Medical device maker says savings from new tax law to fuel innovation and growth

By DBJ Staff/Dec 21, 2017

Medical device maker NuVasive Inc. says savings from President Donald Trump‘s new tax reform will help it to fuel innovation and growth in its business, which could be a boon to local operations that are already experiencing growth.

San Diego-based NuVasive (NASDAQ: NUVA) announced today the potential implications to its business based on the recent passage by Republicans in the U.S. Congress and soon-to-occur signing by President Trump of the tax bill. The new bill will reduce the U.S. corporate tax rate from 35 percent to approximately 21 percent. This is the largest tax overhaul in 30 years and will significantly reduce the future corporate tax rate for NuVasive, which prior to the enactment of the tax overhaul was expected to be approximately 33 percent on a non-GAAP basis in 2018, the company said.

While the Company will be undertaking a thorough analysis over the coming weeks, early analysis indicates that the NuVasive non-GAAP tax rate will drop into the low 20 percent range in 2018 and in future periods converge to a 20 percent non-GAAP tax rate.

“The savings from this landmark decision are expected to boost forward-looking free cash flow and non-GAAP EPS well in excess of 10 percent per year beginning in 2018, delivering incredible incremental value-generating opportunities for our shareholders,” said Gregory T. Lucier, chairman and chief executive officer of NuVasive. “Innovation requires fuel, and this surplus can support increased investments in R&D to provide solutions that empower spine surgeons to change the lives of their patients. This is a tremendous opportunity for the medical device industry, and a major spark in our ability to continue to invest in life-changing innovations.”

 

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MiMedx Agrees To Lawsuit Settlement With Former Employee

MARIETTA, Ga.Dec. 19, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts and patent-protected processes for multiple sectors of healthcare, announced today that the Company has agreed to a confidential lawsuit settlement from one former employee.

MiMedx has reached a mutually agreeable settlement in its lawsuit with former employee, William T. Mills, who voluntarily resigned from MiMedx in January 2017.  In its suit, MiMedx alleged that Mills breached his restrictive covenants and his duty of loyalty to MiMedx by selling another company’s medical products while employed by MiMedx, and continued to breach his restrictive covenants after he voluntarily left MiMedx’s employ.  This lawsuit was a dispute solely over Mr. Mills’ MiMedx employment agreement, and no other allegations have been made by either party.

In addition to an undisclosed monetary settlement, other settlement terms were reached.  In this regard, Mills has agreed not to sell any products of his current employer to any MiMedx customer serviced by Mills for nine months.

Mills also acknowledges and confirms that he made no allegations of “channel stuffing” by MiMedx in this lawsuit.  Mills stated, “I have no knowledge of the agreements or payment terms between MiMedx and its customers.  I also do not know or have any way of knowing of how sales of products were accounted for by the Company in its financial statements.  To my knowledge, the vast majority of the MiMedx products which were sold into my accounts were used and were not returned.  MiMedx makes an excellent product.  I look forward to continuing my employment with my current employer.”

Parker H. “Pete” Petit, CEO, said, “We are pleased to have settled this lawsuit with Mr. Mills.  The prosecution of our other lawsuits is critical to ensuring the appropriate legal remedies and to rectify the misconduct committed by those individuals.  Mr. Mills did not bring any claims alleging channel stuffing, as other employees have, and he does not have enough knowledge of accounting matters to make such an allegation.  We are glad we were able to resolve this matter amicably with Mr. Mills.  We look forward to achieving appropriate outcomes from our legal actions against those other individuals.”

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

Important Cautionary Statement
This press release includes forward-looking statements, including statements regarding potential outcomes of legal actions.  These statements also may be identified by words such as “believe,” “except,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on our current beliefs and expectations. Forward-looking statements are subject to significant risks and uncertainties, and we caution investors against placing undue reliance on such statements.  Actual results may differ materially from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include the risk that different or additional facts may be discovered that change conclusions, and the risks of litigation.  For more detailed information on the risks and uncertainties, please review the Risk Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission.  Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.

SOURCE MiMedx Group, Inc.

Related Links

http://www.mimedx.com

Orthocell Granted European Tendon Regeneration Patent

December 14, 2017

PERTH, Australia–(BUSINESS WIRE)–Regenerative medicine company Orthocell Limited (ASX:OCC, “Orthocell” or the “Company”) is pleased to announce it has been granted a key European Patent. The patent is entitled ‘Culture medium, culturing method and use of tenocytes’ protecting the method of manufacturing tendon regeneration cells (Tenocytes) to form the Autologous Tenocyte Implantation (Ortho-ATI®) product. The patent expires in 2027 and provides additional important intellectual property (IP) to protect Orthocell’s tendon repair applications, now granted in EU, USA, China, Australia, Singapore, Hong Kong and New Zealand.

“Securing this patent for tendon repair in Europe is another milestone in strengthening our IP position as we drive our novel world leading tendon repair product into the global market. Orthocell is focused on building and maintaining patent protection for our regenerative medicine technologies and treatment processes,” Orthocell Managing Director Paul Anderson said.

Global IP protection for Ortho-ATI® further underpins the international rollout of Orthocell’s world leading tendon repair technology. Orthocell is well positioned to commercialise Ortho-ATI® with mature manufacturing facilities in place, proven safety and efficacy, published clinical data and a clear pathway to market.

Orthocell maintains an active program of patenting, with ownership of 29 granted patents across the Ortho-ATI®, Ortho-ACI® and CelGro® technologies, and related methods of treatment and manufacturing.

About Ortho-ATI®:

Ortho-ATI® is a world leading breakthrough in regenerative medicine – a novel, cell therapy developed to treat chronic degenerative tendon injuries (tendinopathy / tendonitis), it can be utilised in both surgical and non-surgical applications.

  • Tendon injury and its end point, tendinopathy, are a common cause of occupational and sporting disability reported to affect 1% to 3% of the general population every year
  • Significant financial burden to the public health care system expected to increase as the population ages, as a result, new treatments are required that are safe, effective and cost efficient
  • Ortho-ATI® meets the market need by enabling the accelerated regeneration of injured tendons, directly addressing the underlying cause of injury, replenishing degenerative tissue with healthy mature tendon cells (known as tenocytes)
  • Extensive clinical validation with published clinical data up to 4.5 years post treatment in leading peer reviewed journals, (e.g. American Journal Sports Medicine) clearly demonstrating durability and efficacy as the leading tendon regeneration treatment

Contacts

General enquiries
Orthocell Limited
Paul Anderson, +61 8 9360 2888
Managing Director
paulanderson@orthocell.com.au
or
Investor and Media enquiries
WE Buchan
Ben Walsh, + 61 411 520 012
bwalsh@buchanwe.com.au

FDA Panel Gives Thumbs Down to Spine Device

By Joyce Frieden, News Editor, MedPage Today/December 13, 2017

GAITHERSBURG, Md. — An FDA advisory committee voted 5-8 Tuesday, with one abstention, against recommending approval of the Barricaid prosthesis for partial anulus replacement in patients with herniated discs.

“There was a high rate of breakage of the device, a high rate of migration, and [there was] the unknown nature of [some endplate] lesions,” said Eli Baron, MD, of the Cedars Sinai Spine Center in Los Angeles, a member of the FDA’s Orthopaedic and Rehabilitation Devices Panel. Many of the users of the device would be younger patients, “most in their 30s and 40s, and we don’t know what will happen down the line.” He voted that the risks of the Barricaid device, which is manufactured by Intrinsic Therapeutics, outweighed its benefits.

But committee member Ty Subhawong, MD, of the University of Miami, disagreed. “[The device is] reasonably safe, and I think the major concerns were centered around the endplate lesions and while there were some theoretical concerns about harbingers of device failure …. the number of lesions observed was sufficient to reassure me that there is nothing catastrophic about these devices,” said Subhawong, who voted in favor of recommending approval. He added, however, that a post-approval study would be a good idea.

The committee also voted 12-1 that the device was shown to be effective in the patients it was indicated for, but by a vote of 5-9, they did not agree that the device was shown to be safe.

The Barricaid implant is a polymeric mesh that sits in the posterior intervertebral disc space; it is connected to a metallic anchor that is attached to the vertebral body, the FDA explained in a briefing document issued prior to Tuesday’s meeting. The implant comes with a delivery tool and manual surgical instruments, which are used in a posterior/posterolateral approach.

The Barricaid Anular Closure Device is a permanent implant used after a limited lumbar discectomy performed for treatment of lumbar radiculopathy. The device is designed to mechanically block an opening in the anulus, thereby maintaining the relative position of nucleus within the disc space to prevent reherniation following limited discectomy in patients with large anular defects at an increased risk of reherniation.

 

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Rep. Erik Paulsen Co-Sponsor of Bill to Suspend Collecting Medical Device Tax

– Some members of the House Ways and Means Committee, including Minnesota Republican Erik Paulsen, want to suspend collection of a medical device tax for five more years.

Paulsen and Republican colleague Jackie Walorski of Indiana on Tuesday introduced a bill to keep the tax from being collected through 2022. The proposal comes as time runs out on the current two-year moratorium that stopped device companies from having to pay a 2.3 percent sales tax on gross receipts in 2016 and 2017.

“Full repeal is my top priority,” Paulsen said.

But for now, he said, a five-year moratorium seemed like the best available vehicle to keep the tax from coming back Jan. 1. Paulsen believes his proposal can be attached to any of a number of year-end spending measures.

Going forward, Paulsen thinks he makes “a good selling argument” for permanent repeal based on the device companies’ willingness to expand operations by investing tax savings realized during the current moratorium.

The device tax was part of the Affordable Care Act. Collected from 2013 to 2015, it produced more than $5 billion in federal revenue. But it has long been targeted for repeal by the medical device industry, including hundreds of Minnesota medical technology businesses.

 

 

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THINK Surgical, Inc. Receives CE Mark Approval for the TSolution One® Surgical System for Total Knee Arthroplasty

FREMONT, Calif.Dec. 11, 2017 /PRNewswire/ — THINK Surgical Inc., a global medical device manufacturer of the only active robotic surgical system for orthopaedic surgery, announces that it has received CE Mark approval for the TSolution One® Surgical System, bringing active robotic precision to Total Knee Arthroplasty (TKA).

The TSolution One Surgical System first entered the European market in 2015 when it received CE Mark approval for Total Hip Arthroplasty (THA). Currently, the system has 510(k) clearance for THA in the United States and four centers are enrolling patients for an IDE clinical study for TKA. Earlier in the year, the TSolution One Surgical System received Korean-FDA clearance for both THA and TKA. It also received approval for sale in Israel by the Ministry of Health for THA.

“We are pleased to offer one of the most advanced technologies in Total Knee Replacement through the TSolution One Surgical System to the European market and other countries that rely on the CE Mark,” said John Hahn, CEO of THINK Surgical, Inc.  “Obtaining the CE Mark represents a key milestone towards continuing the global commercialization of our differentiated robotic technology and our commitment to improving patients’ lives and partnering with surgeons to transform orthopedic surgery.”

TSolution One is a robotic system that enables surgeons to create the patient’s personalized pre-surgical joint replacement plan, using CT-based 3D planning and the system’s open implant library to achieve an optimized surgical plan. During surgery, the robot precisely executes the patient’s individual surgical plan by removing diseased bone and preparing the bone cavity and joint surface with sub-millimeter dimensional accuracy.THINK’s active robotic technology has been shown to improve joint replacement implant fit and alignment as compared to conventional joint replacement surgery.2 Accurate implant fit and alignment may be responsible for reduced postoperative pain, complications, and improved patient function.3,4

1Paul HA, Bargar WL, Mittlestadt B, Musits B, Taylor RH, Kazanzides P, et al. Development of a Surgical Robot for Cementless Total Hip Arthroplasty. Clin Orthop Relat Res 1992;285:57–66

2Netravali, Nathan et al., “A Perspective on Robotic Assistance for Knee Arthroplasty” Advances in Orthopedics (2013): DOI http://dx.doi.org/10.1155/2013/970703

3P. F. Choong, M. M. Dowsey, and J. D. Stoney, “Does accurate anatomical alignment result in better function and quality of life? Comparing conventional and computer-assisted total knee arthroplasty,” Journal of Arthroplasty, vol. 24, no. 4, pp. 560–569, 2009.

4Barrack RL. Dislocation after total hip arthroplasty: Implant design and orientation. J Am Acad Orthop Surg. 2003;11(2):89-99.

About THINK Surgical, Inc.
THINK Surgical, Inc. is committed to the future of orthopaedic surgery and to improving patient care through the development of leading-edge precision technology. THINK Surgical develops, manufactures, and markets the only active robotic surgical system for orthopaedic surgery.

For more information, visit www.THINKSurgical.com.
TSolution One® is a registered trademark of THINK Surgical, Inc.

Contact: Nancy Heinzer
510-249-2318
info@thinksurgical.com

Related Links
THINK Surgical website

SOURCE THINK Surgical, Inc.

Camber Spine Announces FDA Clearance Of Spira™-C Open Matrix Cervical Interbody

WAYNE, Pa.Dec. 7, 2017 /PRNewswire/ — Camber Spine announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its SPIRA™-C Open Matrix Cervical Interbody device, an innovative interbody fusion implant, second in the SPIRA™ family to employ a novel arched design as well as Surface by Design™ technology.  This clearance marks Camber’s second implant clearance in the SPIRA™ family of implant systems to be released in the U.S. market.

The SPIRA™ family of interbody implants represents the next generation of open architecture; 3-D printed, titanium implants designed to enhance fusion.  The combination of smart science and smart surfaces merged with SPIRA™ Arch Technology creates an optimal environment for cell proliferation and bone growth. According to Daniel Pontecorvo, CEO at Camber Spine, “The engineers and designing surgeons leveraged the latest in 3-D printing technology to incorporate the needs at each step of the fusion process with the SPIRA™ family.  To enable immediate stability, significant friction was achieved with the unique surface design.  For short-term stability, other features were added to the surface design.  This includes both a roughened titanium surface designed to promote bone cell proliferation, and a pore size optimized for bone ingrowth.  In a way, robust ingrowth achieves a “mechanical fusion”, where we expect patients to feel better quicker.  Lastly, long-term stability is achieved with the ultimate endplate-to-endplate fusion.  The newly forming bone follows the multiple arches incorporated with the Surface By Design™ to encourage ongrowth and ingrowth throughout the cage. Also, using a key bone-growth principal called “Wolff’s Law”, the arched design structure enables the distribution of load and strain, helping to enhance the fusion.  We are very excited about this great implant design.”

The SPIRA™ Open Matrix ALIF implant, the first product released in the SPIRA™ family, also with an open architecture and arched design, was launched only three months ago, and has already been received with great surgeon enthusiasm for the treatment of their patients.  Together, with the ENZA™ ALIF implant providing simple and stable, zero-profile integrated fixation, Camber Spine is poised to be a leader in the interbody implant arena.

The Camber Spine SPIRA™-C Open Matrix Cervical Interbody device is indicated for use at one or two contiguous levels in the cervical spine, from C3-C7, in skeletally mature patients who have had six weeks of non-operative treatment for the degenerative disk disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. The Camber Spine Technologies SPIRA-C™ Open Matrix Cervical Interbody is intended to be used with additional FDA-cleared supplemental fixation systems.

About Camber Spine

Camber Spine Technologies, LLP, is a fast-growing musculoskeletal implant company founded in 2010 bringing innovative, best-in-class products to the market, providing surgeons and their patients with better treatment options. The company is committed to delivering surgeon inspired new technologies to the spine market. Camber is an ISO 13485 certified medical device company. Camber Spine Technologies, located in Wayne, Pennsylvania, markets a line of proprietary musculoskeletal products nationwide through its exclusive distributor, S1 Spine. For further information please visit www.cambermedtech.com . For inquiries about SPIRA™-C or distribution opportunities please call 484.427.7060.

All of Camber Spine Technologies’ products are proudly MADE IN THE USA.

 

SOURCE Camber Spine Technologies

Related Links

http://cambermedtech.com

Omnia Medical: First PEEK-OPTIMA™ HA Enhanced Vertebral Body Replacement System to Enter US Market

‘Omnia Medical VBR’ has been granted the first US FDA 510(k) clearance for a vertebral body replacement (VBR) system manufactured from PEEK-OPTIMA™ HA Enhanced polymer, from Invibio Biomaterial Solutions, for use in the thoracolumbar spine to replace a collapsed, damaged, or unstable vertebral body. This advancement was the result of a three-way collaboration: orthopaedic implant company Omnia Medical partnered with JALEX Medical on product development and regulatory activities and with Invibio Biomaterial Solutions, who pioneered medical PEEK.

Robert Gewirtz, MD – Neurosurgeon, Columbus, Ohio, comments on the innovative orthopaedic product: “Omnia Medical VBR is an intuitive device that is easy for the surgeon to use, and the benefits of hydroxyapatite incorporated into the structure of the implant is a real advance for our patients as it potentially offers improved outcomes.I am happy that I was able to partner in this collaboration to help bring the product to market.”

The novel single-use device is available in two footprints and allows fine adjustments of height and lordosis using spacers and endplates. It features a hollow center and holes to accommodate autograft or allograft while encouraging formation of new bone and includes anti-migration features.

In PEEK-OPTIMA HA Enhanced, Hydroxyapatite (HA), a well-known osteoconductive material that enhances bone apposition, is fully integrated into the polymer matrix, and not simply coated. Invibio´s enhanced biomaterial offers all the clinical advantages of PEEK OPTIMA Natural including a modulus similar to cortical bone, reduced stress shielding and artifact-free imaging that allows for clear fusion assessment. It has been shown to improve bone apposition compared to unfilled PEEK-OPTIMA Natural in a pre-clinical ovine model at 4 weeks and 12 weeks,(1) and also demonstrated performance advantages in a pre-clinical cervical spine fusion model in sheep at 6 and 12 weeks.(2) In addition, as observed by surgeons, early clinical results have shown solid fusions with dense bone apposition at 6 months and beneficial clinical outcomes for patients, revealing specific improvements in overall pain and neurological function,(3) when a PEEK-OPTIMA HA Enhanced interbody fusion device was used.

Steve Anderson, Vice President of Marketing at Omnia Medical concludes: “We are happy to be the first to be granted FDA 510(k) clearance for a vertebral body replacement (VBR) system manufactured from PEEK-OPTIMA HA Enhanced biomaterial. This unique material combination is a great option for the VBR application due to the large amount of natural anatomy removed during the procedure. Working with JALEX Medical and Invibio Biomaterial Solutions was an excellent experience – and will hopefully enable surgeons and patients to benefit from the new solutions.”

For more information please visit http://www.omniamedical.comhttp://www.jalexmedical.com and https://invibio.com.

REFERENCES
1.    Study evaluated the in vivo response to PEEK-OPTIMA Natural and PEEK-OPTIMA HA Enhanced in a large animal model. Data on file at Invibio. This has not been correlated with human clinical experience.
2.    Study evaluated the in vivo response to PEEK-OPTIMA Natural, PEEK-OPTIMA HA Enhanced and allograft in a cervical spine fusion model in sheep. Data on file at Invibio. This has not been correlated with human clinical experience.
3.    Testimonials presented have been provided by participating orthopaedic surgeons. Their view and experience are their own and do not necessarily reflect those of others. “Invibio” disclaims any liabilities or loss in connection with the information herein

In2Bones Announces FDA Clearance of the CoLink® View “See-Through” Plating System

December 05, 2017

MEMPHIS, Tenn.–(BUSINESS WIRE)–In2Bones Global, Inc. today announced that its In2Bones USA, LLC subsidiary has received U.S. Food and Drug Administration (FDA) clearance for an addition to its CoLink® Forefoot Bone Plating System used to stabilize bones during the post-surgical healing process. The addition will be marketed under the CoLink View brand name.

CoLink View Bone Plates incorporate a unique combination of titanium metal and a high-performance polymer called polyether ether ketone (PEEK). The CoLink View Plates include an X-ray transparent PEEK hub that allows the surgeon to literally watch the patient’s bone heal. This cannot be done with traditional metal plates because metal absorbs X-rays and blocks the image below. The “see-through” hub is unique to this new In2Bones plating system, and one of many device innovations designed by the company.

In addition to X-ray transparency, PEEK has a benefit of being less stiff than metal and more similar to the elasticity of bone. Bones need mechanical stress (elasticity) during the healing process. Stiffer, all metal implants may eliminate the positive elasticity and slow healing.

The CoLink View is the sixth In2Bones PEEK-related implant system that has received FDA clearance; others are expected to be cleared in 2018.

In August 2016, In2Bones USA, LLC and In2Bones, SAS, Lyon, France, merged to form In2Bones Global, Inc, a Delaware Corporation headquartered in Memphis. Since the merger and in addition to the aforementioned product, the company has launched several innovative products including the NeoView® PEEK Distal Radius Plate, the NeoSpan® SuperElastic Compression Staple, the Reference Toe System®AlloAid® PIPAlloAid® Nail, the 5MS® fifth metatarsal fracture repair system, the CoLag® Screw System, an ankle fusion plate system and the PitStop™ PEEK subtalar implant.

For more information about In2Bones Global, Inc. extremity products in the U.S. and France, please visit www.i2b-USA.com or www.In2Bones.com.

About In2Bones USA, LLC

Located in Memphis, Tennessee, In2Bones USA, LLC is a designer, manufacturer and distributor of medical devices for the treatment of disorders and injuries of the upper (hand, wrist, elbow) and lower (foot and ankle) extremities. For more information, visit www.i2b-USA.com.

About In2Bones, SAS

Located in Lyon, France, In2Bones, SAS is a specialty orthopaedic company that develops and distributes upper and lower extremity products to enable surgeons to alleviate pain and restore motion for their patients. For more information, visit www.In2Bones.com.

Safe-Harbor Statement:

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements made in this press release, other than statements of historical fact, are forward-looking statements. Forward-looking statements reflect management’s current view of future performance, results, and trends and may be identified by their use of terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “will,” and other similar terms. The company wishes to caution readers that actual results might differ materially from those described in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties impacting the business, including increased competition, technical obsolescence, regulatory issues, general economic conditions and other risks.

Contacts

Element-R Partners
Susan Duensing, CBC
847.639.8300
susan@rurelevant.com

SeaSpine Announces FDA 510(k) Clearance of OsteoBallast™ Demineralized Bone Matrix in Resorbable Mesh

CARLSBAD, Calif., Nov. 30, 2017 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ:SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for use of its OsteoBallast™ Demineralized Bone Matrix (DBM) in Resorbable Mesh.

The OsteoBallast product is the latest innovation in SeaSpine’s orthobiologics portfolio that is designed to facilitate fusion.  OsteoBallast, which consists of a resorbable mesh containing 100% DBM without a carrier, simplifies graft placement and helps prevent graft migration while maximizing DBM content. OsteoBallast is designed to provide surgeons with a simple means for delivering bone graft in posterior spine surgery that contours to the local anatomy while maintaining shape and volume under compression. The simplified technique is particularly valuable in MIS procedures, where placing the graft accurately through tubes and small incisions can be challenging.

“This product demonstrates SeaSpine’s continued commitment to innovation and our focus on delivering improved procedural spine solutions and clinical value through cost-effective orthobiologics,” commented Tyler Lipschultz, SeaSpine’s Vice President of Orthobiologics and Business Development. “Coupled with the recent launch of our OsteoStrand™ Demineralized Bone Fibers product and our established Accell Bone Matrix (ABM) technology, SeaSpine now can offer surgeons additional options to address the varied needs of their patients.”

SeaSpine plans to launch the OsteoBallast product with a limited release by year-end and full commercial launch by mid-2018.

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 implant 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 fusion hardware product development helps SeaSpine to offer its surgeon customers a complete 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 features and potential benefits of OsteoBallast DBM in Resorbable Mesh, including its ability to provide surgeons a simple means for delivering bone graft in posterior spine surgeries and help prevent graft migration during posterolateral fusion, as well as contour to local anatomy and maintain shape and volume under compression; and the timing of limited and full commercial launches of OsteoBallast DBM in Resorbable Mesh.  Among the factors that could cause or contribute to material differences between our actual results and the expectations indicated by our forward-looking statements are risks and uncertainties that include, but are not limited to: the fact that OsteoBallast DBM in Resorbable Mesh has not been validated clinically, may not address adequately surgeon requirements, and may require substantial additional development activities, which could introduce unexpected expense and delay, including potentially requiring resubmission of one or more products to FDA for clearance, which clearance cannot be certain, whether on a timely basis or at all; surgeons’ willingness to use OsteoBallast DBM in Resorbable Mesh; the risk that OsteoBallast DBM in Resorbable Mesh may not demonstrate adequate safety or efficacy, including improved fusion, independently or relative to competitive products, to support a full commercial launch; the risk of supply shortages, including as a result of our dependence on a limited number of third-party suppliers for components and raw materials, or otherwise; and other risks and uncertainties more fully described in our 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
(415) 937-5402
ir@seaspine.com