additional surgical options for patients who are suffering from pain and immobility associated with this difficult indication.”
About OrthoSpace Ltd. 
OrthoSpace is a privately held medical device company located in Caesarea, Israel. The Company's product, InSpace, is an orthopedic biodegradable balloon system that is simple, safe and a minimally invasive method that addresses unmet clinical needs in rotator cuff repair. InSpace is CE Marked and commercialized in Europe and Israel and has been granted an Investigational Device Exemption (IDE) to initiate a pivotal human clinical study of the InSpace System in the United States.

Published at PRWeb

News: Conventus Orthopaedics announces milestone of 700+ Cage implantations

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MINNEAPOLISDec. 19, 2016 /PRNewswire/ -- Conventus Orthopaedics, Inc. announced that over 700 patients now have been treated with the industry's first expandable fracture cage, an innovative solution to fracture repairs in the upper extremity using a 3-dimensional approach. The Conventus Cage™, made of nitinol, a memory shape alloy, expands within the bone creating robust fixation and preventing further collapse of the fracture by providing a rigid internal scaffold upon completion of the procedure. 

Conventus currently has five FDA-cleared indications in the upper extremity and the company is pursuing additional indications in the lower extremity and other areas of the skeletal anatomy.  Clinical follow-up of the first cage implantations is over four years now, showing not only excellent fracture repair but also fewer complications and reduced pain with faster recoveries for the patients.
"For years, surgeons have expressed the need for more versatile and reliable surgical options to repair simple to complex fractures," said Paul Buckman, Conventus Orthopaedics CEO. "The Conventus Cages expand what is possible in patient care by enabling surgeons to repair a wider variety of fractures through less invasive means."  Eric Fulkerson, M.D. of Muir Orthopaedics, Walnut Creek, CA said, "The Conventus Cage offers a solution that delivers reliably stable fracture repairs with consistently decreased recovery times and decreased pain for my patients. The innovative Cage design allows an expansion of fracture patterns treated with fixation as opposed to primary arthroplasty." Since the Cage is implanted into bone, instead of onto bone, the potential for interference of hardware, as well as the need for a future surgery to remove fixation, is significantly reduced.  Andrew Schmidt, M.D., Chief of Orthopaedics, Hennepin County Medical Center, added, "For especially problematic fractures, such as those in the proximal humerus, the results after Cage fixation seem to be better, with more rapid return of motion and a dramatically lower incidence of surgical complications."  Paul Paterson, M.D., orthopaedic surgeon in Buffalo, NY added, "The Conventus Cage offers tremendous stability of the fracture—better than plates and screws—through the use of 3-dimensional fixation. These fractures just do not move post repair."
Conventus' 3-dimensional Cage platform technology, emphasizes preservation of tissues and blood supply at the fracture site, creating a strong foundation by stabilizing bone fragments and facilitating early motion through less invasive procedures.
Conventus continues to expand their product portfolio and surgical applications in their quest to provide solutions throughout the entire musculoskeletal system.
For more information regarding use of the device please refer to www.conventusortho.com.  
About Conventus Orthopaedics, Inc. 
Conventus Orthopaedics, Inc. was founded by a team of medical device professionals and physicians with the sole purpose of improving patient care by creating a platform technology with less invasive solutions to a broad range of challenging periarticular fractures. Taking its name from the Latin word for coming together or union, Conventus Orthopaedics is focused on creating less invasive solutions for fractures in and around the joints. The company is dedicated to working with surgeons to improve healing and enable their patients' return to normal activities.

Published at PRNewsWire