Xtant Medical Announces Appointment of Interim CEO

Posted On October 15, 2018 By OrthoSpineNews In Spine /

BELGRADE, MT, Oct. 15, 2018 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE American: XTNT), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, announced today the appointment of Michael Mainelli to serve as Interim Chief Executive Officer, replacing Carl O’Connell effective October 12, 2018.

Mr. Mainelli joined the Board of Directors in February 2018 and will remain a member of the Board of Directors while serving as Interim Chief Executive Officer. The Company intends to commence a process to recruit a permanent Chief Executive Officer that will include both internal and external candidates.

Mr. Mainelli commented, “I am excited to continue working with our Board and with our management team in my new role. Xtant has great products, strong business partners, and dedicated, talented employees. We will be working hard to drive superior execution.”

Mr. Jeff Peters, Chairman of the Board, stated that “Mike is a proven leader with over 25 years of successful business leadership in the medical technology industry. He has led businesses at both public and private medical technology companies resulting in growth, operational improvement, and enhanced shareholder value. His unique experience in the global orthopaedic and spinal markets will be particularly valuable, and we are pleased to have him in this interim role.”

Mr. Mainelli succeeds Carl O’Connell, who served as Xtant’s Chief Executive Officer since October 2016. Mr. Peters added, “On behalf of the Board, I want to thank Carl O’Connell for his dedication and contributions, notably guiding the company through the recent restructuring process. We wish Carl all the best.”

About Xtant Medical Holdings, Inc.
Xtant Medical Holdings, Inc. (www.xtantmedical.com) is a global medical technology company focused on the design, development, and commercialization of a comprehensive portfolio of orthobiologics and spinal implant systems to facilitate spinal fusion in complex spine, deformity and degenerative procedures. Xtant people are dedicated and talented, operating with the highest integrity to serve our customers.

™ and ® denote trademarks and registered trademarks of Xtant Medical Holdings, Inc. or its affiliates, registered as indicated in the United States, and in other countries. All other trademarks and trade names referred to in this release are the property of their respective owners.

Important Cautions Regarding Forward-looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements that are predictive in nature, that depend upon or refer to future events or conditions, or that include words such as ‘‘expects,’’ ‘‘anticipates,’’ ‘‘intends,’’ ‘‘plans,’’ ‘‘believes,’’ ‘‘estimates,’’ “continue,” “future,” ‘‘will,’’ “can,” similar expressions or the negative thereof, and the use of future dates. The Company cautions that its forward-looking statements by their nature involve risks and uncertainties, and actual results may differ materially depending on a variety of important factors, including, among others: the Company’s future operating results and financial performance; the ability to increase revenue; the ability to remain competitive; the ability to innovate and develop new products; the effect of management changes and the ability to engage and retain qualified personnel; government and third-party coverage and reimbursement for Company products; the ability to obtain and maintain regulatory approvals; government regulations; product liability claims and other litigation to which we may be subject; product recalls and defects; timing and results of clinical studies; the ability to obtain and protect Company intellectual property and proprietary rights and operate without infringing the rights of others; the ability to service Company debt and comply with debt covenants; the ability to raise additional financing and other factors. Additional risk factors are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017 filed with the Securities and Exchange Commission (SEC) on April 2, 2018 and subsequent SEC filings by the Company, including without limitation its most recent Quarterly Report on Form 10-Q for the quarter ended June 30, 2018 filed with the SEC on August 8, 2018. Investors are encouraged to read the Company’s filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The Company undertakes no obligation to release publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. All forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by this cautionary statement.

COMPANY CONTACT
Kathie Lenzen, Chief Financial Officer
406.388.0480
klenzen@xtantmedical.com

Field Orthopaedics Forms Exclusive Partnership With Ortho Consulting Group to Launch New Micro Screw Into EMEA

Posted On October 15, 2018 By OrthoSpineNews In Extremities /

BASINGSTOKE, England, October 15, 2018 /PRNewswire/ —

Partnering with Ortho Consulting Group, Field Orthopaedics is expanding its market presence for their innovative Micro Screw System in EMEA.
The unique 1.5mm screw with a rigid cannulation is designed for small fractures in the hand.
New to EMEA market, CE registration pending.

Innovators of the Micro Screw System, Australian-based Field Orthopaedics, has signed sales expansion experts, Ortho Consulting Group, to exclusively manage and accelerate growth of their new product in EMEA.

Already established in Australia, and most recently in the US, the Micro Screw is nearly set (CE registration imminent) to break into the EMEA market for the first time. Ortho Consulting Group will take full commercial responsibility for the expansion including setting the strategic direction as well as sourcing, onboarding and managing of distributors throughout the region.

Matt Woods, Founder of Ortho Consulting Group, said: “We are delighted to be managing the EMEA region for Field Orthopaedics. Field are an innovative company with its first product offering being the Micro Screw, we are looking forward to a long partnership with Field.“

Andrew Dubowski, Head of Export, “It is very exciting to be able to offer such a small screw (1.5mm) with a cannulation that is still rigid and effective at fracture fixation. This differentiation truly offers the surgeon an excellent and elegant solution to small bone fractures. I genuinely feel it can stand out in what is a crowed space.“

Field Orthopaedics‘ CEO, Chris Jefferys, commented: “Field Orthopaedics is excited to work within the experienced team at Ortho Consulting Group and expand the Micro Screw range into EMEA. We have the full confidence in OCG‘s ability to capture the market for the Micro Screw and many more to come.”

About Field Orthopaedics

Field Orthopaedics (FO) is an Australian Orthopaedic devices company. FO is a rapidly growing company that focuses on the design and manufacturing of orthopaedic devices to address the shortcomings in the trauma, extremities and biological markets.

Currently, Field Orthopaedics has 12 projects in the entire portfolio, 6 of which are in active development expected to gain regulatory approval within the next 3 years. Field Orthopaedics was formed to bring back innovation to medicine and to realise products that address under-serviced markets and to realise solutions to problems impacting patient care and outcomes. The company was created from within the medical community, when the founders decided to take action and form a significant collaboration with surgeons and physicians asking them what their hurt points were and working alongside them to create answers.

About Ortho Consulting Group

With a network of over 5,000 validated contacts, Ortho Consulting Group (OCG) are a team of industry experts specialising in global strategy and building, strengthening and managing global sales channels, specifically outside of the US.

OCG understand the challenges of growing a global business within Orthopaedics and Spine and offers a holistic consultancy service to advise, support and deliver orthopaedic manufacturers’ expansion strategies.

Made up of two specialist divisions, Orthoconnections and Orthoexecutive, OCG can cover all sales channel expansion solutions, whether that’s growing and onboarding your own senior leadership team or sourcing and managing your distributors.

Media contact:
Tom Edwards, Group Marketing Manager
Ortho Consulting Group
tomedwards@orthocg.com

SOURCE Ortho Consulting Group

TDM USA Enters Domestic Extremity Market, Launches Six Product Systems at OTA

Posted On October 15, 2018 By OrthoSpineNews In Extremities, Top Stories /

TDM USA, based in Salt Lake City, Utah, is pleased to announce its entry into the rapidly expanding US extremity market with the launch of six new product systems at the 2018 Annual Meeting of the Orthopaedic Trauma Association (OTA) in Kissimmee, Florida from October 17-20.

Bringing true value to facilities, surgeons and patients requires going beyond the standard. TDM USA is setting new standards by partnering with medical professionals to define and deliver value-generating solutions for complex healthcare challenges. TDM USA brings a new focus on flexibility to the industry, through its collaborative approach to the unique individual needs of Acute Care Hospitals and Ambulatory Surgery Centers.

The APIS (Advanced Principle Implant System) product group offers surgical solutions for Foot and Ankle, Hand and Wrist, and Shoulder and Elbow. The currently available product offering includes: 2.0mm Locking Plate and Screw System; 2.7mm Locking Plate and Screw System; Proximal Humerus Locking Plate and Screw System; Variable Locking Elbow Plate and Screw System; Variable Locking Foot Plate and Screw System; and Trifix Small Locking Plate and Screw System, a curated product set with a wide variety of plates/screws to address multiple anatomies and procedures in one offering.

“We are excited and humbled by the opportunity to positively impact the US healthcare market by providing high-quality, high-value products for fracture care and extremity reconstruction that have a demonstrated track record around the world,” said Clay Smith, President and General Manager of TDM USA. “In today’s value-driven healthcare environment, our mission is to help achieve clinically equivalent outcomes while reducing costs for providers and patients.”

To learn more about the broad and expanding product portfolio of TDM USA, and its philosophy of value-generating solutions in extremity fixation, please visit www.tdm-usa.com and booth 624 during the OTA meeting.

About TDM USA

TDM USA has a management team with over 60 years of combined Commercial and Operations experience in the US healthcare sector. TDM USA is a wholly owned subsidiary of TDM Co., Ltd., a global medical device manufacturer headquartered in Gwangju, Korea. TDM Co., Ltd. entered the orthopedic market in 2007 and currently distributes over 40 unique product systems in 15 countries. All available on-market TDM USA products are FDA 510(k) cleared and manufactured to ISO 13485 standards.

SeaSpine Prices Public Offering of Common Stock

Posted On October 11, 2018 By OrthoSpineNews In Financial /

CARLSBAD, Calif., Oct. 11, 2018 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ: SPNE) (“SeaSpine” or the “Company”), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced the pricing of its previously announced underwritten public offering of 3,250,000 shares of its common stock at a public offering price of $15.50 per share. The gross proceeds to SeaSpine, before deducting the underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $50.4 million. The offering is expected to close on or about October 15, 2018, subject to customary closing conditions.

Wells Fargo Securities, LLC, Piper Jaffray & Co. and Cantor Fitzgerald & Co. are acting as joint book-running managers and BTIG, LLC is acting as lead manager for the offering. SeaSpine has granted the underwriters a 30-day option to purchase up to an additional 487,500 shares at the public offering price, less underwriting discounts and commissions.

SeaSpine intends to use the net proceeds from this offering to repay all of its outstanding borrowings under the Company’s credit facility with Wells Fargo Bank, National Association, and for general corporate purposes, including general and administrative expenses, capital expenditures and general working capital purposes.

A shelf registration statement on Form S-3 relating to the public offering of the shares of common stock described above was filed with the Securities and Exchange Commission (the “SEC”) and became effective on August 24, 2016. A preliminary prospectus supplement relating to the offering has been filed with the SEC and a final prospectus supplement relating to the offering will be filed with the SEC. Copies of the final prospectus supplement and accompanying prospectus, when available, may be obtained from Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue, New York, New York, 10152, by telephone at (800) 326-5897 or by email: cmclientsupport@wellsfargo.com; or Piper Jaffray & Co., 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, Attn: Prospectus Department, by telephone at (800) 747-3924 or by email: prospectus@pjc.com; or Cantor Fitzgerald & Co., 499 Park Ave., 6^th Floor, New York, New York 10012, Attn: Capital Markets, or by email: prospectus@cantor.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

ABOUT SEASPINE

SeaSpine (www.seaspine.com) is a global medical technology company focused on the design, development and commercialization of surgical solutions for the treatment of patients suffering from spinal disorders. SeaSpine has a comprehensive portfolio of orthobiologics and spinal implants solutions to meet the varying combinations of products that neurosurgeons and orthopedic spine surgeons need to perform fusion procedures on the lumbar, thoracic and cervical spine. SeaSpine’s orthobiologics products consist of a broad range of advanced and traditional bone graft substitutes that are designed to improve bone fusion rates following a wide range of orthopedic surgeries, including spine, hip, and extremities procedures.

FORWARD-LOOKING STATEMENTS

This press release contains certain forward-looking information about SeaSpine that is intended to be covered by the safe harbor for “forward-looking statements” provided by the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. Words such as “expect(s),” “feel(s),” “believe(s),” “will,” “may,” “anticipate(s)” and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements about the Company’s expectations regarding its capital raising efforts, including the closing of the public offering, the underwriters’ exercise of their option to purchase additional shares and the Company’s intended use of proceeds. All such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the control of the Company, which could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include, but are not limited to, surgeons’ willingness to continue to use the Company’s existing products and to adopt its newly launched products, including the risk that the Company’s products do not demonstrate adequate safety or efficacy, independently or relative to competitive products, to support expected levels of demand or pricing; the ability of newly launched products to perform as designed and intended and to meet the needs of surgeons and patients, including as a result of the lack of clinical validation of products in limited commercial (or “alpha”) launch; the Company’s ability to attract new, high-quality distributors, whether as a result of inability to reach agreement on financial or other contractual terms or otherwise, disruption to the Company’s existing distribution network as new distributors are added, and the ability of new distributors to generate growth or offset disruption to existing distributors; continued pricing pressure, whether as a result of consolidation in hospital systems, competitors or others, as well as exclusion from major healthcare systems, whether as a result of unwillingness to provide required pricing or otherwise; the risk of supply shortages and the associated, potentially long-term disruption to product sales, including as a result of the Company’s dependence on a limited number of third-party suppliers for components and raw materials, or otherwise; unexpected expense and delay, including as a result of developing and supporting the launch of new products, the fact that newly launched products may require substantial additional development activities, which could introduce further expense and delay, or as a result of obtaining regulatory clearances; the Company’s ability to continue to invest in product development and sales and marketing initiatives at levels sufficient to drive future revenue growth, including as a result of its inability to obtain funding on a timely basis on acceptable terms, or at all; general economic and business conditions in the markets in which the Company does business, both in the U.S. and abroad, as well as other risks and uncertainties described under the “Risk Factors” contained in the Company’s periodic and interim SEC reports, including but not limited to, its Annual Report on Form 10-K for the fiscal year ended December 31, 2017, its Quarterly Reports on Form 10-Q for the quarters ended March 31, 2018 and June 30, 2018 and its Current Reports on Form 8-K filed from time to time with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof, and the Company does not undertake any obligation to revise and disseminate forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of or non-occurrence of any events.

Investor Relations Contact
Lynn Pieper Lewis
(415) 937-5402
ir@seaspine.com

SpinalCyte Announces Publication Supporting the Therapeutic Effects of Fibroblast Cell Therapy in Disc Degeneration and Inflammation in The Spine Journal

Posted On October 11, 2018 By OrthoSpineNews In Biologics /

HOUSTON, Oct. 11, 2018 /PRNewswire/ — SpinalCyte, LLC, a Texas-based regenerative medicine company focused on regrowth of the spinal disc using Human Dermal Fibroblasts, today announced the publication of results from its study on using cell transplantation as a cell therapy for disc degeneration. The article titled “Therapeutic Effects of Cell Therapy with Neonatal Human Dermal Fibroblasts and Rabbit Dermal Fibroblasts on Disc Degeneration and Inflammation,” was published in The Spine Journal and is available at https://www.thespinejournalonline.com/article/S1529-9430(18)31093-3/fulltext.

The study found that transplanting dermal fibroblasts can significantly increase the markers of disc regeneration and supported the hypothesis that the intervertebral disc is immune privileged. Taken together with previous disc degeneration studies, this suggests that fibroblast cell therapies can prevent the degeneration and promote the regeneration of the spinal disc.

“Autologous and allogenic cell therapies for disc degeneration and back pain are feasible, well tolerated, and appear to have clinical efficacy,” said Howard An, M.D., The Morton International Endowed Chair Professor of Orthopedic Surgery, Director Spine Fellowship Program at Rush University Medical Center, and principal investigator of this study. “Human dermal fibroblasts continue to be found safe and well-tolerated in clinical studies while being both therapeutic and regenerative in diseases including disc degeneration.”

“Fibroblast cell therapy is a viable way to address the cause of disc degeneration rather than just treat symptoms,” said Pete O’Heeron, SpinalCyte Chief Executive Officer. “The results from this preclinical study validate our ongoing Phase 1/Phase 2 trials in the treatment of degenerative disc disease with CybroCell, where over 85% of patients using CybroCell report significant therapeutic improvement at 6 months.”

About Degenerative Disc Disease

Degenerative disc disease (DDD) is a condition in which a patient’s spinal disc breaks down and can begin to collapse. It is estimated that 85% of people over the age of 50 have evidence of disc degeneration and over 1.3 million procedures a year are performed to treat the disease. The most common treatments for patients with DDD are either discectomy or spinal fusion. Discectomy is the partial or full removal of the degenerated disc to decompress and relieve the nervous system but can cause long term spinal pain. In a spinal fusion procedure, the entire disc is removed and the two adjacent vertebrae are fused together. It often increases strain on the adjacent discs and surrounding tissues leading to further degeneration.

About CybroCell

CybroCell is the first off-the-shelf allogenic human dermal fibroblast (HDF) product for the treatment of degenerative disc disease. SpinalCyte’s Phase 1/Phase 2 clinical trial for injected human dermal fibroblasts in the treatment of DDD demonstrated preliminary six-month data whereby 83% of patients had an increase or no change in disc height.

About SpinalCyte

Based in Houston, Texas, SpinalCyte, LLC is a regenerative medicine company developing an innovative solution for spinal replacement using human dermal fibroblasts. Currently, SpinalCyte holds 33 U.S. and international issued patents and has filed for an additional 43 patents pending. Funded entirely by angel investors, SpinalCyte represents the next generation of medical advancement in cell therapy. Visit www.spinalcyte.com.

Contact:
David Schull or Ned Berkowitz
Russo Partners LLC
858-717-2310
646-942-5629
david.schull@russopartnersllc.com
ned.berkowitz@russopartnersllc.com

SOURCE SpinalCyte, LLC

Arthrosurface Launches the Stemless OVOMotion™ Shoulder Arthroplasty System

Posted On October 11, 2018 By OrthoSpineNews In Recon /

FRANKLIN, Mass., Oct. 11, 2018 /PRNewswire/ — Arthrosurface®, Inc. announced today the official launch of its latest product, the stemless OVOMotion™ Shoulder Arthroplasty System with Inlay Glenoid. FDA Cleared in April 2018, this stemless total shoulder system provides the surgeon with an approach that results in increased exposure to the glenoid, minimal bone removal, and is designed for patients with painful and/or severely disabled shoulder joints resulting from arthritis, traumatic events or AVN.

“This truly is a revolutionary stemless total shoulder, which combines the concept of anatomic restoration with an aspherical head design, and also allows improved joint access for ease of preparation of the glenoid,” said Dr. Anthony Miniaci, MD of the Cleveland Clinic. “This combination of an aspherical head and inlay glenoid has shown to be effective in not only active and younger patients but in all of those with glenohumeral arthritis even in the face of posterior subluxation and bone erosion.”

An earlier publication in the Journal of Shoulder and Elbow Surgery demonstrated how the inlay glenoid (socket) design was far superior to the only alternative with respect to the biomechanical stability. Arthrosurface has had long-standing success with the aspherical head design of the existing OVO^® arthroplasty device and the stemless OVOMotion™arthroplasty system expands that technology by maintaining the same external geometry while adding a planar cut for enhanced access to the glenoid. Additionally, the proven fixation method and location are unchanged.

Michael Gombosh, MD from South Florida International Orthopaedics commented, “With the new system, the additional 12.5mm of bone removed from the humeral head has truly improved the technical portion of the procedure. This allows for easier visual and manual access of the glenoid. These steps can be the most challenging portion of the operation, and frequently the most time consuming. With improved visualization, you are able to obtain a more accurate assessment of the morphology and wear pattern within the glenoid, but also establish improved access for glenoid preparation and release of the posterior capsule.”

Steve Ek, CEO said, “The OVOMotion™ Shoulder Arthroplasty System builds upon the outstanding clinical results of the OVO System and greatly facilitates surgical access, speed and reproducibility. It also sets the stage for our future modular components.”

The OVOMotion™ Stemless Shoulder Arthroplasty System is now available for use in the United States.

About Arthrosurface
Arthrosurface, Inc. is a global orthopedic medical technology business providing a broad portfolio of essential products and instrumentation used to treat upper and lower extremity orthopedic conditions caused by trauma, injury and arthritic disease. The product offerings include joint preservation implants, instruments and orthobiologics. Founded in 2002, Arthrosurface markets and distributes its products in the US and around the world and has succeeded in helping patients return to activity for over 14 years. For more information, please visit our website at www.arthrosurface.com

SOURCE Arthrosurface, Inc.

2018 Ambulatory Surgery Center (ASC) Market: Projected to Increase from $36 Billion in 2018, to $40 Billion by 2020 – ResearchAndMarkets.com

Posted On October 11, 2018 By OrthoSpineNews In Financial /

October 11, 2018

DUBLIN–(BUSINESS WIRE)–The “2018 Ambulatory Surgery Center Market” report has been added to ResearchAndMarkets.com’s offering.

The ambulatory surgery center (ASC) market was estimated to reach $36 billion in 2018, and is projected to increase to $40 billion by 2020.

Drivers for revenue growth are: lower outpatient surgery costs in ASCs compared to other settings, improved safety driven by technological advancements, and the aging U.S. population.

There are more than 6,100 ASCs in the U.S, and as of 2016, 5,519 were Medicare-certified. Approximately 70% of ASCs are owned by independent physician groups. The top five industry leaders own less than 20% of ASC market share.

Shift To Outpatient Continues

As of 2017, more than half of outpatient surgeries were performed in an ASC setting, up from 32% in 2005.

Based solely on population growth forecasts, outpatient procedure volumes are predicted to increase 14% from 2016 to 2026. However, analysts predict this number will be higher (16%) due to the growing shift in surgical procedures from inpatient to outpatient settings.

Each year, the Centers for Medicare and Medicaid Services (CMS) evaluates a list of approximately 1,700 procedures that are designated as inpatient-only. With improvement in medical technologies, an increasing number of procedures are being removed from this list, allowing them to be performed in outpatient settings. In 2018, six procedures were removed from this list.

ASCs Cut Costs For Payers, Patients

Commercial payers were 64% of the ASC payer mix in 2017, followed by Medicare at 19%. In an effort to reduce costs and increase value, payers are driving the shift in procedures from high-cost settings to more cost-effective ASCs. For example, joint replacement in a hospital outpatient department (HOPD) costs an average of $40,000 versus $18,000 in an ASC. The same is true for cataract surgery with an average cost of $1,745 in an HOPD and $976 in an ASC.

Patients also benefit from these savings. As ASC volumes increase in coming years, total out-of-pocket expenses for procedures could fall by as much as $5 billion.

Key Topics Covered

Executive Summary
Ambulatory Surgery Center Market Overview
Outpatient Volumes Projected To Increase 16% By 2026
Growth In Outpatient Procedures To Drive Additional ASC Volume
Removal Of Surgeries From Inpatient-Only List Increases Procedures Available To ASCs
Most Operating Costs Spent On Supplies And Salaries
Orthopedic Procedures Most Costly
Commercial Insurance Continues To Make Up More Than Half Of ASC Payer Mix
ASC Nurses Earn Higher Wages
Gastroenterology, Ophthalmology Major ASC Specialties
Orthopedics, Otolaryngology, Podiatry, Generate Highest Revenues
Cataract Procedure Remains The Most Commonly Performed Surgery In ASCs
ASCs Specializing In Cardiology Most Likely To Require Post-Surgery Hospitalization
Patients Save Money Through ASC Utilization
Price Transparency Beneficial To ASCs
ASCs Gain At The Expense Of Hospitals
In 2018, ASC Quality Reporting Program Adds Two Measures, Discontinues Three
Number Of ASCs Higher For States Without CON Requirement
Healthcare Execs To Pursue ASCs For M&A, Most ASCs Expect No Activity
ASC Management Companies Expand Investment In 2018
Health System Affiliation Not On The Horizon For Most ASCs
One-Third Of ASCs Plan To Expand In 2019
HOPD To ASC Conversion Potentially Beneficial To Hospitals

For more information about this report visit https://www.researchandmarkets.com/research/644v8f/2018_ambulatory?w=4

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related Topics: Surgical Procedures

TransEnterix Receives FDA 510(k) Clearance for 3mm Diameter Instruments

Posted On October 11, 2018 By OrthoSpineNews In Regulatory, Robotics /

October 11, 2018

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–TransEnterix, Inc. (NYSE American:TRXC), a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery, today announced that the Company received FDA 510(k) clearance for 3 millimeter diameter instruments, as well as additional 5 millimeter Senhance System instruments.

The clearance of the 3 millimeter diameter instruments will allow the Senhance to be used for microlaparoscopic surgeries, enabling surgeons to operate through tiny incisions considered virtually scarless for patients.

“The ability to perform microlaparoscopic procedures using 3 millimeter instruments represents an unparalleled shift in the world of robotic surgery and a capability exclusive to the Senhance system,” said Todd M. Pope, TransEnterix CEO. “The addition of 3 millimeter instruments will allow many high volume surgeries to be performed with smaller incisions, which supports our mission of advancing minimally invasive surgical capabilities within digital laparoscopy.”

“Utilizing 3 millimeter micro instruments on a robotic system represents a new advancement in reducing the invasiveness of many surgeries,” said Dr. Steven D. McCarus, MD, FACOG, Chief of Gynecologic Surgery at Florida Hospital Celebration Health. “Patients find such small incisions to be virtually scarless and cosmetically desirable. Surgeons may find that using such tiny instruments with the precision and control of a digital interface makes microlaparoscopy a preferred option to treat more conditions.”

About TransEnterix

TransEnterix is a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery by addressing the clinical and economic challenges associated with current laparoscopic and robotic options in today’s value-based healthcare environment. The Company is focused on the commercialization of the Senhance™ Surgical System, which digitizes laparoscopic minimally invasive surgery. The system allows for robotic precision, haptic feedback, surgeon camera control via eye sensing and improved ergonomics while offering responsible economics. The Senhance Surgical System is available for sale in the US, the EU and select other countries. For more information, visit www.transenterix.com.

Forward Looking Statements

This press release includes statements relating to the Senhance Surgical System and related instruments and our current regulatory and commercialization plans for this product. These statements and other statements regarding our future plans and goals constitute “forward looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control and which may cause results to differ materially from expectations and include whether the ability to perform microlaparoscopic procedures using 3 millimeter instruments represents an unparalleled shift in the world of robotic surgery; whether the addition of 3 millimeter instruments will allow many high volume surgeries to be performed with smaller incisions and whether surgeons may find that using tiny instruments with the precision and control of a digital interface makes microlaparoscopy a preferred option to treat more conditions. For a discussion of the risks and uncertainties associated with TransEnterix’s business, please review our filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K filed on March 8, 2018, and our other filings we make with the SEC. You are cautioned not to place undue reliance on these forward looking statements, which are based on our expectations as of the date of this press release and speak only as of the origination date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Contacts

TransEnterix, Inc.
Investor Relations:
Mark Klausner, 443-213-0501
transenterix@westwicke.com
or
Media Relations:
Joanna Rice, 951-751-1858
joanna@greymattermarketing.com

Medacta International Adds Mpact 3D Metal Implants and Augments to Mpact System for Primary Hip Replacement and Revision Surgeries

Posted On October 11, 2018 By OrthoSpineNews In Recon, Regulatory, Top Stories /

October 11, 2018

CASTEL SAN PIETRO, Switzerland–(BUSINESS WIRE)–Medacta^® International, the privately owned, global leader in innovative joint replacement and spinal technologies, today announced it has received clearance from the U.S. Food and Drug Administration (FDA) for the Mpact 3D Metal™ Implants and Augments 3D Metal as enhancements to its Mpact^® System for primary to complex hip revision procedures. The first stateside surgery utilizing the implant and augments was performed this summer by Tyler Goldberg, M.D., of Austin-based Texas Orthopedics, Sports & Rehabilitation Associates.

The new implants, Mpact 3D Metal Acetabular Two-Hole and Multi-Hole Shells, are hemispherical porous shells with multiple highly cross-linked polyethylene liner options. The implants’ ultra-porous material makes them ideal for more demanding primary patient cases or to address difficult revisions with compromised bone. They are complemented by the porous 3D Metal Augments, designed to act as a defect-filling implant in cases of severe bone loss to help increase implant stability. The augments come in a variety of shapes and sizes, giving surgeons intraoperative flexibility to address a wide variety of acetabular defects. Together, these additions strengthen Medacta’s Mpact System and provide surgeons with more options when addressing complex primary hip replacements, as well as revisions.

Dr. Goldberg’s primary case utilized the Mpact Two-Hole Shell. “I was impressed with how firm the Mpact 3D Metal Implant was upon initial impaction. The shell has exceptional grip, making primary fixation easy and solid,” Dr. Goldberg said of his experience. “Knowing the shell is of high porosity and solid nature gave me great confidence for durable bone ingrowth, and my patient is recovering very well.”

The Mpact 3D Metal Implants feature Medacta’s proprietary 3D Metal technology, constructed via additive manufacturing performed by a 3D printer. The result is enhanced initial stability due to a high coefficient of friction at the bone interface and favorable environment for bone without the need for an additional coating. The 3D Metal Shells and Augments have pore sizes of 600-800 micrometers and continuously interconnected open pores with a high-porosity level of 75 percent.

“Medacta continues to expand upon its product portfolios as we seek to help our surgeon partners address more patient cases than ever before, whether it’s a complex primary case or a difficult revision,” said Francesco Siccardi, Executive Vice President of Medacta International. “With the new Mpact 3D Shells and 3D Metal Augments, our Mpact System offers even greater versatility and continues to instill confidence, thanks to both the high-grade materials used and the built-in surgeon education and support system for which Medacta is well known.”

The Mpact 3D Metal Implants and Augments are compatible with several surgical techniques, including Medacta’s Anterior Minimally Invasive Surgery (AMIS^®) approach to hip replacement. The muscle-sparing AMIS approach is supported by the Medacta Orthopaedic Research and Education (M.O.R.E.) Institute, which provides surgeons with educational resources, training and mentorship as well as dedicated tools and instruments as they transition and practice the technique.

For more information, visit Medacta’s Mpact System webpage.

About Medacta International

Medacta^® International is a world leading company, developer and supplier, specializing in joint replacement, spine surgery, and sports medicine solutions. Medacta’s revolutionary approach and responsible innovation, focusing on Minimally Invasive Solutions and Personalized Medicine, have resulted in standard of care breakthroughs in hip replacement with the AMIS^® system and total knee replacement with MyKnee^® patient matched technology. Medacta has grown dramatically by taking a different approach and placing value on all aspects of the care experience from design to training to sustainability. Medacta is headquartered in Castel San Pietro, Switzerland, operates in over 30 countries around the globe, and employs more than 930 people. To learn more about Medacta International, please visit www.medacta.com or follow @Medacta on Twitter and LinkedIn.

Contacts

For Medacta International
Jill Bongiorni, 516-729-2250
Jill@torchcomllc.com

Catalyst OrthoScience Introduces 3-Peg Glenoid To Its Catalyst CSR™ Total Shoulder System

Posted On October 11, 2018 By OrthoSpineNews In Recon /

October 11, 2018

NAPLES, Fla.–(BUSINESS WIRE)–Catalyst OrthoScience Inc. (Catalyst), a cutting-edge medical device company focused on the upper extremity orthopedics market, today introduced the patent pending 3-Peg Glenoid implant to its innovative Catalyst CSR™ Total Shoulder System. The new implant was unveiled at the American Shoulder and Elbow Surgeons (ASES) 2018 Annual Meeting in Chicago, Ill.

Loosening of the glenoid component is the most common mode of failure in total shoulder arthroplasty^1-3. An inability to achieve long-lasting, secure fixation within the glenoid bone that can withstand the effects of repeated eccentric loading and glenohumeral translation leads to failure⁴.

In order to address this, Catalyst has used a science-based approach to design the 3-Peg Glenoid implant with the specific goal of resolving these challenges. Key features include:

1. Immediate interference fit fixation in the strongest regions of the glenoid vault using a new backside anchoring element design.

2. Tapered walls on the bearing surface to reduce the effects of eccentric loading, which can contribute to implant loosening.

3. Quick, accurate placement of the implant using a streamlined procedure resulting in potential time and cost savings.

“The 3-Peg Glenoid is a great addition to our Catalyst CSR system, and it gives surgeons the option between the existing glenoid with two pegs or the new 3-Peg option,” said Brian Hutchison, executive chairman and CEO of Catalyst. “We have had a number of surgeons use the 3-Peg Glenoid with great results so far.”

Designed by surgeons for surgeons, the Catalyst CSR system represents the next evolution in shoulder surgery. The system includes a multi-planar stemless design which preserves bone and an elliptical humeral component that mimics the natural shoulder anatomy. Additionally, the surgical technique and instrumentation were designed to simplify the glenoid exposure and consistently deliver a precise and accurate shoulder reconstruction.

To learn more about the new 3-Peg Glenoid and the Catalyst CSR system, visit Catalyst at booth J at the ASES meeting, Oct. 11 – 14, 2018.

About Catalyst OrthoScience Inc.

Catalyst OrthoScience develops and markets surgical implants that make orthopedic surgery less invasive and more efficient for both surgeons and patients. Catalyst was founded in 2014 by orthopedic surgeon Steven Goldberg, M.D., who saw the need to make shoulder replacement surgery less invasive and give patients a more natural-feeling shoulder after surgery.

The company’s first offering, the Catalyst CSR Total Shoulder System, represents the next evolution in stemless total shoulder arthroplasty. The Catalyst CSR is a single-tray, bone-preserving total shoulder arthroplasty system containing a precision elliptical humeral head and less invasive glenoid component, using specialized ergonomic instrumentation designed for consistent anatomic joint line restoration and glenoid insertion. The Catalyst CSR system can be used in both inpatient and outpatient settings and was cleared for use by the FDA in 2016.

Catalyst OrthoScience has a growing portfolio of 10 granted U.S. patents with several more pending nationally and internationally. The company is headquartered in Naples, Fla., and its products are available across the U.S. For additional information on the company, please visit www.CatalystOrtho.com.

References

1. Wirth et al. Complications of total shoulder replacement arthroplasty. JBJS 1996: 603-16.

2. Franta et al. The complex characteristics of 282 unsatisfactory shoulder arthroplasties JSES 2007: 555-62.

3. Bohsali et al. Complications of total shoulder arthroplasty JBJS 2006: 2279-92.

4. Matsen et al. Glenoid component failure in total shoulder arthroplasty. JBJS 2008: 885-96.

Contacts

Catalyst OrthoScience Inc.
Brent Narkiewicz
bnarkiewicz@catalystortho.com
or
Surgence Communications Strategies
Wendy Crites Wacker, APR, CPRC, 352-494-2129
wendy@surgencecs.com

Author: OrthoSpineNews

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