Xeltis said today it completed its 2nd feasibility trial of its bioabsorbable regenerative heart valve technology designed to allow endogenous tissue restoration. The Swiss med tech firm is designing valves and vessels out of polymers structured as a “porous matrix” designed to be absorbed and leave the patient with its own healthy tissue, the company […]
Regenerative Medicine
INVO Bioscience wins FDA de novo approval for InvoCell
INVO Bioscience said yesterday it won FDA de novo approval for its INVOcell intravaginal culture infertility treatment system. The company said it is the 1st intravaginal culture system with marketing clearance in the U.S. INVOcell is designed for incubating eggs and sperm during fertilization during early embryo development and operates within a woman’s body, unlike in […]
Vital Therapies announces $30m follow-on offering
Vital Therapies (NSDQ:VTL) said today it is planning a $30 million follow-on stock offering to support its ELAD cell-based therapy system. The offering will include a 30-day underwriters option for an additional $4.5 million in shares, the San Diego, Calif.-based company said. The company is developing a cell-based therapy targeting the treatment of acute liver […]
SEC closes InVivo Therapeutics probe
InVivo Therapeutics (NSDQ:NVIV) said today that the U.S. Securities & Exchange Commission ended a probe of the regenerative medicine company and doesn’t plan to recommend any enforcement action. Cambridge, Mass.-based InVivo said in January that the SEC’s Boston office subpoenaed documents concerning former CEO Frank Reynolds and ex-acting CFO Sean Moran and “certain other corporate events.” Today […]
Humacyte pulls down $150m for artificial blood vessels
Humacyte said today that it raised a $150 million Series B round it plans to use to back a Phase III trial of its Humacyl lab-grown blood vessel technology. Research Triangle Park, N.C.-based Humacyte, which raised a $12 million Series A round back in 2010, uses a proprietary technology to engineer human tissues that can be shaped […]
FDA approves expanded trial for InVivo Therapeutics spinal cord treatment
InVivo Therapeutics (OTC:NVIV) said today that it won a nod from the FDA to double the enrollment in a clinical trial of its neuro-spinal scaffold. Cambridge, Mass.-based InVivo enrolled the 5th patient in the pilot study last month. Its bioabsorbable device is designed to treat acute spinal cord injuries. “I am very pleased to have come to such […]
Avita jumps on FDA nod for expanded trial
Avita Medical (ASX:AVH) said yesterday it won FDA approval to expand the Investigational Device Exemption trial of its ReCell wound treatment, which sent shares of the company up nearly 12%. The expansion will allow the trial to cover twice as many patients and extend it to patients to patients with larger, more serious defects than […]
Stratatech scores BARDA deal worth up to $247m
Stratatech said it won a contract from the Biomedical Advanced Research and Development Authority worth up to $247 million to develop its StrataGraft skin tissue designed for patients with severe thermal burns. The 5-year structured BARDA contract grants an initial $60 million for the “base period” and to procure the eventual-finished StrataGraft product to establish an inventory […]
BioTime pulls in $20m, inks deal with Heraeus Medical
Regenerative medicine company BioTime said this week it raised $20 million in a closed round and it inked a development and licensing deal between its subsidiary Orthocyte and orthobiological-focused Heraeus Medical. BioTime and its subsidiaries develop regenerative technologies around pluripotent stem cells and cell-based therapies. Alameda, Calif.-based BioTime said today it closed a direct offering of […]
Avita Medical reels in $53.9m from BARDA
Avita Medical (ASX:AVH) said yesterday it won $53.9 million in contracts from the Biomedical Advanced Research and Development Authority for development and procurement of Avita’s ReCell autologous cell harvesting device. The 5-year contract will provide an initial $16.9 million to support the company’s pursuit of FDA premarket approval for its ReCell device, and to procure more […]
Vital Therapies inks plan for new phase 3 Elad trial
Vital Therapies (NSDQ:VTL) outlined plans for a possible new phase 3 clinical trial to test its Elad treatment for liver failure in patients with alcohol-induced liver decompensation, according to an SEC filing posted yesterday. The company is developing a cell-based therapy targeting the treatment of acute liver failure, using a cartridge system designed to produce cells that […]