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Financial

Misonix Reports Fiscal Year 2017 Financial Results

August 23, 2017 OrthoSpineNews

FARMINGDALE, N.Y., Aug. 22, 2017 (GLOBE NEWSWIRE) — Misonix, Inc. (MSON), a provider of minimally invasive therapeutic ultrasonic medical devices that enhance clinical outcomes, announced today financial results for the fourth quarter and fiscal year ended June 30, 2017.

Financial Highlights for the Fourth Quarter and the Full Year:

  • Revenue for fiscal year 2017 was $27.3 million, an increase of 18% compared with $23.1 million in fiscal 2016. For the fourth quarter, net sales increased 23% to $7.9 million compared with $6.4 million in the fourth quarter of fiscal 2016.
  • Domestic sales in fiscal year 2017 increased 26% to $16.5 million versus $13.1 million in fiscal 2016. For the fourth quarter of fiscal 2017, domestic sales increased 18% to $4.4 million compared with $3.8 million in the fourth quarter of 2016.
  • Consumables sales in the United States increased 32% to $14.9 million for fiscal year 2017 compared with $11.3 million in fiscal 2016.
  • The gross profit margin for the fiscal year was 69.9% primarily from a strong mix of higher margin consumables, compared to 66.9% in fiscal year 2016. Fourth quarter gross profit margin was 69.9% versus 68.0% in the fourth quarter of fiscal 2016.
  • For the fiscal year, operating expenses increased by $4.4 million to $25.7 million driven in part by professional fees relating to the recently completed internal investigation, along with higher sales commissions related to increased sales volume.
  • For fiscal year 2017, the Company reported a net loss of $1.7 million, or $(0.20) per diluted share, compared with a net loss of $1.2 million, or $(0.15) per diluted share, in fiscal year 2016.
  • At June 30, 2017, the Company had cash of $11.6 million with no long-term debt.

Stavros Vizirgianakis, president and chief executive officer of Misonix, said, “We concluded fiscal 2017 on a strong note with fourth quarter revenue increasing 23%, and 18% for the full year as our recurring revenue business model continues to gain traction. Consumables sales, which we define as recurring revenue, accounted for approximately 75% of total sales. Gross margin for the fiscal year was 69.9% up from 66.9% in the previous year.

“Our U.S. business, which we believe offers the best opportunity for growth, grew 26% on a year-over-year basis and accounted for 60% of total revenue. We are making sustainable progress in reigniting the Misonix growth engine.

“One of the contributing factors in the growth of fiscal 2017 revenue has been the addition of new Clinical Sales Specialists to support the sales activities of our distribution channel. Although the second half of the fiscal year is traditionally the strongest for our business, the additional support provided to our distributors generated strong double-digit revenue increases in both the third and fourth quarters of fiscal 2017. We are pleased with the progress achieved to this point.”

Mr. Vizirgianakis continued, “On the international front, we are making necessary changes in distributors and personnel to operate the business more efficiently. Going forward, we will focus on contracting with in-country distributors in the key markets where we believe we can build sustainably growing operations that adhere to single-use of consumable products in surgical procedures.

“As we move ahead, we are working to create a new results-oriented culture within the Company. We have simplified our sales compensation plan with the goal of getting everyone on equal footing and pursuing common goals. In fiscal 2017 Misonix consumables products were used in more than 50,000 surgical procedures worldwide. We have set an aggressive goal of having Misonix consumables products utilized in 100,000 annual surgical procedures worldwide within the next three years. We are dedicated to achieving that goal.

“We enter the new fiscal year with a strong cash position, in excess of $11 million, and no long-term debt. We look forward to the opportunities ahead in fiscal 2018.”

Conference Call
The Company has scheduled a conference call for Tuesday, August 22, 2017, at 4:30 pm ET to review the results.

Interested parties can access the conference call by dialing (844) 861-5497 or (412) 317-6579 or can listen via a live Internet webcast, which is available in the Investor Relations section of the Company’s website at www.misonix.com.

A teleconference replay of the call will be available for three days at (877) 344-7529 or (412) 317-0088, confirmation # 10111207. A webcast replay will be available in the Investor Relations section of the Company’s website at www.misonix.com for 30 days.

Safe Harbor Statement
With the exception of historical information contained in this press release, content herein may contain “forward looking statements” that are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and are subject to uncertainty and changes in circumstances. Investors are cautioned that forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from the statements made. These factors include general economic conditions, delays and risks associated with the performance of contracts, risks associated with international sales and currency fluctuations, uncertainties as a result of research and development, acceptable results from clinical studies, including publication of results and patient/procedure data with varying levels of statistical relevancy, risks involved in introducing and marketing new products, potential acquisitions, consumer and industry acceptance, litigation and/or court proceedings, including the timing and monetary requirements of such activities, the timing of finding strategic partners and implementing such relationships, regulatory risks including approval of pending and/or contemplated 510(k) filings, the ability to achieve and maintain profitability in the Company’s business lines, the impact of the pending investigation by the Department of Justice and Securities Exchange Commission, and other factors discussed in the Company’s Annual Report on Form 10-K for the fiscal year ended June 30, 2016, subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company disclaims any obligation to update its forward-looking statements.

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SpineTop Stories

CoreLink’s Stackable Guide Wire Reduces Potential Risk of SI Joint Fusion

August 22, 2017 OrthoSpineNews

August 22, 2017

ST. LOUIS–(BUSINESS WIRE)–CoreLink, LLC, a fast growing designer and manufacturer of spinal implant systems, announced the release of the Scaltoff™ Wire, a patent pending, stackable guide wire for its Entasis® Sacroiliac Joint Fusion System. The convertible length wire enables constant control during drilling, tapping, and insertion steps yet can be quickly shortened to accommodate the C-arm in lateral view x-rays.

“The most significant threat to patient safety in lateral SI joint fusion procedures is the possibility of the guide wire advancing into the sacral foramina and potentially damaging a nerve root,” says Dr. Donald Sachs (Neurosurgeon, Tampa, FL), “This is a good response to that common risk. Plus, with this, you don’t have to remove the wire, avoiding the frustrations of finding your path again.”

The stackable Scaltoff Wires (blunt and trocar) thread onto and off each other, end-to-end, providing adjustable length. Considered to be the stiffest on the market, the extra rigidity of these stainless steel wires further enhances control for the surgeon.

Now a little more than a year on the market, CoreLink’s Entasis© SI Joint Fusion System has seen more than 500 devices implanted. Surgeons most often cite the device’s Easy-In™ dual-pitch compression threading and the autograft self-harvesting circumferential fenestrations as the most compelling features in their choice of this device. CoreLink expects the addition of the stackable Scaltoff Wire to further accelerate the adoption of this implant system.

For more information or distribution opportunities concerning the Entasis® SI Joint Fusion System, or any of CoreLink’s other spinal implant products, please, visit www.corelinksurgical.com.

About CoreLink

CoreLink, LLC internally designs and manufactures more than 99% of its broad portfolio of spinal implant systems. CoreLink leverages this expertise through collaboration and a dedication to empowering surgeons with the highest quality and most effective instruments and implants possible. That is how CoreLink came to be known as The Source.

Be a part of something. Come to The Source.

Indications for Use

The Entasis Dual-Lead Sacroiliac implant system is intended for sacroiliac joint fusions for conditions including degenerative sacroiliitis and sacroiliac joint disruptions.

Contacts

CoreLink, LLC
Matthew Linhardt, 888-349-7808
Senior Director, Marketing
m.linhardt@corelinksurgical.com

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RoboticsSpineTop Stories

BMC becomes first in state to add robotic spine surgery

August 22, 2017 OrthoSpineNews

August 22, 2017 – JIM MCCONVILLE, Staff Writer, (Journal Photo by Ron Agnir)

MARTINSBURG — WVU Medicine Berkeley Medical Center added its first robot-neurosurgeon to its medical staff on Monday.

On Monday, BMC became the first medical center in West Virginia and the tri-state region to add the Mazor X, a robotic surgical platform, which will be used by its new Medicine Brain and Spine Center.

BMC is the first medical center in West Virginia and within a 60-mile radius from the center to employ the surgical robot technology.

Delivered to BMC on Aug. 17, the Mazor robot performed its first patient surgery Monday afternoon.

“As spinal surgery has evolved, more focus has been placed on minimizing trauma to the body during surgery and expediting a return to function through the use of minimally invasive techniques,” said Dr. John Caruso, neurosurgeon and medical director of WVU Medicine Brain and Spine at Berkeley Medical Center.

Using the the Mazor robot software, doctors can plan a spine operation procedure. During the actual surgical procedure, doctors use the precision mechanics and surgical arm to guide surgical tools and implants at the right trajectory and position, based on that surgical plan.

For patients, minimally invasive surgical procedure means less pain, less blood loss, a smaller surgical cut, a shorter hospital stay, and a shorter recovery period compared to conventional spine surgery.

 

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RegulatoryTop Stories

Opioid makers made payments to one in 12 U.S. doctors

August 22, 2017 OrthoSpineNews

August 9, 2017 – Media contact: David Orenstein   

PROVIDENCE, R.I. [Brown University] — Legally prescribed opioids can be an effective treatment for pain, but they are also the root cause of many of the cases of addiction and overdose deaths that have reached epidemic levels in the U.S. That’s why experts such as Brandon Marshall, an associate professor of epidemiology in the Brown University School of Public Health, are investigating efforts by opioid painkiller manufacturers to promote prescribing of the medicines by wining and dining doctors and paying them large speaking fees.

In a new study published in the American Journal of Public Health, Marshall, lead author Scott Hadland of Boston Medical Center and colleagues report for the first time on the tens of millions of dollars that drug companies are paying doctors through meals, honoraria and other marketing and education programs.

“The opioid epidemic, which is responsible for thousands of deaths every year, is a national tragedy that we must work at every level to combat,” Marshall said in a Boston Medical Center news story detailing the findings. “It’s our hope that this study sparks a bigger conversation about the role of pharmaceutical companies in the over-prescribing of opioid medications and prompts a more thorough investigation about what we need to do to tackle this problem.”

We asked Marshall to share additional thoughts on what the team found and what it may mean.

 

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ExtremitiesSports Medicine

Global Trauma Fixation Devices Market 2017-2021 with Stryker, Zimmer Biomet & Smith & Nephew Dominating – Research and Markets

August 22, 2017 OrthoSpineNews

August 21, 2017

DUBLIN–(BUSINESS WIRE)–The “Global Trauma Fixation Devices Market 2017-2021” report has been added to Research and Markets’ offering.

The global trauma fixation devices market to grow at a CAGR of 7.29% during the period 2017-2021.

Global Trauma Fixation Devices Market 2017-2021, has been prepared based on an in-depth market analysis with inputs from industry experts. The report also includes a discussion of the key vendors operating in this market. To calculate the market size, the report considers the sales and value of the trauma fixation devices market.

According to the report, one of the major drivers for this market is Sports injuries. Sports injuries are common among athletes. According to the CDC, in 2011, sports-related injuries resulted in 3.2 million visits to the emergency room (ER) for children below the age of 19.

The latest trend gaining momentum in the market is Technological advancements. Due to the growing demand for trauma fixation devices, companies are developing technologically advanced products to improve their market share.

The product is Conformité Européene (CE) approved for sales in the US. Similarly, bioresorbable plates, pins, and screw implants are widely used for fracture fixation in orthopedic surgeries and trauma care. These bioresorbable products dissolve in the human body. Hence, operations to remove the synthetic material are not required. They also do not corrode or accumulate metals in the tissue.

Further, the report states that one of the major factors hindering the growth of this market is Complications associated with trauma fixation devices. Trauma fixation devices can cause several complications. Surgical procedures that use trauma fixation devices can cause neurological or soft tissue damage, which can lead to paralysis. In some cases, bones take longer time to fuse with the implants. Sometimes, they might not even fuse. Such complications could require corrective surgeries.

Key vendors

  • Stryker
  • Zimmer Biomet
  • Smith & Nephew

Other prominent vendors

  • Auxein Medical
  • Brace Orthopaedic
  • CONWELL MEDICAL
  • Bioretec
  • Citieffe
  • Invibio
  • B. Braun Melsungen
  • ReWalk Robotics
  • NuVasive
  • FirstRay
  • OMNI
  • Orthopeadic Implant Company
  • PAVIS

Key Topics Covered:

Part 01: Executive summary

Part 02: Scope of the report

Part 03: Research Methodology

Part 04: Introduction

Part 05: Market landscape

Part 06: Segmentation by product type

Part 07: Segmentation by end-user

Part 08: Segmentation by geography

Part 09: Drivers and challenges

Part 10: Market trends

Part 11: Vendor landscape

Part 12: Key vendor analysis

Part 13: Appendix

For more information about this report visit https://www.researchandmarkets.com/research/kcpncl/global_trauma

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: Orthopedic Devices

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Spine

Life Spine Announces First Cases Performed with Multiple Methods of In-situ Expansion

August 22, 2017 OrthoSpineNews

August 22, 2017

HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today the first cases performed with multiple methods of in-situ expansion.

“Surgical intervention for the degenerative spine is a multi-dimensional challenge and by utilizing two methods of expansion, Life Spine allowed for me to cater to my patient’s unique pathologies,” said Dr. Thomas Scully of Tucson, AZ. “At one level, my goal was to provide the patient with restoration of significant disc height and sagittal alignment, while minimizing the need for excessive boney decompression and multiple passes by important neural structures. After reviewing intra-operative images this was accomplished with Life Spine’s PROLIFT® Lordotic system. Adjacent level pathology and patient bone quality dictated increased endplate coverage for stability and the ability to post-pack graft material to increase the chance of fusion, so TiBOW™ was the best choice.”

ProLift Expandable PLIF/TLIF Spacer System and TiBOW Expandable TLIF Spacer System highlight Life Spine’s Micro Invasive Expandable portfolio. ProLift and TiBOW feature OSSEO-LOC™ Surface Treatment Technology, which is a proprietary surface treatment that creates a unique osteophylic surface architecture for potential bone on-growth1.

“It is very exciting to be part of an organization that is able to provide physicians with innovative surgical solutions to accommodate patient’s distinct and challenging pathologies, especially where bone quality and disc access can be compromised. Each patient is unique and their treatment should be as well,” said Mariusz Knap, Vice President of Marketing for Life Spine.

About Life Spine

Life Spine is dedicated to improving the quality of life for spinal patients by increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Life Spine, which is privately held, is based in Huntley, Illinois. For more information, please visit: http://www.lifespine.com.

Life Spine is a registered trademark.

1K.Kieswetter, Z. Schwartz, T. W. Hummert, D. L. Cochran, J. Simpson and B. D. Boyan
“Surface roughness modulates the local production of growth factors by osteoblast-like MG-62 cells” The Journal of Biomedical Materials Research (1996): Web

Contacts

Life Spine
Omar Faruqi
Chief Financial Officer
ofaruqi@lifespine.com
847-884-6117

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Financial

Medtronic misses sales targets but beats earnings expectations

August 22, 2017 OrthoSpineNews

By  Star Tribune – August 22, 2017

Medtronic missed quarterly sales targets because of a weeklong computer outage and slow manufacturing of glucose sensors, but the Minnesota-run medical device company still beat earnings expectations after a decline in its sales tax rate.

Medtronic shares dipped about 2 percent to $81.88 in early morning trading Tuesday.

Revenue from sales of medical devices from pacemakers to heart valves increased 3 percent to $7.39 billion in the three months ended July 28. Wall Street analysts had forecast $60 million more in sales than Medtronic reported.

However, the company beat earnings expectations by four cents per share, with adjusted diluted earnings of $1.12 per share. Adjusted net income climbed 6.7 percent to $1.54 billion, and the operating margin climbed half a percentage point, to 27 percent.

“We have now entered a period of clear acceleration in our innovation cycle, and we expect to see increasing momentum coming from several new product launches over the balance of the fiscal year,” chief executive Omar Ishrak said on the conference call Tuesday.

 

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Spine

EIT Emerging Implant Technologies Acquires 22 Patents for 3D Printed Expandable Cage Technology Based on Living Hinges from Dr. Morgan Lorio

August 22, 2017 OrthoSpineNews

Emerging Implant Technologies GmbH (EIT), a German medical device manufacturer exclusively focused on creating innovative technologies for spinal applications by utilizing additive manufacturing (“3D-Printing”), today announced the acquisition of a full patent portfolio of 22 issued and pending patents for 3D printed expandable spinal fusion cages based on living hinges from Morgan P. Lorio, MD. These patents cover the United States, Europe and many other global markets and provide EIT the option to offer a complete product range of fully 3D printed cages for both vertical and lateral expansion.

Dr. Morgan Lorio is triple board certified in spine, orthopaedic and hand surgery. Since recovering from a significant spinal injury, he has become a renowned advocate for patients with spinal injuries, an expert in spine policy, and a notable pioneer in spinal technology. He has special interests in cervical spine pathology affecting the upper extremity, artificial discs, motion preservation, and minimally invasive spinal surgery, as well as in issues particular to the female spine, such as sacroiliac joint disease and vertebral augmentation. Dr. Lorio practices at Hughston Clinic Orthopaedics in Nashville,TN.

Guntmar Eisen, CEO of EIT says “This IP is our platform to take fully 3D printed fusion cages to the next level by adding functionality to our EIT cellular titanium® cages. This will give the surgeon more options intraoperatively, reduce inventory and support MIS techniques – and at the same time reduce cost of expandable cages.”

Morgan Lorio, MD believes that “The combination of 3D printed cellular structures with functionality is disruptive game changing technology. It will give me better tools to restore my patients´ spinal balance and enlarge the cage footprints for better endplate coverage while experiencing faster spinal fusion. I am thrilled that these technologies will be advanced by the German engineering team of EIT.”

The first functional spinal fusion cages based on the patent acquisition will be launched in 2018.

About EIT

EIT is the first medical device manufacturer to exclusively focus on implants for spinal alignment, that are designed according to latest published science on optimal bone ingrowth in porous titanium scaffolds and produced with additive manufacturing methods.

The EIT implants are made of EIT Cellular Titanium®, that addresses the clinical shortcomings of the current cage designs and materials (non-fusion, biocompatibility, subsidence, migration and imaging distortion), thereby obtaining very promising fusion results and improved clinical outcome due to the qualities of the porous 3-D printing of titanium. The highly porous titanium scaffold ensures extensive bone ingrowth as a result of its specific design and elasticity close to the cancellous bone. Due to its unique design with a porosity of 80% the EIT implants ensure uncompromised imaging on X-ray and MRI and enabling excellent follow up on defining bone ingrowth and fusion with CT.

A complete portfolio of SMART Spinal Implants™ based on EIT Cellular Titanium® is available for the cervical and lumbar spine, with an extensive choice in footprint sizes, heights and lordosis angles to support the recreation of sagittal balance and alignment.

In July 2017 EIT has received full approval from the FDA to commercialize its spinal interbody product offerings for ALIF, TLIF, PLIF and Cervical procedures.

EIT was founded in 2014 by Hans Eekhof and Guntmar Eisen. Since then more than 10.000 EIT cases have been performed in over 15 markets globally.

 

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Biologics

MiMedx Signs Definitive Agreement to Divest Stability Biologics Subsidiary as Company’s Strategic Focus on Biopharma

August 21, 2017 OrthoSpineNews

MARIETTA, Ga., Aug. 18, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts and patent-protected processes for multiple sectors of healthcare, announced today that it has signed a definitive agreement with the former stockholders of Stability Inc. to divest the Company’s subsidiary, Stability Biologics LLC (f/k/a Stability Inc.) back to those stockholders.

The recent announcement by the Company to transition into a biopharmaceutical company was an impetus for this divestiture initiative.  Acquired by MiMedx in January 2016, Stability Biologics developed and processed bioactive bone graft products and tissue allografts including structural/particulate bone, structural allografts, demineralized bone matrix (DBM), skin products for burns and traumatic wound care, and Physio®, a bone grafting material. MiMedx acquired Stability Biologics with a combination of cash and stock paid at closing, with future contingent consideration to be paid through a two-year earn-out arrangement.

Parker H. “Pete” Petit, MiMedx CEO, said, “We remain very confident in our growth trajectory continuing and in our ability to meet or exceed the revenue projections we have previously set for 2017. In our press release of July 26, 2017, we raised our annual revenue guidance to the range of $309 million to $311 million. Assuming this transaction closes in the third quarter, we will maintain our full year revenue guidance. Even without the Stability Biologics revenue contribution in the fourth quarter, we are confident in our ability to meet our increased revenue guidance for the year. As such, we are also reaffirming all other guidance ranges for the third quarter and full year 2017 as communicated in our July 26 press release.”

Petit added, “We have determined that the Stability Biologics business is not a strategic fit with our new focus on becoming predominantly a biopharmaceutical company. While we believe the potential of Stability Biologics products continues to be significant, we expect to have better return on investment (ROI) opportunities in biopharma compared to those in the cadaver tissue category. A major incentive for the MiMedx acquisition of Stability Biologics was its independent sales representative organization. As part of the transaction, MiMedx will retain access to this sales rep organization via a distributor agreement with Stability. This group of sales reps will continue to focus on certain areas of our surgical business.”

Petit continued, “Our human placental tissue allografts are the source material for our primary asset base, which is a key technology differentiator in regenerative biologics. We are focusing our efforts on continuing down the Investigational New Drug/Biologics License Application (IND/BLA) regulatory pathways for numerous new therapeutic applications of our placental-based technology.  MiMedx will continue to demonstrate, through scientific and clinical studies and trials, the clinical and economic effectiveness of our regenerative biologics and therapies. After this divesture, MiMedx’s gross profit and operating profit margins are expected to improve.”

Mike Senken, MiMedx CFO, commented, “The transaction is expected to be completed in the third quarter of 2017, and the consideration will include a promissory note issued by Stability Biologics in the principal amount of $3.5 million in favor of MiMedx and a waiver by the former stockholders of Stability, Inc. of all claims and rights to the Earn-Out consideration. The Company expects to book a one-time gain on this transaction of approximately $8 million to $10 million.”

Bill Taylor, MiMedx President and COO, commented, “Our infrastructure has been carefully adjusted and assembled to pursue our biopharma strategy. With this new strategic focus, the long-term strategy of Stability Biologics is no longer a strategic fit for MiMedx. That said, through a new “private label” distribution agreement with Stability Biologics, we have retained their key sales relationships for the spine and orthopedics areas of our surgical business.”

Brian Martin, CEO of Stability Biologics LLC, added, “We have enjoyed our association with MiMedx and believe we have benefited a great deal during our time as part of the MiMedx organization. We believe this transaction is a very positive event for both companies.”

About MiMedx

MiMedx® is a biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts and patent-protected processes for multiple sectors of healthcare. “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 1,000,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.

Important Cautionary Statement 

This press release includes forward-looking statements, including statements regarding the Company’s confidence in its overall growth trajectory in 2017 and ability to meet revenue projections for the year even without revenue from Stability Biologics, the Company’s expectations regarding the gain on the transaction, the Company’s belief that the potential for Stability Biologics continues to be significant, the Company’s belief that it will have better return on investment in the biopharma category compared to cadaver tissue, that the Company’s placental tissue allografts are its technology differentiator, that the Company will continue to be able to demonstrate the clinical and economic effectiveness of its regenerative biologics and therapies, the Company’s belief that its gross profit and operating margins will improve post-divestiture, and the Company’s belief that the distributor agreement with Stability Biologics retains key sales relationships for the Company. Forward-looking statements also may be identified by words such as “believe,” “except,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on our current beliefs and expectations.

Forward-looking statements are subject to significant risks and uncertainties, and we caution investors against placing undue reliance on such statements. Actual results may differ materially from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include that any of the Company’s growth, revenue, and gross profit and operating margins may not continue as expected or may decline, Stability Biologics may not continue to have great potential post-divestiture, that the financial impact of the transaction may not occur as predicted, that the Company may not experience better return on investment in biopharma over cadaver tissue or may not be able to adequately transition into the biopharma space to realize its perceived advantages, that the Company’s placental tissue allografts do not continue to be a technology differentiator as competition increases and/or new and different technologies are developed, and that the distributor agreement may fail to retain key sales relationships for the Company. For additional risks that might affect the Company, please review the Risk Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.

SOURCE MiMedx Group, Inc.

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SpineTop Stories

Medovex Corporation Appoints Gorlin Companies Managing Partner Jesse Crowne Director and Executive Co-Chairman of the Board

August 21, 2017 OrthoSpineNews

ATLANTA, GA — (Marketwired) — 08/21/17 — Medovex Corp. (NASDAQ: MDVX) (“Medovex” or the “Company“), the developer of the DenerveX™ System, a new and novel device designed for enduring relief of Facet Joint Syndrome related to back pain, today announced it has appointed Jesse Crowne as Director and Executive Co-Chairman of the Board.

Jesse Crowne has been acting as a Vice President of Business Development for the Company since January 2015. Mr. Crowne has been a Managing Partner at Gorlin Companies; a healthcare focused single family office specializing in founding and funding early ventures since July 2015. Crowne replaces Steve Gorlin who will remain with the Company in a consultancy role.

Between August 2015 and January 2017, Mr. Crowne was the President of Vavotar Life Sciences, a private clinical stage biotechnology company developing antibody directed oncology products. Since 2016, Mr. Crowne has served as an Adjunct Professor at Westminster College teaching a course on financing new ventures to MBA students. From October 2013 to March 2014, he was the Co-Founder of Virtual Clinic Trials, LLC, a cloud based document management solution for clinical trials until it was sold to Global Deal Market in 2014. From 2010 to June 2014, he was an associate at White Pine Medical, a subsidiary of Essex Woodlands, which was a private equity investment fund seeking late stage medical device opportunities.

Steve Gorlin, Medovex Co-founder, stated, “I’m pleased to have accomplished my initial goal of seeing Medovex successfully progress from the development stage to the commercialization phase. I’m also extremely proud of our entire management team and their collective effort in getting us to the opportunistic place we find ourselves today. At no point in the Company’s history have I ever been more confident in its future. Over the years, I’ve been intimately involved in many small healthcare related companies which eventually went on to experience sizeable value creation, but few were as personal as Medovex. My continuing commitment to the company can be no better evidenced than by my Form 4 filing made Wednesday memorializing my open market purchase of an additional 200,000 shares of our stock.”

Gorlin continued, “I’ve worked closely with Jesse Crowne at my own company for some time now and I handpicked him based on a steadfast confidence in his ability to finish what we’ve started. I view him as the ideal person to assist in taking Medovex to the next level and I look forward to continuing to work closely with him, the board and management as we together seek to accomplish my ultimate goal of maximizing shareholder value.”

The Company’s DenerveX System recently received CE Mark approval and clearance for commercialization in the European countries and offers a unique way to perform a Facet Joint Syndrome treatment.

Facet Joint Syndrome (FJS), also known as spinal osteoarthritis, spinal arthritis, or facet joint osteoarthritis, is a significant health and economic problem in the United States and other countries in the EU and Rest of World affecting millions each year. Current treatment options are generally temporary and there is no proven long-lasting option for FJS.

The DenerveX System is a highly differentiated technology. It denervates and removes capsular tissue from the Facet Joint in one single procedure. Treatment results from the combined effect of a deburring or polishing action and RF ablation treatment on the Facet Joint. Using this new technique, the slowly rotating burr removes the targeted facet joint synovial membrane and joint surface while the heat ablation destroys tissue and denudes any residual nervous and synovial membrane overlying the joint, removing the end point sensory tissue of the joint.

The DenerveX System consists of the DenerveX Kit which contains the DenerveX Device, a single use medical device and the DenerveX Pro-40 Power Generator. DenerveX system is not yet FDA cleared.

About Medovex
Medovex was formed to acquire and develop a diversified portfolio of potentially ground breaking medical technology products. Criteria for selection include those products with potential for significant improvement in the quality of patient care combined with cost effectiveness. The Company’s first pipeline product, the DenerveX device, is intended to provide long lasting relief from pain associated with facet joint syndrome at significantly less cost than currently available options. To learn more about Medovex Corp., visit www.medovex.com

Safe Harbor Statement
Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company’s filings with the Securities and Exchange Commission (the “SEC”), not limited to Risk Factors relating to its patent business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

CONTACT INFORMATION
Medovex Corp.
Jason Assad
470-505-9905
Email Contact

 

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