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

February 6, 2018 – Authors:     

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.

 

READ THE REST HERE

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

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

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

8 FEBRUARY 2018 – By 

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.

 

 

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

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

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


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

John DeFord To Join NuVasive Board Of Directors

SAN DIEGOFeb. 8, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, announced the appointment of John A. DeFord, Ph.D. to the Company’s Board of Directors, effective upon the filing of the Company’s Form 10-K with the Securities and Exchange Commission.

Dr. DeFord has more than 25 years of experience in the medical device industry, with particular expertise overseeing clinical advancement through innovative R&D and technology-based initiatives. He currently serves as Senior Vice President, Research and Development, Interventional Segment for BD (Becton, Dickinson and Company). He joined BD following its December 2017 acquisition of C.R. Bard, Inc., where he had served as Senior Vice President, Science, Technology and Clinical Affairs since 2007. In that role, Dr. DeFord was responsible for R&D and clinical affairs functions across five global corporate divisions.

“We are pleased to welcome John to the NuVasive Board,” said Gregory T. Lucier, chairman and chief executive officer of NuVasive, Inc. “We expect John’s experience driving innovative products and technology programs at other large medical device companies  will help inform our own strategic direction as we quicken the tempo of our product launches and expand our efforts toward software development and a focus on systematizing spine surgery.”

“I am thrilled to have the opportunity to support NuVasive’s leadership in spine,” said Dr. DeFord. “I have long admired NuVasive as an industry innovator and look forward to sharing my clinical and business perspectives as a member of the Board to help the Company deliver even greater value to its surgeon customers, patients and shareholders.”

As a result of Dr. DeFord’s appointment, the NuVasive Board of Directors consists of 10 directors, nine of whom are independent. Dr. DeFord will stand for reelection at the Company’s annual meeting where Mr. Lesley Howe and Dr. Peter Farrell will retire from the NuVasive Board when their current terms expire, pursuant to the Company’s director retirement age policy.

Prior to his 13-year tenure at C.R. Bard, Dr. DeFord held various executive positions including president and chief executive officer with Cook Incorporated, now a multi-billion dollar privately-held medical device manufacturer, and served as managing director at Early Stage Partners LP, a venture capital firm focused on advanced materials, medical/biotechnology and information technology companies.

Published in numerous scientific journals, Dr. DeFord is currently a member of the executive faculty at Purdue University’s Krannert School of Management and Weldon School of Biomedical Engineering. Dr. DeFord earned a B.S. and M.S. in electrical engineering and a Ph.D. in electrical/biomedical engineering from Purdue University. He holds numerous patents and multiple industry honors.

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With $962 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.

Forward-Looking Statements
NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA™ platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

 

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com

DT MedTech Announces Successful Implantations of the New Hintermann Series H2™ Total Ankle Replacement Prosthesis

BALTIMOREFeb. 7, 2018 /PRNewswire/ — DT MedTech, LLC (DTM) announced today that Prof. Beat Hintermann, world-renowned foot and ankle surgeon and developer of the new, two-component, semi-constrained total ankle prosthesis, Hintermann Series H2™ Total Ankle Replacement System, has successfully implanted five H2 devices in patients in Liestal, Switzerland. Four of the procedures were primary total ankle replacements and the fifth was a takedown of a mal-position arthrodesis.

The H2 Total Ankle Replacement System is indicated for use as a non-cemented implant outside of the United States and as a cemented implant within the United States, to replace painful arthritic ankle joints due to primary osteoarthritis, post-traumatic osteoarthritis, or arthritis secondary to inflammatory disease (e.g., rheumatoid arthritis, hemochromatosis). The Hintermann Series H2™ can also be used as a revision for failed ankle replacements or non-union and mal-union of ankle arthrodesis.

Prof. Hintermann said, “I am extremely pleased with the outcomes of the recent H2 surgeries performed, especially as the patients were able to bear their own weight just 24 hours after the devices were implanted. Adding this semi-constrained option for my patients alongside the Hintermann Series H3™* mobile-bearing prosthesis, enables me to expand patient selection for total ankle replacements.”

DTM’s Hintermann Series H2™ sales and distribution in the United States will be handled directly through its logistics partner HealthLink Europe International from its US headquarters in Raleigh, NC, and through specialized and select distributors. Sales and distribution outside of the United States will be handled through HealthLink Europe BV, from its Netherlands location, and other specialized and select distributors.

David Reicher, President and Chief Executive Officer of DTM, stated, “We anticipate a limited release of the Hintermann Series H2™ beginning in early February outside of the United States, and in late March within the United States. We have been focused on training, sales, and distribution of the Hintermann Series H2™ in markets around the world and are looking forward to a very successful launch.”

For additional DTM information inside the United States, please email info@DTMedTech.com or call Ms. Jeannie Sarda at +1 410-427-0003; outside the United States, please email dt-medtech@healthlinkeurope.com or call +31 73 303 2537.

About DT MedTech, LLC
DT MedTech, LLC is the parent company of DT MedTech International and European Foot Platform, S.A.R.L.  DTM and its subsidiary companies maintain offices in Baltimore, MarylandDublin, IrelandSaint-LouisFrance; and Liestal, Switzerland. As a member of the Data Trace family of businesses, leaders in scientific and medical publishing, marketing, surgical training, clinical trial management, medical malpractice insurance, and information services for more than 30 years, DTM provides innovative surgical solutions for lower extremity surgeons with state-of-the-art devices such as The Hintermann Series Total Ankle Replacement Systems.

*Please note: Hintermann Series H3™ is not available for sale within the United States and its territories.

SOURCE DT MedTech, LLC

joimax® Continues Strong Growth Trend in 2017 with Launch of Its MultiZYTE® Facet and SI Joint Treatment Set in the US

Company also obtains full approval of its Endovapor® 2 system in China

February 08, 2018

KARLSRUHE, Germany–(BUSINESS WIRE)–the joimax® group announces very strong sales figures for 2017. The German based market leader of technologies and training methods for endoscopic minimally invasive spinal surgery shows a jump of almost 80% vs. 2016 in the U.S. Consolidated sales show a growth of nearly 30%, which reflects its CAGR of 35% since 2008.

“joimax® is in line with its top-line plans as well as with its EBIT growth projections,” states Rainer Schmitz, the long-standing CFO of joimax® GmbH. “The company is now active in 50 countries and enjoys a strong reputation in Europe, Asia and the U.S.”

Based on the inclusion of the newly created AMA CPT code 62380 for endoscopic decompression of the lumbar spine as of January 1st, 2017, and the worldwide increasing adoption rate of the joimax® procedures in general, the company is gaining a strong foothold throughout the U.S. The acceptance of endoscopic minimally invasive spine surgery techniques and their benefits to both the patients and the surgeons are steadily growing worldwide.

The understanding and therapy of SI Joint is a rapidly growing new field worldwide. joimax® faces this growing area of unmet needs with its MultiZYTE® Facet and SI Joint Treatment Set in this market segment. The upcoming 3rd International Conference on Sacroiliac Joint Surgery (ICSJS, http://simeg-international.com/en/home/), taking place in Tampa, FL from Feb. 21 to 24, 2018 gives attendees the opportunity to further enhance the level of understanding of the sacroiliac joint and to participate in a cadaver workshop at CAMLS learning center.

Further success in Asia is a result of the recent approval of the joimax® Endovapor® 2 Multi Radio Frequency System also in China, where joimax® has already been successfully in the market for 10 years.

“With this latest approval we now can market all our systems in this important country, which is a great step towards more targeted patient care,” states Wolfgang Ries, Founder and CEO of joimax®.

The Endovapor® 2 generates electrical power for monopolar and bipolar cutting and coagulation of tissue structures in surgical operations. The device is an all-in-one generator with specially integrated programs for spinal surgery with interdisciplinary application. It is equipped with two monopolar and two bipolar sockets and easy and intuitive touchpad technology. With arc control for safe application and easy neutral electrode monitoring, it combines a variety of electro-surgical modes and effects.

About joimax®

Founded in Karlsruhe, Germany, in 2001, joimax® is the leading developer and marketer of complete systems for endoscopic minimally invasive spinal surgery. With TESSYS® (transforaminal), iLESSYS® (interlaminar) and CESSYS® (cervical) for decompression procedures, MultiZYTE® (for facet and sacroiliac joint treatment) or with EndoLIF® and Percusys® for minimally-invasive endoscopic assisted stabilizations, proven endoscopic systems are provided that, together, cover a variety of indications.

In procedures for herniated disc, stenosis, pain therapy or spinal stabilization treatment, surgeons utilize joimax® technologies to operate through small incisions – under local or full anesthetic – via tissue and muscle-sparing corridors through natural openings into the spinal canal (e.g. intervertebral foramen, the “Kambin triangle”).

Contacts

Press Contact USA:
joimax® Inc.
Melissa Brumley
Melissa.brumley@joimaxusa.com
001 949 859 3472

SAGICO Participating in the International Spinal Osteotomy Meeting in Europe with a Focus on Clinical Validation for Aria™ and Arion™ Interbody Devices

Tampa, FL, USA, February 5, 2018: As part of the US commercial launch of Aria Surefit™ Lumbar Expandable Interbody and the first-to-market Arion™ Cervical Expandable interbody, representatives from SAGICO USA and SAGICO EU will be attending the 2018 International Spinal Osteotomy Meeting at Koç University Hospital on February 10, 2018. SAGICO will be meeting with several Key Opinion Leaders and discussing the preliminary data review of clinical research being conducted.

SAGICO anticipates releasing portions of the company’s new and ongoing clinical data efforts focusing on Aria™ and Arion™ which were recently cleared by the FDA.  James Gibson, CEO of SAGICO USA, explained, “with the recent release of our innovative interbody portfolio we are now focusing on the continuous cycle of clinical validation.  With over 4,000 surgical interbody cases completed, we have strong data that will differentiate our products in the North American market.”  He added, “the key to the introduction of our unique portfolio will be continued surgeon and clinical collaboration in both the US and abroad.”

The prestigious International Spinal Osteotomy Meeting is an annual event with scientific lectures and data being presented ranging from principles of thoracolumbar and sagittal balance and osteotomies in cervical and upper thoracic spine.

Koç University hospital is part of the Koç Healthcare group among with two other hospitals, American Hospital and MedAmerican Ambulatory Care Surgery Center. The Koç University Health Science Campus houses the university’s notable school of medicine.

Faculty members include surgeons from leading teaching facilities in the USA and Europe. The meeting’s faculty includes KOLs from Columbia University in New York, UCSF Spine Center in San Francisco, Switzerland, France, Belgium, Italy and the host nation of Turkey.  The multinational meeting is full of excellent lectures from prominent experts, clinical review of new procedures, case discussions, debate sessions, video demonstrations, and workshops from industry experts all designed to raise physician competence. 

MORE ABOUT SAGICO: Spinal Analytics & Geometrical Implant Co, (SAGICO) and its principals have many years of spinal industry success spanning multiple continents in more than 60 countries. SAGICO and its affiliates are privately held companies with global partners and shareholders and an aggressive pipeline that includes: novel artificial disk implants (TDR), Porous Titanium interbody technology, Expandable VBR options and unique Pedicle Screw Systems optimized for Complex & Pediatric surgery are just a few of the product lines SAGICO offers. SAGICO’s US corporate based operations are located in Tampa, Florida.

DISCLOSURE: We at SAGICO are confident in our products and so should our professional surgeons. A surgeon must always rely on his or her own clinical judgment when deciding whether to use a particular medical appliance that may be applicable for a specific patient and adhere to the package insert, product label and/or instructions for use before using any SAGICO product. SAGICO does not diagnose nor does SAGICO offer medical advice on medical conditions and SAGICO requires that all surgeons be trained in the use of any particular product before using it in surgery. The information presented is intended to demonstrate the depth and future of all SAGICO’s product lines. Some products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact SAGICO prior to any medical procedures to learn more.

Learn more @: www.SAGICO.co

To schedule an interview please contact SAGICO in the USA: Telephone: 813-830-3636

 

Limited USA and International Distributor Opportunities Remain

 

SANUWAVE Announces Exhibition at Wounds Canada 2018 Spring Conference

SUWANEE, GA, Feb. 07, 2018 (GLOBE NEWSWIRE) — SANUWAVE Health, Inc. (OTCQB: SNWV) is pleased to announce that the company will exhibit at Wounds Canada 2018 Spring Conference in Winnipeg, Manitoba on 11 -12 May 2018. SANUWAVE cordially invites you to visit us in our booth.  Wounds Canada’s spring conference is a continuing education event designed to support healthcare professionals who work with patients with wounds or patients who are at risk for developing wounds. SANUWAVE is using this occasion to continue the education of Canadian customers on our lead wound care product, dermaPACE®.

“We are very excited about our US FDA approval received in December 2017 for our dermaPACE System to treat diabetic foot ulcers,” stated Kevin A. Richardson II, Chief Executive Officer of SANUWAVE.  “We have received great response to our FDA approval, including in Canada, and now we expect to become a material player in the wound care space in Canada as 2018 unfolds and develops.”

In Canada, 2.4 million people were living with diabetes in 2008-2009, a figure that is expected to rise to close to 4 million people by 2018-2019.  Ulceration of the foot is one of the major health problems for diabetics.  Also, in acute inpatient care the diabetic foot ulcers represent a serious chronic disease.  Wounds Canada, formerly Canadian Association of Wound Care, estimates that the average cost of treating a chronic wound in Canada is $10K and diabetes related ulcers cost the Canadian health care system $150M annually.  Early treatment intervention with dermaPACE System can prevent ulcers from developing complications such as infection that could lead to amputation.

Our Chief Financial Officer, Lisa Sundstrom, will be attending the conference on behalf of SANUWAVE.  Please feel free to contact Lisa directly at lisa.sundstrom@sanuwave.com to set up an appointment during the conference.

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.

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.
Lisa Sundstrom
Chief Financial Officer
678-578-0117 (Office)
678-569-0881 (Fax)
Lisa.Sundstrom@sanuwave.com