From Privi Medical’s FDA clearance to OrthoXel getting FDA clearance and CE Mark approval, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Privi Medical wins FDA nod for hemorrhoid device Privi Medical has received FDA clearance for its Instalief Hemorrhoids Treatment device, according to a Jan. 18 news […]
Orthopedics
Medtech stories we missed this week: Dec. 29, 2017
From NanoVibronix’s new Indian regulatory and distribution agreement to Guided Therapeutics’s Turkish distribution deal, here are five medtech stories we missed this week but thought were still worth mentioning. 1. NanoVibronix inks deal with Indian regulatory and distribution consultant NanoVibronix announced in a Dec. 20 press release that it has signed Morulaa HealthTech as its regulatory […]
Anika Therapeutics wins FDA nod for bone void filler
Anika Therapeutics (NSDQ:ANIK) said today that it won 510(k) clearance from the FDA for its hyaluronic acid-based bone void filler The indication covers filling bone voids or defects that aren’t intrinsic to the stability of the bone, created during surgery or the result of traumatic injury. Made of a synthetic, biocompatible bone graft substitute material, […]
Histogenics inks deal to develop Neocart for the Japanese market
Histogenics (NSDQ:HSGX) has inked a deal with Medinet to develop and commercialize its Neocart implant for the Japanese market. The Waltham, Mass.-based company’s Neocart implant is designed to repair knee cartilage damage. The product is made using a patient’s own cells, harvested from the surface of the patient’s femur. “This transformative collaboration for Histogenics is […]
pSivida touts pilot osteoarthritis trial for Durasert implant
pSivida (NSDQ:PSDV) touted results today from a Phase I safety and efficacy pilot trial of its sustained-release Durasert implant in patients with osteoarthritis of the knee. The company’s Durasert tech, combined with an implantable device from the Hospital for Special Surgery, was designed to continuously deliver a low dose of dexamethasone into the knee joint. Six patients […]
Flexion CEO: Setting Zilretta up to succeed with a history lesson
Locally acting therapies are like a religion to Flexion Therapeutics (NSDQ:FLXN) co-founder & CEO Dr. Mike Clayman, who spent decades at Eli Lilly (NYSE:LLY) with the company’s co-founder, Dr. Neil Bodick, watching promising compounds fail in late-stage trials on the heels of unanticipated safety results. “That’s part of the reason, not the whole reason but part of […]
After FDA nod, Flexion launches osteoarthritis injection
Flexion Therapeutics (NSDQ:FLXN) today launched its Zilretta therapy designed to help patients manage pain associated with osteoarthritis of the knee. The Burlington, Mass.-based company’s extended-release intra-articular injection combines a commonly administered, short-acting corticosteroid with a polylactic-co-glycolic acid matrix using Flexion’s microsphere technology. The FDA approved Zilretta last month after granting it fast track status in 2015. […]
Anika misses revenue, earnings estimates in Q3
Anika Therapeutics (NSDQ:ANIK) missed expectations on Wall Street with its third quarter results, the company reported yesterday after the market closed. The Bedford, Mass.-based company posted profits of $14.6 million, or 47¢ per share, on sales of $27.2 million for the 3 months ended Sept. 30, for a bottom-line loss of -0.3% on sales growth of […]
Medtech stories we missed this week: Oct. 20, 2017
From InspireMD’s distribution deal to RenalGuard touting a new study, here are seven medtech stories we missed this week but thought were still worth a mention. 1. InspireMD inks Chile distribution deal InspireMD announced in an Oct. 12 press release that it has signed a distribution deal with CorpMedical Chile to distribute the MGuard Prime […]
Anika’s Monovisc therapy gets green light in Australia
Anika Therapeutics (NSDQ:ANIK) said yesterday that regulatory authorities in Australia approved the company’s single injection viscosupplement, Monovisc, for the treatment of pain associated with osteoarthritis of the synovial joints. This latest regulatory win means that Monovisc is commercially available in more than twenty countries, including the U.S. and Canada. The Bedford, Mass.-based company said it plans […]
