DFINE, Inc.

Last updated
DFINE, Inc.
Founded2004 [1]
Headquarters,
Number of locations
11 countries (direct in the U.S. and Germany)
Key people
Greg Barrett, CEO [2]
Dan Balbierz - Chief Development Officer [2]
ProductsStabiliT Vertebral Augmentation System [3]
STAR Tumor Ablation System
Number of employees
150
Website www.dfineinc.com

DFINE, Inc. was an American medical device company with headquarters in San Jose, California. [4] It was known for its development of minimally invasive therapeutic devices built upon a radiofrequency platform for the treatment of spinal diseases. [5] The platform included two applications, the StabiliT Vertebral Augmentation System for the treatment of vertebral compression fractures [6] and the STAR Tumor Ablation System for pain relief treatment of metastatic spinal tumors. [7]

Contents

History

DFINE was founded in 2004 in San Jose, California. [1] It has had five rounds of funding since inception. The first being $35 million in 2009 led by Prospect Venture Partners. [8] In January 2010 it received an additional $2.8 million. [4] It received $36.2 million in equity finance in July 2010, led by Split Rock Partners with participation from OrbiMed, Prospect Venture Partners, and Vanguard Ventures. [9] Its fourth round was $25 million [10] with an additional $1.8 million coming in April 2012.

In 2011, DFINE was awarded a five-year Federal Supply Schedule from the United States Department of Veterans Affairs. The contract included DFINE supplying its StabiliT System and related products to the Veterans Health Administration.[ citation needed ]

Merit Medical Systems, Inc. (NASDAQ:MMSI), a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy, announced on June 06, 2016 that it has acquired DFINE, Inc. in a merger transaction through which DFINE became 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. [11]

Products

DFINE developed products for the treatment of spinal diseases using a radiofrequency platform. [1] [12] The platform covers two procedures, one for the treatment of vertebral compression fractures and one for palliative treatment of metastatic spinal tumors. Both have received clearance from the United States Food and Drug Administration and CE Mark approval for use within the European Economic Area. [13]

StabiliT Vertebral Augmentation System

The StabiliT System is an FDA cleared device that uses radiofrequency targeted vertebral augmentation (also written RF-TVA) to repair compression fractures in the vertebrae. [12] it is a minimally invasive procedure designed to preserve good bone while performing kyphoplasty. [6] [12] In contrast with balloon kyphoplasty, RF-TVA is performed by a physician navigating within the vertebral body by placing a working canula into the vertebra and creating a cavity using a small chisel-like instrument. [12] The cavity is then filled with ultra-high viscosity bone cement which then permeates into the surrounding bone, stabilizing the fracture [3] [6] and restoring vertebral height. [14] As of 2014, the system has been used to treat more than 15,000 spinal fractures worldwide.

STAR Tumor Ablation System

The STAR Tumor Ablation System is an FDA-cleared medical device that uses targeted radiofrequency ablation (also written t-RFA) to heat and destroy cancerous tumors caused by metastatic disease that has spread to the spine, causing severe pain and discomfort. [15] [16] STAR is not used as a treatment for cancer, but for pain relief. It is typically an outpatient procedure and can be performed using local anesthesia through a small incision. It works by placing a small steerable device into the vertebra which is guided by the physician to precisely target the tumor. [16] The system then ablates the tumor, destroying the tumor cells while minimizing damage to surrounding tissues. In some cases it has been shown to alleviate pain with one treatment. [16]

See also

Related Research Articles

<span class="mw-page-title-main">Back pain</span> Area of body discomfort

Back pain is pain felt in the back. It may be classified as neck pain (cervical), middle back pain (thoracic), lower back pain (lumbar) or coccydynia based on the segment affected. The lumbar area is the most common area affected. An episode of back pain may be acute, subacute or chronic depending on the duration. The pain may be characterized as a dull ache, shooting or piercing pain or a burning sensation. Discomfort can radiate to the arms and hands as well as the legs or feet, and may include numbness or weakness in the legs and arms.

<span class="mw-page-title-main">Bone tumor</span> Medical condition

A bone tumor is an abnormal growth of tissue in bone, traditionally classified as noncancerous (benign) or cancerous (malignant). Cancerous bone tumors usually originate from a cancer in another part of the body such as from lung, breast, thyroid, kidney and prostate. There may be a lump, pain, or neurological signs from pressure. A bone tumor might present with a pathologic fracture. Other symptoms may include fatigue, fever, weight loss, anemia and nausea. Sometimes there are no symptoms and the tumour is found when investigating another problem.

<span class="mw-page-title-main">Interventional radiology</span> Medical subspecialty

Interventional radiology (IR) is a medical specialty that performs various minimally-invasive procedures using medical imaging guidance, such as x-ray fluoroscopy, computed tomography, magnetic resonance imaging, or ultrasound. IR performs both diagnostic and therapeutic procedures through very small incisions or body orifices. Diagnostic IR procedures are those intended to help make a diagnosis or guide further medical treatment, and include image-guided biopsy of a tumor or injection of an imaging contrast agent into a hollow structure, such as a blood vessel or a duct. By contrast, therapeutic IR procedures provide direct treatment—they include catheter-based medicine delivery, medical device placement, and angioplasty of narrowed structures.

<span class="mw-page-title-main">Vertebral augmentation</span> Type of spinal procedure

Vertebral augmentation, including vertebroplasty and kyphoplasty, refers to similar percutaneous spinal procedures in which bone cement is injected through a small hole in the skin into a fractured vertebra in order to relieve back pain caused by a vertebral compression fracture. After decades of medical research into the efficacy and safety of vertebral augmentation, there is still a lack of consensus regarding certain aspects of vertebroplasty and kyphoplasty.

<span class="mw-page-title-main">Kyphosis</span> Medical condition

Kyphosis is an abnormally excessive convex curvature of the spine as it occurs in the thoracic and sacral regions. Abnormal inward concave lordotic curving of the cervical and lumbar regions of the spine is called lordosis. It can result from degenerative disc disease; developmental abnormalities, most commonly Scheuermann's disease; Copenhagen disease, osteoporosis with compression fractures of the vertebra; multiple myeloma; or trauma. A normal thoracic spine extends from the 1st thoracic to the 12th thoracic vertebra and should have a slight kyphotic angle, ranging from 20° to 45°. When the "roundness" of the upper spine increases past 45° it is called kyphosis or "hyperkyphosis". Scheuermann's kyphosis is the most classic form of hyperkyphosis and is the result of wedged vertebrae that develop during adolescence. The cause is not currently known and the condition appears to be multifactorial and is seen more frequently in males than females.

Spinal tumors are neoplasms located in either the vertebral column or the spinal cord. There are three main types of spinal tumors classified based on their location: extradural and intradural. Extradural tumors are located outside the dura mater lining and are most commonly metastatic. Intradural tumors are located inside the dura mater lining and are further subdivided into intramedullary and extramedullary tumors. Intradural-intramedullary tumors are located within the dura and spinal cord parenchyma, while intradural-extramedullary tumors are located within the dura but outside the spinal cord parenchyma. The most common presenting symptom of spinal tumors is nocturnal back pain. Other common symptoms include muscle weakness, sensory loss, and difficulty walking. Loss of bowel and bladder control may occur during the later stages of the disease.

Bone pain is pain coming from a bone, and is caused by damaging stimuli. It occurs as a result of a wide range of diseases or physical conditions or both, and may severely impair the quality of life.

<span class="mw-page-title-main">Radiofrequency ablation</span> Surgical procedure

Radiofrequency ablation (RFA), also called fulguration, is a medical procedure in which part of the electrical conduction system of the heart, tumor or other dysfunctional tissue is ablated using the heat generated from medium frequency alternating current. RFA is generally conducted in the outpatient setting, using either local anesthetics or twilight anesthesia. When it is delivered via catheter, it is called radiofrequency catheter ablation.

<span class="mw-page-title-main">Cryoablation</span> Process using extreme cold to destroy tissue

Cryoablation is a process that uses extreme cold to destroy tissue. Cryoablation is performed using hollow needles (cryoprobes) through which cooled, thermally conductive, fluids are circulated. Cryoprobes are positioned adjacent to the target in such a way that the freezing process will destroy the diseased tissue. Once the probes are in place, the attached cryogenic freezing unit removes heat from ("cools") the tip of the probe and by extension from the surrounding tissues.

<span class="mw-page-title-main">Vertebral compression fracture</span> Medical condition

A compression fracture is a collapse of a vertebra. It may be due to trauma or due to a weakening of the vertebra. This weakening is seen in patients with osteoporosis or osteogenesis imperfecta, lytic lesions from metastatic or primary tumors, or infection. In healthy patients, it is most often seen in individuals suffering extreme vertical shocks, such as ejecting from an ejection seat. Seen in lateral views in plain x-ray films, compression fractures of the spine characteristically appear as wedge deformities, with greater loss of height anteriorly than posteriorly and intact pedicles in the anteroposterior view.

<span class="mw-page-title-main">Osteoid osteoma</span> Medical condition

An osteoid osteoma is a benign (non-cancerous) bone tumor that arises from osteoblasts and some components of osteoclasts. It was originally thought to be a smaller version of an osteoblastoma. Osteoid osteomas tend to be less than 1.5 cm in size. The tumor can be in any bone in the body but are most common in long bones, such as the femur and tibia. They account for 10 to 12 percent of all benign bone tumors and 2 to 3 percent of all abnormal bone growths. Osteoid osteomas may occur at any age, and are most common in patients between the ages of 4 and 25 years old. Males are affected approximately three times more commonly than females.

<span class="mw-page-title-main">Bone metastasis</span> Medical condition

Bone metastasis, or osseous metastatic disease, is a category of cancer metastases that result from primary tumor invasions into bones. Bone-originating primary tumors such as osteosarcoma, chondrosarcoma, and Ewing sarcoma are rare; the most common bone tumor is a metastasis. Bone metastases can be classified as osteolytic, osteoblastic, or both. Unlike hematologic malignancies which originate in the blood and form non-solid tumors, bone metastases generally arise from epithelial tumors and form a solid mass inside the bone. Bone metastases, especially in a state of advanced disease, can cause severe pain, characterized by a dull, constant ache with periodic spikes of incident pain.

Neuro-oncology is the study of brain and spinal cord neoplasms, many of which are very dangerous and life-threatening. Among the malignant brain cancers, gliomas of the brainstem and pons, glioblastoma multiforme, and high-grade astrocytoma/oligodendroglioma are among the worst. In these cases, untreated survival usually amounts to only a few months, and survival with current radiation and chemotherapy treatments may extend that time from around a year to a year and a half, possibly two or more, depending on the patient's condition, immune function, treatments used, and the specific type of malignant brain neoplasm. Surgery may in some cases be curative, but, as a general rule, malignant brain cancers tend to regenerate and emerge from remission easily, especially highly malignant cases. In such cases, the goal is to excise as much of the mass and as much of the tumor margin as possible without endangering vital functions or other important cognitive abilities. The Journal of Neuro-Oncology is the longest continuously published journal in the field and serves as a leading reference to those practicing in the area of neuro-oncology.

Interventional pain management or interventional pain medicine is a medical subspecialty defined by the National Uniforms Claims Committee (NUCC) as, " invasive interventions such as the discipline of medicine devoted to the diagnosis and treatment of pain related disorders principally with the application of interventional techniques in managing sub acute, chronic, persistent, and intractable pain, independently or in conjunction with other modalities of treatment". Medicare Payment Advisory Commission (MedPAC) defined interventional techniques as, "minimally invasive procedures including, percutaneous precision needle placement, with placement of drugs in targeted areas or ablation of targeted nerves; and some surgical techniques such as laser or endoscopic diskectomy, intrathecal infusion pumps and spinal cord stimulators, for the diagnosis and management of chronic, persistent or intractable pain". Minimally invasive interventions such as facet joint injections, nerve blocks, neuroaugmentation, vertebroplasty, kyphoplasty, nucleoplasty, endoscopic discectomy, and implantable drug delivery systems are utilized in managing subacute or chronic pain.

Microwave ablation is a form of thermal ablation used in interventional radiology to treat cancer. MWA uses electromagnetic waves in the microwave energy spectrum to produce tissue-heating effects. The oscillation of polar molecules produces frictional heating, ultimately generating tissue necrosis within solid tumors. It is generally used for the treatment and/or palliation of solid tumors in patients who are nonsurgical candidate.

Cancer pain can be caused by pressure on, or chemical stimulation of, specialised pain-signalling nerve endings called nociceptors, or by damage or illness affecting nerve fibers themselves.

Radiofrequency targeted vertebral augmentation is a form of kyphoplasty that uses radiofrequency heat to control the viscosity of polymethylmethacrylate cement and deliver it into the vertebral body to treat vertebral compression fractures.

Targeted radiofrequency ablation is a minimally invasive procedure to treat severe pain and discomfort caused from metastatic tumors in the vertebral body of the spine. This procedure uses radiofrequency energy to target and ablate a specific spinal tumor, causing it shrink and reduce the pressure on the surrounding nerves and tissues. The procedure minimizes damage to the vertebrae and surrounding tissues. It is used as a palliative therapy rather with the intention of treating the cancer itself.

Interventional oncology is a subspecialty field of interventional radiology that deals with the diagnosis and treatment of cancer and cancer-related problems using targeted minimally invasive procedures performed under image guidance. Interventional oncology has developed to a separate pillar of modern oncology and it employs X-ray, ultrasound, computed tomography (CT) or magnetic resonance imaging (MRI) to help guide miniaturized instruments to allow targeted and precise treatment of solid tumours located in various organs of the human body, including but not limited to the liver, kidneys, lungs, and bones. Interventional oncology treatments are routinely carried out by interventional radiologists in appropriate settings and facilities.

Damian E. Dupuy, M.D., F.A.C.R. is an Adjunct Professor of Diagnostic Imaging at Brown University's Warren Alpert Medical School and Director of Ablation services at Cape Cod Hospital. He is also a Member of Cape Cod preferred Physicians.

References

  1. 1 2 3 Chandler, Michele (19 September 2010). "Silicon Valley startups bring innovations to back surgery". San Jose Business Journal. Retrieved 5 May 2014.
  2. 1 2 "DFINE Management Team". Dfine, Inc. Archived from the original on 4 April 2014. Retrieved 5 May 2014.
  3. 1 2 Mauro, Matthew A. (2013). Image-Guided Interventions: Expert Radiology Series. Elsevier Health Sciences. ISBN   9781455753970.
  4. 1 2 Ricketts, Camille (11 January 2010). "DFine takes in $2.8M to heal spinal fractures". Venture Beat. Retrieved 5 May 2014.
  5. Chandler, Michele (15 August 2010). "DFine Inc. cements future in vertebrae surgical market". San Jose Business Journal. Retrieved 5 May 2014.
  6. 1 2 3 Krings, Timo (2011). Case-Based Interventional Neuroradiology. Thieme. ISBN   9781604063745.
  7. Parikh, Ravi (22 August 2013). "DFINE STAR Tumor Ablation System Demonstrates Significant Clinical Benefit for Spinal Metastases". Med Gadget. Retrieved 5 May 2014.
  8. "DFine Raises $35 Million". Private Equity Hub. 2 January 2009. Archived from the original on 30 October 2016. Retrieved 5 May 2014.
  9. Klein, Julie (15 July 2010). "DFine raises $36.2M to repair spine fractures". Venture Beat. Retrieved 5 May 2014.
  10. "Dfine Closes $25M Equity Financing". Finsmes. 8 November 2011. Retrieved 5 May 2014.
  11. Inc., Merit Medical Systems. "Merit Medical Acquires DFINE, Inc". GlobeNewswire News Room. Retrieved 2016-12-15.{{cite news}}: |last= has generic name (help)
  12. 1 2 3 4 Robertson, Scott C. (2011). "Percutaneous Vertebral Augmentation: StabilitiT™ A New Delivery System for Vertebral Fractures". Advances in Minimally Invasive Surgery and Therapy for Spine and Nerves. Acta Neurochirurgica Supplementum. Vol. 108. pp. 191–195. doi:10.1007/978-3-211-99370-5_29. ISBN   978-3-211-99369-9. PMID   21107958.
  13. Krishnamurthy, Gaurav (1 October 2013). "DFINE Gets CE Mark for STAR Tumor Ablation System". Med Gadget. Retrieved 5 May 2014.
  14. Dalton, BE; AC Kohm; LE Miller; JE Block; RD Poser (2012). "Radiofrequency-targeted vertebral augmentation versus traditional balloon kyphoplasty". Clin Interv Aging. 7: 525–31. doi: 10.2147/CIA.S37025 . PMC   3508556 . PMID   23204845.
  15. "DFine treatment OKd for spinal cancer". San Jose Business Journal. 4 October 2010. Retrieved 5 May 2014.
  16. 1 2 3 Jennings, J.; W. Irving; B. Gregory; D. Coldwell; B. Zablow; C. DePena; A. Brook (April 2013). "Image-guided targeted radiofrequency ablation (t-RFA) of spinal tumors using a novel bipolar navigational device". Journal of Vascular and Interventional Radiology. 24 (4): S44–S45. doi: 10.1016/j.jvir.2013.01.100 . Retrieved 5 May 2014.