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Recon

Exactech Expands Its Computer-Assisted Surgery System With Revision Total Knee Replacement Application

October 6, 2016 OrthoSpineNews

GAINESVILLE, Fla.–(BUSINESS WIRE)– October 6, 2016

Exactech, Inc. (EXAC), a developer and producer of bone and joint restoration products for hip, knee, shoulder and spine, today announced today the successful first U.S. surgery using the new application of ExactechGPS® Guided Personalized Surgery system for revision knee procedures.

According to Exactech Chief Executive Officer David Petty, “We are pleased to broaden the use of our ExactechGPS computer guidance system with an application for revision total knee replacement. Even with the best implant systems in the hands of the best surgeons, sometimes patients’ existing implants need to be removed and replaced, due to trauma, tumors, infection or implant failure. These ‘revision’ procedures can be challenging and complex. Exactech is committed to developing innovations that can improve patient outcomes for these difficult cases, and within the last 12 months we also launched three new revision implant systems, including the Optetrak Logic® CC Comprehensive Revision Knee System.”

To develop this technology, the company partnered with orthopaedic surgeons, including Bernard Stulberg, MD, of St. Vincent Charity Medical Center in Cleveland, Ohio, who was the first to use the new ExactechGPS revision knee application last week.

“This time last year, I had the privilege of performing the first surgery with Exactech’s new Logic CC revision knee implant system and now I am honored and pleased to report a successful first surgery using the ExactechGPS revision knee application,” said Bernard Stulberg, MD. “I am impressed with the information this computer-assisted surgery system provided me during the case. The revision knee application confirmed the position and alignment of the implants, resulting in a stable and well-aligned knee. This system has great potential to improve predictability and reproducibility in revision total knee procedures.”

The ExactechGPS revision total knee application recently received 510(k) clearance in the U.S., and approval in the European Union.

The other design team members for the ExactechGPS revision knee application include Gérard Giordano, MD, of Joseph Ducuing Hospital in Toulouse, France, and James Huddleston, MD, of Stanford University Medical Center.

The Exactech revision knee system is indicated for use in skeletally mature patients undergoing surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems; this device is also indicated for revision of failed previous reconstruction where sufficient bone stock and soft tissue integrity are present.

About ExactechGPS

ExactechGPS® Guided Personalized Surgery is a powerful, yet compact advanced surgical technology platform that delivers efficiency and reproducibility in total joint replacement. Merging sophisticated computer guidance technology with innovative instrumentation, ExactechGPS delivers a real-time, patient-specific solution designed for improved clinical outcomes. For more information about ExactechGPS®, visit www.exactechgps.com.

About Exactech

Based in Gainesville, Fla., Exactech develops and markets orthopaedic implant devices, related surgical instruments and biologic materials and services to hospitals and physicians. The company manufactures many of its orthopaedic devices at its Gainesville facility. Exactech’s orthopaedic products are used in the restoration of bones and joints that have deteriorated as a result of injury or diseases such as arthritis. Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Additional information about Exactech can be found at http://www.exac.com.

*The ExactechGPS is intended for use during preoperative planning and during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures.

1Hopkins AR, Hansen UN, Amis AA, Emery R. The Effects of Glenoid Component Alignment Variations on Cement Mantle Stresses in Total Shoulder Arthroplasty. J Shoulder Elbow Surgery. 2004 Nov-Dec; 13(6):668–675.
2Gregory TM, Sankey A, Augereau B, et al. Accuracy of Glenoid Component Placement in Total Shoulder Arthroplasty and Its Effect on Clinical and Radiological Outcome in a Retrospective, Longitudinal, Monocentric Open Study. PLoS ONE. 2013 Oct; 8(10):e75791.

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FinancialRegulatory

Amedica Provides Business Update

October 6, 2016 OrthoSpineNews

SALT LAKE CITY, UT — (Marketwired) — 10/06/16 — Amedica Corporation (NASDAQ: AMDA), a biomaterial company that develops and commercializes silicon nitride for biomedical applications, today provided a business update related to its business strategy and certain recent developments.

Briefly, the updates relate to the following items:

  • New patent directed to a threaded design in ceramic implants;
  • Participation at the annual International Society for Technology in Arthroplasty; and
  • Update related to completion of the company’s strategic workforce reduction.

Amedica Awarded Key Patent Protection for Threaded Implant Design Feature
Amedica was recently awarded a patent by the United States Patent and Trademark Office for “threading sinterable materials,” such as silicon nitride and other ceramic materials. U.S. Patent No. 9,399,309, covers methods for threading ceramic materials used for spinal fusion implants, or other biomedical implants. Threading technology is broadly applicable in a wide range of current medical devices made from PEEK or titanium, and this patent is the first for ceramic materials. Amedica’s ability to manufacture threaded biomedical implants made of silicon nitride and other ceramic materials reflects nearly five years of pioneering work by its R&D and engineering teams.

Amedica has implemented this new technology across its portfolio of Valeo® II spinal fusion devices. These fusion devices are made of micro-composite silicon nitride, which favors bone ingrowth and shows antibacterial properties, when compared to competitive PEEK and titanium implants. Valeo II silicon nitride interbody fusion devices are readily imaged on x-rays, CT, and MRI scans; a property unique to Amedica’s silicon nitride technology.

Amedica to Present Research Supporting Silicon Nitride at ISTA
Amedica announced that it will be presenting four papers at the International Society for Technology in Arthroplasty’s (ISTA) 29th Annual Congress occurring October 5-8, 2016 in Boston, Massachusetts. “These papers provide further evidence for the advantages of our proprietary silicon nitride composition in the spine, dental, and arthroplasty markets,” said Dr. Sonny Bal, Chairman and CEO of Amedica Corporation. “Our strength in manufacturing, research, and external collaborations is critical to creating long-term value, even as we reduce costs and address spine sales,” added Dr. Bal

Going Forward Following Strategic Reductions in Workforce
The company also confirmed that the previously-announced work force reduction has been completed, resulting in a leaner and more agile organization that is better positioned to extend its cash runway and execute on its strategic objectives.

Dr. B. Sonny Bal, chairman and chief executive officer of Amedica, stated, “despite the recent 38% reduction in force, the company continues to be in a strong position to timely and efficiently manufacture its silicon nitride products, further scientific research into the properties of our silicon nitride ceramic and how to enhance those properties, and to continue to support its external partnerships and product development opportunities.”

About Amedica Corporation

Amedica is focused on the development and application of interbody implants manufactured with medical-grade silicon nitride ceramic. Amedica markets spinal fusion products and is developing a new generation of wear- and corrosion-resistant implant components for hip and knee arthroplasty as well as dental applications. The Company’s products are manufactured in its ISO 13485 certified manufacturing facility and through its 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 its growing 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:
Kevin Ontiveros
801-839-3502
IR@amedica.com

Source: Amedica Corporation

 

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Spine

Benvenue Medical Presents Clinical Evidence on Luna and Kiva Systems at SMISS Annual Forum ‘16

October 6, 2016 OrthoSpineNews

October 06, 2016

SANTA CLARA, Calif.–(BUSINESS WIRE)–Benvenue Medical, Inc., a developer of minimally invasive solutions for spine repair, today announced key clinical data presentations and company events for the Luna 3D Multi-Expandable Interbody Fusion System and Kiva VCF Treatment System at the Society of Minimally Invasive Spine Surgery (SMISS) Annual Forum ‘16 Oct. 13-15 in Las Vegas.

Data Presentations

  • “Multi-Expandable Cages for Minimally Invasive Posterior/Transforaminal Lumbar (P/TLIF) Interbody Fusion – A Preliminary Report” (Paper #38) will be presented by Dr. Jeffrey Coe of the Silicon Valley Spine Institute (Campbell, California) on Saturday, Oct. 15 at 11:17 a.m. The podium presentation will highlight early experience and encouraging outcomes with the Luna Interbody Fusion System in minimally invasive P/TLIF, including absence of nerve retraction injuries and restoration of disc height, segmental lordosis, and foraminal height, along with lack of subsidence and maintenance of sagittal correction.
  • “Serious Adverse Events Associated with Re-admission through One Year after Two Different Approaches to Vertebral Augmentation” (Paper #27) will be presented by Dr. Douglas Beall of Clinical Radiology of Oklahoma (Edmond, Oklahoma) on Friday, Oct. 14 at 11:45 a.m. The podium presentation will review serious adverse events requiring unplanned re-admission for patients who had vertebral augmentation using the Kiva VCF Treatment System as compared to balloon kyphoplasty.
  • “Superior Articular Process Interbody Reconstruction: Feasibility and Short Term Clinical Outcomes of a Novel Posterior Lumbar Interbody Fusion Approach” (Poster #22) will be moderated by Dr. Joshua Ammerman of Washington Neurosurgical Associates (Washington, DC). The poster highlights Dr. Ammerman’s novel posterior minimally invasive approach to safely access the lumbar disc without intrusion into the spinal canal by use of the Luna 3D interbody cage to restore disc height as a means to achieve indirect canal and foraminal decompression.
  • “Community Practice Experience with Subsequent Vertebral Compression Fractures during the Year after Vertebral Augmentation using an Expandable Implant” (Poster # 17) will be moderated by Dr. Ryon Hennessy of Orthopedic Specialists (Elmhurst, Illinois). The poster reviews the rate of subsequent vertebral compression fractures in the year following vertebral augmentation with the Kiva VCF Treatment System.

“At SMISS 2016, we will be presenting much anticipated early clinical experience with our Luna 3D Interbody Fusion System, highlighting the benefits of the multi-expandable implant,” said Robert K. Weigle, CEO of Benvenue Medical. “We will also be presenting important data on our Kiva VCF Treatment System showing its positive impact on potentially reducing subsequent fractures and other adverse events compared to balloon kyphoplasty.”

Benvenue will also exhibit at booth #100 and sponsor the “Elevating Surgical Outcomes: Sagittal Correction and Height Restoration with Expandable TLIF and VCF Implants” Technology Workshop presented by Dr. Coe on Saturday, Oct. 15 at 7:30 a.m.

About the Luna 3D Interbody Fusion System

The Luna 3D Interbody Fusion System is designed to provide one of the largest yet least invasive devices for posterior lumbar interbody spinal fusion. Cleared by the U.S. Food and Drug Administration in November 2014, the Luna 3D System is comprised of a PEEK implant designed to expand in multiple dimensions within the disc space, first in footprint and secondarily in height, allowing surgeons to effectively restore height via a posterior approach while providing the stability of a larger construct more often associated with an anterior approach. After a discectomy is performed, the Luna 3D Implant is delivered through a small diameter cannula into the disc space. After expanding its footprint, it is then expanded in height with the insertion of a middle section. When the cannula is removed, bone graft is placed in the middle of the implant and the implant is locked in place with a locking wire.

About the Kiva VCF Treatment System

The Kiva VCF Treatment System provides a new implant-based approach to vertebral augmentation in the treatment of painful VCFs. Kiva was recently launched in the U.S. and it is commercially available in Europe. Kiva has been shown, in at least three comparative studies with a total of more than 500 patients, to meet or exceed the performance of balloon kyphoplasty, the standard of care. Kiva is indicated for the reduction and treatment of spine fractures in the thoracic and/or lumbar spine from T6-L5. It is intended to be used in combination with the Benvenue Vertebral Augmentation Cement Kit.

About Benvenue Medical, Inc.

Founded in 2004, Benvenue Medical, Inc. provides next generation minimally invasive systems for spine repair that combine expandable implants with novel delivery instruments to provide enduring functional benefits for patients. The company is privately held and funded by DeNovo Ventures, Domain Associates, Esquilime Partners, InterWest Partners, Technology Partners and Versant Ventures. Its first products are designed for the treatment of vertebral compression fractures and degenerative disc disease, which have combined revenues of $9 billion globally. For more information, visit www.benvenuemedical.com.

Contacts

Merryman Communications
Betsy Merryman, 310-560-8176
betsy@merrymancommunications.com

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Regulatory

Theranos closes its labs and wellness centers, lays off 340

October 6, 2016 OrthoSpineNews

By , , Contributor

 

Theranos is closing its labs and wellness centers, CEO Elizabeth Holmes announced today in a post on the company blog. And this isn’t a temporary closure: the “approximately” 340 employees running them are out of a job.

“After many months spent assessing our strengths and addressing our weaknesses, we have moved to structure our company around the model best aligned with our core values and mission,” Holmes wrote.

The company pivoted away from working on its closely held “nanotainer” technology to a “miniLab” in August. The boxy device — unveiled at the American Association for Clinical Chemistry conference — collects small samples of blood and urine and then uploads them to a centralized system for further analysis.

And it’s a far cry from what the company, once valued at $9 billion, set out to do. According to several experts whom TechCrunch spoke to at the unveiling, it might not be very innovative, either. Although Theranos didn’t want its new device referred to as a “lab on a chip,” that’s essentially what these experts said the miniLab was. And that has been done.

The new device hinges largely on FDA approval — something Holmes said she’d hoped to fast-track under the emergency use authorization (EUA) for Zika detectors. That plan didn’t go so well, however. The FDA denied  Theranos approval after finding the company failed to use proper patient safety protocols.

 

READ THE REST HERE

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Recon

Capital Regional Orthopaedic Associates Performs First Meniscus Replacements in New York with NUsurface® Implant

October 6, 2016 OrthoSpineNews

October 05, 2016

ALBANY, N.Y.–(BUSINESS WIRE)–Capital Regional Orthopaedic Associates, an Albany-based orthopedic practice at The Bone and Joint Center, and Active Implants, a company that develops orthopedic implant solutions, today announced that the first meniscus replacement procedures in New York have been performed by Drs. Richard Alfred and Maxwell Alley. Capital Regional Orthopaedic Associates is just one of 10 sites nationwide enrolling patients with persistent knee pain caused by injured or deteriorated meniscus cartilage in the VENUS (Verification of the Effectiveness of the NUsurface® System) clinical trial, which is designed to assess the safety and effectiveness of the investigational NUsurface Meniscus Implant compared to non-surgical standard of care.

East Greenbush resident Tracy Cullum was the first patient to receive the implant in New York. Eight years ago, the 42-year-old and mother of two discovered she suffered a meniscus tear in her left knee after noticing a constant ache and inability to put any weight on her left side. Although she underwent a partial meniscectomy to treat the tear, her knee pain became progressively worse and resulted in a constant limp while walking. With her pain increasing in severity, Cullum went from working out seven days week to having to stop any exercise activities. As a part-time volunteer firefighter, she found it difficult to move any equipment, and her mobility was compromised when responding to an emergency scene.

“There are limited options for patients who experience persistent knee pain following meniscus surgery,” said Dr. Richard Alfred, orthopedic surgeon at Capital Region Orthopaedic Associates and VENUS study investigator. “It is our hope that the NUsurface implant alleviates pain in these patients, allowing them to return to their previous levels of activity, ultimately delaying or avoiding the need for a more invasive knee surgery.”

The meniscus is a tissue pad between the thigh and shin bones. Once it is damaged, the meniscus has a very limited ability to heal. Over 1 million partial meniscectomies (to remove the torn portion of the meniscus) are performed in the U.S. every year, more than the total number of hip and knee replacement surgeries combined. However, many patients still experience persistent knee pain following meniscus partial excision surgery.

It has been nearly three months since Cullum received the implant on July 6 through a small incision in her knee. She completed a six-week rehabilitation program, and she has now returned to daily leisure activities like hot yoga and her work as a volunteer firefighter.

“In the six months before receiving the NUsurface Meniscus Implant, my knee pain had peaked to where I had a constant dull ache and a limp while walking,” Cullum said. “Now my range of motion is improving, and I am ecstatic to be able to resume one of my favorite activities – volunteering together with my husband and children at our local fire department.”

The NUsurface Meniscus Implant has been used in Europe under CE Mark since 2008 and Israel since 2011.

About the Clinical Trial

As part of the process to gain regulatory approval in the U.S., the VENUS (Verification of the Effectiveness of the NUsurface® System) study will enroll approximately 130 patients at orthopedic centers in the U.S., Europe and Israel. Sites in the U.S. include Indiana (Indianapolis), Massachusetts (Boston), New York (Albany, Rochester and New York), North Carolina (Durham), Ohio (Columbus), Tennessee (Memphis) and Virginia (Richmond). Participants who meet study requirements and agree to enter the trial are randomized to receive either NUsurface or non-surgical treatment, which is the current standard of care for patients with persistent knee pain following meniscus surgery. To be eligible for the study, participants must be between the ages of 30 and 75 and have pain after medial meniscus surgery that was performed at least six months ago. To learn more about the VENUS study, please visit or call (844) 680-8951 or visitwww.meniscus-trial.com.

About the NUsurface® Meniscus Implant

In the U.S., the NUsurface® Meniscus Implant, from Active Implants LLC, is an investigational treatment for patients with persistent knee pain following medial meniscus surgery. NUsurface is made from medical grade plastic and, as a result of its unique materials, composite structure and design, does not require fixation to bone or soft tissue. The NUsurface device mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. It is inserted into the knee joint through a small incision, and patients typically can go home soon after the operation. After surgery, patients undergo a six-week rehabilitation program. NUsurface has been used clinically in Europe since 2008 and Israel since 2011.

About Capital Region Orthopaedic Associates

Capital Region Orthopaedics and their Board-Certified physicians specialize in all Orthopaedic services including: Knee and Hip (Adult Joint Reconstruction), Spine, Neck, Hand, Foot and Ankle, Shoulder and Sports Medicine. The physicians at Capital Region Orthopaedics are among the most experienced and highly trained surgeons in the region.

About Active Implants

Active Implants, LLC develops orthopedic implant solutions that complement the natural biomechanics of the musculoskeletal system, allowing patients to maintain or return to an active lifestyle. Active Implants is privately held with headquarters in Memphis, Tennessee. European offices are in Driebergen, The Netherlands, with R&D facilities in Netanya, Israel. For more information, visitwww.activeimplants.com.

CAUTION Investigational device. Limited by United States law to investigational use.

Note to Editors: Photos of Tracy Cullum are available upon request.

Contacts

Merryman Communications
Joni Ramirez, 323-532-0746
joni@merrymancommunications.com

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Regulatory

Trice Medical Receives FDA 510(K) Clearance for mi-eye 2

October 6, 2016 OrthoSpineNews

KING OF PRUSSIA, Pa., Oct. 6, 2016 — (Healthcare Sales & Marketing Network) — Trice Medical announced today that it received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) for mi-eye 2, a disposable needle with a fully integrated camera that enables physicians to use advanced diagnostic imaging to visualize joint injuries in their clinic. The mi-eye 2 is designed for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. The mi-eye 2 also provides physicians the ability to inject or aspirate under direct visualization.

The mi-eye 2 is Trice Medical’s second, next-generation FDA-cleared patented technology, which includes improvements that significantly enhance the mi-eye’s resolution, field of view, depth of field and overall visualization.

“Based on feedback we received from our surgeon advisory board, we promptly implemented and pursued FDA clearance for the next-generation mi-eye 2,” said Jeffrey O’Donnell, Sr., President and CEO at Trice Medical. “Our team made dramatic enhancements to the technology of the mi-eye, which reflects our continued commitment to patients by introducing our technology into a medical practice, and working to ensure that the mi-eye technology becomes the standard of care for providing an immediate real-time diagnosis. Our long-term goal is to eliminate the need for MRI exams and enable a quicker road to recovery.”

The Need for New Diagnostic Technology

Currently there are approximately 28,000 orthopedic surgeons seeing 20 million office visits annually for knee-related problems. In addition, there are 12 million visits annually related to shoulder pain. MRI’s are often inconclusive, or result in false readings, which has the potential to lengthen the timeline from diagnosis to recovery. In addition, not every patient is a candidate for MRI. The mi-eye 2 provides a diagnostic modality for every patient, and can provide time-savings to the patient by eliminating the multiple visits associated with an MRI. The mi-eye 2 is unlike any other in-office arthroscopy device on the market today, and provides unparalleled optics with the ease of use of a needle.

About Trice Medical

Trice Medical was founded to fundamentally improve orthopedic diagnostics for the patient, physician, and payor by providing instant, eyes-on, answers. Trice has pioneered and evolved, fully integrated camera-enabled technology that provides a clinical solution optimized for the physician’s office. Trice’s mission is to provide more immediate and definitive patient care, eliminating the false reads associated with current indirect modalities and significantly reduce the overall cost to the healthcare system. Trice Medical’s investors include Safeguard Scientifics (SFE), BioStar Ventures and HealthQuest Capital. For more information, visit www.tricemedical.com; follow us on Twitter, LinkedIn and Facebook; or call 844.643.9300.

Source: Trice Medical

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.

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Biologics

Carmell Therapeutics New Management Team

October 5, 2016 OrthoSpineNews

PITTSBURGH, Oct. 5, 2016 /PRNewswire/ — Carmell Therapeutics, a biosurgical technology company focused on the development and commercialization of innovative plasma-based bioactive materials, continues to grow and add the necessary management capabilities to advance its products towards US FDA regulatory approval. Carmell’s first product, REPAIR™ Putty, is designed to accelerate bone healing with the first application in long bone fractures.  Future clinical studies are planned to expand the label to include other orthopedic bone applications. The Carmell near-term pipeline also includes REPAIR™ Paste for accelerated soft tissue healing, such as surgical site and chronic wound management.

To successfully advance these programs through the development and commercialization process, Carmell is significantly expanding their senior management capabilities. Joining Randy Hubbell, CEO, and Dr. James Hart, Chief Medical Officer, are:

  • Donna Godward, Chief Quality Officer – Ms. Godward spent most of her career at J&J before retiring as a Chief Quality Officer for J&J’s Medical Device and Diagnostic Business.
  • Stephanie Kladakis, PhD, VP of R&D – Dr. Kladakis brings with her over 14 years of experience in product development, from concept through CE Mark and PMA approvals, and was most recently the VP of R&D for Cohera Medical.
  • Janet Vargo, PhD, VP of Clinical Sciences – Dr. Vargo has extensive experience in designing and executing clinical trials and most recently worked at Mentor, LLC (J&J) as Head of Clinical Development and Regulatory Affairs.
  • Carmell is also expanding the expertise and capabilities of their Board of Directors with the addition of:
  • David Anderson, President and CEO, Orteq Sports Medicine as an independent board member. Mr. Anderson has over 20 years experience as a senior executive in the orthobiologics space. His insights and knowledge will be extremely useful to the Carmell management team as they expand their development pipeline and prepare for commercialization.

“I am very excited to be able to assemble an extremely experienced team of experts that will ensure success for Carmell,” commented Randy Hubbell.

About Carmell Therapeutics

Founded in 2007 as a spin out from Carnegie Mellon University in Pittsburgh, PA, Carmell Therapeutics Corporation is a privately-owned biosurgical technology company focused on the development and commercialization of innovative plasma-based bioactive materials (PBMs). These PBMs contain a concentration of natural regenerative factors that promote healing, reduce complications, and lead to healthcare savings. Utilizing its proprietary cross-linking process, the company has successfully developed multiple PBM formulations such as pastes, putties, scaffolds, plugs and screws, using pooled plasma from healthy donors.  Unlike previous approaches to delivering growth factors to injuries/surgeries, Carmell’s plasma-based devices can be designed to vary the release time of active biologics to accommodate the needs of the body. Carmell’s first product, REPAIR™ Putty, has been designed to treat bone fractures through accelerated bone healing of the fracture and surrounding soft tissues while reducing complications, infections and duration of care. Early human clinical evidence suggests that REPAIR™ Putty is efficacious, safe, consistent and affordable.  Carmell’s proprietary blood plasma-based technology will serve as the foundation for groundbreaking products designed to improve the lives of patients and to reduce the costs of healthcare across variety of surgical procedures.

For more information on Carmell Therapeutics, please visit the Company’s website at http://www.carmellrx.com/

CERTAIN STATEMENTS IN THIS RELEASE ARE FORWARD LOOKING STATEMENTS ABOUT CARMELL’S FUTURE PLANS, OBJECTIVES AND PROJECTED PERFORMANCE.  THESE FORWARD-LOOKING STATEMENTS ARE BASED ON CERTAIN ASSUMPTIONS THAT THE COMPANY BELIEVES ARE REASONABLE, BUT ARE SUBJECT TO KNOWN AND UNKNOWN RISKS AND UNCERTAINTIES. CARMELL MAKES NO REPRESENTATION, WARRANTY OR CLAIM REGARDING THE INFORMATION IN THIS RELEASE OR ANY OF ITS PRODUCTS. ACTUAL RESULTS MAY VARY SIGNIFICANTLY FROM OUR PREDICTIONS AND DEPEND ON KNOWN AND UNKNOWN RISKS.  CARMELL’S PRODUCTS ARE NOT CURRENTLY AVAILABLE FOR SALE OR USE AND HAVE NOT BEEN APPROVED BY THE U.S. FOOD AND DRUG ADMINISTRATION OR ANY COUNTRY’S REGULATORY AUTHORITY.

Logo – http://photos.prnewswire.com/prnh/20161004/415072LOGO

Contact:
Randy Hubbell
rhubbell@carmellrx.com
(215) 688-6196

SOURCE Carmell Therapeutics Corporation

Related Links

http://www.carmellrx.com

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Spine

ChoiceSpine appoints Christy Cote as Vice President of Biologics

October 5, 2016 OrthoSpineNews

KNOXVILLE, TN, October 5, 2016 – ChoiceSpine, a Knoxville, TN based spinal implant company, today announced it has appointed Christy Cote as Vice President of Biologics. She is a business leader with 14+ years’ experience in stem cell technology, surgical implants, and regenerative therapies. She’s had an award winning sales career and brings with her technical expertise and strategic development focused on developing a Biologics portfolio for ChoiceSpine. Prior to joining, Christy served as Vice President of Biologics of Amendia and Biologics Regional Vice President of Orthofix. She has a Bachelor of Science in Applied Biology with focus in Microbiology from The Georgia Institute of Technology.

 

If you would like more information about ChoiceSpine’s biologics offering please email info@choicespine.com

About ChoiceSpine
ChoiceSpine is a privately held spine company located in Knoxville, TN, and prides itself on providing excellent products and exceptional service to meet the needs of their customers. ChoiceSpine offers a breadth of innovative and surgeon focused systems that are designed to be safe, efficient, and easy-to-use.

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Financial

IPG and NEXGEN OsteoBiologics Create Innovative Tissue Management Solution

October 5, 2016 OrthoSpineNews

October 05, 2016

ATLANTA–(BUSINESS WIRE)–IPG, the industry-leading provider of Device Benefit Management solutions, today announced a partnership with NEXGEN OsteoBiologics, a medical biologics marketplace with a national distribution network. The agreement, effective October 1 will help provide cost-efficient biologics to partnering health plans, providers and members.

Currently procedures utilizing osteobiologics materials (sports medicine, spine, dermatology, and breast reconstruction, among others) are on the rise, as are the related costs. These cost increases are partially driven by the increasing complexity of these materials, where lack of transparency often creates highly variable and unjustified pricing across the board.

“NEXGEN is excited to partner with IPG. As the nation’s leading Device Benefit Management firm dedicated to improving quality of care while lowering the overall cost of care, IPG was the ideal partner for NEXGEN,” said Steve Carbonara, Co-Founder of NEXGEN. “Working with healthcare facilities, health plans, and providers, we can remove a tremendous amount of cost in the healthcare supply chain while automating much of the process.”

IPG partners with all of the major national and regional health plans across the country to bring transparency and high quality, cost efficient care to their members. As a participating manufacturer in IPG’s Device Benefit Management program, NEXGEN will serve as a direct vendor to IPG’s partnering providers. The relationship between IPG and NEXGEN will allow IPG to manage all aspects of the device acquisition process including purchasing, billing, provider education, manufacturer account management/negotiation etc. which relieves the cash outlay burden among IPG’s facility customers and streamlines the overall facility process therefore saving money and increasing facility profitability.

“IPG continues to partner with innovative companies like NEXGEN that increase value to clinicians and patients while containing escalating healthcare costs,” said Brian Holt, Chief Innovation Officer for IPG. “Relationships like this allow us to actively participate with our health plan partners to truly deliver value-based healthcare to their members.”

“We are unique in that our solutions help align health plans, providers, facilities, members and manufacturers in the delivery of high quality and cost efficient care. We are proud of the network we’ve built together to deliver on our mission,” said Vince Coppola, President & CEO of IPG.

About NEXGEN OsteoBiologics

NEXGEN is a Tissue Bank Intermediary that distributes a full portfolio of biologic products nationally, from Allograft to Synthetics, acting as a one stop shop to clients and partners while delivering state of the art products from human tissue processors and synthetic manufacturers. Through our proprietary 5 Pillars of Biologic Fingerprinting methodology, NEXGEN is providing transparency and removing ambiguity in the purchasing process. NEXGEN provides ‘spend efficiency consulting services’ for healthcare facilities, health plans and providers, locating areas that can be immediately impacted, reducing costs by 15-30% on total annual spend. This Spend Efficiency Product Analysis System (SEPAS) is provided to any facility for free prior to any contracting to ensure proper alignment and expectations for NEXGEN and their client and partners. For more information about NEXGEN, please visit our website atwww.NEXGENosteobiologics.com or call us at 844-639-4363.

About IPG

As the Device Benefit Management leader, IPG delivers a customized, data-driven approach to enable their health plan partners to manage their surgical and implant costs more effectively. Providing true end-to-end solutions for the healthcare industry, IPG serves as a strategic capability for health plans to manage cost and risk in a unique way that drives collaboration between the plan, their healthcare providers, manufacturers and physicians to ensure that patients receive increased access to affordable and innovative life-saving and life-enhancing device-intensive medical therapies. Additionally, IPG’s award-winning analytics platform for implantable procedures delivers transparency to impact the entire health care transaction process and all sites of care. Continued expansion of IPG’s surgical cost management platform will help health plans to deploy programs that will improve their ability to manage risk and deliver actionable information to everyone involved in a patient’s surgical procedure to drive lower costs and high-quality care for consumers. For more information about IPG, call us at 866.753.0046, or visit us on the web at www.ipg.com.

Contacts

IPG
Kerry Lee Perry, 866-753-0046
kperry@ipg.com
or
NEXGEN OsteoBiologics
Steve Carbonara, 844-639-4363 x102
steve@NEXGENosteobiologics.com

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Financial

Extremity Reconstruction Market is Expected to Reach $3,041 Million by 2022, Globally – Allied Market Research

October 5, 2016 OrthoSpineNews

PORTLAND, Oregon, October 5, 2016 /PRNewswire

A new report published by Allied Market Research, titled,“Extremity Reconstruction Market by Type and Biomaterial – Global Opportunity Analysis and Industry Forecast 2014- 2022″, states that the global extremity reconstruction market was $1,833 million in 2015 and is expected to reach $3,041 million by 2022, growing at a CAGR of 7.5% from 2016 to 2022. Shoulder reconstruction segment, which accounted for more than 70% in 2015, is expected to dominate the global market throughout the forecast period. North America held the leading position in 2015, and is expected to maintain this trend throughout.

The key drivers of the market include increase in incidence of joint disorders such as osteoarthritis & rheumatoid arthritis coupled with growth in geriatric population and global rise in the prevalence of diabetes & obesity. In addition, increase in awareness among patients about the benefits of small joint reconstruction implants and improvement of technology such as development of stemless shoulder implants, reverse shoulder implants, and ankle reconstruction implants that assist in regaining ankle mobility are expected to propel the market growth. However, unfavorable reimbursement scenario and complications associated with extremity reconstruction surgeries hamper the market growth.

Upper extremity reconstruction implants (such as elbow, radius, hand & wrist, and shoulder) was the leading market segment in 2015, due to increase in the incidences of small joint disorders such as arthritis and fracture. She further added. Ankle replacement segment is expected to grow at a CAGR of 17.4%, owing to technological advancements in this segment. Technological innovations in ankle replacement implants have improved ankle motion in contrast to ankle fusion that restricts movement. Natural biomaterials segment is expected to grow rapidly due to their biocompatible and biodegradable properties.

Key Findings of the extremity reconstruction market Study:

  • The shoulder replacement segment generated the highest revenue in 2015, and is projected to grow at a CAGR of 7.3%.
  • Stemless shoulder implants segment is projected to grow rapidly registering a CAGR of 20.0%.
  • Metallic biomaterial dominated the world extremity reconstruction devices market.
  • Total ankle replacement segment is expected grow at a CAGR of 17.4%.
  • In 2015, the U.S. led in the global extremity reconstruction market, accounting for more than 67% share in the overall market.
  • Germany accounted for about one-third share of the European extremity reconstruction market in 2015.
  • Indian extremity reconstruction devices market is expected to grow at a CAGR of 13.7%.

North America accounted for a major share in 2015, and is expected to maintain this trend throughout the forecast period. This is attributed to rise in prevalence of joint disorders coupled with increase in geriatric population, high awareness regarding the benefits of extremity reconstruction devices, favorable reimbursement rates, presence of innovative technologies, and quest for better quality of life in this region. However, the Asia-Pacific region is expected to grow rapidly owing to the presence of ample growth opportunities in terms of unmet medical needs for the treatment of small joint disorders, increase in awareness about the benefits of extremity reconstruction surgeries, and rise in acceptance of advanced technologies.

Some of the key players profiled in the report include DePuy Synthes (a wholly owned subsidiary of Johnson & Johnson), Stryker Corporation, Zimmer Biomet Holdings, Inc., Smith & Nephew plc., Integra Lifesciences Holdings Corporation, Wright Medical Group N.V., Acumed, Inc., Arthrex, Inc., CONMED Corporation, and Skeletal Dynamics LLC.

 

Summary of Similar Reports can be viewed athttps://www.alliedmarketresearch.com/life-sciences/medical-devices-market-report 

 

About Us: 

Allied Market Research (AMR) is a full-service market research and business-consulting wing of Allied Analytics LLP based in Portland, Oregon. Allied Market Research provides global enterprises as well as medium and small businesses with unmatched quality of “Market Research Reports” and “Business Intelligence Solutions”. AMR has a targeted view to provide business insights and consulting to assist its clients to make strategic business decisions and achieve sustainable growth in their respective market domain.

We are in professional corporate relations with various companies and this helps us in digging out market data that helps us generate accurate research data tables and confirms utmost accuracy in our market forecasting. Each and every data presented in the reports published by us is extracted through primary interviews with top officials from leading companies of domain concerned. Our secondary data procurement methodology includes deep online and offline research and discussion with knowledgeable professionals and analysts in the industry.

 

Contact:
Pankaj Kumar
5933 NE Win Sivers Drive
#205, Portland, OR 97220
United States
Direct: +1-503-894-6022
Toll Free: +1 (800) 792-5285 (U.S. & Canada)
Fax: +1 (855) 550-5975
E-mail: sales@alliedmarketresearch.com
Web: https://www.alliedmarketresearch.com

 

© 2016 PR Newswire

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