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 […]
Orthopedics
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 […]
MiMedx files IND for Ph2 AmnioFix osteoarthritis trial
MiMedx (NSDQ:MDXG) said today that it filed an IND with the FDA for a Phase II trial of its AmnioFix product in patients with osteoarthritis of the knee. The 318-patient study is designed to compare the safety and efficacy of MiMedx’s micronized dehydrated human amnion/chorion membrane (dHACM) injection with a 0.9% sodium chloride USP placebo injection. […]
Replicel prototypes its next-gen dermal injector
RepliCel Life Sciences (OTC:REPCF) said yesterday that it has developed prototypes of its RCI-02 motorized injection device designed with programmable depth and volume, as well as interchangeable needle head configurations. The injector was built to deliver an array of substances, including dermal fillers, drugs, cells or biologics intradermally, subcutaneously or intramuscularly. The company said it hopes […]
MiMedx wins FDA nod for AmnioFix pivotal trial
MiMedx (NSDQ:MDXG) said today that the FDA has approved its Phase III Achilles tendonitis trial. The 158-patient study is designed to compare the company’s AmnioFix Injectable with a saline placebo injection in the treatment of moderate to severe pain due to Achilles tendonitis. The trial, which is the company’s second late-stage study of AmnioFix, will start […]
