Life Spine Announces 510(k) Clearance of the CRANIAL FUSION System with SOLSTICE® Screws for Cervical Spine Indications

May 09, 2017

HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, is pleased to announce the FDA 510(k) clearance of the CRANIAL FUSION System. This clearance expands the indications for utilizing SOLSTICE Polyaxial Screws into the cervical spine.

“With the clearance of the Cranial Fusion System, this is an exciting opportunity for use of our Solstice system screws for posterior cervical fusions,” said Mariusz Knap, Vice President of Marketing for Life Spine. “We continue to focus on advancements that strive to improve surgical efficiencies, ease of use and reliability of posterior occipito-cervico-thoracic fixation of the spine, thus providing the highest value of care to our customers and patients.”

The CRANIAL FUSION System is a multiple component system comprised of titanium alloy, with a variety of occipital plates, occipital bone screws, polyaxial screws, hooks, connectors, rods, and locking caps.

SOLSTICE polyaxial screws used with the CRANIAL FUSION System come in 3.5, 4.0 and 4.5mm diameters. The conical polyaxial head angulation facilitates easy rod placement with minimal contouring, and the “friction head” feature maintains screw head position within the surgical wound.

In order to achieve additional levels of fixation, The CRANIAL FUSION System may be connected to the NAUTILUS® Thoracolumbar Pedicle Screw System using the 3.5mm/5.5mm titanium parallel connectors. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

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
ofaruqi@lifespine.com
847-884-6117

CartiHeal Raises $18.3 Million

KFAR SABA, Israel, May 8, 2017 /PRNewswire/ —

Funds will support IDE clinical study for company’s Agili-C™ implant

CartiHeal (2009) Ltd., developer of a cell-free, off-the-shelf implant for use in cartilage and osteochondral defects, announced today the culmination of an $18.3M financing round. The funds will finance the company’s recently-approved IDE clinical trial toward a PMA application.

The two-year pivotal study will involve US and OUS centers, with the aim of demonstrating the Agili-C™ implant’s superiority over the surgical standard of care.

The investment was led by aMoon, together with CartiHeal’s existing investors: Johnson & Johnson Innovation (JJDC Inc.), Peregrine Ventures and Elron, who has been consistently supporting and investing in CartiHeal over the years.

“CartiHeal delivers hope to those who suffer daily from degenerative and non-degenerative joint conditions, regenerating both bone and cartilage with its Agili-C single-step implantation procedure,” says Dr. Yair Schindel, Managing Partner at aMoon. “We are excited to take part in this promising endeavor, already showing remarkable results, and join the highly capable management team and strong investors, in bringing this technology to a growing population of patients globally.”

“This latest investment round is yet another testament to our investors’ confidence in our technology,” says Nir Altschuler, CartiHeal’s founder and CEO. “We believe the implant can greatly benefit patients suffering from a variety of cartilage lesions, who wish to return to a painless and active lifestyle, and who currently don’t have good alternatives.”

About Agili-C™

CartiHeal’s cell-free, off-the-shelf implant for use in cartilage and osteochondral defects was implanted in a series of clinical trials conducted in leading centers in Europe and Israel, in over 250 patients with cartilage lesions in the knee, ankle, and great toe. In these trials, the implant was used to treat a broad spectrum of cartilage lesions, as per its CE Mark, from single focal lesions to multiple and large defects in patients suffering from osteoarthritis.

Results of these prior investigations demonstrated the potential for cartilage regeneration and the remodeling of underlying subchondral bone, along with pain and symptom relief.

About CartiHeal

CartiHeal, a privately-held medical device company headquartered in Israel, develops proprietary implants for the treatment of cartilage and osteochondral defects in traumatic and osteoarthritic joints.

The company’s flagship product, Agili-C™, is CE marked and has been recently approved by the FDA for an Investigational Device Exemption (IDE) clinical trial toward a PMA application.

(Logo: http://mma.prnewswire.com/media/451231/CartiHeal_Logo.jpg )

For more information, please contact:
Caty Pearl
Catyp@pearlcom.co.il
+972-9-8810400

SOURCE CartiHeal (2009) Ltd.

Medovex Corporation to Attend The NSpine Main Conference June 12-15, 2017

ATLANTA, GA–(Marketwired – May 8, 2017) – Medovex Corp. (NASDAQ: MDVX), a developer of medical technology products, today announced that it will attend The NSpine Main Conference June 12-15, 2017 in London.

The NSpine Main Conference takes place every two years to provide the latest knowledge for spine healthcare professionals. Growing in strength with each meeting, NSpine provides ascendant medical professionals with the supplementary material they need to forge best practice in their careers.

All areas of the meeting are covered comprehensively with parallel sessions being held to allow delegates to tailor their learning experience to their specific needs. Boasting cadaver sessions, workshops, seminars, lunch symposiums and an exhaustive list of lectures and exhibitions by leading practitioners and innovative companies, NSpine endeavours to cater to its delegates’ academic pursuit.

NSpine 2017 will take place in London, UK on June 12-15 and was developed in collaboration with the European Spine Journal, BioSpine, NASS and EANS.

Manfred Sablowski, Senior Vice President Global Sales & Marketing of Medovex, stated, “The NSpine show will be an excellent meeting venue to meet with key surgeons while we continue to prepare for our launch of the DenerveX System. Sablowski went on to say: “The UK market is very important to us since it will be a leading country for our initial entry into Europe once we receive the CE Mark. The Company will conduct both a cadaver lab and a workshop session with advisory board member and leading spine surgeon Dr. Vik Kapoor.”

The Company’s patented DenerveX™ System is not yet commercially available in the EU and the U.S. The DenerveX System 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 that 31% of lower back pain is attributed to facet joint pain.

The DenerveX System consists of the DenerveX Device Kit, containing 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.

DenerveX is not yet CE marked or FDA cleared.

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

CurveBeam Announces FDA 510(k) Clearance for InReach Cone Beam CT Imaging System for the Upper Extremities

WARRINGTON, Pa., May 8, 2017 /PRNewswire/ — CurveBeam announced it has received FDA 510(k) clearance for the InReach, a Cone Beam CT imaging system primarily designed for the hand, wrist & elbow; & lower extremities in non-weight bearing position.

The InReach is an ultra-compact CT scanner that provides high-contrast 3D datasets of bony anatomy, which could potentially replace radiographs as a first line of diagnosis.

Inspired Spine Presents on Groundbreaking OLLIF Procedure at International Spine Surgery Meeting

Inspired Spine recently presented on the Oblique Lateral Lumbar Interbody Fusion (OLLIF) procedure at the International Society for the Advancement of Spine Surgery (ISASS). Dr. Hamid Abbasi, who developed the OLLIF, discussed the revolutionary procedure that has been a dramatic improvement on existing spinal fusion techniques.

At the ISASS meeting April 12-14, 2017, Dr. Abbasi discussed the key findings of Inspired Spine’s study titled “Oblique Lateral Lumbar Interbody Fusion (OLLIF): Technical Notes and Early Results of a Single Surgeon Comparative Study”. The study compared the OLLIF procedure to an open transforaminal lumbar interbody fusion (TLIF) procedure.

Amazingly, the study of 124 patients showed surgery time for the OLLIF was approximately twice as fast as the open TLIF (mean: 135 min) and blood loss was reduced by over 80% compared to TLIF. The OLLIF surgeries were performed with biplanar fluoroscopy with an incision amounting to only one centimeter.

Inspired Spine has continued the data acquisition since the initial 124 patients, with over 500 OLLIF procedures now being performed nationwide. According to Dr. Abbasi “With the OLLIF procedure, we use a tiny incision and don’t cut through the patient’s muscle tissue like traditional procedures. The procedures are faster, have less blood loss and patients experience a dramatically faster recovery with less pain!”

Along with presenting at the meeting, Inspired Spine had two poster presentations as well. One on the Economic Performance of OLLIF and the other on the Minimally Invasive Direct Thoracic Interbody Fusion (MIS-DTIF). The OLLIF procedure saved the hospitals involved over $9500 per case compared to the open TLIF procedure due to the faster OR times and reduced length of stay.

The OLLIF procedure is available to patients nationwide with certified surgeons by calling (877) 378-2828. The full text of the studies is available by visiting http://inspiredspine.com.

About Inspired Spine

Inspired Spine, a Minnesota-based advanced minimally invasive spinal surgery technology developer, has introduced and performed over 500 procedures using revolutionary new technologies and procedures in advanced minimally invasive systems. These new procedures are transforming how spinal surgeries are approached and can replace more traditional “open” spinal fusion surgeries. Inspired Spine is focused on the development of advanced minimally invasive surgical techniques, procedures and other health care technology to minimize or eliminate the physical and economic risks and discomfort that are created by the daily struggles of enduring back pain and its physical limitations.

CONTACTS

For Inspired Spine
David Greene, MBA
(888) 378-2828
dgreene(at)theusleadnetwork(dot)com

International Life Sciences Appoints Aaron C. Smith as New Chief Executive Officer of Artelon®

May 08, 2017

ATLANTA–(BUSINESS WIRE)–International Life Sciences, LLC, announces the appointment of Aaron C. Smith as Chief Executive Officer of Artelon®, the leader in synthetic biomaterial technology for orthopedic soft tissue reinforcement.

Mr. Smith is a 23-year orthopedic industry veteran and biomedical engineer who joins the company after 6 years with Amniox Medical, a subsidiary of TissueTech. As Co-Founder and General Manager of Amniox Medical, Smith and his team launched the first amniotic membrane and umbilical cord tissue product into the orthopedic reconstruction and wound care space, establishing the company as a leader in the $600 million regenerative tissue market. During his previous tenure as Senior Director, Extremity Management Group with Wright Medical Technology Inc., Mr. Smith oversaw the transformation of the company’s legacy extremities portfolio from a niche product line into a market leader in the burgeoning Foot and Ankle Surgery market. Smith also served in leadership roles with Spinal Concepts (acquired by Abbott Laboratories in 2003), Xomed Surgical Products (acquired by Medtronic in 1999), and Acromed (acquired by DePuy Orthopedics in 1997).

“We are extremely pleased to welcome Aaron Smith to Artelon,” said Mark Cohen, Chairman of the Board, International Life Sciences. “His established track record of bringing innovative technologies to bear in emerging musculoskeletal markets is an excellent and timely fit for our organization. Under Aaron’s leadership, we look forward to fulfilling the promise of our Artelon technology.”

Artelon’s biomaterials were developed specifically for medical applications and have demonstrated long-term clinical benefit to patients. The materials are made from a unique polymer textile that provides mechanical strength and tissue scaffolding, while degrading in a highly predictable fashion. They are sterile and biologically inert and avoid the unpredictability and safety concerns associated with reinforcement grafts manufactured from donated human tissue. Artelon’s products are available in the United States and select international markets through its network of independent sales agents.

“Artelon has a suite of proprietary biomaterials that has been in development for over 30 years and has been used by some of the most prominent orthopedists in the world to benefit more than 30,000 patients,” said Mr. Smith. “There is an impressive trove of scientific evidence and intellectual property supporting this unique technology. In our markets of interest, Artelon is well differentiated and highly complementary to other emerging regenerative technologies. We have an excellent opportunity to leverage our core competencies to solve major unmet clinical needs and ultimately improve patient care, recovery and surgical outcomes.”

About International Life Sciences, LLC

US-based medical device company International Life Sciences is committed to solving unmet clinical needs in the orthopedic and podiatric surgical communities with novel biomaterials solutions.

About Artelon

Artelon is a proprietary biomaterial technology designed specifically for soft tissue reinforcement and deformity correction during reconstructive surgery. It is the only synthetic biomaterial on the market with high mechanical strength, proven biocompatibility, and predictable resorption throughout the entire tissue healing process. Artelon products have been in development for more than 30 years and have successfully treated over 30,000 patients worldwide.

Artelon® is a registered trademark of International Life Sciences, LLC.

Contacts

Pascale Communications
Jessica Griffith, 610-618-0013
jessica@pascalecommunications.com

Stryker Orthopaedics 2016 Settlement Program reaches milestone

Kalamazoo, Michigan – May 8, 2017- Stryker Corporation (NYSE:SYK) announced that Howmedica Osteonics Corp. (referred to as “Stryker Orthopaedics”), a subsidiary of Stryker Corporation, has informed the courts in the New Jersey Multicounty and Federal Multidistrict litigations that 95% of additional registered eligible patients have enrolled in the Settlement Program under the Master Settlement Agreement announced in December 2016. As a result, Stryker Orthopaedics will move forward with the 2016 Settlement Program that provides for compensation to additional eligible U.S. patients who had surgery to replace their Rejuvenate Modular-Neck hip stem and/or ABG II Modular-Neck hip stem, known as a revision surgery, prior to December 19, 2016.

Shortly, the Claims Processor will begin notifying claimants and their attorneys regarding compensation payments.  The exact timing and amount of payments will depend on factors and circumstances specific to each claim. It is expected that a majority of the payments under the Settlement Agreement will be made by the end of 2017.

The 2016 Settlement Program follows an initial 2014 Settlement Program that covered patients who had a revision surgery prior to November 3, 2014. In that initial program, over 95% of eligible patients also enrolled. The high participation rates in both the 2014 and 2016 Settlement Programs are a testament to the fair and efficient processes afforded to patients through both of these Programs.

For more information about the Settlement Program, please visit:  www.strykermodularhipsettlement.com.

Stryker is one of the world’s leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world.  Please contact us for more information at www.stryker.com.

Contacts

For investor inquiries please contact:
Katherine A. Owen, Stryker Corporation, 269-385-2600 or katherine.owen@stryker.com

For media inquiries please contact:
Yin Becker, Stryker Corporation, 269-385-2600 or yin.becker@stryker.com

Investor Contacts
Katherine A. Owen
Vice President, Strategy & Investor Relations
Stryker Corporation
2825 Airview Boulevard
Kalamazoo, MI 49002
269-385-2600
Charles DeCoster IV, MSA
Manager, Investor Relations & Strategy
Stryker Corporation
2825 Airview Boulevard
Kalamazoo, MI 49002
P: 269-385-2600
C: 269-532-2118
Charles.DeCoster@Stryker.com

Spinal Stenosis Implant Market Set to Witness an Uptick During 2017–2025: Persistence Market Research

New York, NY — (SBWIRE) — 05/08/2017 — Spinal stenosis is a condition which usually occurs in the elderly patients. Stenosis mean abnormal narrowing of a body channel. This mean spinal stenosis is narrowing of the spinal canal. The narrowing of spinal canal occurs due to degeneration of intervertebral disk and facet joint. This condition mainly affects people above 50 years but can also affect younger people who are born with abnormal spinal canal. If the narrowing is minimal symptoms will not occur but too much narrowing can lead to compression of nerves and can be problematic. Spinal stenosis symptoms include lower back pain, numbness in legs and balance problem. It can occur anywhere along the spine.

Increasing prevalence of spinal stenosis is one of the major factor driving the growth of spinal stenosis implant market. Other factors contributing to the growth of the market are increasing older population and rise in the obesity cases which can lead to spinal injury or stenosis. Increasing demand and adoption of the minimally invasive surgeries and better relief over the medication are also factors driving growth in this market.

Spinal stenosis implant market is expected to show significant growth over the forecast period. Increasing case of arthritis and ageing of the population is expected to be the factor facilitating the growth of spinal stenosis implant market. Spacing is devices are expected to be highest revenue generating and fastest growing product segment due to increasing demand for minimally invasive treatments as this procedure has lesser risks involved and also it allows easy movement in comparison to fusion or fixation devices which involves long surgical process and higher blood loss. Along with this spacing devices provide faster and lasting symptoms relief and has lesser hospital stay. Titanium spinal stenosis implants are expected to be fastest growing, and highest selling as titanium is strong and light in weight when compared to the stainless steel implants and it has better elasticity which allows easy movement. Ambulatory surgical units are expected to have the highest number of such surgeries as these units are being used for performing the minimally invasive surgeries and patients don’t need to stay overnight.

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New long-term data on the effect of lumbar total disc replacement on adjacent level degeneration reinforces outcomes from previous studies

CENTER VALLEY, Pa., May 8, 2017 /PRNewswire/ — Aesculap Implant Systems, LLC announced today that Dr. Richard Guyer of the Center for Disc Replacement at Texas Back Institute presented the adjacent segment disease (ASD) outcomes of the activL® Artificial Disc Investigational Device Exemption (IDE) trial at the International Society for the Advancement of Spine Surgery Annual Meeting (April 12-14, 2017, Boca Raton, FL). The data reiterates the role of lumbar total disc replacement in delaying the progression of ASD, a common downstream complication associated with lumbar fusion. ASD furthers the societal burden imposed by degenerative disc disease, a condition responsible for 62 million physician visits per year and the number two reason – second only to the common cold – for lost work time. The trial found that at five years, the activL Artificial Disc had a protective effect on the progression of DDD at adjacent levels in 91.2% of patients.

According to Dr. Guyer, former president of the North American Spine Society (NASS), “These outcomes complement the large body of evidence already available reporting on the long-term adjacent outcomes following lumbar disc replacement. Previously, lumbar fusion had been reported to be responsible for a rate of ASD as high as 28.6% in patients with five-year follow-up.”

In 2008, Harrop et al. published a systematic review of lumbar disc replacement data and reported that in patients with three to 22 years of follow-up, total disc replacement resulted in a 9% adjacent segment degeneration rate, whereas lumbar fusion resulted in a 34% rate. Later, in 2012, Zigler et al. worked with Medical Metrics Incorporated (MMI) to conduct a post-hoc analysis on ProDisc-L IDE subjects and found a three-fold reduction in ASD rates between lumbar TDR and fusion at five years. MMI employed the same methods used in Zigler et al., 2012 to analyze the ASD outcomes from the activL Artificial Disc IDE trial.

Until recently, patient access to lumbar arthroplasty, or total disc replacement, for patients suffering from symptomatic degenerative disc disease has been a challenge due to the lack of coverage on many insurance policies. However, outcomes such as those presented by Dr. Guyer have caused payers to reconsider their policies.

In May, national insurer Humana, which is responsible for insuring more than six million American lives, overturned their coverage determination for lumbar total disc replacement. This policy change, along with others, resulted in now nearly one in two privately-insured Americans having access to lumbar disc replacement. Additional long-term evidence will likely cause more payers to reconsider their stance in the coming months.

A group of surgeon investigators from the activL Artificial Disc IDE trial are currently compiling the full outcomes of this ASD analysis and are expected to seek publication of the full data set later this year.

SOURCE Aesculap Implant Systems, LLC

Medtronic executive presses Congress to changes in FDA plant inspections

By Star Tribune – May 2, 2017

– A high-ranking Medtronic official appeared on Capitol Hill on Tuesday to ask Congress to make changes in the way government regulators inspect device manufacturing facilities for flaws.

Pat Shrader, Medtronic’s vice president for global affairs, told a House subcommittee that inspections come with too little warning and are too “erratic” for companies to supply information, clarification and follow-up that might keep them from being sanctioned.

“Device facilities in the U.S. are often given very short advance notice of an inspection,” Shrader told the House Energy and Commerce Health Subcommittee. “This short notice, plus the often erratic schedules of investigators, leads to challenges in assembling the appropriate team members to provide the required documents and materials requested by the FDA.”

Shrader spoke not just for Minnesota-run Medtronic, but on behalf of the Advanced Medical Technology Association, the device industry’s main trade group, which includes other major Minnesota employers, such as 3M, St. Jude Medical (through its new owner, Abbott Laboratories) and Boston Scientific.

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