Merit Medical Acquires DFINE, Inc.

SOUTH JORDAN, Utah, July 06, 2016 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ:MMSI), a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy, today announced that it has acquired DFINE, Inc. headquartered in San Jose, California, in a merger transaction through which DFINE has become a wholly-owned subsidiary of Merit.

The purchase consideration was approximately $97.5 million in cash and was financed by a group of banks led by Wells Fargo and included Bank of America, HSBC and U.S. Bank.

DFINE produced revenues of $33.4 million in 2015, with approximately 75% of revenues generated in the United States and 25% outside the United States.  DFINE’s products are directed to vertebral augmentation (kyphoplasty and vertebralplasty), as well as targeted radiofrequency ablation of metastatic spinal tumors.  DFINE’s product lines have 510(k) clearance and CE marking.

“We are delighted to have DFINE join Merit,” said Fred P. Lampropoulos, Merit’s Chairman and Chief Executive Officer.  “Our relationship began a few years ago when Merit was asked to provide key device components for DFINE’s StabiliT® and StabiliT MX® products.  In addition to the spinal compression fracture segment, we believe DFINE’s Star™ Tumor Ablation Kit complements and enhances Merit’s oncology business.”

“We plan to combine Merit’s oncology segments, including embolics, microcatheters and biopsy products into a newly created interventional oncology and spine division (IOS),” Lampropoulos said.  “We believe the restructuring of the sales divisions – cardiovascular, peripheral and IOS – will enable us to devote greater focus on Merit’s broad portfolio of products, align our sales and marketing efforts with Merit’s goal of achieving a more therapeutic and disease state centered product offering, and enhance opportunities for future growth.”

“We believe the opportunity for growth with these best-in-class products is substantial in the United States and also in international markets where Merit already has a broad footprint,” Lampropoulos continued.  “Although DFINE has a presence in Germany and Austria, as well as limited distribution partners, we believe there are many opportunities in Australia, Canada, Japan, China, the Nordic countries and other regions.  We anticipate that DFINE’s IP portfolio of approximately 110 U.S. and international patents will provide substantial coverage for many years ahead.”

The effect of the DFINE acquisition on Merit’s non-GAAP earnings for the balance of 2016 is expected to be neutral due to business restructuring and consolidation expenses and is expected to be dilutive on a GAAP basis by $0.24-$0.26 per share due to intangible amortization and one-time reorganization costs.  In 2017, Merit anticipates the effect of the acquisition on Merit’s non-GAAP earnings to be $0.05-$0.08 per share and to be dilutive on a GAAP basis by $0.05-$0.07 per share.  Merit believes the acquisition will increase its gross margin by approximately 80 basis points on a non-GAAP basis and 55 basis points on a GAAP basis.

Canaccord Genuity acted as Merit’s financial advisor for this transaction.  Piper Jaffray acted as DFINE’s financial advisor.

CONFERENCE CALL TODAY Merit invites all interested parties to participate in its conference call discussing the acquisition (conference ID 41983902) today, Wednesday, July 6, 2016, at 11:00 a.m. Eastern (10:00 a.m. Central, 9:00 a.m. Mountain, and 8:00 a.m. Pacific).  The domestic telephone number is (844) 578-9672, and the international number is (508) 637-5656.  A live webcast of the call and a slide deck showcasing the products and details of the DFINE acquisition are available at www.merit.com.

ABOUT MERIT Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture and distribution of proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology and endoscopy.  Merit serves hospitals, acute care facilities and clinics worldwide, with a domestic and international sales force totaling approximately 200 individuals.  Merit employs approximately 4,000 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Malvern, Pennsylvania; Rockland, Massachusetts; San Jose, California; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil; Markham, Ontario, Canada; Melbourne, Australia; and Mannheim, Germany.

Statements contained in this release which are not purely historical, including, without limitation, statements regarding anticipated revenues, earnings or other financial items; Merit’s plans and objectives for future operations; proposed products or services; integration, development or commercialization of the DFINE operations and assumptions underlying any of the foregoing , are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties such as those described in Merit’s Annual Report on Form 10-K for the year ended December 31, 2015. Such risks and uncertainties include risks relating to Merit’s acquisition of DFINE; Merit’s efforts to integrate, manage and develop DFINE’s operations and products; expenses associated with the integration, management and development of those operations and products; product recalls and product liability claims; expenditures relating to research, development, testing and regulatory approval of Merit’s products (including the DFINE products) and risks that such products may not be developed successfully or approved for commercial use; regulation of the medical device industry; Merit’s need to generate sufficient cash flow to fund its debt obligations, capital expenditures, and ongoing operations; restrictions on Merit’s liquidity or Merit’s ability to operate its business in compliance with its debt agreements; possible infringement of its technology (including the DFINE technology) or the assertion that such technology infringes the rights of other parties; changes in the prices or supply of commodity components; changes in economic and industry conditions in the United States and other countries; termination or interruption of relationships with suppliers, or failure of suppliers to perform; fluctuations in exchange rates; development of new products and technology that could render Merit’ products (including the DFINE products) obsolete; changes in key personnel; potential healthcare regulatory and policy changes; and other factors referred to in Merit’s Annual Report on Form 10-K for the year ended December 31, 2015 and other materials filed with the Securities and Exchange Commission. All subsequent forward-looking statements attributable to Merit or persons acting on its behalf are expressly qualified in their entirety by these cautionary statements. Actual results will likely differ, and may differ materially, from anticipated results. Financial estimates are subject to change and are not intended to be relied upon as predictions of future operating results, and Merit assumes no obligation to update or disclose revisions to those estimates.

Contact: Anne-Marie Wright, Vice President, Corporate Communications Phone: (801) 208-4167 e-mail: [email protected] Fax: (801) 253-1688

Commercial Launch of the Long SpineSTAR® Ablation Instrument

DFINE® Announces Commercial Launch of the Long SpineSTAR® Ablation Instrument for the Palliative Treatment of Metastatic Spine Tumors

SpineSTARs extended working length provides spine specialists greater access and ability to precisely target metastatic spine tumors in order to offer patients rapid, sustained pain relief improving their quality of life. 

San Jose, Calif. (PRWEB) December 15, 2015 — DFINE, Inc., today announced the commercial launch of its Long SpineSTAR® Ablation Instrument.  Long SpineSTAR is the latest innovation by the Silicon Valley medical device manufacturer and is part of the company’s flagship STAR Tumor Ablation System.  The new surgical instrument incorporates new product refinements including a longer working length and a redesigned electrode knob for easier use, enabling the physician to access painful spinal tumors throughout the vertebral body.  The STAR System uses radiofrequency or thermal heat to ablate the tumor to achieve rapid and sustained pain relief in a procedure called targeted-Radiofrequency Ablation (t-RFA).

There are an estimated 280,000 adults in the United States living with metastatic bone disease; with as much as 70% of all cancer patients developing spinal metastases over their lifetime.1, 2  These tumors are often extremely painful and debilitating for patients, negatively impacting their quality of life and social functioning with an increased dependence on narcotic pain medication.  Targeted-Radiofrequency Ablation (t-RFA) is an advanced minimally invasive treatment that provides a new option for patients to relieve their pain while maintaining compatibility with traditional cancer treatments such as chemotherapy and radiation therapy.

Targeted-Radiofrequency Ablation is an outpatient procedure, performed by spine specialists, most commonly under sedation and local anesthesia. Clinical studies have demonstrated that patients typically experience dramatic, immediate and durable pain relief with >50% of the study patients being able to reduce their use of pain medications.3, 4   Compared to conventional radiation therapy alone, the combined therapeutic approach of radiofrequency ablation and conventional radiation therapy has been reported to significantly improve patient outcomes by improving the percentage of patients experiencing overall pain response from 60% to over 90%, decreasing time to pain relief (3 vs. 9 weeks), and resulting in less recurrent pain requiring retreatment.

“We developed the Long SpineSTAR to expand the physician’s ability to utilize this technology in larger patients and certain difficult to access vertebrae,” said Greg Barrett, Chief Executive Officer of DFINE.  “This is a significant step forward in our mission to dramatically improve the lives of all patients suffering from the pain and loss of function caused by metastatic spinal tumors. Clinical evaluation of the STAR System has resulted in a 77% reduction of pain3 and significant improvement (p<0.01) in patients quality of life.6

The SpineSTAR® Ablation Instrument is the only steerable and navigational radiofrequency device on the market, allowing accurate placement and easy repositioning throughout the vertebral body from a unipedicular approach. The articulating design is built for use in the unique anatomy of the spine to allow physicians easy access to the posterior region of the vertebral body to create site-specific targeted ablation zones.

“The STAR System has allowed me to treat patients spine tumor related pain in a minimally invasive fashion resulting in significant improvements in pain and quality of life,” said Jack Jennings, MD, Associate Professor in Radiology, Director of Musculoskeletal and Spine Intervention, Washington University School of Medicine.  “The t-RFA procedure is compatible with traditional cancer therapy, often allowing patients to continue chemotherapy and/or radiation therapy with less discomfort.  The Long SpineSTAR’s increased length will allow us to access and treat a broader spectrum of vertebrae and patients.”

The STAR Tumor Ablation system was released in the US in 2012, and has been performed on over 4,000 patients worldwide.  The Company is also conducting a number of clinical studies including the prospective, multi-center STAART Study which is currently enrolling patients at leading cancer centers across the United States.

You can read the online version of this press release here

  1. Li et al. Clinical Epidemiology 2012:4 87–93
  2. Fisher et al. Radiation Oncology 2014, 9:69
  3. Anchala et al. Pain Physician. 2014 Jul-Aug; 17(4):317-27.
  4. Hillen et al. Radiology. 2014 Oct; 273(1):261-7.
  5. Di Staso et al. Eur Radiol (2011) 21:2004–2010
  6. Bagla et al. J Vasc Interv Radiol 2015; 26:e86.

First Patients Enrolled in the STARRT Clinical Study

DFINE® Announces First Patients Enrolled in the STARRT Clinical Study on Spinal Tumor Ablation with the STAR Tumor Ablation System

Prospective multi-center trial enrolling patients in USA

San Jose, Calif. January 23, 2015 — DFINE, Inc.,announced today that the first two patients have been enrolled in the STARRT Clinical Trial at Providence Sacred Heart Medical Center, Spokane WA. The multi-center trial is the first prospective study to evaluate the treatment of painful metastatic lesions with STAR Targeted Radiofrequency Ablation (t-RFA) and Radiofrequency Targeted Vertebral Augmentation (RF-TVA) prior to or following radiation therapy.

The principal investigator for the study, Jack Jennings, M.D., Ph.D., Director of Spine and Musculoskeletal Intervention at Washington University School of Medicine (St. Louis, MO), commented, “The protocol for this study is designed to clarify t-RFA as part of the treatment algorithm for metastatic spinal tumors and is the result of the collaboration of a multi-disciplinary working group on metastatic spine disease.”

DFINE will enroll 64 patients presenting with painful metastatic spinal lesions at up to 20 centers in the United States. The trial will evaluate the degree and durability of the palliative effect of t-RFA and vertebral augmentation combined therapy. Patients that have either failed or refuse further radiation therapy, or have yet to receive radiation therapy are eligible to be enrolled. Patients will be evaluated through a six month follow up period. The primary outcome is reduction of their pain. Secondary outcomes being evaluated are changes in quality of life, reduction of pain medications and the time to achieve adequate pain relief. Tumor control will also be evaluated.

“We’ve had very promising results with targeted radiofrequency ablation (t-RFA) to ablate localized metastatic spine tumors and augment the fractured vertebrae that is often associated with the disease. This procedure allows me to give patients rapid pain relief that dramatically improves their quality of life,” said Dr. Jayson Brower, the principal investigator at Providence Sacred Heart Medical Center where the first two patients were treated.

Cancer is a major public health problem throughout the world, and when cancer is not found early, it can metastasize (spread) to other parts of the body. A metastatic spinal tumor is a growth of cells (mass) in or around the vertebra of the spine. Over five million Americans are living with cancer that was diagnosed in the last five years and more than 1.67 million new cancer cases were expected to be diagnosed in the US in 2014 1 It is estimated that 30-40% of late-stage cancer patients will likely develop metastatic spinal tumors.2

“t-RFA and RF-TVA provide an innovative new treatment option for the many patients worldwide who suffer from the debilitating effects of metastatic spinal tumors,” said Greg Barrett, Chief Executive Officer of DFINE.

“As a company, we are committed to building a body of scientific evidence supporting the therapy and are excited to partner with several leading medical centers in the United States on this landmark trial.”

To learn more about the STARRT clinical trial, go to Clinical trials.gov/ study ID # NCT02225223.

STAR™ Tumor Ablation System

Indications for Use

The STAR Tumor Ablation System is indicated for palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.

Risks & Contraindications

Like all surgical procedures, radiofrequency ablation procedures using the STAR System involve risks, and some patients are not good candidates for the procedure. For detailed description of risks and contraindications, please review the product Instructions for Use.

Multi-Center Trial Shows Significant Pain Relief For Spine Cancer Patients Following Targeted Radiofrequency Ablation Treatment

SAN JOSE, Calif. – July 21, 2014 – DFINE®, Inc., a market leader in the minimally invasive treatment of spinal diseases, today announced the publication of a multi-center study in the July/August issue of Pain Physician Journal, the official peer-reviewed publication of the American Society of Interventional Pain Physicians (ASIPP). The study followed patients at five leading academic centers and found a significant decrease (p<0.01) in pain scores after Targeted Radiofrequency Ablation™ (t-RFA) with the STAR Tumor Ablation System™.The participating centers included Washington University School of Medicine, Moffitt Cancer Center, Montefiore Medical Center and the Albert Einstein College of Medicine, University of Louisville Hospital and the University of California, San Diego. Physicians treated 128 lesions (metastatic tumors) in 92 patients. The average pain score before the procedure was 7.51 out of 10. Within one week post-procedure, the average pain score was reduced to just 1.73. Researchers also noted no patient complications or injuries.

“More than 40 percent of patients at the highest enrolling institution in this study had previous radiation treatment with little to no relief of symptoms,” said Jack W. Jennings, M.D., Ph.D, Assistant Professor and Director of Musculoskeletal and Spine Interventions, Mallinckrodt Institute of Radiology, Washington University School of Medicine in St. Louis. “Our study showed significant and almost immediate reduction in pain and more than half of the patients also decreased their use of pain medication. The procedure also allowed us to treat tumors close to the spinal cord that we have not been able to treat in the past.”

The American Cancer Society estimates that in 2014 there will be more than 1.7 million new cancer cases diagnosed and 585,720 cancer deaths in the United States.1 Metastatic lesions in bone are common and have been seen in up to 80 percent of patients with cancer at the time of death,2 with spinal metastasis seen in approximately 50 percent of these patients.3

“For late-stage cancer patients, extreme back pain due to spinal tumors degrades quality of life; and until now, limited minimally invasive procedural options for immediate pain relief have been available,” said Nam D. Tran, M.D., and Ph.D., neurooncology surgeon at Moffitt Cancer Center. “This multi-center study validates t-RFA as a treatment option that provides rapid, lasting pain relief without the need to interrupt the patient’s primary cancer therapy.”

About STAR™ Tumor Ablation System

t-RFA with the STAR System does not treat cancer. It is cleared by the FDA for providing palliative treatment (e.g. pain relief) by ablation of metastatic malignant tumors in a vertebral body. For a complete list of indications, risks and contraindications, visit http://www.dfineinc.com/Product-Risk—SpineSTAR

DFINE Announces Commencement Of Clinical Study On Spinal Tumor Ablation With The STAR Tumor Ablation System

San Jose, Calif. and Magdeburg, Germany – June 11, 2014DFINE®, Inc., a market leader in the minimally invasive treatment of spinal diseases, today announced that the first patient has been enrolled in the EU-STAR Clinical Trial. The multi-center trial is the first prospective study to evaluate clinical outcomes in patients receiving treatment with the STAR™ Tumor Ablation System for the palliative treatment of metastatic spinal tumors.

DFINE will enroll 40 patients at five centers in Germany and France. The trial will evaluate pain relief at one month as a primary outcome measure with follow up through six months. Secondary outcome measures include change in function, quality of life and pain medications post-procedure.

“We’ve had very promising results with targeted RF ablation (t-RFA™) to ‘melt’ the tumor followed by RF targeted vertebral augmentation™ (RF-TVA) during the same procedure to repair the damaged vertebrae,” said Dr. Boris Joellenbeck, a principal investigator at The Otto-von-Guericke University Magdeburg in Germany, where the first patient was treated. “Immediately following the procedure, the patient had a significant reduction in pain and increased activity level. We are excited about the many potential benefits of this therapeutic approach for our patients.”

Cancer is a major public health problem throughout the world, with more than 3.4 million new diagnoses each year in Europe alone.1 When cancer is not found early, it can metastasize (spread) to other parts of the body. A spinal tumor is a growth of cells (mass) in or around the vertebra near the spinal cord. It is estimated that 30-40 percent of cancer patients will likely develop metastatic spinal tumors.Many of these tumors also result in fractures of the vertebrae.

“t-RFA and RF-TVA provide an innovative new treatment option for the many patients worldwide who suffer from the debilitating effects of spinal tumors,” said Greg Barrett, Chief Executive Officer of DFINE. “As a company we are committed to building a body of scientific evidence supporting the therapy and are excited to partner with several leading medical centers in Germany and France on this landmark trial.”

To learn more about the EU-STAR clinical trial (ID # NCT02081053), interested parties may contact the study research staff found here: http://www.clinicaltrials.gov/ct2/show/NCT02081053 

About STAR™ Tumor Ablation System

t-RFA with the STAR System does not treat cancer. It is cleared by the FDA for providing palliative treatment (e.g. pain relief) by ablation of metastatic malignant tumors in a vertebral body. For a complete list of indications, risks and contraindications, visit http://www.dfineinc.com/Product-Risk—SpineSTAR

About DFINE, Inc.

DFINE is dedicated to relieving pain and improving the quality of life for patients suffering from spinal diseases through innovative, minimally invasive therapies. The company’s flagship products, the StabiliT® Vertebral Augmentation System and STAR™ Tumor Ablation System, represent generational advancements in the minimally invasive treatment of spinal diseases. DFINE is based in San Jose, Calif. and is a privately held company.

DFINE and StabiliT are registered trademarks and STAR and Targeted Radiofrequency Ablation (t-RFA) are trademarks of DFINE, Inc. [media-contact]

New Studies Highlight Benefits Of STAR Tumor Ablation System For Patients With Spinal Tumors

San Jose, Calif. – Feb. 18, 2014 –Two studies presented at the American Society of Spine Radiology (ASSR) 2014 Annual Symposium in Miami highlighted the benefits of Targeted Radiofrequency Ablation™ (t-RFA) therapy with the DFINE STAR™ Tumor Ablation System. The studies demonstrated the ability of the STAR System to provide significant pain relief to patients suffering from painful spinal metatases; in many cases, these patients had not responded to standard therapies, such as radiation or chemotherapy. The first study, conducted by Bassem Georgy, M.D., Assistant Clinical Professor of Radiology at the University of California, San Diego, noted improvement in pain and functional status (quality of life) in all patients. The study also concluded that the targeted and minimally invasive nature of the STAR System allowed treatment of all of the studied tumors regardless of their location. The second study, conducted by Jack Jennings, M.D., PhD, Director of Musculoskeletal and Spine Interventions at the Mallinckrodt Institute of Radiology in St. Louis, demonstrated the value of the STAR System in treating patients who were not responsive to other standard treatments and who had tumors very close to the spinal cord (posterior lesions). In addition to relieving pain, the study concluded that the STAR System had successfully destroyed the lesions, and that in many patients no regrowth was observed during the study period.< “We are pleased with the continued success of STAR in providing pain relief to the many cancer patients suffering from spinal tumors,” said Greg Barrett, Chief Executive Officer of DFINE. “The therapy continues to gain momentum and we are gratified to see more clinicians embracing the technology to help their patients.” About STAR™ Tumor Ablation System The STAR Tumor Ablation System does not treat cancer. It was cleared by the FDA in 2010 for providing palliative treatment (e.g., pain relief) by ablation of metastatic malignant tumors in a vertebral body. With its use of targeted radiofrequency (RF) energy, the STAR System enables physicians to achieve pain relief through the use of a single, minimally invasive procedure that may be compatible with both chemo and radiation therapy. As with all surgical procedures, there are risks and contraindications associated with the STAR System which are described in the product labeling.  The STAR System is available at more than 200 institutions in the U.S. For more information regarding spinal tumors or to find a physician, visit http://www.spine-tumors.com. About STAR™ Tumor Ablation System t-RFA with the STAR System does not treat cancer. It is cleared by the FDA for providing palliative treatment (e.g. pain relief) by ablation of metastatic malignant tumors in a vertebral body. For a complete list of indications, risks and contraindications, visit http://www.dfineinc.com/Product-Risk—SpineSTAR About DFINE, Inc.DFINE is dedicated to relieving pain and improving the quality of life for patients suffering from spinal diseases through innovative, minimally invasive therapies. The company’s flagship products, the StabiliT® Vertebral Augmentation System and STAR™ Tumor Ablation System, represent generational advancements in the minimally invasive treatment of spinal diseases. DFINE is based in San Jose, Calif. and is a privately held company. DFINE and StabiliT are registered trademarks and STAR and Targeted Radiofrequency Ablation (t-RFA) are trademarks of DFINE, Inc. Media Contact Susan Benton Russell T: 310-697-3488 [email protected]

First Commercial Cases with STAR System in Europe

DFINE ANNOUNCES FIRST COMMERCIAL CASES WITH STAR TUMOR ABLATION SYSTEM IN EUROPE

San Jose, Calif. – October 9, 2013 – DFINE, Inc., a fast-growing market leader in the treatment of spinal diseases, today announced the completion of the first European commercial cases with the STAR™ Tumor Ablation System for the palliative treatment of painful metastatic spinal tumors since the device received CE Mark approval last month.

The Targeted Radiofrequency Ablation (t-RFA) procedures using the STAR System were performed in Germany, Italy and the United Kingdom over the past two weeks.

According to Dr. Winston Rennie at the University of Leicester’s, Leicester Royal Infirmary who performed the first case in the UK, “t-RFA is one of the most innovative and exciting developments I have seen for the palliative treatment of painful spinal tumors in recent years,” he said. “The unique design of the STAR System allows me to deliver a very targeted and controlled ablation next to critical spinal structures, burn tumors and provide rapid pain relief in a single procedure. I was very pleased with the initial experience and can see a significant need for this in percutaneous cancer treatment and spine augmentation in the UK.”

The STAR System received 510k clearance in August 2010 and has demonstrated strong clinical outcomes in the U.S. and abroad. In September, the company announced the CE Mark approval and European product launch at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) Annual Congress.

“We are pleased with the very quick start in Europe and believe that it is indicative of the unmet clinical need for patients with painful spinal metastases,” said Greg Barrett, Chief Executive Officer of DFINE. “Our goal is to expand into centers across all European markets in an effort to make the therapy available to the many thousands of patients suffering from painful spinal tumors.”

About STAR™ Tumor Ablation System

t-RFA with the STAR System does not treat cancer. It is cleared by the FDA for providing palliative treatment (e.g. pain relief) by ablation of metastatic malignant tumors in a vertebral body. For a complete list of indications, risks and contraindications, visit http://www.dfineinc.com/Product-Risk—SpineSTAR

About DFINE, Inc.

DFINE is dedicated to relieving pain and improving the quality of life for patients suffering from spinal diseases through innovative, minimally invasive therapies. The company’s flagship products, the StabiliT® Vertebral Augmentation System and STAR™ Tumor Ablation System, represent generational advancements in the minimally invasive treatment of spinal diseases. DFINE is based in San Jose, Calif. and is a privately held company. DFINE and StabiliT are registered trademarks and STAR and Targeted Radiofrequency Ablation (t-RFA) are trademarks of DFINE, Inc.

CE Mark of Approval for STAR™ Tumor Ablation System

DFINE, INC. RECEIVES CE MARK APPROVAL FOR STAR™ TUMOR ABLATION SYSTEM

European Launch at CIRSE Annual Congress

SAN JOSE, Calif., Sept. 12, 2013 — DFINE, Inc., a fast-growing market leader in the treatment of spinal diseases, today announced it has received CE Mark approval for the STAR™ Tumor Ablation System for treatment of painful metastatic spinal tumors. The company will launch the STAR System in Europe at theCardiovascular and Interventional Radiological Society of Europe (CIRSE) Annual Congress (Booth #12). CIRSE, the world’s largest and most prestigious conference in the field of minimally invasive image-guided therapies, will be held in Barcelona, Spain Sept. 14 – 19, 2013.

The STAR System received 510k clearance in the United States in August 2010 and has demonstrated strong clinical outcomes at centers across the country.

“We are very excited to bring this new treatment modality to Europe so that the hundreds of thousands of patients suffering from painful spinal tumors can receive the rapid pain relief that patients here in the U.S. have experienced. This represents a significant milestone for the company,” said Greg Barrett, Chief Executive Officer of DFINE.

About Metastatic Spinal Tumors

Cancer is a major public health problem throughout the world, with more than 3.4 million new diagnoses each year in Europe alone.1 When cancer is not found early, it can spread or metastasize to other parts of the body. A spinal tumor is a growth of cells (mass) in or around the vertebra near the spinal cord. It is estimated that 30 – 40 percent of cancer patients will likely develop metastatic spinal tumors.2

Patients suffering from painful spinal tumors have limited options. Many are in excruciating pain and unable to perform activities of daily living. Targeted RF ablation (t-RFA) with the STAR Tumor Ablation System was developed specifically for metastatic vertebral body tumors. The physician can target precisely where the device’s energy is delivered to heat and destroy the tumor, providing rapid and lasting pain relief in a single treatment.

1 Bray F, Ren HS, Masuyer E, Ferlay J. Estimates of global cancer prevalence for 27 sites in the adult population in 2008. Int J Cancer. 2013 Mar1;132(5):1133-45. Epub 2012 Jul 26

2 Medscape Reference: Victor Tse, MD, PhD; Chief Editor: Stephen A Berman, MD, PhD, MBA, et al.

About STAR™ Tumor Ablation System

t-RFA with the STAR System does not treat cancer. It is cleared by the FDA for providing palliative treatment (e.g. pain relief) by ablation of metastatic malignant tumors in a vertebral body. For a complete list of indications, risks and contraindications, visit http://www.dfineinc.com/Product-Risk—SpineSTAR

About DFINE, Inc.

DFINE is dedicated to relieving pain and improving the quality of life for patients suffering from spinal diseases through innovative, minimally invasive therapies. The company’s flagship products, the StabiliT® Vertebral Augmentation System and STAR™ Tumor Ablation System, represent generational advancements in the minimally invasive treatment of spinal diseases. DFINE is based in San Jose, Calif. and is a privately held company. DFINE and StabiliT are registered trademarks and STAR and Targeted Radiofrequency Ablation (t-RFA) are trademarks of DFINE, Inc.