WishBone Medical, Inc. Names Andrew J. Miclot as President

Warsaw, Indiana, January 4, 2018 — WishBone Medical, Inc., a new global pediatric orthopedic company, committed to providing anatomically appropriate innovative implants in sterile packed, single-use disposable kits, announces that Andrew “Andy” J. Miclot has taken on the role of President and will continue in his role as Vice Chairman and Director on the WishBone Medical Board of Directors.

Mr. Miclot is a seasoned executive with almost 40 years of global Medical Device experience. He has been President and CEO of several Medical Device Companies with executive leadership positions, put together world-class management teams and completed and integrated acquisitions globally. He has had success in early stage and in Fortune 500 companies turning around unprofitable and growing primarily Orthopedic and ENT companies. Early experience included growing sterile packed, single-use, disposable kit Medical Device companies.

He is joining WishBone Medical after turning around Micro Machine as President and CEO, an orthopedic company with offices in Warsaw, IN and Kalamazoo MI.  Recent experience includes General Manager ENT /Senior Vice President and Officer of ArthroCare where he increased annual revenue from flat to three years of double digit growth generating 33% of the revenue and 50% of the profit for the entire company.

Andrew was President/CEO and Director of Ascension Orthopedics delivering 15% increase the first year, after two consecutive years of flat sales. He was Senior Vice President of Orthofix where he propelled revenue by 15% in orthopedics that included trauma and external fixation products.

As Senior Vice President/Officer and IRO, he propelled Symmetry Medical, for over thirteen years, from a $10 million breakeven medical device company to $300 million and was key in the NYSE IPO raising $120 million, surpassing Wall Street expectations and generating $220 million via a secondary offering. Other Medical Device Supplier experience included the Executive Vice President of Micro Technologies.

He was Director of Medical Products at DePuy Orthopedics, driving revenues from $64 to $80 million. Responsibilities included trauma, sports medicine, surgical instruments and customs for spine, knee, shoulder, foot, trauma and hip Products. Prior to DePuy, he had several Marketing and Sales leadership positions at Zimmer for over five years in three Divisions; Patient Care, Hall Surgical and Trauma.

Early experience includes: Vice President of Ulti-Med, disposable products for the US and Asia, Medline, as the youngest Director, disposable textile and Custom Sterile Procedure Trays, DeRoyal, Sales Manager with orthopedic soft goods and Custom Sterile Procedure Trays and American Hospital Supply/Hospitex, Sales Manager that turned around a territory ranked worst of 50 to number three in two years and then promoted to Sales Trainer.

Nick Deeter, WishBone Medical’s Founder, Chairman and CEO commented, “We are delighted       that Andy is joining WishBone Medical as Global President. He has extensive and relevant global leadership experience in Orthopedics and with single-use, sterile Medical Devices and a strong record of success. Andy will also remain as the Vice Chairman and Director of WishBone Medical’s Board of Directors and we appreciate his guidance over the last year.”

Andy currently serves on three Boards; WishBone Medical as Vice Chairman and Director, Micro Machine as Director and Precision Optics as Director (Public Company). Also, he is on two Advisory Boards; Indiana University Arts and Sciences Alumni Board and ODT (Orthopedic Design and Technology). He was one of a small group of Founders in “The Institute of Orthopaedic Enlightenment” started by Knowledge Enterprises. He has been key note speakers and panel discussion leaders at several Orthopedic and ENT conferences.

He has a BA in Speech and Hearing Sciences and an MA in Audiology from Indiana University, and an MBA from Lake Forest Graduate School of Management.

About WishBone Medical, Inc.

WishBone Medical, a Global pediatric orthopedic company, is committed to providing anatomically appropriate innovative implants and instruments in sterile packed, single use, disposable kits, to prevent infection, reduce overall costs for our customers and achieve the best outcomes for children around the world who are still growing.

For more information, contact Andrew Miclot, Vice Chairman and President, at 574-306-4006 or email CustomerService@WishBoneMedical.com

NuVasive Extends First-Of-Its-Kind Porous PEEK Interbody To TLIF And PLIF Procedures

SAN DIEGOJan. 4, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, announced today the launch of the Company’s COALESCETM Thoracolumbar Interbody Fusion Device as well as FDA 510(k) clearance for expanded indications of its COHERE® Cervical Interbody Fusion Device. The launch and updated claims follow the NuVasive September 2017 acquisition of Vertera Spine, developers of highly innovative interbody implants for spinal fusion using patented porous polyetheretherketone (PEEK) technology.

The NuVasive Advanced Materials Science (AMS) Portfolio includes Porous PEEK™ and Modulus® Titanium interbody implants that are engineered for enhanced osseointegration and biomechanical properties when compared to solid implants with smooth or rough surfaces. Based on animal studies, COALESCE and COHERE provide a unique three-dimensional Porous PEEK architecture to help elicit and encourage bone ingrowth. The technology used to develop these devices utilizes a proprietary processing method that introduces porous structure without compromising implant strength.

“Our strategy in building our AMS portfolio is to provide unprecedented, innovative technologies that enhance the surface, structure and visualization properties of these implants,” said Gregory T. Lucier, chairman and chief executive officer of NuVasive. “Our launch of COALESCE and the expanded clearance of COHERE and COALESCE are all part of our continued commitment to bring disruptive technology to market and investment into our comprehensive AMS portfolio, which converge to provide a better surgical experience and improve patient quality of life.”

COALESCE is now commercially available for TLIF and PLIF procedures in multiple footprint, height and lordotic options, and is magnetic resonance compatible. Following its recently cleared 510(k), COALESCE indications have been expanded to include use for one or two adjacent levels in the thoracolumbar spine (T1– S1) with both autograft and allograft for treatment of degenerative disc disease and degenerative spondylolisthesis as well as multi-level degenerative scoliosis. The device previously received FDA 510(k) clearance for use in anterior, transforaminal, posterior and lateral lumbar interbody fusion procedures.

The expanded FDA 510(k) indications for COHERE allow it to be used at multiple levels in the cervical spine (C2 – T1) with both autograft and allograft. In addition, COHERE received a new ICD code from the Center of Medicare & Medicaid Services (CMS) in October. COHERE is the only product approved for use with the new code, signifying CMS’ recognition of the innovation and potential clinical and tracking benefits of using Porous PEEK technology.

“Patients can gain significant pain relief and improved functional outcomes through the stabilization and fusion of the degenerated spinal motion segment,” said Dr. Kenneth Burkus, orthopaedic surgeon at The Hughston Clinic. “COHERE and COALESCE contribute to these outcomes by retaining the biomechanical properties necessary for intradiscal spinal applications, while helping facilitate osseointegration and bone growth. The use of these new Porous PEEK implants may enhance fusion and limit the risk of stress-shielding, subsidence and implant failure.”

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

AngelMD Investor Group Closes Funding Round in Articulus Bio, LLC

AngelMD, a platform that connects medial startups with doctors that provide guidance and investors that provide funding, today announced that its group of physician and investor members has completed a funding round for Articulus Bio, LLC. Articulus Bio is a seed-stage orthopedic medical device company focused on total ankle replacement (TAR). The (patent-pending) Articulus Bio technology takes a unique engineering approach toward solving the problems behind the majority of total joint replacement failures.

While total joint replacement surgeries are seen as a rousing success in the world of orthopedics, they are not without their own issues. Approximately one million hip and knee replacement procedures are performed each year and as many as 50,000 of these cases will likely fail within 10 years. Ankle joint failure rates are considerably more prevalent than the hip and knee, and some ankle devices may have failure rates as high as 40 percent within five to ten years.

The first area of focus for Articulus Bio is to address the wear debris issue — either metal on metal or metal on plastic — caused by friction occurring at the articulating faces of joint surfaces. These wear particles circulate through the body and often cause an immunological response known as osteolysis. The debris “eats away” where the implant junction interfaces with the body, causing a loosening of the implant that ultimately leads to the need for a revision surgery.

“It has been a privilege to collaborate with AngelMD on advancing our Tendonoid™ Web Joint technology,” said Adam Rubenstein, CEO of Articulus Bio. “Our mission is to improve outcomes and quality of life for total joint replacement patients. That requires access to capital, but for us, it’s just as essential to engage the intellectual and technical horsepower of the orthopedic surgeon community to help guide our development. AngelMD played an invaluable role in facilitating these pivotal relationships for us while assisting raising the capital we needed.”

While the Articulus Bio team remains focused on the development of their TAR product, the company has a parallel goal of deploying their platform-based Tendonoid™ Web Joint System across a host of large and small joint sites. The technology utilizes a novel configuration of the previously FDA approved Ultra High Molecular Weight Polyethylene (UHMWPE) biomaterial spun into the Tendonoid Web Joint System structure. The Tendonoid Web Joint System is designed to reduce/eliminate friction/grinding at the articulating joint faces that are observed in prior generations of devices. When the friction/grinding is reduced/eliminated, so too is the wear debris.

“In conversations with physicians and industry experts focused on Total Ankle Replacements, the feedback on the design of this new generation of TAR shows potential for a substantial leap forward in improving patient outcomes and reducing complication,” said Mark Mescher, Sr. Vice President of Professional Relations for AngelMD.

The team is raising capital in order to address specific seed-stage milestones that, on the other side of completion, will inject material value into the company. First they will capture performance data of the Tendonoid™ sub-assembly components. Second, they will prepare and submit a Q-Sub meeting package to FDA and receive regulatory pathway guidance from the agency. Finally, they will continue to build out their intellectual property portfolio.

The goal of Articulus Bio, as the future takes shape, is to take what the company learns from their TAR cases and apply it to many other large and small joints throughout the body. This should allow for total joint replacement surgeries, without the risk of wear debris, to become as commonplace as those performed on hips.

About AngelMD 
AngelMD is an investment and networking platform connecting innovative medical startups, physicians, investors, and industry partners. Leading physicians from all over the US have joined AngelMD to help source, evaluate and advise companies in biotechnology, medical device, and healthcare technology. For more information, visit http://www.angelmd.co.

About Articulus Bio, LLC 
Articulus Bio, LLC is a seed-stage orthopedic medical device company focused on total ankle replacement (TAR). The (patent-pending) Articulus Bio technology takes a unique engineering approach toward solving the problems behind the majority of total joint replacement failures.

Horizon Technology Finance Provides $12 Million Venture Loan to Conventus Orthopaedics

FARMINGTON, Conn. and MAPLE GROVE, Minn.Jan. 2, 2018 /PRNewswire/ — Horizon Technology Finance Corporation (NASDAQ: HRZN) (“Horizon”) (“Company”), a leading specialty finance company that provides capital in the form of secured loans to venture capital backed companies in the technology, life science, healthcare information and services, and cleantech industries, announced today that it closed a $12 million venture loan to Conventus Orthopaedics, Inc. (“Conventus”) on December 22, 2017. Conventus will use the proceeds for general working capital purposes.

Conventus is a medical device company developing a proprietary nitinol “Cage” technology for treatment of periarticular fractures. The Conventus Cage™ fracture repair solution is designed to offer patients and surgeons an improvement over traditional techniques by providing intramedullary support. Backed by top investors including Deerfield Management and SightLine Partners, the Cage technology has been well received by orthopedic surgeons and their patients.

“We are very pleased to provide this venture loan to Conventus,” said Gerald A. Michaud, President of Horizon. “The company’s 3-dimensional fracture management system enables surgeons to provide robust, stable surgical repair and return patients to their normal lives. With this financing, Conventus will continue to commercialize its proximal humerus fracture fixation therapy while developing further indications for this technology.”

Matthew Jewett, CEO and President of Conventus, stated, “We are excited to have the support of a first class healthcare investor like Horizon as we accelerate the expansion of the Conventus Cage technology with the upcoming launch of our next generation proximal humerus (PH) system. This growth capital will enable us to expand our commercial efforts and bring our technology to more surgeons and ultimately help more patients.”

About Horizon Technology Finance
Horizon Technology Finance Corporation is a leading specialty finance company that provides capital in the form of secured loans to venture capital backed companies in the technology, life science, healthcare information and services, and cleantech industries. The investment objective of Horizon is to maximize its investment portfolio’s return by generating current income from the debt investments it makes and capital appreciation from the warrants it receives when making such debt investments. Headquartered in Farmington, Connecticut, Horizon has regional offices in Pleasanton, CaliforniaReston, Virginia and Boston, Massachusetts. Horizon’s common stock trades on the NASDAQ Global Select Market under the ticker symbol “HRZN”. To learn more, please visit www.horizontechfinance.com.

About Conventus Orthopaedics
Conventus Orthopaedics, Inc. is an early-stage company focused on delivering a new standard of care for orthopedic fracture treatment, including complex and fragility fractures where there is a significant unmet need and a lack of treatment options. Their proprietary Cage™ technology aims to improve patient outcomes, enhance the surgeon experience, and deliver economic value to stakeholders within this market segment. To learn more, please visit www.conventusortho.com.

Forward-Looking Statements
Statements included herein may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Statements other than statements of historical facts included in this press release may constitute forward-looking statements and are not guarantees of future performance, condition or results and involve a number of risks and uncertainties. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described from time to time in our filings with the Securities and Exchange Commission. Horizon undertakes no duty to update any forward-looking statement made herein. All forward-looking statements speak only as of the date of this press release.

Contact:

Horizon Technology Finance

Investor Relations and Media Contacts:

Daniel R. Trolio

The IGB Group

Chief Financial Officer

Scott Eckstein / Leon Berman

(860) 674-9977

(212) 477-8261 / (212) 477-8438

dtrolio@horizontechfinance.com

seckstein@igbir.com / lberman@igbir.com

 

SOURCE Horizon Technology Finance Corporation

Related Links

http://www.horizontechfinance.com

OrthoPediatrics Corp. Expands PediPlates® Franchise with Titanium System

WARSAW, Ind., Jan. 03, 2018 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (NASDAQ:KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, is pleased to announce the launch of Titanium PediPlates®, the Company’s 24th surgical system. The titanium implant system expands OrthoPediatrics’ already comprehensive physeal tethering offering and includes both O-Plates and I-Plates as well as solid and cannulated low-profile screws. As a market leader in guided growth, OrthoPediatrics’ PediPlates technology harnesses the power of the growth plate through a simple, minimally invasive, and reversible tethering technique.

Joe Hauser, OrthoPediatrics’ Vice President of Trauma and Deformity Correction, noted that titanium PediPlates provide another correction option to pediatric orthopedic surgeons worldwide. “Adding a titanium offering to OrthoPediatrics’ market leading PediPlates physeal tethering franchise expands physicians’ treatment options, especially in patients who have a nickel allergy. The launch of our 24th surgical system strengthens our strategy to provide pediatric orthopedic surgeons with superior options for treating children.”

About PediPlates®
The PediPlates® system, which includes the I-Plate, O-Plate, and Delta Plate, provides a physeal tethering technique that does not disrupt the integrity of the physis, or growth plate. It features simple plate and screw constructs that span the growth center and restrain the physis by inhibiting growth where the plates and screws are applied. The system also features stainless steel plates and screws, which provide excellent strength, resistance to breakage, and ease of removal.

About OrthoPediatrics Corp. 
Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 24 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma & deformity, complex spine and ACL reconstruction procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and 35 countries outside the United States.

Investor Contacts
The Ruth Group
Tram Bui / Emma Poalillo
(646) 536-7035 / 7024
tbui@theruthgroup.com / epoalillo@theruthgroup.com

NuVasive To Present At The 36th Annual J.P. Morgan Healthcare Conference

SAN DIEGOJan. 3, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, announced today that management will present at the 36th Annual J.P. Morgan Healthcare Conference at the Westin St. Francis in San Francisco on Monday, Jan. 8, 2018, at 1:30 p.m. PT / 4:30 p.m. ET.

A live webcast of the presentation will be available online from the Investor Relations page of the Company’s website at www.nuvasive.com. A replay of the presentation will remain available on the website for 30 days after the applicable live webcast.

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

Zimmer Biomet Announces FDA Clearance of the Sidus® Stem-Free Shoulder System

WARSAW, Ind.Jan. 3, 2018 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced it has received U.S. Food and Drug Administration (FDA) clearance for the Sidus® Stem-Free Shoulder system as a total shoulder arthroplasty solution for patients with good bone stock that have either osteoarthritis, post-traumatic arthrosis, focal avascular necrosis of the humeral head or who had previous surgeries of the shoulder that do not compromise the fixation. The Sidus Stem-Free Shoulder system is designed to anatomically restore a patient’s anatomy, preserve bone stock and allow for improved pre to post-operative patient outcomes1,2. The Sidus system will be available in the United States beginning in the First Quarter of 2018.

“The Sidus Stem-Free Shoulder system offers a novel approach to total shoulder arthroplasty requiring minimal bone resection,” said Dr. Ryan Krupp, orthopaedic surgeon at Norton Orthopedic Specialists in Louisville, Ky. “The Sidus system is designed to reduce pain and restore range of motion and is clinically proven to help suitable patients.”1,2

“The FDA clearance of the Sidus Stem-Free Shoulder system comes at a time when Zimmer Biomet is accelerating the pace of innovation,” said Bryan C. Hanson, Zimmer Biomet President and Chief Executive Officer. “We launched Sidus in Europe in 2012 and initiated a clinical study in the U.S. in 2015. During that time, the product has demonstrated strong clinical performance. The addition of the Sidus system to Zimmer Biomet’s U.S. portfolio reinforces the Company’s leadership in the innovation of shoulder solutions.”

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.

Cautionary Statement Regarding Forward-Looking Statements
This 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 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 release.

ZBH-Corp

1 Multicenter Trial of the Sidus® Stem-Free Shoulder Arthroplasty System (Protocol CIU2012-12E/G130026, “IDE”).

2 Sidus® Stem-Free Shoulder: A Multicenter, Prospective, Non-Controlled Post Market Clinical Follow-up Study (Clinical Investigation Plan CME2012-01E, “PMCF”).

SOURCE Zimmer Biomet Holdings, Inc.

Related Links

http://www.zimmer.com

First ever Haven Lamina Replacement performed by Dr. Graham Mouw of Robotics Outpatient Center, Los Angeles, CA: ROC – LA

LOS ANGELESJan. 3, 2018 /PRNewswire/ — Robotics Outpatient Center, Los Angeles, CA, “ROC-LA” announces today the First Surgical Implantation of the Globus “Haven” Lamina Replacement Implant, in California by Spinal Neurosurgeon Graham Mouw, MD.

This surgery is part of Robotics Outpatient Center’s efforts to expand the use of the Globus “Haven” Lamina Replacement System worldwide.

Multi-center Study on SImmetry Sacroiliac (SI) Joint Fusion Shows Significant Reduction in Low Back Pain and Opioid Use at 6 Months

MINNETONKA, Minn.Jan. 2, 2018 /PRNewswire/ — Zyga Technology, Inc., a medical device company focused on the design, development and commercialization of minimally invasive devices to treat underserved conditions of the lumbar spine, today announced publication of clinical outcomes for the first 50 patients in the EVoluSIon (EVSI) Clinical Study. This prospective, 40-site, 250-patient trial will evaluate long-term fusion and pain reduction in patients receiving SImmetry® Sacroiliac Joint Fusion.

At 6 months, mean low back pain as measured on a 100-point Visual Analog Scale (VAS) demonstrated a significant reduction from 76.2 pre-operatively  to 35.1 (54% reduction, p<0.0001), with 72% of patients attaining the minimal clinically important difference (MCID, ≥20 point improvement). While pain and disability improvement is comparable to similar studies, the reduction in opioid use (55%) was much greater than previously reported in other studies. Additional follow-up will be performed at 12- and 24-months to assess the presence of bony fusion across the joint via CT imaging as well as ongoing pain reduction.

“It is very exciting to see prospective, multi-center clinical data reaffirm the positive feedback I’ve received from my patients over the past few years,” said Ali Araghi, D.O., an orthopedic surgeon at Core Institute in Phoenix, Ariz. and lead author of the publication. “As a physician working with patients who are in significant pain, it is also incredibly meaningful to know I have a surgical option that can reduce the need for opioid medications. Longer-term follow-up and CT imaging will be important to demonstrate the longevity of these results, but this is very encouraging for our first look at the data.”

Earlier this year, the Company released results of a 19-patient, prospective, multi-center study of Minimally Invasive Sacroiliac Joint Fusion Surgery with Decortication. At 24 months post-op, 94 percent of patients had evidence of bridging bone across the SI joint, with 83 percent categorized as solid fusion. Of patients with solid fusion, 88 percent of the joints were fused within the area of decortication, demonstrating the importance of this step in achieving fusion. In addition to fusion, the study demonstrated a 73 percent reduction in average pain. The EVSI study is designed to build on the findings of this study.

The Centers for Disease Control and Prevention lists back problems as the second most common cause of disability in U.S. adults[i]. It has been reported that approximately 20 percent of all chronic low back pain derives from the sacroiliac joint[ii].

About Zyga Technology, Inc.

The company is marketing the SImmetry® Sacroiliac Joint Fusion System, a minimally invasive procedure intended for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. The SImmetry System is known for its ability to create a true SI joint arthrodesis, including decortication, bone grafting and fixation with a threaded implant. For more information, visit zyga.com.

[i] Centers for Disease Control and Prevention. Prevalence of disabilities and associated health conditions among adults—United States, 1999. JAMA. 2001; 285(12):1571-1572.
[ii] Cohen SP et al. Sacroiliac Joint Pain: A Comprehensive Review of Epidemiology, Diagnosis and Treatment. Expert Rev Neurother. 2013; 13(1):99-116

CONTACT:
Maggie Wallner
Tel 952 698 9953
mwallner@zyga.com

SOURCE Zyga Technology, Inc.

Related Links

http://www.zyga.com

WishBone Medical, Inc. Releases Broken Screw Removal and K-Wire Systems

WARSAW, Ind., Jan. 02, 2018 (GLOBE NEWSWIRE) — WishBone Medical, Inc., a new global pediatric orthopedic company, has announced the official launch of the single-use, sterile packed Broken Screw Removal and K-Wire Systems.  The Broken Screw Removal System is available in three different sizes: 2.7mm, 3.5mm and 4.5mm and is designed to remove broken, stripped and cold-welded screws.

The K-Wire Systems are available in five different configurations; Pediatric Elbow Combo Kit (1.6mm & 2.0mm K-Wires), Pediatric Long Bone Combo Kit (2.0mm & 2.5mm K-Wires), Three Pediatric Extremity Combo Kits; Small (0.7mm & 0.9mm K-Wires), Medium (0.9mm & 1.25mm K-Wires) and Large (1.25mm & 1.6mm K-Wires). Each system includes two different sizes of wires, protective pin covers and instruments.

Nick Deeter, WishBone Medical’s Founder and CEO added, “The Broken Screw Removal and K-Wire Systems both address current issues that Pediatric Surgeons face with their small patients. They need products that are sterile, easy to find, easy to use and designed for pediatric patients. We strongly believe that having these products readily available in sterile packed, single-use kits will be a game changer in the operating room.”

To learn more about WishBone Medical, visit www.WishBoneMedical.com

About WishBone Medical, Inc.

WishBone Medical, a Global pediatric orthopedic company, is committed to providing anatomically appropriate innovative implants and instruments in sterile packed, single use, disposable kits, to prevent infection, reduce overall costs for our customers and achieve the best outcomes for children around the world who are still growing.

For more information, contact Andrew Miclot, Vice Chairman and President, at 574-306-4006 or email CustomerService@WishBoneMedical.com