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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:

Talos® and Meditech logos are registered trademarks of Meditech Spine, LLC. All rights reserved.

PEEK-OPTIMA™ is a trademark of Victrex plc or its group companies. All rights reserved.

SOURCE Meditech Spine, LLC

Photo: (PRNewsfoto/Meditech Spine, LLC)

Related Links

http://www.meditechspine.com

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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

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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 LyotechnologySM, 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®, BIO4® 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 Lyotechnologysm are our trademarks. BIO4® 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

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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

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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

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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

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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 10th 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

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SpineVision® Receives FDA Clearance and CE Mark for Next-Gen Titanium 3D-Printed HEXANIUM TLIF Cage

Posted On September 17, 2018 By OrthoSpineNews In Regulatory, Spine, Top Stories /  

September 17, 2018

ANTONY, France–(BUSINESS WIRE)–SpineVision announced today that it has received FDA clearance and CE mark for its next-generation titanium 3D laser-printed HEXANIUM TLIF (Transforaminal Lumbar Interbody Fusion) cage for back surgery. SpineVision will introduce its new product 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).

Spine fusion surgery is often necessary to stop the motion of a painful segment in the spine by fusing two vertebrae with a TLIF cage. Conditions that may be treated with a spine fusion include tumors, spinal stenosis, herniated discs, and degenerative disc disease. The HEXANIUM TLIF cage combines a roughened titanium surface designed for fast osseointegration along with a honeycomb-like structure that features large windows for maximizing bone in-growth and on-growth from endplate to endplate.

“While TLIF back surgery is successful at relieving patients’ pain in about 60 to 70 percent of cases, there is room for improvement,” said Arnaud Brisard, CEO of SpineVision. “In particular, our HEXANIUM TLIF cage is designed to reduce the risk of subsidence in disc height in the post-operative period. HEXANIUM represents a continuation of our substantial achievements in developing cutting-edge products for all spine pathologies. HEXANIUM TLIF is the first of a complete range of 3D-printed implants SpineVision will be introducing.”

“Hexanium TLIF is an advance for spine fusion surgery,” said Neurosurgeon Gary P. Colon, M.D., NCH Healthcare System, Naples, Fla. (Click here for an interview with Dr. Colon.) “I am able now to deploy the TLIF cage exactly where my intent is when I start the approach. And that’s been a big move forward compared to prior products that I used.”

Click here for the complete news release.

Contacts

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

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Bone Therapeutics SA announces final results from Phase I/IIA ALLOB delayed-union fracture study

Posted On September 14, 2018 By OrthoSpineNews In Biologics /  

Gosselies, Belgium, 14 September 2018, 7 am CEST – BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in orthopaedics and bone diseases, today announces positive final results in the Phase I/IIA delayed-union study of its allogeneic bone cell therapy product ALLOB in 21 patients, supporting the future clinical development of the delayed union indication.

The Company also announces the development of an optimized production process for ALLOB, which the Company believes delivers critical improvements in consistency, scalability, cost-effectiveness and ease of use. In order to streamline the progress of ALLOB through late stage clinical trials and towards commercialization, Bone Therapeutics intends to implement this optimized manufacturing process for all future clinical development programmes, including the Phase IIB trial of ALLOB in delayed union fractures.

Trial results

The Phase I/IIA study was a six-month open-label trial to evaluate the safety and efficacy of ALLOB in the treatment of delayed-union fractures of long bones. The study evaluated 21 patients, who each had a fracture that had failed to consolidate after a minimum of three and a maximum of seven months. Each patient received a single percutaneous administration of ALLOB directly into the fracture site and completed a six-month follow-up. Fracture healing of ALLOB-treated patients was assessed using both radiological evaluation (based on CT-scan) and clinical evaluation (e.g. health status and pain).

At six months post administration, 100% of the patients met the primary endpoint, defined as an increase of at least two points on the radiological Tomographic Union Score (TUS) or an improvement of at least 25% of the clinical Global Disease Evaluation (GDE) score vs. baseline.

From a radiological perspective, the patients improved by on average 3.84 points on the TUS score (statistically significant), almost twice the required increase of two points. This minimum two-point increase was achieved by 16 out of 21 patients (76%).

From a clinical perspective, the health status of patients, as measured by the GDE score, improved statistically significantly by on average 48%. The minimum 25% improvement was achieved by 16 out of 21 patients (76%). Pain at the fracture site, an important secondary endpoint, was statistically significantly reduced by on average 61%.

Overall, ALLOB was shown to be well-tolerated and the safety profile was consistent with the interim analysis reported on 20 September 2017. As previously described in the literature covering clinical studies with allogeneic mesenchymal stem cells or their derivatives, it was observed that blood samples of about half of the patients contained donor-specific antibodies, either pre-existing or developed after administration.

Manufacturing update

With its core focus on its off-the-shelf, allogeneic cell therapy platform, Bone Therapeutics has been optimizing its ALLOB manufacturing process in order to improve consistency, scalability, cost effectiveness and ease of use, which are critical for development and commercialisation in cell therapy.

The Company has successfully developed an optimized process that it believes will satisfy these objectives. The optimized production process significantly increases the production yield, generating tens of thousands of doses of ALLOB per bone marrow donation. Additionally, the final ALLOB product will be cryopreserved, enabling easy shipment and the capability to be stored in a frozen form at the hospital level, making it readily available for patients in need. The process will therefore substantially reduce overall production costs, simplify supply chain logistics, improve patient accessibility and facilitate global commercialisation to large patient populations more affordably.

Bone Therapeutics believes the optimized manufacturing process is vital to the future commercial success of ALLOB. In order to avoid process changes in later phases of development, improve cost effectiveness and streamline ALLOB’s route to market, the Company will implement the optimized production process for all future clinical trials with ALLOB, including the planned Phase IIB delayed-union trial.

The Company’s immediate focus is on submitting a new clinical trial application (CTA) with the regulatory authorities to allow the start of a Phase IIB trial in delayed union, utilising the optimized production process. Bone Therapeutics is currently generating the non-clinical data required for the application and expects to submit the CTA for a multi-centre, randomized, controlled study in H2 2019.

Thomas Lienard, Chief Executive Officer of Bone Therapeutics, commented: “The continued positive clinical development progress with ALLOB, highlighted by these results today, paves the way for the next stage of development.”

“In cell therapy, a robust and consistent manufacturing process is critical to successful commercialisation. We are strongly encouraged by the progress we have made in optimising our manufacturing process, delivering a significant improvement which we believe safeguards the quality, consistency and cost-effectiveness of our allogeneic product and will support our future commercialisation strategy.”

“Whilst progressing this unique allogeneic bone cell therapy product to market as quickly as possible remains our top priority, we want to take this opportunity to align our clinical development as closely as possible with our future commercialization strategy. We believe the positive clinical data reported so far for ALLOB and the optimization of our manufacturing process put us in the right position to move forward with the clinical development of our allogeneic platform and achieve a competitive product profile.”

Key opinion leader event

The Company will host a Key Opinion Leader Event in Paris today at 12.30pm CEST. Presentations will be given by Prof. Dr. Frédéric Dubrana, Orthopaedic Surgeon at the University Hospital of Brest and Professor at the University of Western Brittany, alongside Thomas Lienard, Chief Executive Officer. The event in Paris will be held in French with an English language webcast of the same presentations at 3.30pm CEST. For more information please contact investorrelations@bonetherapeutics.com.

Webcast

To access the webcast, please go to the webcast link below. To participate in the Q&A, dial one of the appropriate numbers below quoting the confirmation code:

Belgium:    +32 (0)2 404 0659
France:   +33 (0)1 76 77 22 74
United Kingdom:   +44 (0)330 336 9105
United States:   +1 929-477-0324
Confirmation Code:   4247192

Webcast link: https://edge.media-server.com/m6/p/8ya7dmns

About Bone Therapeutics

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

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

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

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

Contacts

Bone Therapeutics SA
Thomas Lienard, Chief Executive Officer
Jean-Luc Vandebroek, Chief Financial Officer
Tel: +32 (0) 71 12 10 00
investorrelations@bonetherapeutics.com

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

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

For US Media and Investor Enquiries
Westwicke Partners
John Woolford
Tel: + 1 443 213 0506
john.woolford@westwicke.com

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

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Zimmer Biomet Announces Quarterly Dividend for Third Quarter of 2018

Posted On September 14, 2018 By OrthoSpineNews In Financial /  

WARSAW, Ind., Sept. 13, 2018 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced that its Board of Directors has approved the payment of a quarterly cash dividend to stockholders for the third quarter of 2018.

The cash dividend of $0.24 per share is payable on October 31, 2018 to stockholders of record as of the close of business on September 28, 2018. Future declarations of dividends are subject to approval of the Board of Directors and may be adjusted as business needs or market conditions change.

About the Company

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

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

We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.

ZBH-Fin

SOURCE Zimmer Biomet Holdings, Inc.

Related Links

http://www.zimmer.com

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