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SANUWAVE Signs $1 Million Equipment Financing Line With NFS Leasing

Posted On February 13, 2018 By OrthoSpineNews In Biologics /  

SUWANEE, GA, Feb. 12, 2018 (GLOBE NEWSWIRE) — SANUWAVE Health, Inc. (OTCQB: SNWV) is pleased to announce that the Company has signed a one million dollar equipment financing lease agreement with NFS Leasing, Inc.  This agreement will enable SANUWAVE to begin placing the dermaPACE® System in the hands of clinicians and wound care centers in the United States to utilize in the treatment of diabetic foot ulcers, a billion dollar market.

NFS Leasing, Inc. has an extensive background in medical equipment financing and will be a valuable partner to SANUWAVE in our initial commercialization of dermaPACE in the United States after receiving FDA clearance in December 2017.  The line will be called as we order equipment, which will allow us to distribute the dermaPACE System domestically without dilution to the current shareholders.

“The agreement with NFS is a crucial announcement for the Company as we execute our plan for a successful rollout in the massive US diabetic foot ulcer (DFU) market.  This allows us to access capital to place devices which in turn will drive procedures and ultimately revenue,” stated Kevin A. Richardson II, Chief Executive Officer of SANUWAVE.  “We have a well developed plan in place to roll out dermaPACE methodically throughout 2018.  We are very excited to have this line in place which allows us to launch our rapid revenue growth,” concluded Mr. Richardson.

The Company has had overwhelming inbound information calls and support from the wound care community since the announcement of our FDA clearance.  We anticipate the first draw on this line later in February with our initial delivery shortly thereafter.

“We have been following SANUWAVE’s progress for a while and began discussions about doing business together prior to their good news from the FDA.  We are glad to be providing capital for a business model that will help heal a massive medical problem involving diabetic foot ulcers.  The Company has developed a great go to market strategy and we are looking forward to a successful strategic relationship,” stated David DePamphilis, Chief Operating Officer of NFS Leasing, Inc.

About SANUWAVE Health, Inc.

SANUWAVE Health, Inc. (OTCQB:SNWV) (www.sanuwave.com) is a shock wave technology company initially focused on the development and commercialization of patented noninvasive, biological response activating devices for the repair and regeneration of skin, musculoskeletal tissue and vascular structures. SANUWAVE’s portfolio of regenerative medicine products and product candidates activate biologic signaling and angiogenic responses, producing new vascularization and microcirculatory improvement, which helps restore the body’s normal healing processes and regeneration. SANUWAVE applies its patented PACE technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE®, is US FDA cleared for the treatment of Diabetic Foot Ulcers.  The device is also CE Marked throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, South Korea, Australia and New Zealand. SANUWAVE researches, designs, manufactures, markets and services its products worldwide, and believes it has demonstrated that its technology is safe and effective in stimulating healing in chronic conditions of the foot (plantar fasciitis) and the elbow (lateral epicondylitis) through its U.S. Class III PMA approved OssaTron® device, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its OssaTron, Evotron® and orthoPACE® devices in Europe, Asia and Asia/Pacific. In addition, there are license/partnership opportunities for SANUWAVE’s shock wave technology for non-medical uses, including energy, water, food and industrial markets.

About NFS Leasing, Inc.

NFS Leasing Inc. (www.nfsleasing.com) is an independent equipment leasing company, serving growth-oriented companies in a variety of fields.  NFS specializes in leasing technology equipment, scientific and medical equipment, as well as robotic, manufacturing and construction equipment.  Having helped a wide array of businesses grow for more than a decade, NFS is approaching a billion dollars in lease originations.  NFS’ management team averages over 25 years of technology and finance experience.  NFS has developed a broad base of extensive affiliations throughout the IT, medical, scientific, construction and manufacturing marketplace that can be leveraged to bring their customers unique incremental value.

Forward-Looking Statements

This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to financial results and plans for future business development activities, and are thus prospective. Forward-looking statements include all statements that are not statements of historical fact regarding intent, belief or current expectations of the Company, its directors or its officers. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Company’s ability to control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions and factors that may affect operating results, performance and financial condition are risks associated with the regulatory approval and marketing of the Company’s product candidates and products, unproven pre-clinical and clinical development activities, regulatory oversight, the Company’s ability to manage its capital resource issues, competition, and the other factors discussed in detail in the Company’s periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement.

For additional information about the Company, visit www.sanuwave.com.

Contact:

Millennium Park Capital LLC
Christopher Wynne
312-724-7845
cwynne@mparkcm.com

SANUWAVE Health, Inc.
Kevin Richardson II
Chairman of the Board
978-922-2447
investorrelations@sanuwave.com
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EIT Emerging Implant Technologies Announces CE Mark and First Cases for the World’s First Fully 3D Printed Adjustable Cage.

Posted On February 13, 2018 By OrthoSpineNews In Spine /  

Emerging Implant Technologies GmbH (EIT), a German medical device manufacturer exclusively focused on creating innovative technologies for spinal application by utilizing additive manufacturing, announces that it has received CE mark and performed the first surgeries in Germany with the first fully 3D printed adjustable interbody fusion cage worldwide.

The adjustable EIT PLIF cage is printed as one piece with no assembly needed in the production process. This reduces cost significantly compared to regular expandable cages that are manufactured with traditional machining processes.

The adjustable PLIF allows for restoration of lordosis angles up to 18° and supports minimally invasive insertion techniques. The goal is to reduce intraoperative trauma, optimize size adaptation and improve restoration of sagittal balance to improve fusion rates, reduce subsidence and adjacent segment disease (ASD) related to insufficient sagittal balance restoration. The bone contact areas consist of EIT Cellular Titanium® porous structure to enhance primary stability and bony integration.

“Adjustable cage technology has the potential to change the interbody fusion cage market as it can be offered at reasonable pricing that copes with existing pressures and reimbursement systems all over the globe. Additive manufacturing allows us to bring down cost tremendously. We are thrilled to be the first that have accomplished this platform technology and can now offer this technology to the European spine community” says Guntmar Eisen, founder and CEO of EIT.

Nancy Lamerigts, MD, PhD and VP of Marketing and Research says “with the new devices we now start the launch of our 2nd generation product line combining EIT Cellular Titanium® technology with functionality. So now we can really combine faster fusion and better alignment, respecting the economic environment that has prevented the breakthrough of expandable cage technology for years.”

Dr. Marcus Eif, head of neurosurgery at the Klinikum Görlitz in Germany, who has performed the first case with the new system, experienced that the EIT adjustable PLIF implant allowed for a minimal invasive approach while still being able to restore the required lordosis. “The intuitive instrumentation and the functionality of the implant enabled a straightforward procedure and an excellent postoperative result”.

About EIT

EIT is the first medical device manufacturer to exclusively focus on spinal implants, that are designed according to latest science on optimal bone ingrowth in porous titanium scaffolds and produced with additive manufacturing methods. EIT was founded in 2014. Implants and Instruments are made in Germany.

The EIT implants are made of EIT Cellular Titanium®, that addresses the clinical shortcomings of the current cage designs and materials (non-fusion, biocompatibility, subsidence, migration and imaging distortion), thereby obtaining very promising fusion results and improved clinical outcome due to the qualities of the porous 3-D printing of titanium. The highly porous titanium scaffold ensures extensive bone ingrowth as a result of its specific design and elasticity close to the cancellous bone. Due to its unique design with a porosity of 80% the EIT implants ensure uncompromised imaging on X-ray and MRI and enabling excellent follow up on defining bone ingrowth and fusion with CT.

A complete portfolio of EIT Smart Spinal Implants™ based on EIT Cellular Titanium® is available for the cervical and lumbar spine, with an extensive choice in footprint sizes, heights and lordosis angles to support the recreation of sagittal balance and alignment. Since 2014 over 15.000 EIT cases have been performed in over 15 markets globally. EIT received various FDA approvals and began introducing products in the US in Q4 of 2017.

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K2M Group Holdings, Inc. to Participate in the 2018 RBC Capital Markets Global Healthcare Conference

Posted On February 12, 2018 By OrthoSpineNews In Spine /  

LEESBURG, Va., Feb. 12, 2018 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance™, today announced its participation in the 2018 RBC Capital Markets Global Healthcare Conference at the Lotte New York Palace Hotel in New York, New York. Management will participate in a fireside chat on Thursday, February 22 at 2:05 p.m. Eastern Time.

A live audio webcast of the presentation will be provided under the ‘Events & Presentations’ section of the Company’s investor relations website at http://Investors.K2M.com/. It is recommended that listeners log on 15 minutes early in order to register and download any necessary software. An archive of the webcast will be available for replay following the conference.

About K2M

K2M Group Holdings, Inc. is a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance. Since its inception, K2M has designed, developed, and commercialized innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most complicated spinal pathologies. K2M has leveraged these core competencies into Balance ACS®, a platform of products, services, and research to help surgeons achieve three-dimensional spinal balance across the axial, coronal, and sagittal planes, with the goal of supporting the full continuum of care to facilitate quality patient outcomes. The Balance ACS platform, in combination with the Company’s technologies, techniques and leadership in the 3D-printing of spinal devices, enable K2M to compete favorably in the global spinal surgery market. For more information, visit www.K2M.com and connect with us on Facebook, Twitter, Instagram, LinkedIn and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements that reflect current views with respect to, among other things, operations and financial performance.  Forward-looking statements include all statements that are not historical facts such as our statements about our expected financial results and guidance and our expectations for future business prospects.  In some cases, you can identify these forward-looking statements by the use of words such as, “outlook,” “guidance,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words.  Such forward-looking statements are subject to various risks and uncertainties including, among other things: our ability to achieve or sustain profitability in the future; our ability to demonstrate to spine surgeons the merits of our products and retain their use of our products; pricing pressures and our ability to compete effectively generally in our industry; collaboration and consolidation in hospital purchasing; inadequate coverage and reimbursement for our products from third-party payers; lack of long-term clinical data supporting the safety and efficacy of our products; dependence on a limited number of third-party suppliers; our ability to maintain and expand our network of direct sales employees, independent sales agencies and international distributors and their level of sales or distribution activity with respect to our products; proliferation of physician-owned distributorships in the industry; decline in the sale of certain key products; loss of key personnel; our ability to enhance our product offerings through research and development; our ability to manage expected growth; our ability to successfully acquire or invest in new or complementary businesses, products or technologies; our ability to educate surgeons on the safe and appropriate use of our products; costs associated with high levels of inventory; impairment of our goodwill and intangible assets; disruptions to our corporate headquarters and operations facilities or critical information technology systems, distributors or surgeon users; our ability to ship a sufficient number of our products to meet demand; our ability to strengthen our brand; fluctuations in insurance cost and availability; our ability to comply with extensive governmental regulation within the United States and foreign jurisdictions; our ability  to maintain or obtain regulatory approvals and clearances within the United States and foreign jurisdictions; voluntary corrective actions by us or our distribution or other business partners or agency enforcement actions; recalls or serious safety issues with our products; enforcement actions by regulatory agencies for improper marketing or promotion; misuse or off-label use of our products; delays or failures in clinical trials and results of clinical trials; legal restrictions on our procurement, use, processing, manufacturing or distribution of allograft bone tissue; negative publicity concerning methods of tissue recovery and screening of donor tissue; costs and liabilities relating to environmental laws and regulations; our failure or the failure of our agents to comply with fraud and abuse laws; U.S. legislative or Food and Drug Administration regulatory reforms; adverse effects of medical device tax provisions; potential tax changes in jurisdictions in which we conduct business; our ability to generate significant sales; potential fluctuations in sales volumes and our results of operations over the course of the year; uncertainty in future capital needs and availability of capital to meet our needs; our level of indebtedness and the availability of borrowings under our credit facility; restrictive covenants and the impact of other provisions in the indenture governing our convertible  senior notes and our credit facility;  continuing worldwide economic instability; our ability to protect our intellectual property rights; patent litigation and product liability lawsuits; damages relating to trade secrets or non-competition or non-solicitation agreements; risks associated with operating internationally; fluctuations in foreign currency exchange rates; our ability to comply with the Foreign Corrupt Practices Act and similar laws; our ability to implement and maintain effective internal control over financial reporting; potential volatility in our stock price; our lack of current plans to pay cash dividends; increased costs and additional regulations and requirements as a result of no longer qualifying as an emerging growth company as of December 31, 2017; potential dilution by the future issuances of additional common stock in connection with our incentive plans, acquisitions or otherwise; anti-takeover provisions in our organizational documents and our ability to issue preferred stock without shareholder approval; potential limits on our ability to use our net operating loss carryforwards; and other risks and uncertainties, including those described under the section entitled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the SEC and our Quarterly Report filed with the SEC on November 1, 2017, as such factors may be updated from time to time in our periodic filings with the SEC, which are accessible on the SEC’s website at www.sec.gov.  Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements.  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this release and our filings with the SEC.

We operate in a very competitive and challenging environment.  New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this release.  We cannot assure you that the results, events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements.

The forward-looking statements made in this press release relate only to events as of the date on which the statements are made.  We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law.  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. Unless specifically stated otherwise, our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, investments or other strategic transactions we may make.




	

		

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Bioventus to Continue Distributing SUPARTZ FX™ Through 2028

			


	Posted On February 12, 2018

	By OrthoSpineNews

	In Biologics

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February 12, 2018




DURHAM, N.C.–(BUSINESS WIRE)–Bioventus, a global leader in orthobiologic solutions, has entered into an extension of its agreement with Seikagaku Corporation to continue distributing SUPARTZ FX™, a five-injection, hyaluronic acid (HA) product used for joint lubrication in the treatment of pain associated with knee osteoarthritis (OA). Under terms of this new agreement, Bioventus will be the exclusive distributor of SUPARTZ FX in the US through May 2028.


“We are pleased SUPARTZ FX will remain in the Bioventus portfolio, along with three-injection HA GELSYN-3™ and DUROLANE®, our single-injection HA, for many years to come,” said Tony Bihl, CEO of Bioventus. “Joint fluid treatments safely manage knee osteoarthritis pain allowing people to resume active lives and we believe our complement of HA offerings is unmatched in meeting the varied needs of patients, physicians and payers in the US. This is consistent with our strategy to be a market leading biologics company in treatments for OA.”


About Bioventus


Bioventus is an orthobiologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. Orthobiologic products from Bioventus include offerings for bone healing, bone graft and knee osteoarthritis. Its EXOGEN Ultrasound Bone Healing System uses safe, effective low intensity pulsed ultrasound (LIPUS) to stimulate the body’s natural healing process. EXOGEN has been used to treat more than 1 million patients worldwide and numerous regulatory agencies including the FDA, Health Canada, BSI, TGA, Medsafe, UAE Ministry of Health and SFDA have granted their approval of the product. Today it is the leading bone healing system in the market with complaints for lack of efficacy averaging less than 1%.


Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.BioventusGlobal.com and follow the company on Twitter @Bioventusglobal.


Bioventus, the Bioventus logo, EXOGEN and DUROLANE are registered trademarks and GELSYN-3 is a trademark of Bioventus LLC. SUPARTZ FX is a trademark of Seikagaku.


SUPARTZ FX – Summary of Indications for Use:


SUPARTZ FX is indicated for treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen.


You should not use SUPARTZ FX if you have infections or skin diseases at the injection site or allergies to avian (bird) products (feathers and eggs). SUPARTZ FX is not approved for pregnant or nursing women, or children. Risks can include general knee pain, warmth and redness or pain at the injection site. Full prescribing information can be found in product labeling, at www.SupartzFX.com or by contacting customer service at 1-800-836-4080.






Contacts


Bioventus

Thomas Hill, 919-474-6715

thomas.hill@bioventusglobal.com




	

		

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Camber Spine Technologies Announces First Implantations Of SPIRA™-C Open Matrix Cervical Interbody

			


	Posted On February 12, 2018

	By OrthoSpineNews

	In Spine, Top Stories

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WAYNE, Pa., Feb. 12, 2018 /PRNewswire/ — Camber Spine, a leading innovator in spine and medical technologies, today announced the first surgeries using the company’s proprietary SPIRA™-C Open Matrix Cervical Interbody device, a unique, interbody fusion implant consisting of spiral support arches and Surface by Design™ technology. The first cases were performed successfully this past week with several surgeons across the country performing multilevel ACDF procedures.


Dr. Michael Dorsi, M.D. of Ventura Neurosurgery was one of the first surgeon design team members to perform a multilevel procedure using SPIRA™-C this past week. According to Dr. Dorsi: “I really appreciate the design of this implant. Upon insertion, I feel as though the cage has immediate stability because of the roughened surface which provides significant friction. The arched design has large openings which allows for significant graft packing and creates a snowshoe-like effect of distributed load sharing which should decrease the risk of subsidence. The open matrix architecture eliminates the need for the central lumen in traditional cervical cages, potentially speeding up the mechanical fusion process, optimizing clinical and fusion outcomes.”


Dr. Michael Dorsi, M.D., is a board-certified, fellowship trained neurosurgeon who has been providing state-of-the-art care to the greater Ventura County area since 2012. Dr. Dorsi attended The Johns Hopkins University, graduated Phi Beta Kappa with Highest Honors and a degree in Neuroscience and subsequently completed his residency training in neurosurgery. He was awarded the Cloward Award from the American Association of Neurological Surgeons for Fellowship Training in Minimally and Invasive Spine Surgery at UCLA.


SPIRA™-C was designed to address surgeon frustrations associated with traditional cervical interbody devices such as the need for immediate stability. SPIRA™-C was developed for Camber Spine under a collaborative agreement with the Institute for Musculoskeletal Science & Education (IMSE), an independent, full-service product development and engineering services company. With an extensive faculty of dedicated physicians, IMSE leverages the collaborative balance between engineering and surgeon ingenuity to create next-level medical devices. The SPIRA™-C design team included several John Hopkins trained Neurosurgeons, all with extensive backgrounds treating complicated cervical pathologies.


“Surgeon design team members are a key component to our success. The insight they provide helps us create smarter solutions, maximizing technological advances and ultimately driving innovation in minimally invasive spine surgery. We are fortunate to have an esteemed surgeon such as Dr. Dorsi on our team helping us turn surgeon frustrations into innovations. There is a lot of excitement around the SPIRA™ technology platform and we expect products like SPIRA™-C and SPIRA™ALIF to fuel our continued sales growth.”


– Seth Anderson, Founding Partner and Vice President, Surgeon Relations


SPIRA™-C is the second in the SPIRA™ family to employ a novel arched design as well as Surface by Design™ technology specifically designed to increase fusion rates and stabilization. The spiral support arches decrease subsidence by load sharing over the entire endplate, while also maximizing bone graft capacity. The Surface by Design™ technology is a deliberately designed roughened surface that facilitates bone growth through an optimized pore diameter, strut thickness and trabecular pattern.


About Camber Spine


Camber Spine Technologies, LLP, is a medical device company focused on the design, development and commercialization of innovative and proprietary musculoskeletal implant systems. The company is committed to delivering surgeon inspired new technologies to the spine market. Camber Spine, located in Wayne, Pennsylvania, markets a line of proprietary musculoskeletal products nationwide through its exclusive distributor, S1 Spine.


All of Camber Spine’s products are proudly MADE IN THE USA.


SOURCE Camber Spine Technologies


Related Links


http://cambermedtech.com


	

		

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Use of a Small-Bore Needle Arthroscope to Diagnose Intra-Articular Knee Pathology: Comparison With Magnetic Resonance Imaging

			


	Posted On February 12, 2018

	By OrthoSpineNews

	In Extremities

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February 6, 2018 – Authors: Carl A. Deirmengian  MD  Joshua S. Dines, MD  Joseph V. Vernace MD Michael S. Schwartz MD MBA  R. Alexander Creighton MD James N. Gladstone MD


ABSTRACT


The use of arthroscopy for purely diagnostic purposes has been largely supplanted by noninvasive technologies, such as magnetic resonance imaging (MRI). The mi-eye+TM (Trice Medical) technology is a small-bore needle unit for in-office arthroscopy. We conducted a pilot study comparing the mi-eye+TM unit with MRI, using surgical arthroscopy as a gold-standard reference. We hypothesized that the mi-eye+TM needle arthroscope, which can be used in an office setting, would be equivalent to MRI for the diagnosis of intra-articular pathology of the knee.


This prospective, multicenter, observational study was approved by the Institutional Review Board. There were 106 patients (53 males, 53 females) in the study. MRIs were interpreted by musculoskeletally trained radiologists. The study was conducted in the operating room using the mi-eye+TM device. The mi-eye+ TM device findings were compared with the MRI findings within individual pathologies, and a “per-patient” analysis was performed to compare the arthroscopic findings with those of the mi-eye+TM and the MRI. Additionally, we identified all mi-eye+TM findings and MRI findings that exactly matched the surgical arthroscopy findings.


The mi-eye+TM demonstrated complete accuracy of all pathologies for 97 (91.5%) of the 106 patients included in the study, whereas MRI demonstrated complete accuracy for 65 patients (61.3%) (P < .0001). All discrepancies between mi-eye+TM and arthroscopy were false-negative mi-eye+TM results, as the mi-eye+TM did not reveal some aspect of the knee’s pathology for 9 patients. The mi-eye+TM was more sensitive than MRI in identifying meniscal tears (92.6% vs 77.8%; P = .0035) and more specific in diagnosing these tears (100% vs 41.7%; P < .0001).


The mi-eye+TM device proved to be more sensitive and specific than MRI for intra-articular findings at time of knee arthroscopy. Certainly there are contraindications to using the mi-eye+TM, and our results do not obviate the need for MRI, but our study did demonstrate that the mi-eye+TM needle arthroscope can safely provide excellent visualization of intra-articular knee pathology.


 




 


Surgical arthroscopy is the gold standard for the diagnosis of intra-articular knee pathologies. Nevertheless, the use of arthroscopy for purely diagnostic purposes has been largely supplanted by noninvasive technologies, such as magnetic resonance imaging (MRI). Although MRI is considered the standard diagnostic tool for acute and chronic soft-tissue injuries of the knee, its use is not without contraindication and some potential inconveniences. Contraindications to MRI are well documented. In terms of inconvenience, MRI usually requires a separate visit followed by another visit to the prescribing physician. In addition, required interpretation by a radiologist may lead to a delay in care and increase in cost.


In the early 1990s, in-office needle arthroscopy was described as a viable means of diagnosing pathologies and obtaining synovial biopsies from the knee.1-3 Initial results were good, and the procedures had very low complication rates. Nevertheless, in-office arthroscopy of the knee is not yet widely performed, likely given concerns about the technical difficulties of in-office arthroscopy, the potential for patient discomfort, and the cumbersomeness of in-office arthroscopy units. However, significant advances have been made in the resolution capability of small-bore needle arthroscopy, resulting in much less painful procedures. Additionally, the early hardware designs, which mimicked operating room setups using towers, fluid irrigation systems, and larger arthroscopes, have been replaced with small-needle arthroscopes that use syringes for irrigation and tablet computers for visualization.


The mi-eye+TM technology (Trice Medical) is a small-bore needle unit for in-office arthroscopy with digital optics that does not need an irrigation tower. We conducted a pilot study of the sensitivity and specificity of the mi-eye+TM unit in comparison with MRI, using surgical arthroscopy as a gold-standard reference. We hypothesized that the mi-eye+TM needle arthroscope, which can be used in an office setting, would be equivalent to the standard of care (MRI) for the diagnosis of intra-articular pathology of the knee.




 


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Simplify Medical Closes Additional $23.25 Million in Second Tranche of Series B Financing Totaling $44.25 Million

			


	Posted On February 9, 2018

	By OrthoSpineNews

	In Financial, Spine

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February 09, 2018




SUNNYVALE, Calif.–(BUSINESS WIRE)–Simplify Medical Pty Ltd, maker of the Simplify® cervical artificial disc, today announced a second tranche of its Series B financing of $23.25 million, completing the oversubscribed round totaling $44.25 million.


The lead investor for the second tranche is LSP Health Economics Fund 2 (LSP HEF 2), with participation from existing venture investors LSP Fund V, MH Carnegie & Co., and Sectoral Asset Management. Series B funds will be used to complete two ongoing U.S. pivotal clinical trials of the Simplify Disc studying its use in one level of the spine and in two adjacent levels of the spine as a treatment for cervical degenerative disc disease, and for commercialization outside of the U.S.


“Having an oversubscribed Series B is a testament to the large opportunity presented by the Simplify Disc,” said Simplify Medical Chief Executive Officer David Hovda. “The Simplify Disc is designed to eliminate the need for CT scans post-surgery, reducing patient risk from associated radiation and solving a significant clinical problem in spine arthroplasty today.”


“We have great confidence in the Simplify Disc and the clinical outcomes achieved to date, and expect the U.S. clinical trials to demonstrate the same,” said Fouad Azzam, Ph.D, with LSP. “Risk mitigation is top of mind for hospitals, and products like the Simplify Disc that maximize patient safety are well aligned with their concerns. In addition, the Simplify Disc offers the lowest-profile device, opening up a broader patient population for the technology.”


“Simplify Medical has developed a very attractive cervical disc replacement system and the company has made tremendous progress on their multiple IDE studies and international commercialization. Our funding will allow them to accelerate these programs and expand access to the Simplify Disc to many more patients,” said Mark Carnegie, founding investor of Simplify Medical.


While magnetic resonance imaging (MRI) is widely used pre-operatively for surgical planning, spine surgeons often switch to CT post-operatively in order to accommodate metal components, which can make it difficult to view the devices, as well as the facets and adjacent disc levels. However, CT scans have been shown to expose patients to ionizing radiation that equates to 400 to 550 chest X-rays per scan.


Composed of primarily non-metal materials (PEEK-on-ceramic), the Simplify Disc is designed to be viewed on MRI in order to minimize patient exposure to radiation. With no metal in its articulating components, the disc is also designed for low levels of wear to optimize long-term durability. Implantation of the Simplify Disc is accomplished in a straightforward, three-step procedure. The Simplify Disc is also anatomically designed with low height implant options to accommodate patients with smaller cervical disc spaces, making it ideal for women and certain regional populations. The device is considered MRI-conditional, posing no known hazard in an MRI environment within prescribed conditions of use.


Two Simplify Disc U.S. pivotal trials are currently enrolling. The two-level, prospective pivotal trial will encompass up to 200 patients at up to 18 centers, comparing cervical implantation of the device in two contiguous discs from C3 to C7 with two-level cervical fusion surgery. The other pivotal trial is studying one-level cervical implantation of the device between C3 to C7 compared with one-level cervical fusion surgery. For information about eligibility or enrollment in either pivotal trial, please visit http://www.simplifytrial.com/.


The Simplify Disc has received the CE Mark and is commercially available in select European markets. Early clinical data has shown substantial improvement in patient pain scores and functional improvement after treatment.


ABOUT SIMPLIFY MEDICAL


Simplify Medical is focused on cervical spinal disc arthroplasty, using innovative, MRI-friendly materials designed to decrease the need for ionizing radiation and enhance patient options. Simplify Medical is located in Sunnyvale, California. To learn more, visit http://www.simplifymedical.com/.


ABOUT LSP


LSP (Life Sciences Partners) is an independent European investment firm, providing financing for private and public life sciences companies. LSP’s mission is to connect investors to inventors, focusing on unmet medical needs. With over EUR1.3 billion (USD1.5 billion) of investment capital raised to date and offices in Amsterdam, Munich and Boston, LSP is one of Europe’s leading life sciences investors. In 2017, LSP launched LSP HEF 2 with a fund volume of EUR280 million targeting investment opportunities in private medical technology companies which offer products that can both improve the quality of patient care and lower healthcare spending. To learn more, visit www.lspvc.com.


ABOUT MH CARNEGIE & CO.


M.H. Carnegie & Co. is a leading Australian private equity and alternative asset manager with over AU$500M under management. Carnegie’s investment focus is on high value medical device technologies, with particular emphasis on opportunities that leverage the best innovations, development pathways, management teams and financing strategies. For more information, visit www.mhcarnegie.com.


ABOUT SECTORAL ASSET MANAGEMENT


Sectoral Asset Management is an established global healthcare specialist. Sectoral leverages its expertise and capabilities to capture significant value creation across both public and private companies. More information about the firm and its track record is available at www.sectoral.com.


Caution: The Simplify Disc is an investigational device in the United States and is limited by law to investigational use.






Contacts


Chronic Communications Inc.

Michelle McAdam, (949) 545-6654

michelle@chronic-comm.com






	

		

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Smith & Nephew unveils cost-cutting plan in battle with activist Elliott

			


	Posted On February 9, 2018

	By OrthoSpineNews

	In Financial

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8 FEBRUARY 2018 – By Iain Withers 


Artificial hip and knee maker Smith & Nephew has launched a major cost-cutting programme in an effort to ward off pressure to break up the firm by activist investor Elliott Advisors.


Olivier Bohuon, the outgoing boss of the FTSE 100 firm, said the plan would help deliver improved earnings after Smith & Nephew posted net profits down 3pc for 2017 to $767m (£552m), at the lower end of management guidance.


However sales edged up 2pc to $4.8bn, boosted by double digit growth in emerging markets.








The cost savings programme, called Accelerating Performance and Execution (Apex), is expected to deliver $160m worth of cost savings a year by 2022.


It involves reducing Smith & Nephew’s manufacturing base and supply chain costs, overhauling it sales strategy and collecting more data from products in use by patients in order to help justify pricing levels.









 































 








	

		

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Relievant Announces Publication of Positive Outcomes in 12-Month SMART Sham RCT

			


	Posted On February 9, 2018

	By OrthoSpineNews

	In Spine

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SUNNYVALE, Calif., Feb. 08, 2018 (GLOBE NEWSWIRE) — Relievant Medsystems, a privately held medical device company that developed the Intracept® Procedure, a minimally invasive and clinically proven approach for the treatment of chronic low back pain (CLBP), announced today the publication of the pivotal SMART Trial data in the European Spine Journal. The SMART Trial is a Level 1, randomized, sham-controlled, double-blind clinical trial for chronic low back pain whose rigor, size, and clinical outcomes are unprecedented in the field of spine care. The study included 225 patients, 147 in the treatment arm and 78 in the sham arm, across 15 sites in the United States (U.S.) and 3 in the European Union (E.U.)


The published results demonstrated a statistically significant difference between the per protocol Intracept treatment arm and the sham arm for the primary endpoint of comparative change in Oswestry Disability Index (ODI) from baseline to three months (p = 0.019).  Significant findings from the trial include:


    

  • The per protocol INTRACEPT treatment arm demonstrated a mean ODI improvement of 20.5 points or 48% decrease from baseline at 3 months
    • 

  • These patients also had a statistically significant decreases in pain at 6 and 12 months, as measured by Visual Analog Scale (VAS), with sustained 44% and 41% decrease in pain, respectively
    • 

  • Excellent safety profile with no device-related adverse events
    • 



“The SMART trial confirms that Intracept is an important, new solution for CLBP with the strong results demonstrated by the significant and durable ODI decreases in this highly rigorous sham controlled randomized trial,” said Jeffrey Fischgrund, M.D., chairman, Orthopedics, Beaumont Hospital, Royal Oak and the principal investigator of the study. “The significant improvement in pain and function demonstrated by the SMART trial provides clear proof of the efficacy of this treatment. We are honored to have these data published in the European Spine Journal and look forward to building upon these results.”


“The Intracept Procedure represents a novel, minimally invasive option for the over 5 million indicated patients in the U.S who are suffering from CLPB for whom today’s treatment options have proven ineffective,” stated Kevin Hykes, President and Chief Executive Officer of Relievant.  “Our ability to treat these patients early in the CLBP disease continuum can potentially avoid the later need for opioids, or more costly and invasive therapies.”


About Chronic Low Back Pain (CLBP)


Chronic low back pain is a widespread and often severely debilitating condition that is estimated to affect nearly 30 million people in the U.S., costing nearly $150 billion each year in medical treatment and lost productivity.   Patients suffering from CLBP typically initiate treatment with conservative therapies such as activity modification, medications, bracing, physical therapy, manipulation and steroid injections. Conservative therapies fail to provide adequate pain relief for approximately 80 percent of CLPB patients. Surgery is often performed for eligible candidates to remedy structural defects in the spine in the hope that it will resolve a patient’s pain, but often with disappointing results.


About the Intracept Procedure


Relievant’s Intracept Procedure is a new, proven treatment option for the over 5 million indicated US patients who suffer from CLBP who have not responded to conservative therapies and who may not be candidates for surgery. The marketing clearance from FDA was supported by ground breaking anatomic research that identified and demonstrated the role of the basivertebral nerve (BVN) in generating low back pain from the vertebral body endplates. The procedure uses a transpedicular, minimally invasive approach to reach the BVN near the center of the vertebral body, and uses radiofrequency energy to ablate the nerve; once ablated, these nerves no longer transmit pain signals. Spine Surgeons and Interventional Pain Specialists perform the Intracept Procedure under image guidance in the outpatient setting, with the entire procedure taking 60-90 minutes. Treated patients report nearly immediate relief of their back pain.


About Relievant Medsystems


Founded in 2006 and based in Sunnyvale, California, Relievant Medsystems is a privately held medical device company developing new solutions to improve the quality of life for millions of patients suffering from CLBP.


FDA has cleared the Intracept System for the following Indications for Use:   The Intracept Intraosseous Nerve Ablation System is intended to be used in conjunction with radiofrequency (RF) generators for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least 6 months duration that has not responded to at least six months of conservative care, and is also accompanied by either Type 1 or Type 2 Modic changes on an MRI.


As with any surgical procedure, there are risks and considerations associated with the Intracept Procedure.  Please see www.relievant.com for a discussion of the risks, contraindications, warnings, precautions and a summary of the pivotal clinical trial data on the device.


* Surgical Multi-Center Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain (SMART)


Contact

Carrie Mendivil

Gilmartin Group

415-937-5405

investors@relievant.com


	

		

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Zimmer Biomet’s Rapid Recovery Program Marks Two Decades of Success in Europe

			


	Posted On February 8, 2018

	By OrthoSpineNews

	In Recon

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WARSAW, Ind., Feb. 8, 2018 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, is marking the 20th anniversary of Rapid Recovery, an evidence-based program optimizing all aspects of a patient’s care pathway and surgical experience. Zimmer Biomet pioneered Rapid Recovery in 1997 to complement its commercial product offerings and help healthcare providers improve the quality and cost-efficiency of patient care. Zimmer Biomet’s Rapid Recovery program combines the principles of fast-track surgery with evidence-based approaches to process optimization, clinical enhancements, patient engagement, data collection and evaluation, strategy and marketing.


To date, Zimmer Biomet has implemented the Rapid Recovery program in approximately 250 hospitals throughout Europe. A foundation for this success is the clinical evidence on which the program is built. Since 1997, hundreds of papers have been published on fast-track hip and knee arthroplasty1. In the most recently published review, large cost savings were reported, without any increase in complication rates2.


The Rapid Recovery program’s 20-year track record of success is a testament to Zimmer Biomet’s commitment to offering products, services and the latest digital technologies as part of Zimmer Biomet Signature Solutions. The Zimmer Biomet Signature Solutions offering supports the enhancement of the entire continuum of care, from pre-operative patient education to peri-operative efficiencies and post-operative support to promote early mobilization, rehabilitation and discharge.


“What distinguishes Zimmer Biomet’s Rapid Recovery program is not only two decades of expertise working with Europe’s leading, high-performance orthopaedic surgery units, but also the hands-on support capabilities of our dedicated Rapid Recovery teams, access to our advisory board and to the network of European thought leaders in fast-track medicine,” said Katarzyna Mazur-Hofsäss, Zimmer Biomet President, EMEA.


The Rapid Recovery program supports primary hip and knee arthroplasty, outpatient arthroplasty surgery, fragility hip fracture treatment, sports medicine procedures, spine interventions and shoulder arthroplasty.


“The Rapid Recovery program provides a framework for examining and optimizing every component of the surgical process that can impact outcomes – from blood and pain management including peri-operative anesthesia, to tissue-sparing surgical techniques and post-operative physiotherapy regimens,” said Professor Henrik Kehlet, an inaugural member of Zimmer Biomet’s Rapid Recovery Advisory Board, an innovator in fast-track surgery and professor of perioperative therapy at Copenhagen University. “Over the past two decades, Zimmer Biomet has been at the forefront of educating, encouraging and supporting hospitals across Europe to adopt rapid recovery protocols to improve the quality of patient care and drive down avoidable costs. I’m proud to serve on the Rapid Recovery Advisory Board to continue working toward making fast-track protocols the new standard of care in joint replacement surgery.”


About Zimmer Biomet

Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.


We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.


We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com, or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.


ZB-Corp


Cautionary Statement Regarding Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Forward-looking statements include, but are not limited to, statements concerning Zimmer Biomet’s expectations, plans, prospects, and product and service offerings, including new product launches and potential clinical successes.  Such statements are based upon the current beliefs and expectations of management and are subject to significant risks, uncertainties and changes in circumstances that could cause actual outcomes and results to differ materially.  For a list and description of some of such risks and uncertainties, see Zimmer Biomet’s periodic reports filed with the U.S. Securities and Exchange Commission (SEC).  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in Zimmer Biomet’s filings with the SEC.  Forward-looking statements speak only as of the date they are made, and Zimmer Biomet disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.  Readers of this news release are cautioned not to rely on these forward-looking statements, since there can be no assurance that these forward-looking statements will prove to be accurate.  This cautionary statement is applicable to all forward-looking statements contained in this news release.


1 Pubmed: terms: fast track surgery arthroplasty, access on 1 feb 2018


2 Wilches C, Sulbarán JD, Fernández JE, Gisbert JM, Bausili JM, Pelfort X. Fast-track recovery technique applied to primary total hip and knee replacement surgery. Analysis of costs and complications. Rev Esp Cir Ortop Traumatol. 2017 Jan 7. pii: S1888-4415(16)30104-7.


SOURCE Zimmer Biomet Holdings, Inc.


Related Links


http://www.zimmerbiomet.com










	

		

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