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May 10, 2017 OrthoSpineNews

MINNEAPOLIS, May 9, 2017 /PRNewswire/ — Conventus Orthopaedics, Inc., a medical device company dedicated to revolutionizing extremity fracture treatment, today announced the completion of a $20 million equity financing. Deerfield Management led the financing which was funded entirely by the existing ownership syndicate.

The Conventus CageTM is an intramedullary implant for the repair of extremity fractures, currently FDA cleared for the treatment of shoulder, elbow and wrist fractures.  Early clinical results have been promising as patients have experienced a stable fracture fixation with a quicker recovery period, less pain, improved range of motion, and fewer surgical complications when compared to historical literature for existing fracture repair methods.

Scott Flora, Conventus’ Executive Chairman, said, “The CageTM is the future of fracture repair.  We are pleased that our investor syndicate, led by Deerfield, share that vision and continue to provide financial support with a long-term view to realize the full potential of this technology.”

“The CageTM is a truly innovative technology, poised to disrupt the orthopaedic trauma market.” said Avi Kometz, MD, Partner at Deerfield Management.  “The early clinical results have been outstanding, leading us to continue our long-term investment thesis in the company.”

About Conventus Orthopaedics, Inc.

Conventus Orthopaedics, Inc. is an early-stage company focused on delivering a new standard of care for fracture treatment in the orthopaedic extremities market.  Their proprietary Cage™ technology aims to improve patient outcomes, enhance the surgeon experience, and deliver economic value to stakeholders within this market segment.

 

SOURCE Conventus Orthopaedics, Inc.

Related Links

http://www.conventusortho.com


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May 10, 2017 OrthoSpineNews

May 09, 2017

DUBLIN–(BUSINESS WIRE)–3D4Medical, the world’s leading developer of 3D medical technology, today unveiled the first in its new suite of clinical solutions with the Complete Ortho app for iPhone and iPad, available exclusively on the App Store.

“Complete Consultation” is the new range of clinical solutions from 3D4Medical that will cover areas such as orthopedics, cardiology, internal medicine and trauma. Aiming to transform the relationship between the healthcare professional and patient, the first product in the range, Complete Ortho, allows the healthcare professional to consult with the patient in a whole new way, both educating and empowering them at every step of their orthopedic healthcare journey in magnificent 3D and all across a fully HIPAA-compliant platform.

First introduced in 2013 in one of the largest and most well-known hospital chains in the US, Complete Ortho was particularly well-received. 3D4Medical is now delighted to bring Complete Ortho to individual orthopedic surgeons and clinics around the world and for free to the general public so everyone can directly benefit.

Complete Ortho streamlines and enhances the entire healthcare professional/patient consultation process, allowing the healthcare professional to take their patient through the entire orthopedic concern with the aid of ground-breaking 3D technology and animations: from the anatomy of the troubling region; the possible pathologies related to the structure in question; the potentially beneficial or appropriate procedures; and any additional information that might be relevant. The patient is better engaged and empowered like never before as the step-by-step process allows for a far greater level of understanding than those achieved by traditional methods. If the patient so wishes, the healthcare professional can email a summary of their information, including the 3D animations, to them in the form of a Digital Consultation for their review on any device, in their own time and space, and perhaps with their loved ones for added support, removing the stress of trying to remember everything that the healthcare professional said, and increasing the accuracy of the information that is informing the patient’s decision. This improvement in the level of shared decision-making, education and empowerment will no doubt lead to a decrease in unnecessary physician return visits, an increase in patient-satisfaction and better medical outcomes across the board.

CEO and founder of 3D4Medical, John Moore, said, “We have had Complete Ortho ready for the hospital setting for a long time now so it is great to finally get it into the hands of both healthcare professionals and the general public. We look forward to the positive impact it will make across the world.”

Alan Getgood of the University of Western Ontario and Canada’s Fowler Kennedy Sport Medicine Clinic noted, “Complete Ortho will provide an excellent resource for physicians to provide a more personalized information portfolio for their patients’ diagnosis and treatment plan. For the patient, this will ensure a better understanding of their prognosis and care pathway that should lead to improved levels of satisfaction.”

Maurice Neligan, Director of Orthopaedic Surgery at Ireland’s Beacon Hospital and Associate Clinical Professor at University College Dublin School of Medicine, stated, “Complete Ortho is a significant advancement in engaging patients. It dispenses with the need for plastic models and scribbled diagrams, replacing them with top-quality illustrations, animations, and information that are personalized to the patient’s pathology and treatment. It is well-known that better-engaged patients have better outcomes and the information generated from patient engagement with Complete Ortho allows a more robust consent process for treatment, lowering the risk of malpractice litigation and the process can be seamlessly incorporated into existing practice models with little or no increase in consultation time.”

International expert in hip and knee joint replacement and Director of the Australian Orthopedic Association National Joint Replacement Registry, Steve Graves, added, “3D technology is proven to be the most effective approach to inform patients about their clinical condition. Complete Ortho is a comprehensive high-quality product that will greatly assist surgeons to ensure that their patients are fully-informed about their condition and proposed management.”

3D4Medical is proud to be an Apple Mobility Partner, helping to deliver best-in-class iOS solutions like Complete Ortho to healthcare professionals and patients around the world. Complete Ortho is exclusively available for iPad Mini2, iPad Mini3, iPad Mini4, iPad Air1, iPad Air2, iPad Pro, iPhone SE, iPhone 5S, iPhone 6, 6+, 6S, 6S+ and 7.

About 3D4Medical

3D4Medical is transforming medical learning and practice across the world and is leading the way in the production of ground-breaking 3D medical technology applications. This technology disrupts traditional methods of education by providing revolutionary applications that allow the educator, student, medical professional and patient to explore and experience medical education like never before, putting high-quality accessible 3D medical information at their fingertips. With the receipt of a prestigious Apple Design Award in 2016, over 12 million downloads worldwide and the #1 top-download positions in the App Store in 148 countries, 3D4Medical has enjoyed great success to date as it continues in its pursuit to improve the lives of patients, students, medical professionals and educators around the world. 3D4Medical is headquartered in Dublin and has over 100 employees.

Contacts

3D4Medical
Laura O’Connor
Head of Communications & Regulatory Affairs
media@3d4medical.com


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May 9, 2017 OrthoSpineNews

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


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May 9, 2017 OrthoSpineNews

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.


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May 9, 2017 OrthoSpineNews

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


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May 9, 2017 OrthoSpineNews

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.


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May 9, 2017 OrthoSpineNews

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


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May 9, 2017 OrthoSpineNews

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


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May 9, 2017 OrthoSpineNews

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

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May 8, 2017 OrthoSpineNews

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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