Bridgewater, N.J.-based Valeritas said it intends to offer 6 million shares in an initial public offering with the goal of raising $60 million. The company makes a disposable basal-bolus insulin delivery device for patients with type 2 diabetes.
A round of Series C financing has brought in $50 million for California-based Moximed, which makes the next-generation Atlas unicompartmental unloading knee implant for treating certain patients with steoarthritis knee joint pain. The proceeds will be used to support the company's efforts to obtain FDA approval, as well as for early commercialization of the product in the US.
An offering of 68.1 million shares of common stock has pulled in $45 million for Corindus Vascular Robotics. The proceeds will be used for the commercialization of the next generation of the company's CorPath GRX system, as well as for general corporate functions.
Active Implants, a developer of orthopedic medical devices, has raised $40 million in a round of financing involving its previous investors and the Ls Health Science Partners fund. The company intends to use the money to fund clinical trials of its implant for knee meniscus replacement, as well as for research and development for other products, said President and CEO Ted Davis.
A round of financing involving Omron Healthcare and the Mayo Clinic has pulled in $30 million for Mountain View, Calif.-based medtech company AliveCor, which intends to use the money primarily for hiring. The company makes the Kardia Mobile, an FDA-approved portable electrocardiogram device that connects to the Kardia app, and has also launched the Kardia Pro, a platform designed to detect atrial fibrillation using artificial intelligence.
A round of Series A financing has brought in $14.5 million for RenalGuard Solutions, which makes a system for the prevention of contrast agent-induced acute kidney injury in cardiac interventional procedures. The company plans to use the proceeds for the completion of an existing pivotal trial of its device, as well as for the expansion of research and development efforts to cover other clinical indications.
Bioventus said it plans to conduct further validation research on the ability of its EXOGEN Ultrasound Bone Healing System to mitigate fracture risks. The new clinical research, a series of studies called the Bioventus Observational Non-interventional Exogen Studies, seeks to generate additional clinical knowledge of the system based on previous data.
The Titan Press-Fit Reverse Shoulder for Fracture System has been unveiled by Plainsboro, N.J.-based Integra LifeSciences. The device comes with a two-piece stem that allows for implant-to-bone press-fit fixation under the fracture line in the humeral canal, making cement unnecessary for prosthesis placement.
The total fees charged by the FDA to review and approve new drugs and medical devices would more than double to more than $2 billion under the 2018 budget proposed by the Trump administration. AdvaMed is seeking more details on the budget before it can evaluate the proposal's effect on FDA appropriations or user fee funds, President and CEO Scott Whitaker said.
Initial recommendations have been released by the expert advisory group of the UK's Medicines and Healthcare products Regulatory Agency for conducting premarket and postmarket clinical studies of leadless pacemakers. Sponsors should agree with regulators on the study design, consider the anticipated frequency and seriousness of adverse events when planning the study and evaluate the product's longer-term safety and performance using postmarket clinical follow-up studies or registries, the group suggests.
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