SI-BONE, Inc. Announces that NICE, the UK Nat’l Institute for Health and Care Excellence, Published Medical Technology Guidance Supports iFuse for Treatment of Sacroiliac Joint Pain

Positive Commercial Payor Policy By Priority Health of Michigan Covering coflex® For The Surgical Treatment Of Lumbar Spinal Stenosis

NEW YORKOct. 3, 2018 /PRNewswire/ — Paradigm Spine, LLC, a leader in providing solutions for the treatment of lumbar spinal stenosis, today announced the issuance of a Priority Health of Michigan Medical Policy. The policy, effective August 20 2018, now includes coverage of the coflex®  Interlaminar Stabilization® device for lumbar spinal stenosis with no prior authorization required. This issuance adds to the continual growth of positive commercial payor policies for coflex®.

Lumbar spinal stenosis (“LSS”), affecting 1.6 million patients annually, is a debilitating and degenerative disease in older patients (>50 years) often associated with significant leg and back pain, leg numbness and weakness, causing a significant reduction in an active lifestyle. Traditional surgical treatment options for LSS includes a decompression that removes bone and soft tissue and may also require a fusion to stabilize the spine.  The coflex® device is a non-fusion, motion-preserving stabilization implant, that is FDA PMA-approved for the treatment of lumbar spinal stenosis and is used in conjunction with a decompression, or used in lieu of a spinal fusion.

Marc Viscogliosi, Chairman & CEO of Paradigm Spine, said, “This coverage policy by Priority Health of Michigan reflects the continued adoption and understanding of the benefits coflex® offers patients with lumbar spinal stenosis. We look forward to expanding patient access to the coflex® technology to the more than 786,000 lives covered by Priority Health of Michigan – Michigan’s second largest health plan that is nationally recognized for improving the health and lives of the people it serves by providing quality care that’s accessible and affordable.”

To learn more about coflex® Interlaminar Stabilization®, please visit www.coflexsolution.com.

About Paradigm Spine, LLC
Paradigm Spine, LLC, founded in 2004, is a privately held company and remains focused on the design and development of solutions for the disease management of spinal stenosis.  The Company’s signature product is the coflex® Interlaminar Stabilization® device, which is currently used in over 60 countries worldwide. coflex® is the only lumbar spinal device that has produced Level I evidence in two separate prospective, randomized, controlled studies against two different control groups, changing the standard of care for lumbar spinal stenosis treatment.  For additional information visit www.paradigmspine.com or www.coflexsolution.com.

SOURCE Paradigm Spine, LLC

Related Links

http://www.paradigmspine.com

OMNIlife science™, Inc. Achieves Milestone with OMNIBotics® Active Spacer

RAYNHAM, Mass.Oct. 3, 2018 /PRNewswire/ — OMNIlife science, Inc. (“OMNI”), a privately-held, medical technology company targeting the $15 billion global hip and knee replacement device market, reported today that the positive clinical benefits of the OMNIBotics® Robotic Active Spacer continue to be reinforced by more than 1,000 successful procedures performed to date. Orthopaedic surgeons have been evaluating this revolutionary system that utilizes a miniature robot to ensure the ligaments will be “balanced” after the knee replacement.

A basic tenet of knee replacement is to balance the tension of the ligaments to ensure smoother knee function and better alignment. However, balancing frequently involves making small incisions in tighter ligaments to create equal ligament tension. The Active Spacer helps the surgeon position implants in anatomic alignment while maintaining ligament balance without having to incise ligaments. Early data on the use of the Active Spacer is showing a much higher rate of patient satisfaction at both three and six months’ post-surgery than what has been typically reported in the literature.

“We are pleased the benefits of OMNIBotics Active Spacer technology continue to be validated by multiple surgeons,” said Rick Epstein, CEO of OMNI. “Our OMNIBotics robotic-assisted technology guides the surgeon to the optimal implant position to achieve both mechanical alignment and balance, and each of the cuts are made with robotic precision. We believe a properly aligned and carefully balanced knee will result in optimized patient outcomes and it is exciting to be working with surgeons to advance the field of knee replacement with robotics.”

OMNIBotics with Active Spacer is the first and only robotic system to integrate ligament tension with bone alignment.

“I’ve been doing knee surgery for 25 years,” stated Jeffrey H. DeClaire, M.D. (DeClaire LaMacchia Orthopedic Institute, Rochester Hills, MI), “and I’ve always been very focused on balancing the knee, but there’s never been any way to measure and validate ligament balance and ligament tension in knee arthroplasty until the OMNIBotics Active Spacer.  This is a real breakthrough because now I know that each total knee arthroplasty I perform is precisely balanced with consistency and reproducibility that significantly improves the accuracy of the procedure, in addition to facilitating improved patient outcomes and patient satisfaction.”

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.

Related Links

http://www.omnils.com

ApiFix Surpasses 250 Scoliosis Patients Treated and Six-Year Follow-up of Earliest Cases

October 02, 2018

BOSTON–(BUSINESS WIRE)–ApiFix Ltd., a leading motion-preservation scoliosis correction company, announced today that its patented Minimally Invasive Deformity Correction (MID-C) technology has now been used to treat more than 250 young patients diagnosed with progressive scoliosis. The company also announced that the earliest treated patients have reached their six-year follow-up milestone.

ApiFix’s MID-C technology is a posterior dynamic deformity correction system that enables surgeons to perform a unique treatment providing permanent curve correction while retaining spine flexibility using a least invasive surgical approach. Patient recovery is relatively pain-free and is measured in days, not months. The MID-C system acts as an “internal brace” that incorporates a patented unidirectional, self-adjusting rod mechanism with motion-preserving polyaxial joints allowing additional non-invasive post-operative correction over time and is removable.

The MID-C device has been used for treatment in multiple countries, with more than 100 patients now having greater than two-year follow-up. A typical ApiFix surgical procedure takes about 90 minutes with minimal blood loss (~50cc) and short hospitalization and recovery times (1-2 days and 1-2 weeks, respectively). In contrast to fusion correction procedures, the MID-C system allows for additional deformity correction with standard post-operative exercises. Patients’ normal daily activities are unencumbered since spine flexibility and mobility are retained.

Available treatment options for progressive scoliosis in the U.S. have been limited despite continued advances in both surgical and non-surgical systems – a perspective shared by Randy Betz, MD, past president of the Scoliosis Research Society.

“Despite great recent advancements, our options to address progressive curvature in young patients today remain limited,” said Dr. Betz. “Bracing systems are required to be worn many hours per day and do not correct the deformity. Standard spinal fusions correct the deformity but have a much longer recovery time and result in a permanent loss of mobility. The introduction of a procedure that can effectively correct spinal deformity with less invasive, motion-preserving techniques will have a dramatic effect on the quality of life for these patients and their families.”

“The new ApiFix surgery is much less invasive than standard fusion procedures, allowing for a significantly shorter recovery,” said Ron El-Hawary, MD, Chief of Orthopedics, IWK Health Centre in Halifax, Canada, who has been impressed with his use of the MID-C device in patients. “We see that patients have more flexibility and they will likely have better participation in sports, dance and other activities performing at the same level or higher than previously. Based on my own experience and the overall early experience of many patients beyond two-years follow-up, I believe this device has great promise in offering a completely different option for adolescent idiopathic scoliosis patients with progressive curves.”

Paul Mraz, ApiFix CEO, is committed to establishing a new standard of care for spinal deformity treatment, generating peer-reviewed evidence, and working with the FDA to help make this new technology available for patients in the United States. The device is currently investigational in the United States and is under review by FDA in a Humanitarian Device Exemption application.

“Our review of the extensive clinical experience with the MID-C system and our ongoing collection of new data continue to underscore ApiFix’s positive results realized in patients with progressive spinal deformity,” said Mraz. “ApiFix represents a game-changing opportunity for patients and families and a viable alternative to irreversible fusion procedures. We look forward to making this technology more widely available worldwide.”

About ApiFix Ltd.

Founded in 2011, ApiFix Ltd. is a privately held medical device company based in Misgav, ISRAEL and Boston, Massachusetts, USA and a portfolio company of The Trendlines Group Ltd. (SGX: 42T; OTCQX: TRNLY). ApiFix is a leading motion-preservation scoliosis correction company developing a unique platform technology that represents a disruptive approach to spine deformity treatment. ApiFix’s Minimally Invasive Deformity Correction (MID-C) system has CE Mark approval and is available in Europe, Israel, Singapore and Canada. More information is available at www.apifix.com.

Contacts

for ApiFix Ltd.
Paul Williams, 310/569-0023
paul@medialinecommunications.com

Trice Medical Launches the World’s First Dynamic Imaging Platform, Adding Ultrasound Capability to the mi-eye®

MALVERN, Pa.Oct. 2, 2018 /PRNewswire/ — U.S. based Trice Medical, Inc. announced today the launch of its latest product, mi-ultra™, a high powered 15mHz handheld ultrasound transducer. The mi-ultra™ is enabled by the same platform technology that Trice’s flagship product, mi-eye 2®, operates on, the mi-tablet.

The mi-ultra™, which comes in both convex and linear offerings, has been optimized for Muscular Skeletal (MSK) applications. The addition of this technology to Trice’s Dynamic Imaging Platform will enable orthopedic practices to provide a full suite of MSK imaging at the first point of care. The ability to provide a dynamic evaluation for patients, as opposed to static systems like MRI and X-Ray, has never been easier for orthopedic offices with this all-in-one portable system.

Dr. Don Buford, orthopedic surgeon and founder of the Dallas PRP and Stem Cell Institute, said, “The mi-ultra™ is a combination of the first MSK ultrasound system with sufficient image quality and reliability for all diagnostic and procedure indications with the first tablet based disposable office needle arthroscopy platform. Now, every orthopedic clinician can have a single portable tablet for imaging intra-articular and extra-articular anatomy for diagnosis and procedures. This is a truly revolutionary point of care imaging system and the only such platform available!”

The early success of Trice Medical’s mi-eye 2®, which was launched in the U.S. in 2017, has captured the attention of medical professionals who are embracing the technology as a new diagnostic modality. After the first year of commercial launch, the mi-eye® is currently being used by over 300 institutions across the U.S. The disposable needle embedded with a wide-angle camera lens enables physicians to diagnose joint injuries right in their clinic; deliver biological under direct visualization; and provide their patients with immediate answers to the cause of their pain.

“This is a truly disruptive technology for the orthopedic industry,” said Mark Foster, President and CCO of Trice Medical. “Today’s healthcare environment is asking for innovation in a cost-effective manner. Trice is proud to have combined an arthroscopy tower and a high-powered ultrasound system into one simple, portable tablet. The disposable mi-eye 2®camera is great to identify pathology within the joint and the mi-ultra is a perfect complement for guided injections or assessing soft tissue damage outside of the joint. We believe the system is a “must have” for every orthopedic practice.”

About the mi-eye 2®:

Trice Medical’s mi-eye 2® is a handheld, single-use, and disposable direct visualization tool. The mi-eye 2® was specifically designed for use in the clinic setting, consisting of a single stick percutaneous, and self-blunting design which deploys an integrated camera and a light source. The procedure is performed with local anesthetic and provides patients with an alternative to traditional diagnostic modalities, such as time-consuming and often inaccurate MRIs. The mi-eye® is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. The mi-eye 2® is available for prescription use only.

About Trice Medical:

Trice Medical was founded to fundamentally improve orthopedic diagnostics for the patient, and the physician providing instant answers. Trice Medical has pioneered fully integrated camera-enabled technology, the mi-eye 2®, that provides a clinical solution optimized for the physician’s office. Trice Medical’s mission is to provide more immediate and definitive patient care, eliminating the false reads associated with current indirect modalities and significantly reduce the overall cost to the healthcare system.

Contact Trice Medical:

+1 (610) 989-8080

info@TriceMedical.com

Trice Medical’s mi-eye 2

Related Links

Trice Medical

SOURCE Trice Medical

Related Links

https://tricemedical.com/

Prominent Hand Surgeon Joins NYU Langone Health To Spearhead Orthopedic Innovation

NEW YORK Oct. 2, 2018 /PRNewswire/ — Thomas J. Graham, MD, one of the nation’s most respected hand surgeons and health care innovators, recently joined the Department of Orthopedic Surgery at NYU Langone Health as Director of Strategy and Innovation. Dr. Graham is also serving as Associate Chief of the Division of Hand Surgery.

Dr. Graham will see patients at NYU Langone’s Hand Center, where he is moving his clinical practice — which has treated thousands of professional athletes and performed hand and elbow surgeries of all complexities. Dr. Graham, who joined NYU Langone on September 1, has a national and international reputation as a hand and upper extremity surgeon, and a pioneer in orthopedic innovation.

“We are incredibly fortunate to recruit Dr. Graham to NYU Langone, and to bring his renowned skills as a hand surgeon, innovator and physician leader to our department,” says Joseph D. Zuckerman, MD, the Walter A. L. Thompson Professor of Orthopedic Surgery and chair of the Department of Orthopedic Surgery. “Having a surgeon and visionary like Dr. Graham join our already outstanding hand surgery faculty further catapults our top-ranked program to an even higher level of excellence.”

Sought-After Hand Surgeon to Athletes

Dr. Graham has extensive clinical expertise in surgery of the hand, wrist and elbow, with particular expertise in complicated reconstruction after trauma, complex elbow disorders, and congenital hand ailments. His practice also enjoys worldwide recognition for care of the hand and wrist of professional athletes. Notably, he has served as the hand surgery consultant, team physician or medical director for numerous professional sports teams in the NFL, MLB, NBA, NHL, and the PGA and LPGA Tours, and has personally cared for thousands of elite athletes.

An alumnus of Williams College, Dr. Graham received his medical degree at the University of Cincinnati College of Medicine. He completed his orthopedic surgery residency at the University of Michigan, followed by a fellowship in hand and upper extremity surgery at the Indiana Hand Center, and extended training in surgery of the elbow at the Mayo Clinic.

In addition, he completed a two-year executive management and healthcare administration program sponsored by Cleveland Clinic and Weatherhead School of Management at Case Western Reserve University.

Following his initial faculty appointment at Cleveland Clinic where he was director of the Hand and Upper Extremity Center, Dr. Graham relocated to Baltimore to serve as chief of the congressionally designated Curtis National Hand Center, the largest specialty practice in its field globally, and Vice- Chairman of Orthopedic Surgery at MedStar Union Memorial Hospital. Dr. Graham also was an Associate Professor of both orthopedic and plastic surgery at Johns Hopkins Medicine. While in Baltimore, he also established MedStar SportsHealth and was the founder and Surgeon-in-Chief of the Arnold Palmer Sports Health Center.

After his considerable contributions in Baltimore, Dr. Graham returned to Cleveland Clinic, where he served as its inaugural Chief Innovation Officer and Vice Chairman of Orthopedic Surgery.

An accomplished academician, Dr. Graham has lectured around the world and advanced his specialty by authoring more than 100 publications, numerous books and book chapters, including the best-seller, “Innovation the Cleveland Clinic Way.

Enhancing Orthopedic Innovation

Dr. Graham’s history as a prolific innovator and inventor includes holding more than 50 patents for medical devices, primarily implants to treat fractures or replace joints of the upper extremity. He also is an entrepreneur in his own right, and has started several public and private medical device and artificial intelligence companies.

In his new role at NYU Langone, Dr. Graham will take his vast experience translating strategy and innovation into tangible advancements in techniques, technologies and the delivery of orthopedic care.

“NYU Langone has impressed me with its commitment to innovation and collaboration, where colleagues embrace the responsibilities and opportunities that come with clinical and academic leadership,” Dr. Graham says. “I recognize championship organizations, and I’m honored to join yet another. NYU Langone’s Department of Orthopedic Surgery remains at the vanguard of our specialty by optimizing outcomes and the patient experience.”

Media Contact:
Ryan Jaslow
Ryan.jaslow@nyulangone.org
212-404-3511

SOURCE NYU Langone Health

Solvay’s Ixef® PARA offers alternative to stainless steel in Innovative Surgical Designs’ new Redi-Spine™ system for spinal fusion surgical procedures

Alpharetta, Ga., October 2, 2018  Solvay, a leading global supplier of specialty polymers, announced during NASS 2018 last week that Innovative Surgical Designs, a developer and manufacturer of orthopedic spinal systems, chose Ixef® polyarylamide (PARA) resin to innovate a new single-use surgical instrument kit for minimally invasive spinal fusion surgery. Innovative Surgical Designs’ new Redi-Spine™ kit leverages Ixef® PARA’s mechanical strength, moldability and gamma sterilizability to offer an economical alternative to reusable stainless steel instruments.

Ixef® PARA’s metal-like strength and rigidity enabled us to simplify and deliver Redi-Spine™ instruments in a compact, elegant kit,” explained Jon Rinehart, chief financial officer of Innovative Surgical Designs. “When we first started heading down the path of polymer instruments, I candidly admit that I was skeptical. I didn’t think an injection-molded alternative to stainless steel was possible. But when we started working with Solvay’s Ixef® PARA resin, I realized how wrong I was.  We wouldn’t be able to offer the Redi-Spine™ kit for all of our surgeons’ one- and two-level cases without Solvay’s high-performance polymer and application support.

Designed to withstand the severe torsional forces and rigors of thoracolumbar spinal fixation, Innovative Surgical Designs’ Redi-Spine™ instruments received 510(k) clearance from the U.S. Food & Drug Administration (FDA) in August. It contains multiple disposable, handheld instruments including a T-ratchet handle, counter-torque tool and gearshift probe that are molded entirely or in part from Solvay’s Ixef® GS-1022 PARA.

Ixef® GS-1022 PARA can be sterilized with gamma ray radiation without any significant change to its mechanical properties, ultra-smooth finish or color. Solvay offers the material in a range of gamma-stabilized colors, from which Innovative Surgical Designs, Inc. chose gray for its kit. Solvay’s polymer has also been evaluated for ISO 10993 limited duration biocompatibility and is supported by an FDA Master Access File, which can help streamline regulatory approvals.

The growing adoption of single-use surgical instruments has increasingly established Solvay’s Ixef® PARA as a mainstream material for these applications,” said Jeff Hrivnak, business manager for Healthcare at Solvay’s Specialty Polymers Global Business Unit. “We continue to build on our early and proactive support of this trend by working closely with trailblazers like Innovative Surgical Designs, Inc. to help optimize their products for molding and speed to market.

Innovative Surgical Designs plans to launch the Redi-Spine™ kit during the fourth quarter of 2018. For more related news about specialty polymers for healthcare, please go to www.solvayhealthcarenews.com.

® Ixef is a registered trademark of Solvay
™ Redi-Spine is a trademark of Innovative Surgical Designs

 

CORRECTING and REPLACING – SeaSpine Announces Preliminary Results for Third Quarter 2018

CARLSBAD, Calif., Oct. 02, 2018 (GLOBE NEWSWIRE) — In a release issued under the same headline earlier today by SeaSpine Holdings Corporation (NASDAQ: SPNE) please note that in the fifth paragraph of the release under 2018 Financial Outlook the growth should be 7% to 8% over full-year 2017 revenue, not 6% to 9% over full-year 2017 revenue as previously stated. The corrected release follows:

SeaSpine Holdings Corporation (NASDAQ: SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, announced today preliminary financial results for the three-months ended September 30, 2018.

Preliminary and unaudited revenue for third quarter 2018 is expected to be in the range of $35.5 to $36.0 million, reflecting approximately 12% to 13% growth compared to the prior year period.  Compared to third quarter 2017, total U.S. revenue is expected to increase between 12% to 13% to approximately $31.5 to $31.8 million, with both U.S. Orthobiologics and U.S. Spinal Implants revenue expected to increase more than 10%.  International revenue is expected to increase between 14% and 20% to approximately $4.0 to $4.2 million.

Cash and cash equivalents at September 30, 2018 are expected to be approximately $11.5 million.  The Company borrowed $3.0 million of cash under its credit facility during the third quarter of 2018 and had $7.3 million of outstanding borrowings under the credit facility as of September 30, 2018. The Company has not sold any shares of its common stock under its $50 million “at the market” equity offering program.

“We are pleased by our revenue results for the third quarter, which reflect solid revenue growth across all portfolios,” said Keith Valentine, President and Chief Executive Officer. “This momentum is driven by increasing market penetration from our recently launched products, a more engaged and increasingly exclusive distributor network, and from a deeper commitment in our organization to customer experience and medical education and training. We are confident that we are well positioned to sustain this growth as we continue to deliver cost effective procedural solutions to surgeons and hospitals to improve the quality of patient lives.”

2018 Financial Outlook
SeaSpine is increasing its full-year 2018 revenue guidance range to $141 to $142 million, up from $136 to $139 million, reflecting growth of approximately 7% to 8% over full-year 2017 revenue.

Upcoming Investor Conferences
As previously announced, SeaSpine management is scheduled to present at the Ladenburg Thalmann 2018 Healthcare Conference in New York, NY today, October 2 at 3:00pm ET.  SeaSpine management is also scheduled to present at the Cantor Global Healthcare Conference in New York, NY on Wednesday, October 3 at 9:10am ET. A live webcast of both presentations will be available on the Investor Relations page of the Company’s website at www.seaspine.com. A replay of each presentation will be available on the website for 30 days following the event.

About SeaSpine
SeaSpine (www.seaspine.com) is a global medical technology company focused on the design, development and commercialization of surgical solutions for the treatment of patients suffering from spinal disorders. SeaSpine has a comprehensive portfolio of orthobiologics and spinal implants solutions to meet the varying combinations of products that neurosurgeons and orthopedic spine surgeons need to perform fusion procedures on the lumbar, thoracic and cervical spine. SeaSpine’s orthobiologics products consist of a broad range of advanced and traditional bone graft substitutes that are designed to improve bone fusion rates following a wide range of orthopedic surgeries, including spine, hip, and extremities procedures. SeaSpine’s spinal implants portfolio consists of an extensive line of products to facilitate spinal fusion in minimally invasive surgery (MIS), complex spine, deformity and degenerative procedures. Expertise in both orthobiologic sciences and spinal implants product development allows SeaSpine to offer its surgeon customers a differentiated portfolio and a complete procedural solution to meet their fusion requirements. SeaSpine currently markets its products in the United States and in over 30 countries worldwide.

Forward-Looking Statements
SeaSpine cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that are based on the Company’s current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements relating to: the Company’s preliminary revenue results for the third quarter; the Company’s ability to sustain revenue growth in the future; and the Company’s expectations for full-year 2018 revenue.  In addition, this release contains preliminary financial results for third quarter 2018.  These preliminary results for the third quarter of 2018 are not a comprehensive statement of our financial results for the quarter and provided prior to completion of all internal and external review and audit procedures and therefore are subject to adjustment.  Among the factors that could cause or contribute to material differences between the Company’s actual results and the expectations indicated by the forward-looking statements are risks and uncertainties that include, but are not limited to: surgeons’ willingness to continue to use the Company’s existing products and to adopt its newly launched products, including the risk that the Company’s products do not demonstrate adequate safety or efficacy, independently or relative to competitive products, to support expected levels of demand or pricing; the ability of newly launched products to perform as designed and intended and to meet the needs of surgeons and patients, including as a result of the lack of clinical validation of products in limited commercial (or “alpha”) launch; the Company’s ability to attract new, high-quality distributors, whether as a result of inability to reach agreement on financial or other contractual terms or otherwise, disruption to the Company’s existing distribution network as new distributors are added, and the ability of new distributors to generate growth or offset disruption to existing distributors; continued pricing pressure, whether as a result of consolidation in hospital systems, competitors or others, as well as exclusion from major healthcare systems, whether as a result of unwillingness to provide required pricing or otherwise; the risk of supply shortages and the associated, potentially long-term disruption to product sales, including as a result of the Company’s dependence on a limited number of third-party suppliers for components and raw materials, or otherwise; unexpected expense and delay, including as a result of developing and supporting the launch of new products, the fact that newly launched products may require substantial additional development activities, which could introduce further expense and delay, or as a result of obtaining regulatory clearances; the Company’s ability to continue to invest in product development and sales and marketing initiatives at levels sufficient to drive future revenue growth, including as a result of its inability to obtain funding on a timely basis on acceptable terms, or at all; general economic and business conditions in the markets in which the Company does business, both in the U.S. and abroad; and other risks and uncertainties more fully described in the Company’s news releases and periodic filings with the Securities and Exchange Commission. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov.

You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. SeaSpine does not intend to revise or update any forward-looking statement set forth in this news release to reflect events or circumstances arising after the date hereof, except as may be required by law.

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

Bone Solutions Inc. has successfully completed 250 cases with OsteoCrete® Magnesium-Based Bone Void Filler

InVivo Therapeutics Announces Joint Research Collaboration with Q Therapeutics, Inc.

October 02, 2018

CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (Nasdaq: NVIV), a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries (SCIs), today announced that it has entered into a joint research agreement with Q Therapeutics, Inc., a privately held developer of clinical-stage cell therapies for central nervous system (CNS) disease and injury.

The research collaboration is focused on the evaluation of the combination of InVivo’s proprietary PLGA-PLL based Neuro-Spinal Scaffold with Q Therapeutics’ adult neural progenitor cells, including those from induced pluripotent stem cells (iPSCs). The two companies will share their respective technologies to explore the potential pre-clinical safety, feasibility and synergistic properties of the combined technologies for applications in the CNS.

Richard Toselli, M.D., InVivo’s President and Chief Executive Officer, said, “We are excited about our research collaboration with Q Therapeutics, a leading developer of adult neural progenitor cell therapies to treat debilitating CNS disease and injury. Although InVivo remains very focused on and optimistic about the potential clinical benefit of the Neuro-Spinal Scaffold as a stand-alone technology, we believe this scientific partnership will allow both parties the opportunity to evaluate in parallel whether there is also a potential additive preclinical benefit of the combined technologies.”

About InVivo Therapeutics

InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In January 2018, the company announced updated clinical evidence, including improvements in patients with acute spinal cord injury (SCI), from its INSPIRE study of the Neuro-Spinal Scaffold™. The publicly traded company is headquartered in Cambridge, MA.

About Q Therapeutics, Inc.

Q Therapeutics is a clinical-stage company developing adult neural progenitor cell therapies to treat debilitating CNS disease and injury. The Company has patented processes to derive and manufacture neural progenitor cells from any tissue source, including iPSCs. Its first therapeutic product candidate, Q-Cells® (glial-restricted progenitor cells), is intended to restore or preserve normal CNS activity by supplying essential nerve cell functions. Q-Cells may be suitable to treat a range of CNS disorders, including demyelinating conditions such as multiple sclerosis (MS), transverse myelitis (TM), cerebral palsy and stroke, as well as neurodegenerative diseases and injuries such as amyotrophic lateral sclerosis (ALS), spinal cord injury, traumatic brain injury, and Alzheimer’s disease. Q Therapeutics has obtained Investigational New Drug (IND) clearance from the FDA for Phase 1/2a trials in both ALS and TM for Q-Cells. In addition, the FDA has granted Q-Cells orphan drug status in both ALS and TM as well as fast track designation in ALS. For more information, see www.qthera.com.

Contacts

InVivo Therapeutics
Heather Hamel, 617-863-5530
Investor Relations
ir@invivotherapeutics.com