OrthAlign, Inc. Announces First KneeAlign Cases for Total Knee Arthroplasty in Greece

Posted On June 14, 2017 By OrthoSpineNews In Recon, Top Stories /

ATHENS, GREECE (PRWEB) JUNE 13, 2017

OrthAlign, Inc., a privately held U.S.-based medical device and technology company providing orthopedic surgeons with advanced precision technologies, announced today the first set of KneeAlign® cases completed for total knee arthroplasty (TKA) in Greece. These cases were completed by Athens-based orthopaedic surgeon Spyridon Armpis, MD, MSc and continue to reflect the rapid adoption of OrthAlign’s handheld precision alignment and positioning technologies, by surgeons throughout the world.

OrthAlign provides highly accurate, computer-assisted, handheld technologies for surgeons to receive real-time, actionable data for precise alignment and positioning of components in total knee, unicondylar knee, and total hip (both posterior and anterior) arthroplasty surgeries. Over 15 peer-reviewed clinical studies have been published to date, validating OrthAlign’s accuracy, simplicity of use, and benefits in recovery for the patient.

“The accuracy and simplicity of KneeAlign surprised me,” said Dr. Armpis. “The technology not only gives me confidence in my cuts, but allows me to elevate my standard of care for patients. I no longer have to invade the intramedullary canal, I don’t have to make multiple cuts, and it makes me, my OR staff, and the recovery process for my patients more efficient. Going forward, KneeAlign will be a key part of my practice and my patient-tailored recovery program, as I am convinced it will give my patients the best possible outcomes.”

In a published TKA clinical study by Denis Nam, M.D. (Rush University Medical Center, Chicago, IL), significant differences favoring the use of KneeAlign vs. conventional Computer Assisted Surgery were found with regard to the accuracy of femoral component alignment, with 94.9% of patients in the KneeAlign cohort having an alignment within 2° of neutral vs. 92.5% in the CAS cohort. There was also a significant difference in overall mean mechanical alignment of the limb, with 92.5% of patients within 3° of neutral mechanical axis in the KneeAlign cohort vs. 86.3% in the CAS cohort.

In another study by Dr. Nam (conducted as a randomized controlled trial, consisting of five different surgeons), it was found that KneeAlign decreases the incidence of outliers for tibial component alignment in both the coronal and sagittal planes, and improves the surgeon’s ability to achieve a specific, intraoperative goal, compared to conventional, tibial extramedullary (EM) alignment guides in TKA. In the KneeAlign cohort, 95.7% of tibial components were within 2° of perpendicular to the tibial mechanical axis and 95% of tibial components were within 2° of a 3° posterior slope (compared to 68.1% and 72.1% in the EM cohort, respectively).

“OrthAlign is delighted to have successfully completed its first KneeAlign cases in Athens,” said James Young Kim, OrthAlign’s Vice President and General Manager of International. “As Greece comprises of 25,000 TKAs annually, it is seeking a cost-effective solution that helps surgeons achieve quicker, more precise results for their patients. Dr. Armpis approached us with this strong desire and was the first surgeon in Greece to experience the power of KneeAlign. As OrthAlign continues to focus on expanding customer reach and portfolio expansion, we welcome the country of Greece to the OrthAlign family and look forward to further introducing it in the Greek orthopaedic market.”

About OrthAlign, Inc.

OrthAlign is a privately held medical device and technology company, developing advanced technologies that deliver healthier and more pain-free lifestyles to joint replacement patients, globally. We provide healthcare professionals with cutting edge, computer-assisted surgical tools that seamlessly and cost-effectively deliver vital data and clinical results to optimize outcomes for our patients. For more information regarding OrthAlign, please visit http://www.orthalign.com.

“ORTHALIGN®, ORTHALIGN PLUS®, KNEEALIGN®, KNEEALIGN® 2, HIPALIGN®, and UNIALIGN™ are registered trademarks of OrthAlign, Inc.”

The Dr. Kenneth Pettine drug investigation: ‘I was destroyed’

Posted On June 14, 2017 By OrthoSpineNews In Regulatory /

Alicia Stice and Jacy Marmaduke , Coloradoan – June 8, 2017

Last year, Dr. Kenneth Pettine was arrested on a handful of charges related to prescription fraud. Now, he can never practice medicine again. The Coloradoan takes you inside the investigation.

In hindsight, Sherri Kaspar feels weird about the Fudgsicles.

Nationally renowned spinal surgeon Kenneth Pettine bought them for her after he performed a procedure that Kaspar said left her without use of her legs and triggered relentless, debilitating infection.

Pettine stowed the treats in a freezer at McKee Medical Center in Loveland, scrawling her name on the box he bought for her to enjoy post-surgery.

Kaspar used to think the gesture meant Pettine was her friend. Now that Pettine is a convicted criminal barred from practicing medicine, she considers the ice cream a symbol of the doctor’s knack for manipulation.

“He tried to buy me off,” she said during an interview at her Kersey mobile home.

That incident was a long time ago — 26 years ago, to be exact. But Kaspar’s experiences illustrate the two vastly different versions of the Johnstown surgeon arrested in June 2016 on suspicion of prescription fraud.

Pettine’s supporters paint him as a man of faith, an Eagle Scout, a brilliant surgeon with “hands of gold” who financed college educations and saved children from disease and neglect with his own money.

Others describe a darker side of Pettine: A drug-addled smooth-talker who botched surgeries, lied on medical records and used his position of power to secure an endless stream of prescription drugs. Several former patients said they went to Pettine for help and emerged from surgeries in excruciating pain, suffering from mistreated infections and lifelong disabilities.

Maybe you saw Pettine in the news last year. It was a big story.

On May 2, 2016, Kenneth Pettine was a well-regarded figure in the medical field who’d performed 12,000 spinal surgeries. He had a $2.4 million mansion and ownership stakes in three medical practices and a surgical center.

Then his minority partners at Johnstown’s Premier Regenerative Stem Cell and Wellness Centers turned him in. The criminal investigation that followed left Pettine stripped of his medical license and saddled with lawsuits and misdemeanor convictions.

READ THE REST HERE

ConforMIS Announces Study Comparing Customized Total Knee Replacement Implants to Off-the-Shelf Total Knee Replacement Implants

Posted On June 13, 2017 By OrthoSpineNews In Recon /

BILLERICA, Mass., June 13, 2017 (GLOBE NEWSWIRE) — ConforMIS, Inc. (NASDAQ:CFMS), a medical technology company that offers joint replacement implants customized to fit each patient’s unique anatomy, today announced the publication of a retrospective study comparing adverse events rates and cost of care for total knee arthroplasty (TKA) patients treated with either customized individually made (CIM) implants or standard off-the-shelf (OTS) implants. Results were published in the peer-reviewed journal Arthroplasty Today on June 8, 2017.

According to the study results, a smaller percentage of TKA patients treated with customized implants experienced adverse events at both discharge (3.3% vs OTS 14.1%; P = .003) and 90 days after discharge (8.1% vs OTS 18.2%; P = .023). A greater proportion of patients who received customized implants were discharged in less than 3 days (42.1% vs OTS 30.3%; P = .037). In addition, a smaller percentage of patients treated with customized implants (4.8% vs OTS 16.4%; P = .003) were discharged to a rehabilitation center or other post-acute care facility. Further, fewer patients treated with customized implants (2.4% vs OTS 11.6%; P = .005) required blood a transfusion.

Furthermore, the total average real hospital costs between the CIM and OTS groups were nearly identical (customized implant $16,192 vs OTS $16,240; P = .913), suggesting that patients with customized implants received improved hospital outcomes at no additional cost to the hospital. However, risk-adjusted per patient total cost of care showed a net savings of $913.87 (P = .240) per patient for the customized implant group for bundle of care, including the preoperative computed tomography scan, TKA hospitalization, and discharge disposition. Follow-up care costs demonstrated a savings of $1,313 (customized implant $5,048 vs OTS $6,361; P = .007).

“Our results in this single-site population of patients illustrate that treatment with a customized implant led to significantly lower transfusion rates, fewer adverse events and reduced need for discharge to a rehabilitation facility or post-acute care facility,” said Steven Culler, PhD, a healthcare economist at Emory University. “We also found that improved outcomes among patients treated with customized implants were achieved without increasing overall costs and that post-discharge costs were significantly lower among patients treated with customized implants.”

In this study, which was financially supported by ConforMIS, researchers completed a retrospective review of outcomes and costs for 248 consecutive TKA patients treated at a single institution and by the same surgeon. All surgeries occurred between April 1, 2010, and November 11, 2013 based on consistent intraoperative protocols. Patients received either a customized knee implant (designed and developed based on their unique anatomy (n=126)) or an OTS implant selected from a range of pre-manufactured sizes (n=122). Study data were collected from patients’ medical record or the hospital’s administrative billing record.

When controlling for gender, age, body mass index (BMI) and selected comorbid conditions, patients in the OTS arm were 5.5 times more likely to be discharged to a rehab or post-acute care facility. Patients treated with OTS implants were also 4.6 times more likely to require blood transfusion and 4.4 times more likely to experience an adverse event.

“This study provides compelling data indicating that patients treated with customized total knee implants achieve better outcomes on several important measures without increasing real hospital costs and while reducing the average total cost of the episode of care and the average cost of follow-up care,” said Mark Augusti, Chief Executive Officer and President of ConforMIS. “These findings further demonstrate the benefits of customized total knee implants technology to patients, surgeons, hospitals and payers. Additionally, they are part of an important and changing conversation about the role of total knee implants in the delivery of better outcomes at lower costs – a conversation that we are committed to pursuing.”

About ConforMIS, Inc.

ConforMIS is a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are individually sized and shaped, or customized, to fit each patient’s unique anatomy. ConforMIS offers a broad line of customized knee implants and pre-sterilized, single-use instruments delivered in a single package to the hospital. In clinical studies, ConforMIS iTotal CR demonstrated superior clinical outcomes, including better function and greater patient satisfaction, compared to traditional, off-the-shelf implants. ConforMIS owns or exclusively in-licenses approximately 450 issued patents and pending patent applications that cover customized implants and patient-specific instrumentation for all major joints.

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

Cautionary Statement Regarding Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for ConforMIS, including statements about ConforMIS’ clinical strategy, the potential clinical, economic or other impacts and advantages of using customized implants, the changing view of CIM v. OTS implants, as well as other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar expressions, constitute forward-looking statements within the meaning of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of a variety of risks and uncertainties, including risks related to our clinical studies and the other risks and uncertainties described in the “Risk Factors” sections of our public filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent ConforMIS’s views as of the date hereof. ConforMIS anticipates that subsequent events and developments may cause ConforMIS’s views to change. However, while ConforMIS may elect to update these forward-looking statements at some point in the future, ConforMIS specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing ConforMIS’s views as of any date subsequent to the date hereof.

CONTACT:

Media contacts:
Bill Berry
Berry & Company Public Relations
Bberry@berrypr.com
(212) 253-8881

Lynn Granito
Berry & Company Public Relations
Lgranito@berrypr.com
(212) 253-8881

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

SI-BONE Wins FDA Clearance and Full U.S. Commercial Launch of the iFuse-3D Implant

Posted On June 13, 2017 By OrthoSpineNews In Regulatory, Spine /

SAN JOSE, Calif., June 13, 2017 /PRNewswire/ — SI-BONE, Inc., an innovative medical device company that pioneered the use of the iFuse Implant System^® (“iFuse”), a triangular shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, today announced FDA clearance and full U.S. commercial launch of the iFuse-3D™ Implant (“iFuse-3D”), the first-ever 3D-printed titanium implant for use in the SI joint. SI-BONE developed a proprietary 3D-printing technology to create an implant with a unique patented fenestrated design and enhanced porous surface that resembles the trabecular structure of cancellous bone. Together, these two features provide an excellent environment for bony ongrowth, ingrowth and through growth¹.

iFuse-3D leverages the clinically proven triangular titanium design of the iFuse Implant™ that is supported by more than 50 peer-reviewed publications and has been used in over 26,000 procedures since 2009.

The iFuse-3D Implant’s surface and fenestrated structure were designed to provide enhanced osteointegration and promote intra-articular fusion. A study, published on June 1, 2017, in the International Journal of Spine Surgery (IJSS) titled: Fortifying the Bone-Implant Interface: An In Vivo Evaluation of 3D-Printed and TPS-Coated Triangular Implants¹ shows significant bone growth on and into the implant’s porous surface (Figure 1) as well as through its fenestrations (Figure 2).

Scott Yerby, Chief Technology Officer at SI-BONE, commented, “The design and development of the iFuse-3D implant was a multi-year effort. Our goal was to expand the iFuse family using 3D-printing technology to provide enhanced surface characteristics while retaining key performance features of the iFuse Implant, including superior rotational resistance, mechanical strength and ease of use with our existing instrumentation. iFuse-3D, with its trabecular-like surface, provides 250% greater surface area than our highly successful iFuse Implant. Additionally, the structural fenestrations allow complete bone through growth.”

“The iFuse-3D Implant embodies our commitment to advancing the diagnosis and treatment of chronic SI joint disorders through innovative products, procedures and educational programs in order to help patients suffering from chronic SI joint pain,” said Jeffrey Dunn, President and CEO of SI-BONE. “Our team of almost 200 employees is incredibly excited to support the more than 1,300 surgeons who have used the iFuse Implant, and we believe that expanding the iFuse family has the potential to help thousands more patients. What can be more exciting and rewarding than that?”

On May 30, 2017, the U.S. Patent and Trademark Office issued patent no. 9,662,157 covering various structural design features of the iFuse-3D Implant that will extend intellectual property protection of the unique implant design for 17 years until September 2035.

About SI Joint Dysfunction
The SI joint has been attributed as a source of pain in 15-30 percent of patients with chronic low back pain^2-5, and in up to 43 percent of patients with new onset or persistent low back pain after lumbar fusion.⁶ Patients with SI joint dysfunction may feel pain in the lower back, buttocks and/or legs. This can be especially true while transitioning from sitting to standing, stepping up or down, bending and lifting, walking, sleeping or even just sitting on the affected side.

SI joint dysfunction is often misdiagnosed or the pain misattributed to other causes, as not all healthcare providers evaluate the SI joint, and most patients do not ask about it. While not commonly diagnosed, SI joint disorders can be identified through a series of simple tests that include when a patient identifies their pain by pointing directly to the PSIS (the bony prominence overlying the SI joint), known as the Fortin Finger Test. The diagnosis is confirmed with physical examination and image-guided diagnostic injections directly in the SI joint.

About the iFuse Implant System
The iFuse Implant System provides a minimally invasive surgical solution to fuse the SI joint using patented triangular titanium implants that create an interference fit within the ilium and sacrum. The patented triangular implant shape and patented press fit insertion technique are designed to provide immediate fixation by minimizing the SI joint’s unique motion called nutation. The implants have a porous surface that provides an environment conducive to ongrowth and ingrowth¹, facilitating long-term fusion of the joint. The iFuse Implant, marketed since 2009, is the only commercially available SI joint fusion device in the United States with published prospective clinical evidence from multiple studies that demonstrate improvement in pain, patient function and quality of life.

The iFuse Implant System^® is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit. For information about the risks, visit: www.si-bone.com/risks

About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading innovative medical device company dedicated to the development, manufacture and commercialization of minimally invasive surgical devices for the treatment of patients with low back symptoms related to certain sacroiliac joint disorders. SI-BONE, Inc. first received 510(k) clearance to market its iFuse Implant System from the Food and Drug Administration in November 2008. The CE mark for European commercialization was obtained in November 2010.

MacBarb, et al., “Fortifying the Bone-Implant Interface Part II: An In Vivo Evaluation of 3D-Printed and TPS-Coated Triangular Implants,” Int J Spine Surg, 2017; 11.
Bernard TN, Kirkaldy-Willis WH. Recognizing specific characteristics of nonspecific low back pain. Clin Orthop Relat Res. 1987;217:266–80.
Schwarzer AC, Aprill CN, Bogduk N. The Sacroiliac Joint in Chronic Low Back Pain. Spine. 1995;20:31–7.
Maigne JY, Aivaliklis A, Pfefer F. Results of Sacroiliac Joint Double Block and Value of Sacroiliac Pain Provocation Tests in 54 Patients with Low Back Pain. Spine. 1996;21:1889–92.
Sembrano JN, Polly DW Jr. How Often is Low Back Pain Not Coming From The Back? Spine. 2009;34:E27–32.
DePalma M, Ketchum JM, Saullo TR. Etiology of Chronic Low Back Pain Patients Having Undergone Lumbar Fusion. Pain Med. 2011;12:732–9.

SOURCE SI-BONE, Inc.

Oska® Wellness Announced as the Presenting Sponsor for the 4th Annual Midwest Pain Treatment Education Expo

Posted On June 13, 2017 By OrthoSpineNews In Extremities, Sports Medicine, Top Stories /

CARLSBAD, Calif., April 18, 2017 /PRNewswire/ — Oska Wellness, a technology company committed to developing cutting-edge consumer health and wellness products, is the presenting sponsor for the 4^th Annual Midwest Pain Treatment Education Expo, August 13, 2017 at the Hilton Hotel, Northbrook, Illinois.

Oska Wellness will have a booth at the Expo with top Oska executives on hand to showcase the benefits of the Oska® Pulse, a revolutionary wearable device to combat pain. The company has donated 10 Oska Pulse devices to be given away as door prizes, along with 20 additional devices to be gifted (to the first 10 people in line at 8 a.m. and again to the first 10 people at 1 p.m.).

The Midwest Pain Treatment Education Expo is produced by Gracie Bagosy-Young, a chronic pain patient advocate and president of the GG Chronic Pain Foundation, whose mission is to raise awareness of chronic pain conditions and educate the chronic pain community on non-drug options and current research.

“This is our biggest outreach event, with outstanding speakers, exhibitors and attendees from all over the country, and will be streamed on Facebook Live and Livestream all over the world,” said Bagosy-Young. “I’m thrilled that Oska Wellness has joined me as presenting sponsor for the Expo and to help spread the message about new non-drug options for managing pain.”

Oska Wellness recently unveiled the new Oska Pulse a small, portable, hands-free device that employs safe Pulsed Electromagnetic Field (PEMF) therapeutic technology, a longtime therapy used by medical practitioners to help people enjoy more active, pain-free and drug-free lives.

“We’re very excited to sponsor the Midwest Pain Treatment Education Expo and share our mission on new ways to provide non-invasive, drug free pain management solutions,” said Greg Houlgate, CEO of Oska Wellness. “Oska Pulse is a smart, safe, easy-to-use, wearable health technology product designed to help reduce muscle stiffness, temporarily relieve minor pain and increase mobility for people who have chronic pain. We will be showcasing Oska Pulse and the benefits of PEMF technology to hundreds of attendees at the Expo.”

For more information and ticket options for the Midwest Pain Education Expo, please contact Gracie Bagosy-Young at gracie@ggpainadvocacy.com.

About Oska Wellness
Oska, Inc. is committed to developing health and wellness technology-driven products that assist individuals in living a more active, pain-free lifestyle. Oska Pulse utilizes patented eTec Pulse Technology that specifically optimizes Pulsed Electromagnetic Field (PEMF) therapeutic technology, similar to the PEMF therapies used in many clinical applications for accelerating the body’s ability to heal itself.

The science and technology behind Oska Pulse was engineered and developed by a team of respected scientists and researchers with over 25 years of experience in engineering health and wellness technologies to treat pain. Oska Wellness, Inc. does not claim the product to diagnose, treat, cure or prevent any medical condition. The company is headquartered in Carlsbad, California and can be found online at www.oksawellness.com.

ADD COUPON CODE “ORTHOSPINECO” FOR $55.00 OFF

Vertera Spine Receives New CMS ICD-10 Code for Radiolucent Porous Interbody Fusion Devices

Posted On June 13, 2017 By OrthoSpineNews In Regulatory, Spine, Top Stories /

ATLANTA, June 13, 2017 /PRNewswire/ — Vertera Spine, a developer of medical devices using advanced biomaterial technologies, today announced the U.S. Centers for Medicare & Medicaid Services (CMS) has issued a new ICD-10 code for a radiolucent porous interbody fusion device. The new classification will enable healthcare providers and payers to selectively track the utilization, outcomes and healthcare costs associated with this unique technology class. Vertera Spine’s COHERE Cervical Interbody Fusion Device is the first and only clinically-available porous fusion device manufactured out of the radiolucent plastic polyether ether ketone (PEEK), and is approved for use under the new code. The IDC-10 code is effective October 1, 2017 as an XRG code and listed as “Interbody Fusion Device, Radiolucent Porous.”

Spinal interbody fusion devices have traditionally been classified by the implant material, either synthetic or tissue-derived alternative (e.g. autograft and allograft). However, as more advanced orthopedic biomaterials are developed, the use of a single coding identifier for all synthetic devices may no longer be appropriate for accurately describing fusion procedures. Five years of basic science, preclinical and clinical research^1-3 have shown that porous PEEK possesses several performance characteristics that distinguish it from other fusion devices by combining the osseointegration capabilities of porous metallic devices with the favorable imaging properties of non-porous plastic devices. This valuable combination of device attributes was introduced with FDA clearance of the COHERE device, prompting the issuance of the new ICD-10 code by CMS.

In addition to serving as a tracking method for healthcare payers and providers, the ICD-10 code can also potentially benefit spine surgeons in clearly identifying the best options for patients.

“The issuance of this new code signifies the unique performance of porous PEEK devices compared with other fusion devices and the importance of monitoring how this technology impacts healthcare,” said Richard Guyer, M.D., Texas Back Institute. “As a clinician, I am always looking for innovative technologies, such as Vertera Spine’s porous PEEK COHERE device, that have the potential to improve patient outcomes.”

As stated by Kevin Foley, M.D., Semmes-Murphey Neurologic and Spine Institute:

“The development of porous PEEK has allowed for the combination of radiolucency and porosity in an interbody implant that is completely plastic. In vivo studies have demonstrated that bone will grow into porous implants, improving their osseointegration. Until now, the only porous implants clinically available were made of metal or had a metallic coating, which can limit the surgeon’s ability to assess fusion on imaging. This new code gives us the potential to better correlate bony tissue ingrowth into Vertera Spine’s porous PEEK COHERE device with clinical outcomes.”

Likewise, Erik Westerlund, M.D., St. Francis Spine Center, and an early adopter of Vertera Spine’s COHERE device, shared similar sentiments:

“I began to see my one year follow-up COHERE device patients in May of this year and the results have shown a clear and consistent trend of rapid and readily visible progression to robust osseous union. Not only is there characteristic radiographically visible osseous incorporation at the interconnected porous margin of the COHERE PEEK spacers, there is also a notable continuity of bridging bone across the entire interspace. The grant of a new specific ICD-10 code for porous PEEK will provide myself and other spine surgeons greatly refined capacity to track clinical outcomes and cost savings with this genuinely transformational class of porous PEEK interbody spacers like Vertera Spine’s COHERE.”

With its first clinical use in Q2 of 2016, COHERE is the first device featuring Vertera Spine’s patented porous PEEK biomaterial technology. Intended for use in anterior cervical fusion surgery, COHERE contains a three-dimensional porous architecture on its bone-contacting sides that is specifically designed and optimized to promote cellular bone formation and effectively form a strong interface with bone. Unlike some porous treatments that are coated onto the device, COHERE’s porous architecture is grown directly from the solid PEEK implant using a proprietary processing method that allows for bone tissue ingrowth on the surface, while retaining strength and durability.

“We are excited that CMS has adopted a new code for radiolucent porous devices and are pleased that COHERE will fall under this designation,” said Chris Lee. Ph.D., founder and CEO of Vertera Spine. “The availability of a radiolucent porous fusion device means that for the first time, bone tissue ingrowth can potentially be assessed into the device. This will allow us to further understand the role of implant integration with clinical outcomes.”

¹Smith KE, et al. Techniques in Orthopaedics, 2017 (accepted in press).
²Torstrick FB, et al. CORR, 2016; 474(11): 2373-2383.
³Evans NT, et al. Acta Biomaterialia, 2015; 13: 159-167.

About Vertera Spine:

Vertera Spine is a privately-held medical device company that develops, markets and sells implants that use or complement its patented porous technology to address critical clinical needs in spine surgery. The company has received funding from the National Science Foundation, Georgia Research Alliance and Duke Angel Network to translate its growing technology portfolio into commercial products. For more information, visit www.verteraspine.com or call 678.705.9039.

COHERE is a registered trademark of Vertera Spine. All other trademarks and trade names are the property of their respective holders.

SOURCE Vertera Spine

Vertos Medical Secures $28 Million In Latest Round Of Funding

Posted On June 12, 2017 By OrthoSpineNews In Financial, Spine /

ALISO VIEJO, Calif., June 12, 2017 /PRNewswire/ — Vertos Medical Inc., a leader in the minimally invasive treatment of lumbar spinal stenosis (LSS), announced today it has completed a $28 million financing round. New investor, MVM Life Science Partners LLP, led the round with participation from existing investors Leerink Revelation Partners, Pitango Venture Capital, ONSET Ventures, and Aweida Venture Partners. Proceeds of the financing will be used to expand commercialization of the company’s proprietary mild® procedure, a clinically proven outpatient procedure that removes the cause of the stenosis through a portal the size of a baby aspirin and requires no implants, no general anesthesia, no stitches, and no overnight hospital stay.

In December 2016, Vertos Medical received broad coverage from the Centers for Medicare & Medicaid Services (CMS) for mild. Vertos Medical will use the latest round of funding to help meet the strong demand for the procedure from providers and patients. Funding will also be used to support physician training and education designed to expand access to the novel treatment for appropriate patients.

“There are millions of patients currently suffering from the debilitating effects of lumbar spinal stenosis who are looking for new treatment options that are safe, effective, and treat the underlying cause of stenosis,” said Eric Wichems, President and CEO of Vertos Medical. “We are pleased that we are able to expand access to the mild procedure with the help of MVM and our current investors.”

In addition to leading this latest round, MVM partner Hugo Harrod will join the board of directors of Vertos Medical. Harrod, who has been with MVM since 2005, has extensive board-level experience at pharmaceutical and device companies.

“The proven, low-cost, and safe mild solution stands to benefit the more than 2.4 million Americans who are expected to suffer from LSS by 2021,” Harrod said. “MVM is excited to join with Vertos Medical in extending access to this unique clinical solution for patients living with the debilitating symptoms associated with LSS.”

The mild procedure has been studied in more than 20 peer-reviewed publications and 12 clinical trials and has been performed on more than 20,000 patients. Peer-reviewed clinical data has proven the procedure’s strong safety profile and demonstrated that mild helps patients suffering from LSS stand longer and walk farther with less pain. ¹

Vertos Medical Inc. is a medical device company committed to developing innovative, minimally invasive treatments for lumbar spinal stenosis (LSS). Its proprietary technologies include mild^®, which offers a safe, outpatient, minimally invasive, fluoroscopically guided therapeutic LSS treatment that requires no general anesthesia, no implants, and no stitches. LSS is primarily a degenerative, age-related narrowing of the lower spinal canal that causes symptoms of pain and numbness in the lower back, legs, or buttocks. The mild^®procedure treats this condition by restoring space in the spinal canal using specialized mild^® devices to remove hypertrophic ligamentum flavum through a 5.1-mm treatment portal. Clinical studies show that mild^® can help LSS patients stand longer and walk farther with less pain¹, and no major device-related complications have been reported in any clinical trial.² Vertos Medical headquarters is located in Aliso Viejo, CA. To learn more about how mild^® treats LSS click here.

MVM Life Science Partners LLP, founded in 1997, is a healthcare investment firm with offices in London and Boston. MVM is currently investing from its fourth fund, which has $233M in commitments and broad interests across drugs, devices, and diagnostics.

SOURCE Vertos Medical

Medovex Corporation Releases Letter to Shareholders

Posted On June 12, 2017 By OrthoSpineNews In Spine /

ATLANTA, GA–(Marketwired – Jun 12, 2017) – Medovex Corp. (NASDAQ: MDVX), a developer of medical technology products, today released the following open letter to shareholders:

Dear Fellow Shareholder,

Since my last letter, we have achieved great strides in the development of our flagship product, the DenerveX™ System. These efforts recently culminated in our official receipt of both ISO 13485 Certification and CE Mark approval for the DenerveX System allowing for the Company to now commence selling and marketing the DenerveX System in Europe and other countries that accept the CE Mark. Years in the making, this milestone event officially marks the company’s transition from a development stage company to a commercialization stage company.

Initial orders received:

Since receiving CE Mark, we have received orders for the DenerveX Kits and the DenerveX Pro-40 generators from TCB Distribution Center in Berlin, Germany, as well as orders from TCB Ortho, our Germany distributor and EDGE Medical in the Manchester, England.

First in human cases:

We are pleased to announce that three centers in the EU will perform our first in human cases for the DenerveX System. They include hospitals in Manchester, England; Stuttgart, Germany and Potsdam, Germany with committed initial DenerveX System Cases of ten patients at each center. These cases are scheduled to begin in July.

The DenerveX System is designed to provide longer term relief from debilitating pain associated with Facet Joint Syndrome (FJS). Lower back pain (LBP) remains the second most common cause of disability in the U.S., and affects approximately 10% of adults. Studies indicate that that 31% of lower back pain cases are attributed to FJS.

The DenerveX System consists of the single use DenerveX Kit containing the DenerveX Device, powered by the dedicated DenerveX Pro-40 generator. The system represents a highly disruptive product targeting a large and expanding market opportunity. Importantly, it was specifically designed by surgeons for surgeons, to be less invasive with faster recovery time than current surgical treatment options, while also providing for a longer lasting treatment solution and offering potential savings to the health care system.

A presentation published by Roger Chou, MD, and Associate Professor of Medicine at Oregon Health and Science University, indicated that lower back pain is the fifth most common reason for U.S. doctor office visits, and the second most common symptomatic reason. The presentation indicated that that there is an estimated greater than $100 billion dollars in total health care expenditures for LBP in the U.S. It further cited LBP as the most common cause for activity limitations in persons under the age of 45. The presentation further goes on to discuss the growing epidemic of Opioid addiction related to increased physician prescribing patterns for pain management. Our DenerveX System was specifically designed to address long term pain management seeking to alleviate, and or mitigate pain, in addition to potentially reducing dependence on pharmaceutical based remedy.

The EU launch scope and size:

The team has worked very effectively in securing twelve separate distribution agreements that cover 19 countries mostly in the EU, and a few limited countries in Asia Pacific and Latin America that accept the CE Mark. Our plans are to conduct a controlled pilot launch in the UK and Germany to validate and verify the elements of the launch plan by approaching the market with key opinion leaders in high volume centers. Our plan is to go “narrow and deep” with a few selected high volume key opinion leaders initially. Our pilot will include the UK and Germany followed by designated countries for a controlled launch managing risk while maximizing opportunity in a very sizable market in the EU. Our launch plans are complete and fully covering in scope for all sales, marketing and distribution areas.

NSpine-Launch Meeting-June 12-15, 2017:

This week, our team will be in attendance at The NSpine Main Conference in London, UK where we will be conducting a DenerveX System cadaver lab and work shop lecture with leading spine surgeon and advisory board member Dr. Vik Kapoor. The NSpine show will be an excellent meeting venue to meet with key surgeons. The UK market is very important to us since it will be a leading market for our initial entry into Europe on the heels of receiving the CE Mark.

As part of our European sales launch, I’d like to highlight a few objectives we are actively initiating. A key aspect of our sales initiative is obviously physician training and education. Our objective is to optimize physician training for positive patient treatment outcomes, procedural reproducibility and efficiency for the treatment of Facet Joint Syndrome with the DenerveX System. The DenerveX procedure is taught in a step-by-step reproducible industry standard method, using tools provided by Medovex and their highly skilled and experienced trainers through DenerveX lecture and observation of actual patient cases.

Launch and rollout physician training strategy:

We have planned a highly effective and historically proven customer training process used throughout the industry. We will offer peer-to-peer DenerveX training sessions for physicians at a “DenerveX University” designated training site in the EU. This advanced clinical training is a physician-led program to address any clinical questions regarding this innovative technology. These training physicians have been selected based on their passion and experience in the DenerveX approach.

As we transition from a development focused organization to a revenue generating company, I’m keenly aware that being a public company involves the management of not just our actual fundamental business, but also the public markets, compliance with trading exchanges, and investor communications.

With this in mind, I want to touch on the Company’s recently received Nasdaq deficiency letter, details of which may be found in a Form 8K filed with the SEC. I want you to know that we are taking the notification very seriously and have engaged a strategic consultant proficient in advising companies in similar situations to help us formulate and propose a plan to regain compliance. We have a hearing with Nasdaq on June 15^th to discuss the matter. It is fully our intent to do whatever is necessary to comply and satisfy the matter to preserve our listing on the exchange.

Regarding the current valuation of the company and its shares, I am not satisfied. I believe our stock is significantly undervalued relative to other medical device companies, and especially in light of what many would consider a transformational event; receipt of both ISO Certification and CE Mark. I think it’s important to note that my team and I have real world experiencing in building businesses into profitable enterprises. I personally built my last company from a single office with just four employees, into two hundred and seventy offices located in four states, and employing over five hundred people. I am dedicated to doing the same here by taking our product and building a business that is expected to provide return on investment for all of our shareholders. Again, the DenerveX System was designed for surgeons by surgeons in an effort to address long term pain management.

My personal conviction and commitment, along with other insiders, can be no better evidenced than by reviewing an already long and growing list of repeated insider purchases memorialized in Form 4’s filed with the SEC. You will note that I just personally bought additional shares, along with the Company’s co-founder, since the announcement of our receipt of ISO Certification and CE Mark approval. In addition, board member and DenerveX Device inventor Dr. Scott Haufe also made significant purchases in recent months. I believe it is important that we lead by example, putting our own money where our mouth is. Recent filings can only be seen for what they are, again an affirmation of our commitment and belief in both our team and the opportunity.

In closing, while I want to thank all of you as our shareholders, I want to especially thank the entire Medovex team. Together, we’ve taken a concept to a commercial product and are now entering a growth stage that we’ve all been working towards for the last two years. While we continue to have a lot of work ahead of us as we focus on driving adoption and revenue, I have confidence that we will excel in achieving our future goals, much like we did in getting here today.

“Better living through better medicine” is not just a slogan; it’s a philosophy that management and our board are committed to seeing through in the form of innovative new products like our DenerveX Device. Thank you again for your valued support.

Kind regards,

Jarrett Gorlin
Chief Executive Officer

About Medovex

Medovex was formed to acquire and develop a diversified portfolio of potentially ground breaking medical technology products. Criteria for selection include those products with potential for significant improvement in the quality of patient care combined with cost effectiveness. The Company’s first pipeline product, the DenerveX System, is intended to provide long lasting relief from pain associated with facet joint syndrome at significantly less cost than currently available options. The DenerveX System is CE Marked while not yet FDA approved. To learn more about Medovex Corp., visit www.medovex.com.

Safe Harbor Statement

Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company’s filings with the Securities and Exchange Commission (the “SEC”), not limited to Risk Factors relating to its patent business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

CONTACT INFORMATION

CONTACT INFORMATION
Medovex Corp.
Jason Assad
470-505-9905
Email Contact

SI-BONE, Inc. Announces Blue Cross and Blue Shield of Vermont Establishes Positive Coverage Policy for MIS Sacroiliac Joint Fusion

Posted On June 12, 2017 By OrthoSpineNews In Spine, Top Stories /

SAN JOSE, Calif., June 12, 2017 /PRNewswire/ — SI-BONE, Inc., an innovative medical device company that pioneered the use of the iFuse Implant System^® (“iFuse”), a triangular shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced that Blue Cross and Blue Shield of Vermont (BCBSVT), an independent, local, not-for-profit Vermont company, has established a written positive coverage policy for minimally invasive surgical (MIS) SI joint fusion. The policy, available at the link below, will provide coverage for more than 200,000 BCBSVT health plan members and will become effective on July 1, 2017. BCBSVT becomes the fourth BCBS insurer to cover MIS SI joint fusion joining the BCBS insurers HCSC (that includes BCBS of Illinois, Montana, New Mexico, Oklahoma and Texas), BCBS of Michigan and BCBS of Nebraska bringing the total number of people with BCBS insurance who have access to the procedure to over 18 million in eight states.

Craig Bartlett, MD of the University of Vermont Medical Group in Burlington, VT commented: “This is great news and I am delighted for our SI joint patients with Blue Cross Blue Shield of Vermont coverage. I regularly see patients in my practice with chronic sacroiliac joint pain who could benefit from minimally invasive sacroiliac joint fusion with iFuse but I have been unable to perform the procedure due to coverage limitations. Now, with this positive coverage decision, I will be able to provide iFuse as a treatment option to Blue Cross Blue Shield of Vermont patients who are properly diagnosed surgical candidates and meet the treatment criteria.”

“We are very pleased to learn that Blue Cross Blue Shield of Vermont has established a positive coverage policy based on the published peer-reviewed clinical evidence for patients with SI joint related low back or buttock pain who essentially meet the NASS coverage criteria for MIS SI joint fusion,” said Michael Mydra, Vice President, Health Outcomes & Reimbursement at SI-BONE.

http://www.bcbsvt.com/wps/wcm/connect/50f5e2b1-b03e-4192-95e7-efb0f092e319/diagnosis-and-treatment-of-sacroiliac-joint-pain-medical-policy-2017.pdf?MOD=AJPERES

About SI joint dysfunction
The SI joint has been attributed as a source of pain in 15-30 percent of patients with chronic low back pain^1-4, and in up to 43 percent of patients with new onset or persistent low back pain after lumbar fusion.⁵ Like all other major joints, the SI joint can be injured or degenerate, which can cause debilitating pain in the lower back, buttocks and legs. Simple movements such as standing up, sitting down, stepping up or down, bending and lifting, walking, or even sleeping or sitting on the affected side can provoke a symptomatic SI joint.

SI joint dysfunction is often misdiagnosed and the resulting pain can be misattributed to other causes. Not all healthcare providers evaluate the SI joint and many patients do not know to ask about it. While not commonly diagnosed, SI joint disorders can be identified when a patient points to their source of pain directly over the posterior superior iliac spine (PSIS) known as the Fortin Finger Sign, combined with a number of positive provocative maneuvers to stress the SI joint and elicit the pain, followed by image-guided diagnostic injections.

The other major joints in the human body, such as knees, hips, ankles and shoulders, have specialized device-based surgical solutions. The SI joint is the largest and the last of eight major joints in the human body to have a proven surgical solution. The iFuse Implant^TMwas designed specifically to withstand the extreme forces resulting from load-bearing and the unique rotational and translational motion of the SI joint referred to as nutation, and is supported by more than 50 peer reviewed publications including two level 1 randomized controlled trials.

About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading medical device company that has developed the iFuse Implant System, a proprietary minimally invasive surgical implant system to fuse the sacroiliac joint to treat common disorders of the joint that can cause lower back pain. Patients with sacroiliac joint dysfunction experience pain that can be debilitating. SI-BONE believes that the sacroiliac joint is the last of the eight major joints in the human body to have a proven surgical treatment and that the iFuse Implant is the only device for treatment of SI joint dysfunction supported by significant published clinical evidence, including level 1 trials, showing safety and durable effectiveness, including providing lasting pain relief.

The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit. For information about the risks, visit: www.si-bone.com/risks

Bernard TN, Kirkaldy-Willis WH. Recognizing specific characteristics of nonspecific low back pain. Clin Orthop Relat Res. 1987;217:266–80.
Schwarzer AC, Aprill CN, Bogduk N. The Sacroiliac Joint in Chronic Low Back Pain. Spine. 1995;20:31–7.
Maigne JY, Aivaliklis A, Pfefer F. Results of Sacroiliac Joint Double Block and Value of Sacroiliac Pain Provocation Tests in 54 Patients with Low Back Pain. Spine. 1996;21:1889–92.
Sembrano JN, Polly DW Jr. How Often is Low Back Pain Not Coming From The Back? Spine. 2009;34:E27–32.
DePalma M, Ketchum JM, Saullo TR. Etiology of Chronic Low Back Pain Patients Having Undergone Lumbar Fusion. Pain Med. 2011;12:732–9.

SOURCE SI-BONE, Inc.

ZipLine Medical closes $12m Series E to support Zip closure portfolio

Posted On June 9, 2017 By OrthoSpineNews In Financial /

June 6, 2017 – By FINK DENSFORD

ZipLine Medical said today it closed a $12 million Series E round of financing, with funds slated to support commercialization of its Zip surgical skin closure portfolio and product development.

The round was led by newly invested growth equity fund HighCape Partners, and was joined by existing investor MVM Life Science Partners. As part of the financing round, HighCape Parnters operating partner Dean Tozer will join the company’s medical board of directors.

“ZipLine Medical has introduced a revolution in surgery – advanced wound closure that addresses inherent limitations with traditional, antiquated methods. The ZipLine team is developing and marketing disruptive products that minimize risk, improve clinical outcomes and address the constant pursuit of cost-effective healthcare,” = Tozer said in a prepared statement.

“We are excited to help propel the company to the next level of growth and commercial success,” HighCape Partners founder Matt Zuga said in a prepared release.

READ THE REST HERE

Our Blog

CONTACT INFORMATION