Vertiflex, Inc. Appoints Michael Enxing to Vice President, Chief Commercial Officer

Posted On July 13, 2017 By OrthoSpineNews In Spine /

July 13, 2017

CARLSBAD, Calif.–(BUSINESS WIRE)–Vertiflex, Inc., a leading innovator of advanced, minimally invasive interventions for spinal stenosis, today announced the appointment of Michael Enxing as Vice President and Chief Commercial Officer. Mr. Enxing will be responsible for leading all aspects of the company’s Sales, Marketing, Health Economics/Reimbursement and Professional Education strategies, related to the already successful launch of the Superion® Indirect Decompression System for the treatment of lumbar spinal stenosis.

Mr. Enxing brings over 20 years of successful global leadership experience in product commercialization in the medical device, spinal and chronic pain fields. Most recently, Michael served as Vice President of Sales at Nevro Corporation where he led the company to impressive growth both internationally and domestically over the previous four years. Prior to Nevro, he served as Vice President of Sales and Marketing for Vertos Medical, and has held various executive positions at Cardiovascular Systems, Inc. (f/k/a Cardio Vascular Solutions CSI); Advanced Neuromodulation Systems, Inc. (acquired by St. Jude Medical, Inc.); Stryker Corporation; and Tecnol Medical Products, Inc. (acquired by Kimberly Clark) . Michael is a graduate of Iowa State University with a B.S. in Communications and focus in Business Administration.

Earl R. Fender, President & Chief Executive Officer of Vertiflex, said “We are very pleased to have attracted an executive of Michael’s caliber into our organization. Michael is a visionary leader who understands sales and marketing execution, market dynamics, critical organizational metrics, and cultural drivers that deliver team success and ensures the best customer engagement experiences possible. We are confident that Michael’s track record of significantly scaling businesses, will add considerable value to Vertiflex, our investors, physician providers, and most of all to patients, who will benefit from Superion’s demonstrated and durable clinical and safety profile.”

Mr. Enxing said, “I’m proud to join the Vertiflex team. As a result of the company’s achievements in product development, Level I clinical evidence generation, earning a PMA approval and Category I reimbursement for Superion, the stage is set to build a large, high growth, new category in spine that is focused on compelling clinical outcomes for patients and their physicians. Based on my prior experience in commercializing an early generation product for lumbar spinal stenosis, I believe Superion, having significant published peer-reviewed data, is positioned as the best-in-class minimally invasive solution for lumbar spinal stenosis that will also compare well to open surgical decompression in treating patients suffering from LSS.”

About Vertiflex

Vertiflex is a privately held medical device company dedicated to the advancement of minimally invasive solutions for the treatment of lumbar spinal stenosis, which is the leading cause of spinal surgery in the elderly. Founded in 2005 and headquartered in Carlsbad, CA, Vertiflex has developed proprietary, minimally invasive technologies for performing both indirect and direct decompressions of the lumbar spine. These procedures fill the gap in the stenosis treatment continuum between conservative care and traditional spine surgery. To date, Vertiflex has compiled the largest, most rigorous body of device clinical evidence related to lumbar spinal stenosis. For more information, visit www.vertiflexspine.com.

Contacts

Vertiflex, Inc.
Kathryn Larson, 442-325 5900
info@vertiflexspine.com

Stryker awarded $248.7 million in patent case against Zimmer

Posted On July 13, 2017 By OrthoSpineNews In Financial, Regulatory, Top Stories /

Nate Raymond / July 13, 2017

(Reuters) – A U.S. judge has increased the amount medical device maker Zimmer Biomet Holdings Inc must pay Stryker Corp for infringing patents on a surgical cleaning wand to $248.7 million following a ruling by the U.S. Supreme Court.

The ruling by U.S. District Judge Robert Jonker in Grand Rapids, Michigan, on Wednesday came after the Supreme Court in June 2016 ruled for Stryker in finding that judges should have more discretion to boost penalties in patent infringement cases.

Stryker declined to comment on Thursday. Zimmer did not immediately respond to a request for comment.

The ruling came in a lawsuit filed in 2010 by Kalamazoo, Michigan-based Stryker that claimed its competitor’s Pulsavac Plus device for cleaning wounds during orthopedic surgical procedures infringed three of its patents.

In 2013, a federal jury awarded Stryker $70 million in lost profits and found Warsaw, Indiana-based Zimmer’s conduct to have been willful.

Jonker later that year ruled Stryker deserved triple damages based on the “flagrancy and scope of Zimmer’s infringement.” With other fees, the award came to $228 million.

READ THE REST HERE

Paxeon Reconstruction Announces Successful 12-Month Clinical Follow Up and A Unique Value Solutions Program That Has Produced Over $1.3m in Savings

Posted On July 13, 2017 By OrthoSpineNews In Recon, Top Stories /

Paxeon Reconstruction, a manufacturer of best-in-class orthopedic products including derivative and emerging products, announces successful 12-month clinical data utilizing its Total Hip Arthroplasty (THA) system. Paxeon has partnered with some of the top Orthopedic Surgeons in the country and the results of the follow-up has shown Paxeon products to be easy to use and effective.

In today’s orthopedic environment, companies must not only provide quality products but also financially beneficial products. With that in mind, Paxeon Reconstruction has created a unique Value Solutions Program that has provided hospitals over $1.3m in savings through its first 12-months of clinical use. Physicians utilizing Paxeon’s THA system save on average $1,315.00 per case.

Dr. Kevin Pugh (Pikeville, KY) says “I have been using Paxeon Reconstruction’s Origin hip system for the past 14 months. During that time, I have successfully completed nearly 200 Total Hip Arthroplasties with the Origin stem and Logical acetabular cup with no implant failures or repeat operations. These implants have provided excellent outcomes for my patients. The instrumentation is very user friendly and easy for my staff to learn. My hospital is pleased with the excellent service provided by Paxeon, as well as the tremendous savings that Paxeon has provided on the implants. As a company Paxeon has been very good to work with, as they have been very receptive to my individual needs as a surgeon. I am extremely happy with their products and am excited to watch them grow as a world leader in total joint reconstruction innovation.”

Dr. Chris Christensen (Lexington, KY) added “I am continually impressed with the ease of insertion of the origin stem. Broaching is much less physically demanding than other bone removal broaching systems. Patient comfort postop is excellent. At one year and 300 stems, the hip has performed essentially perfectly.”

Due largely to the success of their product portfolio, Paxeon Reconstruction is advancing through high quality implants and a unique value proposition that offers unparalleled advantages for both the surgeons and their hospitals. Kyle Sineath, President of Paxeon Reconstruction says “It’s proof that improved clinical outcomes are available at a savings to physicians and facilities. By providing showing clinical outcomes and significant savings, Paxeon is positioned as the true leader in the valued solutions market.”

About Paxeon Reconstruction

Paxeon Reconstruction builds best-in-class orthopaedic products, including derivative and emerging products. We collaborate with hospitals, health systems and physicians to create alignment and utilization of value-based solutions combined with efficiency models for today’s changing healthcare environment. Paxeon Reconstruction offer the world’s most comprehensive portfolio of orthopaedic products and services for joint reconstruction. Paxeon Reconstruction has a celebrated clinical history, and has evolved to meet the needs of the changing orthopaedics marketplace. The history that weaves the fabric of the Paxeon Reconstruction is one that is rich with innovation and demonstrates sustained leadership in an ever-changing landscape of patient and professional needs.

Pinnacle Spine Group Issued Newest Patent for In Situ Graft Delivery to a Fusion Device

Posted On July 13, 2017 By OrthoSpineNews In Spine /

DALLAS, July 12, 2017 /PRNewswire/ — Pinnacle Spine Group, LLC, the pioneer of in-situ graft delivery technology, today announced that the company has been granted a U.S. patent that meaningfully reinforces its exclusivity position with respect to its in situ graft delivery technology. Patent No. 9,649,203, titled Methods of Post-Filling an Intervertebral Implant, like previously issued patents of the company, relates to the delivery of graft material to fill the internal chamber(s) of a spinal fusion device, while allowing for graft material to be in flush contact with the endplate surfaces of the adjacent vertebral bodies.

Pinnacle Spine Group pioneered and commercialized the novel concept of delivering bone graft material in situ into an implanted device in order to fill the biologic void that remains with other spinal fusion systems. This latest patent follows the receipt of three earlier U.S. patents covering Pinnacle Spine’s innovative InFill® fusion technology. The company also owns several non-U.S. applications, including applications in Australia, Canada and Europe.

“Years ago, we identified a problem with traditional interbody fusion systems – that a biologic void remained between an implant and its two adjacent vertebrae,” says Zach Sowell, President of Pinnacle Spine Group. “We developed a highly effective solution and are thrilled to now have even stronger patent protection related to in situ graft delivery directly to an implant, a technique whose value is being recognized and appreciated by the spinal fusion industry. This recognition is a testament to the technology’s usefulness and benefits, and we look forward to working with companies that are interested in adopting and using implant designs that require delivery of bone graft material in situ.”

Pinnacle Spine’s InFill® Fusion Systems include an array of innovative interbody fusion devices engineered for easier insertion, reduced subsidence through maximum contact with the apophyseal ring, a generous bone grafting area, and compatibility with the InFill® graft delivery system. The backbone of the technology is predicated on controlled and precise in-situ placement of bone graft material directly into the implanted device, to achieve maximum contact with the adjacent vertebral endplates.

For more information on Pinnacle Spine Group’s unparalleled innovation, or to become a part of the Pinnacle team, please visit www.PinnacleSpineGroup.com, or contact us at info@pinnaclespinegroup.com.

About Pinnacle Spine Group, LLC

Based in Dallas, Texas, Pinnacle Spine Group, LLC is a privately held medical device company that develops and markets innovative technologies to improve spinal fusion procedures. The Company’s family of FDA-approved InFill® Fusion systems provides for superior endplate-to-endplate contact of bone graft material and a complete fill of the disc space, achieved by post-filling the implants after they have been delivered into a targeted intervertebral disc space.

SOURCE Pinnacle Spine Group, LLC

Wright Medical Group N.V. Highlights New Innovations at the American Orthopaedic Foot and Ankle Society (AOFAS) 2017 Annual Meeting

Posted On July 12, 2017 By OrthoSpineNews In Extremities /

AMSTERDAM, The Netherlands , July 12, 2017 (GLOBE NEWSWIRE) — Wright Medical Group N.V. (NASDAQ:WMGI) today announced that it will highlight new innovations at the American Orthopaedic Foot and Ankle Society (AOFAS) 2017 Annual Meeting taking place at the Washington State Convention Center in Seattle, Washington from July 12-15, 2017.

Wright will feature its full range of lower extremities and biologics products at exhibit booth #801 and will showcase, for the first time, three important additions to its foot and ankle portfolio:

INVISION™ Total Ankle Revision System – The first and only system developed specifically for total ankle revision arthroplasty, the INVISION Total Ankle Revision System provides a unique solution for even the most difficult revision procedures. Whether leveraged as a standalone construct or in conjunction with INFINITY and INBONE^TMcomponents, the INVISION Total Ankle Revision System is an important addition to the continuum of care from total ankle replacement through any necessary revisions. The INVISION Total Ankle Revision System helps surgeons re-build bone lost through previous surgeries and provides modularity to help restore natural joint height.

ORTHOLOC™ 3Di Ankle Fracture Low Profile System – The ORTHOLOC 3Di Ankle Fracture Low Profile System features a complete range of ankle fracture plates designed specifically for the foot and ankle surgeon. The system features low-profile, anatomic plate designs and ORTHOLOC 3Di polyaxial locking screw technology, providing an innovative fracture solution that addresses a primary need for one of the foot and ankle’s largest market segments.

MICA™ Minimally-Invasive Foot & Ankle System – As the first minimally invasive solution specifically designed for foot and ankle surgery, the MICA Minimally-Invasive Foot & Ankle System provides a minimally disruptive, procedurally integrated solution that features specifically designed implants and instrumentation for percutaneous surgery of the foot. The MICA Minimally-Invasive Foot & Ankle System can be used to treat multiple pathologies including one of the most common, Hallux Valgus, commonly known as bunions. Compared to a traditional open surgery, the MICA Minimally-Invasive Foot & Ankle System has been shown to provide less pain, shorter operative times and improved cosmesis.

Robert Palmisano, president and chief executive officer, commented, “We have continued to expand our best-in-class foot and ankle product portfolio to meet the needs of orthopaedic physicians and patients and further extend our leadership position in the fast growing lower extremities and biologics markets. The launch of our unique INVISION Total Ankle Revision System will expand our leadership in total ankle technology and highlights our ability to address the total ankle replacement continuum of care. In addition, the ORTHOLOC 3Di Ankle Fracture Low Profile System and MICA Minimally-Invasive Foot & Ankle System further enhances our offering in the foot and ankle market space and allows for an improved surgical experience.”

Wright is also conducting medical education and training courses during the AOFAS annual meeting in its mobile training lab. These courses will address total ankle arthroplasty, Charcot reconstruction and limb salvage, and ankle and hindfoot fusion using Augment^®. More information on Wright Medical’s products can be found at www.wright.com.

Internet Posting of Information

Wright routinely posts information that may be important to investors in the “Investor Relations” section of its website at www.wright.com. The company encourages investors and potential investors to consult the Wright website regularly for important information about Wright.

About Wright Medical Group N.V.

Wright Medical Group N.V. is a global medical device company focused on extremities and biologics products. The company is committed to delivering innovative, value-added solutions improving the quality of life for patients worldwide. Wright is a recognized leader of surgical solutions for the upper extremities (shoulder, elbow, wrist and hand), lower extremities (foot and ankle) and biologics markets, three of the fastest growing segments in orthopaedics. For more information about Wright, visit www.wright.com.

™ and ® denote trademarks and registered trademarks of Wright Medical Group N.V. or its affiliates, registered as indicated in the United States, and in other countries. All other trademarks and trade names referred to in this release are the property of their respective owners.

Cautionary Note Regarding Forward-Looking Statements

This release includes forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “intend,” “could,” “may,” “will,” “believe,” “estimate,” “look forward,” “forecast,” “goal,” “target,” “project,” “continue,” “outlook,” “guidance,” “future,” other words of similar meaning and the use of future dates. Forward-looking statements in this release include, but are not limited to, statements about the performance and market acceptance of the company’s products. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward-looking statement contained in this release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, physician acceptance, endorsement, and use of company products; the effect of regulatory actions, changes in and adoption of reimbursement rates; product liability claims; product recalls; the effects of industry, economic or political conditions outside of the company’s control; competitor activities; and the risks identified under the heading “Risk Factors” in Wright’s Annual Report on Form 10-K for the year ended December 25, 2016 filed by Wright with the SEC on February 23, 2017 and in other subsequent SEC filings by Wright. Investors should not place considerable reliance on the forward-looking statements contained in this release. Investors are encouraged to read Wright’s filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this release speak only as of the date of this release, and Wright undertakes no obligation to update or revise any of these statements. Wright’s business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

Investors & Media: Julie D. Tracy Sr. Vice President, Chief Communications Officer Wright Medical Group N.V. (901) 290-5817 julie.tracy@wright.com

ConforMIS Names Dan Krupp Senior Vice President U.S. Sales

Posted On July 12, 2017 By OrthoSpineNews In Recon /

BILLERICA, Mass., July 11, 2017 (GLOBE NEWSWIRE) — ConforMIS, Inc. (NASDAQ:CFMS), a medical technology company that offers joint replacement implants customized to fit each patient’s unique anatomy, today announced that Dan Krupp has joined the Company as its Senior Vice President of U.S. Sales, effective July 3, 2017.

“The addition of Dan to our leadership team is another example of our commitment to developing additional expertise and support that will help us execute our commercial strategy,” said Mark Augusti, Chief Executive Officer and President of ConforMIS. “We are very excited to have Dan join us. His extensive experience in leading top-ranked sales organizations in startup, turnaround, volatile, and growth markets will be a tremendous asset for ConforMIS.”

Mr. Krupp has more than 20 years of sales and marketing experience in medical devices and total joint arthroplasty. From 2002-2014, he held positions of increasing responsibility at DePuy Synthes, developing and executing sales strategies and managing multiple new product launches. Most recently, he was Vice President, Sales and Marketing, at JACE Medical, where he successfully managed the development and execution of a range of corporate and product branding initiatives.

“I am very pleased to be joining the outstanding team at ConforMIS and to play a role in reshaping the future of arthroplasty with the company’s disruptive technology platform,” said Mr. Krupp. “I look forward to leading the U.S. sales force during what we believe will be a transformative period in orthopedics.”

About ConforMIS, Inc.

ConforMIS is a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are individually sized and shaped, or customized, to fit each patient’s unique anatomy. ConforMIS offers a broad line of customized knee implants and pre-sterilized, single-use instruments delivered in a single package to the hospital. In clinical studies, ConforMIS iTotal CR demonstrated superior clinical outcomes, including better function and greater patient satisfaction, compared to traditional, off-the-shelf implants. ConforMIS owns or exclusively in-licenses approximately 450 issued patents and pending patent applications that cover customized implants and patient-specific instrumentation for all major joints.

For more information, visit www.conformis.com. To receive future releases in e-mail alerts, sign up at http://ir.conformis.com/.

Cautionary Statement Regarding Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for ConforMIS, including statements about ConforMIS’s commercial strategy, future results, and orthopedic and arthroplasty markets, as well as other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar expressions, constitute forward-looking statements within the meaning of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of a variety of risks and uncertainties, including risks related to our clinical studies and the other risks and uncertainties described in the “Risk Factors” sections of our public filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent ConforMIS’s views as of the date hereof. ConforMIS anticipates that subsequent events and developments may cause ConforMIS’s views to change. However, while ConforMIS may elect to update these forward-looking statements at some point in the future, ConforMIS specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing ConforMIS’s views as of any date subsequent to the date hereof.

A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/75f70387-ab76-48cd-bf98-27c3569e87df.

The photo is also available via AP PhotoExpress.

Investor Contact:
Oksana Bradley
ir@conformis.com
(781) 374-5598

Media Contact:
Bill Berry
Berry & Company Public Relations
Bberry@berrypr.com
(212) 253-8881

Active Implants Appoints Charles W. Federico and Gary D. Henley to Board

Posted On July 12, 2017 By OrthoSpineNews In Extremities, Sports Medicine /

July 12, 2017

MEMPHIS, Tenn.–(BUSINESS WIRE)–Active Implants, a company that develops orthopedic implant solutions, today announced the appointments of orthopedic and sports medicine industry veterans Charles W. Federico and Gary D. Henley to its board of managers.

“Both Charlie and Gary are respected leaders with long-term success in medical and orthopedic device industries, and they bring a wealth of strategic and operational experience to our board,” said Ted Davis, president and chief executive officer of Active Implants. “We believe their diverse leadership experience will strengthen our board, and their insights will be invaluable as we continue to develop the NUsurface Meniscus Implant and fulfill a significant unmet need in the orthopedic market here in the U.S. and worldwide.”

Federico has 44 years of experience in the medical device industry, with significant focus in the sports medicine segment while president and chief executive officer of Orthofix International N.V. and president of Smith & Nephew Endoscopy. Additionally, he has held senior management and sales and marketing positions with Dyonics, General Foods Air Products Corporation, Puritan Bennett Corporation and LSE Corporation. Federico has extensive board experience, including chairman of the board and lead director of MAKO Surgical Corp, sold to Stryker; and a board member at Biomimetic Therapeutics, sold to Wright Medical Group.

Henley has more than 35 years of experience in the orthopedic device industry, including president, chief executive officer and board member of United Orthopedic Group, which was sold to Breg. Previously, he was president and chief executive officer of Wright Medical Group, Inc.; president of Orthofix International N.V.’s Americas Division; president of Smith & Nephew’s Endoscopy Video Division; and president and chief executive officer of Cecorp, Inc. Henley is an experienced board member and industry consultant, most recently serving as executive chairman of the board of directors at OrthAlign, Inc. and a director at Orchid Orthopedic Solutions.

With the appointment of Federico and Henley, Active Implants’ board consists of eight members: Henry Klyce, chairman of the board; Ted Davis, Active Implants CEO; James D. Lackie; William T. Mays, Jr.; Haynes Morris; and Spence Wilson, Jr.

About the NUsurface® Meniscus Implant

The NUsurface® Meniscus Implant is an investigational treatment for patients with persistent knee pain following medial meniscus surgery. It is made from medical grade polymer and, as a result of its unique materials, composite structure and design, does not require fixation to bone or soft tissues. The NUsurface Meniscus Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. The NUsurface Meniscus Implant has been used in Europe under CE Mark since 2008 and in Israel since 2011. Clinical trials are underway in the U.S., Europe and Israel to verify the safety and effectiveness of the NUsurface Meniscus Implant.

About Active Implants LLC

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 Haarlem, The Netherlands, with R&D facilities in Netanya, Israel. For more information, visit www.activeimplants.com.

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

Contacts

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

ECA Medical Instruments Sees Major Gains & Market Adoption Of New Sterile-Packed, Disposable Instrument Kits for Orthopaedics

Posted On July 12, 2017 By OrthoSpineNews In Extremities, Top Stories /

July 12, 2017

Thousand Oaks, CA.—ECA Medical Instruments, the leading designer and manufacturer of single-procedure torque-limiting and fixed-driver surgical instruments and procedural kits for the medical industry and surgeons worldwide, has designed and produced sterile-packed, surgery ready disposable instrument kits for a wide range of trauma and extremity implants used by surgeons for fracture and joint degeneration repair.

Tailored to implant manufacturer specifications these kits are being rapidly adopted across the marketplace to reduce cost, eliminate reprocessing, improve patient safety and provide perfect fixation of implants while reducing risk of surgical site infection.

The fully disposable kits include the full complement of instruments needed by surgeons and OR teams including cannulated fixed drivers, torque limiters, cannulated countersinks and depth gauge instrument, drill guides, guide wires and drill bits. The cannulated instrument design permits minimally invasive surgery (MIS), which reduces OR time, blood loss and patient recovery times. All the instruments are packaged in sterile pack and fully disposable trays.

“We recently launched the industry’s first sterile-packed instrument set for securing cannulated titanium screws and also have deployed sterile pack kits and instruments for hand and wrist repair as well as joint arthroplasty and spine implant product lines,” said James Schultz, ECA’s executive vice president, sales & marketing.

ECA Medical Instruments Disposable Instrument Kits

“Single-use instrument kits coupled with sterile packed implants are clearly the way of the future for high volume and relatively low complexity orthopaedic surgeries in both the hospital and outpatient setting,” he said. “We’re excited to partner with major OEMs in the ortho and spine industry and bring these new instrument kits to market.

Single-procedure instruments and procedural kits are providing surgeons and patients alike with a pristine set of ready for surgery instruments for securing a wide range of medical device implants. Sustained benefits include elimination of reprocessing costs, improved OR efficiency, reduced risk of surgical site infection and reduction in hospital and ASC inventory management.

ECA is a one stop shop OEM instrument company providing implant firms with complete product design and development, product and packaging validations, CE Mark and dock to stock operations. This reduces OEM costs and accelerates time to market.

About ECA Medical Instruments

ECA Medical Instruments®, a LongueVue Capital Partners company, was founded in 1979 and located in Thousand Oaks, CA. ECA is the industry leader in single-procedure torque-limiting instruments and surgical fixation kits. The company has manufactured and delivered over 32 million precision torque instruments to the world’s leading producers of CRM, neuromodulation, cardiovascular and orthopaedic and spine implants resulting in over 500 million precision surgical actuations. Every 20 seconds of every day an ECA torque instrument or procedural kit is used to secure a medical implant—one patient at a time. ECA is an ISO 13485, CE Mark certified and FDA registered company and was named Business of the Year 2012 by the Pacific Coast Business Times. www.ecamedical.com

FIDIA PHARMA USA Inc. Continues to Expand U.S. Presence as Fidia Farmaceutici S.p.A. Leads European Orthopedic Biomaterials Market

Posted On July 12, 2017 By OrthoSpineNews In Biologics, Top Stories /

July 11, 2017

PARSIPPANY, N.J.–(BUSINESS WIRE)–Fidia Farmaceutici S.p.A., a world leader in the research, development and manufacturing of hyaluronan (HA)-based products, and its wholly owned subsidiary, FIDIA PHARMA USA Inc., are projecting continued growth in 2017. The global viscosupplementation market is anticipated to increase to over $2.64 billion by 2021, according to a research study by RnR Market Research¹.

Fidia Farmaceutici S.p.A. now leads the orthopedic biomaterials market in Europe after increasing its market share over the past few years. The largest segment of the biomaterials market internationally is HA viscosupplementation, to inject lubricating fluid into a joint. The company’s strong presence in the HA viscosupplementation market, with its product HYALGAN^®, and Fidia’s entrance into the German market have contributed to the expansion.

“Fidia is building upon its structure and experience to expand its business and strengthen its presence in the U.S. and globally,” said Aldo Donati, president, FIDIA PHARMA USA. “Fidia Farmaceutici has invested in research and development of hyaluronic acid-based products for more than 70 years. Today, Fidia is growing its product portfolio with new, innovative solutions to meet challenges in the field of osteoarthritis using science, our legacy and our drive.”

In the United States, FIDIA PHARMA USA Inc. offers HYMOVIS^® and HYALGAN^®, which are viscoelastic hyaluronan injection treatments for osteoarthritis (OA) knee pain that may help to delay total knee replacements².

More than 20 million Americans suffer from knee OA. By 2030, 20 percent of Americans over the age of 65 will be at risk for developing OA, according to the U.S. National Library of Medicine. The rise in OA of the knee diagnoses is reported to be attributed to an increase in life expectancy, obesity and sedentary behavior³.

The United States continues to hold the largest market share in the global viscosupplementation market. Growth is anticipated to be based off of the latest health care infrastructure, well-established reimbursement, aggressive marketing efforts on supply, and trends toward early intervention and demand for nonsurgical OA treatment.

HYMOVIS^® is a breakthrough in HA-based intra-articular (IA) therapy for the treatment of OA knee pain. Specifically engineered to fulfill a need of having a true viscoelastic hydrogel that is non-crosslinked and naturally derived from non-avian sources, HYMOVIS^®maintains enhanced properties of improved lubrication to decrease friction, exhibits greater elasticity in recovering its original structure even after repeated mechanical stresses, and demonstrates increased residence time in the knee joint*. HYMOVIS^® is delivered as an IA injection in a convenient two-dose regimen, with each injection given one week apart.

HYALGAN^® is a solution that contains a natural substance called hyaluronate, which is normally found in the fluid that lubricates and cushions the knee joint. HYALGAN^® is injected into the knee to relieve pain due to osteoarthritis. It is a five-injection regimen given at weekly intervals that provides long-lasting pain relief for up to six months. Some patients get benefits with three injections given at weekly intervals as reported in the published literature in which patients were followed for 60 days.

About FIDIA PHARMA USA Inc.

FIDIA PHARMA USA Inc. is a wholly owned subsidiary of Italian pharmaceutical manufacturer Fidia Farmaceutici S.p.A., an established leader in the hyaluronic acid market segment. FIDIA PHARMA USA Inc. is focused on expanding Fidia’s position in the U.S. and Canadian market, while upholding the company’s mission to provide consumers with innovative products that offer quality, safety and performance. FIDIA PHARMA USA Inc. is headquartered in Parsippany, N.J. For more information, please visit www.fidiapharma.us.

About Fidia Farmaceutici S.p.A.

Fidia Farmaceutici Fidia Farmaceutici is an Italian company founded in 1946 with proven expertise in Neuroscience, acquired over the years thanks to an activity of Research and Development unique in the Italian pharmaceutical scenario. It is also a top leading company in marketing products based on hyaluronic acid, which have many applications in the biomedical field, in areas such as rheumatology, orthopaedics, wound care, tissue repair and dermo-aesthetics, with worldwide leadership in viscosupplementation. Fidia Farmaceutici is part of the Milanese P&R Holding group. The company is well established in Italy, with R&D activities carried out both in Abano (where the company’s headquarter is located) and at the Research Unit in Noto (Sicily, Italy). The turnover will amount over 300 million Euros in 2017, of which 70% generated in international markets. Fidia Farmaceutici’s products are marketed in over 100 countries, through wholly-owned subsidiaries – in USA, Kazakhstan, Germany, Spain, Russia and the Middle East – and a comprehensive network of international partners and distributors. Thanks to its investment in R&D, it has managed to create a time-honored legacy of products, with over 900 patents to its name.

Indications: HYALGAN® and HYMOVIS® are indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and to simple analgesics (e.g. acetaminophen).

Important Safety Information: HYALGAN® and HYMOVIS® are contraindicated in patients with known hypersensitivity to hyaluronate preparations or gram positive bacterial proteins (HYMOVIS® only) or patients with infections/skin diseases in the area of the injection site/joint. The safety and effectiveness of HYMOVIS® has not been tested in pregnant women, nursing mothers or children. See package insert for full prescribing information including adverse events, warnings, precautions, and side effects at www.Hyalgan.comand www.Hymovis.com. Rx Only

HYMOVIS^® and HYALGAN^® are registered trademarks of Fidia Farmaceutici S.p.A., Abano Terme, Italy. ©2017 FIDIA PHARMA USA Inc., Parsippany, NJ, a wholly owned subsidiary of Fidia Farmaceutici S.p.A. FID523-06.2017

*Data on file – Preclinical studies may not be indicative of human clinical outcomes.

Rx Only

¹ http://www.rnrmarketresearch.com/medipoint-viscosupplementation-global-analysis-and-market-forecasts-market-report.html

² Turajane T, Tanavaree A, Labpiboonpong V, Maungsiri, S. Outcomes of intra-articular injection of sodium hyaluronate for the treatment of osteoarthritis of the knee. J Med Assoc Thai. 2007;90(9):1845-1852.

³ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3612336/

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FIDIA PHARMA USA Inc.
Carolyn Kong, 1-973-507-5120
ckong@fidiapharma.us

Carmell Therapeutics closes $4M Series B round of funding

Posted On July 12, 2017 By OrthoSpineNews In Financial /

PITTSBURGH, July 11, 2017 /PRNewswire/ — Carmell Therapeutics, a biotechnology company focused on developing and commercializing regenerative medicine technologies, announced today that on June 30, 2017 it closed a $4M Series B financing that will be used to advance its first product candidate, Bone Healing Accelerant, to phase III clinical development. Carmell received strong support from current investors, Pittsburgh Life Sciences Greenhouse, Harbor Light Capital, Newlin Investments and BlueTree Capital Group and welcomed new investor Keiretsu Forum Capital. This will be the first of many products and indications based on its core technology Plasma-based Bioactive Material (PBM). The PBM technology was developed at Carnegie Mellon University and utilizes pooled plasma to create products which accelerate the healing of both bone and soft tissues. The technology offers the unique benefit of controlling the timing of the release of a broad range of growth and healing factors to the injury site.

Carmell is a biotechnology company focused on developing and commercializing regenerative medicine technologies. Founded as a spin out from Carnegie Mellon University in Pittsburgh, PA, Carmell Therapeutics has created a unique & highly innovative patented technology based on biologically-active materials manufactured from human blood plasma. These Plasma-based Bioactive Materials (PBMs) contain a concentration of natural regenerative factors that promote healing in various clinical settings, reduce infections, reduce complications, and, as a result, save healthcare costs. Unlike previous approaches to delivering growth factors to injuries/surgeries, Carmell has patented the capability to achieve three important technological breakthroughs: form, presence and bioactivity.

The regenerative materials can be manufactured to fit multiple forms, such as putties, pastes, scaffolds, plugs, screws and sheets.
Presence is created by cross linking the proteins as part of the manufacturing process to breakdown in the body over different periods of time (days, weeks or months).
As the regenerative biomaterial (PBM) biodegrades at the local site, active biologics are released where and when the body needs them to accelerate healing.

Some of the statements in this release are “forward looking statements,” which involve known and unknown risks and uncertainties. These statements are only predictions. Carmell makes no representation, warranty or claim regarding its products or any information in this release. Actual results may vary significantly from our predictions and depend on known and unknown factors, including, without limitation, the outcome of our plans to conduct additional human clinical studies to prove the safety and efficacy of our products.

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

SOURCE Carmell Therapeutics Corporation

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