Avita Medical (ASX:AVH) said today that it won FDA premarket approval for its Recell autologous cell harvesting device, now cleared for use in treating severe thermal burns in patients 18 and older, and that it plans to launch the device in the fourth quarter. The Recell autologous cell harvesting device is designed to use the patient’s […]
MiMedx: Ouster of top brass was for cause
MiMedx (NSDQ:MDXG) said yesterday that the ouster this summer of four top executives was “for cause” after a probe into its accounting practices turned up “conduct detrimental to the business or reputation of the company.” Marietta, Ga.-based MiMedx makes regenerative and therapeutic biologics using human placental tissue allografts. Last July CEO Parker Petit and president & COO […]
NFL players get in on $23m Series A for Miach Orthopaedics
The National Football League Players Assn. got in on a nearly $23 million Series A round for Miach Orthopaedics and its knee repair technology, the Boston-based company said today. Miach is developing bio-engineered implants for surgical connective tissue repair, aiming first at anterior cruciate ligament repair with its Bridge-Enhanced ACL Repair product, a sponge that’s designed to […]
Shareholders gut stock after Vital Therapies bails on Elad after failed trial
Vital Therapies (NSDQ:VTL) saw share price drop 91.3% this week after the company announced that the leading clinical trial of its ELAD cell-based therapy for treating liver failure failed to meet its primary and secondary endpoints and that it was “ceasing any further development” of the product. The San Diego-based company’s ELAD cell-based therapy was intended […]
Histogenics plunges on missed endpoint in NeoCart trial
UPDATE: Now includes comment from CEO Adam Gridley Histogenics (NSDQ:HSGX) said today that a pivotal trial of its regenerative NeoCart knee treatment failed to meet its primary endpoint, sending its share price down some -70%. Waltham, Mass.-based Histogenics said NeoCart, which is designed to repair knee cartilage damage using cells harvested from the surface of patients’ […]
Wound Management Tech spins CellerateRX collagen asset into JV with Catalyst Group
Wound Management Technologies (OTC:WNDM), operating under WNDM Medical, said last week it inked a deal to spin out its CellerateRX activated collagen assets into a new joint venture with The Catalyst Group. Fort Worth, Texas-based Wound Management Tech will maintain a 50% ownership interest in the new joint venture, with The Catalyst Group taking up the […]
BioCardia touts preliminary data from heart failure trial
BioCardia (OTC:BCDA) touted data today from the first 10 patients treated in its Phase III CardiAmp heart failure trial. The company’s investigational therapy uses a patient’s bone marrow cells to trigger the body’s natural ability to heal itself, according to BioCardia. These data are the first to be published from any pivotal trial of a stem […]
Avita begins Recell manufacturing in new facility
Avita Medical (ASX:AVH) said today that it successfully finished multiple production runs for its Recell device at its newly-acquired manufacturing facility in Ventura, California. Avita acquired the facility last month from a manufacturer that previously assembled the Recell device on a contract basis. The components being made at the Ventura facility will be used to support the […]
Avista to acquire Organogenesis
Avista Healthcare Public Acquisition group said last Friday it inked deal to acquire Organogenesis for an undisclosed amount. As part of the deal, Avista Capital Partners private equity firm will invest $92 million into the newly acquired company, which is slated to be listed on the Nasdaq under the ticker symbol “ORGO” following the closing […]
Avita Medical wins expanded FDA compassionate use IDE for Recell
Avita Medical (ASX:AVH) said today it won expanded coverage under the FDA’s compassionate use investigational device exemption program for its Recell autologous cell harvesting device. The ReCell autologous cell harvesting device is designed to use the patient’s own skin cells to treat a variety of skin issues, including burns, reconstructive and cosmetic procedures, Avita said. With […]
German Elanix Biotechnologies raises $9m
Regenerative medicine developer Elanix Biotechnologies said today it has raised $9.1 million (EU €7.8 million) with the opportunity to raise an additional $2.6 million (EU €2.1 million) through a private placement. The Germany-based company said that funds in the round are slated to support expanding its product portfolio, distribution and sales network and an e-commerce […]
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