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Current Issues in Spine

February 2-4, 2017
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SpineTop Stories

SI-BONE – SI Joint Fusion Study Showed Patients Were 11X Less Likely to be Taking Opioids at Last Follow-Up Using the iFuse Implant™

May 1, 2017 OrthoSpineNews

SAN JOSE, Calif., May 1, 2017 /PRNewswire/ — SI-BONE, Inc., an innovative medical device company that pioneered the use of the iFuse Implant System® (“iFuse”), a triangular shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced results from two recently published comparative studies showed patients treated with the iFuse ImplantTM were significantly less likely to be taking opioid medications than patients treated with non-surgical care.  The most recently published paper titled Minimally Invasive Sacroiliac Joint Fusion, Radiofrequency Denervation and Conservative Management for Sacroiliac Joint Pain: Six Year Comparative Study,1 published in the journal Neurosurgery, showed that patients treated with iFuse were 11X less likely to be taking opioids at last follow-up than those who were denied coverage for iFuse and treated with either conservative care or radiofrequency ablation (>80% vs, 7%) (Figure 1, below).

“Given the catastrophic opioid addiction epidemic we are currently dealing with in this country today, any procedure, device or technology that demonstrates the ability to significantly reduce opioid use should be made available to anyone who can benefit,” said Frank Guinta, former New Hampshire congressman and co-founder of the Congressional Bipartisan Committee on opioid and heroin addiction. “Given the overwhelming amount of high quality level 1 clinical evidence associated with the iFuse Implant, it seems prudent and obvious to me that anyone properly diagnosed as an appropriate surgical candidate should have access to the procedure.”

Figure 1
Figure 1
Figure 2
Figure 2

 

Figure 1Figure 2

A second publication of two-year results from INSITE,2 a randomized controlled trial of MIS SI joint fusion with the iFuse Implant compared to non-surgical management, showed a 30% decrease from baseline in the number of subjects taking opioids at two years compared to patients treated non-surgically (Figure 2, below).

“It’s rather remarkable that in both studies the number of patients taking opioids in the iFuse Implant group was significantly lower than the number of patients taking opioids in the non-surgical care group in spite of a lack of a structured program focused on opioid use dependence,” said Daniel Cher, MD, Vice President of Clinical Affairs at SI-BONE.  “It’s clear from the evidence in these two studies that treatment with the iFuse Implant was associated with a reduction in opioid use in patients with chronic SI joint pain who were taking opioids and who no longer responded to non-surgical care.”

About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading innovative medical device company dedicated to the development, manufacture and commercialization of minimally invasive surgical devices for the treatment of patients with low back symptoms related to certain sacroiliac (SI) joint disorders.  SI-BONE, Inc. first received 510(k) clearance to market its iFuse Implant System (“iFuse”) from the Food and Drug Administration (FDA) in November 2008. The CE mark for European commercialization was obtained in November 2010.

The iFuse Implant System provides a minimally invasive surgical solution to fuse the SI joint using patented triangular titanium implants that create an interference fit within the ilium and sacrum.  The triangular implant shape, combined with the press fit insertion, is designed to provide immediate fixation by minimizing rotational motion.  The implants have a porous surface that provide an ideal environment for bone on-growth and ingrowth*, facilitating long-term fusion of the joint.  iFuse is the only commercially available SI joint fusion device in the United States with published prospective clinical evidence that demonstrates safety, effectiveness and economic benefits, including three large multicenter studies, two of which are randomized controlled trials.  Currently, there are more than 50 peer-reviewed publications supporting positive clinical outcomes, safety, biomechanics, and the economic value of iFuse (www.si-bone.com/results).  iFuse Implant is the only SI joint fusion device with a FDA clearance recognizing demonstrated improvements in pain, patient function and quality of life following treatment.

The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis.  This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.  There are potential risks associated with the iFuse Implant System.  It may not be appropriate for all patients and all patients may not benefit.  For information about the risks, visit: www.si-bone.com/risks

* MacBarb RF, Lindsey DP, Woods SA, Lalor PA, Gundanna MI, Yerby SA. Fortifying the Bone-Implant Interface Part II: An In Vivo Evaluation of 3D-Printed and TPS-Coated Triangular Implants. Int J Spine Surg. 2017;11. [Accepted, publication pending]

SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2017 SI-BONE, Inc. All Rights Reserved. 9875.050117

1

Vanaclocha V, Herrera JM, Sáiz-Sapena N, Rivera-Paz M, Verdú-López F. Minimally Invasive Sacroiliac Joint Fusion, Radiofrequency Denervation and Conservative Management for Sacroiliac Joint Pain: Six Year Comparative Study. Neurosurgery. 2017 April 20. [Epub ahead of print]. doi: 10.1093/neuros/nyx185.

2

Polly DW, Swofford J, Whang PG, Frank CJ, Glaser JA, Limoni RP, Cher DJ, Wine KD, Sembrano JN, and the INSITE Study Group. Two-Year Outcomes from a Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion vs. Non-Surgical Management for Sacroiliac Joint Dysfunction. Int J Spine Surg. 2016;10.Article 28. doi:10.14444/3028.

 

SOURCE SI-BONE, Inc.

Related Links

http://www.si-bone.com

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RegulatorySpine

Innovasis receives 510k for first Stand-Alone ALIF System made from PEEK-OPTIMA™© HA Enhanced polymer

May 1, 2017 OrthoSpineNews

Salt Lake City, UT, April 28th, 2017 – Innovasis, Inc. is the first company to receive US FDA 510(k) clearance for a Stand-Alone ALIF* System made from PEEK-OPTIMA™© HA Enhanced polymer from Invibio©.  Designed for use in spinal-fusion procedures, the implantable Ax™ Stand-Alone ALIF System implants contain osteoconductive hydroxyapatite (HA) fully integrated into the matrix of the polymer and exposed on all surfaces of the body of the implant, including within the inner walls of the graft chamber.

This is the second PEEK-OPTIMA HA Enhanced device marketed by the company.  At the end of Q416 the company launched a PxHA a PLIF device made from the same material.

The Innovasis Ax Stand-Alone ALIF System is an intervertebral fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-S1). The implant is used to facilitate fusion in the lumbar spine and is inserted using an anterior lumbar interbody fusion (ALIF) procedure.

The Ax Stand-Alone ALIF implant also features a tapered leading edge, which aids in implant insertion within limited anatomical space. It also features a slightly convex profile to match the anatomy of the spine and provide a stable anti-migration surface during the fusion process. The large graft cavity provides increased volume for autograft loading. 

About Innovasis
Innovasis, Inc. is a rapidly growing company engaged in the research, development, manufacturing, and marketing of spinal implant devices and related products. Innovasis offers a spinal product line with implants and instruments that address the major pathologies and focus areas of traditional spinal surgery. Innovasis is fully committed to providing surgeons and distributors with training, support and excellent customer service, thus ensuring the establishment of a strong and long-term strategic partnership.

 

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ReconTop Stories

OrthAlign, Inc. Announces New Leadership Appointments to Drive and Support Corporate Growth Initiatives

May 1, 2017 OrthoSpineNews

ALISO VIEJO, CA (PRWEB) MAY 01, 2017

OrthAlign, Inc., a privately held U.S.-based medical device and technology company providing orthopedic surgeons with advanced precision technologies, announced today the executive appointment of Mike Bushlack as Chief Financial Officer and the promotion of James Young Kim as Vice President and General Manager of International.

Mike Bushlack comes to OrthAlign with over 15 years of financial leadership experience in the medical device industry, working with early growth stage and large multi-national companies. Prior to joining OrthAlign, Mike was Chief Financial Officer of Blue Belt Technologies, Inc. and held executive financial leadership and business development roles at ev3 Inc., Covidien, and Medtronic, garnering a proven track record of partnering with business teams to develop and implement strategic plans and financial processes and focus investments to drive growth and enhance entity value. Mike began his career at KPMG LLP in Minneapolis, where he was a Senior Manager.

James Kim has over 12 years of strategic marketing and sales experience in the medical and healthcare industry, responsible for strategic planning, product and brand management, product development, and multiple launch and global commercialization assignments. Since October 2013, James served as OrthAlign’s Vice President of Sales and Marketing, helping lead the organization through an important growth period, including expansion of OrthAlign technology into key international markets. Prior to joining OrthAlign, James served in key marketing roles with Allergan, CareFusion, and Johnson & Johnson, successfully managing the Natrelle®, Pyxis®, and OneTouch® brands, respectively. James received an MBA from the University of Southern California’s Marshall School of Business.

“The executive appointments of Mike and James are key elements in our continued efforts to successfully expand our customer reach, portfolio of products, and focus in providing world class customer service to our surgeons, hospitals, and surgery centers across the globe,” said Eric B. Timko, OrthAlign’s Chief Executive Officer and Chairman. “We are energized and excited about the growth opportunities before us and are heavily focused on our strategic initiatives as one of the leading technology companies in orthopaedics.”

About OrthAlign, Inc.

OrthAlign is a privately held medical device and technology company, developing advanced technologies that deliver healthier and more pain-free lifestyles to joint replacement patients, globally. We provide healthcare professionals with cutting edge, computer-assisted surgical tools that seamlessly and cost-effectively deliver vital data and clinical results to optimize outcomes for our patients. For more information regarding OrthAlign, please visit http://www.orthalign.com.

“ORTHALIGN®, ORTHALIGN PLUS®, KNEEALIGN®, KNEEALIGN® 2, HIPALIGN®, and UNIALIGN™ are registered trademarks of OrthAlign, Inc.”

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ReconSpine

Ortho Sales Partners Announces the Addition of Amanda Tracy as Senior Vice President of Business Development

May 1, 2017 OrthoSpineNews

SCOTTSDALE, ARIZONA (PRWEB) MAY 01, 2017

Ortho Sales Partners, a global leader in orthopedic sales commercialization services, is pleased to announce the addition of Amanda Tracy as Senior Vice President of Business Development, further filling out its team of orthopedic and spine industry veterans. Ms. Tracy is a talented and well respected industry leader that has spent her career helping companies find solutions to complex problems.

Ms. Tracy is the third high-profile hire for Ortho Sales Partners in recent months and comes at an opportune time as the business continues to grow by assisting companies approach commercialization while mitigating the risks associated with such a big task. In recent years, there has been a huge shift in the market that reveals a reduction of surgeon influence with the adoption of new technologies. Ortho Sales Partners works with orthopedic and spinal device manufacturers to leverage their significant relationships with surgeons, distributors and national buying groups to help their clients realize faster growth while taking advantage of the economies of scale that have been implemented.

Ms. Tracy joins Ortho Sales Partners with 20 plus years of professional expertise. Notable is her most recent 10 years spent as the Vice President of Global Market Development for Musculoskeletal Clinical Regulatory Advisors, LLC ( MCRA).  Ms. Tracy established the business development function after joining MCRA during its early growth stage. Over tenure, Ms. Tracy played an instrumental role in expanding the firm’s portfolio services beyond its initial regulatory affairs service offering. Prior to MCRA, Ms. Tracy held senior product roles that included work for : Cyberonics ( LivaNova), Janssen Pharmaceutica (Johnson and Johnson ) and Eli Lilly and Company.

“I am thrilled to be able to join Ortho Sales Partners executive team at a true industry inflection point, when we can actualize the potential of novel approaches to technology sales execution and commercialization support.” said Ms. Tracy. “As a team, we will work to disrupt a fast-growing industry by building and launching innovative service products that extend Ortho Sales Partners’ current platform and build efficiencies for the industry.”

Maintaining her current geographical location in Southern California, Ms. Tracy will focus on accelerating Ortho Sales Partners innovative line of service offerings to support manufacturers, surgeons, distributors and investors alike. Ms. Tracy will also be representing the brands The De Angelis Group, Surg.io, OrthoExpress and OrthoSpineDistributors.com.

“We are thrilled to bring someone aboard with the pedigree and expertise of Amanda Tracy. We have had the pleasure of knowing her for more than 10 years and have seen first-hand the incremental value she brings to her employers and clients” said Josh Sandberg President, Ortho Sales Partners.  “This hire is another example of our commitment to offering our clients the best possible strategies and outcomes.”

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RoboticsTop Stories

Medrobotics® Corporation Flex® Robotic System Receives Best New Product Award at 2017 Edison Awards

May 1, 2017 OrthoSpineNews

May 01, 2017

RAYNHAM, Mass.–(BUSINESS WIRE)–Medrobotics Corp., a medical products company, announced today that its Flex®Robotic System received a Best New Product Award at the 2017 Edison Awards™. The Company’s rich history of innovation was recognized with a Bronze Award in the Surgical Tools category.

The Edison Awards™ is an annual competition honoring excellence in new product and service development, marketing, human-centered design, and innovation. The competition is open to progressive organizations across the globe. Award winners represent “game changing” products and services, as well as excellence and leadership in innovation. This year, more than 3,000 companies submitted applications. The winners were chosen as the “best of the best” by a panel comprised of individuals selected from the world’s top senior business executives, academics, and innovation professionals.

“Medrobotics is pleased the Flex® Robotic System has received this new recognition for its unique capabilities,” said Samuel Straface, Ph.D., President and CEO of Medrobotics. “Our products overcome the limits of traditional line-of-sight surgical technologies. Surgeons are now able to access difficult to reach anatomy through a single, small entry point and treat patients who might otherwise have required an open surgical procedure.”

Medrobotics’ Flex® Robotic System was designed to provide an affordable, easy-to-use robot-assisted surgical platform for hospitals and surgeons seeking to provide minimally-invasive treatment options to the broadest number of patients. Minimally invasive surgery has demonstrated advantages for patients and providers, such as shorter hospital stays and faster recovery times.

About Medrobotics

Medrobotics Corporation (www.Medrobotics.com) is a privately funded medical device company headquartered in Raynham, Massachusetts. It manufactures and markets the Flex® Robotic System, the world’s first robotic surgical platform with a steerable and shapeable robotic scope. The Flex® Robotic System offers surgeons the unique ability to navigate complex anatomy through a single, small entry point and operate in hard-to-reach anatomical locations that might otherwise be inaccessible with straight, rigid surgical tools. The Company’s vision is to provide more patients with access to minimally invasive surgery. Medrobotics received FDA clearance for the Flex® Robotic System in July 2015, and the CE mark in March 2014.

Contacts

Medrobotics Corp.
Kevin Knight, 214-732-9392

 

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Financial

MiMedx Announces Record Results For First Quarter Of 2017

April 28, 2017 OrthoSpineNews

MARIETTA, Ga., April 28, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative biologics utilizing human placental tissue allografts and patent-protected processes for multiple sectors of healthcare, announced today its record results for the quarter ended March 31, 2017.

First Quarter 2017 Highlights

  • Revenue grew 36% over Q1 2016 revenue
  • Revenue of $72.6 million exceeds upper end of MiMedx guidance range
  • Wound Care revenue of $54.9 million grew 40% over Q1 2016
  • Surgical, Sports Medicine and Orthopedics (SSO) revenue of $17.7 million grew 26% over Q1 2016
  • 24th of last 25 quarters of meeting or exceeding revenue guidance
  • Gross profit margin of 88%
  • Net income of $4.3 million is a 261% increase over Q1 2016
  • Positive Net Cash Flow From Operations of $10.6 million compared to negative $1.0 million in Q1 2016
  • 21st consecutive quarter of positive Adjusted EBITDA*
  • Adjusted Net Income* of $7.4 million is a 51% increase over Q1 2016
  • Adjusted EBITDA* of $12.4 million is a 37% increase over Q1 2016

* See the accompanying tables for definitions of each Non-GAAP metric. Reconciliations of GAAP Net Income to Adjusted EBITDA, GAAP Gross Margin to Adjusted Gross Margin, and GAAP Net Income to Adjusted Net Income and Adjusted Diluted Net Income Per Share appear in the tables below. These non-GAAP measures include, but are not limited to, adjustments for non-cash charges associated with purchase accounting related to the Stability Biologics acquisition, normalization of tax expense, one-time non-recurring cash charges and share based compensation expense.

Results for First Quarter Ended March 31, 2017
The Company recorded record revenue for the 2017 first quarter of $72.6 million, a $19.2 million or 36% increase over 2016 first quarter revenue of $53.4 million. The Company’s gross margin for the quarter ended March 31, 2017, was 88%, as compared to the 85% gross margin in the first quarter of 2016. Net Income for the first quarter of 2017, was $4.3 million, or $.04 per diluted common share, a $3.1 million or 261% increase, as compared to Net Income of $1.2 million, or $0.01 per diluted common share in the first quarter of 2016.  Adjusted EBITDA* for the quarter ended March 31, 2017, was $12.4 million, a $3.3 million or 37% improvement, as compared to Adjusted EBITDA* of $9.1 million for the first quarter of 2016.

Management Commentary on Results
Parker H. “Pete” Petit, Chairman and CEO stated, “We are pleased to have exceeded the top end of our revenue guidance and to have recorded very solid performance on our revenue and profit growth. In light of the impact of the normal seasonality that the market experiences in the first quarter of the year, we are especially satisfied with our growth. With respect to our profit performance, our first quarter GAAP Net Income grew by well over 250% compared to Q1 2016, our Adjusted Net Income grew by 51% over the first quarter of 2016, and our Adjusted EBITDA* grew by 37% over Q1 2016. We expect our profit metrics as a percent of revenue to increase as the year progresses.”

Bill Taylor, President and COO, said, “Both of our sales verticals had strong growth with Wound Care revenue increasing by 40% over the first quarter of 2016 and SSO growing by 26% compared to the first quarter of last year. We are also extremely pleased with our strong operating cash flow performance compared to last year’s first quarter. Our cash flow from operations was $10.6 million, compared to a negative $1.0 million in the first quarter of 2016.  We had another very favorable decline in Days Sales Outstanding (DSO) in our Accounts Receivable during the quarter, which continued the trend experienced in the last half of 2016.”

“Our three new products introduced during 2016, EpiCord®, our new dehydrated human umbilical cord allograft, AmnioFill®, the first product in the MiMedx placental collagen matrix product family to be commercially launched, and OrthoFlo Lyophilized, an extension of the Company’s amniotic fluid product family, are proving to be very impactful in pursuing our market penetration initiatives. We believe the performance of these new products during the first quarter is solid evidence of the contribution they will deliver during 2017 and beyond,” added Taylor.

Petit commented, “I believe that our shareholders are beginning to realize the very productive asset base that the Company has developed over the last six years.  We have developed the management staff, the technology and the intellectual property to smoothly transition our focus towards becoming predominantly a biopharma company.  In addition, our asset base includes the technology differentiator in that it embodies over 220 proteins, the primary methods of action for which we have scientifically proven.  We have also demonstrated the clinical effectiveness of these proteins through approximately 30 different peer reviewed publications.  That is a significant head start in terms of having the resources necessary to proceed down the Investigational New Drug/Biologics License Application (IND/BLA) regulatory pathways for numerous new therapeutic applications of our technology.  As shareholders should be aware, we are completing the phase IIb studies on our first IND for plantar fasciitis.  We will soon be entering our phase III trials.  We have indicated our plans to very shortly file additional INDs on other sports medicine related therapies.  We have indicated some of the areas of focus that will be longer-term opportunities for the Company from the same regulatory approval process.  Your management is quite enthusiastic about our recently announced strategic focus.  We will continue to advise you as our progress in this new strategic area develops.”

Share Repurchase Program
From the May 2014 inception of the Share Repurchase Program through December 31, 2016, the Company acquired $56.1 million in repurchased shares. During the first quarter of 2017, the Company continued to acquire its shares through the Company’s Share Repurchase Program by repurchasing an additional $12.6 million of its shares. Also during the quarter, the Company’s Board of Directors authorized an increase of $20 million to the Company’s Share Repurchase Program. With the first quarter authorizations made by the MiMedx Board, the total amount authorized for the Company’s Share Repurchase Program to date is $86 million.

Liquidity and Cash Flow
Cash on hand as of March 31, 2017, was $30.9 million, as compared to $15.1 million as of March 31, 2016. Net working capital as of March 31, 2017 decreased $3.5 million to $72.3 million, as compared to $75.8 million as of December 31, 2016.  The Company recorded positive net cash flow from operating activities of $10.6 million for the quarter ended March 31, 2016 due primarily to increased Adjusted EBITDA*.

GAAP Earnings
The Company recorded Net Income of $4.3 million for the quarter ended March 31, 2017, or $0.04 per diluted common share, as compared to Net Income of $1.2 million, or $0.01 per diluted common share, for the quarter ended March 31, 2016.  R&D expenses for the first quarter of 2017 were $4.2 million or 6% of Net Sales, an increase of $1.7 million over first quarter 2016 R&D expenses of $2.5 million.

Selling, general and administrative (“SG&A”) expenses for the first quarter of 2017 were $52.9 million, a $12.3 million increase over first quarter of 2016 SG&A expenses of $40.6 million.  Increases in SG&A were due to the continuation of the buildup of the Company’s direct sales force in Wound Care and SSO sales channels, as well as litigation costs.

Revenue Breakdown
The Company distinguishes revenue in two categories: (1) Wound Care and (2) SSO, which includes Original Equipment Manufacturer (“OEM”) applications. For first quarter of 2017, Wound Care revenue was $54.9 million, representing 75.6% of total revenue, and SSO (including OEM) revenue was $17.7 million, representing 24.4% of total revenue.

Second Quarter and Full Year 2017 Guidance Highlights
MiMedx provided its revenue guidance for the second quarter of 2017, increased the low end of its revenue guidance range for full year 2017, and reiterated the remaining full year 2017 guidance that was previously communicated. The Company’s second quarter and full year 2017 guidance includes:

  • Second quarter of 2017 revenue forecasted to be in the range of $73.5 to $75 million
  • 2017 revenue guidance in the range of $303.5 to $307 million
  • Gross profit margins for 2017 expected to be in the range of 86% to 88%
  • 2017 Operating Earnings forecasted to grow by 90% or greater
  • GAAP EPS for 2017 projected to be in the range of $0.18 to $0.20
  • Adjusted EPS* for 2017 projected to be in the range of $0.31 to $0.33
  • 2017 GAAP Net Earnings expected to grow in excess of 95%
  • 2017 Adjusted EBITDA* expected to be in the range of 21% to 23% of revenue

“Our strong first quarter performance and market momentum gives us a high level of confidence in meeting or exceeding our expectations for 2017,” concluded Petit.

Earnings Call
MiMedx management will host a live broadcast of its first quarter of 2017 results conference call on Friday, April 28, 2017, beginning at 10:30 a.m. eastern time.  A listen-only simulcast of the MiMedx Group conference call will be available on-line at the Company’s website at www.mimedx.com.  A 30-day on-line replay will be available approximately one hour following the conclusion of the live broadcast.  The replay can also be found on the Company’s website at www.mimedx.com.

Use of Non-GAAP Financial Measures
Management has disclosed adjusted financial measurements in this press announcement that present financial information that is not in accordance with generally accepted accounting principles (“GAAP”).  These measurements are not a substitute for GAAP measurements, although Company management uses these measurements as aids in monitoring the Company’s on-going financial performance from quarter-to-quarter and year-to-year on a regular basis and for benchmarking against other medical technology companies. For a reconciliation of these non-GAAP financial measures to the most directly comparable GAAP financial measure, see the accompanying tables to this release.  Adjusted financial measures used by the Company may be calculated differently from, and therefore may not be comparable to, similarly titled measures used by other companies.  Investors should consider adjusted measures in addition to, and not as a substitute for, or superior to, financial performance measures prepared in accordance with GAAP.

About MiMedx
MiMedx® is an integrated developer, processor and marketer of patent protected and proprietary regenerative and therapeutic biopharmaceutical products processed from donated placental tissues. “Innovations in Regenerative Medicine” is the framework behind our mission to give physicians products and tissues to help the body heal itself.  We process the human placental tissue utilizing our proprietary PURION® Process among other processes, to produce safe and effective allografts. MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization.  MiMedx is the leading supplier of placental tissue, having supplied over 800,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare.

Safe Harbor Statement
This press release includes statements that look forward in time or that express management’s beliefs, expectations or hopes.  Such statements are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  These statements include, but are not limited to, the Company’s financial expectations for the second quarter and full year 2017,  the contributions that new products will make in the Company’s future performance, that shareholders are beginning to realize the  productive asset base that the Company has developed over the last six years, that the Company’s development of the IT and management staff, technology and intellectual property will enable it to smoothly transition its focus towards becoming predominantly a biopharma company, that the Company’s assets include the technology differentiator, that the Company has a significant head start on having the resources necessary to proceed down the IND/BLA regulatory pathways, that the Company expects to file additional INDs and the areas of focus will be longer-term opportunities for the Company, and that the strong first quarter performance and market momentum gives management a high level of confidence in its ability to meet or exceed expectations for 2017.  Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include that the Company’s revenue may not grow as expected or may decline; even if revenue is achieved, the Company may not be able to achieve its other financial metrics; physician acceptance of new products may not continue and  the Company’s new products may not contribute to financial results as predicted; the asset base developed by the Company may not contribute to the Company’s success as predicted and/or may not help it transition to a biopharma company as predicted; new products from other companies may be commercialized which are able to achieve similar results to the Company’s products; there may be delays in filing for regulatory approval or the anticipated filings may not be made at all; regulatory approvals may be delayed or may not occur at all; the benefits associated with the Company’s perceived head start on proceeding down certain regulatory pathways may not materialize; the momentum gained in the first quarter may not continue for subsequent quarters; and the risk factors detailed from time to time in the Company’s periodic Securities and Exchange Commission filings, including, without limitation, its 10-K filing for the fiscal year ended December 31, 2016.  By making these forward-looking statements, the Company does not undertake to update them in any manner except as may be required by the Company’s disclosure obligations in filings it makes with the Securities and Exchange Commission under the federal securities laws.

 

MIMEDX GROUP, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share data)

 March 31,
2017
(unaudited) 

 December 31,
2016 

ASSETS

Current assets:

Cash and cash equivalents

$            30,924

$           34,391

Accounts receivable, net

66,846

67,151

Inventory, net

16,050

17,814

Prepaid expenses 

6,878

5,894

Other current assets

1,200

1,288

   Total current assets

121,898

126,538

Property and equipment, net of accumulated depreciation

13,763

13,786

Goodwill

20,203

20,203

Intangible assets, net of accumulated amortization

22,788

23,268

Deferred tax asset, net

9,530

9,114

Deferred financing costs and other assets

309

354

    Total assets

$          188,491

$         193,263

LIABILITIES AND STOCKHOLDERS’ EQUITY

Current liabilities:

Accounts payable

$            10,892

$           11,436

Accrued compensation

11,602

12,365

Accrued expenses

9,940

10,941

Current portion of earn out liability

8,740

8,740

Income taxes

7,839

5,768

Other current liabilities

587

1,482

    Total current liabilities

49,600

50,732

Earn out liability

8,769

8,710

Other liabilities

1,086

821

    Total liabilities

59,455

60,263

Commitments and contingencies 

Stockholders’ equity:

  Preferred stock; $.001 par value; 5,000,000 shares authorized and 0  shares issued and
outstanding

–

–

  Common stock; $.001 par value; 150,000,000 shares authorized;
111,195,825 issued and 110,840,873  outstanding at March 31, 2017 and 110,212,547 issued
and 109,862,787 outstanding at December 31, 2016

111

110

  Additional paid-in capital

153,735

161,261

  Treasury stock at cost:
354,952 shares at March31, 2017 and 349,760 shares at December 31, 2016

(2,982)

(2,216)

  Accumulated deficit

(21,828)

(26,155)

    Total stockholders’ equity

129,036

133,000

      Total liabilities and stockholders’ equity

$          188,491

$         193,263

MIMEDX GROUP, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS

(in thousands, except share and per share data) 

(unaudited)

Three Months Ended March 31,

2017

2016

Net sales

$            72,607

$          53,367

Cost of sales

8,743

7,946

Gross margin

63,864

45,421

Operating expenses:

Research and development expenses

4,202

2,496

Selling, general and administrative expenses

52,951

40,648

Amortization of intangible assets

526

810

Operating income 

6,185

1,467

Other expense, net

Interest expense, net

(145)

(56)

Income before income tax provision

6,040

1,411

Income tax provision (expense) benefit

(1,713)

(214)

Net Income

$              4,327

$            1,197

Net income per common share – basic

$                0.04

$              0.01

Net income per common share –  diluted

$                0.04

$              0.01

Weighted average shares outstanding – basic

105,708,526

105,538,271

Weighted average shares outstanding –  diluted

113,730,591

112,039,860

MIMEDX GROUP, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(unaudited)

Three Months Ended March 31,

2017

2016

Cash flows from operating activities:

Net income

$               4,327

$              1,197

 Adjustments to reconcile net income to net cash from operating activities:

  Depreciation

946

734

  Amortization of intangible assets

526

810

  Amortization of inventory fair value step-up

75

734

  Amortization of deferred financing costs

45

49

  Share-based compensation

4,671

4,615

  Change in deferred income taxes

(416)

—

  Increase (decrease) in cash, net of effects of acquisition, resulting from changes in:

    Accounts receivable

305

1,874

    Inventory

1,689

(264)

    Prepaid expenses 

(984)

(2,066)

    Other current assets

87

209

    Accounts payable

(379)

(4,265)

    Accrued compensation

(763)

(5,640)

    Accrued expenses

(942)

493

    Income taxes

2,071

411

    Other liabilities

(618)

132

Net cash flows from operating activities

10,640

(977)

Cash flows from investing activities:

  Purchases of equipment

(923)

(2,008)

  Purchase of Stability Inc., net of cash acquired

–

(7,631)

  Fixed maturity securities redemption

–

500

  Patent application costs

(46)

(147)

  Net cash flows from investing activities

(969)

(9,286)

Cash flows from financing activities:

  Proceeds from exercise of stock options

1,865

1,138

  Stock repurchase under repurchase plan

(12,666)

(3,530)

  Stock repurchase for tax withholdings on vesting of restricted stock

(2,327)

(684)

  Deferred financing costs

–

(20)

  Payments under capital lease obligations

(10)

(10)

Net cash flows from financing activities

(13,138)

(3,106)

Net change in cash

(3,467)

(13,369)

Cash and cash equivalents, beginning of period

34,391

28,486

Cash and cash equivalents, end of period

$             30,924

$            15,117

MIMEDX GROUP, INC. AND SUBSIDIARIES

Non-GAAP Financial Measures and Reconciliation

In addition to our GAAP results, we provide certain Non-GAAP metrics including Adjusted EBITDA, Adjusted Gross Margin, Adjusted Net Income and Adjusted Diluted Net Income per share. We believe that the presentation of these measures provides important supplemental information to management and investors regarding our performance.   These measurements are not a substitute for GAAP measurements, although Company management uses these measurements as aids in monitoring the Company’s on-going financial performance from quarter-to-quarter and year-to-year on a regular basis and for benchmarking against other medical technology companies. Adjusted EBITDA consists of GAAP Net Income excluding: (i) depreciation and amortization, (ii) interest income and expense, (iii) income taxes,  (iv) one time acquisition related costs, (v) the effect of purchase accounting due to acquisitions and (vi) share-based compensation expense.   Due to the impact of the acquisition of Stability in January 2016 and the release of the valuation allowance on the deferred tax asset on reported tax expense in 2015 on results, we have decided to provide additional adjusted non-GAAP measures to provide comparability of normal ongoing operating results. Beginning in 2016, we have reported Adjusted Gross Margin, Adjusted Net Income and Adjusted Diluted Net Income per Share to normalize results for comparison purposes.  Adjusted Gross Margin consists of GAAP gross margin excluding amortization of inventory fair value step-up. Adjusted Net Income and Adjusted Diluted Net Income per share consists of GAAP net income excluding: (i) one time acquisition related costs, (ii) amortization of inventory fair value step-up, (iii) amortization of intangible assets and (iv) share-based compensation. Reconciliations of GAAP net income to Adjusted EBITDA, GAAP Gross Margin to Adjusted Gross Margin and GAAP Net Income to Adjusted Net Income and Adjusted Diluted Net Income per Share for the three months ended March 31, 2017 and 2016 appear in the tables below (in thousands):

Three Months Ended March 31,

2017

2016

Net  Income (Per GAAP)

$         4,327

$        1,197

Add back:

  Income taxes

1,713

214

  One time costs incurred in connection with acquisition

—

713

  One time inventory costs incurred in connection with acquisition

75

734

  Other interest expense, net

145

56

  Depreciation expense

946

734

  Amortization of intangible assets

526

810

  Share-based compensation

4,671

4,615

Adjusted EBITDA

$       12,403

$        9,073

Reconciliation of “Adjusted Gross Margin” defined as Gross Margin before Amortization of inventory fair value step-up (in thousands):

Three Months Ended March 31,

2017

2016

Gross Margin (Per GAAP)

$             63,864

$          45,421

Non-GAAP Adjustments:

  One time inventory costs incurred in connection with acquisition

75

734

Gross Margin before Amortization of inventory fair value step-up

$             63,939

$          46,155

Adjusted Gross Margin

88.1%

86.5%

Reconciliation of “Adjusted Net Income” and “Adjusted Diluted Net Income” per share defined as Net Income less Amortization, One Time Costs and Share-Based Compensation (in thousands, except share and per share data):

Three Months Ended March 31,

2017

2016

Net income (Per GAAP)

$          4,327

$             1,197

Non-GAAP Adjustments:

  Tax rate normalization*

(355)

(350)

  One time costs incurred in connection with acquisition

—

713

  One time inventory costs incurred in connection with acquisition

75

734

  Amortization of intangible assets

526

810

  Share-based compensation

4,671

4,615

  Estimated income tax impact from adjustments

(1,805)

(2,777)

Adjusted Net Income

$          7,439

$             4,942

Adjusted Diluted Net Income per Share

$            0.07

$               0.04

Denominator for diluted earnings per share – weighted average
shares adjusted for dilutive securities

113,730,591

112,039,860

* Assumes a normalized tax rate of 40% for 2016 and 34% for 2017.

SOURCE MiMedx Group, Inc.

Related Links

http://www.mimedx.com

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FinancialTop Stories

Johnson & Johnson scores $260M+ DOD orthopedics contract

April 28, 2017 OrthoSpineNews

by Amirah Al Idrus – April 28, 2017

The Department of Defense awarded Johnson & Johnson a contract worth up to $260.5 million to supply it with orthopedic products.

The deal will see J&J providing orthopedic products to the Army, Navy, Air Force, Marine Corps and the DOD’s federal civilian agencies, according to a statement. The one-year agreement could be extended one year at a time for another four years, the DOD said.

In the first quarter, J&J reported (PDF) $6.3 billion in medical device sales for the first quarter, with its Orthopaedics group and Surgery units leading the pack. The Orthopaedics business, which includes hips, knees, trauma and spine, reeled in $2.33 billion in sales, slightly down from the $2.34 billion reported the previous year.

 

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RegulatoryRobotics

Intuitive Surgical Receives CE Mark for Latest da Vinci® Robotic-Assisted Surgical System

April 28, 2017 OrthoSpineNews

AUBONNE, Switzerland, April 26, 2017 (GLOBE NEWSWIRE) — Intuitive Surgical, a global technology leader in robotic-assisted, minimally invasive surgery, announced today that its new da Vinci X Surgical System received CE Mark approval in Europe. The da Vinci X System will provide surgeons and hospitals with access to some of the most advanced robotic-assisted surgery technology at a lower cost.

The launch of the da Vinci X System underscores Intuitive’s commitment to meeting customers’ needs with a strong value-oriented portfolio of cost-appropriate technologies and an array of financing options.

“Over the past 21 years, Intuitive Surgical pioneered robotic-assisted surgery and we continue to lead the way in developing and bringing to market innovative technologies, outcomes-focused products and value-oriented solutions,” said Dr. Gary Guthart, CEO of Intuitive Surgical. “Our surgeon, hospital and healthcare customers around the world told us that robotic-assisted surgery matters for their programs and their patients while underscoring the importance of providing choice from a clinical, technological and cost standpoint. The da Vinci X product offering provides a lower-cost solution to meet the needs of customers who want a choice in price points, while offering access to many of our recent innovations.”

The da Vinci X System offers surgeons and hospitals access to Intuitive’s portfolio of advanced, innovative robotic-assisted surgical technologies – and its full ecosystem of programs, support, services, and solutions –at a lower price.  The System uses the same vision cart and surgeon consoles that are found on our flagship product, the da Vinci Xi® System, enabling our customers the option of adding advanced capabilities, and providing a pathway for upgrading should they choose to do so as their practice and needs grow.

The da Vinci X System enables optimized, focused-quadrant surgery including for procedures like prostatectomy, partial nephrectomy, hernia repair, benign hysterectomy and sacrocolpopexy, among others. The System features flexible port placement and state-of-the-art 3D digital optics, while incorporating the same advanced instruments and accessories as Intuitive’s flagship system. The new system drives operational efficiencies through set-up technology that uses voice and laser guidance, drape design that simplifies surgery prep, and a lightweight, fully integrated endoscope.

“The da Vinci X System is a value-oriented, highly capable offering that meets – and responds to – our customers’ economic and clinical needs,” said Damien Desmedt, General Manager of Intuitive Surgical in the United Kingdom, Ireland, and Nordic countries. “In the countries we serve around the globe, we know that customers have different needs and wants, and we strive to provide an array of choices to meet their needs today and in the future. The da Vinci X System helps us to continue to do this.”

About Intuitive Surgical, Inc.

Intuitive Surgical, Inc. (Nasdaq:ISRG), headquartered in Sunnyvale, Calif., is a global technology leader in robotic-assisted, minimally invasive surgery. Intuitive Surgical develops, manufactures and markets the da Vinci Surgical System.

About the da Vinci Surgical System

There are several models of the da Vinci Surgical System. The da Vinci Surgical Systems are designed to help surgeons perform minimally invasive surgery. da Vinci Systems are not programmed to perform surgery on their own. Instead, the procedure is performed entirely by a surgeon who controls the system. da Vinci Systems offer surgeons high-definition 3D vision, a magnified view, and robotic and computer assistance. They use specialized instrumentation, including a miniaturized surgical camera and wristed instruments (i.e., scissors, scalpels and forceps) that are designed to help with precise dissection and reconstruction deep inside the body.

Intended Use

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System Model IS4200) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures, thoracoscopically-assisted cardiotomy procedures, and trans-oral otolaryngology surgical procedures restricted to benign tumors and malignant tumors classified as T1 and T2, and for benign base of tongue resection procedures. The System can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization.  The System is indicated for adult and pediatric use (except for trans-oral otolaryngology surgical procedures).  It is intended to be used by trained physicians in an operating room environment.

The da Vinci X Surgical System is a class 2b CE 0543 marked medical device under the European Medical Devices Directive (93/42/EEC) manufactured by Intuitive Surgical, Inc.  Refer to the Instructions For Use before use.

Forward Looking Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding regulatory clearances to market the da Vinci X System in the US. These forward-looking statements are necessarily estimates reflecting the best judgment of our management and involve a number of risks and uncertainties that could cause actual results to differ materially from those suggested by the forward-looking statements. These forward-looking statements should, therefore, be considered in light of various important factors, including those under the heading “Risk Factors” in our annual report on Form 10-K for the year ended December 31, 2016, as updated from time to time by our quarterly reports on Form 10-Q and our other filings with the Securities and Exchange Commission. Statements using words such as “estimates,” “projects,” “believes,” “anticipates,” “plans,” “expects,” “intends,” “may,” “will,” “could,” “should,” “would,” “targeted” and similar words and expressions are intended to identify forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. We undertake no obligation to publicly update or release any revisions to these forward-looking statements, except as required by law.

© 2017 Intuitive Surgical, Inc. All rights reserved. Product names are trademarks or registered trademarks of their respective holders.

A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/0c20bf18-fcc5-4d29-8bab-4ada1ab29eae

PN1035581rA EU 4/2017

Contact
JPA Health Communications
kperry@jpa.com
+44203 884 0650
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Biologics

Biologics Market to Reach $399 Billion by 2025 – Research and Markets

April 28, 2017 OrthoSpineNews

April 28, 2017

DUBLIN–(BUSINESS WIRE)–Research and Markets has announced the addition of the “Biologics Market, 2014-2025” report to their offering.

The global biologics market is anticipated to reach USD 399.5 billion by 2025. Introduction of targeted therapies coupled with rising adoption of patient centric personalized medicine anticipated to fuel demand. Ever-increasing understanding of the cell physiology and stress, as well as the factors involved in protein production and heterologous gene expression have empowered the use of different living factories.

These living factories are the prokaryotic and eukaryotic cells. Enhancement of drug functionality through achieving successful protein folding and post-translational modifications is supportive for projected progress rate.

Moreover, rising adoption of biopharmaceuticals over chemically synthesized molecules is expected to propel revenue generation significantly. In addition to this, presence of several metabolic disorders that can be treated through the use of biologics is attributive to influence demand.

Combination of advanced bioengineering technologies for biopharmaceutical production is expected to boost progress in pharmaceutical industry. With recent advances in automation, the selection process can be done through high throughput screening (HTS) system for selection of viable clones.

Aforementioned method enables robust production of biopharmaceutical products by obtaining high-producing cell line. Advances with respect to upstream and downstream processing would directly translate into the growth in revenue for this market at a larger level.

However, development of biosimilars is expected to restrain the biologics year on year growth to certain extent. Although, the regulatory approval pathway for these products is not framed yet some drug manufacturers are opting to invest in the development of biobetters.

Companies Mentioned

  • Samsung BioLogics
  • Amgen
  • Novo Nordisk A/S
  • AbbVie Inc.
  • Sanofi
  • Johnson & Johnson Services, Inc
  • Pfizer Inc.
  • Merck & Co., Inc.
  • GSK group of companies
  • Celltrion
  • Precision Biologics, Inc.
  • Merck KGaA
  • Eli Lilly and Company
  • Novartis AG
  • Bayer AG
  • F. Hoffmann-La Roche Ltd
  • AstraZeneca

Key Topics Covered:

1 Research Methodology

2 Executive Summary

3 Biologics Market Variables, Trends & Scope

4 Biologics Market: Source Estimates & Trend Analysis

5 Biologics Market: Product Estimates & Trend Analysis

6 Biologics Market: Manufacturing Estimates & Trend Analysis

7 Biologics Market: Disease Category Estimates & Trend Analysis

8 Biologics Market: Regional Estimates & Trend Analysis, by Source, Product, Manufacturing, & Disease Category

9 Competitive Landscape

For more information about this report visit http://www.researchandmarkets.com/research/kcqf7v/biologics_market

Contacts

Research and Markets
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
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Biopharmaceuticals

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Financial

TransEnterix Announces Pricing of $24.9 Million Public Offering of Common Stock and Warrants

April 28, 2017 OrthoSpineNews

April 28, 2017

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–TransEnterix, Inc. (NYSE MKT:TRXC) (“TransEnterix”), a medical device company that is pioneering the use of robotics to improve minimally invasive surgery, announced the pricing of its public offering of units, each consisting of one share of the Company’s common stock, one Series A warrant to purchase one share of common stock and one Series B warrant to purchase 0.75 shares of common stock at a price of $1.00 per unit. Each Series A warrant may be exercised at any time beginning on the date of issuance, and from time to time thereafter, through and including the first anniversary of the issuance date, unless terminated earlier as provided in the Series A warrant. In the event the FDA provides clearance with respect to the company’s Senhance System 510(k) application, which was submitted to the FDA in April 2017, the holders of Series A warrants will have 10 business days following written notice to exercise, in whole or in part, their Series A warrants. Any Series A warrants that remain unexercised after such 10 business day period will expire. Each Series B warrant may be exercised at any time beginning on the date of issuance and from time to time thereafter through and including the fifth anniversary of the issuance date. TransEnterix expects the gross proceeds of the offering to be $24.9 million, before deducting underwriter’s discounts and expenses payable by TransEnterix. If a registration statement registering the resale of the shares of common stock underlying the Series A warrants under the Securities Act of 1933, as amended, is not available, the holder of such Series A warrants may, in its sole discretion, elect to exercise the warrant through a cashless exercise, in which case the holder would receive upon such exercise the net number of shares of common stock determined according to the formula set forth in the warrant. Any holder of Series B warrants may elect to exercise any such Series B warrant through a cashless exercise at any time prior to expiration. All of the securities to be sold in the offering are to be sold by TransEnterix.

Stifel is acting as the sole book-running manager. The offering is expected to close on or about May 3, 2017, subject to customary closing conditions.

A shelf registration statement relating to the securities offered in the public offering described above was filed with the U.S. Securities and Exchange Commission (the “SEC”) on November 7, 2014 and declared effective on December 19, 2014 (File No. 333-199998), and post-effectively amended pursuant to Post-Effective Amendment No. 1 on Form S-3, as filed with the SEC on March 8, 2016 and declared effective on June 22, 2016 and a related registration statement was filed pursuant to Rule 462(b) under the Securities Act of 1933. The offering is being made only by means of the written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement related to the offering has been filed with the SEC and may be obtained for free by visiting EDGAR on the SEC website at www.sec.gov. A final prospectus supplement related to the offering will be filed with the SEC. When available, copies of the final prospectus supplement and the accompanying prospectus relating to the securities being offered may also be obtained by contacting Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104 or by telephone: (415) 364-2720.

This press release does not constitute an offer to sell, or a solicitation of an offer to buy, the securities in the described offering, nor will there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale is unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

About TransEnterix, Inc.

TransEnterix is a medical device company that is pioneering the use of robotics to improve minimally invasive surgery by addressing the clinical and economic challenges associated with current laparoscopic and robotic options. The company is focused on the commercialization of the Senhance™ Surgical Robotic System, a multi-port robotic system that brings the advantages of robotic surgery to patients while enabling surgeons with innovative technology such as haptic feedback and eye sensing camera control. The Company also developed the SurgiBot™ System, a single-port, robotically enhanced laparoscopic surgical platform. The Senhance Surgical Robotic System has been granted a CE Mark but is not currently available for sale in the United States.

Forward Looking Statements

This press release includes statements relating to the proposed offering of TransEnterix’s securities. 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, including our expectations regarding the proposed offering and use of proceeds. For a discussion of the risks and uncertainties associated with TransEnterix’s business, please review our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2016 and subsequent filings 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.
Investor Contact:
Mark Klausner, +1-443-213-0501
invest@transenterix.com
or
Media Contact:
(For EU) Conrad Harrington, +44 (0)20 3178 8914
or
(For US) Hannah Dunning, +1-415-618-8750
TransEnterix-SVC@sardverb.com

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