Mallinckrodt (NYSE:MNK) said today that it enrolled the 1st patient in the pivotal Phase III trial of its StrataGraft skin tissue graft. The study is slated to include patients with 3% to 49% total body surface area of severe thermal burns. Researchers intend to evaluate outcomes including the area of StrataGraft treatment site that requires a subsequent […]
Regenerative Medicine
Cytori launches next-gen Celution cell therapy tech
Cytori Therapeutics (NSDQ:CYTX) said today that the next-gen version of its Celution cell therapy device is available for pre-order and that the 1st shipments will start in the 3rd quarter of 2017. The San Diego-based company’s Celution system automates the extraction and concentration of autologous, clinical-grade adipose-derived regenerative cells. The next-gen Celution tech includes new […]
Anika launches late-stage supplemental Cingal study
Anika Therapeutics (NSDQ:ANIK) said yesterday that it enrolled the 1st patient in a supplemental Phase III efficacy and safety trial of its Cingal hyaluronic acid-corticosteroid combination viscosupplement. The Bedford, Mass.-bsaed company is evaluating Cingal as a treatment for osteoarthritis-related knee pain. The supplemental late-stage trial is slated to enroll patients at 30 European sites and randomize […]
NovaBone launches bioactive bone graft substitutes
NovaBone Products added NovaBone IRM and IRM MacroPOR to its portfolio of biologically active bone graft substitutes today. The Jacksonville, Fla.-based company touted its devices as the industry’s most advanced bioactive synthetic bone graft substitutes available for orthopedic applications. The 2 new formulations are highly irrigation resistant and promote osteogenesis and osteoblastic activity, according to […]
Infertility: There could be a 3D printing solution
New Northwestern University research offers a potential 3D printing solution for women’s infertility – providing hope for cancer survivors who want to start families. The Northwestern researchers successfully 3D printed a bioprosthetic mouse ovary that ovulated when implanted inside a live mouse. Mice with the bioprosthetic ovaries were able to give birth to live pups, […]
6 ways hydrogels are enabling medtech innovation
Hydrogels are water-based biomaterials developed specifically for human use, according to a Biomaterials journal article. They are a water-swollen polymeric material that doesn’t change its distinct 3D structure. They are formed from super-absorbent, chain-like polymers and are not soluble in water. However, their porous surface allows for nutrients and cell waste to pass through. They have shown the […]
Cytori prices $9.5m public offering
Cytori Therapeutics (NSDQ:CYTX) said today that it priced an underwritten public offering of 8.6 million shares of common stock at $1.10 apiece. The company plans to bring in $9.5 million. Cytori granted a 45-day underwriter’s option to purchase up to 15% of additional shares of common stock. The offering is expected to close on April […]
Frequency raises $32m in Series A for hearing loss therapy
Frequency Therapeutics said today that it closed a $32 million Series A round, led by CoBro Ventures. Morningside Ventures, Emigrant Capital Corp., Korean Investment Partnership, Alexandria Real Estate Equities and other groups also invested in the round. The company has developed a proprietary combination of small molecule drugs that they plan to inject in the ear, […]
Cytori wins FDA nod for cell therapy pilot trial
Cytori Therapeutics (NSDQ:CYTX) said today that the FDA approved an Investigational Device Exemption for a pilot trial of the company’s cell therapy in patients with thermal burn injury. The Relief trial is a part of Cytori’s ongoing R&D efforts under its contract with the U.S. Dept. of Health & Human Services’ Biomedical Advanced Research and […]
RepliCel touts tendon regeneration data for its fibroblast therapy
RepliCel Life Sciences (OTC:REPCF) touted data this week from its Phase 1/2 tendon repair study evaluating its type I collagen-expressing, hair follicle-derived fibroblasts as a treatment for Achilles tendinosis. The clinical trial established a complete safety profile for RepliCel’s RCT-01 at 6 months and showed no serious adverse events related to the treatment or injection procedure. […]
