Exclusives

A study that evaluated the efficacy and safety of PRP gel prepared using TKKT01 (a processing device candidate by Rohto Pharmaceutical of Japan) in patients with hard-to-heal DFUs met the primary endpoint with 38/47 (80.9%) patients achieving...

The DOJ charged Alexandra Gehrke and Jeffrey King of AZ with various counts of conspiracy, healthcare fraud, receiving kickbacks, and money laundering in connection with an alleged scheme to fraudulently bill Medicare $900MM for highly...

BioStem Technology announced breakthrough results with its AmnioWrap2 proprietary retention-processed amnion chorion (RE-AC) processing method vs a laminated process. RE-AC showed a greater percent area reduction (PAR) of DFUs of 67.3% vs...

A study of 32 patients with DFUs found the use of chitosan-based gel achieved a 92.0% reduction in wound surface area by week 10 with 4.62-fold higher odds of 75% wound closure vs placebo.BMJ Open Diab

Guard Medical, Inc received FDA 510(K) clearance for NPseal under the product code OKO for Negative Pressure Wound Therapy Non-Powered Suction Apparatus. This new clearance increased the wear time of the NPseal device to 7 days from the...

Foryou Medical, headquartered in China, received 510(k) clearance for LUOFUCON Collagen Particles, a native bovine powder dressing for the treatment of chronic wounds.

A 24-patient RCT will compare using type-I collagen-based skin substitute vs dehydrated human amnion/chorion membrane for treatment of DFUs with primary outcome of percentage of wound reduction from weeks 1 through 4. Recruitment is ongoing...

A 13-patient randomized, controlled, open-label pilot study comparing Debritom+ with sharp debridement was published. The results may indicate a modestly faster reduction in wound area with Debritom+ and provide feasibility for a sufficiently...