Delcath Systems, Inc. is a specialty pharmaceutical and medical device company focused on oncology. Our proprietary product-Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS)-is designed to administer high dose chemotherapy to the liver, while controlling the systemic exposure to those agents. The Company's principal focus is on the treatment of primary and metastatic liver cancers. In the United States, the Melphalan/HDS system is considered a combination drug and device product, and is regulated as a drug by the United States Food and Drug Administration (FDA). The Melphalan/HDS system has not been approved for sale in the United States. In Europe, our proprietary system to deliver and filter melphalan hydrochloride is marketed as a device under the trade name Delcath Hepatic CHEMOSAT^® Delivery System for Melphalan (CHEMOSAT). In April 2012, we obtained authorization to affix a CE Mark for the Generation Two CHEMOSAT system. The right to affix the CE mark allows the Company to market and sell the CHEMOSAT system in Europe. The Company has commenced a global phase 2 clinical trial in Europe to investigate Melphalan/HDS system for primary liver cancer and is initiating plans to evaluate intrahepatic cholangiocarcinoma.

Cancers in the Liver

According to the American Cancer Society, cancers in the liver are among the most prevalent and lethal forms of the disease. They can either be primary, originating in the liver, or metastatic, originating elsewhere and traveling to the liver, creating new tumors there. The current treatment armamentarium for cancers in the liver includes surgery, transplantation, systemic chemotherapy, a variety of focal and regional therapies, and radiation therapy, which have varying degrees of invasiveness, efficacy, and side effects.

Developing liver-directed high dose chemotherapy

Delcath is developing a proprietary system for liver-directed high dose chemotherapy. Years of clinical research have gone into refining this system.

MiMedx, MDXG, Company Profile, Stock Summary

MiMedx^® is a biopharmaceutical company developing, manufacturing and marketing regenerative biologics utilizing human placental allografts for multiple sectors of healthcare. “Innovations in Regenerative Medicine” is the framework behind our mission to provide physicians with products and tissues to help the body heal itself.

The company has developed a proprietary human placental tissue processing method called PURION^®. MiMedx produces safe and effective allografts by employing aseptic processing techniques in addition to terminal sterilization.

Since its founding, research and development has been the cornerstone of this organization. The company is a leader in placental based products with over 40 scientific and clinical publications, multiple published Randomized Controlled Trials (RCTs), and 30 ongoing clinical studies.

MiMedx has over 45 placental tissue issued and allowed patents and over 90 pending applications. MiMedx has supplied over 1.3 million placental tissue-based allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare.

PURION^® Process

Human amniotic membrane allografts have been used for a variety of reconstructive surgical procedures since the early 1900s. The use of the amniotic membrane as an allograft has accelerated due to the development of the PURION^® process, which among other things allows the tissue to be dehydrated and sterilized. 

Anthera Pharma, ANTH, Profile, Summary

Anthera Pharmaceuticals (ANTH) is a clinical-stage biopharmaceutical company focused on developing products to treat serious and life-threatening diseases, including exocrine pancreatic insufficiency and B-cell associated renal diseases. 

The company was developing a Cystic Fibrosis drug called ‘Sollpura’ ,the drug was being developed in partnership with Eli Lilly, Sollpura was targeted for people who were suffering from Cystic Fibrosis which also affects pancreas and makes it much harder to digest food, the slow progression of indigestion could lead to adverse outcome including death.

Sharc International, INTWF, SHRC, is on track to make 2018 a record year!

The company is projecting $20 million in revenues and a substantial increase in new deals. Sharc is ramping up its marketing campaign in the USA, Canada and Europe.