June 18, 2024

FDA / IND

VetPath Consultants has recently assisted our clients in various regulatory issues, INDs  or FDA concerns.

 

Regenity Biosciences

Regenity brings the urgency and vision to deliver breakthrough medtech solutions for medical technology and medical device manufacturers of all sizes.

“CONGRATULATIONS VETPATH AND REGENITY!”

VetPath Consultants and Dr. Carol Meschter warmly congratulates Regenity Biosciences, our friends and colleagues, on their recent FDA clearance of their soft tissue augmentation matrix. VetPath Consultants and Regenty collaborated closely on the histopathologic assessment of the implant surgically placed in a pivotal study mandated by the FDA. VetPath Consultants wishes Regenity and its commercial partner the greatest success with this matrix in clinical use. The study was histopathologically evaluated by Carol Meschter, DVM, PhD, DACVP, the CEO of VetPath Consultants.

• ActivePure

ActivePure is a scientifically proven air and surface purification technology that proactively cleans indoor air and decontaminates surfaces more effectively than passive filtration solutions.

VetPath Consultants and Dr. Carol Meschter provided numerous animal studies, in regard to ActivePure histpathology diagnoses. Dr Carol evaluated the hisitopathology on their pivotal rodent study, examining tissues and/or cells under a microscope.

. Collaborated as a co-author on their publications

. Conducted the photomicroscopy for their publications

. VetPath Histopathologists are responsible for making tissue diagnoses and helping clinicians like ActivePure manage their patient’s care.

• ImmunoGen

ImmunoGen, Inc., a biotechnology company focused on the development of antibody-drug conjugate therapeutics for the treatment of cancer. ImmunoGen was founded in 1981 and was headquartered in Waltham, Massachusetts.

• Astellas Pharma Inc.

Astellas Pharma Inc. is a Japanese multinational pharmaceutical company, formed on 1 April 2005 from the merger of Yamanouchi Pharmaceutical Co., Ltd. and Fujisawa Pharmaceutical Co., Ltd. Astellas is a member of the Mitsubishi UFJ Financial Group keiretsu.

• Planet Biotechnology

Planet Biotechnology produced the first plant-made antibody, or “plantibody”, ever tested in a clinical trial. We are focused on discovering, developing and commercializing new antibody-based therapeutic and preventative products through cultivation of genetically modified green plants to meet significant underserved medical needs.

• Regranion

Regranion, LLC is a clinical-stage biopharmaceutical company delivering breakthrough solutions for autoimmune skin diseases by targeting hyperinflammation.

• Iota Bio

Using innovative science and technology, Iota Bio create and develop state-of-the-art diagnostic and therapeutic bioelectronic devices that are safe and effective.