News – Page 29 – Selby Spine

MALVERN, Pa., Oct. 2, 2018 /PRNewswire/ — U.S. based Trice Medical, Inc. announced today the launch of its latest product, mi-ultra™, a high powered 15mHz handheld ultrasound transducer. The mi-ultra™ is enabled by the same platform technology that Trice’s flagship product, mi-eye 2®, operates on, the mi-tablet.

The mi-ultra™, which comes in both convex and linear offerings, has been optimized for Muscular Skeletal (MSK) applications. The addition of this technology to Trice’s Dynamic Imaging Platform will enable orthopedic practices to provide a full suite of MSK imaging at the first point of care. The ability to provide a dynamic evaluation for patients, as opposed to static systems like MRI and X-Ray, has never been easier for orthopedic offices with this all-in-one portable system.

Dr. Don Buford, orthopedic surgeon and founder of the Dallas PRP and Stem Cell Institute, said, “The mi-ultra™ is a combination of the first MSK ultrasound system with sufficient image quality and reliability for all diagnostic and procedure indications with the first tablet based disposable office needle arthroscopy platform. Now, every orthopedic clinician can have a single portable tablet for imaging intra-articular and extra-articular anatomy for diagnosis and procedures. This is a truly revolutionary point of care imaging system and the only such platform available!”

The early success of Trice Medical’s mi-eye 2®, which was launched in the U.S. in 2017, has captured the attention of medical professionals who are embracing the technology as a new diagnostic modality. After the first year of commercial launch, the mi-eye® is currently being used by over 300 institutions across the U.S. The disposable needle embedded with a wide-angle camera lens enables physicians to diagnose joint injuries right in their clinic; deliver biological under direct visualization; and provide their patients with immediate answers to the cause of their pain.

“This is a truly disruptive technology for the orthopedic industry,” said Mark Foster, President and CCO of Trice Medical. “Today’s healthcare environment is asking for innovation in a cost-effective manner. Trice is proud to have combined an arthroscopy tower and a high-powered ultrasound system into one simple, portable tablet. The disposable mi-eye 2®camera is great to identify pathology within the joint and the mi-ultra is a perfect complement for guided injections or assessing soft tissue damage outside of the joint. We believe the system is a “must have” for every orthopedic practice.”

About the mi-eye 2®:

Trice Medical’s mi-eye 2® is a handheld, single-use, and disposable direct visualization tool. The mi-eye 2® was specifically designed for use in the clinic setting, consisting of a single stick percutaneous, and self-blunting design which deploys an integrated camera and a light source. The procedure is performed with local anesthetic and provides patients with an alternative to traditional diagnostic modalities, such as time-consuming and often inaccurate MRIs. The mi-eye® is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. The mi-eye 2® is available for prescription use only.

About Trice Medical:

Trice Medical was founded to fundamentally improve orthopedic diagnostics for the patient, and the physician providing instant answers. Trice Medical has pioneered fully integrated camera-enabled technology, the mi-eye 2®, that provides a clinical solution optimized for the physician’s office. Trice Medical’s mission is to provide more immediate and definitive patient care, eliminating the false reads associated with current indirect modalities and significantly reduce the overall cost to the healthcare system.

Contact Trice Medical:

+1 (610) 989-8080

info@TriceMedical.com

Trice Medical’s mi-eye 2

Related Links

Trice Medical

SOURCE Trice Medical

Related Links

https://tricemedical.com/

NEW YORK , Oct. 2, 2018 /PRNewswire/ — Thomas J. Graham, MD, one of the nation’s most respected hand surgeons and health care innovators, recently joined the Department of Orthopedic Surgery at NYU Langone Health as Director of Strategy and Innovation. Dr. Graham is also serving as Associate Chief of the Division of Hand Surgery.

Dr. Graham will see patients at NYU Langone’s Hand Center, where he is moving his clinical practice — which has treated thousands of professional athletes and performed hand and elbow surgeries of all complexities. Dr. Graham, who joined NYU Langone on September 1, has a national and international reputation as a hand and upper extremity surgeon, and a pioneer in orthopedic innovation.

“We are incredibly fortunate to recruit Dr. Graham to NYU Langone, and to bring his renowned skills as a hand surgeon, innovator and physician leader to our department,” says Joseph D. Zuckerman, MD, the Walter A. L. Thompson Professor of Orthopedic Surgery and chair of the Department of Orthopedic Surgery. “Having a surgeon and visionary like Dr. Graham join our already outstanding hand surgery faculty further catapults our top-ranked program to an even higher level of excellence.”

Sought-After Hand Surgeon to Athletes

Dr. Graham has extensive clinical expertise in surgery of the hand, wrist and elbow, with particular expertise in complicated reconstruction after trauma, complex elbow disorders, and congenital hand ailments. His practice also enjoys worldwide recognition for care of the hand and wrist of professional athletes. Notably, he has served as the hand surgery consultant, team physician or medical director for numerous professional sports teams in the NFL, MLB, NBA, NHL, and the PGA and LPGA Tours, and has personally cared for thousands of elite athletes.

An alumnus of Williams College, Dr. Graham received his medical degree at the University of Cincinnati College of Medicine. He completed his orthopedic surgery residency at the University of Michigan, followed by a fellowship in hand and upper extremity surgery at the Indiana Hand Center, and extended training in surgery of the elbow at the Mayo Clinic.

In addition, he completed a two-year executive management and healthcare administration program sponsored by Cleveland Clinic and Weatherhead School of Management at Case Western Reserve University.

Following his initial faculty appointment at Cleveland Clinic where he was director of the Hand and Upper Extremity Center, Dr. Graham relocated to Baltimore to serve as chief of the congressionally designated Curtis National Hand Center, the largest specialty practice in its field globally, and Vice- Chairman of Orthopedic Surgery at MedStar Union Memorial Hospital. Dr. Graham also was an Associate Professor of both orthopedic and plastic surgery at Johns Hopkins Medicine. While in Baltimore, he also established MedStar SportsHealth and was the founder and Surgeon-in-Chief of the Arnold Palmer Sports Health Center.

After his considerable contributions in Baltimore, Dr. Graham returned to Cleveland Clinic, where he served as its inaugural Chief Innovation Officer and Vice Chairman of Orthopedic Surgery.

An accomplished academician, Dr. Graham has lectured around the world and advanced his specialty by authoring more than 100 publications, numerous books and book chapters, including the best-seller, “Innovation the Cleveland Clinic Way.”

Enhancing Orthopedic Innovation

Dr. Graham’s history as a prolific innovator and inventor includes holding more than 50 patents for medical devices, primarily implants to treat fractures or replace joints of the upper extremity. He also is an entrepreneur in his own right, and has started several public and private medical device and artificial intelligence companies.

In his new role at NYU Langone, Dr. Graham will take his vast experience translating strategy and innovation into tangible advancements in techniques, technologies and the delivery of orthopedic care.

“NYU Langone has impressed me with its commitment to innovation and collaboration, where colleagues embrace the responsibilities and opportunities that come with clinical and academic leadership,” Dr. Graham says. “I recognize championship organizations, and I’m honored to join yet another. NYU Langone’s Department of Orthopedic Surgery remains at the vanguard of our specialty by optimizing outcomes and the patient experience.”

Media Contact:
Ryan Jaslow
Ryan.jaslow@nyulangone.org
212-404-3511

SOURCE NYU Langone Health

Alpharetta, Ga., October 2, 2018 — Solvay, a leading global supplier of specialty polymers, announced during NASS 2018 last week that Innovative Surgical Designs, a developer and manufacturer of orthopedic spinal systems, chose Ixef® polyarylamide (PARA) resin to innovate a new single-use surgical instrument kit for minimally invasive spinal fusion surgery. Innovative Surgical Designs’ new Redi-Spine™ kit leverages Ixef® PARA’s mechanical strength, moldability and gamma sterilizability to offer an economical alternative to reusable stainless steel instruments.

“Ixef^® PARA’s metal-like strength and rigidity enabled us to simplify and deliver Redi-Spine™ instruments in a compact, elegant kit,” explained Jon Rinehart, chief financial officer of Innovative Surgical Designs. “When we first started heading down the path of polymer instruments, I candidly admit that I was skeptical. I didn’t think an injection-molded alternative to stainless steel was possible. But when we started working with Solvay’s Ixef® PARA resin, I realized how wrong I was. We wouldn’t be able to offer the Redi-Spine™ kit for all of our surgeons’ one- and two-level cases without Solvay’s high-performance polymer and application support.”

Designed to withstand the severe torsional forces and rigors of thoracolumbar spinal fixation, Innovative Surgical Designs’ Redi-Spine™ instruments received 510(k) clearance from the U.S. Food & Drug Administration (FDA) in August. It contains multiple disposable, handheld instruments including a T-ratchet handle, counter-torque tool and gearshift probe that are molded entirely or in part from Solvay’s Ixef^® GS-1022 PARA.

Ixef^® GS-1022 PARA can be sterilized with gamma ray radiation without any significant change to its mechanical properties, ultra-smooth finish or color. Solvay offers the material in a range of gamma-stabilized colors, from which Innovative Surgical Designs, Inc. chose gray for its kit. Solvay’s polymer has also been evaluated for ISO 10993 limited duration biocompatibility and is supported by an FDA Master Access File, which can help streamline regulatory approvals.

“The growing adoption of single-use surgical instruments has increasingly established Solvay’s Ixef® PARA as a mainstream material for these applications,” said Jeff Hrivnak, business manager for Healthcare at Solvay’s Specialty Polymers Global Business Unit. “We continue to build on our early and proactive support of this trend by working closely with trailblazers like Innovative Surgical Designs, Inc. to help optimize their products for molding and speed to market.”

Innovative Surgical Designs plans to launch the Redi-Spine™ kit during the fourth quarter of 2018. For more related news about specialty polymers for healthcare, please go to www.solvayhealthcarenews.com.

® Ixef is a registered trademark of Solvay
™ Redi-Spine is a trademark of Innovative Surgical Designs

CARLSBAD, Calif., Oct. 02, 2018 (GLOBE NEWSWIRE) — In a release issued under the same headline earlier today by SeaSpine Holdings Corporation (NASDAQ: SPNE) please note that in the fifth paragraph of the release under 2018 Financial Outlook the growth should be 7% to 8% over full-year 2017 revenue, not 6% to 9% over full-year 2017 revenue as previously stated. The corrected release follows:

SeaSpine Holdings Corporation (NASDAQ: SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, announced today preliminary financial results for the three-months ended September 30, 2018.

Preliminary and unaudited revenue for third quarter 2018 is expected to be in the range of $35.5 to $36.0 million, reflecting approximately 12% to 13% growth compared to the prior year period. Compared to third quarter 2017, total U.S. revenue is expected to increase between 12% to 13% to approximately $31.5 to $31.8 million, with both U.S. Orthobiologics and U.S. Spinal Implants revenue expected to increase more than 10%. International revenue is expected to increase between 14% and 20% to approximately $4.0 to $4.2 million.

Cash and cash equivalents at September 30, 2018 are expected to be approximately $11.5 million. The Company borrowed $3.0 million of cash under its credit facility during the third quarter of 2018 and had $7.3 million of outstanding borrowings under the credit facility as of September 30, 2018. The Company has not sold any shares of its common stock under its $50 million “at the market” equity offering program.

“We are pleased by our revenue results for the third quarter, which reflect solid revenue growth across all portfolios,” said Keith Valentine, President and Chief Executive Officer. “This momentum is driven by increasing market penetration from our recently launched products, a more engaged and increasingly exclusive distributor network, and from a deeper commitment in our organization to customer experience and medical education and training. We are confident that we are well positioned to sustain this growth as we continue to deliver cost effective procedural solutions to surgeons and hospitals to improve the quality of patient lives.”

2018 Financial Outlook
SeaSpine is increasing its full-year 2018 revenue guidance range to $141 to $142 million, up from $136 to $139 million, reflecting growth of approximately 7% to 8% over full-year 2017 revenue.

Upcoming Investor Conferences
As previously announced, SeaSpine management is scheduled to present at the Ladenburg Thalmann 2018 Healthcare Conference in New York, NY today, October 2 at 3:00pm ET. SeaSpine management is also scheduled to present at the Cantor Global Healthcare Conference in New York, NY on Wednesday, October 3 at 9:10am ET. A live webcast of both presentations will be available on the Investor Relations page of the Company’s website at www.seaspine.com. A replay of each presentation will be available on the website for 30 days following the event.

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. SeaSpine’s spinal implants portfolio consists of an extensive line of products to facilitate spinal fusion in minimally invasive surgery (MIS), complex spine, deformity and degenerative procedures. Expertise in both orthobiologic sciences and spinal implants product development allows SeaSpine to offer its surgeon customers a differentiated portfolio and a complete procedural solution to meet their fusion requirements. SeaSpine currently markets its products in the United States and in over 30 countries worldwide.

Forward-Looking Statements
SeaSpine cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that are based on the Company’s current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements relating to: the Company’s preliminary revenue results for the third quarter; the Company’s ability to sustain revenue growth in the future; and the Company’s expectations for full-year 2018 revenue. In addition, this release contains preliminary financial results for third quarter 2018. These preliminary results for the third quarter of 2018 are not a comprehensive statement of our financial results for the quarter and provided prior to completion of all internal and external review and audit procedures and therefore are subject to adjustment. Among the factors that could cause or contribute to material differences between the Company’s actual results and the expectations indicated by the forward-looking statements are risks and uncertainties that 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; and other risks and uncertainties more fully described in the Company’s news releases and periodic filings with the Securities and Exchange Commission. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov.

You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. SeaSpine does not intend to revise or update any forward-looking statement set forth in this news release to reflect events or circumstances arising after the date hereof, except as may be required by law.

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

DALLAS, Oct. 2, 2018 /PRNewswire/ — Bone Solutions Inc. (BSI), an ortho-biologics technology company announces the first 250 cases of implanted OsteoCrete^®. OsteoCrete^® is a Magnesium-based bone void filler is designed to assist with bone repair and generation, and it’s the first in the U.S. to incorporate magnesium, a critical property for bone health and development.

“In our initial launch phase, we have successfully implanted over 2200cc’s of OsteoCrete® bone void filler. OsteoCrete^®provides a combination of compressive strength, non-expanding features, and characteristics for optimal binding qualities. OsteoCrete^® is 100% resorbable which makes it ideal for surgeons while providing enhanced patient outcomes. Many modern devices used for bone repair or replacement are calcium-based and do not exhibit the same quality or features as OsteoCrete®.

BSI will be immediately expand our clinical and commercial footprint, establishing various distribution partners throughout US. This will allow the company to build a stronger presence in the marketplace for bone graft substitutes.” stated BSI president and CEO, Drew Diaz.

About Bone Solutions Inc.

Bone Solutions Inc. (‘BSI’) (www.bonesolutionsinc.com) is an orthobiologics company with a vision to provide orthopedic surgeons a means to improve clinical outcomes in a number of complex procedures while lowering costs. The company is revolutionizing a new solution for orthopedic surgeons for human uses with their FDA-cleared magnesium-based platform bone void filler.

Media Contact:

Bone Solutions Inc.:
Drew Diaz
President/CEO
817-809-8850
diaz@bonesolutions.net

SOURCE Bone Solutions Inc.

Contacts

InVivo Therapeutics
Heather Hamel, 617-863-5530
Investor Relations
ir@invivotherapeutics.com

October 02, 2018

GAINESVILLE, Fla.–(BUSINESS WIRE)–Exactech, a developer and producer of innovative implants, instrumentation and computer-assisted technologies for joint replacement surgery announced today the appointment of Stuart Kleopfer as Senior Vice President of Global Sales, effective Oct. 1, 2018.

Kleopfer will provide leadership for Exactech’s global sales functions with responsibility for the United States sales organization and the company’s current international team. Kleopfer is a veteran of the orthopaedics industry with 30 years experience in sales and marketing. He had a distinguished career at Biomet that included serving as president, U.S. Commercialization, and then with ZimmerBiomet where he served as president, Americas, until 2017.

“I am excited to be back in orthopaedics and look forward to re-engaging with surgeons and sales representatives,” Kleopfer said. “Exactech has a great product offering and with what we have in the research and development pipeline, I am confident we will be able to strengthen our global sales channel, generate top line revenue and grow market share.”

According to Exactech CEO David Petty, “Stuart is a great addition to Exactech and an excellent fit for our surgeon-focused culture. It’s an exciting time of growth for the company and we are eager to leverage Stuart’s expertise,” he said.

Exactech Co-Executive Chairman Jeff Binder also commented, “We are excited to add Stuart, with his proven track record of success, to the Exactech team and I am looking forward to working with him again.”

About Exactech

Based in Gainesville, Fla., Exactech develops and markets orthopaedic implant devices, related surgical instruments, and biologic materials, as well as computer assistance and other Augmented Orthopaedic^TMtechnologies to hospitals and physicians. The company manufactures many of its orthopaedic devices at its Gainesville facility. Exactech’s orthopaedic products are used in the restoration of bones and joints that have deteriorated as a result of injury or diseases such as arthritis. Exactech markets its products throughout the United States and in more than 30 markets in Europe, Latin America, Asia and the Pacific. Additional information about Exactech can be found at www.exac.com.

Contacts

Exactech Inc.
Media Contact
Priscilla Bennett, 352-377-1140
Vice President, Corporate & Marketing Communication
media@exac.com

October 02, 2018

HOOFDDORP, Netherlands–(BUSINESS WIRE)–Bioventus, a global leader in orthobiologic solutions, has received approval from Agência Nacional de Vigilância Sanitária (ANVISA) to market DUROLANE, its single-injection joint-fluid osteoarthritis (OA) treatment, in Brazil. ANVISA has approved DUROLANE for the symptomatic treatment of mild to moderate knee and hip OA. In addition, Bioventus has selected Pfizer as its exclusive distribution partner for the market.

OA involves the breakdown, or degeneration, of cartilage and the synovial fluid that cushions and lubricates joint tissues. Hyaluronic acid (HA)-based products like DUROLANE, help manage pain in the knees and hips of patients with OA.

Pfizer has more than 100 sales representatives throughout Brazil and will offer DUROLANE as part of its arthritis pain management portfolio which also includes CELEBRA^®, a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID).

“Brazil is the largest market for patients seeking osteoarthritis pain solutions in Latin America and one of the larger markets worldwide,” said Tony Bihl, CEO of Bioventus. “Introducing DUROLANE here gives patients and physicians access to a proven pain reliever for knee OA, expands the footprint of Bioventus and underscores our continuing efforts to bring orthobiologic solutions to patients around the world.”

“We are very pleased Pfizer is adding DUROLANE to its pain management portfolio for OA patients in Brazil,” said John Nosenzo, Chief Commercial Officer, Bioventus. “The company’s sales representatives have tremendous knowledge regarding osteoarthritis pain solutions. In addition, they have deep relationships with physicians and hospitals, making this a natural fit for Bioventus.”

DUROLANE is based on a natural, safe and proven technology process called NASHA^®. This process yields stabilized (HA) which is a naturally occurring molecule that provides the lubrication and cushioning in a normal joint. It has been proven to provide greater reduction in OA knee pain versus Synvisc-One^®1* and longer lasting pain relief versus a steroid injection². DUROLANE is also safe for repeated courses of therapy. Repeated use of DUROLANE does not increase the incidence of adverse events.^2,3

About Bioventus

Bioventus is an orthobiologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The orthobiologic products from Bioventus include offerings for osteoarthritis, surgical and non-surgical bone healing. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.BioventusGlobal.com and follow the company on Twitter @Bioventusglobal.

Bioventus, the Bioventus logo, and DUROLANE are registered trademarks of Bioventus LLC. NASHA is a registered trademark of Nestle Skin Health s.a. CELEBRA is a registered trademark of Pfizer. Synvisc-One and Synvisc are registered trademarks of Genzyme Corporation.

Summary of Indication for Use: Symptomatic treatment of mild to moderate knee or hip osteoarthritis. There are no known contraindications. You should not use DUROLANE if you have infections or skin disease at the injection site. DUROLANE has not been tested in pregnant or lactating women, or children. Risks can include transient pain, swelling and/or stiffness at the injection site.,Indications presented are those approved in Brazil; indications and product offerings vary by country. Consult with your local Bioventus representative for approved use within your region of interest. Full prescribing information can be found in product labeling, at www.DUROLANE.com.

References: 1. McGrath AF, McGrath AM, Jessop ZM, et al. A comparison of intra-articular hyaluronic acid competitors in the treatment of mild to moderate knee osteoarthritis. J Arthritis. 2013; 2(1):108. doi:10.4172/2167-7921.1000108. 2. Leighton R, Åkermark C, Therrien R, et. al. NASHA hyaluronic acid vs methylprednisolone for knee osteoarthritis: a prospective, multi-centre, randomized, non-inferiority trial. Osteoarthritis Cartilage. 2014; 22(1):17-25. 3. DUROLANE [package insert]. Durham, NC: Bioventus LLC; 2017.

Contacts

Bioventus LLC
Thomas Hill, 919-474-6715
thomas.hill@bioventusglobal.com

CINCINNATI (PRWEB) OCTOBER 01, 2018

Lambda Technologies has developed a surface treatment for modular orthopedic implants that eliminates the chance of failure from fretting fatigue. Low plasticity burnishing (LPB®) applies a deep, beneficial surface layer of designed residual compression to mitigate fretting fatigue in titanium implants. By putting the edge of contact region in high residual compression much deeper than the shallow shear cracks formed by fretting, the cracks cannot propagate and the chance of fracture from fretting is eliminated.

Millions of people have regained their mobility because of hip or knee implant technology. Day- to-day activities of the implant recipient, particularly those who are active, can lead to repeated metal-to-metal sliding contact in the joint, leaving the implant vulnerable to fretting induced fatigue cracks and, potentially, failure in the edge-of-contact region. If failure does occur, revision surgeries are required, significantly affecting the quality of life of patients. Fatigue testing of the modular hip and knee prosthesis systems by original manufacturers showed that LPB treatment improves the baseline fatigue strength by nominally 40%, and completely eliminated the occurrence of fretting induced failure.

The FDA has approved Lambda’s LPB process for extending the life of modular prostheses. During the twelve-plus years that orthopedic surgeons have been using LPB treated hip implants, and approximately three years of LPB treated knee implants, no LPB processed implant has failed from fretting fatigue. Dr. N. Jayaraman, Director of Materials Research for Lambda Technologies noted that, “The cost savings and improvement in the quality of life for patients is immeasurable. And as an added bonus, the ease of implementation of LPB into existing production environments in CNC mills or lathes has made it very cost-effective for the manufacturers.“

Lambda Technologies is an innovative company incorporating a premier materials research laboratory with a world-class engineering and production enterprise dedicated to the development and optimization of surface treatments to improve component performance. For additional information on Lambda Technologies or the LPB process, contact Julie Prevéy at (513) 561-0883 or visit http://www.lambdatechs.com.

October 01, 2018

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–TransEnterix, Inc. (NYSE American:TRXC), a medical device company that is digitizing the interface between surgeons and patients to improve minimally invasive surgery, today provided a corporate update, including preliminary unaudited revenue for the third quarter ended September 30, 2018.

“We made significant progress during the third quarter, including the continued adoption of Senhance, driven by the advancement of our sales and marketing strategy, the announcement of the MST acquisition agreement and the expansion of our instrument portfolio,” said Todd M. Pope, President and CEO at TransEnterix. “As we look towards the remainder of 2018 and into 2019, we are focused on increasing the applicability of Senhance to more patients, surgeons, and hospitals and growing on a global basis.”

Third Quarter 2018 Revenue Outlook

For the third quarter ended September 30, 2018, the Company expects to report revenue of approximately $5.4 million. This revenue is primarily driven by the sale of four Senhance systems, as follows:

In the US, UPMC purchased a Senhance Surgical System to be utilized at its Magee-Womens Hospital in Pittsburgh. Magee combines a wealth of specialty services with a focus on gynecologic and obstetric services. UPMC is a $19 billion world-renowned health care provider and insurer, which is focused on new models of accountable, cost-effective, and patient-centered care.
In EMEA (Europe, Middle East, Africa), three systems were sold:
- A system was sold to Maxima Medical Center, in Veldhoven, the Netherlands, which is a member of a cooperative association of the 20 largest Dutch teaching hospitals that work together in areas of education and quality control, to guarantee the best level of healthcare.
- Two systems were sold to distributors, one of which was a demonstration system purchased to support territory marketing and regulatory initiatives.

Balance Sheet

Preliminary unaudited cash and cash equivalents as of September 30, 2018 totaled approximately $82 million. The Company anticipates that it has sufficient cash to fund the business through 2020, assuming the funding of the $20 million in potential future debt tranches available under the Company’s existing debt financing agreements.

Acquisition Agreement with MST

On September 23, 2018, the Company announced that it had entered into an agreement to acquire substantially all of the assets of MST Medical Surgery Technologies Ltd. (“MST”), an Israel medical technology company. MST is a leader in the field of surgical technology, having developed a software-based image analytics platform powered by advanced visualization, scene recognition, artificial intelligence, machine learning and data analytics.

The addition of MST’s technology, IP portfolio, and R&D team will support and accelerate TransEnterix’s vision to leverage its Senhance Surgical System to deliver digital laparoscopy, thereby increasing control in the surgical environment and reducing surgical variability. In addition, the acquisition will provide immediate access to an established R&D center in Israel with a core team of experienced engineers. The acquisition is expected to close in the fourth quarter of 2018, and is subject to customary closing conditions.

Instrument Portfolio Expansion

Ultrasonic Instrument System

On September 6, 2018, the Company announced that it had filed its application for FDA 510(k) clearance for its Senhance Ultrasonic Instrument System, ahead of expectations. The Company expects to achieve an FDA 510(k) clearance in the first quarter of 2019.
As announced on October 1, 2018, the Company received a CE Mark for its Senhance Ultrasonic Instrument System. The Company continues to expect to commercially launch the Ultrasonic Instrument System in CE Mark countries in the fourth quarter of 2018.

3mm Diameter Instrument Set

The Company continues to anticipate receiving FDA 510(k) clearance for its expanded instrument set, including 3mm diameter instruments, by the end of 2018.

Articulating Instruments

The Company continues to expect to submit its application for FDA 510(k) clearance for its 5mm diameter articulating instruments during the fourth quarter of 2018.
The Company continues to expect to receive CE Mark for its 5mm diameter articulating instruments during the fourth quarter of 2018.

Expansion of Geographic Regulatory Approvals

The Company continues to expect to receive Taiwanese FDA approval for the Senhance Surgical System instruments by the end of 2018. In the second quarter of 2018, the Company received approval in Taiwan for the Senhance Surgical System.

Appointment of Chief Commercial Officer

On September 4, 2018, the Company announced that Eric Smith has been named Chief Commercial Officer, effective August 31, 2018. In this newly created role, which reports directly to the Chief Executive Officer, Mr. Smith leads the company’s global commercialization efforts, with a focus on both strategic and tactical execution efforts in sales, upstream and downstream marketing, field clinical support and training with a focus on adoption and clinical excellence.

About TransEnterix, Inc.

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 anticipated third quarter 2018 financial results, the acquisition agreement with MST, the Senhance Surgical System, the Senhance Ultrasonic Instrument System and our current regulatory and commercialization plans for these and our other products. 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 preliminary unaudited 2018 third quarter revenue will be approximately $5.4 million, whether preliminary cash and cash equivalents will be $82 million as of September 30, 2018, whether, for the remainder of 2018 and into 2019, we will be able to increase the applicability of Senhance to more patients, surgeons and hospitals and growing on a global basis, whether the MST transaction will be able to close in the 2018 fourth quarter, whether we will achieve an FDA clearance of the Senhance Ultrasonic Instrument System in the 2019 first quarter, whether we will commercially launch the Ultrasonic Instrument System in CE Mark countries in the 2018 fourth quarter, whether we will receive FDA 510(k) clearance for our expanded instrument set, including 3mm diameter instruments, by the end of 2018, whether we will submit our FDA 510(k) clearance for our 5mm diameter articulating instruments during the 2018 fourth quarter, whether we will receive CE Mark for our 5mm diameter articulating instruments during the 2018 fourth quarter, whether we will receive Taiwanese FDA approval for the Senhance Surgical System instruments by the end of 2018 and whether we will have sufficient cash to fund the business through 2020, assuming the funding of the $20 million in potential future debt tranches available under our existing debt financing agreements. 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

For TransEnterix, Inc.
Investors:
Mark Klausner, +1-443-213-0501
invest@transenterix.com
or
Media:
Joanna Rice, + 1-951-751-1858
joanna@greymattermarketing.com

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