SteadyMed develops therapeutic product candidates that address limitations of market-leading products in orphan and other well-defined, high-margin specialty markets. Its lead program, Trevyent, pairs the company’s PatchPump drug-delivery platform with treprostinil to treat pulmonary arterial hypertension (PAH). Trevyent is a development-stage product not approved by the FDA; SteadyMed intends to pursue approval via the 505(b)(2) regulatory pathway and to commercialize approved products using a targeted sales force. PatchPump is a compact, prefilled, preprogrammed, disposable parenteral administration platform designed to deliver sterile, preservative-free drug at a preset rate. The company operates offices in San Ramon, California and Rehovot, Israel. Financially, the company announced an equity financing to support regulatory and development milestones for Trevyent. SteadyMed Therapeutics develops drug products built around its PatchPump parenteral drug-delivery platform, targeting orphan and high-value diseases with unmet parenteral delivery needs. Its lead development program is Trevyent, a PatchPump-enabled, prefilled, preprogrammed disposable system to deliver treprostinil for Pulmonary Arterial Hypertension. The company plans to pursue approval via the 505(b)(2) regulatory pathway and to commercialize through a targeted SteadyMed sales and marketing infrastructure. SteadyMed said it has met with the FDA and received positive guidance on the registration pathway toward an NDA submission planned for the second half of 2015. The company intends to use proceeds to complete development and qualification activities to support that NDA and to build out outsourced manufacturing capabilities and industrialization partners for commercial supply. SteadyMed is a private, venture-funded company with offices in San Ramon, CA and Rehovot, Israel. SteadyMed Therapeutics develops the PatchPump, a prefilled, size-efficient and disposable electronic subcutaneous drug-delivery system that can be programmed to control delivery of liquid drugs across a range of volumes and viscosities. The company positions the PatchPump as a customizable family of devices intended to serve chronic conditions and to act as a delivery platform for large-volume biologics. SteadyMed has ongoing collaborations with biopharmaceutical companies that are evaluating the PatchPump for their large-volume biologics pipelines. The company is focused on completing clinical trials and obtaining FDA approval for its drug-plus-device combinations. SteadyMed is venture-backed by KB Partners and Samson Ventures and operates internationally with offices in the San Francisco Bay Area and Rehovot, Israel. Proceeds from recent financing are being used for working capital as it continues development and regulatory work toward commercialization. SteadyMed Therapeutics develops a novel, prefilled, size-efficient and disposable subcutaneous drug delivery system called PatchPump®. The company’s PatchPumps can be customized to deliver liquid drugs, including biologics, across a wide range of volumes and viscosities in a consistent and controllable manner. SteadyMed intends to use the proceeds from the financing to support development and commercialization of its lead drug product that leverages PatchPump® technology. The company is led by CEO Jonathan M.N. Rigby and operates from offices in San Francisco, CA and Rehovot, Israel. It aimed to complete pivotal clinical trials in 2013 with a planned commercial U.S. launch in 2014. The report states the company raised $10.4M in funding from existing and new backers to advance these plans.

Total raised

$45M

Funding rounds

4

Latest round

Equity

Latest activity

Jan 2015