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Flexan to Collaborate with KSE Scientific to Bring Expanded Medical Device Capabilities to Market

Prnewswire | April 13, 2023 | Read time : 02:00 min

Flexan to Collaborate with KSE

Flexan LLC announced that it is expanding its services to include custom manufacturing of sterile liquids and custom formulated solutions for a variety of medical device applications. Flexan is partnering with its parent company, ILC Dover, and its KSE Scientific division to expand offerings to its medical device customers. KSE Scientific provides standard and custom formulations and packaging while following the most stringent quality standards. The company is FDA registered for medical devices and 510(k) for sterile water and saline. With over 50,000L of Water for Injection (WFI) production capacity per day and more than 113,000 square feet of manufacturing, controlled storage, and laboratory space, KSE Scientific is ready to solve customers' challenges for sterile liquids.

Recently, both Flexan and KSE Scientific partnered to deliver a custom solution and packaging service to Clyra Medical Technologies.

"Clyra is pleased to find a high-quality partner under one roof in KSE Scientific and Flexan, to support manufacturing for our best-in-class wound management and surgical product 'Bioclynse'. Bioclynse is 510(k) cleared by the FDA, and is an efficacious, safe, long-acting wound irrigation solution that can be used during wound management, during surgery and for post-surgical wounds, with no need to rinse out throughout the entire procedure," said Steve Harrison, CEO of Clyra Medical Technologies. "We look forward to working with KSE Scientific and Flexan to support solution manufacturing and developing customized packaging and components to ensure we meet the market demand and customer requirements for delivering our solutions."

"Flexan serves a broad range customers in the medical device market and we are excited to expand our services to include custom sterile fluids for various clinical applications. In addition to adding sterile fluids, we are also excited to share that we are now offering platinum-cured silicone tubing, tubing assemblies and molded components to better serve ILC's biopharmaceutical customers worldwide," said Tony Gonzalez, President of Flexan.

About ILC Dover

ILC Dover is a world-leader in the innovative design and production of solutions for biopharmaceutical, pharmaceutical, medical device markets as well as a leading supplier for the (aero)space industries. Our customers will attest to our relentless dedication to high value products, advanced technology, and responsive service, as our visionary solutions have improved efficiency while safeguarding people, product, and infrastructure in hazardous conditions through flexible protective solutions since 1947.

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Now Available – XDEMVY™ (lotilaner ophthalmic solution) 0.25%, the First and Only FDA Approved Treatment for Demodex Blepharitis

globenewswire | August 28, 2023

Tarsus Pharmaceuticals, Inc. whose mission is to focus on unmet needs and apply proven science and new technology to revolutionize treatment for patients, starting with eye care, announced that XDEMVY™ (lotilaner ophthalmic solution) 0.25% is now available at pharmacies nationwide for prescription. The U.S. Food and Drug Administration (FDA) approved XDEMVY on July 24, 2023, for the treatment of Demodex blepharitis. “We are delighted that within weeks of FDA approval, XDEMVY is now available to millions of patients with Demodex blepharitis,” said Bobak Azamian, MD, PhD, Chief Executive Officer and Chairman of Tarsus. “The efforts of our team have created incredible interest in XDEMVY, the first and only approved solution for this highly prevalent disease. I’m so appreciative of our team and our partners who’ve worked diligently to bring this product to eye care providers and patients quickly and seamlessly following regulatory approval. We are proud to introduce XDEMVY to the eye care community and look forward to its potential to significantly change the way this disease is treated.” XDEMVY is the only FDA approved treatment to directly target Demodex mites, the root cause of Demodex blepharitis. Demodex blepharitis is characterized by redness, inflammation, missing or misdirected eyelashes, itching along the eyelid base, and the presence of collarettes. XDEMVY is a prescription eye drop that is administered with one drop in each eye twice daily (approximately 12 hours apart) for 6 weeks. Tarsus is committed to ensuring that patients have affordable and broad access to XDEMVY and developed Tarsus Connect, a suite of assistance programs that provide financial support for eligible patients. More information about Tarsus Connect can be found on xdemvy.com or by calling: 1-866-846-3092. About Demodex Blepharitis Blepharitis is a common lid margin disease that is characterized by eyelid margin inflammation, redness and ocular irritation. Demodex blepharitis is caused by an infestation of Demodex mites, the most common ectoparasite found on humans and accounts for over two-thirds of all blepharitis cases. Demodex blepharitis may affect as many as 25 million Americans based on an extrapolation from the Titan study indicating 58% of patients presenting to U.S. eye care clinics have collarettes, a pathognomonic sign of Demodex mite infestation, and that at least 45 million people annually visit an eye care clinic. Demodex blepharitis can have a significant clinical burden and negative impact on patients’ daily lives. The Titan study also showed that current management tools, such as tea tree oil and lid wipes, are ineffective at targeting the root cause of Demodex blepharitis. About XDEMVY™ XDEMVY (lotilaner ophthalmic solution) 0.25%, formerly known as TP-03, is a novel prescription eye drop for the treatment of Demodex blepharitis and is designed to target and eradicate the root cause of the disease – Demodex mite infestation. The active ingredient in XDEMVY is lotilaner, a well-characterized agent that eradicates Demodex mites by selectively inhibiting the GABA-Cl channels. It is a highly lipophilic molecule, which may promote its uptake in the oily sebum of the eyelash follicles where the mites reside. XDEMVY was evaluated in two pivotal trials collectively involving more than 800 patients. Both trials met the primary endpoint and all secondary endpoints, with statistical significance and no serious treatment-related adverse events. Most patients found XDEMVY to be neutral to very comfortable. The most common ocular adverse reactions observed in the studies were site stinging and burning which was reported in 10% of patients. Other ocular adverse reactions reported by less than 2% of patients were chalazion/hordeolum (stye) and punctate keratitis. About Tarsus Pharmaceuticals, Inc. Tarsus Pharmaceuticals, Inc. applies proven science and new technology to revolutionize treatment for patients, starting with eye care. Tarsus is advancing its pipeline to address several diseases with high unmet need across a range of therapeutic categories, including eye care, dermatology, and infectious disease prevention. Tarsus is studying three investigational medicines in clinical trials. In addition to XDEMVY (lotilaner ophthalmic solution) 0.25%, which is FDA approved in the United States for the treatment of Demodex blepharitis, Tarsus is also investigating TP-03 for the treatment of Meibomian Gland Disease, which is currently being studied in a Phase 2a clinical trial. In addition, Tarsus is developing TP-04 for the potential treatment of Rosacea and TP-05, an oral tablet for the prevention of Lyme disease. TP-04 and TP-05 are both currently being studied in Phase 2a clinical trials to evaluate safety, tolerability, and proof-of activity.

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globenewswire | August 28, 2023

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Karyopharm Receives FDA Fast Track Designation for Selinexor for the Treatment of Myelofibrosis

PRNewswire | July 18, 2023

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Read More

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Signant Health Extends the Power of Clinical Supply Management Software to the Small and Mid-Size Market Through Updated

PRNewswire | July 11, 2023

Signant Health, the leader in evidence generation for modern clinical trials, announced expanded flexibility and capabilities for its leading Signant SmartSignals Supplies software, empowering small and mid-size customers to experience the advantages of technology-driven clinical supply management. Relaunched as Signant SmartSignals Supplies GxP Inventory, the solution provides sponsors and contract research organizations (CROs) with efficient, comprehensive management and oversight of the end-to-end supply chain. Unlike spreadsheet-based supply chain management, the GxP Inventory solution offers centralized, full visibility of clinical trial material creation, release, and distribution activities within a single system. Available as either an Essential or Enterprise option, clinical research sponsors can select the optimal solution for their needs, which is often dictated by size or trial volume. The Essential option enables sponsors to deploy quickly using our pre-configured system for inventory manufacturing, management, and QA/QP release. The Enterprise option provides more advanced features for larger customers with internal supply chain capabilities to meet more individualized requirements, sponsor-specific terminology/labels, and additional workflow/process options. Both options are SaaS-based for cost-effective implementation, reduction of internal technology investments, and ease of ongoing maintenance. "Signant is extremely proud of its heritage as a leading provider of GxP inventory management solutions to many top-20 sponsor organizations. Our Essential option now extends the same benefits to smaller sponsors and CROs who wish to have the same level of inventory control, regulatory compliance, and visibility in a more compact, per-protocol commercial offering," said Sanjiv Waghmare, Signant's chief product officer. Technology-based solutions make clinical trials safer for patients through better visibility and control of supplies, particularly with respect to investigational products. From sourcing drug substance ingredients to randomized patient kits, these solutions ensure that all supply chain data is in one place, and not distributed across spreadsheets, emails, and external inventory management systems. With the launch of the Essential option, we are making the technology-based solution for clinical supply management accessible to sponsors of all sizes. About Signant Health Signant Health is the evidence generation company. We are focused on leveraging software, deep therapeutic and scientific knowledge, and operational expertise to consistently capture, aggregate, and reveal quality evidence for clinical studies across traditional, virtual, and hybrid trial models. For more than 20 years, over 600 sponsors and CROs of all sizes – including all Top 20 pharma – have trusted Signant solutions for remote and site-based eCOA, eConsent, RTSM, supply chain management, and data quality analytics.

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