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Mortise Medical Receives FDA Clearance for SyndesMetrics Syndesmosis Repair System

Posted On November 14, 2017 By OrthoSpineNews In Extremities, Regulatory, Top Stories /

LOGAN, Utah, November 14, 2017 – Mortise Medical, a start-up medical device company focused on advanced soft tissue repair systems for ankle injuries, announces that it has recently received FDA 510(k) clearance for its innovative SyndesMetricsÔ Syndesmosis Repair System.

The Mortise Medical SyndesMetricsÔ Syndesmosis Repair System was developed to address three clinical needs for syndesmotic disruption injuries: predictable and repeatable anatomic reduction, restoration of physiological motion, and restoration of ankle stability. Anatomic reduction is achieved using the SyndesMetricsÔ Reduction Clamp, which features: anatomic referencing clamp points; precision, surgeon controlled, calibrated clamping force; and an integrated drill guide to prepare the bone for the SyndesMetricsÔ implant system. Both the SyndesMetricsÔ Reduction Clamp and implant system are compatible with distal fibula plating systems. Also, the SyndesMetricsÔ implant system features minimal hardware prominence, no suture prominence and a reversible locking mechanism for securing the high strength suture tape that connects the tibial and fibular implant components.

Based on biomechanical testing on matched pair human cadaveric ankle specimens at the University of Iowa, the SyndesMetricsÔ implant system was found to more closely reproduce normal physiological ankle motion when compared to a 4.5mm cortical screw or a suture button construct.¹ Additionally, mechanical testing conducted by a third party medical device testing company demonstrated that SyndesMetricsÔ repair constructs had higher static strength and higher fatigue strength than 3.5mm cortical screw or suture button repair constructs.²

“Surgeons will find this innovative system more intuitive to use and more reproducible for positioning and tensioning the distal tibiofibular syndesmosis than anything we now have available,” states Dr. Charles L. Saltzman, Professor and Chairman of Orthopaedics at the University of Utah and immediate past President of the International Federation of Foot and Ankle Societies.

Mortise Medical is a medical device company incubated and operated by Surgical Frontiers.

¹ Goetz JE, et al., Annual Meeting of the American Society of Biomechanics, 2017

² Data on file

About Surgical Frontiers

Surgical Frontiers funds, launches and operates start-up companies to develop 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.

Contacts:

Mr. Wade Fallin

CEO

wade@surgicalfrontiers.com

www.surgicalfrontiers.com

800-230-3710

OrthoPediatrics Corp. to Start Distributing Bioretec Devices via Private Label

Posted On November 13, 2017 By OrthoSpineNews In Biologics, Extremities, Sports Medicine, Top Stories /

WARSAW, Ind., Nov. 13, 2017 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (“OrthoPediatrics”) (NASDAQ:KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, and Bioretec Ltd. (“Bioretec”), announced today that they have amended their existing distribution agreement in order for OrthoPediatrics to market and sell Bioretec’s unique, bioresorbable orthopaedic bone and soft-tissue fixation implants under the OrthoPediatrics brand, TorqLoc™. Bioretec’s bioresorbable implants are ideal for repairing musculoskeletal defects of children and young people. Treatment of musculoskeletal defects and trauma related bone and soft-tissue injuries are steadily increasing, as well as the need for surgeries related to treating such conditions. Bioretec’s fully bioresorbable implants have shown excellent results in repairing the growing bones of children and young people.

“We are excited to start OrthoPediatrics’ private label collaboration, whose enthusiasm towards developing and improving surgical care for children, we admire. Our products are ideal for surgeries of children, since the bioresorption of our implants eliminates the need for secondary removal operation after the healing of musculoskeletal tissues. This is especially important with children, for whom the risks and inconveniences associated with surgical procedures are much higher,” commented Tomi Numminen, CEO of Bioretec.

OrthoPediatrics’ Vice President for Trauma & Deformity Correction, Joe Hauser, added, “This evolving strategic partnership and collaboration with Bioretec represents another area for tremendous growth within OrthoPediatrics’ portfolio. The TorqLoc™ screw portfolio will provide a truly innovative option for many unmet pediatric orthopedic sports and tissue repair surgical needs. In addition to OrthoPediatrics’ all epiphyseal ACL system, we now can help our surgeon partners with MPFL, foot, shoulder, and hand solutions by providing this new generation bioabsorbable implant offering.”

About Bioretec
Bioretec Ltd. is a Finnish material technology company focused on the development, manufacturing and marketing of bioabsorbable, bioactive and drug-releasing surgical implants for orthopedic, trauma and sport medicine surgeries. Bioretec implants, designed and manufactured in Finland, have been used in 33 countries, including United States, China, Russia, UK, Germany, Italy and Spain.

About OrthoPediatrics Corp.
Founded in 2006, OrthoPediatrics is the only diversified orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market. OrthoPediatrics is dedicated to the cause of improving the lives of children with orthopedic conditions. OrthoPediatrics currently markets 22 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma & deformity, complex spine and ACL reconstruction procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and 35 countries outside the United States.

Investor Contact
The Ruth Group
Zack Kubow
(646) 536-7020
zkubow@theruthgroup.com

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Extremity Reconstruction Market is evolving at fast pace

Posted On November 13, 2017 By OrthoSpineNews In Extremities, Top Stories /

11-13-20017 / Health & Medicine, Press Release from: TMR Research

Extremity reconstruction implies the restoration of limbs and limb functions to patients who have suffered the removal of limbs due to trauma or medical removal after cancer or other issues. This also includes limb removal after vascular diseases, metabolic diseases, infections, or rheumatoid arthritis. Lower extremity reconstruction involves three key segments based on the location of the wound, into knees, feet, and the tibia bone. Extremity reconstruction can allow for a high level of restoration of mobility and lifestyle to patients. Owing to the increasing counts of patients suffering from cancers, chronic diseases, and accident related injuries that result in the removal of extremities, it is becoming increasingly important for developments in this field to take up greater investments from the healthcare industry.

Request a sample copy of the Report @ www.tmrresearch.com/sample/sample?flag=B&rep_id=1175

Plastic surgeons can also make use of flaps or skin grafts to hide the wounds on extremities, giving patients a significantly faster recovery rate into daily life and a normal lifestyle. Nearly all types of extremity reconstruction surgeries will require the use of general anesthesia. Additional care is also needed from the patient’s side post-surgery. For example, they are expected to follow s stricter diet for the speedy recovery of limbs. Smokers are especially encouraged to quit in order to prevent deterioration of wound and to normalize the overall healing rate.

Global Extremity Reconstruction Market : Snapshot

The global market for extremity reconstruction is expected to witness a high level of growth in the next few years. The rising number of cases of abnormalities and injuries in the lower and upper extremity of the human body is one of the vital factors estimated to encourage the growth of the global market in the coming years. In addition, several advancements in the healthcare infrastructure are anticipated to accelerate the development of the market in the near future. The implant devices for different parts of the human body comprises the extremity reconstruction market in the coming years.

A tremendous rise in the geriatric population and the rising incidences of obesity and diabetes are some of the major factors that are estimated to fuel the development of the global extremity reconstruction market in the near future. Moreover, the increasing cases of osteoarthritis and rheumatoid are likely to accelerate the growth of the market in the coming years. The rising awareness regarding the benefits of small joint reconstruction implants among patients is predicted to encourage the growth of the global extremity reconstruction market in the next few years.

Request TOC of the report @ www.tmrresearch.com/sample/sample?flag=T&rep_id=1175

Technological advancements and the availability of required infrastructure are projected to augment extremity reconstruction market in North America market in the next few years. The leading players operating in the extremity reconstruction market across the globe are emphasizing on introducing innovative implants in order to attract a large number of consumers and attain a leading position in the market. Additionally, the rising level of competition is predicted to expand the product portfolio and benefit the patients in the coming years.

Global Extremity Reconstruction Market: Overview

The increasing incidence of injuries, abnormalities, and congenital defects in the upper or lower extremity of human body has fuelled the demand for reconstructive surgical procedures. Implant devices for the shoulder, wrist, ankle joints, digits, elbow, and foot are part of the extremity reconstruction market.

The primary driver of the global extremity reconstruction market is the large pool of geriatric population. According to the Centers of Disease Control and Prevention, with a rise in the geriatric population in the U.S., by the year 2040, the number of patients affected by arthritis is expected to increase to 78 million. Since aged people are more prone to injuries, growth in geriatric population is expected to fuel the demand for reconstructive surgical procedures.

Global Extremity Reconstruction Market: Key Trends

The rising incidence of joint disorders such as rheumatoid and osteoarthritis arthritis, coupled with the globally increasing incidence of diabetes and obesity, and rising geriatric population are driving the global extremity reconstruction market. Moreover, growing awareness among patients about the advantages of small joint reconstruction implants and enhanced technology such as development of reverse shoulder implants, stem less shoulder implants, and ankle reconstruction implants, which aid in recovering ankle mobility are projected to boost the market. The zest to get back to the active lifestyle, post-injury or trauma will supplement the demand for extremity reconstruction surgeries.

Read Comprehensive Overview of Report @ www.tmrresearch.com/extremity-reconstruction-market

On the downside, complications associated with extremity reconstruction surgeries and unfavorable reimbursement scenario will pose as threat to the global extremity reconstruction market.

Global Extremity Reconstruction Market: Market Potential

The global market for extremity reconstruction surgeries is evolving at fast pace. 3D implants are fast gaining traction among arthritis patients. It helps in better motion, it is less painful, and results in quick recovery. Various market giants have largely invested in this technology, to hold their position over the forecast period.

In February 2016, Zimmer Biomet received the US FDA approval for its 3D printed ankle fusion system. Similarly, in 2015 Stryker added 3D printed patellas and tibial baseplates to their Triathlon Tritanium Cone Augments and Triathlon Tritanium Knee System, which are used in knee surgeries. The company also has plans to build 3D manufacturing facility with investment of around US$ 400 mn.

Recently, a shoulder hemiarthroplasty or a shoulder replacement surgery was successfully carried out in Gandhi Hospital. This is a first-of-its-kind surgery performed by the doctors of the state-run hospital. Shoulder arthroplasty is a fast evolving field of orthopedics concentrated on treating specific, painful ailments of the gleno humeral articulation.

Global Extremity Reconstruction Market: Regional Outlook

The region to hold a leading share of the market is North America, and is expected to grow at a strong rate during the forecast period. Increased awareness regarding the benefits of extremity reconstruction devices, rise in occurrence of joint disorders, coupled with escalating geriatric population, encouraging reimbursement rates, presence of innovative technologies, and quest for better quality of life are the factors fuelling the demand for reconstruction procedures in this region.

During the forecast period, Asia Pacific is forecast to emerge as a lucrative market for extremity reconstruction. The rate of growth can be attributed to increase in acceptance of advanced technologies, presence of ample growth opportunities for the treatment of small joint disorders, and rise in awareness about the advantages of extremity reconstruction surgeries.

Global Extremity Reconstruction Market: Competitive Analysis

Some of the leading players operating in the global extremity reconstruction market are Arthrex, Inc., DePuy Synthes, Integra Lifesciences Holdings Corporation, Acumed, Inc., CONMED Corporation, Stryker Corporation, Zimmer Biomet Holdings, Inc., Wright Medical Group N.V., Smith & Nephew plc, and Skeletal Dynamics LLC.

The key market participants are bringing out innovative implants, which are wear and corrosion resistant to gain a stronghold in the market. Established players to boost clinical outcomes are making improvements in reconstruction procedures.

About Us:
TMR Research is a premier provider of customized market research and consulting services to business entities keen on succeeding in today’s supercharged economic climate. Armed with an experienced, dedicated, and dynamic team of analysts, we are redefining the way our clients’ conduct business by providing them with authoritative and trusted research studies in tune with the latest methodologies and market trends.

This release was published on openPR.

Arthrex Announces Plans for Expansion of Global Headquarters

Posted On November 10, 2017 By OrthoSpineNews In Extremities, Top Stories /

NAPLES, FL – November 9, 2017 – Arthrex announced details of its planned expansion for its North Naples global headquarters on Thursday in an event with Florida Governor Rick Scott and other state and local elected officials.

Construction is scheduled to begin next month with completion by the end of 2019.

“As Arthrex continues to experience unprecedented growth around the world, we remain committed to expanding in Southwest Florida,” said President and Founder Reinhold Schmieding. “This project was designed to accommodate our growth into the next decade, while maintaining the beautiful aesthetic of the Naples community.”

The project will demolish the Arthrex Manufacturing Inc. North building, located at 1250 Creekside Way, just east of the post office. Two grey office buildings located along Goodlette Road will also be demolished for the project.

Arthrex will construct three facilities for the project. The Arthrex Event and Administration Building will be a six-story, 300,000-square-foot modern office building with meeting space and will include a 15,000-square-foot cafeteria, a six-story parking garage with space for 1,400 vehicles and an outdoor terrace area overlooking a one-acre lake.

The INNovation Hotel, which will be located on the corner of Goodlette Road and Creekside Boulevard, will accommodate Arthrex guests and business travelers. The four-story, 170,000-square-foot full-service hotel will have approximately 160 rooms.

The third building, the Arthrex Wellness and Medical Center, will be located on the current site of the two office buildings along Goodlette Road. The two-story, 38,000-square-foot building will have a fitness center for employees with state-of-the-art equipment and group classes such as spinning and yoga. The building will also have a juice bar and lounge, a retail shop with Arthrex apparel and merchandise, and will be home to the Arthrex Medical Center, which provides free medical care to Arthrex employees and their families.

The campus expansion also includes a road project that will close the mid-section of Creekside Boulevard to create a university-style campus with abundant green space, interconnected walking and bicycle paths, a three-acre outdoor park area with a 1,000-square-foot pavilion for outdoor events and other activities.

Arthrex Boulevard, which is the street that runs between the post office and the Naples Daily News, will become the main entrance to Arthrex’s global headquarters and will undergo a renovation to expand the two-way street to include a median.

The expansion project is expected to create 560 jobs by 2021 and approximately 1,200 construction-related jobs through 2019.

About Arthrex

Arthrex Inc., headquartered in Naples, FL, is a global leader in orthopedic product development and medical education for orthopedic surgeons. More than 11,000 products for arthroscopic and minimally invasive orthopedic surgical procedures have been developed by Arthrex and are currently marketed worldwide. For more information, visit www.Arthrex.com.

DT MedTech Announces 510(k) FDA Clearance for Hintermann Series H2™ Total Ankle Replacement System

Posted On November 10, 2017 By OrthoSpineNews In Extremities, Regulatory /

BALTIMORE, Nov. 8, 2017 /PRNewswire/ — DT MedTech, LLC (DTM) today announced that the Hintermann Series H2™ Total Ankle Replacement System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

The Hintermann Series H2™ is a semi-constrained, total ankle replacement prosthesis developed by Prof. Beat Hintermann, a world-renowned foot and ankle surgeon based in Liestal, Switzerland. The Hintermann Series H2™ Total Ankle Replacement System is indicated for use with bone cement to treat ankle arthritis in either primary or revision surgery of ankle joints damaged by systemic arthritis of the ankle (e.g., rheumatoid arthritis, hemochromatosis), primary arthritis (e.g., degenerative disease), and secondary arthritis (e.g., post-traumatic, avascular necrosis). The Hintermann Series H2™ is also indicated for patients with a failed total ankle replacement or non-union/mal-union of the ankle arthrodesis, provided that sufficient bone stock is present. The Intellectual Property of the Hintermann Series H2™ is protected by numerous patents with additional patents pending.

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

David Reicher, President and Chief Executive Officer of DTM, stated, “We are extremely pleased to receive marketing clearance from the FDA for our innovative Hintermann Series H2™ Total Ankle Replacement System. I want to thank our employees, M Squared Associates and other advisors, and key stakeholders, who were all so instrumental in helping DT MedTech achieve this momentous milestone.”

DTM continues to market and distribute its Hintermann Series H3™ mobile-bearing Total Ankle Replacement System outside of the United States in over 30 countries. The Hintermann Series H3™ is a substantiated leader for the international ankle replacement market with more than 17 years of proven clinical efficacy outside of the United States.

Prof. Beat Hintermann, developer of the Hintermann Series™ Total Ankle Systems, stated, “I am looking forward to adding the H2 as a semi-constrained option for my patients alongside the H3* mobile-bearing prosthesis. With the addition of the new H2 prosthesis, I will be able to expand my indications and patient selection for total ankle replacements.”

DTM anticipates a limited release of the Hintermann Series H2™ in early December 2017 outside the United States, as it has already received the CE mark for the device, along with registrations in many additional key markets. DTM will be focusing on training, sales, and distribution of the Hintermann Series H2™ in the United States markets and in markets outside the United States through DT MedTech International Limited (DTMI), DTM’s subsidiary and distribution arm located in Dublin, Ireland, in the upcoming months.

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

About DT MedTech, LLC

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

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

SOURCE DT MedTech, LLC

Paragon 28® Increases its Robust Ankle Fracture Offering – Gorilla® Ankle Fracture Plating System – Hook Plating System Launched

Posted On November 3, 2017 By OrthoSpineNews In Extremities /

ENGLEWOOD, Colo., Nov. 2, 2017 /PRNewswire/ — Since its inception, Paragon 28 has obsessed over every aspect of foot and ankle surgery. Committed to creating tailored solutions to improve surgical outcomes, Paragon 28 has launched innovative products and instrumentation that help to streamline procedures, allow surgeons flexibility in technique and approach and facilitate reproducible results benefitting both the surgeon and patient.

Today Paragon 28 increases its robust foot and ankle specific portfolio even further with the addition of Hook Plates to the Gorilla® Ankle Fracture Plating System. The Gorilla® Ankle Fracture Plating System now offers surgeons 52 total plates in ten families. The Hook Plates are offered across three families and provide surgeons eight unique options to address fractures of the tibia and fibula with a hook plate design.

Paragon 28 Gorilla® Ankle Fracture Plating System – Hook Plates

All plates are 1.5mm thick and have a proximal and distal taper to assist in percutaneous insertion
All plates have chamfered edges to minimize soft tissue irritation
All plates accept 2.7, 3.5, and 4.2 mm locking and non-locking polyaxial screws

Straight Fibular Hook Plates

Available in 5 and 6 hole configurations
Hooks optimized to address comminuted lateral malleolus or avulsion fragments

Anatomic Fibular Hook Plates

Available in 5 and 6 hole right and left side specific configurations
Distal screw cluster allows for an interfrag screw to be placed through the hooks to provide support and additional fixation to distal fragment of the lateral malleolus

Medial Malleolus Hook Plates

Available in 2 and 4 hole plate configurations
Intended for fixation of comminuted or small fractures of the medial malleolus that may not be conducive to lag screw fixation

Case Specific Instrumentation

Single and Double Hook Plate Tamps
- May be used to assist in initial plate placement, biasing of the plate (Single Plate Tamp), and seating of hook into distal aspect of fragment
Hook Screw Drill Guide
- May be used with the Anatomic Fibular Hook Plates to aid in centering a screw between the hooks and distal plate screws
- Placement of this screw through the hooks is intended to prevent distal fragment rotation and provide additional stability to the construct

Paragon 28 is grateful for the significant contributions Dr. Christopher Zingas, MD, Dr. John Kwon, MD and Dr. Michael Houghton, MD made as the surgeon designers of this system.

Product Page:
http://www.paragon28.com/products/ankle-fracture-plating-system/

CONTACT: Jim Edson, Director of Product Management and Marketing, jedson@paragon28.com

SOURCE Paragon 28

Corin Group acquire Belgium & Luxemburg large joint business unit of MBA NV

Posted On October 19, 2017 By OrthoSpineNews In Extremities, Recon, Spine, Top Stories /

18 October 2017

Corin Group, after the successful acquisition of the Tornier Hip and Knee business is announcing a further European expansion by acquiring the large joint business unit of MBA Belgium & Luxemburg NV.

Over the last 7 years MBA has successfully distributed the Corin portfolio. The team have gone from strength to strength, expanding and developing solid collaborative relationships with key surgeons throughout the countries. The combination of Corin technologies and the MBA team’s passion for orthopaedics will deliver greater value to the Belgium and Luxemburg Orthopaedic community.

Stefano Alfonsi, Chief Executive Officer of Corin commented “With MBA’s, responsive service and solid working relationships they are well placed to engage their attentive audience with Corin’s world leading innovative technologies. We are delighted to welcome the team who are transitioning to Corin from MBA and look forward to building an even stronger surgeon focused organisation.”

Paul Griffin, International Business Director, MBA, commented, “Building on MBA’s success in Belgium & Luxemburg in the recent past, Corin’s involvement will streamline the representation from MBA and Tornier to a single Corin entity, simplifying the customer experience, and enabling more surgeons to engage with Corin’s Ecosystem of ground breaking technologies’.”

About Corin

Since its inception, Corin has led the way in orthopaedic innovation — providing a faster, positive and more assured return to quality of life for people all over the world. Today, as a dynamic, growing, global business, Corin’s approach is revolutionising orthopaedics.

We offer a unique combination of clinically-proven hip, knee, ankle and shoulder solutions and world-leading technologies that enable patients, surgeons and healthcare providers to connect more closely than ever.

The deep insight we gain, understand and share at every stage of the connected orthopaedic experience leads to advanced, patient-specific solutions that exceed expectations, maximise value in healthcare and positively impact lives.

About MBA

MBA is a leading company in the European medical and surgical technology field. Our objective is to create value for the specialist through technology, service and sharing knowledge.

MBA currently has two divisions:

MBA

The Company began by specialising in providing complete solutions for Orthopaedic and Neurosurgeons via a full range of product lines for the following specialities:

Knee
Hip
Shoulder
Other joints: Elbow, Hand, Wrist, Foot and Ankle.
Tumour and Extremity Reconstruction
Biomaterials
Spine
Trauma

BIOSER

This Division provides solutions for nine surgical specialties: Anaesthesiology, General Surgery, Cardiovascular Surgery, Thoracic surgery, Urology, Gynaecology, Obstetrics, ENT, Plastic Surgery and Emergency Medicine.

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Arthrex Announces Plans for New Surgical Device Manufacturing Facility

Posted On October 18, 2017 By OrthoSpineNews In Extremities, Top Stories /

NAPLES, FL – October 16, 2017 – Arthrex announced plans Monday to build a state-of-the-art surgical device and implant manufacturing facility in Anderson County, South Carolina.

Construction on the $30 million, 200,000-square-foot facility is scheduled to begin in the first quarter of 2018 with completion by early 2019.

“This investment is part of Arthrex’s global expansion plan to support the growth and development of new and innovative products that help surgeons treat their patients better,” said Andy Owen, Arthrex Vice President of Manufacturing. “It also represents our continued commitment to manufacturing quality products in the United States.”

The Anderson facility will be Arthrex’s fourth U.S.-based manufacturing facility. The others are located in Ave Maria, FL, Santa Barbara, CA and City of Industry, CA.

Arthrex plans to work with Tri-County Technical College in Anderson to develop a strong pipeline of qualified manufacturing personnel, utilizing their in-depth programs and long-standing relationships with institutions like Clemson University that are dedicated to supporting the manufacturing industry.

“Arthrex is pleased to bring its innovative spirit and unique culture to South Carolina and we look forward to leveraging the outstanding work done in the area to prepare future employees for high-level manufacturing jobs,” Owen said.

The construction of the Anderson facility will not affect operations or employees in Southwest Florida or California, and Owen reiterated that Arthrex is committed to its future growth, job creation and investment in Southwest Florida. This includes a significant expansion project at its corporate headquarters in North Naples scheduled to begin in the first quarter of 2018, as well as partnering with community leaders to develop advanced manufacturing training programs in Collier County.

About Arthrex

Category: Corporate Press Releases

Anika Announces Regulatory Approval for MONOVISC® in Australia

Posted On October 16, 2017 By OrthoSpineNews In Extremities, Regulatory /

October 16, 2017

BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedics medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, today announced that regulatory authorities in Australia granted approval to MONOVISC^®, Anika’s single injection viscosupplement for the treatment of pain associated with osteoarthritis of all synovial joints, including the hip and knee. MONOVISC is commercially available in over twenty countries, including the United States, Canada, and various European countries. MONOVISC also recently received approval in the Asia-Pacific countries of India and Taiwan. Anika intends to further expand MONOVISC into additional international markets in 2018.

“The Asia-Pacific region presents an important growth opportunity for our global orthobiologics franchise, and we’re excited to bring MONOVISC to patients in Australia and New Zealand,” said Charles H. Sherwood, Ph.D., Chief Executive Officer of Anika Therapeutics. “With this approval, MONOVISC is poised to become the most widely available single-injection viscosupplement in the world and will be a key driver in growing global market share.”

The global expansion of MONOVISC is an important international orthobiologics revenue driver for Anika, and Australia and New Zealand represent a large and growing market opportunity. Anika has a multi-year, exclusive distribution agreement with Surgical Specialties Pty. Ltd. to market MONOVISC in Australia and New Zealand. Established in 2006, Surgical Specialties is an independent distributor of innovative medical devices, with a team of over 70 people in sales offices throughout Australia and New Zealand. Surgical Specialties is an ideal partner for Anika with its established relationships with leading orthopaedic surgeons and sports physicians, a successful track record, and a highly skilled and dedicated national sales force.

About MONOVISC

MONOVISC is Anika’s next-generation HA-based therapy for treating osteoarthritis that features enhanced durability in a safe, easy-to-use, single injection regimen. MONOVISC is made from highly purified, non-animal, natural hyaluronan. Hyaluronan occurs naturally throughout the body, especially in articular cartilage, synovial fluid in joints and in the skin. For more information about MONOVISC, please visit www.monovisc.com.

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 cartilage 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.

Forward-Looking Statements

The statements made in the last sentences of the first and second paragraphs and first sentence of the third paragraph of this press release, which are not statements of historical fact, are 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. These statements include, but are not limited to, those relating to the Company’s international expansion plans for MONOVISC, the market for the Company’s products in foreign countries, including Australia and New Zealand, and the status of MONOVISC as a global revenue driver for the Company. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks, uncertainties, and other factors. The Company’s actual results could differ materially from any anticipated future results, performance, or achievements described in the forward-looking statements as a result of a number of factors including, but not limited to, (i) the Company’s ability to successfully commence and/or complete clinical trials of its products on a timely basis or at all; (ii) the Company’s ability to obtain pre-clinical or clinical data to support domestic and international pre-market approval applications, 510(k) applications, or new drug applications, or to timely file and receive FDA or other regulatory approvals or clearances of its products; (iii) that such approvals will not be obtained in a timely manner or without the need for additional clinical trials, other testing or regulatory submissions, as applicable; (iv) the Company’s research and product development efforts and their relative success, including whether we have any meaningful sales of any new products resulting from such efforts; (v) the cost effectiveness and efficiency of the Company’s clinical studies, manufacturing operations, and production planning; (vi) the strength of the economies in which the Company operates or will be operating, as well as the political stability of any of those geographic areas; (vii) future determinations by the Company to allocate resources to products and in directions not presently contemplated; (viii) the Company’s ability to successfully commercialize its products, in the U.S. and abroad; (ix) the Company’s ability to provide an adequate and timely supply of its products to its customers; and (x) the Company’s ability to achieve its growth targets. Additional factors and risks are described in the Company’s periodic reports filed with the Securities and Exchange Commission, and they are available on the SEC’s website at www.sec.gov. Forward-looking statements are made based on information available to the Company on the date of this press release, and the Company assumes no obligation to update the information contained in this press release.

Contacts

For Investor Inquiries:
Anika Therapeutics, Inc.
Sylvia Cheung, 781-457-9000
Chief Financial Officer
or
For Media Inquiries:
Pure Communications
Sonal Vasudev, 917-523-1418
sonal@purecommunicationsinc.com

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The Big Squeeze – Reps are ditching Big Ortho bags to build their own. Why it’s happening, and how to be successful.

Posted On October 13, 2017 By OrthoSpineNews In Extremities, Recon, Spine, Top Stories /

Published on October 11, 2017/ By Drue DeAngelis, Executive Search in Ortho Spine Industry

I have seen a lot of tenured ortho sales people leave the comfort of “Big Ortho” and take on the role of Distributor or rep for much smaller start-ups. I want to deconstruct the forces driving this change and the dynamics between all the players. Then, we will explore what drives the variability in results of this new model. Finally, I will leave you with some ideas on how you can become a high caliber distributor prepared to thrive in a new role.

Big Ortho vs The Rep

As pricing pressures continue to push profits down, manufacturers are looking for more ways to improve their bottom line. As referenced in my previous article The Unsung Hero of the Orthopedic Industry – The Rep, the distributors and reps bear the brunt of much of the pricing compression. It seems as though the easy target for the squeezing is the one furthest from the boardroom – the Sales Reps and Distributors.

We have seen large companies’ commission rates fall well below 20%. At the same time, ASP’s (Average Selling Prices) continue to fall with corporate negotiated hospital or GPO contracts. The result is an inverse relationship where reps have to do more cases to make the same amount of money as last year. Increasing business 20-30% is a more difficult challenge than ever before due to increased consolidation and competition in the marketplace.

We are left with a dynamic where Small Ortho can capitalize on the inverse relationship Big Ortho reps face. By offering significantly higher commission and the ability to be their own boss, small ortho is attracting experienced representation that can leverage established relationships and navigate familiar approval processes.

“The days of only courting your surgeons and hospitals is passing away along with paper-only records and whiteboard logistics.The Ortho Startup & The Rep”

The orthopedic start up market continues to attract venture and private equity funding as forecasts like, “OrthoBiologics market to reach $6.06B by 2022” present fertile ground. Additionally, as Big Ortho seems more comfortable investing in M&A rather than R&D, start-ups have a clear exit strategy.

As the device market matures and patents expire, new doors open for clever copycats. This phenomenon presents opportunity for smaller, more nimble competitors to gain a strategic advantage and capture business that was once securely owned by Big Ortho. Innovative technology or even just novel improvements to antiquated systems can lead to profitable acquisitions.

This is not to say it is an easy endeavor for start-ups to break into orthopedic implants. R&D, Regulatory affairs, and the rapidly evolving landscapes of hospitals and GPO requirements present evermore complex and time-consuming barriers for small companies. As with any new venture, more time translates into more money and that unknown timeline can be very detrimental to a small company. Finding representatives and distributors capable of steering through this “mine field” is a critical driver of their success.

The Challenge

The challenge for many smaller orthopedic companies is that the caliber of distributor that they are able to attract tend to be limited to a Sales Rep who decided to bail out of a larger company for the reasons described above. They require very little support or training and they can hit the ground running to achieve some success fairly quickly. But, for what these reps bring in strong relationships and technical know-how, they often lack in infrastructure and leadership experience. As a result, what the company ends up with is little more than what we call a “Super Rep” who’s sales plateau sooner than expected.

The reason most plateau quickly is that they don’t have any of the infrastructure that a seasoned distributor typically does. No one can blame them since they are essentially a rep who now enjoys the full distributor commission rather than a split. Rather than owning a business, they effectively only own a job and want to keep overhead low and profits high. This is a short-sighted solution and the distributors who are in this category are quite vulnerable. Without a team and support infrastructure, they are little more than the sum value of the surgeon relationships.

For the manufacturer, this poses a problem of scalability. If these Super Reps don’t begin to take on the responsibilities of a true distributor or agent, they will struggle to capture more geography and build a valuable and sustainable business. While it may satisfy some, manufacturers don’t see these players as long-term partners. The success of Big Ortho came from having strong, long-term partnerships with distributors and agents who invested in their businesses and built sustainable enterprises that were able to scale.

Where many of these new distributors are failing is in building a foundation of scalability and making the necessary investments into their company’s future sustainability. Setting the right foundation for success early in the scaling process is paramount. It’s not necessary to make large capital investments, but setting up the right foundation is paramount to prolonged success.

“As margins continue to tighten, operational efficiencies achieved through smarter distribution and sales will separate winners from losers.”

Data-driven Distribution

Where does one start? First, start with the basics: as a distributor, you need to have a legitimate company website if you want to be seen and prospected by companies looking for new distributors. You and I both know the surgeons and hospitals don’t give much thought to that. But, if you’re successful, M&A will eventually impact the lines you carry. Continually prospecting and being visible to companies with new technologies is a key part of remaining relevant and positioning yourself for success in your local market. Having a website enables you to project the image that you take your business seriously and are taking steps to be professional. Manufacturers want to see that you work ON your business and not merely in it.

Having a website also enables you to use an email address with your company’s name on it rather than a gmail, or worse: your AOL address. Nothing says “mom & pop” like a distributor using a internet service provider’s email address. The quality of your website is also important as it projects the image of your company. If it is too “1990’s,” people will draw the conclusion that you are still back in the dark ages and not availing yourself of the latest technologies. This can be an impediment to attracting some of the companies with newer innovations that are seeking representation. A website can be done very inexpensively and deliver the right message and image.

Another inexpensive way to differentiate your distributorship is by leveraging technology to manage your business. Using a whiteboard, Google Calendar and group text messages to manage inventory presents you as a risky proposition when it comes to companies allocating valuable assets to you. As margins continue to tighten, operational efficiencies achieved through smarter distribution and sales will separate winners from losers. Technology should impact your business in several ways: coordinate your team’s schedules, quickly schedule cases, manage day to day sales activities, track your inventory from multiple manufacturers, consolidate your manufacturer’s invoices and open PO’s. In other words, run your business in the 21st century.

While I am biased in believing our platform, Surg.io, is the best solution for reps and distributors, any electronic system is better than none. Keep in mind that manufacturers entrust a great deal of money into your hands by way of implant and instrument inventories. Your existing and future partners want to see that your utilization brings about a healthy return on investment. Nothing is more compelling than efficient infrastructure and solid data to support your request for additional inventory or even, data to support keeping the inventory you currently have. Equally, nothing more undermines your partnership with a manufacturer than inefficient use and tracking of their inventory.

Implementing one of these platforms doesn’t need to be onerous. While there is always a bit of a learning curve when starting up, once you get through the on-boarding process and everyone is using it, it will be a lifesaver. In addition to better organization and inventory utilization, using Surg.io, or a similar platform, helps you create margin in your day for more selling by streamlining all your processes. It enables you to better communicate as well as ensure that everyone is singing from the same sheet of music. If all you’re using is Google Calendar, you’re missing a whole host of features and analytics that can take your business to the next level.

Looking Ahead

As challenges continue to mount and the odds continue to stack against orthopedic distributors, only those who embrace technology and figure out how to leverage it will be able to thrive through the next 10 years of the evolution of the industry. Doing more with less will continue to be the pressure and will require a strategic approach to supply chain management. Projecting a “no tech” business to manufacturers poses a profound risk to distributors and with how easy and inexpensive as it is, seems to be a very risky proposition. The days of only courting your surgeons and hospitals is passing away along with paper-only records and whiteboard logistics.

To learn more about Surg.io and how to leverage it for growth and scalability, visit www.Surg.io and request a demo.

Extremities