Advanced Biomedical Technologies Inc. Granted New Patent Strengthening its Core Technology

SHENZHEN, CHINA and NEW YORK, Jan. 30, 2018 (GLOBE NEWSWIRE) — Advanced Biomedical Technologies Inc. (OTCQB:ABMT), a developer and manufacturer of orthopaedic internal fixation devices, today announced the State Intellectual Property Office of The People’s Republic of China (“SIPO”) has issued the Company a new patent titled “Bone Fracture Plate Made of High Polymer Materials”.

The company’s subsidiary Shenzhen Changhua Biomedical Engineering Company Limited is entitled for the new patent (ZL 2014 1 0647464.1), which strengthens the Company’s position in manufacturing process and related controls using our unique polyamide materials (“PA”).

Ms. Wang Hui, CEO of the company said, “This new patent strengthens our IP rights and enables us to develop new products. The combination of fiber-reinforced technology and bionic structure design, allows the medical devices to contain similar mechanical properties to human bone. The elastic fixation does not produce stress shielding, resulting in good fixation effect and biocompatibility. The devices can stimulate bone tissues to achieve effective biological integration, which will benefit bone regeneration. Our uniquely formulated materials can be widely used in the field of orthopaedic internal fixation in an ever-growing and prospective market which is currently dominated by existing materials such as metal and Poly-Lactic-Acid based devices.”

About Advanced Biomedical Technologies Inc. (OTCQB: ABMT)

Advanced Biomedical Technologies, Inc.’s primary product line includes internal fixation devices consisting of proprietary high grade polymers (polyamide – “PA”). Our products are used in a variety of applications including orthopaedic trauma, sports related medical treatment, or cartilage injuries, and reconstructive dental procedures. During the healing process, the products stimulate new bone growth which replaces the degrading device, leaving newer, stronger bone in the exact location of the injury; thus making the site of the injury stronger and more resistant to recurring damage.

These products provide an alternative to metal implants and overcome the limitations of other re-absorbable fixation devices. The material is utilized in producing human body implant screws, binding wires, rods and related implantation products. With over 15 years of meticulous in clinical trials, the company has developed the internal fixation devices to be clinically effective and safe.

The products and materials that the Company has created differ from competing bio-degradable and metal based products being marketed today by:

–  The ability to control the speed that the device degrades; therefore improving upon the healing time.

–  Eliminating the need for a second surgery to replace device due to infection or other post-operative complications.

–  The capability of being evenly absorbed from outer layer inwards, so that it gives enough restoration time for bone healing and re-growth.

The company is establishing broad and new intellectual property protection schemes around our unique PA product lines, not only on its combination compounds, but also to lead as an outstanding material in the future of clinical activity.

Forward-Looking Statements

This release contains forward-looking statements which are made pursuant to provisions of Section 21E of the Securities Exchange Act of 1934. Investors are cautioned that such statements in this release, including statements relating to regulatory and business strategies, plans and objectives of management and growth opportunities for existing or proposed products, constitute forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the forward-looking statements. The risks and uncertainties include, without limitation, risks that product candidates may fail in the clinic or may not be successfully marketed or manufactured, we may lack financial resources to complete development or marketing of our products, government regulatory agencies may interpret the results of studies differently than us, competing products may be more successful, demand for new pharmaceutical products may decrease, the biopharmaceutical industry may experience negative market trends, our continuing efforts to develop bone fixation devices may be unsuccessful, our common stock could be delisted from the over-the-counter market, and other risks and challenges detailed in our filings with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on any forward-looking statements which speak only as of the date of this release. We undertake no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this release or to reflect the occurrence of unanticipated events.

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Kai Gui

Advanced Biomedical Technologies Inc.

TEL: 1-718-766-7898


Source: Advanced Biomedical Technologies Inc.

MCRA Assists IlluminOss Medical with Successful De Novo Decision: 1st Orthopedic De Novo Granted by the FDA

WASHINGTONJan. 23, 2018 /PRNewswire-USNewswire/ — Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) has announced its role in the successful granting of the first orthopedic de novo by the U.S. Food and Drug Administration (FDA) on December 19, 2017, enabling IlluminOss Medical, Inc. to initiate commercialization in the U.S. of the Bone Stabilization System for treatment of impending and actual pathological fractures of the humerus, radius and ulna from metastatic bone disease.

IlluminOss Medical retained MCRA in August of 2016 to lead interactions and correspondence with the FDA for the Bone Stabilization System. The IlluminOss System is a PET balloon infused with a photodynamic monomer, which when exposed to light, polymerizes the monomer, resulting in a solid intramedullary (IM) rod. This is an important treatment option for the fixation and stabilization of actual and impending pathological fractures of the humerus through a minimally invasive procedure. IlluminOss Medical’s Founder & Chief Technical Officer, Robert Rabiner said “Being granted the first orthopedic de novo by the FDA is a significant achievement for both IlluminOss Medical and our partner, MCRA. We knew messaging and presentation of data was critical to the success of our submission, and we knew MCRA had an incredible track record of positive FDA interactions, regulatory strategies, and success. After our successful U.S. clinical trial, MCRA was able to effectively present our clinical and performance data to the FDA in a clear concise manner. Their interactions minimized the potential miscommunications with the agency, and delivered the first Ortho de novo.”

Dave McGurl, Director of Regulatory Affairs, at MCRA, said “We are pleased that FDA has implemented the de novo pathway which allows innovative technologies, such as those being developed by IlluminOss Medical, find a pathway to U.S. market and ultimately to patients. MCRA is at the forefront of helping companies navigate this relatively new regulatory pathway, and achieve success in bringing novel devices to the U.S. market that was not possible even a few years ago.”

About Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA)
Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) is the leading adviser and clinical research organization to the neuro-musculoskeletal and orthopedic industry. MCRA’s value lies in its industry experience and integration of five business value creators: regulatory, reimbursement, clinical research, healthcare compliance, and quality assurance. MCRA’s integrated approach of these key value creating initiatives, as well as orthopedic specialization, provides unparalleled expertise for its clients. MCRA has offices in Washington, DCManchester, CT, and New York, NY, and serves nearly 450 clients globally. MCRA has a demonstrated history of driving successful de novo and other regulatory submissions in all areas of the medical device industry including spine, orthopedics, cardio-vascular, diagnostic imaging, endoscopy, ophthalmics, general/plastic surgery, drug delivery, wound care, diabetes, dental, general healthcare, nephrology, neurology, cardiology, and in vitro diagnostic (IVD) devices.


David W. Lown
General Manager
212.583.0250 ext. 2111

SOURCE Musculoskeletal Clinical Regulatory Advisers, LLC

Additional US Patents Issued to Catalyst OrthoScience, Inc. for Its Stemless Shoulder Arthroplasty Technology

NAPLES, Fla.Jan. 19, 2018 /PRNewswire/ — Catalyst OrthoScience, Inc. has been granted four new patents by the United States Patent and Trademark Office for technologies incorporated in the CSR™ Total Shoulder Replacement System.  The Catalyst CSR™ Total Shoulder System is a new canal-sparing, anatomic shoulder arthroplasty system that provides consistently reproducible shoulder joint restoration with an humeral implant that is smaller, more anatomically-shaped, and less invasive than traditional shoulder replacement surgery.

U.S. Patent Number


Patent Issue Date


Glenoid Arthroplasty with Multi-directional Fixation

November 14, 2017


Humeral Arthroplasty

November 14, 2017


Glenoid Arthroplasty with Offset Reamers

November 14, 2017


Glenoid Arthroplasty

October 3, 2107

These patents expand the portfolio of Catalyst intellectual property related to the Company’s proprietary glenoid and humeral implant designs and instrumentation. “The granting of these patents endorses the extent of our technology and provides Catalyst with further protection for its product offerings in the shoulder replacement market,” said Bob Kaufman, CEO of Catalyst OrthoScience. “We have built a solid intellectual property portfolio and will continue to work to extend the depth and breadth of that protection.”

With core technology driven by surgeon and patient need, Catalyst has been able to draw a loyal following of orthopedic surgeons since receiving FDA clearance for the CSR™ total shoulder replacement solution last year. “Catalyst’s core technology is truly innovative, as evidenced by not only the growing patent portfolio, but also by the growing number of high caliber shoulder specialists who have embraced Catalyst as an important part of their clinical offering,” said Rod Allen, Catalyst’s Senior Vice President of Sales and Marketing.

Catalyst OrthoScience was founded in 2014 by orthopedic surgeon Steven Goldberg, M.D. who realized, based on his own experience as a fellowship-trained shoulder specialist, that improvements were needed to make shoulder replacement surgery less invasive and to give patients a more normal feeling shoulder after surgery.  “It feels great to be granted these patents,” said Dr. Goldberg. “I’m still amazed at how much our team has accomplished in such a short timeframe, and now patients are seeing the benefit.”

About Catalyst OrthoScience Inc.

Headquartered in Naples, FL, Catalyst OrthoScience develops and markets innovative medical device solutions that make orthopedic surgery less invasive and more efficient for both surgeons and patients.

The company’s first offering is the Catalyst CSR Shoulder System. The Catalyst CSR is a single-tray total shoulder arthroplasty system containing a non-spherical humeral implant for consistent anatomic joint line restoration and specialized glenoid instrumentation for a less invasive approach that preserves the natural anatomy and removes less of the patient’s bone.

Catalyst OrthoScience’s products are marketed under a portfolio of brands including Catalyst OrthoScience® and Catalyst CSR™. For additional information on the Company, please visit

SOURCE Catalyst OrthoScience, Inc.

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Centric Medical™ Announces FDA 510(k) Clearance of the Cannulated Screw Internal Fixation System for Foot and Ankle Indications

January 16, 2018

HUNTLEY, Ill.–(BUSINESS WIRE)–Centric Medical, a division of Life Spine, Inc., which focuses on developing surgical implants for the treatment of distal extremity pathology, announced today announced today that the U.S. Food and Drug Administration (FDA) has given 510(k) marketing clearance to the Cannulated Screw Internal Fixation System. This clearance further expands the offering of Cannulated Screws for Centric Medical, to be used in Foot & Ankle reconstruction procedures.

“I am excited to add another cannulated screw option to our rapidly growing foot and ankle portfolio. This addition has allowed for a more robust offering for distal extremity procedures including reconstruction, joint fusion, osteotomies, fracture repair, arthrodesis and fracture fixation,” said Mariusz Knap, Vice President of Marketing and Business Development for Life Spine. “The system is extremely easy to use, low profile and offers partially and fully threaded options. I am incredibly proud that Centric Medical saw five 510K clearances in 2017 and I think a full cannulated screw selection is an integral step to a complete foot and ankle portfolio.”

The Cannulated Screw Internal Fixation System is a streamlined multi-component system comprised of titanium alloy, with a wide variety of diameters and lengths. The new options, which are specifically indicated for the forefoot, come in 2.0, 2.5, and 3.0mm diameters with headed and headless designs. This system complements the previously FDA cleared range of 3.5-7.5mm diameters indicated for the midfoot and hindfoot which also offer designs with and without a head.

About Centric Medical

Centric Medical is dedicated to improving the quality of life for patients with distal extremity symptomatology, increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Centric Medical, which is privately held, is based in Huntley, Illinois. For more information, please visit:


Centric Medical
Mr. Omar Faruqi
Chief Financial Officer

Orthocell Secures New Patent for Suture-Less Repair of Soft Tissue

January 17, 2018

PERTH, Australia–(BUSINESS WIRE)–Regenerative medicine company Orthocell Limited (ASX:OCC, “Orthocell” or the “Company”) is pleased to announce it has been granted a further Australian patent for its CelGro® collagen medical device platform for soft tissue regeneration and repair applications. The patent entitled “Suture-less repair of soft tissue” provides additional important intellectual property to protect the CelGro® product platform.

Orthocell Managing Director Paul Anderson said: “This is an important addition to our current global IP portfolio. Not only does it further strengthen our IP position in regenerative medicine products and surgical techniques for soft tissue repair, but it also acts to validate CelGro® as a collagen medical device platform, for use across multiple indications including bone, tendons, peripheral nerves and aid in the repair of spinal cord injuries. This comes at a perfect time for the company as we move our products through the registration processes in the US.”

The patent has an expiry date of 12 October 2035. This is the first patent granted in the suture-less repair of tissue patent family. Further patent applications are in progress in all major jurisdictions including US, EU and Japan.

Suture-less repair of soft tissue refers to the method of repairing damaged soft tissue without the use of stitches. Suture-less repair has the potential to greatly improve the efficiency and efficacy of surgical procedures by simplifying techniques, reducing surgery time and reducing the risk of additional trauma to soft tissue through the use of sutures. Therefore, Orthocell’s patented method of suture-less repair provides surgeons with an alternative to direct suture repair of soft tissue defects within tendons, ligaments and nerves.

For example, in the US alone, over 20 million people suffer from peripheral nerve injury as a result of motor vehicle, sporting or work related incidents every year, at an annual cost of approximately US$150 billion. Many of these injuries require surgical nerve reconstruction involving the use of collagen conduits that are secured in place using sutures. To address the disadvantages of suturing, Orthocell developed the CelGro® collagen medical device platform with handling characteristics to assist surgeons in performing complex reconstructive surgical procedures and enabling the suture-less repair of soft tissue defects.

CelGro®’s nerve addressable market is estimated to be worth more than US$1.1 billion per annum, with approximately 700,000 procedures that could utilise CelGro® completed each year. Market growth is expected to be underpinned by the surgeons’ preference for quality and functional bio-absorbable membranes. The company believes CelGro® represents a breakthrough in soft tissue reconstruction and offers significant global commercial potential in its existing addressable markets of bone, tendon, nerve and cartilage as well as much wider applications in general surgical and soft tissue reconstructive applications.

About CelGro®

CelGro® is a collagen medical device platform for soft tissue regeneration and repair applications manufactured by Orthocell at its quality controlled Good Manufacturing Practices (GMP) licensed facility in WA.

Orthocell has received market authorisation (CE Mark) of CelGro® collagen scaffold medical device in the EU for dental bone and soft tissue applications. The CE Mark allows CelGro® to be sold within EU countries, validates CelGro®’s quality manufacturing and product performance, and provides a strong foundation for indication expansion and regulatory approvals.

CelGro® has been shown to improve tissue in-growth and repair in clinical studies using the collagen medical device to augment repair of the rotator cuff tendon within the shoulder, to guide bone regeneration within the jaw and to assist in the rejoining of severed, or damaged peripheral nerves. CelGro® is a customisable collagen medical device with numerous competitive advantages over existing synthetic and biologic tissue repair devices, particularly in the areas of cell compatibility, tensile strength and the promotion of quality tissue in growth and repair.

Medical scaffolds are analogous to construction scaffolds in that they provide integral support to the soft tissue whilst it undergoes repair.


General enquiries
Orthocell Limited
Paul Anderson, +61 8 9360 2888
Managing Director
Investor enquiries
Vesparum Capital
Joel Seah, +61 3 8582 4800
Media enquiries
WE Buchan
Ben Walsh, +61 411 520 012

Molecular Matrix, Inc. Receives a 510K Clearance for its Revolutionary Bone Graft Substitute Technology, Osteo-P™

Molecular Matrix, Inc (MMI) today announced the FDA clearance (510k) of Osteo-P™, a value-driven, effective musculoskeletal solution for bone regeneration.

The Osteo-P™ bone graft substitute is a non-mineralized, synthetic bone void filler made of a hyper-crosslinked carbohydrate polymer (HCCP). It is highly porous, biocompatible, biodegradable, and has shown exceptional capabilities of bone repair.

The polymer technology offers several advantages over current bone graft substitutes, including exceptional bone formation and implant resorption, real-time fusion monitoring, and the ability to hold a suture.

Based on proprietary research, Osteo-P™ is intended for the filling of bone defects created surgically or through traumatic injury. When placed or gently packed into bone voids, Osteo-P™ supports and guides the ingrowth of new bone across the graft site, after which it is resorbed and replaced by newly formed bone during the healing process.

“Osteo-P™ provides an optimal microenvironment for infiltration of bone precursors such as osteoblasts that have been known to play a key role in bone regeneration,” says Molecular Matrix founder and CEO Charles Lee, PhD. “This microenvironment includes a significant surface area that allows the flow of fluids and metabolites, leading to the formation of healthy bone.”

The product is available in large pore granules, sheets, cubes, wedges and cylinders offering greater application, flexibility, and excellent handling characteristics. Additionally, customized products are routinely manufactured for collaborative research projects and may be useful for complex anatomic defects.

“The compressibility and tensile strength of Osteo-P™ allows the scaffold to be gently packed in to fill a void.” says Kee D. Kim, MD, Professor of Neurological Surgery and Co-Director of the University of California Davis Health, Spine Center. “The degradation profile, in conjunction with host bone regeneration, results in the formation of the patient’s own healthy bone.”

Osteo-P™ is intended for single patient use only, and is provided in a one-time use, with double sterile packaging. It is not indicated for use as a structural support in load bearing applications. The technology is delivered in a ready to use sterile package, and stores at room temperature. Additionally, Osteo-P™ is not subject to degradation through hydrolysis, making shipping logistics more convenient.

“The Osteo-P™ bone void filler provides cutting edge technology for our sales channels, offering significant advantages over other bone void fillers in the market today. In addition, this technology platform ensures Molecular Matrix will continue to develop this technology for multiple other tissue regeneration initiatives and other specific clinical applications” states Jim Keefer, COO of Molecular Matrix. “We are all very excited about our future, and expect significant market penetration over the coming months and years.”

Molecular Matrix’s HCCP technology provides a broad platform for tissue engineering in the orthopedic disciplines. Its HCCP has been shown to be effective for bone regeneration, evidenced by bone precursor cell activities. The technology will bring advancements in orthopedics, spine, trauma, and dental applications with superior bone regeneration products.

About Molecular Matrix

MMI has assembled a strong management team and Board of Directors (BOD) and believes that the quality and experience of the group is a critical factor to the success of the Company. MMI’s management team and BOD have over 75 years of experience in research and development, spine and biologics, and commercialization of new technologies.

EIT Emerging Implant Technology announces first FDA multilevel approval for their 3D printed cervical cage

Emerging Implant Technologies GmbH (EIT), a German medical device manufacturer exclusively focused on creating innovative 3D printed titanium implants for spinal applications today announced the U.S. Food and Drug Administration (FDA) clearance of the expansion of the label of their EIT Cellular Titanium® Cervical Cage to be used in multiple contiguous cervical levels (C2 to T1).

EIT Cellular Titanium® is a 3D printed porous titanium structure that has been designed according to scientific insights on ideal pore shape and size to optimize cell proliferation and bone ingrowth. The anatomical design of the EIT cervical cage assists the surgical and biomechanical challenges of cervical multi-level fusion by adapted to maximized vertebral endplate contact and sagittal balance restoration.

The fusion potential of the implants is supported by EIT’s proprietary 3D process including post-printing etching procedures, allowing for unique porous structures that are impossible to manufacture with traditional manufacturing techniques. “This is another important regulatory milestone for EIT,” said Guntmar Eisen, Founder and CEO of EIT. “Only very few cervical cages are approved for multilevel use and we are poised to quickly enter the US market with the most advanced technology and state of the art FDA labeling and compliance.”

This marks the first multi-level 3D printed cervical cage to enter the US market. The EIT cervical cage is to be used with supplemental fixation and designed for use with autogenous and/or allogenic bone graft to facilitate fusion. Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA), assisted EIT on the FDA strategy and submission. Justin Eggleton, Senior Director of Regulatory Affairs commented “this clearance represents continued synergy between FDA and the medical community. The expanded indications to multiple levels in the cervical spine facilitates improved surgeon collaboration and the ability to collect data that will strengthen the total product lifecycle, which ultimately benefits patients.”

The company’s plans to complete the current product portfolio with a lateral lumbar cage in Q2 and a fully printed lateral expanding cage in Q4. For more information about the EIT 3D platform, visit

About EIT

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

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

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

OrthoXel Announce FDA 510k and CE Mark Approval for their Orthopaedic Trauma Product the Apex Tibial Nail System

CORK, IrelandJan. 16, 2018 /PRNewswire/ — OrthoXel, an innovative new orthopaedic trauma company, pioneering the use of enhanced fracture fixation to stimulate callus formation with the goal to reduce healing time, is delighted to announce that FDA 510k clearance and European CE mark approval have been granted for their Apex Tibial Nailing System. These approvals allow commercialization of the system in the US and EU markets.

The Apex Tibial Nailing system offers surgeons the greatest range of locking options of any intramedullary nail on the market, allowing tailored patient care with a simple and intuitive surgical procedure. The Apex system’s revolutionary micromotion locking mode allows controlled axial movement with exceptional torsional stability, providing the ideal conditions for callus formation. Research shows that controlled small axial movements along the length of the bone help to accelerate healing, while twisting movements slow down healing.

The Apex system has a unique design featuring the first-ever implementation of this controlled micromotion in an intramedullary nailing platform, all with no changes to the established evidence-based reamed insertion technique. The Apex system also provides additional locking modes so the surgeon can customize the fixation to suit the needs of the patient, including: standard cross-locking, true rigid fixation with multiple proximal screw clamping to generate a substantially rigid construct, and dynamization locking with unparalleled built-in torsional stability. The state of the art reusable implantation kit allows fast and reliable nail implantation in any locking mode.

No other intramedullary nail currently on the market in the US or the EU gives surgeons the freedom to choose this ideal combination of flexibility and stability for their patients.

Pat O’ Connor CEO OrthoXel – “We are excited that the approvals in the major markets of the US and EU opens the opportunity for OrthoXel to get our devices in the hands of orthopaedic surgeons.  We look forward to identifying the best route to market for the product portfolio and rolling out the technology in the coming months.”

Professor James Harty Chief Medical Officer – “We have worked closely with the clinical research Facility in University College Cork and other agencies within the Health Service Executive (HSE), such that we are now in a position to commence implanting this unique nailing technology in patients at Cork University Hospital (CUH).  I am very excited by this implant, and we have already completed the control arm of the data analysis and look forward to publishing data in 2018.”

About OrthoXel

Founded in 2014, OrthoXel DAC is the only orthopaedic trauma company focused exclusively on improving patient outcomes through enhanced fixation to stimulate callus formation, with the aim of reducing healing time when OrthoXel intramedullary nails are implanted.

The novel Apex Tibial Nailing system is patent protected and the first technology that OrthoXel will commercialize for treatment of tibial fractures followed by a second device for femoral fractures.

For more information visit:

Press Contact:

Alanna Carty Global Marketing Manager
Tel: +353 (0) 86 274 1539


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Ceterix Orthopaedics Awarded New Patent for Circumferential Suturing Method in Meniscus Repair

January 15, 2018

FREMONT, Calif.–(BUSINESS WIRE)–Ceterix® Orthopaedics today announced the issuance of a new patent related to the company’s method of placing a suture around a tear to affect a meniscus repair1, adding to the company’s already robust portfolio of issued patents.

Ceterix’s new patent further protects the company’s unique products and methods that allow surgeons to arthroscopically pass suture through soft tissue in very tight joint compartments. Specifically, the new patent covers the company’s proprietary method of arthroscopically placing a circumferential compression stitch around a tear in the knee meniscus.

The knee meniscus sits tightly between the femur and tibia, and is surrounded by critical nerves, arteries and cartilage. Using the NovoStitch®Plus Meniscal Repair System, surgeons can work within that tight compartment to place a stabilizing circumferential compression stitch around a meniscus tear.

“The circumferential compression stitch is the only meniscus repair technique that treats the femoral and tibial sides of the tear simultaneously,” said Dr. Justin Saliman, founder and chief medical officer of Ceterix. “Other methods do an inadequate job of sewing the tibial side, which can lead to healing of the femoral side only and may lead to eventual re-tearing.”

“This new patent further establishes our leadership in meniscal repair,” said John McCutcheon, president and CEO of Ceterix. “We are proud that our NovoStitch Plus Meniscal Repair System is supported by more than 180 issued claims related to its minimally invasive technology enabling orthopaedic surgeons to treat complex tears with suture patterns that were not previously possible.”

Arthroscopic surgery is a minimally-invasive procedure in which an orthopaedic surgeon treats the damaged joint through small incisions using specialized tools guided by a tiny camera called an arthroscope. Meniscus surgery is the most common arthroscopic procedure in the United States, with roughly one million performed annually.

About Ceterix Orthopaedics

Founded in 2010 with the vision of improving outcomes of arthroscopic procedures, Ceterix® Orthopaedics develops surgical tools that expand and improve what is possible for physicians who treat soft tissue joint injuries such as meniscus tears. Ceterix’s novel meniscal repair system enables surgeons to place suture patterns that were previously only possible in open procedures, or not at all. The NovoStitch Plus meniscal repair system has received 510k clearance in the United States and is indicated for approximation of soft tissue in meniscal repair procedures. The company is based in Fremont, Calif. and is backed by investors Versant Ventures, 5AM Ventures and CRG. For more information, please visit

1. U.S. Patent No.: 9,861,354


For Ceterix Orthopaedics
Jessica Volchok, 310-849-7985

FDA Clears Bone Scaffold ReBOSSIS® for New Indication

Last month, the Food and Drug Administration cleared ReBOSSIS®, the only biosynthetic bone scaffold with electrospun microfiber construction, for use in posterolateral spine procedures.

“Having ReBOSSIS® used in these types of procedures reaffirms its place in today’s biologic market,” says Doris Blake, president and COO of ORTHOReBIRTH USA, a wholly owned subsidiary of ORTHOReBIRTH Co. Ltd., which produces ReBOSSIS®. “Surgeons have been impressed with the superior handling characteristics and the clinical results produced utilizing ReBOSSIS® as one of a number of treatment modalities that support successful outcomes for their patients.”

In addition, tests performed at the Cleveland Clinic Lerner Research Institute and at the Orthopaedic Stem Cell Research Laboratory at Cedars-Sinai further validated the fact that ReBOSSIS® supports cell activation, retention, and proliferation. ReBOSSIS® also stands out from the competition with its demonstrated 54 percent compression recovery rate and optimal fit and fill—qualities that have led ReBOSSIS® to recently surpassing the 1,500-procedure milestone.

“We have been pleased with the outcomes seen with ReBOSSIS®,” says Blake, “and we are excited to witness its continued success in this new application.”


We recognize the challenges associated with orthopedic surgery—for patients, surgeons and hospitals alike. We are committed to bringing to market cutting-edge orthopedic biologics that improve patients’ quality of life and offer superior outcomes. We have carried out extensive studies on what makes biologic materials successful and have used that knowledge to engineer world-class products for use in a host of orthopedic surgical procedures. ORTHOReBIRTH USA is proud to bring premium orthopedic biologics, such as ReBOSSIS®, to surgeons practicing around the world.