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801 E. Morehead Street Suite 201
Charlotte, NC 28202 USA
phone:704-332.4308
fax:704-332-5628
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Private |
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| Founded |
2004 |
| Employees |
60 |
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| www.ushifu.com
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| Research Sector |
Medical Devices & Tech |
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| Summary Description |
| A privately held health care company focused on treating primary and recurrent prostate cancer. |
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| Management |
Stephen R. Puckett, Sr. - Chairman
Stephen R. Puckett, Jr.- CEO
George M. Suarez, MD - Co-Founder & Medical Director Emeritus
Naren Sanghvi - Chief Scientific Officer
Mark Schoenberg, MD - Chief Medical Officer
Adam G. Lowe - VP, Scientific Affairs & Device Operations
Karen Kaplan - General Counsel
Jim Bobbitt - VP, Corporate Services
John Linn - VP, Finance
Alex Gonzalez - VP, International Operations |
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| Keywords |
| privately held, health care, company, primary, prostate cancer |
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| Description |
US HIFU, LLC is a privately held health care company focused on treating primary and recurrent prostate cancer using HIFU, a minimally invasive outpatient procedure which potentially improves patients’ quality of life. US HIFU was founded in 2004 and is headquartered in Charlotte, N.C.
US HIFU is the parent company of:
International HIFU—The entity through which US HIFU conducts its international business operations and makes HIFU technologies available to patients outside the United States.
Focus Surgery, Inc.—headquartered in Indianapolis, Ind., Focus Surgery is the developer and manufacturer of the Sonablate® 500, a medical device that uses HIFU energy to treat prostate cancer.
US HIFU, LLC is funding FDA-approved U.S. clinical trials of the Sonablate® 500, including a trial for primary prostate cancer patients and a trial for patients who have experienced radiation failure. |
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| Products / Services |
USHIFU's primary objective is US commercialization of the Sonablate® 500 HIFU system. This device is approved in 33 countries and uses focused ultrasound to precisely treat prostate disease with fewer complications when compared to conventional therapies such as surgery and radiation. In addition to conducting 2 phase III FDA trials for primary and recurrent localized prostate cancer, USHIFU is treating US patients and training US urologists in approved jurisdictions such as Canada, Mexico, Bermuda and the Bahamas. Upon US approval, the company will have approximately 500 US urologists trained on the device for rapid US rollout and adoption. Currently, the company is using a services model and owns all of the Sonablate® 500 devices located outisde the US.
The company recently acquired the rights to the Sonatherm 600, a 510k approved device in the US for general tissue ablation using a laparoscopic HIFU probe. The Sonatherm has been studied in Europe and further testing will be completed in the US before the device is marketed.
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| Technology / Differentiation |
HIFU - the energy
* HIFU, or high intensity focused ultrasound, is a therapy that destroys unhealthy tissue with rapid heat elevation.
* Ultrasound energy, or sound waves, is focused at a specific location in the body. At that location, or focal point, the temperature rapidly rises to almost 90 degrees Celsius (195 degrees Fahrenheit). Any tissue at the focal point is destroyed, but any tissue outside of the focal point is unharmed.
* Unlike radiation, HIFU uses clean (also known as non-ionizing) energy, so the procedure can be repeated, if necessary, without damaging healthy tissue.
* HIFU is being studied around the world to treat all types of cancer and soft tissue diseases.
HIFU with the Sonablate® 500
* The Sonablate 500 is a minimally invasive medical device developed by Focus Surgery, Inc. that uses HIFU to treat localized prostate cancer and benign prostatic hyperplasia (BPH) in countries where it is approved.
* The Sonablate 500 obtains real-time ultrasound images of the prostate and surrounding areas. From these images, the doctor plans where the ultrasound energy will be delivered. The Sonablate software allows the physician to precisely define the treatment zones in order to destroy the entire gland.
* Sonablate HIFU is non surgical, radiation-free and usually performed as an out-patient procedure.
* The Sonablate 500 is the only HIFU device for prostate cancer that does not require a transurethral resection of the prostate—known as TURP, an invasive, surgical procedure—prior to treatment in order to achieve effective results when the prostate is enlarged.
* The Sonablate 500 system is composed of a console, premium display monitor, transrectal ultrasound probe and the Sonachill, an active cooling system.
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* With the addition of Tissue Change Monitoring (TCM) software, the Sonablate can detect real-time changes in the tissue during HIFU therapy guiding the user to optimal delivery of energy and enabling the assessment of indiviudal lesions. |
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| Market / Customers |
Other than skin cancer, prostate cancer is the most common cancer in American men. In 2009, approximately 250,000 cases of prostate cancer were diagnosed and 27,360 men died of prostate cancer. About 1 man in 6 will be diagnosed with prostate cancer during his lifetime. More than 2 million men in the United States who have been diagnosed with prostate cancer at some point are still alive today. Prostate cancer is the second leading cause of cancer death in American men, behind only lung cancer. About 1 man in 35 will die of prostate cancer. Prostate cancer accounts for about 10% of cancer-related deaths in men. Additionally, another 3- 7 million US men suffer from BPH (enlarged prostate) that can be treated using HIFU.
The market for prostate cancer is huge and will continue to grow with the aging population, increased screening and improving diagnostics. The Sonablate® 500 will be used by oncologists and take make share from all forms of therapy in the US. HIFU and especially focal HIFU is the optimal therapy for patients that refuse traditional therapies due to the associated impact to quality of life functionality. It is estimated that up to 25% of patients diagnosed with prostate cancer do not actively treat the disease, but manage it through watchful waiting and testing.
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| Competitors / Substitutes / Alternatives |
EDAP, a French company, is the primary HIFU competitor. EDAP recently halted its phase III FDA trial for primary prostate cancer and mainly operates in Europe. USHIFU will be competing directly with EDAP in Europe after acquiring the Sonablate® 500 distribution rights from Misonix in late May.
Most prostate cancer patients in the US are treated with various forms of surgery (open / robotic) or radiation (brachytherapy / external beam). Other forms of treatment include cryotherapy, hormone therapy and watchful waiting. HIFU already competes directly with each of these therapies and will take significant market share after FDA approval.
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