The FDA this week laid out guidelines for a new framework it’s implementing for the development and oversight of regenerative medicine products including novel cellular therapies. The framework is laid out through four guidance documents which build on the FDA’s existing regulatory approach and describe more clearly which products are regulated as drugs, devices and […]
Regenerative Medicine
7 medtech stories we missed this week: Nov. 17, 2017
From Skyline Medical’s joint venture to Lensar receiving FDA clearance and CE Mark, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Skyline Medical launches JV deal with Helomics Skyline Medical announced in a Nov. 15 press release that it has signed a joint venture agreement with Helomics. […]
Researchers reverse diabetes in mice by infusing them with blood stem cells
Researchers at Boston Children’s Hospital successfully reversed Type I diabetes in a mouse model using blood stem cells, according to a study published this week in Science Translational Medicine. The researchers used cells that were pre-treated to make more of a protein, PD-L1, which is deficient in mice and people with Type I diabetes. “There’s really a reshaping […]
Xeltis raises $53m Series C round for replacement heart valve programs
Xeltis said today that it closed a Series C round worth more than $53 million (€45 million) for the bioresorbable heart valve technology it’s developing. The Eindhoven, Holland- and Zurich-based company said the round was led by “a global strategic investor,” joined by Ysios Capital, “a number of large private investors,” prior backers LSP, Kurma Partners […]
RTI Surgical reveals FDA warning letter over Map3 allograft classification
RTI Surgical (NSDQ:RTIX) today revealed a warning letter it received from the FDA related to processes used to manufacture its Map3 cellular allogeneic bone graft over issues with the regulatory classification of the product. The Alachua, Fla.-based company said it received the letter on November 9 based on an inspection of its facilities from April and […]
Orthocell wins CE Mark for CelGro device
Orthocell (ASX:OCC) said today that its CelGro collagen medical device won CE Mark approval for a range of dental bone and soft tissue regeneration procedures. The company said it’s in talks with the strategic commercial partners to distribute its product throughout Europe and other key regions. Orthocell is also reportedly holding discussions with key opinion leaders […]
The top 10 medical disruptors of 2018
Each year the Cleveland Clinic determines what the top 10 disruptors in healthcare will be for the following year. The criteria to be considered a disruptor or innovation is that it has to be innovative and could change care in a significant way in the next year. Approximately 150 to 200 Cleveland Clinic physicians from […]
How slugs, snails & worms inspired Gecko Biomedical’s biocompatible sealant
The story behind Gecko Biomedical’s biocompatible sealant starts in the summer of 2009, when Boston Children’s Hospital‘s chief of cardiac surgery reached out to Jeffrey Karp about a problem he was experiencing in the operating room. Dr. Pedro del Nido told Karp, a professor of medicine at Harvard and the director of the Laboratory for Accelerated Medical Innovation […]
Smith & Nephew puts $210m on the table for Rotation Medical
Smith & Nephew (NYSE:SNN) said today that it agreed to pay as much as $210 million for Rotation Medical and its regenerative shoulder repair treatment. The deal calls for the British orthopedics and wound care giant to pay $125 million in up-front cash, with another $85 million on the line over the next five years […]
Meet the two former Johns Hopkins residents disrupting the wound care market
Ned Swanson and Denver Lough were plastic surgery residents at Johns Hopkins when they made a choice that would change the course of their lives – they decided to drop out and start a business. Lough had a technology that they thought could help patients if it ever made it to the market, but their […]
BrainStorm enrolls first ALS patient in late-stage NurOwn trial
Brainstorm Cell Therapeutics (NSDQ:BCLI) said today that the first patients have been enrolled in its Phase III trial evaluating NurOwn as a treatment for amyotrophic lateral sclerosis, or ALS, at Massachusetts General Hospital and UC Irvine Medical Center. The trial, which is slated to enroll 200 patients, is designed to include the pre-specified patient subgroups who […]