Safe Orthopaedics Announces the Commercial Launch of SteriSpineTMVA, a Balloon for the Vertebral Augmentation

Posted On September 18, 2018 By OrthoSpineNews In Spine /

September 18, 2018

ERAGNY-SUR-OISE, France–(BUSINESS WIRE)–Regulatory News:

SAFE ORTHOPAEDICS (FR0012452746 – SAFOR) (Paris:SAFOR), a company offering innovative ranges of sterile implants combined with their single-use instruments for back surgery, today announces its worldwide launch of its Kyphoplasty System: the SteriSpine^TM VA.

The new system adds to an already existing portfolio of sterile & single use devices and establishes Safe Orthopaedics as the only company that can offer a comprehensive portfolio of ready to use spinal fracture treatment options, which consists of a balloon and cement systems for restoring the vertebral body and a complete range of implants for stabilizing the spinal segment (Screw, rod, cross connectors…) post-fracture…

The European market for the treatment of vertebral compression fractures (VCF) via vertebral augmentation (Kyphoplasty) is estimated at €82M in 2018 and is expected to grow to over €120M in 2026¹ with a CAGR of 4.8%, in large part, because of the ageing population in Europe.

Sjors Hermans, Global sales director of Safe Orthopaedics comments: “The SteriSpine^TM VA is one of the two first systems in the market to offer a high quality, high pressure balloon of 700 PSI. Safe Orthopaedics is now the only one in the world to propose a full ready to use spinal treatment for the vertebral fracture.”

Pierre Dumouchel, CEO of Safe Orthopaedics, concludes: “Reinforcing our leadership in the fracture segment, we address a new segment representing €72M in France, Germany and the UK that will sustain our strong growth and reinforce our gross margin.”

In last July, Safe Orthopaedics announced the launch of its kyphoplasty offer in the countries where Safe Orthopaedics has a direct sales force. From September 2018, this offer is extended to all countries where the Safe Orthopaedics is present. This cement injection method, performed with a balloon, allows Safe Orthopaedics to provide a complete emergency fracture treatment package to push the penetration of its products towards the surgeons and strengthen its gross margin.

The SteriSpine^TM VA balloon is a high pressure, high quality balloon that can be inflated up to 700 PSI. The majority of the systems in the market today allow between 300 and 400 PSI. It comes in different sizes to accommodate all different kinds of patient anatomy.

¹ 2017 Millennium Research data

Next financial publication: First half 2018 results, September 28, (after market close)

About Safe Orthopaedics

Founded in 2010, Safe Orthopaedics is a French medical technology company that offers the safest technologies to treat spinal fracture. Delivered sterile, all implants and respective disposable instrumentation are available to the surgeon at any time, any place. These technologies enable minimally invasive approaches, reducing risks of cross contamination and infection in the interest of the patient. Protected by 17 patent families, the SteriSpine™ Kits are CE marked and FDA cleared. The company is based at Eragny-Sur-Oise (France), and has 37 employees.

For more information, visit: www.SafeOrtho.com

Contacts

Safe Orthopaedics
François-Henri Reynaud, Tel. : +33 (0)1 34 21 50 00
Chief Financial Officer
investors@safeorthopaedics.com
or
Investor relations
NewCap
Valentine Brouchot, Tél. : +33 (0)1 44 71 94 94
SafeOrtho@newcap.eu
or
Press Relations
Ulysse Communication
Bruno Arabian, +33 (0)6 87 88 47 26
barabian@ulysse-communication.com
Nicolas Daniels, +33 (0)6 63 66 59 22
ndaniels@ulysse-communication.com

NuVasive Announces UK Launch Of MAGEC® X For Early Onset Scoliosis Treatment

Posted On September 18, 2018 By OrthoSpineNews In Spine /

SAN DIEGO, Sept. 18, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced the United Kingdom (U.K.) launch of MAGEC^® X, the newest product generation within the MAGEC pediatric portfolio that addresses early-onset scoliosis (EOS).

The development of MAGEC X is distinguished by the inclusion of 5.0mm diameter patient rods, delivering a 68 percent improved fatigue-strength performance over the traditional 4.5mm option.ⁱIt also incorporates several advanced rod mechanisms, most notably a robust actuator seal designed to help further contain and reduce the release of titanium wear debris. Additionally, the rod includes an anti-jam feature to simplify intraoperative and postoperative rod lengthening. Key aesthetic improvements, such as laser-marked sagittal bending lines, help to enhance surgeon workflow efficiency and ease of use.

“I am extremely impressed with the NuVasive MAGEC X 5.0mm solution and its ability to provide superior rod strength without having to sacrifice the ideal fixation size thus meeting the clinical needs of pediatric patients,” said Dr. Stewart Tucker, MBBS, FRCS, orthopedic surgeon at Great Ormond Street Hospital in London, England. “Additionally, MAGEC X substantially improves intra-op workflow with enhanced ease of use. It provides surgeons with tremendous flexibility, enabling upsizing of rods while maintaining small screw heads, giving optimal profile and soft tissue cover.”

The 5.0mm growing rod in the MAGEC X system pairs with the NuVasive Reline^® Small Stature fixation system, the first pediatric deformity fixation solution that combines rod strength with low-profile implants. Together, the two systems help minimize the occurrence of revision surgeries by adding enhanced construct strength with an optimized low-profile for EOS patients.

“Following in the footsteps of our proven MAGEC solution, MAGEC X brings several new capabilities to the MAGEC portfolio and is a testament to NuVasive’s continuing practice of innovating and delivering next-generation spinal technologies for surgeons and patients in the pediatric space,” said Matt Link, executive vice president, strategy, technology and corporate development for NuVasive. “MAGEC X’s 5.0mm rod is truly game-changing as it supports patients with a small implant profile, but with significantly increased fatigue strength over the previous generation.”

This U.K. commercial launch of MAGEC X follows the Company’s U.S. commercial launch which occurred in July 2018. The Company will also host a MAGEC Users Meeting in Lisbon, Portugal on November 16, 2018, following the International Congress on Early Onset Scoliosis (ICEOS) Annual Meeting. This global users meeting will bring together surgeons and surgical staff from around the world to discuss challenges, shared successes, and review best practices related to the use of MAGEC as a treatment for EOS.

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, 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 over $1 billion in revenues, NuVasive has an approximate 2,400 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.

ⁱData on File: TR 9604057; dynamic 4-point bending testing per ASTM F2193.

Logo – https://mma.prnewswire.com/media/454552/NuVasive_Logo.jpg

SOURCE NuVasive, Inc.

Zavation Medical Products, LLC, a LongueVue Capital Portfolio Company, Completes Investment in Pan Medical U.S. Corp.

Posted On September 18, 2018 By OrthoSpineNews In Financial /

JACKSON, Miss., Sept. 18, 2018 /PRNewswire/ — Zavation Medical Products (“Zavation”), a LongueVue Capital (“LVC”) portfolio company, is pleased to announce it has partnered with the management team of Pan Medical U.S. Corp (“PanMed” or the “Company”) to acquire the Company. This partnership broadens Zavation’s service offering by adding a full suite of minimally invasive products, including the novel CurvePlus kyphoplasty system, the simplest and most complete curved kyphoplasty system on the market. The CurvePlus system is the only FDA approved kyphoplasty system that allows for both the balloon and cement to be passed through a curved needle. This not only facilitates precise balloon placement, but limits the number of steps in the procedure and decreases overall procedure time.

Based in Jackson, MS, Zavation designs, engineers, and manufactures a portfolio of spinal hardware and biologics covering key areas including cervical, thoracolumbar, interbody fusion, and minimally invasive surgery. Founded in 2012, Zavation has experienced exceptional growth and created a national network of 150+ distributors across approximately 40 states. The Company has commercialized over 12 product families since inception, with approximately 10 additional novel products expected to launch over the next year. Zavation operates a 30,000 square foot vertically integrated facility with approximately 60 employees.

PanMed, headquartered in Tampa, FL, designs, develops, and manufactures highly complex medical products used in minimally invasive procedures, primarily in the kyphoplasty and interventional radiology markets. PanMed has built a differentiated position with its extensive expertise in highly specialized balloons, catheters, needles, and instrument kits. PanMed was founded in the United Kingdom over 30 years ago with a focus on the catheter balloon market. Recognizing the sizable opportunity in the U.S., the Company shifted its focus to the kyphoplasty and interventional radiology markets and relocated operations to the United States in 2016. PanMed sells branded products through a network of independent distributors, agents, and OEMs, while also maintaining a private label program for spinal hardware companies throughout the world. The Company is currently expanding into a 14,000 square foot facility to meet outsized demand for its novel and new CurvePlus platform.

“We are delighted to partner with Zavation, a high growth complementary hardware business with incredible customer service and a deep knowledge of the U.S. market. We have a strong relationship with the Zavation team, as PanMed has been a supplier to Zavation for over three years. We see significant value in the transaction, and, as such, have invested in the combined business,” said Dr. Max Nasralla, visionary Founder and President of PanMed, who will continue in his current role throughout the integration process and remain as a shareholder and strategic advisor to the combined entity thereafter. “With our growth trajectory, we need to ensure the ability to continue to provide exceptional customer service, which the Zavation partnership will enable us to do.”

“An important component of choosing a partner for PanMed was a cultural fit that will provide continuity to our customers, who are critical to our ongoing success,” said Jennie Budding, COO of PanMed and incoming Vice President at Zavation. “I have watched this business grow over the past 15 years, and I am delighted that our new partners will provide our team with the resources needed to successfully scale the business while never compromising our commitment to quality and to our customers, both domestically and abroad.”

Jeffrey Johnson, CEO of Zavation, added, “After years of testing a variety of different kyphoplasty balloons for our ZVPlasty system, we realized that many competitive products on the market are substantially inferior to those of PanMed. We saw an opportunity to partner with PanMed to provide a unique and proprietary curved kyphoplasty solution, and we could not be more excited about the future of our partnership. The combined business will have an industry leading product portfolio, and we are thrilled to offer PanMed’s products to our network of distributors and surgeons.”

“I am extremely excited to work with Jennie [Budding], Max [Nasralla], and the rest of the PanMed team to methodically grow PanMed for the years to come,” said Brad Risher, Senior Vice President of Interventional Spine at Zavation. “PanMed has the potential to disrupt the kyphoplasty and interventional radiology markets, and we look forward to welcoming the PanMed organization into the Zavation family.”

Baird served as exclusive financial advisor to LVC and Zavation on the transaction. Abacus Finance Group, LLC provided the senior debt financing to Zavation in support of the transaction. Zavation and LVC’s legal counsel was provided by McGuireWoods, LLP.

To learn more information about Zavation and its products, visit www.zavation.com

To learn more information about PanMed and its products, visit www.panmed.us

ABOUT LONGUEVUE CAPITAL
LongueVue Capital is a private equity firm focused on making situation-driven, value-oriented equity and debt investments in lower middle market companies (up to $150 million in annual revenue) to support buy-outs, recapitalizations, acquisitions and growth. LVC currently has approximately $500 million under management across two funds. Since its formation in 2001, LVC has made successful investments in a wide variety of industries, including healthcare, business services, transportation and logistics, energy services, and niche manufacturing. LVC is based in New Orleans with additional offices in New York and Salt Lake City. For more information, please visit www.lvcpartners.com.

SOURCE LongueVue Capital

Meditech Spine Receives FDA Clearance for its Cure™ Opel-C Plating System

Posted On September 18, 2018 By OrthoSpineNews In Regulatory, Spine, Top Stories /

ATLANTA, Sept. 18, 2018 /PRNewswire/ — Meditech Spine has received FDA 510(k) clearance to market the Cure™ Opel-C Plate System, an add-on technology to its already cleared CURE™ ACP System and Talos®-C (HA) Interbody Systems. With this approval, Meditech will now offer two additional CURE™ ACP plating options with its Talos® line of cervical interbodies made with the osteoconductive PEEK-OPTIMA® HA Enhanced material. Since Meditech’s introduction of the CURE™ ACP System in late 2016, its adoption and usage have seen double-digit growth. By adding the Opel™-C plating options to the CURE™ ACP product line, surgeons now have two modular snap-on plate styles providing rigid fixation while minimizing adjacent level impact. The Cure™ Opel-C Plate System incorporates the same unique, patented, one-step locking mechanism of the CURE™ ACP System preventing screws from backing out when anchored in the vertebral body. Meditech will be demonstrating the newly approved system at the North American Spine Society (NASS) meeting held in Los Angeles, CA from September 26-28 along with its proprietary Talos® HA Peek Interbody Systems in booth 1757.

Meditech is excited to continue its relationship with CURE International, the namesake of the CURE™ ACP, an organization serving children with physical disabilities in underserved areas of the world. A portion of proceeds from the sale of every plate helps CURE International treat patients in need of surgical care.

For more information visit Meditech Spine.

ABOUT MEDITECH SPINE, LLC

Meditech Spine, LLC, is a growing spinal implant company that partners with leaders in the industry to design, develop, and distribute implant devices that make a positive difference in the market. As Meditech builds on its IP platform, it seeks strategic partnerships and applications to provide surgeons and patients with the best technologies available. Meditech’s belief in the spinal marketplace is to value and honor their partners and all who are touched by their interactions in the development and distribution process so that each experience leaves a positive impact upon those they serve.

CONTACT

Meditech Spine, LLC
(678) 974-5287
support@meditechspine.com

Caption & Copyright:

SOURCE Meditech Spine, LLC

Photo: (PRNewsfoto/Meditech Spine, LLC)

OrthoPediatrics Corp. Announces First PNP | FEMUR Cases Performed in Australia

Posted On September 18, 2018 By OrthoSpineNews In Extremities /

WARSAW, Ind., Sept. 17, 2018 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (“OrthoPediatrics”) (NASDAQ: KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, is pleased to announce the first surgeries in Australia utilizing the new Pediatric Nailing Platform | FEMUR (“PNP | FEMUR”). OrthoPediatrics’ sales agent in Australia and New Zealand is Surgical Specialties, headquartered in Frenchs Forest, New South Wales.

Joe Hauser, OrthoPediatrics’ Vice President of Trauma & Deformity Correction, stated, “We are extremely pleased by the success of the first PNP|FEMUR cases in Brisbane. Our new pediatric nailing system continues to better serve the unique complexity associated with pediatric anatomy, and we are delighted that we are able to bring this innovative technology to pediatric orthopedic surgeons and their patients in Australia.”

The PNP | FEMUR system is designed for use in pediatric and small stature adult patients to address femoral shaft fractures, subtrochanteric femur fractures, ipsilateral neck/shaft fractures, prophylactic nailing of impending pathologic fractures, nonunions, malunions, and fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity.

Dr. Geoff Donald, the orthopedic surgeon who performed the first cases, commented, “All aspects have gone smoothly in my first cases utilizing OrthoPediatrics’ innovative new system. We performed a rotational femoral osteotomy to correct severe out-toeing gait, as well as a femoral shaft fracture with flawless instrumentation performance. We look forward to utilizing the exceptional system in more procedures.”

About OrthoPediatrics Corp.
Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 25 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma & deformity, scoliosis, and sports medicine/other procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and 38 countries outside the United States.

About Surgical Specialties
OrthoPediatrics’ sales agent, Surgical Specialties, is an independent distributor of innovative medical devices to the Australian and New Zealand medical community. The business focuses on the following surgical areas: Arthroplasty, Extremities, Specialty Trauma, Orthobiologics, Critical Care and Operating Room Products. Established in 2006, Surgical Specialties now has a team of over 70 professionals, with sales offices throughout Australia and New Zealand. To learn more about Surgical Specialties, visit: http://www.surgicalspecialties.com.au/

Investor Contacts
The Ruth Group
Tram Bui / Emma Poalillo
(646) 536-7035 / 7024
tbui@theruthgroup.com / epoalillo@theruthgroup.com

Osiris Therapeutics, Inc. Announces GrafixPL PRIME™ Launches October 1, 2018

Posted On September 18, 2018 By OrthoSpineNews In Biologics /

COLUMBIA, Md., Sept. 17, 2018 (GLOBE NEWSWIRE) — Osiris Therapeutics, Inc. (NASDAQ: OSIR), a regenerative medicine company focused on developing and marketing products for wound care, orthopedics, and sports medicine, announces that GrafixPL PRIME™, a human placental membrane that can be stored at ambient temperatures, launches for sale on October 1, 2018. The structural matrix, growth factors, and cell viability of GrafixPL PRIME is equivalent to those of Grafix^®, a cryopreserved placental membrane, but without the constraints of ultra-low temperature storage.

GrafixPL PRIME is processed using Prestige Lyotechnology^SM, which is Osiris’s preservation technique for ambient storage of living tissues. GrafixPL PRIME is flexible and conforming and designed as a wound cover/barrier for application directly to hard-to-treat acute and chronic wounds, including but not limited to diabetic foot ulcers, venous leg ulcers and thermal burns.

Jason Keefer, Interim President and CEO said: “I am pleased to announce that our ambient temperature stable GrafixPL PRIME product will be available in all settings of care, in addition to our cryopreserved Grafix products. This allograft will preserve the original characteristics of the fresh placental membrane that support natural tissue repair process, but in contrast to cold-stored cryopreserved tissues, GrafixPL PRIME is stored at ambient temperature.”

About Osiris Therapeutics
Osiris Therapeutics, Inc., based in Columbia, Maryland, researches, develops, manufactures and commercializes regenerative medicine products intended to improve the health and lives of patients and lower overall healthcare costs. We have achieved commercial success with products in orthopedics, sports medicine and wound care, including the Grafix product line, Stravix^®, BIO^4® and Cartiform^®. We continue to advance our research and development by focusing on innovation in regenerative medicine, including the development of bioengineered stem cell and tissue‑based products. Osiris^®, Grafix^®, GrafixPL^®, GrafixPL PRIME^™ Cartiform^®, and Prestige Lyotechnology^sm are our trademarks. BIO^4® is a trademark of Howmedica Osteonics Corp., a subsidiary of Stryker Corporation. More information can be found on the Company’s website, www.Osiris.com. (OSIR-G)

Forward-Looking Statements
Statements herein relating to the future of Osiris Therapeutics, Inc. and the ongoing research and development of our products are forward-looking statements. Osiris Therapeutics, Inc. cautions that these forward looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading “Risk Factors” in the Osiris Therapeutics Inc. Annual Report on Form 10-K for the years ended December 31, 2017, 2016 and 2015 and Quarterly Report on Form 10-Q for the quarters ended March 31, 2018 and June 30, 2018, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. Examples of forward-looking statements may include, without limitation, statements regarding the anticipated efficiencies and advantages of products and the likelihood of customer clinical adoption of any new products. Although well characterized in scientific literature and studies, preservation of tissue integrity, including cells, may not be indicative of clinical outcome. Accordingly, you should not unduly rely on these forward-looking statements. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

For additional information, please contact:

Diane Savoie
Osiris Therapeutics, Inc.
(443) 545-1834
OsirisPR@Osiris.com

SpineVision® Receives CE Mark for Next-Gen P.L.U.S.® Deformity-Correction Spinal System

Posted On September 18, 2018 By OrthoSpineNews In Regulatory, Spine, Top Stories /

ANTONY, France–(BUSINESS WIRE)–SpineVision announced today that it has received CE mark for its next-generation Pivot Link Universal System (P.L.U.S.) spine deformity-correction system. SpineVision will introduce the next-generation P.L.U.S. to spine surgeons at “EuroSpine 2018” (Booth #24C) in Barcelona, Spain (Sept. 19-21), and “NASS 2018” (Booth #1311) in Los Angeles (Sept. 26-29).

Deformity of the spine includes any abnormality of the formation, alignment, or shape of the vertebral column. Diagnoses that are associated with spine deformity include scoliosis, spina bifida, Becker and Duchenne muscular dystrophy, kyphosis, and spondylolisthesis, among others. Spine stabilization surgery is recommended in cases where there is severe pain, neurological problems, or curvature greater than 50 degrees. The goal of surgery is to straighten and hold the spine straight. Several surgical techniques can be used, including spinal fusion and the use of implants such as the P.L.U.S. to secure the fusion.

“The introduction of our Pivot Link Universal System (P.L.U.S.) extends our successful track record of commercializing cutting-edge products encompassing all spine pathologies,” said Arnaud Brisard, CEO of SpineVision. “We believe that this next generation of an already successful product will be enthusiastically embraced by orthopedic surgeons, because the P.L.U.S. is designed to make every step of spine deformity surgery more facile for the orthopedic surgeon—especially correction maneuvers before final locking.”

CLICK HERE FOR THE COMPLETE VERSION OF THIS NEWS RELEASE.

Contacts

Ronald Trahan Associates Inc.
Ronald Trahan, APR, +1 508-816-6730
rtrahan@ronaldtrahan.com

Conformis Announces Settlement of Patent Dispute with Smith & Nephew

Posted On September 17, 2018 By OrthoSpineNews In Regulatory /

BILLERICA, Mass., Sept. 17, 2018 (GLOBE NEWSWIRE) — Conformis, Inc. (NASDAQ:CFMS), a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that fit each patient’s unique anatomy, announced today that it has entered into a settlement and license agreement with Smith & Nephew that resolves all patent disputes between Conformis and Smith & Nephew.

Pursuant to the agreement, Smith & Nephew is required to pay $10.5M to Conformis, and the parties have entered into a limited patent cross-license.

“We are very pleased to announce the complete settlement of the various patent proceedings we have with Smith & Nephew. Through this settlement, we have once again monetized our patient-specific instrument patents and steadfastly protected our core business of patient-specific implants,” stated Mark Augusti, Conformis’ President and Chief Executive Officer.

About Conformis, Inc.

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

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

Cautionary Statement Regarding Forward-Looking Statements

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

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

Form fit function.png

Spine Wave Announces the Commercial Launch of the Paramount® Anterior Cervical Cage

Posted On September 17, 2018 By OrthoSpineNews In Spine /

SHELTON, Conn., Sept. 17, 2018 (GLOBE NEWSWIRE) — Spine Wave is pleased to announce the commercial launch of the Paramount® Anterior Cervical Cage. The Paramount® Anterior Cervical Cage is a titanium anterior cervical implant with integrated fixation blades. The patented system offers controlled, less invasive blade deployment and maximized bone grafting. The Paramount® Anterior Cervical Cage performed very well during its limited market release and is now fully launched and available, effective immediately. The Paramount® Anterior Cervical Cage is Spine Wave’s second new cervical spine product since 2017 and its seventh major new product launch since 2016.

The Paramount® Anterior Cervical Cage is a titanium implant with a roughened endplate surface and integrated fixation blades. The fixation blades deploy toward and behind the anterior vertebral cortex and away from the spinal cord using a unique threaded deployment mechanism. Used in conjunction with the novel scoring trial, this mechanism gently positions the fixation blades in a controlled manner without force or impaction. This unique design is less invasive because it does not require the exposure necessary to implant non-integrated blades or screws at challenging angles and trajectories. Surgeons using the device can also completely fill the disc space with bone graft, endplate to endplate regardless of endplate anatomy, because of its innovative open face implant design and modular graft cap. The Paramount® Anterior Cervical Cage was co-invented by Sandeep Kunwar, M.D., Medical Director, Bell Neuroscience Institute, Clinical Professor, UCSF Department of Neurological Surgery, San Francisco, California, and Bradley Jones, M.D., Director of the Joint and Spine Center, Dignity Health Medical Center, Redding, California.

“The Paramount® Anterior Cervical Cage is a novel and less invasive solution for anterior cervical interbody fusion,” said Dr. Kunwar. “The unique integrated blade design and in-line implant insertion approach make difficult cases safer and easier in my hands. The procedure can be performed through a smaller insertion window without a struggle to accommodate challenging screw or blade insertion angles.” Dr. Jones continued, “one major goal of our design effort was to eliminate forceful blade impaction from this procedure, and Spine Wave’s engineers did a phenomenal job delivering on that objective. I am very pleased with the finished product.”

The Paramount® Anterior Cervical Cage is the latest example of creative surgeons partnering with our R&D team to develop and deliver a technology that is not only truly differentiated, but also addresses real surgical challenges,” said Spine Wave CEO, Mark LoGuidice. “Prior to 2018, Spine Wave had very little presence in the cervical market segment with the bulk of our revenues being generated by expandable and other MIS technologies designed for the lumbar spine. This launch of the Paramount® system, when combined with the recently launched Proficient® Posterior Cervical Spine System, provides the company with a very strong cervical portfolio and positions us as a full line company to both hospitals and distributors.”

About Spine Wave
Spine Wave is a leader in expandable fusion technologies and is committed to continually delivering highly differentiated products to enable improved and less invasive solutions for spine surgeons and their patients. In addition to the Paramount® Anterior Cervical Cage, Spine Wave also offers many highly differentiated spine technologies, including a full portfolio of expandable devices marketed under the StaXx®, Velocity® and Leva® brand names. These expandable technologies comprise various materials, including PEEK, Titanium (and the combination of the two) that can be utilized in posterior, anterior and lateral surgical approaches. Additionally, Spine Wave has a full suite of less invasive products including our two newest lines, the Proficient® Posterior Cervical Spine System and the GraftMag® Graft Delivery System. The company is expanding rapidly and continues to recruit sales managers and independent distributors to fuel growth. For more information on Spine Wave and its products, please visit www.spinewave.com.

Contact
Terry Brennan, Chief Financial Officer
tbrennan@spinewave.com
(203) 712-1810

Simplify® Medical Technology Selected for Innovative Technology Paper at NASS 2018 Annual Meeting

Posted On September 17, 2018 By OrthoSpineNews In Spine /

SUNNYVALE, Calif., Sept. 17, 2018 (GLOBE NEWSWIRE) — Simplify Medical Pty Ltd, maker of the Simplify® cervical artificial disc, announced today that an abstract for preliminary data from the Company’s 1-level Investigational Device Exemption (IDE) clinical trial has been selected as an Innovative Technology Presentation during the 2018 North American Spine Society (NASS) Annual Meeting, being held September 26-29 in Los Angeles, Calif. Richard Guyer, M.D., Co-Principal Investigator for the study, will present the data at the session, and it will also be featured in a poster presentation.

David Hovda, CEO of Simplify Medical, commented, “We look forward to sharing initial results from a key site of our multi-center, prospective pivotal U.S. trial evaluating the Simplify Disc at one-level, for which we completed enrollment in February of this year. Our PEEK on ceramic Simplify Disc is engineered for durability, enhanced imaging with MRI, and with lower height options to better match patient anatomies. We are encouraged by our early data. If FDA-approved, we believe the Simplify Disc will offer patients and physicians in the U.S. a meaningful alternative to cervical fusion surgery and other currently available discs.”

Details of the oral presentation follow:

Simplify Medical: Clinical Outcomes of the PEEK-on-Ceramic Simplify Disc: Preliminary Data from One Site Participating in the Single-Level Cervical FDA IDE Trial

Session:		Innovative Technology Presentations
Date, Time:		Wednesday, September 26, 1:21-1:28pm
Location:		Room 404AB
Presenting Author:		Richard D. Guyer, MD, and Donna D. Ohnmeiss, PhD.
Institutions:		Texas Back Institute and Texas Back Institute Research Foundation,
		Plano, Texas

In addition, during NASS, the Simplify Cervical Artificial Disc will be awarded as a winner in the 10^th Annual 2018 Spine Technology Awards, presented by RRY Publications and Orthopedics This Week. The Spine Technology Awards recognize the best new spine technologies, engineering teams and inventors for 2018 and, in the process, reward excellence in innovation.

To learn more about the Simplify Disc at one and two-levels, please visit Simplify Medical at Booth # 1911 in the Exhibit Hall.

About Simplify Disc
Simplify Disc is a motion preserving cervical artificial disc designed to allow for advanced imaging capability of MRI, and better match patients’ anatomies and kinematics. It is composed of advanced, primarily non-metal materials (PEEK-on-ceramic) to permit the full diagnostic imaging capability of MRI and may eliminate the need for CT/Myelogram and CT imaging in order to minimize patient exposure to radiation. The Simplify™ Disc is anatomically designed, offering a broader range of disc heights including low height implant options to better fit patients’ anatomies. With no metal in its articulating components, the disc is also designed for low levels of wear to optimize long-term durability. Implantation of the Simplify Disc is accomplished in a straightforward, three-step procedure.

About Simplify Medical
Simplify Medical is a medical device company focused on cervical spinal disc arthroplasty, using innovative, MRI-compatible materials designed to decrease the need for ionizing radiation and enhance patient options. Simplify Medical is located in Sunnyvale, California. To learn more, visit http://www.simplifymedical.com/.

Caution: The Simplify Disc is an investigational device in the United States and is limited by law to investigational use.

Simplify Medical Contacts:

Investor Contact:
Brian Johnston, The Ruth Group
Tel: +1 646-536-7028
Email: bjohnston@theruthgroup.com

Media Contact:
Kirsten Thomas, The Ruth Group
Tel: +1 508-280-6592
Email: kthomas@theruthgroup.com

Author: OrthoSpineNews

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