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

Posted On December 20, 2016 By OrthoSpineNews In Sports Medicine /

CAESAREA, ISRAEL (PRWEB) DECEMBER 16, 2016

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.

Skin cells ‘crawl’ together to heal wounds treated with unique hydrogel layer

Posted On December 20, 2016 By OrthoSpineNews In Biologics /

December 14, 2016 – Credit: Marit Mitchell / U of T Engineering

Time may not heal all wounds, but a proprietary mix of peptides and gel developed by U of T Engineering researchers heals most.

A team led by Professor Milica Radisic has demonstrated for the first time that their peptide-hydrogel biomaterial prompts skin cells to “crawl” toward one another, closing chronic, non-healing wounds often associated with diabetes, such as bed sores and foot ulcers.

The team tested their biomaterial on healthy cells from the surface of human skin, called keratinocytes, as well as on keratinocytes derived from elderly diabetic patients. They saw non-healing wounds close 200 per cent faster than with no treatment, and 60 per cent faster than treatment with a leading commercially used collagen-based product.

“We were happy when we saw the cells crawl together much faster with our biomatieral, but if it didn’t work with diabetic cells, that would have been the end of the story,” says Radisic. “But even the diabetic cells travelled much faster — that’s huge.”

Until now, most treatments for chronic wounds involved applying topical ointments that promote the growth of blood vessels to the area. But in diabetic patients, blood vessel growth is inhibited, making those treatments ineffective. Radisic and her team have been working with their special peptide — called QHREDGS, or Q-peptide for short — for almost 10 years. They knew it promoted survival of many different cell types, including stem cells, heart cells and fibroblasts (the cells that make connective tissues), but had never applied it to wound healing.

“We thought that if we were able to use our peptide to both promote survival and give these skin cells a substrate so they could crawl together, they would be able to close the wound more quickly,” says Radisic. “That was the underlying hypothesis.”

READ THE REST HERE

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

Posted On December 20, 2016 By OrthoSpineNews In Regulatory /

December 19, 2016

BEDFORD, Mass.–(BUSINESS WIRE)–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

Conventus Orthopaedics announces milestone of 700+ Cage implantations

Posted On December 20, 2016 By OrthoSpineNews In Extremities /

MINNEAPOLIS, Dec. 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.

SOURCE Conventus Orthopaedics, Inc.

Providence Medical Technology Announces New Equity Financing Of $10.5 Million

Posted On December 20, 2016 By OrthoSpineNews In Financial /

WALNUT 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™ Screw Systems, 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.”

About MVM Life Science Partners LLP.

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

About Providence Medical Technology, Inc.

Providence Medical Technology, Inc. is a privately-held medical device company developing innovative solutions addressing the $2 billion worldwide cervical spine market. The company 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.

SOURCE Providence Medical Technology, Inc.

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

Posted On December 20, 2016 By OrthoSpineNews In Recon /

WARSAW, Ind., Dec. 19, 2016 /PRNewswire/ — 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 other recent registry evidence which has shown that survivorship for the ATTUNE Knee compares favorably to other knee systems in its class.² In addition, recently-presented interim data have shown improved patient reported outcomes measures with the ATTUNE Knee compared to other leading knee systems.³

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), 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 performance^3,5, helping patients get back sooner with a reduced hospital length of stay,” 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.”

From a health economics standpoint, a large U.S. hospital administrative database review showed ATTUNE Knee patients had a 39% lower odds of discharge to a skilled nursing facility compared to patients 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.

*DePuy Synthes represents the products and services of DePuy Orthopaedics, Inc. and its subsidiaries.

The third party trademarks used herein are the trademarks of their respective owners.

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

Australian Orthopedic Association National Joint Replacement Registry 2016 Annual Report

Extracted from Table KT9 Cumulative Percent Revision of Primary Total Knee Replacement with Cemented Fixation
Femoral Component	Tibial Component	N Revised	N Total	1 Yr	3 Yrs	5 Yrs	7 Yrs	10 Yrs	15 Yrs
Attune CR	Attune	17	3199	0.5 (0.3, 0.9)
Attune PS	Attune	7	1632	0.4 (0.2, 0.9)
Genesis II CR	Genesis II	421	13019	0.9 (0.8, 1.1)	2.4 (2.2, 2.7)	3.1 (2.8, 3.5)	4.0 (3.6, 4.4)	4.3 (3.9, 4.7)	5.6 (4.7, 6.7)
Genesis II PS	Genesis II	518	14812	1.2 (1.1, 1.4)	2.8 (2.6, 3.1)	3.7 (3.4, 4.1)	4.3 (3.9, 4.7)	5.0 (4.5, 5.5)
Journey Oxinium	Journey	220	3032	1.4 (1.0, 1.9)	4.5 (3.8, 5.3)	6.4 (5.5, 7.4)	8.8 (7.6, 10.0)
Nexgen CR Flex	Nexgen	254	16286	0.7 (0.6, 0.8)	1.5 (1.3, 1.7)	2.0 (1.8, 2.3)	2.3 (2.0, 2.6)	2.7 (2.2, 3.2)
Nexgen LPS Flex	Nexgen	838	27014	0.9 (0.8, 1.0)	2.3 (2.1, 2.5)	3.2 (3.0, 3.4)	3.9 (3.6, 4.2)	5.0 (4.7, 5.5)
PFC Sigma CR	PFC Sigma	277	11461	0.8 (0.7, 1.0)	1.9 (1.6, 2.2)	2.4 (2.1, 2.7)	2.9 (2.5, 3.3)	3.4 (3.0, 3.9)
PFC Sigma PS	PFC Sigma	241	7167	1.2 (1.0, 1.5)	2.6 (2.2, 3.0)	3.2 (2.7, 3.6)	3.5 (3.1, 4.0)	4.5 (3.9, 5.3)
Triathlon CR	Triathlon	497	25632	0.8 (0.7, 0.9)	2.1 (1.9, 2.3)	2.6 (2.4, 2.8)	3.0 (2.7, 3.4)	3.8 (3.2, 4.5)
Triathlon PS	Triathlon	185	5886	1.5 (1.2, 1.8)	3.2 (2.7, 3.7)	4.0 (3.4, 4.6)	4.6 (3.9, 5.3)
Vanguard CR	Maxim	133	6778	0.6 (0.4, 0.8)	2.2 (1.8, 2.7)	2.8 (2.4, 3.4)	3.3 (2.7, 4.0)
Vanguard PS	Maxim	166	3500	1.9 (1.5, 2.4)	4.6 (3.9, 5.4)	5.7 (4.9, 6.7)	6.8 (5.7, 8.0)

Table KT22 Cumulative Percent Revision of Primary Total Knee Replacement by Fixation (Primary Diagnosis OA)
Fixation	N Revised	N Total	1 Yr	3 Yrs	5 Yrs	7 Yrs	10 Yrs	15 Yrs
Cemented	8439	258789	1.0 (0.9, 1.0)	2.6 (2.5, 2.6)	3.4 (3.4, 3.5)	4.2 (4.1, 4.3)	5.1 (5.0, 5.3)	7.3 (6.9, 7.7)
Cementless	4612	103903	1.2 (1.1, 1.3)	3.2 (3.1, 3.3)	4.3 (4.2, 4.4)	5.0 (4.9, 5.2)	6.1 (5.9, 6.3)	8.1 (7.7, 8.6)
Hybrid	3964	119262	0.9 (0.9, 1.0)	2.5 (2.4, 2.6)	3.3 (3.2, 3.5)	3.9 (3.8, 4.1)	4.8 (4.7, 5.0)	6.6 (6.2, 7.0)
TOTAL	17015	481954

Note: Excluding cementless Genesis Oximium and Profix Oxinium femoral prostheses

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%20Report/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.

DSUS/JRC/1216/1887

SOURCE DePuy Synthes

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

Posted On December 20, 2016 By OrthoSpineNews In Financial, Recon /

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

Investor Contacts

Katherine A. Owen
Vice President, Strategy & Investor Relations
Stryker Corporation
2825 Airview Boulevard
Kalamazoo, MI 49002
269-385-2600

Charles DeCoster IV, MSA
Associate Manager, Investor Relations & Strategy
Stryker Corporation
2825 Airview Boulevard
Kalamazoo, MI 49002
P: 269-385-2600
C: 269-532-2118
Charles.DeCoster@Stryker.com

Zimmer Biomet Announces Quarterly Dividend for Fourth Quarter of 2016

Posted On December 19, 2016 By OrthoSpineNews In Financial /

WARSAW, Ind., Dec. 19, 2016 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced that its Board of Directors has approved the payment of a quarterly cash dividend to stockholders for the fourth quarter of 2016.

The cash dividend of $0.24 per share will be paid on or about January 27, 2017 to stockholders of record as of the close of business on December 30, 2016. Future declarations of dividends are subject to approval of the Board of Directors and may be adjusted as business needs or market conditions change.

About Zimmer Biomet

Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.

We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.

We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com, or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.

SOURCE Zimmer Biomet Holdings, Inc.

Stem cell ‘living bandage’ for knee injuries trialed in humans

Posted On December 19, 2016 By OrthoSpineNews In Recon, Sports Medicine /

December 16, 2016 – University of Liverpool

A ‘living bandage’ made from stem cells, which could revolutionise the treatment and prognosis of a common sporting knee injury, has been trialed in humans for the first time by scientists at the Universities of Liverpool and Bristol.

Meniscal tears are suffered by over one million people a year in the US and Europe alone and are particularly common in contact sports like football and rugby. 90% or more of tears occur in the white zone of meniscus which lacks a blood supply, making them difficult to repair. Many professional sports players opt to have the torn tissue removed altogether, risking osteoarthritis in later life.

The Cell Bandage has been developed by spin-out company Azellon, and is designed to enable the meniscal tear to repair itself by encouraging cell growth in the affected tissue.

A prototype version of the Cell Bandage was trialled in five patients, aged between 18 and 45, with white-zone meniscal tears. The trial received funding support from Innovate UK and the promising results have been published today in the journal Stem Cells Translational Medicine.

The procedure involved taking stem cells, harvested from the patient’s own bone marrow, which were then grown for two weeks before being seeded onto a membrane scaffold that helps to deliver the cells into the injured site. The manufactured Cell Bandage was then surgically implanted into the middle of the tear and the cartilage was sewn up around the bandage to keep it in place.

READ THE REST HERE

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Kuros Acquires Xpand to Form Orthobiologics Firm with Bone Graft Substitute

Posted On December 19, 2016 By OrthoSpineNews In Biologics, Financial /

December 19, 2016

Kuros Biosciences is to acquire Xpand Biotechnology by way of a share-swapping deal structured as an exchange of all Xpand shares for up to 2.105 million new Kuros shares. A total of 1.36 million Kuros shares will be issued immediately upon the deal closing. Another 0.74 million Kuros shares will be issued on the achievement of product approval milestones. Kuros says that if all milestones are achieved its shareholders will own about 71% of the combined company. The transaction has been approved by both firms’ boards of directors.

The combined entity will exploit two complementary technologies—Xpand’s synthetic surface science technology and Kuros’s fibrin/PTH biologics platform. The Netherlands-based Xpand Biotechnology develops products for bone repair and regeneration. A granular formulation of the firm’s bone graft substitute, MagnetOs, was approved in the EU during mid-2016 and is under FDA 510(k) review. A putty formulation of MagnetOs is also being prepared for submission in the EU for orthopedic and dental applications and for submission in the U.S. for spinal fusion applications.

Switerland-based Kuros says the acquisition will also give it an operation in the EU, and certified GMP manufacturing facilities. Kuros’s in-house pipeline is headed by lead product Neuroseal (KUR-023), a synthetic dural sealant for the prevention of cerebrospinal fluid (CSF) leakage following cranial or spinal surgery. KUR-023 is being submitted to the European regulator for CE marking, and market launch is projected for 2017. The Kuros pipeline also includes the fibrin/parathyroid hormone (PTH) bone graft KUR-111 and a fibrin/PTH bone-healing polymer candidate, KUR-113, both of which have completed Phase IIb clinical trials. KUR-113 is also being prepared for Phase II trials in spinal fusion, which are projected to start in 2018.

“Kuros and Xpand’s products are highly complementary,” commented Didier Cowling, CEO of Kuros. “As a result of the acquisition, we will have leading products in key segments of the orthobiologics field and the opportunity to build an integrated business with promising products on the market and in development.” Professor Joost de Bruijn, CEO of Xpand Biotechnology, will be joining the Kuros executive management team. He added, “we are pleased to be joining forces with Kuros. With the unique and complementary synthetic and biologic technology platforms of Kuros and Xpand, we can proceed to build a leading, commercial stage orthobiologics company.”

Kuros Biosciences was formed by the merger of Cytos Biotechnology and Kuros Biosurgery Holdings in January 2016.

Month: December 2016

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