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

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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

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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.

 

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Photo Source: Thinkstock

 

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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.

 

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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

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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

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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

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Globus Medical Enters International Market with ExcelsiusGPS® Robotic Guidance and Navigation System

AUDUBON, Pa., Dec. 06, 2018 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, recently announced the entrance of ExcelsiusGPS®, a revolutionary robotic guidance and navigation system, to the international market with system installations completed in several European countries. This past October, the first European Excelsius GPS® procedure was performed at the Metropolitan Hospital in Neo Faliro, Athens, Greece by Mr. Panagiotis E. Zoumpoulis. Since then, numerous open and minimally invasive spine procedures have been performed at Bonifatius Hospital in Germany and at the Fornaca Clinic in Italy.

“Surgeons and hospital administrators in the United States have shown tremendous levels of interest in ExcelsiusGPS® since it first launched domestically at the end of 2017,” said Dave Demski, Chief Executive Officer at Globus Medical. “Users have realized the system’s ability to help advance patient care and provide tangible benefits for surgeons and their staff. As we begin to scale our efforts abroad, we have seen similar levels of enthusiasm within the international surgeon community and look forward to the continued adoption of ExcelsiusGPS® into these markets.”

Italy’s first surgeries were performed by Prof. Franco Benech, and Dr. Carlo Alberto Benech, from Benech Neurosurgery and Spine Specialists in Turin, Italy at the Fornaca Clinic. “With the addition of ExcelsiusGPS® we now offer patients seeking spine surgery a level of accuracy that was not possible without this technology,” said Prof. Benech. “Our team is committed to providing the highest level of care to our patients by offering the latest advancements in robotic-assisted spine surgery at our facilities.”

Professor Peter Douglas Klassen with Bonifatius Hospital in Lingen, Germany echoes a similar sentiment, commenting, “ExcelsiusGPS® is truly a revolutionary technology designed to improve surgeon wellness and patient care. We are excited about the potential impact that robotic guidance and navigation may have in improving screw placement accuracy, MIS efficiency, and reducing radiation exposure.”

About Globus Medical, Inc.
Globus Medical, Inc. is a leading musculoskeletal solutions company based in Audubon, PA. The company was founded in 2003 by an experienced team of professionals with a shared vision to create products that enable surgeons to promote healing in patients with musculoskeletal disorders. Additional information can be accessed at http://www.globusmedical.com.

Safe Harbor Statements
All statements included in this press release other than statements of historical fact are forward-looking statements and may be identified by their use of words such as “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and other similar terms. These forward-looking statements are based on our current assumptions, expectations and estimates of future events and trends. Forward-looking statements are only predictions and are subject to many risks, uncertainties and other factors that may affect our businesses and operations and could cause actual results to differ materially from those predicted. These risks and uncertainties include, but are not limited to, factors affecting our quarterly results, our ability to manage our growth, our ability to sustain our profitability, demand for our products, our ability to compete successfully (including without limitation our ability to convince surgeons to use our products and our ability to attract and retain sales and other personnel), our ability to rapidly develop and introduce new products, our ability to develop and execute on successful business strategies, our ability to comply with changing laws and regulations that are applicable to our businesses, our ability to safeguard our intellectual property, our success in defending legal proceedings brought against us, trends in the medical device industry, general economic conditions, and other risks. For a discussion of these and other risks, uncertainties and other factors that could affect our results, you should refer to the disclosure contained in our most recent annual report on Form 10-K filed with the Securities and Exchange Commission, including the sections labeled “Risk Factors” and “Cautionary Note Concerning Forward-Looking Statements,” and in our Forms 10-Q, Forms 8-K and other filings with the Securities and Exchange Commission. These documents are available at www.sec.gov. Moreover, we operate in an evolving environment. New risk factors and uncertainties emerge from time to time and it is not possible for us to predict all risk factors and uncertainties, nor can we assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Given these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements. Forward-looking statements contained in this press release speak only as of the date of this press release. We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.

Contact:
Brian Kearns
Vice President, Business Development and Investor Relations
Phone: (610) 930-1800
Email:  investors@globusmedical.com
www.globusmedical.com

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Kuros Reports Publication of MagnetOs Data Demonstrating Equivalence to Autologous Bone in Spinal Fusion

SCHLIEREN (ZURICH), Switzerland, Dec. 06, 2018 (GLOBE NEWSWIRE) — Kuros Biosciences (SIX: KURN) today announced the publication of data from a clinically-relevant preclinical model comparing MagnetOs with autologous bone in instrumented posterolateral spinal fusion in sheep. Utilizing multiple assessments for fusion, the study concluded that MagnetOs is a suitable alternative to autograft when used as a standalone graft.

The publication, which is entitled “Biphasic calcium phosphate with submicron surface topography in an Ovine model of instrumented posterolateral spinal fusion” was included in the December issue JOR Spine, an open-access Orthopaedic Research Society (ORS)journal.

Joost de Bruijn, Chief Executive Officer of Kuros, said: “This latest study demonstrates early bone healing and physiologically-appropriate graft resorption for MagnetOs in this clinically-relevant model of posterolateral spinal fusion and adds to the growing body of evidence proving that MagnetOs is a reliable alternative to autologous bone graft.”

Professor Bill Walsh, University of New South Wales, Australia, who was principal investigator of the study said: “I’ve investigated many of the leading synthetic bone grafts in this model and, in my experience, MagnetOs leads to the most compelling fusion outcomes of all the grafts I’ve tested.”

About the study
MagnetOs Granules and MagnetOs Putty were implanted standalone and compared to autograft bone. Twenty-five adult, female Merino sheep underwent posterolateral spinal fusion at L2-3 and L4-5 levels with instrumentation. After 6, 12, and 26 weeks, outcomes were evaluated by manual palpation, range of motion testing, micro-computed tomography, histology and histomorphometry. Fusion assessment by manual palpation 12 weeks after implantation revealed 100% fusion rates in all treatment groups. Similarly, the three treatment groups showed a statistically significant decrease in lateral bending at the fusion levels at 12 weeks and 26 weeks compared to the 6-week time-point, which further confirmed spinal fusion. No significant differences in range of motion were observed between the treatment groups at any of the time-points investigated. Histological assessment at 12 weeks showed fusion rates of 75%, 92%, and 83% for autograft, MagnetOs Granules and MagnetOs Putty, respectively. The fusion rates were further increased 26 weeks post-implantation. Similar trends of bone growth were observed by histomorphometry.

Citation 
https://onlinelibrary.wiley.com/doi/pdf/10.1002/jsp2.1039

For further information, please contact: 
Kuros Biosciences AG
Michael Grau
Chief Financial Officer
Tel +41 44 733 47 47
michael.grau@kurosbio.com

Media & Investors
Hans Herklots
LifeSci Advisors
+41 79 598 7149
hherklots@lifesciadvisors.com

About MagnetOs
MagnetOs promotes local bone formation equivalent to current gold standard, autograft. A substantial number of clinically relevant and predictive studies have demonstrated its equivalence to the current gold standard (patient’s own bone, which may not be available in sufficient quantities and/or involves morbidity, costs and pain associated with its harvesting from another healthy site of the patient’s body). MagnetOs is a bone graft comprising biphasic calcium phosphate with an advanced submicron surface topography that directs bone formation after implantation. With its unique submicron surface topography, MagnetOs preferentially directs early wound healing toward the bone-forming pathway, resulting in an osteoinductive claim in Europe. MagnetOs is available as granules and as a putty formulation.

US indications statement
MagnetOs is an implant intended to fill bony voids or gaps of the skeletal system, i.e., posterolateral spine. MagnetOs must be used with autograft as a bone graft extender in the posterolateral spine. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure.

EU indications statement
MagnetOs is intended for use as bone void filler for voids and gaps that are not intrinsic to the stability of the bony structure. MagnetOs is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. MagnetOs is intended to be packed into bony voids or gaps of the skeletal system (i.e. extremities, spine, cranial, mandible, maxilla and pelvis) and may be combined with autogenous bone. MagnetOs should not be used to treat large defects that in the surgeon’s opinion would fail to heal spontaneously. In load bearing situations, MagnetOs is to be used in conjunction with internal or external fixation devices.

About Kuros Biosciences AG 
Kuros Biosciences (SIX:KURN) is focused on the development of innovative products for bone regeneration and is located in Schlieren (Zurich), Switzerland and Bilthoven, The Netherlands. Visit www.kurosbio.com for additional information on Kuros, its people, science and product pipeline.

Forward Looking Statements 
This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “will” or “expect” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors, Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.

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IntraFuse Granted US Patent for FlexThread™ Intramedullary Fracture Fixation System

LOGAN, UtahDec. 6, 2018 /PRNewswire/ — IntraFuse, a start-up medical device company operated by Surgical Frontiers, is focused on advanced surgical devices for improving outcomes for orthopedic extremity procedures, announced today that the United States Patent and Trademark Office has recently granted the company a key patent related to its FlexThread Intramedullary Fracture Fixation system.

US Patent 10,136,929 entitled “Flexible Bone Implant” is the first patent to issue from the intellectual property portfolio held by the company that includes additional pending US and international patent applications. The patent covers the novel combination of an intramedullary rod with cross fixation on end and a flexible bone screw on the other end. This platform technology enables percutaneous, secure fracture fixation of long bones of the extremities, especially for curved bones or where the surgical technique requires an off-axis approach to the intramedullary canal.

The simple and elegant design is easier to implant and lower cost than today’s standard-of-care fracture fixation hardware. Incorporating IntraFuse’s proprietary FlexThread technology, the distal end of the implant is a flexible, intramedullary screw and the proximal end is a rigid, high-strength intramedullary rod. Upon insertion of the implant into the bone, the rigid rod portion of the implant spans and supports the fracture and the flexible screw portion bends as needed to thread into the intramedullary canal. With internal screw fixation on one side of the fracture and cross screw fixation through the rod on the other side of the fracture, proper bone alignment and length can be maintained during the healing period.

The FlexThread System is currently FDA 510(k) cleared for fibula and clavicle indications, and the FlexThread™ technology is in further development for additional indications, include fractures of the fifth metatarsal bone, also known as a Jones fracture.

IntraFuse is a development stage medical device company incubated and operated by Surgical Frontiers.

About Surgical Frontiers
Surgical Frontiers develops advanced surgical technologies that are ready for clinical use.   Focused primarily on musculoskeletal injuries and pathologies, the company collaborates with surgeons, industry, universities, and investors to bring advanced surgical technologies to the market that improve healthcare.

Media Contact:
Mr. Wade Fallin 
CEO
205883@email4pr.com 
http://surgicalfrontiers.com/intrafuse/ 
800-230-3710

SOURCE Surgical Frontiers

Related Links

http://surgicalfrontiers.com

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