Trial offers hope of a treatment for spinal muscular atrophy

Posted On September 21, 2016 By OrthoSpineNews In Neuro, Spine /

September 20, 2016 – University of Oxford

SMA occurs when people lack a gene called survival motor neuron 1 (SMN1). It can affect children in the womb or adults. This makes them unable to produce enough SMN protein, resulting is motor neuron degeneration and increasing muscle weakness. However, people have an almost identical gene called SMN2.

Existing proposed treatments are based on altering SMN2 to include a crucial part that is found in SMN1, enabling the production of SMN protein. This uses a splice-switching oligonucleotide or SSO. However, the difficulties of getting SSOs across the blood-brain barrier and into the central nervous system mean that they have to be injected into the spine with a lumbar puncture.

Researcher Dr Suzan Hammond explained: ‘Intrathecal delivery — injection around the spinal cord — makes a treatment less straightforward. Around a third of patients experience side effects. An additional complication is that SMA frequently leads to scoliosis — twisting of the spine — which can restrict such injections.’

The team at Oxford’s Department of Physiology, Anatomy and Genetics developed a treatment called Pip6a-PMO, in which the SSO was delivered using a peptide called Pip6a.

Dr Hammond explained: ‘Pip6a is highly effective at delivering SSOs to a wide variety of tissue in the body. We have confirmed that it can also get them into the brain and spinal cords in young and adult mice.’

When young mice — known as pups — with genetically engineered SMA were injected with the Pip6a-PMO, the results were rapidly clear: At just seven days old they were noticeably heavier and faster growing than untreated pups; at 12 days, tests found the treated pups much stronger than untreated counterparts. They also lived much longer, a median 167 days for mice treated with one dose of 10 microgrammes per gram of weight of Pip6a-PMO, compared to untreated pups’ 12 days.

Tests also found that two such doses of Pip6a-PMO markedly improved survival — with all mice treated in this way surviving at least 200 days and median survival of 457 days, 38 times longer than untreated mice and nearly three times longer than those who received a single dose.

Study of neuromuscular junctions, where motor neurons connect to muscles, showed that the effect of SMA, which destroys nerves at the junctions, was reversed by a single dose of the treatment, returning the connections to normal levels.

Professor Matthew Wood said: ‘While Pip6a was initially designed for Duchenne muscular dystrophy, we have shown that it can also be highly effective in SMA treatment. The survival of mice in this trial was far longer than any other treatment. The advantage is that it is both a central nervous system treatment and a systemic treatment for the wider body. Such an approach could also work for diseases like Parkinson’s, Huntingdon’s and ALS, and our focus will be extending the clinical applications of Pip-PMOs.’

The team are currently planning a 2-year study that would start next year, to evaluate this treatment in patients.

Story Source:

The above post is reprinted from materials provided byUniversity of Oxford. Note: Content may be edited for style and length.

Journal Reference:

Suzan M. Hammond, Gareth Hazell, Fazel Shabanpoor, Amer F. Saleh, Melissa Bowerman, James N. Sleigh, Katharina E. Meijboom, Haiyan Zhou, Francesco Muntoni, Kevin Talbot, Michael J. Gait, Matthew J. A. Wood. Systemic peptide-mediated oligonucleotide therapy improves long-term survival in spinal muscular atrophy.Proceedings of the National Academy of Sciences, 2016; 201605731 DOI: 10.1073/pnas.1605731113

Cite This Page:

University of Oxford. “Trial offers hope of a treatment for spinal muscular atrophy.” ScienceDaily. ScienceDaily, 20 September 2016. <www.sciencedaily.com/releases/2016/09/160920154551.htm>.

Medical Device Testing Services Expands Orthopaedic Capabilities

Posted On September 21, 2016 By OrthoSpineNews In Recon, Spine /

MINNETONKA, Minn., Sept. 20, 2016 /PRNewswire/ — Medical Device Testing (MDT) Services has added spine and knee wear testing to its extensive orthopaedic device testing portfolio. For the past 26 years, MDT has served the medical device industry as a contract test laboratory focused on mechanical testing and materials characterization.

MDT was founded in 1990 as a division of EnduraTEC Systems Corporation, which specialized in the development of novel material test instruments for the medical device community. In 2000, MDT was spun off as a separate company to provide greater focus on testing services. MDT is an ISO 17025 certified laboratory that provides test design, execution, and documentation using a rigorous quality program that helps customers fast-track their submissions to the FDA and other regulatory agencies.

MDT recently added an MTS Bionix Spine Wear Tester and multiple Knee Motion Wear Simulators to expand capabilities in orthopaedic medical device testing. While MDT has a strong brand recognition in the medical device market for cardiovascular device testing, a significant part of its business has always been in orthopaedics. “In fact, the very first applications we worked on when we launched the company in 1990 were spinal fixation device fatigue testing and knee motion simulation. Over the last 26 years, we have been fortunate to work with the most original device designs targeting applications from head to toe,” saidKent Vilendrer, President and CEO of MDT.

About Medical Device Testing Services

Medical Device Testing Services is one of the largest A2LA accredited medical device testing companies in the world with over$6 million in commercial fatigue and durability test systems, inspection instruments, and test fixturing inventory. Find out more about the medical device mechanical testing and materials characterization specialists at www.devicetesting.com.

SOURCE Medical Device Testing Services

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Band-LOK, LLC Announces the First Surgery of its Pedicle-Sparing Polyester Band Spinal Technology.

Posted On September 20, 2016 By OrthoSpineNews In Spine /

WAXHAW, NC (PRWEB) SEPTEMBER 20, 2016

Band-LOK, LLC a developer of anatomy friendly medical technologies for orthopedics, today announced the first-of-its-kind spinal surgery using the company’s pedicle-sparing polyester band technology; made available to the market via a licensing agreement with OrthoPediatrics Corp (Warsaw, IN).

“The Band-LOK technology was developed as a novel way to approach various orthopedic defects using polyester bands and intuitive instrumentation. The Band-LOK system changes the paradigm for treating bone pathologies, including complex spinal deformities like scoliosis,” said John Kapitan, head of R&D and Co-Founder of Band-LOK.

Dr. Mike Albert performed the first case on August 22, 2016, at Dayton Children’s Hospital in Dayton, Ohio. “The technology’s unique Tether Clamp System was used in a neuromuscular scoliosis measuring 90 degrees,” said Dr. Albert. “The case went exceptionally well; demonstrating the versatility, simplicity and power of the band to correct severe spinal deformities. The system performed flawlessly, gradually correcting this large spinal deformity with no bone or band failures.”

Band-LOK, LLC was granted a patent by the United States Patent and Trademark Office (USPTO) in November, 2015, and has other patents pending. The company is focused on expanding its band technology to other orthopedic applications and exploring synergistic licensing agreements beyond spine.

Randy Roof, President and Co-Founder added, “We are in the business of pushing boundaries of tether band technology for orthpedics, and the first clinical case is an important step in that direction.”

About Band-LOK, LLC.

Based in Waxhaw, NC, Band-LOK, LLC. is a medical technology incubator composed of industry veterans and scientists focused on developing a suite of less invasive, anatomy friendly band technologies and a robust IP portfolio.

Contact Information
Randy Roof (President/Co-founder)
Phone: 704-839-1916
Email: mrnuspine(at)me.com

Life Spine Announces FDA Clearance of PRO-LINK® Ti Stand-Alone Cervical Spacer System

Posted On September 20, 2016 By OrthoSpineNews In Spine /

September 20, 2016

HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today that the U.S. Food and Drug Administration (FDA) has given 510(k) marketing clearance to the PRO-LINK Ti Stand-Alone Cervical Spacer System.

“PRO-LINK Ti offers a low-profile, stand-alone cervical interbody with our groundbreaking Osseo-Loc™ technology. Osseo-Loc is a proprietary surface treatment for titanium with 500-600 microns of porosity, which helps create an environment for potential bone growth,” said Rich Mueller, Chief Operating Officer for Life Spine. “Due to the structural integrity of titanium, we were also able to include lateral graft windows for maximum bone graft volume and visibility.”

PRO-LINK® Ti is scheduled for full product release by the end of 2016 and joins Life Spine’s portfolio of twenty products launching in 2016.

About Life Spine

Life Spine is dedicated to improving the quality of life for spinal patients by increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Life Spine, which is privately held, is based in Huntley, Illinois. For more information, please visit: http://www.lifespine.com.

Life Spine is a registered trademark.

Contacts

Life Spine
Mr. Omar Faruqi
Chief Financial Officer
847-884-6117
ofaruqi@lifespine.com

Don’t Forget the Pulses! Aortoiliac Peripheral Artery Disease Masquerading as Lumbar Radiculopathy—A Report of 3 Cases

Posted On September 19, 2016 By OrthoSpineNews In Neuro, Spine /

Am J Orthop. 2016 July

Lumbar radiculopathy is a common problem encountered by orthopedic surgeons, and typically presents with lower back or buttock pain radiating down the leg.¹ While the most common causes of lumbar radiculopathy are lumbar disc herniation and spinal stenosis, the differential diagnosis for lower extremity pain is broad and can be musculoskeletal, vascular, neurologic, or inflammatory in nature.^1,2Differentiating between orthopedic, neurologic, and vascular causes of leg pain, such as peripheral artery disease (PAD), can sometimes be challenging. This is especially true in aortoiliac PAD, which can present with hip, buttock, and thigh pain. Dorsalis pedis pulses can be palpable due to collateral circulation. A careful history and physical examination is crucial to the correct diagnosis. The history should clearly document the nature of the pain, details of walking impairment, and the alleviating effects of standing still or positional changes. A complete neurovascular examination should include observations regarding the skin, hair, and nails, examination of dorsal pedis, popliteal, and femoral pulses in comparison to the contralateral side, and documentation of dural tension signs. Misdiagnoses can send the patient down a path of unnecessary tests, unindicated procedures, and ultimately, a delay in definitive diagnosis and treatment.¹

To our knowledge, this is the first report on a series of patients with thigh pain initially diagnosed as radiculopathy who underwent unproductive diagnostic tests and procedures, and ultimately were given delayed diagnoses of aortoiliac PAD. The patients provided written informed consent for print and electronic publication of these case reports.

Case 1

An 81-year-old woman with a medical history notable for hypertension, hyperlipidemia, and stroke initially presented to an outside orthopedic institution with complaints of several months of lower back and right hip, thigh, and leg pain when walking. She did not report any history of night pain, weakness, or numbness. Examination at the time was notable for painful back extension, 4/5 hip flexion strength on the right compared to 5/5 on the left, but symmetric reflexes and negative dural tension signs. X-rays showed multilevel degenerative disc disease of the lumbar spine, and magnetic resonance imaging (MRI) showed a small L3/4 disc protrusion causing impingement of the L4 nerve root.

A transforaminal epidural steroid injection at the L4 level was performed with minimal resolution of symptoms. Several months later, right-sided intra-articular facet injections were performed at the L4/5 and L5/S1 levels, again with minimal relief of symptoms. At this point, the patient was sent for further physical therapy.

Over a year after symptom onset, the patient presented to our institution and was evaluated by a vascular surgeon. Physical examination was notable for 1+ femoral artery and dorsal pedis pulses on the right side, compared to 2+ on the left. An aortoiliac duplex ultrasound showed severe significant stenosis of the right common iliac artery (>75%).

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UNYQ Showcases 3D Printed Scoliosis Brace with Embedded Wearable Technology at White House Event Celebrating Inclusive Design, Assistive Technology & Prosthetics

Posted On September 19, 2016 By OrthoSpineNews In Spine /

September 15, 2016

WASHINGTON–(BUSINESS WIRE)–

UNYQ, the San Francisco- and Seville-based pioneer in personalized prosthetics and orthotics, today showcased their new state-of-the-art scoliosis brace, UNYQ Align™, and their personalized prosthetic cover, UNYQ Performance™, at a White House event hosted by the White House Office of Public Engagement and Office of Science and Technology Policy. UNYQ Align™ combines 3D-printing and digital design, powered by the Intel® Curie™ module, into a stylish, customized, and lightweight medical device that assists scoliosis sufferers.

This Smart News Release features multimedia. View the full release here:http://www.businesswire.com/news/home/20160915006398/en/

For this special White House event, UNYQ teamed up with Studio Bitonti, led by famed designer, Francis Bitonti, to imagine a brand new type of UNYQ Align™ brace. The result is not only fashionable, but, through innovative topology optimization technology, Studio Bitonti and UNYQ were able to reduce the material significantly to create their most breathable and lightweight scoliosis brace yet.

“It was a privilege to collaborate with UNYQ on this solution. These are the kinds of projects designers need to be paying very close attention to,” said Francis Bitonti, CEO of Studio Bitonti. “UNYQ Align™ demonstrates how innovative technologies, designers, and technologists can combine to revolutionize treatment of medical conditions and dramatically improve the lives of the people who rely on assistive devices.”

Around 7 million US citizens suffer from scoliosis, a curvature of the spine that afflicts both young and old. Bracing is the most common treatment for children and teens, with prescribed usage of up to 16-18 hours a day. Traditional braces make it difficult for patients to reach the minimum recommended bracing period per day because they are constricting, bulky and perceived as unattractive.

UNYQ Align™ uses sensors to detect how long a user wears the device, and monitors pressure points to ensure fit and function. A mobile app collects the data for use by clinicians to make adjustments based on empirical data. At 3.5mm thick, the new brace is lightweight and slim enough to wear under a shirt, and comes in a wide variety of colors and patterns. These innovations dramatically improve the patient’s experience and impact their willingness to wear the brace.

“We are thrilled to have been invited to feature 2 of our products, UNYQ Performance™ and UNYQ Align™ at the White House Event Celebrating Inclusive Design, Assistive Technology & Prosthetics,” said Eythor Bender, UNYQ CEO and Co-Founder. “I’m continually inspired by people who have overcome personal barriers, and am proud we have developed products that allow them more opportunities to do so.”

The White House event included remarks from administration officials, industry experts, and designers, and featured a fashion show highlighting inclusive creations.

Included in the fashion show:

The UNYQ Align™ concept scoliosis brace designed by Studio Bitonti for UNYQ, was modeled by Grace Mosier, a 15-year-old with scoliosis. Grace demonstrated how the tiny, yet powerful embedded Intel Curie™ Module is helping her reach her treatment goals, while its stylish, customized, and lightweight design gives her more confidence and increases her willingness to wear the brace.
An example of UNYQ Performance™, personalized prosthetic covers, that empower amputees to celebrate their authenticity in a fashionable way was worn by retired US Marine Corps Sergeant, Kyle Garcia, whose left leg was amputated after suffering a blast injury from an IED during his third deployment in Afghanistan.

UNYQ Align™ will be launched to a limited number of the top clinics in the U.S. in October. The UNYQ Align™ App will be available in the spring of 2017. Sign up for updates at www.unyq.com.

About UNYQ
UNYQ delivers personalized non-invasive orthopedic devices that improve quality of life and celebrate user’s authenticity fashionably. The company employs digitization and 3D printing and cognitive systems to enhance device functionality and democratize access to everyone affordably. To learn more about UNYQ, its Hub Network and complete product lines, visit unyq.com.

About Studio Bitonti
Studio Bitonti creates tools that push ideas into the world. It designs manufacturing processes, products, and software to enable clients to use emerging technologies on a variety of projects with a variety of materials. The studio’s goal is to help clients produce their ideas with the most innovative tools available. Studio Bitonti is based in Brooklyn, NY. More information can be found at studiobitonti.com

About Intel
Intel (INTC) expands the boundaries of technology to make the most amazing experiences possible. Information about Intel can be found at newsroom.intel.com and intel.com.

View source version on businesswire.com: http://www.businesswire.com/news/home/20160915006398/en/

MULTIMEDIA AVAILABLE:http://www.businesswire.com/news/home/20160915006398/en/

ApiFix® Ltd. Reaches 100-Patient Milestone with the Expansion of European Clinical Sites to Treat Children and Adolescents who have Scoliosis with its Minimally Invasive, Non-Fusion Device

Posted On September 19, 2016 By OrthoSpineNews In Spine /

CHARLESTON, S.C. and MISGAV, Israel, Sept. 19, 2016 /PRNewswire/ — ApiFix, Ltd. announced today that the company’s ApiFix® system has now been used to correct scoliosis in 100 patients with a first case at the PAUL GERHARDT DIAKONIE hospital in Berlin, Germany. The 100th case was Dr. Miguel Alquiza’s first time implanting the ApiFix system. It took about an hour with excellent results, leaving the surgical team enthusiastic about the device.

The ApiFix system is a minimally invasive, fusionless spinal implant system for the correction of Adolescent Idiopathic Scoliosis (AIS). Traditional surgical correction is a highly invasive procedure involving fusion which results in a rigid spine, compared to the ApiFix system which can be implanted with a minimally invasive procedure, does not require fusion, and retains flexibility of the spine.

ApiFix has opened new European clinical centers in Italy, Germanyand France in the first half of 2016. PAUL GERHARDT DIAKONIE hospital in Berlin is one of the newest German centers that has started twork with the ApiFix system. The 100 patient clinical experience in Europe and Israel now includes twelve sites in nine countries, with the earliest patients being over four years out post operatively and excellent results overall. The Company expects to double the number of cases by the end of 2017.

ApiFix’s US based Chairman, Ted Bird commented, “I am very happy with the progress being made by the ApiFix team in managing the controlled clinical release in Europe and Israel since receiving a CE Mark in December, 2012. The company has also made great progress on preparing a submission to the FDA for a Humanitarian Device Exemption, (HDE) clearance in the US after receiving approval from the agency for this pathway last year.”

Apifix Principals will attend the annual meeting of the Scoliosis Research Society, (SRS) in Prague, Czech Republic onSeptember 21-23 to present the ApiFix system, clinical cases and their follow-up to potential users from all over the world.

Contact: Saar Wollach, ApiFix Sales & Marketing Manager, +972-54-4511512, Email

SOURCE ApiFix

Related Links

http://www.apifix.com

Spinal fusion operations may be needlessly crippling patients: expert

Posted On September 16, 2016 By OrthoSpineNews In Spine /

By GRANT McATHUR, HEALTH EDITOR, Herald Sun – September 15, 2016

SURGEONS are being warned to stop routinely undertaking spine fusing operations over fears too many patients are being left needlessly crippled.

A gathering of Australian pain specialists will this weekend be told to scale back their reliance on common lumber fusion operations by visiting US expert Dr Gary Franklin.

It comes as the appropriateness of all spinal surgeries are being reviewed for and clinical relevance by the spinal surgery clinical committee as part of the Medicare Benefits Schedule Review Taskforce.

In the past five years Australian surgeons have performed more than 34,000 stand procedures to fire two or more vertebrae together to prevent any movement between them, a well as thousands of other fusions as part of other spinal operations.

While the operation was designed as a last resort for patients with significant measurable instability in their spinal bones, Dr Franklin will tell The annual gathering of the Faculty of Pain Medicine that most disc-related cases now undertaken in Australia and the US could be better treated with less invasive measures.

“I cannot think of another surgical procedure that has such terrible outcomes,” Dr Franklin said.

“A lot of people have back pain and we just need to learn to use (other) methods of treating it.”

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Alphatec Holdings Announces Company Updates

Posted On September 15, 2016 By OrthoSpineNews In Financial, Spine /

CARLSBAD, Calif., Sept. 15, 2016 (GLOBE NEWSWIRE) — Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a provider of spinal fusion technologies, today announced changes to the Company’s executive leadership team and an update on its compliance with Nasdaq’s listing requirements.

The Company’s Board of Directors has appointed Leslie H. Cross, Chairman of Alphatec’s board, to the role of Chief Executive Officer on an interim basis, effective September 16, 2016. Mr. Cross, who previously served as Alphatec’s CEO between 2012 and 2014, succeeds James Corbett, who resigned his role as President and CEO and as a Director, effective September 12, 2016. Mr. Cross will continue his role as Chairman of the Board. As a result of Mr. Cross serving as both Chairman and CEO, the Company anticipates naming a Lead Independent Director in the near future.

Leslie Cross, Chairman of the Board of Directors, said, “Over the past few years, Alphatec has made significant progress under Jim’s leadership on its strategic journey to reshape the organization, including the successful sale of our international business to Globus Medical. We have strengthened our product development pipeline and as a result our commercial product portfolio has never been stronger. Similarly, we made significant progress on streamlining our cost structure through the outsourcing of manufacturing operations and improvements to our supply chain management processes through our partnership with outside suppliers. With a robust product suite that is attractive to surgeons, an improved balance sheet and a singular focus on the U.S. market, Alphatec is now well-positioned to undertake the next stage of transformation – improving commercial execution and accelerating revenue growth. The leadership changes we are announcing today are designed to fast track this vision to reality. We appreciate Jim’s contributions and wish him the best in his future endeavors.”

Other Executive Appointments

As part of today’s announcement, Michael J. Plunkett, the Company’s current Chief Operating Officer, COO, has been promoted to President and COO. Mike has served as the Company’s COO since January 2014. He originally joined Alphatec Spine in March 2012 as Vice President of Operations. During his time with the Company, Mike has been instrumental to the development of the Company’s strategy to accelerate growth and improve profitability, including the development of the Company’s product portfolio, streamlining supply chain management and partnering with external suppliers to successfully outsource the Company’s manufacturing operations.

The Company also announced today that Craig Hunsaker has accepted a newly created position at Alphatec as its Executive Vice President of People and Culture. In this role, Craig will be responsible for all aspects of employee recruitment, development, engagement and corporate culture. Craig’s professional career includes 16 years practicing law at some of the world’s largest technology focused law firms, advising and defending companies and management with respect to their people decisions, while holding various leadership positions. Craig left full-time legal practice in 2009, when he joined NuVasive, Inc., a publicly traded spinal implant company, first to serve as Vice President, Legal Affairs, then from late-2009 through March 2014 as Senior Vice President, Global Human Resources. Since April 2014, Craig has engaged in consulting in the areas of Employment Law and Human Resources, including most recently (since April 2016) as Senior Advisor, Human Resources at San Diego-based General Atomics. He received a B.S. in International Business & Finance from Brigham Young University and a J.D. from Columbia University School of Law.

In addition, the Company announced today that Jeff Rydin has agreed to serve in the role of Special Advisor to the Board, Commercial, and will advise the Board with respect to sales, marketing and revenue acceleration. Jeff most recently served as Chief Sales Officer with Ellipse Technologies, Inc., before its purchase by NuVasive in February 2016. He was previously at NuVasive, for over seven years, where he held various senior sales roles, including serving as President of Global Sales from October 2011 through March 2013. Prior to joining NuVasive, from January 2004 to December 2005 Jeff was Area Vice President of Orthobiologics for DePuy Spine, where he was responsible for the DePuy sales team in the Southeastern U.S. He also served in various executive and leadership sales roles at Orquest, Inc. (acquired by Johnson & Johnson), Symphonic Devices, Inc., General Surgical Innovations, Inc. (acquired by Tyco International Ltd), Baxter Healthcare, US Surgical and Xerox. Jeff received a Bachelor of Arts in Social Ecology from the University of California, Irvine.

Mr. Cross added, “This leadership transition is the next step in connecting surgeons and patients in the U.S. with Alphatec’s new and robust products. As part of this transition, the Board, the executive team and I will be focused on the next phase of the Company’s transformation – accelerating U.S. revenue growth and superior performance for Alphatec. I am pleased to expand the breadth and experience of the executive team with the expansion of Mike Plunkett’s role and the addition of Craig Hunsaker. In addition, we are fortunate to engage the counsel of Jeff as we transform our U.S. commercial execution and drive future revenue growth. I look forward to all of their contributions and have tremendous confidence in this leadership team and the dedicated employees we have at Alphatec.”

Nasdaq Listing Compliance

Today the Company also announced that it has received formal notification from the Listing Qualifications Department of The NASDAQ Stock Market (“NASDAQ”) notifying Alphatec that it has regained compliance with Listing Rule 5450(a)(1), the minimum bid price requirement for continued listing on The NASDAQ Stock Market, and that the matter is now closed. Alphatec’s common stock will continue to be listed on The NASDAQ Global Select Market.

About Alphatec Spine

Alphatec Spine, Inc., a wholly owned subsidiary of Alphatec Holdings, Inc., is a global medical device company that designs, develops, manufactures and markets spinal fusion technology products and solutions for the treatment of spinal disorders associated with disease and degeneration, congenital deformities and trauma. The Company’s mission is to improve lives by delivering advancements in spinal fusion technologies. The Company and its affiliates market products in the U.S. and internationally via a direct sales force and independent distributors.

Additional information can be found at www.alphatecspine.com.

Forward Looking Statements

This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainty. Such statements are based on management’s current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Alphatec Spine cautions investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors. Forward-looking statements include references to the Company’s: product development pipeline and product portfolio; ability to streamline its cost structure; ability to improve its balance sheet; and ability to accelerate its revenue growth or grow its revenues at all. Please refer to the risks detailed from time to time in Alphatec Spine’s SEC reports, including its Annual Report Form 10-K for the year ended December 31, 2015, filed on March 15, 2016 with the Securities and Exchange Commission, as well as other filings on Form 10-Q and periodic filings on Form 8-K. Alphatec Spine disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law.

Investor/Media Contact:
Christine Zedelmayer
Investor Relations
Alphatec Spine, Inc.
(760) 494-6610
czedelmayer@alphatecspine.com

Complication risk of minimally invasive sacroiliac joint fusion surgery may be higher than previously reported

Posted On September 15, 2016 By OrthoSpineNews In Spine /

Minimally invasive sacroiliac joint fusion surgery has been shown to be an effective treatment and potentially cost-saving for sacroiliac joint pain, with low adverse event and reoperation rates, as compared to open surgery. According to the study authors, “possibly as a result of this combination of factors,” the procedure has become a commonly-used technique. Current literature reports over 87% of sacroiliac joint arthrodesis as performed minimally invasively. This “has created the need for reliable data addressing the safety of the procedure,” the authors from Los Angeles, USA, state, noting that “existing literature has largely failed to…address this issue.” Because of the relative novelty of the procedure, the authors speculate that “acquiring a large sample population” has been difficult, with most current literature addressing outcome results via case series.

The Pearl Driver database—cataloguing patient records from US insurer, Humana Incorporated—holds data on 18,620,198 patients “from every major geographic region of the country.” The research team searched the database using International Classification of Disease, Ninth Revision and Current Procedural Terminology codes to distinguish patients who had undergone the minimally invasive procedure. The team specified their search parameters in order to account for changing terminology and pathologies indicated for open procedures, narrowing a population of 508 sacroiliac fusion patients down to 469, once exclusions had been made for neoplasms, pelvic ring trauma and reoperations. Of this patient population, 164 patients were male and 305 were female.

The corresponding records data were evaluated for novel postoperative complications in six categories; postoperative infection, nervous system, pain, urinary tract infection, osteomyelitis and joint derangement. Complication rates were investigated at 90 days and six months postprocedure, with a 30-day point used to evaluate infection rates. Novel lumbar pathology was also investigated as an outcome.

The researchers observed an incidence of 62 complications within the first 90 days (13.2%), and 77 (16.4%) within six months of the procedure. An infection rate of 4.1% (19) was observed within six months. Novel lumbar pathology was found in 3.6% of patients (n=17) at 90 days following the procedure, and in 5.3% (25) at six months, with a 9.1% (15) prevalence among on the male population at this time point.

“The results of our study show higher overall complication rates for minimally invasive sacroiliac joint fusion than have been previously reported,” write the authors. Whilst the team note that their population size is not particularly large, “it is nonetheless significantly bigger than nearly all previously published studies, and as a result has the statistical power that these smaller case series lack.” Whilst the team report that one study (Smith et al, Ann Surg Innov Res, 2013) has previously reported a higher overall complication rate of 18% (114, n=5319), others have reported rates as low as 3.5% (Miller et al, Med Devices (Auckl), 2013).

The observed infection rate, which was comparable to other results in the literature, was highlighted as notably higher than is associated with other minimally invasive procedures. “Minimally invasive sacroiliac joint fusion surgery potentially carries a relatively high risk of postoperative infection,” the authors of this study report. Furthermore, the study “for the first time also demonstrated substantial rates of postoperative complications involving the nervous systems, pain, and urinary tract infections,” with respective rates of 6.2%, 4.1% and 4.9% found for each subtype at six months.

Speculating on reasons for the novel lumbar pathology reported, the authors comment, “previous studies suggest that lumbar fusion can lead to sacroiliac joint degeneration in up to 75% of cases within five years.” “One potential limitation of this finding,” they report, “is that lumbar and sacroiliac joint pains are often difficult to distinguish.” Misdiagnosis, they suggest, may account for some of these findings.

As well as observing higher complication rates, the team observed a stark increase in the incidence of minimally invasive sacroiliac joint fusion procedures performed, particularly in the latter three years of the study data. This spike corresponds with a notable increase in studies of the procedure around this time, as well as “the US Food and Drug Administration approval of multiple minimally invasive sacroiliac fusion devices” at the beginning of 2008. “this notion is further supported”, they state, “by data which show that 92% of the original patient population remained after excluding patients with…indications for open sacroiliac fusion.”

Noting limitations including the potential for missing data as a result of changing billing codes, as well as “some degree of misclassification bias and unmeasured confounding,” the authors conclude that their study was “able to provide a unique analysis of minimally invasive sacroiliac joint fusion complications.” “As more data become available in the long term,” they comment, “adverse events need to be analysed to gain a better understanding of the procedures’ safety.”