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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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Horm Metab Res DOI: 10.1055/s-0044-101144Glucocorticoids are widely used for immunosuppression in autoimmune diseases. After the resolution of hypercortisolemia, the immune system recovers allowing for autoimmune diseases to manifest. Here we investigated the presence of autoimmune and related diseases that developed after cure of endogenous Cushing syndrome (CS) in children. We identified 129 children who were diagnosed and successfully treated for endogenous CS at the National Institutes of Health from 1997 until 2017, and who were followed for at least 6 months after treatment. We performed a retrospective chart review ...
Source: Hormone and Metabolic Research - Category: Endocrinology Authors: Tags: Endocrine Care Source Type: research
Abstract Climate change contributes to the increase in severity and frequency of flooding, which is the most frequent and deadly disaster worldwide. Flood‐related damage can be very severe and include health effects. Among those health impacts, dermatological diseases are one of the most frequently encountered. Both infectious and noninfectious dermatological conditions are increasing after flooding. We searched PubMed using the search term climate change OR global warming OR rainfall OR flooding OR skin. Articles published in the English‐language literature were included. We also searched the International Society of ...
Source: International Journal of Dermatology - Category: Dermatology Authors: Tags: Review Source Type: research
This article looks at skin conditions that are related to ulcerative colitis, including psoriasis, vitiligo, and hives. Learn about causes and prevention.
Source: Health News from Medical News Today - Category: Consumer Health News Tags: Dermatology Source Type: news
This article is protected by copyright. All rights reserved. PMID: 29315555 [PubMed - as supplied by publisher]
Source: Immunology - Category: Allergy & Immunology Authors: Tags: Immunology Source Type: research
This article is protected by copyright. All rights reserved.
Source: Photochemistry and Photobiology - Category: Science Authors: Tags: Research Article Source Type: research
We report the case of a 59-year-old woman who simultaneously suffered from psoriasis and vitiligo. The depigmented areas were predominantly but not exclusively limited to current or former psoriatic plaques. These two diseases share many common features, e. g., both are T‑cell-mediated autoimmune diseases in which the Koebner phenomenon occurs. However, it is still not known whether the coincidence is random or significant. Prospective clinical and epidemiological research will hopefully reveal the association soon. PMID: 29299628 [PubMed - as supplied by publisher]
Source: Der Hautarzt: Zeitschrift fur Dermatologie, Venerologie, und verwandte Gebiete - Category: Dermatology Tags: Hautarzt Source Type: research
Strata Skin Sciences (NSDQ:SSKN) said today that its board of directors has begun a process to explore and review “strategic alternatives” focused on improving shareholder value, which could include a sale of the company or other transactions. The Horsham, Penn.-based company said that as part of its exploration of strategic alternatives, it is in the process of engaging with a financial advisor. “We believe we have made significant progress in developing our products and continue to implement changes to our business with the goal of enhancing our strategic position in the medical and aesthetic derma...
Source: Mass Device - Category: Medical Devices Authors: Tags: Business/Financial News Strata Skin Sciences Source Type: news
AbstractThe development of immune checkpoint inhibitors [monoclonal antibodies targeting cytotoxic T lymphocyte-associated antigen-4 (CTLA-4), programmed cell death protein 1 (PD-1) or programmed death ligand 1 (PD-L1)] represents a major breakthrough in cancer therapy. Although they present a favorable risk/benefit ratio, immune checkpoint blockade therapies have a very specific safety profile. Due to their unique mechanism of action, they entail a new spectrum of adverse events that are mostly immune related [immune-related adverse events (irAEs)], notably mediated by the triggering of cytotoxic CD4+/CD8+  T cell ac...
Source: American Journal of Clinical Dermatology - Category: Dermatology Source Type: research
Publication date: Available online 1 December 2017 Source:Journal of Food and Drug Analysis Author(s): Junjun Yang, Jing Yang, Jie Du, Yuxin Feng, Xin Chai, Mingming Xiao, Yuefei Wang, Xiumei Gao Fructus Psoraleae, a traditional Chinese medicine, is widely used for preventing and treating various diseases such as vitiligo, osteoporosis and psoriasis. Coumarin, such as psoralenoside, isopsoralenoside, psoralen and isopsoralen, are important compounds in Fructus Psoraleae. In our study, ultra performance liquid chromatography coupled with diode array detector was employed for an excellent method validation for simultaneous ...
Source: Journal of Food and Drug Analysis - Category: Food Science Source Type: research
The link between the metabolic syndrome (MetS) and skin diseases is increasingly important, with new associations being discovered. The association between MetS and psoriasis or MetS and hidradenitis suppurativa is well known, although the relationship between MetS and various autoimmune or inflammatory diseases has only recently attracted interest. Some inflammatory skin diseases, such as vitiligo, scleredema, recurrent aphthous stomatitis, Beh çet disease, rosacea, necrobiosis lipoidica, granuloma annulare, skin tags, knuckle pads, and eruptive xanthomas, have possible associations with MetS.
Source: Clinics in Dermatology - Category: Dermatology Authors: Source Type: research
More News: Clinical Trials | Psoriasis | Skin | Vitiligo