HSS Receives Landmark $10 Million Grant from Stavros Niarchos Foundation for Complex Joint Reconstruction Center

Posted On October 16, 2018 By OrthoSpineNews In Recon, Top Stories /

NEW YORK, Oct. 16, 2018 /PRNewswire/ — An unprecedented $10 million grant from the Stavros Niarchos Foundation (SNF) has been given to Hospital for Special Surgery (HSS) to name the Complex Joint Reconstruction Center (CJRC). This new commitment will support the endowment of the CJRC for the operation and expansion of its clinical, research and educational programs.

According to the American Joint Replacement Registry, there are over 7 million Americans living with replaced hip and knee joints and, should they fail, treatment is complex and requires specialized management.

“This generous gift will improve the lives of countless patients who suffer from debilitating complications or need revision surgery due to failed implants,” said Thomas P. Sculco, MD, surgeon-in-chief emeritus and director of the CJRC at HSS. “We are deeply honored by the visionary leadership of the SNF in supporting our endeavor to lessen implant failure, restore function, and relieve pain for patients who need specialized joint reconstructions.”

As the first of its kind, the Stavros Niarchos Foundation Complex Joint Reconstruction Center provides the best in diagnosis and treatment for patients with the most challenging conditions in joint reconstructions, regardless of their financial circumstances, and conducts cutting-edge basic and clinical research on the causes and prevention of implant failure.

“Having partnered with HSS for over a decade, the SNF has witnessed first-hand the deep commitment of the people of HSS to excellence and progress in orthopedic care,” said Andreas Dracopoulos, Co-President of the SNF. “We are especially proud to support Dr. Sculco’s vision to improve the lives of patients with the most complex cases of joint reconstruction, and to seek solutions to issues that impact the field at large.”

“HSS is uniquely positioned to develop new techniques and improvements in implant design that will significantly impact global care for these complex problems.” said Dr. Sculco. “People are living longer and leading more active lives thus making the need for progress in our knowledge and treatment of these failed implants more critical than ever.”

Dr. Sculco is internationally recognized as a leader in hip and knee replacement surgery, having pioneered minimally invasive surgical techniques. Now, he is leading efforts to improve the success and longevity of implants to benefit millions of patients worldwide.

Over the past year, the CJRC has expanded its surgical team to 16 experienced orthopedic surgeons and successfully launched a patient registry with over 800 surgical cases already recorded. This registry is the first in the world solely dedicated to capturing vital clinical and outcomes data from patients undergoing joint reconstruction and complex primary joint replacement surgery. This data creates a platform for clinical trials, translational research and innovations in treatment that will lead to improved standards of care. In 2017, the CJRC performed 534 surgeries on patients with complex joint reconstructions.

The Stavros Niarchos Foundation is one of the world’s leading private international philanthropic organizations, making grants in the areas of health and sports, arts and culture, education, and social welfare. The SNF supports projects that aim to achieve a broad, lasting and positive impact on society.

Spanning over a decade, HSS and SNF’s longstanding relationship has spurred programs such as the Stavros Niarchos Foundation-Thomas P. Sculco, MD International Orthopaedic Fellowship Program, HSS Stavros Niarchos Foundation Orthopaedic Seminar and Academic Visitor Program to educate Greek orthopedic surgeons on ways to improve treatment and outcomes in joint replacement.

Since 2006, HSS has hosted Greek surgeons for the annual HSS Stavros Niarchos Foundation Orthopaedic Seminar Program, which teaches the latest techniques and innovations in complex and primary total hip and knee replacement with the ultimate goal of improving healthcare in Greece.

This year, the seminar will take place on November 27-28, 2018 with two days of didactic sessions, case consultations, roundtable discussions, hands-on workshops and operating room observation at operations at HSS. The following three days will include attendance at the 30^th Annual HSS Holiday Knee & Hip Course, a CME-accredited professional education course.

The program immerses visiting Greek surgeons, typically those early in their careers, in the high-volume joint replacement environment at HSS.

SNF also previously granted HSS $1 million to fund the Thomas P. Sculco, Chair in Orthopedic Surgery, which played an instrumental role in the creation of the CJRC.

About HSS | Hospital for Special Surgery
HSS is the world’s leading academic medical center focused on musculoskeletal health. At its core is Hospital for Special Surgery, nationally ranked No. 1 in orthopedics (for the ninth consecutive year) and No. 3 in rheumatology by U.S.News & World Report (2018-2019). Founded in 1863, the Hospital has one of the lowest infection rates in the country and was the first in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center four consecutive times. The global standard total knee replacement was developed at HSS in 1969. An affiliate of Weill Cornell Medical College, HSS has a main campus in New York City and facilities in New Jersey, Connecticut and in the Long Island and Westchester County regions of New York State. In 2017 HSS provided care to 135,000 patients and performed more than 32,000 surgical procedures. People from all 50 U.S. states and 80 countries travelled to receive care at HSS. In addition to patient care, HSS leads the field in research, innovation and education. The HSS Research Institute comprises 20 laboratories and 300 staff members focused on leading the advancement of musculoskeletal health through prevention of degeneration, tissue repair and tissue regeneration. The HSS Global Innovation Institute was formed in 2016 to realize the potential of new drugs, therapeutics and devices. The culture of innovation is accelerating at HSS as 130 new idea submissions were made to the Global Innovation Institute in 2017 (almost 3x the submissions in 2015). The HSS Education Institute is the world’s leading provider of education on the topic on musculoskeletal health, with its online learning platform offering more than 600 courses to more than 21,000 medical professional members worldwide. Through HSS Global Ventures, the institution is collaborating with medical centers and other organizations to advance the quality and value of musculoskeletal care and to make world-class HSS care more widely accessible nationally and internationally.

About the Stavros Niarchos Foundation
The Stavros Niarchos Foundation [(SNF) (www.SNF.org)] is one of the world’s leading private, international philanthropic organizations, making grants in the areas of arts and culture, education, health and sports, and social welfare. Since 1996, the Foundation has committed more than $2.6 billion, through more than 4,000 grants to nonprofit organizations in 124 nations around the world.

The SNF funds organizations and projects, worldwide, that aim to achieve a broad, lasting and positive impact, for society at large, and exhibit strong leadership and sound management. The Foundation also supports projects that facilitate the formation of public-private partnerships as an effective means for serving public welfare.

SOURCE Hospital for Special Surgery

TransEnterix to Showcase First Digital Laparoscopic Surgical Platform, the Senhance Surgical System, at American College of Surgeons Clinical Congress 2018

Posted On October 16, 2018 By OrthoSpineNews In Robotics /

October 16, 2018

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–TransEnterix, Inc. (NYSE American: TRXC), a medical device company that is digitizing the interface between surgeons and patients to improve minimally invasive surgery, today announced demonstrations of its Senhance™ Surgical System at the American College of Surgeons (ACS) Clinical Congress 2018 at the Boston Convention & Visitors Center in Boston, MA, October 21 – 25.

Surgeons, Hospital Administrators and related staff are invited to experience Senhance Surgery during the Company’s daily demonstrations located at the TransEnterix booth #577, from Monday, October 22 – Wednesday, October 24 from 10:30 a.m. – 11:30 a.m. ET. Participants will witness how digital laparoscopy is redefining minimally invasive surgery through meaningful technology, designed to compete in today’s value-based healthcare landscape. To schedule a demonstration in advance, visit transenterix.com/events.

“Digital laparoscopy with the Senhance System provides a digitized interface between the surgeon and patient, giving surgeons improved control, comfort, clinical intelligence and confidence when performing a wide variety of procedures with the goal of delivering superior value to more patients,” said TransEnterix Chief Commercial Officer, Eric Smith. “We look forward to attending ACS and demonstrating how digital laparoscopy with the Senhance is ushering in a new era of minimally invasive surgery.”

The Senhance Surgical System received U.S. FDA clearance in October 2017 and represents the first robotic surgery platform to enter the U.S. market since 2000. It is the only digital laparoscopic platform available that offers reusable instruments to help keep costs down, as well as haptic feedback, which allows surgeons to experience and sense pressure/tension with alerts if pressure threshold is reached – an added layer of security. The System combines much-needed technological advances with economic advantages and represents a fundamental change in the approach to minimally invasive surgery.

About TransEnterix

TransEnterix is a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery by addressing the clinical and economic challenges associated with current laparoscopic and robotic options in today’s value-based healthcare environment. The Company is focused on the commercialization of the Senhance Surgical System, which digitizes laparoscopic minimally invasive surgery. The system allows for robotic precision, haptic feedback, surgeon camera control via eye sensing and improved ergonomics while offering responsible economics. The Senhance Surgical System is available for sale in the US, the EU and select other countries. For more information, visit www.transenterix.com.

Forward Looking Statements

This press release includes statements relating to the Senhance Surgical System and our current regulatory and commercialization plans for this product. These statements and other statements regarding our future plans and goals constitute “forward looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control and which may cause results to differ materially from expectations and include whether the Senhance System will usher in a new era of minimally invasive surgery. For a discussion of the risks and uncertainties associated with TransEnterix’s business, please review our filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K filed on March 8, 2018, and our other filings we make with the SEC. You are cautioned not to place undue reliance on these forward looking statements, which are based on our expectations as of the date of this press release and speak only as of the origination date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Contacts

TransEnterix, Inc.
Investor Contact:
Mark Klausner, 443-213-0501
transenterix@westwicke.com
or
Media Contact:
Joanna Rice, 951-751-1858
joanna@greymattermarketing.com

Amplitude Surgical: Mrs. Muriel Benedetto is Appointed to the Newly-Created Position of COO

Posted On October 15, 2018 By OrthoSpineNews In Extremities /

October 15, 2018

VALENCE, France–(BUSINESS WIRE)–Regulatory News:

Amplitude Surgical (ISIN: FR0012789667, Ticker: AMPLI, PEA-PME eligible) (Paris:AMPLI), a leading French player on the global surgical technology market for lower-limb orthopedics, announces the appointment of Mrs. Muriel Benedetto Marmilloud to the newly-created position of Chief Operating Officer (COO). She will report directly to Olivier Jallabert, Chairman and CEO of Amplitude Surgical.

Olivier Jallabert, Chairman and CEO of Amplitude Surgical, says: “All of Amplitude Surgical’s staff members and I are delighted to welcome Muriel Benedetto Marmilloud to the newly-created position of Chief Operating Officer. Muriel is a senior executive who is recognized for her focus on innovation and her knowledge of global markets – in particular the US market. Her experience and strategic vision will be very valuable to our Group’s future growth, its global deployment and the expansion of its portfolio of innovative products”.

Graduated from the ECAM engineering school in Lyon, Muriel Benedetto Marmilloud has over twenty years of experience in the orthopedic medical device sector. She has notably been the global director of a product line generating over a billion-dollar at Zimmer Biomet, the global leader of this sector.

Muriel Benedetto Marmilloud will work alongside Chairman and CEO Olivier Jallabert, more focused on the Group’s strategic developments, and in particular international development. She will be in charge of steering the R&D, Supply chain and Quality assurance & Regulatory affairs departments, in order to ensure total control over the entire logistics value chain. Working in close collaboration with the current teams, she will also be responsible for continuing the structuring of operations in order to accompany the Company’s international development and comply with future regulatory changes.

About Amplitude Surgical
Founded in 1997 in Valence, France, Amplitude Surgical is a leading French player on the global surgical technology market for lower-limb orthopedics. Amplitude Surgical develops and markets high-end products for orthopedic surgery covering the main disorders affecting the hip, knee and extremities, and notably foot and ankle surgery. Amplitude Surgical develops, in close collaboration with surgeons, numerous high value-added innovations in order to best meet the needs of patients, surgeons and healthcare facilities. A leading player in France, Amplitude Surgical is developing abroad through its subsidiaries and a network of exclusive distributors and agents distributing its products in more than 30 countries. Amplitude Surgical operates on the lower-limb market through the intermediary of its Novastep subsidiaries in France and the United States. At June 30, 2018, Amplitude Surgical had a workforce of nearly 400 employees and recorded sales of over 100 million euros.

Contacts

Amplitude Surgical
Philippe Garcia, +33 (0)4 75 41 87 41
CFO
finances@amplitude-surgical.com
or
NewCap
Investor Relations
Marc Willaume, +33 (0)1 44 71 00 13
amplitude@newcap.eu
or
NewCap
Media Relations
Nicolas Merigeau, +33 (0)1 44 71 98 55
amplitude@newcap.eu

Zimmer Biomet and Apple Collaborate to Launch Major Clinical Study Detailing Patient Experience and Improving Joint Replacement Journey

Posted On October 15, 2018 By OrthoSpineNews In Recon /

WARSAW, Ind., Oct. 15, 2018 /PRNewswire/ — Zimmer Biomet Holdings, Inc., a global leader in musculoskeletal healthcare, is working with Apple by using Apple Watch and iPhone to change the patient journey for two of the most common surgeries Americans undergo each year – knee and hip replacement. This collaboration has yielded Zimmer Biomet mymobility™, an app that uses Apple Watch to facilitate a new level of connection between patients and their surgical care teams, which can immediately impact the journey patients experience when they undergo these procedures.

In addition to the app, Zimmer Biomet is commencing the mymobility Clinical Study, designed to study the app’s impact on patient outcomes and overall costs for joint replacement patients. During this research study, patients will use Zimmer Biomet mymobility with Apple Watch as they progress through their hip or knee replacement journey. Researchers will combine patient-reported feedback with continuous health and activity data from Apple Watch to provide new insights into the power of the Zimmer Biomet mymobility app to impact the standard of care for these common surgeries. The study is launching today and has the possibility to enroll as many as 10,000 patient participants in the United States.

“We are incredibly excited to work with Apple to transform the knee and hip replacement experience for patients and surgeons,” said Bryan Hanson, President and CEO, Zimmer Biomet. “At Zimmer Biomet, we are committed to improving care decisions through digital health and we are thrilled to launch one of the largest evidence-gathering clinical studies in orthopaedic history.”

“We believe one of the best ways to empower consumers is by giving them the ability to use their health and activity information to improve their own care,” said Jeff Williams, Chief Operating Officer, Apple. “We are proud to enable knee and hip replacement patients to use their own data and share it with their doctors seamlessly, so that they can participate in their care and recovery in a way not previously possible through traditional in-person visits. This solution will connect consumers with their doctors continuously, before and after surgery.”

More than one million knee and hip replacements occur annually in the U.S. This number is expected to grow to 3.5 million by 2035, yet standardization of care and recovery for the procedures is still lacking and costs to the U.S. healthcare system continue to rise. Zimmer Biomet mymobility and Apple Watch will act as a virtual and continuous care team on a patient’s wrist. Patients will be provided with support and guidance as they prepare for and recover from these surgeries, while surgeons will be delivered continuous data to optimize care. The new Zimmer Biomet mymobility app has several features that use both Apple Watch and iPhone through the joint replacement journey, including the ability for surgeons to send education and therapy reminders directly to the patient’s Apple Watch. The app also allows surgeons to monitor patient activity levels throughout the days and weeks while they are preparing for and recovering from surgery.

Facilities participating in the mymobility Clinical Study include:

Academic centers: University of Utah Health; Rush University Medical Center; University of Pennsylvania Health System; Emory University Orthopaedics & Spine Hospital/Emory Healthcare
Hospitals: Hoag Orthopedic Institute in Southern California; Newton-Wellesley Hospital, member of Partners HealthCare founded by Massachusetts General Hospital and Brigham and Women’s Hospital; Centura Health, Porter Hospital – Colorado Joint Replacement (CJR)
Group practices/ambulatory surgery centers: ROC Orthopedics, affiliated with Legacy Meridian Park Medical Center; OrthoBethesda; OrthoArizona; Midwest Center for Joint Replacement; Hartzband Center for Hip & Knee Replacement; New Mexico Orthopaedic Associates; The DeClaire LaMacchia Orthopaedic Institute, affiliated with Michigan Institute for Advanced Surgery; Joint Implant Surgeons; Orthopedic and Fracture Clinic; Panorama Orthopedic and Spine Center

To learn more about the mymobility Clinical Study, visit zbmymobility.com/clinical-study.

Apple, Apple Watch and iPhone are registered trademarks of Apple, Inc.

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

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

We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com.

Contacts:

Media
Jon Siegal
781-684-6557
jon.siegal@mslgroup.com

SOURCE Zimmer Biomet Holdings, Inc.

Xtant Medical Announces Appointment of Interim CEO

Posted On October 15, 2018 By OrthoSpineNews In Spine /

BELGRADE, MT, Oct. 15, 2018 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE American: XTNT), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, announced today the appointment of Michael Mainelli to serve as Interim Chief Executive Officer, replacing Carl O’Connell effective October 12, 2018.

Mr. Mainelli joined the Board of Directors in February 2018 and will remain a member of the Board of Directors while serving as Interim Chief Executive Officer. The Company intends to commence a process to recruit a permanent Chief Executive Officer that will include both internal and external candidates.

Mr. Mainelli commented, “I am excited to continue working with our Board and with our management team in my new role. Xtant has great products, strong business partners, and dedicated, talented employees. We will be working hard to drive superior execution.”

Mr. Jeff Peters, Chairman of the Board, stated that “Mike is a proven leader with over 25 years of successful business leadership in the medical technology industry. He has led businesses at both public and private medical technology companies resulting in growth, operational improvement, and enhanced shareholder value. His unique experience in the global orthopaedic and spinal markets will be particularly valuable, and we are pleased to have him in this interim role.”

Mr. Mainelli succeeds Carl O’Connell, who served as Xtant’s Chief Executive Officer since October 2016. Mr. Peters added, “On behalf of the Board, I want to thank Carl O’Connell for his dedication and contributions, notably guiding the company through the recent restructuring process. We wish Carl all the best.”

About Xtant Medical Holdings, Inc.
Xtant Medical Holdings, Inc. (www.xtantmedical.com) is a global medical technology company focused on the design, development, and commercialization of a comprehensive portfolio of orthobiologics and spinal implant systems to facilitate spinal fusion in complex spine, deformity and degenerative procedures. Xtant people are dedicated and talented, operating with the highest integrity to serve our customers.

™ and ® denote trademarks and registered trademarks of Xtant Medical Holdings, Inc. 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.

Important Cautions Regarding Forward-looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements that are predictive in nature, that depend upon or refer to future events or conditions, or that include words such as ‘‘expects,’’ ‘‘anticipates,’’ ‘‘intends,’’ ‘‘plans,’’ ‘‘believes,’’ ‘‘estimates,’’ “continue,” “future,” ‘‘will,’’ “can,” similar expressions or the negative thereof, and the use of future dates. The Company cautions that its forward-looking statements by their nature involve risks and uncertainties, and actual results may differ materially depending on a variety of important factors, including, among others: the Company’s future operating results and financial performance; the ability to increase revenue; the ability to remain competitive; the ability to innovate and develop new products; the effect of management changes and the ability to engage and retain qualified personnel; government and third-party coverage and reimbursement for Company products; the ability to obtain and maintain regulatory approvals; government regulations; product liability claims and other litigation to which we may be subject; product recalls and defects; timing and results of clinical studies; the ability to obtain and protect Company intellectual property and proprietary rights and operate without infringing the rights of others; the ability to service Company debt and comply with debt covenants; the ability to raise additional financing and other factors. Additional risk factors are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017 filed with the Securities and Exchange Commission (SEC) on April 2, 2018 and subsequent SEC filings by the Company, including without limitation its most recent Quarterly Report on Form 10-Q for the quarter ended June 30, 2018 filed with the SEC on August 8, 2018. Investors are encouraged to read the Company’s filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The Company undertakes no obligation to release publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. All forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by this cautionary statement.

COMPANY CONTACT
Kathie Lenzen, Chief Financial Officer
406.388.0480
klenzen@xtantmedical.com

Field Orthopaedics Forms Exclusive Partnership With Ortho Consulting Group to Launch New Micro Screw Into EMEA

Posted On October 15, 2018 By OrthoSpineNews In Extremities /

BASINGSTOKE, England, October 15, 2018 /PRNewswire/ —

Partnering with Ortho Consulting Group, Field Orthopaedics is expanding its market presence for their innovative Micro Screw System in EMEA.
The unique 1.5mm screw with a rigid cannulation is designed for small fractures in the hand.
New to EMEA market, CE registration pending.

Innovators of the Micro Screw System, Australian-based Field Orthopaedics, has signed sales expansion experts, Ortho Consulting Group, to exclusively manage and accelerate growth of their new product in EMEA.

Already established in Australia, and most recently in the US, the Micro Screw is nearly set (CE registration imminent) to break into the EMEA market for the first time. Ortho Consulting Group will take full commercial responsibility for the expansion including setting the strategic direction as well as sourcing, onboarding and managing of distributors throughout the region.

Matt Woods, Founder of Ortho Consulting Group, said: “We are delighted to be managing the EMEA region for Field Orthopaedics. Field are an innovative company with its first product offering being the Micro Screw, we are looking forward to a long partnership with Field.“

Andrew Dubowski, Head of Export, “It is very exciting to be able to offer such a small screw (1.5mm) with a cannulation that is still rigid and effective at fracture fixation. This differentiation truly offers the surgeon an excellent and elegant solution to small bone fractures. I genuinely feel it can stand out in what is a crowed space.“

Field Orthopaedics‘ CEO, Chris Jefferys, commented: “Field Orthopaedics is excited to work within the experienced team at Ortho Consulting Group and expand the Micro Screw range into EMEA. We have the full confidence in OCG‘s ability to capture the market for the Micro Screw and many more to come.”

About Field Orthopaedics

Field Orthopaedics (FO) is an Australian Orthopaedic devices company. FO is a rapidly growing company that focuses on the design and manufacturing of orthopaedic devices to address the shortcomings in the trauma, extremities and biological markets.

Currently, Field Orthopaedics has 12 projects in the entire portfolio, 6 of which are in active development expected to gain regulatory approval within the next 3 years. Field Orthopaedics was formed to bring back innovation to medicine and to realise products that address under-serviced markets and to realise solutions to problems impacting patient care and outcomes. The company was created from within the medical community, when the founders decided to take action and form a significant collaboration with surgeons and physicians asking them what their hurt points were and working alongside them to create answers.

About Ortho Consulting Group

With a network of over 5,000 validated contacts, Ortho Consulting Group (OCG) are a team of industry experts specialising in global strategy and building, strengthening and managing global sales channels, specifically outside of the US.

OCG understand the challenges of growing a global business within Orthopaedics and Spine and offers a holistic consultancy service to advise, support and deliver orthopaedic manufacturers’ expansion strategies.

Made up of two specialist divisions, Orthoconnections and Orthoexecutive, OCG can cover all sales channel expansion solutions, whether that’s growing and onboarding your own senior leadership team or sourcing and managing your distributors.

Media contact:
Tom Edwards, Group Marketing Manager
Ortho Consulting Group
tomedwards@orthocg.com

SOURCE Ortho Consulting Group

TDM USA Enters Domestic Extremity Market, Launches Six Product Systems at OTA

Posted On October 15, 2018 By OrthoSpineNews In Extremities, Top Stories /

TDM USA, based in Salt Lake City, Utah, is pleased to announce its entry into the rapidly expanding US extremity market with the launch of six new product systems at the 2018 Annual Meeting of the Orthopaedic Trauma Association (OTA) in Kissimmee, Florida from October 17-20.

Bringing true value to facilities, surgeons and patients requires going beyond the standard. TDM USA is setting new standards by partnering with medical professionals to define and deliver value-generating solutions for complex healthcare challenges. TDM USA brings a new focus on flexibility to the industry, through its collaborative approach to the unique individual needs of Acute Care Hospitals and Ambulatory Surgery Centers.

The APIS (Advanced Principle Implant System) product group offers surgical solutions for Foot and Ankle, Hand and Wrist, and Shoulder and Elbow. The currently available product offering includes: 2.0mm Locking Plate and Screw System; 2.7mm Locking Plate and Screw System; Proximal Humerus Locking Plate and Screw System; Variable Locking Elbow Plate and Screw System; Variable Locking Foot Plate and Screw System; and Trifix Small Locking Plate and Screw System, a curated product set with a wide variety of plates/screws to address multiple anatomies and procedures in one offering.

“We are excited and humbled by the opportunity to positively impact the US healthcare market by providing high-quality, high-value products for fracture care and extremity reconstruction that have a demonstrated track record around the world,” said Clay Smith, President and General Manager of TDM USA. “In today’s value-driven healthcare environment, our mission is to help achieve clinically equivalent outcomes while reducing costs for providers and patients.”

To learn more about the broad and expanding product portfolio of TDM USA, and its philosophy of value-generating solutions in extremity fixation, please visit www.tdm-usa.com and booth 624 during the OTA meeting.

About TDM USA

TDM USA has a management team with over 60 years of combined Commercial and Operations experience in the US healthcare sector. TDM USA is a wholly owned subsidiary of TDM Co., Ltd., a global medical device manufacturer headquartered in Gwangju, Korea. TDM Co., Ltd. entered the orthopedic market in 2007 and currently distributes over 40 unique product systems in 15 countries. All available on-market TDM USA products are FDA 510(k) cleared and manufactured to ISO 13485 standards.

SeaSpine Prices Public Offering of Common Stock

Posted On October 11, 2018 By OrthoSpineNews In Financial /

CARLSBAD, Calif., Oct. 11, 2018 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ: SPNE) (“SeaSpine” or the “Company”), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced the pricing of its previously announced underwritten public offering of 3,250,000 shares of its common stock at a public offering price of $15.50 per share. The gross proceeds to SeaSpine, before deducting the underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $50.4 million. The offering is expected to close on or about October 15, 2018, subject to customary closing conditions.

Wells Fargo Securities, LLC, Piper Jaffray & Co. and Cantor Fitzgerald & Co. are acting as joint book-running managers and BTIG, LLC is acting as lead manager for the offering. SeaSpine has granted the underwriters a 30-day option to purchase up to an additional 487,500 shares at the public offering price, less underwriting discounts and commissions.

SeaSpine intends to use the net proceeds from this offering to repay all of its outstanding borrowings under the Company’s credit facility with Wells Fargo Bank, National Association, and for general corporate purposes, including general and administrative expenses, capital expenditures and general working capital purposes.

A shelf registration statement on Form S-3 relating to the public offering of the shares of common stock described above was filed with the Securities and Exchange Commission (the “SEC”) and became effective on August 24, 2016. A preliminary prospectus supplement relating to the offering has been filed with the SEC and a final prospectus supplement relating to the offering will be filed with the SEC. Copies of the final prospectus supplement and accompanying prospectus, when available, may be obtained from Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue, New York, New York, 10152, by telephone at (800) 326-5897 or by email: cmclientsupport@wellsfargo.com; or Piper Jaffray & Co., 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, Attn: Prospectus Department, by telephone at (800) 747-3924 or by email: prospectus@pjc.com; or Cantor Fitzgerald & Co., 499 Park Ave., 6^th Floor, New York, New York 10012, Attn: Capital Markets, or by email: prospectus@cantor.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

ABOUT SEASPINE

SeaSpine (www.seaspine.com) is a global medical technology company focused on the design, development and commercialization of surgical solutions for the treatment of patients suffering from spinal disorders. SeaSpine has a comprehensive portfolio of orthobiologics and spinal implants solutions to meet the varying combinations of products that neurosurgeons and orthopedic spine surgeons need to perform fusion procedures on the lumbar, thoracic and cervical spine. SeaSpine’s orthobiologics products consist of a broad range of advanced and traditional bone graft substitutes that are designed to improve bone fusion rates following a wide range of orthopedic surgeries, including spine, hip, and extremities procedures.

FORWARD-LOOKING STATEMENTS

This press release contains certain forward-looking information about SeaSpine that is intended to be covered by the safe harbor for “forward-looking statements” provided by the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. Words such as “expect(s),” “feel(s),” “believe(s),” “will,” “may,” “anticipate(s)” and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements about the Company’s expectations regarding its capital raising efforts, including the closing of the public offering, the underwriters’ exercise of their option to purchase additional shares and the Company’s intended use of proceeds. All such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the control of the Company, which could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include, but are not limited to, surgeons’ willingness to continue to use the Company’s existing products and to adopt its newly launched products, including the risk that the Company’s products do not demonstrate adequate safety or efficacy, independently or relative to competitive products, to support expected levels of demand or pricing; the ability of newly launched products to perform as designed and intended and to meet the needs of surgeons and patients, including as a result of the lack of clinical validation of products in limited commercial (or “alpha”) launch; the Company’s ability to attract new, high-quality distributors, whether as a result of inability to reach agreement on financial or other contractual terms or otherwise, disruption to the Company’s existing distribution network as new distributors are added, and the ability of new distributors to generate growth or offset disruption to existing distributors; continued pricing pressure, whether as a result of consolidation in hospital systems, competitors or others, as well as exclusion from major healthcare systems, whether as a result of unwillingness to provide required pricing or otherwise; the risk of supply shortages and the associated, potentially long-term disruption to product sales, including as a result of the Company’s dependence on a limited number of third-party suppliers for components and raw materials, or otherwise; unexpected expense and delay, including as a result of developing and supporting the launch of new products, the fact that newly launched products may require substantial additional development activities, which could introduce further expense and delay, or as a result of obtaining regulatory clearances; the Company’s ability to continue to invest in product development and sales and marketing initiatives at levels sufficient to drive future revenue growth, including as a result of its inability to obtain funding on a timely basis on acceptable terms, or at all; general economic and business conditions in the markets in which the Company does business, both in the U.S. and abroad, as well as other risks and uncertainties described under the “Risk Factors” contained in the Company’s periodic and interim SEC reports, including but not limited to, its Annual Report on Form 10-K for the fiscal year ended December 31, 2017, its Quarterly Reports on Form 10-Q for the quarters ended March 31, 2018 and June 30, 2018 and its Current Reports on Form 8-K filed from time to time with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof, and the Company does not undertake any obligation to revise and disseminate forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of or non-occurrence of any events.

Investor Relations Contact
Lynn Pieper Lewis
(415) 937-5402
ir@seaspine.com

SpinalCyte Announces Publication Supporting the Therapeutic Effects of Fibroblast Cell Therapy in Disc Degeneration and Inflammation in The Spine Journal

Posted On October 11, 2018 By OrthoSpineNews In Biologics /

HOUSTON, Oct. 11, 2018 /PRNewswire/ — SpinalCyte, LLC, a Texas-based regenerative medicine company focused on regrowth of the spinal disc using Human Dermal Fibroblasts, today announced the publication of results from its study on using cell transplantation as a cell therapy for disc degeneration. The article titled “Therapeutic Effects of Cell Therapy with Neonatal Human Dermal Fibroblasts and Rabbit Dermal Fibroblasts on Disc Degeneration and Inflammation,” was published in The Spine Journal and is available at https://www.thespinejournalonline.com/article/S1529-9430(18)31093-3/fulltext.

The study found that transplanting dermal fibroblasts can significantly increase the markers of disc regeneration and supported the hypothesis that the intervertebral disc is immune privileged. Taken together with previous disc degeneration studies, this suggests that fibroblast cell therapies can prevent the degeneration and promote the regeneration of the spinal disc.

“Autologous and allogenic cell therapies for disc degeneration and back pain are feasible, well tolerated, and appear to have clinical efficacy,” said Howard An, M.D., The Morton International Endowed Chair Professor of Orthopedic Surgery, Director Spine Fellowship Program at Rush University Medical Center, and principal investigator of this study. “Human dermal fibroblasts continue to be found safe and well-tolerated in clinical studies while being both therapeutic and regenerative in diseases including disc degeneration.”

“Fibroblast cell therapy is a viable way to address the cause of disc degeneration rather than just treat symptoms,” said Pete O’Heeron, SpinalCyte Chief Executive Officer. “The results from this preclinical study validate our ongoing Phase 1/Phase 2 trials in the treatment of degenerative disc disease with CybroCell, where over 85% of patients using CybroCell report significant therapeutic improvement at 6 months.”

About Degenerative Disc Disease

Degenerative disc disease (DDD) is a condition in which a patient’s spinal disc breaks down and can begin to collapse. It is estimated that 85% of people over the age of 50 have evidence of disc degeneration and over 1.3 million procedures a year are performed to treat the disease. The most common treatments for patients with DDD are either discectomy or spinal fusion. Discectomy is the partial or full removal of the degenerated disc to decompress and relieve the nervous system but can cause long term spinal pain. In a spinal fusion procedure, the entire disc is removed and the two adjacent vertebrae are fused together. It often increases strain on the adjacent discs and surrounding tissues leading to further degeneration.

About CybroCell

CybroCell is the first off-the-shelf allogenic human dermal fibroblast (HDF) product for the treatment of degenerative disc disease. SpinalCyte’s Phase 1/Phase 2 clinical trial for injected human dermal fibroblasts in the treatment of DDD demonstrated preliminary six-month data whereby 83% of patients had an increase or no change in disc height.

About SpinalCyte

Based in Houston, Texas, SpinalCyte, LLC is a regenerative medicine company developing an innovative solution for spinal replacement using human dermal fibroblasts. Currently, SpinalCyte holds 33 U.S. and international issued patents and has filed for an additional 43 patents pending. Funded entirely by angel investors, SpinalCyte represents the next generation of medical advancement in cell therapy. Visit www.spinalcyte.com.

Contact:
David Schull or Ned Berkowitz
Russo Partners LLC
858-717-2310
646-942-5629
david.schull@russopartnersllc.com
ned.berkowitz@russopartnersllc.com

SOURCE SpinalCyte, LLC

Arthrosurface Launches the Stemless OVOMotion™ Shoulder Arthroplasty System

Posted On October 11, 2018 By OrthoSpineNews In Recon /

FRANKLIN, Mass., Oct. 11, 2018 /PRNewswire/ — Arthrosurface®, Inc. announced today the official launch of its latest product, the stemless OVOMotion™ Shoulder Arthroplasty System with Inlay Glenoid. FDA Cleared in April 2018, this stemless total shoulder system provides the surgeon with an approach that results in increased exposure to the glenoid, minimal bone removal, and is designed for patients with painful and/or severely disabled shoulder joints resulting from arthritis, traumatic events or AVN.

“This truly is a revolutionary stemless total shoulder, which combines the concept of anatomic restoration with an aspherical head design, and also allows improved joint access for ease of preparation of the glenoid,” said Dr. Anthony Miniaci, MD of the Cleveland Clinic. “This combination of an aspherical head and inlay glenoid has shown to be effective in not only active and younger patients but in all of those with glenohumeral arthritis even in the face of posterior subluxation and bone erosion.”

An earlier publication in the Journal of Shoulder and Elbow Surgery demonstrated how the inlay glenoid (socket) design was far superior to the only alternative with respect to the biomechanical stability. Arthrosurface has had long-standing success with the aspherical head design of the existing OVO^® arthroplasty device and the stemless OVOMotion™arthroplasty system expands that technology by maintaining the same external geometry while adding a planar cut for enhanced access to the glenoid. Additionally, the proven fixation method and location are unchanged.

Michael Gombosh, MD from South Florida International Orthopaedics commented, “With the new system, the additional 12.5mm of bone removed from the humeral head has truly improved the technical portion of the procedure. This allows for easier visual and manual access of the glenoid. These steps can be the most challenging portion of the operation, and frequently the most time consuming. With improved visualization, you are able to obtain a more accurate assessment of the morphology and wear pattern within the glenoid, but also establish improved access for glenoid preparation and release of the posterior capsule.”

Steve Ek, CEO said, “The OVOMotion™ Shoulder Arthroplasty System builds upon the outstanding clinical results of the OVO System and greatly facilitates surgical access, speed and reproducibility. It also sets the stage for our future modular components.”

The OVOMotion™ Stemless Shoulder Arthroplasty System is now available for use in the United States.

About Arthrosurface
Arthrosurface, Inc. is a global orthopedic medical technology business providing a broad portfolio of essential products and instrumentation used to treat upper and lower extremity orthopedic conditions caused by trauma, injury and arthritic disease. The product offerings include joint preservation implants, instruments and orthobiologics. Founded in 2002, Arthrosurface markets and distributes its products in the US and around the world and has succeeded in helping patients return to activity for over 14 years. For more information, please visit our website at www.arthrosurface.com

SOURCE Arthrosurface, Inc.

Month: October 2018

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