From InspireMD’s Swiss distribution deal to CoreLink’s stackable guide wire launch, here are seven medtech stories we missed this week but thought were still worth a mention. 1. InspireMD announces Swiss distribution deal InspireMD announced in an Aug. 25 press release that it has signed an agreement with 1a Medical to distribute the CGuard EPS (Embolic […]
Regenerative Medicine
Cytori Therapeutics posts mixed Q2
Shares in Cytori Therapeutics (NSDQ:CYTX) fell today after the biotech missed sales expectations on Wall Street with its second quarter results, but topped EPS estimates. The San Diego, Calif.-based company posted a net loss of -$6 million on sales of $1.5 million for the 3 months ended June 30, for bottom-line growth of 6% on sales […]
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 […]
Researchers develop stem cell therapy to fight inflammatory lung conditions
Researchers from the UNC School of Medicine and North Carolina State University showed that they could harvest and multiply lung stem cells in volumes sufficient for human therapy. In a second study, the team used their cell therapy to treat a model of idiopathic pulmonary fibrosis. The scientists reported that they are in talks with […]
Brainstorm adds UCal Irvine Medical Center to late-stage NurOwn trial
Brainstorm Cell Therapeutics (NSDQ:BCLI) said today that it inked an agreement with the University of California Irvine Medical Center to enroll patients in the Phase III trial of its NurOwn mesenchymal stem cell-based platform for amyotrophic lateral sclerosis. This marks the third medical center to work with Brainstorm to enroll patients in the late-stage pivotal trial. […]
Brainstorm Cell Therapeutics wins $16m grant for pivotal NurOwn ALS study
Brainstorm Cell Therapeutics (NSDQ:BCLI) said today it won a $16 million grant from the California Institute of Regenerative Medicine to engage in a phase 3 study of its NurOwn mesenchymal stem cell-based platform for treating amyotrophic lateral sclerosis. Brainstorm said it is in the advanced stages of planning a Phase 3 clinical trial investigating NurOwn for […]
FDA grants regenerative medicine advanced therapy status to Mallinckrodt’s StrataGraft
Mallinckrodt Pharmaceuticals (NYSE:MNK) said today that its StrataGraft regenerative skin tissue won regenerative medicine advanced therapy status from the FDA. The tissue-based therapy is among the first products to be granted the designation. The 21st Century Cures Act, which was passed in 2016, enabled the FDA to give accelerated review approval to products that meet RMAT criteria. […]
Carmell Therapeutics raises $4m for regenerative biomaterial
Carnegie Mellon spin-out Carmell Therapeutics said today that it closed a $4 million Series B financing round last month that it plans to use to bring its first product candidate to Phase III clinical development. Its Bone Healing Accelerant uses pooled plasma to boost the healing of bone and soft tissues. Current investors, including Pittsburgh […]
Brainstorm lands $2.1m Israeli grant for NurOwn stem cell therapy
Brainstorm Cell Therapeutics (NSDQ:BCLI) said today that it landed a $2.1 million grant from the Israel Innovation Authority. The funds are slated to support the development of Brainstorm’s NurOwn mesenchymal stem cell-based platform for the treatment of neurodegenerative diseases, including ALS. This is the 10th year that Brainstorm has won grant support from the Israeli office […]
Small Utah biotech regenerates skin, hair in pigs
Utah-based biotech PolarityTe Inc. (NSDQ:COOL) has successfully regenerated skin and triggered hair growth in pigs with burns and abrasions. The breakthrough is a win in regenerative medicine, especially for tissue engineers hoping to help burn victims recover their skin. The firm’s approach involves using a patient’s own healthy tissue to grow human skin as a […]