Elutia (Nasdaq:ELUT) announced today that it entered into a securities purchase agreement worth total proceeds of $26.2 million. The drug-eluting biomatrix company expects the private placement financing to result in initial gross proceeds of approximately $10.5 million. The full exercise of warrants would add $15.8 million to reach a total of $26.2 million. Silver Spring, […]
Stem Cells
BioCardia seeks Japanese approval of heart failure cell therapy
BioCardia (Nasdaq:BCDA) announced today that it completed the submission of its CardiAMP cell therapy system to Japan’s regulatory authorities. Sunnyvale, California-based BioCardia submitted CardiAMP to Japan’s Pharmaceutical and Medical Device Agency (PMDA). It seeks approval for the indication of ischemic heart failure with reduced ejection fraction (HFrEF). It expects a formal consultation with PMDA to […]
Magenta Therapeutics rises on Street-beating Q4
Magenta Therapeutics (NSDQ:MGTA) shares ticked up today on fourth-quarter earnings that topped the consensus forecast. The Cambridge, Mass.-based stem cell transplantation technology developer posted losses of -$18.2 million, or -38¢ per share for the three months ended Dec. 31, 2020, marking a 21.8% bottom-line gain. Get the full story at our sister site, Drug Delivery Business […]
Mayo Clinic, W.L. Gore team up on stem cell therapy treatments
Mayo Clinic and W. L. Gore & Associates have announced a partnership to develop implantable cell therapies to treat debilitating conditions with no cure. The for-profit company, Avobis Bio, will combine a patient’s own stem cells with bioabsorbable scaffolds to stimulate the healing of perianal fistulas, painful tunneling wounds that affect patients with Crohn’s disease. […]
Frequency Therapeutics registers $100m IPO
Frequency Therapeutics has registered an initial public offering of common stock worth $100 million. Woburn, Mass.-based Frequency Therapeutics did not disclose the number of shares it seeks to sell or the price range of the offered units. The company applied to the Securities and Exchange Commission have its common stock listed on The Nasdaq Global Market […]
AxoSim touts results of nerve-on-a-chip study
A new study of AxoSim’s Nerve-on-a-Chip technology shows that the platform accurately provides key physiological readouts that could help speed the development of drugs to treat neurological disorders. The study also shows that Nerve-on-a-Chip technology is the first all-human in vitro model that can measure critical factors that were formerly only available using live animal models. These […]
FDA goes after California stem cell doc for unapproved breast implant device
The FDA this week sent a warning letter to a Beverly Hills, Calif.-based surgeon for their marketing of an unapproved implantable device, dubbed the Pocket Protector, which the surgeon claims can prevent and treat capsular contracture, or scar tissue tightening, during breast implant procedures. In its letter, the federal watchdog also accuses the surgeon, Dr. […]
RenovaCare chairman ponies up nearly $16m for wound-healing stem cell SkinGun
RenovaCare (Scottsdale, Ariz.) has announced an equity financing for $15.5 million from Kalen Capital Corporation, the family office of Harmel Rayat, who is the majority shareholder and chairman of RenovaCare. The equity financing increases his family office’s total equity investment in RenovaCare to over $20 million. “Our long-term investment in RenovaCare speaks to our conviction that […]
Anika collabs to develop injectable stem cell therapy for osteoarthritis
Anika Therapeutics (NSDQ:ANIK) has inked an agreement with the Institute of Integrative Biology at the University of Liverpool to develop an injectable mesenchymal stem cell therapy to treat osteoarthritis. As a result of the three-year research collaboration, the group hopes to have a lead candidate that it can take into clinical trials. Get the full story at our […]
Frequency touts first-in-human safety study for hearing loss therapy
Frequency Therapeutics has finished a first-in-human study of its progenitor cell activation therapy, FX-322, in nine adults with severe to profound sensorineural hearing loss. The company’s candidate is a combination of small molecules that are designed to activate progenitor cells and trigger the formation of new hair cells in the inner ear. Get the full story […]
Semma Therapeutics closes $114m round to advance cell therapy for Type I diabetes
Semma Therapeutics has closed an oversubscribed $114 million Series B round to help fund the development of its encapsulated stem cell-derived islet therapy for Type I diabetes. The Cambridge, Mass.-based company reported that it plans to use the newly-acquired funds to bring its cell therapy through clinical proof-of-concept studies, as well as explore other regenerative medicine […]