Aspect Biosystems announced today that it entered into a partnership with the Juvenile Diabetes Research Foundation (JDRF). The partnership will support Aspect’s focus on developing a bioengineered tissue therapeutic for type 1 diabetes that will provide insulin independence and control of blood sugar without the need for chronic immune suppression. Vancouver, British Columbia-based Aspect said […]
Regenerative Medicine
FDA grants breakthrough nod to Zetagen’s metastatic bone cancer treatment
Zetagen Therapeutics announced today that it received FDA breakthrough device designation for its ZetaMet cancer treatment technology. Syracuse, New York-based Zetagen designed its ZetaMet (previously known as ZetaFuse) as a synthetic, small-molecule, inductive biologic technology for targeting and resolving metastatic bone lesions while inhibiting future tumor growth and regenerating bone. According to a news release, […]
MiMedx confirms shelf registration to sell $350M
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 […]
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 […]
