Monday, June 13, 2016

News: Tyber Medical Expands, Enters Australian Market

Tyber Medical, a privately held medical device company focused on developing innovative orthopaedic and spine devices for private label opportunities, announces the acceptance of its entire interbody family of products into the Australian Registry of Therapeutic Goods. 

Since the inception of Tyber Medical, requests for their products in Australia has been very strong. The commitment to a new market and length of the approval process discourages some, but in Australia, unlike many other markets, TGA approval, along with product reimbursement codes, ensures straightforward access. Tyber Medical’s private label partners plan to begin launching products for this market in Q3 of 2016. 

“We are very excited to be in a position to meet the strong demand for our innovative products and provide access to our unique private label model in Australia. We expect that access to the Australian market will increase our growth trajectory and allow our private label partners a rapid pathway into the Australian market and vice versa for our Australian partners desiring entry into the US and European markets” said Tyber Medical CEO, Jeff Tyber. 

Tyber Medical‘s market analysis shows a large and increasing opportunity for their private label model and has strategic plans for the Australian market. In the near future, look for Tyber to seek registration for its extremity line of products. 

About Tyber Medical, LLC 

Tyber Medical
Tyber Medical, LLC, Morristown, New Jersey, a private label original equipment manufacturer (OEM), is creating new pathways to regulatory approved implants and instruments for orthopaedic companies, distributors, and hospital organizations. Tyber Medical designs and develops class II orthopaedic systems; verifies and validates those systems using a QSR and ISO 13485 certified quality system; and pursues and maintains both US (FDA 510(k)) and OUS (CE Mark) regulatory approvals. The Tyber Medical Cervical Plating System is the latest addition to a product portfolio which already includes a full line of spinal interbody spacers featuring both sterile and non-sterile PEEK and TyPEEK™, a proprietary titanium plasma sprayed PEEK. Tyber Medical Interbody systems are made with PEEK-OPTIMA® from Invibio® Biomaterial Solutions. For more information, please visit www.tybermedical.com.



Published at Tyber Medical News

Education: Vertebral Motion Analysis at Spine Navada - Minimally Invasive Spine Institute

SpineNevada has the region’s only “real time” x-ray to view spinal motion like a movie — known as Vertebral Motion Analysis (VMA). Vertebral Motion Analysis, or VMA, is an FDA-cleared system for assessing lumbar and cervical spinal motion. It is an updated method of assessing spinal motion compared to the standard flexion/extension bending x-rays that are currently used to assess spinal motion, including instability.
If you were trying to capture a special moment, would you rather see a single picture frame or a movie of the special event? Until recently, spine surgeons have relied upon archaic and old-fashioned x-rays to guide their decisions on whether the patient should undergo surgery for excess movement in their spine. The forward bending (flexion) and backward bending (extension) x-ray have been the mainstay of evidence for spinal 
vertebral motion analysis, spine motion imaging for back and neck pain
instability surgery. These are single pictures taken at one moment in time with the patient being asked to voluntarily bend past their painful point in an attempt to “catch” the bones in misalignment. Most patient’s will “cheat” and bend until they feel pain then move their hips forward or backward to finish the motion. Unfortunately, this makes it very difficult for these x-rays to “catch” the disease state and guide the surgeon. Our unique VMA imaging takes an x-ray movie of the patient while the patient is gently guided through the forward and backward bending motions by the x-ray machine itself!

An advanced software analysis of the motion is then performed highlighting any levels of instability. This analysis is read by a Board Certified Diagnostic Radiologist and provided to the surgeon who can reliably make decisions about the need for surgery based on whether the spinal bones remained properly aligned with motion. This technology has been proven to be more sensitive and reproducible in determining instability requiring surgical fusion. One of the major advantages of this technology is that the radiation dose is lower than what the patient would be exposed to with a standard six view x-ray series, which has been the standard until now. VMA represents the future of functional spine imaging.
SpineNevada's InMotion Diagnostics is excited about being one of the first in the country to offer this new Spine Motion Imaging option. The VMA offers a new diagnostic tool that provides additional imaging data to surgeons, which may help him/her to locate the source of your spinal issues. The VMA motion test provides more data than ever before by taking hundreds of x-ray type pictures of your spine while you move in a gentle, controlled manner to create a video. It may provide more accurate motion measurements to help surgeons in diagnosing your unique condition, which may lead to surgeons choosing potentially helpful treatment options.
The VMA is a new test that o ffers doctors motion imaging technology that may pinpoint the source of your issues. The VMA, unlike a common x-ray, takes hundreds of x-ray type pictures of your spine while you move to create a video. The VMA provides more accurate motion measurements to help diagnose your unique condition. The VMA motion imaging technology is a game-changer! Your spine deserves the latest in imaging technology.

“Real time” x-ray, Vertebral Motion Analysis (VMA) to view spinal motion at SpineNevada


Published at Spine Navada

News: Ortho Kinematics Secures Health Canada Approval

New regulatory approval enables commercialization in Canada 

AUSTIN, Texas – May 25, 2016 — Ortho Kinematics‚ Inc. (OKI), a privately held healthcare diagnostics company focused on spine imaging informatics, announced today it has received Health Canada authorization for its lead product, Vertebral Motion Analysis “VMA”. The VMA is now licensed for sale in Canada, expanding the VMA’s current list of markets, which include the United States and Europe. 

OKI CEO Paul Gunnoe stated, “Expanding into Canada is a big step forward in positioning the VMA as a global standard of care for assessing spinal motion and instability.” Mr. Gunnoe continued, “We believe Canadian patients and their providers stand to benefit significantly.” 

The VMA is a diagnostic test for the assessment of spinal motion and radiographic instability. Today’s current test for assessing spinal radiographic instability is ordered over 5 million times per year in the United States, largely by spine surgeons, because it provides diagnostic data that is necessary for many patients being considered for potential spine surgery. Relative to today’s current standard test, the VMA has been shown in peer-reviewed studies to increase the sensitivity in detecting radiographic instability with no decrease in specificity. Furthermore, the VMA has shown to be more accurate, repeatable and result in a lower dose of radiation. 

OKI plans to begin offering the VMA in Canada later this year, limiting initial distribution to a select group of spine care institutions. 
________________________________________________________________________


About Ortho Kinematics Ortho Kinematics is a privately held diagnostic technology company, focused on spine imaging informatics and committed to the idea that spine motion matters. The company is working with a group of leading clinicians, researchers, and developers who are passionate about leveraging spine biomechanical data to improve the diagnosis and treatment of back pain. Ortho Kinematics is located in Austin, Texas and at www.orthokinematics.com. 



Published at orthoKINEMATICS Press

News: Ortho Kinematics Secures CE Mark Approval to Support International Expansion

New regulatory approval enables commercialization in Europe 

AUSTIN, Texas – April 19, 2016 — Ortho Kinematics‚ Inc. (OKI), a privately held healthcare diagnostics company focused on spine imaging informatics, announced today it has received CE mark approval for its lead product, Vertebral Motion Analysis “VMA”. CE mark approval is required for the commercialization of the VMA in European markets. Prior to securing CE mark approval, the VMA had regulatory clearance from the US Food and Drug Administration (FDA) to commercialize in the United States. With this additional approval, OKI can begin selling the VMA technology in European Countries.

OKI CEO Paul Gunnoe said, “The VMA technology has a multi-billion-dollar annual worldwide revenue potential, and with CE mark approval, we can now expand our efforts toward realizing that potential.” Mr. Gunnoe continued, “Europe is very attractive in that it represents the largest market for the VMA technology outside of the US.” 

VMA, or Vertebral Motion Analysis, is a diagnostic test for the assessment of spinal motion and radiographic instability. Today’s current test for assessing spinal radiographic instability is ordered over 5 million times per year in the US, largely by spine surgeons, because it provides diagnostic data that is necessary for many patients being considered for potential spine surgery. The VMA has been shown in peer-reviewed studies to increase the sensitivity in detecting radiographic instability with no decrease in specificity relative to today’s current standard test. It has also been shown to be more accurate, repeatable, and result in a lower dose of radiation. 

OKI intends to begin commercialization efforts later this year in the United Kingdom, then expand from there. To support commercial efforts, OKI will be working closely with local distribution partners in each country. 
________________________________________________________________________


About Ortho Kinematics Ortho Kinematics is a privately held diagnostic technology company, focused on spine imaging informatics and committed to the idea that spine motion matters. The company is working with a group of leading clinicians, researchers, and developers who are passionate about leveraging spine biomechanical data to improve the diagnosis and treatment of back pain. Ortho Kinematics is located in Austin, Texas and at www.orthokinematics.com. 

Published at orthoKINEMATICS Press

News: Acumed Launches New State-of-the-Art System for Ankle Fractures

Portland, Oregon (PRWEB) May 25, 2016

The Acumed Ankle Plating System 3 is composed of seven plate families that span the lateral, medial, and posterior malleoli.

The Ankle Plating System 3 and Small Fragment Base Set features a variety of fracture-specific plating options designed to address fractures of the distal tibia and fibula. This system marks Acumed's continued commitment to provide industry-leading fracture fixation solutions.
The Acumed Ankle Plating System 3 is composed of seven plate families that span the lateral, medial, and posterior malleoli.
Fragment-specific plating of the posterior malleolus is a key area of innovation, as other companies tend to utilize more generic fixation options with less anatomic fit and contour. The importance of fixing the posterior malleolus has been a topic of discussion at nearly every recent orthopaedic conference, with literature demonstrating that the incidence of post-traumatic arthritis increases if the posterior malleolus is involved and that fixation of posterior malleolar fractures provides greater syndesmotic stability.1
Ankle Plating beauty shot
The Acumed Ankle Plating System 3 addresses fractures of the lateral, medial, and posterior malleoli.
One of the design surgeons of the system, Anish R. Kadakia MD, said: "The posterior distal tibia plates uniquely provide fragment-specific fixation for posterior malleolar fractures. The rigid, anatomically contoured plates have allowed me to use them as a reduction tool and, with the low-profile design, have allowed placement adjacent to the PTT and FHL tendons. The plates have changed the way I address posterior malleolar fractures and have helped in decreasing my operative time and achieving articular congruity."
The system includes Hook Plates and Locking Peg Hook Plates, designed to treat challenging avulsion fragments with the option of either hooks or a 2.3 mm cortical peg to capture the fragment distally.
To address disruption of the syndesmosis, the Lateral and Posterolateral Fibula Plates include built-in fixation options. The Lateral Fibula Plate includes two screw holes angled 30 degrees anterior to target the center of the tibia and the Posterolateral Fibula Plate includes three scallops that allow for syndesmotic screw heads to sit flush against the plate.
4.0 mm cannulated screws are also included in the Ankle Plating System 3 tray for the treatment of medial malleolar fractures.
The Ankle Plating System 3 is used in combination with the Acumed Small Fragment Base Set. The Small Fragment Base Set includes one-third tubular plates, as well as cut-to-length and bend-to-fit 2.7 mm L-shaped, T-shaped, and straight fragment plates that can also be used to address ankle fractures. A selection of Tension Band Pins and Acutrak® AcuTwist® Compression Screws are also included in the tray.
The 2.7 mm and 3.5 mm variable angle screws included in the Small Fragment Base Set can be angled up to 15 degrees off axis in any direction, helping to accommodate varying patient anatomies, avoid the joint space and other implants, and capture best bone quality.
Together, these systems provide nine plate families, ten screw families, and simplified instrumentation. This provides surgeons with a comprehensive solution to treat nearly any ankle fracture, all within two streamlined trays. The Ankle Plating System 3 and Small Fragment Base Set offers both standard of care, low-cost options in addition to more anatomic, fragment-specific options, allowing the surgeon to select his or her implant based on the severity of the fracture.
For more information about the Ankle Plating System 3, please visit the product page on the Acumed website.
About Acumed 
Acumed LLC is a global leader of innovative orthopaedic implant solutions. Founded in 1988, Acumed is headquartered in Hillsboro, Oregon, with offices and a distribution network around the world. Acumed is dedicated to developing products, service methods, and approaches that improve patient care. For more information, please visit http://www.acumed.net.

Availability 
These materials contain information about products that may or may not be available in any particular country or may be available under different trademarks in different countries. The products may be approved or cleared by governmental regulatory organizations for sale or use with different indications or restrictions in different countries. Products may not be approved for use in all countries. Nothing contained on these materials should be construed as a promotion or solicitation for any product or for the use of any product in a particular way which is not authorized under the laws and regulations of the country where the reader is located. Specific questions physicians may have about the availability and use of the products described on these materials should be directed to their particular local sales representative. Specific questions patients may have about the use of the products described in these materials or the appropriateness for their own conditions should be directed to their own physician.


1. Liu, G. Posterior Malleolar Fractures: Why Are We Trying to Fix Them All? Presented at: American Orthopaedic Foot & Ankle Society Conference; February 11, 2016; Austin, TX.
Published at PRWeb

Wednesday, June 8, 2016

News: Orthocell receives ethics approval for collagen scaffold study

Image result for orthocell
Regenerative medicine company Orthocell (ASX:OCC) has been granted ethical approval by St Vincent’s Hospital Melbourne for a clinical study using its Celgro SMRT Grant collagen scaffold.

Set to begin in the second quarter of 2016, the primary objective of the 25-patient study is to demonstrate the safety and tolerability of Celgro when used as a collagen matrix treatment for osteochondral defects in the hip. The treatment is known as autologous matrix-induced chondrocyte (AMIC) and is an enhanced version of the original micro fracture technique, in which a type I/III collagen matrix is placed over a cartilage defect to stabilise the fragile bone marrow cell infiltrate and provide infrastructure for tissue repair and regeneration.
“Celgro SMRT Graft is a novel biological device that has the potential to augment AMIC treatment for osteochondral defects within the hip,” said principal investigator Dr John O’Donnell, referring to the product’s characteristics of cell compatibility, tensile strength and the ability to actively promote and guide quality tissue ingrowth and repair. “The unique properties of Celgro SMRT Graft may provide a more effective repair than currently available treatments.”
The news comes just two days after the company received an R&D tax incentive refund of over $1.5 million for the financial year 2014–15. Managing director Paul Anderson noted that the refund “increases our operational runway at a time when the company is actively driving further clinical trials” in Celgro, as well as its cellular therapy for tendon regeneration, Ortho-ATI, in a range of applications.
Orthocell (ASX:OCC) shares were trading 1.21% higher at $0.42 as of around 11 am on Wednesday.


Published at - LifeScientist

News: Kohlberg & Company buys majority of Amendia

May 2, 2016
Amendia Inc said April 29 that Kohlberg & Company LLLC has acquired a majority stake in the company. Financial terms weren’t announced. Marietta, Georgia Amendia develops, designs and makes medical devices used in spinal surgical procedures.
PRESS RELEASE
MARIETTA, GA (PRWEB) APRIL 29, 2016
Amendia, Inc., a leading designer, developer, manufacturer and marketer of medical devices used in spinal surgical procedures, today announced the completion of a significant transaction and partnership that positions Amendia for accelerated growth and an enhanced value proposition for current and future customers and partners. Kohlberg & Company, L.L.C. (“Kohlberg”), a leading private equity firm specializing in middle market investing, has acquired majority ownership of the Company and intends to support Amendia’s growth initiatives from its $1.6 billion private equity fund, Kohlberg Investors VII.

As part of the transaction, Amendia has expanded its senior management team to include several experienced executives, including three spine industry veterans: Chris Fair, who has joined Amendia as Chief Operating Officer and a member of its Board of Directors; Larry Boyd, PhD, who has joined Amendia as Executive Vice President, Research & Development; and Scott Bruder, MD, PhD, a Kohlberg strategic advisor who has joined Amendia’s Board of Directors and Executive Committee.

“We are thrilled with our new partners and the resources they bring to the Amendia organization,” stated Jeff Smith, Amendia founder & CEO. “Kohlberg & Company’s reputation of investment success along with a track record of fostering world-class operational performance makes them the ideal partner to help implement our plans for strategic growth. Chris Fair has been a trusted advisor to Amendia for many years, and together with Scott Bruder and Larry Boyd we are adding more than six decades of world-class spine industry experience to our management team. The Amendia team and I look forward to working closely with our new partners to take our company to new heights.”

“Amendia has carefully and steadily grown organically and through thoughtful M&A to become one of the premier growth companies offering a complete suite of products that meet the needs of surgeons and their patients,” commented Chris Fair, Amendia’s Chief Operating Officer, whose experience includes a decade at DePuy Spine, a Johnson & Johnson Company and leading Sales & Marketing at St. Francis Medical prior to their acquisition by Kyphon. “I am excited to be joining Jeff Smith, Tim Lusby and their team of professionals at Amendia, and I look forward to helping the company expand its footprint, add resources, and build value for all customers and partners.”
“The solid foundation already in place at Amendia is a distinguishing characteristic that gives this platform so much potential,” added Scott Bruder, MD, PhD, who previously served as Chief Medical and Scientific Officer of Stryker, Chief Science and Technology Officer of BD, and as a Worldwide Vice President at DePuy, alongside Chris Fair. “I’m very enthusiastic about helping to pave the way for success in the evolving landscape of spine care by providing clinically meaningful innovations that improve patient outcomes.”

Amendia, headquartered in Marietta, GA, operates from an integrated design and manufacturing facility, offering a full suite of products to address the deformity and degenerative market segments, as well as minimally invasive and biologic solutions to treat even the most challenging cases. The company markets and sells its products through direct sales employees, independent agencies, and distributor partners.

“We see tremendous growth opportunities for Amendia,” commented Chris Anderson, Partner of Kohlberg & Company. “Through its broad portfolio of innovative products and intellectual property, scalable operational infrastructure, and continued dedication to its mission to exceed surgeon and patient expectations, Amendia is uniquely positioned to serve the growing demands of the spinal surgery marketplace in the US and beyond.”

About Amendia
Image result for amendia
Headquartered in a state-of-the-art manufacturing facility in Marietta, GA, Amendia is a leading designer, developer, manufacturer and marketer of medical devices used in spinal surgical procedures. Amendia’s mission is to exceed surgeon and patient expectations by creating balanced solutions with disruptive technologies for medical devices paired with biologics and instrumentation. Amendia’s vertically-integrated strategy focuses on improving surgical outcomes and the lives of patients with spinal disorders. For more information, please visithttp://www.amendia.com.

About Kohlberg & Company
Kohlberg & Company
Kohlberg & Company is a leading private equity firm headquartered in Mount Kisco, New York. Since its inception in 1987, Kohlberg has organized seven private equity funds, through which it has raised over $5 billion of committed equity capital. Over its 29-year history, Kohlberg has completed 66 platform investments and over 140 add-on acquisitions, with an aggregate transaction value of approximately $10 billion. For more information, please visit http://www.kohlberg.com.

Published at PE Hub Network

News: Stryker’s Spine Division Debuts 3D-Printed Tritanium® Posterior Lumbar Cage at AANS Meeting

This Proprietary Tritanium Technology, in Spinal Applications, Is Designed for Bone In-Growth & Enhanced Biological Fixation

April 29, 2016 08:02 AM Eastern Daylight Time
Image result for stryker
ALLENDALE, N.J.--()--Stryker’s Spine division will introduce the Tritanium Posterior Lumbar (PL) Cage, a 3D-printed intervertebral body fusion device that aids in lumbar spinal fixation for patients with degenerative disc disease, at the American Association of Neurological Surgeons Annual Meeting April 30–May 4, 2016, in Chicago (booth No. 3611).
“We are pleased to bring this technology advancement to spine surgeons and their patients”
Tweet this
The Tritanium PL Cage is manufactured with Stryker’s innovative additive manufacturing process, also known as 3D printing. The cage is constructed using Stryker’s Spine division proprietary Tritanium technology, a novel, highly porous titanium alloy material designed for bone in-growth and biological fixation.1 Stryker’s 3D-printing process allows for the creation of porous structures that are designed to mimic cancellous bone, a type of spongy bone tissue.
“We are pleased to bring this technology advancement to spine surgeons and their patients,” said Stryker’s Spine division President Brad Paddock. “Stryker is a pioneer in 3D additive manufacturing, investing nearly 15 years in research and development. Unlike traditional manufacturing techniques, the flexibility of our 3D additive manufacturing capabilities allows us to precisely engineer and produce porous Tritanium devices. The Tritanium PL Cage is an exciting addition to our growing suite of unique spinal products.”
“Spine surgeons need a cage that has the capability of bony integration or bony in-growth, as well as radiolucency so that we can evaluate the fusion long term,” said Dr. Wellington Hsu, M.D., Orthopaedic Surgeon at Northwestern Medical Group. “Because Tritanium has favorable radiographic capabilities, as well as the integrative surface technology, that really in my opinion is what I would ask for from an interbody cage.”
Implanted via a posterior approach, the Tritanium PL Cage is available in a variety of widths, lengths, heights, and lordotic angles that can adapt to a variety of patient anatomies. Its large lateral windows and open architecture allow visualization of fusion on CT and X-ray, and its solid-tipped, precisely angled serrations are designed to allow for bidirectional fixation and to maximize surface area for endplate contact with the cage. The Tritanium PL Cage also is designed to minimize subsidence into the endplates.
The Tritanium PL Cage, which is produced at Stryker’s state-of-the-art 3D additive manufacturing facility, will be widely available to orthopaedic and neurosurgeons in mid-2016.
Tritanium Technology
In lumbar spinal fusion procedures, advancement of bony fusion at the target levels is at the cornerstone of a successful clinical outcome. In an effort to enhance the bony in-growth potential of implants, the scientific community has focused on porous metal implants in the hope of establishing a material similar in structure and mechanical properties to bone. Studies also have sought to understand which geometry and pore size would provide an optimal environment for cells to attach and multiply within this structure.2–4
Stryker’s Spine division conducted a pre-clinical animal study to investigate the biomechanical performance and bone in-growth potential of various lumbar interbody fusion implants utilizing different surface technologies (including the Tritanium PL Cage). The study has been accepted as a podium presentation at the NASS Annual Meeting being held Oct. 26-29, 2016, in Boston.
Indications for Use
The Tritanium PL Cage is indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease at one level or two contiguous levels from L2 to S1. Degenerative disc disease is back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The degenerative disc disease patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the Tritanium PL Cage may be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. It is to be implanted via a posterior approach and is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
About Stryker
Stryker is one of the world’s leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world. Please contact us for more information at www.stryker.com.
Editor’s note: For images, video footage, or animation of Tritanium products and Stryker’s 3D additive manufacturing process, contact Barbara Sullivan at 714/374-6174 or bsullivan@sullivanpr.com. A backgrounder about Tritanium and the Tritanium PL Cage also is available.
References
  1. Project #43909: Tritanium Technology Claim Support.
  2. Bobyn JD, Pilliar RM, Cameron HU, Weatherly GC. (1980) The optimum pore size for the fixation of porous-surfaced metal implants by the ingrowth of bone. Clinical Orthopaedics and Related Research, 150, 263-270.
  3. Webster TJ, Ejiofor JU. (2004) Increased osteoblast adhesion on nanophase metals; Ti, Ti6AI4V, and CoCrMo. Biomaterials, 25, 4731-4739.
  4. Karageorgiou V, Kaplan D. (2005) Porosity of 3D biomaterial scaffolds and osteogenesis. Biomaterials, 26, 5474-5491.
Content ID TRITA-PR-3

Contacts

Sullivan & Associates
Barbara Sullivan, 714/374-6174