The LIMBO-ATX trial was designed to use Mercator's proprietary Bullfrog micro-infusion catheter to test a new treatment strategy to potentially improve blood flow and decrease repeat revascularisation procedures in below-the-knee (BTK) critical limb ischemia (CLI), a debilitating vascular disease that may result in amputation.
LIMBO-ATX is a prospective, multi-center, randomized, controlled trial that enrolled over 100 patients with arterial obstructions in their BTK arteries.
Lack of blood flow through these arteries to the foot causes complications such as resting pain, non-healing wounds or tissue loss.
Positive results from the study can be used by the company to seek new indications for the use of Bullfrog to deliver the generic steroid dexamethasone for patients with CLI to improve the outcomes of revascularization alone.
The Mercator Bullfrog Micro-Infusion Device is a FDA 510(k)-cleared and CE-Marked system that infuses therapeutic and diagnostic agents directly, non-systemically, and safely through blood vessel walls into adventitial tissues.
The closed balloon provides a protective covering for a tiny, perpendicular-oriented injection microneedle as it is guided safely through the vascular system to target vessels with diameters of 2 to 8 millimeters.
Privately held Mercator MedSystems develops proprietary catheter-guided micro-infusion systems for targeted delivery of drugs and biologics deep inside the body to treat a growing portfolio of medical conditions, including peripheral disease, cardiovascular disease, cancer, hypertension and heart disease.
Apotex launches Teriparatide Injection in US
Teva Pharmaceuticals secures FDA approval for generic Forteo (teriparatide injection)
Upsher-Smith Laboratories introduces Pitavastatin Tablets
Par Pharmaceutical starts shipping colchicine 0.6mg capsules
Padagis launces Brinzolamide Ophthalmic Suspension with CGT exclusivity
Novartis completes Sandoz Spin-off
Novartis completes Sandoz spin-off, focusing on innovative medicines
Sanofi and Teva collaborate on innovative IBD treatment
Hikma marks KLOXXADO two-year anniversary by surpassing 375,000 doses donated in the US
STADA seeks full approval for Kinpeygo in IgA nephropathy from UK MHRA
Azurity Pharmaceuticals completes Slayback Pharma acquisition
Sandoz secures European approval for Tyruko biosimilar in MS treatment
Senores Pharmaceuticals introduces Nicardipine Hydrochloride Capsules USP, 20mg and 30mg in US
Lupin collaborates with Mark Cuban Cost Plus Drug Company and COPD foundation
Certara Simcyp receives FDA grants for advanced pharmacokinetic modelling