Cervical Disc News
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Is the CO2 fractional laser damaging to the skin
The best fractional CO2 laser machine is a minimally invasive treatment. It works by heating the dermis and epidermis with a fractional laser, causing microscopic columnar damage to the skin, activating fibroblasts, stimulating collagen remodelling reactions, thickening the dermis and achieving cosmetic results such as wrinkle reduction, skin rejuvenation and spot removal. Today the CO2 laser ...
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Cerapedics Announces FDA approval of an IDE supplement
Cerapedics, a private ortho-biologics company, today announced the U.S. Food and Drug Administration (FDA) has approved the company’s Investigational Device Exemption (IDE) supplement, reducing the enrollment requirement for the on-going clinical trial, ASPIRE, for P-15L Bone Graft in a single level transforaminal lumbar interbody fusion (TLIF) surgery. “We are pleased to announce ...
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Cerapedics Announces Results from Clinical Trial of i-FACTOR Peptide Enhanced Bone Graft in Lumbar Fusion Surgery
Cerapedics, a private ortho-biologics company, today announced that results from a clinical trial evaluating i-FACTOR Peptide Enhanced Bone Graft in non-instrumented lumbar fusion surgery has been published in the May 2020, Volume 20, Issue 5 print of The Spine Journal as the lead article. The data demonstrate that elderly patients in Denmark treated with i-FACTOR bone graft plus local bone had a ...
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Excite Medical displays the DRX9000 at the Wave 2019
Excite Medical, the leading provider of non-surgical spinal decompression machines, announced that they will participate in the upcoming WAVE Convention and Expo held at the Oakland Marriot City Center in Oakland, CA starting on August 16th. As an exhibitor, Excite Medical will present their flagship product, the DRX9000® non-surgical spinal decompression machine in front of over 2000 ...
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Guided Therapeutics Announces Testing Completion of First 150 Patients in Chinese Clinical Study and Receives Milestone Payment of $177,740
Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of the LuViva Advanced Cervical Scan, announced today that testing of 150 patients has been completed in the ongoing clinical trial for Chinese National Medical Products Administration (NMPA) approval. The trial is underway at four sites in China. The trial is expected to be completed in the second quarter of this year and submitted for approval ...
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Guided Therapeutics Announces Start of Chinese Clinical Trial for Approval to Market and Sell LuViva in China
Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of the LuViva Advanced Cervical Scan, based on its patented biophotonic technology, announced today that enrollment and testing of patients has begun at the Department of Obstetrics & Gynecology Hospital of Fudan University located in Shanghai. The data will be submitted to the Chinese National Medical Products Administration (NMPA; formerly ...
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Guided Therapeutics Ships LuViva Devices to China for Start of Clinical Trial; Receives Additional $100,000 Payment
Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of the LuViva Advanced Cervical Scan, based on its patented biophotonic technology, announced today that its Chinese partner, Shandong Yaohua Medical Instrument Corporation (SMI), had received ethics board approval and placed LuViva devices at two of the three participating hospitals for clinical trials aimed at achieving Chinese FDA approval. ...
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Guided Therapeutics Receives Notification of Successful Clinical Trial Regulatory Review and $133,000 Payment from China
Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of the LuViva® Advanced Cervical Scan, based on its patented biophotonic technology, announced today it had passed the regulatory compliance review at the Department of Obstetrics & Gynecology Hospital of Fudan University located in Shanghai. Clinical trials there and at three other centers are expected to begin this quarter. GTHP also ...
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Cerapedics Announces Publication of Results of Study Evaluating the Cost-Effectiveness of i-FACTOR vs. Local Autologous Bone in ACDF Surgery
Cerapedics Inc., a private ortho-biologics company dedicated to enhancing the science of bone repair, announced today that results of a study to evaluate the cost-effectiveness of i-FACTOR Peptide Enhanced Bone Graft compared to autograft for patients undergoing ACDF surgery were recently published in ClinicoEconomics and Outcomes Research (July 2021, Volume 2021, Issue 13). In this landmark ...
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New European Published Study Shows LuViva Detects 20% More Precancerous and Cancerous Cervical Disease than HPV Test
Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of the LuViva Advanced Cervical Scan, based on its patented biophotonic technology, announced today that an independent study of 166 women in Hungary showed that LuViva detected 20% more cervical precancer and cancer than the HPV test. Specifically, LuViva had a very high sensitivity of 94%, detecting disease in 48 of 51 women with biopsy results ...
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Guided Therapeutics Receives News from Chinese State Food and Drug Administration that LuViva Meets Product Technical Requirements
Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of the LuViva™ Advanced Cervical Scan, based on its patented biophotonic technology, announced today its Chinese co-manufacturing partner and distributor for China, Shandong Yaohua Medical Instrument Corporation (SMI), has received notice from the Jinan Medical Device Quality Supervision and Testing Center of the State Food and Drug ...
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Guided Therapeutics Replaces Convertible Note Facility and Significantly Reduces Dilution
Guided Therapeutics, Inc. or the “Company” (OTCQB: GTHP), the maker of a rapid and painless testing platform based on its patented biophotonic technology, announced today that it has raised an additional US $1.13 million under the terms of a 3-year convertible debenture. The proceeds are intended to pay off an existing convertible note that matures at the end of 2021. The convertible ...
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Guided Therapeutics Closes $2.114 Million Series F Preferred Stock Financing
Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of a rapid and painless testing platform based on its patented biophotonic technology, announced today that it had closed its Series F Preferred Stock Financing on March 26, 2021. This oversubscribed sale of 2,114 Series F Preferred Shares resulted in gross proceeds to the Company of $2,114,000, netting approximately $1,980,000 after legal costs, ...
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Guided Therapeutics Raises US $1.1 Million in New Preferred Stock Offering
Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of a rapid and painless testing platform based on its patented biophotonic technology, announced today that it has thus far raised a total of US $1.1 million under the terms of a Series F Preferred Stock Offering. The private placement offering targeted at least U.S. $1 million and the financing can continue to raise additional funds until ...
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Cerapedics Announces Commercial Launch of i-FACTOR+ Matrix in Canada
Cerapedics, a private ortho-biologics company, today announced the full commercial availability of i-FACTOR+ MATRIX for surgical implantation in Canada. “We are excited to announce that i-FACTOR+ Matrix is now fully available in Canada through our distributor Surgi-One and can be used in both spine and general orthopedic applications,” said Glen Kashuba, Chief Executive Officer of ...
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Cerapedics Announces Canadian Approval of its next-generation bone graft
Cerapedics, a private ortho-biologics company, today announced the Health Canada approval of the company’s next-generation bone graft called i-FACTOR+ Matrix, making it the first market to approve the commercial launch of this product. “We are excited to announce Canadian regulatory approval of our next-generation product, based on P15 osteogenic cell-binding peptide , i-FACTOR+ ...
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Excite Medical displays the DRX9000 at Arab Health 2020
Excite Medical, the leading provider of non-surgical spinal decompression machines for back pain and neck pain, showcases the DRX9000® spinal decompression unit at Arab Health 2020 held at the Dubai World Trade Center. The DRX9000® non-surgical spinal decompression machine, grasped many distributors, hospital owners and doctors attention with its remarkable highly advanced technology and ...
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Cerapedics Announces FDA Approval of PMA Supplement Based on Two-Year Clinical Data
Cerapedics, a private ortho-biologics company, today announced the U.S. Food and Drug Administration (FDA) has approved the company’s Premarket Approval (PMA) supplement for i-FACTOR Peptide Enhanced Bone Graft in anterior cervical discectomy and fusion (ACDF) procedures in patients with degenerative cervical disc disease. Cerapedics requested approval for an updated package insert that ...
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Guided Therapeutics Ships First Four LuViva Advanced Cervical Scans for $14 million Turkish Ministry of Health Order
Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of a rapid and painless testing platform based on its patented biophotonic technology, announced today that it has shipped the first four LuViva® Advance Cervical Scan units to its Turkish distributor for its order with the Turkish Ministry of Health (MOH). In total, the company plans to ship 25 LuViva units and 40,000 disposable Cervical ...
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Guided Therapeutics and U.S. FDA Agree on Meeting Date to Plan Path Forward for LuViva Advanced Cervical Scan Premarket Approval Application
Guided Therapeutics, Inc. (OTCQB:GTHP), the maker of a rapid and painless testing platform based on its patented biophotonic technology, announced today it will meet with the U.S. Food and Drug Administration (FDA) November 6, 2015, to review the company’s plan to submit an approvable application for the LuViva® Advanced Cervical Scan. The LuViva is designed to detect cervical ...
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