August 29, 2016 03:13 AM Eastern Daylight Time

SAINT PREX, Switzerland–(BUSINESS WIRE)–Ferring Pharmaceuticals announced today that it has signed an agreement with Seikagaku Corporation granting Ferring the exclusive worldwide rights (excluding Japan) to SI-6603 (condoliase), a chemonucleolytic product in Phase III development for the treatment of radicular leg pain (e.g. sciatica) due to lumbar disc herniation.

Seikagaku has been developing condoliase for the U.S. and Japan and has two on-going Phase III clinical trials (a pivotal double-blind study and an open-label safety study). Seikagaku is responsible for completing development and obtaining U.S. regulatory approval. Following approval from the Food and Drug Administration, Ferring will commercialize the product in the United States and has received further rights to develop, register and commercialize condoliase worldwide, excluding Japan. In consideration, Ferring will pay Seikagaku an upfront licensing fee, development and regulatory milestones and royalties.

“We believe condoliase may answer a substantial unmet need among those patients suffering from radicular leg pain due to lumbar disc herniation,” said Michel Pettigrew, President of the Ferring Executive Board and COO. “This is a significant opportunity to expand our global Orthopaedics franchise with a new innovative drug therapy.”

“Condoliase is an exciting product being developed with the potential to return a proven mechanism, chemonucleolysis, as a treatment alternative for radicular leg pain associated with lumbar disc herniation,” said Gunnar Andersson, MD, Professor and Chairman Emeritus of the Department of Orthopaedic Surgery at Rush University Medical Center in Chicago, U.S.A.

“Condoliase could offer a non-surgical alternative to patients for whom conservative therapy and/or corticosteroid injections have failed to provide durable relief, while maintaining the option for surgery should it later become medically necessary,” said Ray Baker, MD, past president, North American Spine Society.

About radicular leg pain and Condoliase (SI-6603)

Lumbar disc herniation (LDH) is the result of a progressive and degenerative process within the intravertebral disc (IVD) that affects between 1.6% of the general population to 43% of individuals in selected working groups worldwide, with the majority of incidents occurring in the fourth and fifth decades of life^1,2. In the US, 3 to 5% of the population is symptomatic (i.e. sciatica)³. The IVD is made up of the nucleus pulposus and annulus fibrosis that together cushion and allow flexibility within the spine. The disc herniation may increase pressure on a surrounding root nerve resulting in lower back pain and radicular leg pain (e.g. sciatica).

Condoliase is being developed for use as a chemonucleolysis treatment to break down selected components of the IVD, primarily within the nucleus pulposus. This reduces its water content and volume, thereby relieving disc pressure and compression on the spinal nerve root. A Japanese Phase III study (163 patients) met its primary endpoint of significantly reducing worst leg pain at 13 weeks (vs. a saline placebo injection) with sustained relief at 52 weeks⁴.

About Ferring Pharmaceuticals

Headquartered in Saint-Prex, Switzerland, Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of reproductive health, urology, gastroenterology, endocrinology and orthopaedics. Ferring has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries. To learn more about Ferring or its products please visit www.ferring.com.

FERRING is a trademark of Ferring B.V.

¹ Konstantinou, K., Dunn, K.M. Spine (Phila Pa 1976) 2008, 33, 2464-2472

² Ropper, A.H., Zafonte, R.D. New Engl J Med 2015, 372, 1240-1248

³ Tarulli, A, W et al. Neurol Clin 2007, 25, 387-405

⁴ Seikagaku (Study 6603/1031) Data on File)

Contacts

US
Patrick Gorman
+1-862-286-5035
patrick.gorman@ferring.com
or
Global
Lindsey Rodger
+41-58-451-40-23
lindsey.rodger@ferring.com

Written by  Laura Dyrda

CMS is proposing to add eight spine codes to the list of ASC covered procedures in 2017, according to the International Society for the Advancement of Spine Surgery.

The eight procedures are:

1. Autograft for spine surgery (includes harvesting the graft); local (eg, ribs, spinous process or laminar fragments) obtained from the same incision (List separately in addition to code for primary procedure): 20936

2. Autograft for spine surgery only (includes harvesting the graft); morselized (through separate skin or fascial incision) (List separately in addition to code for primary procedure): 20937

READ THE REST AT BECKER’S

By STEPHEN MATTHEWS FOR MAILONLINE

A toddler with a crooked spine must wear a special cast for 24 hours a day to prevent his lungs from being crushed.

Charlie Ferris can not even bathe while he wears the suit because water would prevent it from working properly.

The 13-month-old, from County Tyrone, Northern Ireland, has scoliosis – twisting of the spine – which if left untreated could kill him.

His family were told he would need to wear a plaster jacket for four months to stop the curve from becoming worse.

But after scans revealed his condition was deteriorating rapidly, his alarmed parents travelled to the US for a special cast which moulds his spine back into shape – in an attempt to save his life.

‘But I didn’t care how much it cost. We’d live in a tent if needs be to pay for the treatment and getting there. I was prepared to move.’

They first noticed Charlie’s back was twisted in October 2015 after his father Jody, 36, noticed an abnormal bend.

After an X-ray at Belfast’s Musgrave Park Hospital, he was officially diagnosed with infantile scoliosis and doctors confirmed he had a 28° curvature.

Read more: http://www.dailymail.co.uk/health/article-3759667/Toddler-42-degree-curve-spine-wear-body-cast-prevent-crushing-lungs-killing-him.html#ixzz4IVGjAOYb

Written by  Megan Wood

READ THE REST HERE

ATLANTA, GA–(Marketwired – Aug 25, 2016) – Medovex Corp. (NASDAQ: MDVX), a developer of medical technology products, announced today that it has added orthopedic industry veteran Ron Lawson to its Board of Directors.

Ron Lawson’s 35 plus years of experience in the orthopedic industry include the role as Senior Vice President of Worldwide Sales and Customer Service for Pfizer’s Orthopedic Division, Howmedica (1996). In 1998, he became part of the Stryker Corporation with Stryker’s acquisition of Howmedica. At Stryker, he served as Senior Vice President of Sales, Marketing and Product Development. Mr. Lawson also played a critical and insightful role in the successful integration of the two companies. In 2000, he was asked to lead the revitalization of Stryker’s European business as President, EMEA. He shortly thereafter assumed the role of leadership for all of Stryker’s International distribution businesses and was promoted to Group President, International in 2001.

In 2005, Stryker assigned global responsibility of their orthopedic division to Mr. Lawson making him Group President for International and Global Orthopedics. He then focused on strengthening the Stryker Orthopedic business worldwide. Ron retired from Stryker at the end of 2007.

Ron Lawson is currently a member of the Lawson Group where he provides strategic consulting services specializing in orthopedic medical technology. He previously served as Chairman of the Board of IMDS, Corporation. He also served as a member of the Health Care Advisory Board of Arsenal Capital Partners. He presently serves as a Director of Plasmology 4, Corporation as well as a Director of DJO Global, a Blackstone company.

Jarrett Gorlin, Medovex Corporation Chief Executive Officer, stated, “Mr. Lawson is well regarded as one of the key leaders aided in the development of the orthopedic industry. With the progress of our flagship DenerveX™ Device and other opportunities currently under review, his addition to our team is highly strategic. We look forward to working with Ron and leveraging his relationships throughout the world. I’d also like to say a special thank you to outgoing board member Thomas Hills for all of his invaluable support over the last couple years.”

Ron Lawson added, “I am pleased to have the opportunity to serve on the Board of Medovex Corporation at a time I believe to be an inflection point for the Company. The company is now strategically positioned to offer great value to both surgeons and patients dealing with pain associated with the Facet Joint. I look forward to assisting management in identifying and vetting other potentially complementary additions to its portfolio of assets, as well as helping to further strengthen the Company’s relationships with surgeon opinion leaders around the world.”

The Company’s patented DenerveX System is currently in the final development stages. It is designed to provide longer lasting relief of pain associated with the facet joint. Lower back pain is the second most common cause of disability in the U.S. for adults. Studies indicate that 10% of the U.S. adult population suffers from lower back pain and 31% of those affected are attributed to facet joint pain.

The DenerveX System consists of the DenerveX device kit, a single use device, and the DenerveX Pro-40 Power Generator. The DenerveX system is designed to provide a minimally invasive treatment option which combines two actions into one device. The combined procedure is expected to provide a longer lasting solution and potential savings to the health care system.

DenerveX system is not yet CE marked or FDA cleared and is not yet commercially available.

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 device, is intended to provide long lasting relief from pain associated with facet joint syndrome at significantly less cost than currently available options. 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

August 26, 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 company has successfully completed initial cases with the SENTRY Lateral Plate System. SENTRY is a revolutionary lateral plate that has a low profile, intuitive design with a cam locking mechanism which allows the system to provide visual, tactile and audible confirmation of final locking.

SENTRY rounds out Life Spine’s full procedural offering for eLIF^™ lateral fusion which consists of the LONGBOW^™Expandable Spacer, CENTRIC^® Expandable Retractor System, OSTEO-LINK^® biologics, PLATEAU^®-X Lateral Spacer System and an integrated full line neuromonitoring system.

“The SENTRY Lateral Plate System is a key innovation and has changed the way I approach my MIS procedures. The slim profile and small size work seamlessly with my minimally invasive approach, allowing me to keep the incision site as small as possible,” said Dr. Zeshan Hyder, Orthopedic Spine Surgeon at the Bone and Joint Specialists in Indiana. “I am also able to achieve the ideal amount of fixation without having to use percutaneous screws. Because of that, I am only creating one incision site instead of multiple.”

SENTRY is scheduled for full product release by the end of 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.

View source version on businesswire.com: http://www.businesswire.com/news/home/20160826005083/en/

SAN JOSE, Calif., Aug. 24, 2016 /PRNewswire/ — SI-BONE, Inc., a medical device company that pioneered the use of the iFuse Implant System^® (“iFuse”), a patented triangular-shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced the publication of two-year results from INSITE (Investigation of Sacroiliac Fusion Treatment – NCT01681004) a landmark prospective, multicenter, randomized controlled trial (RCT) of MIS SI joint fusion with iFuse compared to non-surgical management (NSM).  Results of this Level 1, high quality study were published in the International Journal of Spine Surgery titled: Two-Year Outcomes from a Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion vs. Non-Surgical Management for Sacroiliac Joint Dysfunction¹.  The study showed that rapid improvements in pain, disability and quality of life for the iFuse group were larger than those seen for the NSM group and were durable to two years. This large, Level 1 RCT adds to the more than 40 peer-reviewed publications on iFuse and further reinforces positive outcomes and product durability demonstrated in previously reported 3 year, 4.5 year and 5 year publications.^2-4

148 subjects were enrolled, randomized 2:1 (102 iFuse/46 NSM), and treated at 19 centers in the United States including both private practice and academic institutions.  In the iFuse group, the mean SI joint pain score improved from 82.3 at baseline to 30.1 at 6 months, 28.6 at 12 months and 26.7 at two years, corresponding to improvements from baseline of 52.3, 53.7 and 55.4 points, respectively (all p<.0001, Figure 1).  Disability, as measured using the Oswestry Disability Index (ODI), decreased from a mean 57.2 at baseline to 29.9, 28.3 and 28.7 at months 6, 12 and 24, representing mean improvements of 27.4, 28.9 and 28.4 points, respectively (p<.0001)

The revision surgery rate was low at 3.4% (3/89) consistent with previously reported long-term results for iFuse^2,5 and roughly one-third that for lumbar fusion surgery⁶. Two-year results also showed a 29.7% decrease from baseline in the number of study subjects taking opioids (Figure 2) which is consistent with a 28% reduction in opioid use observed in a previously reported prospective multicenter two-year study⁵.

“These two-year results from the INSITE study illustrate the durability of SI joint fusion with iFuse and further validate previously reported 6- and 12-month results that showed rapid improvement in pain, function and quality of life in this highly debilitated patient population,” said Frank Phillips, MD of Rush University Medial Center in Chicago, IL. “This positive publication validates the consistency of the earlier publications on iFuse and will hopefully encourage health plans across the U.S. to establish coverage for this effective procedure.”

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

MORRISTOWN, N.J., Aug. 24, 2016 /PRNewswire/ — Tyber Medical, a privately held company focused on developing innovative medical devices for private label opportunities and advancing the science of bioengineered surfaces, announces the commercial launch of their lateral plating system.

Tyber Medical is excited to announce a product portfolio expansion with a low profile lateral plate including an innovative fixation technology. Through the use of new and patented features, the implant provides three points of fixation in each vertebral body, eliminating some instrumentation required by other systems on the market while minimizing surgical steps. In addition, to reduce the possibility of neurologic deficit, the elegant design of the screw mates it flush with the surface of the plate when locked. The result is potentially the best fixation option available.

“The market for lateral access instruments and implants is one of the fastest growing segments. Companies that haven’t already secured their share of the market will soon find it harder and harder to compete. This new lateral plating system, together with Tyber’s lateral retractor and interbody product, creates one of the best lateral access systems available in the market today,” said Steve Zeiger, Senior Director of Sales and Marketing at Tyber Medical.

According to multiple market research sources, the global market for minimally invasive surgery is forecast to grow faster than any other segment over the next 3 – 5 years. Further, in todays OR, the posterior lumbar business goes hand in hand with the lateral business. The launch of Tyber Medical’s competitive lateral implant, complete with a lateral plating system, is very timely considering the inflection point the market is approaching where the utilization of other approaches to the lumbar spine is reported to be stabilizing or even shrinking.

About Tyber Medical:

Tyber Medical, LLC, Morristown, New Jersey, a rapid commercialization device company, is creating new pathways to regulatory approved bioengineered implants and instruments for orthopedic companies, large distributors, and hospital organizations. Tyber Medical designs and develops full class II orthopedic systems; verifies and validates those systems using a QSR and ISO 13485 certified quality system; and pursues and maintains both US (FDA 510k) and OUS (CE Mark) regulatory approvals. Current products include the opening osteotomy system, headless and headed compression screws, snap-off screws, cervical plating system, lateral retractor system and spinal interbody spacers featuring both standard sterile and non-sterile PEEK andTyPEEK^®, a proprietary titanium plasma sprayed PEEK. The company is also developing BioTy™, a nanotopography surface modification which limits the adherence of bacteria to implants.  For more information, please visit www.tybermedical.com.

The TyWedge™ System and Spinal Interbody Spacers are made with PEEK-OPTIMA^® from Invibio^® Biomaterial Solutions.

Contact:
Steve Zeiger
89 Headquarters Plaza North, #1464
Morristown, New Jersey 07960
(866) 761-0933
szeiger@tybermed.com

SOURCE Tyber Medical, LLC

Related Links

http://www.tybermedical.com