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 […]
Orthopedics
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 […]
Bioventus wins FDA nod for knee osteoarthritis pain injection
Bioventus said today that its Durolane single-injection, hyaluronic acid product won FDA approval for the treatment of pain associated with knee osteoarthritis. When a person develops osteoarthritis in their knee, the cartilage breaks down and so does the synovial fluid that provides lubrication to joint tissues. Hyaluronic acid provides cushioning and lubrication to the knee, […]
Medtech stories we missed this week: Aug. 18, 2017
From Nemaura’s new Oceania distribution deal to Sanuwave’s promissory note expansion, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Nemaura inks Oceania distribution deal for SugarBeat patch Nemaura announced in an Aug. 15 press release that it has signed a non-binding distribution deal with Device Technologies for […]
MiMedx files IND for Achilles tendonitis trial
MiMedx (NSDQ:MDXG) said today that it filed an IND application with the FDA for the company’s late-stage Achilles tendonitis trial. The 158-patient study is designed to compare MiMedx’s AmnioFix Injectable with a saline placebo injection in the treatment of moderate to severe pain due to Achilles tendonitis. If approved, the trial will be the second […]
Anika tops EPS estimate by 32 cents in Q2
Shares in Anika Therapeutics (NSDQ:ANIK) rose today after the orthopedics medicine company topped expectations on Wall Street with its second quarter results. The Bedford, Mass.-based company posted profits of $11.4 million, or 78¢ per share, on sales of $33.5 million for the 3 months ended June 30, for bottom-line growth of 32% on sales growth […]
India approves Anika’s Monovisc osteoarthritis treatment
Anika Therapeutics (NSDQ:ANIK) said today that regulatory authorities in India approved its single injection viscosupplement, Monovisc, as a therapy for pain associated with osteoarthritis in synovial joints. The Bedford, Mass.-based company’s product is already available in the U.S. Canada and Europe. Anika said it hopes to expand into Australia, New Zealand and other international markets in the […]
Antibiotic-eluting polymer could help treat prosthetic joint infections
Researchers from Massachusetts General Hospital have developed an antibiotic-eluting polymer that could be used to treat infections in orthopedic implants, according to a report published in Nature Biomedical Engineering. Traditionally, treating a prosthetic joint infection involves removing an implant and replacing it with a temporary spacer made from antibiotic-releasing bone cement for at least six […]
