Halyard Health Introduces Five New COOLIEF* Multi-Cooled RF Kits

Posted On September 7, 2017 By OrthoSpineNews In Extremities, Top Stories /

ALPHARETTA, Ga., Sept. 6, 2017 /PRNewswire/ — Halyard Health (NYSE: HYH), a medical technology company focused on eliminating pain, speeding recovery and preventing infection, today announced the introduction of five new COOLIEF* Multi-Cooled RF Kits for use in performing COOLIEF Cooled Radiofrequency (RF) treatments. The new kits expand upon the four existing COOLIEF Multi-Cooled RF Kits by offering different component lengths and active tip sizes to treat additional modalities with our multi-probe kits. These kits allow physicians to ablate up to three nerves at once, saving time and the inconvenience of having to open multiple kits and components.

The new COOLIEF Multi-Cooled RF Kits have been developed to target nerves within the spine and knee. Each kit is equipped with all the components necessary to conduct a multi-probe COOLIEF Cooled RF treatment including the new COOLIEF* Fluid Delivery Introducer (FDI). The FDI enables fluids to be instilled through the port so that the physician can maintain probe placement and reduce instances of repositioning. The five new configurations of COOLIEF Multi-Cooled RF Kits include:

MCK2-17-50-2 (Cervical): 2 Probes, 4 Introducers, 2 Tube Kits
MCK2-17-50-4 (Knee): 2 Probes, 4 Introducers, 2 Tube Kits
MCK2-17-75-2 (Cervical): 2 Probes, 4 Introducers, 2 Tube Kits
MCK2-17-75-5.5 (Thoracic): 2 Probes, 4 Introducers, 2 Tube Kits
MCK3-17-50-4 (Knee): 3 Probes, 6 Introducers, 2 Tube Kits

“The addition of these five new multi-probe kits more than doubles the number of COOLIEF Multi-Cooled RF Kits available to pain physicians,” said Phil Cranmer, associate marketing director, Interventional Pain Management, Halyard Health. “Rather than having to piece together multiple kits and components, the COOLIEF Multi-Cooled RF Kit provides everything they need to perform multiple lesions simultaneously in one cost-effective package based on the type of procedure required.”

COOLIEF Cooled RF is the first and only treatment to receive clearance from the U.S. Food and Drug Administration (FDA) for the relief of chronic moderate to severe knee pain caused by osteoarthritis (OA). COOLIEF Cooled RF is a minimally-invasive and non-surgical outpatient procedure to target and treat the nerves causing chronic pain. This advanced thermal radiofrequency pain management system uses water-cooled technology to safely deactivate pain-causing sensory nerves. COOLIEF Cooled RF has been shown to provide up to 24 months of pain relief, improved physical functionality, and reduced drug utilization.

To learn more about COOLIEF Cooled RF, please visit http://www.halyardhealth.com/chronicpain.

About Halyard Health

Halyard Health Inc. (NYSE: HYH) is a medical technology company focused on eliminating pain, speeding recovery and preventing infection for healthcare providers and their patients. Headquartered in Alpharetta, Georgia, Halyard is committed to addressing some of today’s most important healthcare needs, such as reducing the use of opioids while helping patients move from surgery to recovery and preventing healthcare-associated infections. Halyard’s business segments – Medical Devices and Surgical and Infection Prevention (S&IP) – develop, manufacture and market clinically superior solutions that improve medical outcomes and business performance in more than 100 countries. For more information, visit www.halyardhealth.com.

*Registered Trademarks or Trademarks of Halyard Health, Inc. or its affiliates.

SOURCE Halyard Health, Inc.

Medacta Announces the 250th M.O.R.E. AMIS Learning Center for Surgeons Adopting the Anterior Approach to Hip Replacement

Posted On September 6, 2017 By OrthoSpineNews In Recon, Top Stories /

September 06, 2017

CASTEL SAN PIETRO, Switzerland–(BUSINESS WIRE)–The number of surgeons adopting the anterior approach to hip replacement is on the rise, with an estimated 20 percent of hip surgeons now performing the procedure. Medacta International, the family-owned global leader in the design of innovative joint replacement and spine surgery products, is leading the charge in training and supporting surgeons transitioning to this muscle-sparing technique. Today, the company and the Medacta Orthopaedic Research and Education (M.O.R.E.) Institute announced the execution of the 250^th M.O.R.E. AMIS^® Learning Center, where surgeons from all over the world will come to learn Medacta’s Anterior Minimally Invasive Surgery (AMIS) technique, complete with a system of tools and educational resources designed to support surgeons practicing the anterior approach for hip replacement.

“The promotion of patient well-being through AMIS is a cornerstone of Medacta’s mission, as it exemplifies our belief that only with a strong focus on medical education can surgical innovation truly move the industry forward,” said Francesco Siccardi, Executive Vice President of Medacta International. “The patient-centric technique is also ideal for the outpatient or same-day surgery setting, providing more options for both surgeons and patients in today’s changing healthcare landscape.”

The AMIS technique, informed by decades of clinical experience, is a muscle-sparing approach to total hip replacement that is associated with potential positive patient outcomes like shorter hospitalization and rehabilitation time, as well as a faster return to daily activities.

Offered as part of the M.O.R.E. Institute, the M.O.R.E. AMIS Education Program is a comprehensive offering for surgeons seeking to become proficient in the technique, including ongoing medical education and dedicated implants and instruments. To date, more than 5,500 surgeons across 31 countries have received training through the program. At the end of 2016, that translated to more than 80,000 hours of proctoring and surgeon-to-surgeon mentoring. In the field, surgeons have performed more than 250,000 total hip replacements utilizing the AMIS platform so far.

“The anterior approach to hip replacement has also been gaining traction among patients who are attracted to the possibility of a faster recovery and return to their daily lives,” said Frédéric Laude, M.D., a pioneer of the technique from Paris, France. “There is a learning curve associated with the approach though, so both hands-on and technical support are crucial to success. The level of attention and support Medacta provides through its M.O.R.E. AMIS Education Program is unparalleled.”

The 250^th M.O.R.E. AMIS Learning Center will be held September 15-16, 2017 in Chicago, IL, followed by a European installment September 25-26, 2017 in Basel, Switzerland. More information on the AMIS platform can be found at https://www.medacta.com/EN/amis.

About the M.O.R.E. AMIS Education Program

Education is the most crucial tool to drive clinical proficiency and innovation, as well as patient outcomes across the globe. To support positive outcomes in the operating room, Medacta created the AMIS Education Program, a comprehensive multistep training process within its M.O.R.E. Institute. The Program involves visiting a Reference Center to watch live surgery, attending a M.O.R.E. AMIS Learning Center, and ultimately performing surgery with support from an AMIS certified surgeon proctor. Throughout, product specialists and surgeons are available to provide mentorship and support. Approximately 85 percent of surgeons trained via the M.O.R.E. AMIS Education Program continue to use the approach once their training is complete.

About the M.O.R.E. Institute – “Where the surgeon is never alone”

Strongly aware of its role to provide continuing education as products and techniques evolve, Medacta International founded the Medacta Orthopaedic Research and Education (M.O.R.E.) Institute to highlight this commitment. Built on the ideal of sharing experience within the international medical community, the mission of the M.O.R.E. Institute is to provide ongoing support to Medacta partners worldwide as they strive to make an impact by learning about and adopting emerging technologies, surgical techniques and orthopaedic products. The Institute includes the M.O.R.E. AMIS Education Program for total hip arthroplasty, which has revolutionized the teaching of the anterior approach to hip replacement throughout the world, as well as platforms to impact the specialties of partial and total knee arthroplasty, total and reverse shoulder arthroplasty, sports medicine and spine surgery. The Institute relies on Medacta consultants and the healthcare provider community to create networking opportunities and hundreds of educational events, including courses, wet labs, scientific evenings, surgeon-to-surgeon visits, international symposia, guesting and hosting thousands of participants from all over the world. With a strong focus on young and promising surgeons, the M.O.R.E. Institute also supports fellowship programs worldwide.

About Medacta

Medacta^® International is a world leading manufacturer of orthopedic implants, neurosurgical systems, and instrumentation. Medacta’s revolutionary approach and responsible innovation have resulted in standard of care breakthroughs in hip replacement with the AMIS^®system and total knee replacement with MyKnee^® patient matched technology. Over the last 10 years, Medacta has grown dramatically by taking a holistic approach and placing value on all aspects of the care experience from design to training to sustainability. Medacta is headquartered in Castel San Pietro, Switzerland, and operates in over 30 countries. To learn more about Medacta International, please visit www.medacta.com or follow @Medacta on Twitter.

Contacts

for Medacta International, Inc.
Jill Bongiorni, 516-729-2250
Jill@torchcomllc.com

OMNIlife science™, Inc. Receives 510(k) Clearance from FDA for Revolutionary Robotic Tissue Balancing Device

Posted On September 6, 2017 By OrthoSpineNews In Regulatory, Robotics, Top Stories /

AYNHAM, Mass., Sept. 6, 2017 /PRNewswire/ — OMNIlife science, Inc. (“OMNI™”), a privately-held, established medical technology company targeting the $15 billion global hip and knee replacement device market, announced today that the FDA has issued 510(k) clearance for its proprietary robotic tissue balancing device which is used with OMNI’s market-leading OMNIBotics® robotic-assisted total knee replacement technology platform.

This new technology, in clinical use since March in Australia, provides the surgeon with a quantitative tool to actively manage the soft tissue envelope with dynamic real-time feedback. When combined with the accuracy of alignment and bone cuts provided by the OMNIBotics system, the result is a completely customized procedure from both a skeletal perspective as well as a soft tissue perspective.

“Our proprietary Active Spacer technology represents a unique and significant step in the development of our OMNIBotics robotic platform. We have been convinced that a perfect knee alignment is not enough to enable good outcomes for our surgeons and their patients,” said Guy Mayer, Executive Chairman of OMNI’s Board of Directors. “We believe that our surgeons can now perform the perfect total knee replacement with our innovative robotic soft tissue balancing technology coupled with the optimum knee alignment provided by our OMNIBotics technology.”

The OMNIBotics system enables optimized knee implant placement using robotics driven by OMNI’s proprietary ART™ software. With more than 16,000 OMNIBotics procedures performed to date worldwide, it eliminates the need for preoperative CT scans or x-rays. Intraoperative adjustments are easily made, and the precise alignment of the implant may lead to a more rapid recovery and a more natural feeling total knee replacement.^1,2

“This is a major milestone for both OMNI and for the orthopedic market,” stated Christian Joly, Vice President of Robotics at OMNI. “We are now the only company in the world to provide a robotic technology to quantitatively drive the total knee replacement surgical procedure with both alignment and ligament balancing.”

¹Koenig JA, Suero EM, Plaskos C: Surgical Accuracy and Efficiency of Computer-Navigated TKA with a Robotic Cutting Guide – Report on First 100 Cases. J Bone Joint Surg Br 2012 vol 94-B no. SUPP XLIV 103.
²Revenga C, et al, Computer-Assisted Navigation Versus Conventional Total Knee Arthroplasty In A Spanish Multicenter Study. 16th EFORT Congress. London. 2014.

ABOUT OMNI

OMNI is a privately held company with a proprietary robotic platform, OMNIBotics®, which allows surgeons to conduct patient-specific total knee surgery designed to enhance patient satisfaction and reduce hospital costs. In addition, OMNI designs, engineers, manufactures and distributes a wide range of proprietary hip and knee implants and is focused on providing cutting edge technologies to transform outcomes in joint replacement surgery and enhance a surgeon’s ability to help patients live active and pain-free lives. For more information about OMNI, please visit www.omnils.com.

FORWARD LOOKING STATEMENTS

Statements in this press release concerning the future business, operations and prospects of OMNIlife science, Inc., including its plans specific to OMNIBotics systems, as well as statements using the terms “plans,” “believes” or similar expressions are “forward-looking” statements as defined in the Private Securities Litigation Reform Act of 1995. These statements are based upon management’s current expectations and are subject to a number of factors and uncertainties. Information contained in these forward-looking statements is inherently uncertain, and actual performance and results may differ materially due to many important factors. Such factors include, among others, changes in competitive conditions and pricing in OMNI’s markets, decrease in the demand for OMNI’s products, delays in OMNI’s product research and development cycles, decreases in the use of OMNI’s principal product lines or in procedure volume, unanticipated issues in complying with domestic or foreign regulatory requirements related to OMNI’s current products or securing regulatory clearance or approvals for new products or upgrades or changes to OMNI’s current products, the impact of the United States healthcare reform legislation on hospital spending and reimbursement, any unanticipated impact arising out of the securities class action or any other litigation, inquiry, or investigation brought against OMNI, increases in costs of OMNI’s sales force and distributors, and unanticipated intellectual property expenditures required to develop, market, and defend OMNI’s products. OMNI cannot guarantee any future results, levels of activity, performance or achievement. OMNI undertakes no obligation to update any of its forward-looking statements after the date of this press release.

CONTACT

Cindy Holloway, Director of Marketing Communications
Phone: (508) 824-2444
cholloway@omnils.com

SOURCE OMNIlife science, Inc.

NuVasive Receives FDA 510(k) Clearance For Leading EOS Innovation

Posted On September 6, 2017 By OrthoSpineNews In Regulatory, Spine, Top Stories /

SAN DIEGO, Sept. 6 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use of the Company’s redesigned MAGEC® system with its RELINE® Small Stature system. NuVasive will feature these new product offerings at the Scoliosis Research Society (SRS) 52nd Annual Meeting & Course to be held September 6-9, 2017 in Philadelphia.

The MAGEC system uses innovative magnetic technology within adjustable growing rods to treat early-onset scoliosis in a less invasive manner. The latest advancements to the MAGEC system include redesigned components to help provide ease-of-use for the surgeon and help make surgical outcomes more reproducible. In addition, the MAGEC system is introducing a new 5.0 millimeter rod diameter offering, that when paired with the low-profile RELINE Small Stature system, is designed to provide optimal strength to growing-rod constructs to help improve clinical outcomes.

RELINE Small Stature is a comprehensive pediatric deformity fixation system allowing to achieve optimal construct strength with a reduced implant profile. RELINE Small Stature is the only small stature system that is compatible with the new 5.0 millimeter MAGEC rod.

“As a low-profile pediatric fixation system, RELINE Small Stature is the first-of-its-kind system to offer competitively-sized pediatric implants that accept up to a 5.0mm rod,” said Matt Link, executive vice president of strategy, technology and corporate development at NuVasive. “The clearance for our redesigned MAGEC system with RELINE Small Stature highlights our speed to market and our further commitment to bringing procedural solutions that transform care to the pediatric deformity market.”

NuVasive has reached meaningful gains in both the adult and pediatric deformity markets, a $2.5 billion opportunity over the last two years and is a leading sponsor of SRS. The Company’s ‘Embracing the Journey Together’ initiative includes pediatric spinal deformity research, education and spinal deformity event support, assisting leading surgeons as they educate other surgeons around the world.

NuVasive will showcase its market-leading, procedurally-integrated technologies in Meeting Room #406 at the Philadelphia Marriot Downtown. Visit here for more details.

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, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA™ platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties 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.

CollPlant in Advanced Negotiations for US Private Placement of USD 5.0 million; Agreement Includes Plan for NASDAQ Uplisting

Posted On September 6, 2017 By OrthoSpineNews In Financial, Top Stories /

NESS ZIONA, Israel, September 5, 2017 /PRNewswire/ —

CollPlant (TASE: CLPT) – a regenerative medicine company utilizing its proprietary plant-based rhCollagen technology for tissue repair products (recombinant human, “rhCollagen”), announce that management is in advanced negotiations with a US investor for a USD 5.0 million private placement. A non-binding term sheet was signed between the parties in July 2017.

Yehiel Tal, CEO of CollPlant: “The planned US investment is intended to further ensure implementation of the Company’s stated strategy, including advancing our work in 3D printing for tissues and organs, the continued commercialization of our products throughout Europe, development of our pipeline products, and upgrading of our manufacturing capabilities. Additionally, we plan to up-list and register the Company’s ADSs for trading on NASDAQ in order to expand our investor base outside of Israel, increase the Company’s trading volume, and enhance public exposure for the Company.”.

The proposed private placement will take place in three tranches. The first will include a payment of USD 2.0 million, which will be transferred to the Company shortly after signature of the transaction agreements. The second tranche will include a payment of an additional USD 2.0 million, which will be transferred to the Company shortly after approval of the transaction by a general meeting of the Company’s shareholders, which will be convened shortly after signature of the transaction agreements. The third tranche will entail a payment of USD 1.0 million, which will be transferred to the Company shortly after the up-listing to NASDAQ.

In return, the Company will issue the investor ordinary shares in a restricted private placement and will issue a convertible bond as detailed below. The shares to be allocated upon completion of the first tranche will represent, upon issue, up to 9.99% of the Company’s issued and paid up share capital immediately following the issue. The price per share will be calculated at a company valuation of NIS 50 million (pre-money value), including for shares that will be allocated as a result of conversion of the bond.

For the balance of the proceeds the Company will issue the investor a convertible, non-interest bearing bond, with the bond being automatically converted (subject to fulfillment of several technical terms) to pre-funded warrants when the ADSs are registered for trading on NASDAQ. The bond can be converted by the investor at any time.

Similarly, upon completion of registration on NASDAQ, the Company will issue the investor warrants that can be exercised for a period of five years from the date of issuance, at an exercise price of 200% of the share price in the transaction (for each warrant). The warrants will be subject to regular adjustments.

Under terms of the proposed transaction, the investor will assist the Company in its registration on NASDAQ, and in return, the Company will allocate the investor (upon completion of the first and second tranches) equity securities representing 5% of the Company’s issued share capital, as it was immediately prior to completion of the first tranche. The investor will be entitled to receive registration rights on NASDAQ for the ordinary shares (or ADSs) that it will hold.CollPlant also noted today that several main shareholders have announced their intent to make a significant investment in the Company, subsequent to closing of to the US private placement.

CollPlant has begun penetrating the European market with two products based on the Company’s unique rhCollagen technology, which is produced from the tobacco plant. The first is Vergenix™STR, for the treatment of tendinopathy. Arthrex GmbH, a leading multinational company in the orthopedic market with a leading reputation and experienced sales network, is the exclusive distributor for the product in Europe, the Middle East, India and Africa. Sales of Vergenix^®FG, an injectable gel compound, indicated for the treatment of chronic wounds and operating room incisions — including diabetic ulcers — are also underway in several European countries through local distributors.

About CollPlant

CollPlant is a regenerative medicine company leveraging its proprietary, plant-based recombinant human collagen (rhCollagen) technology for the development and commercialization of tissue repair products, initially for the orthobiologics, 3D Bio-printing of tissue and organs, and advanced wound care markets. The Company’s cutting-edge technology is designed to generate and process proprietary rhCollagen, among other patent-protected recombinant proteins. Given that CollPlant’s rhCollagen is identical to the type I collagen produced by the human body, it offers significant advantages compared to currently marketed tissue-derived collagen, including improved biofunctionality, superior homogeneity and reduced risk of immune response. The Company’s broad development pipeline includes biomaterials indicated for orthopedics and advanced wound healing. Lead products include: Vergenix^®STR (Soft Tissue Repair Matrix), for the treatment of tendinopathy; and Vergenix^®FG (Flowable Gel) wound filler, for treatment of acute and chronic wounds. CollPlant’s business strategy includes proprietary development and manufacture of tissue repair products and their commercialization and distribution, together with leading third parties, alongside alliances with leading companies for joint development, manufacture and marketing of additional products.

For more information about CollPlant, visit http://www.collplant.com

Contact at CollPlant:
Eran Rotem
Chief Financial Officer
Tel: + 972-73-2325600/612
Email: Eran@collplant.com

Contact at Rx Communications Group, LLC:
Paula Schwartz (for US Investors)
Managing Director
Tel: 917-322-2216
Email: pschwartz@rxir.com

SOURCE CollPlant

SpineGuard Announces 3 Promotions to Strengthen Its Organization

Posted On September 6, 2017 By OrthoSpineNews In Spine, Top Stories /

September 06, 2017

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

SpineGuard (Paris:ALSGD) (FR0011464452 – ALSGD), an innovative company that designs, develops, and markets disposable medical devices intended to make spine surgery safer, announced today three promotions to optimize its organization toward its goal of operational profitability by the end of 2018.

Stéphane Bette, CEO of SpineGuard, said: ‘We are very proud to announce these internal promotions as they reward highly talented members of our team with significant experience: Patricia, Olivier and Steve all contributed greatly to the development of our company over many years. Through their new responsibilities and expanded scope, they will further support me in executing on our strategic goals in particular to reach operational profitability.’

Steve McAdoo, adds: ‘I am very excited to assume my new role within SpineGuard as we to continue to leverage our DSG™ technology in medical device markets, drive additional growth and progress toward profitability. We will continue to work with our customers and partners in the mission of making surgery safer through implementation of DSG Technology, a unique differentiating factor in the market.’

Olivier Frézal, continues: ‘I am thrilled by this this new position. I have been involved in the technical activities of the company over the last years and I have the privilege to lead a strong, dedicated and experienced team. Our current Research projects and subsequent patent filing activities will materialize the incredible potential of our DSG technology.’

Patricia Lempereur concludes: ‘I look forward to taking on these expanded responsibilities as we continue to develop our disruptive technology. Over the years, I have been intimately involved in the international sales process and feel confident in embracing this new role. With our Marketing and Sales teams, we will continue to provide the same quality of support and service to our customers and we are poised to positively impact our international business in line with the new strategy of the company.’

Broadened missions

Steve McAdoo (over 28 years of experience with Sales, Marketing and Business Development of Medical Devices, Bachelor of Science in Biology, Smith & Nephew, Danek, Medtronic, Cerapedics, Biomet, with SpineGuard since 2016) will manage the American subsidiary SpineGuard, Inc. replacing Stephane Bette who was appointed CEO on July 13^th. Steve will continue to lead global initiatives in Business Development.
Olivier Frézal (17 years of experience in R&D and Management in the Spine Industry, ENSAM Master of Engineering and Biomechanics, LBM, SpineVision, worked on the DSG™ technology for 12 years, with SpineGuard since 2009) will lead the innovation strategy, IP, development of new products and technologies and will supervise Manufacturing and RAQA activities.
Patricia Lempereur (15 years of experience in Medical Device, Master in Biotechnologies & Management, SpineVision, Medicrea, with SpineGuard since 2009), will be in charge of the International Sales in addition to International Marketing and Worldwide lead for marketing tools and programs.

Next financial press release: H1 2017 results on Sept 14^th 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 55,000 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
Stéphane Bette, Tel. : +33 (0) 1 45 18 45 19
Chief Executive Officer
s.bette@spineguard.com
or
Manuel Lanfossi, Tel: +33 (0)1 45 18 45 19
Chief Financial Officer
m.lanfossi@spineguard.com
or
NewCap
Investor Relations & Financial Communication
Florent Alba / Pierre Laurent
Tel: +33 (0)1 44 71 94 94
spineguard@newcap.fr

$8.7 Million Awarded to Support Phase III Femoral Neck Fracture Trial by EU Horizon 2020 Program

Posted On September 6, 2017 By OrthoSpineNews In Biologics, Top Stories /

HAIFA, Israel, Sept. 05, 2017 (GLOBE NEWSWIRE) — Pluristem Therapeutics Inc. (NASDAQ:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, announced today that its Phase III study of PLX-PAD cells to support recovery following surgery for femoral neck fracture has been awarded an $8.7 million (7.4 million Euro) non-dilutive grant from the Horizon 2020 program, the European Union’s largest research and innovation program. Final approval of the grant is subject to the finalization of the consortium and Horizon 2020 grant agreements. This marks the second grant awarded to a Pluristem Phase III trial by Horizon 2020, following an $8 million (7.6 million Euro) award for its ongoing Phase III study of PLX-PAD cells in the treatment of Critical Limb Ischemia (CLI), which was awarded in August 2016.

The Phase III trial of PLX-PAD cells in the treatment of femoral neck fracture will be a collaborative effort between Pluristem and an international consortium led by the Charité – Universitätsmedizin Berlin, under the leadership of Dr. Tobias Winkler, Principal Investigator at the Berlin-Brandenburg Center for Regenerative Therapies, Julius Wolff Institute and Center for Musculoskeletal Surgery. Dr. Winkler also served as Senior Scientist for Pluristem’s completed Phase I/II study of PLX-PAD for hip surgery. That trial demonstrated that patients treated with Pluristem’s PLX-PAD cells during total hip arthroplasty experienced significant muscle regeneration compared to the control group with an improvement in muscle force and in muscle volume six months after surgery.

Dr. Winkler commented, “Following the impressive results from the Phase I/II study of PLX-PAD cells in a similar orthopedic indication, we are excited to advance PLX-PAD cell therapy into a Phase III study to aid in muscle regeneration in patients recovering from femoral neck fracture. If similar results are achieved in this Phase III trial, it could show that PLX-PAD cells can improve outcomes in these procedures and change the way recovery is managed worldwide.”

Femoral neck fracture is the most common form of hip fracture, with mortality rates of up to 36%, and annual treatment costs estimated to be between $10-$15 billion in the U.S. alone. The number of surgeries performed annually to treat femoral neck fractures is increasing as populations age. Following surgery, many patients do not regain their baseline capabilities due to poor muscle healing and regeneration, which leads to significantly increased morbidity and a lower quality of life.

“We are honored to receive this second grant from the Horizon 2020 program,” stated Pluristem Chairman and Co-CEO Zami Aberman. “We believe this grant reflects a vote of confidence by the European Union and signals the need for cell therapy solutions to enable patients to lead healthier lives and to relieve health systems’ financial burdens. We are confident that this grant will help us move towards rapid entry into the European and U.S. markets.”

Pluristem’s PLX-PAD program is one of only a handful to be accepted into Europe’s Adaptive Pathway program, the purpose of which is to shorten the time it takes for innovative medicines to reach patients with serious conditions that lack adequate treatment options. Pluristem plans to enroll patients at clinical sites throughout Europe and the U.S. The study is expected to serve as a pivotal trial for regulatory approval in both regions.

About the Berlin-Brandenburg Center for Regenerative Therapies

The Berlin-Brandenburg Center for Regenerative Therapies (BCRT) was founded as a cooperative research institution of the Charité University Hospital in Berlin, which is one of the largest university hospitals in Europe, and Germany’s largest research association, the Helmholtz Association. The goal of the BCRT is to enhance endogenous regeneration by cells, biomaterials, and factors which can be used to develop and implement innovative therapies and products. The primary focus of the BCRT is on diseases of the immune system, the musculoskeletal system and the cardiovascular system for which currently only unsatisfactory treatment options are available.

About Pluristem Therapeutics

Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells, and is entering late-stage trials in several indications. PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage. The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.

Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.

Safe Harbor Statement

This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, Pluristem is using forward-looking statements when its discusses the Phase III Studies of PLX-PAD cells and possible results, that the final approval of the Horizon 2020 grant is subject to finalizing the consortium and Horizon 2020 grant agreements, that Pluristem believes the grant is a vote of confidence by the European Union and signals the need for cell therapy solutions to enable patients to lead healthier lives and to relieve health systems’ financial burdens, when Pluristem states it is confident that the grant will help it move towards rapid entry into the European and U.S. markets and that the Phase III femoral neck fracture study is expected to serve as a pivotal trial for regulatory approval in the European Union and the U.S. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.

Contact:

Karine Kleinhaus, MD, MPH 
Divisional VP, North America 
1-914-512-4109 
karinek@pluristem.com                                     

Efrat Kaduri 
Head of Investor and Public Relations 
972-74-7108600 
efratk@pluristem.com

Medtronic Launches Long Term Clinical Study Program of INFUSE Bone Graft in Two Common Spine Procedures: PLF and TLIF

Posted On September 5, 2017 By OrthoSpineNews In Spine, Top Stories /

DUBLIN – September 5, 2017 – Medtronic plc (NYSE: MDT) today announced the launch of a long term clinical study program to collect prospective data on INFUSE^® Bone Graft in Posterolateral Fusion (PLF) and Transforaminal Lumbar Interbody Fusion (TLIF) spine procedures. The first patient has been enrolled in the PLF study at Fort Wayne Orthopedics in Fort Wayne, Ind. The Spine team led by Dr. Kevin Rahn and Dr. Robert Shugart performed the procedure. The use of INFUSE Bone Graft in PLF and TLIF procedures is investigational only.

“Failed back surgery is a real concern with long-term implications, and successful outcomes in PLF and TLIF procedures require solid fusion,” said Dr. Brian Subach, president at The Virginia Spine Institute. “We believe there is significant data on the safety and efficacy profile of INFUSE in approved ALIF and OLIF procedures, and we are hopeful this clinical study program can generate evidence about the potential to use this important technology to help a broader group of patients.”

INFUSE Bone Graft is used with certain Medtronic interbody fusion devices to treat lumbar degenerative disc disease, and eliminates the need to harvest bone from the patient’s body in a secondary surgical procedure.

The global clinical program, called B.O.N.E (BMP Outcomes and New Evidence in PLF and TLIF Procedures), is designed to expand the clinical understanding of INFUSE and to evaluate efficacy, safety and health-economic outcomes for use in PLF and TLIF spine procedures. The current plan for the prospective, multi-center, ten-year program will include approximately 40-50 sites and 550-700 patients between the Pilot and Pivotal studies of both procedures. The PLF Pilot dosing study, which will include approximately 125 patients, will be followed by a TLIF Pilot dosing study in 2018. If successful, the Pilot studies would be followed by a larger Pivotal study. The results may also potentially be used to support peer-reviewed publications and regulatory filings.

“INFUSE is one of the most extensively-researched biologic agents commercially available today and Medtronic continues to invest in research of INFUSE to deepen the understanding of the benefits and risks of this novel treatment,” said Doug King, senior vice president and president of Medtronic’s Spine division, which is part of the Restorative Therapies Group. “We’re hopeful that if successful, the trials will generate additional data to expand indications and provide surgeons with additional options to help alleviate pain and restore health for more patients.”

About Degenerative Disc Disease
Back pain, including degenerative disc disease (DDD), is a significant issue that is increasing as the population ages. One in four adults suffer from chronic low back pain and it causes 52 million health care visits annually. DDD is typically a result of an aging disc or repeated physical stresses over extended periods of time. In the United States, more than 300,000 individuals with a variety of spinal conditions, like DDD, undergo spinal fusions annually to treat degenerative changes in the lumbar spine.

About INFUSE BONE GRAFT
INFUSE Bone Graft is FDA-approved for certain spine, oral-maxillofacial and orthopedic trauma surgeries. The active ingredient in INFUSE Bone Graft (rhBMP-2) is a manufactured version of a protein already present in the body that promotes new bone growth. During surgery, INFUSE is applied to an absorbable collagen sponge (ACS). The ACS is a carrier to deliver the rhBMP-2 to the implant site and acts as a scaffold for the formation of new bone, and it will resorb, or disappear, over time. INFUSE has been on the market since 2002 and more than one million patients have used INFUSE.

About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world’s largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 84,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

Contacts:
Eric Epperson
Public Relations
+1-901-344-1435

Ryan Weispfenning
Investor Relations
+1-763-505-4626

ApiFix Signs Distribution Agreement in Canada; Completes First Cases in North America at IWK Health Centre Hospital, Halifax

Posted On September 5, 2017 By OrthoSpineNews In Spine, Top Stories /

ApiFix has invented and developed a non-fusion spinal implant system for the correction of Adolescent Idiopathic Scoliosis (AIS). The implant system is inserted in a minimally invasive surgical procedure. The ApiFix system aims to improve the quality of life of patients who undergo scoliosis surgery, save hospitalization and OR time, and substantially reduce costs and recovery time associated with standard scoliosis surgery. In contrast to standard scoliosis surgery, the ApiFix system represents a game-changer in the market, with a spinal implant system, inserted in a short procedure, followed by a brief recovery period, and maintains spine flexibility.

“With our vast experience in the spine surgical field, we instantly understood the significance of the device for scoliosis patients and its market potential. We are delighted to join forces with ApiFix and exclusively distribute their products in Canada,” stated Joint Solution Alliance President, Alan Tanner.

ApiFix CEO Eran Feldhay, M.D. remarked: “We are excited to begin our penetration in the North American markets with Canadian patients. We are convinced that together with JSA we’ll succeed in delivering the ApiFix solution to more patients around the world.”

About ApiFix

ApiFix is an innovation-driven medical device company focused on providing less invasive solutions for scoliosis patients. ApiFix’s leading product for non-fusion treatment of adolescent idiopathic scoliosis (AIS) is used today in Europe. ApiFix is led by a team of highly-regarded spine surgeons and veteran spine specialists. The company has CE clearance and is marketed in Germany, Italy, Greece, The Netherlands, Spain, Australia and Israel.

ApiFix Principals will be available to discuss the ApiFix system, clinical cases and their follow-up to potential spine surgeons from all over the world during the annual meeting of the Scoliosis Research Society, (SRS) in Philadelphia, USA on September 5-8.

Contact:
Saar Wollach,
ApiFix Sales & Marketing Manager,
+972-54-4511512,
saar@apifix.com

SOURCE ApiFix

MiMedx Reports MultiCenter randomized Controlled VLU Clinical Study Accepted for Publication in The International Wound Journal

Posted On August 31, 2017 By OrthoSpineNews In Biologics, Top Stories /

MARIETTA, Ga., Aug. 31, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare, announced today that their latest peer-reviewed clinical study of the MiMedx dehydrated human amnion/chorion membrane (“dHACM”) allografts was accepted for publication in the International Wound Journal.

The paper entitled “A Multicenter Randomized Controlled Trial Evaluating the Efficacy of Dehydrated Human Amnion/Chorion Membrane (EpiFix) Allograft for the Treatment of Venous Leg Ulcers,” was authored by Christian Bianchi, MD, FACS; Shawn Cazzell, DPM, FACFAS; Dean Vayser, DPM, FACFAS; Alexander M. Reyzelman, DPM, FACFAS; Hasan Doslouglu, MD, FACS; Gregory Tovmassian, DPM; and the EpiFix VLU Study Group of Delores Farrer, DPM, MBA, CWS; Elisa Taffe, MD; Lacey Loveland, DPM; David O’Connor, MD; Marc D. Baer, DPM, FACFAS; and Sara Dahle, DPM, MPH. The electronic publication of the article in the International Wound Journal is expected to be made in the next few weeks. At that time, MiMedx expects to issue a follow-up press release with the detailed study results and link to the article.

Parker H. Petit, Chairman and CEO, stated, “This is the first large scale successful Venous Leg Ulcer (VLU) study to be completed in nearly 20 years, and the first large randomized controlled trial (RCT) of this quality on a biological allograft. No other organization has completed such a VLU study and achieved such compelling results. Our EpiFix bilayer allograft is the first and only biologic with these confirmed clinical results. This study is evidence that MiMedx continues to distance itself from our competitors.”

Bill Taylor, President and COO, said, “The 16 week randomized, fifteen-center, clinical trial evaluated the efficacy of MiMedx EpiFix® as an adjunct to moist wound dressings and multilayer compression bandages for the treatment of non-healing full-thickness VLUs. The 109 subjects were randomized to receive EpiFix in addition to moist dressings and compression or moist dressings and compression alone. The primary endpoint was time to complete healing. Secondary endpoints were the proportion of subjects with complete healing by 12 and 16 weeks.”

Taylor continued, “The study results for the patients treated with EpiFix showed VLU healing rates of 60% within 12 weeks and 71% within 16 weeks. Healing rate in this context means the percentage of patients that achieved complete healing. These results are vastly superior to VLU healing rates reported in studies of other advanced wound care products. In the 1998 randomized study of VLU healing rates with Apligraf® conducted by Falanga, et al., a healing rate of 63% was reported at 24 weeks, which, while a separate study, nevertheless corresponds to the week 12 healing rate of 60% with EpiFix reported in this study. The healing results observed with EpiFix within 12 weeks are even more remarkable given that Falanga, et al. reported a mean wound size of 1.33 ± 2.69 cm²for Apligraf treated subjects, and excluded patients with uncontrolled diabetes and other clinically significant medical conditions that could impair wound healing. In this EpiFix study, patients with these types of comorbidities were included and mean wound size was considerably larger at 7.6 ± 6.1 cm².”

“While we have achieved Medicare reimbursement coverage for both VLU’s and Diabetic Foot Ulcers (DFUs), our breadth of reimbursement coverage with commercial payers is primarily for DFUs. Commercial health insurance plans are heavily influenced by the results of published clinical studies, and numerous clinical studies have been conducted and published that confirm the healing effects of EpiFix on DFUs. With the publication of this study and its compelling results in VLU healing rates, we expect a significant revenue opportunity will develop for MiMedx as commercial payers see this body of evidence demonstrating the clinical efficacy of EpiFix in the treatment of VLUs. We have used very conservative parameters to calculate the impact of gaining additional VLU coverage with payers. We estimate with the impact of this study, MiMedx can obtain VLU coverage for approximately 133 million additional commercial lives,” noted Petit.

Taylor added, “Published data indicates that the prevalence rate of VLUs in the commercial population is 0.183 percent. Assuming three to four EpiFix applications for a VLU, which is a very moderate assumption, and assuming an extremely conservative market penetration rate of 10 to 15 percent, we believe our incremental annual revenue opportunity based on patients presenting with VLUs not currently covered by our commercial insurance will be between approximately $75 million and $150 million.”

Chris Cashman, EVP and Chief Commercialization Officer, commented, “We are extremely confident in our ability to achieve and exceed our VLU market penetration estimates if additional commercial insurance coverage is gained. Currently, only about 30% of the commercial plans that cover EpiFix for DFUs also cover EpiFix for VLUs as well. This study should dramatically increase that ratio. We now have approximately 350 sales professionals focused on the commercial wound care market, and we anticipate that number to grow to approximately 375 sales professionals by year-end. Given the VLU market opportunity, without even considering the approximate one million acute pressure ulcers that could also benefit from EpiFix applications, we are very excited about the revenue opportunities that this landmark clinical study can facilitate for MiMedx.”

“We are looking forward to soon reporting the full details of this study when the article is electronically published,” concluded Petit.

About MiMedx
MiMedx® is a biopharmaceutical company developing and marketing regenerative biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. “Innovations in Regenerative Medicine” is the framework behind our mission to give physicians products and tissues to help the body heal itself. We process the human placental tissue utilizing our proprietary PURION® Process among other processes, to produce safe and effective allografts. MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization. MiMedx is the leading supplier of placental tissue, having supplied over 1,000,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.

Important Cautionary Statement
This press release includes forward-looking statements, including statements regarding the timing, results, and publication of clinical studies; the potential safety and efficacy, and additional approved uses and markets for our products; our expectations of how insurers will respond to this data and the size and timing of additional revenue opportunities; the estimated number of sales professionals by year-end; and the advantage over competitors that will be conferred by this result. These statements also may be identified by words such as “believe,” “except,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on our current beliefs and expectations. Forward-looking statements are subject to significant risks and uncertainties, and we caution investors against placing undue reliance on such statements. Actual results may differ materially from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include the risk that unexpected concerns may arise from additional data or analysis from our clinical trials; regulatory submissions may take longer or be more difficult to complete than expected; insurance coverage decisions may not occur as anticipated or coverage requirements may change; that regulatory authorities may require additional information or further studies or may fail to approve or may delay approval or grant marketing approval that is different than anticipated; and we may be unable to hire sufficient qualified sales persons in a timely manner. For more detailed information on the risks and uncertainties associated with new product development and commercialization activities, please review the Risk Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.

SOURCE MiMedx Group, Inc.