FDA details possible regulatory paths for Strata Sciences Optimal Dosing Tech

Strata Skin Sciences (NSDQ:SSKN) said this week it received a response letter from the FDA concerning possible 510(k) clearance paths for its Optimal Dosing Technology initially designed for treating psoriasis, vitiligo and other skin conditions. The Horsham, Penn.-based said the federal watchdog proposed 2 alternative paths, the 1st of which would require a clinical trial to substantiate its potential claims for the device and the 2nd would seek clearance “with no new claims regarding treatment or efficacy.” Strata said that should the company pursue the 2nd option, it would “likely consider initiatives to develop potential proprietary features” for the tech, according to an SEC filing. “The company is assessing the alternatives for proceeding and is considering related costs and the availability of cash resources,” Strata wrote in an SEC filing. The company said that it would have cash to pursue either option, or a combination of the 2, from a proposed conversion of outstanding convertible debentures due 2021. Last January, Strat Skin Sciences said it entered into a $12 million debt restructuring agreement, led by MidCap Financial Trust. The post FDA details possible regulatory paths for Strata Sciences Optimal Dosing Tech appeared first on MassDevice.
Source: Mass Device - Category: Medical Devices Authors: Tags: 510(k) Food & Drug Administration (FDA) Regulatory/Compliance Strata Skin Sciences Source Type: news

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Source: David Bradley Sciencebase - Songs, Snaps, Science - Category: Science Authors: Tags: Science Source Type: blogs
Conclusion Ameliorative effect of V. anthelmintica in psoriasis might be attributed to the presence of essential fatty acids and thus corroborates its traditional use in the treatment of skin ailments. Graphical abstract
Source: Journal of Ethnopharmacology - Category: Drugs & Pharmacology Source Type: research
Strata Skin Sciences (NSDQ:SSKN) said today it raised $17 million in a new round of financing and announced a number of changes to its executive roster, including an incoming CEO, new board chair and new chief financial officer. The Horsham, Penn.-based company said that the $17 million round of financing was led by Accelmed Growth Partners and was joined by existing investors Broadfin Capital and Sabby Management and its incoming CEO Dr. Dolev Rafaeli. The company specified that of the $17 million, $3 million will be used to pay down a portion of its current loan with MidCap financial. The remaining proceeds from the...
Source: Mass Device - Category: Medical Devices Authors: Tags: Business/Financial News Strata Skin Sciences Source Type: news
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Source: The American Journal of Clinical Hypnosis - Category: Complementary Medicine Authors: Tags: Am J Clin Hypn Source Type: research
In this study we investigated if tofacitinib may facilitate the melanocyte migration during repigmentation process by using mice model of rhododendrol-induced leukoderma (RIL).
Source: Journal of Investigative Dermatology - Category: Dermatology Authors: Tags: Pigmentation and Melanoma Source Type: research
The prevalence of inflammatory skin diseases in United States is 11%, suggesting that approximately 1 in 10 people suffer from an inflammatory skin disease. Most drug development for these diseases is conducted using animal models or 2D cell culture systems, which make it difficult to predict patient-specific drug responses. Here, we developed new 3D skin models for psoriasis and vitiligo by combining skin components together with disease-relevant immune cell populations. We isolated T cells from peripheral blood mononuclear cells (PBMCs) of psoriasis patients and incorporated them into healthy control derived 3D skin cons...
Source: Journal of Investigative Dermatology - Category: Dermatology Authors: Tags: Tissue Regeneration and Wound Healing Source Type: research
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Source: Current Pharmaceutical Design - Category: Drugs & Pharmacology Authors: Tags: Curr Pharm Des Source Type: research
In this study we investigated if tofacitinib may facilitate the melanocyte migration during repigmentation process by using mice model of rhododendrol-induced leukoderma (RIL).
Source: Journal of Investigative Dermatology - Category: Dermatology Authors: Tags: Pigmentation and Melanoma Source Type: research
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Source: Journal of Investigative Dermatology - Category: Dermatology Authors: Tags: Tissue Regeneration and Wound Healing Source Type: research
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Source: Annales de Dermatologie et de Cenereologie - Category: Dermatology Authors: Tags: Ann Dermatol Venereol Source Type: research
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