Month: December 2018

Anika to Showcase HYALOFAST at the International Cartilage Regeneration and Joint Preservation Society (ICRS) Focus Meeting in Milan

December 12, 2018

BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedic and regenerative medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, today announced plans to showcase its entire Orthobiologics franchise, including HYALOFAST, at the upcoming ICRS Focus Meeting in Milan, Italy at the Humanitas Research University. The ICRS is the main forum for international collaboration in cartilaginous tissue research and joint preservation, with 1300 active members from 65 countries.

HYALOFAST is a non-woven, single-step, off-the-shelf, biodegradable HA-based scaffold for hyaline-like cartilage regeneration to treat cartilage injuries and defects. HYALOFAST is commercially available in approximately 15 countries and has been used to successfully treat more than 15,000 patients internationally, and with strong eight-year patient follow-up data. HYALOFAST is pending regulatory submission in the United States and its FastTRACK Phase III trial is currently enrolling patients across the U.S. and Europe.

“The ICRS Focus Meeting in Milan is an excellent venue to further showcase the significant advantages of our entire Orthobiologics franchise before a collection of world-renowned experts in the field of cartilage repair and regeneration,” said Joseph Darling, President and CEO, Anika Therapeutics. “We believe that continuing this peer-to-peer dialogue and technical training is central to further advancing the HYALOFAST Phase III clinical trial, as well as increasing commercial adoption. HYALOFAST is a truly remarkable advancement in the treatment of cartilage injuries and defects due to its flexible minimally-invasive means of application and adaptive fit to individual patient needs.”

HYALOFAST will be featured at the International Cartilage Regeneration and Joint Preservation Society (ICRS) Focus Meeting in Milan, Italy during a technical session. The meeting, which will be attended by many of the world’s leading cartilage specialists, will showcase HYALOFAST as part of its “RE-LIVE SURGERY SESSIONS” and its clinical data program.

HYALOFAST Technical Session
Title: “Scaffolds: How to do It. Re-live Surgery and Relevant Results”
Presenter: Dr. Alberto Gobbi, OASI Bioresearch Foundation, Milano – Italy
Date/Time: December 14, 2018 at 9:30 – 10:15am

Company-Sponsored Booth
Anika will be a Gold Sponsor and will host a booth (#12) featuring guest physicians leading guided, hands-on demonstrations of HYALOFAST procedures using the HYALOFAST Arthroscopic Virtual Surgery Simulator. The company will also host “watch & try” sessions at the Anika booth.

About ICRS
The ICRS (International Cartilage Regeneration and Preservation Society) is the main forum for international collaboration in cartilaginous tissue research that brings together basic scientists, clinical researchers, physicians and members of industry, engaged or interested in the field of articular biology, its genetic basis and regenerative medicine. It provides continuing education and training to physicians and scientists with an active interest in the prevention and treatment of joint disease to improve patient care through regenerative medicine approaches.

2018 HYALOFAST Publications

1.

Gobbi A., et al. Use of bone marrow aspirate concentrate combined with hyaluronan-based scaffold for early osteoarthritis in athletes. Football Medicine Outcomes Abstract book XXVII Isokinetic Medical Group International Conference – Camp Nou, Barcelona 2-4 June 2018. Ed Calzetti & Mariucci. Page 442.

2.

Sofu H. et al. Clinical and radiographic outcomes of chitosan-glycerol phosphate/blood implant are similar with hyaluronic acid-based cell-free scaffold in the treatment of focal osteochondral lesions of the knee joint. Knee Surg Sports Traumatol Arthrosc. 2018 Aug 1. (Epub ahead of print).

3.

Gollwitzer H. Operative Therapie – Knorpelschäden der Hϋfte Einzeitiges arthroskopisches Verfahren zur Regeneration. Sportärztezeitung 03/2018 (Cartilage Damage to the Hip. One-Stage Arthroscopic Method of Regeneration).

About Anika Therapeutics, Inc.
Anika Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated orthopedic medicines company based in Bedford, Massachusetts. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions with clinically meaningful therapies along the continuum of care, from palliative pain management to regenerative tissue repair. The Company has over two decades of global expertise developing, manufacturing, and commercializing more than 20 products based on its proprietary hyaluronic acid (HA) technology. Anika’s orthopedic medicine portfolio includes ORTHOVISC®MONOVISC®, and CINGAL®, which alleviate pain and restore joint function by replenishing depleted HA, and HYALOFAST, a solid HA-based scaffold to aid cartilage repair and regeneration. For more information about Anika, please visit www.anikatherapeutics.com.

Contacts

For Investor Inquiries:
Anika Therapeutics, Inc.
Sylvia Cheung, 781-457-9000
Chief Financial Officer

For Media Inquiries:
W2O Group
Sonal Vasudev, 917-523-1418 sonal@w2ogroup.com

DJO Announces New Global Headquarters in Dallas, Texas to Accommodate Growth and Accelerate Innovation

December 12, 2018

DALLAS–(BUSINESS WIRE)–DJO (“DJO” or the “Company”), a leading global provider of medical technologies designed to get and keep people moving, today announced its plans to relocate its global headquarters from San Diego, California to Dallas, Texas by early 2019. DJO’s Bracing and Supports business unit, which develops and markets DonJoy®, the market-leading line of bracing solutions, and DJO’s Consumer business unit will remain in San Diego, California in a new and improved contemporary space.

“We made the strategic decision to move our headquarters to Dallas to expand our presence into a market with a strong and larger pool of talent, gain greater and more efficient customer access and take advantage of what we believe is a better corporate environment for our company as we grow,” said Brady Shirley, DJO’s President and Chief Executive Officer. “At the same time, we felt it was important to continue the 40-year legacy of DonJoy in Southern California by continuing to build our Bracing business in Carlsbad.”

Over the next three months, DJO will transition many of its corporate functions to Dallas, which will serve as the global headquarters for the Company featuring a state-of-the-art customer experience center and a comfortably modern environment that supports employee well-being while encouraging collaboration. In addition to the relocation of many current employees to the new headquarters, DJO is creating hundreds of new job opportunities in the Dallas area, including many at its new distribution center in Fort Worth which opened a few months ago and already employs over 200.

By bringing teams, processes and systems together into one location in close proximity to its new distribution hub in Fort Worth, DJO continues to demonstrate its commitment to delivering value to its customers, employees and shareholders.

“This move is a key component of a multi-phase facility optimization strategy that DJO embarked on earlier in the year to enhance the look and feel of many of our offices, bring teams together and remove unneeded workspace in our U.S. locations,” said Jeanine Kestler, Executive Vice President and Chief Human Resources Officer for DJO. “We are excited to become one of the leading medical device companies headquartered in Dallas and an active member of the community!”

About DJO

DJO is a leading global provider of medical technologies designed to get and keep people moving. The Company’s products address the continuum of patient care from injury prevention to rehabilitation, enabling people to regain or maintain their natural motion. Its products are used by orthopaedic surgeons, primary care physicians, pain management specialists, physical therapists, podiatrists, chiropractors, athletic trainers and other healthcare professionals. In addition, many of the Company’s medical devices and related accessories are used by athletes and patients for injury prevention and at-home physical therapy treatment. The Company’s product lines include rigid and soft orthopaedic bracing, hot and cold therapy, bone growth stimulators, vascular therapy systems and compression garments, therapeutic shoes and inserts, electrical stimulators used for pain management and physical therapy products. The Company’s surgical division offers a comprehensive suite of reconstructive joint products for the hip, knee and shoulder. DJO’s products are marketed under a portfolio of brands including Aircast®, Chattanooga, CMF™, Compex®, DonJoy®, ProCare®, DJO® Surgical, Dr. Comfort® and Exos™. For additional information on the Company, please visit www.DJOglobal.com.

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements relate to, among other things, the Company’s expectations for growth of the Company, the acceleration of innovation and the delivery of value to its customers, employees and shareholders. These forward-looking statements are based on the Company’s current expectations and are subject to a number of risks, uncertainties and assumptions, many of which are beyond the Company’s ability to control or predict. The Company undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. The important factors that could cause our results to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to the successful execution of the Company’s business transformation and facility consolidation plans. Other important factors that could cause results to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to the risk factors detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017, filed with the Securities and Exchange Commission on March 16, 2018.

Contacts

DJO Media Contact:
Katie Sweet
Communications Director
Katie.sweet@djoglobal.com

DJO Investor Contact:
David Smith
SVP, Treasurer and Investor Relations
760.734.3075
IR@djoglobal.com

Kinamed’s CarboJet® System Employed in Study Showing Tourniquetless Total Knee Arthroplasty Decreases Pain and Opioid Consumption in Women

A new clinical study published in the Journal of Arthroplasty comparing total knee replacement (TKR) surgery with and without use of the traditional thigh tourniquet demonstrated that female patients in the no-tourniquet group experienced significantly less post-operative pain and consumed fewer opioids as compared to female patients in the tourniquet group.

In 2017, there were approximately 50,000 opioid drug overdose deaths in the United States. Although opioids are effective at reducing pain after surgery, patients receiving prescription opioids are at risk for developing an opioid use disorder. Therefore, development of surgical protocols that reduce post-operative pain and the need for opioid medication are of critical importance and are highly sought after.

Maintaining appropriate penetration and inter-digitation of bone cement is extremely important for ensuring long-term success of TKR, because aseptic implant loosening has been identified as a leading failure mode in the modern TKA procedure. When performing knee arthroplasty without a tourniquet, achieving an optimal “cement technique” can be a challenge because of the additional fluid debris present in the bone and at the implant-interfaces. The CarboJet® CO2 Bone Preparation system employed in this study addresses this challenge by using medical-grade compressed carbon dioxide gas to remove lipids/fatty marrow elements, blood, and saline from the bone surface prior to the application of bone cement. The lead author of this study, R. Michael Meneghini, MD, Associate Professor of Clinical Orthopedic Surgery at Indiana University School of Medicine, chose to employ the CarboJet system to manage these blood and lipid debris and optimize cement penetration for his patients.

With nearly 800,000 procedures performed in the United States each year, knee replacement surgery is one of the most widely accepted and effective treatments for relieving the pain and disability associated with degenerative osteoarthritis. Because of the sheer number of knee replacements being performed, approaches that can reduce opioid consumption as demonstrated in this study are noteworthy.

About Kinamed 

Kinamed is a leading developer, manufacturer, and distributor of innovative specialty orthopedicneurosurgical, and cardiothoracic medical devices. In addition to the CarboJet system, Kinamed’s other orthopedic products include: the SuperCable® Iso-Elastic Polymer Cerclage system: a revolutionary cabling system that eliminates problems associated with traditional metal cables; and the KineMatch® Patello-Femoral Replacement: a patient–specific (custom) unicompartmental joint replacement implant. Since the company’s founding, Kinamed has manufactured and sold over 2.5 million surgical implants.

For additional information on Kinamed, Inc., please visit http://www.Kinamed.com.

Dr. Meneghini is a consultant for Kinamed.

DiscGenics Receives Approval from Japanese Pharmaceuticals and Medical Devices Agency to Begin Clinical Evaluation of Non-Surgical Degenerative Disc Disease Treatment in Japan

In2Bones Expands Its Lead in PEEK Lower Extremity Implants with the Global Launch of the Unique PitStop® Subtalar Implant

December 11, 2018

MEMPHIS, Tenn.–(BUSINESS WIRE)–In2Bones Global, Inc. today announced the global launch of the unique, “see-through” PitStop®implant.

Manufactured from a high-performance polymer called polyether ether ketone (PEEK), the PitStop® Implant is used to help facilitate the surgical correction of progressive flat foot deformity in both pediatric and adult populations.

Flexible flatfoot is one of the most common deformities of the foot, often starting during adolescence and continuing into adulthood. The PitStop® Implant helps to restore the stability of a patient’s arch during the gait or walking process.

Several traditional metallic brands of subtalar implants are currently available today which can be limiting because of the excessive stiffness of the material compared to the adjacent bones, causing pain and biomechanical adaptation in some cases. PEEK has the benefit of being less stiff (softer) than metal and more similar to the elasticity of bone. The PEEK material in the PitStop® Implant may lead to increased and long-term patient tolerance.

Additionally, PEEK is radiolucent, meaning that it won’t show up on X-ray, something that traditional metal implants cannot do because metal absorbs X-rays and blocks the image underneath.

The Unique “see-through” PitStop® Implant demonstrates In2Bones’ commitment to expanding the extremities market by launching innovative technological advancements that improve surgical outcomes and patient care.

To support the commercial launch of the PitStop® Implant, In2Bones recently published the micro website, http://www.PitStop-Implant.com providing physicians and healthcare professionals with easy to access educational content. The materials on the site will include surgical animations and videos, surgical technique guides, case studies, patient support materials, and more.

For more information about In2Bones Global, Inc. extremity products, please visit www.In2Bones.com.

About In2Bones

Headquartered in Memphis, Tennessee, In2Bones is a global designer, manufacturer and distributor of medical devices for the treatment of disorders and injuries of the upper (hand, wrist, elbow) and lower (foot and ankle) extremities. For more information, visit www.in2bones.com.

Contacts

Jon Simon | Sr. Vice President of Marketing
In2Bones USA
M: 512.739.5793 • O: 901.260.7931 • F: 844-712-6637
Email: jsimon@i2b-usa.com
https://www.linkedin.com/company/22344175/

Bob Reed
Element-R Partners
630.579.1770
bob@rurelevant.com

Institutional Investors to Pump $200B More Into Healthcare Infrastructure

By Fred Donovan

 – Global institutional investors are forecast to increase their investment in healthcare infrastructure by $200 billion over the next five years.

For its report, the Octopus Group surveyed more than 100 global institutional investors with a total of $6.8 trillion in assets under management.

The institutions said they currently allocated 6.1 percent of their investment portfolio to healthcare infrastructure but expect that allocation to rise to 9.5 percent over the next five years.

Around 37 percent of respondents expect to boost allocations to healthcare infrastructure investment by up to 10 percent over that same time period. Insurance companies will increase their allocations more than any other type of investor.

“The investment case for healthcare infrastructure is already resonating with institutional investors. Across region and investor type there is demand for opportunities to allocate funds to the sector,” the report observed.

More than half of respondents said that demographics is the key driver for investing in healthcare infrastructure.

Around 71 percent of global institutional investors said their healthcare infrastructure investments are performing as expected or better than expected.

For UK institutional investors, 22 percent said their healthcare infrastructure investments are overperforming. Close to one-quarter of UK respondents said they plan to increase allocations, and one-quarter plan to do so by more than 10 percent.

Asian respondents had the highest level of current allocations to healthcare infrastructure, 10.6 percent, and will invest the most into the sector of any other region in the coming years. They said they expect 12.1 percent of their portfolio to be allocated to healthcare infrastructure in the next five years.

Australian investors plan to increase investment by the largest margin. Although Australian investors have a relatively low current investment allocation to healthcare infrastructure at 4.1 percent, this is expected to increase by 5.3 percent over the next five years to 9.4 percent.

 

READ THE REST HERE

 

Photo Source: Thinkstock

 

The $49 billion/year of waste in healthcare spending we can solve

December 8, 2018 / Peter Nichol

It is estimated that 30% of healthcare costs are lost to waste in the system. These costs get passed on to the insurer and ultimately the patients. With healthcare bills being the leading cause of personal bankruptcies in the country (60%) that 30% is the difference between solvency and destitution for a lot of people.  This is a compelling moral argument to wring all waste out of the system as quickly as possible. That moral argument is even stronger when one considers that poverty is the greatest threat/risk to one’s health.

So, what if I told you that there is a segment of healthcare spending that accounts for $165 billion/year and we could eliminate the waste in that space ($49 Billion) in the next ten years. That we have a very sound grasp of the root causes of that waste, that we have all the technology to solve it.

That segment is sterile processing or the cleaning and sterilization of surgical instruments and medical equipment. And most of us are completely unaware of this critical pillar in surgical services unless something goes terribly wrong and a lawsuit ensues.

Sterile processing employees work in windowless rooms typically in the basement of hospitals, the rooms are hot, they have to wear personal protective equipment which makes it hotter. They are frequently injured by the errant sharp instrument or scalpel blade left on the knife handle. Their wages are miserable ($15-$22/hour) meaning that many live in poverty in major metropolitan areas. They are relentlessly pushed by clinicians to rapidly turnover instruments knowing that they are sacrificing safety and quality. They are verbally abused when they can’t meet these demands and to most people in the hospital, they are invisible. Yet, the entire economic engine of the hospital hinges on their performance.  And under these brutal conditions they somehow perform this critical task at a very high level in an environment that can best be characterized as a pre-Henry Ford assembly line.  Everyone one of them that I have met is purpose driven in knowing that their work will touch multiple patients in a day. This is the one reason they do what they do and hospitals should be kissing the ground they walk on.

But I digress.

This really is an argument about economics and waste because in this agency driven world of western capitalism, large, impersonal organizations really do not care about these people unless it affects their bottom line. So, let me begin by telling you that every hospital is losing hundreds of thousands to tens of millions of dollars a year because they ignore these people.

 

READ THE REST HERE

 

Successful First in Human for ZygoFix’s Spinal Facet Joint Fixation System

MISGAV, IsraelDec. 10, 2018 /PRNewswire/ — ZygoFix Ltd. (“ZygoFix”), a portfolio company of The Trendlines Group Ltd.(“Trendlines”) (SGX: 42T) (OTCQX: TRNLY), announced the successful start of a first In human clinical study for its zLOCK spinal facet joint fixation system. The clinical study comprised several procedures to date and a 6-month follow-up of the first case. The first case, a fusion procedure using the zLOCK system, was performed on a 67-year-old female suffering from severe back and leg pain. The patient reported a drop in her VAS (Visual Analog Scale of 0-10 for pain measurement) from 9 pre-operation, to 1 one day post-operation and to 0 at 6 months post-op.

Spinal fusion is a common surgical procedure for the treatment of severe back and leg pain due to conditions such as degenerative discs or “slipped” discs. Spinal fusion is one of the most common surgical procedures – fifth in terms of OR procedure frequency1.

The zLOCK implant is designed as a miniature facet fusion cage to stabilize the segment. Its unique combination of rigid and flexible elements withstands loads and accommodates the anatomy of any facet joint. zLOCK utilizes the natural anatomy of the spine to form a “bridge” between the two adjacent vertebrae, without screws and rods. A percutaneous approach allows placement of zLOCK with only one small incision per side, making it significantly less invasive than the standard pedicle screw procedure.

Prof. Attila Schwarcz, Vice-Chairman and Leader of Spine Surgery, Department of Neurosurgery, University of Pecs, Hungary, and principal investigator in ZygoFix’s study, commented, “The zLOCK implantation is a significantly less invasive procedure compared to other posterior spinal stabilization systems. It appears superior to pedicle screw procedures, since zLOCK has an almost zero risk of causing nerve root injury that can happen in pedicle screw misplacement. Additionally, the zLOCK implant may have the ability to provide better long-term stabilization due to solid bony fusion of the facet joints.”

ZygoFix CEO Ofer Levy remarked, “We are extremely pleased with this successful start to our clinical study – another step toward making spinal fusion simpler, faster and less invasive. zLOCK’s unique design simplifies fusion procedures by self-adjusting to the spine’s anatomy, eliminating the need for pedicle screw placement.”

1 https://www.hcup-us.ahrq.gov/reports/statbriefs/sb186-Operating-Room-Procedures-United-States-2012.jsp

Contact:    
Ofer Levy, CEO ZygoFix   
ofer@zygofix.com    
+972-52-2664-981

www.zygofix.com

SOURCE ZygoFix Ltd

NuVasive Grows Cervical Spinal Interbody Portfolio With PEEK Corpectomy Implant

SAN DIEGODec. 10, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for expanded use of its Monolith®Corpectomy System, providing surgeons with a modular PEEK interbody solution for cervical corpectomy procedures.

The FDA 510(k) indications for expanded use of the Company’s Monolith Corpectomy System include procedures in the cervical spine (C3-C7 vertebral bodies) to treat a diseased or damaged vertebral body caused by fracture, tumors, osteomyelitis or to support reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissue in cervical degenerative disorders.

“Expanding the indicated use of our Monolith Corpectomy System to include cervical corpectomy procedures demonstrates the Company’s continued commitment to expanding our cervical spine interbody portfolio,” said Matt Link, president, Strategy, Technology and Corporate Development for NuVasive. “We are pleased to provide surgeons with a PEEK cervical interbody solution to help round out our cervical portfolio as we continue to advance our mission to improve patient lives.”

NuVasive’s Monolith Corpectomy System was initially cleared by the FDA for indicated use in thoracolumbar corpectomy procedures in 2015, offering a fully modular, imaging-friendly PEEK implant solution. The system is comprised of a monolithic core with modular endcaps that allow surgeons to customize the device to meet the patient’s specific anatomical requirements. The endcaps are available in multiple footprint and lordosis options intended to help maximize endplate coverage while addressing the surgeon’s alignment goals. The Monolith cage is constructed entirely from PEEK and includes radiographic markers, which provides increased clarity in postoperative x-rays and imaging, allowing surgeons to more easily assess fusion following procedures. The cage also includes large central graft apertures designed to help facilitate bony through-growth and fusion.

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 over $1 billion in revenues, NuVasive has an approximate 2,400-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

MinInvasive Announces Successful Limited Market Release with OmniCuff™ System in the US

Magal, Israel, December 7, 2018 – MinInvasive Ltd., developer of the OmniCuff™ device for treatment of rotator cuff repair, reported positive progress following its initial two months of limited market release activity in the US with 26 OmniCuff™ System cases successfully concluded to date.

Shoulder rotator cuff repair is a fast-growing market segment within the sports medicine market, with over one million procedures performed annually worldwide. The OmniCuff™ System is an arthroscopic transosseous rotator cuff repair device that eliminates the need for suture anchors. The device provides the advantages of minimally invasive transosseous repair in a disposable device. MinInvasive CEO Ronen Raz stated, “We are very pleased that within the first 8 weeks of limited US market release, the OmniCuff™ System has been successfully used by several very reputable sports medicine surgeons in 26 rotator cuff repair procedures”.

Joseph Abboud, MD, Professor of Orthopedic Surgery at the Rothman Institute at Thomas Jefferson University in Philadelphia, recently performed several OmniCuff cases and confirmed that he is “extremely pleased with the technical ease and reproducibility of the device, as well as the tremendous potential for direct cost savings.”

Walter Stanwood, an Orthopedic surgeon at Beth Israel Deaconess Hospital in Plymouth, Massachusetts has completed over a dozen surgeries with the Omnicuff, and commented that the System offers “a very straightforward technique that minimizes steps, with an elegant device to consistently create transosseous fixation in a rotator cuff repair model. OmniCuff has enormous potential in any location that a tendon-bone repair is performed.”

Nikhil Verma, MD Professor and Director of the Division of Sports Medicine and Shoulder Surgery at Rush University Medical Center in Chicago, remarked that the device “allows for a seamless transition between traditional anchor-based repair, and an anchorless solution. In addition, the availability of a technologically advanced and easy to use anchorless device has the potential to disrupt the market with a lower cost solution which is of paramount importance given recent movement of these types of cases to outpatient facilities and the emphasis on value-based care.”

Frank Cordasco, MD, MS, Professor of Orthopaedic Surgery at the Hospital for Special Surgery and the 35th President of the American Shoulder and Elbow Surgeons has observed “remarkably diminished pain in the post-operative period in patients treated with the OmniCuff System compared to those treated with the transosseous equivalent rotator cuff repair technique during the first 3 weeks following surgery. This has resulted in a decreased need for Opioid medications in the patients treated with the OmniCuff System”.

MinInvasive plans to gradually expand the availability of the device in the US and is currently in the process of securing CFDA approval for OmniCuff™ in China, another huge potential market for innovative medical technologies.

MinInvasive Ltd.

MinInvasive has developed the OmniCuff™ System – an innovative device enabling arthroscopic, transosseous rotator cuff repair. In 2016, MinInvasive entered into a strategic partnership with MicroPort Scientific Corporation to obtain CFDA approval for the OmniCuff™ system. MinInvasive has validated manufacturing of its new OmniCuff™ disposable version and initiated a limited market release in early October in the US.

Contact:

Ronen Raz, CEO, MinInvasive Ltd. 137 Hashachaf, Magal, Israel

ronen.raz@mininvasive.com

+972-54-6222410