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Regenerating Knee Cartilage with Stem Cells: Groundbreaking Clinical Trial Underway at Andrews Institute

Posted On July 6, 2017 By OrthoSpineNews In Regulatory, Sports Medicine, Top Stories /  

GULF BREEZE, Fla., July 6, 2017 /PRNewswire/ — A groundbreaking randomized clinical trial (RCT) evaluating the use of a patient’s own stem cells to regenerate knee cartilage is underway at Andrews Institute for Orthopaedics & Sports Medicine in Gulf Breeze, Florida. The study, led by Adam Anz, M.D., an orthopaedic surgeon at Andrews Institute, is the first multicenter Phase II United States Food and Drug Administration (FDA) observed RCT of its kind.

While early regenerative medicine treatment options utilizing stem cells are currently being used and studied at Andrews Institute to facilitate healing of ligaments and tendons, this is the first time stem cells will be evaluated in a clinical trial to regenerate cartilage in massive knee cartilage injuries.

“In the United States, there are currently no proven treatment options that utilize stem cells to regenerate a patient’s knee cartilage once it has deteriorated,” said Dr. Anz. “This clinical trial is a monumental step to get FDA approved stem cell technology to our patients.”

The study is being conducted in conjunction with the Kuala Lumpur Sports Medicine Center (KLSMC) in Kuala Lumpur, Malaysia, and will be funded in part by the Malaysian government. It will attempt to replicate outcomes from clinical treatments currently available to patients in Malaysia using a cartilage regeneration technology developed by Dr. Khay-Yong Saw, an orthopaedic surgeon who practices at KLSMC.

“The whole concept of regenerating cartilage is totally different from what’s being used now to treat damaged cartilage,” said Dr. Saw. “We are hoping this study will help the FDA evaluate the safety and the effectiveness of this clinical application.”

The RCT will be facilitated through the Andrews Research & Education Foundation, an independent 501(c)(3) not-for-profit entity that serves as the research and education wing of Andrews Institute. The study could take up to six years; however, there may be a possibility to stop the RCT earlier if results show statistical significance.

Baptist Health Care opened the Andrews Institute in 2007. Named for internationally renowned orthopaedic surgeon James R. Andrews, M.D., the Andrews Institute has secured northwest Florida as a cradle for musculoskeletal treatments and research.

SOURCE Andrews Institute for Orthopaedics & Sports Medicine

Related Links

http://www.theandrewsinstitute.com

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SpineGuard posts 16% growth for H1 2017, appoints co-Founder Stéphane Bette as CEO

Posted On July 6, 2017 By OrthoSpineNews In Financial /  

July 06, 2017

PARIS & SAN FRANCISCO–(BUSINESS WIRE)–Regulatory News:

SpineGuard (FR0011464452)(Paris:ALSGD), an innovative company that develops and markets disposable medical devices designed to make spine surgery safer, announced:

  • First-half global revenue growth of 16% (13% cc) to €4.2M, compared with €3.6M in the first half of 2016;
  • The appointment of Stéphane Bette, co-Founder, CTO and US General Manager, as CEO of the company effective on July 13th; Pierre Jérôme, who has served as CEO since the company’s founding, will continue to serve as Board Director of the company;
  • The implementation of a profitability plan to reach monthly breakeven by the end of 2018.

H1 and Q2 2017 revenues
€ thousands – IFRS 2017 2016 Variance
First Quarter 2,169 1,760 +23%
Second Quarter 2,030 1,873 +8%
Half-Year 4,199 3,633 +16%

Unaudited

Global revenue in the second quarter of 2017 increased 8% on a reported basis and 6% at constant exchange rate (cc). In the first half, global revenue increased 16% (13% cc) to €4,199k, compared with €3,633k in the first half of 2016.

In the first half of 2017, 4,264 DSG units were sold compared with 4,351 in the first half of 2016, including 2,589 (61%) in the United States, where revenue grew 19% (15% cc) to €3,397k in the first half of 2017 compared with €2,866k in the same period last year.

Appointment of Stéphane Bette, Co-founder, as CEO

The Board of Directors has appointed Stéphane Bette, its US General Manager, CTO and co-Founder, as CEO of SpineGuard SA in succession of Pierre Jérôme, who continues to serve as a Board Director of the company.

Stéphane brings more than 20 years of experience in the spinal industry to the role. He co-founded the company and has led the US operations since 2009 while also retaining his role as Chief Technology Officer during this period. Prior to this, Stéphane spent 10 years at SpineVision, a private spine company, in a number of roles, ending as US General Manager. He started his career at Sofamor Danek in the 1990’s, prior to its acquisition by Medtronic. Stéphane received a Master’s degree in Mechanical Engineering from ENSAM, France, and a Postgraduate Degree in Biomechanics from LBM in Paris, France.

“The Board is very pleased to appoint Stéphane as CEO to lead the company through its next stage of growth,” said Alan Olsen, Chairman. “He has led the company’s increasingly important US operations since 2009 as well as overseen the development of SpineGuard’s core DSG™ technology platform. He is a natural successor to his co-Founder Pierre Jérôme, whom we warmly thank for his leadership of the company over the past 8 years. Under Pierre’s stewardship, SpineGuard has grown from a one-product company with €1 million in sales, through multiple fund-raising rounds, including an IPO in 2013, to the strong position it is in today. We are very pleased to have Pierre continue his association with the company in his role as Director with a particular focus on strategic and business development initiatives.”

“SpineGuard is a high-performing company with a cohesive team and a unique technology in DSG™”, Stéphane Bette commented. “We delivered double-digit growth this first half of the year in a context where we are preparing for the US launch of our smart DSG™ screw. I look forward to intensifying SpineGuard’s focus on leveraging our core DSG™ platform through additional deals in spine and other musculoskeletal segments while continuing to grow our organic sales, capitalizing on our strong commercial, marketing and clinical foundations and rebalancing the organization. In order to reach financial freedom, we have set a specific goal that SpineGuard reaches breakeven by the end of 2018 and then profitability.”

Pierre Jérôme concluded: “After driving SpineGuard with close support from Stéphane since its inception, I am particularly glad to hand over the baton to him now – when momentum is building for the company with sustained growth, promising perspectives in China and the further deployment of our DSG™ technology platform in spine and dental through our partnership strategy. This smooth transition will provide continuity for our employees, customers and partners.”

Business focus for 2017 and 2018

To reach breakeven by the end of 2018, SpineGuard will concentrate its efforts on:

  • Signing new industry partnerships for expanded commercial applications of its proprietary digital DSG™ technology within the spinal and broader musculoskeletal sector to trigger new sources of revenue;
  • Growing its worldwide sales with a primary commercial focus on the US market which accounts for close to 80% of revenues;
  • Implementing a profitability plan to right size its organization, capitalizing on its strengths and leveraging its cutting-edge proprietary DSG™ platform.

Next financial press release: 2017 Half-year financial results on September 14, 2017

About SpineGuard®

Founded in 2009 in France and the USA, by Pierre Jérôme and Stéphane Bette, SpineGuard’s mission is to make spine surgery safer by bringing real-time digital technology into the operating room. Its primary objective is to establish its proprietary DSG™ (Dynamic Surgical Guidance) technology as the global standard of surgical care, starting with safer screw placement in spine surgery and then in other surgeries. PediGuard®, the first device designed using DSG, was co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and Alain Vanquaethem, Biomedical Engineer. It is the world’s first and only handheld device capable of alerting surgeons to potential pedicular or vertebral breaches. Over 50,000 surgical procedures have been performed worldwide with DSG™ enabled devices. Numerous studies published in peer-reviewed medical and scientific journals have demonstrated the multiple benefits that PediGuard® delivers to patients, surgical staff and hospitals. SpineGuard is expanding the scope of its DSG™ platform through strategic partnerships with innovative medical device companies and the development of smart instruments and implants. SpineGuard has offices in San Francisco and Paris. For further information, visit www.spineguard.com.

Disclaimer

The SpineGuard securities may not be offered or sold in the United States as they have not been and will not be registered under the Securities Act or any United States state securities laws, and SpineGuard does not intend to make a public offer of its securities in the United States. This is an announcement and not a prospectus, and the information contained herein does and shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities referred to herein in the United States in which such offer, solicitation or sale would be unlawful prior to registration or exemption from registration.

Contacts

SpineGuard
Manuel Lanfossi, +33 (0)1-4518-4519
Chief Financial Officer
m.lanfossi@spineguard.com
or
Europe / NewCap
Investor Relations & Financial Communication
Florent Alba / Pierre Laurent
+33 (0)1-44-7194-94
spineguard@newcap.fr
or
US
Ronald Trahan Associates Inc.
Ronald Trahan, APR
+1-508-359-4005, x108

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Nextremity Solutions, Inc. and Ignite Orthopedics, LLC Form Business Alliance

Posted On July 6, 2017 By OrthoSpineNews In Extremities, Top Stories /  

Warsaw, Indiana, July 05, 2017 — Nextremity Solutions, Inc., a musculoskeletal product development company located in “The Orthopedic Capital of the World” Warsaw, IN, has announced a business alliance with Ignite Orthopedics, LLC. The two medical device companies will be leveraging space, resources and capital.

Ignite Orthopedics, an emerging start-up that shares the same exclusive focus on surgeon specialists, plans to develop and commercialize a unique portfolio of products in areas complimentary to Nextremity Solutions.  Having recently appointed its Board of Directors and completed its first round of funding, Ignite is currently building the infrastructure of the company and will be launching development programs in the near future.

“The Nextremity team is excited about the opportunity to co-labor with Ignite Orthopedics as they start this new venture.  Co-locating, sharing key resources, and providing a bit of capital is a great way for Nextremity to support a talented, like-minded team and help accelerate their strategy.  I’ve worked with co-founders Brian Hodorek and Matt Purdy in the past and have tremendous respect for what they’ve been able to achieve. We are excited to watch what they accomplish and see tremendous long-term value through this alliance, for both our shareholders and for our industry partners,” commented Ryan Schlotterback, Chief Commercial Officer for Nextremity Solutions.

“The alliance with Nextremity creates a very unique opportunity for Matt and I to focus on what we do best with minimal disruption from day to day operational tasks,” said Hodorek.  Purdy added, “In essence, it allows us to dedicate our attention to the needs of our surgeon partners and the patients they serve.”

Nextremity Solutions has historically focused on the Lower Extremity market and is currently working closely with surgeon specialists to develop and commercialize Revenue Ready™ products and solutions focused on musculoskeletal care through its recently launched i3™ Strategic Solutions strategy.

Rod K. Mayer, President and CEO of Nextremity Solutions added, “Nextremity Solutions has always had a very strong product development focus. Since our company was founded, we committed to developing innovative solutions alongside surgeons to develop products that meet unmet needs and improve patient health. Ignite Orthopedics shares this vision and mission. It made perfect sense for our two companies to work together to continue to provide surgeons and patients with products that will meet their musculoskeletal needs.”

Ignite Orthopedics is located within the current Nextremity Solutions offices located at 210 N. Buffalo Street, Warsaw, IN. To learn more about the Ignite Orthopedics’ story, the team or how to engage and connect, visit www.igniteorthopedics.com. 

About Ignite Orthopedics, LLC. 

Ignite Orthopedics, LLC. Is a privately held musculoskeletal product development company committed to partnering with those who share a passion to fuel motion whether it be through new ways to innovate, clinical advancements, or improved patient experiences and outcomes. 

About Nextremity Solutions, Inc.

Nextremity Solutions, Inc. is a privately held medical device company offering innovative solutions and approaches to foot and ankle surgical intervention. The Company’s procedure-ready, sterile implant systems for the correction of foot and ankle pathologies include uniquely precise, proprietary technology designed to achieve repeatable and superior clinical outcomes.

For further information, visit www.nextremitysolutions.com or call Dave Temple, Director of Marketing & Corporate Communications at 574-635-3022.

 

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NuVasive Announces Conference Call And Webcast Of Second Quarter 2017 Results

Posted On July 6, 2017 By OrthoSpineNews In Financial /  

SAN DIEGO, July 5, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced the Company will release its second quarter 2017 earnings results on Thursday, July 27, 2017 after the close of the market.

NuVasive will hold a conference call on Thursday, July 27, 2017 at 4:30 p.m. ET / 1:30 p.m. PT to discuss the results of its financial performance for the second quarter 2017. The dial-in numbers are 1-877-407-9039 for domestic callers and 1-201-689-8470 for international callers. A live webcast of the conference call will be available online from the Investor Relations page of the Company’s website at www.nuvasive.com.

After the live webcast, the call will remain available on NuVasive’s website through August 28, 2017. In addition, a telephone replay of the call will be available until August 3, 2017. The replay dial-in numbers are 1-844-512-2921 for domestic callers and 1-412-317-6671 for international callers. Please use pin number: 13665648.

About NuVasive

NuVasive, Inc. (NASDAQ: NUVA) is transforming spine surgery and beyond with minimally invasive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With $962 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.

Forward-Looking Statements

NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, but are not limited to, the risk that NuVasive’s revenue or earnings projections may turn out to be inaccurate because of the preliminary nature of the forecasts; the risk of further adjustment to financial results or future financial expectations; unanticipated difficulty in selling products, generating revenue or producing expected profitability; and those  other risks and uncertainties more fully described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

SOURCE NuVasive, Inc.

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Is Mazor Robotics Really on Track for Its Best Quarter Ever?

Posted On July 6, 2017 By OrthoSpineNews In Financial, Robotics /  

By  – July 6, 2017

Mazor Robotics Ltd. (NASDAQ: MZOR) saw its shares make a handy gain on Thursday after the Israeli firm announced that it’s projecting it will report record revenues for the second quarter. It didn’t stop here. Mazor also said that it received a total of 19 purchase orders during the quarter as well, setting up for what could be its strongest quarter ever.

Currently the firm is expecting to see roughly $15.4 million in revenue for the second quarter, which compares to $8.3 million in the same period of last year. Obviously that’s incredible growth, but what do the analysts have to say?

Thomson Reuters consensus estimates are calling for only $12.36 million in this quarter, so Mazor might see a pretty solid beat. Even the highest revenue target among the six analysts covering Mazor is $13.45 million.

Looking at the bottom line, the firm didn’t give out any predictions, but the consensus estimate is $0.19 in earnings per share (EPS), versus last year’s $0.18 in EPS. Considering the ramp up in purchase orders, we might see this number come up in the weeks ahead of the report.

 

READ THE REST HERE

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Stimwave Announces First Patient in Brazil to Receive Wireless Pain Relief® Technology

Posted On July 6, 2017 By OrthoSpineNews In Neuro, Top Stories /  

July 05, 2017

FORT LAUDERDALE, Fla.–(BUSINESS WIRE)–Stimwave LLC, a medical device manufacturer and independent research institute headquartered in South Florida in the United States, today announced the first patients in Brazil will receive a Stimwave Wireless Pain Relief® device for the treatment of chronic pain. The minimally-invasive procedures will be completed prior to and during the 4th Conference of the Brazilian Society of Interventional Pain Physicians (BSIPP) when the leading authorities in the field of pain management gather in Campinas, São Paolo, Brazil from July 6-9, 2017.

Charles Amaral de Oliveira, MD of Singular Centro de Controle da Dor in Campinas, Sao Paolo will perform the procedures as part of the conference’s focus on new trends in neuromodulation. The patients will receive Stimwave’s Wireless Pain Relief® technology as a non-opioid alternative to treating chronic pain. Singular is the first Brazilian pain treatment center to earn the International Excellence in Pain Practice Award from the World Institute of Pain (WIP), as well Singular’s medical staff being the first Brazilian doctors to earn Fellow in Interventional Pain Practice (FIPP) accreditations.

“We expect to improve the quality of life for our patients by allowing them to perform day-to-day activities with more freedom,” said Oliveira. “We already know about 85 percent of people who have spine problems will need an MRI in five years, and Stimwave offers no impediment to this exam, which represents another important achievement.”

The leading authorities in the field of pain management will convene in Campinas, São Paulo from July 6-9 for the 4th Conference of the Brazilian Society of Interventional Pain Physicians. The scientific program includes over 50 activities, including educational lectures by 13 international guest speakers and nine live surgical demonstration procedures to be held July 6. The event’s multidisciplinary focus and comprehensive program features talks on craniofacial pain, neuropathic pain, cancer pain, neck and back pain, the role of ultrasound as an important tool in diagnosing the causes of pain, and on new trends in neuromodulation, as well as the social impact of pain and the standardization of pain professional-health insurance provider relations.

Stimwave has pioneered the Stimwave Freedom Spinal Cord Stimulation (SCS) System and the StimQ Peripheral Nerve Stimulator (PNS) System. Stimwave’s devices are 95 percent smaller than any other neuromodulation device on the market and are the only system to have full body 3T MRI Conditionality. Representing a life-changing technological breakthrough for the more than 400 million people who endure daily chronic pain worldwide, the Stimwave Freedom Spinal Cord Stimulation (SCS) System is the most versatile system available in the industry. The Freedom-8A SCS System can provide patients with up to 64 electrode contacts and offer traditional programming options, as well as other programming options, including frequencies up to 10,000 Hz or waveform customization. The Freedom-8A SCS System with eight electrodes continues to utilize the Apple iPad programmer, leveraging Bluetooth protocols for ease of use in programming the variety of options. The devices deliver small pulses of energy to specific nerves, triggering a reaction that enables the brain to remap pain pathways, thus providing pain relief.

For more information, visit www.stimwave.com.

About Stimwave

Stimwave LLC is a privately held medical device company engaged in the development, manufacturing, and commercialization of wirelessly powered, microtechnology neurostimulators, providing patients with a convenient, safe, minimally invasive, and highly cost-effective pain management solution that is easily incorporated into their daily lives. Stimwave’s goal is to evolve its patented, cutting-edge platform into the default for neuromodulation, increasing the accessibility for patients worldwide while lowering the economic impact of pain management. www.stimwave.com

Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes are forward-looking statements. A number of risks and uncertainties such as risks associated with product development and commercialization efforts, expected timing or results of any clinical trials, ultimate clinical outcome and perceived or actual advantages of the company’s products, market and physician acceptance of the products, intellectual property protection, and competitive offerings could cause actual events to adversely differ from the expectations indicated in these forward looking statements.

Contacts

Glodow Nead Communications
Evan Nicholson, Sonia Sparks, Kati Stadum, and Sarah Rogers, 415-394-6500
StimwavePR@GlodowNead.com

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MedShape Sells ExoShape® ACL Product Line to CONMED Corporation

Posted On July 6, 2017 By OrthoSpineNews In Extremities, Top Stories /  

ATLANTA, July 5, 2017 /PRNewswire/ — MedShape, Inc., the industry leader in orthopaedic devices using advanced functional materials, announced today that it has reached a definitive agreement with CONMED Corporation (Nasdaq:CNMD) for CONMED to acquire the ExoShape® ACL Fixation System. The acquisition, which closed July 3, 2017, includes both the ExoShape FEMORAL and TIBIAL Soft Tissue Fasteners, used to fixate soft tissue grafts in anterior cruciate ligament (ACL) reconstruction surgery.

“The ExoShape System has represented a valuable portion of MedShape’s business since 2011, and this acquisition further demonstrates the success of the development and commercialization efforts invested in the product,” said Kurt Jacobus, MedShape’s CEO. “While we will certainly miss serving our patients, doctors and distributors with this product line, we look forward to focusing our efforts towards growing our core foot and ankle business with new investments.”

The ExoShape ACL Fixation System represents a breakthrough in soft tissue fixation, as it was the first all-PEEK system to offer a non-rotational deployment and interference fixation approach for ACL reconstruction. Manufactured out of shape memory PEEK Altera®, the ExoShape fasteners are delivered in a low-profile shape for easy insertion and then fully expanded upon instantaneous deployment to effectively compress and secure the soft tissue graft inside the bone tunnel.

About CONMED Corporation

CONMED is a medical technology company that provides surgical devices and equipment for minimally invasive procedures. The Company’s products are used by surgeons and physicians in a variety of specialties, including orthopedics, general surgery, gynecology, neurosurgery and gastroenterology. CONMED has a direct selling presence in 17 countries, and international sales constitute approximately 50% of the Company’s total sales. Headquartered in Utica, New York, the Company employs approximately 3,300 people. For more information, visit www.conmed.com.

About MedShape, Inc.

MedShape, Inc. is a privately held medical device company working to develop and commercialize a portfolio of surgical solutions for foot and ankle and trauma surgeons that use its patented advanced material technologies. For more information, visit: www.medshape.com.

Media Contact:
Jenn Pratt
Carabiner Communications
404.655.2273
jpratt@carabinerpr.com

MedShape, Inc. Contact:
Kathryn Smith, Ph.D.
678.235.3304
Kathryn.smith@medshape.com

CONMED Corporation Contact:
Luke Pomilio
Chief Financial Officer
315.624.3202
LukePomilio@conmed.com

 

SOURCE MedShape, Inc.

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Bone Therapeutics Strengthens Board of Directors

Posted On July 5, 2017 By OrthoSpineNews In Biologics, Top Stories /  

Gosselies, Belgium, 3 July 2017, 7am CEST – BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in orthopaedics and bone diseases, today announces that Steve Swinson has been elected as Chairman of the Board of Directors. He will replace Michel Helbig, who has stood down as Chairman but will continue as a Non-Executive Director.

Bone Therapeutics has also continued to strengthen its Board with the appointment of Dirk Dembski as a Non-Executive Director. The appointment of Dirk, a seasoned executive with expertise in orthopaedics and biotechnology and experience in sales, marketing, business development and medical education for global life sciences companies, complements the recent appointments of Steve Swinson and Damian Marron, who both joined the Bone Therapeutics Board in May. These appointments significantly increase the breadth of specialist orthopaedic and regenerative therapy expertise at the Company and will help support the new management team, led by Chief Executive Thomas Lienard.

Steve Swinson has served in a number of senior roles in orthopaedic medical technology and electronics, including general management, senior strategy, sales, marketing and commercial operation positions at Medtronic. At Medtronic, he led the Spine and Biologics division for Canada and Western Europe, and was Vice President and General Manager for the international spine division. with substantial revenue responsibility. In a 30-year international business career covering Asia, US, Europe and Africa, he has also held senior positions in the diagnostic and medical divisions of General Electric and Hewlett Packard. Steve has a PhD in electrical engineering from the University of Manchester and a MBA from the University of Chicago. Steve Swinson is currently chairman of the board of Vexim, a medical device company specializing in minimally invasive treatment of vertebral fractures and is also on the board of directors of Acteon Group, a leader in dental equipment and imaging products.

Dirk Dembski has held a variety of roles in biotechnology, orthopaedics and medical companies and has built and driven global sales and marketing operations and served in business development positions. He is currently serving as Managing Director of bricon Group, the German business unit of Naton Medical Group, one of China’s largest Medtech companies, where he completed several acquisitions and drives the international business. He also worked as Vice President of Sales, Marketing and Business Development at Olympus Biotech for EMEA, Asia Pacific and Latin America, where he successfully marketed a portfolio of bone growth factors, cell technologies and innovative biomaterials. Dirk has also worked as director of sales and marketing for Small Bone Innovations, a bone medical technology company which was acquired by Stryker.

Marc Nolet de Brauwere van Steeland, stepped down as a Non-Executive Director on 30 June having served on the Bone Therapeutics Board since 2015.

Thomas Lienard, Chief Executive of Bone Therapeutics, said: “With the election of Steve Swinson as Chairman, and the appointments of Dirk Dembski and Damian Marron, we have a world-leading Board to support Bone Therapeutics as we approach critical inflection points for our allogeneic cell therapy platform. Our new Board members bring a unique and highly complementary set of skills and expertise in the development and commercialisation of orthopaedic and cell therapy products. I would like to welcome Steve and our other new Board members and also to thank Michel Helbig for his four years of service to Bone Therapeutics. Michel has provided calm and judicious guidance to the company through key strategic developments, including helping to steer the Company through its 2015 Initial Public Offering. Michel was instrumental in building the strong management team that will prove critical as the Company advances its allogeneic cell therapy platform towards commercialization, as well as in the development of the board since IPO. He has also played a key role more recently in recruiting top-level board members with strong international experience in the field in which Bone Therapeutics operates. We are delighted that he will remain on the Board to provide continued support.“

Steve Swinson, Chairman of Bone Therapeutics, commented: “I feel excited and privileged to be taking the role of Chairman at Bone Therapeutics. This is the most advanced Company in regenerative therapies for bone diseases which I believe has the potential to transform medical practice in this field. I hope to be able to apply my deep experience in medical technology to support Thomas Lienard and his team, alongside my colleagues on the Board, as we move this key product platform towards commercialization.“

Dirk Dembski added: “I feel my previous experience and expertise wil be invaluable to Bone Therapeutics as it develops into a commercially ready company. I look forward to working with Steve and the rest of the Board to help steer the company as it brings its exciting technologies to market.“

About Bone Therapeutics

Bone Therapeutics is a leading cell therapy company addressing high unmet needs in orthopaedics and bone diseases. Based in Gosselies, Belgium, the Company has a broad, diversified portfolio of bone cell therapy products in clinical development across a number of disease areas targeting markets with large unmet medical needs and limited innovation.

Our technology is based on a unique, proprietary approach to bone regeneration which turns undifferentiated stem cells into “osteoblastic”, or bone-forming cells. These cells can be administered via a minimally invasive procedure, avoiding the need for invasive surgery.

Our primary clinical focus is ALLOB®, an allogeneic “off-the-shelf” cell therapy product derived from stem cells of healthy donors, which is in Phase II studies for the treatment of delayed-union fractures and spinal fusion. The Company also has an autologous bone cell therapy product, PREOB®, obtained from patient`s own bone marrow and currently in Phase III development for osteonecrosis and non-union fractures.

Bone Therapeutics` cell therapy products are manufactured to the highest GMP standards and are protected by a rich IP estate covering nine patent families. Further information is available at: www.bonetherapeutics.com.

Contacts

Bone Therapeutics SA
Thomas Lienard, Chief Executive Officer
Wim Goemaere, Chief Financial Officer
Tel: +32 (0)2 529 59 90
investorrelations@bonetherapeutics.com

For Belgium and International Media Enquiries:
Consilium Strategic Communications
Amber Fennell, Jessica Hodgson and Hendrik Thys
Tel: +44 (0) 20 3709 5701
bonetherapeutics@consilium-comms.com

For French Media and Investor Enquiries:
NewCap Investor Relations & Financial Communications
Pierre Laurent, Louis-Victor Delouvrier and Nicolas Merigeau
Tel: + 33 (0)1 44 71 94 94
bone@newcap.eu

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors` current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person`s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

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Smith & Nephew and University of Hull collaborate to drive research into pioneering approaches to advanced wound care

Posted On July 5, 2017 By OrthoSpineNews In Biologics /  

Smith & Nephew (LSE:SN, NYSE:SNN), the global medical technology business, and the University of Hull today announce a long-term collaboration driving research into pioneering approaches to advanced wound care.

The partnership will create one of the world’s largest Wound Care Research Clusters, combining world-leading academia and industry with the aim of developing scientific insights and innovative treatments for advanced wound care.

A five year framework has been established which sees a co-investment of around £3 million. Within this, eight multi-disciplinary PhD studentships have been created.

Dr David Richards, Pro-Vice Chancellor for Research and Enterprise at the University of Hull, said: “This partnership goes to further strengthen our links with industry at the same time as creating a global hub for pioneering new approaches in this field. By combining the considerable expertise we have at the University with those at Smith & Nephew, we will drive research which will help to position ourselves as global leaders in this field.”

Dr Matthew Hardman, Wound Healing Research Group Head, University of Hull, said: “I am delighted by the establishment of this exciting new multi-disciplinary wound care cluster. This venture brings together a team of experts from across the University and builds upon our existing links with a world-leader in advanced wound management. This exciting partnership will ultimately deliver significant patient benefits.”

The collaboration has been welcomed by new local MP Emma Hardy, who commented: “Britain is a global leader in medical technology innovation. Partnerships such as this between Smith & Nephew and University of Hullfurther strengthen our position at the forefront of global medical research and development. Creating one of the largest wound care clusters in the world is a huge vote of confidence in the UK as a whole and Hull in particular, as we build a ‘global Britain’ with pioneering medical technology at its heart.”

Supporting the collaboration is Smith & Nephew’s new state-of-the-art Research & Development (R&D) centre in Hull, UK, and the University of Hull’s £28-million new Health Campus, due to open in the summer. Smith & Nephew’s R&D hub for wound management technologies, which opened on 12 May, specialises in toxicology, chemistry and microbiology among other specialist fields. Smith & Nephew’s Hull site also manufactures some of the world’s most advanced wound care products, including pioneering products such as PICO◊, a unique single use negative pressure wound therapy system and ALLEVYN◊  Life advanced foam dressings.

The University of Hull’s new Health Campus is due to open in July this year. At its heart is the Allam Medical Building which will house the University’s new Institute for Clinical and Applied Health Research and includes specialist biomedical and clinical research facilities, as well as a mock hospital ward, operating theatre and intensive care nursing facilities.

Smith & Nephew will extend the use of its facilities to the Wound Care Cluster PhD students through dedicated workshops and providing industrial placement supervisors. University of Hull alumni make up around 25% of staff within wound research and development at Smith & Nephew in Hull, with many more across different roles within the company.

Stewart McKinlay, Vice President of Research & Innovation, Smith & Nephew, said “We are thrilled that the University of Hull shares our passion for the importance of advancing the science of wound care. Pioneering innovation is a strategic priority for Smith & Nephew. This partnership will combine the brightest minds with the finest R&D facilities available with the aim of better supporting healthcare professionals in the advanced treatment of wounds, which is an area of significant unmet medical need and a substantial cost to healthcare systems.

“There will be opportunities for students and employees to interact on a daily basis to share knowledge, best practice and support our ambitious R&D pipeline. Combine that with the scale of scientific specialities that is based here, then this partnership is a truly exciting prospect.”

 

Enquiries

Media
Charles Reynolds
Smith & Nephew

 

 +44 (0) 1923 477314
Ben Atwell / Matthew Cole
FTI Strategic Consulting

 

 +44 (0) 20 3727 1000
Investors
Ingeborg Oie
Smith & Nephew		 +44 (0) 20 7401 7646
   


About Smith & Nephew

Smith & Nephew is a global medical technology business dedicated to helping healthcare professionals improve people’s lives. With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma & Extremities, Smith & Nephew has around 15,000 employees and a presence in more than 100 countries. Annual sales in 2016 were almost $4.7 billion. Smith & Nephew is a member of the FTSE100 (LSE:SN, NYSE:SNN).

For more information about Smith & Nephew, please visit our website www.smith-nephew.com, follow @SmithNephewplc on Twitter or visit SmithNephewplc on Facebook.com.

Forward-looking Statements

This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading margins, market trends and our product pipeline are forward-looking statements. Phrases such as “aim”, “plan”, “intend”, “anticipate”, “well-placed”, “believe”, “estimate”, “expect”, “target”, “consider” and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith & Nephew, these factors include: economic and financial conditions in the markets we serve, especially those affecting health care providers, payers and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls or other problems with quality management systems or failure to comply with related regulations; litigation relating to patent or other claims; legal compliance risks and related investigative, remedial or enforcement actions; disruption to our supply chain or operations or those of our suppliers; competition for qualified personnel; strategic actions, including acquisitions and dispositions, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational nature. Please refer to the documents that Smith & Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith & Nephew’s most recent annual report on Form 20-F, for a discussion of certain of these factors. Any forward-looking statement is based on information available to Smith & Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith & Nephew are qualified by this caution. Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith & Nephew’s expectations.

 

◊ Trademark of Smith & Nephew.  Certain marks registered US Patent and Trademark Office.

 

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prolift.jpg

Life Spine Announces Full Commercial Release of Key Additions to the OSSEO-LOC™ Product Family

Posted On July 5, 2017 By OrthoSpineNews In Spine /  

July 03, 2017

HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders today announced the full commercial launch of key additions to the OSSEO-LOC™ spinal implant family.

ProLift® Expandable PLIF/TLIF Spacer System and TiBOW™ Expandable TLIF Spacer System join Life Spine’s OSSEO-LOC offering of titanium surface treated implants. OSSEO-LOC is a proprietary surface treatment that creates a unique osteophylic surface architecture for potential bone on-growth.1 The unique surface architecture promotes mineralization of implant, while negating potential challenges associated with surface treated implants.2 OSSEO-LOC surface treatment maintains native titanium grain structure and material, and has been designed to optimize intervertebral stability.1

Other key OSSEO-LOC implants include the static spinal spacer systems PLATEAU®-C (cervical spacer system), PLATEAU-Z Ti (TLIF spacer system), PRO-LINK® TI (stand-alone cervical spacer system), PLATEAU TI (straight and curved PLIF and TLIF spacer systems); SImpact™ lag and compression screws for sacroiliac fixation and stabilization.

Mariusz Knap, Vice President of Marketing noted, “We are excited to launch the key additions to the OSSEO-LOC family of spinal implants, as it deepens Life Spine’s commitment to provide surgeons with access to our highly differentiated, minimally invasive spinal products. Addressing a variety of pathologies, Life Spine’s procedural based solutions increase the value of care by delivering both the ability to correct spinal alignment and improved patient experiences and outcomes. This will be a driving force as we continue to expand Life Spine’s wide range of surgical solutions.”

About Life Spine

Life Spine is dedicated to improving the quality of life for spinal patients by increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Life Spine, which is privately held, is based in Huntley, Illinois. For more information, please visit: http://www.lifespine.com.

Life Spine is a registered trademark.

1Feighan, J.E., Goldberg, V.M., Davy, D., Parr, J.A., Stevenson, S.
“The Influence of Surface Blasting on the Incorporation of Titanium-Alloy Implants in a Rabbit Intramedullary Model.” The Journal of Bone and Joint Surgery 77.9 (1995): 1380-96. Web.

2K.Kieswetter, Z. Schwartz, T. W. Hummert, D. L. Cochran, J. Simpson and B. D. Boyan
“Surface roughness modulates the local production of growth factors by osteoblast-like MG-62 cells” The Journal of Biomedical Materials Research (1996): Web.

Contacts

Life Spine
Mr. Omar Faruqi
Chief Financial Officer
ofaruqi@lifespine.com
847-884-6117

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