Acelity Names R. Andrew Eckert President and Chief Executive Officer

April 05, 2017

SAN ANTONIO–(BUSINESS WIRE)–Acelity L.P. Inc., a leading global advanced wound care company, today announced that it has named R. Andrew Eckert as President and Chief Executive Officer. Eckert succeeds Joseph Woody, who is leaving Acelity following the successful divestiture of the company’s LifeCell division earlier this year.

“We have a proven and experienced leader at the helm as we embark on a promising new phase in the transformation of Acelity,” said Buddy Gumina, Chairman of the Acelity Board of Directors. “Andy brings a significant set of expertise and experience from across the healthcare and technology sectors and will be a tremendous addition to the team as we concentrate on developing and expanding our industry-leading portfolio of advanced wound therapies.”

Eckert is a seasoned executive and brings to his new role considerable experience as chief executive of numerous public and private healthcare technology and services companies. He is the former CEO of TriZetto Corporation, a provider of world-class healthcare information technology and service solutions that was acquired by Cognizant Technology Solutions in 2014. In addition to TriZetto, Eckert has led five other companies, including CRC Health Group, Eclipsys Corporation, ADAC Laboratories, and most recently, Valence Healthcare in 2016. He serves as Chairman of the Board of Directors of Varian Medical Systems, and is a member of the Board of Directors of Becton, Dickinson and Company.

“This is a remarkable time for Acelity as we navigate the complex evolution of healthcare delivery in markets around the world,” said Eckert. “I welcome the challenge and look forward to leading Acelity’s talented team of more than 4,800 colleagues worldwide at this point in the company’s progression. We have an important opportunity to realize growth by embracing the shift to value-based care and delivering to patients and customers innovative products and therapies that address the burdens of treating chronic and acute wounds.”

“On behalf of the Acelity Board of Directors, I would like to thank Joe Woody for his leadership of the company since 2011,” added Gumina. “Joe introduced Acelity to the marketplace by successfully leading the integration of KCI, Systagenix and LifeCell to create a global leader in medical device and technology and oversaw a period of significant expansion in new product development and therapy adoption. With the successful divestiture of LifeCell, we look ahead to an exciting new chapter of growth and opportunity for Acelity.”

“I am proud of our achievements at Acelity during the past several years,” said Joe Woody. “As I reflect on what we accomplished, perhaps most important to me is the number of patients we are able to now reach with the Acelity portfolio. Looking ahead, I know that the passion and drive of everyone at Acelity to improve the lives of people around the world will lead to innovative new solutions in advanced wound therapy and as an ongoing shareholder of Acelity, I am very excited about the company’s next phase of growth.”

About Acelity

Acelity L.P. Inc. and its subsidiaries are a global advanced wound care company that leverages the strengths of Kinetic Concepts, Inc. and Systagenix Wound Management, Limited. Available in more than 90 countries, the innovative and complementary ACELITY™ product portfolio delivers value through solutions that speed healing and lead the industry in quality, safety and customer experience. Headquartered in San Antonio, Texas, Acelity employs nearly 5,000 people around the world.

Contacts

Acelity L.P. Inc.
Corporate Communications
Cheston Turbyfill, +1-210-515-7757
cheston.turbyfill@acelity.com
or
Investor Relations
Caleb Moore, +1-210-255-6433
caleb.moore@acelity.com

Integra LifeSciences Announces Expansion of Credit Facility to include new $700 million term loan

PLAINSBORO, N.J., April 04, 2017 (GLOBE NEWSWIRE) — Integra LifeSciences Holdings Corporation (NASDAQ:IART), a leading global medical technology company, today announced that it has increased its credit facility with its bank group led by Bank of America, N.A.

The expanded credit facility includes the following terms:

  • An increase in the credit facility from $1.5 billion to $2.2 billion, consisting of an expanded term loan of $1.2 billion with no change to the existing revolving line of credit of $1.0 billion;
  • The $700 million incremental term loan will be made available in a single drawing on a delayed basis, at the time of closing the Codman Neurosurgery acquisition;
  • An increase in the Company’s maximum consolidated total leverage ratio to 5.5 times EBITDA, as calculated per the credit agreement, for an incremental 25 basis point rate as well as a 5 basis point incremental commitment fee;
  • No other changes in pricing terms or commitment fees; and,
  • No change in maturity of the credit facility (December 7, 2021).

“We are pleased to announce that we have secured the financing for our planned acquisition of Codman Neurosurgery under favorable credit terms,” said Glenn Coleman, chief financial officer, Integra LifeSciences.  “We continue to expect the acquisition to close in the fourth quarter of 2017, and with this new agreement in place, retain the strength and flexibility of our balance sheet.”

Integra LifeSciences plans to use $700 million of the incremental term loan, together with borrowings from the existing revolving facility, to finance the acquisition of Codman Neurosurgery from Johnson & Johnson, which was previously announced on February 15, 2017. Borrowings from the existing revolving facility will also be used to cover fees and expenses incurred in connection with the credit facility expansion and for general corporate purposes.

The incremental term loan will be made available upon closing of the Codman Neurosurgery acquisition.  As a result, Integra LifeSciences will not incur a material financial impact related to this financing until the closing date of the acquisition, which is expected to be in the fourth quarter of 2017. Around the time of closing, Integra will provide an update to its 2017 financial outlook.

As previously stated on February 15, 2017, Integra expects the Codman Neurosurgery transaction to be accretive to adjusted* EPS by at least $0.22 in the first full year after closing and increasing thereafter, and to GAAP EPS by the end of the third year.

About Integra

Integra LifeSciences is dedicated to limiting uncertainty for clinicians, so they can concentrate on providing the best patient care.  Integra offers innovative solutions, including leading plastic and regenerative technologies, in specialty surgical solutions, orthopedics and tissue technologies.  For more information, please visit www.integralife.com.

Forward-Looking Statements

This news release contains “forward-looking statements”, including statements regarding the proposed transaction and the ability to consummate the proposed transaction. Statements in this document may contain, in addition to historical information, certain forward-looking statements. Some of these forward-looking statements may contain words like “believe,” “may,” “could,” “would,” “might,” “possible,” “should,” “expect,” “intend,” “plan,” “anticipate,” or “continue,” the negative of these words, other terms of similar meaning or they may use future dates. Forward-looking statements in this document include without limitation statements regarding the planned completion of the proposed acquisition, the benefits of the proposed acquisition, including future financial and operating results, Integra’s or the Codman Neurosurgery business’s plans, objectives, expectations and intentions and the expected timing of completion of the proposed acquisition.   It is important to note that Integra’s goals and expectations are not predictions of actual performance.  Actual results may differ materially from Integra’s current expectations depending upon a number of factors affecting the Codman Neurosurgery business and Integra’s business and risks and uncertainties associated with acquisition transactions.  These factors include, among other things: successful closing of the proposed acquisition; the risk that competing offers will be made for the Codman Neurosurgery business before the binding offer is accepted; the risk that the binding offer may not accepted on a timely basis or at all; the ability to obtain required regulatory approvals for the proposed acquisition (including the approval of antitrust authorities necessary to complete the proposed acquisition), the timing of obtaining such approvals and the risk that such approvals may result in the imposition of conditions, including with respect to divestitures, that could materially adversely affect Integra, the Codman Neurosurgery business and the expected benefits of the proposed acquisition; the risk that a condition to closing of the proposed acquisition may not be satisfied on a timely basis or at all, the failure of the proposed acquisition to close for any other reason and the risk liability to Integra in connection therewith; access to available financing (including financing for the acquisition) on a timely basis and on reasonable terms; the effects of disruption caused by the proposed acquisition making it more difficult for Integra to execute its operating plan effectively or to maintain relationships with employees, vendors and other business partners; stockholder litigation in connection with the proposed acquisition; Integra’s ability to successfully integrate the Codman Neurosurgery business and other acquired businesses; global macroeconomic and political conditions; the difficulty of predicting the timing or outcome of product development efforts and regulatory agency approvals or actions, if any; physicians’ willingness to adopt and third-party payers’ willingness to provide reimbursement for Integra’s and the Codman Neurosurgery business’s existing, recently launched and planned products; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; and other risks and uncertainties discussed in Integra’s filings with the SEC, including the “Risk Factors” sections of Integra’s Annual Report on Form 10-K for the year ended December 31, 2016 and subsequent quarterly reports on Form 10-Q. Integra undertakes no obligation to update any forward-looking statements as a result of new information, future developments or otherwise, except as expressly required by law. All forward-looking statements in this document are qualified in their entirety by this cautionary statement.

*Non-GAAP Financial Metrics

Adjusted EPS is calculated by dividing adjusted net income attributable to diluted shares by diluted weighted average shares outstanding. The measure of adjusted net income consists of GAAP net income from continuing operations, excluding: (i) global enterprise resource planning (“ERP”) implementation charges; (ii) structural optimization charges; (iii) certain employee severance charges; (iv) acquisition-related charges; (v) convertible debt noncash interest; (vi) intangible asset amortization expense; and (vii) income tax impact from adjustments and other items.

A reconciliation of Integra’s estimate for accretion to adjusted EPS is not available because estimates for acquisition-related charges, interest expense associated with financing transactions that have not yet closed, and tax rate will not be available until the transaction closes.

The Company believes that the presentation of the various adjusted metrics provide important supplemental information to management and investors regarding financial and business trends relating to the Company’s financial condition and results of operations.

Contacts:

Integra LifeSciences Holdings Corporation

Investor Relations:
Angela Steinway
(609) 936-2268
angela.steinway@integralife.com

Michael Beaulieu
(609) 750-2827
michael.beaulieu@integralife.com

Restructuring at Stryker will mean ‘limited reductions of workforce’

By Al Jones | March 29, 2017

PORTAGE, MI — Stryker Instruments division is undergoing an organizational restructuring that will mean a loss of jobs for an undisclosed number of people at the medical technologies company.

“After a thoughtful evaluation, we have determined that organizational changes are needed to help drive efficiencies across our business, including limited reductions in our workforce,” the company stated in a press release issued in response to inquiries Wednesday.

It went on to say, “These changes will allow us to invest in important areas to build new capabilities that will help us keep growing in Kalamazoo and continue meeting the needs of our customers.”

Stryker Instruments designs, manufactures and markets specialty surgical equipment, operating room products, orthopedic saws, drills and accessories. It also make advanced systems for such things as pain management and waste management.

“The Kalamazoo community has played an important role in our company’s history,” the company stated. “Our founder started the business here and today we have multiple manufacturing and corporate offices in the area. We are committed to strengthening that relationship through our upcoming expansion in Portage.”

Portage Mayor Peter Strazdas said he has not been told how many people will be affected by the restructuring and he hopes the company is working to find them other opportunities. But he said he understands that large corporations have ups and downs and hopes internal changes will help make Stryker a stronger company in the long run.

 

READ THE REST HERE

Providence Medical Technology Receives New FDA 510(k) Clearances and Bolsters Executive Management Team

WALNUT CREEK, Calif., Mar 29, 2017 /PRNewswire/ — Providence Medical Technology, Inc., an innovator in tissue-sparing, cervical-fusion technology, announced the addition of two industry veterans to the commercial leadership team.  Scott Lynch has joined the company to lead Global Marketing, and Michael Scott is assuming International leadership.  Together, Mr. Lynch and Mr. Scott have over 40 years of relevant industry experience.

Mr. Lynch joins the company with over 22 years of medical device and 15 years of spine industry marketing experience having previously served as Vice President of Global Marketing at DFINE, VertiFlex, and Zimmer Spine.

Mr. Scott joins Providence following over 16 years at ArthroCare as Vice President of OUS Sports Medicine, Vice President of Asia Pacific Commercial Operations, and US Vice President ENT Sales at Smith & Nephew.

Providence also announced recent 510(k) clearances from the FDA for the standalone use of the CAVUX™ Cervical Cage-L System as well as approval for its ALLY™ Facet Screws.  These new clearances are complimentary to the company’s flagship DTRAX® Spinal System and are all provided terminally sterile for single-use to ensure efficiency and consistency.

Scott Lynch and Michael Scott are important additions to our Executive Management team at Providence.  Their veteran leadership and successful experience with high growth businesses make them an ideal fit for Providence at this exciting stage of our business,” said Jeff Smith, CEO of Providence Medical Technology.  “With these new 510(k) clearances, we are pleased to offer our surgeon customers stand-alone anterior stabilization and posterior non-segmental stabilization for their cervical fusions.”

The CAVUX™ Cervical Cage-L System is manufactured from medical grade titanium and available in a variety of sizes.  The implant offers proprietary grit-blasted and acid-etched surfaces, a large space for allogenic and autogenous bone graft and includes self-drilling and self-tapping screws for additional, standalone fixation.

The ALLY™ Facet Screws provide temporary stabilization as an adjunct to spinal fusion.  The titanium implants are available in a variety of sizes to accommodate patient anatomy and are intended to provide mechanical support and stability until spinal fusion is achieved.

Providence Medical Technology’s family of products for cervical spinal fusion includes instruments, intervertebral cages, orthopedic bone screws, and allograft bone.  All products are provided sterile for single use only.

About Providence Medical Technology, Inc.
Providence Medical Technology, Inc. is a privately-held medical device company developing innovative solutions addressing the $2 billion worldwide cervical spine market. The company’s focus is on commercializing the DTRAX® platform of single-use, tissue-sparing instruments and CAVUX™ and ALLY™ implants for cervical fusion, as well as other technologies that improve cervical spine procedures for both physicians and patients.

For more information, visit www.providencemt.com

 

SOURCE Providence Medical Technology, Inc.

Integra LifeSciences Announces Commercial Expansion of the Cadence® Total Ankle System

PLAINSBORO, N.J., March 28, 2017 (GLOBE NEWSWIRE) — Integra LifeSciences Holdings Corporation (NASDAQ:IART), a leading global medical technology company, today announced full commercial availability of its Cadence® Total Ankle System, a new ankle prosthesis developed in partnership with four world leading foot and ankle surgeons – Dr. Tim Daniels (University of Toronto), Dr. David Pedowitz (Rothman Institute, Philadelphia, Pa.), Dr. Selene Parekh (Duke University, Durham, N.C.) and Dr. Christopher Hyer (Orthopedic Foot & Ankle Center, Westerville, Ohio).

More than 200 Cadence total ankle procedures have been successfully performed in seven countries, since initial clinical use more than a year ago.  During this period, instrumentation updates and enhanced surgeon training were introduced, designed to further improve quality, patient safety, and procedural efficiency of the system.

Integra completed corrective actions required to close an FDA recall related to the clarification of the system surgical technique, which addressed a small percentage of intra-operative posterior tibial fractures occurring due to technique error.  The recall required no return of product, and since the implementation of the clarified surgical technique, no subsequent posterior tibial fractures have occurred in more than 100 procedures.

The Cadence system has garnered positive feedback among its users for advancements in implant and instrument design, along with a streamlined surgical technique.  Cadence incorporates several features to accommodate various patient anatomies, reduce potential clinical complications, and address common challenges associated with ankle arthroplasty procedure.  Key implant features include:

  • Side-specific, anatomical tibial components, designed to avoid fibular impingement.
  • Side-specific, anatomical talar components, designed to minimize resected talar bone and to preserve vascularity in the ankle.
  • Bearing insert components manufactured from a highly crosslinked ultra-high molecular weight polyethylene (HXL UHMWPE) for improved wear characteristics, and patent pending-biased sagittal profile options to address patients with subluxed talar anatomy.

“I’ve implanted over 50 Cadence Total Ankle prostheses.  I am very impressed with the versatility, reliability, reproducibility, and short-term outcomes of this implant,” said Dr. Tim Daniels. “The streamlined and reliable operative instruments and techniques of this procedure, combined with an anatomical design, offer significant advantages over other ankle systems on the market today.”

The Cadence Total Ankle System was previously available in a limited market release. The Cadence system is now fully available in the United States, Canada, and select European countries.  Integra plans to initiate several global post-market clinical studies with the Cadence system to further support product efficacy.

About Integra
Integra LifeSciences is dedicated to limiting uncertainty for clinicians, so they can concentrate on providing the best patient care.  Integra offers innovative solutions, including leading plastic and regenerative technologies, in specialty surgical solutions, orthopedics and tissue technologies.  For more information, please visit www.integralife.com.

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning the products and services provided by Integra. Such forward looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results. Among other things, the willingness of surgical professionals to use Integra products may affect the prospects for their use in surgical procedures. In addition, the economic, competitive, governmental, technological and other factors, identified under the heading “Risk Factors” included in Item IA of Integra’s Annual Report on Form 10-K for the year ended December 31, 2015 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.

CONTACT: Integra LifeSciences Holdings Company

Investors
Angela Steinway
609-936-2268
angela.steinway@integralife.com

Michael Beaulieu
609-750-2827
michael.beaulieu@integralife.com

Media
Laurene Isip
609-750-7984
laurene.isip@integralife.com

Researchers Find Knee Replacement Surgery May Have Minimal Effect on Quality of Life and Unattractive Economic Outcomes

(NEW YORK — April 1, 2017) Knee replacement surgery for patients with osteoarthritis, as currently used, provides minimal improvements in quality of life and is economically unattractive, according to a study led by Mount Sinai researchers and published today in the BMJ. However, if the procedure was only offered to patients with more severe symptoms, its effectiveness would rise, and its use would become economically more attractive as well, the researchers said.

“Given its limited effectiveness in individuals with less severely affected physical function, performance of total knee replacement in these patients seems to be economically unjustifiable,” said Bart Ferket, MD, PhD, Assistant Professor, Department of Population Health Science and Policy at the Icahn School of Medicine at Mount Sinai and lead author on the study. “Considerable cost savings could be made by limiting eligibility to patients with more symptomatic knee osteoarthritis. Our findings emphasize the need for more research comparing total knee replacement with less expensive, more conservative interventions, particularly in patients with less severe symptoms.”

About 12 percent of adults in the United States are affected by osteoarthritis of the knee. The annual rate of total knee replacement has doubled since 2000, mainly due to expanding eligibility to patients with less severe physical symptoms. The number of procedures performed each year now exceeds 640,000 at a total annual cost of about $10.2 billion, yet health benefits are higher in those with more severe symptoms before surgery.

A team of researchers from the Icahn School of Medicine at Mount Sinai and Erasmus University Medical Center in Rotterdam, the Netherlands, set out to evaluate the impact of total knee replacement on quality of life in people with knee osteoarthritis. They also wanted to estimate differences in lifetime costs and quality adjusted life years or QALYs (a measure of years lived and health during these years) according to level of symptoms.

They analyzed data from two U.S. cohort studies: one with 4,498 participants aged 45-79 with or at high risk for knee osteoarthritis from the Osteoarthritis Initiative (OAI), and the other involving 2,907 patients from the Multicenter Osteoarthritis Study (MOST). OAI participants were followed up for nine years and MOST patients were followed up for two years. Quality of life was measured using a recognized score of physical and mental function, known as SF-12, and using some osteoarthritis-specific quality of life scores.

They found that quality of life outcomes generally improved after knee replacement surgery, although the effect was small. The improvements in quality of life outcomes were found higher when patients with lower physical scores before surgery were operated on.

In a cost-effectiveness analysis, current practice was more expensive and in some cases seemed even less effective compared with scenarios in which total knee replacement was performed only in patients with lower physical function.

“Our findings show opportunity for optimizing delivery of total knee replacement in a cost-effective way, finding the patients who will benefit the most, delivering the treatment at the correct point in their disease progression, and optimizing the cost so we can deliver the benefit to all who need it,” said Madhu Mazumdar, PhD, Director of the Institute for Healthcare Delivery Science at the Mount Sinai Health System, Professor of Biostatistics, Department of Population Health Science and Policy at the Icahn School of Medicine at Mount Sinai, and co-author of the study.

Funding for the cohort studies used in the analysis was provided by the National Institutes of Health, Merck Research Laboratories, Novartis Pharmaceuticals Corporation, GlaxoSmithKline, and Pfizer. Dr. Ferket is supported by the American Heart Association. The researchers have no competing interests to disclose.

About the Mount Sinai Health System

The Mount Sinai Health System is an integrated health system committed to providing distinguished care, conducting transformative research, and advancing biomedical education. Structured around seven hospital campuses and a single medical school, the Health System has an extensive ambulatory network and a range of inpatient and outpatient services—from community-based facilities to tertiary and quaternary care.

The System includes approximately 7,100 primary and specialty care physicians; 12 joint-venture ambulatory surgery centers; more than 140 ambulatory practices throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and 31 affiliated community health centers. Physicians are affiliated with the renowned Icahn School of Medicine at Mount Sinai, which is ranked among the highest in the nation in National Institutes of Health funding per investigator. The Mount Sinai Hospital is in the “Honor Roll” of best hospitals in America, ranked No. 15 nationally in the 2016-2017 “Best Hospitals” issue of U.S. News & World Report.  The Mount Sinai Hospital is also ranked as one of the nation’s top 20 hospitals in Geriatrics, Gastroenterology/GI Surgery, Cardiology/Heart Surgery, Diabetes/Endocrinology, Nephrology, Neurology/Neurosurgery, and Ear, Nose & Throat, and is in the top 50 in four other specialties. New York Eye and Ear Infirmary of Mount Sinai is ranked No. 10 nationally for Ophthalmology, while Mount Sinai Beth Israel, Mount Sinai St. Luke’s, and Mount Sinai West are ranked regionally. Mount Sinai’s Kravis Children’s Hospital is ranked in seven out of ten pediatric specialties by U.S. News & World Report inBest Children’s Hospitals.”

For more information, visit http://www.mountsinai.org/, or find Mount Sinai on Facebook, Twitter and YouTube.

Medtronic, DePuy Synthes Lead Cervical and Lumbar Artificial Disc Market

BY MILITARY NEWS

VANCOUVER, BC–(Marketwired – March 28, 2017) – According to a new series of reports on the U.S. spinal implants and vertebral compression fracture market by iData Research (www.idataresearch.com), the motion preservation segment will be the fastest growing in the market fueled by the release of a vast array of new devices in already established markets, most notably the cervical (CAD) and lumbar artificial disc (LAD) markets. Procedure number growth, as well as favorable reimbursement policies is expected for these devices driven by positive clinical results involving novel and emerging technologies.

However, traditional fixation procedures will limit growth of the artificial disc market. The traditional cervical, thoracolumbar and interbody fixation and fusion markets are currently the gold standard for treatment of many indications that artificial discs address. These devices cost less than artificial discs, which can be a major preference factor for many doctors and patients.

“Traditional fusion markets are expected to show consistent growth rate but will eventually begin to stabilize in value over the next several years as motion preservation and minimally invasive surgery (MIS) procedures become increasingly common,” explains Dr. Kamran Zamanian, CEO of iData. “As the U.S. spinal implant market grows in size, more competitors will enter the markets as well as existing competitors broadening their portfolios with new products including motion preservation implants.”

 

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SafeOp Surgical Files for Ninth Patent

March 27, 2017

HUNT VALLEY, Md.–(BUSINESS WIRE)–SafeOp Surgical, Inc. (“SafeOp”), a privately held medical device company, today announced that it has filed its ninth patent application for innovations surrounding the monitoring of somatosensory-evoked potentials during surgeries. SafeOp developed and markets the EPAD™ system, a revolutionary neuromonitoring system that enables the detection of nerve damage and post-operative residual paralysis during surgical procedures. This latest filing is for the capability to reduce false positive alerts to nerve damage during surgeries. The company already holds patents for detection of nerve injury in the United States, Australia, Japan and China, and has several patents pending that include signal processing and high specificity in alerting to signal change, and on neuromuscular junction testing and spinal cord stimulator paddle placement.

“Electrical noise from nearby equipment often causes false alerts that are time consuming to deal with,” said Richard O’Brien, MD, MBA, SafeOp’s vice president of development and chief medical officer. “This new patent provides a method to condition the monitored responses and calculate an alert so that the likelihood of a false positive from a noisy signal is dramatically reduced while preserving the sensitivity of the monitoring to real changes.”

SafeOp’s EPAD™ system, which allows monitoring of both the spinal cord and peripheral nerves, was developed specifically for the rapid detection of perioperative nerve injury (“PNI”). PNI is a frequent complication of some surgeries (e.g., orthopedic, general, cardiac, or urological surgery), whereby peripheral nerves may be damaged due to unrecognized extended compression or stretching, or compromise of their blood supply. The EPAD™ system also allows easy-to-use quantitative monitoring of the neuromuscular junction to help detect another frequent complication, post-operative residual paralysis. This may occur when paralyzing agents have not sufficiently worn off at the end of surgery. The EPAD™ system provides real-time feedback, allowing caregivers to adjust the patient’s position in time to avoid nerve injury, or intervene when residual paralysis is present.

“We continue to innovate our EPAD™ system technology with powerful capabilities that will make it the most cost-effective intraoperative monitoring solution available,” said Gene Cattarina, SafeOp’s president and chief executive officer. “With its unique ability to economically and efficiently acquire somatosensory-evoked potentials, the EPAD™ is appropriate for all types of surgeries and an ideal low cost alternative to expensive insourced- and outsourced-driven neuromonitoring for certain spine and other surgeries.”

About SafeOp Surgical, Inc.

SafeOp Surgical, Inc. is a Hunt Valley, MD-based medical device company that has developed the FDA-approved EPAD™ system. The EPAD™ system enables simple-to-use neurological monitoring in a wide array of surgical procedures where full monitoring – which requires the continuous presence of a technologist and neurologist – may not be indicated, cost-effective or feasible. SafeOp currently markets the EPAD™ system to medical centers throughout the United States. For more information, visit SafeOp’s website at www.safeopsurgical.com.

Contacts

SafeOp Surgical, Inc.
Chris Brown, 410-773-9601
Cell: 214-213-9379
cbrown@safeopsurgical.com

Altus Spine announces Silverstone Titanium FDA 510(k) Clearance

West Chester PA, March 17, 2017 – Altus Spine, a leader in the development and innovation of medical devices used in spinal correction surgery, announces the FDA clearance of the Silverstone Titanium Interbody Fusion (IBF) System.  The Silverstone Titanium IBF System is designed to be implanted in the lumbar spine to aid in the stability and support of vertebral bodies during fusion.

The Silverstone Titanium IBF System is a simple, yet comprehensive, system that includes both PLIF and TLIF implants, and supporting instrumentation.  Introducing Altus Spine’s MicroLOC™ technology, the Silverstone Titanium IBF System incorporates the latest combination of macro- and micro-endplate surface texture design.  MicroLOC™ surface technology results in a proprietary, porous grip surface intended to provide an optimal environment for initial bone growth while minimizing the potential for implant migration.

“The development of MicroLOC™ surface technology was in response to surgeon requests for implant surfaces that encourage better on-growth of bone,” says Michael Fitzgerald, CEO and President of Altus Spine.  “The Silverstone Titanium implant is the first implant to employ MicroLOC™ surface technology.  The combination of easy implant insertion with the MicroLOC™ porous surface results in a state-of-the-art IBF implant.”

The Silverstone Titanium IBF System was created through the concentrated efforts of surgeons, engineers, and machinists to deliver the most advanced and cost effective implant system possible.  Its release closely follows last month’s market release of the Fuji Cervical Plate System.

Indications

The Altus Spine Titanium Interbody Fusion System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease (“DDD”) at one or two contiguous spinal levels from L2-S1.  DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.  These patients should have had six months of non-operative treatment.  These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

The Altus Spine Titanium Interbody Fusion System is to be combined with cleared supplemental fixation systems, such as the Altus Spine Pedicle Screw System.

Altus Spine

Based in West Chester, PA, Altus Spine is dedicated to creating the next generation of medical devices.  Altus strives to improve patient care by designing and developing products to meet the highest standards in an ever changing and evolving field.  Implemented and used by over 100 hospitals across the United States, Altus is among the fastest growing spinal implant companies in the world.  For additional information, and to inquire about distribution opportunities , please visit www.altus-spine.com

Forward Looking Statements

All statements made in the above press release, with the exception of historical fact, may be forward-looking statements that include risk, uncertainty, and assumptions.  These factors could cause Altus Spine’s results to differ from those predicted if they do not occur as expected.  These uncertain factors include, but are not limited to; acceptance and clearance of the company’s surgical products and procedures, development of new products and procedures, innovations and alterations to existing products and procedures, clinical and statistical verification of the success using Altus Spine’s products, company’s ability to maintain and monitor inventory as it releases new products, its ability to hire and retain personnel, and any other risks stated in prior or subsequent news releases.  All risks and potential complications can be found in our most recent 510k report from the Food and Drug Administration (FDA).  Given the constantly changing market, readers are encouraged to not place undue reliance on forward looking statements.  Altus Spine assumes no obligation to update forward-looking statements as these changes occur, or as events and circumstances are altered, after the date they are posted.

Organogenesis Inc. Announces Acquisition of NuTech Medical

CANTON, Mass. and BIRMINGHAM, Ala., March 28, 2017 /PRNewswire/ — Organogenesis Inc., a commercial leader in the field of regenerative medicine, is expanding beyond wound care with the acquisition of NuTech Medical.  The newly-combined company will offer a portfolio of advanced and next generation products for the wound care and surgical biologics markets.

Based in Birmingham, AL, NuTech Medical is an emerging player, offering a diverse portfolio of amniotic products for a variety of surgical and wound care needs.  NuTech Medical’s non-biologics product line will remain as a separate company, NuTech Spine.

“This is an important transaction for the regenerative medicine field.  It unites two pioneering companies, each with decades of experience in bringing quality biologics products to patients around the world,” said Gary S. Gillheeney, Sr., President and CEO of Organogenesis.  “This is a compelling, highly complementary combination of best-in-class, innovative products in both the regenerative wound and surgical biologics markets. Organogenesis is currently growing at 40% a year, and we have patiently waited to enter the amniotic tissue space.  Specifically, we’ve been watching the development of next-generation amniotic products, and we’ve found in NuTech Medical what we believe is the field’s most promising product portfolio and pipeline, with a technology platform that’s really unparalleled in the field.”

NuTech Medical will continue existing operations as a new division of Organogenesis Inc., focused on the surgical biologics arena.  It will continue to develop and distribute NuTech’s product line from its existing facilities in Birmingham, AL, with plans to grow its existing surgical sales network of approximately 150 representatives, significantly expanding Organogenesis’ sales capabilities.  NuTech’s President & CEO Howard Walthall will join Organogenesis Inc. as President of the company’s Surgical Division, and as Senior Vice President for Strategy and Development for Organogenesis Inc.

“This is an exciting time for NuTech Medical, as we share with Organogenesis a commitment to regenerative product innovation, and a culture of scientific advancement and exceptional customer service,'” said Mr. Walthall.  “Like NuTech, Organogenesis has decades of experience bringing ground-breaking technology to market, and building a large and loyal customer base.  This acquisition enables us to drive significant growth in both the wound and surgical biologics markets together, through our combined R&D programs, and our strong and proven distribution networks.”

NuTech Medical’s portfolio includes an amniotic product line for both soft tissue and bone applications, utilized in multiple markets including wound healing and surgery.  The product line includes Affinity, a novel, fresh amniotic allograft; NuShield, a dehydrated terminally-sterilized allograft that comprises both the amnion and chorion layers; and NuCel and ReNu, cryopreserved allografts derived from human amnion and amniotic fluid, as well as other complementary products.  NuTech’s proprietary BioLoc™ process is the field’s state-of-the-art technology for preserving the native structure of the amnion and chorion membranes, optimized to provide excellent strength, flexibility, and handling.  NuTech’s proprietary AlloFresh™ process allows for the fresh hypothermic storage of amniotic tissues while retaining their structural integrity, viability and native benefits.

About Organogenesis
Having pioneered the field, Massachusetts-based Organogenesis Inc. is a global leader in regenerative medicine, offering a portfolio of bioactive and acellular biomaterials products for advanced wound care, orthopedics and spine. Organogenesis’ versatile portfolio is designed to treat a variety of patients with repair and regenerative needs.

Originally founded as a spin-off from technology developed at MIT in 1985, Organogenesis pioneered the advanced wound care space with the first-ever FDA approval of a mass-produced living cell-based therapy, Apligraf®, for the treatment of chronic venous leg ulcers.  In 2014, Organogenesis acquired Dermagraft®, a living cell-based technology approved by the FDA for the treatment of chronic diabetic foot ulcers. In 2016, the company launched PuraPly Antimicrobial™, an FDA-cleared purified type 1 collagen + PHMB-antimicrobial device, designed to manage and prevent the reformation of biofilm in wounds.

CONTACT:
Angelyn Lowe
(781) 830-2353
alowe@organo.com

SOURCE Organogenesis Inc.