From Intricon expanding its manufacturing space to Arthrex signing a global distribution deal, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Intricon expands medical footprint Intricon announced in a March 13 press release that it has signed a 5-year lease that will secure 30,000 sq. ft of manufacturing […]
Arch Therapeutics (OTC:ARTH) is looking to bring advanced material technology to wound care, and in July, the company got one step closer by submitting its application to the FDA for 510(k) clearance for its 1st commercial product, a topical gel based on its AC5 wound care platform. The company’s products are designed around technology out of […]
Arch Therapeutics (OTC:ARTH) said today it submitted a 510(k) application to the FDA as it seeks approval for tis AC5 topical gel designed for hemostatic and wound care, seeking an indication for external wounds. The Framingham, Mass.-based company said that it will still seek regulatory approval for its other AC5 products, designed for internal use, through […]
Arch Therapeutics (OTC:ARTH) today priced an upcoming direct offering, looking to float 10.2 million units at 60¢ per share, bringing in approximately $6.1 million for the company. Each unit sold in the offering consists of a share of common stock and 0.55 of a Series F warrant to purchase an additional share of common stock. The […]
Arch Therapeutics (OTC:ARTH) today announced it accelerated the timeframe for FDA 510(k) clearance submission for its AC5 hemostasis device, moving from late 2017 to mid-2017. The Framingham, Mass.-based company’s AC5 surgical and topical hemostatic devices are being designed using a self-assembling materials technology platform, seeking to improve hemostasis during surgical, wound and interventional care. “Our anticipated […]
Arch Therapeutics (OTC:ARTH) yesterday announced the completion of the 1st-in-human study of its novel AC5 topical hemostatic device, touting that study primary objectives were met with no serious adverse events and safety outcomes similar between the AC5 and control groups. The study aimed to evaluate the safety and performance of the AC5 in patients undergoing excision of […]
Arch Therapeutics (OTC:ARTH) said last week it raised $3.4 million through the private placement of the company’s securities with a group of investors. The Framingham, Mass.-based company said it floated approximately 9.5 million shares at 36¢ per share in the placement round. Each unit offered in the round includes 1 share of common stock and […]
Arch Therapeutics (OTC:ARTH) said today that it launched a European safety-and-efficacy study of its AC5 surgical hemostat in bleeding wounds incurred during dermatology procedures. Framingham, Mass.-based Arch, which won approval for the randomized, controlled, single-blind study last December, said the 46-patient trial will include a 10-subject arm who are taking blood thinners. Each patient will have […]
Arch Therapeutics (OTC:ARTH) said it won approval for a European safety-and-efficacy study of its AC5 surgical hemostat in bleeding wounds incurred during dermatology procedures. Framingham, Mass.-based Arch said the endpoints for the single-blinded study of up to 50 patients include time to hemostasis and product-related adverse effects at 30 days. One arm of the trial will include patients taking blood […]
As 2014 draws to a close, MassDevice.com asked several medical device company CEOs for their takes on 2014 and what they’re looking for in 2015.
We wanted to get their views on the major trends seen in medtech this year, including the red-hot M&A and IPO scenes, the medical device tax, the regulatory environment in the U.S., and more.
Intact Vascular said yesterday that it named medical device veteran Bruce Shook as its new president & CEO.