MiMedx (NSDQ:MDXG) announced today that its recently filed shelf registration with the SEC has become effective. Marietta, Georgia-based MiMedx last month filed the shelf registration statement on Form S-3 with the SEC with the intent to be allowed to sell up to $350 million in various types of securities over the next three years once […]
Regenerative Medicine
MiMedx files SEC shelf registration to sell up to $350M in securities
MiMedx (NSDQ:MDXG) announced today that it filed a shelf registration statement on Form S-3 with the SEC. Marietta, Ga.-based MiMedx, which develops AmnioFix, a micronized dehydrated human amnion/chorion membrane (dHACM) injection as regenerative medicine, will be allowed to sell up to $350 million in various types of securities over the next three years once the […]
Tenaya Therapeutics prices $180M IPO for targeted therapies
Tenaya Therapeutics announced that it priced an underwritten, upsized initial public offering of common stock worth $180 million. South San Francisco-based Tenaya develops therapies for rare generic disorders and more prevalent heart conditions through gene therapy, cellular regeneration and precision medicine. The company is actively exploring different routs of administration and different infusion- and injection-based methods […]
Frequency Therapeutics drug shows promise in restoring hearing in small study
Frequency Therapeutics (Woburn, Mass.) recently announced data related to its experimental FX-322 drug. The small Phase 1/2 study, which was published in Otology & Neurotology, found hearing improvements in adults with age-related sensorineural hearing loss. At present, there are no FDA-approved drugs for preventing or restoring such hearing loss, although administering steroids can facilitate recovery […]
Graphite Bio closes $150M Series B
Graphite Bio announced that it closed an oversubscribed Series B financing round with proceeds totaling $150 million. South San Francisco-based Graphite Bio’s funding is earmarked for the expansion and advancement into the clinic of its pipeline of investigational targeted gene integration therapies with curative potential for serious diseases, according to a news release. The company […]
Locate Bio lands FDA breakthrough nod for bone infection device
Regenerative medicine company Locate Bio announced today that the FDA has granted breakthrough device designation to a bone graft/antibiotic combination designed to combat chronic bone infection, also known as osteomyelitis. Osteomyelitis is a progressive, inflammatory infection of the bone, usually caused by bacteria and is estimated to account for up to 50% of all non-trauma […]
BioCardia wins CE Mark renewal for Helix, Morph catheters
BioCardia (OTC:BCDA) said yesterday that it won CE Mark renewal for its Helix biotherapeutic delivery catheter and Morph universal deflectable guide catheter for delivery of biotherapeutics to the heart. With the renewed CE Mark, BioCardia said it can continue supporting partners outside the U.S. and move forward with commercial sales of the Helix and Morph systems […]
PolarityTE launches two chronic wound treatment trials
PolarityTE (NSDQ:PTE) said it has begun enrolling patients in two new randomized clinical trials of its SkinTE regenerative tissue product for chronic wounds. The trials will evaluate the SkinTE’s effectiveness in treating diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). SkinTE is a human cellular and tissue-based product designed to regenerate full-thickness, functional skin […]
PolarityTE reveals SEC investigation
PolarityTE (NSDQ:PTE) this week revealed that it is the target of an SEC investigation into possible violations of federal securities laws. The Salt Lake City, Utah-based company said that it received a copy of a formal order of investigation from the SEC on March 4, exploring possible violations of fraud and price manipulations, according to an […]
Frequency Therapeutics raises $42m for hearing regeneration drug
Frequency Therapeutics said today that it closed a $42 million Series B round to support the clinical development of its hearing regeneration drug, FX-322. The company is slated to publish top-line data from an ongoing Phase I/II study of FX-322 in the first half of the year. The Series B round was led by Taiwania […]
