Organovo expects FDA meeting in 2019 on 3D-bioprinted tissues for liver disease treatment
Organovo Holdings Inc said it expects to meet this year with the Food and Drug Administration on its development of 3D-bioprinted tissues for the treatment liver diseases and added that it has sufficient cash through fiscal 2020.
The biotech said Thursday in a press release that it’s on track for the submission of its investigational new drug (IND) application with the FDA in 2020.
As part of its third-quarter financial report, the company added that it had cash and cash equivalents of $35.2 million as of December 31. It now expects an improved spending rate of $20.5 million-$21.5 million in fiscal 2019 and estimates it has sufficient funds to meet its operating and capital requirements through fiscal 2020.
READ: Lipocine rallies after therapy candidate achieves meaningful liver fat reduction
Development of the healthy therapeutic liver tissue patch could treat a broad range of liver diseases, according to the company. It said it continues to conduct proof-of-concept studies aimed at treating adult and pediatric liver disease.
“Our objective in implanting a healthy tissue patch is to restore function or offset the deficiencies related to a specific condition,” CEO Steve Moster said in a statement.
The company added that it has presented data on the performance of tissues in animal models for Alpha-1-antitrypsin deficiency (A1AT) and hereditary tyrosinemia Type 1 (HTT1) at industry meetings over the past several months.
With 3D bioprinting, 3D printers are used to produce tissue from materials including living cells.
For the three months ended December 31, Organovo reported that its net loss narrowed to $6.4 million, or $0.06 per share, from $7.8 million, or $0.07 per share, a year earlier. The average estimate of analysts was $0.07.
Shares traded at $0.99 in Friday’s Nasdaq trading.
Contact Dennis Fitzgerald at [email protected]
Story by ProactiveInvestors
Source: https://www.proactiveinvestors.com/companies/news/214293/organovo-expects-fda-meeting-in-2019-on-3d-bioprinted-tissues-for-liver-disease-treatment-214293.html
Anyone can join.
Anyone can contribute.
Anyone can become informed about their world.
"United We Stand" Click Here To Create Your Personal Citizen Journalist Account Today, Be Sure To Invite Your Friends.
Please Help Support BeforeitsNews by trying our Natural Health Products below!
Order by Phone at 888-809-8385 or online at https://mitocopper.com M - F 9am to 5pm EST
Order by Phone at 866-388-7003 or online at https://www.herbanomic.com M - F 9am to 5pm EST
Order by Phone at 866-388-7003 or online at https://www.herbanomics.com M - F 9am to 5pm EST
Humic & Fulvic Trace Minerals Complex - Nature's most important supplement! Vivid Dreams again!
HNEX HydroNano EXtracellular Water - Improve immune system health and reduce inflammation.
Ultimate Clinical Potency Curcumin - Natural pain relief, reduce inflammation and so much more.
MitoCopper - Bioavailable Copper destroys pathogens and gives you more energy. (See Blood Video)
Oxy Powder - Natural Colon Cleanser! Cleans out toxic buildup with oxygen!
Nascent Iodine - Promotes detoxification, mental focus and thyroid health.
Smart Meter Cover - Reduces Smart Meter radiation by 96%! (See Video).